Issues Paper on
Radiation Site Cleanup Regulations
September 1993
Office of Radiation and Indoor Air
U.S. Environmental Protection Agency
Washington, DC 20460
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Contents
1. Introduction 1
1.1 Purpose and Scope of the Cleanup Regulations 1
1.2 Interagency Coordination and Public Participation 1
1.3 Purpose and Organization of the Issues Paper 2
2. Significant Issues . . '. 3
2.1 Selecting a Statutory Authority 3
2.2 Determining Acceptable Cleanup Levels 4
2.2.1 Clean up to Detection Limits 5
2.2.2 Clean up to Background , 5
2.2.3 Clean up to Risk-Based Levels 6
2.2.4 Clean up to Technology-Based Levels 8
2.3 Future Uses of Cleaned-up Sites 9
2.4 Additive Effects 11
2.5 Target Individuals/Populations to be Protected 11
2.6 Protection of the Environment in Addition to Human Health 13
2.7 Time Frame to be Considered 14
2.8 Measurement and Modeling Techniques , 15
2.9 Technological Feasibility 15
3. Regulatory Approaches 17
3.1 Dose or Risk Limit 19
3.2 Table of Radionuclide Concentrations 21
3.3 Table of Radionuclide Concentrations Combined With a Pathway Model 22
3.4 Technology-Based Approach 24
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4. Summary and Next Steps 27
4.1 Summary 27
4.2 Next Steps 28
Appendix A Background 31
A.I Radioactive Materials and Wastes 31
A.1.2 Radioactive Wastes 33
A.1.3 Radioactive Sites 35
A.3 Authorities and Roles for Cleanup of Radioactive Sites 39
A.4 Current Regulatory Controls 41
A.4.1 Federal Programs 41
A.4.2 State Programs 41
A.4.3 International Programs 44
A.5 EPA Coordination Activities 45
Appendix B Statutory Authorities 47
B.I Atomic Energy Act (AEA) 48
B.2 Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) .. 49
B.3 Toxic Substances Control Act (TSCA) 50
B.4 Resource Conservation and Recovery Act (RCRA) 51
Appendix C Text of Memorandum of Understanding—Guiding Principles of EPA/NRC Cooperation
and Decisionmaking 53
Appendix D NRC's Enhanced Participatory Rulemaking on Radiological Criteria for
Decommissioning 57
Appendix E List of Acronyms 61
Appendix F Glossary 63
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List of Tables and Figures
Table 1 Selected Annual Dose Limits for Exposure to Ionizing Radiation 7
Table 2 Preliminary Criteria for Evaluating Regulatory Approaches 18
Table 3 Comparison of Regulatory Approaches 19
Table A-l Categories of Radioactive Material 33
Table A-2 Statutory and Regulatory Categories of Radioactive Waste 34
Table A-3 Example Definitions of Site, Facility, and Installation 36
Table A-4 Statutory Authorities for Radiation Protection 40
Table A-5 Examples of Federal Regulatory Controls 42
Table B-l Evaluation of Statutory Authorities 48
Figure 1 Spectrum of Regulatory Approaches 17
iii
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Chapter 1
Introduction
No one knows exactly how many sites in the U.S. are contaminated with radionuclides, but the
number may run in the thousands. Sites range from corners of laboratories contaminated with small
amounts of short-lived, low-level wastes to sprawling former nuclear weapons facilities replete with long-
lived transuranic and high-level wastes. Buildings and equipment often are contaminated along with soil,
water, and other environmental media. Many sites also are contaminated with nonradioactive hazardous
chemicals. Cleaning up these sites to protect human health and the environment from exposure to ionizing
radiation poses complex scientific and technical challenges; it will require novel approaches and will be
very expensive.
Progress in radiation site cleanups in general has been limited and slow. This has been due to
uncertainties about the nature and extent of contamination and the lack of specific cleanup standards. The
result has been confusion, public consternation, and costly delays. Congress, federal agencies, state
governments, the regulated community, and the public are concerned about, among other issues, the
difficulties in identifying consistent cleanup requirements for radioactive sites. To remedy the lack of
consistent cleanup standards, the U.S. Environmental Protection Agency (EPA) is developing regulations
that will establish cleanup levels for radioactive sites. This paper identifies many of the issues related to
that effort, which will include numerous opportunities for public involvement both during the rulemaking
and during site-by-site cleanup deliberations.
1.1 Purpose and Scope of the Cleanup Regulations
EPA believes that developing specific cleanup standards for radioactive sites will ensure consistent,
protective, and cost-effective site remediation. To that end, EPA is pursuing a comprehensive regulatory
strategy. First, the Agency is developing cleanup regulations for soil and groundwater contaminated with
radionuclides. Under a separate rulemaking, EPA will develop waste management regulations which will
include requirements for handling and disposing of radioactive waste generated during remediation. The
Agency also will explore the feasibility of recycling or reusing site structures, equipment, and metals after
cleanup. The cleanup and waste management regulations will apply to all sites contaminated with
radioactive material subject to the Atomic Energy Act (AEA) and to sites covered under authority of the
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).
1.2 Interagency Coordination and Public Participation
The EPA regulations will apply to a broad range of site types, so the Agency is coordinating its
regulatory development activities with numerous interested parties, including other federal agencies such
as the Department of Energy (DOE), Department of Defense (DoD), and the Nuclear Regulatory
Commission (NRC). (EPA is coordinating with NRC, which is developing regulations that will govern
the decommissioning of NRC-licensed facilities.) The Agency also is involving state and local
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governments, Native American tribes, environmental groups, industry and trade associations, and the
general public.
The Agency strongly encourages members of the public to participate throughout the process to
ensure that their concerns are understood and addressed. EPA will establish a computerized Cleanup
Regulation Electronic Bulletin Board (800 700-STDS outside the Washington, DC area, and 703 790-
0825 locally) to answer questions and provide information on rulemaking activities and available
documents.
1.3 Purpose and Organization of the Issues Paper
EPA prepared this document to present issues, approaches, and preliminary analyses related to its
development of radiation site cleanup regulations. It focuses exclusively on issues and approaches related
to developing cleanup regulations; it does not address issues specific to waste management regulations,
which will be addressed in a separate document
The three chapters that follow discuss Significant Issues, Regulatory Approaches, and Summary
and Next Steps. Appendix A presents background information on radioactive waste and provides
additional details of EPA coordination of its rulemaking effort Appendix B discusses statutory authorities
upon which EPA may base its cleanup regulations. Appendix C is a copy of the EPA/NRC MOU.
Appendix D discusses the issues raised in NRC's Enhanced Participatory Rulemaking on Radiological
Criteria for Decommissioning, in which EPA participated. Appendix E is a list of acronyms, and
Appendix F is a glossary of terms used throughout this document
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Chapter 2
Significant Issues
Before EPA can adopt a strategy for developing radiation site cleanup regulations, the Agency
must evaluate a number of significant issues. These issues, which are discussed in this chapter, include:
• Which statute, or combination of statutes, should be used as the basis for Agency radiation site
cleanup regulations?
• What is an acceptable cleanup level and how should it be determined?
• What consideration should be given to future land use when specifying cleanup levels?
• How should additive risks be handled?
• Who should the regulations protect:
— Individuals, whole populations, or both?
— Populations especially sensitive to radiation?
— The general public, remediation workers, or both?
• How should the regulations ensure that people and the environment are protected?
• What time frame should be considered when calculating individual doses?
• Are available measuring and modeling techniques adequate to support the regulations?
• Are technologies available to achieve specified cleanup levels?
2.1 Selecting a Statutory Authority
Selecting one or more statutory authorities on which to base the radiation site cleanup regulations
is fundamental to the rulemaking process. The statutory authorities that underlie the rule will determine
such issues as which sites and radionuclides will be covered by the rule and how the rule will be enforced.
Under the Atomic Energy Act and Reorganization Plan No. 3 of 1970, EPA is authorized to
develop federal guidance and to establish standards to protect health and the environment from the effects
of radiation. The Comprehensive Environmental Response, Compensation, and Liability Act authorizes
the President to take response action whenever there is an actual or threatened release of hazardous
substances, including radionuclides.
A variety of other federal laws authorize the regulation of radionuclides. Appendix A discusses
the major relevant federal statutes. Appendix B discusses, evaluates, and compares four major statutory
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authorities upon which EPA could draw, alone or in combination, as it develops the radiation site cleanup
regulations. The statutory authorities evaluated in Appendix B are the:
• Atomic Energy Act (AEA)
• Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA)
• Resource Conservation and Recovery Act (RCRA)
• Toxic Substances Control Act (TSCA)
Many environmental statutes (e.g., RCRA, the Safe Drinking Water Act, and the Clean Water Act)
allow EPA to delegate program enforcement authority to the states through a lengthy and exacting
process—so long as they meet certain criteria. One general criterion is that states must adopt regulations
at least as stringent as EPA's. But if some states were to adopt more stringent radiation regulations, the
Agency goal of consistent radiation site cleanup standards might be undermined. Delegation also poses
implementation issues that the Agency probably would want to consider. For example, the drinking water
program expends much effort to ensure the effectiveness of state enforcement programs and that states
report complete and accurate information to EPA. Among the problems the drinking water program faces
are inconsistent definitions, inconsistent interpretations of program requirements, and inconsistent data
reporting formats.
On the other hand, delegation of program enforcement to states gives more authority to officials
closer to local concerns and conditions. It also gives states more say in determining which sites are
cleaned up first and how they are addressed.
2.2 Determining Acceptable Cleanup Levels
Ionizing radiation causes cancer and other health problems in people. When EPA develops
regulations that cover carcinogens, the Agency assumes that any exposure, no matter how small, to a
carcinogen poses some risk.1 People are exposed to radiation from a variety of natural sources, so it is
impossible to eliminate this risk. The Agency can, however, set radiation site cleanup levels to limit
exposure and reduce radiation concentrations to what are considered acceptable levels. Several approaches
are available for doing so:
• Requiring cleanup to the lowest levels of radiation that instruments can detect.
• Requiring cleanup to levels equal to background, or natural, radiation levels.
• Requiring cleanup to a radiation level that corresponds to a risk level or a range of risk
considered protective of human health and the environment.
• Requiring cleanup to a level based on the performance of the Best Demonstrated Available
Technology (BOAT).
Each approach is explored in greater detail hi the subsections that follow.
^'Risk Assessment Guidance for Superfund: Volume I — Human Health Evaluation Manual (Part A,
Baseline Risk Assessment)," Interim Final, EPA Office of Emergency and Remedial Response, EPA/540/1-
89-002, December 1989.
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2.2.1 Clean up to Detection Limits
EPA could set the cleanup level equal to the detection limit for radionuclides, or, the Agency
could require additional cleanup to bring radiation levels below currently detectable levels. EPA might
adopt the latter approach if it thought that new technologies might be able to detect lower levels of
radioactivity and that additional site cleanup would be effective in reducing radionuclide concentrations.
Detection limits for radiation at the surface and below ground can be difficult to define in a
scientifically defensible manner, and they do not relate directly to protection of human health and the
environment. In addition, it is often technically impractical or infeasible to reduce radionuclide
concentrations to detection limits. Furthermore, implementing standards that are below the quantifiable
levels of detection cannot be justified scientifically. For these reasons, EPA determined in the proposed
RCRA Subpart S corrective action rule (40 CFR Part 264, Subpart S) that it could not set media cleanup
standards below detectable limits.2
2.2.2 Clean up to Background
The Agency could require that radioactive contamination of environmental media be reduced to
background levels. Typically, this involves measuring radiation concentrations in relatively undisturbed,
offsite soils or up-gradient groundwater to establish background levels at individual sites. Adoption of
this approach would require EPA to develop statistical procedures for sampling and for calculating
background levels of radionuclides. The Agency also would need to consider how to handle situations
in which the background radiation levels are quite high (for example, because of localized concentration
of radon) or influenced by contamination in adjacent sites.
The RCRA Subpart F groundwater monitoring program provides a precedent for this
approach—although it is one that EPA has moved away from in recent years. Subpart F requires the
cleanup of groundwater contamination to background levels, to maximum contaminant levels for 14
constituents, or to alternate concentration limits.3 EPA promulgated these requirements in the early 1980's
as part of the initial set of RCRA regulations. In developing more recent RCRA regulations, the Agency
moved away from background levels toward risk-based levels. According to the preamble discussion:
Experience in the Subpart F program has demonstrated that the determination of
background levels can be a lengthy, controversial process. Furthermore, background
levels will often be much lower than [risk-based] levels. Thus, this alternative was
rejected, since it might delay [ultimate cleanups] and might often require [studies] even
where levels were significantly below health- and environmental-based standards.4
255 FR 30828
340 CFR 264.94
455 FR 30815
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2.2.3 Clean up to Risk-Based Levels
The long-term effects of exposure to ionizing radiation "manifest themselves in human populations
simply as a statistical increase in the incidence of certain already existing conditions."5 Consequently,
cleanup levels can be linked to likely exposures that will result in a statistical increase in cancer cases;
the more protective the cleanup regulations, the fewer the additional statistical cancer cases from exposure
to ionizing radiation.
The primary objective of a risk-based approach would be to establish cleanup levels that ensure
a specified level of protection for human health and the environment. If EPA were to promulgate a risk-
based cleanup regulations for radionuclides, the Agency would have to determine an acceptable level of
cancer risk on which to base them.
As Table 1 shows, a wide range of dose limits and corresponding estimated risk levels have been
specified by several agencies under a number of radiation protection regulations. In addition to these
radiation protection standards, the revised National Contingency Plan (NCP) has established an acceptable
lifetime risk range for carcinogens of 104 to W6 for site cleanups under CERCLA. (That corresponds
to a statistical increase in the cancer incidence rate ranging from one case for every 10,000 people to one
case for every million people exposed.)
RCRA Subpart S adopted the NCP risk range largely to achieve substantial consistency with the
Superfund cleanup program; media cleanup standards specified in Subpart S are potential applicable or
relevant and appropriate requirements (ARARs) for the Superfund program. ARARs can affect the
cleanup levels Superfund site remediations must achieve. EPA did not want regulated entities to "program
shop" for the least stringent standards, so the Agency adopted the NCP risk range for Subpart S.6
Several, often competing, factors may influence the determination of an acceptable risk level for
radiation site cleanup regulations. Lower risk levels would be more protective of human health and the
environment, would be more likely to permit the release of cleaned-up sites for residential use (see section
4.2, below), and may be more acceptable to the public. They also could lead to costlier cleanups, higher
radiation exposures to cleanup workers, and more remediation waste that also will require disposal.
Specifying a risk range as the NCP does may strike an acceptable balance between these
competing factors. A range of 10"* to 10"6 could be, in most situations, a convenient and practical level
for radiation site cleanup regulations—especially if CERCLA provides at least part of the statutory
authority for this rulemaking. And since the RCRA corrective action program already has adopted the
CERCLA risk range, this approach would be familiar to the RCRA-regulated community that handles
mixed waste. (The radioactivity associated with such a risk range, however, often is a small percentage
of the background radiation.)
If the Agency were to adopt a risk range, it would need to determine whether the specific exposure
assumptions used by the RCRA and CERCLA programs are appropriate for radiation exposures at
contaminated sites. For example, the RCRA and CERCLA risk range considers fatal and nonfatal cancers,
but international and NRC radiation protection guidance considers only fatal cancers. EPA also would
have to develop guidance on how such factors as current and future uses of a site would influence the
5Mackenzie L. Davis and David A. Cornwell, Introduction to Environmental Engineering (New York:
McGraw-Hill, Inc., 1991), 743.
655 FR 30852
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cleanup level achieved at a site. The sensitivity of available methods for measuring radioactivity is
another important consideration; it is not clear whether current measurement techniques are sufficiently
Table 1
Selected Annual Dose Limits for Exposure to Ionizing Radiation3
Dose Limit
(mrem/yr)
Corresponding
Estimated Lifetime
Excess Cancer
Risk"
Citation
100
2X10"3
NRC: 10 CFR Part 20, Standards for Protection Against Radiation - applies to all
radioactive sources and all exposure pathways.
DOE: Proposed 10 CFR 834, Radiation Protection of the Public and the Environ-
ment - applies to all radioactive sources and all exposure pathways.
25
5x10*
NRC: 10 CFR Part 61, Licensing Requirements for Land Disposal of Radioactive
Waste - applies to all radioactive sources and all exposure pathways.
DOE: Proposed 10 CFR Part 834, Radiation Protection of the Public and the
Environment - applies to all radioactive sources and all exposure pathways associ-
ated with waste management
EPA: 40 CFR Part 190, Environmental Radiation Protection Standards for Nuclear
Power Operations - applies to all radioactive sources and all exposure pathways.
15
3x10*
EPA: Proposed 40 CFR Part 191, Environmental Standards for the Management
and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive
Waste - applies to all radioactive sources and all exposure pathways.
10
2x10*
DOE: Proposed 10 CFR Part 834, Radiation Protection of the Public and the
Environment - applies as a reporting requirement for all radioactive sources and
pathways, and as a limit for all radionuclide sources via air emissions.
EPA: 40 CFR Part 61, National Emission Standards for Hazardous Air Pollutants
— applies as a limit for all radionuclide sources via air emissions.
7x10's
EPA: 40 CFR Part 141, Interim Primary Drinking Water Regulations (1976) —
applies as a limit on anthropogenic radionuclides in drinking water.
EPA: 40 CFR Parts 141 and 142, proposed rule for National Primary Drinking
Water Regulations - Radionuclides — applies as a limit for all beta-gamma emitting
radionuclides in drinking water.
° Excludes annual radiation doses from natural background and medical sources. According to the National Council on Radiation
Protection and Measurements Report No. 94 ("Exposure of the Population in the United States and Canada from Natural Background
Radiation," published in 1987), background radiation exposure results in a dose of approximately 300 mrem/yr, or an estimated lifetime
cancer risk of about 1 x 102.
b Includes fatal and non-fatal cancers (i.e., cancer incidence). Calculated assuming a 30-year residential exposure duration consistent
with EPA OSWER Directive 9285.6-037 and a cancer incidence risk conversion factor of 6 x 10'7 per millirem, taken from EPA's "Risk
Assessments Methodology, Environmental Impact Statement, NESHAPS for Radionuclides, Background Information Document —
Volume I," EPA/520/1-89-005, September 1989.
7Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual,
Supplemental Guidance: "Standard Default Exposure Factors," Interim Final, OSWER Directive 9285.6-
03.
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sensitive to determine compliance with a more stringent (e.g., 10"6) radiation risk limit. For example, a
10"6 lifetime excess cancer risk level corresponds to an external exposure rate of about 0.003
microroentgens per hour (jiR/hr). Typical field survey instruments can measure no less than luR/hr, which
corresponds to a lifetime excess cancer risk level of 3 x 10"4. Risk-based approaches other than the one
adopted by CERCLA are also possible. For example, the Agency might consider the risk goal approach
discussed in the NRC rulemaking issues paper8 or in DOE Order 5400.5 and proposed 10 CFR 834. This
approach includes a constraint on radiation doses below the 100-mrem per year limit? for all radiation
sources and pathways and the application of requirements to reduce dose, and risk, "as low as is
reasonably achievable" (ALARA) below the dose constraint level. In this situation, the dose constraint
would ensure that minimum requirements for individual risk are achieved and population risk (collective
dose) and other factors (including cost, social concerns, and ecological considerations) are used to reduce
risk to an optimum level of protection.
Because NRC and DOE already have adopted less than 100 mrem/year plus ALARA for their
current radiation protection regulations, this approach would be familiar to the regulated community that
handles radioactive waste. It is unclear, however, how far below the dose constraint additional cleanup
would be considered practical, what dose/risk goal would ultimately be achieved, and how ALARA would
be applied to reach this goal.
2.2.4 Clean up to Technology-Based Levels
Cleanup regulations could base cleanup levels on the performance of the Best Demonstrated
Available Technology (BDAT). Requirements could be expressed as radionuclide-specific concentrations
(i.e., numerical performance standards) or as specified technologies to be employed at site cleanups. In
the former case, the rule would allow the use of any technology, so long as it could be shown that the
chosen technology achieves cleanup levels specified by EPA and attainable by BDAT. In the latter case,
the rule would specify a technology, or combination of technologies, to be used depending on the nature
of contamination at a site. In either case, however, EPA would write the regulations to ensure that sites
were cleaned up in a manner that protects human health and the environment.
One example of technology-based regulations is the RCRA land disposal restrictions (LDR)
program, which requires the treatment of as-generated hazardous wastes prior to land disposal. The LDR
framework rule10 contains the following definitions:
• "Best" means technologies that yield the most effective results from well-designed and well-
operated systems.
• "Demonstrated" means technologies currently in use on a full-scale, as opposed to a pilot- or
bench-scale, basis.
'"Proposed Rulemaking to Establish Radiological Criteria for Decommissioning: Issues for Discussion
at Workshops," Nuclear Regulatory Commission, November 30, 1992.
9A millirem, or mrem, is one one-thousandth of a rem (see glossary).
1051 FR 40572
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• "Available" means available for lease or purchase, as opposed to a patented process that could
not be licensed outside a firm.
, • . i'
It should be noted that previous applications of technology-based standards, such as the Clean Air
Act requirements, frequently require future re-evaluations of the residual risks associated with the
standards.
2.3 Future Uses of Cleaned-up Sites
Contaminated sites subject to the radiation cleanup regulations may be found in industrial parks,
commercial developments, agricultural areas, residential settings, mixed-use zones, and other settings.
Land uses, however, may change drastically over time. For example, with the end of the Cold War,
dozens of military bases nationwide are being converted to nondefense uses, possibly including housing
and recreation. The prospect of such widespread base closings was unseen just a few years ago. The
considerable uncertainty in forecasting uses of radioactive sites^-even those in heavily industrialized
areas—must be considered in the selection of a protective cleanup standard.
Given this uncertainty, EPA recognizes the importance of tailoring cleanup levels to particular land
uses and of involving the public—which likely will have a strong interest in establishing future uses—in
the process of determining appropriate cleanup levels site by site. Public involvement in radiation site
cleanup decisions also will help focus the process on environmental justice concerns.
The linkage of cleanup levels with land use is nothing new. When proposing RCRA Subpart S
soil cleanup levels, for example, EPA recognized that using exposure assumptions tailored to industrial
land uses might be appropriate when facilities were located in areas likely to remain industrial for the
foreseeable future. The Agency "Draft Contaminated Media Principles" also suggests that cleanup levels
should consider reasonably expected uses of environmental media, as well as the costs and technical
limitations associated with their cleanup.11 The Superfund program also has developed guidance12 on
identifying future land uses at NPL sites and procedures13 for assessing human health risks associated
with alternate land-use scenarios, including residential and commercial/industrial land uses.
Consistent with these EPA initiatives, NRC guidance for cleaning up sites contaminated with
uranium and thorium establishes different cleanup levels for different land uses. In particular, the guidance
defines five disposal and storage approaches, each with increasingly higher permissible concentrations of
""Draft Contaminated Media Principles," Contaminated Media Cluster, EPA Office of Solid Waste
and Emergency Response, August 12, 1993.
12"Risk Assessment Guidance for Superfund: Volume I — Human Health Evaluation Manual (Part A,
Baseline Risk Assessment)," Interim Final, EPA Office of Emergency and Remedial Response, EPA/540/1-
89-002, December 1989. Also, "Human Health Evaluation Manual, Supplemental Guidance: Standardized
Default Exposure Factors," EPA Office of Solid Waste and Emergency Response, Toxics Integration
Branch, OSWER Directive 9285.6-03, March 25, 1991.
13"Risk Assessment Guidance for Superfund: Volume I — Human Health Evaluation Manual (Part
B, Development of Risk-based Preliminary Reduction Goals)," Interim Final, EPA Office of Emergency
and Remedial Response, Publication 9285.7-01B, October 1991.
9
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uranium and thorium in soil and correspondingly stringent land-use restrictions.14 A 1992 NRC
document, "Action Plan to Ensure Timely Cleanup of Site Decommissioning Management Plan Sites,"
however, notes that only the first two approaches remain viable; the remaining three are inconsistent with
decommissioning requirements.15
To help maintain current land use patterns, restrictions on future site uses could be part of EPA's
cleanup regulations. (Such restrictions would help ensure that cleanup levels appropriate for current land
uses would not become inappropriate because the use of the land has changed.) EPA has explored the
use of institutional controls on land uses at RCRA and CERCLA sites undergoing cleanup. (Institutional
controls include fences to restrict access to contaminated areas, deed restrictions or laws and ordinances
limiting site access or resource use, and techniques such as providing alternative water supplies or
prohibitions against the use of onsite groundwater for drinking.16) RCRA Subpart S, for example,
proposes the use of institutional or other controls to prevent any significant exposure to hazardous wastes
at RCRA facilities that use "conditional" remedies. The rule also indicates that institutional controls may
play a role in final remedies.
The NCP discourages the use of passive institutional controls, such as deed restrictions, in favor
of active measures, such as security patrols, unless active measures are found to be impractical. For
example, the final remedial action at the Maxey Flats Disposal Site left hazardous and radioactive
materials on site; consequently, institutional controls are being used to restrict site use and to ensure that
the site is monitored and maintained in perpetuity.17 Such "perpetual" active measures, however, may
face difficulties gaining acceptance by the public, which may view them as neither practical nor protective.
Considering Agency approaches in the programs just discussed, EPA may want to develop
radiation site cleanup regulations for a range of future uses, from residential and recreational to agricultural
to commercial/industrial. For example, regulations might allow some low level of residual radioactivity
to remain after cleanup so long as institutional controls are employed to ensure that a site is not used for
an unsuitable purpose, such as a school. On the other hand, EPA also may have to consider that some
heavily contaminated sites, such as the Nevada Test Site or Hanford nuclear site, may never be available
for public use under any circumstances. Less restrictive cleanup criteria may be appropriate at such sites
simply to ensure that contamination does not migrate off site or that workers are not exposed to unaccepta-
bly high levels of radioactivity.
Cultural resource management may also play a role in future land-use decisions involving cleaned
up sites. Historic sites and national landmarks or sites sacred to Native Americans, for example, may
affect cleanup decisions and influence the acceptability of certain regulatory approaches.
""Disposal or On-site Storage of Thorium or Uranium from Past Operations," Branch Technical
Position, 46 FR 52061, October 23, 1981.
1S57 FR 13389
1655 FR 30833-34
"Draft "Maxey Hats Disposal Site Remedial Action Fact Sheet," EPA/OSWER, December 16,1992.
10
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2.4 Additive Effects
In developing and implementing cleanup regulations, the additive risks associated with exposure
to multiple radionuclides from multiple sources via multiple pathways must be considered. Many health-
based radiation protection regulations define acceptable concentrations or quantities for individual
radionuclides and individual exposure pathways; they then provide a "sum of the fractions" procedure for
estimating the effects of simultaneous exposure to multiple radionuclides.
An individual's total exposure and risk is determined by adding exposures from disparate sources
at a site, such as contaminated soil and groundwater. While such an approach is routinely used, it may
result in levels of individual radionuclides that are below current detection limits. In such cases,
compliance with cleanup regulations might be difficult to demonstrate.
Sources and pathways of exposure to ionizing radiation will not be limited to those found at a
contaminated site. EPA will have to decide how its cleanup regulations should handle the risks arising
from indoor exposures to radionuclides—including elevated radon levels caused by technologically
enhanced sources of indoor or outdoor radium contamination. And depending on the scope of the cleanup
regulations, the additive risks from exposure to naturally occurring radionuclides (i.e, NARM/NORM) and
other radionuclides (i.e., source, byproduct, and special nuclear material) may be an issue. For example,
if the cleanup regulations do not include NARM/NORM, EPA would need to consider adding the risks
associated with NARM/NORM exposures to the exposures to radionuclides included within the scope of
the regulations.
Ionizing radiation is not the only carcinogenic contaminant at many sites. A significant fraction
of radioactive sites also contain hazardous chemical wastes. Therefore, the risk to the public from these
sites derives from exposure to ionizing radiation and exposure to hazardous chemicals. Although radiation
site cleanup regulations may be intended to protect against harmful exposures to ionizing radiation,
cleanup activities at mixed-waste sites also might have to address the risks posed by hazardous chemicals,
EPA will examine such situations during development of the radiation site cleanup regulations. The
procedures used by other Agency programs should prove instructive. For example, CERCLA cleanup
guidance provides suggestions for summing such risks to determine baseline risk conditions at Superfund
sites.18
2.5 Target Individuals/Populations to be Protected
The EPA risk assessment approach assesses exposure to a "reasonably" exposed maximum
individual. EPA standards always include an individual risk limit, but population risk may dictate more
control than would individual risk alone. Although NRC also assesses exposure to a "reasonably" exposed
maximum individual, public exposure is generally limited by individual risk; population risk may be used
in conjunction with individual limits.19
18"Risk Assessment Guidance for Superfund: Volume I — Human Health Evaluation Manual (Part
A, Baseline Risk Assessment)," Interim Final, EPA Office of Emergency and Remedial Response,
EPA/540/1-89-002, December 1989.
19NRC-EPA Risk Harmonization, Phase I: Risk Assessment, Briefing Document, November 25,1992.
11
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If EPA decides to employ a risk-based approach to radiation cleanup standards, the Agency will
have to decide whether the regulations should be applied to individuals or total populations, or both.
Standards that apply to populations (i.e., collective dose standards) sum all of the individual doses received
by population members over a designated period of time.20 If a collective dose is used, EPA will have
to consider (1) how small a dose should be included in the summation of individual doses, (2) the time
frame for the population's exposure, (3) how the dose might be limited by the location of receptor
populations relative to the source(s) of contamination, and (4) how to include the entire population or
ensure that a representative portion of the population is used to determine collective exposure.
Which individuals should be considered in risk calculations also will have to be determined.
Among the questions to be answered are: Should the regulations protect the average person, or persons
such as children who are most sensitive to radiation exposure? Should the regulations be designed to
protect members of the general public during and after remediation, workers who perform the cleanups,
and/or workers employed at a site after it is cleaned up?
Workers engaged in hazardous waste operations and emergency responses, including workers
employed in hazardous waste site cleanups,21 are protected under identical standards promulgated by EPA
and the U.S. Occupational Safety and Health Administration (OSHA) under section 126 of the Superfund
Amendments and Reauthorization Act. (OSHA defers to NRC on radiation protection matters under the
terms of an MOU.22) The applicability of these standards to remediation workers at radioactive sites
would have to be considered if the radiation cleanup regulations are designed to limit remediation worker
exposures.
Agency guidance promotes the use of a range of descriptors to characterize the results of a risk
assessment.23!^ descriptors include total population risk; average and/or maximum individual risk; and
risk to sensitive or highly exposed segments of the population. Presentation of the results of the risk
assessment in terms of one or more risk descriptors provides insight on the range of different exposure
concentrations encountered in the risk assessment. The regulations could specify risk levels for a range
of risk descriptors based on specific exposures.
Individual levels could be based on either the average person's risk or that of the most exposed
person in the population to be protected. Population risk is calculated by summing individual risks for
all individuals in the exposed population. (Or, if the average individual risk is used, multiplying that risk
by the size of the population.) Determining population risk, however, is not always possible due to data
limitations.
20The radiation protection standards contained in DOE's proposed 10 CFR Part 834 regulations are
individual dose levels. These regulations, however, specify reporting requirements on individual and
collective dose bases to "provide timely notification before collective doses become substantial." NRC's
10 CER Part 20 specifies provisions on collective dose.
"The EPA regulations, published on June 23, 1989 at 54 FR 26654, incorporate the Occupational
Safety and Health Administration standards by reference and are codified at 40 CFR Part 311.
^SFR 43950
^"Guidance on Risk Characterization for Risk Managers and Risk Assessors." Memorandum from
EPA Deputy Administrator F. Henry Habicht II to Assistant Administrators and Regional Administrators,
February 26,1992.
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Using a variety of risk levels describes the variability in exposures, lifestyles, and other factors
that lead to a distribution of risk across a population.24 For meaningful interpretation of a risk level, the
exposed population, or target population, must be defined clearly with respect to location relative to the
site, activity patterns, and the presence of sensitive groups.25 In many cases, determining the cut-off
between exposed and nonexposed individuals can be technically challenging.
2.6 Protection of the Environment in Addition to Human Health
Most research on the harmful effects of radiation has focused on people. EPA, however, also is
concerned with the broader issue of potential harm to the environment The effects of ionizing radiation
on the environment as well as on people are a concern at many NPL sites.26 In developing its cleanup
regulations, therefore, EPA also must consider cleanup levels that provide ample protection for plants and
animals as well as for people.
National and international radiation protection advisory committees have concluded that levels
protecting human health should be sufficient to protect the environment as well. The National Academy
of Science, for example, states:
The principal potential impact of radioactive effluents on the biosphere is the induction
of deleterious health effects in [people]. Comparable levels of impact undoubtedly exist
in other biota, but there is no present evidence that there is any biological species whose
sensitivity is sufficiently high to warrant a greater level of protection than that adequate
for [people].27
Similarly, the International Commission on Radiological Protection (ICRP) has stated as part of its
recommended objectives that:
Although the principal objective of radiation protection is the achievement and
maintenance of appropriately safe conditions for activities involving human exposure, the
level of safety required for the protection of all human individuals is thought likely to be
adequate to protect other species, although not necessarily individual members of those
species. The Commission therefore believes that if [people are] adequately protected then
other living things are also likely to be sufficiently protected.28
^Habicht (1992)
""Risk Assessment Guidance for Superfund: Volume I—Human Health Evaluation Manual (Part A,
Baseline Risk Assessment)," Interim Final, EPA Office of Emergency and Remedial Response, EPA/540/1-
89-002, December 1989.
2eMemorandum from John Thomas, DynCorp-Viar, to Jim Konz, EPA/Toxics Integration Branch,
March 26, 1993.
27"The Effects on Population Exposure to Low Levels of Ionizing Radiation," Report of the Advisory
Committee on the Biological Effects of Ionizing Radiation, National Research Council, National Academy
of Sciences, November 1972.
28"Recommendations of the International Commission on Radiological Protection," ICRP Publication
26, January 1977.
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In a more recent study requested by DOE, the National Council on Radiation Protection and
Measurements (NCRP) reviewed the literature on how radiation affects aquatic organisms. Based on this
review, and on estimates of radiation dose rates to aquatic biota calculated using a combination of aquatic
pathways for the total exposures of 100 mrem per year, NCRP concluded:
[Our] estimates indicate that the ICRP statement, "if man is adequately protected then
other living things are also likely to be sufficiently protected," is reasonable, at least
within the generic scenario considered here.29
Based on these conclusions, there may be a technical basis for focusing on human health risks in
the development and implementation of the radiation site cleanup regulations.
This is not necessarily the case, however, for nonradioactive chemicals. In the proposed RCRA
corrective action rule, for example, EPA took a different position for nonradioactive hazardous wastes by
stating that:
There may be instances where adverse environmental effects may occur at or below levels
that are protective of public health. Sensitive ecosystems (e.g., wetlands) or threatened
or endangered species or habitats that may be affected by releases of hazardous waste or
constituents should be considered in establishing media cleanup standards. The Agency
plans to develop guidance on evaluating ecological impacts. Until more substantive
guidance is developed, the Agency intends to determine on a case-by-case basis when
standards must be established at lower concentrations [e.g., at the lower end of the risk
range] to protect sensitive ecosystems or environmental receptors.30
2.7 Time Frame to be Considered
In calculating individual doses to verify compliance with regulations, the radiation community
traditionally has assumed that an individual is exposed to the source of radiation over his or her entire
lifetime (approximately 70 years, on average). The EPA Superfund program, however, recognizes that
individuals do not spend their entire lives living at the same location. Accordingly, the Superfund risk
assessment guidance31 recommends that, in lieu of site-specific information to the contrary, risk assessors
assume that members of the general public are exposed for 350 days per year for 30 years when evaluating
future residential, agricultural, and recreational land use scenarios for contaminated sites. For future
commercial/industrial scenarios, the guidance recommends that risk assessors assume a worker is exposed
for 250 days per year for 25 years. Should an approach that considers different exposure time frames for
different land use scenarios be used in developing and implementing the radiation site cleanup regulations?
29"Effects of Ionizing Radiation on Aquatic Organisms," Recommendations of the National Council
on Radiation Protection and Measurements, NCRP Report No. 109, August 30,1991.
X55 FR 30827
31"Human Health Evaluation Manual, Supplemental Guidance: Standardized Default Exposure
Factors," EPA Office of Solid Waste and Emergency Response, Toxics Integration Branch, OSWER
Directive 9285.6-03, March 25,1991.
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Another time frame-related issue is whether multiple-generation exposure to radiation should be
considered and, if so, how. When developing regulations to protect entire populations, it may be
appropriate to consider exposures to multiple generations—especially for sites contaminated with long-
lived radionuclides. Given the residual levels of long-lived radionuclides and the growth of their decay
products, the health of several successive generations may be affected; and it may be appropriate to protect
them. Some radiation protection regulations (such as the EPA proposed high-level waste regulations in
40 CFR Part 191) are designed to protect human health and the environment for 10,000 years. Of course,
uncertainty increases significantly as the time frame extends so far into the future.
2.8 Measurement and Modeling Techniques
The availability of measurement and modeling techniques to demonstrate compliance with cleanup
levels is an important consideration. As noted above, it is not clear that available measurement techniques
are sufficiently sensitive to demonstrate compliance with a 10"6 radiation risk limit.
Selecting appropriate models to determine the extent of cleanup required to achieve desired
cleanup levels also is important. Several models (e.g., PRESTO32 and RESRAD33) are available for
direct use or adaptation to the requirements of radiation cleanup regulations. Because different models
are based on different assumptions regarding exposure levels and pathways of concern, their results can
vary significantly. Developing procedures and criteria to help standardize dose and risk estimates may
be necessary. Key questions to be addressed include: How would uncertainties be handled? Should site
owners/operators have the freedom to choose and apply pathway models on their own, or should EPA
prescribe models and procedures?
2.9 Technological Feasibility
The feasibility of any cleanup approach will depend on the availability of technologies that can
achieve the desired cleanup levels. In 1990, the EPA Office of Emergency and Remedial Response
(OERR) and the Office of Radiation and Indoor Air (ORIA) jointly reviewed technologies that could be
used to remediate soil, water, and structures at 25 Superfund sites contaminated with radioactive
materials.34 They evaluated the reliability, effectiveness, and development status of the technologies.
Their review showed that a number of technologies show potential for addressing radioactive
contamination and merit further study. The remediation technologies include soil washing, chemical
extraction, physical screening, classification, gravity concentration, flotation, vitrification, and
solidification. In addition, a joint ORIA - EPA Control Technology Center report indicates that
32"Low-Level and NARM Radioactive Wastes, Model Documentation, PRESTO-EPA-CPG,
Methodology and Users Manual," EPA Office of Radiation Programs, EPA 520/1-87-026, December 1987.
33Gilbert, T.L., MJ. Musko, K.F. Eckerman, W.R. Hanson, W.E. Kennedy, Jr., B.A. Napier, and J.K.
Soldat. "A Manual for Implementing Residual Radioactive Material Guidelines," January 1988. For U.S.
Department of Energy.
3411 Assessment of Technologies for the Remediation of Radioactively Contaminated Superfund Sites,"
EPA Office of Solid Waste and Emergency Response and Office of Radiation Programs, EPA/540/2-
90/001, January 1990.
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incineration of radioactive and mixed waste, used as a volume-reduction process, is a viable treatment
technology.35
DOE and EPA continue to test and evaluate the applicability of a number of technologies for
radioactive contamination problems. As EPA develops its radiation site cleanup regulations, additional
data on the performance and cost of technologies appropriate for addressing different types of radioactive
contamination problems will become available.
^"Background Document on Radioactive and Mixed Waste Incineration: Volume I - Technology,"
EPA 520/1-91-010-1, May 1991.
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Chapter 3
Regulatory Approaches
EPA is considering four basic approaches for the cleanup regulations:
1. Establishing a dose or risk limit.
2. Requiring the use of a "lookup table" of radionuclide- and medium-specific concentrations that
would specify cleanup standards applicable to all sites.
3. Requiring the use of a lookup table and a pathway model to calculate cleanup levels site by
site hi response to site-specific conditions.
4. Recommending specific technologies to be employed in radiation site cleanups.
From a site owner's point of view, the four approaches span a range from flexible to restrictive.
Figure 1 shows the relative flexibility of each approach. A dose or risk limit would be the least
prescriptive; it would define an overall health-based goal to be achieved, but would provide site owners
with complete flexibility in deciding how to meet that goal. At the other end of the spectrum, the
regulations could specify the technologies that must be used in radiation site cleanup. This approach
would leave little room for flexibility in
cleanup work.
Whatever approach the Agency
finally chooses will be used to achieve
risk- or health-based cleanup levels de-
signed to protect the public and the envi-
ronment. The Agency also will provide
opportunity for the public to participate in
the approach selection process because
public acceptance of, and support for, the
selected approach is critical.
Least
Prescriptive
Dose/Risk
Limit
Table of
Concentrations
and Pathways
Model
Table of
Concentrations
Most
Prescriptive
Cleanup
Technologies
Figure 1 Spectrum of Regulatory Approaches
To provide a framework in which to begin considering the approaches, Table 2 presents six
preliminary evaluation criteria. At this early stage, rigorously evaluating each approach against each
criterion is difficult; the approaches need to be refined, and more information needs to be gathered. Once
EPA has resolved such outstanding issues as the acceptable risk level, the expected future uses of remedi-
ated sites, and the particular radionuclides and pathways to be considered, the Agency will continue its
analysis and will consider additional criteria as appropriate.36 Until then, tradeoffs between the
36The Agency plans to evaluate potentially favorable approaches against criteria in addition to those
listed hi Table 2. Examples include exposures to remediation workers and waste management implications
(i.e., the different types and quantities of wastes that may be generated under different clean-up
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approaches can be evaluated only in a general way to support preliminary decisions and the selections of
promising approaches that warrant further analysis.
Table 2
Preliminary Criteria for Evaluating Regulatory Approaches
Criterion
Ability to promulgate
Ability to implement
and enforce
Compatibility with
current environmental
regulations
Costs
Coverage of
NARM/NORM-
contaminatod waste
Coverage of mixed
waste
Description
There may be important tradeoffs between the approaches in terms of the availability of
information and models needed to develop technically sound regulations.
Once cleanup regulations are promulgated, the government and regulated community must
be able to implement and enforce it effectively. Major issues that have a bearing on the
ability to implement and enforce a given regulatory approach include technical feasibility
(such as the suitability of available technologies, measurement techniques, and risk models)
and resource demands (such as required personnel skills and the need for training,
guidance, and outreach).
Compatibility with other environmental radiation protection regulations and programs is
desirable, because EPA cleanup regulations would apply to NRC licensees, DOE installa-
tions, and additional sites under the purview of other government agencies.
The potential economic costs associated with each regulatory approach will vary consider-
ably depending on the. levels of protection. Costs may be defined in terms of human and
monetary resources, the time required to clean up sites, or the technical effort required to
achieve the desired cleanup objectives. In general, as cleanup levels are reduced, costs
increase.
Existing regulatory controls for NARM/NORM-contaminated waste are inconsistent and non-
uniform. Covering NARM/NORM-contaminated waste in the cleanup regulations, therefore,
may provide an opportunity to standardize radiation protection in this area.
Mixed waste is of special interest because a large fraction of the radioactive waste at sites
that require cleanup is mixed with non-radioactive hazardous waste. The combined
radiation and chemical threat associated with mixed waste is also a special concern that
could be addressed in the cleanup regulations.
Table 3 compares each of the four approaches EPA is considering with the six evaluation criteria
presented in Table 2. The following sections discuss each approach in turn. They cover the major issues
that would have to be resolved if an approach were selected and its major advantages and disadvantages.
Although not explicitly addressed in this paper, EPA could choose to combine two or more approaches
to create additional ones.
approaches). Insufficient information is currently available to evaluate the approaches against these other
criteria.
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Table 3
Comparison of Regulatory Approaches
Regulatory Approach
Dose or Risk Limit
Look-Up Table
Look-Up Table & Pathways Model
Technology Requirement
Criterion
Ability to
Promulgate
Easy
Difficult
More
Difficult
Most Difficult
Ability to
Implement
and Enforce
Most Difficult
Easy
Difficult
Easy
Compatibility
With Current
Environmental
Regulations
Most
Consistent
Consistent
Consistent
Least
Consistent
Costs
Most
Expensive
Expensive
More
Expensive
Least
Expensive
Coverage
of NORM'
Yes
Yes
Yes
Yes
Coverage
of Mixed
Waste*
No (if dose)
Yes (if risk)
No
No
Yes
8 "Yes" means an approach could easily accommodate NORM contaminants and/or non-radioactive chemicals if such contaminants
are to be included within the scope of the cleanup regulations. "No" means that an approach could not easily accommodate such
contaminants, even if they are covered by the regulations.
3.1 Dose or Risk Limit
EPA's cleanup regulations could take the form of a dose or risk limit. For example, the
regulations could require that land be cleaned up in a manner that ensures people will not receive a given
radiation dose, expressed in millirems per year and that a given radiation dose would correspond to an
acceptable lifetime cancer incidence risk. Or, since for regulatory purposes EPA assumes a simple linear
relationship between radiation dose and cancer risk, the regulations could express the allowable exposure
level in terms of a lifetime cancer incidence risk, such as 1 x 10"*. The Agency could specify a single
dose or risk limit or a range of limits, like the 1 xlO"4 to 1 x W6 used in Superfund. Having specified
a dose or risk limit, the regulations would leave open-ended the exact nature and extent of cleanup
activities—so long as compliance with the limit could be demonstrated.
Three major issues are associated with this approach. First, EPA would have to determine the
appropriate dose or risk level. As discussed in section 2.1, there are several precedents for dose limits,
ranging from 4 mrem/year (2 x 10"4 cancer risk) to 100 mrem/year (4 x 10"3 cancer risk). The risk levels
used in selecting remedies under CERCLA are lower, ranging from 1 x 10"6 to 1 x 10"4 excess lifetime
cancer incidence risk.
Second, EPA would have to decide whether the dose or risk limit would apply to individuals,
entire populations, or both. (Issues associated with these choices were discussed in section 2.5.) Third,
the Agency would have to consider whether to express the limit as a radiation dose or a cancer risk.
Radiation standards traditionally have been expressed as an acceptable dose rather than a risk; most RCRA
and CERCLA standards for protection from exposure to hazardous substances, however, are expressed in
terms of acceptable risk or risk range.
A risk limit offers two important advantages over an acceptable limit on dose:
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• If dose-to-risk conversion factors change, as they have in the past, a future revision to the
standard would not be necessary.
• A risk limit could be applied to mixed-waste sites to limit the combined cancer risk from
exposure to radiation and to nonradioactive chemicals, since exposure to radiation and to
chemical carcinogens is additive.37
An issue unique to a risk-based approach is whether to consider nonfatal as well as fatal cancers
when determining an acceptable risk level. The precedents regarding this issue are varied. International
and NRC radiation protection guidance consider only fatal cancers; CERCLA considers both types.
A dose or risk limit approach to regulation has a number of advantages:
• The process of developing regulations consisting of only a dose or risk limit would be
straightforward. EPA simply would have to determine an acceptable level or range of risk
based on the available evidence. No pathway modeling or other detailed analyses would be
required to determine the level. (Such analysis, however, would still be necessary for purposes
of predicting regulatory impact.)
• Most current radiation standards are expressed in terms of radiation dose, therefore, a dose
limit would be consistent with other radiation regulations. A risk limit would be consistent
with the approach taken under CERCLA and would be generally consistent with existing dose
standards since radiation dose can be easily related to risk.
• A dose or risk limit could be applied to all types of radioactive contamination, including
naturally occurring or accelerator-produced radioactive material (NARM) and naturally
occurring radioactive material (NORM).
The primary disadvantages of this approach include:
• There are potential difficulties in implementing and enforcing regulations that specify only a
dose or risk limit Estimating dose and risk at a specific site often requires substantial
technical understanding and resources. Also, dose or risk modeling requires making numerous
assumptions, and the results may vary significantly under different assumptions. This potential
variability may make enforcement difficult.
• Difficulties in implementation also may make demonstrations of compliance difficult.
• Implementation costs for site owners may be highest under this approach. The process of
estimating doses and risks, translating dose/risk limits into medium- and radionuclide-specific
concentrations, and selecting remedial alternatives can be resource-intensive and can require
substantial technical skills. In addition, the process would have to be performed for every site.
"Addressing the combined risks of radionuclides and chemicals would delay promulgation of the
cleanup regulations and would make the regulations more difficult and expensive to implement. This is
because a combined-risk approach would be more complex technically and would require significant input
from other EPA offices. An approach that attempts to address the combined cancer risk posed by
radionuclides and nonradioactive chemicals at cleanup sites likely would require CERCLA authority.
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3.2 Table of Radionuclide Concentrations
This approach involves development of default exposure scenarios for a generic radioactive site
and the use of an exposure pathways model to "back calculate" medium-specific radionuclide
concentrations that correspond to an acceptable dose or risk. ;Site owners/operators would determine what
radionuclides are present at their sites, men look up the corresponding required cleanup levels in a table.
Depending on the types of sites and number of exposure scenarios and land-use assumptions considered,
EPA might have to generate several radionuclide concentration tables to match different site situations.
There is considerable precedent for such an approach. In EPA regulations, 40 CFR Part 192
establishes acceptable concentrations of radium in soil at uranium mill tailings sites; 40 CFR Part 141
specifies maximum levels for contaminants, including radionuclides, in drinking water; and 40 CFR Part
302 lists quantities of radionuclides reportable under CERCLA, which are based on medium-specific
pathway modeling conducted by EPA. In its hazardous waste program, EPA has proposed contaminant-
specific concentrations in land, water, and air for corrective action at RCRA facilities.38 NRC radiation
protection regulations in 10 CFR Part 20 (Appendix B) also list radionuclide-specific reference levels for
air and water. Similarly, NRC Regulatory Guide 1.8639 provides a lookup table of surface contamination
limits for classes of radionuclides.
EPA selection of appropriate exposure scenarios and models to derive radionuclide concentrations
is a major issue associated with this approach. The scenarios and models would have to be reasonable,
yet protective of human health and the environment across the wide range of contaminated sites. (See
Appendix A for a discussion of the various site-specific conditions and expected exposure pathways.)
Because radionuclide concentration limits are used in other regulatory programs inside and outside
the Agency, EPA plans to examine the underlying assumptions and methods used in such rules and
guidance to ensure appropriate consistency. Fof example, the Agency could develop radionuclide
concentrations for the cleanup regulations by using current concentration-to-dose conversion factors
developed for other programs. EPA could, for example, combine the dose conversion factors listed in
Federal Guidance Report No. II40 with appropriate exposure assumptions, or it could consider adopting
NRC draft factors for converting radionuclide concentrations to dose.41
Advantages of this approach include:
• EPA could develop and use conservative exposure scenarios and default parameters to derive
radionuclide- and medium-specific concentrations that would be protective of human heath and
the environment in most, if not all, circumstances.
38Corrective Action for Solid Waste Management Units at Hazardous Waste Management Facilities,
Proposed Rule, 55 FR 30798, July 27, 1990.
^"Termination of Operating Licenses for Nuclear Reactors," June 1974.
'""Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for
Inhalation, Submersion, and Ingestion," Federal Guidance Report No. 11, Prepared for the EPA Office of
Radiation Programs by Oak Ridge National Laboratory, EPA-520/1-88-02, September 1988.
4l"Residual Radioactive Contamination from Decommissioning, Technical Basis for Translating
Contamination Levels to Annual Dose," Draft Report for Comment, Prepared for NRC Office of Nuclear
Regulatory Research by Pacific Northwest Laboratory, NUREG/CR-5512, PNL-7212, August 1992.
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• It would be easier to implement than would a dose or risk limit. Radiation site cleanups
would have to attain concentrations clearly specified in a table, regardless of individual site
characteristics. Environmental sampling would be necessary to demonstrate attainment of the
required concentrations, but pathway modeling and numerous assumptions at individual sites
would be unnecessary.
• This approach would be consistent with many current radiation protection standards.
• EPA could use this approach to address all categories of radioactive materials and wastes at
sites, including naturally occurring radionuclides and radionuclides controlled under the
Atomic Energy Act (AEA).
• This approach could be incorporated into the current CERCLA process without reducing its
flexibility.
Disadvantages of this approach include:
• The conservative hypothetical modeling required to develop concentration limits for a diverse
range of sites could result in limits that may be unnecessarily low for some sites (i.e., the
hypothetical modeling exposure conditions used in the modeling might be very different from
the actual conditions at some sites).
• A table of radionuclide concentrations that would apply to all sites would be more difficult
for the Agency to develop than would a dose or risk limit.
* A look-up table would not cover the combined cancer risks of radionuclides and chemicals at
mixed-waste sites. To address this combined risk, a parallel table of chemical-specific
concentrations also would have to be adapted or developed.
3.3 Table of Radionuclide Concentrations Combined With a Pathway Model
This regulatory approach combines a table of generic radionuclide- and medium-specific
concentrations as described above with a standardized pathway model to derive concentrations site by site.
Under this approach, EPA would develop equations and initial exposure assumptions and parameters that
site owners/operators could use to derive site-specific cleanup levels. The table and pathway model could
be used in a tiered fashion: either the standard default concentrations in the table could be used or the
pathway model could be used to calculate site-specific concentrations.
Pathway models have been used in radiation protection. The airborne emission limits for
radionuclides (40 CFR Part 61), for example, allow the use of a table of release quantities and specify the
use of the COMPLY model in demonstrating compliance.42 Several NRC regulations are implemented
using Regulatory Guides that recommend procedures and equations for calculating site-specific doses and
^"User's Guide for the COMPLY Code," EPA Office of Radiation Programs, EPA/520/1-89-003,
October 1989.
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concentrations.43 Although EPA and NRC allow the use of "equivalent" models, the specified models
almost always are used to avoid the costs of demonstrating equivalence.
Perhaps the most relevant use of pathway modeling is in EPA risk assessment guidance for
Superfund sites.44 This guidance outlines procedures for calculating "preliminary remediation goals" for
radionuclides in all environmental media and for most conceivable exposure pathways.
The primary advantages of a combined lookup table and pathway model include:
• Radionuclide concentrations could be derived by using standardized equations with inputs that
reflect actual site conditions. Unlike the use of a lookup table alone, this approach would
avoid the possibility that concentrations would be unnecessarily low or high given site-specific
conditions.
• The pathway model would provide specific procedures for translating radionuclide
concentrations into doses and risks. This would make implementation easier and would lead
to less variability, uncertainty, and inaccuracy than would specifying a dose or risk limit alone.
• The use of a pathway model would be consistent with the approaches taken in several other
radioactive waste and hazardous materials programs.
• A lookup table and pathway model could address all categories of radioactive materials and
wastes at sites, including radionuclides controlled under the AEA and naturally occurring
radionuclides.
The disadvantages of this approach include:
• It may be more difficult to develop than would a dose or risk limit or a table of radionuclide
concentrations alone. Besides determining an acceptable dose or risk limit and developing a
table of corresponding radionuclide concentrations, EPA would have to provide detailed
guidance on how to develop site-specific concentrations to be used in place of the ..table.
concentrations. (This additional effort may be reduced, however, if EPA can use an existing
model or guidance with little or no modification.)
• It may be more difficult to implement than would a table of radionuclide concentrations alone,
depending on how much site-specific modeling is conducted. This approach may impose
higher burdens and costs than would a concentration table approach alone, which would
require only environmental sampling. This approach also might be more difficult to enforce
than would a concentration table alone because more effort and expertise would be required
to review the pathways analysis.
43For example, Regulatory Guide 1.109 establishes procedures for NRC licensees to use in calculating
annual doses to members of the public resulting from routine releases of reactor effluents for the purpose
of evaluating compliance with 10 CFR Part 50.
^"Risk Assessment Guidance for Superfund: Volume I — Human Health Evaluation Manual (Part
B, Development of Risk-based Preliminary Reduction Goals)," Interim Final, EPA Office of Emergency
and Remedial Response, Publication 9285.7-01B, October 1991.
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• A comparable model for estimating the combined cancer risks of exposure to radiation and
nonradioactive chemicals would have to be found or developed should the Agency decide to
consider additive risks under this approach.
3.4 Technology-Based Approach
EPA could promulgate cleanup regulations lhat require the use of best available control
technology. This approach would link the technology requirement to a risk-based standard to ensure that
technologies are used in ways that ensure protection of human health and the environment. As indicated
in Chapter 2, EPA has two basic ways to pursue a technology-based approach. The Agency could require:
• Use of specific technologies that have been shown to be effective in cleaning up certain types
of radioactive contamination.
• Sites to meet cleanup standards (which could be concentration limits) that are known to be
achievable based on the performance of certain technologies. (This would provide greater
flexibility in selecting technologies based on site-specific conditions.)
The EPA approach under the RCRA land disposal restrictions (LDR) program is a combination
of the two. The Agency prefers to set treatment levels (i.e., concentration limits) whenever possible,
because the effectiveness of a technology standard depends on how well the technologies are operated.
When EPA lacks sufficient data to set treatment levels for certain wastes, however, the Agency specifies
a technology as the treatment standard.45
Many other EPA programs also use technology-based approaches. Under Section 111 of the Clean
Air Act (CAA), for example, EPA establishes New Source Performance Standards (NSPS) that reflect the
emissions reductions possible through the use of the best achievable control technology. The technology
must have been adequately "demonstrated," or proven in use, and its costs and other impacts also must
be considered. The drinking water program also uses technology-based standards such as "best available
technology" or BAT. National Pollutant Discharge Elimination System (NPDES) permits require facilities
to install end-of-pipe controls to reduce pollutant discharges to specific levels, which are based on the
performance of control technology rather than on health risk. DOE includes the BAT concept in addition
to health-based dose limits and ALARA process requirements in DOE 5400.5 and proposed in 10 CFR
834.
Selection of a technology-based approach would require the Agency to:
• Develop criteria for assessing current technologies.
• Evaluate the effectiveness of current technologies.
• Determine the best way to express the technology-based cleanup standard (either as a
requirement to use a specific technology or as a requirement to meet a concentration level
based on the known performance of certain technologies).
^"Implementing the LDR: Q&A Document," EPA Office of Solid Waste and Emergency Response,
October 1989, p. 1.2.
24
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• Select the standard.
Perhaps most important, EPA would need to determine whether current technologies sufficiently protect
human health and the environment. In determining how best to express the requirement, EPA would have
to decide whether the Agency or site owners/operators should determine which technologies are to be
used. The Agency also would have to decide how the regulations would accommodate future advances
in technology.
The primary advantages of a technology-based approach include:
• It would be easy to implement, demonstrate compliance with, and enforce because the required
cleanup methods would be spelled out clearly.
• It could be developed to apply to all types of radionuclides, including NARM/NORM, and to
nonradioactive chemicals.
The primary disadvantages of such an approach include:
• It might be the most difficult to promulgate of all the approaches discussed in this paper
because EPA initially would need to undertake an enormous amount of analysis and study to
determine an appropriate range of technologies, given the wide variation in types of
radioactive contamination problems.
• It would require EPA to spend considerable effort keeping abreast of technological advances
and keeping the regulations up to date.
• It would not allow cleanup actions to be tailored to site-specific conditions, which are likely
to vary greatly.
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Chapter 4
Summary and Next Steps
4.1 Summary
This issues paper, including Appendixes A and B, discussed the issues, alternative regulatory
approaches, and preliminary analyses relevant for Agency development of radiation site cleanup
regulations. Among the significant issues are:
• Which statute, or combination of statutes, should be used as the basis for EPA radiation site
cleanup regulations?
• What is an acceptable cleanup level and how should it be determined?
• What consideration should be given to future land use when specifying cleanup levels?
• How should additive risks be handled?
• Who should the regulations protect—individual, whole populations or both? Populations
especially sensitive to radiation? The general public, remediation workers, or both?
• How should the regulations ensure protection of people and the environment?
• What time frame should be considered when calculating individual doses?
• Are available measuring and modeling techniques adequate to support the regulations?
• Are technologies available to achieve specified cleanup levels?
The paper also discussed four regulatory approaches currently under consideration by EPA.
From the site owner's point of view, these four approaches range from flexible to prescriptive. They are:
• Establishing a dose or risk limit.
• Requiring the use of a lookup table of radionuclide- and medium-specific concentrations and
pathway modeling to calculate cleanup levels based on individual site conditions.
• Requiring the use of a "lookup table" that would specify cleanup levels that apply to all
regulated sites.
• Recommending specific technologies to be employed in radiation site cleanups.
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Whichever approach EPA finally chooses will be used to achieve risk- or health-based cleanup
levels designed to protect the public and the environment. As the Agency develops its radiation site
cleanup regulations, it will provide opportunity for the public to participate in the approach selection
process, since public acceptance and support will be critical to its successful implementation. The public
also will be given opportunity to participate hi the site-by-site decisionmaking process. Public
participation also will help focus the process on environmental justice concerns.
4.2 Next Steps
EPA is committed to moving forward with the rulemaking as expeditiously as possible,
coordinating with all interested parties, as follows:
• The public will have opportunity to review and comment on supporting EPA documents.
• EPA also will coordinate with other federal agencies, state and local governments, Native
American tribes, environmental groups, and industry and trade associations.
• The Agency is establishing a subcommittee under the auspices of the National Advisory
Council for Environmental Policy and Technology (NACEPT). Chartered under the Federal
Advisory Committee Act, NACEPT provides environmental policy information and advice to
the EPA Administrator and other Agency officials. To ensure balanced representation and a
wide range of viewpoints, the NACEPT subcommittee will comprise representatives of various
governmental agencies, industry, and public interest groups.
• EPA also is coordinating its regulatory development activities with the NRC, DOE, and DoD.
These agencies face several of the same steps during cleanup, and each step represents many
technical challenges. All four agencies understand the advantages of a unified approach to
meeting these challenges that combines the best scientific and technical resources and
experiences of each agency. EPA intends to coordinate this federal effort and to ensure that
all facets of the technical implementation guidance are based on scientifically sound and
technologically feasible principles and methods.
• EPA is cooperating with NRC efforts to codify radiological criteria for decommissioning
NRC-licensed facilities. Under the terms of an MOU with the NRC, EPA will "endeavor to
resolve issues of concern to both agencies that relate to the regulation of radionuclides in the
environment." If EPA determines that the NRC regulatory program achieves a sufficient level
of protection of the public health and the environment, EPA will propose in the Federal
Register that NRC licenseholders be exempted from EPA radiation site cleanup regulations.
EPA believes this dual-track approach provides the best means of ensuring consistency
between EPA cleanup regulations and NRC decommissioning standards.
In addition, EPA is preparing a Background Information Document (BID) to support the
development of its radiation site cleanup regulations. Among the topics to be covered by the BID are:
• Radiation site characteristics.
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• Current regulatory cleanup programs and strategies, and a summary baseline analysis of
current cleanup practices.
• Risk assessment and multimedia pathway modeling analyses.
• Evaluation of current remediation technologies and methodologies.
Much of the information generated for the BID also will be used in the preparation of a
Regulatory Impact Analysis (RIA), which will quantify the costs and benefits of the regulations developed
by EPA.
EPA invites comments on this issues paper from the general public and from other federal
agencies, state and local governments, American Indian Tribes, environmental groups, and industry and
trade associations. The Agency requests that comments be submitted by November 15,1993. Comments
should be submitted, in duplicate, to the docket clerk at this address:
U.S. Environmental Protection Agency
Mail Stop LE-131
Air Docket No. A-93-27
RoomM-1500
First Floor Waterside Mall
401 M Street, S.W.
Washington, DC 20460
The docket is open from 8:30 a.m. to noon and from 1:30 p.m. to 3:30 p.m., Monday through Friday,
excluding federal holidays. A reasonable fee may be charged for copies of docket materials.
Further information on other rulemaking activities and documents is available from EPA's
Superfund/RCRA Hotline, 800 424-9346 from outside the Washington, DC area and 703 412-9810 within
the Washington area. The Cleanup Regulation Electronic Bulletin Board is another source of information.
To access the bulletin board, call 800 700-STDS (800 700-7837) outside the Washington area and 703
790-0825 locally.
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Appendix A
Background
Understanding current radiation protection programs is a complex task. Although primarily the
responsibility of the federal government, regulations currently are written at many different levels of
government, each using its own terms and implementing its own requirements. Several federal agencies
administer radiation protection programs, and many of these programs overlap, further complicating
matters. Further, the technical issues involved make understanding radiation protection programs even
more intricate.
To help simplify things, this appendix briefly describes the:
• Different categories of radioactive materials and wastes that may be subject to EPA cleanup
regulations.
• Type and number of sites contaminated with radioactive materials may be subject to the
cleanup regulations.
• Current authorities and roles of government agencies for responding to these sites.
• Regulations and programs being implemented by the different agencies.
Appendix B briefly compares and evaluates the four statutes available to EPA as authority for its radiation
site cleanup regulations.
A.1 Radioactive Materials and Wastes
For the purposes of this paper, "radioactive" refers to any material that contains, in whole or in
part, elements that spontaneously undergo nuclear transformations. Such elements are called radionuclides.
Radioactive materials, and the waste and contamination often associated with their production and use,
generally are categorized by their origin or composition. (They may, however, also be classified by their
level of radioactivity.) The principal categories of radioactive materials subject to regulation are defined
by statute, although a number of different, interchangeable terms are often used in practice.
Radioactivity is a process in which the nucleus of an atom spontaneously undergoes a nuclear
transformation, releasing one or more types of ionizing radiation. Radiation emitted by radioactive
substances can transfer sufficient localized energy to atoms to remove electrons from the electric field of
their nucleus (ionization). In living tissue this energy transfer can destroy cellular constituents and
produce electrically charged molecules (i.e., free radicals). Extensive biological damage can lead to
adverse health effects. The type of ionizing radiation emitted by a particular radionuclide depends on the
exact nature of the nuclear transformation, and may include emission of alpha particles, electrons (beta
particles or positrons), and neutrons; each of these transformations may be accompanied by emission of
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photons (gamma radiation or x-rays). Each type of radiation differs in its physical characteristics and in
its ability to inflict damage to biological tissue. These characteristics and effects are summarized below.
• Alpha particles are doubly charged cations, composed of two protons and two neutrons, which
are ejected monoenergetically from the nucleus of an atom when the neutron-to-proton ratio
is too low. Because of their relatively large mass and charge, alpha particles tend to ionize
nearby atoms quite readily, expending their energy in short distances. Alpha particles will
usually not penetrate an ordinary sheet of paper or the outer layer of skin. Consequently,
alpha particles represent a significant hazard only when taken into the body, where their
energy is completely absorbed by small volumes of tissues.
• Beta particles are electrons ejected at high speeds from the nucleus of an unstable atom when
a neutron spontaneously converts to a proton and an electron. Unlike alpha particles, beta
particles are not emitted with discrete energies but are ejected from the nucleus over a
continuous energy spectrum. Beta particles are smaller than alpha particles, carry a single
negative charge, and possess a lower specific ionization potential. Unshielded beta sources
can constitute external hazards if the beta radiation is within a few centimeters of exposed skin
surfaces and if the beta energy is greater than 70 keV. Beta sources shielded with certain
metallic materials may produce low energy x-ray radiation which may also contribute to the
external radiation exposure. Internally, beta particles have a much greater range than alpha
particles in tissue. However, because they cause fewer ionizations per unit path length, beta
particles deposit much less energy to small volumes of tissue and, consequently, inflict much
less damage than alpha particles.
• Gamma radiations are photons emitted from the nucleus of a radioactive atom. X-rays, which
are extra-nuclear in origin, are identical in form to gamma rays, but have slightly lower energy
ranges. There are three main ways in which x- and gamma rays interact with matter: the
photoelectric effect, the Compton effect, and pair production. All three processes yield
electrons which then ionize or excite other atoms of the substance. Because of their high
penetration ability, x- and gamma radiations are of most concern as external hazards.
A.1.1 Radioactive Materials
The major categories of radioactive materials used in different regulatory programs are:
Source Material
Special Nuclear Material
Byproduct Material
Naturally Occurring or Accelerator-Produced Radioactive Material (NARM)
Naturally Occurring Radioactive Material (NORM)
Source, special nuclear, and byproduct material are given special status under the Atomic Energy Act
(AEA) because they are uniquely associated with atomic energy production; consequently, they are often
referred to as "AEA materials." NARM is a catch-all term for radioactive materials not defined by the
AEA, and NORM is a subset of NARM. Although these classifications are commonly used, they are not
mutually exclusive, and that can be a source of confusion. Some source materials, for example, also are
naturally occurring. Table A-l defines the categories as they are used in regulatory programs.
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Table A-l
Categories of Radioactive Material
Category of Radioactive
Material
Definition
Examples of Materials and Uses
Source Material
Uranium or thorium, or any combination thereof,
in any physical or chemical form, or ores that
contain (by weight) 0.05 percent or more of urani-
um, thorium, or any combination of the two.
Unrefined and refined ores from which
thorium, uranium, and other elements are
extracted; and purified materials or by-
products (e.g., depleted uranium) used or
produced in the uranium enrichment and
fuel fabrication process.
Special Nuclear Material
Plutonium, uranium-233, uranium enriched in the
U-233 or U-235 isotope, and any other material
that the Nuclear Regulatory Commission, pursu-
ant to the provisions of section 51 of the Atomic
Energy Act, determines to be special nuclear
material.
Enriched uranium at nuclear fuel fabri-
cation plants, nuclear fuel at reactor
sites, nuclear weapons components, and
purified radiation sources used in re-
search.
Byproduct Material
Any radioactive material (except special nuclear
material) yielded in, or made radioactive by, expo-
sure incident to the process of producing or utiliz-
ing special nuclear material; and the tailings or
wastes produced by the extraction or concentra-
tion of uranium and thorium from ore processed
primarily for its source material content, including
discrete surface wastes resulting from uranium
solution extraction processes. (Underground ore
bodies depleted in uranium by solution extraction
operations do not constitute "byproduct" material
within this definition.)
A wide range of radionuclides used for
medical diagnosis and therapy, research,
and commercial/industrial applications
(e.g., density gauges and well logging
devices); also includes uranium and
thorium mill tailings, which contain
radionuclides very similar to many
NORM wastes, but excludes uranium
and thorium mine tailings. Specific ex-
amples include strontium-90, cesium-
137, cobalt-60, nickel-63, and uranium
and thorium series radionuclides.
Naturally Occurring or
Accelerator-Produced
Radioactive Material
(NARM)
Any radioactive material produced as a result of
nuclear transformations in an accelerator, and any
nuclide that is radioactive in its natural physical
state (i.e., not anthropogenic), excluding source
and special nuclear material.
Numerous radionuclides produced in
accelerators and used for medical and
other purposes; and NORM sources.
Specific examples include cobalt-60,
cobalt-57, manganese-54, sodium-22,
and radium-226.
Naturally Occurring
Radioactive Material
(NORM)
A subset of NARM (i.e., naturally occurring radio-
nuclides excluding source and special nuclear
material).
Radium sources, such as radium nee-
dles, gauges and dials; ores and large-
volume wastes at mining and mineral
processing sites; coal and coal ash; and
radioactive wastes generated during oil
and gas exploration and production.
Radionuclides also can be categorized according to their principal type of radioactive emission:
i.e., alpha, beta, or gamma emitters. This categorization is significant with regard to radiation protection
and public health because the types of emissions represent different types of hazards (e.g., threats via
external exposure and threats via internal exposure, such as through inhalation and ingestion). Finally,
radionuclides are often categorized according to the principal physical and chemical properties that
influence their mobility and behavior in the environment.
A.1.2 Radioactive Wastes
Many different terms are used to refer to categories of radioactive waste. Table A-2 presents and
defines the terms used in various statutes and regulations. This method of grouping radioactive waste is
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sometimes confusing because many of the categories are based on waste origin, not its properties pertinent
to safe management and disposal. In addition, many of the definitions ate ambiguous and overlapping.
Table A-2
Statutory and Regulatory Categories of Radioactive Waste
Category of
Radioactive Waste
Hlgh-Level Waste
(HLW)
Low-Level Waste
(LLW)
Class A, B, C, and
Greater-Than-
C!ass-C (GTCC)
Wastes
Transuranic Waste
(TRU Waste)
AEA Wastes
NARM/NORM
Wastes
Mixed Wastes
Definition
Irradiated reactor fuel; liquid waste resulting from the operation of
the first cyde solvent extraction system, or equivalent, and the
concentrated wastes from subsequent extraction cycles, or equiv-
alent, in a facility reprocessing irradiated reactor fuel; and solids
into which such liquid wastes have been converted.
Radioactive waste not classified as high-level waste, transuranic
waste, spent fuel, or byproduct materials such as uranium and
thorium mill tailings.
LLW categorized according to its radionuclide concentration and
half-life. In general, Class A wastes have the lowest concentra-
tions of particular radionudides. Class B and C wastes contain
radionuclides in higher concentrations. GTCC wastes exceed the
concentration limits established for Class C waste.
Waste containing elements with atomic numbers greater than 92
and half-lives greater than 20 years, in concentrations greater
than 100 nCi/g of alpha-emitting isotopes.
Wastes containing or contaminated with source, byproduct, or
special nuclear material.
Wastes containing or contaminated with any radioactive material
produced as a result of nuclear transformations in an accelerator,
and any nudide that is radioactive in its natural physical state
(i.e., not anthropogenic), excluding source and special nuclear
material.
Hazardous waste as defined by RCRA containing or contami-
nated with source, byproduct, or special nuclear material.
Citation
Nuclear Waste Policy
Act
[10 CFR 60]
Low Level Radioactive
Waste Policy Act
[10 CFR 61]
10 CFR 61
40 CFR 191
Atomic Energy Act
State authority
Federal Facilities Com-
pliance Act of 1992
In general, radioactive wastes are grouped in categories defined by the Nuclear Regulatory
Commission (NRC) regulations governing their management and disposal. High-level and transuranic
waste (HLW and TRU, respectively) are considered more hazardous than low-level wastes (LLW) arid
require more stringent disposal practices. TRU wastes contain certain alpha-emitting radionuclides that
are radiotoxic if inhaled or ingested. They also tend to have long half-lives; for example, the half-lives
of the isotopes uranium-238 and uranium-235 are 4.47 billion years and 704 million years, respectively.
Consequently, TRU wastes are defined as a unique category of radioactive waste requiring special
consideration.
Commercial LLW is subdivided into Class A, Class B, Class C, and Greater-Than-Class-C
(GTCC) wastes based on the NRC regulations that govern their disposal. As the concentrations of
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radionuclides increase from Class A to GTCC, the wastes are considered more hazardous and warrant
increasingly stringent disposal methods.
The U.S. Department of Energy (DOE) manages its waste differently from the NRC. Through
DOE Order 5820.2A, DOE waste management facilities conduct performance assessments to determine
waste acceptance criteria, instead of managing wastes according to NRC generally applicable classes.
DOE waste acceptance criteria are based on the ability of a facility to manage and dispose of the waste
safely; this ability, in turn, depends on site-specific design factors, geological and hydrological conditions,
and other considerations. Waste not meeting the acceptance criteria for a particular disposal site is
considered special case waste. Special case waste must be transferred to a waste management site that
has acceptance criteria matching the waste. DOE 5320.2A recognizes GTCC waste and indicates that
LLW that has radionuclides in concentrations exceeding Class C limits must be handled as special case
waste. Disposal of GTCC waste requires special authorization and must be justified by a National
Environmental Policy Act (NEPA) analysis.
"NARM/NORM waste" is waste contaminated with naturally occurring or accelerator-produced
radionuclides not defined under AEA. EPA is evaluating the need to divide NORM waste into two
groups: discrete NORM waste and diffuse NORM waste. Discrete NORM wastes contain radionuclides
in relatively high concentrations (greater than 2,000 pCi/g), but in small volumes (e.g., radium needles).
Diffuse NORM wastes contain relatively low radionuclide concentrations (less than 2,000 Pci/g), but in
large volume (e.g., radioactive waste generated from oil and gas exploration and production).46 EPA also
is considering the question of 1 l(e)(2) byproduct material, a class of waste comprising uranium and
thorium processing residues that is similar to diffuse NORM waste in radionuclide concentrations and
hazards.
"Mixed waste" is any hazardous waste mixed with AEA waste. The Resource Conservation and
Recovery Act (RCRA) regulations define hazardous waste as any solid waste listed hi Subpart D of 40
CFR Part 261, or that exhibits any of the characteristics of ignitability, reactivity, corrosivity, or toxicity
as described in 40 CFR Part 261 Subpart C. RCRA explicitly excludes source, byproduct, and special
nuclear material (i.e., AEA waste) from the definition of "solid," and therefore "hazardous," waste; but
it does not explicitly exclude NARM/NORM. Mixed waste presents unique waste management challenges
because the radioactive and the chemically hazardous components must be handled and disposed of safely.
Under current regulations, the disposal of mixed waste must satisfy both RCRA and AEA regulatory
requirements.
A.1.3 Radioactive Sites
Although no one knows for certain how many sites are contaminated with radioactive materials,
EPA estimates the number requiring cleanup may be in the thousands. Part of the difficulty in identifying
such sites is that the responsible government agencies lack a uniform, consistent definition of "site."
Even a single agency may have more than one definition. Some programs use "site" to mean specific
areas of contamination at a facility, while other programs use "site" to mean the entire facility. Table A-3
presents some examples of definitions of "site," "facility," and "installation" that have been adopted by
different government agencies to meet the various needs of specific programs or regulations. Reconciling
and consolidating these definitions to derive a clear picture of the number and types of sites that may be
'""Low-Level and NARM Radioactive Wastes, Draft Environmental Impact Statement for Proposed
Rules, Volume 1, Background Information Document," EPA Office of Radiation Programs, EPA 520/1-87-
012-1, June 1988.
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covered by the radiation site cleanup regulations will likely be a major effort associated with regulation
development. This paper uses "site" broadly to refer to the land and facilities that might be subject to the
regulations.
Radioactive sites can be grouped into three main categories according to the agency or agencies
with jurisdiction over them. The categories are:
• Licensees of the Nuclear Regulatory Commission and its Agreement States
• Department of Energy and Department of Defense sites
• Other sites (generally under state or Superfund authority) where naturally occurring or
accelerator-produced radioactive materials have been used
The NRC and its Agreement States (states to which NRC has delegated licensing authority)
currently license about 22,000 facilities for the production and handling of radioactive materials.47 (To
become an Agreement State, a state must have adopted regulations compatible with those of NRC.) About
one-third of the facilities are NRC licensees, and the remainder are licensed by Agreement States under
Section 274 of the AEA. Licensees include power plants, universities, medical facilities, radioactive
source manufacturers, and companies that use radioisotopes for industrial purposes. About 75 percent of
the 22,000 licensed facilities use either sealed radioactive sources or only small amounts of short-lived
radioactive materials. These facilities are unlikely to require cleanup because the radionuclides generally
remain encased and cause little, if any, contamination or they rapidly decay to nonradioactive elements.
A few licensees (e.g., radioactive source manufacturers, radiopharmaceutical makers, and radioactive ore
processors) conduct operations that could result hi substantial radioactive contamination in portions of their
facilities. In addition, about 250 facilities associated with the nuclear fuel cycle48 maintain large
inventories of radioactive materials, and many of these facilities may require cleanup before their licenses
can be terminated.
DOE currently is responsible for cleaning up more than 100 contaminated facilities49 in 36 states
and territories. They include about 45 national laboratories and nuclear weapons production and testing
facilities where environmental restoration and waste management activities are now taking place. Many
are large sites with facilities that have been used for multiple activities related to weapons research,
production, and testing and that have many contaminated areas. Many DOE facilities also have extensive
mixed-waste contaminatioa Several DOE facilities have literally hundreds of areas that are being
investigated and cleaned up separately. For example, the DOE facility in Hanford, Washington,
encompasses 570 square miles and is divided into about 1,100 individual waste sites containing radioactive
and/or hazardous materials. These sites range from 1 square foot to 1,800 acres and have been grouped
into 78 "operable units" based on their waste characteristics or other factors.
47"Nuclear Regulatory Commission Information Digest, 1993 Addition," Office of the Comptroller,
NUREG 1350, Vol. 5, March 1993.
48These include nuclear power plants, nonpower (research and test) reactors, fuel fabrication plants,
uranium hexafluoride production plants, uranium mill facilities, and independent spent fuel storage
installations.
49From the "Mission, Vision, and Objectives" statement (p.8) in the Environmental Restoration and
Waste Management Plan, Fiscal Years 1994-1998, Volume I, U.S. Department of Energy, January 1993.
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In addition, the DOE Formerly Utilized Sites Remedial Action Program (FUSRAP) is responsible
for cleaning up about 30 privately owned sites that were used during the 1940's and 1950's by the former
Atomic Energy Commission and the Manhattan Engineering District for research, processing, and
production of uranium and thorium and for storage of residues. Most of the FUSRAP sites are
contaminated with uranium or depleted uranium (source material), or 1 l(e)(2) byproduct material (uranium
or thorium) processing tailings. The Surplus Facilities Management Program (SFMP) oversees the
environmental restoration of about 30 miscellaneous DOE sites that have been declared surplus to
government needs. Also, approximately 25 inactive uranium mill tailings sites are being addressed under
the Uranium Mill Tailings Remedial Action Project (UMTRAP) established under the Uranium Mill
Tailings Radiation Control Act of 1978 (UMTRCA). EPA would expect its new radiation site cleanup
regulations to apply to all of these DOE sites—except for those being addressed under UMTRAP—since
the UMTRAP sites are being remediated under specific cleanup standards already promulgated by EPA
at 40 CFR Part 192.
The DoD Installation Restoration Program (ERP) comprises more than 17,500 potential hazardous
waste sites at 1,877 installations.50 Only a few of these are known to have radioactive contamination.
Since these sites have not been fully characterized, however, the number of radioactive sites cannot be
estimated reliably. DoD sites vary widely in function and size; they include hospitals and laboratories,
bombing and gunnery practice ranges, weapons manufacturing and storage facilities, and reactors. DoD
sites may contain small enclosed radiation sources, such as radium and tritium instruments; larger sources,
such as research reactors contaminated with fission products; and dispersed sources, such as laboratory
waste storage areas and test ranges.
The thud jurisdictional category includes sites that are not licensed by the NRC or Agreement
States but are under state or Superfund authority. This category includes about 1,000 particle accelerator
sites, which generally contain small amounts of residual radioactivity after shutdown. Other sites in this
category are contaminated with long-lived naturally occurring radionuclides that range from small
packaged sources to large areas of mostly dispersed wastes from mining and ore processing, university
or commercial research, or oil and gas exploration and production.
Almost any of the sites just discussed could be placed on the National Priorities List (NPL), the
EPA roster of high-priority hazardous waste sites eligible for federally funded clean up under the
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The two
exceptions are:
• Current NRC license holders (but not facilities licensed by Agreement States), which are not
listed on the NPL as a matter of policy.51
• Sites being cleaned up by DOE under UMTRAP. (Releases of radioactivity from such sites
are exempted from the definition of "release" under CERCLA.)
As of June 1993, the NPL contained 75 sites contaminated with radioactive material. They included DOE
facilities, Air Force bases, mill tailings sites, processing and disposal sites, commercial landfills, research
facilities, commercial manufacturing facilities, and a former LLW disposal facility. Varying greatly in
size, complexity, and environmental setting, each site poses unique cleanup challenges.
Thomas E., "DoD Environmental Requirements and Priorities," Federal Facilities
Environmental Journal, Autumn 1992.
5148FR 40661
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A.3 Authorities and Roles for Cleanup of Radioactive Sites
A variety of laws authorizes the regulation of radiohuclides to protect human health and the
environment. Table A-4 lists the major relevant federal statutes.
EPA, NRC, DOE, and DoD are the federal agencies with primary regulatory authority for the
cleanup of radioactively contaminated sites. Several other federal agencies, such as the Department of
Transportation (DOT), also have radioactive waste programs, but they generally are more narrow in scope
than those of EPA, NRC, DOE, and DoD. States also may have major roles in site cleanups, The main
functions and jurisdictions of the federal agencies are discussed briefly below:
• EPA authority to protect public health and the environment from the adverse affects of
exposure to ionizing radiation derives from several statutes, including the AEA; the Clean Air
Act (CAA); UMTRCA; the Nuclear Waste Policy Act (NWPA); the Energy Policy Act of
1992; the Low-Level Radioactive Waste Policy Act of 1980, as amended in 1985; CERCLA;
and the Toxic Substances Control Act (TSCA). Major EPA responsibilities in this area
include the development of federal guidance and standards, surveillance of radiation in the
environment, and cleanup of CERCLA sites. Agency authority extends to all types of radio-
active material. Under the AEA, NRC and DOE prepare and enforce regulations that are
consistent with EPA regulations and generally applicable guidance.
• NRC licenses and regulates the possession and use of source, byproduct, and special nuclear
material, primarily by the private sector. The NRC does not license NARM, although NARM
may be subject to NRC regulation when it is associated with material licensed by the NRC.
NRC licensing and regulatory requirements do not apply to most DOE operations or to certain
DoD activities involving nuclear weapons and the use of nuclear reactors for military purposes.
• DOE is responsible for conducting or overseeing radioactive material operations at its
contractor-operated facilities, which compose the largest component of government facilities.
Under its AEA authority and responsibility to protect the public from radioactive materials
used at its production and research-and-development facilities, DOE regulates source,
byproduct, special nuclear material, and NARM through its directive system. DOE also is
responsible for managing several inactive sites that contain radioactive waste, such as sites
associated with the FUSRAP, SFMP, and UMTRAP, as discussed in Section A.2 above.
• DoD, through its Departments of the Army, Navy, and Air Force, controls a large number of
sites in and outside of the continental United States. (DOT controls U.S. Coast Guard
installations.) Most DoD radioactive waste management activities are regulated by NRC, EPA,
or both. Since 1983, the DoD Defense Environmental Restoration Program (DERP) has been
working to restore active and former defense sites.
• DOT has issued regulations that set packaging, labeling, record keeping, and reporting
requirements for the transport of radioactive material (49 CFR Parts 171 - 179). Other federal
agencies, such as the Department of the Interior, also may play a role in certain radiation site
cleanups.
Besides these federal agencies, a number of national and international bodies provide
recommendations on protecting humans from exposure to ionizing radiation. They include the National
Council on Radiation Protection and Measurements (NCRP), the International Commission on Radiological
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Table A-4
Statutory Authorities for Radiation Protection
Legislation or Executive Order
EXECUTIVE ORDER 10831, "Federal Compliance With Pollution Control Standards": Executive Order 10831 charges the
Administrator of the Environmental Protection Agency to "...advise the President with respect to radiation matters, directly or
indirectly affecting health, including guidance for all Federal agencies in the formulation of radiation standards and in the
establishment and execution of programs of cooperation with States.' EPA issues its Federal radiation guidance under this
Order. (Reorganization Plan No. 3 of 1970 transferred to EPA responsibility for promulgating generally applicable radiation
protection standards and the advisory functions of the former Federal Radiation Council.)
ATOMIC ENERGY ACT, AS AMENDED (AEA): The AEA requires the management, processing, and utilization of radioactive
materials In a manner that protects public health and the environment. It is the principal basis for EPA, NRG and DOE
authorities.
COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION, AND LIABILITY ACT (CERCLA): CERCLA, as
amended, authorizes EPA to act, consistent with the national contingency plan, to provide for remedial action in response to
releases or substantial threats of releases of hazardous substances into the environment. Hazardous substances are defined
as any substance designated or listed under the Clean Air Act, the Federal Water Pollution Control Act, the Toxic Substances
Control Act, and the Resource Conservation and Recovery Act. Because the CAA designated radionuclides as a hazardous
air pollutant, the provisions of CERCLA apply to radionuclides.
TOXIC SUBSTANCES CONTROL ACT (TSCA): TSCA regulates the manufacture, distribution in commerce, processing, use,
and disposal of chemical substances and mixtures. Materials defined in the AEA are expressly excluded from TSCA.
However, naturally-occurring and accelerator produced radionuclides are not.
RESOURCE CONSERVATION AND RECOVERY ACT (RCRA): RCRA provides for detailed regulation of hazardous waste
from generation to final disposal. Hazardous waste generators and transporters must comply with EPA standards. Owners
and operators of treatment, storage, or disposal facilities must obtain RCRA permits. Materials defined in the AEA are
expressly excluded from the definition of solid waste, and, thus from regulation under RCRA. Naturally-occurring and
accelerator produced radioactive materials, however, are not.
URANIUM MILL TAILINGS RADIATION CONTROL ACT (UMTRCA): UMTRCA requires stabilization and control of
byproduct materials (primarily mill tailings) at licensed commercial uranium and thorium processing sites. NRG and DOE
Implement standards under this Act.
FEDERAL WATER POLLUTION CONTROL ACT (FWPCA): FWPCA protects the nations's water quality, chiefly through the
use of technology-based effluent limits; the national pollutant discharge elimination system (NPDES) permitting system;
protreatmont requirements for industrial discharges; and toxicity based water quality standards. A 1976 U.S. Supreme Court
opinion held that source, special nuclear, and byproduct material are not pollutants within the meaning of the Act.
CLEAN AIR ACT (CAA): CAA protects and enhances the nation's air quality through national ambient air quality standards,
new source performance standards, and other provisions. Radionuclides are a hazardous air pollutant regulated under
Section 112 of the Act
SAFE DRINKING WATER ACT (SDWA): As amended in 1986, SDWA seeks to protect public water supply systems through
protection of groundwater. Any radioactive substances that may be found in water are regulated under the Act (although the
current regulations specify some individual substances).
NUCLEAR WASTE POLICY ACT (NWPA): The NWPA is intended to provide an orderly scheme for the selection and
development of repositories for high-level radioactive waste and spent nuclear fuel.
LOW LEVEL RADIOACTIVE WASTE POLICY ACT, AS AMENDED (LLRWPA): LLRWPA assigns States responsibility for
ensuring adequate disposal capacity for low-level radioactive waste generated within their borders.
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Protection (ICRP), and the National Academy of Sciences National Research Council (NAS/NRC). The
NCRP was chartered by Congress to collect, analyze, develop, and disseminate information and
recommendations about radiation protection and measurements. The ICRP's function is basically, the
same, but on an international level. The NAS/NRC summarizes available scientific knowledge and
recommendations on radiation protection through its Committee on the Biological Effects of Ionizing
Radiations (BEIR) reports. Although the NCRP, ICRP, and NAS/NRC have no regulatory authority, their
recommendations often serve as the basis for many of the general (i.e., not source-specific) regulations
on radiation protection developed at the federal and state levels. Several professional organizations, such
as the Health Physics Society, also provide nonregulatory guidance and recommendations on radiation
protection and measurement.
Although they often overlap in scope and purpose, the standards, advisories, and guidance of these
various agencies and advisory groups are designed primarily to be consistent with each other.
Nevertheless, there are some important differences between agencies and programs, such as in the radiation
doses that are permitted for members of the general public.
A.4 Current Regulatory Controls
A.4.1 Federal Programs
Very few current standards expressly govern the cleanup of radioactively contaminated sites and
structures. The principal exceptions are health and environmental protection standards for mill tailings
under UMTRCA. Table A-5 summarizes the relevant federal regulatory programs.
A.4.2 State Programs
Each state has its own authority and regulations for managing certain types of radioactive material
and waste. Twenty-nine states (known as Agreement States) have signed agreements with NRC in which
the Commission relinquishes to the state its authority over source, byproduct, and small quantities of
special nuclear material (defined in Section 274 of the AEA). Agreement and Nonagreement States can
regulate NARM, although not all do so.
The Conference of Radiation Control Program Directors (CRCPD) has prepared Part N (fifth draft)
radiation regulations relating to NORM for states to consider. The regulations specify criteria for the
handling and disposition of NORM-contaminated oil and gas production equipment in terms of
concentration and surface contamination limits. Several state agencies also are developing NORM
policies, regulations and requirements. A few examples include:
• The New Jersey Department of Environmental Protection and Energy (NJDEPE) published a
draft document (Jan. 20, 1993) on "Proposed Amendments to NJAC 7:28-11: Generation,
Storage and Disposal Requirements for Radioactive Waste Licensing of Naturally-Occurring
and Accelerator-Produced Radioactive Material." NJDEPE's proposed regulations specify
limits and waste management requirements for concentration and volumes of diffuse and
discrete NORM for four categories of waste generators. The regulations also set a residential
indoor air concentration limit for radon (1 pCi/l above natural background) associated with the
unrestricted release of properties contaminated with NORM soil concentrations of less than
5 pCi/g and waste volumes of less than 100 cubic feet.
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• The Mississippi Department of Health has drafted radiation protection standards for the
possession, use, transfer, transport, storage, and disposal of NORM. These draft regulations
address the introduction of NORM into materials or products; sludge and scale in pipes and
equipment; soil and water contaminated by the cleaning of scale deposits; and waste
generation, management, transfer, and disposal at inactive and active sites involved in storing
and/or treating contaminated pipes and equipment.
• Louisiana has promulgated final regulations, similar to the CRCPD draft regulations. The
Louisiana regulations identify criteria for unrestricted release, which are similar to the
American National Standards Institute recommendations of ANSI N13.12.
• Texas has issued an interim policy establishing guidelines for the handling and disposal of
NORM in pipe scale. The guidelines also address radiation protection measures for workers.
Specific numeric criteria are provided reflecting, in part, the proposed CRCPD NORM
criteria and draft proposed EPA regulations for NORM.
• Illinois and EPA have signed an MOU regarding the management of materials contaminated
with radium. The MOU addresses disposal of such waste in landfill faculties, land spreading,
and for unrestricted use. Eventually, the state plans to address the disposal of NORM waste
in a broader set of regulations covering the disposal of all forms of radioactive waste.
• New Hampshire is modifying existing regulations to address the disposal of water treatment
wastes containing NORM.
• Wisconsin is revising its regulations mat govern the application of radium-contaminated
sludge on agricultural fields. The regulations specify limits on radium concentrations,
frequency, and application rates, and also require that the sludge be analyzed to determine
the presence and levels of NORM.
States and organizations such as the CRCPD also are closely following the ongoing NRC and EPA
activities related to the development of radiation cleanup regulations. EPA is monitoring state activities
in this area as well.
States can become authorized to implement the RCRA program, including the regulation of mixed
waste, by developing a program that is equivalent to or more stringent than the EPA RCRA program. So
far, 32 states and 1 territory have received authorization to regulate mixed waste under RCRA. California
and New Jersey are two of the states that have adopted mixed waste regulatory programs that are more
stringent than the Federal program.
A.4.3 International Programs
The International Atomic Energy Agency (IAEA) has issued Principles for the Exemption of Radiation
Sources and Practices from Regulatory Control (Safety Series No. 89). This guidance states that an
individual effective dose of 1 to 10 mrem per year would result in trivial risks. However, based on the
possibility of multiple exposures from several exempted practices, the guidance recommends an annual
de minimis dose of 1 mrem.
The IAEA also has drafted a technical report titled Criteria for Unrestricted Release of Facilities, Sites
or Materials from Decommissioning, but has delayed its issuance until the technical basis for NRC
decommissioning guidance is complete. In addition, IAEA consultants and an advisory group have held
44
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meetings and are preparing a document titled National Policies and Regulations for Decommissioning
Nuclear Facilities, which is still in the early stages of preparation and is not yet available. Furthermore,
an IAEA advisory group is preparing a document concerning the recycling of contaminated materials titled
Exemption from Regulatory Control: Recommended Unconditional Exempt Levels for Solid Radioactive
Materials.
A.5
EPA Coordination Activities
The current rulemaking effort is not taking place in a vacuum. As noted earlier, several federal
agencies are involved in the regulation of radionuclides. Coordination of the EPA rulemaking effort with
these other agencies is an important part of the current effort.
EPA is working with the Interagency Steering Committee on Radiation Site Cleanup Standards to
ensure that appropriate resources and priority are given to the development of the regulations. The
Director of the EPA Office of Radiation and Indoor Air chairs the committee, which comprises senior
managers from DOE, DoD, NRC, and other EPA program Offices. An Interagency Workgroup is
examining technical issues related to developing and implementing radiation site cleanup regulations.
The Agency will be working with the Conference of Radiation Control Program Directors (CRCPD)
Committee on Decontamination and Decommissioning. EPA is establishing a subcommittee under the
National Advisory Council for Environmental Policy and Technology (NACEPT) to ensure scientific and
technical objectivity and public openness. (NACEPT provides environmental policy information and
advice to the EPA Administrator and other Agency officials.) To ensure a balanced perspective, the
subcommittee will include representatives from government and the private sector. EPA also has
organized an internal workgroup drawn from various program offices to oversee development of the
radiation site cleanup regulations.
EPA also is coordinating its rulemaking with the NRC, which is developing separate regulations
governing the decommissioning of NRC-licensed facilities. A Memorandum of Understanding (MOU)
signed by EPA and NRC on March 16, 1992 discusses NRC authority to develop such regulations and
defines how EPA and NRC will avoid overlapping regulations affecting NRC license holders. If EPA
determines that the NRC regulatory program achieves a sufficient level of protection of the public health
and environment, EPA will propose in the Federal Register that NRC licensees be exempted from the
EPA radiation site cleanup regulations.
EPA and NRC are sharing information received and developed in support of their respective
rulemaking efforts. For example, EPA recently participated in NRC Enhanced Participatory Rulemaking
Workshops. The Agency believes this parallel approach will ensure that its cleanup regulations and NRC
decommissioning standards will be consistent, fully protective of public health and the environment, and
issued as soon as possible.
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Appendix B
Statutory Authorities
As noted in Appendix A, several federal statutes, alone or in combination, could serve as the basis
for EPA's development of radiation site cleanup regulations. This Appendix briefly evaluates and
compares the four statutory authorities that EPA could use to develop these regulations. They are:
• The Atomic Energy Act (AEA) and Reorganization Plan No. 3 of 1970
• The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA),
as amended by the Superfund Amendments and Reauthorization Act (SARA)
• The Resource Conservation and Recovery Act (RCRA), as amended by the Hazardous and
Solid Waste Amendments (HSWA)
• The Toxic Substances Control Act (TSCA)
Medium-specific statutes, such as the Clean Air Act (CAA) and the Safe Drinking Water Act
(SDWA), and contaminant-specific statutes, such as the Uranium Mill Tailings Radiation Control Act
(UMTRCA), are not being considered in detail because they either exclude most radionuclides or cannot
address all media or exposure pathways. Approaches that would combine these statutes to cover all
radionuclides, all media, and all exposure pathways might result in conflicting requirements (e.g.,
regarding acceptable levels of risk) and a patchwork of regulatory controls and oversight. For example,
the CAA airborne emission standards for radionuclides apply to individual source categories (e.g., NRC
licensees) and are based on a dose limit of 10 mrem per year52 (a lifetime cancer risk of roughly 4 x 10"
4). The maximum contaminant levels for radionuclides in drinking water established under the SDWA,
however, are based on a dose limit of 4 mrem per year (a lifetime cancer risk of roughly 2 x 104).
Regulatory approaches using the combined authority of the CAA and SDWA would have to reconcile
these risk differences and, even then, would apply only to certain types of sites.
EPA has developed several criteria to guide its evaluation of the statutory approaches:
• Provides authority to develop radiation site cleanup regulations. This criterion evaluates
the extent to which the statute authorizes EPA to develop radiation site cleanup regulations.
• Applies to the universe of sites contaminated with radionuclides. The universe includes
all federal and nonfederal sites, including Superfund sites, DOE and DoD federal facilities,
NRC and Agreement State licensees, and sites controlled under state authority.
52A11 dose limits are effective dose equivalents (e.d.e.) to the whole body.
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• Considers all radionuclides. "All radionuclides" means source, byproduct, and special
nuclear materials as defined by the AEA, as well as NARM/NORM regardless of their origin
or legal definition.
• Covers multiple media and multiple exposure pathways. This criterion addresses whether
a statute permits the development of regulations covering all contaminated media and all
human and ecological exposure pathways.
• Provides EPA with implementation and enforcement authority. This criterion addresses
whether a statute gives EPA, instead of other agencies, implementation and direct enforcement
authority.
Table B-l provides a broad comparison of the four statutory authorities using the criteria outlined
above. Each statute is described in greater detail below. The discussion of each statute highlights the
major issues that are critical in weighing and comparing the different authorities.
Table B-l
Evaluation of Statutory Authorities
Evaluation Criterion
(1) Provides EPA with au-
thority to develop radiation
site cleanup regulations
(2) Applies to the universe
of sites contaminated with
radioactivity
(3) Considers all
radionuclides
(4) Covers multi-media and
multiple exposure path-
ways.
(5) Provides EPA with im-
plementation and enforce-
ment authority
AEA
Yes. Clear author-
ity to set regula-
tions for certain
types of radioactive
material.
No. Sites contain-
ing NARM/NORM
only may be ex-
cluded.
No. May exclude
NARM/NORM.
Yes.
No. Responsibility
likely to be vested
with NRC and
DOE.
CERCLA
Yes.
Yes. However, EPA
excludes active NRC
licensees and
UMTRAP sites as a
matter of policy.
Yes.
Yes.
Yes.
TSCA
No. TSCA does
not cover AEA
materials.
No. Covers only
NARM/NORM
sites.
No. Excludes
AEA materials.
Yes.
Yes.
RCRA
No. RCRA
does not cover
AEA materials.
No. Applies
only to RCRA
TSD facilities.
No. Excludes
AEA materials.
Yes.
Yes.
B.1 Atomic Energy Act (AEA)
The AEA requires that radioactive materials be managed, processed, and used in a manner that
protects public health and the environment. Traditionally, the AEA has been interpreted as applying only
to the regulation of source, special nuclear, and byproduct materials and not to NARM/NORM.
Under the AEA and Reorganization Plan No. 3 of 1970, EPA is authorized to issue federal
guidance on radiation protection matters as deemed necessary by the Agency or as mandated by Congress.
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This guidance could be issued as regulations, given EPA authority to promulgate generally applicable
radiation protection standards under Reorganization Plan No. 3. (EPA promulgated its environmental
radiation protection standards for nuclear power operations at 40 CFR Part 190, for example, under AEA
authority). Specific advantages and disadvantages of using AEA authority include the following:
Advantages
• The AEA clearly gives EPA authority to develop site cleanup guidance and regulations for
most types of radioactive material.
• EPA's generally applicable standards would be implemented and enforced by federal agencies.
• The regulations could apply to all environmental media and exposure pathways.
• Regulations developed under AEA might be considered applicable or relevant and appropriate
requirements (ARARs) at Superfund sites.53
Disadvantages
• Implementation and enforcement responsibilities would be vested in agencies other than EPA,
such as NRC and DOE. The possibility exists that NRC and DOE might promulgate
inconsistent regulations implementing these requirements.
• Cleanup regulations promulgated under the AEA might not apply to NARM/NORM-
contaminated waste and materials. The Act has been used mainly to regulate source, special
nuclear, and byproduct materials.
B.2 Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA)
CERCLA provides broad federal authority to respond to releases of hazardous substances, which
are defined under the law to include all radionuclides. CERCLA provides that "whenever . . . any
hazardous substance is released or there is a substantial threat of such release into the environment...
the President is authorized to act, consistent with the National Contingency Plan (NCP), to ... provide
for remedial action relating to such hazardous substance." Although EPA has never promulgated a cleanup
regulation under CERCLA, the Agency could develop regulations to extend the NCP definition of
"protective of human health and the environment"—which is currently defined in terms of the remedial
risk range (1&4 to 10"6 lifetime excess risk of cancer incidence)—by establishing clear and measurable
levels applicable to remedial actions at radioactively contaminated sites.
The major advantages and disadvantages of using CERCLA authority for the radiation site cleanup
regulations are as follows:
S3Specific cleanup regulations have not been developed under CERCLA. Instead, CERCLA remedial
actions are required to meet ARARs established under other statutory authorities.
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Advantages
• Cleanup levels could be set for all radionuclides because all radionuclides, including
NARM/NORM, are considered hazardous substances under CERCLA.
• CERCLA applies to all environmental media and exposure pathways, so cleanup levels would
cover multiple media and multiple exposure pathways.
• CERCLA gives EPA comprehensive enforcement mechanisms for implementing cleanup
regulations.
• The cleanup requirements would be binding on all CERCLA cleanups, including those
conducted by other federal agencies.
Disadvantages
• As stated above, with the exception of rulemaking on adjustments to reportable quantities,
EPA has never used CERCLA to develop regulations, preferring instead to use standards
established under other statutory authorities as ARARs for CERCLA remedial actions.
• In accordance with the NRC deferral policy54, active NRC licensees generally are not cleaned
up under CERCLA. In addition, based on the statute's definition of "release," CERCLA
cannot be used to respond to releases of source, byproduct, or special nuclear material at DOE
UMTRAP sites.
B.3 Toxic Substances Control Act (TSCA)
Toxic substances controlled under this Act are defined to exclude source, special nuclear, and
byproduct material as defined in the AEA (Section 3(2)(B) of TSCA). However, EPA might be able to
use TSCA Section 6(a) to set cleanup regulations for diffuse NORM. The Agency has considered using
that section to propose disposal requirements for discrete NORM waste, which currently is not covered
under any other law and which can pose a significant risk of injury to health and the environment if
handled or disposed of improperly. The advantages and disadvantages of basing radiation site cleanup
regulations on TSCA include the following:
Advantages
• TSCA requirements could be applied to federal facilities and to NRC licensees.
• The cleanup levels would cover multiple environmental media and multiple exposure
pathways.
• Cleanup regulations developed under TSCA likely would be considered ARARs under
CERCLA.
• TSCA gives EPA numerous enforcement mechanisms.
"48 FR 40661
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Disadvantages
• TSCA does not cover source, byproduct, and special nuclear material.
B.4 Resource Conservation and Recovery Act (RCRA)
RCRA explicitly excludes the regulation of source, special nuclear, or byproduct material as
defined by the AEA, but not NARM/NORM (RCRA Section 1004(27)). It also does not designate
"radioactivity" as a characteristic of hazardous waste. Therefore, RCRA would need to be amended before
it could be used to develop cleanup regulations for all radionuclides.
Currently, when wastes have hazardous and radioactive components (i.e., the wastes are known
as "mixed waste"), RCRA applies to the nonradioactive components and AEA applies to the radioactive
components. The two laws are not fundamentally inconsistent or incompatible, but when the application
of both regulatory regimes is inconsistent or incompatible, RCRA (Section 1006) defers to AEA.
Problems associated with the regulation of mixed waste, however, are more institutional than legal in
nature. The advantages and disadvantages of using RCRA as the basis for radiation site cleanup
regulations include:
Advantages
• Developing radiation site cleanup regulations under RCRA might help ensure an effective,
coordinated approach to addressing mixed-waste cleanups.
• Cleanup regulations developed under RCRA would cover multiple environmental media and
multiple exposure pathways.
• Cleanup regulations developed under RCRA likely would be considered ARARs under
CERCLA.
• RCRA provides numerous enforcement mechanisms that EPA can use to ensure compliance
with applicable requirements.
Disadvantages
• Source, byproduct, and special nuclear materials under the AEA are not subject to RCRA
regulations. In addition, radioactivity is not considered a defining "characteristic" of
hazardous waste. Therefore, RCRA regulations would need to be amended before they could
be applied to radionuclides.
• RCRA corrective action jurisdiction is limited to facilities defined as "treatment, storage or
disposal" (TSD) facilities under the Act.
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Appendix C
Text of Memorandum of Understanding—Guiding Principles of
EPA/NRC Cooperation and Decisionmaking55
Introduction
The Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC), in
recognition of a mutual commitment to the effective and efficient protection of public health and safety
and the environment, have developed this Memorandum of Understanding in order to establish a basic
framework within which EPA and NRC will endeavor to resolve issues of concern to both agencies that
relate to the regulation of radionuclides in the environment.
Goal
The goal of this Memorandum of Understanding is to foster cooperation in fulfilling the
responsibilities of each agency to ensure protection of the public health and safety and the environment
in accordance with existing agency responsibilities and authorities.
Principles
EPA and NRC, in carrying out the respective responsibilities of the two agencies in the regulation
of radionuclides, will strive to:
1. Base regulatory decisions on a determination that such actions will result in a substantial
reduction of significant risk to the public health and safety and the environment, and in making such
decisions consider, to the extent permitted by law, the importance of the risk reductions to be achieved
when compared to other radiological risks already subject to existing regulations, the overall economic
impact on NRC licensees of additional regulatory requirements to achieve such reductions, and pursue the
most efficient, cost-effective course in the regulation of those licensees.
2. Focus agency priorities on those significant safety and environmental problems subject to'the
authority of both agencies that offer the greatest potential for substantial risk reduction;
3. Avoid unnecessary duplicative or piecemeal regulatory requirements for NRC licensees,
consistent with the legal responsibilities of the two agencies, and ensure that standards and regulations,
when issued, can be effectively implemented; and
4. Effectively and responsibly carry out the provisions of Reorganization Plan No. 3 of 1970.
Under the Plan, EPA issues generally applicable environmental limits on radiation exposure or levels, or
concentrations or quantities of radioactive materials, in the environment outside the boundaries of locations
5S57 FR 54127, November 16, 1992.
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under the control of persons possessing or using radioactive materials, and NRC implements these
standards by the use of its licensing and regulatory authority.
Implementation Guidance
A. Scope
For certain facilities or materials licensed or regulated by the NRC, EPA is required by statute to
develop environmental standards for radionuclides which are applicable directly to NRC- regulated
facilities or materials. For example, EPA is required to develop generally applicable environmental
standards for offsite releases from radioactive material in high-level waste repositories under the Nuclear
Waste Policy Act. For other program activities, such standards are authorized but, depending sometimes
on the circumstances, are not legally required. With exception of Section C, below, this Memorandum
of Understanding is intended to address issues associated with both types of standards. Section C applies
according to its terms where EPA standards are not legally mandated. This MOU does not apply to
matters arising under RCRA or CERCLA.
B. General
Each agency will keep the other generally informed of its relevant plans and schedules regarding
such activities, will respond to the other agency's requests for information to the extent reasonable and
practicable, and will strive to recognize and ameliorate to the extent practicable anticipated problems with
regard to implementation and consistency with other program activities.
Each agency will deal with the other hi a spirit of cooperation to achieve the goals of this
Memorandum of Understanding. Agency management will endeavor, to the maximum possible extent,
to resolve informally and in a timely manner those differences identified as a result of the procedures
contained in this Memorandum of Understanding. If differences cannot be resolved, the respective General
Counsels of each agency will arrange for the matter to be presented by the necessary parties to the heads
of both agencies for resolution.
Each agency will keep the other fully informed of its priorities for the development of regulations
and will endeavor to develop a common understanding of the priorities and schedules for resolution, with
the highest priorities accorded to initiatives which offer the greatest potential for significant risk reduction.
If both agencies agree, in accordance with these principles and guidance, that duplicative
regulation in a particular area is undesirable, but nevertheless is required by law, then the agencies will
cooperate in considering and, if appropriate, supporting legislative changes.
C. Governing Criteria and Procedures
This Section applies to the issuance of regulations for releases applicable to NRC regulated
facilities or activities for releases into the environment of source, byproduct or special nuclear materials
under the Clean Air Act. It also applies to the issuance of such regulations under the Atomic Energy Act
and other provisions of law which may give rise to duplication of effort and overlapping regulation of
NRC regulated facilities or activities, but only to the extent issuance of such standards is authorized but
not legally mandated. Subjected to the above, EPA and NRC agree as follows:
1. Criteria. EPA's decisions not to impose emission standards for hazardous air pollutants under
the Clean Air Act for NRC licensed materials or facilities will, hi accordance with 112(d)(9) of the Clean
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Air Act, be based upon a determination that NRC's regulatory program provides an ample margin of
safety to protect the public health. Similarly, EPA's decisions to impose or not impose other regulations
regarding NRC licensed materials or facilities will be based upon a determination as to whether NRC's
regulatory program achieves a sufficient level of protection of the public health and environment. This
determination may be influenced by particular risk reduction or risk prevention goals being pursued and
this Memorandum of Understanding does not reflect agreement on such goals at this time. Ideally,
agreement on risk reduction or prevention goals for radionuclides will be reached pursuant to paragraph
D. below but in a particular case where EPA and NRC cannot agree on such goals, this Memorandum of
Understanding is without prejudice to EPA deciding to proceed with
regulation, without NRC concurrence, based upon an EPA inability to find that NRC's program provides
a sufficient level of protection.
EPA and NRC will jointly seek to minimize unnecessary duplication of effort and overlapping
regulation of NRC-licensed materials and facilities.
2. Procedures. In developing regulations in accordance with its authorities, if EPA, after finding
that NRC's regulatory program fails to provide a sufficient level of protection of the public health and
safety or the environment, identifies an area where it believes that EPA regulation applicable to NRC
licensees regarding radionuclides may be necessary, EPA will, before developing and proposing rules in
the Federal Register, informally and promptly inform the NRC of the basis for its position. If NRC
believes that such direct regulation of its licensees by EPA is unnecessary, the two agencies will endeavor
to resolve any issues, including consideration of information from NRC regarding the level of protection
achieved by NRC regulatory programs and any necessary modification to NRC's regulatory program, so
that duplicative regulation and implementation are avoided. Decisions rendered pursuant to this paragraph
will fully consider the implementation of existing regulatory programs in assessing the level of protection
being achieved by regulated facilities. Final EPA conclusions on whether EPA will impose regulations
applicable to NRC-licensed materials or facilities, and final NRC conclusions on whether NRC will
develop modifications to its program, will be accomplished in a public process based upon a full and
public record. Any decision made pursuant to this memorandum is subject to review and modification
based upon actual experience with its implementation.
Similarly, if NRC undertakes the development of new regulations that would affect the level of
protection of public health and safety and the environment related to an area where EPA has authority to
issue regulations applicable to NRC licensees, or if NRC undertakes any rulemaking or other regulatory
activity to fulfill its agreements made pursuant to this Memorandum of Understanding, NRC will promptly
and informally notify and consult with EPA before developing and proposing rules in the Federal Register,
and before any final decision by the commission on the proposal.
Where either agency is developing new regulations for radionuclides in an area not covered by
an exiting regulatory program, the agencies will, before proposing new regulations, consult concerning
what the proper division of responsibility should be.
D. Risk Assessment
In carrying out this Memorandum of Understanding, the agencies will actively explore ways to
harmonize risk goals and will cooperate in developing a mutually agreeable approach to risk assessment
methodologies for radionuclides.
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E. Other Provisions
1. Nothing in this Memorandum of Understanding limits the authority of either agency to exercise
independently its authorities with regard to matters that are the subject of this Memorandum of
Understanding.
2. Nothing in this Memorandum of Understanding shall be deemed to establish any right nor
provide a basis for any action, either legal or equitable, by any person or class of persons challenging a
government action or a failure to act.
3. This Memorandum of Understanding will remain in effect until terminated by the written notice
of either party submitted six months in advance of termination.
Ivan Selin
Chairman, US. Nuclear Regulatory Commission
William K. Reilly
Administrator, U.S. Environmental Protection Agency.
This Memorandum of Understanding was signed by the Chairman of the Nuclear Regulatory
Commission and the Administrator of the Environmental Protection Agency on March 16, 1992.
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Appendix D
NRC's Enhanced Participatory Rulemaking
on Radiological Criteria for Decommissioning
August 1993
In November 1992, the Nuclear Regulatory Commission initiated a rulemaking to establish
radiological criteria for decommissioning through a process that provides enhanced opportunities for public
participation. The rulemaking began with a series of public workshops involving individuals from diverse
perspectives in roundtable discussions on key aspects associated with the rulemaking. NRC held the
workshops from January through May 1993 in Chicago, San Francisco, Boston, Philadelphia, Dallas,
Atlanta, and Washington, DC. The workshops provided a forum for participants to communicate and
explore their positions on the issues prior to the formulation of a proposed NRC staff position on the rule.
In addition to the Environmental Protection Agency, active participants in the workshops included
representatives from State and local governments, Indian tribes and tribal organizations, industry groups
(utilities, non-power reactors, fuel cycle facilities, and materials facilities), citizen groups, environmental
and environmental justice organizations, professional societies, and decommissioning contractors.
NRC focused the workshop discussions using a Rulemaking Issues Paper that identified key issues
associated with the development of radiological criteria for decommissioning. NRC developed the Issues
Paper with input from EPA, States, Industry, and public interest groups in an attempt to ensure that the
paper presented the issues in an unbiased manner. The two primary issues identified in the Issues Paper
were: (1) what health and safety objectives should the criteria be based on, and (2) how should practicality
considerations be considered in developing the criteria. NRC described four alternative approaches for
defining the health and safety objectives: risk limits, risk goals, best effort (technology based standards),
and return to background. Secondary issues described in the paper included: individuals or populations
to be considered, potential for reuse/recycle of materials released, time frame for calculations, need for
pathway specific criteria, consideration of radon, and consideration of previously buried radioactive wastes.
The workshops began with a general introduction to the subject of decommissioning and the issues
associated with the development of radiological criteria for decommissioning to provide a context for the
workshops. The discussions quickly launched into a general exploration of whether NRC should develop
generally applicable requirements. Following that discussion, most of the workshop focused on four cross-
cutting issues that were used to elaborate on the strengths and weaknesses of the four alternative regulatory
approaches. The cross-cutting issues included protection of human health and the environment, waste
management implications, relationship to existing regulatory framework, and technical capabilities and
implementation considerations. The purpose of the workshops was not to seek consensus on the issues,
but rather to ensure complete ventilation of the viewpoints of the various participants in each workshop.
The remainder of this article briefly summarizes some of the diverse viewpoints expressed in the
workshops. NRC is actively considering these views in developing the draft radiological criteria. All of
the views are captured in transcripts prepared for the workshops and in written comments submitted to
NRC. In addition, the views have been catalogued in a comment data base and summary document. The
views described below were expressed by some, but by no means all participants. No significance should
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be drawn by the inclusion or exclusion of views herein. However, these views are representative of the
range of perspectives discussed in each of the workshops.
One of the most unexpected views that surfaced in each of the workshops was the questioning of
the unrestricted use objective that is currently incorporated in NRC's requirements. A diverse group of
interests challenged the credibility and practicality associated with requiring each nuclear facility to be
sufficiently remediated to release it for unrestricted use at the time its license is terminated. Other general
views expressed in the workshops included: (1) meaningful public involvement is needed in each phase
of rulemaking and implementation of the decommissioning criteria, (2) the ultimate goal of decommission-
ing should be the return to radiological background (i.e., the radiological level that existed prior to
construction and operation of a nuclear facility) at each site, and (3) it may be appropriate to establish
different requirements for different types of licensed activities (e.g., distinguish between medical facilities
and nuclear utilities).
In terms of the four alternative regulatory approaches described in NRC's Issues Paper,
participants generally recognized that risk or dose limits are important to ensure compliance. However,
some participants believed that the risk level that NRC would use to establish these limits would be too
high, thus allowing too much risk to humans and the environment. In contrast, participants believed that
goals may be more appropriate in some situations, but would be difficult to enforce. Participants generally
discounted the utility of technology-based or best effort standards because they could allow too much risk
and create future liabilities for additional decommissioning in the future if technology improves. The
fourth alternative, return to background, was favored by many participants as the ultimate objective of
decommissioning. However, some participants stressed that it may be difficult to demonstrate compliance
with a background standard through measurements and may not be justifiable from a risk or cost
standpoint. Additional views included the need to provide flexibility in the standards to adjust for site-
specific variations that could increase or decrease risk and cost. In addition, while industry and
professional society representatives generally supported applying the concept of ALARA (that doses or
risk be kept as low as is reasonably achievable), citizen groups and environmental organizations tended
to distrust its application because of cost implications and insufficient opportunities for public oversight
of the process.
Regarding human and environmental protection, participants generally agreed that the requirements
should protect existing and future generations from risks associated with residual radioactivity. A number
of participants pointed out that removing radiological contamination from a nuclear facility to a waste
disposal facility may merely transfer the risks. Participants believed that the requirements should provide
equal protection for individuals, especially rural populations, people of color, and the environment.
Diverse opinions were offered on whether requirements established to protect human health are sufficiently
protective of the environment Strong views were also expressed on the scientific basis for health risk
estimates associated with ionizing radiation. Some participants stressed reliance on national and
international organizations, such as the National Council on Radiation Protection and Measurements or
the International Commission on Radiological Protection. Others openly distrusted the recommendations
of these organizations and urged NRC to consider alternative risk estimates developed by scientists that
are not considered part of the mainline scientific movement.
Diverse participants suggested that all types of risk be considered in developing and applying the
requirements, such as occupational risk, public risk, and transportation risk. The assessments should also
consider both radiological and non-radiological risks. Participants urged NRC to ensure that non-
radiological and radiological risks are sufficiently mitigated or eliminated prior to terminating a license.
In terms of appropriate magnitudes for the radiological criteria, the views varied widely, ranging from
using the new public dose limit in 10 CFR Part 20 (100 mrem/yr) to dose values as low as 0.03 mr/yr or
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"0" (background level). Other options presented and discussed included use of the exemption levels
recommended by the International Atomic Energy Agency (a few mrem/yr) and values consistent with the
risk range EPA finds acceptable in selecting remedial goals for Superfund sites (10"4 to 10"6 lifetime risk
of cancer).
Most participants recognized the close linkage between decommissioning and waste disposal.
Some participants argued for containing and storing wastes from decommissioning onsite, where they were
generated, until demonstrably safe disposal facilities can be developed or until the waste decays away.
Participants also opined that wastes formerly disposed at nuclear facilities should not be "grandfathered"
in applying the new requirements, unless they pose no significant health or safety hazards. Individual
participants urged NRC against allowing any decommissioning activities without an approved
decommissioning plan. Some participants encouraged NRC to reconsider the merits of the ENTOMB
option, which was severely restricted in NRC's 1988 rulemaking to establish procedural and financial
requirements for decommissioning. In contrast, other participants noted that some existing nuclear sites
would be unsatisfactory for long-term storage of waste because the environmental characteristics of the
sites do not contribute to long-term isolation, such as locations in floodplains or areas of shallow
groundwater.
Other broad issues discussed included the need to ensure that future designs of nuclear facilities
enable return to background levels and minimize the generation of waste and contaminated materials.
Diverse groups questioned how NRC will determine and require compatibility of Agreement State
programs, including the prerogative of the States to set more stringent standards. Some participants
stressed the need for NRC and EPA to consider potential implications of the decommissioning criteria on
sites that have been contaminated with naturally occurring radioactive material (NORM).
NRC is currently considering the workshop comments, as well as written comments received on
the Rulemaking Issues Paper, in developing the draft radiological criteria for decommissioning. NRC is
also developing a Generic Environmental Impact Statement (GEIS) as a decision-aiding document in the
development of the radiological criteria. Scoping meetings for the GEIS were held in Washington, DC,
San Francisco, Oklahoma City, and Cleveland at the end of July 1993. EPA is participating in the
development of the GEIS as a cooperating agency. A draft of the GEIS should be complete by December
1993.
NRC plans to circulate the draft radiological criteria for decommissioning to the Agreement States,
workshop participants, and other interested parties in January 1994, in advance of formal Commission
review of the draft proposed rule. The NRC staff will forward the draft proposed rule for Commission
consideration in May 1994, allowing publication of the proposed rule for formal public comment in June
1994. On this schedule, the final rule should be complete by May 1995.
NRC staff contacts regarding the rulemaking are Mr. Francis X. Cameron, Office of General
Counsel, telephone 301-504-1642, and Dr. Robert A. Meek, Office of Nuclear Regulatory Research,
telephone 301-492-3737. Information related to the rulemaking is also available on an electronic bulletin
board which can be accessed by calling 800 880-6091. The NRC staff contact for the bulletin board-is
Ms. Christine Daily, telephone 301 492-3999.
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Appendix £
List of Acronyms
AEA Atomic Energy Act
ALARA As Low As is Reasonably Achievable
ANSI American National Standards Institute
ARARS Applicable or Relevant and Appropriate Requirements
BAT Best Available Technology
CAA Clean Air Act
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act of 1980
CRCPD Conference of Radiation Control Program Directors
DERP DoD's Defense Environmental Restoration Program
DoD Department of Defense
DOE Department of Energy
DOT Department of Transportation
FEMA Federal Emergency Management Agency
FFCA Federal Facilities Compliance Act of 1992
FUSRAP Formerly Utilized Sites Remedial Action Program
GTCC Greater Than Class C Waste
HLW ffigh-Level Waste
HSWA Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act
IAEA International Atomic Energy Agency
ICRP International Commission on Radiological Protection
IRP DoD's Installation Restoration Program
LLW Low-Level Waste
MCL Maximum Contaminant Level
MOU Memorandum Of Understanding
NARM Naturally occurring and Accelerator-produced Radioactive Materials
NCP National Contingency Plan
NCRP National Council on Radiation Protection and Measurements
NESHAPS National Emission Standards for Hazardous Air Pollutants
NORM Naturally Occurring Radioactive Materials
NPL National Priorities List
NRC Nuclear Regulatory Commission
NWPA Nuclear Waste Policy Act of 1982
OERR Office of Emergency and Remedial Response (EPA)
OSWER Office of Solid Waste and Emergency Response (EPA)
RAGS Risk Assessment Guidance for Superfund
RCRA Resource Conservation and Recovery Act
SARA Superfund Amendments and Reauthorization Act of 1986
SDWA Safe Drinking Water Act
SFMP Surplus Facilities Management Program
TSCA Toxic Substances Control Act
TRU Transuranic(s)
UMTRAP Uranium Mill Tailings Remedial Action Program
UMTRCA Uranium Mill Tailings Radiation Control Act
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Appendix F
Glossary
ACTIVITY - The mean number of nuclear transformations occurring in a given quantity of radioactive
material per unit time. The International System (SI) unit of activity is the becquerel (Bq) and the
conventional unit is the curie (Ci). 1 Bq = 1 nuclear transformation per second; 1 Ci = 3.7 x 1010 Bq.
ALARA (Acronym for "As Low As Is Reasonably Achievable") - A basic concept of radiation protection
that specifies that exposure to ionizing radiation and releases of radioactive materials should be reduced
as far below regulatory limits as is reasonably achievable considering economic, technological, and societal
factors, among others. ALARA is not a dose limit, but rather a process with the objective of limiting dose
levels as far below applicable limits as reasonably achievable.
AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) - An organization that develops standards
for a wide variety of practices, using a consensus process so that the standards are broadly agreed upon.
ANSI has developed a large number of standards that apply to the nuclear industry and to radionuclide
measurement.
APPLICABLE OR RELEVANT AND APPROPRIATE REQUIREMENTS (ARARs) - Standards,
requirements, criteria or limitations under any federal environmental law, or more stringent standards
under State environmental law or facility siting laws, that apply in selecting a remediation approach and
determining the level of cleanup required. The National Contingency Plan provides guidance on how to
determine ARARs.
ATOMIC ENERGY ACT (AEA) as amended — 42 USC 2011-2296. Provides authority for EPA to
establish generally applicable environmental radiation standards and guidance, applicable to all radioactive
materials (including source, byproduct, and special nuclear material). EPA establishes standards and other
agencies are responsible for actual implementation. It is also a basis of NRC's and DOE's authorities.
BACKGROUND RADIATION - Ionizing radiation in the natural environment from cosmic sources and
naturally occurring radioactive elements in their unaltered forms. Background radiation does not include
radiation from technologically enhanced levels of naturally occurring radionuclides or radiation from
source, byproduct, or special nuclear materials regulated by the Nuclear Regulatory Commission.
BYPRODUCT MATERIAL - Two types of materials are defined: 1) any radioactive material (except
special nuclear material) yielded in, or made radioactive by, exposure to the radiation generated by
producing or using special nuclear material; and 2) the tailings or wastes produced by extracting or
concentrating uranium or thorium from ore processed primarily for those purposes, including surface
wastes resulting from uranium solution extraction processes. (Underground ore bodies depleted by
solution extraction operations are not "byproduct material" under this definition.)
CLEAN AIR ACT (CAA) as amended — 42 USC 7401 - 7671 q. The CAA began to take its current
form in 1970 and 1971, with major amendments in 1977. It was substantially revised, particularly with
respect to hazardous materials (including radionuclides), in 1990.
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COLLECTIVE DOSE - The sum of the individual doses received in a given period of time by a specified
population from exposure to a specified source of radiation,
COMPREHENSIVE ENVIRONMENTAL, RESPONSE, COMPENSATION, AND LIABILITY ACT OF
1980 (CERCLA) as amended—42 USC 9601-9657. Commonly known as "Superfund," this act provides
for cleanup and emergency response when hazardous substances are or may be released into the
environment, and for cleaning up inactive hazardous waste disposal sites. The major amendment was the
Superfund Amendments and Reauthorization Act of 1986 (P.L. 99-499, known as SARA.)
CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS (CRCPA) - An organization of
state officials responsible for radiation protection that works to establish programs to protect public health
and safety from exposure to radiation. CRCPD cooperates with federal agencies in these efforts.
DECOMMISSIONING - The process for safely removing a nuclear facility from service and reducing
residual radioactivity to a level that permits release of the facility for unrestricted use and termination of
the license.
DOSE — Specifically, the energy imparted by ionizing radiation to a unit mass of matter, measured in
rads. In general usage, dose also may refer to dose-equivalent which is measured in rems. Dose-
equivalent is the product of the dose times a quality factor that accounts for increased biological damage
that can be inflicted (per unit dose) by neutrons and alpha particles. [Note: In measuring the intensity
of photons, the term exposure also has a specific meaning and is measured in roentgens. In this document,
the common usage of the word is meant unless otherwise specified.]
EXPOSURE - Direct contact with or assimilation of radioactive materials or proximity to unshielded
sources of ionizing radiation.
EXPOSURE PATHWAY - The physical course a chemical or pollutant takes from the source to the
organism exposed.
EXPOSURE ROUTE - The way a chemical or pollutant enters an organism after contact, e.g., by
ingestion, inhalation, or dermal absorption.
EXTERNAL EXPOSURE - Radiation exposure from radioactive sources located outside of the body.
FORMERLY UTILIZED SITES REMEDIAL ACTION PROGRAM (FUSRAP) - A DOE program to
clean up certain sites that are no longer in use. These sites are not covered by UMTRCA, but have similar
contamination problems, so similar cleanup criteria may apply.
HALF-LIFE, RADIOACTIVE - The time required to decrease the original number of atoms of a given
radioactive substance by 50% due to radioactive decay. Each radionuclide has a unique half-life.
HAZARD RANKING SYSTEM (HRS) - A scoring system developed and used by EPA to assess the
relative risk to human health and the environment posed by actual or potential releases of hazardous
substances from sites and facilities. The HRS is the principal mechanism for placing sites on the National
Priorities List (NPL). It was adopted by EPA as appendix A to the National Oil and Hazardous
Substances Contingency Plan, 40 CFR Part 300, on My 16, 1982 (47 FR 31180) and was revised
substantially (55 FR 51532, on December 14, 1990) to comply with statutory requirements in the
Superfund Amendments and Reauthorization Act of 1986.
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HAZARDOUS SUBSTANCE - Substances (usually thought of as chemicals or mixtures) that are declared
hazardous by various environmental statutes. Radioactive materials are not always considered hazardous
substances. For example, radionuclides are hazardous substances under the CAA, but other acts exclude
'source, special nuclear, or byproduct material" from their definitions. RCRA exempts radionuclides from
its definition of solid waste and, hence, does not consider radionuclides to be hazardous waste.
HIGH-LEVEL WASTE (HLW) - The highly radioactive material resulting from the processing of spent
nuclear fuel, including liquid waste produced directly in processing and any solid material derived from
such liquid waste that contains fission products in sufficient concentrations and other highly radioactive
material that the [Nuclear Regulatory] Commission, consistent with existing law, determines by rule
requires permanent isolation.
INTERNAL EXPOSURE (INTERNAL EMITTER) - Radiation exposure from radionuclides distributed
within the body.
INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA) - Based in Vienna, Austria, IAEA helps to
assure that atomic energy programs in all countries meet certain standards through a program of voluntary
compliance and inspection. IAEA also offers guidance on a wide variety of radiological topics, including
waste mitigation, minimization, and prevention of radiation risks to the environment.
INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION (ICRP) - An international
organization that develops guidance and standards for radiological measurement and protection of public
and occupational health. The ICRP is composed of a Chairman and never more than 12 other members.
The selection of the members is made by the ICRP from nominations submitted to it by the National
Delegations to the International Congress of Radiology and the ICRP staff itself. Members of the ICRP
are chosen on the basis of their recognized activity in the fields of medical radiology, radiation protection,
physics, biology, genetics, biochemistry, and biophysics. The Commission's rules require that its members
be elected every four years.
IONIZING RADIATION - Alpha, beta, or neutron particles, and gamma photons and x-rays (or both),
released during the radioactive decay of an unstable atom, that have sufficient energy to produce ionization
directly in their passage through a substance.
ISOTOPES - Atoms of the same chemical element that have the same number of protons but different
numbers of neutrons in the nucleus. Isotopes of an element have the same atomic number but different
atomic weights.
LOW-LEVEL WASTE (LLW) - Radioactive waste that is not classified as high-level waste, transuranic
waste, spent nuclear fuel, or byproduct material as defined in the Atomic Energy Act of 1954.
Commercial LLW is subdivided into Class A, Class B, Class C, and Greater-Than-Class-C (GTCC) wastes
based on the NRC regulations that govern their disposal. As the concentrations of radionuclides increase
from Class A to GTCC, the wastes are considered more hazardous and warrant increasingly stringent
disposal methods. DOE Order 5820.2A further specifies that test specimens of fissionable material
irradiated for research and development only, and not for the production of power or plutonium, may be
classified as low-level waste, provided the concentration of transuranic elements is less than 100 nCi/g.
MAXIMUM CONTAMINANT LEVEL (MCL) - An enforceable standard under the Safe Drinking Water
Act, set as close to the maximum contaminant level goal as feasible considering cost, availability of
treatment technologies, and other practical issues.
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