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The Regulatory Framework
MECHANICS OF EXISTING AND FORMER STANDARDS
GOVERNING RELEASES OF RADIOACTIVELY
CONTAMINATED MATERIAL
The technical assumptions underlying existing and former radiation stan-
dards are integral to the standards themselves and thus critical to evaluating them.
In this section, the study committee reviews several of the most important con-
cepts used in establishing radiation standards, including dose-based versus activ-
ity-based standards, the role of calculated simulations in assessing risks, the
importance of defining critical groups, and important uncertainties in assessing
risks (see Box 2-1 for description of different types of radiation standards).
The general trend in environmental regulation is toward risk-based stan-
dards, which typically focus on the estimated increased lifetime risk of cancer
posed by the regulated material (NRC, 1994~. Certain statutes, however (e.g.,
sections of the Clean Air Act), continue to use technology-based standards. That
is, they prescribe the use of a particular control technology rather than establish-
ing an acceptable exposure level. Calculating the health risks associated with a
radioactively contaminated object involves a two-step process. First, the dose
must be calculated, which entails constructing a range of scenarios to represent
the range of potential doses to individuals. Second, for each estimated dose, the
attendant health risk or harm must be estimated. As discussed below, both steps
necessarily introduce uncertainties and typically use simplifying assumptions.
The virtues of a risk-based approach are that it establishes standards close to
the level of public health concern, ensures that contaminant levels are controlled
33
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34
THE DISPOSITION DILEMMA
to achieve acceptable levels of public health protection, and promotes consis-
tency among different regulations. Risk-based standards are meant to be respon-
sive to public policy decisions on widely acceptable levels of risk and are pre-
sumed to be rationally based on carefully conducted estimates of dose and risk.
The unavoidable uncertainties in risk-based standards are therefore more than
offset by their capacity to incorporate policy determinations into a rigorous,
scientifically based framework. However, an important challenge is to ensure
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THE REGULATORY FRAMEWORK
35
that the methods used, including their simplifying assumptions and inherent con-
straints, are sufficiently transparent to both technical peers and the concerned
public.
As noted earlier, two types of standards exist in the area of radiation safety
for slightly radioactive solid material (SRSM). One type is based on the level of
radiation exposure, or dose. The other is based on the level of radioactivity of the
material in question and is therefore often called an activity-based standard.
Superficially, a radioactivity-based standard appears to be the more direct of the
two approaches because it prescribes a maximum level of radiation that may be
emitted by an object that is to be used or disposed in a specified manner. A
radioactivity-based standard does not appear to require the complex process of
assessing how individuals might be exposed to the object's radioactivity and
what the resulting doses are likely to be. Technical analyses such as draft
NUREG-1640 (USNRC, 1998b) derive radioactivity-based limits for selected
disposition cases that are based on risk or dose limits (see Chapter 5~. However as
discussed further below, whether there is in fact a significant difference in com-
plexity between these two types of standards depends on whether the governing
regulation is based on technology (i.e., a control or measurement limitation) or on
limiting exposure, hence risk.
Technology-Based Regulations
Regulatory standards may be based on the limitations of existing control or
measurement technologies. The U.S. Nuclear Regulatory Commission's
(USNRC's) existing guidance document concerning release of solid materials
with surface contamination from regulatory control, developed in the 1970s, is
based on the decontamination survey practices that were in use at that time (see
Box 2-2~. Some environmental laws, such as specific provisions in the Clean Air
Act, base regulations on the "best available control technologies." In this ap-
proach to regulation, the focus is not on risk, which is difficult to estimate and
even harder to defend, but on promoting the use of the most advanced technolo-
gies and fostering their further development.
Regulations that require the use of best available control technology obviate
the need for dose estimates. In some instances, specifying activity limits is not
necessary. The salient issue is maximizing the use of the most effective control
technologies. To achieve this, a regulation could prescribe limits on radioactivity
levels (e.g., annual emissions limits on radionuclides) or require that specified
instruments or methods, and defined limits, be employed when radioactively
contaminated materials are monitored. To a large degree, the existing guidance
embodies this latter principle, relying on extensive guidance for procedures and
practices (AEC, 1974; USNRC, 1981~.
Technology-based regulation has the advantage of being relatively simple to
implement. It avoids the complexities of determining the myriad ways in which
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THE DISPOSITION DILEMMA
people might be exposed to radiation from radioactively contaminated materials.
A major disadvantage, however, is that if the approach were applied in total
ignorance of the potential harms, it could result in either serious underregulation
and thus increased risk to the public or overregulation and hence increased costs
to the regulated industries. Thus, when developing technology-based regulations,
regulatory agencies are well advised to conduct at least brief analyses of the risk
reduction and cost-benefit achieved by the specific technologies that might be
implemented.
Risk-Based Regulations
In practice, many standards are a hybrid of dose-based and activity-based
approaches. For example, any risk-based standard, whether its allowed maximum
levels are expressed as doses or radioactivity levels, entails that the ultimate dose
to a certain class of individuals, termed the "critical group," be assessed. To
bound the analysis in the assessment requires fairly elaborate simulations and
numerous technical judgments. The inherent uncertainty associated with these
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THE REGULATORY FRAMEWORK
37
simulations and judgments varies with the quality of data and the range of poten-
tial exposure scenarios that must be considered.
Constructing Critical Groups and Exposure Scenarios
Often, relatively clear bounding hypotheses for the analysis can be identified
by using conservative assumptions about possible routes of exposure. For ex-
ample, in developing its analyses for risk-based standards, the Environmental
Protection Agency (EPA) has sought to identify plausible examples from which
significant exposures could arise. It uses these exposure scenarios to construct the
critical groups for the analysis. The doses to these critical groups, estimated by
simulating the exposure scenario, dictate the level of radioactivity that is permit-
ted in materials subject to regulation.
As an illustration of how critical groups are used, one critical group consid-
ered by the EPA is represented by an operator of an industrial lathe made with
radioactively contaminated cast iron. This is a relatively high-dose scenario be-
cause of the time spent next to the radioactive object, as well as its size and
proximity. The larger the object, given the same concentration of radioactive
material, and the longer the time in proximity, the higher is the exposure (EPA,
1997a).
In most cases, as in the above example, the doses to the critical groups are
constructed to provide the upper bound on what is permissible under the regula-
tion. The method assumes that most of the public will be exposed to far lower
levels of radiation than would members of the critical groups.
An important question that is frequently raised about such simulations is
whether exposure from a number of different sources could lead to much higher
levels of risk. Returning to the example of the lathe operator, multiple exposures
would occur if this individual were exposed not only to radiation from the indus-
trial lathe but also to radiation from cast iron cooking utensils and large home
appliances. In theory, these multiple routes of exposure could raise the
individual's exposure above the level that the applicable regulation is attempting
to ensure is not exceeded.
Regulators work to account for the potential that multiple exposures will
occur by using information on the volume of materials at issue, the materials'
potential uses, the relative importance of different routes of exposure, and the
circumstances under which the materials are used (EPA, 1997a). Using this infor-
mation and a conservative set of assumptions, regulators attempt to assess the
likelihood and importance of multiple exposures. For completeness, it is impor-
tant to take into account the potential for such multiple exposures, even where the
levels of contamination in the materials are very low, since multiple exposures
can result in a higher dose to an individual than originally analyzed. Allowance
for multiple exposures may be in the form of choosing a level for a standard that
reflects the likelihood of multiple exposure. Thus, the standard for release of a
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THE DISPOSITION DILEMMA
site may be a relatively large fraction of the public exposure safety limit, while
the standard for release of material into commerce would be a much smaller
fraction, even a de minimis level.
Uncertainty and Sensitivity of Analytical Assumptions
The inherent complexity of dose assessment analyses requires that numerous
simplifying assumptions be made. For example, assumptions must be made about
the length of time a person spends next to a contaminated object and at what
distance, as well as whether the contaminated material is mixed with clean mate-
rials before being fabricated into a consumer product. These assumptions and the
variability in the quality of information available mean that the exposure simula-
tions on which the analysis depends are subject to significant uncertainties. These
uncertainties are typically difficult to quantify. If overly conservative assump-
tions are used in the analysis, the assessment will err on the side of caution.
Conversely, if simplifying assumptions minimize or underestimate potential risks,
the assessment will err toward inadequate control to protect health and safety. If
uncertainty distributions or ranges for the input assumptions are available, ana-
lysts can perform studies, using methods such as Monte Carlo simulations, to
obtain estimates of the uncertainties in the dose calculations or other predictions
from the analysis (see Chapter 5 for further discussion).
In addition to uncertainty, the difference that any given assumption makes to
the overall analysis can be quantified by using a sensitivity analysis. The sensitiv-
ity of the final dose estimate to a particular input assumption or factor is mea-
sured by varying the value assumed for that assumption without varying any
other factors.
Although Monte Carlo simulations and sensitivity analyses can be compli-
cated by variables that are strongly dependent, they provide an important means
by which analysts can gain a qualitative sense of the reliability, or variability, of
their estimates and an understanding of what factors are most important. Regula-
tors therefore have at their disposal an array of analytical methods that can be
used to assess whether their judgments are reasonable.
Critical Uncertainties
Although the analytical methods employed by regulators in establishing stan-
dards have become increasingly sophisticated, uncertainty and judgment are un-
avoidable in assessing potential risks and deciding how much extra conservatism
to embed in the regulations. In the present context, there are several particularly
important uncertainties, which the committee discusses at several points in this
report. Among these uncertainties are the following:
· The risk that radionuclides will concentrate in certain solid materials that
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THE REGULATORY FRAMEWORK
39
are unconditionally released into commerce;
· The limits on existing radiation monitoring equipment and survey meth-
ods;
The significance of multiple potential exposure pathways for cumulative
exposure to the public; and
· The reliability of conservative, or bounding, hypotheses in designating
critical groups.
.
The consequences of these uncertainties for assessing risks associated with
radionuclides are particularly complex because many radionuclides are long-
lived and because monitoring for low levels of radioactivity requires sophisti-
cated instrumentation and rigorous methods. In making conservative estimates,
regulators must carefully take these factors into account. As discussed in Chapter
5, analysts attempt to incorporate these factors into their calculations and assess
their significance, at least qualitatively.
HISTORICAL EVOLUTION OF THE REGULATORY FRAMEWORK
FOR CONTROLLING RADIOACTIVELY CONTAMINATED
SOLID MATERIALS
Under the Atomic Energy Act of 1946 as amended in 1954 (AEA), the
Atomic Energy Commission (AEC) and its successor agency, the USNRC, were
granted the authority to regulate radioactive materials associated with nuclear
fission. These materials are categorized in the AEA as source materials (i.e.,
uranium and thorium), special nuclear materials (e.g., plutonium), and byproduct
materials (e.g., most radioactive material including common radioactive wastes)
(42 U.S.C. §§ 2073, 2091, 2111~.1 Byproduct material includes any radioactive
material (except special nuclear material) yielded in or made radioactive by the
process of nuclear fission. This process includes both fission fragments (fission
products) and activation products (42 U.S.C. § 2014(e)~.2 Notably, the AEA does
cover naturally radioactive source materials, but does not cover naturally occur-
ring radioactive material (NORM) (e.g., radon gas), technologically enhanced
1References to the United States Code (U.S.C.) are given parenthetically using the conventional
format with the title number first (Title 42 in this reference), followed by the initials U.S.C. and the
section numbers within the title.
2The Uranium Mill Tailings Radiation Control Act of 1978 (Public Law 95-604) added a second
category of byproduct materials at section ll(e)(2) of the AEA, defining them as the "tailings" or
waste produced by the extraction or concentration of uranium or thorium from any ore processed
primarily for its source material (i.e., uranium or thorium) content. This and other terms have been
paraphrased from their original sources, the Atomic Energy Act and 10 CFR Part 20. These sources
should be consulted with regard to the precise legal meaning and effect of these terms.
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THE DISPOSITION DILEMMA
NORM (TENORM), or materials made radioactive from particle accelerator ex-
periments.
In establishing the AEC's regulatory authority, the AEA delineated appro-
priate regulatory procedures in substantial detail (42 U.S.C. § § 2073,2091,2111~.
It did not prescribe specific technical requirements, deferring instead to the AEC,
and later the USNRC, to develop and promulgate requirements for specific ac-
tivities. Accordingly, all activities that were to be licensed by the AEC originally
required the applicant to submit technical justifications for the proposed practice
and to undergo a case-by-case review for authorization. Over time, specific re-
quirements have been established for recurring or routine license applications.
Regulatory Practices and Controls
Title 10 (Energy) of the Code of Federal Regulations establishes licensing
requirements for all practices using nuclear materials under the jurisdiction of the
USNRC and agreement states. Examples include 10 CFR Part 40 for source
material, 10 CFR Part 50, et seq., for facilities that produce or utilize special
nuclear material, and a series of regulations beginning with 10 CFR Part 30 for
byproduct material. These regulations codify licensing requirements in a generi-
cally applicable way to the extent possible.
The USNRC issues two basic types of licenses, specific and general. A
specific license is required for practices involving significant quantities of nuclear
material that warrant licensee control employing at least one radiation control
professional. Commercial nuclear power plants, for example, are operated under
a specific license issued by the USNRC. A general license may be issued if the
quantity of nuclear material is significant but adequately protected through de-
sign and administrative controls (e.g., an industrial gauge that uses a strong
radiation source). General licensees are not required to have radiation control
professionals but are required to use a generally licensed device under the speci-
fied controls. The design and administrative controls are imposed through the
specific licensee who makes and distributes a generally licensed device, as well
as the end user of the device.
Certain radioactive materials may be deemed exempt from regulation if the
amount of radioactive material involved is small enough or adequately protected
by design. Examples include ionization smoke detectors and the small quantities
and concentrations listed as exempt in 10 CFR §§ 30.70, 30.71.
Extensive regulations govern the disposal of radioactive wastes generated by
or from licensed facilities. The regulations for high-level radioactive waste, 10
CFR Part 60 and Part 63, define high-level radioactive waste by its origin, not its
radioactive content, and delineate detailed requirements for its licensed disposal.
The disposal requirements for the three classes of low-level radioactive waste
(LLRW) are contained in 10 CFR Part 61. Although these regulations impose
upper bounds on the radioactive content for Class A, B. and C low-level waste,
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THE REGULATORY FRAMEWORK
41
they do not specify a floor or threshold content of radioactivity below which
material may be treated as nonradioactive waste. Accordingly, under existing
regulations there is no generally applicable criterion for determining that the
radioactive content in solid waste is de minimis.3
Formal USNRC regulations are augmented by a series of guidance docu-
ments, referred to as "Regulatory Guides," that establish preferred or acceptable
methods for regulatory compliance purposes. Regulatory Guides are developed
and proposed by committees of technical experts in a specific area, such as
radiation monitoring or facility engineering requirements. If the USNRC en-
dorses a proposed practice, it is formally published as a Regulatory Guide. Lic-
ensees who adopt a Regulatory Guide by incorporating it by reference in their
license application are subject to inspection and enforcement of its requirements.
A license applicant may choose instead to propose different practices for special
reasons. However, doing so can lead to substantial delays in licensing decisions.
One such guidance document, Regulatory Guide 1.86, Termination of Oper-
ating Licenses for Nuclear Reactors (AEC, 1974), is of particular interest to the
study committee's task (see Box 2-2~. Issued in June 1974, this guide was re-
leased in the midst of the transition from the former AEC to the newly established
USNRC. This was also the time when the first generation of demonstration power
reactors was decommissioned. Unlike the typical document in this series, Regu-
latory Guide 1.86 was not developed by an expert committee; it was promulgated
as a placeholder to enable reactor decommissioning to proceed. Thus, it enumer-
ates licensing administrative requirements and different approaches to reactor
decommissioning and specifies, in its fourth and final section, a systematic ap-
proach for license termination and release of equipment and the site.
Regulatory Guide 1.86 includes a table, Table I, of acceptable surface con-
tamination levels. This AEC guidance for permitting clearance of radioactive
materials dates back more than 25 years, to the initial preparation of Regulatory
Guide 1.86. The Table I guidance had been in informal use for some time before
1974 and apparently was based on the detection limits of the instruments avail-
able at that time, not on an assessment of risk.4 Table I contains guidance on
clearance standards for surfaces such as floors, walls, structural materials, and
equipment; it contains no standards for volume contamination. The table, which
became the USNRC's de facto standard for clearance of solid materials with
residual surface contamination, has been widely used for decades.
Selecting a clearance level requires that specific implementing protocols be
developed. Office of Inspection and Enforcement (IE) Circular No. 81-07, Con-
3For two radionuclides only, in solid materials, and in one specific application, section 2005(a)(2)
of 10 CFR Part 20 does contain release criteria. These criteria allow disposal of volume-contami-
nated animal tissue containing less than 1.85 kBq/g of 3H or 14C as if it were not radioactive.
4The committee was not able to uncover substantial evidence that this early work was based on an
assessment of risk.
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THE DISPOSITION DILEMMA
trot of Radioactively Contaminated Material, provides guidance on radiation
control programs, including material clearance protocols (USNRC, 1981~. It con-
tains guidance for implementing the surface contamination standards in Table I,
such as data on radiation detection instrumentation, as well as radiation control
systems required generally of licensees. Like Regulatory Guide 1.86, this guid-
ance is not specific to volume-contaminated materials.
Authorized Releases of Radioactive Materials from
Regulatory Control Existing and Proposed Standards
The USNRC's general radiation protection regulations in 10 CFR Part 20
prescribe acceptable radiation exposures for workers and the public, as well as
permissible levels of radioactivity in gaseous or liquid emissions from licensed
facilities. Section 2002 of Part 20 provides for a case-by-case review to obtain
approval to dispose of radioactive materials in unlicensed facilities when proce-
dures are not specifically prescribed by existing regulations. (The USNRC re-
ceived approximately 15 such requests over the past 5 years [USNRC, 2001bj.
As the committee understands it, these requests cover only proposed disposals
that are different from standard practices.)
In addition to the requirements specified in Part 20, the USNRC frequently
incorporates directly into a facility's license specific requirements for release of
certain radioactively contaminated solid materials. Except for the exemption
tables in 10 CFR Part 30, general standards for the unrestricted release of vol-
ume-contaminated solid materials have not been promulgated.
First in 1986 and again in 1990, the USNRC proposed to formalize and
update the existing guidance and other regulations by establishing policies on
radiation levels that would be considered "below regulatory concern" (BRC).
These proposals were meant to establish a threshold for residual levels of radio-
activity, below which the solid material could be cleared from further regulatory
control. Section 10 of the Low-Level Radioactive Waste Policy Amendments Act
of 1985 (42 U.S.C. § 2021j) specifically addresses low-level waste. Consistent
with this statute, the proposed BRC policy attempted to set general criteria for
allowable individual dose and collective doses resulting from authorized releases
of radioactively contaminated materials from licensed activities.
The BRC proposal was intended to be an overarching approach that would
establish specific quantitative standards for site releases at license termination,
unrestricted release of waste materials, and consumer or industrial product uses
of radioactive materials, as well as other standards. In some quarters, however,
this proposal was perceived as a subterfuge to reclassify a large part of the low-
level waste from commercial reactors as nonradioactive waste, thereby allowing
Collective dose is 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.
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THE REGULATORY FRAMEWORK
43
licensees to avoid the costs of disposal at a licensed LLRW facility (USNRC,
1991a). Many comments from the general public, the states, and Congress re-
jected the BRC approach for releasing radioactively contaminated materials for
unrestricted reuse or disposal. In response to these criticisms, the USNRC placed
a moratorium on the proposed BRC policy while it attempted to build public
consensus for it. That effort failed, and Congress formally revoked the BRC
policy in the Energy Policy Act of 1992. The USNRC rescinded its proposed
BRC policy statement soon afterward.
In response to the USNRC's deregulation efforts, at least 16 states subse-
quently passed regulations or laws that were stricter than the federally proposed
allowable releases. The intent evident in most of these new restrictions was to
continue regulatory control if the federal government allowed deregulation. Ma-
jor concerns voiced by the public included the uncertain risks, a lack of confi-
dence in the USNRC and the Department of Energy (DOE), and general concerns
about the release of radioactive materials into consumer products (USNRC,
l991a,1991b). Chapter 8 provides further details on public reactions to the BRC
proposal.
The committee has been asked to address questions related to a proposal that
may be considered another attempt by the USNRC to establish uniform standards
for the unrestricted release of SRSM. In 1998 the Commission directed the
USNRC staff to consider a rulemaking for establishing a dose-based standard for
release of SRSM (USNRC, 1998a), and in January 1999 the USNRC initiated an
enhanced participatory rulemaking directed at establishing a clearance standard
(USNRC, l999c). At the same time, the USNRC sponsored a draft technical
report on the topic, NUREG-1640, Radiological Assessments for Clearance of
Equipment and Materials from Nuclear Facilities (USNRC, 1998b). This draft
report was criticized severely when concerned parties learned that the contractor
developing the draft, Science Applications International Corporation (SAIC),
was concurrently also doing work for a company that stood to gain financially
from the promulgation of a clearance standard.
The USNRC published an issues paper in the Federal Register (64 Federal
Register 35090-35100; June 30, 1999) and held a series of public meetings from
September through December 1999. Its proposal for rulemaking on release crite-
ria aroused the same skepticism that had greeted its earlier BRC policy. Con-
sumer and environmental groups were particularly incensed that in their view, the
USNRC had predetermined the outcome before it started. These concerns led to a
broad-based boycott of the first two 1999 public meetings. At the same time, the
USNRC, through its contract with SAIC, was conducting a detailed technical
analysis that would become NUREG-1640 to assess the risks associated with
establishing a clearance standard. As discussed in the section "Stakeholder In-
volvement" below, significant concerns about public health and safety issues and
negative economic impacts on certain industries were raised. A USNRC paper
summarizing the public meetings, technical bases, and alternatives was issued on
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THE DISPOSITION DILEMMA
March 23, 2000 (USNRC, 2000a). A final stakeholder briefing occurred on May
9, 2000. As part of its response to the concerns expressed at these meetings, the
Commission requested that a study be undertaken by the National Academy of
Sciences.
COMPARATIVE ASSESSMENT OF EXISTING REGULATIONS IN
THE UNITED STATES
There are numerous regulations in the United States governing releases of
radioactively contaminated materials and facilities. Three agencies the USNRC,
DOE, and EPA have promulgated regulations and/or guidance according to
their respective statutory authorities. The standards range from about 1 mrem/yr
(USNRC' s Regulatory Guide 1.86, as estimated in USNRC, 1998b), to 100 mrem/
yr (10 CFR Part 20.1301, which limits the annual dose received by members of
the public from a licensee), to 500 mrem (10 CFR Part 35.75, which allows a
licensee to release a person who has received radiopharmaceuticals provided
doses to other persons will not exceed 500 mrem). In radiation control the USNRC
generally applies the standards as limits supplemented by explicit steps to main-
tain the exposures at levels that are as low as reasonably achievable (ALARA).
The EPA generally applies specific limits to specific applications. While there is
general agreement among the three agencies, differences persist with regard to
standards for protection of groundwater and for an all-pathways dose. Even within
one agency' s regulations, there are apparent discrepancies. For instance, the can-
cer risks associated with EPA standards for water, air, and Superfund cleanup
range over more than two orders of magnitude (NRC, 1999~. In summary, the
levels of protection afforded by federal regulation of radioactive materials vary
widely.
USNRC Regulations
There are two sets of USNRC regulations for unrestricted release. One set
pertains to the release of facilities from regulatory control; the other pertains to
materials to be released on an unrestricted basis from regulated facilities. Each set
of regulations provides for significant regulatory flexibility depending on the
circumstances.
The USNRC's License Termination Rule: Release of Facilities
The USNRC's License Termination Rule, 10 CFR Part 20, Subpart E, gov-
erns unrestricted and restricted release of USNRC-licensed facilities from regula-
tory control. This rule establishes procedures and specific standards that must be
met before regulatory oversight of a facility can be terminated. The rule's key
requirements are as follows:
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45
Unrestricted release of a USNRC-licensed facility is permitted if the all-
pathways dose, including groundwater, does not exceed 25 mrem/yr and
radioactive residues have been reduced to levels that are ALARA.
Restricted release of a USNRC-licensed facility is permitted if (1) the net
public and environmental harm is comparable to compliance with the 25
mrem/yr limit for unrestricted release and the residue levels are ALARA;
(2) institutional controls are adequately funded and legally enforceable;
(3) requirements for restricted release have the advice of a broad cross
section of the community interests; and (4) in the event that institutional
controls fail, the maximum dose is ALARA and does not exceed 100
mrem/yr (or 500 mrem/yr under exceptional circumstances substantiated
by detailed information).
Alternative criteria may be submitted by a licensee for review if they are sup-
ported by adequate plans and analyses prepared with community advice. The
dose limits apply to the total effective dose equivalent for the average member of
the critical group, calculated over the first 1,000 years after decommissioning.
The USNRC's Case-by-Case Approach: Release of Materials
Overview. As noted in Chapter 1, the USNRC's regulations under 10 CFR Part
20 limit the radiation dose that an individual can receive from the operation or
decommissioning of a USNRC-licensed facility and also require that doses re-
ceived are ALARA. Although Part 20 sets standards for releases of effluents
(liquids or gases), it sets no specific standard for release of solid materials with
surface or volume contamination.6 The USNRC generally evaluates releases on a
case-by-case basis using license conditions and existing regulatory guidance.
6According to the USNRC (1999a):
For most NRC licensees, solid materials have no contamination because these licens-
ees use sealed sources in which the radioactive material is encapsulated. These include
small research and development facilities and industrial use of various devices including
gauges, measuring devices, and radiography.
For other licensees (including nuclear reactors, manufacturing facilities, larger educa-
tional or health care facilities, including laboratories) materials generally fall into one of
three groups based on its location or use in the facility:
· Clean or unaffected areas of a facility, from which areas the solid materials would
likely have no radioactive contamination;
Areas where licensed radioactive material is used or stored, from which areas mate-
rials can become contaminated although the levels would likely be low to none; and
Material used for radioactive service in the facility or located in contaminated areas
or areas where contamination can occur, from which materials generally have levels
of contamination that would not allow them to be candidates for release unless they
are decontaminated.
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THE DISPOSITION DILEMMA
In Section 2002 of Part 20, "Method for obtaining approval of proposed
disposal procedures," the basis for the case-by-case review is virtually the same
as that in the old Section 302 of Part 20. As noted above, neither version provides
specific standards for exemption.7 The pertinent portion of Part 20.2002 reads as
follows:
A Licensee or applicant for a license may apply to the Commission for approval
of proposed procedures, not otherwise authorized in the regulations in this chap-
ter, to dispose of licensed material generated in the licensee's activities. Each
application shall include:
a. A description of the waste containing licensed material to be disposed of,
including the physical and chemical properties important to risk evaluation,
and the proposed manner and conditions of waste disposal; and
b. An analysis and evaluation of pertinent information on the nature of the
environment; and
c. The nature and location of other potentially affected licensed and unlicensed
facilities; and
d. Analyses and procedures to ensure that doses are maintained ALARA and
within dose limits in this part.
Under the case-by-case approach, the USNRC does not consider most re-
leases of solid materials to be "disposals" authorized under Part 20 or Part 61.
Instead, these releases are frequently authorized by specific license conditions,
that is, a specific provision contained in the facility's license.8
Categories of Release. USNRC guidance on release of SRSM falls into three
categories: (1) release of solid materials with surface residual radioactivity at
reactors, (2) release of surface-contaminated solid materials possessed by a mate-
rials licensee (i.e. nonreactor licensee), and (3) release of volume-contaminated
solid materials possessed by reactor and materials licensees (USNRC, 2001b).
The guidance for each category is summarized next.
7The 1957 issue of Part 20 had a short section on waste disposal that included Part 20.302,
"Method for obtaining approval of proposed disposal procedures," the basis for case-by-case review
of disposal procedures not authorized by the two succeeding sections on disposal in sewerage sys-
tems or in soil. The original Part 20 gave general requirements for waste disposal of byproduct
material. The 1957 standard did not include any criteria for a floor to the amount or concentration of
controlled radionuclides, which criteria might be used as the basis for exemption of waste from
regulatory control.
sit is not appropriate to apply the ALARA principle at or below the dose limits that are typically
proposed for clearance calculations. These are not dose safety limits in the ordinary sense of the
word, but are levels at which SRSM may be released from regulatory control. The dose limits of 0.1
to 10 mrem/yr are already orders of magnitude below natural background levels. Additionally, the
variation in natural background dose is larger than the level of the selected dose limit. Since the
proposed dose limits are already well below most established safety limits, it is not appropriate to
apply the ALARA principle to the clearance dose limits as calculated in NUREG-1640.
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47
Release of solid materials with surface residual radioactivity at reactors. Reactor
licensees typically follow a policy established by IF Circular 81-07, Control of
Radioactively Contaminated Material, and Information Notice 85-92, Surveys of
Wastes Before Disposalfrom Nuclear ReactorFacilities(USNRC, 1981, 1985~.
Under this policy, reactor licensees must survey equipment and material before
its release. If the survey indicates the presence of licensed AEA material above
natural background levels, the equipment or material cannot be released (USNRC,
2001b). The IF Circular 81-07 and related guidance basically set the sensitivity
required of survey instruments, a sensitivity similar to that used in applying
Regulatory Guide 1.86.
Release of surface-contaminated solid materials possessed by a materials lic-
ensee (i.e., nonreactor licensee). For materials licensees, the USNRC usually
authorizes the release of solid material through specific license conditions. Table
I of Regulatory Guide 1.86 is used to evaluate surface contamination on solid
materials before they are released (AEC,1974~. Similar guidance is found in Fuel
Cycle Policy and Guidance Directive FC 83-23, Guidelines for Decontamination
of Facilities and Equipment Prior to Release for Unrestricted Use or Termina-
tion of Byproduct, Source or Special Nuclear Materials Licenses (USNRC,1983~.
Both documents contain a table of surface contamination criteria, which may be
used by licensees as the basis for demonstrating that solid material with surface
contamination can be released safely with no further regulatory control.
Release of volume-contaminated solid materials possessed by reactor and mate-
rials licensees. The USNRC has not provided guidance for volume-contaminated
materials analogous to the guidance in Regulatory Guide 1.86 for surface con-
tamination. Instead, the USNRC has decided these situations on a case-by-case
basis by evaluating the doses associated with the proposed release of the material.
Typically, the evaluation and decision is made in such a way as to ensure that the
maximum doses are a small percentage of the Part 20 dose limit for members of
the public of 100 mrem/yr.
The Role of States. Under the AEA, the USNRC has preemptive authority to
license and regulate the ownership, possession, use, and transfer of AEA materi-
als source, byproduct, and special nuclear materials and to set standards, as
are necessary to protect public health, for the ownership, possession, use, and
transfer of AEA materials. However, Section 274 of the AEA specifically autho-
rizes the Commission to enter into agreements with states to transfer limited
elements of that authority. These agreements constitute a discontinuance of
USNRC's authority, not a delegation; a state assumes the USNRC's authority
over selected radioactive materials (specifically, byproduct materials, source
materials, or special nuclear materials in quantities not sufficient to form a criti-
cal mass). Once an agreement is signed, the USNRC continues to have an over-
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48
THE DISPOSITION DILEMMA
sight responsibility to ensure that the state, called an "agreement state," has a
program for the regulation of ALA material that is adequate to protect public
health and safety and is compatible with USNRC regulations (USNRC, l999b).
As of December 2001, 32 states had entered into agreements with the Com-
mission, and four more states had applied for agreement state status. The USNRC
has extensive arrangements and procedures for communicating and interacting
with the agreement states, especially to ensure that agreement state regulations
are compatible with USNRC regulations.
For some USNRC requirements, such as basic radiation protection standards
or those that have significant implications for interstate commerce or related
activity (sometimes referred to as "transboundary implications"), the agreement
state must adopt essentially identical requirements, in order to be compatible with
the USNRC. For other USNRC requirements, such as most licensing require-
ments, the agreement state has some flexibility to adopt its own requirement if the
state's requirements meet the essential objective of the USNRC. States may also
establish more restrictive requirements provided that they have an adequate sup-
porting health and safety basis and the requirements do not preclude a practice
that is in the national interest (USNRC, l999b). Criteria that have been applied
by states on a case-by-case basis include the use of radiation levels that are
indistinguishable from background, the use of guidelines similar or equivalent to
Regulatory Guide 1.86, and the use of dose-based analyses (USNRC, l999b).
Cited Advantages and Disadvantages of the Case-by-Case Approach. The
USNRC document Control of Solid Materials: Results of Public Meetings, Status
of Technical Analyses, and Recommendations for Proceeding (USNRC, 2000a)
discusses issues and concerns related to a set of alternatives for establishing
control of solid materials. In particular, it summarizes the following broad advan-
tages and disadvantages of the current case-by-case approach, an appraisal with
which the committee generally agrees:
Advantages. The advantages of the case-by-case approach are the following
(adapted from USNRC, 2000a):
.
.
It is a flexible tool that is currently in use and well understood. The
USNRC staff and licensees have developed a common understanding of
the criteria involved.
· It is protective of public health and safety. The potential exposures re-
ceived are a fraction of public health guidelines.
Leaving it in place would not involve additional rulemaking resources.
USNRC resources would be devoted to specific requests from licensees,
which would bear the cost. The USNRC would not have to expend its
resources on a rulemaking.
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THE REGULATORY FRAMEWORK
Disadvantages. The disadvantages of the case-by-case approach are the fol-
lowing (adapted from USNRC, 2000a):
.
49
The criteria are inconsistent and incomplete. The absence of uniform
criteria for controlling solid materials results in inconsistent release lev-
els. Licensees also can have difficulty determining what information to
provide for USNRC approval because the existing guidance and criteria
may not be clear.
· The criteria are not risk informed. The current detection-based approach
does not relate regulatory requirements to the potential risk that might be
associated with the regulated activity.
· Expenditures of time and resources are required to resolve specific cases.
Each review involves establishing and justifying criteria for that case.
DOE Standards on Clearance of Solid Materials
DOE's standards for surface contamination are set forth in Order DOE
5400.5,9 which incorporates Table I, the surface-activity standards, from
USNRC's Regulatory Guide 1.86. At about the same time as the issuance of
Regulatory Guide 1.86, the regulatory staff at the AEC were asked to develop
solid release standards for volume-contaminated materials from modification of
the uranium enrichment plants (see Chapter 5 for a discussion of NUREG-0518~.
The development of that standard was set aside after publication of NUREG-
0518 (USNRC, 1980~. Since then, DOE has maintained a policy that generally
precluded the release of radioactively contaminated materials for unrestricted use
or disposal. Not until Assistant Secretary of Environmental Management Alvin
Alm issued a policy statement in September 1996 promoting, on a provisional
basis, the recycling of radioactively contaminated scrap steel did DOE formally
alter its long-standing policy against unrestricted release of contaminated materi-
als. DOE's release policy had initially focused narrowly on restricted end uses of
recycled steel at DOE facilities. It was subsequently broadened, at least unoffi-
cially, to include recycling into industrial and consumer products generally.
The 1996 policy change was implemented on a conditional basis while DOE
evaluated the safety and economics of recycling these materials. The first large-
scale project involving the recycling of radioactively contaminated materials was
initiated at the Oak Ridge Reservation's gaseous diffusion plants, which contain
border DOE 5400.5, Radiation Protection of the Public and Environment, Department of Energy,
February 8, 1990, revised January 7, 1992. A DOE memorandum dated November 17, 1995, from
R.F. Pelletier, provided field and program offices with additional guidance regarding control of
residual radioactive material, including the relationship of DOE standards to similar standards set by
the USNRC and the states.
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more than 100,000 tons of contaminated metals (EPA, 1997a; NRC, 1996~. The
Oak Ridge project was intended to establish a precedent for a much broader
reliance on reuse of radioactively contaminated materials throughout the nuclear
weapons complex (NRC, 1996~. Under current estimates, DOE facilities contain
about 1 million tons of contaminated metals that could be recycled (EPA, 1997a).
Contrary to the recommendations of a prior National Research Council re-
port (NRC, 1996), the Oak Ridge project proceeded with little public outreach,
and it ultimately provoked significant opposition from the public and the metals
recycling industry. In response to this strong opposition from both the private
sector and the public, Secretary of Energy Bill Richardson halted further releases
of volume-contaminated metals but not surface-contaminated metals from
DOE facilities in January 2000. The moratorium was limited to volume-contami-
nated metals because no generally accepted regulatory standard or guidance ex-
isted. In July 2000, Secretary Richardson reaffirmed this moratorium on volume-
contaminated materials and added a temporary suspension on unrestricted
recycling of all scrap metal originating from within radiologically controlled
areas. He proposed continuing the moratorium and suspension until the USNRC
resolved whether to proceed with promulgating a standard governing the clear-
ance of radioactively contaminated solid materials. DOE, however, recently ini-
tiated the process for drafting a programmatic environmental impact statement on
alternatives for recycling surface-contaminated metals (DOE, 2001~.
The EPA Role
Under the ALA and Reorganization Plan No.3 of 1970, the EPA has respon-
sibility for establishing radiation standards, with which USNRC's and DOE's
standards must conform. EPA has used its AEA authority to promulgate stan-
dards such as 40 CFR Part 190, which sets limits on doses received by members
of the public from nuclear power operations. Pursuant to other statutes, EPA has
promulgated radiation standards for air emissions and safe drinking water levels.
Under the Safe Drinking Water Act, the EPA established a 4 mrem/yr standard
for the dose that an individual is permitted to receive from drinking water (40
CFR Parts 141-142~. This standard is based on a single pathway of exposure,
under which an individual consumes 2 liters of water per day from a single source
of drinking water. Under the Clean Air Act, the EPA promulgated the National
Emission Standards for Hazardous Air Pollutants (NESHAP), which permits a 10
mrem/yr dose to the reasonably maximally exposed individual from airborne
emission of radioactive materials (40 CFR Part 61~. The basis for this standard
includes multiple exposure pathways, including exposure from airborne plumes,
inhalation, and ingestion of foods on which radioactive materials have been
deposited.
In August 1997 the EPA issued guidance on residual levels of radionuclides
permitted under the Comprehensive Environmental Response, Compensation,
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51
and Liability Act (CERCLA) (EPA, 1997b). The agency premised its standard on
the policy that remediation goals for radionuclides should be consistent with a
lifetime risk ranging from 10= to 10-6. According to EPA guidance, clearance
levels for CERCLA sites cannot result in a dose that exceeds 15 mrem/yr, which
EPA guidance states "equates to approximately 3 x 10= increased lifetime risk"
(EPA, 1997b).
In the context of evaluating potential clearance, or de minimis, standards, the
EPA has provided technical analyses in the form of two major studies. In 1997 it
completed a draft technical support document, Evaluation of the Potential for
Recycling of Scrap Metals from Nuclear Facilities (EPA, 1997a), and a cost-
benefit analysis, Radiation Protection Standards for Scrap Metal: Preliminary
Cost-Benefit Analysis (EPA, 1997c).
The focus of EPA standard setting for unrestricted release has been on pro-
moting consistent international import-export controls for materials containing
residual radioactivity. This issue has become increasingly important with the
erosion of regulatory controls at nuclear facilities in the countries of the former
Soviet Union. A number of incidents have occurred in the United States and
elsewhere in which radioactive materials have been discovered in scrap metal
loads at steel mills and, less frequently, have contaminated the metal used to
fabricate consumer products as in the Ciudad Juarez, Mexico, incident in 1983
(Lubenau, 1998~.
In 1998 the EPA began to work with the International Atomic Energy Agency
(IAEA) on clearance issues and import-export standards. EPA personnel initially
worked on technical issues in an effort to promote agreement between the parties
on appropriate methodologies for estimating exposure levels.
Control of TENORM
Naturally occurring radionuclides are found throughout the United States,
primarily in the form of elements such as uranium, thorium, radium, potassium,
and radon gas (NRC, 1999~. Industrial activities such as oil and gas extraction,
water treatment, mining, fossil fuel processing, and aluminum production gener-
ate tens of billions of metric tons of TENORM, some of which contain high
levels of radioactivity (NRC, 1999~. However, TENORM is not subject to the
AEA because it cannot be classified as a source material, special nuclear mate-
rial, or byproduct material.
Federal regulation of TENORM has been largely absent. In 1986 the Radon
Gas and Indoor Air Quality Act directed the EPA to study the dangers of
TENORM, particularly radon gas. After completing this study, the EPA drafted
proposed rules to regulate TENORM under the Toxic Substances Control Act,
which gives EPA the authority to regulate chemical substances, including those
that are naturally occurring, that may present an "unreasonable risk of injury to
health or the environment" (EPA, 1989~. The EPA's draft proposed rules were
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52
THE DISPOSITION DILEMMA
stayed indefinitely. An exception to this void in regulating TENORM is Order
DOE 5400.5, which DOE issued under its general responsibility to protect health
and safety in conducting activities authorized under the AEA.
This regulatory gap persists despite the fact that many forms of TENORM
can be substantially more radioactive than LLRW subject to regulation under the
AEA (NRC, 1999~. The existing state regulations that apply to TENORM have
largely been limited to disposal and handling requirements enacted under the
state's general radiation protection laws or under other authority, such as the
Resource Conservation and Recovery Act. The Conference of Radiation Control
Program Directors (CRCPD) has drafted model state regulations for TENORM,
but these have been neither finalized nor adopted by any states. State regulations
remain limited and vary greatly from state to state (CRCPD, 1997~.
STAKEHOLDER INVOLVEMENT
As noted earlier, the current evaluation of clearance of solid materials by the
USNRC is not the first time it has attempted to update and formalize guidance for
unrestricted releases of SRSM. The most notable prior attempts were those in
1986 and 1990 (discussed above) to establish policy and guidance for solid
materials whose residual radioactivity would be "below regulatory concern."
These attempts and the subsequent stakeholder reactions provide invaluable in-
sight into the current USNRC effort to establish uniform standards for release of
SRSM.
After the 1990 BRC policy statement was published in the Federal Register
(55 Federal Register 27522; July 3, 1990), the USNRC held public meetings in
five cities (USNRC, 1991a). These meetings were contentious and well attended
by representatives of a large number of stakeholder groups. The USNRC esti-
mated that more than 900 people attended, and oral statements were taken from
215 people. The oral statements were supplemented by numerous written ques-
tions and comments. "The prevailing sentiment expressed at each of the meetings
was one of opposition to the BRC policy and to its implementation" (USNRC,
1991a).
In 1991 the USNRC staff reported that three themes were common to the
five public meetings. First, "extreme concern was expressed concerning the pos-
sibility of deregulation of nuclear power waste." Second, many attendees from
the public (including a large number of environmental groups) stated their strong
opposition to recycling of materials that could be used in unlabeled consumer
products. Third, many attendees perceived that the policy would "permit a large
number of deaths per year per practice despite the presence of collective dose
criterion" (USNRC, 1991a). In short, stakeholders' concerns expressed at the
meetings centered on whether the USNRC could adequately protect the public.
Many of these stakeholders also expressed the belief that low levels of radia-
tion were much more harmful than the regulatory agencies had determined them
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THE REGULATORY FRAMEWORK
53
to be. This expressed fear was compounded by concerns that it would not be
possible to monitor solid materials adequately for radioactivity when they were
being surveyed before release. Many of the stakeholders also raised two closely
related issues. First, many alleged that the regulatory system failed to take into
account multiple exposures. Second, general standards for release would under-
mine individual rights to decide the nature and magnitude of the risks to which
members of the public would be exposed. These issues continue to be central to
stakeholder criticisms. Most of the stakeholder concerns still revolve around
safety and protection of the public.
The nuclear industry strongly supported the 1990 BRC policy, as did a few
other stakeholder groups, on the grounds of economic and resource efficiency.
However, the sheer number of groups opposing the policy; the intensity of their
viewpoints; and their consistency in raising issues of public health, safety, and
welfare doomed this policy from the outset. After the policy was announced in
1990, the USNRC hired a consultant to begin a phased consensus-seeking pro-
cess. This effort collapsed shortly after it started because public interest groups
refused to engage in the process (USNRC, l991b). As noted above, Congress
formally nullified the BRC policy as part of the Energy Policy Act of 1992. Even
before Congress acted, the USNRC issued a moratorium on the BRC policy in
July 1991 (56 Federal Register 36068-36069; July 30, 1991~; after the Energy
Policy Act was signed into law, the USNRC rescinded the policy in August 1993.
The BRC policy was defeated largely by the efforts of these public interest
groups, which successfully used the political arena to expand the controversy
over the issue and to make the issue salient to a large number of stakeholder
groups and other interested parties.
The lines that were drawn in 1991 over the BRC policy do not seem to have
altered appreciably. Many of the public interest groups that the USNRC con-
cluded were indispensable to any effort to promote a consensus-seeking process
are adamantly opposed to the proposed USNRC rulemaking on SRSM. The only
shifts that have occurred are in the positions of officials from several states,
whose representatives had opposed the BRC policy solely because of concerns
that it would abrogate the states' enforcement authority. However, even among
the agreement states from which the committee has heard, there is no consensus
on the proposed rule. Many of those who addressed the committee questioned
whether such a rule is necessary at all. What lessons, if any, the USNRC has
learned from the BRC controversy is a question that the committee addresses in
Chapter 9.
FINDINGS
Finding 2.1. The USNRC does not have a clear, overarching policy statement for
management and disposition of SRSM. However, SRSM has been released from
licensed facilities into general commerce or landfill disposal for many years
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54
THE DISPOSITION DILEMMA
pursuant to existing guidelines (e.g., Regulatory Guide 1.86) and/or following
case-by-case reviews. The USNRC advised the committee of no database for
these releases.
Finding 2.2. A dose-based clearance standard can be linked to the estimated risk
to an individual in a critical group from the release of SRSM. The general regu-
latory trend is toward standards that are explicitly grounded in estimating risks.
Finding 2.3. For clearance of surface-contaminated solid materials, the clearance
practices regulated by the USNRC and agreement states are based on the guid-
ance document Regulatory Guide 1.86, which is technology based and has been
used satisfactorily in the absence of a complete standard since 1974.
Finding 2.4. For clearance of volume-contaminated solid materials, the USNRC
has no specific standards in guidance or regulations. Volume-contaminated SRSM
is evaluated for clearance on a case-by-case basis. This case-by-case approach is
flexible, but it is limited by outdated, incomplete guidance, which may lead to
determinations that are inconsistent.
Finding 2.5. Industrial activities are generating very large quantities of techno-
logically enhanced naturally occurring materials (TENORM). Federal regulation
of TENORM has been largely absent. State regulations vary in breadth and depth.
Representative terms from entire chapter:
radioactively contaminated
