[Federal Register Volume 80, Number 58 (Thursday, March 26, 2015)]
[Proposed Rules]
[Pages 16082-16125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06429]
[[Page 16081]]
Vol. 80
Thursday,
No. 58
March 26, 2015
Part II
Nuclear Regulatory Commission
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10 CFR Parts 20 and 61
Low-Level Radioactive Waste Disposal; Proposed Rule
Federal Register / Vol. 80 , No. 58 / Thursday, March 26, 2015 /
Proposed Rules
[[Page 16082]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20 and 61
[NRC-2011-0012; NRC-2015-0003]
RIN 3150-AI92
Low-Level Radioactive Waste Disposal
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations that govern low-level radioactive waste (LLRW)
disposal facilities to require new and revised site-specific technical
analyses, to permit the development of site-specific criteria for LLRW
acceptance based on the results of these analyses, to facilitate
implementation, and to better align the requirements with current
health and safety standards. This proposed rule would affect LLRW
disposal licensees or license applicants that are regulated by the NRC
or the Agreement States.
DATES: Submit comments on the proposed rule by July 24, 2015. Submit
comments specific to the information collection aspects of this
proposed rule by May 26, 2015. Comments received after these dates will
be considered if it is practical to do so, but the NRC is able to
ensure consideration only for comments received on or before these
dates.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0012. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: [email protected]. For technical questions, contact
one of the individuals listed in the FOR FURTHER INFORMATON CONTACT
section of this document.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Gary Comfort, telephone: 301-415-8106,
email: [email protected]; or Andrew Carrera, telephone: 301-415-
1078, email: [email protected]. Both of the Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
Excutive Summary
A. Need for the Regulatory Action
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations that govern low-level radioactive waste (LLRW) disposal
facilities to require new and revised site-specific technical analyses
and to permit the development of criteria for LLRW acceptance based on
the results of these analyses. These amendments would ensure that LLRW
streams that are significantly different from those considered during
the development of the current regulations (i.e., depleted uranium and
other unanalyzed waste streams) can be disposed of safely and meet the
performance objectives for land disposal of LLRW. These amendments
would also increase the use of site-specific information to ensure
performance objectives are met that are designed to provide protection
of public health and safety. This proposed rule would affect LLRW
disposal licensees or license applicants that are regulated by the NRC
or the Agreement States.
B. Major Provisions
Major provisions of the proposed rule include changes to:
Revise the existing technical analysis for protection of
the general population to include a 1,000-year compliance period;
Add a new site-specific technical analysis for the
protection of inadvertent intruders that would include a 1,000-year
compliance period and a dose limit;
Add new analyses that would include a 10,000-year
protective assurance period and annual dose minimization target;
Add a new analysis for certain long-lived LLRW that would
include a post-10,000-year performance period;
Add new analyses that would identify and describe the
features of the design and site characteristics that provide defense-
in-depth protections;
Add a new requirement to update the technical analyses at
closure; and
Add a new requirement to develop site-specific criteria
for the future acceptance of LLRW for disposal based on either the
results of these technical analyses or the existing LLRW classification
requirements.
C. Costs and Benefits
The NRC prepared a draft regulatory analysis to determine the
expected quantitative costs and benefits of the proposed rule, as well
as qualitative factors to be considered in the NRC's rulemaking
decision. The analysis concluded that the proposed rule would result in
net costs to the industry and the NRC. The key findings of the analysis
are as follows:
Cost to the Industry. The proposed rule would result in an
average implementation cost per licensee of $1,000,000, followed by an
estimated annual cost of $4,000. Overall, the industry will incur an
estimated implementation cost of $4 million, followed by an estimated
annual cost of $16,000.
Cost to the Agreement States. The proposed rule would
result in additional costs to the Agreement States with all costs
resulting from implementation. On average, each Agreement State would
incur an estimated implementation cost of $525,000. Overall, the
Agreement States will incur an estimated implementation cost of $2.1
million.
Cost to the NRC. The NRC would incur an implementation
cost for drafting and implementing a final rulemaking based on the
proposed rule. This cost is estimated to be $333,000. Because the NRC
does not have any LLRW disposal licensees, no annual NRC cost is
expected. The NRC would also incur an estimated implementation cost of
$216,000 for drafting a final guidance document based on the final
rule.
The regulatory analysis also considered, in a qualitative fashion,
direct benefits that would accrue and the indirect benefits from risks
that could be avoided if the NRC adopted the rule. The principal
qualitative benefits of the proposed action would include: (1) Ensuring
that LLRW streams that are significantly different from those
considered during the development of the current regulations can be
disposed of safely and meet the performance objectives for land
disposal of LLRW; (2) facilitating the use of site-specific
[[Page 16083]]
information and up-to-date dosimetry methodology in site-specific
technical analyses to ensure public health and safety is protected; and
(3) promoting a risk-informed regulatory framework that specifies what
requirements need to be met and provides flexibility to a licensee or
applicant with regard to what information or approach they use to
satisfy those requirements.
The draft regulatory analysis concludes that the proposed rule
should be adopted because the proposed regulatory initiatives enhance
public health and safety by ensuring the safe disposal of LLRW that was
not analyzed in the regulatory basis for the original part 61 of Title
10 of the Code of Federal Regulations (e.g., large quantities of
depleted uranium). For more information, please see the draft
regulatory analysis (Accession No. ML14289A158 in the NRC's Agencywide
Documents Access and Management System).
Table of Contents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
B. Submitting Comments
II. Background
A. Existing Regulatory Framework
B. Low-Level Radioactive Waste Classification System
C. Previous Public Interactions
III. Discussion
A. What action is the NRC taking?
B. Who would this action affect?
C. Why do the regulatory requirements need to be revised?
D. When would this rule become effective?
E. What LLRW streams are affected by this proposed rule?
F. What are site-specific technical analyses?
1. Performance Assessment
2. Intruder Assessment
3. Performance Period Analyses
4. Defense-in-Depth Analyses
5. Site Stability Analyses
G. Updated Safety Case and Technical Analyses for Closure
H. What options were considered for selecting approach and
timeframes and what is the NRC's preferred option?
1. Considerations Made in Developing Options
2. Options Considered
3. NRC Proposed Option
I. Why are the 1,000-year compliance period and 10,000-year
protective assurance period appropriate?
J. Why is a 5 milliSievert per year (500 mrem per year) target
appropriate for dose minimization during the protective assurance
period?
K. What are waste acceptance criteria (WAC)?
1. Options Considered
2. NRC Proposed Option
L. What other changes are proposed?
1. Adding New Definitions to 10 CFR 61.2 and Updating Concepts
in 10 CFR 61.7
2. Implementing Changes to Appendix G to 10 CFR Part 20 To
Conform to Proposed LLRW Acceptance Requirements
3. Modifying the Site Suitability Requirements in 10 CFR 61.50
To Be Consistent With the Proposed Analyses Framework
4. Updating the Dose Calculation System Used in 10 CFR Part 61
5. Implementing the Safety Case in 10 CFR Part 61
M. What guidance documents will be available?
N. Are there any cumulative effects of regulation associated
with this proposed rule?
O. Request for Additional Public Comments
P. What should I consider as I prepare my comments to submit to
the NRC?
IV. Discussion of Proposed Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Writing
VIII. Voluntary Consensus Standards
IX. Draft Environmental Assessment and Draft Finding of No
Significant Environmental Impact
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfitting
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2011-0012 when contacting the U.S.
Nuclear Regualtory Commission (NRC) about the availability of
information for this action. You may obtain publicly-available
information related to this action by any of the following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0012.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to [email protected]. The
ADAMS accession number for each document referenced (if it is available
in ADAMS) is provided the first time that it is mentioned in the
SUPPLEMENTARY INFORMATION section.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2011-0012 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Background
A. Existing Regulatory Framework
The NRC's licensing requirements for the disposal of commercial
low-level radioactive waste (LLRW) in near-surface disposal facilities
can be found in part 61 of Title 10 of the Code of Federal Regulations
(10 CFR), ``Licensing Requirements for Land Disposal of Radioactive
Waste.'' The NRC adopted 10 CFR part 61 on December 27, 1982 (47 FR
57446). The existing LLRW disposal facilities are located in and
licensed by Agreement States, and those Agreement States have
incorporated many of the requirements in current 10 CFR part 61 into
their corresponding regulations and as license conditions.
The current 10 CFR part 61 emphasizes an integrated systems
approach to the disposal of commercial LLRW, including site selection,
disposal facility design and operation, LLRW characteristics, and
disposal facility closure. To reduce reliance on institutional
controls, the current 10 CFR part 61 emphasizes passive (e.g., site
stability) rather than active systems to limit and retard the releases
of LLRW to the environment. This integrated systems approach is similar
to the defense-in-depth concept that has been well known for some time
for the NRC's nuclear reactor safety design and licensing activities.
However, defense-in-depth is not explicitly discussed in the existing
10 CFR part 61 regulations. Currently, the defense-in-depth concept is
implicitly contained in the 10 CFR
[[Page 16084]]
part 61 regulations (e.g., requiring that the disposal site design
complement and improve upon the ability of the site's natural
characteristics to ensure the performance objectives will be met;
imposing concentration limits on waste that presents a higher hazard
through the waste classification requirements; requiring the
segregation of unstable waste from waste that presents a larger hazard
and should be stable for proper disposal; imposing requirements on
wasteform and packaging characteristics; and requiring the use of
barriers to intrusion for wastes that will not decay to levels which
present an acceptable hazard to an intruder within 100 years).
Subparts of the existing 10 CFR part 61 cover general provisions
and procedural licensing matters; performance objectives; technical
requirements for near-surface disposal; financial assurance; state and
tribal participation; and records, reports, tests, and inspections. The
regulations cover all phases of near-surface commercial LLRW disposal
from site selection through facility design, licensing, operations,
closure, postclosure stabilization, and the end of active institutional
controls. The overall philosophy that underlies the regulatory
requirements of 10 CFR part 61 is provided in 10 CFR 61.7,
``Concepts.''
The following are key provisions in current 10 CFR part 61:
Standards for: (1) Protection of the general population in
10 CFR 61.41, ``Protection of the general population from the releases
of radioactivity;'' (2) protection of an inadvertent intruder in 10 CFR
61.42, ``Protection of individuals from inadvertent intrusion;'' (3)
protection of individuals during facility operations in 10 CFR 61.43,
``Protection of individuals during operations;'' and (4) site stability
in 10 CFR 61.44, ``Stability of disposal site after closure.'' These
standards are collectively known as the ``Performance Objectives'' in
subpart C of 10 CFR part 61.
Specification of the minimum geologic and geomorphic
characteristics for an acceptable near-surface LLRW disposal site in 10
CFR 61.50, ``Disposal site suitability requirements for land
disposal.''
A LLRW classification system (LLRW being categorized as
Class A, Class B, Class C, or greater-than-Class C) for commercial LLRW
in 10 CFR 61.55, ``Waste classification,'' based on the concentration
of certain radionuclides.
Specification of the LLRW characteristics in 10 CFR 61.56,
``Waste characteristics,'' that commercial LLRW forms must meet to be
acceptable for disposal.
Requirements for caretaker oversight in the form of
institutional controls of LLRW disposal facilities in 10 CFR 61.59,
``Institutional requirements,'' for a period of 100 years following
facility closure.
Currently, to grant a license, the NRC must conclude that there is
reasonable assurance that the performance objectives will be met. To
demonstrate that a license applicant will meet these performance
objectives, 10 CFR part 61 license applicants need to prepare the
analyses required by 10 CFR 61.13, ``Technical analyses.''
To demonstrate that the general population is protected from
releases of radioactivity, license applicants are required to prepare
an analysis of exposure pathways leading to potential radiological
doses to the general population. The current 10 CFR part 61 does not
impose a specific performance timeframe for use in the analysis to
protect the general population, and there are currently differences
among Agreement States regarding the analysis timeframe. For example,
some Agreement States have required licensees to analyze the disposal
facility for only 500 years, while others have required analyses to the
peak dose. For certain long-lived LLRW, a shorter timeframe for the
analysis could result in a situation where the long-term impacts from
the disposal of long-lived LLRW are not adequately identified in a
licensee's analysis. Conversely, the increasing uncertainties
associated with very long timeframes could diminish the value of the
information generated with technical analyses for applicants,
regulators, and other stakeholders. The NRC has drafted this proposed
rule to balance the consideration of the risks from disposal of long-
lived LLRW with significant uncertainties that may be associated with
long-term analyses.
License applicants must also demonstrate that potential inadvertent
intruders into the LLRW disposal facility will be protected.
Inadvertent intruders might occupy the site at any time after
institutional controls over the LLRW disposal facility are no longer
effective and may not be aware of the radiation hazard from the LLRW.
Under the current regulations, protection of inadvertent intruders is
demonstrated by compliance with the LLRW classification (10 CFR 61.55)
and segregation requirements (10 CFR 61.52, ``Land disposal facility
operation and disposal site closure''), and by providing adequate
barriers to inadvertent intrusion. The NRC developed the LLRW
classification requirements as part of the original 10 CFR part 61
rulemaking. Explicit dose limits for an inadvertent intruder are not
currently provided in 10 CFR part 61 because an intruder dose
assessment is not required, but the LLRW classification concentration
limits for radionuclides, in tables 1 and 2 of 10 CFR 61.55, were based
on a dose of 5 milliSieverts per year (mSv/yr) (500 millirem per year
(mrem/yr)) to an inadvertent intruder. The LLRW classification tables
were developed assuming that only a fraction of the LLRW being disposed
would approach the LLRW classification limits (note that the dose to an
intruder exposed to a large volume of disposed LLRW at the
classification limits could exceed 5 mSv/yr (500 mrem/yr)). By
complying with the LLRW classification and segregation requirements, an
inadvertent intruder will be protected if the underlying assumptions
are not violated.
In the existing 10 CFR part 61 regulations, 10 CFR 61.13(a) through
(d) require the technical analyses needed to demonstrate that the
performance objectives are met. The regulations in 10 CFR part 61 are
risk-informed and performance-based, and ensure public health and
safety are protected in the operation of any commercial LLRW disposal
facility. Applicants can demonstrate how their proposals meet the
respective performance objectives for the specific near-surface
disposal method selected (47 FR 57446). The NRC is proposing to modify
the current regulations to ensure that LLRW streams that are
significantly different than those considered in the development of the
existing 10 CFR part 61 are adequately considered during the licensing
of LLRW disposal facilities, to require licensees to explicitly
identify how disposal site characteristics and design provide defense-
in-depth, and to ensure that the 10 CFR part 61 performance objectives
will be met for disposal of those LLRW streams.
B. Low-Level Radioactive Waste Classification System
The NRC developed current 10 CFR part 61 based on assumptions
regarding the types of LLRW likely to go into a commercial disposal
facility. These were based on a survey of LLRW generators and the
results were published in 1982 in NUREG-0945, ``Final Environmental
Impact Statement on 10 CFR part 61, `Licensing Requirements for Land
Disposal of Radioactive Waste' '' (ADAMS Accession Nos. ML052590184,
ML052920727, and ML052590187). The results of this survey ultimately
formed the regulatory basis for the source terms used in the analysis
to define the allowable isotopic concentration limits
[[Page 16085]]
in tables 1 and 2 of 10 CFR 61.55 that establish four classes of LLRW
(Class A, Class B, Class C, and greater-than-Class-C). Table 1 provides
limiting concentrations for long-lived radionuclides and table 2
provides limiting concentrations for short-lived radionuclides. As the
LLRW class increases in hazard, greater controls (e.g., protection for
a longer period of time or greater burial depth) are required in order
to reduce the risk from disposal of the LLRW. Class A LLRW is the least
hazardous to the inadvertent intruder and requires the fewest controls,
while Class C LLRW is more hazardous and requires additional controls.
For example, Class C LLRW may require either greater burial depth or an
engineered barrier that will prevent inadvertent intrusion for 500
years. The additional controls for Class C LLRW reduce the radiological
risk from the greater hazard. Low-level radioactive waste with greater-
than-Class-C concentrations of radionuclides is generally not suitable
for near-surface disposal because of the radiological risk that can
result from disposal of this LLRW without adequate barriers or other
protective measures.
As part of the initial 10 CFR part 61 rulemaking, the NRC
considered inadvertent intrusion scenarios and the physical stability
and isotopic concentration of the LLRW when it developed the 10 CFR
part 61 LLRW classification system. These isotopic concentration limits
were based on the NRC's understanding of the characteristics and
volumes of commercial LLRW reasonably expected for commercial disposal
through the year 2000, as well as the potential disposal methods likely
to be used.
In the Statement of Considerations for the final rule (47 FR
57457), the Commission noted the following:
[W]aste that is stable for a long period helps to ensure the long-
term stability of the site, eliminating the need for active
maintenance after the site is closed. This stability requirement
helps to assure against water infiltration caused by failure of the
disposal covers and, with the improved leaching properties implicit
in a stable wasteform, minimizes the potential for radionuclide
migration in groundwater. Stability also plays an important role in
protecting an inadvertent intruder, since the stable wasteform is
recognizable for a long period of time and minimizes any effects
from dispersion of the waste upon intrusion.
The Commission also noted that ``to the extent practicable,
wasteforms or containers should be designed to maintain gross physical
properties and identity over 300 years, approximately the time required
for Class B waste to decay to innocuous levels . . . '' (47 FR 57457).
In addition to determining the acceptability of LLRW for disposal
in a near-surface land disposal facility, the LLRW classification
system is also integral to determining Federal and State
responsibilities for LLRW and requirements for transfers of LLRW
intended for disposal. The Low-Level Radioactive Waste Policy Act of
1980 (as amended in 1985) defines Federal and State responsibilities
for the disposal of LLRW based on 10 CFR 61.55, as in effect on January
26, 1983. Specifically, the Act assigns responsibility for disposal of
Class A, Class B, and Class C commercial LLRW to the States and
responsibility for disposal of commercial LLRW with concentrations that
exceed the limits for Class C LLRW to the Federal Government.
Appendix G to 10 CFR part 20, ``Requirements for Transfers of Low-
Level Radioactive Waste Intended for Disposal at Licensed Land Disposal
Facilities and Manifests'' (60 FR 15664; March 27, 1995), imposes
manifest requirements on shipments of LLRW consigned for disposal.
Manifests for LLRW shipments must identify the LLRW classification and
a certification that the LLRW is ``. . . properly classified,
described, packaged, marked, and labeled. . . .''
C. Previous Public Interactions
On May 3, 2011, the NRC published preliminary proposed rule
language (76 FR 24831) and an associated regulatory basis document,
``Technical Analysis Supporting Definition of Period of Performance for
Low-level Waste Disposal'' (ADAMS Accession No. ML111030586) for public
comment. The NRC staff conducted a public meeting on May 18, 2011, in
Rockville, Maryland, to discuss the preliminary proposed rule language
and its associated regulatory basis document. A summary and transcript
of this meeting can be found in ADAMS under Accession No. ML111570329.
The comment period ended on June 18, 2011, and the NRC received 15
comment letters from public interest groups, industry, and government
organizations.
As a result of additional direction from the Commission in a SRM-
COMWDM-11-0002/COMGEA-11-0002, ``Revisions to Part 61,'' dated January
19, 2012 (ADAMS Accession No. ML120190360), the NRC staff published,
for public comment (77 FR 72997; December 7, 2012), a second version of
the preliminary proposed rule language (ADAMS Accession No.
ML12311A444) and an associated regulatory basis document, ``Regulatory
Basis for Proposed Revisions to Low-Level Waste Disposal Requirements
(10 CFR part 61)'' (ADAMS Accession No. ML12356A242). The comment
period ended on January 7, 2013, and the NRC received an additional 24
comment letters from public interest groups, industry, and government
organizations. Since these early comment periods were outside of the
formal proposed rule notice-and-comment rulemaking process, the NRC
staff did not and does not plan to prepare formal responses to the
comments received on the preliminary documents. However, the NRC staff
did consider these comments in the development of the proposed rule and
some of the comments did result in modifications to the preliminary
proposed rule language.
The NRC staff also briefed the Advisory Committee on Reactor
Safeguards (ACRS), Radiation Protection and Nuclear Materials
Subcommittee, on June 23 and August 17, 2011, and the full committee on
July 13 and September 8, 2011. The NRC staff again briefed the ACRS,
Radiation Protection and Nuclear Materials Subcommittee, on April 9,
2013, and the full committee on July 10, 2013. Summaries and
transcripts of these meetings can be found at the ACRS' Web site,
http://www.nrc.gov/about-nrc/organization/acrsfuncdesc.html.
Based on early comments and interactions with the ACRS, the NRC
staff revised the preliminary proposed rule language.
III. Discussion
A. What action is the NRC taking?
The NRC is proposing to amend 10 CFR part 61 to require LLRW
disposal licensees or license applicants to prepare a safety case that
includes a defense-in-depth analysis and new and revised site-specific
technical analyses to ensure that LLRW streams that are significantly
different from the LLRW streams considered in the current 10 CFR part
61 regulatory basis can be disposed of safely and meet the performance
objectives in subpart C of 10 CFR part 61. These new and revised
analyses would also more easily identify any additional measures that
would be prudent to implement for continued disposal of radioactive
LLRW at a particular facility.
The NRC is also proposing to amend 10 CFR part 61 to require LLRW
disposal facility licensees or license applicants to develop site-
specific criteria for the acceptability of LLRW for disposal. These
amendments maintain
[[Page 16086]]
the existing LLRW classification system, but permit disposal facility
licensees or license applicants to account for facility design,
disposal practices, and site characteristics to determine criteria for
accepting future shipments of LLRW for disposal at their site. Because
licensees or license applicants are required to develop site-specific
criteria for the acceptability of LLRW for disposal, the NRC is also
proposing to amend appendix G of 10 CFR part 20, ``Standards for
Protection Against Radiation,'' to conform to the proposed requirements
for LLRW acceptance. The NRC is also proposing additional amendments to
the regulations to facilitate implementation and better align the
requirements with current health and safety standards.
Table 1 compares the proposed new and revised technical analyses to
the current 10 CFR part 61 requirements. The inadvertent intruder
assessment would be a new requirement under 10 CFR 61.13 to demonstrate
compliance with the performance objective to protect inadvertent
intruders at 10 CFR 61.42. The inadvertent intruder assessment would
have to demonstrate that the annual dose would not exceed a proposed 5
mSv (500 mrem) limit over a newly defined 1,000-year compliance period.
A performance assessment would also be required for the protection of
the general population from releases of radioactivity. This analysis
would update the current exposure-pathway analysis to use a more modern
performance-assessment methodology that would better align 10 CFR part
61 with the Commission's policy regarding the use of probabilistic risk
assessment methods in nuclear regulatory analysis (60 FR 42622; August
16 1995). The performance assessment would also use a newly defined
1,000-year compliance period. The performance assessment would retain
the current 0.25 mSv (25 mrem) annual dose limit and the as low as
reasonably achievable (ALARA) concept, but the dose methodology would
be consistent with the dose methodology specified in the standards for
radiation protection set forth in the current 10 CFR part 20.
Given the significant uncertainties inherent in demonstrating
compliance with the performance objectives over a long timeframe, a
protective assurance period analysis would be required to demonstrate
that the annual dose would be minimized below 5 mSv (500 mrem) or a
level that is supported as reasonably achievable based on technological
and economic considerations from the end of the compliance period
through 10,000 years. Further, this analysis would need to consider new
site features and processes occurring at the site that are different
than what is considered during the compliance period.
Finally, a qualitative analysis covering a performance period of
10,000 years or more after site closure will also be required in 10 CFR
61.13 for those sites disposing of long-lived waste or if necessitated
by site-specific conditions. This analysis would be required to assess
how the disposal facility and site characteristics limit the potential
long-term radiological impacts, consistent with available data and
current scientific understanding, for the protection of the general
population and the inadvertent intruder.
Defense-in-depth is an integral part of the safety case presented
by the disposal applicant or licensee. Therefore, the defense-in-depth
analyses are required in each one of the periods that are analyzed, as
noted in Table 1.
Table 1--Comparison Table of Current and Proposed 10 CFR Part 61 Regulations
----------------------------------------------------------------------------------------------------------------
Protection of the Protection of Stability of the
general population individual from disposal site
from releases of inadvertent after closure Long- Defense-in-depth
radioactivity (10 intrusion (10 CFR term analyses (10
CFR 61.41) 61.42) CFR 61.44)
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Current 10 CFR Part 61 --Pathway analysis --Comply with 10 Analyses of active Implicit in
regulations. --Undefined period CFR 61.55 LLRW natural processes Subpart D
of performance. classification that demonstrate technical
--0.25 mSv (25 and segregation that there will requirements.
mrem) annual requirements. not be a need for
whole body dose --Provide adequate ongoing active
limit for the barriers to maintenance of
protection of the inadvertent the disposal site
general intrusion. following closure.
population from --Undefined period
releases of of performance.
radioactivity. --No annual dose
--ALARA concept... limit..
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Proposed 10 CFR Part 61 Within 1,000 Years Following Closure of Disposal Facility (Compliance Period).
regulations.
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--Performance --Comply with LLRW Analyses of active Analyses that
assessment that acceptance natural processes demonstrate the
estimates peak criteria. that demonstrate proposed disposal
annual dose that --Provide adequate that long-term system includes
occurs within barriers to stability of the defense-in-depth
1,000 years inadvertent site can be protections.
following closure intrusion. ensured and that
of disposal --Intruder there will not be
facility. assessment that a need for
--0.25 mSv (25 estimates peak ongoing active
mrem) annual dose annual dose that maintenance of
limit for the occurs within the disposal site
protection of the 1,000 years following closure.
general following closure
population from of disposal
the releases of facility.
radioactivity --5 mSv (500 mrem)
that occurs annual dose limit.
within 1,000
years following
closure of
disposal facility.
--ALARA concept...
-------------------------------------------------------------------------------
Between 1,000 and 10,000 Years Following Closure of Disposal Facility
(Protective Assurance Period).
-------------------------------------------------------------------------------
[[Page 16087]]
--Performance --Intruder --Analyses of --Analyses that
assessment that assessment that active natural demonstrate the
estimates peak estimates peak processes that proposed disposal
annual dose that annual dose that demonstrate that system includes
occurs between occurs between long-term defense-in-depth
1,000 and 10,000 1,000 and 10,000 stability of the protections.
years following years following site can be
closure of closure of ensured and that
disposal facility. disposal facility. there will not be
--Annual dose --Annual dose a need for
shall be below 5 shall be below 5 ongoing active
mSv (500 mrem) or mSv (500 mrem) or maintenance of
a level that is a level that is the disposal site
reasonably reasonably following closure.
achievable based achievable based
on technological on technological
and economic and economic
considerations considerations
for the for the
protection of the protection of the
general inadvertent
population from intruders from
releases of exposures that
radioactivity may occur between
that may occur 1,000 and 10,000
between 1,000 and years following
10,000 years closure of
following closure disposal facility.
of disposal
facility.
-------------------------------------------------------------------------------
After 10,000 Years Following Closure of Disposal Facility (Performance
Period).
-------------------------------------------------------------------------------
--Analyses for --Analyses for .................. --Analyses that
10,000 or more 10,000 or more demonstrate the
years following years following proposed disposal
closure of closure of system includes
disposal facility disposal facility defense-in-depth
that demonstrates that demonstrates protections.
releases will be exposures will be
minimized to the minimized to the
extent reasonably extent reasonably
achievable for achievable for
the protection of the protection of
the general inadvertent
population. intruders.
--Analyses only --Analyses only
apply for apply for
disposal sites disposal sites
containing long- containing long-
lived lived
radionuclides radionuclides
exceeding exceeding
concentrations concentrations
listed in table A listed in table A
of 10 CFR of 10 CFR
61.13(e), or if 61.13(e), or if
necessitated by necessitated by
site-specific site-specific
conditions. conditions.
--Analyses that --Analyses that
demonstrate how demonstrate how
the facility has the facility has
been designed to been designed to
limit long-term limit long-term
releases. exposures to an
inadvertent
intruder.
----------------------------------------------------------------------------------------------------------------
B. Who would this action affect?
This proposed rule would affect existing and future LLRW disposal
facilities that are regulated by the NRC or an Agreement State.
C. Why do the regulatory requirements need to be revised?
Recently, the industry and the NRC have identified new LLRW streams
that were not envisioned during the development of 10 CFR part 61.
These LLRW streams include depleted uranium (DU) from enrichment
facilities, LLRW from the U.S. Department of Energy (DOE) operations,
and blended LLRW streams in quantities greater than previously
expected. In addition, new technologies might result in the generation
of different LLRW streams not previously evaluated during the
development of the current 10 CFR part 61 regulations.
The renewed interest in licensing new uranium enrichment facilities
in the United States has brought disposal of DU LLRW to the forefront
of commercial LLRW disposal issues. In the regulatory basis supporting
the development of current 10 CFR part 61, the NRC did not consider the
relatively high concentrations and large quantities of DU LLRW that are
generated by enrichment facilities. Additionally, the NRC did not
anticipate that the DOE would dispose of large quantities of DU LLRW or
any other defense-related LLRW in commercial disposal facilities. With
the existing DOE DU stockpile at the Paducah and Portsmouth Gaseous
Diffusion Plants, and the recent licensing of the Louisiana Energy
Services National Enrichment Facility and the United States Enrichment
Corporation American Centrifuge Plant, the DOE and the industry might
need to dispose of more than 10\9\ kilograms (1 million metric tons) of
DU LLRW.
In a 2008 analysis provided in SECY-08-0147, ``Response to
Commission Order CLI-05-20 Regarding Depleted Uranium,'' dated October
7, 2008 (ADAMS Accession No. ML081820762), involving a land disposal
scenario for large quantities of DU, the NRC staff identified
conditions that would likely not meet the current performance
objectives in 10 CFR 61.41 and 10 CFR 61.42, if large quantities of DU
were disposed under those conditions (e.g., shallow disposal, such as
that commonly associated with Class A LLRW, or disposal at humid sites
with a potable ground water supply). The NRC staff determined that the
disposal of large quantities of DU as Class A LLRW, with no additional
restrictions, could result in inadvertent intruders receiving a dose
greater than 5 mSv/yr (500 mrem/yr) for both acute and
[[Page 16088]]
chronic exposure scenarios. The estimated dose would result from
pathways such as inadvertent ingestion of uranium-contaminated soil and
inhalation of radon gas (a member of the uranium decay chain). These
results are consistent with those found in an earlier analysis of
possible DU disposal in an LLRW disposal facility discussed in a Sandia
National Laboratories report titled, ``Performance Assessment of the
Proposed Disposal of Depleted Uranium as Class A Low-Level Waste''
(ADAMS Accession No. ML101890179).
The blending of different classes of LLRW could also result in LLRW
streams with concentrations that are inconsistent with the assumptions
used to develop tables 1 and 2 of 10 CFR 61.55. Blending of LLRW would
enable some materials that would otherwise have been disposed of as a
higher class (e.g., Class B or Class C LLRW) to be blended with a lower
class (e.g., Class A LLRW) or lower concentration LLRW of the same
class. The result of the blending process would be to create large
volumes of blended LLRW that have concentrations near the LLRW
classification limits. The NRC did not evaluate the disposal of large
volumes of LLRW with concentrations near the LLRW classification limits
in the final regulatory basis for the current 10 CFR part 61. The LLRW
concentration values published in the draft regulatory basis for the
current 10 CFR part 61 were based on the assumption that all LLRW would
be disposed at the LLRW classification limit. However, the final LLRW
classification tables were developed with the assumption that only a
fraction of the LLRW being disposed would approach the LLRW
classification limit. In SECY-10-0043, ``Blending of Low-Level
Radioactive Waste,'' dated April 7, 2010 (ADAMS Accession No.
ML090410246), the NRC staff noted that large-scale blending of Class B
and Class C concentrations of LLRW with Class A to produce a Class A
mixture could result in a dose to an inadvertent intruder that is above
5 mSv/yr (500 mrem/yr) (i.e., the dose limit used in developing the
current LLRW classification in 10 CFR 61.55(a)).
Other unanticipated LLRW streams may also need to be considered for
future disposal at LLRW disposal facilities. For example, the Energy
Policy Act of 2005 expanded the NRC's regulatory authority under the
Atomic Energy Act of 1954, as amended (AEA), to include discrete
sources of naturally occurring radioactive material (including radium-
226) that might be produced, extracted, or converted as a byproduct
material. The regulatory basis for the current 10 CFR part 61
considered only a small quantity of radium-226 bearing LLRW in the
development of the 10 CFR part 61 LLRW classification system.\1\ More
recently, consistent with the National Defense Authorization Act for
Fiscal Year 2013,\2\ LLRW also includes radioactive material that,
notwithstanding Section 2 of the Nuclear Waste Policy Act of 1982,
results from the production of medical isotopes that have been
permanently removed from a reactor or subcritical assembly, for which
there is no further use, and the disposal of which can meet the
performance objectives in 10 CFR part 61. Because the types of LLRW
streams requiring disposal at a LLRW disposal facility have expanded
over time, the NRC has concluded that rulemaking is necessary to better
ensure that a broad spectrum of LLRW types and volumes are disposed of
in a manner that is protective of public health and safety and the
surrounding environment.
---------------------------------------------------------------------------
\1\ For example, the equivalent of 0.5 nanocuries/gram of
radium-226 contained in about 68 kg (about 150 pounds) of natural
uranium ore (at equilibrium with its daughter products) was
considered for the purposes of designating Class A LLRW (47 FR
57453-57454).
\2\ National Defense Authorization Act for Fiscal Year 2013.
Subtitle F, Sec. 3173. Improving the reliability of Domestic Isotope
Supply. H.R. 4310 (112th).
---------------------------------------------------------------------------
Further, as part of its regulatory effectiveness strategy described
in NUREG-1614, Volume 6, ``Strategic Plan Fiscal Years 2014-2018''
(ADAMS Accession No. ML14246A439), the Commission strives, through its
regulatory processes, to use risk-informed and performance-based
approaches, where appropriate, to enhance the effectiveness and
efficiency of the regulatory framework. The NRC concluded that amending
the regulations to permit licensees or license applicants to develop
criteria for LLRW acceptance from the results of the site-specific
technical analyses as an alternative to the LLRW classification
requirements allows for increased use of site-specific information to
develop risk insights to support the safe disposal of LLRW. The new
amendments also provide flexibility to determine how licensees can best
meet the performance objectives for the specific design and operational
practices of their disposal facility, as well as the specific
environmental characteristics of their site.
Finally, the concept of ``defense-in-depth'' is currently not
explicit in 10 CFR part 61. On February 11, 2011 (ADAMS Accession No.
ML110680621), the NRC Chairman, Gregory B. Jaczko, created a Risk
Management Task Force (RMTF), to develop a strategic vision and options
for adopting a more comprehensive and holistic risk-informed,
performance-based regulatory approach for reactors, materials, waste,
fuel cycle, and transportation that would continue to ensure the safe
and secure use of nuclear material. The RMTF issued NUREG-2150, ``A
Proposed Risk Management Regulatory Framework,'' dated April 30, 2012
(ADAMS Accession No. ML12109A277). Three recommendations for LLRW were
proposed in NUREG-2150. One of these recommendations was that the NRC
should develop an explicit characterization of how defense-in-depth,
within the proposed risk management framework, applies to the LLRW
program and build this into current and future staff guidance documents
and into training and development activities for the staff. This
proposed rule would add a defense-in-depth requirement in 10 CFR part
61 to address the LLRW recommendations in NUREG-2150.
When would this rule become effective?
For the NRC licensees and license applicants, the rule would become
effective 1 year after the final rule is published in the Federal
Register. The Agreement States will have 3 years from the published
date of the Federal Register notice for the final rule to adopt
compatible regulations.
D. What LLRW streams are affected by this proposed rule?
The NRC considered a number of options in developing this proposed
rule. The agency decided that requiring a safety case comprised of a
collection of information that demonstrates the safety of a land
disposal facility and includes site-specific technical analyses and
defense-in-depth protections for all LLRW inventories would be the most
comprehensive approach. This approach would ensure that as LLRW streams
are generated, analyses would be performed to determine if the
performance objectives would be met for disposal of all isotopic
concentrations and volumes of LLRW. Under the proposed rule, all sites
would be required to complete performance assessments and intruder
assessments for the compliance period and the protective assurance
period. In addition, land disposal sites with long-lived LLRW, or land
disposal sites with site-specific conditions that would necessitate it,
would be required to complete performance period analyses for the
performance period.
[[Page 16089]]
E. What are site-specific technical analyses?
This rulemaking would require licensees and license applicants to
prepare a performance assessment, a new intruder assessment, and new
defense-in-depth analyses to demonstrate that its disposal site and
design meet the performance objectives. Licensees and license
applicants under 10 CFR part 61 would be required to prepare the
following as part of their site-specific technical analyses: (a) A
revised analysis, called a performance assessment, to demonstrate the
protection of the general population from releases of radioactivity (10
CFR 61.41); (b) a new analysis, called an intruder assessment, to
demonstrate the protection of inadvertent intruders (10 CFR 61.42); (c)
performance period analyses to evaluate how the disposal system may
mitigate the long-term risk from disposal of long-lived LLRW (10 CFR
61.13(e)); and (d) new analyses that demonstrate the disposal site
includes defense-in-depth protections. The site-specific technical
analyses would be required to be updated at facility closure, to
provide assurance of compliance with the performance objectives for the
disposal of LLRW streams that were not analyzed in the original 10 CFR
part 61 regulatory basis.
1. Performance Assessment
The first performance objective of subpart C of 10 CFR part 61,
which provides protection of the general population from releases of
radioactivity, would continue to be demonstrated with a technical
analysis that would be revised and renamed in 10 CFR 61.13 as a
``performance assessment.'' \3\ A performance assessment, as described
in NUREG-1636, ``Regulatory Perspectives on Model Validation in High-
Level Radioactive Waste Management Programs: A Joint NRC/SKI White
Paper'' (ADAMS Accession No. ML012260054), would be a systematic
analysis that addresses what can happen, how likely it is to happen,
what the resulting impacts are, and how these impacts compare to
regulatory standards. The essential elements of a performance
assessment for a LLRW disposal site are the same as the essential
elements of a performance assessment for a HLW repository described in
``Risk Assessment: A Survey of Characteristics, Applications, and
Methods Used by Federal Agencies for Engineered Systems'' (ADAMS
Accession No. ML040090236). The essential elements of a performance
assessment for a LLRW disposal site are: (a) A description of the site
and engineered system, (b) an understanding of events likely to affect
long-term facility performance, (c) a description of processes
controlling the movement of radionuclides from LLRW disposal units to
the general environment, (d) a computation of doses to members of the
general population, and (e) an evaluation of uncertainties in the
computational results.
---------------------------------------------------------------------------
\3\ The current 10 CFR part 61 refers to a ``technical
analysis.''
---------------------------------------------------------------------------
Many features, events, and processes can influence the ability of a
LLRW disposal facility to limit releases of radioactivity to the
environment. Disposal system behavior is influenced by the LLRW
disposal facility design, the characteristics of the LLRW, and the
geologic and environmental characteristics of the disposal site. A
performance assessment evaluates the projected behavior of an LLRW
disposal system and the uncertainties in the projected performance of
the system. The performance assessment identifies the specific
characteristics of the disposal site (e.g., hydrology, meteorology,
geochemistry, biology, geomorphology); degradation, deterioration, or
alteration processes of the engineered barriers (including the
wasteform and container) and natural system; and interactions between
the disposal site characteristics and engineered barriers that might
affect the performance of the LLRW disposal system. The performance
assessment examines the effects of these processes and interactions on
the ability of the LLRW disposal system to limit LLRW releases, and
calculates the annual dose to a member of the public for comparison
with the appropriate performance objective.
Currently, the descriptions of the technical information, technical
analysis, and requirement to demonstrate compliance with the protection
of the general population from releases of radioactivity can be found
in 10 CFR 61.12, ``Specific technical information,'' 10 CFR 61.13(a),
and 10 CFR 61.41, respectively, although these analyses are not called
a ``performance assessment.'' In addition, these technical analyses do
not have a prescribed compliance period. The original guidance
documents associated with these requirements can be found in NUREG-
1300, ``Environmental Standard Review Plan for the Review of a License
Application for a Low-Level Radioactive Waste Disposal Facility''
(ADAMS Accession No. ML053010347); NUREG-1199, Revision 2, ``Standard
Format and Content of a License Application for a Low-Level Radioactive
Waste Disposal Facility'' (ADAMS Accession No. ML022550605); and NUREG-
1200, Revision 3, ``Standard Review Plan for the Review of a License
Application for a Low-Level Radioactive Waste Disposal Facility''
(ADAMS Accession No. ML061370484).
Proposed 10 CFR 61.41 would require licensees or license applicants
to complete a performance assessment to estimate peak dose within the
compliance period following closure of the disposal facility. The
proposed compliance period is defined as 1,000 years following closure
of the facility.
After the compliance period, licensees or license applicants would
be required to provide analyses of the disposal facility performance
from the end of the compliance period to 10,000 years. This period of
time is referred to the protective assurance period. The analysis for
the protective assurance period is an extension of the performance
assessment to the timeframe following the compliance period. From a
technical standpoint, the analysis for the protective assurance period
is likely to be very similar to the compliance period performance
assessment, but, given the uncertainty in projecting the performance of
the disposal site over long time periods, uses a different metric
(i.e., minimize releases and keep annual doses below 5 mSv/yr (500
mrem/yr) or to a level that is supported as reasonably achievable based
on technological and economic considerations). The metric for the
protective assurance analyses is different from the dose limits
provided for the compliance period. The protective assurance analyses
are being proposed as a minimization process (i.e., optimization) with
guidance provided on the goals to use in the minimization process. The
NRC is seeking feedback on the proposed approach.
The definition of compliance and protective assurance periods would
add important technical parameters to the current technical analyses.
Appropriate time periods are important for the evaluation of LLRW
streams that were not considered in the original 10 CFR part 61
rulemaking as well as for evaluation of long-lived LLRW that were
considered in the original rulemaking. The NRC believes that the
results of a performance assessment would assist in demonstrating that
the protection of the general population from releases of radioactivity
can be achieved. The proposed 10 CFR 61.41, new definitions, technical
analyses requirements, and concepts are risk-informed and flexible.
Proposed 10 CFR 61.41 uses a risk-informed regulatory
[[Page 16090]]
framework that specifies what requirements need to be met and provides
flexibility to a licensee or applicant with regard to what information
or approach they use to satisfy those requirements. The NRC believes
that the proposed approach is warranted because of the site-specific
nature of LLRW disposal, which can rely on different designs operating
at different sites.
The proposed amendments formally introduce the concept of features,
events, and processes (FEPs), which ensure appropriate
comprehensiveness of any site-specific technical analysis. For the
protective assurance period, the performance assessment would need to
reflect new FEPs different from the compliance period that address
significant uncertainties inherent in the long timeframes only if
scientific information compelling such changes is available. The NRC
staff has developed a draft guidance document, NUREG-2175, ``Guidance
for Conducting Technical Analyses for 10 CFR part 61,'' to facilitate
the development of information and analyses that will support licensees
or license applicants in addressing the regulatory requirements. This
draft guidance document is being made available for public comment
concurrent with this proposed rule. (See Docket ID NRC-2015-0003 in the
Proposed Rules section of this issue of the Federal Register.)
2. Intruder Assessment
In 10 CFR part 61, the NRC recognizes that it is possible, though
unlikely, that an inadvertent intruder might occupy a disposal site in
the future and engage in normal pursuits without knowing that they are
receiving radiation exposure. Therefore, the second performance
objective in subpart C of 10 CFR part 61 is the protection of
inadvertent intruders. Currently, 10 CFR part 61 does not require a
site-specific analysis to demonstrate the protection of an inadvertent
intruder. Instead, the safety of an inadvertent intruder is
demonstrated by compliance with the LLRW classification system and the
disposal requirements imposed for each class of LLRW. The connection
between the LLRW classification system and protection of an inadvertent
intruder is reflected in the LLRW classification tables in 10 CFR
61.55. The regulatory basis for the current 10 CFR part 61, published
in NUREG-0945, contains an analysis of a reference disposal facility
that evaluates the impacts of LLRW disposal on an inadvertent intruder.
This analysis supported the concentration-based LLRW classification
tables developed for 10 CFR 61.55.
Consistent with the development of the LLRW classification system,
the technical analysis requirements currently found in 10 CFR 61.13(b)
specify that the analyses of the protection of inadvertent intruders
must include a demonstration that there is reasonable assurance that
the LLRW classification and segregation requirements will be met and
that adequate barriers to inadvertent intrusion will be provided. The
regulations ensure the safety of the inadvertent intruder through the
LLRW classification system and the LLRW disposal requirements imposed
for each class of LLRW. However, as they are presently written, the
regulations do not explicitly require an analysis of inadvertent
intruder doses. Differences between LLRW disposal inventories, disposal
practices, and the underlying assumptions used to develop the LLRW
classification tables in 10 CFR 61.55 can result in varying doses with
respect to the protection of an inadvertent intruder. Therefore, the
new proposed regulatory provisions require licensees and license
applicants to conduct an analysis of inadvertent intruder doses.
The proposed revisions would add a requirement for licensees and
license applicants to conduct a site-specific intruder assessment to
demonstrate compliance with 10 CFR 61.42. The proposed intruder
assessment would quantitatively estimate the radiological exposure of
an inadvertent intruder at an LLRW disposal facility following an
assumed loss of institutional controls at the end of the active
institutional control period. The results of the intruder assessment
would then be compared to the performance objective in 10 CFR 61.42.
The intruder assessment would identify the intruder barriers, examine
the capability of the barriers, and address the effects of uncertainty
on the performance of the barriers. The capabilities of the barriers to
inhibit contact with the disposed LLRW or limit the radiological
exposure of an inadvertent intruder and the time period over which the
capability persists must be demonstrated and a technical basis must be
provided. In performing the proposed intruder assessment, licensees
would be expected to employ a methodology similar to that used for a
performance assessment, but the intruder assessment would assume that
an inadvertent intruder occupies the LLRW disposal site after closure,
engages in normal activities, and is unknowingly exposed to radiation
from the LLRW.
With the intruder assessment requirement, the NRC is proposing to
specify an intruder dose limit for the compliance period and protective
assurance period as described in the original 10 CFR part 61 analysis
to develop the LLRW classification tables. The regulatory basis for 10
CFR part 61 assumed that inadvertent intrusion occurred following a
cessation of a caretaker or active institutional control period.
Institutional control of the site was expected to occur beyond the
active institutional control period, although it could not be assured
because of the long timeframes involved. Therefore, an intruder was
assumed to occupy the LLRW disposal facility and engage in normal
activities, such as agriculture or dwelling construction. The analysis
assumed that the intruder directly contacted the disposed LLRW, and was
exposed to radionuclides through inhalation of contaminated soil and
air, direct radiation, and ingestion of contaminated food and water.
The NRC based the LLRW classification tables in 10 CFR 61.55 on
radionuclide concentrations that would yield a 5 mSv/yr (500 mrem/yr)
dose.
The dose limit used to develop the current LLRW classification
tables was selected from a range of values that were consistent with
exposure guidelines of different orders of magnitude: 0.25 mSv/yr (25
mrem/yr), 5 mSv/yr (500 mrem/yr), and 50 mSv/yr (5,000 mrem/yr). In
NUREG-0945, the NRC selected the 5 mSv/yr (500 mrem/yr) dose based
primarily on safety as reflected in the effective dose limit in 10 CFR
part 20 at that time and public opinion gained through the four
regional workshops held on the preliminary draft of 10 CFR part 61. The
NRC continues to believe that this dose limit provides an acceptable
level of protection to an inadvertent intruder. The NRC is proposing to
add an annual intruder dose limit to 10 CFR 61.42 to ensure protection
of any inadvertent intruder who occupies the disposal site or contacts
the LLRW at any time after active institutional controls are removed.
Given the uncertainty in projecting performance of disposal sites
over long time periods such as those beyond the compliance period, the
amendments proposed in 10 CFR 61.42 would require that annual doses be
minimized, as estimated by an intruder assessment, for the protective
assurance period. The minimization target is for annual doses to be
below 5 mSv/yr (500 mrem/yr) or a level that is supported as reasonably
achievable based on technological and economic considerations. The NRC
is seeking feedback on the proposed
[[Page 16091]]
approach, especially with regard to whether a 5 milliSievert (500 mrem)
annual dose target is appropriate for the protective assurance period
and whether it is appropriate to require licensees or license
applicants to consider alternative levels to minimize exposures to an
inadvertent intruder.
Given the uncertainty in predicting human behavior into the distant
future and to limit associated speculation, the NRC is proposing to
change the definition of the inadvertent intruder to limit the
scenarios to reasonably foreseeable activities that are realistic and
consistent with activities in and around the disposal site at the time
of closure.
As discussed in Section M of this document, the NRC has prepared a
draft guidance document that describes acceptable approaches for
determining reasonably foreseeable intruder activities that are
consistent with activities in and around the disposal site at the time
of closure to be assessed in the intruder assessment. The draft
guidance describes how licensees or license applicants can take credit
for physical characteristics (e.g., water quality) and societal
information (e.g., land use patterns) related to the disposal facility
to limit speculation about the types of activities in which an
inadvertent intruder might engage.
The proposed approach, consistent with the current approach, is to
assume that the active institutional controls will fail after the end
of the active institutional control period. The NRC does not believe
that controls will fail, but rather that the durability of the controls
cannot be assured. In addition, the NRC is not assuming the probability
is 100 percent that contact with the LLRW by an intruder will occur. As
in the current regulation, engineered barriers and disposal practices,
such as greater disposal depth, are to be considered in the intruder
assessment. For example, with a protective cover of at least 5 m (16
feet) thickness, consideration of a scenario in which a dwelling
foundation is excavated in a disposal unit would not be reasonable. A 5
mSv (500 mrem) dose limit for the intruder, compared to a 0.25 mSv (25
mrem) annual dose limit for the public during the compliance period in
10 CFR 61.41, demonstrates the NRC expectation that the intruder
scenario is unlikely. As previously stated, the NRC is making available
the draft guidance document (see Docket ID NRC-2015-0003) for public
comment concurrent with the publication of this proposed rule and is
seeking comments on whether the approaches described in the guidance
are adequate or if further specification for inadvertent intruder
scenarios in the proposed rule is necessary.
As previously indicated, the current 10 CFR part 61 provides LLRW
classification and segregation requirements. The NRC considered, based
on comments received on the preliminary proposed rule language (76 FR
24831), whether additional requirements such as minimum depth of
disposal were needed for large quantities of long-lived LLRW (e.g.,
DU). The NRC proposes that a more risk-informed approach would be to
require an intruder assessment that would allow the actual disposal
depth and form of LLRW to be considered in the analysis.
3. Performance Period Analyses
The current regulations in 10 CFR part 61 limit radiological risks
from land disposal of LLRW regardless of the half-life of the LLRW. To
ensure protection of public health and safety, 10 CFR part 61 includes
regulations regarding analyses, LLRW classification, site-selection,
LLRW characteristics, and other requirements. A long-term analysis
(e.g., longer than 10,000 years) was not necessary under 10 CFR part
61, as originally written, because the NRC developed LLRW
classification limits for long-lived radionuclides. The regulatory
system was designed to ensure the short- and long-term impacts were
limited by regulatory requirements such as the LLRW classification
system. The NRC is now proposing additional analyses to ensure that
LLRW streams that are significantly different from those considered in
the original 10 CFR part 61 regulatory basis (e.g., large quantities of
DU) can be disposed of safely and that the performance objectives will
be met or LLRW disposal will be prohibited. The use of a three-tiered
analyses system with different performance metrics for each tier should
allow licensees or applicants to perform risk-informed assessments of
the land disposal of LLRW for the protection of public health and
safety. The analyses-based approach to regulation is more risk-informed
than the concentration-based approach used in the current 10 CFR part
61 regulations. The concentration-based approach cannot be easily
adjusted to differing site conditions because concentration limits were
derived based on conservative assumptions.
The long-term analyses, termed ``performance period analyses'' as
set forth in 10 CFR 61.13(e), would require licensees or license
applicants to prepare long-term analyses (i.e., after the compliance
and protective assurance periods) that assess how the disposal facility
and site characteristics limit the potential long-term radiological
impacts, consistent with available data and current scientific
understanding. The proposed performance period analyses will only be
required for land disposal sites with long-lived LLRW that contains
radionuclides with average concentrations exceeding the values listed
in the proposed table A of 10 CFR 61.13(e), ``Average Concentrations of
Long-lived Radionuclides Requiring Performance Period Analyses,'' or if
necessitated by site-specific conditions. The average concentrations,
as explained in greater detail in the associated draft guidance
document, are disposal site-averaged concentrations. Disposal site-
averaged concentrations can include the volume of the LLRW,
uncontaminated materials used to stabilize LLRW or reduce void space
within LLRW packages, the volume of uncontaminated materials placed
within the disposal units, and the volume of engineered or natural
materials used to construct the disposal units. For the purpose of
determining if performance period analyses are necessary, the disposal
site-averaged concentrations should be based on the total volume of
LLRW averaged over the total volume of all disposal units. For
radionuclides where the concentrations are based on mass and not
volume, the average density of the different materials within the
disposal units can be used. The averaging calculations are explained in
further detail in the draft guidance document.
The metric for the performance period analyses would be to minimize
releases to the public to the extent reasonably achievable. The NRC
considered a variety of approaches for metrics to evaluate the
performance period analyses. The aforementioned metric was selected
because it would allow socioeconomic information to be considered in a
risk-informed manner. Considering the timeframes involved,
uncertainties may be considerable and therefore the precision typically
assigned to a dose limit is not warranted. Whereas the calculated dose
in a numerical model may be precise, the significance of that dose to a
future generation is unknowable in the present. Although a dose limit
is not prescribed, it is recommended that doses or concentrations and
fluxes of radionuclides in the environment are calculated as they are
appropriate to use to compare alternatives using a common metric. The
NRC believes the value of information an applicant would provide to
describe its actions to mitigate long-
[[Page 16092]]
term impacts to future generations is higher than the value of long-
term dose estimates. The minimization of releases and barrier analyses
for the performance period can demonstrate how an applicant is
proposing to limit impacts to future generations. The draft guidance
document discusses in more detail an acceptable approach to performing
the analyses for the performance period.
The proposed performance period analyses must identify and describe
the features of the design and site characteristics that will
demonstrate that the performance objectives set forth in 10 CFR
61.41(c) and 10 CFR 61.42(c) will be met. These analyses would also
help determine whether any additional measures are needed at a disposal
site to ensure the protection of the general population and the
inadvertent intruder from disposal of long-lived LLRW with average
concentrations exceeding the values listed in the proposed table A of
10 CFR 61.13(e), or if necessitated by site-specific conditions, and to
determine whether limitations on the disposal of some LLRW streams at
certain sites may be needed to properly manage the disposal of LLRW.
An ending time for the performance period analyses is not specified
in the proposed regulation. A number of factors influenced this
decision. First, the analyses may demonstrate the time when the peak
impact is likely to occur such that further calculation beyond this
time is unnecessary. Because long-term impacts are going to be driven
by site-specific characteristics and the particular LLRW that is
disposed, the timing of peak impacts may differ substantially from site
to site. A licensee or license applicant must demonstrate that impacts
are minimized to the extent reasonably achievable, ensuring that
facilities and disposal cells are not under-designed. Second, the
analyses that are developed for the performance period may differ from
traditional projections of long-term radiological doses. Performance
period analyses may demonstrate that the performance period metrics
have been satisfied irrespective of peak radiological impacts. The
proposed approach is based on the position that there are many
uncertainties in the risks imposed on future generations, especially
from processes or events other than LLRW disposal. In addition, there
is uncertainty in the projected radiological risk to future populations
from LLRW disposal, which may be based on a number of assumptions about
the behavior and characteristics of future society. The proposed
approach focuses on a demonstration of how the natural and engineered
barriers of the disposal system could limit releases of material rather
than the radiological impact to an individual or group. The NRC is
seeking feedback on the proposed approach, especially with regard to
whether a dose limit is needed for the long-term analyses or whether
the proposed metric combined with barrier analyses is more appropriate.
4. Defense-In-Depth Analyses
The defense-in-depth principle has served as a cornerstone of the
NRC's deterministic regulatory framework for nuclear reactors, and it
provides an important tool for making regulatory decisions, with regard
to complex facilities, in the face of significant uncertainties. The
NRC also has applied the concept of defense-in-depth elsewhere in its
regulations to ensure safety of licensed facilities through
requirements for multiple, independent layers, and, where possible,
redundant safety systems. Traditionally, the reliance on independence
and redundancy of barriers has been used to provide assurance of safety
when reliable, quantitative assessments of barrier reliability are
unavailable. The NRC maintains, as it has in other regulations for
disposal, such as for high-level radioactive waste, that the
application of the defense-in-depth concept to a LLRW land disposal
facility is appropriate and reasonable. Therefore, the NRC is now
proposing additional analyses to ensure that the land disposal facility
includes defense-in-depth protections.
However, implementation of defense-in-depth protections, in the
context of a LLRW land disposal facility, should be consistent with the
NRC's goal of achieving a regulatory program and associated
requirements that are risk-informed and performance-based. While waste
is being disposed, and before a LLRW land disposal facility is closed,
defense-in-depth protections would typically be comparable to other
operating nuclear fuel cycle facilities licensed by the NRC.
Application of defense-in-depth principles for regulation of disposal
facility performance for long time periods following closure, however,
must account for the difference between a closed land disposal facility
and an operating facility with active safety systems and the potential
for active control and intervention. A closed land disposal facility is
essentially a passive system, and assessment of its safety over long
timeframes is best evaluated through consideration of the relative
likelihood of threats to its integrity and performance. Although it is
relatively easy to identify multiple, independent and redundant layers
that comprise the engineered features and site characteristics, the
capabilities of any of these design features and site characteristics
may not be either independent or totally redundant. The NRC continues
to believe that multiple layers of defense must each make a definite
contribution to the isolation of the waste, so that the NRC may find,
with reasonable assurance, that no single layer of defense will be
exclusively relied upon to achieve the overall safety objectives over
timeframes of hundreds to thousands of years. Disposal of LLRW is also
predicated on the expectation that a portion of the site in combination
with engineered features will minimize the migration of radionuclides
away from the disposal site. However, the capabilities of site
characteristics and engineered features over the long timeframes are
subject to interpretation and include many uncertainties. These
uncertainties can be quantified generally and are addressed by
requiring the use of a multiple layers. Similarly, although the
composition and configuration of engineered features, as well as their
capacity to limit releases or function as intruder barriers, may be
defined with a degree of precision in the near-term that may not be
possible for site characteristics, it is recognized that except for a
few archaeologic analogues, there is no experience base for the
performance of complex, engineered structures over periods longer than
a few hundred years. Therefore, the NRC expects that licensees will
rely on both the characteristics and the engineered features, in
combination, to provide reasonable assurance that the overall
performance of the disposal site will be adequate over long time
periods.
5. Site Stability Analyses
Currently, 10 CFR 61.50, which is also being revised in this
rulemaking, requires that LLRW disposal sites not be susceptible to
erosion, flooding, seismicity, or other disruptive events or processes
to such a degree or frequency that compliance with the 10 CFR part 61
performance objectives cannot be demonstrated with reasonable
assurance. Currently, 10 CFR 61.44 also includes a performance
objective for stability at the disposal site after closure. It states
that the disposal facility must be sited, designed, used, operated, and
closed to achieve long-term stability of the disposal site and to
eliminate, to the extent practicable, the need for ongoing active
maintenance of the disposal site following closure. To demonstrate with
areasonable assurance
[[Page 16093]]
that the 10 CFR 61.44 performance objective will be met, licensees must
conduct site stability analyses.
Site stability analyses focus on stability of the wasteform,
stability of the engineered disposal facility, and geologic/geomorphic
stability of the disposal site. For disposal of traditional LLRW (i.e.,
range and type of LLRW that was analyzed in the current 10 CFR part
61), site stability analyses will likely focus on the former two areas.
For disposal of large quantities of long-lived waste, the focus will
likely be on the latter two areas. The extent of the site stability
analyses will be strongly influenced by the type of waste to be
disposed. Stability of wasteforms, disposal units, engineered barriers
(such as cover systems), disposal site, disposal facility, and disposal
system may all be within the scope of the stability assessment.
However, the current 10 CFR 61.44 performance objective does not
specify an analysis timeframe for the site stability analyses. Without
an analysis timeframe, the applicability of the stability requirement
would be subject to different interpretations.
The NRC proposes to revise 10 CFR 61.44 to specify that stability
of the disposal site must be demonstrated for the compliance and
protective assurance periods. This change was necessary to clarify that
the post-closure site stability requirements apply to the compliance
and protective assurance periods created in this proposed rule.
F. Updated Safety Case and Technical Analyses for Closure
Currently, 10 CFR 61.28, ``Contents of application for closure,''
requires licensees to submit an application to amend the license for
closure. This application must include (1) a final revision and
specific details of the disposal site closure plan, and (2) an
environmental report or a supplement to an environmental report.
Currently, 10 CFR 61.28 does not require licensees to prepare updated
site-specific technical analyses. The proposed rule would require
licensees to include updated safety case and technical analyses in
their applications to amend their licenses for closure, to provide
greater assurance of compliance with the performance objectives that
ensure the safe disposal of LLRW streams significantly different from
those considered in the original 10 CFR part 61 regulatory basis (i.e.,
large quantities of depleted uranium). In particular, 10 CFR 61.28
would be revised to require licensees to also prepare updated
performance period analyses required by proposed 10 CFR 61.13, 10 CFR
61.41, and 10 CFR 61.42. The NRC believes that this change, coupled
with current 10 CFR 61.28(c) which is not being amended by this
rulemaking, may require licensees to take additional action prior to
closure to ensure that the LLRW that has been disposed of will meet the
performance objectives.
G. What options were considered for selecting approach and timeframes
and what is the NRC's preferred option?
1. Considerations Made in Developing Options
Currently, 10 CFR 61.7 discusses a number of timeframes that
licensees or license applicants should consider in selecting a site,
designing stable wasteforms or containers, controlling access to the
site, and developing intruder barriers. The timeframes discussed are
provided within the context of a LLRW management system that attempts
to ensure that LLRW decays to innocuous levels prior to public exposure
to radiation. The concentrations and quantities of long-lived LLRW for
disposal would be limited thereby limiting potential exposures. For
instance, 10 CFR 61.7(a)(2) indicates that in choosing a disposal site,
site characteristics should be considered for the indefinite future and
evaluated for at least a 500-year timeframe. However, 10 CFR part 61
does not provide a value for the time period \4\ to demonstrate
compliance with the performance objectives. The existing regulatory
basis for 10 CFR part 61 in NUREG-0945 and the related guidance in
NUREG-1573, ``A Performance Assessment Methodology for Low-Level
Radioactive Waste Disposal Facilities: Recommendations of NRC's
Performance Assessment Working Group'' (ADAMS Accession No.
ML003770778), recognize the need to use an analysis timeframe
commensurate with the persistence of the hazard of the source. In
selecting an analysis timeframe, the general practice is to consider
the characteristics of the LLRW, the analysis framework (e.g., assumed
scenarios, receptors, and pathways), societal uncertainties, and
uncertainty in predicting the behavior of natural systems over time.
Both technical factors (e.g., the characteristics and persistence of
the radiological hazard attributed to the LLRW) and socioeconomic
factors (e.g., transgenerational equity) should be considered.\5\ The
purpose of completing a performance assessment of a LLRW disposal
facility is to ensure that public health and safety are protected with
an acceptable degree of confidence.
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\4\ Different terminology has historically been used to refer to
the timeframe assessed for regulatory compliance or other analyses,
including ``performance period,'' ``time of compliance,''
``compliance period,'' and other variants.
\5\ International Commission on Radiological Protection (ICRP),
``Radiation Protection Recommendations as Applied to the Disposal of
Long-lived Solid Radioactive Waste,'' ICRP Publication 81, Annals of
the ICRP, Vol. 28, No. 4, ICRP Publication 81, 2000.
---------------------------------------------------------------------------
The NRC evaluated what other countries and international agencies
use to manage the radiological risks from the disposal of long-lived
LLRW. Some organizations impose a requirement to identify impacts from
the disposal of long-lived LLRW using technical analyses. Results of
the analyses are used to impose appropriate restrictions on LLRW
disposal, if necessary. Almost every country that the NRC looked at
places restrictions on how much LLRW can be disposed of in the near
surface or does not allow near-surface disposal of long-lived LLRW.
Most countries place explicit numerical limits on concentrations of
long-lived alpha-emitting LLRW. These concentration limits are set by
regulators based on generic technical analyses or policy decisions. The
concentration limits are not developed based on the results of site-
specific technical analyses. Site-specific technical analyses are
performed, but only for LLRW that satisfies the generic limits. This
approach is very similar to what was done for the initial development
of 10 CFR part 61. The current requirements in 10 CFR part 61
supplement technical analyses with LLRW concentration limits and other
disposal requirements, such as minimum disposal depth for certain types
of LLRW. The development of concentrations limits by generic analysis
or policy works well for countries that only have one disposal site.
However, if numerous sites are regulated in this manner the
concentration limits must be based on the most limiting conditions in
order to assure that public health and safety is protected.
In general, different international programs have used regulatory
approaches that vary considerably in methodology used to achieve
protection of future generations from the disposal of LLRW. However,
countries and international safety organizations consistently apply
limiting conditions on the near-surface disposal of LLRW (e.g.,
prohibit disposal, or impose concentration limits, disposal depth
requirements, flux limits, and/or long-term analyses). Performance
assessments are used to understand how a system (e.g., a disposal
facility and
[[Page 16094]]
natural environment) may perform. They are used to understand the
potential impacts of uncertainties on public health and safety
decisions that decision makers need to consider. The many sources of
uncertainty associated with projecting the future risks from disposal
of LLRW include, but are not limited to, natural, engineering, and
societal sources. The selection of analyses timeframes or an approach
to selection of analyses timeframes for the evaluation of the disposal
of LLRW should consider the different sources of uncertainty and how
the uncertainties may impact projected future radiological risk. The
uncertainties influence how the projected future radiological risks are
interpreted by decision makers. The staff evaluated these uncertainties
and their impact on intergenerational decision making through review of
the work by the National Academy of Public Administration, the
Organization for Economic Co-Operation and Development, and others.
2. Options Considered
The NRC has considered a variety of options for selection of the
analysis timeframe for the assessment of LLRW disposal.\6\ These
options were based on two different approaches to waste management:
---------------------------------------------------------------------------
\6\ The NRC developed a position paper on the analyses timeframe
for LLRW disposal and a revised regulatory basis that provides more
detail than the summary provided here. For more information, refer
to the NRC's ``Technical Analysis Supporting Definition of Period of
Performance for Low-level Waste Disposal,'' issued in April 2011,
and ``Regulatory Basis for Proposed Revisions to Low-Level Waste
Disposal Requirements (10 CFR part 61),'' issued in December 2012.
---------------------------------------------------------------------------
Analyses-based approach to safety, and
Design- and control-based approach to safety.
These two approaches are not mutually-exclusive and each can
contain elements of the other approach. Traditionally, for the disposal
of LLRW, analyses-based approaches projecting performance of the
disposal facility into the future have been used. Disposal of municipal
and industrial waste that is non-radioactive have used the design- and
control-based approach to safety. The primary decision is what specific
regulatory requirements are needed to ensure that public health and
safety will be protected.
Analyses-based approach: A variety of different options were
considered with respect to the analyses-based approaches. A key
consideration of these approaches is the obligation of the current
generation to protect future generations from the disposal of LLRW.
Though this section discusses the NRC's options for analyses
timeframes, the technical analyses should be considered in context with
all the requirements of the regulation. The primary decision variables
with respect to analyses timeframes considered by the NRC were:
How many tiers should be used for the analyses?
What should be the duration of the tiers?
What limits should be prescribed to each tier?
Table 2 provides a summary of the analyses-based approaches
considered by the NRC. A more in-depth discussion of the advantages and
disadvantages of each approach can be found in the NRC's ``Technical
Analysis Supporting Definition of Period of Performance for Low-level
Waste Disposal,'' and ``Regulatory Basis for Proposed Revisions to Low-
Level Waste Disposal Requirements (10 CFR part 61)''.
Table 2--Summary of Timeframes Considered for Analyses-Based Approaches
----------------------------------------------------------------------------------------------------------------
Tiers Approach Duration Limits
----------------------------------------------------------------------------------------------------------------
Single..................... Current--no change..... Variable, from 500 years to 25 mrem/yr.
peak dose as currently
implemented by Agreement
States.
Single..................... Peak dose approach..... Determined by specific waste 25 mrem/yr.
and site characteristics.
Single..................... Concentration limits... A few thousand.............. 25 mrem/yr, Concentration
limits.
Single..................... Limited duration....... 1,000 years or less......... 25 mrem/yr.
Two........................ Risk-informed analysis. Tier 1: up to 10,000 years.. Tier 1: 25 mrem/yr.
Tier 2: undefined........... Tier 2: minimize releases to
the extent reasonably
achievable.
Two........................ Risk-informed analysis Tier 1: 10,000 years........ Tier 1: 25 mrem/yr.
with long-term dose Tier 2: undefined........... Tier 2: 100 mrem/yr.
limit.
Two........................ Site specific.......... Tier 1: a few hundred to Tier 1: 25 mrem/yr.
10,000 years. Tier 2: site-specific.
Tier 2: site-specific.......
Three...................... Uncertainty limitation. Tier 1: 1,000 years......... Tier 1: 25 mrem/yr.
Tier 2: 10,000 years........ Tier 2: minimize releases
Tier 3: undefined........... using a target of keeping
doses below 500 mrem/yr.
Tier 3: minimize releases to
the extent reasonably
achievable.
Three...................... Uncertainty informed... Durations not defined but Limits not defined but
examples are provided in examples are provided in
``Technical Analysis ``Technical Analysis
Supporting Definition of Supporting Definition of
Period of Performance for Period of Performance for
Low-level Waste Disposal''. Low-level Waste Disposal''.
----------------------------------------------------------------------------------------------------------------
Single Tier Options: The regulatory requirements for a single-tier
approach would involve specifying the timeframe of the analyses as well
as an associated metric to be met during the timeframe. Variants of the
single tier approach considered by the NRC included the following:
(a) Current--no change approach: In this approach, a compliance
period is not specified for the assessment of the performance
objectives. All four currently operating commercial low-level waste
disposal facilities are located in Agreement States, and they all have
different requirements for the compliance period. No additional action
would be required by the NRC to maintain the current approach.
[[Page 16095]]
(b) Peak dose approach: This approach would require the calculation
of peak dose for the compliance determination regardless of when the
peak occurs (which could be greater than 10,000 years if large amounts
of DU are disposed at the site). If regulatory limits are met, this
approach ensures that all future generations would be provided with the
same level of protection as the current generation. It would also
ensure that the burden from the disposal of LLRW by the present
generation is not deferred to any future generations, no matter how
distant in the future.
(c) Regulator-derived concentration limits approach: This approach
would involve using a single tier for the analyses of up to a few
thousand years, complemented with regulator-derived concentration and
quantity limits for long-lived isotopes. This approach is used by some
other countries. The NRC believes this approach can be effective at
mitigating the impact of long-term uncertainties while avoiding
unnecessary speculation and ensuring protection of public health and
safety for present and future generations. The challenge of using this
approach is that it would be difficult to take into account different
site, disposal facility, and other characteristics when determining
regulator-derived concentration and quantity limits for long-lived
isotopes. The NRC believes that this approach could work well for a
single LLRW disposal site (which is most common in foreign nations),
but would be difficult to implement in a risk-informed manner for
numerous disposal sites. To ensure protection of public health and
safety, the limits that would be derived using this approach may need
to be set at values derived for the most limiting conditions (e.g.,
site and design) and may be inappropriately restrictive for some sites.
(d) Limited duration approach: This approach would assign a 1,000-
year compliance period to the analysis using a single tier. No limits
would be prescribed for impacts that would occur after this period.
Proposed guidance would indicate that it may be useful to evaluate
longer-term impacts and consider modifications to the disposal system,
if practical. A challenge with this approach is that, without limits on
the disposal of long-lived isotopes, the dose estimated in a 1,000-year
analysis timeframe may not be close in magnitude to the peak dose even
for disposal of traditional LLRW. Another shortcoming of this approach
is that a performance assessment could demonstrate that the performance
objectives would be met within the first 1,000 years but then be
exceeded by a large margin afterwards. In fact, this result would be
expected, especially for the disposal of DU where the maximum dose
achieved within 1,000 years is only about 1/1000th of the peak dose.
Because Agreement States have selected different compliance periods,
staff anticipates that the lack of a standard approach with respect to
long-term impacts (after 1,000 years) will likely result in differences
in interpretation among Agreement States. The approach would also
create ambiguity with respect to the Commission's objectives for the
management of long-term impacts. The decisions for additional action
under this approach will be subjective, with case-by-case decisions
being made by different regulators using different metrics.
Two Tier Options: The regulatory requirements for a two-tier
approach would involve specification of a duration for the analyses for
each tier as well as an associated metric to be met for each tier.
Variants of the two-tier approach considered by the NRC included the
following:
(a) Risk-informed analyses approach: This approach sets standards
for the analyses timeframes to ensure consistency, but then affords
flexibility to licensees with respect to the technical analyses used to
demonstrate compliance with the subpart C performance objectives. To
ensure the long-term protection of public health and safety from the
disposal of LLRW, the risk-informed analyses approach would be
characterized by:
A compliance period of up to 10,000 years.
A second tier (i.e., performance period) that would only
be applicable when facility-averaged LLRW concentrations exceed certain
values, or if necessitated by site-specific conditions. The
concentrations would be developed by the NRC.
The analyses for the second tier would include: (1) A screening
process to identify if performance period analyses are necessary, and
(2) performance period analyses, if applicable. The performance
requirement for the performance period analyses would be to minimize
releases to the extent reasonably achievable. The analyses that could
be used for the second tier would be described in guidance. The
regulations would describe the analyses at a high-level.
Under this two-tiered approach, licensees or license applicants of
LLRW disposal facilities that dispose of short-lived LLRW or limited
quantities of long-lived LLRW would perform their compliance analyses,
and no additional analyses would be required. If LLRW has average
concentrations exceeding the values developed by the NRC, or if
necessitated by site-specific conditions, then the licensees or license
applicants would have to perform analyses for the second tier. Guidance
would describe the use of a conservative screening analysis or, if
desired, a site-specific technical analysis for the second tier. The
screening analysis would be based on a conservative approach (e.g.,
peak in-growth of progeny, no retardation during transport, defined
scenarios) to manage long-term uncertainties and ensure that public
health and safety is protected. If the screening analysis results
showed the performance objectives would not be met, then inventory
limits would be established based on the screening analysis or
quantitative performance period analyses could be performed to
demonstrate that public health and safety will be protected. Using this
framework, the analyses would be risk-informed.
(b) Risk-informed analysis with long-term dose limits approach:
This approach is conceptually similar to the previous two-tiered
approach but differs in that a dose limit for the second tier (i.e.,
post 10,000 years) of the analysis would be specified in the regulation
(e.g.,1 mSv (100 mrem)) to align the requirement with regulatory
precedent in similar programs (e.g., high-level waste disposal at Yucca
Mountain, LLRW disposal staff guidance).
(c) Site-specific approach: A final option using a two-tiered
approach would be described as involving a compliance period of
somewhere between a few hundred to 1,000 years, which would cover what
the NRC believes is a reasonably foreseeable period for estimating
future human activities. If uncertainty associated with the societal
component of the problem is managed by specifying reasonably
conservative scenarios, then the compliance period could be as long as
10,000 years. The time period for the second tier of this approach
would not be defined in the regulation, instead it would be determined
on a site-specific basis. Under this option a dose limit could be
established for the second tier or an alternative metric could be used.
Three Tier Options:
a) Uncertainty limitation approach: This three-tiered approach
involves a compliance period, a protective assurance period, and a
performance period.
The compliance period would be defined as 1,000 years following
closure of the disposal facility. The period of 1,000 years was
selected to cover the
[[Page 16096]]
reasonably foreseeable future during which there would be a high degree
of confidence that the requirements could be realistically met.
Further, the compliance period would limit speculation on future human
activities, as well as waste- and site-performance. The NRC would limit
the impact of uncertainty on the compliance period decision making by
limiting the duration of the compliance period.
The NRC recognizes that there is merit in considering timeframes
longer than 1,000 years for some types of waste. Therefore, this
approach would also establish a protective assurance period which would
ensure that the disposal of LLRW would not present an unacceptable risk
to future generations by minimizing radiation doses from the end of the
compliance period until 10,000 years. The minimization process would be
designed to ensure that radiological doses are maintained below 5
millisieverts (500 mrem) per year, or to a level that is reasonably
achievable based on technological and economic considerations. The use
of a protective assurance period with a minimization target rather than
a dose limit would recognize the uncertainty in estimating future
social patterns, living conditions, and environmental conditions in and
around a disposal facility. The standard for the second tier is more
similar to ALARA or optimization than a strict dose limit. The types of
questions a licensee, license applicant, or regulator may consider when
applying this approach would include but are not limited to:
What are the projected doses?
What other technologies are available to reduce those
projected doses (e.g. different wasteforms, engineered covers)?
If the doses are projected to be above 5 mSv/yr (500 mrem/
yr), can they be reduced using technology in an economically
justifiable manner?
Could the waste stream be disposed at a different site? Is
this site not suitable for this waste (i.e., excess instability)?
The third tier of the approach is the performance period. The
performance period would be used to evaluate the performance of the
site after the protective assurance period and ensure that disposal
system's ability to mitigate long-term risks associated with the
disposal of long-lived LLRW is evaluated. The performance period would
only apply if a facility is projected to contain sufficient long-lived
radioactivity that could pose an unacceptable risk beyond 10,000 years.
(b) Uncertainty informed approach: This approach would provide
decision points and regulatory limits that would consider major sources
of uncertainty associated with the projection of radiological risk from
the disposal of LLRW. This approach would be divided into three
timeframes--compliance period, assessment period, and performance
period--and is referred to as the Compliance, Assessment, and
Performance approach (CAP).
The compliance period would be defined as the period of time when
the disposal facility performance could be estimated quantitatively
with relative confidence. Societal uncertainties, though large, would
not prevent the performance calculations from providing meaningful
information.
The assessment period would be the period of time after the
compliance period where performance of the disposal facility would be
assessed quantitatively and the results would be interpreted semi-
quantitatively considering the increasing uncertainties in natural and
engineered system components. The assessment period would be used to
evaluate the relative performance of natural and engineered barriers.
The performance period would be the period of time after the
assessment period where performance of the disposal facility would be
evaluated qualitatively or quantitatively, as appropriate, because
numerous and significant sources of uncertainty could significantly
influence the results.
The objective of the CAP approach is to balance the need to
consider radiological risks to future generations, even over long
periods of time, with the uncertainties that could impact the
interpretation of the results of the performance calculations. For LLRW
inventories with long-lived radionuclides and with in-growth of more
mobile progeny, the CAP approach is one way to ensure that the long-
term risks would be incorporated into decision making. This three-
tiered approach would ensure that the potential long-term radiological
risks are communicated to decision makers while properly reflecting the
uncertainties associated with the calculations. In the NRC's
``Technical Analysis Supporting Definition of Period of Performance for
Low-level Waste Disposal,'' examples were given for defining the tiers
and providing associated dose limits, however, specific values for each
variable were not selected.
Design- and control-based approach: The NRC considered an approach
to managing long-lived LLRW that requires periodic review and
reassessment (e.g., perpetual institutional control, monitoring, and
maintenance), as is done with facilities that dispose of industrial
metals. Currently, 10 CFR part 61 contemplates that involvement of a
disposal site operator will follow a well-defined timeline. The more
open-ended process associated with the disposal of industrial metals is
viewed as a disadvantage to adoption of this type of approach.
Under current 10 CFR part 61, after satisfactory disposal site
closure, licenses are transferred to the State or Federal Government,
one of which is required to own the disposal site. A 5-year period
during which the licensee would remain at the disposal site to ensure
that the site is stable and ready for institutional control is
required, though the Commission would be able to prescribe longer
periods of time to demonstrate that the disposal site is stable, if
warranted.\7\ The disposal site is transferred to the State or Federal
Government after this period.
---------------------------------------------------------------------------
\7\ 10 CFR 61.29.
---------------------------------------------------------------------------
3. NRC Proposed Option
The NRC proposed option is an approach to analyses timeframes that
is based on a three-tiered conceptual framework. The proposed option
includes a compliance period of 1,000 years applicable to both a
performance assessment used to demonstrate compliance with 10 CFR 61.41
and to an intruder assessment used to demonstrate compliance with 10
CFR 61.42.
The second tier of the proposed option includes a 10,000 year
protective assurance period, during which doses, as estimated by
technical analyses, would be minimized. The objective of the
minimization process would be to keep doses below 500 mrem/yr or to a
level that is reasonably achievable based on technological and economic
considerations. Should doses exceed the minimzation target, changes to
the disposal site design, inventory limits, or alternative methods of
disposal would be needed to ensure doses are minimized to avoid
unacceptable consequences unless those changes can be shown to not be
technically or economically practical. Given the significant
uncertainties inherent in these long timeframes, the performance
assessment should reflect changes in features, events, and processes of
the natural environment such as climatology, geology, and geomorphology
only if scientific information compelling such changes from the
compliance period is available. The NRC is not proposing that features,
events, and processes that are dynamic be arbitrarily fixed as static.
Rather that
[[Page 16097]]
the scope of the features, events, and processes considered does not
need to be expanded unless information is available to do so.
The third tier of the proposed option includes a performance period
of undefined duration during which a licensee must demonstrate that
effort has been made to minimize releases to the extent reasonably
achievable. This metric for the third tier would afford the flexibility
for consideration of long-term radiological doses, cost-benefit type of
analyses, and concentration and fluxes of radionuclides in the
environment. The duration is undefined to allow for consideration of
site- and waste-specific factors as well as different methods to
demonstrate that the requirements have been met. This approach was
informed by the views expressed by various members of the public about
the consideration of long-term uncertainties. Conditions have been
established to determine when the performance period analyses should be
performed, therefore risk-informing the approach. In order to determine
if performance period analyses are necessary, it is proposed that a
licensee or license applicant compare LLRW disposal site-averaged
concentrations of long-lived radionuclides to values provided in the
proposed table A of 10 CFR 61.13(e). This requirement would ensure that
the analyses are performed only when dictated by the radiological
characteristics of the LLRW or if necessitated by site-specific
conditions. The concentration values are primarily, but not solely,
based on the Class A LLRW concentration values from table 1 of 10 CFR
61.55. Unlike the existing table 1, the proposed table A includes non-
transuranic long-lived isotopes, as well as transuranic long-lived
isotopes. It is appropriate to include the non-transuranic isotopes in
the performance period analyses if they could potentially be disposed
of in significant concentrations and quantities. The radiological risk
is estimated using the dose conversion factors of individual isotopes
at the concentration provided (10 nanoCuries per gram (nCi/g)). The
dose conversion factors for all isotopes have variability; there are
different values of dose conversion factors for different solubility
classes of an isotope as well as different values of dose conversion
factors for different isotopes. When deriving the 10 nCi/g
concentration value for transuranic isotopes in Class A LLRW, the NRC
applied the same conversion of concentration to dose for all of these
isotopes. The dose conversion factors for non-transuranic isotopes are
generally comparable to the transuranic isotopes, and the NRC believes
it is appropriate to simplify the variability similar to what was done
in the original rulemaking. This simplification results in a single
concentration value for all long-lived alpha emitting radionuclides
rather than a table of values for different isotopes. The
concentrations provided in the proposed table A of 10 CFR 61.13(e) are
only used to determine if performance period analyses are necessary. As
explained in detail in the draft guidance document, the complexity of
the analyses would be driven by the projected impacts. The results of
the performance period analyses would determine if any resultant
actions are necessary (e.g., establish inventory limits).
The specification of certain LLRW for which the performance period
calculations apply to eliminates the need for all licensees or license
applicants to develop performance period analyses. However, the
language ``or if necessitated by site-specific conditions'' is needed
because it is difficult to determine an absolute threshold for all
sites below which the projected radiological risk, especially for 10
CFR 61.41, would be acceptably low. The risk to the public from the
land disposal of LLRW can be driven by many variables, including but
not limited to, concentration of LLRW, quantity of LLRW, disposal
facility design, hydrogeology, release pathways, and receptor location
and behavior. It is technically challenging to reduce this multi-
dimension problem into one-dimension (i.e., concentrations) in a risk-
informed manner. The approach proposed in this rule attempts to address
this issue by providing disposal site-averaged concentrations for which
the long-term radiological risk is expected to be suitably low for most
facilities, but would afford flexibility for additional analyses if
warranted by site-specific conditions. The draft guidance document
describes the types of conditions that may warrant performance period
analyses even with the disposal of low concentrations of long-lived
LLRW.
The reasons for selecting this option are:
The tiered analysis that is required allows for tailoring
of the analysis to the problem.
The 1,000 year compliance period, appropriate for the
disposal of short-lived LLRW, would ensure consistency among Agreement
State regulators.
By providing a 1,000-year compliance period, it would
limit speculation and limit the impact of uncertainties on the
compliance period decision making.
By providing a protective assurance period, it would
ensure that radiological impacts are minimized up to 10,000 years after
closure. The miminization process would strive to maintain doses below
5 mSv/yr (500 mrem/yr) thereby providing protection to the public from
the disposal of long-lived LLRW.
By providing a goal rather than a limit for the second
tier (i.e., between 1,000 and 10,000 years), it would recognize the
uncertainty about future society and environmental characteristics and
allow consideration of economic and technological arguments to justify
that doses are minimized to a level that is reasonably achievable. It
may be economically and technically justifiable to reduce doses well
below the target.
Selective constraints are provided while affording
regulatory flexibility, where warranted.
H. Why are the 1,000-year compliance period and 10,000-year protective
assurance period appropriate?
The NRC's perspective is that impacts should be reliably calculated
for the compliance period. The NRC is proposing to manage the
increasing uncertainties associated with long timeframes by limiting
the timeframe of the analyses and the scope of the analyses. Licensing
decisions should be based on information that is reasonable, reliable,
and knowable based on current understanding. The proposed approach
limits the consideration of uncertainties associated with long
timeframes.
One of the factors underlying the proposed approach was the DU LLRW
stream. The DU radiological characteristics are somewhat unique in that
DU is very long-lived and there is potentially a large quantity of DU
that needs to be disposed. In addition, the hazard of DU increases over
very long periods of time because of the slow decay of uranium and the
in-growth of progeny. The time at which the concentration of
radionuclides in the LLRW is within one order of magnitude of the peak
concentration is sensitive to the assumed isotopic mass fractions in
the initial LLRW. For depleted uranium this time is approximately
10,000 years or longer. The recommended approach is suitable for
depleted uranium because though the impacts after 1,000 years would not
be part of a compliance decision, they would be considered in the
licensing process and a licensee must demonstrate that the impacts have
been minimized after 1,000 years.
Performing analyses that ensure public health and safety are
protected
[[Page 16098]]
when disposing of long-lived LLRW, and considering the information from
the analyses in the decision-making process, is a risk-informed
approach. However, it is not a risk-informed approach to disregard
potential long-term impacts in the decision-making process because of
large uncertainties without applying other regulatory requirements to
ensure public health and safety will be protected. It would also not be
a risk-informed approach to apply expensive and burdensome requirements
on the present generation to offset hypothetical and unknown risks to
generations long into the future. The proposed three-tiered approach
balances these competing influences by having a 1,000-year compliance
period, followed by site-specific technical analyses (minimization) for
the period up to 10,000 years, and additional analyses beyond 10,000
years, when sufficient quantities and concentrations of long-lived LLRW
would be disposed of. In the analyses performed in 2008 as part of the
development of SECY-08-0147, the NRC staff estimated that concentrated,
long-lived LLRW (e.g., DU) could be disposed of in the near-surface but
only in either limited quantities or under certain conditions. Without
specifying regulatory requirements to either identify when the
conditions for disposal are appropriate or to prevent disposal under
inappropriate conditions, there may be instances when the performance
objectives will not be met. Most other concentrated, long-lived LLRW in
significant quantities may need some type of restrictions for near
surface disposal. The proposed approach is to use site-specific
technical analyses to identify what restrictions are necessary. Because
waste disposal is a proposed future action, when all else fails or is
too uncertain, inventory limits can be used to mitigate future risks.
I. Why is a 5 milliSievert per year (500 mrem per year) target
appropriate for dose minimization during the protective assurance
period?
Given the significant uncertainties inherent in demonstrating
compliance with the performance objectives over a very long timeframe
and to ensure a reasonable analysis, the analyses would be required to
demonstrate that the annual dose should be minimized below 5 mSv (500
mrem) or a level that is supported as reasonably achievable based on
technological and economic considerations from the end of the
compliance period through 10,000 years. This 500 mrem/yr minimization
target was chosen to limit releases to values that have been previously
established by the NRC in 10 CFR part 20. For example, paragraph (e) in
10 CFR 20.1403, ``Criteria for license termination under restricted
conditions,'' and paragraph (d) in 10 CFR 20.1301, ``Dose limits for
individual members of the public,'' require annual dose limits of 5
milliSievert (500 mrem) in limited cases. This approach is designed to
provide a target for minimization that takes into account the
significant uncertainties over these long periods of time. As discussed
in the guidance document, the minimization process most likely will
result in projected impacts that are significantly lower then this
mimization target. The NRC is seeking feedback on the proposed
approach, especially with regard to whether a 5 milliSievert (500 mrem)
annual dose goal is appropriate for the protective assurance period and
whether it is appropriate to consider alternative, higher levels based
on technological and economic considerations.
J. What are waste acceptance criteria (WAC)?
The NRC's current WAC can be found in subpart D of 10 CFR part 61,
which specifies technical requirements for land disposal facilities for
commercial LLRW. The technical requirements specify the classes and
characteristics of LLRW that are acceptable for near-surface disposal,
as well as other requirements. Currently, 10 CFR 61.55 provides the
primary criteria related to LLRW acceptance and identifies the classes
of LLRW acceptable for near-surface disposal (i.e., the LLRW
classification system). Section 61.56 identifies the minimum
characteristics for all classes of LLRW and characteristics intended to
provide stability of certain LLRW (i.e., Class B and Class C LLRW).
Additionally, 10 CFR 61.52(a) specifies requirements for near-surface
LLRW disposal facility operation, including segregation and intruder
barrier requirements for various classes of LLRW. Section 61.58
currently allows for other provisions for the classification and
characteristics of LLRW on a case-by-case basis if, after evaluation,
the Commission finds reasonable assurance of compliance with the
performance objectives.
The LLRW classification system is well integrated with the
requirements for LLRW characteristics and disposal facility operation.
This integration stemmed from the generic nature of the original
regulatory basis for 10 CFR part 61. The integrated requirements are
intended to ensure that the performance objectives are met.
In addition to reviewing other regulatory approaches, the NRC also
considered the original regulatory basis for 10 CFR part 61 in the
development of the proposed revisions to 10 CFR 61.58. The principle
basis used for setting the current 10 CFR part 61 classification
limits, LLRW characteristic requirements, and operational requirements
was limiting exposures to a potential inadvertent intruder at a
reference LLRW disposal facility. Other considerations, such as long-
term environmental impacts, LLRW disposal facility stability,
institutional control costs, and financial impacts to small entities,
were also considered. The NRC developed the LLRW classification system
in 10 CFR part 61 from an analysis performed in 1981 of a
representative LLRW disposal facility that was operated consistent with
then-current practices and considered a projected set of LLRW streams
(46 FR 38081; July 24, 1981). Specifically, the LLRW class limits were
derived from an analysis that considered a combination of factors
including radionuclide characteristics and concentrations, the
wasteform, the methods of emplacement, and to some extent, the site
characteristics. These factors influenced the concentration of
radionuclides transferred from the disposed LLRW to the access points
for the intruder scenarios. These factors are dependent upon the LLRW
disposed, methods of emplacement, engineering design, and site
characteristics, which can vary from facility to facility.
For example, one of the factors the NRC considered is site
characteristics, which plays a role in the movement of radionuclides
between environmental media (e.g., soil to air). The movement of
radionuclides depend on the environmental conditions at the location of
the LLRW disposal facility. The reference LLRW disposal facility used
in the original regulatory basis was not intended to represent any
particular location, but rather, it was used to reflect the typical
environmental conditions within its region. The NRC chose the
southeastern region because, at the time, most of the LLRW was produced
in the eastern portion of the nation and was projected to be disposed
regionally. Today, only one of the four operating LLRW disposal sites
is located in the eastern United States; the other three are located in
the arid or semi-arid western United States. The Southeastern region
was selected for the reference facility location because the
environmental characteristics of the reference LLRW disposal facility
were
[[Page 16099]]
expected to be conservative compared to more arid site locations.
Regardless of whether the assumptions regarding the LLRW,
operational practices, facility design, or site characteristics of the
reference LLRW disposal facility are consistent with current
facilities, the NRC believes that the 10 CFR part 61 LLRW
classification system remains protective of public health and safety
for the LLRW streams that were analyzed in the development of the
regulations because of the reasonably conservative nature of the
analysis used to develop the LLRW classification system. However,
inconsistency between actual site conditions and practices at an LLRW
disposal facilities and the generic assumptions used to develop the
LLRW classification system may cause the radionuclide concentration
limits to be either overly restrictive or permissive. If radionuclide
concentration limits are overly restrictive based on actual site
characteristics, facility design, and operational practices, the LLRW
classification system would ensure the safe disposal of LLRW, but it
would impose unnecessary regulatory burdens on licensees and LLRW
generators. Whereas, if the generic concentration limits at a LLRW
disposal facility are overly permissive based on actual site
characteristics, facility design, and operational practices, the LLRW
classification system alone may not adequately ensure the protection of
public health and safety. If the Commission found that the LLRW
classification requirements were overly permissive at a particular
disposal facility, it could impose additional requirements to ensure
that the 10 CFR part 61 performance objectives would be met. Therefore,
it's the 10 CFR part 61 performance objectives that ultimately ensure
protection of public health and safety. However, the inconsistency
between the generic assumptions and current practices highlights the
need for flexibility to develop site-specific WAC. The site-specific
WAC would provide assurance that public health and safety can be
protected, while offering the possibility for the relief of unnecessary
regulatory burdens for facilities with superior site characteristics,
design, and operational practices. The specifics of WAC background
information, other regulatory approaches regarding LLRW acceptance
practices, technical considerations, and public comments are discussed
further in Section 5.2, ``Flexibility for Site-Specific Waste
Acceptance Criteria,'' of the regulatory basis document issued in
December 2012.
In addition to considering the original regulatory basis for 10 CFR
part 61, the NRC also performed a review of other regulatory
approaches, domestic and international, regarding LLRW acceptance
practices to develop the proposed revisions to 10 CFR 61.58. In
general, practices vary but are constrained between specification of
criteria by the regulatory agency and development of site-specific WAC
by LLRW disposal facility operators. In all cases, the regulatory
authority maintains oversight of disposal, including approval of the
LLRW acceptance requirements.
1. Options Considered
The NRC considered three options for revising the regulatory
framework associated with waste acceptance criteria for the near-
surface disposal of LLRW. In the first option, the NRC considered
maintaining the current approach for determining LLRW acceptability,
namely the generic LLRW classification system. The NRC staff also
considered a second option, in which the current LLRW classification
system is replaced with criteria allowing flexibility for licensees or
license applicants to determine site-specific WAC. Finally, the NRC
considered a third option that would add flexibility to establish site-
specific WAC to the existing LLRW classification system. These options
are summarized as follows:
Option 1. No change from current approach. The regulations in 10
CFR part 61 currently provide general criteria for LLRW acceptability
for near surface disposal through the classification and LLRW
characteristics requirements set forth in 10 CFR 61.55 and 10 CFR
61.56. Because of the conservative nature of the assumptions used in
the original 10 CFR part 61 regulatory basis to develop the LLRW
classification, the LLRW classification system is expected to be
protective of public health and safety as long as LLRW disposal
facilities operate within the regulatory basis of the original 10 CFR
part 61 regulations.
However, new practices that differ from the assumptions of the
original analyses create uncertainty regarding the protectiveness of
the LLRW classification system. For instance, new LLRW streams that
were not considered during the development of 10 CFR part 61 are being
considered for disposal (e.g., large quantities of concentrated DU and
LLRW resulting from the production of medical isotopes). Also, current
LLRW disposal facility design and operational practices can differ from
the generic assumptions employed in the development of the LLRW
classification system (e.g., disposal of LLRW containers in concrete
vaults).
Currently, 10 CFR part 61 allows for alternative provisions for
LLRW acceptability (i.e., LLRW classification and characterization) on
a case-by-case basis through 10 CFR 61.58. Section 61.58 allows the
Commission, either upon request or upon its own initiative, to
authorize alternate provisions for classification or characteristics of
LLRW. The requirements for LLRW classification and characteristics are
found in 10 CFR 61.55 and 10 CFR 61.56, respectively. Such alternative
provisions could be authorized after an evaluation showing that the
specific LLRW disposal facility, and disposal method being proposed,
would provide reasonable assurance of compliance with the performance
objectives. Agreement States that regulate LLRW facilities would apply
their own regulatory provisions in these situations.
At present, only one of the four Agreement States that has an
operating near-surface LLRW disposal facility has adopted a
corresponding regulation to 10 CFR 61.58. Currently, Agreement States
are not required to adopt 10 CFR 61.58, therefore, the Agreement State
compatibility designation for 10 CFR 61.58 must be changed in order to
require Agreement States to adopt an alternative provision for LLRW
classification and characteristics. Agreement State compatibility
designation for 10 CFR 61.58 is discussed further in Section VI,
``Agreement State Compatibility,'' of this notice.
Option 2. Site-specific waste acceptance approach. Another possible
approach to provide flexibility for licensees or license applicants to
determine site-specific WAC would be for the NRC to abandon the
existing LLRW classification system and replace it with requirements
for developing site-specific WAC from the results of the site-specific
technical analyses. This approach would require LLRW disposal
facilities to define the acceptability of LLRW. In defining LLRW
streams with acceptable radionuclide concentrations or activities and
wasteforms, LLRW disposal facilities would be required to use the
results of the site-specific technical analyses set forth in the
proposed 10 CFR 61.13. Under the site-specific LLRW acceptance
approach, licensees and license applicants would also need to develop
strategies for characterizing LLRW and methods to certify that LLRW
meets acceptance criteria that are commensurate with the
[[Page 16100]]
analyses used to derive the site-specific WAC.
Removal of the current LLRW classification system from 10 CFR part
61 would present challenges because the LLRW classification
requirements are well integrated with other requirements of 10 CFR part
61. For instance, license requirements for the operation of a LLRW
disposal facility may reference the LLRW classes of 10 CFR 61.55.
Therefore, complete replacement of the LLRW classification system would
likely expand the effect of the rule revisions beyond the intended
scope of this rulemaking.
Further, removal of the LLRW classification system from 10 CFR part
61 would not result in total abandonment of the system because the
classification of LLRW is referenced in the Low-Level Radioactive Waste
Policy Act of 1980 (as amended in 1985). The Low-Level Radioactive
Waste Policy Act of 1980 (as amended in 1985) establishes Federal and
State responsibilities for the disposal of LLRW based on the LLRW
classification system in 10 CFR part 61 as it existed on January 26,
1983. Specifically, Section 3 of the Low-Level Radioactive Waste Policy
Act of 1980 (as amended in 1985) states that the responsibilities of
each State shall include the disposal of LLRW generated within the
State (other than by the Federal Government) that consists of, or
contains, Class A, Class B, or Class C LLRW, as defined by 10 CFR
61.55, in effect on January 26, 1983. Likewise, the Low-Level
Radioactive Waste Policy Act of 1980 (as amended in 1985) states that
the Federal Government responsibilities shall include LLRW with
concentrations of radionuclides that exceed the Class C limits
established in 10 CFR 61.55 in effect on January 26, 1983.
Because the Low-Level Radioactive Waste Policy Act of 1980 (as
amended in 1985) relies on 10 CFR part 61 as it existed in 1983,
removing the LLRW classification system from 10 CFR part 61 would not
change the assignment of responsibilities for the disposal of
commercial LLRW to the States and Federal Government. Therefore, the
existing LLRW classification system would remain relevant to assigning
responsibilities to the States and Federal Government, regardless of
its presence in 10 CFR part 61.
Removal of the LLRW classification system from 10 CFR part 61,
however, may create confusion among stakeholders about how
responsibility is assigned. One possible approach to avoid confusion
would be to maintain a version of the LLRW classification system in an
appendix to 10 CFR part 61, for the sole purpose of aiding in the
determination of Federal and State responsibilities for the disposal of
LLRW. Alternatively, the LLRW classification requirements could be
included in appendix G to 10 CFR part 20, where LLRW is manifested for
shipment. The purpose of appendix G to 10 CFR part 20 is to address the
various regulatory information needs for the transfer and disposal of
LLRW. These informational needs, which were identified in the Statement
of Consideration that accompanies the final rule (60 FR 15664) include,
among others, access to information needed for assessments to
demonstrate compliance with the performance objectives in 10 CFR part
61. This includes information necessary for the States and Compacts to
carry out their responsibilities. Therefore, preserving the LLRW
classification requirements in appendix G to 10 CFR part 20 would
minimize confusion for shippers to provide accurate information that
allows the States and Compacts to carry out their responsibilities.
The NRC is assuming that changes to the Low-Level Radioactive Waste
Policy Act of 1980 (as amended in 1985) will not be made to accommodate
any revisions to the 10 CFR part 61 regulations. Instead, as previously
noted, the NRC has developed a proposal that would implement this
option without requiring changes to the Low-Level Radioactive Waste
Policy Act of 1980 (as amended in 1985).
Option 3. Hybrid waste acceptance approach. A third approach that
the NRC considered would be to allow licensees or license applicants to
develop site-specific WAC from the results of the technical analyses or
from the requirements of the existing LLRW classification system. This
proposed approach would still require licensees or license applicants
to determine the acceptability of LLRW. In defining LLRW streams with
acceptable radionuclide concentrations or activities and wasteforms,
licensees or license applicants would be allowed to use either the
results of the site-specific technical analyses set forth in 10 CFR
61.13, or the LLRW classification requirements in 10 CFR 61.55. Beyond
the radionuclide limits and acceptable LLRW characteristics, licensees
or license applicants would, as discussed previously in the site-
specific waste acceptance approach, need to develop strategies for
characterizing LLRW and methods to certify that LLRW meets acceptance
criteria.
For licensees that choose to develop WAC based on the LLRW
classification system in 10 CFR 61.55, this approach would not result
in a significant additional burden to their current operating practices
since they are currently using acceptance practices with essentially
the same type of criteria. Licensees typically develop these site-
specific WAC from the existing 10 CFR part 61 requirements and the NRC
guidance.\8\ These licensees would still be required to demonstrate
through the technical analyses set forth in 10 CFR 61.13 that they will
meet the performance objectives. The required analyses may demonstrate
that additional mitigation should be performed for certain LLRW
streams, particularly those that were not considered in the development
of the LLRW classification system.
---------------------------------------------------------------------------
\8\ NRC, ``Branch Technical Position on Concentration Averaging
and Encapsulation'', January 17, 1995, Division of Waste Management.
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Because the hybrid waste acceptance approach would not alter the
LLRW classification requirements in 10 CFR part 61, the approach also
would maintain consistency between the LLRW classification requirements
in 10 CFR part 61 and the assignment of Federal and State
responsibilities in the Low-Level Radioactive Waste Policy Act of 1980
(as amended in 1985), for the disposal of commercial LLRW. For
instance, States may choose to permit the acceptance of LLRW designated
as a Federal responsibility (e.g., greater-than-Class-C LLRW) under the
Low-Level Radioactive Waste Policy Act of 1980 (as amended in 1985), if
the results of the site-specific technical analyses demonstrate that
greater-than-Class-C LLRW would be acceptable for disposal at a
specific disposal facility. Further, under the existing 10 CFR part 61
regulations, though States are responsible for disposal of LLRW with
concentrations less than the upper limits for Class C, some States have
exercised flexibility to further limit disposal of certain LLRW for
which they are responsible at specific LLRW disposal facilities. The
NRC proposes not to alter this flexibility under this proposed
approach. In all cases, the regulatory authority maintains oversight of
disposal, including approval of the LLRW acceptance requirements.
The NRC also considered whether licensees and license applicants
should have the flexibility to consider alternative active
institutional control periods to derive site-specific WAC, under both
the site-specific waste acceptance and hybrid waste acceptance
approaches. To allow this flexibility when developing site-specific
WAC, the NRC would need to revise 10 CFR 61.59 to permit licensees or
license applicants
[[Page 16101]]
to develop site-specific WAC for periods beyond 100 years.
During the original development of 10 CFR part 61, in NUREG-0782,
``Draft Environmental Impact Statement (EIS) on 10 CFR part 61
`Licensing Requirements for Land Disposal of Radioactive Waste' ''
(ADAMS Accession No. ML052590348), the NRC considered a range of time
periods for active institutional controls but decided that 100 years is
an appropriate period for determining how long the government would be
able to ensure custodial care for a near-surface disposal facility.
When the public commented that longer times would be appropriate, the
NRC determined that, while the longevity of government may reasonably
be assumed to extend beyond 100 years, the limit is tied to the
possibility of bureaucratic error, which is more difficult to assess.
For example, the government could, at some future date, unintentionally
permit activities on the site as a result of an incomplete records
search. The NRC indicated that it saw no compelling reason to abandon a
100-year institutional control period. Further, the institutional
control period is a regulatory component of defense-in-depth by
limiting the period of time over which oversight would need to be
effective. Federal regulations for disposal of a variety of waste,
including municipal and hazardous wastes, allow for a wide range of
institutional control periods. International approaches for LLRW
disposal vary for the period over which institutional controls are
assumed to function, but generally they are limited to 300 years or
less. Therefore, allowing unlimited flexibility would appear to be
inconsistent with current international practice regarding the
longevity of institutional controls.
Since the 100-year time duration is an integral assumption in the
analyses that originally derived the radionuclide concentration limits
set forth in 10 CFR 61.55, the hybrid waste acceptance approach would
also need to maintain the current 100-year limit for licensees or
license applicants that continue to use the LLRW classification system.
The NRC maintains its earlier assessment and sees no new compelling
reason to consider a revision to 10 CFR 61.59. Therefore, the NRC
proposes to maintain the 100-year limit set out in 10 CFR 61.59.
2. NRC Proposed Option
In the proposed rule, the NRC is proposing the hybrid waste
acceptance approach (Option 3) as the regulatory LLRW acceptance
framework for the near-surface disposal of LLRW. The hybrid waste
acceptance approach provides a framework for the use of either the
generic LLRW classification system specified in 10 CFR 61.55 or the
results of the technical analyses required in 10 CFR 61.13. Either
approach, when combined with the other revisions recommended for this
rulemaking, would provide reasonable assurance that public health and
safety would be protected. The hybrid waste acceptance approach would
provide a framework for determining LLRW acceptability at a disposal
facility while achieving the following:
Providing flexibility to develop site-specific WAC;
minimizing revisions to 10 CFR part 61;
maintaining consistency with the Low-Level Radioactive
Waste Policy Act of 1980 (as amended in 1985);
limiting additional regulatory burden on licensees and
license applicants;
providing States flexibility to exercise their regulatory
authority within a national framework; and
maintaining consistency with the range of domestic and
international practices for the disposal of LLRW.
The implementation of the hybrid waste acceptance approach would
require revisions to 10 CFR part 61 that allow land disposal facilities
flexibility to establish site-specific WAC based either on the LLRW
classification system specified in 10 CFR 61.55 or the results of the
analyses required in 10 CFR 61.13 for any land disposal facility. The
use of the LLRW classification system would be limited to a near
surface disposal facility because the LLRW classification requirements
were originally developed as technical requirements for disposal in a
near-surface LLRW disposal facility. The revisions would specify the
minimum content of the WAC and the proposed 10 CFR 61.52(a)(12) would
limit the disposal facility to disposing only LLRW that meet the WAC.
The revisions would also require licensees or license applicants to
develop approaches and methods for generators to characterize LLRW, to
certify that LLRW meets acceptance criteria in order to demonstrate
compliance with the WAC, and to annually review the content and
implementation of the LLRW acceptance program. Requiring licensees and
license applicants to specify acceptable methods to characterize LLRW,
ensures that generators appropriately characterize the LLRW and that
the data are sufficient to demonstrate that the disposal facility's WAC
are met. Certification requirements ensure an appropriate
administrative process developed by the licensees or license applicants
is used by generators to demonstrate that the WAC are met, that
necessary records are maintained, and that certified LLRW is managed to
maintain its certification. Resource burdens associated with
administrative and recordkeeping processes used to demonstrate
compliance with disposal facility's WAC requirements are further
discussed in Section X, ``Paperwork Reduction Act Statement,'' of this
document and the accompanying draft regulatory analysis.
Additionally, implementation of the hybrid waste acceptance
approach requires revisions to specific manifesting requirements
specified in sections I, II, and III of appendix G to 10 CFR part 20
and the related guidance in NUREG/BR-0204, ``Instructions for
Completing NRC's Uniform Low-Level Radioactive Waste Manifest'' (ADAMS
Accession No. ML071870172), that provide information considered
important for demonstrating compliance with the performance objectives
and for States and Compacts to carry out their responsibilities under
the Low-Level Radioactive Waste Policy Act of 1980 (as amended in
1985). The proposed revisions to appendix G to 10 CFR part 20 ensure
that specific manifesting requirements, which were previously linked
directly to the LLRW classification requirements, are revised to
maintain consistency with the proposed requirements for LLRW acceptance
in 10 CFR part 61. The proposed revisions to appendix G to 10 CFR part
20 also ensure that information important for States and Compacts to
carry out their responsibilities under the Low-Level Radioactive Waste
Policy Act of 1980 (as amended in 1985) will continue to be reported.
K. What other changes are proposed?
The NRC is proposing additional changes to the 10 CFR part 61
regulations to facilitate implementation and better align the
requirements with current health and safety standards. These changes
would include: (1) Adding new definitions to 10 CFR 61.2,
``Definitions,'' and updating concepts in 10 CFR 61.7; (2) implementing
changes to appendix G to 10 CFR part 20, to conform to proposed LLRW
acceptance requirements; (3) modifying site suitability requirements in
10 CFR 61.50, to be consistent with the proposed analyses framework;
and (4) Updating the dose calculation system used in 10 CFR part 61.
[[Page 16102]]
1. Adding New Definitions to 10 CFR 61.2 and Updating Concepts in 10
CFR 61.7
Currently, 10 CFR 61.2 defines common terms used in 10 CFR part 61
and 10 CFR 61.7 provides conceptual information for the disposal
facility LLRW classification and near-surface disposal, and licensing
process for LLRW disposal facilities. These concepts include
descriptions of: (a) The parameters for near-surface disposal in
engineered facilities and the layout of land and buildings necessary to
carry out the disposal; (b) the safety objectives for near-surface LLRW
disposal, which emphasize the stability of the wasteforms and disposal
sites; and (c) the licensing processes that the licensees or license
applicants go through during the preoperational, operational, and site
closure periods.
The NRC proposes to add definitions and concepts to 10 CFR 61.2 and
10 CFR 61.7, respectively, to support the site-specific technical
analyses and LLRW acceptance requirements. These terms and concepts are
needed to provide consistency and facilitate implementation of the
proposed 10 CFR part 61 regulations.
The NRC is proposing to add definitions for ``compliance period,''
``defense-in-depth,'' ``intruder assessment,'' ``long-lived waste,''
``performance assessment,'' ``performance period,'' ``protective
assurance period,'' and ``safety case'' to facilitate implementation of
the proposed requirements for site-specific analyses. The definitions
for the various analyses and time periods are necessary to support the
requirements for the performance objectives and technical analyses.
Three specific definitions deserve to be discussed in greater detail
are ``long-lived waste'' because the proposed performance period
analyses are only necessary for the disposal of long-lived LLRW,
``defense-in-depth'' because licensees will be required to demonstrate
how the disposal facility relies upon multiple independent and
redundant layers, and ``safety case'' because the requirements are
central to demonstrating that public health and safety will be
adequately protected at present and in the foreseeable future.
The performance period analyses are designed to be completed if a
facility will be disposing of long-lived LLRW. The proposed ``long-
lived waste'' definition contains three components. The first component
is a radionuclide that does not decay sufficiently over the compliance
period. The reason the NRC is expressing this as a percentage of
initial activity of a radionuclide that remains after 10,000 years,
instead of a half-life value such as 3,000 years as suggested by some
members of the public, is to ensure that stakeholders understand that
the ``long-lived waste'' definition is conditional on the analyses
framework. If the analysis framework were to be changed in the future
or if a different framework was used, for instance, in a different
country, a half-life of 3,000 years may or may not be appropriate. The
second component is a long-lived radionuclide parent that produces
short-lived radionuclide progeny. The second component is designed to
ensure that the analysis includes radionuclide progeny, such as those
resulting from the uranium decay series. The third component is a
short-lived radionuclide parent that results in long-lived radionuclide
progeny. Examples would include the curium decay series or the isotope
Am-241 which produces Np-237, a long-lived radionuclide that can be
fairly mobile in the environment. The inventory of LLRW at the time of
disposal can differ considerably from the inventory at future times.
The ``long-lived waste'' definition is designed to take this into
account.
The concept of defense-in-depth has been implicitly used in LLRW
regulations in the past, but it has not previously been explicitly
defined in 10 CFR part 61. Defense-in-depth is implicitly provided
through the various regulatory requirements. For instance, while 10 CFR
61.59 imposes land ownership and institutional control requirements
that are intended to limit the potential for intrusion into a closed
disposal facility, licensees may not take credit for these protections
beyond 100 years when assessing whether the performance objectives will
be met. The NRC's defense-in-depth approach to risk management ensures
that safety is not wholly dependent on any single element of the
design, construction, maintenance or operation of a regulated facility.
With the potential disposal of DU and other long-lived LLRW in shallow
land disposal facilities, defense-in-depth takes on additional
importance and it is now being defined and explicitly used in this
proposed revision to 10 CFR part 61 to provide assurance that safe
disposal can be achieved in light of the significant uncertainties
associated with projecting doses far into the future. Defense-in-depth
for a land disposal facility includes, but is not limited to, the use
of remote siting, consideration of waste forms and radionuclide
content, engineered features, and natural geologic features of the
disposal site.
Regarding the proposed definition for ``safety case,'' licensing
decisions are based on whether there is reasonable assurance that the
performance objectives can be met. The technical analyses are used to
demonstrate that the performance objectives can be met. These analyses
together with defense-in-depth protections and the supporting evidence
and reasoning for the strength and reliability of these analyses and
protections form the ``safety case'' for licensing a LLRW facility. The
safety case must make a convincing conclusion that public health and
safety will be adequately protected from the disposal of LLRW
(including long-lived LLRW). A clear case for the safety of a disposal
facility would also enhance communication among stakeholders.
2. Implementing Changes to Appendix G to 10 CFR Part 20 to Conform to
Proposed LLRW Acceptance Requirements
Appendix G to 10 CFR part 20 imposes manifest requirements on
shipments of LLRW consigned for disposal. The purpose of the
requirements in appendix G to 10 CFR part 20 is to address various
regulatory information needs for the transfer of LLRW. These
information needs, which were identified in the Statement of
Consideration accompanying the current regulations (60 FR 15664),
include access to information needed for the analyses to demonstrate
compliance with the performance objectives and that the States and
Compacts believe is necessary to carry out their responsibilities. In
particular, manifests for LLRW shipments must identify the LLRW
classification and certify that the LLRW is ``. . . properly
classified, described, packaged, marked, and labeled . . . .''
Therefore, the NRC is proposing changes to these requirements to
conform to the proposed addition of the LLRW acceptance requirements in
10 CFR 61.58.
To meet these needs, the requirements in appendix G to 10 CFR part
20 require shippers to properly classify, describe, package, mark, and
label LLRW that will be transferred and is intended for disposal.
Further, shippers must certify that these actions have been completed
in accordance with the applicable requirements, including those in 10
CFR part 61 for LLRW classification (i.e., 10 CFR 61.55),
characteristics (i.e., 10 CFR 61.56), and labeling (i.e., 10 CFR
61.57). Therefore, the NRC is also proposing to amend the regulations
at appendix G to 10 CFR part 20 to conform to the flexibility afforded
by the proposal to determine site-specific WAC.
[[Page 16103]]
Specifically, sections I.C.12 and I.D.4 of appendix G to 10 CFR
part 20 currently require the shipper of LLRW consigned to a LLRW
disposal facility to identify the LLRW classification per 10 CFR 61.55
and to state if it meets the structural stability requirements of 10
CFR 61.56(b) on the uniform manifest. Because the proposed revisions to
10 CFR 61.58 allow a licensee or license applicant to use the
classification system to develop site-specific WAC, shipping manifest
requirements related to LLRW classification will be retained so that
States and Compacts continue to receive information allowing them to
carry out their responsibilities as defined by the Low-Level
Radioactive Waste Policy Act of 1980 (as amended in 1985).
Information on LLRW acceptability at a disposal facility is
essential to demonstrate compliance with the performance objectives.
Therefore, the NRC proposes adding a requirement to section II of
appendix G to 10 CFR part 20 to specify in the uniform manifest whether
the LLRW being shipped to a disposal facility conforms to the
facility's WAC. The addition of this requirement would also require a
revision of NRC Form 541, ``Uniform Low-Level Radioactive Waste
Manifest-Container and Waste Description,'' to conform to this new
requirement and the accompanying guidance NUREG/BR-0204, Revision 2.
Further, the proposed requirements for LLRW acceptance would
require revisions to the certification requirements of section II of
appendix G to 10 CFR part 20. Section II requires LLRW generators,
processors, or collectors to certify that the transported LLRW is
properly classified. Since the proposed 10 CFR part 61 requirements
would require licensees and license applicants to develop criteria for
LLRW acceptability using either the existing LLRW classification system
or the results of site-specific analyses, this certification
requirement would be updated so that shippers are certifying that LLRW
consigned to a disposal facility meets the facility's waste acceptance
criteria for LLRW acceptability.
The proposed 10 CFR part 61 requirements for LLRW acceptability
would also require revisions to section III of appendix G to 10 CFR
part 20. Section III of appendix G to 10 CFR part 20 imposes
requirements on the control and tracking of LLRW transferred to a
disposal facility. Specifically, current sections III.A.1 through 3 and
III.C.3 through 5 require the LLRW to be classified according to 10 CFR
61.55 and meet the LLRW characteristics requirements in 10 CFR 61.56.
The container must be labeled with the appropriate LLRW class, and the
licensee who transfers the LLRW must implement a quality assurance
program to assure compliance with 10 CFR 61.55 and 10 CFR 61.56. Since
the proposed 10 CFR part 61 requirements would require licensees or
license applicants to develop criteria for LLRW acceptability using
either the existing LLRW classification system or the results of site-
specific technical analyses, these requirements would be revised so
that shippers are preparing, labeling, and providing quality assurance
in accordance with the disposal facility operator's criteria for LLRW
acceptability.
3. Modifying the Site Suitability Requirements in 10 CFR 61.50 To Be
Consistent With the Proposed Analyses Framework
The site suitability requirements in 10 CFR 61.50 specify the
minimum characteristics a disposal site must possess to be acceptable
for use as a near-surface disposal facility. The primary factors
considered for disposal site suitability are isolation of LLRW--which
is dependent on the radiological characteristics of the LLRW--and
disposal site features that ensure that the long-term performance
objectives of subpart C of this part are met, as opposed to short-term
convenience or benefits. The concept of site characteristics is
explained in 10 CFR 61.7. Site characteristics should be considered in
terms of the indefinite future, take into account the radiological
characteristics of the LLRW, and be evaluated for at least a 500-year
timeframe. Site characteristics and site suitability requirements play
an integral role in ensuring that the site is appropriate for the type
of LLRW proposed for disposal. When the site suitability requirements
were originally developed, it was envisioned that LLRW would primarily
contain short-lived radionuclides with low concentrations of long-lived
radionuclides. The NRC developed the LLRW classification framework
around this concept. However, the regulation at 10 CFR 61.55(a)(6)
allows long-lived LLRW not currently listed in table 1 or 2 of 10 CFR
61.55 to be disposed in the near surface as Class A LLRW.
In the proposed revision, it is recognized that not all LLRW may
decay to relatively innocuous levels within 500 years and so a
technical analysis would be required to determine if site-specific
restriction of disposal of LLRW is necessary. The regulation at 10 CFR
61.50 would be revised to clarify the interpretation of site
characteristics. The site suitability characteristics have not been
changed, but have been reorganized to distinguish the hydrological site
characteristics from other characteristics. The hydrological site
characteristics have been separated to clarify that for 500 years the
hydrological site characteristics must be met regardless of the results
of any technical analyses. Historically, most of the problems
encountered in LLRW disposal resulted from water impacting the LLRW
disposal system. A site that is unlikely to satisfy the hydrological
site characteristics (e.g., disposal of LLRW in the zone of water table
fluctuation, flooding) in the next 500 years is unlikely to be
defensibly characterized and modeled. If the site cannot be defensibly
characterized and modeled, the radiological risk from the disposal of
LLRW cannot be reliably projected. The short-lived radionuclides that
are disposed of can result in significant impacts if they are
improperly managed. Therefore, the hydrological site characteristics
are treated differently than the other site characteristics. After 500
years for hydrological characteristics and for all timeframes for other
characteristics, it is appropriate to consider if the characteristics
will limit the ability of the licensee or applicant to meet the 10 CFR
part 61 subpart C performance objectives. Historically, the other
characteristics have not been associated to a significant degree with
problems encountered in LLRW disposal. Therefore it is anticipated that
it is less likely that the other characteristics will be associated
with performance issues compared to the hydrological characteristics.
The proposed revisions to 10 CFR 61.50 clarify the requirements for
site suitability. Stability is a cornerstone of waste disposal. Future
instability of a waste disposal site may provide the basis to limit or
prohibit disposal of certain types of waste if the stability of the
disposal site cannot be ensured. Future instability of a disposal
facility may prohibit accurate characterization and performance
assessment modeling.
4. Updating the Dose Calculation System Used in 10 CFR Part 61
Currently, 10 CFR 61.41 requires that concentrations of radioactive
material released to the general environment ``not result in an annual
dose exceeding an equivalent of 0.25 mSv (25 mrem) to the whole body,
0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to any other
organ of any member of the public.'' The objective of modeling in a
performance assessment that would be
[[Page 16104]]
used to evaluate compliance with 10 CFR 61.41 is described in NUREG-
1573, and provides estimates of doses to humans from radioactive
releases from an LLRW disposal facility after it has been closed.
Currently, 10 CFR part 20 provides for the use of current NRC
health physics practices for NRC licensees. In May 1991, the NRC
updated 10 CFR part 20 based on a dosimetric modeling and effective
dose equivalent approach described in the International Commission on
Radiological Protection (ICRP) Publications 26 and 30.\9\ In 1991, the
10 CFR part 20 standards were updated to the total effective dose
equivalent (TEDE) approach, consistent with the Federal radiation
protection guidance signed by the President on January 20, 1987 (56 FR
23360), for occupational exposure to implement the ICRP recommendations
found in Publication 26. The current 10 CFR part 61 dose limits, and
several others within the regulations, stem from a method of
calculating and limiting doses that date back to the late 1950s and
were based on recommendations in ICRP Publication 2.\10\ The NRC
proposes to revise the 10 CFR part 61 regulations to require licensee
to use the dose calculation methodology found in ICRP Publication 26
and allow the use of more up-to-date ICRP recommendations for dosimetry
modeling purposes.
---------------------------------------------------------------------------
\9\ ICRP, ``Recommendations of the International Commission on
Radiological Protection,'' Annals of the ICRP, Vol. 1, No. 3, 1977,
(ICRP Publication 26); ICRP, ``Limits for Intakes of Radionuclides
by Workers,'' Annals of the ICRP (Part 1), Vol. 2, Nos. 3-4, 1979,
(ICRP Publication 30).
\10\ ICRP, ``Report of ICRP Committee II on Permissible Dose for
Internal Radiation (1959), with Bibliography for Biological,
Mathematical and Physical Data,'' Health Physics, Vol. 3, [1959],
(Reprinted in 1975 as ICRP Publication 2).
---------------------------------------------------------------------------
The topic of using updated dosimetry has been raised before. In the
matter of the NRC's site-specific regulations for a geologic repository
for high-level radioactive waste at Yucca Mountain, for example, the
Commission was aware of the potential for future updates to the ICRP's
recommendations that might be available following promulgation of its
regulations in 10 CFR part 63, ``Disposal of High-Level Radioactive
Wastes in a Geologic Repository at Yucca Mountain, Nevada.'' As a
consequence, rather than index the site-specific regulations to a
particular version of the ICRP, the Commission alternatively allowed
the DOE to use ``. . . the most current and appropriate . . .''
dosimetry in its performance assessment calculations, without
specifying which particular version or edition of that guidance to
employ. Any updated radiation and organ or tissue weighting factors,
however, would need to have been incorporated by the U.S. Environmental
Protection Agency (EPA) into Federal radiation protection guidance. The
Commission also stated that, ``Additionally, as scientific models and
methodologies for estimating doses are updated, the DOE may use the
most current and appropriate (e.g., those accepted by the ICRP)
scientific models and methodologies to calculate the TEDE. The
weighting factors used in the calculation of the TEDE must be
consistent with the methodology used to perform the calculation'' (74
FR 10828; March 13, 2009). The specific language in current 10 CFR
63.102(o), ``Concepts,'' reads, in part, as follows:
After the effective date of this regulation, the Commission may
allow [a licensee] to use updated factors, which have been issued by
consensus scientific organizations and incorporated by EPA [U.S.
Environmental Protection Agency] into Federal radiation guidance.
Additionally, as scientific models and methodologies for estimating
doses are updated, [a licensee] may use the most current and
appropriate (e.g., those accepted by the International Commission on
Radiological Protection) scientific models and methodologies to
calculate the TEDE. The weighting factors used in the calculation of
TEDE must be consistent with the methodology used to perform the
calculation.
The topic of using updated methodology and terminology was also
addressed by the Commission in SRM-SECY-12-0064, ``Recommendations for
Policy and Technical Direction to Revise Radiation Protection
Regulations and Guidance,'' dated December 17, 2012 (ADAMS Accession
No. ML12352A133). The Commission approved the staff's development of
the regulatory basis for a revision to 10 CFR part 20 to align with the
most recent methodology and terminology for dose assessment. The
Commission further directed that appropriate steps should be undertaken
to assure that conforming changes are made as soon as practical to make
these methods consistent throughout all NRC regulations.
During the development of the regulatory basis that supports this
rulemaking, the majority of the public commenters supported the
proposal to allow licensees or license applicants the flexibility to
use the latest ICRP dose methodologies in a site-specific performance
assessment. However, some people questioned the value and the safety
significance in removing critical organ dose limits in updating the
dose limits in 10 CFR 61.41.
The benefit of updating the dose limit to an effective dose,
whether it is the TEDE or a more current effective dose methodology, is
that it provides a holistic and consistent evaluation of the risks of
radiation, whether the worker or member of the public is exposed from
external radiation, inhalation, ingestion, or some combination of
these. Because an effective dose methodology compares, and more
importantly, sums the doses from different organs, exposure routes, and
radionuclides, an overall risk is evaluated. This was not possible with
the critical organ system provided by the ICRP Publication 2. When the
ICRP Publication 2 was developed, organ weighting factors were unknown.
The doses to different organs, in the critical organ system, do not
account for the radiosensitivity of the organ, nor did the system use
the wider range of organs and tissues evaluated with modern approaches.
A holistic approach provides a large benefit in LLRW disposal dose
assessment because of the range of radionuclides that co-mingled within
the LLRW. Each radionuclide has its own predominant exposure pathway
and dose rate, depending on the manner in which a member of the public
may get exposed. Without a holistic method that sums the total
exposures across exposure pathways and radionuclides, a risk-informed,
performance-based decision is harder to make, as the doses between
scenarios or situations would not be comparable especially when one is
trying to optimize the resources to provide maximum protection within
the disposal system.
The critical organ dose approach was developed to limit doses from
the intake of radioactive materials. In the critical organ dose
approach, doses to a limited number of individual organ systems were
calculated based on models of the movement of elements within the human
body. For example, iodine collects mainly in the thyroid, ingested
uranium provides doses largely to the bones and kidneys, ingested
cesium provides doses to multiple organ systems with total body or
liver being the critical organ.\11\ However, the potential result of a
dose to a specific organ was not well-known at the time. Without this
radiosensitivity information, doses could not be added together to
evaluate the overall risk to the individual from radionuclides present
in multiple organs. In addition, any external dose was only added to
the ``whole body'' critical organ (which is not directly comparable to
the TEDE in the ICRP Publication 26 or later
[[Page 16105]]
publications). Because of the uncertainty, limits for the public were
developed that gave each of the organs equal weighting, except the
thyroid (for which some data was available). In the final rule for 10
CFR part 20 (56 FR 23360), the NRC responded to comments about proposed
appendix B as follows:
---------------------------------------------------------------------------
\11\ Battelle Pacific Northwest Laboratories, ``Age-Specific
Radiation Dose Commitment Factors for a One-Year Chronic Intake,''
NUREG-0172, NRC, November 1977 (Adams Accession No. ML14083A242).
The former ICRP-2 ``critical organ'' concept based the limiting
intake upon controlling the dose rate to the organ receiving the
highest dose rate (the ``critical organ''). The doses to organs
other than the critical organ did not have to be evaluated, even if
these doeses [sic] were close to the estimated dose to the critical
---------------------------------------------------------------------------
organ.
The TEDE approach, recommended in ICRP Publication 26, and
subsequently updated by ICRP Publication 60 and ICRP Publication 103,
uses a different approach to limiting the risk from radiation. Because
more information on the risk associated with dose to specific organs
exists, it is possible to calculate the overall increased risk of
stochastic effects (e.g., cancer) to an individual. Each of the major
organ or tissue systems and the six remaining highest organs or tissues
were assigned weighting factors based on the age and gender averaged
risk for each organ or tissue. The internal dose to each organ system
from an intake of a radionuclide, or mixture of radionuclides, is
calculated, multiplied by the appropriate weighting factor, and then
the results are summed to give a risk-weighted ``effective dose.'' To
calculate the TEDE, the external dose is added to the risk-weighted
effective dose. This radiation protection system therefore reflects the
doses to all principal organs or tissues that are irradiated, not just
the one organ that receives the highest dose, as was done in 10 CFR
part 20 before 1991.
In the TEDE approach, the dose to individual organs also needs to
be considered to ensure that deterministic effects do not occur. For
this reason, an organ limit of 0.5 Sv (50 rem) is applied in addition
to the TEDE dose limit for workers of 50 mSv (5 rem). Because the dose
limit in 10 CFR part 20 for a member of the public is 50 times less
than the occupational limit, the same concern for deterministic effects
in organs does not occur. As noted in appendix B to 10 CFR part 20,
``Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs)
of Radionuclides for Occupational Exposure; Effluent Concentrations;
Concentrations for Release to Sewerage,'' consideration of
nonstochastic effects is unnecessary at the dose levels established for
members of the public because the organ dose can never reach the organ
limit for the nonstochastic effects of 0.5 Sv/year (50 rem/year),
without the TEDE dose being greater than the public dose limit (or any
fraction of the public dose limit stated in 10 CFR 61.41(a)).
Therefore, in modifying a dose limit such as 10 CFR 61.41(a) to be
consistent with 10 CFR part 20, organ dose limits are unnecessary. The
TEDE approach protects all the organ systems and provides adequate
protection to members of the public, from both individual
radionuclides, as well as multiple radionuclides through all exposure
routes (i.e., external, inhalation, and ingestion). In addition, the
proposed regulations in 10 CFR 61.41(b) and 10 CFR 61.42(b) do provide
a pathway for a licensee to exceed the proposed minimization target of
5 milliSieverts per year (500 millirems per year) by demonstrating a
level that is supported as reasonably achievable based on technological
and economic considerations. However, the NRC does not anticipate that
technological and economic considerations could justify a target that
would necessitate the consideration of nonstochastic effects.
The NRC considered the following three options to revise the 10 CFR
part 61 regulations to allow the use of more up-to-date ICRP
recommendations for dosimetry modeling purposes:
Option 1. No change from current approach. The NRC considered
allowing the rule to remain silent on this matter and address the issue
in the accompanying LLRW performance assessment guidance.
Option 2. Edition-specific approach. The NRC considered requiring a
dose calculation approach found in ICRP Publication 26 and specifying
in the regulations which version of the ICRP the licensees or license
applicants should implement in any 10 CFR part 61 license application.
Option 3. Edition-neutral approach. The NRC considered requiring a
dose calculation approach found in ICRP Publication 26 and adopting an
edition-neutral approach, to allow the use of more up-to-date ICRP
recommendations, for dosimetry modeling purposes.
The NRC is proposing to adopt option 3, the edition-neutral
approach, for the revision of the 10 CFR part 61 regulations, to allow
the use of more up-to-date ICRP recommendations for dosimetry modeling
purposes. The NRC favors this approach because it has already approved
and implemented this particular type of regulatory approach in its 10
CFR part 63 regulations. As the ICRP's recommendations have
historically been updated more frequently than the Commission's LLRW
regulations, adopting an edition-neutral approach in the regulations
would obviate the need for updating 10 CFR part 61 at some future date
in response to some comparable update to Federal radiation protection
guidance and the associated ICRP recommendations provided that the
guidance and the ICRP recommendation continue to ensure the Agency's
approach to adequate protection. Licensees would need to use the dose
calculation method required in 10 CFR part 20 (currently based on ICRP
Publication 26). Since 10 CFR part 61 would not refer to a specific
dose calculation method, the general radiation protection regulations
of 10 CFR part 20 would apply.
5. Implementing the Safety Case in 10 CFR Part 61
Licensees are responsible for demonstrating that their land
disposal facilties are constructed, operated, and closed safely. To
this end, 10 CFR part 61 establishes requirements that licensees must
meet to demonstrate that a land disposal facility will be constructed,
operated, and closed so as to provide reasonable assurance that public
health and safety and the environment will be protected. While the NRC
believes that the existing requirements specified in 10 CFR 61.10
through 10 CFR 61.16, together with the performance objectives of
subpart C and the technical requirements of subpart D, ensure that a
licensee demonstrates the safety of a land disposal facility, the
regulations do not explicitly establish requirements for the
development of a safety case.
The safety case concept in the context of radioactive waste
disposal, which has been developed internationally, is generally
regarded as a collection of arguments and evidence to demonstrate the
safety and performance of a disposal facility. A safety case for a land
disposal facility covers the suitability of the site and the design,
construction and operation of the facility, as well as the assessment
of radiation risks and assurance of the adequacy and quality of all of
the safety related work associated with the disposal facility. The
purpose of a safety case is to provide a sufficient level of detail
regarding the description of all safety relevant aspects of the site,
the design of the facility, and the managerial control measures and
regulatory controls to inform the decision whether to grant a license
for the disposal of LLRW and provide the public assurance that the
facility will be
[[Page 16106]]
designed, constructed, operated, and closed safely.\12\
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\12\ IAEA Safety Standards Series No. SSG-23. The Safety Case
And Safety Assessment For The Disposal Of Radioactive Waste Specific
Safety Guide International Atomic Energy Agency Vienna, 2012.
---------------------------------------------------------------------------
The NRC believes that the current 10 CFR part 61 implicitly
includes components of the safety case concept. For instance, an
important component of the international safety case concept is the
safety assessment, which consists of the assessment of radiological
impacts as well as an analysis of site and engineering aspects and
operational safety. Currently, the NRC's regulations at 10 CFR 61.13
require analyses that achieve the intent of a safety assessment.
The safety case, as specified in the proposed requirements, would
include the same type of information currently required to be submitted
as part of a license application. To explicitly ensure that a robust
safety case is made for each disposal facility, the NRC is proposing
requirements that licensees prepare a safety case that demonstrates the
assessment of the safety of a land disposal facility. In explicitly
specifying a requirement for a safety case, the NRC is proposing to
require the incorporation of the safety assessment and defense-in-depth
components into the safety case.
The revised regulations would incorporate the 10 CFR 61.13 analyses
into the licensee's safety case. Further, the proposed regulations also
would require new defense-in-depth analyses in 10 CFR 61.13 which would
add an explicit assessment of defense-in-depth provisions to the
proposed safety case. Finally, the NRC envisions that the safety case
for a land disposal facility would evolve over time as new information
is gained during the various phases of the facility's development and
operation. Therefore, the NRC expects that the safety case will be
updated as new information that could significantly impact safety of
the facility is learned and is proposing that the application for
closure of a licensed land disposal facility must include a final
revision to the safety case.
L. What guidance document will be available?
As previously noted, the NRC is making available for public comment
a draft guidance document, ``Guidance for Conducting Technical Analyses
for 10 CFR part 61'' (Docket ID NRC-2015-0003), concurrent with this
proposed rule. The draft guidance document is intended to supplement
existing guidance on performance assessment (e.g., NUREG-1573, ``A
Performance Assessment Methodology for Low-Level Radioactive Waste
Disposal Facilities--Recommendations of NRC's Performance Assessment
Working Group,'' issued in October 2000; and NUREG-1854, ``NRC Staff
Guidance for Activities Related to U.S. Department of Energy Waste
Determinations--Draft Report for Interim Use,'' issued in August 2007)
and to provide additional guidance on the new requirements that would
be added to 10 CFR part 61 by this rulemaking. The draft guidance
covers performance assessment topics such as source term, radionuclide
transport, consideration of uncertainty, and model support. It also
represents detailed guidance on conducting technical analyses, such as
intruder assessment, analysis of site stability after closure of the
disposal site, a performance period analysis for the disposal site
beyond the compliance period, and an analysis demonstrating the
disposal facility includes defense-in-depth protections. Additionally,
the document contains guidance on acceptable approaches for determining
WAC based on the results of the site-specific analyses, establishing
LLRW characterization methods, and implementing a certification
program. The document also contains guidance on conducting risk-
informed, performance-based analyses; general technical analysis
considerations, such as the incorporation of features, events, and
processes into performance assessments; as well as other
considerations, such as setting inventory limits, mitigation
techniques, and demonstration of defense-in-depth.
M. Are there any cumulative effects of regulation associated with this
proposed rule?
In the SRM to SECY-11-0032, ``Consideration of the Cumulative
Effects of Regulation in the Rulemaking Process'' (ADAMS Accession No.
ML112840466), dated October 11, 2011, the Commission provided direction
to the staff on issues related to the implementation of the cumulative
effects of regulation process enhancements. The concept of cumulative
effects of regulation describes the challenges that licensees, or other
impacted entities (such as State partners) face while implementing new
regulatory positions, programs, and requirements (e.g., rules, generic
letters, backfits, or inspections). Cumulative effects of regulation is
an organizational effectiveness challenge that results from a licensee
or impacted entity implementing a number of complex positions, programs
or requirements within a limited implementation period and with
available resources (which may include limited available expertise to
address a specific issue). Cumulative effects of regulation can
potentially distract licensees from executing other primary duties that
ensure safety or security. The NRC is specifically requesting comment
on the cumulative effects of this rulemaking. In developing comments on
cumulative effects of regulation, consider the following questions:
(1) In light of any current or projected cumulative effects of
regulation challenges, does the proposed rule's effective date provide
sufficient time to implement the new proposed requirements, including
changes to programs, procedures, and the facility?
(2) If current or projected cumulative effects of regulation
challenges exist, what should be done to address this situation (e.g.,
if more time is required to implement the new requirements, what period
of time would be sufficient)?
(3) Do other (NRC or other agency) regulatory actions (e.g.,
orders, generic communications, license amendment requests, or
inspection findings of a generic nature) influence the implementation
of the proposed requirements?
(4) Are there unintended consequences? Does the proposed rule
create conditions that would be contrary to the proposed rule's purpose
and objectives? If so, what are the consequences and how should they be
addressed?
(5) Is the cost and benefit estimate developed in the regulatory
analysis sufficient?
N. Request for Additional Public Comments
The NRC is requesting public comment on the following questions:
Is the proposed three-tiered approach (a compliance
period, followed by a protective assurance period, followed by a
performance period, if applicable) appropriate?
Is 500 mrem/yr an appropriate analytical threshold for the
protective assurance period?
Should there be a quantitative goal or dose limit
associated with the performance period analysis, and if so, what should
that goal or dose limit be?
Is Compatibility Category B appropriate for the compliance
period, protective assurance period, and the waste acceptance criteria?
P. What should I consider as I prepare my comments to submit to the
NRC?
When submitting your comments, remember to:
[[Page 16107]]
Identify the rulemaking with the Regulation Identifier
Number (RIN 3150-AI92) and NRC Docket ID (NRC-2011-0012).
Explain why you agree or disagree with the proposed
revisions, and suggest alternatives and substitute language to the
proposed changes.
Describe any assumptions and provide any technical
information or data that support your comments.
If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
Provide specific examples to illustrate your concerns, and
suggest alternatives.
Explain your views as clearly as possible.
Make sure to submit your comments by the comment period
deadline.
The NRC is particularly interested in your comments
concerning the issues raised in Section Ill, Discussion, of this
notice. In addition, the NRC is requesting comment on the information
in the following sections of this document: (1) Section VI, Agreement
State Compatibility; (2) Section VII, Plain Writing; (3) Section IX,
Draft Environmental Assessment and Draft Finding of No Significant
Environmental Impact; (4) Section X, Paperwork Reduction Act Statement;
(5) Section XI, Regulatory Analysis; and (6) Section XII, Regulatory
Flexibility Certification.
IV. Discussion of Proposed Amendments by Section
Section 20.1003 Definitions
Section 20.1003 defines common terms used in 10 CFR part 20. The
NRC is proposing to revise the term ``waste'' to capture waste streams
resulting from the production of medical isotopes that have been
permanently removed from a reactor or subcritical assembly, for which
there is no further use, and the disposal of which can meet the
requirements of this part, consistent with the National Defense
Authorization Act for Fiscal Year 2013.
10 CFR Part 20, Appendix G, Section II Certification
Currently, section II of appendix G to 10 CFR part 20, requires
LLRW generators, processors, or collectors to certify that the
transported LLRW is properly classified. Since 10 CFR 61.58 would
require licensees to develop criteria for LLRW acceptability, using
either the existing LLRW classification system or the results of site-
specific technical analyses, the NRC proposes to revise the
requirements in section II so that shippers are certifying that LLRW
consigned to a disposal facility meets the facility's criteria for LLRW
acceptability. Section II would also be revised to enhance its
readability.
10 CFR Part 20, Appendix G, Section III Control and Tracking
Currently, section III of appendix G to 10 CFR part 20 places
requirements on the control and tracking of LLRW transferred to a
disposal facility. Currently, sections III.A and III.C only require the
LLRW to be classified according to 10 CFR 61.55 and meet the LLRW
characteristic requirements in 10 CFR 61.56, and does not provide
requirements for compliance with the WAC of the proposed 10 CFR 61.58.
Since the amended rule would require site-specific technical analyses,
and then have LLRW disposal licensees develop criteria for LLRW
acceptability using either the existing LLRW classification system or
the results of site-specific technical analyses, the NRC proposes to
revise the requirements in sections III.A.1, III.A.2, III.A.3, III.C.3,
III.C.4, and III.C.5, to ensure that shippers prepare, label, and
provide quality assurance in accordance with the disposal facility
operator's criteria for LLRW acceptability, if applicable.
Section 61.2 Definitions
Section 61.2 defines common terms used in 10 CFR part 61. The NRC
is proposing to make the following revisions: (1) Revise the
definitions of ``site closure and stabilization'' and ``stability'' to
correct misspellings; (2) revise the definition of ``inadvertent
intruder'' to include the phrase ``reasonably foreseeable'' to limit
speculation of the analyses; and (3) revise the term ``waste'' to
capture waste streams resulting from the production of medical isotopes
that have been permanently removed from a reactor or subcritical
assembly, for which there is no further use, and the disposal of which
can meet the requirements of this part, consistent with the National
Defense Authorization Act for Fiscal Year 2013. The NRC is also
proposing to add definitions for ``compliance period,'' ``defense-in-
depth,'' ``intruder assessment,'' ``long-lived waste,'' ``performance
assessment,'' ``performance period,'' ``protective assurance period,''
and ``safety case'' to facilitate implementation of the proposed
requirements for site-specific analyses. For more information on
``compliance period,'' ``defense-in-depth,'' ``intruder assessment,''
``long-lived waste,'' ``performance assessment,'' ``protective
assurance analysis,'' ``protective assurance period,'' and ``safety
case,'' see Section III, Discussion, of this document.
Section 61.7 Concepts
Currently, 10 CFR 61.7 provides conceptual information for the
licensing of a disposal facility, the LLRW classification system, and
near-surface disposal. Paragraph 61.7(a) describes the parameters for
near-surface LLRW disposal in engineered facilities and the layout of
land and buildings necessary to carry out the disposal. Paragraph
61.7(b) describes the safety objectives for near-surface LLRW disposal
and emphasizes the stability of the wasteforms and disposal sites.
Paragraph 61.7(c) describes the licensing processes that the applicant
and licensee must complete during the preoperational, operational, and
site closure periods.
The NRC proposes to revise 10 CFR 61.7(a)(1) and 10 CFR 61.7(a)(2)
to enhance readability. An additional sentence would be added to
clarify that the additional technical criteria may be developed on a
case-by-case basis for land disposal techniques that are not explicitly
considered in 10 CFR part 61.
The NRC proposes to redesignate paragraphs (b)(1), (b)(2) through
(b)(5), and (c) as paragraphs (b), (f), and (g), respectively. The NRC
proposes to revise redesignated paragraphs (b), (f), and (g) to enhance
the readability of these paragraphs. Additionally, paragraph (b) would
be revised to describe the performance objectives of the 10 CFR part 61
regulations. Paragraph (f)(1) would be revised to clarify that for
long-lived waste and certain radionuclides prone to migration, a
maximum disposal site inventory based on the characteristics of the
disposal site may be established to limit potential exposure and to
mitigate the uncertainties associated with long-term stability of the
disposal site. Some waste, depending on its radiological
characteristics, may not be suitable for disposal if uncertainties
cannot be adequately addressed with technical analyses. Paragraph
(f)(2) would be revised to clarify that the effective life of these
intruder barriers should be at least 500 years and an additional
sentence would be added to clarify that the disposal of LLRW above the
Class C limit will be evaluated on a case-by-case basis with the
technical analyses required in 10 CFR 61.13. Paragraph (f)(3) would be
revised to clarify that waste that will not decay to levels which
present an acceptable hazard to an intruder within 100 years is
typically designated as Class C waste. Also paragraph (f) would provide
conceptual
[[Page 16108]]
information on the requirement for enhanced controls or limitations at
a particular LLRW disposal facility to provide reasonable assurance
that the LLRW will not present an unacceptable risk over the compliance
period. Paragraph (g) would be revised to include the concept of a
safety case in the licensing process.
The NRC proposes to add new paragraphs (b), (c), (d), and (e) to 10
CFR 61.7. Proposed 10 CFR 61.7(c) would provide conceptual information
for demonstrating compliance with the performance objectives of the
technical analyses, which include a performance assessment and an
intruder assessment, and performance period analyses for waste
containing significant concentrations and quantities of long-lived
radionuclides. Additionally, proposed paragraph (c)(5) would provide
conceptual information on the requirement for the use of dose
methodology that is consistent with those set forth in 10 CFR part 20
and would also describe the flexibility of the licensees' ability to
consistently use the latest dose methodology to demonstrate compliance
with the performance objectives.
Proposed 10 CFR 61.7(d) would provide conceptual information on the
role of defense-in-depth protections with respect to LLRW disposal.
Proposed 10 CFR 61.7(e) would provide conceptual information for
demonstrating compliance with the performance objectives through a
determination of criteria for the acceptance of LLRW.
Section 61.8 Information Collection Requirements: OMB Approval
Currently, 10 CFR 61.8 (b) lists sections that contain the approved
information collection requirements in 10 CFR part 61.
The NRC proposes to revise 10 CFR 61.8(b) to include 10 CFR 61.41
and 61.42.
Section 61.10 Content of Application
Currently, 10 CFR 61.10 identifies the contents that an application
for a land disposal facility must contain. This information includes
the general information, specific technical information, institutional
information, and financial information set forth in 10 CFR 61.11
through 61.16 and an environmental report.
The NRC is proposing to divide this section into two paragraphs,
assigned as paragraphs (a) and (b). Paragraph (a) would retain the
current rule language. Paragraph (b) would be added to convey that the
information provided in an application comprises the safety case,
supports the licensee's demonstration that the disposal facility will
be constructed and operated safely, and provides reasonable assurance
that the disposal site will be capable of meeting the performance
objectives.
Section 61.12 Specific Technical Information
Currently, 10 CFR 61.12 lists specific technical information that
must be included in an application for a 10 CFR part 61 disposal
facility license. This information is needed to demonstrate that the
performance objectives of 10 CFR part 61, subpart C, and the applicable
technical requirements of 10 CFR part 61, subpart D, ``Technical
requirements for land disposal facilities,'' would be met. The specific
technical information includes a description of natural and demographic
disposal site characteristics as determined by disposal site selection
and characterization activities.
The NRC proposes to revise the introductory text of this section to
enhance its readability and identify that the specific technical
information supports the safety case. The NRC also proposes to revise
10 CFR 61.12(a) to include geochemistry and geomorphology in the
description of the natural and demographic disposal site
characteristics. Geochemical and geomorphological characteristics need
to be included in the description because they play a role in the
transportation of long-lived radionuclides and the long-term erosion of
the disposal site, respectively. Paragraphs 61.12(e) and (g) would be
revised to enhance the readability of these sections. Proposed 10 CFR
61.12(i) would require applicants to include the criteria for
acceptance of LLRW for disposal, and 10 CFR 61.12(j) would require
applicants to include the development of technical analyses to the
description of the quality assurance program.
Section 61.13 Technical Analyses
Currently, 10 CFR 61.13 lists technical information that must be
included in an application for a 10 CFR part 61 disposal facility
license to demonstrate that the performance objectives of subpart C of
10 CFR part 61 would be met.
Currently, 10 CFR 61.13 does not specify the safety case and does
not indicate how existing licensees would be captured in the
requirements to conduct the 10 CFR 61.13 site-specific technical
analyses. The NRC proposes to revise the introductory text of 10 CFR
61.13 to specify the requirements for technical analyses as one element
of the safety case and to clarify that licensees must conduct the
analyses set forth in 10 CFR 61.13 to demonstrate that the performance
objectives of subpart C will be met. Licensees with licenses for land
disposal facilities in effect on the effective date of this subpart
must submit these analyses at the next license renewal or within 5
years of the effective date of this subpart, whichever comes first.
Currently, 10 CFR 61.13(a) does not require considerations of
features, events, and processes that can influence the ability of the
LLRW disposal facility to limit the releases of radioactivity to the
environment; these features, events, and processes are important
elements of a performance assessment. The NRC proposes to revise 10 CFR
61.13(a) to require a licensee or applicant prepare a performance
assessment to demonstrate compliance with the proposed dose limit in 10
CFR 61.41(a) during the compliance period and a dose goal in 10 CFR
61.41(b) during the protective assurance period. The performance
assessment would be required to consider features, events, and
processes which can influence the ability of the disposal facility to
meet the performance objectives, evaluate environmental pathways,
account for uncertainty, consider alternative conceptual models, and
identify and differentiate the roles performed by site characteristics
and design features of the disposal facility. Further, the proposed
revisions to 10 CFR 61.13(a) would require that the performance
assessment used to demonstrate compliance with a new 10 CFR 61.41(b)
during the protective assurance period reflect new features, events,
and processes different from those in the compliance period only if
scientific information compelling such changes is available.
In addition, the NRC proposes a new subparagraph 10 CFR 61.13(a)(4)
to further clarify that the performance assessment must reflect new
features, events, and processes different from the compliance period
that address significant uncertainties inherent in the long timeframes
associated with demonstrating compliance with Sec. 61.41(b) only if
scientific information compelling such changes is available.
Currently, 10 CFR 61.13(b) requires an applicant to prepare
analyses that demonstrate there is reasonable assurance an applicant
will meet the LLRW classification and segregation requirements and that
it will provide adequate barriers to inadvertent intrusion. The NRC
proposes to revise 10 CFR 61.13(b) to require a site-specific intruder
assessment to demonstrate the protection of inadvertent intruders. The
[[Page 16109]]
intruder assessment would be required to assume an intruder occupies
the site and engages in normal activities that are consistent with
activities in and around the site at the time of closure, identify
adequate intruder barriers and provide a basis for the time period that
they are effective, and account for uncertainty and variability. The
NRC also proposes to revise the term ``analyses of the protection of
individuals from inadvertent intrusion'' to ``inadvertent intruder
analyses.'' This paragraph would also be revised to enhance its
readability.
Currently, 10 CFR 61.13(d) requires an applicant to prepare
analyses that demonstrate long-term stability of the site and the need
for ongoing active maintenance after closure. However, the analyses are
not currently required to provide reasonable assurance that long-term
stability of the disposal site can be ensured. The NRC is proposing to
require that the analyses also provide reasonable assurance that long-
term stability of the disposal site can be ensured.
The NRC proposes to add a new paragraph (e) to 10 CFR 61.13 to
require licensees and applicants to prepare performance period analyses
that assess how the disposal facility and site characteristics limit
the potential long-term radiological impacts, consistent with available
data and current scientific understanding. The analyses would be
required for LLRW disposal facilities with long-lived LLRW that
contains radionuclides with average concentrations exceeding the values
listed in proposed table A of 10 CFR 61.13(e), or if necessitated by
site-specific conditions. The analyses would identify and describe the
features of the design and site characteristics that will demonstrate
that the performance objectives set forth in 10 CFR 61.41(b) and 10 CFR
61.42(b) will be met. The NRC also proposes to include table A in this
paragraph to facilitate the implementation of this requirement.
Finally, the NRC proposes to add a new paragraph (f) to 10 CFR
61.13 to require licensees and applicants to prepare analyses that
demonstrate the land disposal facility includes defense-in-depth
protections. The analyses would identify and describe the features of
the design and site characteristics that provide multiple independent
and redundant layers of defense so that no single layer, no matter how
robust, is exclusively relied upon during operations of the facility
and after closure during the compliance period, protective assurance
period, or performance period.
Section 61.23 Standards for Issuance of a License
Currently, 10 CFR 61.23 lists standards that must be met for the
Commission to issue a license for receipt, possession, and disposal of
LLRW containing or contaminated with source, special nuclear, or
byproduct material.
The NRC proposes to revise 10 CFR 61.23(b), (c), (d), and (e) to
include the proposed WAC in the list of standards for issuance of a
license. In addition, the NRC proposes to add a new paragraph (m) to 10
CFR 61.23 that adds a safety case as one of the standards for issuance
of a license.
Section 61.25 Changes
Currently, 10 CFR 61.25 provides restrictions on the licensee to
make changes in the LLRW disposal facility procedures described in the
license application.
The NRC proposes to revise 10 CFR 61.25(a) to correct a
misspelling, and 10 CFR 61.25(b) to include a provision restricting
changes to the WAC.
Section 61.28 Contents of Application for Closure
Currently, 10 CFR 61.28 lists items that must be included in an
application for closure. These items include (1) a requirement for a
final revision and specific details of the disposal site closure plan,
and (2) an environmental (or a supplemental) report.
Proposed revisions to 10 CFR 61.28(a) would add a requirement to
submit a final revision to the safety case, which would be required in
the proposed revisions in 10 CFR 61.10, and require licensees to
provide updated site-specific technical analyses, which would be
required in the proposed revisions in 10 CFR 61.13, using the details
of the final closure plan and LLRW inventory as would be required in
the proposed revisions in 10 CFR 61.13. Under current 10 CFR 61.28(c),
which is not being amended by this rulemaking, the NRC can only
authorize closure of the LLRW disposal facility if there is reasonable
assurance that the long-term performance objectives of subpart C will
be met. As a result of the proposed revision to 10 CFR 61.28(a),
licensees may be required to take additional action prior to closure to
ensure that the LLRW that has already been disposed, including large
quantities of depleted uranium and other LLRW streams that were not
analyzed in the original 10 CFR part 61 regulatory basis, will meet the
long-term performance objectives of subpart C.
Section 61.41 Protection of the General Population From Releases of
Radioactivity
Currently, 10 CFR 61.41 specifies a dose limit (organ and whole
body equivalent) for protection of the general population from the
releases of radioactivity and requires licensees to exercise reasonable
effort to keep all doses ALARA.
The NRC proposes to revise 10 CFR 61.41 by adding paragraphs (a),
(b), and (c). Proposed 10 CFR 61.41(a) would retain the dose limits and
the ALARA concept during the compliance period, and would be updated to
use a dose methodology that is consistent with the dose methodology
used in 10 CFR part 20. Compliance with the proposed 10 CFR 61.41(a)
would be demonstrated through analyses that meet the requirements
specified in the proposed 10 CFR 61.13(a).
Proposed 10 CFR 61.41(b) would require that the licensee minimize
releases of radioactivity from a disposal facility to the general
environment during the protective assurance period. Proposed 10 CFR
61.41(b) would specify that an annual dose, established on the license,
shall be below 5 milliSieverts (500 millirems) or a level that is
supported as reasonably achievable based on technological and economic
considerations in the information submitted for review and approval by
the Commission. Compliance with this paragraph must be demonstrated
through analyses that meet the requirements specified in 10 CFR
61.13(a).
Proposed 10 CFR 61.41(c) would require that the licensee make an
effort to minimize releases of radioactivity from a disposal facility
to the general environment to the extent reasonably achievable at any
time during the performance period. Compliance with the proposed 10 CFR
61.41(c) would be demonstrated through analyses that meet the
requirements specified in the proposed 10 CFR 61.13(e).
Section 61.42 Protection of Inadvertent Intruders
Currently, 10 CFR 61.42 requires the facility to be designed,
operated, and closed to ensure the protection of any inadvertent
intruder after the lifting of institutional controls.
The NRC proposes to revise 10 CFR 61.42 by adding new paragraphs
(a), (b), and (c). Proposed 10 CFR 61.42(a) would retain the current
regulatory language and would be updated to add an annual dose limit of
5 mSv/yr (500 mrem/yr) for the intruder assessment during the
compliance period.
[[Page 16110]]
Compliance with the proposed 10 CFR 61.42(a) paragraph would be
demonstrated through analyses that meet the requirements specified in
the proposed 10 CFR 61.13(b).
Proposed 10 CFR 61.42(b) would require that the licensee minimize
exposures to any inadvertent intruder during the protective assurance
period. Proposed 10 CFR 61.42(b) would also specify that an annual
dose, established on the license, shall be below 5 milliSieverts (500
millirems) or a level that is supported as reasonably achievable based
on technological and economic considerations in the information
submitted for review and approval by the Commission. Compliance with
this paragraph must be demonstrated through analyses that meet the
requirements specified in 10 CFR 61.13(b).
Proposed 10 CFR 61.42(c) would require that the licensee make an
effort to minimize exposures to any inadvertent intruder to the extent
reasonably achievable at any time during the performance period.
Compliance with the proposed 10 CFR 61.42(c) would be demonstrated
through analyses that meet the requirements specified in the proposed
10 CFR 61.13(e).
Section 61.44 Stability of the Disposal Site After Closure
Currently, 10 CFR 61.44 requires the disposal facility to be sited,
designed, used, operated, and closed to achieve long-term stability of
the disposal site and to eliminate to the extent practicable the need
for ongoing active maintenance of the disposal site following closure
so that only surveillance, monitoring, or minor custodial care are
required.
The NRC proposes to revise 10 CFR 61.44 to specify that stability
of the disposal site must be demonstrated for the compliance and
protective assurance periods.
Section 61.50 Disposal Site Suitability Requirements for Land Disposal
Currently, 10 CFR 61.50 specifies site suitability requirements for
the minimum characteristics a disposal site must possess to be
acceptable for use as a near-surface LLRW disposal facility. Site
suitability requirements play an integral role in ensuring that the
site is appropriate for the type of LLRW proposed for disposal.
The NRC proposes to revise 10 CFR 61.50 to clarify the
interpretation of site characteristics. The technical content of the
site suitability characteristics would not be changed. However, the
site suitability characteristics would be reorganized to distinguish
the hydrological site characteristics from other characteristics.
Section 61.51 Disposal Site Design for Land Disposal
Currently, 10 CFR 61.51 specifies disposal design requirements for
a near-surface LLRW disposal facility. Site design requirements play an
integral role in ensuring that the site is appropriate for the type of
LLRW proposed for disposal.
The NRC proposes to revise 10 CFR 61.51(a)(1) to clarify that site
design features must be directed toward providing defense-in-depth
protections in addition to long-term isolation and avoidance of
continuing active maintenance after site closure.
Section 61.52 Land Disposal Facility Operation and Disposal Site
Closure
Currently, 10 CFR 61.52 imposes requirements to ensure the
integrity of the LLRW, the proper marking of the disposal unit
boundary, and the proper maintenance of the buffer zone.
The NRC proposes to revise 10 CFR 61.52(a)(3) and (a)(8) to enhance
its readability and to conform to the proposed new requirements in 10
CFR 61.52(a)(12) and (a)(13).
The NRC proposes to add new paragraphs (a)(12) and (a)(13).
Proposed 10 CFR 61.52(a)(12) would only allow the disposal of LLRW
meeting the disposal facility's LLRW acceptance criteria, and proposed
10 CFR 61.52(a)(13) would require licensees to prepare updated site-
specific analyses using the details of the final closure plan and LLRW
inventory.
Section 61.55 Waste Classification
The NRC proposes to revise 10 CFR 61.55(a)(6) to enhance its
readability. The change would not alter the meaning or intent of this
regulation.
Section 61.56 Waste Characteristics
Currently, 10 CFR 61.56(a) lists minimum requirements for all
classes of LLRW, intended to facilitate handling at the disposal site
and provide protection of health and safety of personnel at the
disposal site.
The NRC proposes to revise 10 CFR 61.56(a) to replace the phrase
``all classes of wastes'' with the phrase ``all waste'' which includes
all classes of LLRW and WAC.
Section 61.57 Labeling
Currently, 10 CFR 61.57 requires the listing of LLRW class in
accordance with 10 CFR 61.55 and does not reference the proposed WAC.
The NRC proposes to revise 10 CFR 61.57 to include any information
required by the land disposal facility's criteria for LLRW acceptance
developed according to 10 CFR 61.58.
Section 61.58 Waste Acceptance
Currently, 10 CFR 61.58 grants exemptions for the classification
and characterization of LLRW, on a case-by-case basis, if the
Commission finds reasonable assurance of compliance with the
performance objectives. In the proposed rule, the alternative
requirements in 10 CFR 61.58 would be replaced by the proposed LLRW
acceptance requirements.
The NRC proposes to retitle and revise 10 CFR 61.58 to specify the
minimum content of the WAC and require disposal facility licensees to
develop approaches for generators to characterize LLRW and methods for
generators to certify that such LLRW meets the acceptance criteria for
demonstration compliance with the site-specific WAC. Proposed 10 CFR
61.58 would also require licensees to annually review their LLRW
acceptance plan and to comply with 10 CFR 61.20 when modifying their
approved WAC. Additionally, the new regulatory language would indicate
that the NRC would incorporate, where consistent with State and Federal
law, the WAC into existing licenses.
Section 61.80 Maintenance of Records, Reports, and Transfers
Currently, 10 CFR 61.80 requires the licensee to keep records on
the LLRW received for disposal, to provide annual reports of site and
financial activities, and to comply with specified provisions of 10 CFR
parts 30, 40, and 70 for any transfer by the licensee of byproduct,
source, or special nuclear material.
The NRC proposes to restructure 10 CFR 61.80(i)(2) to meet
codification requirements of the Office of the Federal Register. In 10
CFR 61.80(i)(1), the erroneous reference to 10 CFR 60.4 would be
corrected to reference 10 CFR 61.4.
The NRC also proposes to add a new paragraph (m) to 10 CFR 61.80.
This addition would require licensees and license applicants to
maintain their provisions for LLRW acceptance and audits and other
reviews of program content and implementation.
V. Criminal Penalties
For the purpose of Section 223 of the AEA, the NRC is proposing to
amend 10 CFR part 61 under one or more of Sections 161b., 161i., or
161o. of the AEA. Willful violations of the rule would be subject to
criminal enforcement.
[[Page 16111]]
VI. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register (62 FR 46517; September 3, 1997),
this proposed rule would be a matter of compatibility between the NRC
and the Agreement States, which would ensure consistency between the
Agreement State requirements and the NRC requirements. The NRC staff
analyzed the proposed rule in accordance with the procedure established
in Part III, ``Categorization Process for NRC Program Elements,'' of
the Handbook for Management Directive 5.9, ``Adequacy and Compatibility
of Agreement State Programs'' (see http://www.nrc.gov/reading-rm/doc-collections/management-directives/).
The NRC program elements (including regulations) are placed into
four compatibility categories (see the proposed compatibility table in
this section). In addition, the NRC program elements can be identified
as having particular health and safety significance or as being
reserved solely to the NRC. Compatibility Category A applies to those
program elements that are basic radiation protection standards and
scientific terms and definitions that are necessary to understand
radiation protection concepts. An Agreement State should adopt
Compatibility Category A program elements in an essentially identical
manner to provide uniformity in the regulation of agreement material on
a nationwide basis. Compatibility Category B includes those program
elements that apply to activities that have direct and significant
effects in multiple jurisdictions. An Agreement State should adopt
Compatibility Category B program elements in an essentially identical
manner. Compatibility Category C includes those program elements that
do not meet the criteria of Compatibility Categories A or B, but
reflect essential objectives that an Agreement State should adopt to
avoid conflict, duplication, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement material
on a nationwide basis. An Agreement State should adopt the essential
objectives of the Compatibility Category C program elements.
Compatibility Category D applies to those program elements that do not
meet any of the criteria of Compatibility Categories A, B, or C and,
therefore, do not need to be adopted by Agreement States for
compatibility.
Health and Safety (H&S) program elements are elements that are not
required for compatibility, but are identified as having a particular
health and safety role (i.e., adequacy) in the regulation of agreement
material within the State. Although not required for compatibility, the
State should adopt program elements in this H&S category based on those
elements that embody the essential objectives of the NRC program
elements because of particular health and safety considerations.
Compatibility Category NRC contains those program elements that address
areas of regulation that cannot be relinquished to Agreement States
under the Atomic Energy Act or 10 CFR. These program elements are not
adopted by Agreement States.
Proposed definition ``compliance period'' in 10 CFR 61.2 would be
assigned to Compatibility Category B. The NRC believes the program
elements of this definition need to be adopted to ensure a consistent
regulatory approach across the Nation and inconsistent definitions of
this term would have direct and significant transboundary implications.
Proposed definition ``defense-in-depth'' in 10 CFR 61.2 would be
assigned to Compatibility Category H&S. The NRC believes the essential
objectives of this definition need to be adopted to ensure consistent
application of 10 CFR 61.41 and 10 CFR 61.42. Proposed definition of
``intruder assessment'' in 10 CFR 61.2 would be assigned to
Compatibility Category H&S. The NRC believes that the H&S compatibility
designation of this definition is appropriate to support paragraphs
61.13(a) and 61.13(b). Proposed definition of ``long-lived waste'' in
10 CFR 61.2 would be assigned to Compatibility Category B because
inconsistent definitions of this term could have direct and significant
effects in multiple jurisdictions. Proposed definition ``performance
period'' in 10 CFR 61.2 would be assigned to Compatibility Category C.
The NRC believes the essential objectives of this definition need to be
adopted to ensure consistent application of 10 CFR 61.41 and 10 CFR
61.42. Proposed definition of ``performance assessment'' in 10 CFR 61.2
would be assigned to Compatibility Category H&S. The NRC believes that
the H&S compatibility designation of this definition is appropriate to
support paragraphs 61.13(a) and 61.13(b). Proposed definition
``protective assurance period'' in 10 CFR 61.2 would be assigned to
Compatibility Category B. The NRC believes the program elements of this
definition need to be adopted to ensure a consistent regulatory
approach across the Nation and inconsistent definitions of this term
would have direct and significant transboundary implications. Proposed
definition ``safety case'' in 10 CFR 61.2 would be assigned to
Compatibility Category H&S. The NRC believes the essential objectives
of this definition need to be adopted to ensure consistent application
of 10 CFR 61.40. The compatibility category of other amended
definitions in 10 CFR 61.2 would remain unchanged.
Paragraphs 61.7(c)(1), (c)(2), (c)(4), (c)(5), (c)(6)(d), (e), and
(f)(4) would be assigned to Compatibility Category H&S to be consistent
with the designation of the rest of 10 CFR 61.7. The compatibility
category of other amended paragraphs in 10 CFR 61.7 would remain
unchanged.
The NRC is proposing to retain the existing Compatibility Category
D for paragraph 61.10(a) because this paragraph provides a list of
contents of an application that would not be applicable for all
Agreement States (i.e., an environmental report). Paragraph 61.10(b)
would be assigned to Compatibility Category H&S. The NRC believes the
safety case information of this paragraph needs to be included in the
application for operating license for the protection of health and
safety but is not required for compatibility with the national program.
Section 61.12 in its entirety would be reassigned from
Compatibility Category D to Compatibility Category H&S. The NRC
believes that all the requirements in 10 CFR 61.12 should be designated
as Compatibility Category H&S to support the demonstration of the
subpart C performance objectives. The NRC believes that the absence of
these provisions could create a situation that could result in
individual exposures that exceed the basic radiation protection
standards of the subpart C performance objectives.
Section 61.13, in its entirety, would be reassigned from
Compatibility Category H&S to Compatibility Category C. The NRC
believes the essential objectives of this section need to be adopted to
ensure consistent application of 10 CFR 61.40.
Proposed paragraph 61.23(m) would be assigned to Compatibility
Category H&S. The compatibility category of other amended paragraphs in
10 CFR 61.23 would remain unchanged.
Section 61.28 in its entirety would also be reassigned from
Compatibility Category D to Compatibility Category H&S. The NRC
believes that all the information in this paragraph has to be included
in the application for closure. The NRC believes that the presence of
[[Page 16112]]
these provisions are necessary for the Commission to make a final
decision on the amendment authorizing a disposal site closure, based on
protection of health and safety but is not required for compatibility
with the national program.
The NRC is proposing to retain the existing Compatibility Category
A for paragraph 61.41(a) because this paragraph provides a basic
radiation protection standard. Paragraph 61.41(b) would be assigned to
Compatibility Category B. The NRC believes the program elements of this
paragraph need to be adopted to ensure a consistent regulatory approach
across the Nation and inconsistent application of this paragraph would
have direct and significant transboundary implications. Paragraph
61.41(c) would be assigned to Compatibility Category C because the NRC
believes that the Agreement States need to adopt the essential
objectives of this paragraph.
Similarly, the NRC is proposing to designate paragraph 61.42(a) as
Compatibility Category A (instead of Compatibility Category H&S, which
is the current compatibility level for 10 CFR 61.42) because of the
prescribed annual dose limit of 5 mSv (500 mrem) for the protection of
an inadvertent intruder. Paragraph 61.42(b) would be assigned to
Compatibility Category B. The NRC believes the program elements of this
paragraph need to be adopted to ensure a consistent regulatory approach
across the Nation and inconsistent application of this paragraph would
have direct and significant transboundary implications. Paragraph
61.42(c) would be assigned to Compatibility Category C because the NRC
also believes that the essential objectives of this paragraph need to
be adopted by the Agreement States.
Paragraphs 61.52(a)(12) and (a)(13) would be assigned to
Compatibility Category H&S. The compatibility categories of 10 CFR
61.52(a)(3) and (a)(8) would remain unchanged.
At present, only one of the four Agreement States that has an
operating near-surface LLRW disposal facility has adopted a
corresponding regulation to 10 CFR 61.58. Currently, Agreement States
are not required to adopt 10 CFR 61.58, therefore, the compatibility
designation for this section must be changed in order to require
Agreement States to adopt an alternative provision for LLRW
classification and characteristics. Therefore, the NRC is retitling,
revising and reclassifying the compatibility for 10 CFR 61.58. Section
61.58 would be assigned to Compatibility Category B because the NRC
believes the program elements of this section need to be adopted to
ensure a consistent regulatory approach across the Nation and
inconsistent application of this section would have direct and
significant transboundary implications.
Paragraph 61.80(m) would be assigned to Compatibility Category C.
The compatibility category of 10 CFR 61.80(i)(1) and (i)(2) would
remain unchanged.
The compatibility categories of the remaining sections (10 CFR
20.1003; appendix G to 10 CFR part 20, sections II and III; and 10 CFR
61.8, 61.25, 61.44, 61.50, 61.51, 61.55, 61.56, and 61.57) would remain
unchanged.
The NRC invites comment on the compatibility category designations
in this proposed rule and suggests that commenters refer to the
Handbook for NRC Management Directive 5.9 for more information.
Comments on the proposed compatibility categories need to be received
by the end of the public comment period.
The following table lists the parts and sections that would be
revised and their corresponding categorization under the ``Policy
Statement on Adequacy and Compatibility of Agreement State Programs.''
Proposed Compatibility Table for 10 CFR Part 20, Appendix G
----------------------------------------------------------------------------------------------------------------
Compatibility
10 CFR Part 20, Appendix G Change Subject --------------------------------------
proposed rule section Existing New
----------------------------------------------------------------------------------------------------------------
20.1003....................... Amend............ Definition Waste...... B B
II............................ Amend............ Certification......... D D
III.A......................... Amend............ Control and Tracking.. D D
III.C......................... Amend............ Control and Tracking.. D D
----------------------------------------------------------------------------------------------------------------
Proposed Compatibility Table for 10 CFR Part 61
----------------------------------------------------------------------------------------------------------------
Compatibility
10 CFR Part 61 proposed rule Change Subject --------------------------------------
section Existing New
----------------------------------------------------------------------------------------------------------------
61.2.......................... New.............. Definition-Compliance .................. B
period.
61.2.......................... New.............. Definition-Defense-in- .................. H&S
depth.
61.2.......................... Amend............ Definition-Inadvertent C................. C
intruder.
61.2.......................... New.............. Definition-Intruder .................. H&S
assessment.
61.2.......................... New.............. Definition-Long-lived .................. B
waste.
61.2.......................... New.............. Definition-Performance .................. H&S
assessment.
61.2.......................... New.............. Definition-Performance .................. C
period.
61.2.......................... New.............. Definition-Protective .................. B
assurance period.
61.2.......................... New.............. Definition-Safety case .................. H&S
61.2.......................... Amend............ Definition-Site D................. D
closure and
stabilization.
61.2.......................... Amend............ Definition-Stability.. D................. D
61.2.......................... Amend............ Definition-Waste...... B................. B
61.7(a)(1).................... Amend............ Concepts.............. H&S............... H&S
61.7(a)(2).................... Amend............ Concepts.............. H&S............... H&S
61.7(b)....................... Amend............ Concepts. (Previously H&S............... H&S
61.7(b)(1)).
61.7(c)(1).................... New.............. Concepts.............. .................. H&S
61.7(c)(2).................... New.............. Concepts.............. .................. H&S
61.7(c)(3).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(b)(3)).
61.7(c)(4).................... New.............. Concepts.............. .................. H&S
61.7(c)(5).................... New.............. Concepts.............. .................. H&S
[[Page 16113]]
61.7(c)(6).................... New.............. Concepts.............. .................. H&S
61.7(d)....................... New.............. Concepts.............. .................. H&S
61.7(e)....................... New.............. Concepts.............. .................. H&S
61.7(f)(1).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(b)(2)).
61.7(f)(2).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(b)(4)).
61.7(f)(3).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(b)(5)).
61.7(f)(4).................... New.............. Concepts.............. .................. H&S
61.7(g)(1).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(c)(1).
61.7(g)(2).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(c)(2).
61.7(g)(3).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(c)(3).
61.7(g)(4).................... Amend............ Concepts. (Previously H&S............... H&S
61.7(c)(4).
61.8.......................... Amend............ Information collection D................. D
requirements: Office
of Management and
Budget approval.
61.10(a)...................... Amend............ Content of application D................. D
61.10(b)...................... New.............. Content of application .................. H&S
61.12(a)...................... Amend/Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(b)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(c)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(d)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(e)...................... Amend/Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(f)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(g)...................... Amend/Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(h)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(i)...................... Amend/Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(j)...................... Amend/Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(k)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(l)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(m)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.12(n)...................... Revised Specific technical D................. H&S
Compatibility information.
Category.
61.13(a)...................... Amend/Revised Technical analyses.... H&S............... C
Compatibility
Category.
61.13(b)...................... Amend/Revised Technical analyses.... H&S............... C
Compatibility
Category.
61.13(c)...................... Amend/Revised Technical analyses.... H&S............... C
Compatibility
Category.
61.13(d)...................... Amend/Revised Technical analyses.... H&S............... C
Compatibility
Category.
61.13(e)...................... New.............. Technical analyses.... .................. C
61.13(f)...................... New.............. Technical analyses.... .................. C
61.23(b)...................... Amend............ Standards for issuance H&S............... H&S
of a license.
61.23(c)...................... Amend............ Standards for issuance H&S............... H&S
of a license.
61.23(d)...................... Amend............ Standards for issuance H&S............... H&S
of a license.
61.23(e)...................... Amend............ Standards for issuance H&S............... H&S
of a license.
61.23(m)...................... New.............. Standards for issuance .................. H&S
of a license.
61.25(a)...................... Amend............ Changes............... D................. D
61.25(b)...................... Amend............ Changes............... D................. D
61.28(a)(2)................... Amend............ Contents of D................. D
application closure.
61.41(a)...................... Amend............ Protection of the A................. A
general population
from releases of
radioactivity.
61.41(b)...................... New.............. Protection of the .................. B
general population
from releases of
radioactivity.
61.41(c)...................... New.............. Protection of the .................. C
general population
from releases of
radioactivity.
61.42(a)...................... Amend............ Protection of H&S............... A
individuals from
inadvertent intrusion.
61.42(b)...................... New.............. Protection of .................. B
individuals from
inadvertent intrusion.
61.42(c)...................... New.............. Protection of .................. C
individuals from
inadvertent intrusion.
[[Page 16114]]
61.44......................... Amend............ Stability of the H&S............... H&S
disposal site after
closure.
61.50......................... Amend............ Disposal site H&S............... H&S
suitability
requirements for land
disposal.
61.51(a)...................... Amend............ Disposal site design H&S............... H&S
for land disposal.
61.52(a)(3)................... Amend............ Land disposal facility H&S............... H&S
operation and
disposal site closure.
61.52(a)(8)................... Amend............ Land disposal facility H&S............... H&S
operation and
disposal site closure.
61.52(a)(12).................. New.............. Land disposal facility .................. H&S
operation and
disposal site closure.
61.52(a)(13).................. New.............. Land disposal facility .................. H&S
operation and
disposal site closure.
61.55(a)(6)................... Amend............ Waste classification.. B................. B
61.56(a)...................... Amend............ Waste characteristics. H&S............... H&S
61.57......................... Amend............ Labeling.............. H&S............... H&S
61.58......................... Retitled, revised Waste acceptance...... D................. B
and Revised (Previously titled
Compatibility Alternative
Category. requirements for
waste classification
and characteristics).
61.80(i)(1)................... Amend............ Maintenance of C................. C
records, reports, and
transfers.
61.80(i)(2)................... Amend............ Maintenance of C................. C
records, reports, and
transfers.
61.80(m)...................... New.............. Maintenance of .................. C
records, reports, and
transfers.
----------------------------------------------------------------------------------------------------------------
VII. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has written this document to be consistent with the
Plain Writing Act as well as the Presidential Memorandum, ``Plain
Language in Government Writing,'' published June 10, 1998 (63 FR
31883). The NRC requests comment on the proposed rule with respect to
the clarity and effectiveness of the language used.
VIII. 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
the use of such a standard is inconsistent with applicable law or
otherwise impractical. In this proposed rule, the NRC is proposing to
amend its regulations that govern LLRW disposal facilities to require
new and revised site-specific technical analyses and to permit the
development of criteria for LLRW acceptance based on the results of
these analyses. These amendments would ensure that LLRW streams that
are significantly different from those considered in the regulatory
basis for the current regulations can be disposed of safely and meet
the performance objectives for land disposal of LLRW. These amendments
would also increase the use of site-specific information to ensure
public health and safety is protected. Additionally, the NRC is also
proposing amendments to facilitate implementation and better align the
requirements with current health and safety standards. The NRC is not
aware of any voluntary consensus standards that address the proposed
subject matter of this proposed rule. The NRC will consider using a
voluntary consensus standard if an appropriate standard is identified.
If a voluntary consensus standard is identified for consideration, the
submittal should explain why the standard should be used.
IX. Draft Environmental Assessment and Draft Finding of No Significant
Environmental Impact
A. The Proposed Action and the Need for the Proposed Action
The proposed action is to add new, and amend some of the existing,
requirements in 10 CFR part 61. The NRC is proposing to amend its
regulations that apply to LLRW disposal facilities to require new and
revised site-specific technical analyses, to permit the development of
criteria for LLRW acceptance based on the results of these analyses,
and to require the application for closure to include updates to the
safety case and the technical analyses. These amendments would ensure
that LLRW streams that are significantly different from those
considered in the regulatory basis for the current regulations can be
disposed of safely and meet the performance objectives for land
disposal of LLRW. These amendments would also increase the use of site-
specific information to ensure public health and safety is protected.
These amendments would revise the existing technical analysis for
protection of the general population (i.e., performance assessment) to
include a 1,000-year compliance period; add a new site-specific
technical analysis for the protection of inadvertent intruders (i.e.,
intruder assessment) that would include a 1,000-year compliance period
and a dose limit; add new analyses (i.e., performance assessment and
intruder assessment) that would include a 10,000-year protective
assurance period and dose minimization target; new analyses that
demonstrate the disposal site includes defense-in-depth protections for
the compliance period, protective assurance period, and performance
period; add a new analysis for certain long-lived LLRW (i.e.,
performance period analysis) that would include a post-10,000 year
performance period; and revise the application for closure to include
updates to the safety case and the technical analyses. The NRC would
also be adding a new requirement to develop criteria for the acceptance
of LLRW for disposal based on either the results of these technical
analyses or the existing LLRW classification requirements.
Additionally, the NRC is proposing amendments to facilitate
implementation and better align the requirements with current health
and safety standards.
B. Environmental Impact of the Proposed Action
The proposed action is to add new, and amend some of the existing,
requirements in 10 CFR part 61. The proposed rulemaking would modify
the analyses that licensees need to perform
[[Page 16115]]
to demonstrate compliance with the subpart C performance objectives and
to permit the development of criteria for LLRW acceptance based on the
results of these analyses. These amendments would not authorize the
construction of LLRW disposal facilities and do not authorize the
disposal of additional LLRW in existing facilities. Licensees and
applicants would need to request and receive separate regulatory
approval before construction of new disposal facilities or disposal of
additional LLRW in existing facilities. Consequently, because this
rulemaking will not result in any physical impacts to the environment
the NRC has determined that the proposed action would result in no
significant environmental impacts.
C. Alternatives to the Proposed Action
As an alternative to the proposed action, the NRC staff considered
the ``no-action'' alternative. Under this alternative, the NRC would
not modify 10 CFR part 61, no performance period analyses would be
required, no period of compliance and no protective assurance period
would be specified, no intruder assessment would be required, and
development of waste acceptance plan would not be required. However,
requiring new and revised site-specific technical analyses to
demonstrate compliance with the subpart C performance objectives and
development of LLRW site-specific acceptance criteria for LLRW
acceptance would ensure the safe disposal of waste streams not
previously analyzed in the development of part 61 and would provide
assurance that these waste streams comply with the subpart C
performance objectives. Further, these analyses would identify any
additional measures that would be prudent to implement, and these
amendments would improve the efficiency of the regulations by making
changes to facilitate implementation and better align the requirements
with current health and safety standards. Not taking the proposed
action would not provide the added assurance that disposal of the LLRW
streams not considered in the original 10 CFR part 61 regulatory basis
comply with the subpart C performance objectives. Therefore, the NRC
has decided to reject the no-action alternative and publish the
proposed rule for public comment.
D. Alternative Use of Resources
This action would not result in any irreversible commitments of
resources.
E. Agencies and Persons Contacted and Resources Used
The NRC sent a copy of this proposed rule containing this draft
environmental assessment and the proposed rule to all State Liaison
Officers and requested their comments on the assessment. Aside from
those sources referenced in this notice, the NRC staff did not use any
additional sources and did not contact any additional persons or
agencies to develop this environmental assessment.
F. Draft Finding of No Significant Impact
The Commission has preliminarily determined under the National
Environmental Policy Act and the Commission's regulations in subpart A,
``National Environmental Policy Act--Regulations Implementing Section
102(2),'' of 10 CFR part 51, ``Environmental Protection Regulations for
Domestic Licensing and Related Regulatory Functions,'' that the
proposed amendments to 10 CFR part 61 described in this document would
not be a major Federal action significantly affecting the quality of
the human environment, and therefore, an environmental impact statement
would not be required. The amendments would require LLRW disposal
facility licensees and license applicants to conduct new and updated
site-specific technical analyses and safety case to demonstrate
compliance with the performance objectives in 10 CFR part 61 and
develop criteria for LLRW acceptance based on the results of these
analyses, which would ensure the safe disposal of LLRW. The amendments
would also make additional changes to the regulations to facilitate
implementation and better align the requirements with current health
and safety standards. The amendments would be primarily procedural and
administrative in nature and would have no significant impact on the
quality of the human environment.
The preliminary determination of this draft environmental
assessment is that there would be no significant impact to the quality
of the human environment from this proposed action. The NRC is,
however, seeking public comment on this draft environmental assessment
and draft finding of no significant impact. Comments on the draft
environmental assessment and draft finding of no significant impact may
be submitted to the NRC by any of the methods provided in the ADDRESSES
section of this document.
X. Paperwork Reduction Act Statement
This proposed rule contains new or amended collections of
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq). This proposed rule has been submitted to the Office of
Management and Budget (OMB) for review and approval of the information
collections.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR parts 20 and 61,
``Low Level Radioactive Waste Disposal.''
The form number if applicable: NRC Forms 540 and 541.
How often the collection is required or requested: On occasion.
Who will be required or asked to respond: Current and future LLRW
disposal facilities that are regulated by the NRC or an Agreement
State.
An estimate of the number of annual responses: 0.
The estimated number of annual respondents: 0.
An estimate of the total number of hours needed annually to comply
with the information requirement or request: New applicants and current
LLRW disposal facility licensees seeking to amend their licenses to
address the requirements in these amendments will incur a reporting
burden to submit performance period analyses, compliance period
analyses, and LLRW acceptance plans beginning approximately 4 years
from publication of the final rule. The estimated one-time reporting
burden per licensee to perform these analyses is 22,200 hours. An
additional 80 hours of annual recordkeeping per licensee would be
required once its LLRW acceptance plan has been submitted. However, the
NRC does not expect to receive any license applications or license
closure applications within the OMB information collection period of 3
years following publication of the final rule, and no current licensees
are anticipated to amend their licenses within the information
collection period; therefore, there is no estimated annual burden (0
hours) for the next 3 years.
Abstract: The NRC is proposing to amend its regulations to require
LLRW disposal facilities to conduct site-specific technical analyses to
demonstrate compliance with the performance objectives of 10 CFR part
61. The intent of the rule is to ensure performance objectives are met
at disposal sites for safe disposal of LLRW that was not analyzed in
the original 10 CFR part 61 regulatory basis (i.e., large quantities of
depleted uranium). The site-specific technical analyses would
[[Page 16116]]
include compliance period analyses with both a performance assessment
and an intruder assessment, analyses for the protective assurance
period that include both a performance assessment and an intruder
assessment, performance period analyses to evaluate how the disposal
system could mitigate the risk from long-lived LLRW, new analyses that
demonstrate the disposal site includes defense-in-depth protections,
and an LLRW acceptance plan identifying the WAC for the disposal
facility. In addition, licensees must review their LLRW acceptance plan
annually and update the safety case and analyses as part of the
application for closure.
The NRC Forms 540 and 541 would be updated to allow licensees to
indicate the use of LLRW acceptance criteria.
The U.S. Nuclear Regulatory Commission is seeking public comment on
the potential impact of the information collections contained in this
proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of the burden of the proposed information
collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the proposed information collection on
respondents be minimized, including the use of automated collection
techniques or other forms of information technology?
A copy of the OMB clearance package and proposed rule is available
in ADAMS under Accession No. ML14289A143 or may be viewed free of
charge at the NRC's PDR, One White Flint North, 11555 Rockville Pike,
Room O-1 F21, Rockville, Maryland, 20852. You may obtain information
and comment submissions related to the OMB clearance package by
searching on http://www.regulations.gov under Docket ID NRC-2011-0012.
You may submit comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
previously stated issues, by the following methods:
Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0012.
Mail comments to: FOIA, Privacy, and Information
Collections Branch, Office of Information Services, Mail Stop: T-5 F53,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 or to
Vlad Dorjets, Desk Officer, Office of Information and Regulatory
Affairs (3150-0135, 3150-0164, and 3150-0166), NEOB-10202, Office of
Management and Budget, Washington, DC 20503; telephone: 202-395-1741,
email: [email protected].
Submit comments by May 26, 2015. Comments received after this date
will be considered if it is practical to do so, but the NRC staff is
able to ensure consideration only for comments received on or before
this date.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless the document requesting
or requiring the collection displays a currently valid OMB control
number.
XI. Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation, and it is available in ADAMS under Accession No.
ML14289A158. The draft regulatory analysis examines the costs and
benefits of the alternatives considered by the Commission.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft analysis may be submitted to the NRC by
any of the methods provided in the ADDRESSES section of this document.
XII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would not, if adopted,
have a significant economic impact on a substantial number of small
entities. The LLRW licensees and license applicants impacted by this
rule do not fall within the scope of the definition of ``small
entities'' given in the Regulatory Flexibility Act or the standards
established by the NRC in 10 CFR 2.810, ``NRC size standard.''
The NRC is seeking public comment on the potential impact of the
proposed rule on small entities. The NRC particularly desires comments
from licensees who qualify as small businesses, specifically as to how
the proposed rule would affect them and how the rule may be tiered or
otherwise modified to impose less stringent requirements on small
entities while still adequately protecting the public health and safety
and common defense and security. Comments on how the rule could be
modified to take into account the differing needs of small entities
should specifically discuss:
(a) The size of the business and how the proposed rule would result
in a significant economic burden upon it as compared to a larger
organization in the same business community;
(b) How the proposed rule could be modified to take into account
the business's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the NRC adopts the commenter's suggestion;
(d) How the proposed rule, as modified, would more closely equalize
the impact of NRC regulations as opposed to providing special
advantages to any individuals or groups; and
(e) How the proposed rule, as modified, would still adequately
protect the public health and safety and common defense and security.
Comments should be submitted by any of the methods provided in the
ADDRESSES section of this document.
XIII. Backfitting
A backfit analysis is not required for this rule. The NRC's backfit
provisions appear in the regulations at 10 CFR 50.109, 52.39, 52.63,
52.83, 52.98, 52.145, 52.171, 70.76, 72.62, and 76.76. The requirements
in this proposed rule do not involve any provisions that would impose
backfits on nuclear power plant licensees as defined in 10 CFR part 50,
``Domestic Licensing of Production and Utilization Facilities,'' or in
10 CFR part 52, ``Licenses, Certifications, and Approvals for Nuclear
Power Plants,'' or on licensees under 10 CFR part 70, ``Domestic
Licensing of Special Nuclear Material,'' 10 CFR part 72, ``Licensing
Requirements for the Independent Storage of Spent Nuclear Fuel and
High-Level Radioactive Waste, and Reactor-Related Greater Than Class C
Waste,'' and 10 CFR part 76, ``Certification of Gaseous Diffusion
Plants.''
List of Subjects
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 61
Criminal penalties, Low-level waste, Nuclear materials, Reporting
and recordkeeping requirements, Waste treatment and disposal.
[[Page 16117]]
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; and 5 U.S.C. 552 and 553, the NRC is proposing
to adopt the following amendments to 10 CFR parts 20 and 61.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
0
1. The authority citation for 10 CFR part 20 continues to read as
follows:
Authority: Atomic Energy Act secs. 53, 63, 65, 81, 103, 104,
161, 182, 186, 223, 234 1701 (42 U.S.C. 2073, 2093, 2095, 2111,
2133, 2134, 2201, 2232, 2236, 2273, 2282, 2297f), Energy
Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005 sec. 651(e), Pub. L. 109-58, 119
Stat. 549 (2005) (42 U.S.C. 2014, 2021, 2021b, 2111).
0
2. In Sec. 20.1003, revise the definition of ``Waste'' to read as
follows:
Sec. 20.1003 Definitions.
* * * * *
Waste means those low-level radioactive wastes containing source,
special nuclear, or byproduct material that are acceptable for disposal
in a land disposal facility. For the purposes of this definition, low-
level radioactive waste means radioactive waste not classified as high-
level radioactive waste, transuranic waste, spent nuclear fuel, or
byproduct material as defined in paragraphs (2), (3), and (4) of the
definition of Byproduct material set forth in this section. Consistent
with the National Defense Authorization Act for Fiscal Year 2013, low-
level radioactive waste also includes radioactive material that,
notwithstanding Section 2 of the Nuclear Waste Policy Act of 1982,
results from the production of medical isotopes that have been
permanently removed from a reactor or subcritical assembly, for which
there is no further use, and the disposal of which can meet the
requirements of this part.
* * * * *
0
3. In appendix G to part 20:
0
a. Revise section II; and
0
b. Revise paragraphs III.A.1, III.A.2, III.A.3, III.C.3, III.C.4, and
III.C.5.
The revisions read as follows:
Appendix G to Part 20--Requirements for Transfers of Low-Level
Radioactive Waste Intended for Disposal at Licensed Land Disposal
Facilities and Manifests
* * * * *
II. * * *
An authorized representative of the waste generator, processor,
or collector shall certify by signing and dating the shipment
manifest that the transported materials meet the waste acceptance
criteria for disposal for a specific site; are properly classified,
described, packaged, marked, and labeled; and are in proper
condition for transportation according to the applicable regulations
of the U.S. Department of Transportation and the Commission. A
collector who signs the certification is certifying that nothing has
been done to the collected waste that would invalidate the waste
generator's certification.
III. * * *
A. * * *
1. Prepare all wastes according to the land disposal facility's
criteria for waste acceptance developed in accordance with Sec.
61.58 of this chapter;
2. Label each disposal container (or transport package if
potential radiation hazards preclude labeling of the individual
disposal container) of waste in accordance with Sec. 61.57 of this
chapter;
3. Conduct a quality assurance program to assure compliance with
the land disposal facility's criteria for waste acceptance that has
been developed in accordance with Sec. 61.58 of this chapter (the
program must include management evaluation of audits);
* * * * *
C. * * *
3. Prepare all wastes according to the land disposal facility's
criteria for waste acceptance developed in accordance with Sec.
61.58 of this chapter;
4. Label each package of waste in accordance with Sec. 61.57 of
this chapter;
5. Conduct a quality assurance program to assure compliance with
the land disposal facility's criteria for waste acceptance that has
been developed in accordance with Sec. 61.58 of this chapter (the
program shall include management evaluation of audits);
* * * * *
PART 61--LICENSING REQUIREMENTS FOR LAND DISPOSAL RADIOACTIVE WASTE
0
4. The authority citation for 10 CFR part 61 continues to read as
follows:
Authority: Atomic Energy Act secs. 53, 57, 62, 63, 65, 81, 161,
181, 182, 183, 223, 234 (42 U.S.C. 2073, 2077, 2092, 2093, 2095,
2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy Reorganization Act
secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846), sec. 211, Pub. L.
95-601, sec. 10, as amended by Pub. L. 102-486, sec. 2902 (42 U.S.C.
5851). Pub. L. 95-601, sec. 10, 14, 92 Stat. 2951, 2953 (42 U.S.C.
2021a, 5851); Government Paperwork Elimination Act sec. 1704 (44
U.S.C. 3504 note); Energy Policy Act of 2005, sec. 651(e), Pub. L.
109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).
0
5. In Sec. 61.2:
0
a. Add the definitions of ``Compliance period'' and ``Defense-in-
depth'';
0
b. Revise the definition of ``Inadvertent intruder'';
0
c. Add the definitions of ``Intruder assessment,'' ``Long-lived
waste,'' ``Performance assessment,'' ``Performance period,''
``Protective assurance period,'' and ``Safety case''; and
0
d. Revise the definitions of ``Site closure and stabilization,''
``Stability,'' and ``Waste.''
The revisions and additions read as follows:
Sec. 61.2 Definitions.
* * * * *
Compliance period is the time out to 1,000 years after closure of
the disposal facility.
* * * * *
Defense-in-depth means the use of multiple independent and
redundant layers of defense such that no single layer, no matter how
robust, is exclusively relied upon. Defense-in-depth for a land
disposal facility includes, but is not limited to, the use of siting,
waste forms and radionuclide content, engineered features, and natural
geologic features of the disposal site.
* * * * *
Inadvertent intruder means a person who might occupy the disposal
site after closure and engage in normal activities, such as
agriculture, dwelling construction, resource exploration or
exploitation (e.g., well drilling) or other reasonably foreseeable
pursuits that might unknowingly expose the person to radiation from the
waste included in or generated from a low-level radioactive waste
facility.
* * * * *
Intruder assessment is an analysis that:
(1) Assumes an inadvertent intruder occupies the site and engages
in normal activities or other reasonably foreseeable pursuits that are
realistic and consistent with expected activities in and around the
disposal site at the time of site closure and that might unknowingly
expose the person to radiation from the waste;
(2) examines the capabilities of intruder barriers to inhibit an
inadvertent intruder's contact with the waste or to limit the
inadvertent intruder's exposure to radiation; and
(3) estimates an inadvertent intruder's potential annual dose,
considering associated uncertainties.
* * * * *
Long-lived waste means waste containing radionuclides:
(1) Where more than 10 percent of the initial activity of a
radionuclide remains after 10,000 years (e.g., long-lived parent),
(2) Where the peak activity from progeny occurs after 10,000 years
(e.g., long-lived parent--short-lived progeny), or
[[Page 16118]]
(3) Where more than 10 percent of the peak activity of a
radionuclide (including progeny) within 10,000 years remains after
10,000 years (e.g., short-lived parent--long-lived progeny).
* * * * *
Performance assessment is an analysis that
(1) Identifies the features, events, and processes that might
affect the disposal system;
(2) Examines the effects of these features, events, and processes
on the performance of the disposal system; and
(3) Estimates the annual dose to any member of the public caused by
all significant features, events, and processes.
* * * * *
Performance period is the timeframe established for considering
waste and site characteristics to evaluate the performance of the site
after the protective assurance period.
* * * * *
Protective assurance period is the period from the end of the
compliance period through 10,000 years following closure of the site.
* * * * *
Safety case is a collection of information that demonstrates the
assessment of the safety of a waste disposal facility. This includes
technical analyses, such as the performance assessment and intruder
assessment, but also includes information on defense-in-depth and
supporting evidence and reasoning on the strength and reliability of
the technical analyses and the assumptions made therein. The safety
case also includes description of the safety relevant aspects of the
site, the design of the facility, and the managerial control measures
and regulatory controls.
* * * * *
Site closure and stabilization means those actions that are taken
upon completion of operations that prepare the disposal site for
custodial care and that assure that the disposal site will remain
stable and will not need ongoing active maintenance.
* * * * *
Stability means structural stability.
* * * * *
Waste means those low-level radioactive wastes containing source,
special nuclear, or byproduct material that are acceptable for disposal
in a land disposal facility. For the purposes of this definition, low-
level radioactive waste means radioactive waste not classified as high-
level radioactive waste, transuranic waste, spent nuclear fuel, or
byproduct material as defined in paragraphs (2), (3), and (4) of the
definition of Byproduct material set forth in Sec. 20.1003 of this
chapter. Consistent with the National Defense Authorization Act for
Fiscal Year 2013, low-level radioactive waste also includes radioactive
material that, notwithstanding Section 2 of the Nuclear Waste Policy
Act of 1982, results from the production of medical isotopes that have
been permanently removed from a reactor or subcritical assembly, for
which there is no further use, and the disposal of which can meet the
requirements of this part.
* * * * *
0
6. Revise Sec. 61.7 to read as follows:
Sec. 61.7 Concepts.
(a) The disposal facility. (1) Part 61 is intended to apply to land
disposal of radioactive waste and not to other methods such as sea or
extraterrestrial disposal. Part 61 contains procedural requirements and
performance objectives applicable to any method of land disposal. It
contains specific technical requirements for near-surface disposal of
radioactive waste, a subset of land disposal, which involves disposal
in the uppermost portion of the earth, approximately 30 meters. Near-
surface disposal includes disposal in engineered facilities that may be
built totally or partially above-grade provided that such facilities
have protective covers. Near-surface disposal does not include disposal
facilities that are partially or fully above-grade with no protective
cover, which are referred to as ``above-ground disposal.'' Burial
deeper than 30 meters may also be satisfactory. Technical requirements
for alternative methods may be added in the future. Alternative methods
of disposal may be approved on a case-by-case basis as needed under
Sec. 61.6.
(2) Near-surface disposal of radioactive waste takes place at a
near-surface disposal facility, which includes all of the land and
buildings necessary to carry out the disposal. The disposal site is
that portion of the facility used for disposal of waste and consists of
disposal units and a buffer zone. A disposal unit is a discrete portion
of the disposal site into which waste is placed for disposal. A buffer
zone is a portion of the disposal site that is controlled by the
licensee and that lies under the site and between the boundary of the
disposal site and any disposal unit. It provides controlled space to
establish monitoring locations, which are intended to provide an early
warning of radionuclide movement. An early warning allows a licensee to
perform any mitigation that might be necessary. In choosing a disposal
site, site characteristics should be considered in terms of the
indefinite future, take into account the radiological characteristics
of the waste, and be evaluated for at least a 500-year timeframe to
provide assurance that the performance objectives can be met.
(b) Performance objectives. Disposal of radioactive waste in land
disposal facilities has the following safety objectives: Protection of
the general population from releases of radioactivity, protection of
inadvertent intruders, protection of individuals during operations, and
ensuring stability of the site after closure. Achieving these
objectives depends upon many factors including the design of the land
disposal facility, operational procedures, characteristics of the
environment surrounding the land disposal facility, and the radioactive
waste acceptable for disposal.
(c) Technical analyses. (1) Demonstrating compliance with the
performance objectives requires assessments of the site-specific
factors including engineering design, operational practices, site
characteristics, and radioactive waste acceptable for disposal.
Technical analyses assess the impact of site-specific factors on the
performance of the disposal facility and the site environment both
during the operational period, as in the analysis for protection of
individuals during operations and, importantly for disposal of
radioactive waste, over the longer term, as in the analyses for
protection of the general population from releases of radioactivity,
protection of inadvertent intruders, and stability of the disposal site
after closure.
(2) A performance assessment is an analysis that is required to
demonstrate protection of the general population from releases of
radioactivity. A performance assessment identifies the specific
characteristics of the disposal site (e.g., hydrology, meteorology,
geochemistry, biology, and geomorphology); degradation, deterioration,
or alteration processes of the engineered barriers (including the waste
form and container); and interactions between the site characteristics
and engineered barriers that might affect performance of the disposal
site. A performance assessment examines the effects of these processes
and interaction on the ability of the disposal site to limit waste
releases and estimates the annual dose to a member of the public for
comparison with the appropriate performance objective of subpart C of
this part.
(3) Inadvertent intruders might occupy the site in the future and
engage
[[Page 16119]]
in normal pursuits without knowing that they were receiving radiation
exposure. Protection of inadvertent intruders can involve two principal
controls: Institutional control over the site after operations by the
site owner to ensure that no such occupation or improper use of the
site occurs; or, designating which waste could present an unacceptable
dose to an intruder, and disposing of this waste in a manner that
provides some form of intruder barrier that is intended to prevent
contact with the waste. These regulations incorporate both types of
protective controls.
(4) The intruder assessment must demonstrate protection of
inadvertent intruders through the assessment of potential radiological
exposures should an inadvertent intruder occupy the disposal site
following a loss of institutional controls after closure. The intruder
can be exposed to radioactivity that has been released into the
environment as a result of disturbance of the waste or from radiation
emitted from waste that is still contained in the disposal site. The
results of the intruder assessment are compared with the appropriate
performance objective of subpart C of this part. An intruder assessment
can employ a similar methodology to that used for a performance
assessment, but the intruder assessment must assume that an inadvertent
intruder occupies the disposal site following a loss of institutional
controls after closure, and engages in activities that unknowingly
expose the intruder to radiation from the waste.
(5) Implementation of dose methodology. The dose methodology used
to demonstrate compliance with the performance objectives of this part
shall be consistent with the dose methodology specified in the
standards for radiation protection set forth in part 20 of this
chapter. After the effective date of these regulations, applicants and
licensees may use updated factors incorporated by the U.S.
Environmental Protection Agency into Federal radiation protection
guidance or may use the most current scientific models and
methodologies (e.g., those accepted by the International Commission on
Radiological Protection) appropriate for site-specific circumstances to
calculate the dose. The weighting factors used in the calculation of
the dose must be consistent with the methodology used to perform the
calculation.
(6) Waste with significant concentrations and quantities of long-
lived radionuclides may require special processing, design, or site
conditions for disposal. Demonstrating protection of the general
population from releases of radioactivity and inadvertent intruders
from the disposal of this waste requires an assessment of long-term
impacts. Performance period analyses are used to evaluate the
suitability of this waste for disposal on a case-by-case basis. In
general, for disposal facilities with limited quantities of long-lived
waste, performance period analyses are not necessary to demonstrate
protection of the general population from releases of radioactivity and
protection of inadvertent intruders. However, there may be site-
specific conditions that require licensees to assess disposal
facilities beyond the compliance period even when long-lived waste is
limited. These conditions should be evaluated on a case-by-case basis
to determine whether analyses beyond the compliance period would be
required.
(d) Defense-in-depth. With respect to waste disposal, defense-in-
depth is the use of multiple independent and redundant layers of
defense to compensate for uncertainties in the estimation of long-term
performance. Defense-in-depth protections, commensurate with the risks,
are intended to ensure that no single layer, no matter how robust, is
exclusively relied upon by the disposal system to provide protection of
the public and environment from radiation that may be released from the
facility to the environment. Defense-in-depth protections, such as
siting, wasteforms, radiological source-term, engineered features, and
natural system features of the disposal site, combined with technical
analyses and scientific judgment form the safety case for licensing a
low-level waste disposal facility. The insights derived from technical
analyses include supporting evidence and reasoning on the strength and
reliability of the layers of defense relied upon in the safety case.
These insights provide input for making regulatory decisions.
(e) Waste acceptance. Demonstrating compliance with the performance
objectives also requires a determination of criteria for the acceptance
of waste. The criteria can be determined from the results of the
technical analyses that demonstrate compliance with the performance
objectives for any land disposal facility or, for a near-surface
disposal facility, the waste classification requirements of subpart D
of this part.
(f) Waste classification and near-surface disposal. (1) A
cornerstone of the waste classification system is stability of both the
waste and disposal site, which minimizes the access of water to waste
that has been emplaced and covered. Limiting the access of water to the
waste minimizes the migration of radionuclides, which may avoid the
need for long-term active maintenance and reduces the potential for
release of radioactivity into the environment. While stability is
desirable, it is not necessary from a health and safety standpoint for
most waste because the waste does not contain sufficient radioactivity
to be of concern. This lower-activity waste (e.g., ordinary trash-type
waste) tends to be unstable. If unstable waste is disposed with the
waste requiring stability, the deterioration of unstable waste could
lead to the failure of the system. The failure of the system could
permit water to penetrate the disposal unit, which may cause problems
with the waste that requires stability. Therefore, to avoid placing
requirements for a stable waste form on relatively innocuous waste,
these wastes have been classified as Class A waste. Unstable Class A
waste will be disposed of in separate disposal units at the disposal
site. However, stable Class A waste may be disposed of with other
classes of waste. Wastes that must be stable for proper disposal are
classified as Class B and C waste. To the extent that it is
practicable, Class B and C waste forms or containers should be designed
to be stable (i.e., maintain gross physical properties and identity)
over 300 years. The stability of the disposal site for the disposal of
long-lived waste may be more uncertain and require more robust
technical evaluation of the processes that are unlikely to affect the
ability of the disposal system to isolate short-lived waste. For long-
lived waste and certain radionuclides prone to migration, a maximum
disposal site inventory based on the characteristics of the disposal
site may be established to limit potential exposure and to mitigate the
uncertainties associated with long-term stability of the disposal site.
Some waste, depending on its radiological characteristics, may not be
suitable for disposal if uncertainties cannot be adequately addressed
with technical analyses.
(2) Institutional control of access to the site is required for up
to 100 years. This permits the disposal of Class A and B waste without
special provisions for intrusion protection, since these wastes contain
types and quantities of radionuclides that generally will decay during
the 100-year period and will present an acceptable hazard to the
intruder. However, waste that is Class A under 10 CFR 61.55(a)(6) may
not decay to acceptable levels in 100 years. For waste classified under
10 CFR 61.55(a)(6), safety is provided by
[[Page 16120]]
limiting the quantities and concentrations of the material consistent
with the disposal site design. Safe disposal of waste classified under
10 CFR 61.55(a)(6) is demonstrated by the technical analyses and
compliance with the performance objectives. The government landowner
administering the active institutional control program has flexibility
in controlling site access, which may include allowing productive uses
of the land provided the integrity and long-term performance of the
site are not affected.
(3) Waste that will not decay to levels that present an acceptable
hazard to an intruder within 100 years is typically designated as Class
C waste. Class C waste must be stable and be disposed of at a greater
depth than the other classes of waste so that subsequent surface
activities by an intruder will not disturb the waste. Where site
conditions prevent deeper disposal, intruder barriers such as concrete
covers may be used. The effective life of these intruder barriers
should be at least 500 years. A maximum concentration of radionuclides
is specified in tables 1 and 2 of Sec. 61.55 so that at the end of the
500-year period, the remaining radioactivity will be at a level that
does not pose an unacceptable hazard to an inadvertent intruder or to
public health and safety. Waste with concentrations above these limits
is generally unacceptable for near-surface disposal. There may be some
instances where waste with concentrations greater than permitted for
Class C would be acceptable for near-surface disposal with special
processing or design. Disposal of this waste will be evaluated on a
case-by-case basis with the technical analyses required in Sec. 61.13.
(4) Regardless of the classification, some waste may require
enhanced controls or limitations at a particular land disposal
facility. A performance assessment and an intruder assessment are used
to identify these enhanced controls and limitations, which are site-
and waste-specific. Enhanced controls or limitations could include
additional limits on waste concentration or total activity, more robust
intruder barriers, deeper burial depth, and waste-specific stability
requirements. These enhanced controls or limitations could mitigate the
uncertainty associated with the evolutionary effects of the natural
environment and the disposal facility performance over the compliance
period.
(g) The licensing process. (1) During the preoperational phase, the
potential applicant goes through a process of disposal site selection
by selecting a region of interest, examining a number of possible
disposal sites within the area of interest, and narrowing the choice to
the proposed site. Through a detailed investigation of the disposal
site characteristics the potential applicant obtains data on which to
base an analysis of the disposal site's suitability. The potential
applicant uses these data and analyses to develop a safety case that
describes the safety relevant aspects of the site, the design of the
facility, and the managerial control measures and regulatory controls.
The safety case demonstrates the level of protection of people and the
environment and provides reasonable assurance that the performance
objectives will be met. Along with these data and analyses, the
applicant submits other more general information to the Commission in
the form of an application for a license for land disposal. The
Commission's review of the application is in accordance with
administrative procedures established by rule and may involve
participation by affected State governments or Indian tribes. While the
proposed disposal site must be owned by a State or the Federal
Government before the Commission will issue a license, it may be
privately owned during the preoperational phase if suitable
arrangements have been made with a State or the Federal Government to
take ownership in fee of the land before the license is issued.
(2) During the operational phase, the licensee carries out disposal
activities in accordance with the requirements of these regulations and
any conditions on the license. Periodically, the authority to conduct
the above ground operations and dispose of waste will be subject to a
license renewal, at which time the operating history will be reviewed
and a decision made to permit or deny continued operation. When
disposal operations are to cease, the licensee applies for an amendment
to the site license to permit site closure. After final review of the
licensee's site closure and stabilization plan, the Commission may
approve the final activities necessary to prepare the disposal site so
that ongoing active maintenance of the site is not required during the
period of institutional control.
(3) During the period when the final site closure and stabilization
activities are being carried out, the licensee is in a disposal site
closure phase. Following that, for a period of 5 years, the licensee
must remain at the disposal site for a period of postclosure
observation and maintenance to assure that the disposal site is stable
and ready for institutional control. The period of postclosure
observation and maintenance is used to ensure that the final site
closure and stabilization activities have not resulted in unintended
instability at the disposal site. The Commission may approve shorter or
require longer periods if conditions warrant. At the end of this
period, the licensee applies for a license transfer to the disposal
site owner.
(4) After a finding of satisfactory disposal site closure, the
Commission will transfer the license to the State or Federal Government
that owns the disposal site. If the U.S. Department of Energy is the
Federal agency administering the land on behalf of the Federal
Government the license will be terminated because the Commission lacks
regulatory authority over the Department for this activity. Under the
conditions of the transferred license, the owner will carry out a
program of monitoring to assure continued satisfactory disposal site
performance, perform physical surveillance to restrict access to the
site, and carry out minor custodial activities. During this period,
productive uses of the land might be permitted if those uses do not
affect the stability of the site and its ability to meet the
performance objectives. At the end of the prescribed period of
institutional control, the license will be terminated by the
Commission.
0
7. In Sec. 61.8, revise paragraph (b) to read as follows:
Sec. 61.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 61.3, 61.6, 61.9, 61.10, 61.11, 61.12,
61.13, 61.14, 61.15, 61.16, 61.20, 61.22, 61.24, 61.26, 61.27, 61.28,
61.30, 61.31, 61.32, 61.41, 61.42, 61.53, 61.55, 61.57, 61.58, 61.61,
61.62, 61.63, 61.72, and 61.80.
* * * * *
0
8. Revise Sec. 61.10 to read as follows:
Sec. 61.10 Content of application.
(a) An application to receive from others, possess and dispose of
wastes containing or contaminated with source, byproduct or special
nuclear material by land disposal must consist of general information,
specific technical information, institutional information, and
financial information as set forth in Sec. Sec. 61.11 through 61.16.
An environmental report prepared in accordance with subpart A of part
51 of this chapter must accompany the application.
(b) The information provided in an application comprises the safety
case and supports the licensee's demonstration that the disposal
facility will be constructed and operated safely and provides
reasonable assurance that the disposal site will be capable of
[[Page 16121]]
isolating waste and limiting releases to the environment.
0
9. In Sec. 61.12, revise the introductory text and paragraphs (a),
(e), (g), (i), and (j) to read as follows:
Sec. 61.12 Specific technical information.
The specific technical information, which supports the safety case,
must include the following to demonstrate that the performance
objectives of subpart C of this part and the applicable technical
requirements of subpart D of this part will be met:
(a) A description of the natural and demographic disposal site
characteristics as determined by disposal site selection and
characterization activities. The description must include geologic,
geotechnical, geochemical, geomorphological, hydrologic, meteorologic,
climatologic, and biotic features of the disposal site and vicinity.
* * * * *
(e) A description of codes and standards that the applicant has
applied to the design and that will apply to construction of the land
disposal facilities.
* * * * *
(g) A description of the disposal site closure plan, including
those design features that are intended to facilitate disposal site
closure and eliminate the need for ongoing active maintenance.
* * * * *
(i) A description of the kind, amount, and specifications of the
radioactive material proposed to be received, possessed, and disposed
of at the land disposal facility, including the criteria for acceptance
of waste for disposal.
(j) A description of the quality assurance program, tailored to
low-level radioactive waste disposal, developed and applied by the
applicant for:
(1) The determination of natural disposal site characteristics;
(2) The development of technical analyses; and
(3) Quality assurance during the design, construction, operation,
and closure of the land disposal facility and the receipt, handling,
and emplacement of waste.
* * * * *
0
10. In Sec. 61.13:
0
a. Revise the introductory text and paragraphs (a), (b), and (d); and
0
b. Add paragraphs (e) and (f).
The revisions and additions read as follows:
Sec. 61.13 Technical analyses.
The specific technical information must also include the following
analyses needed to demonstrate that the performance objectives of
subpart C of this part will be met. The technical analyses are one of
the elements of the safety case. Licensees with licenses for land
disposal facilities in effect on the effective date of this subpart
must submit these analyses at the next license renewal or within 5
years of the effective date of this subpart, whichever comes first.
(a) A performance assessment that demonstrates that there is
reasonable assurance that the exposure to humans from the release of
radioactivity will meet the performance objective set forth in Sec.
61.41. A performance assessment shall:
(1) Consider features, events, and processes that might affect
demonstrating compliance with Sec. 61.41. The features, events, and
processes considered must represent a range of phenomena with both
beneficial and adverse effects on performance, and must consider the
specific technical information required in Sec. 61.12(a) through (i).
A technical basis for either inclusion or exclusion of specific
features, events, and processes must be provided.
(2) Evaluate specific features, events, and processes in detail if
their omission would significantly affect meeting the performance
objective specified in Sec. 61.41.
(3) Consider the likelihood of disruptive or other unlikely
features, events, or processes for comparison with the limits set forth
in Sec. 61.41.
(4) Reflect new features, events, and processes different from the
compliance period that address significant uncertainties inherent in
the long timeframes associated with demonstrating compliance with Sec.
61.41(b) only if scientific information compelling such changes is
available.
(5) Provide a technical basis for either inclusion or exclusion of
degradation, deterioration, or alteration processes (e.g., of the
engineered barriers, waste form, site characteristics) and interactions
between the disposal facility and site characteristics that might
affect the facility's ability to meet the performance objective in
Sec. 61.41.
(6) Provide a technical basis for models used in the performance
assessment such as comparisons made with outputs of detailed process-
level models or empirical observations (e.g., laboratory testing, field
investigations, and natural analogs).
(7) Evaluate pathways including air, soil, groundwater, surface
water, plant uptake, and exhumation by burrowing animals.
(8) Account for uncertainties and variability in the projected
behavior of the disposal system (e.g., disposal facility, natural
system, and environment).
(9) 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 understanding of the performance of the
disposal facility.
(10) Identify and differentiate between the roles performed by the
natural disposal site characteristics and design features of the
disposal facility in limiting releases of radioactivity to the general
population.
(b) Inadvertent intruder analyses that demonstrate there is
reasonable assurance that:
(1) the waste acceptance criteria developed in accordance with
Sec. 61.58 will be met,
(2) adequate barriers to inadvertent intrusion will be provided,
and
(3) any inadvertent intruder will not be exposed to doses that
exceed the limits set forth in Sec. 61.42 as part of the intruder
assessment. An intruder assessment shall:
(i) Assume that an inadvertent intruder occupies the disposal site
at any time after the period of institutional controls ends, and
engages in normal activities including agriculture, dwelling
construction, resource exploration or exploitation (e.g., well
drilling), or other reasonably foreseeable pursuits that are consistent
with activities in and around the site at the time of closure and that
unknowingly expose the intruder to radiation from the waste.
(ii) Identify adequate barriers to inadvertent intrusion that
inhibit contact with the waste or limit exposure to radiation from the
waste, and provide a basis for the time period over which barriers are
effective.
(iii) Account for uncertainties and variability.
* * * * *
(d) Analyses of the long-term stability of the disposal site and
the need for ongoing active maintenance after closure must be based
upon analyses of active natural processes such as erosion, mass
wasting, slope failure, settlement of wastes and backfill, infiltration
through covers over disposal areas and adjacent soils, and surface
drainage of the disposal site. The analyses must provide reasonable
assurance that long-term stability of the disposal site can be ensured
and that there will not be a need for ongoing active maintenance of the
disposal site following closure.
(e) Analyses that assess how the disposal site limits the potential
long-
[[Page 16122]]
term radiological impacts, consistent with available data and current
scientific understanding. The analyses shall be required for disposal
sites with waste that contains radionuclides with average
concentrations exceeding the values listed in table A of this
paragraph, or if necessitated by site-specific conditions. For wastes
containing mixtures of radionuclides found in table A, the total
concentration shall be determined by the sum of fractions rule
described in paragraph 61.55(a)(7). The analyses must identify and
describe the features of the design and site characteristics that will
demonstrate that the performance objectives set forth in Sec. Sec.
61.41(c) and 61.42(c) will be met.
Table A--Average Concentrations of Long-Lived Radionuclides Requiring
Performance Period Analyses
------------------------------------------------------------------------
Concentration
Radionuclide (Ci/m\3\) \1\
------------------------------------------------------------------------
C-14.................................................... 0.8
C-14 in activated metal................................. 8
Ni-59 in activated metal................................ 22
Nb-94 in activated metal................................ 0.02
Tc-99................................................... 0.3
I-129................................................... 0.008
Long-lived alpha-emitting nuclides \2\.................. \3\ 10
Pu-241.................................................. \3\ 350
Cm-242.................................................. \3\ 2,000
------------------------------------------------------------------------
\1\ Values derived from Sec. 61.55 Class A limits.
\2\ Includes alpha-emitting transuranic nuclides as well as other long-
lived alpha-emitting nuclides.
\3\ Units are nanocuries per gram.
(f) Analyses that demonstrate the proposed disposal facility
includes defense-in-depth protections.
0
11. In Sec. 61.23:
0
a. Revise paragraphs (b), (c), (d), and (e); and
0
b. Add paragraph (m).
The revisions and addition read as follows:
Sec. 61.23 Standards for issuance of a license.
* * * * *
(b) The applicant's proposed disposal site, disposal design, waste
acceptance criteria, land disposal facility operations (including
equipment, facilities, and procedures), disposal site closure, and
postclosure institutional control demonstrate that they are adequate to
protect the public health and safety because they provide reasonable
assurance that the general population will be protected from releases
of radioactivity as specified in the performance objective in Sec.
61.41.
(c) The applicant's proposed disposal site, disposal site design,
waste acceptance criteria, land disposal facility operations (including
equipment, facilities, and procedures), disposal site closure, and
postclosure institutional control demonstrate that they are adequate to
protect the public health and safety because they provide reasonable
assurance that individual inadvertent intruders are protected in
accordance with the performance objective in Sec. 61.42.
(d) The applicant's proposed waste acceptance criteria and land
disposal facility operations (including equipment, facilities, and
procedures) demonstrate that they are adequate to protect the public
health and safety because they provide reasonable assurance that the
standards for radiation protection set out in part 20 of this chapter
will be met.
(e) The applicant's proposed disposal site, disposal site design,
waste acceptance criteria, land disposal facility operations, disposal
site closure, and postclosure institutional control demonstrate that
they are adequate to protect the public health and safety because they
provide reasonable assurance that long-term stability of the disposed
waste and the disposal site will be achieved and will eliminate to the
extent practicable the need for ongoing active maintenance of the
disposal site following closure.
* * * * *
(m) The applicant's safety case is adequate to support the
licensing decision.
* * * * *
0
12. In Sec. 61.25, revise paragraphs (a) and (b) to read as follows:
Sec. 61.25 Changes.
(a) Except as provided for in specific license conditions, the
licensee shall not make changes in the land disposal facility or
procedures described in the license application. The license will
include conditions restricting subsequent changes to the facility and
the procedures authorized that are important to public health and
safety. These license 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 prior notice to the Commission. Features and procedures falling
in this paragraph (a)(3) may not be changed without prior Commission
approval if the Commission so orders, after having received the
required notice.
(b) Amendments authorizing waste acceptance criteria changes, site
closure, license transfer, or license termination shall be included in
paragraph (a)(1) of this section.
* * * * *
0
13. In Sec. 61.28, revise paragraphs (a) introductory text and (a)(2)
to read as follows:
Sec. 61.28 Contents of application for closure.
(a) Prior to final closure of the disposal site, or as otherwise
directed by the Commission, the applicant shall submit an application
to amend the license for closure. This closure application must include
a final revision of the safety case and specific details of the
disposal site closure plan included as part of the license application
submitted under Sec. 61.12(g) that includes each of the following:
* * * * *
(2) The results of tests, experiments, or any other analyses
relating to backfill of excavated areas, closure and sealing, waste
migration and interaction with emplacement media, or any other tests,
experiments, or analysis pertinent to the long-term containment of
emplaced waste within the disposal site, including revised analyses for
Sec. 61.13 using the details of the final closure plan and waste
inventory.
* * * * *
0
14. Revise Sec. 61.41 to read as follows:
Sec. 61.41 Protection of the general population from releases of
radioactivity.
(a) Concentrations of radioactive material that may be released to
the general environment in ground water, surface water, air, soil,
plants, or animals must not result in an annual dose exceeding an
equivalent of 0.25 milliSievert (25 millirems) to any member of the
public within the compliance period. Reasonable effort should be made
to maintain releases of radioactivity in effluents to the general
environment as low as is reasonably achievable during the compliance
period. Compliance with this paragraph must be demonstrated through
analyses that meet the requirements specified in Sec. 61.13(a).
[[Page 16123]]
(b) Concentrations of radioactive material that may be released to
the general environment in ground water, surface water, air, soil,
plants, or animals shall be minimized during the protective assurance
period. The annual dose, established on the license, shall be below 5
milliSieverts (500 millirems) or a level that is supported as
reasonably achievable based on technological and economic
considerations in the information submitted for review and approval by
the Commission. Compliance with this paragraph must be demonstrated
through analyses that meet the requirements specified in Sec.
61.13(a).
(c) Effort shall be made to minimize releases of radioactivity from
a disposal facility to the general environment to the extent reasonably
achievable at any time during the performance period. Compliance with
this paragraph must be demonstrated through analyses that meet the
requirements specified in Sec. 61.13(e).
0
15. Revise Sec. 61.42 to read as follows:
Sec. 61.42 Protection of inadvertent intruders.
(a) Design, operation, and closure of the land disposal facility
must ensure protection of any inadvertent intruder into the disposal
site who occupies the site or contacts the waste at any time after
active institutional controls over the disposal site are removed. The
annual dose must not exceed 5 milliSieverts (500 millirems) to any
inadvertent intruder within the compliance period. Compliance with this
paragraph must be demonstrated through analyses that meet the
requirements specified in Sec. 61.13(b).
(b) Design, operation, and closure of the land disposal facility
shall minimize exposures to any inadvertent intruder into the disposal
site at any time during the protective assurance period. The annual
dose, established on the license, shall be below 5 milliSieverts (500
millirems) or a level that is supported as reasonably achievable based
on technological and economic considerations in the information
submitted for review and approval by the Commission. Compliance with
this paragraph must be demonstrated through analyses that meet the
requirements specified in Sec. 61.13(b).
(c) Effort shall be made to minimize exposures to any inadvertent
intruder to the extent reasonably achievable at any time during the
performance period. Compliance with this paragraph must be demonstrated
through analyses that meet the requirements specified in Sec.
61.13(e).
0
16. Revise Sec. 61.44 to read as follows:
Sec. 61.44 Stability of the disposal site after closure.
The disposal facility must be sited, designed, used, operated, and
closed to achieve long-term stability of the disposal site for the
compliance and protective assurance periods and to eliminate to the
extent practicable the need for ongoing active maintenance of the
disposal site following closure so that only surveillance, monitoring,
or minor custodial care are required.
0
17. Revise Sec. 61.50 to read as follows:
Sec. 61.50 Disposal site suitability requirements for land disposal.
(a) Disposal site suitability for near-surface disposal. The
purpose of this section is to specify the minimum characteristics a
disposal site must possess to be acceptable for the disposal of
radioactive waste in the near surface.
(1) To the extent practicable, the disposal site shall be capable
of being characterized, modeled, analyzed, and monitored.
(2) The hydrologic characteristics that a site must have for 500
years following closure of the land disposal facility to be acceptable
for the disposal of radioactive waste in the near surface include:
(i) Waste disposal shall not take place in a poorly drained site or
a site subject to flooding or frequent ponding, or in a 100-year flood
plain, coastal high-hazard area or wetland, as defined in Executive
Order 11988, ``Floodplain Management Guidelines.''
(ii) Upstream drainage areas must be minimized to decrease the
amount of runoff which could erode or inundate waste disposal units.
(iii) The disposal site must provide sufficient depth to the water
table that ground water intrusion, perennial or otherwise, into the
waste will not occur. The Commission will consider an exception to this
requirement to allow disposal below the water table if it can be
conclusively shown that disposal site characteristics will result in
molecular diffusion being the predominant means of radionuclide
movement and the rate of movement will result in the performance
objectives of subpart C of this part being met. In no case will waste
disposal be permitted in the zone of fluctuation of the water table.
(iv) The hydrogeologic unit used for disposal shall not discharge
ground water to the surface within the disposal site.
(3) After 500 years, the hydrologic characteristics specified in
paragraph (2) of this section shall not significantly affect the
ability of the disposal site to meet the performance objectives of
subpart C of this part.
(4) Other characteristics of the site shall not significantly
affect the ability of the disposal site to meet the performance
objectives of subpart C of this part, or preclude defensible modeling
and estimation of longer-term impacts. The characteristics include:
(i) Within the region or state where the facility is to be located,
a disposal site should be selected so that projected population growth
and future developments are not likely to affect the ability of the
disposal facility to meet the performance objectives of subpart C of
this part.
(ii) Areas must be avoided having known natural resources which, if
exploited, would result in failure to meet the performance objectives
of subpart C of this part.
(iii) Areas must be avoided where tectonic processes such as
faulting, folding, seismic activity, or volcanism may occur with such
frequency and extent to significantly affect the ability of the
disposal site to meet the performance objectives of subpart C of this
part, or may preclude defensible modeling and prediction of long-term
impacts.
(iv) Areas must be avoided where surface geologic processes such as
mass wasting, erosion, slumping, landsliding, or weathering occur with
such frequency and extent to significantly affect the ability of the
disposal site to meet the performance objectives of subpart C of this
part, or may preclude defensible modeling and prediction of long-term
impacts.
(v) The disposal site must not be located where nearby facilities
or activities could adversely impact the ability of the site to meet
the performance objectives of subpart C of this part or significantly
mask the environmental monitoring program.
(b) Disposal site suitability requirements for land disposal other
than near-surface (reserved).[Reserved]
0
18. In Sec. 61.51, revise paragraph (a)(1) to read as follows:
Sec. 61.51 Disposal site design for land disposal.
(a) * * *
(1) Site design features must be directed toward defense-in-depth,
long-term isolation and avoidance of the need for continuing active
maintenance after site closure.
* * * * *
0
19. In Sec. 61.52, revise paragraphs (a)(3) and (a)(8) and add
paragraphs (a)(12) and (13) to read as follows:
Sec. 61.52 Land disposal facility operation and disposal site
closure.
(a) * * *
[[Page 16124]]
(3) All wastes shall be disposed of in accordance with the
requirements of paragraphs (a)(4) through (13) of this section.
* * * * *
(8) A buffer zone of land must be maintained between any buried
waste and the disposal site boundary and beneath the disposed waste.
The buffer zone shall be of adequate dimensions to allow a licensee to
carry out environmental monitoring activities specified in Sec.
61.53(d) of this part and take mitigative measures if needed.
* * * * *
(12) Only waste meeting the acceptance criteria shall be disposed
of at the disposal site.
(13) Waste will be disposed of consistent with the description
provided in Sec. 61.12(f) and the technical analyses required by Sec.
61.13.
* * * * *
0
20. In Sec. 61.55, revise paragraph (a)(6) to read as follows:
Sec. 61.55 Waste classification.
(a) * * *
(6) Classification of wastes with radionuclides other than those
listed in tables 1 and 2 of this section. If radioactive waste does not
contain any nuclides listed in either table 1 or 2 of this section, it
is Class A.
* * * * *
0
21. In Sec. 61.56, revise paragraph (a) to read as follows:
Sec. 61.56 Waste characteristics.
(a) The following requirements are minimum requirements for all
waste and are intended to facilitate handling at the disposal site and
provide protection of health and safety of personnel at the disposal
site.
* * * * *
0
22. Revise Sec. 61.57 to read as follows:
Sec. 61.57 Labeling.
Each package of waste must be clearly labeled to identify any
information required by the land disposal facility's criteria for waste
acceptance developed according to Sec. 61.58. Each package of waste
disposed in a land disposal facility with waste acceptance criteria
developed in accordance with the waste classification requirements must
indicate whether it is Class A waste, Class B waste, or Class C waste,
in accordance with Sec. 61.55.
0
23. Revise Sec. 61.58 to read as follows:
Sec. 61.58 Waste acceptance.
(a) Waste acceptance criteria. Each applicant shall provide, for
approval by the Commission, criteria for the acceptance of waste for
disposal that provide reasonable assurance of compliance with the
performance objectives of subpart C of this part. Waste acceptance
criteria shall specify, at a minimum, the following:
(1) Allowable activities and concentrations of specific
radionuclides. Allowable activities and concentrations shall be
developed from the technical analyses required by either Sec. 61.13
for any land disposal facility or the waste classification requirements
set forth in Sec. 61.55 for a near-surface disposal facility.
(2) Acceptable wasteform characteristics and container
specifications. The characteristics and specifications shall meet the
minimum requirements for waste characteristics set forth in Sec.
61.56(a) for all waste, and the requirements in Sec. 61.56(b) for
waste that requires stability to demonstrate compliance with the
performance objectives of subpart C of this part.
(3) Restrictions or prohibitions on waste, materials, or containers
that might affect the facility's ability to meet the performance
objectives in subpart C of this part.
(b) Waste characterization. Each applicant shall provide, for
Commission approval, acceptable methods for characterizing the waste
for acceptance. The methods shall identify the characterization
parameters and acceptable uncertainty in the characterization data. The
following information, at a minimum, shall be required to characterize
waste:
(1) Physical and chemical characteristics;
(2) Volume, including the waste and any stabilization or absorbent
media;
(3) Weight of the container and contents;
(4) Identities, activities, and concentrations;
(5) Characterization date;
(6) Generating source; and
(7) Any other information needed to characterize the waste to
demonstrate that the waste acceptance criteria set forth in Sec.
61.58(a) are met.
(c) Waste certification. Each applicant shall provide, for
Commission approval, a program to certify that waste meets the
acceptance criteria prior to shipment to the disposal facility. The
certification program shall:
(1) Designate authority to certify and receive waste for disposal
at the disposal facility.
(2) Provide procedures for certifying that waste meets the waste
acceptance criteria.
(3) Specify documentation required for waste acceptance including
waste characterization, shipment (including the requirements set forth
in appendix G of 10 CFR part 20), and certification.
(4) Identify records, reports, tests, and inspections that are
necessary to comply with the requirements in Sec. 61.80.
(5) Provide approaches for managing waste that has been certified
as meeting the waste acceptance criteria in a manner that maintains its
certification status.
(d) Licensees with licenses for land disposal facilities in effect
on the effective date of this subpart shall comply with the
requirements of paragraphs (a), (b), and (c) of this section at the
next license renewal or within 5 years of the effective date of this
subpart, whichever comes first.
(e) For license applicants, the waste acceptance criteria will be
incorporated into the facility license. For licensees with licenses for
land disposal facilities in effect on the effective date of this
subpart, upon Commission approval and if otherwise consistent with
applicable State and Federal law, the NRC will issue an amendment to
the license incorporating the waste acceptance criteria in to the
existing license.
(f) Each licensee shall annually review the content and
implementation of the waste acceptance criteria, waste characterization
methods, and certification program.
(g) Applications for modification of approved waste acceptance
criteria must be filed in accordance with Sec. 61.20.
(h) In determining whether waste acceptance criteria will be
approved, the Commission will apply the criteria set forth in Sec.
61.23.
0
24. In Sec. 61.80, revise paragraphs (i)(1) and (2) and add paragraph
(m) to read as follows:
Sec. 61.80 Maintenance of records, reports, and transfers.
* * * * *
(i)(1) Each licensee authorized to dispose of waste materials
received from other persons under this part shall submit annual reports
to the Director, Office of Nuclear Material Safety and Safeguards, by
an appropriate method listed in Sec. 61.4, with a copy to the
appropriate NRC Regional Office shown in appendix D to 10 CFR part 20.
Reports must be submitted by the end of the first calendar quarter of
each year for the preceding year.
(2) The reports shall include:
(i) Specification of the quantity of each of the principal
radionuclides released to unrestricted areas in liquid and in airborne
effluents during the preceding year;
(ii) The results of the environmental monitoring program;
[[Page 16125]]
(iii) A summary of licensee disposal unit survey and maintenance
activities;
(iv) A summary of activities and quantities of radionuclides
disposed of;
(v) Any instances in which observed site characteristics were
significantly different from those described in the application for a
license; and
(vi) Any other information the Commission may require.
(3) If the quantities of radioactive materials released during the
reporting period, monitoring results, or maintenance performed are
significantly different from those expected in the materials previously
reviewed as part of the licensing action, the report must cover this
specifically.
* * * * *
(m) Each licensee shall maintain waste acceptance records
including:
(1) Provisions for waste acceptance including the waste acceptance
criteria, characterization methods, and certification program.
(2) Audits and other reviews of program content and implementation.
The licensee shall retain records of audits and other reviews for 3
years after the record is made.
Dated at Rockville, Maryland, this 16th day of March, 2015.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2015-06429 Filed 3-25-15; 8:45 am]
BILLING CODE 7590-01-P