[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):
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#5b183a293437751c3a37373a3c333e291b352938753c342d"><span class="__cf_email__" data-cfemail="054664776a692b4264696964626d6077456b77662b626a73">[email protected]</span></a>. For technical questions, contact 
one of the individuals listed in the FOR FURTHER INFORMATON CONTACT 
section of this document.
    <bullet> Email comments to: <a href="/cdn-cgi/l/email-protection#1042657c757d717b797e773e537f7d7d757e6463507e62733e777f66"><span class="__cf_email__" data-cfemail="98caedf4fdf5f9f3f1f6ffb6dbf7f5f5fdf6ecebd8f6eafbb6fff7ee">[email protected]</span></a>. If you do 
not receive an automatic email reply confirming receipt, then contact 
us at 301-415-1677.
    <bullet> Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.
    <bullet> Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#b4f3d5c6cd9af7dbd9d2dbc6c0f4dac6d79ad3dbc2"><span class="__cf_email__" data-cfemail="733412010a5d301c1e151c0107331d01105d141c05">[email protected]</span></a>; or Andrew Carrera, telephone: 301-415-
1078, email: <a href="/cdn-cgi/l/email-protection#6a2b040e180f1d44290b18180f180b2a041809440d051c"><span class="__cf_email__" data-cfemail="febf909a8c9b89d0bd9f8c8c9b8c9fbe908c9dd0999188">[email protected]</span></a>. 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:
    <bullet> Revise the existing technical analysis for protection of 
the general population to include a 1,000-year compliance period;
    <bullet> 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;
    <bullet> Add new analyses that would include a 10,000-year 
protective assurance period and annual dose minimization target;
    <bullet> Add a new analysis for certain long-lived LLRW that would 
include a post-10,000-year performance period;
    <bullet> Add new analyses that would identify and describe the 
features of the design and site characteristics that provide defense-
in-depth protections;
    <bullet> Add a new requirement to update the technical analyses at 
closure; and
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0012.
    <bullet> 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 <a href="/cdn-cgi/l/email-protection#631307114d1106100c16110006230d11004d040c15"><span class="__cf_email__" data-cfemail="98e8fceab6eafdebf7edeafbfdd8f6eafbb6fff7ee">[email protected]</span></a>. 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.''
    <bullet> 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.
    <bullet> Specification of the LLRW characteristics in 10 CFR 61.56, 
``Waste characteristics,'' that commercial LLRW forms must meet to be 
acceptable for disposal.
    <bullet> 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)
----------------------------------------------------------------------------------------------------------------
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..
                                 -------------------------------------------------------------------------------
Proposed 10 CFR Part 61           Within 1,000 Years Following Closure of Disposal Facility (Compliance Period).
 regulations.
                                 -------------------------------------------------------------------------------
                                  --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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    <bullet> Analyses-based approach to safety, and
    <bullet> 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:
    <bullet> How many tiers should be used for the analyses?
    <bullet> What should be the duration of the tiers?
    <bullet> 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:
    <bullet> A compliance period of up to 10,000 years.
    <bullet> 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:
    <bullet> What are the projected doses?
    <bullet> What other technologies are available to reduce those 
projected doses (e.g. different wasteforms, engineered covers)?
    <bullet> 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?
    <bullet> 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:
    <bullet> The tiered analysis that is required allows for tailoring 
of the analysis to the problem.
    <bullet> The 1,000 year compliance period, appropriate for the 
disposal of short-lived LLRW, would ensure consistency among Agreement 
State regulators.
    <bullet> By providing a 1,000-year compliance period, it would 
limit speculation and limit the impact of uncertainties on the 
compliance period decision making.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
---------------------------------------------------------------------------

    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:
    <bullet> Providing flexibility to develop site-specific WAC;
    <bullet> minimizing revisions to 10 CFR part 61;
    <bullet> maintaining consistency with the Low-Level Radioactive 
Waste Policy Act of 1980 (as amended in 1985);
    <bullet> limiting additional regulatory burden on licensees and 
license applicants;
    <bullet> providing States flexibility to exercise their regulatory 
authority within a national framework; and
    <bullet> 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\
---------------------------------------------------------------------------

    \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:
    <bullet> Is the proposed three-tiered approach (a compliance 
period, followed by a protective assurance period, followed by a 
performance period, if applicable) appropriate?
    <bullet> Is 500 mrem/yr an appropriate analytical threshold for the 
protective assurance period?
    <bullet> 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?
    <bullet> 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]]

    <bullet> Identify the rulemaking with the Regulation Identifier 
Number (RIN 3150-AI92) and NRC Docket ID (NRC-2011-0012).
    <bullet> Explain why you agree or disagree with the proposed 
revisions, and suggest alternatives and substitute language to the 
proposed changes.
    <bullet> Describe any assumptions and provide any technical 
information or data that support your comments.
    <bullet> If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    <bullet> Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    <bullet> Explain your views as clearly as possible.
    <bullet> Make sure to submit your comments by the comment period 
deadline.
    <bullet> 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:
    <bullet> Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0012.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#b3c5dfd2d7dad89dd7dcc1d9d6c7c0f3dcded19dd6dcc39dd4dcc5"><span class="__cf_email__" data-cfemail="b4c2d8d5d0dddf9ad0dbc6ded1c0c7f4dbd9d69ad1dbc49ad3dbc2">[email protected]</span></a>.
    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


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