[Federal Register Volume 68, Number 222 (Tuesday, November 18, 2003)]
[Proposed Rules]
[Pages 65120-65151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28651]
[[Page 65119]]
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Part II
Environmental Protection Agency
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40 CFR Chapter 1
Approaches to an Integrated Framework for Management and Disposal of
Low-Activity Radioactive Waste: Request for Comment; Proposed Rule
Federal Register / Vol. 68, No. 222 / Tuesday, November 18, 2003 /
Proposed Rules
[[Page 65120]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter 1
[FRL-7585-6]
RIN 2060-AL71
Approaches to an Integrated Framework for Management and Disposal
of Low-Activity Radioactive Waste: Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking (ANPR).
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SUMMARY: This Advance Notice of Proposed Rulemaking (ANPR) requests
public comment regarding options to promote a more consistent framework
for the disposal of radioactive waste with low concentrations of
radioactivity (``low-activity''). Of immediate interest is low-activity
mixed waste (LAMW). This waste is both chemically hazardous according
to the Resource Conservation and Recovery Act (RCRA) and is radioactive
with low radionuclide concentrations under the purview of the Atomic
Energy Act of 1954 (AEA). Such waste is regulated and managed under
both authorities but under certain conditions, one authority may be
sufficient to provide public health and environmental protection. In
particular, given appropriate limits on radionuclide concentrations in
LAMW, disposal of LAMW in RCRA Subtitle C hazardous waste landfills,
with their prescribed engineering design and associated RCRA
requirements (e.g., waste treatment, waste form), may provide
protection of public health and the environment. This document focuses
on effective use of the RCRA-C disposal technology for the disposal of
LAMW. We (the Environmental Protection Agency) seek comment on
standards that would codify this approach and provide greater
flexibility for the safe disposal of LAMW.
Beyond LAMW, however, there is a wide variety of radioactive wastes
with relatively low concentrations of radioactivity; these wastes are
not considered mixed wastes because they are not regulated under both
RCRA and the AEA. Examples of such low-activity waste include certain
AEA radioactive wastes, certain wastes from the extraction of uranium
or thorium (such as those generated by the Formerly Utilized Sites
Remedial Action Program (FUSRAP)), a variety of wastes that fall into
the technologically enhanced naturally occurring radioactive materials
(TENORM) category, and certain decommissioning wastes. Some AEA wastes
are deferred from regulation, such as ``unimportant quantities'' of
source material with less than 0.05 percent uranium or thorium, and
would be characterized as another form of low-activity radioactive
waste (LARW, of which low-activity mixed waste would be a subset). Some
radioactive wastes are regulated strictly down to the last atom while
other low-activity wastes are regulated primarily for their chemically
hazardous constituents. Some of these wastes may be unregulated or
regulated under a framework lacking clarity and consistency. We seek
comment on possible regulatory and non-regulatory options to provide a
more coherent framework to manage LARW, and information to improve the
scientific characterization of such wastes.
We envision that any standards promulgated to address the use of
the RCRA-C disposal technology for LAMW (or, more broadly, LARW) would
offer a new disposal option for these wastes. This would provide the
flexibility to allow States, disposal facility operators, and waste
generators to account for specific State or local regulatory
constraints and economic considerations in determining whether they
would choose to implement this disposal option for protective
management and disposal of these wastes.
DATES: To ensure that your comments will be considered in future
actions related to this document, please submit your comments no later
than March 17, 2004.
ADDRESSES: Comments may be submitted by mail to: Air and Radiation
Docket, Environmental Protection Agency, EPA West Room B108, Mailcode:
6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention
Docket ID No. OAR-2003-0095. Comments may also be submitted
electronically, or through hand delivery/courier. Follow the detailed
instructions as provided in Unit I.B of the SUPPLEMENTARY INFORMATION
section. Please be aware that mail addressed to EPA headquarters may
experience delays in delivery resulting from physical security
screening. We will consider that fact when evaluating comments received
after the end of the comment period.
FOR FURTHER INFORMATION CONTACT: Dan Schultheisz, Radiation Protection
Division, Office of Radiation and Indoor Air, Mailcode: 6608J, United
States Environmental Protection Agency, Washington, DC, 20460-0001;
telephone (202) 343-9300; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. How Can I Get Copies of Related Information?
1. Docket. EPA has established an official public docket for this
action under Docket ID No. OAR-2003-0095. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA
West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is (202) 566-1744, and the telephone number
for the Air and Radiation Docket is (202) 566-1742.
2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. It will also be available,
along with general information relevant to this ANPR, such as
Frequently Asked Questions (FAQ), through EPA's Radiation Program Home
Page at http://www.epa.gov/radiation/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket identification number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public
[[Page 65121]]
docket. To the extent feasible, publicly available docket materials
will be made available in EPA's electronic public docket. When a
document is selected from the index list in EPA Dockets, the system
will identify whether the document is available for viewing in EPA's
electronic public docket. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.A.1.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
For additional information about EPA's electronic public docket
visit EPA Dockets online or see 67 FR 38102, May 31, 2002.
B. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket identification number in the subject line on the
first page of your comment. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments, but will do so at its
discretion.
1. Electronically. If you submit an electronic comment as
prescribed below, EPA recommends that you include your name, mailing
address, and an e-mail address or other contact information in the body
of your comment. Also include this contact information on the outside
of any disk or CD ROM you submit, and in any cover letter accompanying
the disk or CD ROM. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. EPA's policy is that EPA
will not edit your comment, and any identifying or contact information
provided in the body of a comment will be included as part of the
comment that is placed in the official public docket, and made
available in EPA's electronic public docket. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. To
access EPA's electronic public docket from the EPA Internet Home Page,
select ``Information Sources,'' ``Dockets,'' and ``EPA Dockets.'' Once
in the system, select ``search,'' and then key in Docket ID No. OAR-
2003-0095. The system is an ``anonymous access'' system, which means
EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by electronic mail (e-mail) to [email protected], Attention Docket ID No. OAR-2003-0095. In
contrast to EPA's electronic public docket, EPA's e-mail system is not
an ``anonymous access'' system. If you send an e-mail comment directly
to the Docket without going through EPA's electronic public docket,
EPA's e-mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.B.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By Mail. Send your comments to: Air and Radiation Docket,
Environmental Protection Agency, EPA West Room B108, Mailcode: 6102T,
1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID
No. OAR-2003-0095.
3. By Hand Delivery or Courier. Deliver your comments to: Air and
Radiation Docket in the EPA Docket Center, EPA West Room B108, 1301
Constitution Ave., NW., Washington, DC, 20004, Attention Docket ID No.
OAR-2003-0095. Such deliveries are only accepted during the Docket's
normal hours of operation as identified in Unit I.B.
4. By Facsimile. Fax your comments to (202) 566-1741, Attention
Docket ID. No. OAR-2003-0095.
C. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be Confidential
Business Information electronically through EPA's electronic public
docket or by e-mail. Send or deliver information identified as CBI only
to the following address: Dan Schultheisz, U.S. Environmental
Protection Agency, Office of Radiation and Indoor Air, Mailcode: 6608J,
1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID
No. OAR-2003-0095. You may claim information that you submit to EPA as
CBI by marking any part or all of that information as CBI (if you
submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is CBI). Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person identified in the FOR FURTHER INFORMATION CONTACT section.
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D. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
identification number in the subject line on the first page of your
response. It would also be helpful if you provided the name, date, and
Federal Register citation related to your comments.
Acronyms and Abbreviations
We use many acronyms and abbreviations in this preamble. For your
convenience and reference, they are:
AEA--The Atomic Energy Act
AEC--The Atomic Energy Commission
ANPR--Advance notice of proposed rulemaking
CED(E)--Committed effective dose (equivalent)
CERCLA--Comprehensive Environmental Response, Compensation, and
Liability Act (also known as Superfund)
CFR--Code of Federal Regulations
DOE--The United States Department of Energy
EPA--The United States Environmental Protection Agency
FR--Federal Register
FUSRAP--Formerly Utilized Sites Remedial Action Program
GTCC--Greater-Than-Class C low-level radioactive waste
HWIR--Hazardous Waste Identification Rule
LAMW--Low activity mixed waste
LARW--Low activity radioactive waste
LLRW--Low-level radioactive waste
MCL--Maximum Contaminant Level
MLLW--Mixed low-level radioactive waste
MW--Mixed waste
NESHAPS--National emission standards for hazardous air pollutants
NRC--The United States Nuclear Regulatory Commission
OMB--The Office of Management and Budget
ORIA--EPA's Office of Radiation and Indoor Air
OSW--EPA's Office of Solid Waste
OSWER--EPA's Office of Solid Waste and Emergency Response
RCRA--The Resource Conservation and Recovery Act
RCRA--C--Subtitle C of RCRA
TEDE--Total effective dose equivalent
TENORM--Technologically Enhanced Naturally Occurring Radioactive
Materials
TRU--Transuranic waste
TSCA--Toxic Substance Control Act
UMTRCA--Uranium Mill Tailings Radiation Control Act
USACE--United States Army Corps of Engineers
UTS--Universal Treatment Standards
What Do We Mean by Certain Terms?
Throughout this ANPR, we refer to ``Low-Level Radioactive Waste,''
``Mixed Waste,'' ``Low-Activity Low-Level Radioactive Waste,'' ``Low-
Activity Mixed Waste,'' and ``Low-Activity Radioactive Waste.'' Each of
these terms has a distinct meaning within the context of this document
(though not necessarily a regulatory or statutory definition). We want
to avoid confusion wherever possible, so we offer these definitions to
help you better understand the discussion.
When we say ``Low-Level Radioactive Waste'' (or LLRW), we always
mean a specific kind of radioactive material defined at section 2(16)
of the Nuclear Waste Policy Act as radioactive waste that is not spent
nuclear fuel, high-level waste, transuranic waste, or uranium and
thorium mill tailings. Under 10 CFR part 61, ``Licensing Requirements
for Land Disposal of Radioactive Waste,'' the NRC regulates disposal of
LLRW in near-surface disposal facilities. The NRC has defined three
classes of LLRW in part 61 (classes A, B, and C) based on their
radionuclide content and half-life. Under the part 61 waste
classification and disposal site design, siting, and waste acceptance
scheme, waste with radionuclide content that exceeds Class C still is
regulated as LLRW, but generally is not acceptable for near-surface
disposal. The Department of Energy (DOE) regulates LLRW under its own
AEA authority (see DOE Order 435.1).
When we say ``Mixed Waste'' (or MW), we always mean waste that is
regulated under both the Resource Conservation and Recovery Act (RCRA)
as hazardous waste and under the AEA as radioactive material. This
document is concerned only with MW containing LLRW, so-called mixed
low-level waste (MLLW). MLLW can include LLRW Classes A, B, and C, and
greater-than-class C. Non-AEA radioactive wastes mixed with hazardous
waste are not technically MW, although they may be managed in a similar
way.
We are introducing today the term ``low-activity'' to represent the
idea that some radioactive wastes may contain radionuclides in small
enough concentrations to allow them to be managed in ways that are
fully protective of public health and the environment but do not
require all of the radiation protection measures necessary to manage
higher-activity radioactive material. As used in this document, ``low-
activity'' is a conceptual term that does not have a statutory or
regulatory meaning. This document outlines and requests public comment
on methods that could be used in future actions to define ``low-
activity'' wastes. ``Low-activity'' wastes would be subsets of broader
waste categories, such as those defined previously. This document
discusses several types of ``low-activity'' waste, including:
[sbull] ``Low-activity'' LLRW;
[sbull] ``Low-activity'' MW (LAMW);
[sbull] ``Low-activity'' radioactive waste (LARW)--this is a broad
category that includes low-activity LLRW and LAMW, as well as other
wastes such as those primarily regulated at the State level (e.g.,
TENORM wastes, where the term ``technologically enhanced'' means that
human activity has concentrated the natural radioactivity or increased
the potential for human exposure).
Finally, when we say ``byproduct material'' we are using the
definition in section 11e of the AEA. The discussion in section III of
this document focuses on ``pre-UMTRCA byproduct materials'' not
regulated by the NRC. (``Pre-UMTRCA byproduct materials'' are tailings
or wastes produced by the extraction or concentration of uranium or
thorium from any ore processed primarily for its source material
content that NRC has concluded are outside its jurisdiction under
section 11e.(2) of the AEA. This is discussed further in section III.B
of this document. The FUSRAP cleanups address much of the pre-UMTRCA
byproduct material.)
Questions for Public Comment
Consistent with the purpose of an Advance Notice of Proposed
Rulemaking, we are asking many questions about the concepts described
in this document. Because this document covers a broad variety of
topics and possibilities, we note throughout the text the issues on
which we would like public comment. We
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have also collected questions at the end of sections II, III, and IV,
and additional questions may be found in the ``Request for
Information'' sections (see the ``Outline of Today's Action''). The
questions at the end of each section are focused on the material
presented in those sections; however, commenters may feel that
information in a later section is relevant to a question in an earlier
section, or vice versa. We encourage commenters to address the
questions as they believe most appropriate. Further, we welcome
comments on any aspect of the text, not just on those points for which
we specifically request comment. However, to facilitate our evaluation
of and response to public comment, we ask that commenters clearly
identify which issue(s) they are addressing and refer to relevant
portions of the text in their comment.
Outline of Today's Action
I. Why Are We Publishing Today's ANPR?
II. How Can the Disposal of LAMW be Simplified?
A. What Needs to be Done to Allow Protective Disposal of LAMW?
1. Assess Characteristics of LAMW
2. Assess Alternative Disposal Methods
a. RCRA Subtitle C Land Disposal
b. Establish a Risk or Dose Basis for Allowable Concentrations
3. Coordination with Nuclear Regulatory Commission
B. Why is There a Need to Simplify Disposal of LAMW?
1. Dual Regulatory Structure
2. Recent EPA Mixed Waste Actions
C. How Would the RCRA Regulatory Framework Support a Viable
Disposal Concept?
1. Technological Basis for Disposal (RCRA Hazardous Waste
Landfill Criteria)
2. RCRA Treatment Standards
3. RCRA Disposal Facility Operating Standards
4. How does AEA Licensing Compare to RCRA Permitting?
D. What Methods Could be Used to Assess the Risk of Disposing of
LAMW?
1. Modeling as a Basis for Establishing Risk or Dose Basis
2. Comparison of Risks from Radioactive and Hazardous Waste
Disposal
3. Modeling Scenarios
a. Situations to be Addressed
b. Long-term Disposal Cell Performance
i. General Discussion
ii. ``Wet'' and ``Dry'' Sites
iii. Modeling Timeframe
c. ``Off-Normal'' Events
d. Disposal Facility Worker
e. Transportation Worker
f. Post-Closure Site Use
4. Other Considerations Affecting Risk Analysis
a. Use of Part 61 Classification System
b. Waste Form and Packaging
c. Activity Caps
d. Unity Rule
5. Risk or Dose Basis for a LAMW Standard
E. What Legal Authority Does EPA Have Under the AEA?
F. What Regulatory Approaches Could NRC Take With Respect to
LAMW?
1. Regulatory Approaches That Could Apply to RCRA Facilities
2. Regulation of LAMW Generators
G. How Might DOE Implement a LAMW Standard?
1. DOE's ``Authorized Limits'' System
2. DOE's Radiological Control Criteria
H. How Would States Implement the Standard?
1. Would States be Required to Implement the Standard?
2. State Programs
a. Facility Permitting/Public Participation
b. Implementation at the Disposal Facility
c. Agreement States d. Non-Agreement States
3. Regional Low-Level Radioactive Waste Compacts
I. Request for Information: LAMW
J. Background Information Regarding LAMW
1. Commercial LAMW
2. DOE LAMW
K. Questions for Public Comment: Disposal Concept for LAMW
III. Is it Feasible to Dispose Other Low-Activity Radioactive Wastes
(LARW) in Hazardous Waste Landfills?
A. How Would the Proposed Disposal Concept Apply to Other Low-
Activity Radioactive Wastes?
1. From a Technological Perspective
2. Pre-UMTRCA Byproduct Material
3. TENORM
4. Low-Activity LLRW/Source Material Exempted by NRC
B. What Legal and Regulatory Issues Might Affect Applying the
RCRA-C Disposal Concept to Other Low-Activity Radioactive Wastes?
1. Lack of Federal Regulation
2. How They are Regulated Now
a. Pre-UMTRCA Byproduct Material (FUSRAP)
b. TENORM
3. Existing Federal Regulation (Low-Activity LLRW)
4. Potential for a New ``Class'' of Disposal Facilities
C. Request for Information: Other LARW
D. Background Information Regarding Other LARW
1. Pre-UMTRCA Byproduct Material (and FUSRAP)
2. TENORM
3. Low-Activity LLRW/Source Material Exempted by NRC
4. Decommissioning Wastes
E. Questions for Public Comment: Disposal of Other LARW in
Hazardous Waste Landfills
IV. What Non-Regulatory Approaches Might be Effective in Managing
LAMW and Other Low-Activity Radioactive Wastes?
A. General Discussion
1. Advantages and Disadvantages of Non-Regulatory Approaches
2. Examples of Existing EPA Non-Regulatory Programs
3. National Academy of Sciences Studies
B. Non-Regulatory Approaches for LAMW and Other Low-Activity
Radioactive Wastes
1. Develop Guidance
2. Partner with Selected Stakeholders to Develop Waste-Specific
``Best Practices'
C. Request for Information: Non-Regulatory Alternatives to Our
Disposal Concept
D. Questions for Public Comment: Non-Regulatory Alternatives to
Our Disposal Concept
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
I. Why Are We Publishing Today's ANPR?
Today's ANPR introduces a variety of approaches that might be
applicable to certain low-activity radioactive waste categories
(LARW).\1\ We (the Environmental Protection Agency) seek public comment
on the appropriateness of these approaches towards a coherent framework
assuring appropriate management and disposal of such a diverse set of
LARW. As discussed below, our intent is to develop a regulatory
framework applicable to all LARW, which could include disposal of LARW
at RCRA facilities, whether radioactive material addressed by the
Atomic Energy Act under the jurisdiction of NRC or not. Our more
immediate focus regards a simpler but protective approach to the
present dual regulatory system applicable to low-activity mixed waste
(LAMW). We seek comment on approaches that would reduce the burden of
the dual regulatory framework for LAMW. One possibility would be to
establish a regulatory framework to allow, under certain conditions,
the disposal of LAMW at hazardous waste landfills under the purview of
Subtitle C of RCRA. Under this approach, we and NRC could reach
agreement on the appropriate conditions under which such disposal could
take place. Ideally, the conditions that would apply to disposal of
low-activity waste would be much simplified over those requirements
that now apply to low-level waste disposal facilities which allow the
disposal of higher concentrations of radioactive material. Upon such
agreement, NRC would need to take regulatory action to allow AEA
material under its jurisdiction to be sent to Subtitle C landfills.
This would, in
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effect, expand the disposal options available for LAMW.
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\1\ It is important to understand that the term ``low-activity''
does not have a precise statutory or regulatory definition. We use
the term throughout today's action to refer to wastes in which the
radioactivity is low enough to potentially allow management
alternatives that do not incorporate the entire range of radiation
control practices, such as disposal at RCRA Subtitle C landfills.
The situations and conditions that would define ``low-activity''
waste are the subject of today's action and potentially future
rulemakings.
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We recently took a similar approach to minimize dual regulation for
mixed waste. Recognizing the compliance difficulties associated with
the dual regulatory framework applicable to mixed waste, we promulgated
subpart N to 40 CFR part 266 (``Conditional Exemption for Low-Level
Mixed Waste Storage, Treatment, Transportation and Disposal''). (See 66
FR 27218, May 16, 2001.) This conditional exemption provides for a
reduced regulatory burden for facilities that store, treat, transport,
or dispose of mixed low-level waste (MLLW). Under certain conditions,
certain mixed wastes are exempt from RCRA regulation, leaving only the
requirements of the AEA to govern their storage, treatment,
transportation.
In addition to LAMW, there are a variety of wastes with relatively
low concentrations of radioactivity such as certain TENORM waste,
certain AEA materials and certain decommissioning wastes for which the
present institutional framework is less than clear. Some wastes are
tightly regulated from origin through final disposal while others are
presently unregulated. These wastes present a variety of radiological
risks and, ideally, wastes with similar risks should be managed
proportionately to the risk they represent. In this regard, there are a
variety of tools that may achieve acceptable risk levels, with
regulatory controls being one such tool. However, we recognize that
other tools, such as voluntary guidance, ``best practices,'' industry
standards, and the like have the potential to result in acceptable risk
levels. In section III of this document, we seek comment on the use of
these non-regulatory approaches for assuring and achieving acceptable
risk levels from the disposal of these various wastes and what role EPA
should play in creating a consistent and protective framework for
limiting risk. Just as importantly, our ANPR seeks information
regarding the characterization of wastes that fall in these categories,
or information on other wastes that might be considered in conjunction
with those named in this ANPR. Such information can only help to better
characterize the risk inherent in these waste categories and lead to a
more consistent, protective institutional framework.
We believe that the approach presented in today's action could
provide the necessary flexibility for the safe disposal of LAMW and
other LARW and might facilitate site cleanups. Informal discussions
with various stakeholders (commercial mixed waste generators, DOE,
disposal facility operators, State regulators, public interest groups)
suggest a broad level of interest in the potential advantages of this
approach. Today's document offers an opportunity for stakeholders to
provide detailed comment on a variety of concepts and possibilities
that could be used in a future rulemaking. If affected entities
demonstrate support for such a rulemaking and provide information
needed to develop technical and economic analyses, we would have a
strong basis to pursue this effort beyond the ANPR stage. Similarly,
NRC could use the approach described in this document to develop
regulations addressing the disposal of LAMW or other low activity
radioactive wastes from its (or Agreement State) licensees. In an
effort that may affect the disposal of LARW, NRC held a workshop on May
21-22, 2003, to discuss alternatives for safely controlling solid
materials that have no, or very small amounts of, radioactivity. One
alternative for that material is placement in a RCRA Subtitle C
(hazardous waste) or Subtitle D (solid waste) disposal facility.
Therefore, some of the issues discussed in that workshop may be similar
to some of the approaches discussed in this ANPR. Background materials
(including the information collection efforts conducted by NRC) and
current activities (including recent documents issued and plans for
stakeholder input), as well as transcripts of the workshop, can be
found at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=SM_RFC&st=ipcr.
II. How Can the Disposal of LAMW Be Simplified?
As noted above, we have recently promulgated regulations that
describe conditions under which RCRA defers to the NRC and Agreement
State requirements under the AEA for the storage, treatment,
transportation, and disposal of mixed low-level waste. We based this
deferral on our determination that the AEA requirements as addressed by
NRC's regulations for management of radioactive waste offered an
adequate degree of human health and environmental protection when
compared to that offered by RCRA for the hazardous components of MLLW.
Our RCRA authority is much more comprehensive and wide-ranging than our
AEA authority. Under RCRA, we define hazardous waste and regulate
hazardous waste generation, transportation, treatment, and disposal,
including the operation of facilities handling hazardous waste.
However, RCRA specifically excludes certain AEA material from its
jurisdiction (40 CFR 261.4(a)(4)). Under the AEA, for the protection of
the general environment, we can establish generally applicable
radiation protection standards that apply outside the boundaries of
locations under the control of persons possessing or using radioactive
material. NRC and DOE are responsible for establishing requirements for
disposal of AEA material by such persons. For example, we have used
this AEA authority to establish effluent release limits from facilities
comprising the uranium fuel cycle in 40 CFR part 190. In the case of
low-activity mixed waste a dual regulatory framework already exists to
address the storage, treatment, transportation, and disposal of such
waste. With the promulgation of subpart N to 40 CFR part 266, some of
these requirements are eased but widespread implementation of this rule
awaits adoption by the States before it can be implemented. (See 66 FR
27257, May 16, 2001.)
In an effort to further reduce the burden of this dual regulatory
framework for mixed waste, one option would be to promulgate a standard
(such as regulatory limits for radionuclides in the waste) in
coordination with the NRC allowing the disposal of LAMW in Subtitle C
(hazardous waste) RCRA landfills. We believe an appropriate rulemaking
by EPA and NRC of this nature will achieve the same level of
protectiveness while at the same time significantly reducing the effort
(and cost) otherwise required to comply with two separate regulatory
regimes. We focus on disposal because we are aware of a few thousand
small generators who store their mixed waste indefinitely because of
the lack of disposal options, or the high costs of disposal. We are
concerned that this situation may lead to mishandling, illegal dumping,
or the elimination of research on, and use of, medical diagnostic
techniques resulting in less than optimum health care. A protective
regulatory framework that is less expensive and less burdensome would
encourage prompt disposal of such waste, avoiding the risks of
mishandling and illegal disposal, while improving options for health
care. Some Subtitle C treatment standards for land disposal result in
stabilized, solidified, or vitrified treatment residues that will
immobilize radiological components, as well as hazardous constituents.
Also, RCRA requires landfills to have certain engineered barriers to
minimize infiltration and prevent releases. These factors make disposal
of LAMW in RCRA hazardous waste landfills an
[[Page 65125]]
attractive approach for a rulemaking. The key in this approach would be
to determine what concentrations of radioactivity in LAMW are
appropriate for disposal in a RCRA Subtitle C landfill. As the preamble
to subpart N to 40 CFR part 266 noted, an evaluation of the
requirements embodied in the respective regulatory frameworks for RCRA
and AEA revealed that both offer significant protections to human
health and the environment. (See 66 FR 27223, May 16, 2001.) In the
following sections, we discuss more fully the option of pursuing a
rulemaking allowing disposal of LAMW in a RCRA Subtitle C landfill.
A. What Needs To Be Done To Allow Protective Disposal of LAMW?
Because mixed waste contains both a hazardous chemical component
and a radioactive component, the safe disposal of low-activity mixed
waste must combine elements pertinent to both types of hazards. The
RCRA regulatory standards and permitting process provide for control of
the chemically hazardous waste components. If EPA pursues rulemaking
for the disposal of LAMW, we would focus on the controls necessary to
ensure protective disposal of the radioactive component of the waste.
We do not propose to change, either directly or indirectly, any of the
RCRA provisions regulating the disposal of the chemically hazardous
components of the waste. For the radioactive component of the waste,
limits on the concentration of radiological waste that can be disposed
of in a RCRA Subtitle C landfill may be the most straightforward method
to use. These limits would be protective of the public health and would
take into account the waste forms derived from the RCRA treatment
standards and the design and performance of engineered barriers
associated with such landfills.
1. Assess Characteristics of LAMW
The characteristics of low-activity mixed waste are important
factors in determining whether a given disposal concept will be
appropriate. By ``characteristics'' we mean the properties that will
influence our technical analysis of LAMW disposal, because they affect
the way the waste will behave in a Subtitle C disposal cell and
potential radiation exposure to people. Properties of interest will
include physical form and chemical composition of the wastes, and
radionuclide content (specific radionuclides and their concentrations).
There is limited information available on mixed waste, particularly
when compared to waste that is only low-level radioactive or RCRA
hazardous. The most comprehensive survey of commercial mixed waste was
conducted by NRC and EPA in 1992 (``National Profile on Commercially
Generated Low-Level Radioactive Mixed Waste,'' NUREG/CR-5938). A
summary of this survey is available at http://www.epa.gov/radiation/mixed-waste/nat-prof.htm. NRC indicated that, based on 1990 practices,
commercial facilities generated about 3,950 cubic meters of mixed waste
annually and held another 2,120 cubic meters in storage. The profile
divides mixed waste properties and generation into five categories:
medical facilities, academic institutions, government institutions,
industrial facilities, and nuclear power plants. For various reasons,
such as improved waste management practices and information collected
by a few States, we believe the volumes of mixed waste being generated
today may be significantly lower than those described in NRC's profile.
For example, when developing our mixed waste rule of May 2001, our
discussions with mixed waste generators suggested that the industry has
recognized the limited progress in developing mixed waste treatment and
disposal capacity and taken steps to reduce mixed waste generation in
order to reduce the associated financial and regulatory burden.
Mixed waste (and therefore LAMW) is also generated by DOE. In fact,
DOE has a legacy of environmental and process wastes requiring disposal
and significant volumes are expected in the future as DOE sites undergo
continued cleanup. As discussed in more detail later (see section
II.J), DOE has indicated that tens of thousands of cubic meters of low-
level radioactive waste that is mixed waste (MLLW) may be considered
for disposal in commercial disposal facilities. Some fraction of this
waste may have concentrations low enough to qualify as LAMW. The
approach presented in this ANPR may also facilitate the cleanup of
contaminated DOE sites in a protective, expedited, and cost-effective
manner. We request comment on the application of a rulemaking based on
this approach to DOE LAMW.
We encourage mixed waste generators to give us their perspective on
the current status of mixed waste generation, storage, and disposal. In
particular, we would like to know whether generators believe the 1992
EPA/NRC profile accurately describes the state of mixed waste
generation today and how their mixed waste experience compares to that
profile. Further, since an approach using radionuclide concentration
limits to define LAMW for disposal at Subtitle C facilities may be the
most workable, we would like generators to tell us which radionuclides
are of most concern to them and the concentrations that would address a
significant portion of their waste (e.g., what concentration of a
particular radionuclide is found in 25%, 50%, 75% of a generator's
waste).
2. Assess Alternative Disposal Methods
Because we are focusing on simplifying disposal of LAMW, we must
assess the suitability of land disposal methods that have features that
could contribute to containment and isolation of low concentrations of
radionuclides or treated hazardous constituents. Disposal facilities
meeting this description would include:
[sbull] Low-level radioactive waste facilities licensed under 10
CFR part 61;
[sbull] Hazardous waste disposal facilities permitted under RCRA
Subtitle C;
[sbull] Uranium mill tailings facilities operating under 10 CFR
part 40; and
[sbull] Solid waste disposal facilities permitted under RCRA
Subtitle D.
Today's ANPR focuses on hazardous waste facilities permitted under
RCRA Subtitle C. We do not see a need to address low-level waste
facilities, which are licensed with conditions on acceptable
radionuclides and concentrations (which may vary for each licensed
facility). Further, the rule we issued in 2001 at 40 CFR part 266,
subpart N established conditions under which mixed waste could be sent
to an NRC or Agreement State licensed low-level waste facility without
requiring a RCRA permit. Similarly, while NRC has explored the
possibility of allowing mill tailings facilities to accept RCRA
hazardous and low-level radioactive waste, those facilities are not
generally able to accept either without site-specific licensing.
Finally, at this time, we do not expect to extend our disposal concept
to RCRA Subtitle D (non-hazardous solid waste) landfills. However, the
most recent EPA standards for such facilities (40 CFR part 258) require
them to have engineered features that are similar in many ways to
Subtitle C facilities. Further, our recent Hazardous Waste
Identification Rule (HWIR) effort was intended to identify levels at
which hazardous constituents pose a sufficiently low risk that they may
be sent to Subtitle D facilities. (See 66 FR 27266, May 16, 2001.) We
also note that NRC, in collaboration with the State of Michigan, has
recently concluded that certain very low-activity wastes from the
decommissioning of the Big Rock Point nuclear facility may be sent to a
[[Page 65126]]
Subtitle D landfill. (See 66 FR 63567-63568, December 7, 2001.) Other
States have also determined that Subtitle D facilities may offer
sufficient protection for certain types of radioactive material.\2\
Therefore, we request comment on the suitability of Subtitle D
facilities for low concentrations of radionuclides, under what
conditions such disposal would be appropriate, and how comparable
Subtitle D and Subtitle C facilities should be considered. We also
request comment on the suitability of other types of disposal
facilities not mentioned above.
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\2\ The State of Texas allows certain radioactive material with
half-life less than 300 days to be disposed in solid waste
landfills. (See Texas Administrative Code, Title 25, Chapter 289,
Section 202(fff).) In 2001, the Radiation Focus Group of the
Association of State and Territorial Solid Waste Management
Officials (ASTSWMO) stated ``Currently, prohibitions against all
radioactive materials are too broad'' and that ``the list of
radioactive materials that should be excluded from landfills * * *
should include only wastes that are long-lived, and/or soluble, or
otherwise pose a significant hazard.'' (``Detection and Response to
Radioactive Materials at Municipal Solid Waste Landfills,'' Final
Report, July 18, 2001.)
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a. RCRA Subtitle C Land Disposal. The design requirements for RCRA
Subtitle C hazardous waste landfills include engineered barriers (e.g.,
liners, see 40 CFR part 264, subpart N) while the hazardous waste
itself must be treated to meet the land disposal restriction (LDRs)
requirements. (See 40 CFR part 268.) Determining when disposal of LAMW
at Subtitle C landfills is appropriate could involve deriving limiting
radionuclide concentrations in the waste through modeling the
performance of these disposal cells. We would consider the
effectiveness of the RCRA-permitted landfill disposal cells under a
variety of performance and release scenarios. These performance
scenarios would take these design and waste treatment requirements into
account and would anticipate the range of site-specific conditions at
disposal sites that may occur in practice. The scenarios could assess
performance of the RCRA Subtitle C design with respect to ground-water
contamination under various climatic and hydrogeological conditions.
Scenarios could also evaluate worker exposure situations, including
both the worker at the disposal site and the transportation worker.
RCRA facilities are highly regulated and implement measures to protect
workers against associated hazards. The personal protective equipment
provided to RCRA workers might be expected to offer some protection
against radiological constituents. Presuming low concentrations of
radionuclides (which we would expect would keep exposures well below
those allowable for workers at AEA-licensed disposal facilities), these
workers might not need to be considered as occupational workers for the
purposes of a radiation protection program under NRC regulations.
Indeed, if the benchmark for exposure is low enough, from a
radiological perspective, these workers would be more like members of
the general public in the exposures they would be likely to receive
(requirements related to RCRA hazardous waste would still apply). Other
scenarios could also be considered as appropriate to assure the
protection of the public health and the environment. Consequently, this
approach would establish concentration limits appropriate for RCRA
Subtitle C landfills accepting LAMW without requiring site-specific
performance assessments. As a point of reference, consistent with the
concept of LAMW (and ``low-activity'' waste in general), radionuclide
concentration limits would not exceed the values NRC has established
for Class A radioactive waste, as described in 10 CFR 61.55. (See 47 FR
57473, December 27, 1982.) See section II.D for a more detailed
discussion of our concept for modeling.
b. Establish a Risk or Dose Basis for Allowable Concentrations. The
basic modeling scenarios provide a method for identifying appropriate
risk-or dose-based concentration limits on radionuclides in LAMW.\3\
However, we still must consider the appropriate level of risk or dose
on which the concentrations would be based. We are considering a number
of factors in selecting an appropriate level, including other risk
management decisions for radiation protection. In this regard, we are
also working with NRC to understand how risk considerations will be
incorporated into NRC's selection of a regulatory approach. We give
more detail on these factors in section II.D.4.
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\3\ A ``risk-based'' limit would consider the probability that a
person being exposed to radiation would develop a health effect. A
``dose-based'' limit would consider the amount of radiation exposure
that person could receive. The correlation between risk and dose is
not the same for every radionuclide.
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3. Coordination With the Nuclear Regulatory Commission
Because a significant purpose of our proposed approach is to
address low-activity mixed waste generated by NRC licensees, we and NRC
will work closely together in modifying the existing regulatory
structure to encourage more flexibility in LAMW disposal. The lack of
facilities to treat and dispose of mixed waste has been the subject of
Congressional hearings and EPA and NRC were encouraged to devote
resources to develop a strategy to address these issues.\4\ Concern was
also expressed to the Council on Environmental Quality about this
problem, which ``has persisted for over 11 years [with] no resolution
in sight.'' \5\ The Council was asked what action was being taken to
create alternatives for dealing with these waste streams.\6\ We and NRC
have worked together in the past to develop guidance and regulatory
solutions for certain broad mixed waste issues.\7\
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\4\ Hearing Before the Subcommittee on Energy and Power of the
Committee on Commerce, House of Representatives, 104th Cong., 2d
Sess., Sept. 5, 1996, Serial Number 104-114.
\5\ Hearing Before the Subcommittee on Oversight and
Investigations, of the Committee on Energy and Natural Resources,
United States Senate, 104th Cong., 2d Sess., Sept. 26, 1996, Serial
Number 104-775, at 71.
\6\ Id.
\7\ EPA and NRC have issued joint guidance on mixed waste
testing (``Joint EPA/NRC Guidance on Testing Requirements for Mixed
Radioactive and Hazardous Waste,'' 62 FR 62079, November 20, 1997)
and disposal (``NRC/EPA Siting Guidelines for Disposal of LLMW,''
OSWER Directive 9480.00-14, June 1987; ``Joint NRC/EPA Guidance on a
Conceptual Design Approach for Commercial LLMW Disposal
Facilities,'' OSWER Directive 9487.00-8, August 3, 1987). These
documents are available at http://www.epa.gov/radiation/mixed-waste.
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In that vein, EPA and NRC view the disposal of LAMW in a Subtitle C
RCRA landfill as a viable approach deserving further examination
through a public notice and comment process. EPA and NRC believe this
approach has the potential to offer needed flexibility in the
regulation of mixed waste and be fully protective of the public health
and the environment. This approach would also be consistent with
actions taken by both agencies to address specific situations. Note
that the NRC, in consultation with us, has issued guidance such that,
under certain conditions, radioactively contaminated electric arc
furnace dust containing cesium-137 below specified levels--the result
of accidental melting of sealed sources by steel mills--appropriately
may be disposed of in commercially operated RCRA hazardous waste
facilities (62 FR 13176, March 19, 1997).
We anticipate that implementing the disposal option discussed in
today's action for all low-activity radioactive waste, including those
waste streams discussed in section III, will require regulatory action
by both agencies (although our respective responsibilities clearly vary
for the different waste streams). We invite commenters to provide their
perspective on the appropriate roles of the two agencies in developing
regulatory standards and implementing them for waste generators
[[Page 65127]]
and disposal facilities, including the appropriate level of Federal
and/or State oversight. What regulatory arrangement, including division
of responsibilities between EPA and NRC, would be most likely to
facilitate the safe management and disposal of these wastes? We would
also welcome suggestions as to the most effective ways to minimize the
effects of dual regulation.
In our discussions, NRC has identified several regulatory options
that it might apply to LAMW. We discuss these potential NRC regulatory
approaches to LAMW in section II.F, and have included some questions to
elicit public comment on those approaches. However, NRC will discuss
issues specific to NRC's regulatory system in greater detail as it
proceeds through its own rulemaking process. Our action today focuses
more on technical and policy questions surrounding the use of RCRA-C
technology and regulatory framework for disposal of LAMW, the
applicability of the RCRA-C technology to other low-activity
radioactive wastes, and non-regulatory approaches that might prove
effective in managing and disposing of low-activity wastes. We
encourage commenters to respond to all questions in today's action.
B. Why Is There a Need To Simplify Disposal of LAMW?
1. Dual Regulatory Structure
Mixed waste is regulated under both RCRA and the AEA. The need to
comply with two separate regulatory systems, each of which is targeted
to a different component of the waste, creates a certain regulatory and
economic burden on mixed waste generators. While many of the
requirements of the two systems have similar purposes (e.g.,
inspections), they can have the effect of creating two distinct
regulatory compliance infrastructures. Generators (as well as treatment
and disposal facilities) must achieve compliance with both systems. In
some cases, these requirements may appear to be duplicative.
Approximately 3000 small volume generators store mixed wastes, in
part because disposal options are extremely limited. Some estimates are
that the number of individual sites storing mixed waste could be
significantly higher, though there is greater uncertainty in these
estimates. The lack of disposal options for these generators causes
increased management costs. It also can result in mishandling and
perhaps illegal dumping of the waste. Some mixed waste has been in
storage for over a decade. These concerns are not limited to small
generators. The EPA rule discussed in section II.B.2 was largely driven
by power companies' concern over dual regulation of mixed waste. We
believe, in general, that treatment and permanent disposal of waste,
when available, is preferable to storage.
Also, we are concerned that the high costs and difficulty of
disposing of mixed waste will cause doctors, hospitals, and diagnostic
laboratories to suspend certain procedures, which could result in the
provision of less than optimum health care.\8\ There are reports that
the inability to store and dispose of radioactive waste has caused
researchers to avoid scientific procedures that are known to be
effective and to develop less effective alternatives.\9\ We also are
concerned that such problems indirectly may be hampering medical
research.
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\8\ Kaye, Gordon J, ``The Crisis in LLRW Disposal Short- and
Long Term Effects on the Biomedical Community,'' Newsletter for
Appalachian Compact Users of Radioactive Isotopes, June 1991.
\9\ Isaac, Peter G, et al., ``Nonradioactive Probes,'' Molecular
Biology, p 259-160, vol. 3, June 1995.
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We believe it is possible to alleviate the problem if more of the
facilities that can accommodate hazardous waste safely were allowed,
under certain conditions, to dispose of LAMW. Of the commercial
facilities currently permitted to dispose of hazardous waste under
RCRA, only one is also licensed to dispose of AEA radioactive waste
(and mixed waste). (This facility and one other that we are aware of
that has applied for a license to dispose of AEA radioactive waste are
special cases, as their original plans involved accepting radioactive
waste.) This situation may be due, in part, to the additional burden
faced by the RCRA disposal facility operators in applying for a site-
specific license under 10 CFR part 61 or its equivalent to establish a
full-fledged low-level radioactive waste (LLRW) disposal facility. Both
10 CFR part 61 and RCRA Subtitle C describe fairly lengthy, data
intensive, and costly processes for regulatory approval. The somewhat
different focus of the two systems (RCRA as ``technology based'', part
61 as ``performance based'') may also serve to limit the number of
facilities willing to demonstrate compliance under both regulatory
systems. (See section II.C for more detail on the licensing-permitting
issue.) A few commercial Subtitle C landfills have accepted non-AEA
radioactive waste with the approval of State authorities, which
supports our belief that, with the proper controls, the RCRA-C
technology can provide protective disposal of certain types of
radioactive material. Issues associated with non-AEA radioactive wastes
are discussed in section III.
We asserted RCRA authority over the hazardous portion of mixed
waste in the mid-1980s; however, section 1006 of RCRA states that the
AEA takes precedence over RCRA in cases where the regulatory
requirements are inconsistent. Because the approach we are considering
would rely on RCRA Subtitle C landfill technology, and because low-
activity mixed waste would have relatively low concentrations of
radionuclides, our approach would permit the disposal of LAMW if it met
RCRA-C regulations and practices. This implies that the risks to
workers, the public, and the environment (including ground water)
presented by the radioactive portion of LAMW would be effectively
minimized considering the controls already in place at the RCRA-C
landfills. Waste generators would also bear responsibility for ensuring
that their waste met conditions for disposal as low-activity mixed
waste.
This approach would take into account the practicalities of
implementing LAMW disposal at RCRA-permitted hazardous waste landfills,
rather than transforming them into more AEA-like facilities. We believe
that this will introduce sufficient flexibility as to allow LAMW
generators to take advantage of additional disposal options. Similarly,
the number of commercial facilities currently permitted under RCRA to
accept hazardous waste (roughly 20) is significantly higher than the
number licensed to accept low-level waste (3) or mixed waste (1),
offering the prospect of greater competition and disposal capacity.
Though this comparison is instructive, we do not want to limit our
focus to commercial disposal facilities. A significant number of
companies have been issued permits for their own ``captive'' or
privately-owned hazardous waste disposal facilities, which typically
accept waste only from generators owned by or affiliated with the
landfill operator. It is conceivable that mixed waste generators might
be among those with access to such facilities. These facilities must
meet the same RCRA permitting requirements as commercial facilities and
therefore, this approach should be equally appropriate for the receipt
of LAMW. We request comment on whether we should consider only a subset
(i.e., only the commercial or private sector) of the RCRA-C universe in
our analyses. On a related topic, should RCRA landfills operated by DOE
on its own sites be considered within the scope of this approach?
[[Page 65128]]
2. Recent EPA Mixed Waste Actions
As described above, on May 16, 2001, we promulgated regulations
related to the storage, treatment, transportation, and disposal of
mixed low-level radioactive waste (subpart N of 40 CFR part 266). These
regulations describe conditions under which MLLW can be exempted from
certain RCRA hazardous waste requirements. In particular, a generator
of MLLW may store and treat the waste at the generator's facility
without obtaining a RCRA permit (required for hazardous waste
treatment, disposal, and on-site storage beyond 90 days), as long as
the storage and treatment take place in tanks or containers and conform
to the generator's AEA license conditions. Similarly, transportation to
an AEA-licensed low-level radioactive waste disposal facility, and
subsequent disposal, may also take place solely according to AEA
requirements. However, eligible MLLW must still meet the RCRA land
disposal treatment standards prior to transportation for disposal at a
licensed low-level waste disposal facility.
We believe our conceptual approach to disposal of low-activity
mixed waste is complementary to the regulations we promulgated in
subpart N. We believe that a significant proportion of MLLW could
qualify as low-activity mixed waste (just as most low-level waste is in
the lowest-activity class), depending on where the technical analyses
indicate the limits should be set. The approach we are outlining today
would also significantly increase disposal options, if fully
implemented. Compared to the three operating low-level radioactive
waste disposal facilities, there are roughly twenty commercial RCRA
Subtitle C disposal facilities operating today, with many more that
take waste from only a limited number of generators.
The approach we took in promulgating the subpart N disposal
requirements relied on a comparison of the RCRA and AEA requirements
for disposal. In that context, and recognizing that RCRA waste meeting
the treatment standards for land disposal would likely be significantly
lower in risk, we determined that AEA disposal requirements offered
sufficient protectiveness for the hazardous constituents in MLLW. Our
approach to establishing disposal standards for low-activity mixed
waste is similar in concept. For example, our approach would consider
the effects of waste form for the treated LAMW and containerization in
minimizing the availability of radionuclides in the waste for release
in the presence of water. However, our approach will rely on modeling
to determine when the risk to workers and the public from disposal of
radionuclides is acceptably low. The LAMW concentration limits
developed under this approach will be analogous to the RCRA
concentration-based treatment standards that reduce the toxicity and
mobility of hazardous constituents in the waste. Additional measures
that support and build public confidence in this determination, such as
ground-water monitoring for radionuclides, may be advisable.
There will be unavoidable overlap of the mixed waste eligible for
disposal under the two rules. Our subpart N regulations cover a broader
spectrum of MLLW, while we expect the LAMW concept to address only the
lower-activity portion of that MLLW spectrum. Generators with waste
eligible under both rules may make their disposal choice based on cost,
access to a disposal facility, and regulatory constraints.
C. How Would the RCRA Regulatory Framework Support a Viable Disposal
Concept?
We propose to rely to a large extent on the protections offered by
the RCRA hazardous waste disposal facilities for disposal of low-
activity mixed waste. We believe that the RCRA Subtitle C requirements
provide a uniform level of waste containment and isolation technology
that warrants confidence in their ability to address low concentrations
of radionuclides; although RCRA does not regulate on the basis of
radioactivity, there is no general prohibition on disposal of material
not regulated as hazardous in a hazardous waste facility, and some RCRA
facilities are permitted to accept certain types of TENORM waste. In
addition, requirements related to hazardous waste characteristics have
evolved over the life of the Subtitle C program to the point that they
are tightly controlled through application of treatment standards.
Below we discuss several points that we believe provide strong support
for the LAMW disposal approach.
1. Technological Basis for Disposal (RCRA Hazardous Waste Landfill
Criteria)
To assess the protectiveness of LAMW disposal at RCRA-C facilities,
we first need to understand how the disposal cell itself will
contribute to the isolation of radionuclides. It is recognized that
RCRA and AEA employ different regulatory philosophies. RCRA has
explicit engineering and construction criteria for Subtitle C
landfills. Therefore, any permitted RCRA-C facility is expected to meet
these basic criteria and they can be accounted for in the technical
analyses. In contrast, as discussed further in section II.C.4, AEA low-
level waste facilities in 10 CFR part 61 must meet certain performance
objectives to be licensed. Thus the AEA approach allows for some
variation among AEA facilities, depending upon factors such as climate
and site geology. This provides flexibility in facility design in that
it can be tailored to the hazard of the waste. Ultimately, the purpose
of both systems is to contain and isolate the waste in order to protect
public health and the environment.
We believe RCRA's uniformity of design, and the specific
engineering features required, provide assurance that RCRA-C facilities
can limit contact of waste with water (and subsequent leachate
generation) and should allow disposal of LAMW containing low
concentrations of radionuclides. The RCRA regulations describing
landfill attributes are located in 40 CFR part 264, subpart N. They
require, among other things, that a disposal facility have:
[sbull] A cap on the disposal cell that minimizes infiltration of
liquids, promotes drainage, minimizes erosion, accommodates settling
and subsidence, and has permeability no greater than that of the
disposal cell liner system or natural subsoils;
[sbull] A liner system beneath the disposal cell constructed of
materials of specified thickness, hydraulic conductivity, physical
strength, and chemical resistance;
[sbull] A leachate collection and removal system capable of
limiting leachate depth above the liner to 30 cm; and
[sbull] A leak detection system constructed with a specific slope
and materials of a certain thickness, hydraulic conductivity, physical
strength, and chemical resistance.
2. RCRA Treatment Standards
Besides having specific requirements for disposal cell
construction, RCRA also requires that hazardous waste be treated prior
to land disposal. This treatment may serve two purposes: First, it can
reduce the concentration of hazardous constituents in the waste, which
also reduces the associated risk; second, it may change the physical
form of the waste, which can change the volume of the waste, make the
waste easier to handle, reduce the likelihood of releasing hazardous
constituents from the waste, or reduce the likelihood that the waste
itself will migrate out of the disposal cell (e.g., as a liquid or
[[Page 65129]]
leachate) and reach ground water. (By contrast, NRC requirements
address waste characteristics, but NRC does not require specific
treatment methods for waste prior to disposal. However, low-level
radioactive waste is generally compacted, which reduces volume and
increases stability but also increases radionuclide concentrations on a
per unit volume basis. In addition, liquids and chelating agents must
be minimized or otherwise managed to limit their impact on facility
performance.)
The RCRA Universal Treatment Standards (UTS) are located in 40 CFR
part 268. Most are in the form of concentration limits of the
respective hazardous constituents, but some are in the form of
specified treatment technology (particularly in the case of hard-to-
treat wastes). The UTS are based on the level of reduction that can be
achieved by available technology, not on risk reduction. However, by
reducing the concentration of toxic constituents, the practical effect
is some reduction in risk. We would appreciate comments on the need for
measures, such as waste treatment to a specific waste form, that would
help ensure that radionuclide concentrations established under the
approach outlined today remain protective when implemented.
We expect this approach to require that low-activity mixed waste
comply with the RCRA UTS before allowing disposal at RCRA-C facilities,
in keeping with existing restrictions. To the extent that treatment
involves some kind of waste stabilization or solidification, we would
consider this advantageous to keeping radionuclides immobilized in the
disposal cell. We ask readers whether they believe there are situations
in which compliance with the UTS may be unnecessary or inadvisable for
wastes containing radionuclides. We request comment on the need to
require a certain waste form for LAMW and the desirability of having
standards (e.g., concentrations) that are dependent on waste form. We
also request comment on whether a rule should explicitly require
segregating treated LAMW meeting the UTS from untreated hazardous waste
(waste disposed of before treatment standards were required). This
would limit potential interactions with chemicals that could influence
the ability of radionuclides to move in the environment. We believe
this is probably not necessary, as disposal cells that were open prior
to the treatment requirements are likely to have been closed for some
time.
3. RCRA Disposal Facility Operating Standards
RCRA is also explicit about how the facility must approach
operational functions, both while the facility is operating and during
the closure and post-closure phases. In particular, facility operators
must follow specific procedures regarding (see 40 CFR part 264):
[sbull] Inspections--the facility operator must inspect equipment
and procedures in accordance with a written schedule (including
inspecting the installation of the liner and leachate collection
system), must inspect the operation of the landfill after storms, and
must inspect the leachate collection system regularly during operation
and post-closure;
[sbull] Recordkeeping--the facility operator must maintain
inspection records for at least three years and maintain records
detailing the location, dimensions, and contents of disposal cells;
[sbull] Monitoring/corrective action--the facility operator must
conduct a ground-water monitoring program and implement corrective
action when a hazardous constituent is detected in ground water at
concentrations that exceed those listed in the facility's permit;
[sbull] Closure/post-closure--the facility operator must install a
permanent cap on the disposal cell that complies with engineering
specifications, must have an approved closure plan that minimizes the
need for further maintenance, must perform maintenance that becomes
necessary throughout the post-closure period, and must submit a survey
plat showing the locations and contents of disposal cells.
4. How Does AEA Licensing Compare to RCRA Permitting?
Both the NRC and EPA have designed their disposal regulations with
the intent of isolating waste from the environment to minimize
exposures from the radiological or chemical constituents (in this
document, we are focusing on the NRC requirements for LLRW disposal
under 10 CFR part 61). There are a number of broad similarities between
the two regulatory approaches that could translate into ``simplified''
AEA oversight. For example, both the AEA and RCRA:
[sbull] Accept and regulate near-surface disposal as a means to
contain and isolate waste;
[sbull] Include measures to limit infiltration into the disposal
cell (such as a cover/cap);
[sbull] Require site monitoring during operations;
[sbull] Require continued maintenance after facility closure; and
[sbull] Recognize that there are certain site characteristics to be
avoided (such as floodplains and other geologic hazards).
However, there are also some noteworthy differences in the
technical requirements for waste disposal. Some of these differences
exist because of the way the regulations are written and implemented.
RCRA regulations are more prescriptive and design-based than are the
NRC requirements. Although both systems have basic requirements for
site selection, RCRA does not require a landfill seeking a hazardous
waste disposal permit to conduct performance assessments (site-specific
modeling) to assess how waste disposal at the facility will protect
human health and the environment after facility closure. Instead, by
requiring a uniform (minimum) level of technology designed to provide
containment and prevent releases, RCRA places the burden on the
technology to perform as expected and thereby protect the public and
environment. For example, RCRA requires that a disposal cell have a
double liner constructed of certain materials and a leachate collection
system capable of performing to certain specifications. RCRA
regulations say, in effect, ``this level of technology is protective.''
An important point is that, under RCRA, leachate from a hazardous waste
disposal cell is hazardous waste, and must be collected and treated
accordingly. Similarly, leachate containing radionuclides could be
newly generated mixed waste and be treated accordingly. We request
comment on how we should address radionuclides in the LAMW leachate,
particularly if the LAMW has been disposed of under some exemption from
NRC requirements.
On the other hand, NRC, in its regulations under the AEA, focuses
more on standards of performance, rather than on construction
specifications. The NRC has established a maximum dose level to the
public; however, the burden is on the facility operator to satisfy the
licensing authority that the facility, as sited and constructed, will
not allow that dose to be exceeded. Thus, the NRC regulations require a
detailed, site-specific operational and post-closure performance
assessment to show that the facility will perform adequately. NRC
regulations say, in effect, ``show that the level of technology you
select, combined with the characteristics of the site you have
selected, will meet this level of protection.'' License conditions,
often including monitoring facility performance, are then established
to
[[Page 65130]]
ensure that the level of protection is achieved.
The nature of the waste can also affect the time needed for the
hazard to diminish. RCRA establishes a minimum period of 30 years for
facility maintenance and monitoring after closure of the disposal cell
(with extensions as necessary to protect human health and the
environment). NRC assumes a minimum period of 100 years for active
maintenance, with control of the site continuing for an indefinite
period before license termination because of the variety and
concentration of radionuclides that could be disposed at such a site.
Performance assessments conducted to meet 10 CFR part 61 licensing
requirements include projections well beyond both the 30- and 100-year
active institutional control periods.
The environment in the disposal cell (e.g., pH, temperature,
moisture) can affect the decomposition of many hazardous constituents
(primarily organics, as many heavy metals persist essentially forever).
Radionuclides, however, break down more predictably than do hazardous
constituents. A radionuclide remains radioactive, and will take the
same time to decay, regardless of its physical and chemical
environment. Because some radionuclides take hundreds or thousands of
years to decay, under the AEA, facilities are not expected to maintain
perfect containment for these long periods until the waste is no longer
radioactive. In fact, evaluations of AEA facilities typically include
situations in which the disposal system does not perform as well as
expected, with resulting limited releases. These projected limited
releases become the basis for performance assessments used to make
compliance or licensing decisions. Under NRC regulation, the
combination of engineered barriers, waste form requirements, and
natural site characteristics are evaluated to assure that the
concentration of radionuclides reaching the accessible environment does
not exceed regulatory limits. Although AEA regulatory practice focuses
on preventing infiltration, if the cell cover degrades it is preferable
for infiltrating water to move quickly out of the disposal cell in
order to minimize contact time with the waste (avoiding a ``bathtub''
situation). Thus, this approach of recognizing the potential for
limited releases delays and spreads out the releases over time and
minimizes peak doses. In practice, many long-lived radionuclides will
not move with ground water, but will remain within the general area of
disposal because of their chemical characteristics. (Assumptions and
knowledge about the mobility of individual elements in various
environments influence the selection of modeling parameters. Typically,
conservatism is introduced into performance assessments to help account
for uncertainties in long-term modeling. It should also be noted that
the behavior of a particular element in the environment will be
essentially the same whether it is radioactive or not.) In this vein,
NRC regulations expect the evaluation of a potential disposal site for
``at least a 500 year time frame'' while also considering the
``indefinite future.''\10\
---------------------------------------------------------------------------
\10\ 10 CFR 61.7(a).
---------------------------------------------------------------------------
There are several fundamental issues to be considered in
determining the feasibility of an approach involving simplified NRC
oversight for RCRA-C facilities, particularly where NRC requirements
are more extensive than RCRA requirements. Areas of overlap in which
one regulatory regime would take primacy also are important. These
issues include:
[sbull] Post-Closure Care: Should operators be required to maintain
the facility for periods longer than the minimum 30 years required by
RCRA? (RCRA has discretion to extend this period, and some States have
done so.) What about for 100 years, with the expectation of longer site
control, as NRC requires?
[sbull] Land Ownership: RCRA allows private ownership of disposal
sites, with the possibility of future sale. NRC licensing under 10 CFR
part 61 is contingent on eventual ownership of the site by a Federal or
State government entity.
[sbull] Financial Assurance: AEA disposal facilities generally put
up a higher initial financial assurance than RCRA facilities to account
for longer periods of care.
[sbull] Ground-Water Monitoring and Corrective Action: If there are
releases of hazardous constituents, RCRA authorizes corrective action
(corrective action for hazardous constituents might be effective for
AEA materials combined with the hazardous constituents). RCRA
regulations have specific requirements for ground-water monitoring of
hazardous constituents (40 CFR 264.92-94), which are incorporated into
the facility permit. While NRC regulations have general requirements
for site monitoring ``capable of providing early warning of releases of
radionuclides from the disposal site before they leave the site
boundary'' (10 CFR 61.53), they do not contain separate ground-water
standards. Detailed monitoring requirements may be developed in the
facility license.
This ANPR addresses the possibility of alternate disposal methods
for LARW. We will work with NRC to develop appropriate concentration
limits that are protective of the general public and that minimize the
need for additional NRC requirements. However, NRC may decide that
additional requirements on generators or disposal facilities are
necessary for NRC to meet its obligations under the AEA. We request
comment on these issues.
D. What Methods Could Be Used To Assess the Risk of Disposing of LAMW?
1. Modeling as a Basis for Establishing Risk or Dose Basis
Mathematical modeling is a fundamental tool of radioactive waste
management. It assists regulators in assessing expected releases (and
subsequent doses) to the environment from disposal facilities over
periods of hundreds to thousands of years. However, these projections
over time should not be viewed as firm predictions. Instead, they can
give regulators and the public confidence that certain limits will not
be exceeded. Actual ``proof'' of performance would involve active
measures such as facility monitoring.
2. Comparison of Risks From Radioactive and Hazardous Waste Disposal
The public may not have a good understanding of the relative risks
from radiation and hazardous waste. It is probably true that many
people would consider radioactive waste to be more of a danger than
hazardous waste. It is important that the public be informed of the
risks involved in our approach and be satisfied that those risks are
managed appropriately. We have included a general discussion of risks
from both types of waste below.
The risk from radioactive material depends on the type of radiation
emitted and the path(s) of exposure. Gamma radiation is most
significant for external exposures. Alpha emissions are of most concern
for inhalation. NRC requirements for land disposal typically put limits
on radiation doses to the public. Dose can be converted to risk,
although risk can also be calculated directly from exposures; the
results tend to differ for the two methods, and dose itself can be
expressed in several ways that may not be equivalent (a more detailed
discussion of various dose standards is located in section II.D.5). As
discussed above, facilities seeking an NRC radioactive waste disposal
license
[[Page 65131]]
must satisfy the licensing authority that they can meet these limits
through long-term performance assessments. The performance assessment
evaluates the projected inventory of radionuclides in the disposal cell
at closure and models the movement of those radionuclides in the
environment using site-specific conditions.
RCRA considers risk when deciding which wastes should be defined as
hazardous. RCRA evaluates how individual constituents, when land
disposed, will behave in the environment over long periods of time.
Listed wastes (those designated by F, K, P, or U waste codes)
automatically include substances that have a lifetime cancer risk of
10-\4\ or higher to a nearby receptor (i.e., exposures to
the contaminant would cause a fatal cancer to one person or more in a
population of 10,000). RCRA lists substances with a lifetime cancer
risk between 10-\4\ and 10-\6\ on a case-by-case
basis. It does not list those substances with a lifetime cancer risk
less than 10-\6\ (i.e., fewer than one in 1,000,000). For
non-cancer toxic effects, if the concentration of the constituent in
leachate exceeds the drinking water treatment standard for that
constituent (i.e., the ``Hazard Quotient'' is greater than or equal to
1), the waste is listed as hazardous. Toxicity characteristic wastes
(designated by the D waste code) are defined at the concentration that
corresponds to a 10-\5\ lifetime fatal cancer risk. In
determining whether to list a waste as hazardous, RCRA does not focus
on individual site characteristics, but conducts generalized
assessments that consider climatological and hydrogeological variations
around the country along with how much of a particular waste is
generated and how many sites across the country might accept such
waste, and does not credit the engineered features required in the
regulations (as we would expect to do for LAMW).
Since 1998, hazardous waste must meet the Universal Treatment
Standards (UTS) in 40 CFR part 268 before being land disposed. The UTS
are constituent-specific concentration or treatment technology
standards that effectively reduce the toxicity, although the waste must
still be disposed of as hazardous. Our recent Hazardous Waste
Identification Rule (HWIR) effort is intended to establish risk-based
constituent concentrations at which listed hazardous wastes could
``exit'' regulation under Subtitle C. They could then be disposed of as
``solid waste'' under Subtitle D.
In sum, both the NRC and RCRA approaches serve to limit the risk to
the public from waste disposal. Although we plan to conduct modeling of
the disposal cell (that may combine aspects of the site-specific and
generalized approaches), we will also examine the NRC and RCRA disposal
regulations to support the modeling efforts.
3. Modeling Scenarios
The modeling effort would have two aims. The first aim would be
simply to assess the performance of the generic RCRA-C design in terms
of long-term radionuclide containment. The second aim would be to
derive limits for radionuclide concentrations in the wastes to be
disposed of in such a facility. Both NRC and EPA will have to be
satisfied with the modeling to successfully implement this approach.
EPA's modeling approach is detailed below and will be coordinated with
the NRC.
a. Situations to be Addressed. The initial step in a risk or dose
assessment is to determine how a person might be exposed to the
material in question. If there is no exposure, as for the period when
waste is contained and isolated within an intact disposal cell, the
risk or dose will be zero. There are four situations that could result
in human exposures to the radionuclides in low-activity mixed waste:
[sbull] The gradual degradation of the disposal cell through
expected natural processes, which results in radionuclide releases over
long periods of time (100 years or more);
[sbull] Releases caused by ``off-normal'' events, such as unusually
high precipitation over a period of years;
[sbull] Exposures to RCRA disposal facility workers handling LAMW;
and
[sbull] Exposures caused by human activity that disrupts the
disposal site.
These scenarios are discussed in more detail in the following
sections. We request comment on the adequacy of these scenarios and
whether there are others we should consider. We recognize that similar
scenarios could be used to describe potential exposures to the
hazardous constituents already handled at the facilities under
consideration, and that such exposures may be of equal or greater risk
than would be presented by radionuclides; however, our purpose in this
discussion is to determine the best way to demonstrate that the RCRA
technology is adequately protective for radionuclides.
b. Long-term Disposal Cell Performance. i. General Discussion. To
model the long-term performance of the RCRA hazardous waste disposal
cell, assumptions must be made about the initiation of failure of the
cap and liner system to allow water to enter the cell, interact with
the wastes, and exit the disposal cell to the surrounding area. Once
released from the disposal cell, contaminated water would percolate
downward through the unsaturated zone above the local water table,
eventually reaching the water table and migrating laterally in the
direction of ground-water flow toward a receptor at some distance from
the disposal facility. For this conceptual model, the receptor is a
person living close to the facility who receives doses from the use of
contaminated ground water. Other pathways of exposure would include the
surface transport of waste accidentally spilled during operation of the
disposal facility.
With this simple conceptual model, potential releases from the
disposal cell can be calculated for assumed waste concentrations by
specifying the other parameters involved in contaminant transport
calculations. Important factors for consideration in the modeling
calculations include:
[sbull] Rainfall rates;
[sbull] Thickness of the unsaturated zone under the disposal cell;
[sbull] Distance from the disposal cell to the well supplying water
to the receptor;
[sbull] Drinking water consumption rate from the contaminated well
and amounts of contaminated food consumed;
[sbull] Ground-water flow rates;
[sbull] Effectiveness of the cap in controlling water infiltration
and the liner in retarding contaminant movement;
[sbull] Radionuclide retardation effects (primarily sorption into
the geologic media and solubility constraints); and
[sbull] Radioactive decay along the flow paths.
To test the performance of the disposal cells, we would model a
wide range of site-specific conditions in arid and humid climatic
settings as well as variations in hydrogeologic conditions, such as
variations in the thickness of the unsaturated zone below the disposal
facility and ground-water flow rates in the saturated zone. Variations
in all these parameters will affect the exposures incurred by the
receptor for the scenarios analyzed. We would expect to base our
modeling on data available for actual sites in order to capture the
variation in various site parameters. We could use the data for DOE
sites, because they represent a wide range of climatic and
hydrogeologic conditions across the nation, and because they are
relatively well-characterized and a good data base of site-specific
conditions is available for them. We also could use site data
[[Page 65132]]
from RCRA-C facilities across the nation; the most comprehensive
approach would probably be to create a combined data set to ensure that
the modeled sites reasonably address the range of potential waste
disposal facilities subject to RCRA-C landfill requirements. We would
expect to adopt a conservative approach to selecting model parameters,
as described in more detail later. Additional sensitivity studies would
be done to identify the variables that most prominently control
disposal cell performance and exposures to the hypothetical receptor
outside the facility.
We expect to address a variety of site characteristics and exposure
scenarios in the analyses described below. These analyses will
encompass a broad range of potential conditions from which waste
concentrations could be derived for uniform waste acceptance criteria
nationwide. It is possible that some hazardous waste landfills could
dispose of waste containing higher concentrations of radionuclides than
would be appropriate for the ``average'' facility while maintaining the
appropriate level of protection for the public and environment. For
example, waste acceptance criteria could be derived by explicitly
examining site characteristics, such as annual precipitation levels.
Alternatively, disposal facilities with unique features, such as very
deep ground-water tables, may be able to safely contain wastes with
higher radionuclide content than the levels defined in a broadly
applicable standard. Therefore, we request comment on whether
individual disposal facilities should be given the opportunity to
demonstrate that they can accept waste with radionuclide concentrations
that exceed those that would be established by such a standard.
The basic scenario to model would be an expected performance case,
in which the disposal cell degrades over time and radionuclide releases
from the bottom of the cell infiltrate the underlying unsaturated zone
and move into the saturated zone. From that point, the ground-water
flow in the saturated zone carries radionuclides laterally to a well
supplying the water needs of a defined receptor (person) living near
the former disposal cell. The modeling would allow us to calculate
exposures to the receptor from direct ingestion of drinking water and
ingestion of food produced using contaminated ground water from
hypothetical wells. We could also examine the impact of volatile
radionuclides, such as might be encountered during irrigation. These
radionuclides can sometimes give significant exposures through
inhalation. However, we would expect ingestion exposures from various
ground-water uses to be much higher than those from inhalation of
volatile radionuclides.
We believe that the modeling approach should be appropriately
conservative. By ``conservative,'' we mean that we would select
modeling parameters so that releases from the disposal cell are more
likely to be over-estimated than under-estimated. This approach helps
to account for uncertainty by incorporating an additional margin of
safety. However, it would not be appropriate to be overly conservative.
Focusing on ``worst case'' conditions leads to reliance on unrealistic
modeling results. Major areas of conservatism could include:
[sbull] The distance from the disposal cell to the receptor well
could be assumed to be short--
--Prevents expected dilution of the contamination plume with larger
volumes of ``clean'' ground water
--Less radionuclide retardation by soils along ground-water flow path
--Institutional control over site may prevent a well close to the
disposal cell
--Early detection of radionuclide release could trigger facility
closure and corrective action
[sbull] Radionuclide retardation parameters could be selected for
less retardation and faster transport
[sbull] Disposal facility cap and liner could be assumed to fail
sooner than normally anticipated after facility closure
--Cap and liner designed to exceed RCRA 30-year post-closure monitoring
period
--Assumption of failure introduces infiltration and flow through
disposal cell earlier than normal, when radionuclide inventories are
highest.
As stated above, a primary purpose of modeling the long-term
performance of the RCRA-C disposal cell would be to derive radionuclide
concentrations in wastes that would assure that exposures from any
disposal cell releases would be at acceptably low levels to support a
simpler NRC regulatory process for the disposal of low-activity
radioactive waste at RCRA-permitted hazardous waste landfills. We
expect that modeling will show that some radionuclides reach the
receptor well within the modeling period. For these radionuclides,
waste concentration limits would likely be calculated by simply scaling
the exposures calculated in the modeling exercise to the acceptable
level of protection (we request comment on the appropriate level of
protection to consider for this approach in section II.D.5). These
limits would function as waste concentration limits for implementing
the RCRA-C disposal option. Wastes with radionuclide concentrations
higher than established in the rule would not be eligible for disposal
in the RCRA-C disposal cell, although consideration could be given to
including in the rule specific additional conditions that would permit
such disposal (essentially, a ``graded'' approach in which more
extensive radiation protection measures are applied as radionuclide
concentrations increase). Another alternative would be to allow a
disposal facility to petition to have higher waste concentration limits
based upon the results of site-specific performance assessments.
However, this would make it more difficult for NRC to pursue a
simplified regulatory approach.
ii. ``Wet'' and ``Dry'' Sites. We believe that using a conservative
modeling approach will incorporate a significant margin of safety
sufficient to compensate for any uncertainties in the eventual
performance of the RCRA-C disposal design. Assessing just how
significant the margin of safety will be depends on how waste
radionuclide concentrations will be applied to disposal facilities. We
see two basic approaches, discussed generally below. We request comment
on these and other potential approaches.
The first option (``Option 1'') would be to have all disposal
facilities use the same waste concentration limits regardless of the
projected disposal cell performance. Experience tells us we would
expect to see significant variation in performance under the wide range
of climatic and hydrogeologic conditions that we model. Essentially,
Option 1 imposes the concentration limits determined for the worst case
disposal cell we would model on all potential disposal sites,
regardless of the relative merits of any particular site conditions.
Option 1 would thus add an additional level of conservatism to an
already conservative approach. This approach has the potential to
significantly decrease the usefulness of the rule by placing additional
limitations on the waste streams addressed by our proposal (i.e., waste
concentration limits based on a ``worst case'' situation). An advantage
of Option 1 is that it is simple to implement, in the sense that no
variations in the waste concentration limits would be permitted.
Option 2 would allow different concentration limits to be used
depending on the projected performance of the disposal facility. For
example,
[[Page 65133]]
performance modeling might indicate that sites with lower rainfall and
deeper ground-water tables perform significantly better with respect to
limiting off-site doses from radionuclides that can be transported away
from the disposal cells by infiltrating ground water. Such a result
would not be surprising, simply because the travel time for
radionuclides to produce an off-site dose to individuals is likely to
be longer if infiltration is less and it takes longer to reach ground
water in the first place. For these ``dry'' sites, higher waste
concentrations for those radionuclides readily transported with ground
water could apply to the disposal facility while still meeting the same
exposure limits as the ``wet'' sites (with higher rainfall and
shallower ground-water tables). For both options, the exposure limits
which underlie the rule would be the same. If site conditions leading
to superior overall performance were clearly seen in the modeling,
Option 2 would take advantage of that projected performance, whereas
Option 1 would not.
Should Option 2 prove preferable, we would then face the challenge
of defining desirable site conditions that would allow disposal of
waste with higher radionuclide concentrations in some subset of RCRA-C
facilities. In general, annual precipitation is an important parameter
(and is also one for which data can be obtained easily), but often
varies too much to be used by itself to characterize site behavior.
Experience in modeling the movement of radionuclides through the
environment, as well as empirical observation, indicate that the depth
from the bottom of the disposal cell to the ground water is another
important parameter that also is measured easily. Although depth to
ground water also can vary (e.g., with seasonal variation in
precipitation), we believe that it could be possible to use
precipitation and depth to ground water, in combination with other
parameters, to distinguish sites that can accept higher concentrations
of some radionuclides without presenting undue hazards to human health
and the environment. This approach essentially favors sites that have
long travel times from the disposal cell to the ground-water table
(generally through some combination of deep ground water and soil types
that tend to slow the movement of infiltrating water) and limited
infiltration of water through the cap to the waste layer (generally
through a combination of low precipitation and high
evapotranspiration).
We recognize that there are many other parameters that affect
radionuclide transport. However, it may be difficult to obtain the
necessary information, and necessarily more complex to devise a method
to combine the parameters. We encourage public comment on the concept
of distinguishing among sites, as well as ideas on methods to make that
distinction. As an initial point of review for interested commenters,
we have examined this issue for relatively small Subtitle D facilities
in remote locations. Because many of these facilities are in
communities with limited resources, we determined that ground-water
monitoring could be limited if annual precipitation (including
evapotranspiration) was less than roughly 25 inches, as long as there
is no evidence of ground-water contamination. We also developed a
screening tool for Subtitle D facilities seeking no-migration variances
that considers precipitation, depth to ground water, net infiltration,
evapotranspiration potential, and permeability of the unsaturated zone.
This approach implicitly estimates travel time from the disposal cell
to the ground water. See ``Preparing No-Migration Demonstrations for
Municipal Solid Waste Disposal Facilities: A Screening Tool,'' EPA530-
R-99-008, February 1999 (available at http://www.epa.gov/osw).
We are aware that the approach embodied in Option 2 is somewhat
different from that taken by existing RCRA regulations. RCRA is a
national program and we have written regulations accordingly. In
practice, this means that all members of the regulated community have
to meet the same standard, whether it is numeric or technological
(i.e., a site with ``good'' transport characteristics does not get to
accept higher concentrations of hazardous constituents than sites with
relatively poorer characteristics). Under certain conditions, the
standard may be adjusted to meet the regulated party's specific
circumstances (e.g., through a delisting petition or variance). In
these cases, we create a process that an applicant can use to justify
an alternative standard. This would be somewhat analogous to allowing a
disposal facility operator to calculate site-specific concentration
limits, as we discussed earlier in this section.
Another option would be to set other restrictions on site
characteristics for RCRA-permitted landfills accepting low-activity
mixed waste for disposal. We believe the modeling should be conducted
with the intent that any facility that could be sited and permitted
under RCRA Subtitle C could safely dispose of LAMW. However, some
commenters may believe that some locations would not be appropriate for
radionuclide disposal without additional conditions or site-specific
analysis, especially if these locations have relatively poor overall
transport characteristics or geologic features such as fractures in the
subsurface that might provide faster transport pathways to the ground
water. If we were to identify such criteria that go beyond the existing
RCRA criteria (i.e., if simply having a RCRA permit is not sufficient),
what should they be? If a site did not meet the basic eligibility
criteria, should there be an alternative ``qualification'' process
(e.g., through the type of site-specific analysis discussed earlier in
this section)? For purposes of an implementable standard, the basic
eligibility criteria would need to be clearly defined in the rule
itself (NRC may or may not require additional conditions or
restrictions on waste streams under its authority before RCRA-C
facilities could accept those wastes). We also would need to clearly
relate these specific characteristics to a performance objective.
Therefore, we also ask that commenters provide supporting technical or
scientific information that describes how their recommendations would
improve facility performance, and how they would define ``good''
performance. The criteria could include climatological characteristics
such as annual precipitation, transport characteristics of the
unsaturated zone, depth to ground water, or proximity to other features
that affect site suitability. These minimum criteria then would be
factored into the basis for deriving radionuclide concentrations from
off-site exposures.
We also note that RCRA authorized States can issue standards that
are more stringent than the national program. This means that some
States could already have siting criteria for RCRA facilities that
explicitly address some of the factors mentioned above. We would
welcome comments that identify such criteria and indicate the technical
and scientific basis for their adoption. As we have stated before, we
believe that the modeling should be sufficiently conservative to
account for reasonably anticipated variations in site performance, so
that special conditions would not be necessary.
iii. Modeling Timeframe. Another factor in modeling the long-term
performance of a disposal cell is the time period covered by the
modeling. We believe that a 1,000 year modeling period may be
appropriate, although we
[[Page 65134]]
also expect to examine performance over longer times (e.g., up to
10,000 years) to see how well a 1,000 year modeling period captures the
behavior of most radionuclides. There is no consensus on the most
appropriate time for performance assessments. Periods from 100 years to
10,000 years have been used in assessments for various waste disposal
methods. While NRC regulations do not specify a time period in 10 CFR
part 61, NRC guidance in ``A Performance Assessment Methodology for
Low-Level Radioactive Waste Disposal Facilities,'' NUREG-1573 (2000),
endorses a 10,000-year modeling period for licensed LLRW sites.
However, NRC generally uses a 1,000-year period for assessing the dose
consequence of residual radioactive material at the time of license
termination. NRC has its radiological criteria for license termination
in 10 CFR part 20, subpart E. The 1,000-year period is typical for
evaluations of low-level waste disposal (as opposed to high-level waste
or spent fuel disposal, which generally focus on much longer time
periods), and is specified by DOE for performance assessments at its
disposal facilities (DOE Manual 435.1-1, ``Radioactive Waste Management
Manual''). However, some believe that modeling for low-level
radioactive waste must also look at periods well beyond 1,000 years (to
10,000 years or longer) to fully address the possibility of significant
change to the site from erosion or other long-term or cyclic processes.
Others believe that a modeling period of 1,000 years or longer
stretches the credibility of what modeling can reasonably project, and
that at most it is possible to examine with confidence only a few
hundred years (particularly with near-surface facilities, which are
more easily affected by climatic or geologic changes than are deep
subsurface facilities). We believe that 1,000 years may be appropriate
because it is likely that the rule will involve such low radionuclide
concentrations that the value of modeling over longer periods becomes
more questionable in the light of expected changes in surface
conditions over longer periods. It may also be appropriate to consider
periods on the order of 100 years as more consistent with the RCRA
approach to post-closure site care. We request comment on the
appropriate timeframe for modeling.
c. ``Off-Normal'' Events. In assessing the long-term performance of
the disposal cell, we typically use fairly well defined climatic
conditions (e.g., precipitation rates) and incorporate assumptions
about the behavior of the engineered cap and liner. However, we must
also consider what happens when the system departs from ``normal''
behavior. Situations to be examined would include heavier than normal
precipitation over a period of years (or possibly the indefinite
future), alternative cap and liner degradation scenarios, and the
possibility that the rate of water entering into the disposal cell
would exceed the rate exiting the cell, causing water levels to rise
inside the cell. In such a situation (also known as the ``bathtub
effect''), waste remains in contact with water and radionuclide
concentrations can build up in the water collected in the disposal
cell, so that when releases to the subsurface occur, radionuclide
concentrations are higher than they would be if the water spent less
time in contact with the waste. Alternatively, continued heavy
precipitation could cause the water level to overflow the disposal
cell, providing a surface pathway for radionuclide transport.
d. Disposal Facility Worker. For radionuclides that remain immobile
under the off-site exposure modeling described above (i.e., those that
do not reach the receptor well within the modeling period, even with
conservative transport assumptions), there must be another means of
developing waste concentration limits. One approach that might be
considered is the possible exposure that workers at the RCRA disposal
facility might receive because of radiation from the waste material. In
this case, exposures to the RCRA-C worker would also serve as a
benchmark for public exposures, both during the facility's operational
life and after final closure. Assessing worker dose will allow
estimations of exposures to the public without relying on excessively
speculative exposure scenarios; as discussed below, we believe that
anyone who is not directly handling the waste will receive much lower
exposures than would be expected of a worker.
The worker exposure analysis being considered would serve two
functions. First, it would limit potential exposures to the general
public in a manner that is generally consistent with the risk
management approach for radiation exposure to members of the general
public that EPA uses in its regulatory programs and NRC uses at fully-
licensed low-level waste disposal facilities. We would expect exposures
to people not directly handling waste to be much less than the
exposures considered as a reference level for modeling. We believe that
this will ensure that actual exposures to true members of the general
public, such as visitors during the operating life of the facility,
will be minimal. We believe such an approach is appropriate for the
disposal of low-activity mixed waste under this proposal. Second, it
should provide a reasonable basis for NRC, and Agreement States, to
determine whether significant additional worker protection requirements
beyond those of RCRA are necessary. Specifically, whether NRC should
consider requiring inclusion of training, personal dosimetry, record
keeping and reporting, in its regulatory approach. The goal is to
identify radionuclide concentrations that are low enough for the NRC to
conclude that it is unnecessary to consider RCRA workers as
occupational workers under NRC regulations. We also note that workers
handling AEA material are subject to NRC's occupational radiation
standards, rather than Occupational Safety and Health Administration
(OSHA) standards. Workers handling non-AEA material are subject to the
ionizing radiation standards issued by OSHA, which are found in 29 CFR
1910.1096. We anticipate that NRC's consideration of worker protection
requirements would be likely to address the necessary elements of the
OSHA requirements.
We emphasize that we do not intend to set a standard for worker
exposure. However, we are considering modeling several worker exposure
scenarios to assist in setting the radionuclide concentration limits
for LAMW. Some scenarios might assume that the waste already has been
treated and stabilized in a cement/concrete mixture, or in a less dense
medium such as polyethylene. This would mean that the radionuclides
most likely to be limited by a worker scenario are those that emit
strong gamma radiation. Alpha, beta, and weak gamma emissions are not
as likely to be able to escape the stabilized waste form to expose the
worker. However, we are also considering scenarios involving bulk waste
that is neither solidified nor containerized. These scenarios would
present a greater risk of waste becoming airborne, leading to exposure
by inhalation or ingestion. In such cases, the alpha, beta, and weak
gamma emissions would be of more importance than for stabilized waste
forms. We seek comment on the proportion of bulk waste that might be
disposed under this rulemaking.
e. Transportation Worker. It might be necessary to consider
exposures to a worker involved in transporting waste to the RCRA
disposal facility. The transportation worker would most likely be
exposed through pathways similar to a disposal facility worker who
handles waste containers within the facility. In
[[Page 65135]]
such a case, we would make assumptions about how close the worker is to
the waste and for what length of time. We would also consider
Department of Transportation requirements for transportation of
radioactive material.
f. Post-Closure Site Use. The worker exposure modeling we envision
would also help assure limited exposures to the public in the future,
when all waste is buried and the site is closed. Because existing
regulations allow RCRA sites to remain privately owned, it is possible
that a site could be made available for some limited (surface) use
after closure. People who casually traverse the site, or even spend
hours at a time engaged in an activity, would not be expected to
receive doses that exceed those calculated for the worker, and
therefore such doses should be acceptable.
When a Subtitle C disposal facility closes, RCRA requires that the
owner/operator file a survey plat with the local land-use authorities
and the EPA Regional Administrator that shows the location of all
hazardous waste units.\11\ The survey plat must note that the future
use of the land is restricted in accordance with applicable
regulations. The deed to the property also must state that it has been
used to manage hazardous waste and must cite the appropriate
restrictions on future use. At a minimum, use of the property that will
disturb the integrity of the final cover, the liner, or other parts of
the containment system is not permitted unless necessary to protect
human health and the environment, or if such use will not increase the
potential hazard to human health and the environment.
---------------------------------------------------------------------------
\11\ 40 CFR part 264, subpart G.
---------------------------------------------------------------------------
The facility's owner or operator must construct the final closure
cap to minimize infiltration and erosion and accommodate settling or
subsidence with little maintenance (40 CFR 264.310, although active
maintenance would be possible during the post-closure care period).
Even in the event of some noticeable erosion of the cap, which would
not occur until well after final closure, doses to an exposed person
should remain well within acceptable public dose limits. Because of the
multi-layer cap construction, erosion by itself should not be
sufficient to expose the waste. We believe that the controls
established by RCRA will be adequate to prevent intrusion, more
extensive use, or disruption of the site. NRC may apply the 10 CFR part
20, subpart E, unrestricted use standard of 25 mrem to RCRA sites
chosen for disposal of low-activity mixed waste. If subpart E is
applied, NRC might not impose additional facility requirements. On the
other hand, NRC could decide that additional controls for such sites
are necessary. Specifically, NRC could impose extended post closure
care, restricted access after closure, limitations on land use and
restricted site ownership requirements to such disposal sites. In this
ANPR, we are assuming that such additional requirements will not exist.
Although we believe limited use of an undisturbed LAMW disposal
site is not likely to present a significant risk to members of the
public, we must consider the possibility of more extensive use
involving a disturbance of the disposal cell. A common scenario for
such an analysis involves a person who builds a house on the disposal
site, where the construction involves excavation of some portion of the
disposal cell, disturbing the waste layer and scattering of the
contaminated material on the surface. The foundation and basement could
be constructed at some depth in the disposal cell, and the resident
could engage in small-scale crop production or raise some livestock on
the contaminated site. Further, in locating water to support the
resident, it might be assumed that a well is drilled through the
disposal cell, involving some exposure to the driller(s) as
contaminated material is brought to the surface.
This last possibility introduces the prospect that some disturbance
of the cell would enhance transport of radionuclides to the off-site
receptor. In past actions (e.g., geological disposal) we have addressed
a person who uses heavy equipment, such as a drill rig, to penetrate
the waste layer and cell liner, essentially creating a pathway for
radionuclides to move through the unsaturated zone to the aquifer. If
one assumes this type of drilling scenario, how would such a
disturbance affect the release and transport of radionuclides? The most
likely effect would be to create a pathway for the transport of
material containing radionuclides through the unsaturated zone into
direct contact with the aquifer. We would expect that only a very small
volume of waste would be affected by such action. Whether the waste is
solidified or not, the bulk of the radioactive material would be likely
to stay within the confines of the original disposal cell. It is also
clear that there would be no change in the way radionuclides are
released from the waste material remaining in the cell. Once a
radionuclide is released, however, the penetration may provide a
preferred pathway that decreases the travel time through the
unsaturated zone.
If they could occur, the types of site disturbances described above
would happen at some time in the future beyond the end of the RCRA
post-closure period. We do not consider such disturbances to be very
likely, given the site controls prescribed by RCRA regulations,\12\ but
must examine them as an extreme scenario. In its rulemaking for 10 CFR
part 61, NRC concluded that the possibility of extensive inadvertent
intrusion activities at near surface disposal facilities was not
credible for waste in a structurally stable waste form (that is, as
long as the waste remained in a form recognizably man-made, either in a
stabilizing medium or container, intruders would determine that it
should not be disturbed).\13\ If we assume that the intrusion occurs
after any solidified waste has broken down or containers have degraded,
this would likely be several hundred years beyond site closure,
suggesting that shorter-lived radionuclides will have decayed. We note
that hazardous constituents that do not degrade over time, such as
heavy metals, will still be present in the disposal cell and may
present a risk comparable to or greater than the risk from
radionuclides. We also note that the closure requirements described
above apply to Subtitle C facilities. As commenters consider the
applicability of this approach to Subtitle D facilities (see section
II.A.2), it would be appropriate to consider whether the same post-
closure exposure scenarios would apply to those facilities.
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\12\ 40 CFR part 264.
\13\ See Draft Environmental Impact Statement on 10 CFR part 61,
NUREG-0782, Vol. 2, page 4-53, Sept. 1981.
---------------------------------------------------------------------------
4. Other Considerations Affecting the Risk Analysis
a. Use of Part 61 Classification System. For LLRW, the NRC system
defines three waste classes (A, B, C) by the concentration of each
radionuclide. Class A has the lowest concentrations of short- and long-
lived radionuclides and is the least restrictive in terms of packaging
requirements. Classes B and C have more stringent packaging and
stabilization requirements. Class C waste must be located at least 5
meters below ground. NRC does not consider low-level radioactive waste
that exceeds Class C concentrations (``Greater-than-Class C'' waste) to
be generally suitable for disposal in a near-surface facility. Some
radionuclides do not move easily with ground water (or are very short-
lived) and may also not be significant contributors to worker or post-
closure
[[Page 65136]]
public exposure. This means that the limiting concentrations could be
very high if we relied solely on the various modeling scenarios we have
identified. In some cases the limiting concentrations from modeling may
exceed the maximum concentrations established by the NRC for Class A
low-level radioactive waste (see 10 CFR 61.55). In these cases, we
believe that it might be appropriate to set the concentration limit
equal to the Class A maximum value.
It is important to use credible modeling scenarios to the extent
possible to establish the capability of the RCRA-C technology for
radionuclide containment and isolation, and not to rely on the Class A
restriction or other such considerations, except in special cases. We
are concerned that it could be very difficult for us and NRC to justify
a ``simplified'' regulatory approach if a significant number of
radionuclides were at their Class A maximum values. That is, it would
be less likely that the resulting concentration limits would be
appropriate for disposal in RCRA-C facilities in the absence of
significant NRC licensing criteria. In any event, it would defeat the
purpose of simplifying LAMW disposal to require RCRA-C facilities to
undergo a complicated licensing process.
b. Waste Form and Packaging. An important factor in this analysis
is waste treatment prior to disposal. Mixed waste must undergo
treatment for its hazardous constituents to comply with the RCRA land
disposal restrictions of 40 CFR part 268. Treated RCRA waste often is
solidified or stabilized in some type of encapsulating medium to
prevent migration of the remaining hazardous constituents. Cement/
concrete is the most common encapsulating medium because of its ready
availability, cost, and experience in its use. Other encapsulating
technologies, such as vitrification or use of polymers or ceramics, are
less common but may be more effective than cement/concrete at binding
mobile constituents. There are no such treatment requirements for Class
A LLRW, other than restrictions on liquid content (although LLRW must
be treated ``to reduce to the maximum extent practicable'' the hazard
from non-radiological material). The modeling is expected to consider
various waste forms. Of the available encapsulating technologies, we
would consider use of cement/concrete as the most conservative case.
Though a common practice, stabilization is not necessarily a
requirement for compliance with land disposal restrictions. If
solidification or stabilization is not the treatment standard for a
particular hazardous constituent, RCRA requires that the solidified
waste form be tested to show that it meets the prescribed treatment
standard. We request comment on whether it is reasonable to assume a
stabilized waste form as a treatment of choice for LAMW and whether a
rule should require waste stabilization. Such a requirement, however,
could make the disposal of bulk low-activity waste in RCRA C landfills
prohibitively expensive. (Bulk wastes could include such items as soil,
demolition debris, and slag or other industrial process residuals.)
Alternatively, it may be appropriate to have a different set of
concentration limits for disposal of bulk wastes.
As stated earlier, we request comment on the possibility of
individual disposal facilities developing alternative concentration
limits. The performance of less-common encapsulating technologies could
be a factor in permitting such alternative calculations. However, there
are limited data available compared to the extensive literature
available on cement/concrete. In addition to comment, we request
information regarding the long-term performance of encapsulating
technologies, particularly as they pertain to radionuclides.
Waste containers also provide a barrier against radionuclide
releases, as well as adding structural stability to the waste form.
Containers are typically drums or boxes, made of metal or polymer. It
is not unusual for RCRA treatment to result in a waste form that is
solidified inside a container (for example, mixing ash or other
treatment residue with cement). NRC regulations require Class B and C
LLRW to be in containers; if Class A waste is not in containers, it
must be segregated from the waste that is in containers. We request
comment on the need to specify container requirements in the rule.
c. Activity Caps. As stated above, under our basic concept, wastes
with radionuclide concentrations higher than established in the rule
would not be eligible for disposal in the RCRA-C disposal cell.
However, waste with higher concentrations might be acceptable if the
total number of curies in the disposal cell remained below a certain
level (in conjunction with or in lieu of concentration limits). This
could mean placing limits on the total curies of radionuclides disposed
of at a site, inventory limits on specific radionuclides, or waste
volume limitations (as an indirect and more conservative method to
limit activity, since not all the waste would be expected to contain
the maximum radionuclide concentrations). Further, because modeling the
performance of facilities over the long term involves estimates of the
inventory of radionuclides present at site closure, limits of this type
would help reduce uncertainty in those estimates. We request comment on
this issue. We also request comment on how facilities could demonstrate
compliance with such activity limits, how such demonstrations might
relate to on-going operations at a RCRA-C facility, and the limitations
to such an approach.
d. Unity Rule. Overall doses to a receptor could be limited through
a ``sum of fractions'' approach similar to the methodology used in 10
CFR 61.55. Under this approach, a disposal facility could accept waste
containing multiple radionuclides only if the sum of the fractions of
the individual radionuclide concentration limits did not exceed one (or
``unity''). For example, a disposal facility could not accept waste
containing radionuclides X, Y, and Z at concentrations \1/2\, \1/3\,
and \1/3\ of their individual concentration limits because \1/2\ + \1/
3\ + \1/3\ 1. Concentration tables might be based on
several methods of analysis, such as long-term performance assessment
and worker exposure, and a simple sum of fractions approach may not be
the most appropriate way to account for the different methods used to
derive waste concentrations. It is also possible that peak exposures
from different radionuclides in a long-term performance assessment may
be separated by hundreds of years (given differences in half-life and
environmental mobility), indicating that summing may not be appropriate
even if the exposure mechanisms are the same. NRC derived its tables in
10 CFR part 61 from a common analysis for all radionuclides,\14\ and
issued separate tables for short- and long-lived radionuclides. As we
are coordinating this effort with NRC, we request comment regarding
alternative methods to accomplish the same goal of limiting overall
doses.
---------------------------------------------------------------------------
\14\ See Draft Environmental Impact Statement on 10 CFR part 61,
NUREG-0782, Vol. 2, Section 7-2, September 1981.
---------------------------------------------------------------------------
5. Risk or Dose Basis for a LAMW Standard
The modeling described in section II.D.3 will be designed to
protect members of the public during the operating life of the disposal
facility and beyond. By modeling long-term facility performance, ground
water and future residents near the disposal facility will be
protected. Basing radionuclide
[[Page 65137]]
concentrations in the waste on a worker exposure analysis ensures that
people at or near the site while waste is being handled are not exposed
to unacceptable levels of radiation (see section II.D.3.d). Also, we
expect that exposures to people who might be at the site after the
facility is closed would be well within acceptable public dose limits.
The radionuclide concentrations in the mixed waste will be based on
levels that are bounded by the risk management approach for radiation
exposure to members of the public that EPA uses in its regulatory
programs and NRC uses at licensed low-level waste disposal facilities.
There are a range of possible exposure levels that could be considered
to be consistent with EPA risk management policies. We believe setting
dose or risk limits within these values will be appropriate for the
disposal of mixed waste under the approach. We, in cooperation with the
NRC, intend to select exposures that should result in concentration
limits that will be protective for all RCRA-C facilities, should
minimize the need for additional NRC requirements, and will help
generators to dispose of a considerable portion of their mixed waste.
Numerous factors will play a role in deciding what reference
exposure levels should be used. Many of these factors reflect prior
Federal and non-Federal risk management decisions related to
radioactive waste management and disposal, supporting technical
information, and risk levels applied under different statutory and
regulatory actions. The regulatory approach selected by NRC may be an
important factor.
When we use the term ``risk'' in general, we are talking about
correlating exposures to contaminants with health effects resulting
from those exposures. Risk is often expressed as the likelihood of an
exposure resulting in a given health effect within a population. A risk
of 10-\4\ for example, means that a level of exposure will
cause (on average) a health effect in one person out of a population of
10,000. Where radiation is concerned, there are two basic ways to
express this correlation (radiation risk focuses on cancer, either
incidence or fatality). Radiation protection standards (including those
issued by EPA) have traditionally been written in terms of dose (e.g.,
in millirem), which is an expression of the physical effect on body
tissue of the energies transmitted by radiation. Dose can be translated
to risk; however, there have been a number of different ways to
calculate dose (see Table 1), and the correlations with risk are
affected by the dose system used. Our current estimates are that an
annual committed effective dose equivalent of 15 millirem (mrem),
incurred each year for a period of 30 years, carries a lifetime risk of
fatal cancer of approximately 3 x 10-\4\ (3 in 10,000). This
is an ``average'' dose, and the correlation will differ for individual
radionuclides (i.e., taking each radionuclide separately, the lifetime
risk associated with an annual exposure of 15 mrem may be somewhat
higher or lower than x 10-\4\). It is generally estimated
that the average person in the United States can expect to receive an
annual dose of about 300 mrem from natural sources, such as cosmic
radiation, radon, and naturally occurring radionuclides in soil, rocks,
and building materials.
The other way to express this correlation is to calculate risk
directly. This is the approach used by our Superfund program in
determining cleanup levels, and applies methods developed more recently
than the dose-to-risk correlations. The differences in risk estimates
using the two methods can be significant for some radionuclides;
however, in some cases the direct risk calculation is higher, in other
cases the conversion from dose gives the higher risk. The dose-to-risk
method is more familiar to the radiation community and consistent with
radiation protection standards, while the direct calculation of risk is
more consistent with the way non-radiation hazards (such as RCRA
hazardous waste) are evaluated. We request comment on which method
should underlie the calculation of radionuclide concentration limits in
LAMW.
To provide perspective, we examined risk management decisions we
made in areas other than radiation risk. Though the RCRA corrective
action standards do not specify radionuclides (61 FR 19432, May 1,
1996), cleanup levels are to be determined on a site-by-site basis,
using other promulgated standards where appropriate. Generally, EPA
considers 10-\4\ to 10-\6\ to be the acceptable
lifetime risk range for all contaminants. However, the preference is
for remedies at the lower (more protective) end of the risk range;
10-\6\ is considered a point of departure, and applying
situation-specific factors may result in risk within the target range
but above 10-\6\. The RCRA corrective action standards also
are designed to be consistent with Superfund.
In order to provide context for the reference exposure levels that
will be used to derive the limiting radionuclide waste concentrations,
we list current EPA and NRC radiation limits in Table 1, which are
given in terms of dose. It is important to understand that some of
these limits are in the ``whole body'' format, while other, more recent
limits are in the ``effective dose'' format. Further, the ``committed''
effective dose (CED) explicitly accounts for internal radiation
contributions from radionuclides remaining in the body from earlier
intakes (the ``total'' effective dose equivalent, or TEDE, has a
similar purpose). The dose under the ``old'' format translates into
different doses for different radionuclides under the ``new'' format.
The translation depends on how a particular radionuclide distributes
itself throughout the body. Iodine, for example, preferentially
deposits in the thyroid, which is a very small organ. Iodine's
effective dose at the 4 mrem/year whole body or any organ Maximum
Contaminant Level (MCL) for drinking water is less than 1 mrem/year.
However, in an evaluation completed in December 2000, we reaffirmed
that the radionuclide MCLs derived from a 4 mrem/yr whole body dose
generally fall within our target lifetime risk range of
10-\4\ to 10-\6\ when more recent risk assessment
methods are applied (65 FR 76716, December 7, 2000).
Table 1.--Current EPA and NRC Radiation Dose Limits
------------------------------------------------------------------------
------------------------------------------------------------------------
Uranium Fuel Cycle (40 CFR 190.10(a)).. 25 mrem/year whole body, 75
mrem/year thyroid, mrem/year
any other organ.
Generally Applicable Standard for 25 mrem/year whole body, 75
Management and Storage of Spent mrem/year thyroid, mrem/year
Nuclear Fuel (SNF) and High Level any other critical organ.
Waste (HLW) (40 CFR 191.03).
Land Disposal of Low-Level Radioactive 25 mrem/yr whole body, 75 mrem/
Waste (10 CFR 61.41). yr thyroid, 25 mrem/yr any
other organ.
Decommissioning Nuclear Facilities (10 25 mrem/yr TEDE, all pathways
CFR 20.1402). (unrestricted use, although
use of alternative criteria
may allow up to 100 mrem/yr
TEDE)).
Generally Applicable Individual-Dose 15 mrem CED/year.
Standard for Disposal of SNF and HLW
(40 CFR 191.15).
[[Page 65138]]
Individual-Protection Standard for 15 mrem CEDE/year.
Disposal of SNF and HLW at Yucca
Mountain, NV (40 CFR 197.20).
National Emission Standards for 10 mrem EDE/year.
Hazardous Air Pollutants (40 CFR part
61).
SNF and HLW Disposal Limit for 4 mrem/year for manmade beta-
Underground Sources of Drinking Water and photonemitting
(40 CFR 191.24, 197.30). radionuclides whole body or
any internal organ, 15 pCi/l
alpha 197.30) 5 pCi/l radium.
Maximum Contaminant Levels for 4 mrem/year for manmade beta-
Community Drinking Water systems (40 and photonemitting
CFR 141.16). radionuclides whole body or
any internal organ, 15 pCi/l
alpha, 5 pCi/l radium, 30
micrograms/liter uranium.
------------------------------------------------------------------------
Our analysis of our 40 CFR part 191 standard for disposal of spent
nuclear fuel and high-level waste found that, for the radionuclides and
conditions associated with disposal of those wastes, 15 mrem/year under
the more recent effective dose method carries a risk roughly equivalent
to a 25 mrem/year dose using the whole body method.\15\
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\15\ 58 FR 66402, December 20, 1993.
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As noted above, facilities licensed under 10 CFR part 61 must limit
all-pathways exposures to the public (as calculated through long-term
performance assessment) to 25 mrem/year (whole body), and facilities
requesting license termination without restrictions on future site use
must satisfy the licensing authority that doses will not exceed 25
mrem/yr total effective dose equivalent (TEDE) from all potential
pathways. However, in both of these situations dose assessments are
typically well below these regulatory thresholds. In selecting a
reference exposure that would be used to derive concentration limits
and allow for a simpler regulatory approach, we believe it would be
appropriate for facilities operating under such a simplified approach
to consider doses as being at or below the level applicable to other
types of licensed facilities.
When compared to public exposures, there may be some additional
flexibility in selecting a reference exposure level for the worker
exposure scenario. For one thing, pathways such as inhalation and
direct radiation, rather than ground water, would be expected to
predominate. An evaluation of worker exposures will also consider the
fact that these doses would not be to the broader public from
radionuclides in the environment, but generally would be limited to a
fairly small group of individuals. It may also be that workers would
not expect to receive consistent annual exposures for a period of years
because certain exposure scenarios might not occur regularly.
Nevertheless, workers may be examined in the context of both maximally
exposed members of the public and as workers under NRC exposure
regulations (workers handling AEA material are subject to NRC
occupational requirements even if the facility is not licensed). The
goal is to coordinate the selection of a level that provides
appropriate protection and will not cause NRC to require significant
additional worker protection requirements.
We request comment on the appropriate level of protection to use in
our analyses (e.g., on a dose basis, 1 mrem, 10, 15, 25; on a risk
basis, 10-\4\, 10-\5\, 10-\6\;
lifetime or annual exposure). We would like commenters to address
whether the same level(s) should apply to all analyses, or whether
specific types of modeling (e.g., long-term performance or worker
protection) should be based on different exposures, and if so, why.
Would it depend on when the exposures would occur? The predominant
pathways? Who the exposed person would be?
On a related issue, some of the radionuclides we examine may also
have toxic effects separate from their radioactive properties. Many of
these elements, such as lead, have already been evaluated within the
RCRA framework. Others have not. Uranium, for example, is known to have
effects on kidney function that may be of more concern than its
radiation effects. The drinking water MCL in Table 1 did consider these
toxic effects. How should we address such situations? Are there other
elements that would be of particular concern?
E. What Legal Authority Does EPA Have Under the AEA?
The crux of our approach would be to provide an additional
regulatory avenue for expanding the availability of mixed and other
low-activity radioactive waste disposal options. Typically, when EPA
establishes radiation protection standards, the statutory authority is
the Atomic Energy Act of 1954, as amended,\16\ and Reorganization Plan
No. 3 of 1970 (the Plan).\17\ The Plan transfers to EPA the ``functions
of the Atomic Energy Commission (AEC) [now the NRC and the DOE] under
the Atomic Energy Act'' to the extent that those functions consist of
establishing ``generally applicable environmental standards for the
protection of the general environment from radioactive material.''\18\
The Plan defines standards as ``limits on radiation exposures or
levels, or concentrations or quantities of radioactive material, in the
general environment outside the boundaries of locations under the
control of persons possessing or using radioactive material.''\19\ The
functions of the AEC under the AEA include the authority to ``establish
by rule, regulation, or order, such standards and instructions to
govern the possession and use of special nuclear material, source
material, and byproduct material as the Commission may deem necessary
or desirable to promote the common defense and security or to protect
health or to minimize danger to life or property. * * * 42 U.S.C.
2201(b). To the extent that such rulemaking activity involves the
establishment of generally applicable environmental standards this
authority is vested in the Administrator of the EPA.
---------------------------------------------------------------------------
\16\ 42 U.S.C. 2011 et seq. (1994).
\17\ Reorganization Plan No. 3 of 1970. 35 FR 15623 (1970).
Published October 6, 1970; effective December 2, 1970. 84 Stat. 2086
(1970) (codified at 5 U.S.C. App. 1).
\18\ Id. at section 2(a)(6).
\19\ Id.
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F. What Regulatory Approaches Could NRC Take With Respect to Disposal
of LAMW?
NRC has provided us with general information on regulatory
approaches it would consider for low-activity mixed waste disposal.
These are:
1. Regulatory Approaches that Could Apply to RCRA Facilities
[sbull] Specific License for RCRA-C Disposal Facility--In this
case, NRC would modify its regulations to allow a RCRA-C landfill
facility wanting to accept for disposal LAMW meeting the
[[Page 65139]]
specified conditions (e.g., radionuclide concentration limits) to apply
for a specific NRC license under NRC regulations, such as 10 CFR part
61. NRC would assess the protections offered by RCRA-C technology on a
site-specific basis. NRC would retain its authority to enforce and
inspect as in the case of all NRC licensees.
[sbull] General License for RCRA-C Disposal Facility--In this case
NRC would modify its regulations (e.g., 10 CFR part 61) through
rulemaking to include RCRA-C disposal facilities as a class of
facilities under an NRC general license that enables the facility to
accept (``possess'') LAMW for disposal. Disposal facilities would not
have to supply applications or paperwork to NRC for specific approval
of a license. NRC could choose to place additional conditions or
requirements on the disposal facility in granting a general license, or
could defer completely to the protection offered by the RCRA-C
requirements. An example would be that the facility meets RCRA-C
requirements and that the LAMW accepted by the facility meets the
concentration limits established in accordance with the approach
presented in this ANPR. Under a general license, NRC retains its
authority to inspect and enforce its requirements, including issuance
of civil penalties where warranted; however, in this case, it may be
appropriate for NRC to rely on EPA for facility oversight.
[sbull] Exemption for RCRA-C Disposal Facility--In this case, NRC
would modify its regulations, as appropriate, to exempt RCRA-C disposal
facilities that accept LAMW from NRC requirements (including
requirements to obtain an NRC or Agreement State license), and modify
10 CFR 20.2001 to allow transfer of waste to exempted facilities. This
would essentially be NRC deferring regulatory oversight of licensed
material at the disposal site to a regulatory system that already has
jurisdiction over the non-AEA portion of the waste and has demonstrated
sufficient protectiveness for specified concentrations of
radionuclides. Failure of a RCRA-C facility to meet the conditions of
the exemption could lead to regulatory action by NRC. NRC would still
maintain the ability to conduct inspections; however, in this case, it
may be appropriate for NRC to rely on EPA for facility oversight.
2. Regulation of LAMW Generators
NRC could modify its regulations, as appropriate, to allow the LAMW
generator to transfer certain material to an approved RCRA-C facility
for disposal under one of the above approaches.
We request comment on these options.
G. How Might DOE Implement a LAMW Standard?
DOE regulates the management of its own LLRW and the radioactive
component of its mixed waste under the authority granted to DOE by the
AEA. The AEA and principles of sovereign immunity limit the States'
ability to regulate DOE's management and disposal of its own AEA
materials, including the radioactive component of MW. Because DOE is
``self-regulating'' under the AEA, the low-activity mixed waste
disposal approach presented in this ANPR would not be applicable to DOE
LAMW unless DOE takes action under its AEA authority to implement it.
Several options for implementation are plausible. Most DOE wastes are
disposed of in facilities at the generating site. For situations where
sufficiently protective on-site disposal is not feasible, costs are
excessive, or off-site disposal is otherwise advantageous, other
disposal alternatives are considered. DOE could establish some sort of
internal authorization process before allowing LAMW to be transported
and disposed at a RCRA Subtitle C landfill. Alternatively, DOE could
choose to exempt LAMW meeting the radionuclide concentrations derived
in this approach from its AEA regulatory purview and send such waste to
its own RCRA Subtitle C landfills or commercial Subtitle C landfills
accepting such waste. Because of the potentially larger volumes of LAMW
generated by DOE, stakeholder interests and concerns should be given
consideration by DOE in determining how DOE would implement the
approach suggested in this document.
1. DOE's ``Authorized Limits'' System
At present, DOE has in place a process to evaluate waste on a
``case by case'' basis to determine the radiological risk. This
``authorized limits'' system allows DOE generating sites to provide
waste characterization information to support disposal at non-AEA
regulated facilities. Approvals for disposal of volumetrically
contaminated waste (as opposed to surface contamination) are given by
the Assistant Secretary of Environment, Safety and Health. DOE also
seeks to ensure that releases are consistent with the receiving
facility's waste acceptance criteria and are coordinated with, and
acceptable to, facility operators and Federal, State, and local
regulators. DOE's approach relies on a disposal facility's existing
procedures to maintain protectiveness, and typically does not place
additional radiation protection requirements on the facility operator.
The rule could provide a more uniform basis for allowing such disposal.
Because DOE is self-regulating under the AEA, the rule would not limit
DOE's ability to dispose, at facilities not regulated by NRC or
Agreement States, wastes that have been evaluated on a ``case by case''
basis pursuant to DOE's existing ``authorized limits'' process.
DOE manages its operations through a series of directives,
including Orders (which describe basic requirements), Manuals (more
detailed procedures), and Guides (recommendations or ``best
practices''). The ``authorized limits'' process described above is
included in DOE's Order 5400.5, ``Radiation Protection of the Public
and the Environment'' (note that the ``authorized limits'' decisions
are handled through the radiation protection program, not the waste
management program). Adopting the approach presented in this ANPR would
probably require DOE to revise one or more of its directives.
2. DOE's Radiological Control Criteria
For several years, DOE has been developing an approach similar to
the disposal concept in today's action. DOE has been modeling exposures
from treatment, transportation, and disposal to assess the feasibility
of setting uniform limits that would allow certain mixed waste meeting
established activity limits to be handled solely within the RCRA
system. DOE believes its analyses show that a significant portion of
its mixed waste could be handled without presenting a significant
radiological risk, and believes that the approach presented here has
the potential to facilitate that process. Throughout the development of
this process, DOE has sought advice and review from Federal agencies
and State regulators, and kept them apprised of its progress and
intent.
H. How Would States Implement the Standard?
1. Would States Be Required To Implement the Standard?
Even if we and NRC both take regulatory action to allow LAMW
disposal, it is likely that much of the actual implementation will
occur at the State level. Many States are authorized to carry out both
AEA regulatory functions and RCRA programs. There are 32 NRC Agreement
States and 45 States are authorized under RCRA to carry out a mixed
waste program. Under section 274b of the Atomic Energy Act,
[[Page 65140]]
States can enter into agreements with the NRC such that the NRC
relinquishes Federal authority and the Agreement States assume
regulatory responsibility over certain byproduct, source, and small
quantities of special nuclear material under State laws. The degree of
compatibility for such programs is determined by NRC. (NRC also retains
certain functions, such as licensing and oversight of nuclear power
plants.) NRC also reviews Agreement State programs for continued
adequacy to protect public health and safety and compatibility with
NRC's regulatory programs. We understand that State programs will have
to evaluate carefully this approach and any implementing regulations
issued by the NRC as they would apply to specific hazardous waste
disposal facilities. We also understand that some States have statutory
restrictions on disposal of radionuclides with hazardous waste, and
that others may be otherwise opposed to allowing such disposal.
However, many States already allow disposal of waste with very low
radionuclide concentrations in RCRA Subtitle C or D landfills on a
case-by-case basis. The approach that we are presenting in this ANPR
would not affect NRC's or the States' authority under the AEA to make
such individual decisions for mixed waste under their purview. However,
identifying acceptable concentrations of radionuclides in LAMW (and/or
low-activity radioactive waste in general) in cooperation with the NRC,
should allow a more consistent approach supported by rigorous technical
analyses while providing a regulatory framework to ensure that disposal
of LAMW/LARW in hazardous waste landfills is protective of human health
and the environment.
Previous discussions with State regulators have raised a number of
important questions that we believe all States should consider,
including:
[sbull] Whether a disposal facility's RCRA permit would need
revision;
[sbull] How even reduced dual regulation would affect the disposal
facility's day-to-day operation (assuming NRC and/or DOE opt to exert
some authority over the disposal facility);
[sbull] How corrective actions would be addressed;
[sbull] To what extent public input should be sought; and
[sbull] Whether the State should consider further limits on the
facilities or the waste.
Our authority is limited and our standard may not resolve all such
issues. Changing the regulatory system for mixed waste disposal
requires action from both Federal and State authorities to provide a
workable, protective, and comprehensive institutional framework. We
recommend that States consider how they might use their distinct
authorities to assist in developing such a framework. We welcome
comment from States that would facilitate a workable approach to a
meaningful standard incorporating radionuclide concentrations in the
waste. We are also interested in knowing whether States believe such a
standard should allow the flexibility to dispose of higher
concentrations if disposal facilities implement additional radiation
protection provisions or demonstrate site-specific conditions
particularly favorable for containment and isolation of radionuclides.
2. State Programs
a. Facility Permitting/Public Participation. Although we believe
that the technical approach to low-activity mixed waste disposal is
sound, we recognize that we are considering disposal of radionuclides
in facilities that were not sited or permitted with the expectation
that they would receive significant quantities of such material. We
anticipate that States will view the facility's RCRA permit as one
means to ensure the State retains the level of RCRA oversight it
believes necessary, although legal considerations suggest that the
ability to use a RCRA permit as a vehicle to implement provisions
related to AEA material would be limited. We also believe that public
participation in the States' adoption of this proposed approach to LAMW
disposal is necessary. In general, we believe that the existing RCRA
permitting and NRC or Agreement State regulatory processes should
provide ample opportunity for public involvement. We request comment on
this assumption.
If EPA decides to conduct a rulemaking, public participation will
necessarily be part of that process. In addition, when a RCRA permit is
modified, the extent of the modification determines the amount of
public participation required. For example, if a facility wants to
accept a completely new waste stream for disposal (that is, a
fundamentally different kind of waste), this is a significant permit
modification requiring certain public participation activities.
However, adding additional constituents to the ground-water protection
program is less significant because it may not by itself represent a
change in the way the facility operates or the waste it handles. Again,
there would be legal considerations involved in addressing AEA material
through the RCRA permit.
We anticipate that NRC might choose from a variety of alternatives,
described in section F, to implement the approach described in this
ANPR. NRC will conduct a rulemaking with public participation to
establish the manner in which it will implement the approach presented
here.
We are interested in public comment on the issue of public
participation, and how the States' adoption process would provide an
opportunity for public participation.
b. Implementation at the Disposal Facility. Although a RCRA-C
disposal facility that accepts low-activity mixed waste under the
approach presented here may have to modify its operations, we are
optimistic that these modifications will not have to be extensive or
costly. The facility certainly may need to instruct its workers on the
potential effects and proper handling of radioactive material and take
steps to limit exposures, although it may not have to apply a full
radiation worker program that includes dosimetry. Most facility
requirements related to radionuclides likely will be extensions of the
administrative, recordkeeping, environmental monitoring, and reporting
requirements already involved in hazardous waste disposal. We expect to
model a fairly conservative worker exposure scenario, in part, to keep
additional requirements minimal. We expect that NRC will address during
its rulemaking process the issue of the appropriate level of worker
training and procedures needed, if any, to limit exposures to LAMW.
The one major aspect of the facility's operation that may need
significant modification is waste acceptance. Because the LAMW disposal
concept is based on the radionuclide content of the waste, the facility
must be able to verify that the waste accepted for disposal complies
with the rule. This situation is analogous to the current requirement
that hazardous waste comply with the land disposal restrictions in 40
CFR part 268. In that case, both the generator and treatment facility
must certify that the waste does or does not meet the standards in part
268, and attach any supporting information, including waste analysis.
Before it can dispose of waste, the disposal facility must have the
appropriate certifications and supporting information, and must make
certain that the waste accepted for disposal indeed meets the RCRA land
disposal restrictions.
At present, generators of low-level radioactive waste are required
to certify, before disposal, the radiological content of their LLRW.
Generators of LLRW frequently base their characterizations
[[Page 65141]]
on process knowledge when workers' exposure to radiation is of concern
and knowledge of the waste generating process allows adequate
characterization of radionuclide activity. It is common practice to
store waste for a period that allows short-lived radionuclides to decay
to minimal levels. The most common types of treatment for LLRW are
solidification or compaction of dry waste. A treatment facility may
simply calculate radionuclide concentrations based on the extent of
volume increase or decrease. Disposal facilities commonly use hand-held
instruments to survey the exterior of waste containers, which may
provide sufficient information to characterize the waste; however,
packages are not normally opened for sampling in order to limit
occupational exposures. This is in keeping with good health physics
practice.
Under the approach presented here, RCRA-permitted hazardous waste
disposal facilities will continue to ensure that mixed waste complies
with the land disposal restrictions. If the generator sending LAMW for
disposal at a RCRA-permitted hazardous waste facility is required to
certify compliance with applicable regulatory requirements, it may or
may not be necessary for a landfill to conduct independent radiological
sampling. The cost associated with extensive radiological sampling and
analyses might be a critical factor in a disposal facility's
willingness to accept LAMW. Facilities also may perform external
radiological surveys to maintain worker safety, if necessary or deemed
appropriate. We expect that under the approach presented here, the
waste generator would bear primary responsibility for compliance with
the standards, including those under RCRA. The generator would thus be
responsible for providing the information necessary to determine
whether the waste can be disposed of as LAMW at the hazardous waste
disposal facility. It might be necessary for the generator to provide
analytical confirmation of the radiological content of the waste prior
to treatment or disposal. We invite comment on the most appropriate way
to ensure that radionuclide concentrations in waste sent for disposal
comply with the criteria that would be established, and on whether
practices common at RCRA facilities might need modification to limit
potential exposures to workers.
In a related question, we would like commenters to consider whether
a rule should address volume averaging or ``blending'' of wastes to
meet the radionuclide concentrations. RCRA regulations prohibit
dilution as a means of meeting treatment standards; however, assuming
that LAMW has met the RCRA standards, to what extent should higher-
activity waste be allowed to combine with lower-activity waste to meet
radionuclide concentration limits? Recently, NRC raised a similar
question as part of a rulemaking effort for 10 CFR 40.51(e). (See 67 FR
55175, August 28, 2002.) Should this be permitted for waste from
similar processes, or with the same radionuclides or RCRA waste codes?
This question may be more important in the context of other low-
activity radioactive wastes that are not RCRA hazardous, which are
discussed in section III. For example, TENORM wastes can be high in
volume with significant variation in radionuclide content, and usually
a narrow range of radionuclides. Should blending be allowed for these
waste streams? Would ``post-blending'' analytical results be necessary
to demonstrate compliance with concentration limits, or would knowledge
of ``pre-blending'' concentrations be sufficient? What would be the
problems associated with analyzing blended waste?
c. Agreement States. Under section 274b of the Atomic Energy Act,
States can enter into agreements with the NRC such that the NRC
relinquishes Federal authority and the Agreement States assume
regulatory responsibility over certain byproduct, source, and small
quantities of special nuclear material under State laws. The degree of
compatibility for such programs is determined by NRC. (NRC also retains
certain functions, such as licensing and oversight of nuclear power
plants.) NRC has established requirements for specific program elements
which States must meet. These compatibility requirements consider
trans-boundary issues and program element effects on public health and
safety. Depending on the outcome of the NRC rulemaking and the degree
of compatibility required for State programs, a LAMW rule could be
implemented differently among Agreement States.
d. Non-Agreement States. In States that have not entered into
agreements with NRC under section 2746 of the AEA, NRC regulations
apply directly. Approximately one-third of the States are not Agreement
States.
3. Regional Low-Level Radioactive Waste Compacts
The Low-Level Radioactive Waste Policy Act authorizes and
encourages States to form regional ``compacts'' to address their long-
term disposal needs for ``commercial'' low-level radioactive waste.
Most compacts do not plan to accept mixed waste. In general, the terms
of a compact spell out the process for selecting a ``host'' State;
picking an appropriate site for the disposal facility; and funding site
selection, construction, and operation. The ultimate purpose of the
compact is to ensure that its member States are self-sufficient and
able to manage commercial LLRW generated within the compact. At
present, there are ten compacts, encompassing 44 States. Six States
remain unaffiliated with any compact. Only the Northwest Compact has an
operational waste disposal site, in Richland, WA. The Rocky Mountain
Compact may use the Northwest Compact site by agreement. The Barnwell
site in South Carolina will remain open to States outside the Atlantic
Compact for several more years.\20\ Some compacts have delayed their
siting process, and at least one compact and several unaffiliated
States apparently have no intention of siting disposal facilities. To
date the siting of new compact facilities has had very limited success.
A number of compact host States, including California, Illinois,
Nebraska, Texas, and North Carolina, have expended large amounts of
time and money, and undergone a great deal of sensitive political
debate, without yet establishing new disposal sites. Regional compacts
have procedures to allow waste to enter and exit the compact, which
could influence the disposal of low-activity mixed waste at RCRA
facilities. Compacts may determine that it is necessary to approve RCRA
facilities that accept LAMW as ``regional'' disposal facilities. The
limited number of compacts with LLRW disposal facilities has lessened
the impact of these ``cross-boundary'' issues thus far. We request
comment on how the approach would impact regional low-level waste
compacts.
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\20\ Barnwell may accept waste from outside the Atlantic Compact
(South Carolina, Connecticut, and New Jersey) as long as the non-
regional waste does not cause the facility to exceed overall volume
limits. Those overall volumes drop from 160,000 cubic feet in fiscal
year 2001, the year after South Carolina joined the Atlantic
Compact, to 35,000 cubic feet in fiscal year 2008. Under current
plans, generators outside the Atlantic Compact will not have access
to Barnwell after 2008.
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I. Request for Information: LAMW
In order to assist us in planning and conducting our future
deliberations related to low-activity mixed waste, we are requesting
the voluntary submission of data describing the present situation with
respect to the storage, management, transportation, and disposal of
LAMW. We are aware that some States perform annual inventories of the
different kinds of radioactive waste generated or disposed annually
[[Page 65142]]
and any data relating to LAMW is welcome. We are also aware of numerous
generators that store, rather than dispose, LAMW because of the
regulatory and economic difficulties associated with disposal. We would
welcome data from a variety of generators on these matters to obtain a
more accurate picture of the present issues associated with storing and
disposing of LAMW. We would also welcome comment and information from
the perspective of companies that operate low-level radioactive waste
disposal facilities or RCRA Subtitle C hazardous waste landfills.
We realize that there are quite a number of different generators of
LAMW, such as
[sbull] Industrial-manufacturing facilities
[sbull] Industrial-research and development facilities
[sbull] Other industrial facilities
[sbull] Academic institutions
[sbull] Medical facilities (hospitals and colleges)
[sbull] Medical research facilities
[sbull] Federal facilities
[sbull] Nuclear power plants and associated fuel cycle facilities
To supplement and update currently available data, we are
requesting the following types of information (information with clearly
labeled units is appreciated):
[sbull] LAMW Generation, Treatment, and Disposal: For individual
waste types or categories of waste, current low-activity mixed waste
generation rates and storage, treatment, and disposal practices. Data
on types of mixed waste generated, RCRA codes, radionuclide
concentrations, storage and treatment techniques, and disposal
practices for these waste types or categories of waste, and data on
waste volumes before and after treatment would be very useful and
informative. In terms of waste concentrations, information that
describes the amount of waste within different concentration ranges
would be most useful and would assist in gauging the potential
usefulness of a standard aimed at LAMW.
[sbull] LAMW Cost Data: The costs associated with the management of
LAMW, including storage costs, costs of sampling and analysis for
compliance with RCRA vs AEA requirements. This could include the costs
for meeting the universal treatment standards, pre-treatment and
treatment costs (by method), packaging and transport costs, disposal
costs, and reporting and recordkeeping costs. To the extent the costs
can be broken out for meeting RCRA vs AEA requirements, greater
understanding of the regulatory burden posed by each authority would
follow.
[sbull] Impacts of Actions to Facilitate Disposal: We also request
comments regarding the potential effects of a standard to facilitate
the disposal of LAMW. If such a standard were in place today, and such
waste could be disposed in a RCRA Subtitle C landfill with little, or
no, further NRC requirements, would such a standard enhance the conduct
of your business? For example, would it free up resources that could be
better directed? Would research or manufacturing activities be
facilitated, knowing that a potentially more cost-effective disposal
method became available for a certain kind of waste? What impacts, if
any, would there be on the choice of health care options? What factors
(e.g., economic, regulatory) would influence your decision to dispose
of or accept LAMW for disposal under such a standard? Would limiting a
standard to commercial RCRA-C facilities be an important consideration?
How might this affect DOE disposal policies? How do disposal facilities
view the need for a permit modification or AEA license?
J. Background Information Regarding LAMW
In 1976, RCRA authorized us to regulate hazardous waste from
``cradle to grave.'' This includes the minimization, generation,
transportation, treatment, storage, and disposal of hazardous waste.
The definition of solid waste in the RCRA legislation specifically
excludes source, special nuclear, or byproduct material as defined by
the AEA of 1954, as amended. In the 1984 Hazardous and Solid Waste
Amendments to RCRA, Congress established land disposal restrictions
(LDR) for hazardous waste and directed us to establish treatment
standards for hazardous waste. Hazardous waste has been prohibited from
land disposal unless treated to our established standards in 40 CFR
part 268.
Mixed waste is regulated under multiple authorities: by RCRA, as
implemented by us or authorized States for hazardous waste components;
and by the AEA of 1954, as amended, for radiological components as
implemented by either the DOE (for radioactive waste subject to DOE's
AEA authority), or the NRC or its Agreement States (for all other mixed
waste). DOE is responsible for the disposal of, but does not regulate,
commercial Greater-than-Class C mixed waste. Under the AEA, EPA has the
authority to issue certain generally applicable environmental
standards.
Low-activity mixed waste is a special class of mixed waste. It may
be viewed as waste that meets the definition of hazardous waste under
RCRA and, under AEA, is LLRW containing ``low'' radionuclide
concentrations. In this context, ``low'' concentrations are
concentrations no higher than Class A LLRW, as defined in 10 CFR
61.55.\21\
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\21\ Note that LLRW is defined by exclusion, that is, by what it
is not. For example, the Low-Level Radioactive Waste Policy Act of
1980 defines LLRW as radioactive material that is not high-level
radioactive waste, transuranic waste, spent nuclear fuel, or
byproduct material as defined in section 11e.(2) of the AEA (i.e.,
uranium or thorium mill tailings).
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1. Commercial LAMW
The radioactive component of mixed waste, and by extension, LAMW is
regulated by either the Nuclear Regulatory Commission and the Agreement
States (for commercial facilities) or the DOE (for DOE's energy and
defense related activities). Commercially-generated (i.e., non-DOE)
LAMW is produced across the country, at nuclear power plants, fuel
cycle facilities, pharmaceutical companies, medical and research
laboratories, universities, and other facilities. Processes such as
medical diagnostic testing and research, pharmaceutical and
biotechnology development, and generation of nuclear power result in
some mixed waste. The last comprehensive evaluation of mixed waste was
published in a 1992, known as the joint EPA and NRC ``National Profile
on Commercially Generated Low-Level Radioactive Mixed Waste'' (NUREG/CR
5938). Accordingly, 3,950 cubic meters of low-level radioactive mixed
waste was generated in the United States in 1990, while another 2,120
cubic meters were in storage. Of the 3,950 cubic meters generated in
1990, about 72% were liquid scintillation counting fluids, 17% were
other organics and aqueous liquids, 3% were metals, and 8% were
``other'' waste. Approximately 3000 small volume generators were
storing mixed waste. A report published by DOE in 1995 revisited the
issue of mixed waste. Using the data from the ``National Profile,''
this report examined the variety of options available for managing
commercially-generated mixed waste and reached the following
conclusions (``Mixed Waste Management Options: 1995 Update,'' DOE/LLW-
219):
[sbull] Most, but not all, mixed waste can be treated by
commercially available technology.
[sbull] Approximately 128 cubic meters per year of commercially
generated waste volumes would require disposal
[[Page 65143]]
in a jointly regulated mixed waste disposal facility.
More recent information reported in our advance notice of proposed
rulemaking regarding increased flexibility in RCRA regulations for
storing mixed low-level radioactive waste (64 FR 10064, March 1, 1999)
confirms the continued storage of mixed waste due to lack of treatment
and reasonable disposal options. In particular, the Electric Power
Research Institute documented such problems for certain mixed waste
from nuclear power plants. EPA visits to nuclear power plants,
hospitals, and universities in 1998 found small amounts of mixed waste
with no commercially available treatment technologies, and our
discussions with the American Chemical Society and the International
Isotope Society further highlighted the difficulty of treating and/or
disposing of certain mixed waste.
2. DOE LAMW
The DOE also continues to generate mixed waste (and therefore
LAMW). In fact, DOE has a legacy of environmental and process wastes
that require disposal. For many decades, many DOE sites did not dispose
of their waste streams in a timely manner, allowing these wastes to
accumulate in storage. DOE has indicated that continued indefinite
storage of such wastes is unacceptable; however, continued storage in
many cases was deemed necessary because appropriate treatment methods
were not available. The Federal Facilities Compliance Act of 1992
recognized this situation and directed DOE to develop plans and
timetables for treatment and disposal of mixed waste at its sites. DOE
determined that it was necessary to conduct a programmatic review of
waste management activities throughout the DOE complex. As a result,
DOE has reviewed its options for managing of different categories of
radioactive waste, including LLRW and MLLW. (See the ``Final Waste
Management Programmatic Environmental Impact Statement (WM PEIS),''
DOE/EIS-0200F, May 1997.)
The WM PEIS evaluated various options for managing and disposing of
MLLW and identified preferred alternatives, narrowing the list of sites
that would be capable of treating or disposing of MLLW. In evaluating
the role of the various DOE sites within each option, the following
criteria were applied to the sites in question (WM PEIS Summary, Table
1.6-1):
[sbull] Consistency
[sbull] Cost
[sbull] Cumulative impact
[sbull] DOE mission
[sbull] Economic dislocation
[sbull] Environmental impact
[sbull] Equity
[sbull] Human health risk
[sbull] Implementation flexibility
[sbull] Mitigation
[sbull] Regulatory compliance
[sbull] Regulatory risk
[sbull] Site mission
[sbull] Transportation
DOE worked with affected States, stakeholders, and Tribal Nations
to provide input towards qualitative criteria such as equity and
stakeholder acceptance.
On February 18, 2000, DOE announced its record of decision
regarding the treatment and disposal of MLLW. Accordingly, MLLW will be
treated on a regional basis at the Hanford Site, the Idaho National
Engineering and Environmental Laboratory, the Oak Ridge Reservation,
the Savannah River Site, or on-site; MLLW will be disposed at the
Hanford Site and the Nevada Test Site. (See ``Record of Decision for
the Department of Energy's Waste Management Program: Treatment and
Disposal of Low-Level Waste and Mixed Low-Level Waste; Amendment of the
Record of Decision for the Nevada Test Site,'' 65 FR 10061, February
25, 2000.) DOE has indicated that 43,000 cubic meters of MLLW from
waste management operations will require off-site disposal, considering
both waste in storage and waste to be generated over the next 20 years.
While the above referenced record of decision did not address the use
of commercial disposal facilities, DOE's decision does not preclude use
of commercial treatment or disposal facilities for DOE's MLLW. DOE has
estimated that approximately 22,000 cubic meters of MLLW from waste
management operations may be considered for commercial disposal
facilities. In addition, 53,000 cubic meters of MLLW from environmental
restoration activities may be considered for commercial disposal
facilities. Significant additional volumes of MLLW may also be
generated from future cleanup activities. There is no breakdown of how
much of this waste may be ``low activity'' MLLW. (See ``Information
Package on Pending Low-Level Waste and Mixed Low-Level Waste Disposal
Decisions to be made under the Final Waste Management Programmatic
Environmental Impact Statement,'' U.S. Department of Energy, September
1998.)
K. Questions for Public Comment: Disposal Concept for LAMW
We request public comment on a number of aspects related to this
action. In addition to the questions raised earlier in this action, the
questions below generally highlight areas in which there is a lack of
information or there are a variety of approaches that may prove viable.
You are not limited to responding to the specific questions below; as
always, you are welcome to comment on any aspect of this document or
questions raised earlier in the text. In particular, we ask:
1. Is our description of the problems associated with mixed waste
accurate? For example, what is the present status regarding the ability
to dispose of low-activity mixed waste in a protective and cost-
effective manner? Are some generators, such as medical or other
researchers, using less current practices to avoid generating mixed
waste? (section II.B.1)
2. What new information is available concerning the
characteristics, treatment, storage, and disposal of LAMW? (II.A.1)
3. Is the approach we have outlined to allow disposal of LAMW in
RCRA-C facilities viable? Would it help to alleviate generators'
concerns?
4. What roles should EPA and NRC take in further developing this
approach? Are there other actions that can be taken to minimize dual
regulation or facilitate permanent disposal of LAMW? (II.A.3)
5. Are radionuclide concentration limits adequate for limiting the
impacts from LAMW?
6. What concentration limits would address a significant proportion
of your mixed waste? (II.A.1)
7. Should any rule or guidance apply only to commercial RCRA-C
disposal facilities (roughly 20 operating)? To privately-owned
facilities? To DOE facilities? (II.B.1)
8. Should a rule address disposal of low-activity material in RCRA-
D (solid waste) facilities? (II.A.2)
9. Should such a rule apply to DOE wastes? Are there special issues
associated with DOE waste (e.g., characterization, knowledge of
historic generating processes, volumes)? (II.G)
10. What additional requirements would be necessary for RCRA
facilities (e.g., related to post-closure care, land ownership,
financial assurance, monitoring and corrective action)? (II.C.4)
11. Are the exposure scenarios we have outlined adequate? Is there
a method other than modeling that could effectively determine the
protectiveness of RCRA-C disposal of LAMW? (II.D.3.a, b)
12. What is the appropriate way to select site data for modeling?
What level
[[Page 65144]]
of conservatism is appropriate? (II.D.3.b.i)
13. Should disposal facility operators have the opportunity to
calculate site-specific radionuclide concentration limits? For mobile
radionuclides only? Based on specific practices to protect workers?
(II.D.3.b.i, H.1)
14. What is the appropriate way to assess long-term protection? Is
dose the appropriate measure? Is risk? Based on annual or lifetime
exposures? What about radionuclide concentrations in the environment
(as a basis for modeling)? (II.D.5)
15. What is the appropriate level of protection to derive waste
concentrations (in terms of risk or dose)? Should the same level apply
to all exposure scenarios? (II.D.5)
16. Should such a standard have different waste concentration
limits for ``dry'' sites versus ``wet'' sites? What criteria should we
use to differentiate between ``wet'' and ``dry'' sites? Is there
another generic way to distinguish ``better'' sites? (II.D.3.b.ii)
17. Should we establish minimum site suitability requirements? What
should they be? How would your suggested requirements make LAMW
disposal more protective? (II.D.3.b.ii)
18. What is the appropriate timeframe for modeling? (II.D.3.b.iii)
19. How should we evaluate a post-closure disturbance of the
disposal site? (II.D.3.f)
20. To what extent should bulk waste be included in this approach?
As a generator, is bulk waste a significant proportion of your waste?
(II.D.3.d)
21. Should such a rule require a specific waste form, such as
solidified/stabilized? Should different standards apply to different
waste forms, or should a generator be able to demonstrate the
performance of a particular waste form? Should containers be required?
Should there be special conditions for bulk waste? (II.D.4.b)
22. What types of solidification/stabilization would be most
effective at containing radionuclides? What are the relative costs of
these methods? (II.D.4.b)
23. Is the Class A maximum an appropriate additional control on
radionuclide concentrations? What other methods might we use?
(II.D.4.a)
24. Should a curie or volume limit apply to each disposal facility,
in addition to radionuclide concentration limits? To each disposal
cell? To individual radionuclides? An overall limit, or an annual
limit? (II.D.4.c)
25. Is the ``unity rule'' an appropriate method to limit exposures?
Under what circumstances might it not be appropriate? How else might we
achieve the same goal? (II.D.4.d)
26. How should the chemical toxicity of radionuclides, particularly
those elements not addressed by RCRA regulations (e.g., uranium), be
considered in developing waste concentrations? (II.D.5)
27. What regulatory approach should NRC take? Are there particular
advantages or disadvantages to each? What aspects of LAMW disposal need
special consideration? (II.F)
28. How would States and facilities implement the rule? What
concerns would States need to have addressed? (II.H)
29. RCRA requires ground-water monitoring for hazardous
constituents. How should ground-water protection be addressed for
radionuclides?
30. What factors would States, generators, and disposal facilities
consider in supporting or opposing (choosing not to use) a standard for
LAMW disposal? How would you characterize your interest in this
approach? What would increase or decrease your interest?
31. Is it appropriate for the generator to be responsible for
documenting compliance with waste form requirements? What is the best
way to ensure that radionuclide concentrations in waste comply with a
standard? How might disposal facility sampling procedures need to be
modified? (II.C.2, H.2.b)
32. What level of public participation is appropriate? (II.H.2.a)
33. Should volume averaging or ``blending'' be allowed? Under what
conditions? (II.H.2.b)
34. How will LAMW disposal facilities be affected by the regional
low-level waste compacts? (II.H.3)
35. Do you anticipate cost savings if the approach in this document
were to be implemented? Where would you expect to see cost savings?
III. Is It Feasible To Dispose Other Low-Activity Radioactive Wastes
(LARW) in Hazardous Waste Landfills?
Aside from low-activity mixed waste, there are a variety of other
wastes with ``low'' concentrations of radionuclides, which are either
unregulated or are subject to an inconsistent or uncertain regulatory
framework. While some of these other low activity wastes may be mixed
waste, we are widening the scope of consideration here to include both
mixed and non-mixed waste within each of these categories. Wastes
included in this category are residuals from the processing of uranium
or thorium ore that NRC has determined are not subject to the Uranium
Mill Tailings Radiation Control Act of 1978 (UMTRCA) (we refer to these
residuals in this document as ``pre-UMTRCA byproduct material,'' much
of which is subject to remediation under the Formerly Utilized Sites
Remedial Action Program (FUSRAP)), certain categories of
Technologically Enhanced Naturally Occurring Radioactive Materials
(TENORM) wastes, and Atomic Energy Act (AEA) radioactive waste
presently exempted from regulation.
A. How Would the Proposed Disposal Concept Apply to Other Low-Activity
Radioactive Wastes?
1. From a Technological Perspective
The RCRA-C technology itself offers no barriers to extending the
disposal concept to other low-activity radioactive wastes. There is no
physical difference between a radionuclide in low-activity mixed waste
and the same radionuclide in pre-UMTRCA byproduct material or TENORM
waste. It may in fact be easier to assess the protectiveness of the
landfill technology for pre-UMTRCA byproduct material or TENORM wastes,
as they will contain a much narrower range of radionuclides (primarily
uranium, thorium, and radium, with daughter products), and lesser
amounts of other components that could have an effect on the physical
and chemical behavior of the radionuclides in the disposal system, than
will LAMW. Waste form and volume issues may be more important for these
other low-activity waste streams in assessing their behavior in the
disposal system. From a safety perspective, the RCRA-C disposal system
should be no less effective for these other waste streams than for
LAMW.
2. Pre-UMTRCA Byproduct Material
The Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA)
explicitly extended AEA jurisdiction to waste from the processing of
uranium or thorium ore (``byproduct material'' newly defined in section
11e.(2) of the AEA) and designated NRC to regulate this material at
active processing sites (see section III.D, ``Background Information
Regarding Other LARW'' for more detail). ``Pre-UMTRCA'' byproduct
material is physically and chemically very similar to 11e.(2) byproduct
material regulated by NRC pursuant to its responsibilities under
UMTRCA. Pre-UMTRCA byproduct materials are residuals from ore
processing activities mixed with soil or residual contaminants of
building debris. They comprise the majority of the material being
remediated from commercial and
[[Page 65145]]
residential properties under the Formerly Utilized Sites Remedial
Action Program (FUSRAP) and are also found at some Superfund sites.
Pre-UMTRCA material has generally been disposed in bulk and shipped by
rail car to licensed or permitted disposal facilities. Most is
relatively low-activity, because it resulted from the extraction of
uranium or thorium from ore material. It has been disposed of at a
limited number of RCRA Subtitle C disposal facilities having State
permits that allow acceptance of low concentrations of certain
radioactive materials (equating generally to ``unimportant quantities''
as defined by NRC). Materials with concentrations exceeding State RCRA
permit conditions have been disposed in NRC or Agreement State licensed
facilities.
3. TENORM
``Technologically Enhanced'' Naturally Occurring Radioactive
Material is material (whether as a waste or product) in which the
natural radioactivity has been concentrated or the potential to expose
humans has been increased, generally through human activity (TENORM
does not include material in its natural setting, such as soil or rocks
that emit ``background'' radiation). TENORM waste can take a variety of
forms, including soil, pipe scale, sludges from water treatment, and
residues from processing of mineral ores. As the name suggests, some
TENORM wastes are highly radioactive because the processes that produce
them tend to concentrate the radionuclides. A number of RCRA Subtitle C
disposal facilities accept certain types of TENORM waste (e.g.,
commercial facilities in California, Idaho, and Texas). Only wastes
that meet the radionuclide concentration limits derived for the RCRA-C
disposal option described here would be candidates for disposal under
that approach. Higher-concentration TENORM wastes would not be
included.
4. Low-Activity LLRW/Source Material Exempted by NRC
Some wastes under the AEA are exempted from regulation. In
particular, NRC deferred ``unimportant quantities'' of source material
containing less than 0.05 % by weight uranium or thorium, from its
regulation. Certain consumer products and some mining wastes may
contain uranium or thorium originating from ores not meeting the 0.05%
criterion. For example, zircon contains minute quantities of uranium
and thorium and is used as a glaze for ceramics and metal molds.
Thorium is used to make a more dense glass for prescription glasses.
Uranium or thorium may be a side product emanating from certain
phosphate extraction operations or rare earth mining.
Low-level radioactive waste that is not mixed waste currently has
several disposal options, as noted in section II.H.3 above. However,
generators have limited access to one of those facilities, and access
to another facility will be limited in a few years. It might be
advantageous to provide additional disposal options for low-activity
LLRW that may not require the extensive radiation controls of 10 CFR
part 61.
As previously noted, NRC held a workshop on May 21-22, 2003, to
discuss alternatives for safely controlling solid materials that have
no, or very small amounts of, radioactivity. One alternative for that
material is placement in a RCRA Subtitle C or RCRA Subtitle D disposal
facility. Therefore, some of the issues discussed in that workshop may
be similar to some of the approaches discussed in this ANPR. Background
materials (including the information collection efforts conducted by
NRC) and current activities (including recent documents issued and
plans for stakeholder input), as well as transcripts of the workshop,
can be found at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=SM_RFC&st=ipcr.
B. What Legal and Regulatory Issues Might Affect Applying the RCRA-C
Disposal Concept to Other Low-Activity Radioactive Wastes?
1. Lack of Federal Regulation
As noted above, we believe it is reasonable, given the similarity
in radiological characteristics and general similarity in physical
attributes (i.e., large volume), to evaluate the applicability of our
low-activity mixed waste disposal concept to these other low-activity
radioactive wastes. To the extent that such a regulation could cover a
large percentage of low-activity pre-UMTRCA byproduct material and
TENORM wastes, clarity and consistency in regulation would be achieved
for wastes now addressed by a patchwork of regulations. Some of these
waste streams are not currently regulated by Federal agencies (with the
exception of FUSRAP or other waste generated from CERCLA site cleanups,
where the Record of Decision specifies acceptable disposal), and there
is no uniform State approach to regulating these wastes. Unfortunately,
it is not clear at this time what single Federal authority might be
invoked. For example, NRC has stated that pre-UMTRCA byproduct material
and TENORM wastes do not fall under the purview of NRC's AEA authority.
(See, e.g., ``Issuance of Director's Decision Under 10 CFR 2.206,'' 65
FR 79909, December 20, 2000.) The logical implication of NRC's position
is that the exclusion of ``source, special nuclear, and by-product
material as defined by the Atomic Energy Act of 1954'' from the
definition of ``solid waste'' under RCRA does not apply to pre-UMTRCA
byproduct material that does not otherwise contain source material or
would otherwise fall within NRC's AEA authority (i.e., pre-UMTRCA
byproduct material would be identical to TENORM in that regard). (See
40 CFR 261.4(a)(4).) Thus, EPA could perhaps use its RCRA authority to
address these waste streams. However, while these wastes likely fall
under RCRA jurisdiction by virtue of being ``solid waste'' (if not
subject to AEA), there is no clear mechanism to regulate them under
Subtitle C. There is no RCRA characteristic for radioactivity, and many
mineral processing wastes are specifically excluded from regulation as
hazardous (40 CFR 261.4(b), ``solid wastes which are not hazardous
wastes''). While non-hazardous waste can be disposed of in Subtitle C
facilities, disposal standards associated with non-RCRA hazardous
properties of the waste (in this case, radioactivity) would generally
be the purview of State authorities.
2. How They Are Regulated Now
a. Pre-UMTRCA Byproduct Material (FUSRAP). Because concerns over
disposal of pre-UMTRCA byproduct material have been most closely
associated with FUSRAP, we are focusing our attention on that program.
FUSRAP was created to evaluate and remediate wastes generated as a
result of activities of the Manhattan Engineer District and the Atomic
Energy Commission beginning in the 1940s through the 1960s. These
activities were related to the development of nuclear weapons. These
wastes were first managed by the Atomic Energy Commission, then, in
1975 by the Energy Research and Development Administration, until 1997
by the Department of Energy, and since 1997 by the U.S. Army Corps of
Engineers (USACE). USACE now manages such waste under CERCLA and
internal guidance directives.
There has been some discussion of the legal authority under which
such wastes should be managed. (See ``Corps of Engineers'' Progress in
Cleaning Up 22 Nuclear Sites,'' GAO/RCED-99-48,
[[Page 65146]]
February 1999.) Following transfer of FUSRAP to the Corps of Engineers,
USACE requested a determination from NRC regarding the regulatory
requirements for off-site disposal of waste generated through site
cleanups. NRC determined that the largest-volume waste stream at FUSRAP
sites, wastes that resulted from the extraction of uranium or thorium
from ore material, was outside its jurisdiction because of the
circumstances under which it was generated (pre-UMTRCA). NRC was later
petitioned to review its position (February 24 and March 13, 2000). NRC
reaffirmed its position in a 2000 Director's Decision (65 FR 79909,
December 20, 2000). As a result, the off-site disposal of the bulk of
waste from FUSRAP cleanups is unregulated at the Federal level except
through the Superfund program (although USACE uses the CERCLA process
at all FUSRAP sites, relatively few of the sites have actually been
placed on the National Priorities List).
The Corps of Engineers has pursued a disposal program that includes
use of RCRA Subtitle C facilities for its low-activity waste, with
higher-activity waste sent to AEA-licensed facilities. Under USACE
policies applicable to FUSRAP, appropriate State authorities are
requested to verify approval of acceptance of FUSRAP materials prior to
disposal. States have varied in their responses to USACE's disposal
efforts, with some being receptive to RCRA facilities accepting waste
and others opposing it. USACE plans to continue using Subtitle C
facilities as a disposal option.
b. TENORM. Many TENORM wastes are also relatively low-activity.
Many of these wastes are regulated by States. Wastes with similar
radiological characteristics may be managed more or less rigorously
from State to State. Some wastes are regulated primarily for chemically
hazardous components. Some wastes are not regulated with regard to
their radioactive content. Of course, in many instances, there is a
lack of information on the radiological characterization of a given
TENORM waste and undoubtedly, this has contributed to today's
inconsistent regulatory framework. Examples of TENORM wastes include
sludges and resins resulting from treating ground water for drinking
water, scales and sludges arising from oil and gas production,
tailings, slag, or residues from the mining and processing of a variety
of ores, and the overburden remaining from the mining of uranium ores
to name a few. (Uranium mines are not covered under the AEA. Rather,
airborne radon emissions from underground uranium mines are addressed
under the Clean Air Act. (See subpart B of 40 CFR part 61, 54 FR 51654,
December 15, 1989.)) Ideally, wastes of similar characteristics
presenting similar risks might be managed in a similar fashion.
Although these wastes include a wide variety of waste categories,
some delineated by more or less clear institutional boundaries, there
are some common traits that may allow the development of a common
strategy for management and disposal. Many of these wastes include
radioactive uranium and thorium, and/or the daughters of the
radioactive isotopes of uranium or thorium, respectively. Many of the
wastes are in bulk form, whether it be tailings, or sludge, or residues
that might infer a similar management strategy, given a similar range
in volumes. We welcome comment on appropriate risk-based strategies to
manage and dispose of reasonably similar wastes in a similar manner.
For example, would it be better to focus on wastes that are relatively
well-controlled but may be somewhat higher in activity, such as
drinking water treatment residues, or on larger volume wastes, such as
soils, that have the potential for wider dispersal in the environment
and subsequent exposures to the public? Which wastes are most difficult
to manage? Which pose the greatest risks?
3. Existing Federal Regulations (Low-Activity LLRW)
From the perspective of the Atomic Energy Act, low-activity mixed
waste is regulated identically to other forms of low-level radioactive
waste. Some LAMW may be identical in radiological characteristics to
low-activity LLRW. Logically, it is difficult to argue that the
presence of additional hazards (i.e., chemically hazardous material)
makes the RCRA-C technology suitable for LAMW but unsuitable for non-
mixed low-activity LLRW. However, there are currently several
commercially operating disposal facilities capable of accepting low-
activity LLRW (though generators will have limited access to two of the
three commercial facilities), and the need for additional disposal
options is not clear at this time. Nevertheless, we request comment on
whether our rule should address non-mixed low-activity LLRW (these
wastes would be subject to the same restrictions placed on LAMW in
deriving concentration limits, such as using the Class A maximum values
as an upper benchmark).
4. Potential for a New ``Class'' of Disposal Facilities
While we and NRC agree that RCRA Subtitle C landfills could offer
appropriate protections for disposal of low concentrations of
radionuclides, neither agency intends at this time to create a new
regulatory structure comparable to the existing RCRA or LLRW
requirements. Rather, the intent is to apply the necessary elements of
radiation protection to the hazardous waste framework. In dealing with
low-activity mixed waste, we believe this approach is sensible, as
individuals disposing of mixed waste must comply with the requirements
for both hazardous and low-level radioactive waste. Further, compared
to the volume of materials disposed of in RCRA facilities, LAMW volumes
are relatively small, even when considering DOE LAMW, so disposal
capacity should not be excessively given over to LAMW. However, in
extending this approach to pre-UMTRCA byproduct material, TENORM, or
non-mixed low-activity LLRW (including that from DOE), we must
recognize the potentially large volumes of waste that could be accepted
at Subtitle C facilities. It is possible that facilities would apply to
be sited and permitted under Subtitle C based on the prospect of taking
low-activity waste that is not regulated under Subtitle C (or subject
to RCRA at all), but may in fact be predominantly AEA material. This
would not necessarily be inappropriate, since the intent is to
demonstrate that the Subtitle C technology would be adequately
protective in such a situation, but we believe it important to
acknowledge the possibility. We request comment on this issue, and how
we might alleviate any concerns.
C. Request for Information: Other LARW
To assist us in understanding the present situation regarding Pre-
UMTRCA byproduct material, TENORM wastes, and other low activity
radioactive wastes we request information to clearly understand the
present regulatory framework associated with each waste and to provide
more complete waste characterization. Information on these wastes has
been produced by industry, States, Federal agencies, and academic
institutions and it is important to garner up to date information to
better guide our deliberations for future efforts. Along these lines,
we welcome the following types of information:
[sbull] Regulatory Requirements: What are the significant
regulatory requirements applicable to the waste in question? We
recognize that a given waste might be
[[Page 65147]]
covered under regulations issued by various levels of government
(Federal, State, local) and may vary among jurisdictions (i.e., from
State to State).
[sbull] Waste Generation, Treatment, and Disposal: For individual
waste types or categories of waste, we request current waste generation
rates and storage, treatment, and disposal practices. Data on types of
waste generated, RCRA codes, radionuclide concentrations, storage and
treatment techniques, and disposal practices for these waste types or
categories of waste, and data on waste volumes before and after
treatment would be very useful and informative. In terms of waste
concentrations, information that portrays the amount of waste within
different concentration ranges would be most useful.
[sbull] Cost Data: The costs associated with the management and
disposal of the waste in question: This could include storage costs,
costs of sampling and analysis for compliance with regulatory
requirements, the costs for meeting treatment standards, pre-treatment
and treatment costs (by method), packaging and transport costs,
disposal costs, and reporting and recordkeeping costs.
D. Background Information Regarding Other LARW
1. Pre-UMTRCA Byproduct Material (and FUSRAP)
The processing of ores to extract uranium or thorium (milling)
generates large volumes of waste material (tailings). These tailings
resemble fine, sandy soil and are generally relatively low in activity
because the primary source of radioactivity has been reduced. However,
because of the large volumes generated, if they are not properly
controlled, these materials can present a long-term hazard to human
health and the environment. In addition, the milling process can
introduce chemical hazards into the waste. The Uranium Mill Tailings
Radiation Control Act of 1978 (UMTRCA) was passed to address management
of tailings (11e.(2) byproduct material) and remediation of milling and
tailings storage sites. These responsibilities were divided between DOE
(for inactive sites) and NRC (for active sites). EPA was directed by
UMTRCA to establish radiation protection standards to be implemented by
DOE and NRC. These standards are found at 40 CFR part 192 (``Health and
Environmental Protection Standards for Uranium and Thorium Mill
Tailings'').
The Formerly Utilized Sites Remedial Action Program (FUSRAP) was
established as a program under the former Atomic Energy Commission in
1974. The original objective of this program was to identify,
investigate, and take appropriate cleanup action at contaminated sites
associated with the nation's early atomic weapons program. During the
1940s through the 1960s, the Manhattan Engineer District and later, the
Atomic Energy Commission (AEC) used a variety of sites across the
United States to process and store uranium and thorium ores for nuclear
weapons. In the 1970s, the AEC evaluated these old weapons production
sites to determine the risks to human health and the environment,
taking into account new health and environmental standards. In 1975,
this program was transferred to the newly formed (from the AEC) Energy
Research and Development Administration, and subsequently in 1977 to
its successor, DOE. Of the 400 sites that were revisited, 46 required
some type of cleanup. DOE initiated cleanups in 1979 and completed
cleanup of roughly half of the 46 sites by 1997. DOE managed tailings
from FUSRAP cleanups in a manner consistent with its responsibilities
under UMTRCA, although the FUSRAP sites were not among those identified
by UMTRCA. Late in 1997, Congress transferred responsibility for FUSRAP
to the U.S. Army Corps of Engineers. At the request of USACE, NRC
considered its jurisdiction over pre-UMTRCA byproduct tailings
generated by FUSRAP cleanups. NRC determined that its jurisdiction, as
defined by UMTRCA, did not extend to tailings generated prior to
passage of UMTRCA if the generating process had not been licensed by
NRC (or its predecessor, the AEC).
2. TENORM
Numerous activities produce TENORM wastes, including mining (coal,
metals, rare earths, and uranium), fertilizer production, oil and gas
production, incorporation into consumer products, and treatment of
ground water for drinking water among others. TENORM can be found in
all 50 States. Total amounts of TENORM wastes produced in the United
States annually may be in excess of 1 billion tons. In many cases, the
levels of radiation are relatively low and dispersed in large volumes
of waste. This causes a dilemma because of the high cost of disposing
of radioactive waste in comparison with (in many cases) the relatively
low value of the product from which the TENORM is separated. There are
few disposal locations that can accept radioactive waste from licensed
activities, and not many more that can take certain types of TENORM.
Large quantities of TENORM wastes are currently undisposed and may be
found at many of the thousands of pre-1970s abandoned mine sites and
processing facilities around the nation. Of particular concern are the
isotopes of uranium and thorium. Radium-226, a daughter of the decay of
uranium-238, is troublesome because of its long half life (about 1600
years) and its relatively high radiotoxicity. Additional detailed
information on TENORM may be found on our Web site at http://www.epa.gov/radiation/tenorm/. EPA has developed information on the
categories of TENORM over the last fifteen years from our own
independent studies, various rulemakings, data provided by States, and
studies performed by industry.
3. Low-Activity LLRW/Source Material Exempted by NRC
Under the AEA, source material is uranium or thorium in any
physical or chemical form. NRC has traditionally regulated source
material if it contains one-twentieth of one percent (0.05%) or more by
weight of uranium, thorium, or any combination of these two. Some
mining and mineral extraction processes may also result in the
production of uranium, or thorium, at concentrations under the NRC's
threshold for regulation and hence, not be regulated under the AEA.
Such low-activity source material may result from refining ores mined
for other precious metals, rare earths, or phosphate processing. This
low-activity source material may be regulated with regard to its
chemical characteristics, rather than any radiological hazard
associated with the commingled uranium or thorium. NRC has determined
that ores containing less than 0.05% uranium or thorium by weight are
not considered source material (10 CFR 40.4) and may be labeled as NORM
or TENORM. AEA does not provide authority to regulate NORM or TENORM.
As described in section II.D.4.a, NRC classifies commercially
generated LLRW in 10 CFR 61.55 as Class A, B, C, or Greater-Than-Class
C (GTCC). All LLRW classes must meet minimum waste characterization
requirements specified in Sec. 61.56(a). Among these requirements,
waste must be a solid with minimal free standing liquid, not explosive,
pyrophoric, or capable of generating toxic gases; any hazardous,
biological, pathogenic, or infectious waste must be treated to reduce
to the maximum extent practicable these non-radiological hazards.
Tables 1 and 2 of Sec. 61.55 are used to determine waste class based
on radionuclide content. Class A waste contains the lowest
[[Page 65148]]
concentrations of short-lived and/or long-lived radionuclides. Class B
waste contains low concentrations of long-lived radionuclides but
larger concentrations of short-lived radionuclides; in addition to the
requirements of Sec. 61.56(a), Class B waste must meet the stability
requirements of Sec. 61.56(b). Class C waste contains the largest
concentrations of long-lived radionuclides and/or short-lived
radionuclides that are acceptable for near surface disposal, meets the
same waste characterization requirements as Class B waste (minimum
requirements and stability requirements), plus Class C waste requires
additional measures to protect against inadvertent intrusion as listed
in Sec. 61.52(a). LLRW whose concentrations exceed the highest values
in Table 1 or Table 2 is GTCC and not generally suitable for near-
surface disposal.
Numerous studies and surveys have shown that Class A comprises the
largest volume of LLRW compared to Classes B, C, and GTCC. For example,
a nationwide assessment of LLRW received at commercial disposal
facilities revealed that 97.6% (by volume) of the LLRW disposed was
Class A. Class B and Class C comprised only 1.5% and 0.9%,
respectively. (``1998 State-by-State Assessment of Low-Level
Radioactive Wastes Received at Commercial Disposal Sites,'' May 1999,
DOE/LLW-252.) For example, the 1996 survey of LLRW shipped from
Connecticut to disposal facilities reports that Class A contributed
only 8.9% of the total radioactivity in LLRW disposed in 1996; in 1999,
Class A LLRW represented only about 2% of the total activity. For the
period 1995-1999, Class A LLRW made up about 14% of the total activity.
(``Low-Level Radioactive Waste Management in Connecticut--1996,''
prepared by the Connecticut Hazardous Waste Management Service,
December 1997; figures for 1999 can be found in the October 2000
report.) A comprehensive analysis of the nationwide characteristics of
commercial LLRW shipped for disposal between 1987 and 1989 indicated
that Class A represented from 3.3% to 10.9% of the total radioactivity
in LLRW disposed in any given year and 96.4% to 97.4% of the total
volume in any given year. (``Characteristics of Low-Level Radioactive
Waste Disposed During 1987 through 1989,'' NUREG-1418, December 1990.)
Thus, while Class A LLRW may predominate the volume of waste sent to
LLRW disposal facilities, Class A typically contributes only a small
percentage of the total radioactivity disposed. Class A LLRW is limited
to the lowest concentrations of short-lived and long-lived
radionuclides in the NRC's waste classification system in 10 CFR 61.55,
and much of the waste in Class A LLRW is incidentally contaminated
trash. Class A LLRW with radionuclide concentrations at some fraction
of the Class A limits, so-called low-activity LLRW may represent an
acceptable candidate for disposal by alternative means, such as
disposal in an RCRA Subtitle C landfill.
4. Decommissioning Wastes
When facilities that use or process radioactive materials are
closed, they go through a process of decontamination and
decommissioning to reduce the amount of residual radioactivity left at
the site. The extent and type of contamination depends on the kind of
work done at the facility, the length of time the facility operated,
and the operational practices employed at the facility. For example,
facilities that processed uranium or thorium ore, such as those
involved in FUSRAP, will have a relatively narrow range of
radionuclides (uranium, thorium, radium, and their decay products), but
also tend to have contaminated soils from managing the processing
wastes. Nuclear power plants, on the other hand, typically have to
address a much wider spectrum of radionuclides generated by the fission
process, but much waste will primarily consist of contaminated
equipment. Because of its widely varied operations, the scope of
contamination at DOE facilities and sites is likely to encompass that
found at commercial facilities. The decontamination process also
produces waste, such as the removal of surface contamination from
buildings using high-pressure sprays.
Waste volumes from decommissioning vary widely. Some contaminated
facilities lie unused for years before decommissioning, and a number of
DOE sites are being evaluated for accelerated decommissioning
schedules. The scope of waste from decommissioning can change during
the process. For example, some buildings that are expected to be
lightly contaminated, and therefore amenable to surface
decommissioning, can be found to be more extensively contaminated,
thereby affecting the decommissioning procedure. Similarly, soil
contamination is often found to be more prevalent than anticipated.
Another uncertainty at present surrounds the decommissioning of nuclear
power plants. A few years ago, it appeared that nearly all reactors
would be decommissioned at the end of their current licenses (a few
have decommissioned in the past decade). Now, however, some utilities
are pursuing license renewals. Assuming they operate to the end of the
renewed license, that would push the major wave of decommissioning
farther into the future.
In addition, technological advances in either decommissioning
practices, radioactive waste treatment, or waste disposal could
significantly affect the volumes and characteristics of these wastes.
While we can say with certainty that some, and possibly a large
percentage, of these wastes would be ``low-activity,'' we have no way
of projecting the proportion that would be mixed waste or the actual
waste characteristics. For purposes of modeling, we request information
that would help us describe the wastes resulting from decommissioning.
E. Questions for Public Comment: Disposal of Other LARW in Hazardous
Waste Landfills
1. Should a rule include pre-UMTRCA byproduct material, such as
that generated by FUSRAP cleanups? Are there remaining public health or
environmental concerns over management of this material? (section
III.B.2.a)
2. What authorities are most appropriate to regulate disposal of
pre-UMTRCA byproduct material?
3. Are there significant sources of pre-UMTRCA byproduct material,
other than FUSRAP cleanups?
4. How does pre-UMTRCA byproduct material resemble or differ from
11e.(2) byproduct material regulated by NRC?
5. What Federal or State authorities presently regulate TENORM?
What Federal or State authorities might be used to regulate TENORM?
6. What regulatory standards do State authorities apply to TENORM
disposal? How might a rule simplify TENORM disposal?
7. What approach to managing similar TENORM wastes is most
appropriate? Are there particular waste streams that need immediate
attention (based on risk or occurrence)? (III.B.2.b)
8. Should volume averaging or ``blending'' be allowed for TENORM
and other LARW? Under what conditions?
9. Should a rule include low-activity LLRW that is not mixed waste?
What about source material exempted by NRC? Under what conditions?
(III.B.3)
10. What issues are associated with siting new disposal facilities
for these other LARW? How might they be alleviated? (III.B.4)
[[Page 65149]]
11. Would there be special concerns about waste from facility
decommissioning? Would such concerns depend on the type of facility
being decommissioned? Are there credible projections of the volumes and
types of waste expected to be generated when decommissioning large
numbers of nuclear reactors? (III.D)
IV. What Non-Regulatory Approaches Might Be Effective in Managing LAMW
and Other Low-Activity Radioactive Wastes?
Many of the wastes just described appear to share similar physical
and radiological characteristics. This might imply that a common
approach, or a limited number of approaches, could effectively manage
and dispose of such wastes. Such an approach could eliminate the need
for separate actions addressing individual waste streams. The real
question is to decide which approach (or approaches) may be most
promising in terms of practicality, legal applicability, cost-
effectiveness, and risk reduction potential. In order to develop
meaningful approaches, it is necessary to obtain the advice of
potentially affected stakeholders. We therefore welcome comment on some
of the possible approaches to managing and disposing of these other
categories of low-activity waste. We also welcome advice on new or
innovative approaches that are not described below.
A. General Discussion
Our conceptual approach to disposal of low-activity mixed waste
relies on regulatory actions by us and by NRC, although the envisioned
regulatory action would be permissive (that is, it would allow actions
not possible under the existing regulatory structure) and LAMW
generators or disposal facilities could choose not to take advantage of
the increased disposal flexibility. By contrast, as discussed above,
some other low-activity wastes might not be as clearly addressed by us
through regulatory action. However, we believe it is in the public's
interest to address the issues presented by disposal of these other
low-activity wastes. Therefore, we are considering how best to
accomplish this through actions that do not involve rulemakings or
other regulatory methods. These non-regulatory approaches may also be
effective to some extent in addressing issues related to LAMW disposal.
1. Advantages and Disadvantages of Non-Regulatory Approaches
A prime complaint about regulatory programs is that they are too
prescriptive and limit the flexibility of the regulated parties in
meeting goals. This can be true, and to some extent they also limit the
flexibility of regulatory agencies in improving the effectiveness of
the program, because modifying a regulatory program takes significant
time and resources. In addition, enforcement actions, while necessary
to maintain the integrity of the program, by their very nature often
result in adversarial relationships with limited trust. In short, the
burden of regulatory programs to all parties can sometimes outweigh the
positive benefits.
In a non-regulatory program, the regulatory agency and regulated
community typically work more closely together to achieve a common
goal. In many cases, the regulated parties participate in designing the
program. Non-regulatory programs are usually less prescriptive,
offering flexibility to participants to meet goals in the way they find
most effective. In turn, the regulatory agency focuses less on strict
compliance and more on technical assistance, training, guidance, and
encouraging use of innovative technologies. The flexibility of such
programs can make them easier to modify as found necessary. Compliance
with regulatory requirements is still necessary, and some programs
offer flexibility only to ``superior'' performers. Some programs
encourage self-reporting by offering reduced penalties.
The main concern about non-regulatory approaches is that they can
result in a lessening of regulatory oversight. When a regulatory agency
reduces its emphasis on inspections and enforcement, allows
``innovative'' methods, and relies on self-reporting, there is always
the potential for serious non-compliance with requirements and
subsequent environmental damage. For example, offering reduced
penalties for reporting findings of ``self-audits'' has been criticized
as encouraging abuses.
2. Examples of Existing EPA Non-Regulatory Programs
EPA has developed a number of programs targeted to improve
environmental performance. ``Partners for the Environment'' is the
collective name for voluntary programs developed by EPA Headquarters or
regional offices. These programs primarily involve agreements between
EPA and individual regulated entities, and focus on taking performance
to a level beyond simple compliance with regulatory requirements (or,
in some cases, innovative approaches may be developed that provide some
flexibility in the strict regulatory framework to achieve overall
goals). In that sense, it may be difficult to apply non-regulatory
approaches where there are competing requirements (as for mixed waste)
or inconsistent requirements (as for individual States and TENORM). We
offer this discussion not to endorse any specific program as especially
suited to address low-activity radioactive wastes, but to encourage
thought and comment about innovative approaches that might be
developed, and to provide examples of the types of efforts EPA has
traditionally embraced. Individual EPA programs include:
[sbull] Project XL (eXcellence and Leadership)--Project XL is a
national pilot program that allows State and local governments,
businesses and Federal facilities to develop with EPA innovative
strategies to test better or more cost-effective ways of achieving
environmental and public health protection. In exchange, EPA will issue
regulatory, program, policy, or procedural flexibilities to conduct the
experiment. Project XL uses eight criteria to assess potential
projects, including producing superior environmental results, cost
savings, or regulatory flexibility; demonstrating innovative processes;
pollution prevention; and ability to transfer lessons or data to other
facilities. ``Project XL for Communities'' also looks for strategies
that provide economic opportunity and incorporate community planning.
Project XL has approved projects related to mixed waste treatment.
[sbull] National Environmental Performance Track--The National
Environmental Performance Track program is a voluntary partnership
program that recognizes and rewards businesses and public facilities
that demonstrate strong environmental performance beyond current
requirements. It encourages continuous environmental improvement
through the use of environmental management systems, local community
involvement, and measurable results. Incentives to participants include
public recognition, low priority for routine inspections, partnerships
with State agencies, and regulatory changes to streamline requirements.
There are nearly 300 participants in the program.
[sbull] Code of Environmental Management Principles (CEMP)--CEMP
was developed in response to Executive Order 12856 (``Federal
Compliance with Right-to-Know Laws and Pollution Prevention,'' August
3, 1993), which called for EPA to develop an environmental challenge
program for Federal agencies. CEMP incorporates elements of state-of-
the-art
[[Page 65150]]
environmental management systems (such as the ISO 14000 series) to
emphasize sustainable environmental performance and an integrated view
of environmental activities to move agencies ``beyond compliance.''
CEMP was reaffirmed as a basis for environmental performance and
leadership in Executive Order 13148 (``Greening the Government Through
Leadership in Environmental Management,'' April 21, 2000).
[sbull] Energy Star--Energy Star was introduced by the U.S.
Environmental Protection Agency in 1992 as a voluntary labeling program
designed to identify and promote energy-efficient products, in order to
reduce carbon dioxide emissions. EPA partnered with the U.S. Department
of Energy in 1996 to promote the Energy Star label, with each agency
taking responsibility for particular product categories. Energy Star
has expanded to cover new homes, most of the buildings sector,
residential heating and cooling equipment, major appliances, office
equipment, lighting, consumer electronics, and other product areas.
3. National Academy of Sciences Studies
Though not limited to non-regulatory considerations, two efforts of
the National Academy of Sciences (NAS) have a bearing on our approach
to LARW. In 1999, NAS provided a report evaluating the existing
guidelines for exposures to TENORM. NAS concluded that different
guidelines among regulatory agencies were primarily related to policy,
rather than scientific or technical, judgments. (See ``Evaluation of
Guidelines for Exposures to Technologically Enhanced Naturally
Occurring Radioactive Materials,'' National Academy Press, 1999.) In
addition, NAS is about to conduct a study of options for managing LARW,
including low-level radioactive waste, TENORM, and FUSRAP wastes. NAS
could make recommendations for statutory, regulatory, policy, or other
actions. Financial support for this study is being provided by EPA,
NRC, DOE, USACE, and the Southeastern Low-Level Radioactive Waste
Compact. We believe this study will help us in developing our
rulemaking and in identifying other non-regulatory approaches that
might prove effective. We intend to follow this study and, with this
action, seek the views of the general public on these matters as input
to develop an integrated strategy for assuring the proper management of
such diverse wastes.
B. Non-Regulatory Approaches for LAMW and Other Low-Activity
Radioactive Wastes
1. Develop Guidance
While establishing Federal regulations for pre-UMTRCA byproduct
material and TENORM wastes faces certain hurdles, establishing guidance
may achieve many of the same goals but without a complex regulatory
framework. While guidance would not have the enforcement ``teeth'' of a
regulation, guidance does provide a common reference point and to
depart from such guidance risks damaged credibility for those
industries or entities not following accepted guidance. Another
question is what kind of guidance; Federal guidance, suggested
guidance, joint guidance, and State guidance are all possibilities. It
may be possible to establish Federal guidance for both pre-UMTRCA
byproduct material and TENORM wastes but Federal guidance has
traditionally been used to guide Federal agencies in matters related to
radiation protection. Given that not all of this material falls under
Federal agency purview, the usefulness of Federal guidance for pre-
UMTRCA byproduct material and TENORM may be limited. While not Federal
guidance, strictly speaking, we have published suggested guidance for
dealing with the radioactive residues from treating drinking water.
(See 56 FR 33091, July 18, 1991.) Guidance in the form of ``suggested
State regulations'' has been developed over the years for a variety of
radiation protection issues, including TENORM, by the Conference of
Radiation Control Program Directors (CRCPD). Whether a unified guidance
applicable to both pre-UMTRCA byproduct material and TENORM wastes is
possible and practical is open to question. We welcome the views of
stakeholders on this matter. Perhaps joint State-Federal guidance would
be appropriate to cover both pre-UMTRCA byproduct material and TENORM
wastes.
2. Partner With Selected Stakeholders To Develop Waste-Specific ``Best
Practices''
An alternative approach to guidance might be a partnership between
Federal, State, and industry representatives to establish ``best
practices'' targeted to specific industries or waste types. Again,
lacking the ``teeth'' of a formal regulation, a code of ``best
practice'' creates a common reference point of accepted practice that
brings peer pressure and public pressure on those entities failing to
abide by such a code. Establishing such best practice that is endorsed
and used by the industries in question may also lessen the need for
formal regulation and result in cooperation rather than confrontation.
It is possible that industry could establish an in-house panel of
recognized experts and affected stakeholders that would develop,
monitor, and facilitate the implementation of best practices by
companies within a given industry, even allowing the use of the panel's
code of ``best practices'' logo to companies abiding by this code. This
might work in a manner similar to our Energy Star program, a voluntary
program to identify and promote energy efficient products. We welcome
views on the possible application of this approach, or other
approaches. What wastes or specific industries could benefit most from
this approach? How useful might the development of best practices be
for the affected industries? What incentives exist or may be encouraged
to promote the development and implementation of best practices?
In an action that combines aspects of the guidance and ``best
practices'' approaches, EPA recently issued a ``Guide for Industrial
Waste Management'' (EPA530R-03-001). EPA joined with members of State
governments, tribes, industry, and environmental groups to develop this
guidance on how best to manage non-hazardous industrial solid wastes,
which are generated in much larger volumes than municipal solid wastes.
The Guide is intended to be a practical resource, covering engineering
and scientific principles applicable to developing and operating waste
management units, effective communication, risk assessment, and other
topics. Computer models and other tools are included in the Guide,
which is also available on CD-ROM (EPA530-C-03-002). See http://www.epa.gov/epaoswer/non-hw/industd/index.htm for more information.
C. Request for Information: Non-Regulatory Alternatives to Our Disposal
Concept
In general, we request information that would help us to evaluate
whether non-regulatory approaches might be effective in addressing
issues associated with low-activity radioactive waste management and
disposal (see also questions in D, below). We also request information
that would help us determine what types of non-regulatory actions would
be most effective, how they would be developed, and who might need to
be involved in their
[[Page 65151]]
development. We welcome information on:
[sbull] The effectiveness of various non-regulatory programs at
achieving their stated goals
[sbull] The relative cost of implementing a non-regulatory vs.
regulatory program
[sbull] The ease of implementing a non-regulatory vs. regulatory
program
[sbull] Whether existing non-regulatory programs could be used to
address LARW
D. Questions for Public Comment: Non-Regulatory Alternatives to Our
Disposal Concept
1. In general, do you think that a non-regulatory approach could be
effective at addressing the problems associated with management and
disposal of low-activity radioactive waste? Why or why not? (section
IV)
2. What has been your experience with EPA non-regulatory programs,
such as those described in section IV.A.2? Which programs have been
most effective? Why?
3. What is your experience with non-regulatory programs at other
Federal or State agencies?
4. Do you see particular aspects of LARW management and disposal
that could not be addressed outside of regulatory action? Aspects that
would be particularly amenable to non-regulatory action?
5. Is guidance a viable mechanism to support proper management of
LARW? Who should develop such guidance? What topics should it cover?
(IV.B.1)
6. Would a ``best practices'' approach to management of LARW give
generators and disposal facilities sufficient support to ensure proper
management practices? Would incentives to adopt a ``code of conduct''
be necessary? Could such a ``code'' encompass the wide range of
generating processes and waste characteristics? How would regulators
view such an approach? (IV.B.2)
7. What other non-regulatory approaches might be appropriate to
address LARW management?
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether a regulatory action is ``significant'' and
therefore subject to Office of Management and Budget (OMB) review and
the requirements of the Executive Order. The Executive Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
OMB has determined that this Advance Notice of Proposed Rulemaking
is ``non-significant'' according to the criteria of Executive Order
12866.
Dated: November 4, 2003.
Marianne Lamont Horinko,
Acting Administrator.
[FR Doc. 03-28651 Filed 11-17-03; 8:45 am]
BILLING CODE 6560-50-P