United Slates
Environmental Prote
Agency
Air And Radiatioi
High-Level And Transuranic
Radioactive Wastes
Response To Comments
For Amendments To
40 CFR Part 191
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EPA 402-R-93-072
RESPONSE TO COMMENTS FOR AMENDMENTS TO
40 CFR PART 191
ENVIRONMENTAL STANDARDS FOR THE MANAGEMENT AND DISPOSAL OF
SPENT NUCLEAR FUEL, HIGH-LEVEL AND
TRANSURANIC RADIOACTIVE WASTES
December 1993
U.S. Environmental Protection Agency
Office of Radiation and Indoor Air
Washington, D.C. 20460-0001
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TABLE OF CONTENTS
1. INTRODUCTION 1-1
2. POLICY ISSUES 2-1
PI. Opportunity for Public Comment 2-1
P2. Scope of Comments Permitted 2-2
P3. Ground-Water Protection 2-3
P4. Compliance with UIC Requirement 2-10
P5. Release Scenarios 2-16
P6. Use of Engineered Barriers 2-17
P7. Implementation Guidance in Standard 2-18
P8. Above-Ground Waste Storage 2-19
P9. Potential Use of Standards at Sites Other Than WIPP 2-19
P10. General ,.„..„. 2-23
3. TECHNICAL ISSUES 3-1
Tl. Regulatory Time Period 3-1
T2. Individual Dose Limit 3-3
T3. Background Information Document 3-7
T4. Economic Impact Analysis 3-10
T5. General , 3-11
4. APPENDIX A - LIST OF COMMENTERS A-l
5. APPENDIX B - ACRONYMS B-l
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Chapter 1. INTRODUCTION
The U.S. Environmental Protection Agency (EPA) has the responsibility of developing and
promulgating the Federal environmental standards for spent nuclear fuel, high-level and
transuranic radioactive wastes. Standards for disposal were first promulgated in 1985. The
standards were challenged in court in 1987 and Subpart B was remanded to the Agency for
further consideration. The court found that the bases for the ground-water and individual
protection requirements were insufficient. Following the court decision, the Agency began
developing the necessary technical bases and preparing to reissue the standards.
In 1992, the Waste Isolation Pilot Plant Land Withdrawal Act (WIPP LWA) reinstated the
1985 disposal standards, Subpart B, except for the portions that were the subject of the
remand. The legislation requires the Agency to issue final disposal regulations and specifies
that the regulations shall not be applicable to sites characterized under Section 113(a) of the
Nuclear Waste Policy Act (Public Law 97-425).
In response to the WIPP LWA, the Agency published the proposed amendments to
40 CFR 191 in the Federal Register on February 10, 1993 (58 FR 7924). The proposal
addressed a portion of the underground injection control (UIC) program regulations (40 CFR
144.31) and the portions of 40 CFR Part 191 that deal with individual and ground-water
protection.
*•
This document addresses comments received on the proposed regulations. Comments were
initially solicited by the Agency for a 40-day period beginning with the publication of the
Federal Register notice. In response to input from the public, the comment period was
extended until April 12, 1993. Public hearings were held in Carlsbad, Albuquerque, and
Santa Fe, New Mexico. In addition, written comments were received from individuals and
organizations. Comments were also received on the Background Information Document and
the supporting technical documents.
The comments were categorized as either policy issues or technical issues. These groups
were then subdivided into the following areas:
Policy Issues
PI. Opportunity for Public Comment
P2. Scope of Comments Permitted
P3. Ground-Water Protection
P4. Compliance With UIC Requirements
P5. Release Scenarios
P6. Use of Engineered Barriers
P7. Implementation Guidance in Standard
P8. Above-Ground Waste Storage
P9. Potential Use of Standards at Sites Other Than WIPP
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P10. General
Technical Issues
Tl. Regulatory Time Period
T2. Individual Dose Limit
T3. Background Information Document
T4. Economic Impact Analysis
T5. General
The Agency has considered all substantive and relevant comments, both written and oral.
This document summarizes the concerns expressed by the commenters and presents the
Agency's response to the comments. Some comments addressed parts of the standards that
are not under the purview of this rulemaking and thus are not all listed in this document.
EPA has decided not to reopen, at this time, the portions of the standards which have been
reinstated by the WIPP LWA. Each commenter is identified by a letter and a number after
the comment. In the interest of clarity and economy, some comments are paraphrased and
some closely related comments are combined. Policy issues are addressed hi Chapter 2 and
technical issues are addressed in Chapter 3. A list of the commenters and their identification
numbers is given in Appendix A. A list of acronyms and the terms they represent are in
Appendix B.
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Chapter 2: POLICY ISSUES
PI. Opportunity for Public Comment
Comment P1.A1: The public comment period is too short.
(A-04,13,14,22,29,30,32,45,61,63),
(D-07,19,20,24,36,39,40,41,42,53,60,62,73,88),
(S-06,07,11,26,29,30,31,32,33,34,37,41,49,50,54,55,59,63,75,83,88,90,93,96,101,104)
Comment P1.A2: The public comment period should be extended to 60 days. (S-09,22,57),
(D-53,60)
Comment PI.A3: The public comment period should be extended to 90 days. (S-56)
Response (Comments P1.A1 through 3):
In response to public comments, the comment period deadline was extended
from March 22, 1993 to April 12,1993.
Comment P1.B1: Additional public hearings should be conducted in states other than New
Mexico. (A-45,49), (D-04,08,16,20,65), (S-04,06,29)
Comment P1.B2: Citizens and/or agencies in Mexico should be allowed to comment on the
Standard because of WIPP's proximity to the border. (S-59)
Response (Comments P1.B1 through 2):
The Agency believes that the most relevant comments to the proposed
Standard would be in the state of New Mexico because of the research being
conducted at the WIPP facility. The Agency therefore opted to accept
comment via public hearings in that state. The Agency did not limit or deter
any individual from commenting in written form or speaking at these public
hearings. Furthermore, comments received in writing receive the same
consideration as public testimony at a hearing.
Comment P1.C1: The revised standard should be subject to an additional review cycle.
(D-04), (S-14,87)
Response:
The Agency believes the present process provides adequate review and is in
accord with the Administrative Procedure Act (5 U.S.C. 553).
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P2.
Scone of Comments Permitted
Comment P2. Al: Public comments should be accepted for the entire Part 191, not just the
individual and ground-water protection portions. (A-25,32,49),(D-22,26,40,49,51,53,
54,62,64,73), (S-04,08,11,28,31,33,34,51,55,56,57,59,68,69,82,89,90,92,93,94)
Comment P2.A2: By accepting comments only on the individual and ground-water
protection requirements, EPA has violated both the intent of Congress in the WIPP Land
Withdrawal Act and the ruling of the Appeals Court in the 1987 remand. (S-02,93),
(D-24,71,73)
Comment P2.A3: New definitions in the proposed Standard affect the entire Standard.
Therefore the entire standard should be open for public comment. (A-06),(D-49,53)
Comment P2.A4: DOE has agreed to limit the scope of its comments to the individual and
ground-water protection requirements, as requested by EPA in the Federal Register notice
and in the interest of complying with the timetable for issuing final disposal regulations.
Limiting DOE's comments to these specific provisions, however, does not negate previous
comments provided to EPA on four working drafts of revised disposal regulations. (D-87)
Comment P2.A5: EPA should review all public comments. (D-53,54)
Comment P2.A6: EPA should commit to reevaluate the Standard if it is ever applied to a
commercial spent fuel repository. (D-77)
Response (Comments P2.A1 through A6):
The EPA stated its position and reasoning for reviewing only the individual
and ground-water protection requirements in the Federal Register notice
containing the proposed rule (58 FR 7924) and has done so again in the
preamble to the final rule. The Agency acknowledges the court action
remanding all of Subpart B of the 1985 Standards (50 FR 38066), but also
accepts the Congressional reinstatement of the original Standards with the
exception of the sections being reviewed here, which were also the focus of
the remand. Any regulation applicable to disposal at sites required to be
characterized under §113(a) of the Nuclear Waste Policy Act of 1982 will be
subject to a separate rulemaking.
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P3. Ground-Water Protection
Comment P3.A1: No explanation is given for the departure from the four millirem (mrem)
dose limit in the SDWA. (S-91)
Comment P3.A2: A higher standard should be applied for the protection of especially
valuable ground water. (A-05,09,21,59), (D-03,07,38,39,51)
Comment P3.A3: EPA should develop a no-degradation requirement for especially valuable
ground water. (D-76)
Comment P3.A4: A zero-degradation criterion should be applied for ground-water
protection.
(A-22,32,34,45,49,52,53),(D-01,03,04,06,07,15,20,29,37,40,41,42,51,53,54,55,62,64,
68,83), (S-03,13,14,22,26,30,31,32,33,34,38,49,51,54,55,57,58,68,82,89,94,95,96,105)
Comment P3.A5: Any ground-water contamination at WIPP is unacceptable. (A-30)
Comment P3.A6: All ground water should be protected from contamination. (S-17,38,102),
(D-89)
Comment P3.A7: The proposed Subpart C should not be adopted. (S-14)
Comment P3.A8: The maximum contaminant levels (MCLs) should not be applied to any
underground sources of drinking water (USDWs). Ground water is already adequately
protected by the containment and individual protection requirements. (D-77)
Response (Comments P3.A1 through 9):
In the early 1980s, EPA recognized that the legal bases for protection of ground water
were scattered among numerous authorities and largely undefined. In 1984, the
Agency adopted a Ground-Water Protection Strategy which presented, for the first
time, a consolidated statement of EPA's ground-water policy. A primary goal of this
policy was to protect ground water according to its value and use. The most
beneficial use of ground water is as drinking water. More pertinent to the present
rulemaking, in 1986, a number of States and environmental groups filed petitions for
review of EPA's standards for the management and disposal of spent nuclear fuel,
high-level and transuranic waste, 40 CFR 191, 50 FR 38066. The petitions were
consolidated in the First Circuit. The court issued its ruling on July 17, 1987, NRDC
v. EPA. 824 F. 2nd 1258 (1st Cir. 1987) and remanded all of Part 191, including the
individual and ground-water protection requirements, for further consideration of their
inter-relationship with Part C of the Safe Drinking Water Act (SDWA), among other
issues. The court emphasized the parallel environmental goals that exist in the
SDWA and the Atomic Energy Act and found that EPA had not adequately explained
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why the Part 191 standards were different from those of the SDWA. In accord with
the court's findings, EPA does not believe there are persuasive scientific or policy
reasons for going forward with a level of radiation protection less stringent than
would apply under the SDWA. Therefore, the Agency is adopting the MCLs for
radionuclides to protect USDWs outside the controlled area. This approach is also
consistent with EPA's overall ground-water protection strategy ("Protecting The
Nation's Ground Water: EPA's Strategy for the 1990's," EPA 21Z-1020, July 1991).
Accordingly, MCLs under the SDWA are to be used as "reference points" for water
resource protection efforts when the ground water in question is a potential source of
drinking water. Breaching an MCL would be considered a failure of prevention. For
these legal and policy reasons, the Agency believes that MCLs are the appropriate
level of protection for USDWs in the accessible environment. The following
discussion considers other levels of protection contemplated by the Agency.
The Agency took comment as to whether there could be some types of ground water
that warrant additional protection either because they are unusually valuable or are
more susceptible to contamination. The Agency had attempted to accomplish this
while developing its ground-water protection strategy. The 1984 Ground-Water
Protection Strategy proposed a category of ground water called Class I, which is
generally characterized as both highly vulnerable to contamination and either an
irreplaceable source of drinking water for a substantial population or a valuable
ecological habitat. After issuing draft guidelines for ground-water classification in
1986, which further defined three classes of ground water, including Class-I ground
waters, the Agency did not codify these classes but left the draft classification system
as an example to assist States in their classification efforts. Comments on the draft
ground-water classification proposed by EPA revealed that numerous States had
established their own classification systems for ground water, usually tailored to their
specific needs. For the present rulemaking, the Agency evaluated whether other
Agency water protection programs used this approach and found some do but to a
much more limited degree and with different purposes. One primary difficulty is in
legally defining the ground water that deserves special protection in the context of a
standard covering such an extended time period as does Part 191. Another difficulty
is the choice of the level of protection. Some level affording greater protection than
the MCLs might be set at some fraction of the MCLs. The Agency has not found or
been given a convincing reason for picking any specific fraction of the MCLs as a
standard in demonstrating compliance. The Part 191 standards are design standards
and will likely rely upon computer modelling over extended time periods. Given the
uncertainty associated with such modelling and the presumed lack of institutional
controls, it will be exceedingly difficult and probably impossible to demonstrate
absolutely no degradation of surrounding ground water over thousands of years.
The Agency is interested in protecting all ground water. The final rule accomplishes
this by providing both individual protection requirements (40 CFR 191.15) and
standards for ground-water protection (Subpart C of 40 CFR 191). (The containment
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requirements at 40 CFR 191.13 protect populations from repository releases.) While
Subpart C protects USDWs, the individual protection requirements limit doses
delivered via all pathways of radiation exposure, except for water withdrawn from the
controlled area. Thus, if ground water in the accessible environment is used for
irrigation, for example, such exposures would fall under the umbrella of the
individual dose requirements. Subpart C, on the other hand, covers radiation
exposures delivered through a single pathway, drinking contaminated water from a
USDW in the accessible environment.
Comment P3.B1: EPA proposes to require a disposal facility to comply with the provisions
of whatever EPA drinking water standards are in effect at the time when compliance is
demonstrated. This constitutes a "moving target" that will make it difficult to design a
disposal facility. It is also impossible to evaluate the stringency of the proposed standards or
the technical or economic practicality of achieving compliance with them. EPA should
determine a fixed level of ground-water protection to codify in the standard. (D-58,78)
Comment P3.B2: Compliance with the ground-water protection requirements is based on a
one-time assessment using the MCLs in effect at that time. If the MCLs subsequently
change, a demonstration of compliance using the new MCLs should be required. (D-71)
Response (Comments P3.B1 through 2):
The final rule states that the MCLs applicable to a disposal system shall be those
MCLs that exist in 40 CFR 141 on the effective date of subpart C. The Agency
believes that it is more reasonable to adopt established MCLs rather than speculative
future MCLs. This establishes a specific goal for disposal system designers and
reviewers of those plans. The Agency desires Part 191 to remain current with the
MCLs and has, therefore, stated in the preamble that when the radionuclide MCLs
change in the future, the Agency will revise Part 191 to be consistent. This
represents a change from the February 1993 proposal, which would have imposed on
a disposal system those MCLs in existence at the time the implementing agency
determines compliance. Note, however, that in a case where the agency should
change the MCLs in part 141 and amend part 191 to incorporate these changes before
the date of a compliance determination, the new set of MCLs would then apply.
The USDWs to which the aforementioned MCLs would apply are those which have
been identified as of the date on which a compliance determination of the disposal
system occurs. The Agency recognizes that there may be disposal systems for which
multiple determinations of compliance will be made during the system's operational
phase. Any USDWs identified after one determination of compliance must be
considered in the next determination. For example, should a new USDW be
identified after an initial compliance determination has been made, such a USDW
would have to be taken into consideration in the next compliance determination.
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Comment P3.E4: EPA's proposed groundwater protection standards restrict the combined
concentrations of natural and man-made radionuclides from all sources. This is a substantial
departure from EPA's 1985 standards, which restricted the incremental increase in
groundwater concentrations caused by a disposal facility. EPA should allow an incremental
increase, above natural levels, unless EPA can demonstrate that doing so would unacceptably
endanger the health of the public. (D-78)
Response (Comments P3.E1 through 2):
The Agency proposed to apply the MCLs to USDWs and has chosen to incorporate
the current MCLs as the quantitative measure for protection of USDWs. The Agency
has not been convinced that limits different from those acceptable in the regulations
developed under the SDWA are justified for the situations covered in this rulemaking.
The EPA considered applying the MCLs incrementally, that is using the MCLs as the
measure of allowable contamination from sources other than natural background.
However, in those situations where there are pre-existing concentrations of
radionuclides, this approach would not prevent additional contamination of a USDW
by a disposal system. Such additional contamination, if allowed to occur in a quantity
as great as the quantity that would result in contamination at the level of the MCLs,
could cause the total concentration of contaminants to greatly exceed the health-based
MCL concentration. Conversely, the Agency's approach in Part 191 will prevent
contamination exceeding MCLs without imposing an unreasonable burden on siting or
licensing disposal systems.
The Agency recognizes there may be situations in which a potential disposal site is
located in the vicinity of a USDW which already contains contaminants. Under the
proposed Part 191 standards, a potential disposal system, chosen for its superb
capability for isolating wastes, could be precluded from consideration in an area with
elevated levels of radionuclides because of the difficulty or impossibility of adequately
demonstrating that not a single atom or molecule would be released if that release
could cause exceedance of an MCL. Accordingly, EPA has added a new §191.26 to
subpart C that sets forth procedures under which the Administrator could develop
alternative provisions should the situation of pre-existing elevated levels of
radionuclides arise. In such circumstances, EPA believes it is reasonable to consider,
on a case-by-case basis, pre-existing concentrations in USDWs in the vicinity of the
disposal site along with the isolation capabilities of the disposal site when applying the
MCLs.
In particular, an alternative provision would allow for the siting of a good disposal
system that has a reasonable expectation of adding only an insignificant amount to
existing background concentrations, i.e., an amount that would not significantly
increase the effect of contamination on human health and the environment. In
contrast, without a de minimis provision, the difficulty or impossibility of adequately
demonstrating that not a single atom or molecule would be released from the disposal
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system would prevent its being sited in an area that already exceeds the MCLs. In
this way, a disposal system offering effective isolation is not precluded just because a
USDW in the vicinity suffers from elevated background concentrations. At the same
time, a de minimis approach limits the potential for a disposal system to cause or
contribute to exceedance of the MCLs to only those amounts that, as a legal and
technical matter, are trivial.
The Agency's experience in applying the MCLs has always had public health and
environmental protection as the primary goal. EPA is not aware of any grounds for
departing from that goal in adopting the MCLs in the Part 191 standards being
promulgated in this final action or in providing for alternative standards in §191.26.
Nevertheless, in situations where there is an existing background concentration above
the MCLs, EPA believes that provisions should be made to allow a disposal system to
add a de minimis amount to that concentration. De minimis exceptions from
regulatory requirements are generally permissible, except where Congress has
explicitly precluded them. See, e.g. Alabama Power Co. v. Costle. 636 F. 2d 323,
360-61 (D.C. Cir. 1979). None of the sources of statutory authority-the Atomic
Energy Act, Reorganization Plan No. 3 of 1970, the Nuclear Waste Policy Act, and
the WIPP Land Withdrawal Act—upon which EPA relies in this rulemaking contain
such a prohibition. Accordingly, de minimis exceptions are legally permissible. This
approach for considering pre-existing natural or anthropogenic concentrations
maintains environmental and public health protection as the paramount goal but allows
the regulatory agency limited discretion to consider the use, value and vulnerability of
the ground water in question in establishing site-specific limits in accordance with
Agency policy.
Under the SDWA, variances may be issued under sections 1415 or 1416. These
apply to public water supply systems and both sections require that some compliance
schedule and actions be established to return to compliance. While more flexible
limits or variances may be appropriate during a period of active institutional control,
such governmental controls cannot be expected beyond the institutional control period
applicable to a geologic repository. Given such a long regulatory time period with no
presumed institutional controls, 40 CFR 191 establishes environmentally protective
standards in the context of a pre-operational compliance assessment to encourage the
selection of geologies offering long-term isolation and good engineering designs.
CommentP3.FJ: The entire controlled area should be excluded from ground-water use in
performance assessments. (D-87)
Comment P3.F2: EPA states (58 FR 7929) that use of ground water within the controlled
area need not be considered when evaluating compliance with the individual protection
requirements. NRC agrees with this view, but is concerned that the wording of EPA's
standards might permit other interpretations. (D-58,78)
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Response (Comments P3.F1 through 2):
The individual protection requirements and ground-water protection
requirements apply to undisturbed performance. Therefore, if an individual
intrudes into the controlled area to obtain water for drinking or other purposes,
such exposures are not to be considered in the context of the individual or
ground-water protection requirements. However, if water from the controlled
area would contaminate, through likely processes and events, water in the
accessible environment, radiation doses resulting from such contamination
would have to be included in the analysis of individual doses or the ground-
water protection requirements.
Comment P3.G1: In section 191.24(b), it would be helpful to substitute "performance
assessment" for "compliance assessment." (D-58,78)
Response:
The term "performance assessment" is already defined in 40 CFR 191 and has
particular meaning and application to 40 CFR 191.13, Containment Requirements.
As such, the term "performance assessment" incorporates the consideration of all
pertinent disruptive events which relates to the examination of disturbed performance.
The final amendments to 40 CFR 191 relate to ground-water contamination and
individual doses delivered through all pathways which occur as a result of the
undisturbed performance of the repository. Therefore, the Agency believes the term
"compliance assessment" is a more appropriate term to describe the kind of
assessment required for the individual and ground-water requirements in the context
of an analysis of undisturbed performance to prevent confusion with the term
"performance assessment".
P4. Compliance with UIC Requirements
Comment P4.A1: Disposal in a repository constitutes underground injection and therefore
must comply with all requirements of the SDWA [SDWA § 1421(b)(3)(c)]. (A-05)
Comment P4.A2: It needs to be clarified whether or not a geologic repository constitutes
underground injection. (C-01),(A-01),(S-01),(D-23)
Response (Comments P4.A1 through 2):
In the preamble to the proposed Part 191 amendments, EPA stated that it was not
necessary to address whether the disposal of radioactive waste in a geologic repository
covered under Part 191 constitutes underground injection under the SDWA since the
proposed Part 191 standards conformed with the MCL standards for radionuclides
under the SDWA. EPA maintains this position and, in further explanations in the
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final rule, the Agency has concluded that the underground disposal of containerized
radioactive waste in geologic repositories subject to the Part 191 standards does not
constitute underground injection within the meaning of the SDWA or EPA's
regulations governing the UIC program. In keeping with these further explanations,
EPA has revised that portion of the proposed rule that amended Part 144 by
withdrawing that proposed amendment.
Section 1421 of the SDWA defines "underground injection" as "the subsurface
emplacement of fluids by well injection." 42 U.S.C. § 300h(d)(l). The statute
defines neither "fluids" nor "well injection." Moreover, neither the statute nor the
legislative history directly addresses whether the underground disposal of
containerized radioactive waste constitutes the "subsurface emplacement of fluids by
well injection." Even though the legislative history states, "[tjhe definition of
'underground injection' is intended to be broad enough to cover any contaminant
which may be put below ground level and which flows or moves, whether the
contaminant is in semi-solid, liquid, sludge, or any other form or state," H.R. Rep.
No. 1185, 93d Cong., 2d Sess. 31 (1974), the legislative history does not specifically
address whether the underground disposal of containerized radioactive waste into
geologic repositories of the type covered by these Part 191 rules constitutes the
"subsurface emplacement of fluids by well injection."
The EPA has concluded that the underground disposal of containerized radioactive
waste in geologic repositories subject to Part 191 does not constitute underground
injection both because the materials to be emplaced are not "fluids" and because the
mode of emplacement of these materials is not "well injection."
The EPA does not consider the type of containerized radioactive wastes which are
covered under Part 191 to be "fluids." Instead, the wastes, which consist almost
entirely of solid materials themselves are enclosed in steel or metal barrels and drums
or other types of containers. The Agency does not believe the SDWA's reference to
"subsurface emplacement of fluids" was intended to address the subsurface disposal of
solid or containerized materials.
The position adopted by the Agency, furthermore, is consistent with the legislative
history of the SDWA. In floor debate in 1980, Senator Domenici stated that "the
[UIC] regulations would cover all types of injection wells, e.g., industrial and nuclear
disposal wells, oil and gas wells, solution mining wells or any hole in the ground
designed for the purpose of injecting water or other fluids below the surface." See
126 Cong. Rec. 30189 (November 19, 1980)(remarks of Sen. Domenici, emphasis
added). Similarly, when amending the SDWA in 1985, Congress stated "underground
injection is the process of forcing liquids underground through a well." (H.R. Rep.
No. 168, 99th Cong., 1st Sess. 540, 1985). In both instances, the legislative intent
was focused on the injection of liquids, not the containerized solids to be disposed of
in radioactive waste repositories.
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Reflecting this statutory approach, EPA's UIC regulations similarly do not treat
containerized radioactive wastes as fluids or liquids for the purpose of control under
the UIC program. EPA's regulations at 40 CFR 146.3, tracking the legislative
history, define "fluid" as "material or substance which flows or moves whether in a
semisolid, liquid, sludge, gas, or any other form or state." In adopting this
regulatory definition of fluid, EPA did not consider the emplacement of containerized
radioactive wastes in geologic repositories to be fluids subject to the UIC regulations.
EPA's past stated policy on well injection clearly is directed at other than
containerized solid materials. Administrator's Decision Statement #5 (39 FR 12922),
defines parameters for well injection which include data requirements for volume,
rate, injection pressure of the fluid, degree of fluid saturation, and formation fluid
pressure.
EPA has never interpreted its UIC regulations to encompass the subsurface
emplacement of containerized wastes or solid materials that do not flow or move.
EPA has stated instead that in general the placement of containerized hazardous waste
in geologic repositories such as underground salt formations, mines, or caves, is
regulated under the Subtitle C of the Resource Conservation and Recovery Act
(RCRA) hazardous waste program.
EPA specifically addressed the status of containerized waste under RCRA and SDWA
in the preamble to the final rule promulgating standards for hazardous waste
miscellaneous units under Subpart X of the RCRA regulations at 40 CFR 264. See
52 FR 46946, 46952 (December 10, 1987). As EPA indicated in the preamble to the
Subpart X regulations, the 40 CFR 146 technical standards do not address practices
other than the injection of noncontainerized liquids, slurries, and sludges, and do not
fully address some potential disposal or storage practices that may fall under EPA's
regulatory definition of well injection. (52 FR 46953). In the Subpart X rule, EPA
provided that, to the extent that miscellaneous disposal practices subject to Subpart X
may be determined to be underground injection, a Subpart X permit would constitute
a UIC permit for well injection of hazardous waste for which current 40 CFR 146
technical standards are not generally appropriate. EPA stated, however, that it was
not "specifying that these miscellaneous management practices constitute underground
injection."
In NRDC v. EPA. 824 F.2d at 1258, the First Circuit was concerned that radiation
itself might be considered a fluid within the meaning of the SDWA and EPA's UIC
regulations at 40 CFR 146.3. The Agency believes that radiation itself does not meet
the UIC regulatory or statutory definition of "fluid." Radioactivity is a specific
characteristic of the waste but does not define the form of the waste. Radioactivity
results hi the emission from the waste of ionizing radiation in the form of
electromagnetic energy or subatomic particles. Electromagnetic radiation is a form of
energy, not a "material or substance," and hence not a "fluid." Subatomic particles,
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such as alpha and beta particles, will either be absorbed in the waste or the container
and, therefore, not travel beyond the container, or will travel very short distances in
comparison to the distance to the boundary of the controlled area. In any event, EPA
believes that since the activity at geologic repositories consists of the emplacement of
containers of radioactive wastes underground, this is emplacement of solid materials,
not "fluids." Even though these containers may eventually disintegrate or dissolve
and release some radiation, liquids, or gasses, the activity in question still consists of
emplacement of containers and solid materials that will not flow or move at the time
of emplacement underground.
Moreover, EPA does not consider the emplacement into geologic repositories of
containerized and solid wastes that do not flow or move to be subsurface emplacement
"by well injection." For example, at the WIPP, a potential repository subject to part
191, containerized waste will be placed in a mined underground repository, located in
a salt bed formation approximately 2150 feet below the earth's surface. The waste
containers are lowered mechanically down a vertical elevator shaft. Once
underground, the waste containers are transported and placed in rooms mined into the
formation or in underground horizontal boreholes in the salt formation. Once enough
containers are accumulated, the room is sealed. To date, approximately 15 acres of
underground disposal rooms have been mined.
The EPA's UIC regulations define "well injection" as "subsurface emplacement of
fluids through a bored, drilled or driven well, or through a dug well, where the depth
of the dug well is greater than the largest surface dimension." 40 CFR 146.3. A
"well" is defined as "a bored, drilled, or driven shaft, or a dug hole, whose depth is
greater than the largest surface dimension." IdL Although transmission of the
materials underground in geologic repositories such as the WIPP involves waste
handling "shafts," or "holes," these are elevator shafts or tunnels through which
containerized solid materials are transported, not "wells" into which fluids are being
"injected" within the meaning and intent of the SDWA or EPA's UIC regulations. In
addition, the overall configuration of a repository is, for example, a complete network
of interconnecting, mined rooms, and is far different from a "drilled," "driven," or
"dug" injection well.
EPA does not believe that the emplacement of containerized waste by conveyors or
elevators down a shaft should be covered under the UIC program. Such emplacement
is in no way similar to the pressurized or gravity-fed flow of fluids, liquids, or
sludges injected into a well that has been the traditional focus of the UIC program.
See 41 FR 36726, 36732 (August 31, 1976). Even Class-V wells, a general category
of injection wells not included in Classes I-IV, are not used for the disposal of
containerized waste. Class V covers the subsurface emplacement of fluids, usually by
gravity flow, into the injection well. Although Class-V wells include some types of
wells that may not traditionally be thought of as injection wells, e.g. septic systems,
all of these well types do involve the emplacement of noncontainerized fluids into
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drilled, bored, dug, or driven wells, typically through gravity flow rather than
pressurized flow.
Moreover, the regulatory criteria and standards applicable to underground injection,
contained in 40 CFR 144 and 146, have never been intended to apply to a geologic
repository. The concepts of area of review, pressure buildup and pressure
monitoring, restrictions on injection pressure and other operating requirements and the
mechanical integrity testing of injection wells that are included in the Part 146
regulations are meaningless as applied to geologic repositories. As noted above, some
of the repositories, like the WIPP, may be mined containment areas in which humans
operate mechanical equipment to transport waste packaged in containers surrounded
by both engineered and natural barriers designed to isolate such waste from the
environment. The UIC regulations are directed at injection of fluids by pressure or
gravity flow; this activity is different from an engineering perspective from the
subsurface emplacement of containerized wastes into geologic repositories.
EPA, in the final rulemaking of 40 CFR 191, has provided substantive protection of
the general environment equivalent to that called for under the SDWA by requiring
that MCLs be met at the boundary between the controlled area and the accessible
environment. Subpart C of 40 CFR 191 has incorporated the primary radiation
protections provided under the SDWA, namely, that such repositories be designed to
assure that the USDWs not be endangered, i.e., the radionuclide MCLs are not to be
exceeded in USDWs in the accessible environment.
Comment P4JB1: EPA's proposed amendment to 40 CFR 144.31 fails to fully comply with
the SDWA. (D-76)
Comment P4.B2: Subpart C, which changes the UIC requirements, is not legal because it
presumes to take away the states' authority to regulate the UIC program. This leaves states
out of the review process. (A-06), (D-04,24,29,53,60,64,71,73,89),
(S-02,03,06,11,15,30,34, 49,51,54,55,58,62,88,89,95,96,102,105)
Comment P4.B3: The Standard should indicate specifically which requirements of
40 CFR 144 are satisfied through compliance with 40 CFR 191. (D-82)
Comment P4.B4: EPA's claim that compliance with Part 191 constitutes compliance with
underground injection control requirements is unsubstantiated. (A-05)
Response (Comments P4.B1 through 4):
The Agency has decided to withdraw the proposed addition to the UIC regulations at
40 CFR 144.31(a). As indicated in the preamble to these final amendments, while
comments regarding a potential lack of procedural equivalence at potential disposal
sites other than WIPP may have some merit because detailed and extensive procedural
requirements for facilities other than WIPP are not specified, they may have no
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bearing on the outcome of this Part 191 rulemaking. In the final amendments the
Agency has determined that the disposal of radioactive waste in geologic repositories
is not underground injection, as explained in the response to comments P4.A. The
preemption effect of this determination, if any, cannot be determined in this
rulemaking, but rather must be addressed by the parties to any future proceeding that
seeks to apply State Underground Injection provisions to disposal systems. No other
repository is under consideration that is arguably within this category and, thus, there
is no prospect that disposal at such a repository would occur before EPA completes
rulemaking. The final rule reserves §191.24(a)(2) for further development of
provisions for disposal systems above or within a formation which within one-quarter
mile contains an underground source of drinking water. EPA is reserving final action
with respect to such repositories in order to explore in greater detail what effect, if
any, the prohibition on "class IV" wells under the SDWA regulations at
40 CFR 144.13 might have on them. The EPA will address this category of disposal
systems in the same context as its rulemaking to establish disposal standards for
Yucca Mountain pursuant to the 1992 Energy Policy Act.
Comment P4.C1: DOE is concerned about potential far-reaching impacts to the future of
deep geologic disposal of radioactive waste by application of the SDWA to facilities under
40 CFR 191. The key concerns are the potential implications of interpreting geologic
repositories as underground injection wells under the SDWA and the stringency of the
SDWA MCLs as they would apply to repositories under 40 CFR 191. (D-87)
Comment P4.C2: The SDWA should not be applicable to the disposal facility. (D-85)
Response (Comments P4.C1 through 2):
The promulgation of the final amendments to 40 CFR 191 addresses a significant
feature of the SDWA requirements, namely, that USDWs not be endangered. The
need for EPA to address this issue was clearly articulated by the findings of the court
in NRDC v. EPA. 824 F.2d 1258 (1st Cir. 1987). This is accomplished by limiting
radioactive contamination, caused by disposal that might endanger USDWs in the
accessible environment, to the MCLs. The Agency believes it is prudent to protect
ground-water resources from contamination rather than rely upon clean-up after the
ground-water has been contaminated. This helps to prevent present or future
community water suppliers from having to implement expensive treatment processes.
Also, in the final amendments, the Agency has concluded that the disposal of
radioactive waste in geologic repositories is not underground injection under the
provisions of the SDWA and regulations promulgated under its authority.
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P5. Release Scenarios
Comment P5.A1: Human intrusion should be included as a viable release scenario when
evaluating compliance with individual and ground-water protection standards. The
consideration of only the undisturbed performance of the repository is unrealistic.
(A-05,25,60), (D-03,04,07,22,39,49,53,62,71,89), (S-02,03,08,17,90,95)
Response:
The purpose of disposal systems is to contain radioactive materials in the area where
they are emplaced. This results in high concentrations of radionuclides within the
controlled area. An intruder would, therefore, be exposed to potentially large doses.
It is illogical to require both containment and dilution simultaneously. The Agency
has found no method of lowering individual doses other than at the expense of
potentially larger population doses. Therefore, the Agency has maintained the
exclusion of human intrusion from the individual and ground-water protection
requirements. It should be noted that human intrusion is a part of the analyses
required for the containment requirements.
Comment P5.B1: In addition to human intrusion scenarios, unusual natural events should be
factored into the performance assessment for individual and ground-water protection
standards. (D-49), (S-11,37,92)
Comment P5.B2: Climate change scenarios should be considered in compliance
demonstrations. (S-45)
Response (Comments P5.B1 through 2):
The purpose of the individual and ground-water standards is to provide
protection from radionuclides released because of likely events. In contrast,
the containment requirements are written to take into account unlikely events.
If any scenario, including a climate change scenario, were shown to be a likely
event, it would need to be considered in the individual and ground-water
protection analyses. It should be noted that Appendix C (formerly Appendix
B) to 40 CFR 191 provides some non-binding guidance for handling unlikely
events, though this is a matter left to the implementing agency. For example,
in performing its implementation duties with respect to the WIPP LWA, EPA
will be further considering this question in the context of developing criteria to
demonstrate compliance with 40 CFR 191 for the WIPP facility in New
Mexico.
Comment P5.C1: Undisturbed performance is adequate for analyzing compliance with the
Standard because it simplifies the long-term modeling. (S-16)
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Comment P5.C2: It should be assumed that ftiture human intrusion will be avoided or
adequately responded to through developing technology. (D-85)
Comment P5.C3: Human intrusion scenarios are subject to arbitrary assumptions and should
not be part of a compliance assessment. Rather, siting and design criteria should be used to
minimize both the probability and the consequences of human intrusion. (D-77)
Response (Comments P5.C1 through 3):
Human intrusion is not a consideration in the current rulemaking and is, in
fact, expressly excluded. The Agency agrees that undisturbed performance is
adequate to show compliance with the individual and ground-water protection
requirements. The Agency does not agree that future human intrusion can
always be avoided or adequately responded to through developing technology.
In fact, the assurance requirements allow a maximum 100-year period for
active institutional controls. Further, the Agency has not been shown an
adequate method to maintain the overall protection possible by the entirety of
Part 191 and separate out human intrusion except for the individual and
ground-water protection requirements where such a requirement is in conflict
with the Agency's policy of containment versus dilution (see the response to
comment P5.A1).
P6. Use of Engineered Barriers
Comment P6.A1: The Standard should require the use of robust engineered barriers, such as
waste containers, improved waste form, backfill, and seals. (A-25,30,32,34,47,52,54),
(D-04,22,24,25,29,42,53,62,64,71,83,86,88), (S-02,08,11,15,30,31,49,51,54,55,57,88,91)
Comment P6.A2: EPA should specify performance standards for engineered barriers
consistent with those specified by the NRC. (D-71,89)
Comment P6.A3: Releases from a repository should comply with NRC limits. (S-37,91)
Response (Comments P6.A1 through 3):
The individual and ground-water protection requirements set implicit performance
requirements on engineered barriers but allow disposal system designers to take into
account all pertinent site-specific factors. The determination of what are the most
appropriate engineered barriers and their performance is specific to the waste form
and the geologic conditions and, therefore, the Agency has left the specification of
engineered barrier requirements to the implementing agency.
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FT. Implementation Guidance in Standard
Comment P7.A1: EPA should determine an acceptable drilling rate on a site-by-site basis,
rather than leave it to the applicant's discretion. (A-25), (D-22)
Comment P7.A2: A drilling rate of 30 boreholes per square kilometer per 10,000 years is
too low for a salt site. (D-71)
Comment P7.A3: Future drilling rates should be determined on a site-specific basis and
could be based on maximum historic drilling rates. (D-86,89)
Response (Comments P7.A1 through 3):
The Agency does not believe it is appropriate to attempt to make site-specific
decisions in generic standards since it is not possible to know to what sites these
standards will apply in the future, and, indeed, the Agency does not have the
authority to make site-specific decisions under the authority of the Atomic Energy Act
of 1954, as amended, as assigned to EPA by Reorganization Plan Number 3 in 1970.
Rather, this authority charges EPA with the responsibility to develop generally
applicable environmental standards. The guidance which discusses the upper bound
drilling rate is not mandatory and, therefore, leaves to the discretion of the
implementing agency the determination of an appropriate rate.
Comment P7.B1: The Standard should include specific techniques for extrapolating data for
long-term assessments. (D-48,87), (S-16)
Comment P7.B2: The guidance should contain specific assumptions about future population
and exposure pathways for long-term calculations. (D-87)
Comment P7.B3: Prediction of future environmental and societal conditions will consist
chiefly of evaluation based on expert judgment and opinion, with significantly less basis in
fact than similar predictions made for the physical system. A defined baseline is required
upon which to base such predictions and the resulting analyses. (D-87)
Response (Comments P7.B1 through 3):
The Agency agrees that specification of future states would be helpful in focussing the
evaluation of potential disposal systems upon factors which the Agency believes are
critical rather than upon potentially fanciful scenarios for the environment or society.
However, the Agency has decided not to reopen the reinstated portions of the disposal
standards at this time. When 40 CFR 191 is reevaluated in the future, this issue will
be considered.
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Comment P7.C1: EPA should issue an implementation guidance document. (D-82)
Response:
Guidance for implementation is provided in Appendix C of 40 CFR 191. The Agency
believes that the guidance is sufficient for these purposes.
P8. Above-Ground Waste Storage
Comment P8.A1: Waste should remain or be placed in above-ground monitored retrievable
storage facilities and not be disposed under the ground. (A-15,35,43,46,57,70,73),
(D-04,06,17,29,34,37,39,42,45,46,47,50,51,61,62,65,72,79),
(S-ll, 19,21,25,37,47,48,51,52,53,54,58,59,61,64,74,91,94,96,98,99,106)
Comment P8.A2: Waste should remain in above-ground storage until a way is found to
detoxify it. (A-40,44,45), (D-50,51,61,70), (S-10,18,44,66,72,87,104)
Comment P8.A3: Waste requires proper access so that it may be visually inspected. (D-51)
Response (Comment P8.A1 through 3):
The Federal laws addressing the disposal of high-level and transuranic waste call for
the examination of deep geologic disposal. There are several good reasons why this
approach has been taken. It was felt that it was inappropriate to leave the matter of
disposal of this generation's waste as something for which future generations are
forced to care. Above-ground emplacement in a building is perceived as requiring
continuous care and maintenance and this did not fit the intergenerational guideline.
Although storage in an above-ground facility appears feasible for a period of time, it
is not seen as a practical solution. It also appears from the past history of
above-ground facilities that they are more vulnerable to both natural forces and
actions by man than underground facilities. This consideration includes storms, fires,
vandalism, sabotage, and terrorism. While an above-ground facility may lend itself
more readily to some types of inspection, it also more readily lends itself to human
intrusion. Methods to "detoxify" nuclear waste do not appear feasible at this time and
research efforts have not been sufficiently promising to dissuade the Congress from
their presently chosen path of deep geologic emplacement.
P9. Potential Use of!
Comment P9.A1: The Standard should not exempt waste disposed before November 18,
1985. (S-54)
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Comment P9.A2: The proposed rule states that the amended rule will not be applicable to
waste disposed of before November 18, 1985, implying that the amended standard will apply
to waste disposed of after November 18, 1985. (D-87)
Comment P9.A3: The exemption of wastes disposed before November 18, 1985 is unclear
and causes confusion as to which wastes may be affected. The exemption adds unnecessary
confusion and could lead to litigation. (D-76)
Response (Comments P9.A1 through 3):
In response to a comment which requested that the new sections not be applied
retroactively, the Agency reconsidered the applicability provisions and has changed
the date of applicability for the individual and ground-water protection sections to 30
days after the date of publication in the Federal Register. Part 191 was in effect from
November 18, 1985 until July 17, 1987 at which time the Court vacated and
remanded the entirety of Part 191 including, of course, the individual and ground-
water protection sections. With today's repromulgation of the individual and ground-
water protection provisions, the Agency believes that it is more reasonable to require
compliance with them only for waste disposed of after the effective date of these
amendments.
The effective date of the 1985 Part 191 standards was November 18, 1985, and the
1985 standards did not apply to wastes disposed of prior to that date. Similarly,
today's standards do not reach back to apply to wastes disposed of prior to November
18, 1985. On July 17, 1987, the First Circuit decision vacated and remanded Subpart
B, which included four categories of requirements: containment, assurance, individual
protection, and ground-water protection. From that time until 1992, when Congress
enacted the WIPP LWA, Subpart B was not in effect. However, applicability of the
regulations changed when Congress, in section 8 (a)(2)(A) of the WIPP LWA,
reinstated all of Subpart B except for those aspects of sections 191.15 and 191.16 that
were the subject of the First Circuit remand, that is Congress reinstated the
containment and assurance requirements as they were promulgated in 1985.
Since there is no indication that Congress intended to allow a regulatory gap in this
important area, EPA interprets section 8(a) of the WIPP LWA as reinstating Part 191
Subpart B except for those aspects that were remanded by the court, retroactive to
July 17, 1987, the date of the First Circuit decision vacating Part 191.
Because the containment and assurance requirements were not found inadequate by
the First Circuit decision, Congress' action in the WIPP LWA reinstated these
regulatory provisions exactly as they were in effect in 1985. Promulgation of today's
standards does not change these 1985 containment and assurance requirements, and
thus they remain effective today, with provisions unchanged from those effective on
November 18, 1985. As a consequence of their initial promulgation in 1985,
Congress' reinstatement in 1992, and promulgation of today's regulations that do not
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change their provisions, the containment and assurance requirements became effective
on November 18,1985, have been effective since that time and continue to be
effective after the effective date. Thus, the containment and assurance requirements
of Part 191 as promulgated in 1985 and reinstated in 1992 apply to wastes disposed of
on or after November 18, 1985.
However, the effective date of the individual protection and ground-water protection
requirements, the other two categories of Subpart B, is necessarily different. This is
because the First Circuit's decision specifically found that aspects of the individual
protection and ground-water protection provisions were inadequate or inconsistent
with other statutory mandates and because the WIPP LWA specifically did not
reinstate them. New regulations were required, and these are the regulations
promulgated today. Therefore, the effective date for the individual protection and
ground-water protection requirements is the effective date of today's standard, and it
is today's individual protection and ground-water protection requirements that apply to
wastes disposed of after today. Any facilities at which disposal-related activities were
initiated after the date of the First Circuit decision might not be covered by the
ground-water and individual protection requirements of Part 191 as promulgated in
1985, which were vacated by the court and not reinstated by Congress. However,
EPA is not aware of any such facility.
The Agency believes that it is reasonable, due to the design nature of the 40 CFR 191
standards, that the standards which were in existence from 1985 until the First Circuit
decision in 1987 are appropriate to be used for activities which occurred, or were
begun, during that time rather than imposing new and different standards on such
activities. The effective date for § 191.13, Containment Requirements, and indeed all
of 40 CFR 191, except those provisions being promulgated today, remains November
18, 1985. In accord with this, disposal which occurred on or after November 18,
1985 is subject to the containment and assurance standards as they existed on
November 18, 1985.
EPA informed the Department of Energy, prior to the First Circuit decision in 1987,
that the 1985 version of Part 191 was applicable to any disposal activities at the
Greater Confinement Disposal (GCD) Facility. Therefore, any radioactive waste, as
defined in § 191.02, that was disposed of at the GCD facility is subject to all of the
requirements of 40 CFR 191 promulgated in 1985, and the First Circuit decision, the
WIPP LWA, or today's promulgation of revised regulations change that
determination.
Finally, it continues to be the Agency's intention that any waste which was disposed
prior to the effective date of today's action is not exempt from Subparts B and C of
40 CFR 191 if it is exhumed and redisposed. That disposal will be subject to all the
provisions of 40 CFR 191 as they exist at the time of redisposal.
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Comment P9.B1: The Standard should reflect the fact that it will apply only to the WIPP for
the foreseeable future. (A-25,34), (D-22,62)
Comment P9.B2: EPA should state that the regulation is specifically applicable to the WIPP.
(D-83)
Comment P9.B3: The disposal standards should be tailored to the WIPP as much as
possible. (D-89)
Response (Comments P9.B1 through 3):
While it is correct to say that 40 CFR 191 applies to the WIPP, it also applies to the
GCD system and any other waste disposal system not required to be characterized by
section 113(a) of the Nuclear Waste Policy Act. This is a result of the authority
under which the Agency is promulgating these amendments, the Atomic Energy Act
of 1954, as amended (42 U.S.C. 2201 et. seq.), and Reorganization Plan No. 3 of
1970. The Reorganization Plan assigned to EPA the authority to issue generally
applicable environmental standards. This means that if no other authorities are
applicable, EPA's standards cannot be site specific. Therefore, these amendments
cannot be and are not tailored to any particular site.
Comment P9.C1: The relationship of 40 CFR 191 to sites regulated under the Nuclear
Waste Policy Act is unclear. (C-01), (A-01,05), (S-01), (D-23,82)
Response:
The preamble and the applicability statements for Subparts B and C both state that the
standards are not applicable to sites characterized under section 113(a) of Public Law
97-425 (the Nuclear Waste Policy Act of 1982). The site at Yucca Mountain, Nevada
is the only current site which falls under that restriction.
Also discussed is the fact that the Energy Policy Act of 1992 has mandated the
National Academy of Sciences to conduct a study for the purpose of providing EPA
advice on writing standards for the Yucca Mountain site.
Comment P9.D1: The Standard should apply to temporary waste storage facilities. (D-29),
(S-30,49)
Response:
The Subpart A standards apply to NRC-licensed management and storage facilities
and to non-NRC-licensed disposal facilities. To change coverage at this time would
require reopening Subpart A. However, as stated above, the Agency has decided not
to reopen sections of 40 CFR 191, other than those being promulgated, at this time.
Therefore, Subpart A coverage has not been changed at this time.
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P10. General
Comment P10.A1: The Standard should be as strict as possible.
(A-23,24>32,33,36)37,42,43,53,56,58,61,62,63,64,69,72,75),(D-02,20>39,62),
(S-06,12,30,37,40,67,71,86,88)
Response:
The EPA, with the input of many individuals and organizations from the
scientific community outside the EPA, has established standards that it
considers protective of public health and the environment.
Comment P10.B1: More research is needed on disposal technologies, especially the
possibility of transmutation of radionuclides to non-radioactive isotopes.
(A-07,11,31,40,41,44,56,63,73),
(D-01,08,11,14,41,50,51,56,61,62), (S-l 1,32,43,61,65,72,75,78,83,84,87,94,100,102)
Comment P10.B2: All waste should be vitrified before disposal. (S-37), (D-39)
Response (Comments P10.B1 through 2):
The Part 191 standards do not preclude the application of any technology to
stabilize or "neutralize" the waste. Technology research in this area is carried
out by the Department of Energy.
Comment P10.C1: It is too early to finalize the standards; more public and technical input is
needed. (A-06), (D-19), (S-14,101)
Comment P10.C2: The EPA's programs should not be driven by deadlines, as they are now.
(S-39,59,89,93,103)
Comment P10.C3: No waste should be disposed until long-term modeling uncertainties can
be reduced. (A-02,67), (S-53)
Comment P10.C4: The Standard should not be issued in its present form. It contains errors
which should not be propagated. (D-71)
Comment P10.C5: EPA should periodically reevaluate the scientific soundness of the
standard. (D-89)
Response (Comments P10.C1 through 5):
Work on amendments to Part 191 has been underway since 1987. Much technical
review and advice has been received since that time. Since Congress has mandated
expedited amendments, EPA is legally bound to make these changes now. If in the
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future new scientific data demonstrate that there is a flaw in the rationale behind the
rule, EPA can then reopen the rulemaking process and amend all or part of these
standards.
Comment P10.D1: The regulations should be written in less technical language. (S-39,62)
Response:
The Agency attempts to write standards which are readily understandable by all
readers. However, this is a highly technical area and to be useful to those who must
implement the standards, there is a need to be as technically accurate and complete as
possible. The Agency makes technical documents containing information supporting
its standards available upon request, as availability allows. In addition, the Agency is
receptive to comments and questions on these matters.
Comment P10.E1: When disposal regulations are issued for facilities under the NWPA,
there may well be two sets of disposal regulations for geologic repositories. DOE is
concerned about the potential differences between the two standards and how such differences
will be reconciled. It is essential that EPA make a commitment as to how they will reconcile
any differences before issuing this standard as final. (D-87)
Response:
As required by the Energy Policy Act of 1992, EPA is required to seek advice from
the NAS on the development of standards for Yucca Mountain. The form of the
ensuing standards may or may not be quite different from those of 40 CFR 191. In
view of this, the Agency believes it would be premature to commit to future
amendments to the existing 40 CFR 191. The Agency will determine the necessity
of future amendments at such a time as the NAS study has been completed.
Comment P10.F1: The 10,000-year "regulatory period" should be referred to as the
"modeling period" to be consistent with 40 CFR 268.60 (solid waste regulations). (D-82)
Response:
The Agency uses the words "regulatory period" to signify the period during which the
ground-water, containment and individual protection requirements apply. The
meaning of this term is not and need not be affected by the use of similar terms in
other regulations.
Comment P10.G1: EPA proposes to redefine "radioactive material." This proposed
definition is contrary to common usage, since most people refer to all radioactive material as
"radioactive material." (D-58,78)
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Comment P1Q.G2: Introduction of the new term in 191.12, "radioactive material," appears
to broaden the scope of material covered under this rule. (D-87)
Response (Comments P10.G1 through 2):
The term "radioactive material", as defined in the standard, is meant to include
materials other than spent fuel, high-level and transuranic wastes that might be
disposed in the same disposal systems as these wastes. Examples of such radioactive
materials are greater-than-class-C low-level, low-level, and naturally occurring
radioactive wastes (54 FR 22578). Use of this term is not intended to broaden the
scope of coverage of the rule but merely to clarify it.
Comment P10.H1: The difference between "implementing agency" and "certifying agency"
should be clarified. (D-87)
Comment P10.H2: The term "implementing agency" is not adequately defined. EPA's
regulatory authority over the WIPP should be made clear. (D-71)
Response (Comments P10.H1 through 2):
Three agencies are responsible for determining compliance with 40 CFR 191,
however, the term "certifying agency" is not used for any of them. There is one case
where an agency is held responsible for "certifying" compliance and that is EPA in
the case of the Waste Isolation Pilot Plant under the provisions of the WIPP LWA.
The definition of "implementing agency" has been amended to more clearly reflect
EPA's role as it pertains to Part 191, at WIPP. In addition, EPA is required under
§8(c) of the WIPP LWA to promulgate compliance criteria, which will further define
EPA's responsibilities as an implementing agency for the WIPP site.
Comment P10.il: The EPA's description of the legal basis for Nuclear Regulatory
Commission licensing authority (58 FR 7929) notes NRC's licensing role for Yucca
Mountain under the Nuclear Waste Policy Act (NWPA), as amended. NRC's authority is
broader than this and has a different genesis. There exists a significant potential for NRC
implementation of the Part 191 standards even though they do not apply to Yucca Mountain.
(D-58,78)
Response:
The Agency agrees with this comment.
Comment P10.J1: The term "reasonable expectation" should be better defined. (A-60),
(D-62)
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Comment P10.J2: The concept of "reasonable expectation" was omitted from the ground-
water and individual protection requirements and should be retained. (D-87)
Comment P10.J3: Compliance with the individual and ground-water protection requirements
should be based on a 95th percentile curve generated through random sampling. (D-71)
Response (Comments P10J1 through 3):
The term "reasonable expectation" and associated expanded explanatory sections have
been added to 191.15(c) and 191.24(b), making the amendments consistent with the
reinstated containment requirements from the 1985 issuance of the rule. These added
provisions are found in the final rule at 191.15(c) and 191.24(b). These provisions
are intended to make it clear that compliance assessments need not provide complete
assurance that the requirements will be met. They note that proof of the future
performance of a disposal system is not to be had in the ordinary sense of the word in
situations that deal with much shorter time frames. For the WIPP facility, this matter
is subject to further consideration in EPA's development of the compliance criteria.
For other facilities to which this rule may be applicable, this issue would be addressed
by the appropriate implementing agency. EPA notes that Appendix B of the 1985
standards, now Appendix C, discusses compliance determinations for 191.13 as
using "complex computational models, analytical theories, and prevalent expert
judgment relevant to the numerical predictions." The Appendix goes on to say that
implementing agencies may choose to supplement numerical predictions with
qualitative judgments as well. The results of such evaluations must provide
reasonable expectation that regulatory requirements are met.
Comment P10.K1: The Standard needs to consider possible synergistic effects of radiation
and hazardous chemicals. (S-68)
Response:
EPA is not aware of synergistic effects that would take place in the environment at
levels of exposure allowed by EPA's radioactive and hazardous waste disposal
standards.
Comment P10.L1: All waste should be fully retrievable for a period of approximately 50
years after disposal. (D-71)
Comment P10.L2: Mixed waste should not be allowed for disposal at WIPP. (S-37)
Comment P10.L3: Thermally stressed halite at WIPP will move the radioactive wastes
packages "significant distances". (D-62)
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Comment P10.L4: The WIPP site is not suitable for waste disposal.
(A-04,07,13,19,26,27,32,35,36,39,40,49,50,65,66,68,73,74),
(D-09,11,16,18,34,35,39,52,62,88), (S-04,14,19,35,36,37,41,46,47,51,60,62,74,85,100,104)
Comment P10.L5: The WIPP site is unstable and should not be used for waste disposal.
(D-09,39), (S-05)
Comment P10.L6: The WIPP project is needed and should move ahead. (S-27,77)
Comment P10.L7: Disposing radioactive waste in underground salt formations is contrary to
the traditional beliefs of the Acoma People who reside near the WIPP site. (S-86), (D-52)
Comment P10.L8: Monitoring at WIPP would be difficult, so the site should be
disqualified. (A-ll), (S-14,32)
Comment P1Q.L9: The EPA should use data from DOE only after the data has been
carefully reviewed and verified by non-DOE reviewers. (A-39)
Comment P10.L10: Effective oversight of DOE activities is necessary to ensure compliance
with the Standard. (S-02), (D-71)
Response (Comments P10.L1 through 10):
The EPA uses data from many sources and uses its judgment as to the reasonableness
of that data. Almost all data that is used is from publicly available printed
documents. The Agency's authority for oversight of other agencies' activities is
specifically assigned by Congress. In relation to 40 CFR 191, EPA has direct
oversight only at the WIPP. The EPA will be writing standards for Yucca Mountain
but that will be under the authority of the Energy Policy Act of 1992 and will likely
be separate from 40 CFR 191.
A decision on the suitability of WIPP is outside the purview of this rulemaking but
will be addressed thoroughly during the certification-of-compliance process.
Comment PIO.M1: The standards should include requirements for site stability.
(D-16,63,72)
Comment P10.M2: A repository should not be sited in an area with valuable natural
resources. (A-32,34,47,52), (D-04,25,29,31,37,39,53,62,64,88),
(S-08,15,30,49,51,53,54,96)
Comment P10.M3: Strengthen the siting criteria to exclude areas with oil and gas resources.
(A-60), (D-62), (S-41)
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Response (Comments P10.M1 through 3):
This is outside the purview of the rulemaking.
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Chapter 3: TECHNICAL ISSUES
Tl. Regulatory Time Period
Comment Tl. Al: The time period for the ground-water and individual protection standards
should be extended beyond 10,000 years. (A-03,07,09,10,11,28,29,32,37,53,63),
(D-04,06,24,28,37,41,54,55,62,63,7i),(S-02,07,31,32,48,50,58,73,86,87,94,105)
Comment T1.A2: The time period for the radionuclide containment requirement should be
extended beyond 10,000 years. (A-03,06,22), (D-04,07,28,37,41,71), (S-02,49,105)
Comment Tl.A3: The time period should extend far enough beyond 10,000 years to
determine any long-term trends in disposal system performance. (A-25), (D-22)
Comment T1.A4: The regulatory assessment period in the Standard should be 100,000
years.
(A-04,06,16,34,38,48,51,52,60), (D-19,20,25,29,42,53,62,64,68,71,73,83,84,88),
(S-03,11,17,36,49,51,54,55,57,73,82,88,87,95,96,105)
Comment T1.A5: The regulatory assessment period should be about 240,000 years.
(A-15,20,45,49), (D-39,61,65,66,72), (S-12,37,68)
Comment T1.A6: The regulatory assessment period should be 1,000,000 years.
(A-02), (D-63), (S-22)
Comment T1.A7: The regulatory assessment period should extend for as long as the waste
remains hazardous. (D-12), (S-08,59)
Comment T1.A8: The regulatory assessment period should extend forever into the future.
(D-55)
Comment T1.A9: EPA has previously agreed to require more than a 10,000-year analysis,
but this is not in the proposed Standard. (S-23)
Comment T1.A1Q: The regulatory time period should be no shorter than the proposed
10,000 years. (D-76)
Comment T1.A11: There needs to be more technical justification for choosing a 10,000-year
regulatory assessment period. (C-01), (A-01,05,32), (D-21,23,47,62), (S-01,55)
Comment T1.A12: The 10,000-year time period is too long because geologic parameters are
too uncertain. (D-48), (S-16)
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Comment T1.A13: A time period of no more than 1,000 years should be used for individual
and ground-water protection. A longer time frame has not been shown to provide a higher
level of protection. (D-77)
Comment T1.A14: The ground-water protection and individual protection regulatory periods
should be 1000 years. (D-85)
Comment T1.A15: The 10,000-year regulatory framework is adequate. (A-25), (D-22,52),
(S-24,92)
Comment T1.A16: The 10,000-year period for individual dose regulation is appropriate. (D-
89)
Comment T1.A17: The 10,000-year period for ground-water protection is appropriate. (D-
89)
Response (Comments P1.A1 through 17):
The First Circuit court decision required the EPA to reexamine the regulatory
time frame for the individual protection requirements. The court made this
decision based on the determination that the 1985 1,000-year regulatory time
frame was not adequately justified. The use of a 10,000-year time frame for
the containment requirements was considered adequate to differentiate between
poor sites and potentially acceptable sites and yet avoid gross uncertainties.
When evaluating the long-term performance of potential sites, as is done
generically in the BID, a time period on the order of 10,000 years is often
necessary to reveal differences among or between disposal systems. While a
time period of more than 10,000 years can provide insight into the
performance of the disposal system, the uncertainties associated with these
long time periods makes it difficult to rely on them. The 10,000-year period
for ground-water and individual risk assessments had been thought to be too
uncertain to include in the 1985 standards. However, other regulatory
programs and recent assessments have shown that it is feasible. With this
information in mind, EPA believes a 10,000-year time frame is appropriate
and long enough to help differentiate among potential sites, but at the same
time, short enough that uncertainties do not invalidate the modeling results.
The EPA has never "agreed" to use any particular time period. In a working
draft, EPA had indicated an interest in using 100,000 years but that was
associated with the containment and assurance requirements. Those
requirements were reinstated and are not under consideration in this
rulemaking.
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Comment Tl .Bl: A 10,000-year quantitative assessment could be supplemented with a
qualitative assessment for the period beyond 10,000 years. (A-05)
Comment T1.B2: The regulatory period should be 10,000 years, but trends should be
evaluated out to 100,000 years. (D-86)
Response (Comments T1.B1 through 2):
EPA has not included such a requirement since in these generally applicable
standard neither the impact of the additional analysis nor the standard of
judgment to be used was able to be defined. An implementing agency may
wish to consider this requirement under its own authority on a site-specific
basis.
Comment T1.C1: EPA's selection of 10,000 years as the regulatory time frame for the
individual and ground-water protection requirements should not be implemented unless
adequate detailed guidance is provided for dealing with uncertainties. (D-87)
Response:
Due to the site-specific nature of uncertainties that arise in a compliance
demonstration, EPA feels it is not appropriate to give detailed guidance on the
treatment of uncertainties. This is left to the discretion and technical judgment
of the implementing agency.
T2. Individual Dose Limit
Comment T2.A1: The EPA should present a health-based justification for the 15-millirem-
per-year (mrem/yr) dose limit. (D-71)
Comment T2.A2: The 15 mrem/yr dose limit is based on insufficient information. (S-90)
Comment T2.A3: The draft BID does not provide justification for the 15 mrem/yr dose
limit. It shows zero dose from ground water for all analyses. (S-23)
Comment T2.A4: The 15 mrem/yr dose limit is too high.
(A-22,32),(D-29,39,53,62,64,76),((S-08,49,53,54,58,64,73,87,94,96)
Comment T2.A5: The 15 mrem/yr dose limit is too low. (D-48), (S-16)
Comment T2.A6: The dose limit should be 10 mrem/yr. (A-37), (D-53,68,73,86), (S-03)
Comment T2.A7: The individual dose limit should be 4 mrem/yr. (S-22,49,91), (D-76)
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Comment T2.A8: The dose limit should be a few (1-3) mrem/yr. (A-54), (S-ll)
Comment T2.A9: Any level of individual dose is too high; the dose limit should be lowered
to zero, or near zero. (A-05,15,55,71), (D-04,15,37), (S-51,54,58,73,90,93)
Response (Comments T2.A1 through 9):
The dose limit of 15 mrem/yr was chosen because it is believed that this level is
sufficiently protective in situations where, at most, only a few individuals will likely
receive the maximum dose. Further, the Agency finds it consistent and reasonable to
adopt a standard for multi-media exposure (through all media, i.e. food, air and
ground water) that is greater than that allowed by regulations for a single
environmental medium (compare 10 mrem/yr allowed for air releases and 4 mrem/yr
for drinking water). Analyses of the undisturbed ground-water flow scenario made
using base case parameter values show no individual doses or ground-water
contamination at any of the sites during the first 10,000 years after disposal.
Comment T2.B1: The dose limit should be based on the most up-to-date information on
radiation effects. (S-04)
Comment T2.B2: The organ-weighting factors in Appendix B are taken from ICRP 60,
rather than from ICRP 26, as was done in the BID. (D-87)
Comment T2.B3: Appendix B appears to be based on ICRP Publication 60. This is
inconsistent with current Federal guidance and the consensus developed in a Federal
Interagency Working Group. The consensus of that group (chaired by EPA) is that the
incremental benefit associated with adoption of ICRP 60 methodology is not sufficient to
justify the associated cost and regulatory burden. Thus, EPA's proposed Appendix B should
be rewritten, based on ICRP-26 methodology, to be consistent with current Federal guidance
and the practices of other Federal agencies. (D-58,78)
Comment T2.B4: The proposed amendments to the individual protection requirements
include calculational techniques incorporating weighting factors from ICRP Publication 60,
which has not been accepted by the technical community in the United States. (D-87)
Comment T2.B5: The use of the CED dose calculation method developed by the ICRP is
endorsed as the basis for the individual protection requirements. (D-49)
Response (Comments T2.B1 through 4):
While not rejecting the validity of the ICRP 60 factors, the Agency has determined
that the proposal was premature and has adopted the organ-weighting factors in
ICRP 26, for purposes of this rulemaking, in order to be consistent with Federal
Guidance Number 11.
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Comment T2.C1: The dose limits should not be changed from 25 mrem to 15 mrem until
adequate opportunity is given to comment on the different methodology for the dose (whole
body vs. committed effective dose) and the "equivalent risk" approach presented in the
proposal. (D-77)
Response:
The Agency believes there has been adequate opportunity for comment. The EPA
first announced its intention to use CED in 1987 (52 FR 2822) when recommending
standards for exposure of workers to radiation (Federal Guidance Number 11). The
methodology was first recommended by the ICRP and is now employed by the EPA
and other Federal agencies. And finally, notice of the opportunity for public
comment was provided with the newly published amendments to 40 CFR Part 191.
Comment T2.D1: Consistency of general radiological terminology in the proposed rule is
not consistent with current usage by national and international agencies. (D-87)
Comment T2.D2: The terminology for the individual dose is inconsistent with other sources,
such as ICRP 26 and 30. (D-30,87)
Comment T2.D3: The symbols used in the equations of the proposed Appendix B
("Calculation of Annual Committed Effective Dose") cause confusion. In the second
equation, "HT" is used to denote the equivalent dose in tissue T. Then, in the third equation,
the same symbol is used for both the integrated 50-year equivalent dose and the equivalent
dose rate. The right-hand side of the third equation should use a symbol that clearly
indicates the dose rate, i.e., the derivative of HT with respect to time. (D-58,78)
Response (Comments T2.D1 through 3):
The nomenclature used in these equations is the same as that used by ICRP. For
clarification, please note that the symbol for committed equivalent dose is HT as a
function of tau, T, whereas the symbol for the equivalent-dose rate is HT as a function
oft.
Comment T2.E1: EPA's proposed individual protection standards would restrict potential
doses to "any member of the public." This seems to mean the most highly exposed member
of the public. (D-58,78)
Response:
The EPA standard does apply to the maximally exposed individual, consistent with
other EPA regulations.
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Comment T2.F1: In 1985, EPA established individual protection requirements of 25
mrem/yr for the whole body or 75 mrem/yr for other organs. At that time, EPA did not
provide a convincing basis of support for those dose limits. In 1985, EPA equated its dose
limits to a lifetime risk of 5x10"*. However, EPA did not argue that SxlO4 was the
maximum level of risk that could be considered acceptable, nor did EPA demonstrate that its
dose limits were reasonably achievable. In addition, EPA never proposed its individual
protection requirements for public comment. (D-58,78)
Comment T2.F2: The individual dose limit should be 25 mrem/yr unless there is some basis
for changing it. (D-85)
Comment T2.F3: The justification for the individual protection requirements has not been
sufficiently provided, neither for the proposed new dose limit of 15 mrem annual committed
effective dose nor the 1985 dose limits of 25/75 mrem (for the whole body/organs). (D-87)
Comment T2.F4: Replacement of 25 mrem whole body/75 mrem critical organ with 15
mrem annual dose equivalent needs further justification. (D-87)
Comment T2.F5: Retain the limit at 25 mrem EDE/yr or amend the Supplemental
Information to include the technical justification for the use of a 15 mrem annual CED
(which should be EDE/yr, see Issue G.4), and demonstrate that it is equivalent to the 25/75
mrem limit. (D-87)
Response (Comments T2.F1 through 5):
The 25 mrem/yr dose limit in the 1985 standard was based on a lifetime fatal
cancer risk of about 5 x 104 using a cancer risk factor of 2.8 x 10"* fatal
cancers per rem. More recent information on radiation risks, described in the
1993 BID, leads to a cancer risk factor of 3.9 x 10"* fatal cancers per rem
(BID p. 6-75). Thus, the radiation risk factor has increased by about 40
percent. The dose limit is correspondingly decreased by approximately the
same percentage to arrive at 15 mrem CED/yr.
Comment T2.G1: The 15 mrem/yr CED appears consistent with the previous 25 mrem
annual whole-body dose. (A-25), (D-22)
Response:
EPA chose the new dose rate with the goal of being consistent with the previous
whole-body dose limit.
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T3. Background Information Document
Comment T3.A1: Tables 3.3-1 and 3.3-2 in the draft "Background Information Document
for Proposed Amendments to 40 CFR Part 191" (EPA 402-R-93-007) need revision. The
Idaho Chemical Processing Plant (ICPP) values in both tables for liquid, sludge, salt cake,
slurry and calcine have been shifted to the right by one column. In addition, the commercial
acid waste values for liquid, sludge, salt cake, slurry and calcine in Table 3.3-1, and the
commercial acid waste and alkaline waste values for the same waste types in Table 3.3-2
have been shifted to the right by one column. In addition, the subtotal and grand total values
in both tables have numerous errors that require correction. (D-82,87)
Response:
The final background information document (BID) contains the correct values.
Comment T3.B1: EPA's proposed standards would restrict radionuclide concentrations in
ground-water and potential doses to individuals outside a "controlled area" that is allowed to
extend up to five kilometers from a disposal facility. The analyses of EPA's draft BID
evaluate potential concentrations and doses at a two-kilometer distance, rather than the full
five-kilometer distance allowed by EPA's standards. In EPA's analyses, an individual is
assumed to withdraw ground water for drinking at a distance of two kilometers from a deep
geologic repository containing transuranic wastes. (D-58,78)
Response:
The two-kilometer distance is consistent with the generic risk analyses supporting the
original promulgation of the rule in 1985. It is correct that the standards allow the
implementing agency to assume a distance of up to five kilometers to the accessible
environment. The analyses in the BID used two kilometers and showed that the
Standard is technically feasible at this distance. The BID analyses are conservative in
this respect. If the implementing agency chooses to use a five-kilometer distance
instead, the performance assessment will show a greater margin of safety than if a
two-kilometer distance is used.
Comment T3.C1: EPA uses essentially the same conceptual model for all four hypothetical
repositories considered in its BID. Using the NEFTRAN-S code, EPA uses a single "pipe"
to simulate transport of radionuclides from a repository to an overlying or underlying aquifer
and then uses a second "pipe" to simulate transport to a ground-water well located two
kilometers away. The coarseness of this model precludes simulation of fractures, failures of
borehole or shaft seals, or other inhomogeneities in the geologic media. NEFTRAN-S may
not be adequate for such purposes anyway, and a computer program implementing
mathematical models of the appropriate processes would have to be used. Thus, EPA is
unable to determine whether relatively rapid transport of small amounts of waste might
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occur, leading to potential violations of the proposed individual and ground-water protection
standards. (D-58,78)
Response:
The Agency believes that the NEFTRAN-S model is adequate for the BID analyses.
The comment is correct that the same conceptual model was used for all sites; this is
in keeping with the Agency's approach of modeling generic sites. Some capabilities
of the NEFTRAN-S code were not used in the generic analyses. One, in particular,
is the capability to model a dual-porosity medium. Fracture flow could be modeled
with this option but the required data would be highly site-dependent. As is the case
with any computer code, NEFTRAN-S will not model all types of inhomogeneities in
the geologic medium. However, NEFTRAN-S has the capability to model flow and
transport through boreholes or failed shaft seals, although separate computer runs are
required for each of these scenarios. Flow through shaft seals and improperly sealed
boreholes were included in the risk assessment for the containment requirements and
are contained in the Technical Support Document.
The NEFTRAN-S model was used in the generic risk assessments for a number of
reasons. Among these are its ability to model generic geologic media and its ability
to perform uncertainty evaluations by varying a wide range of input parameters. The
code can be used for sensitivity studies and Monte Carlo probabilistic analyses. The
NEFTRAN-S model is a useful tool for demonstrating technical feasibility of the
standard and estimating the impacts on ground water and individuals.
Comment T3.D1: Some of EPA's simplifying assumptions presented in the BID may be
causing EPA to underestimate doses. For example, Table 7.5-15 postulates an aquifer
thickness of 2400 meters at a tuff site. Even if the physical thickness of an aquifer were this
great, the effective thickness within which radionuclides would be mixed and transported
would be much less. Thus, EPA may have overestimated dilution of releases (and
underestimated doses) by one to two orders of magnitude. (D-58,78)
Response:
The Agency has performed an analysis in which the aquifer characteristics of the
generic tuff site are consistent with the characteristics assumed for the generic basalt
and granite sites, i.e., an aquifer thickness of 30 meters. This enhances the Agency's
intent of providing comparative analyses of the technical feasibility of the health-based
standard at a variety of generic sites. The results of the analysis did not affect the
standard.
Comment T3.E1: In the BID, EPA uses retardation factors originally developed for the
National Academy of Sciences' 1983 Waste Isolation Systems Panel's HLW report. The
waste form for EPA's current analyses is transuranic waste, which includes organic trash,
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chelating agents, etc. EPA should explain why it thinks the retardation factors developed for
HLW would be appropriate for transuranic wastes with much different chemical
characteristics. (D-58,78)
Response:
Radionuclide retardation factors in geologic materials are highly uncertain. Among
other things, the retardation factors are sensitive to the physical properties of the
geologic material, the presence of minerals, and the chemical form of the
radionuclides. The retardation values may vary over several orders of magnitude.
The values from the National Academy of Sciences report are considered to be
reasonably conservative and appropriate for use in generic analyses of TRU waste
disposal. However, the values would likely not be suitable for an assessment of a
real disposal site where more site- and waste- specific information would be required.
Comment T3.F1: The reinstated criteria of 40 CFR Part 191 define "undisturbed
performance" as "...the predicted behavior... if the disposal system is not disrupted by human
intrusion or the occurrence of unlikely natural events." Use of the term "undisturbed
performance" in the BID is confusing because it includes disturbed performance to the extent
that natural disruptions are likely to occur. It is recommended that EPA drop the word
"unlikely" from the definition of undisturbed performance. (D-58,78)
Response:
The inclusion of likely natural disturbing events in "undisturbed performance" is
intended to assure that repository design will consider such events. This will prevent
situations arising in which a projected release might meet the containment
requirements yet exceed the individual and ground-water requirements. To ignore
likely natural events could allow, in theory, a disposal system to be sited on an active
fault zone without any concern for the individual dose. If one were to ignore all
"natural events", any effect due to shifts in land, no matter how small or frequent,
would constitute "disturbed performance" and therefore would not be considered in
the repository design.
Comment T3.G1: Section 7.6.2 of EPA's BID seems to endorse use of elicited expert
judgment in a performance assessment for demonstration of compliance with the proposed
standards. While we recognize that use of expert judgment will be a necessary part of any
demonstration of compliance with these standards, NRC staff believe that it is inappropriate
to substitute judgment for data unless data are not reasonably obtainable. (D-58,78)
Response:
EPA agrees that expert judgment is not appropriate as a replacement for reasonably
obtainable data. However, in the context of the types of assessments that are
anticipated in showing compliance with these standards, where projections must be
made over thousands of years, it is anticipated that there may be cases when expert
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judgment will be necessary to interpret the implications of the data. In the case
where there is data available, EPA believes that it is not proper to use "expert
judgment".
T4. Economic Impact Analysis
Comment T4.A1: The Economic Impact Analysis does not support the determination that no
Regulatory Impact Analysis is required. The Economic Impact Analysis contains inadequate
bases, findings, and conclusions. Therefore, a Regulatory Impact Analysis is required.
(D-87)
Response:
A regulatory impact analysis is required by Executive Order 12291 only if there is a
significant economic impact. The only economic impact identified by the Agency is a
small percentage of the total cost of modeling and, obviously, an even smaller
percentage of the total cost of disposal. The EPA's experience in environmental
pathway modeling suggests that this cost will not exceed one million dollars. This is
not a significant impact as defined in Executive Order 12291.
Comment T4.B1: Information in the BID to support the Economic Impact Analysis does not
address the cost of compliance demonstrations for the number and types of facilities to which
it could apply. (D-87)
Response:
The Agency has found that information related to the various wastes which could fall
under the amendments is not available. In addition, it is not possible to know
precisely what types of waste treatments and disposal systems may be developed in
the future. Finally, the Agency believes that other types of disposal systems for the
subject wastes should be at least as protective as would a geologic repository.
Therefore, not only is it impossible to, there is also no need to attempt to, include all
possible types of waste and disposal systems.
Comment T4.C1: It is incorrect to conclude that because the containment requirements have
been reinstated there is no economic impact from the current amendments. (D-87)
Comment T4.C2: The calculations in the BID do not support the conclusion of no cost or
low cost. Although the BID analyses show no doses, this conclusion may not be true for
other types of disposal (such as the Hanford HLW tanks). (D-87)
Response (Comments T4.C1 through 2):
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The Agency's conclusion of no impact depends upon the fact that the containment
portions of the standard were reinstated by Congress and were effective before the
amendments were proposed. While there could be costs involved to implement the
disposal standards which were reinstated, they cannot be attributed to these
amendments. If the argument were to be accepted that both the containment standards
and the amendments of the individual and ground-water protection requirements
should have costs allocated to them separately, there is no feasible way to allocate the
costs since only a single technological solution is envisioned as being used to
guarantee both. The Agency did point out that there could be a small cost, as high as
one million dollars, as part of the effort to demonstrate compliance with the
amendments.
Comment T4.D1: Future costs are discounted to obtain a present value, but projected
statistical health effects are not discounted. Health effects should also be discounted to
maintain a meaningful comparison of costs vs. benefits. (D-87)
Response:
The EPA had several reasons for not discounting health effects over the 10,000-year
regulatory period. The first is remarked upon by DOE -- that the health effects
would essentially be reduced to zero (which implies that the effects of discounting
have been made implicit in the analysis). A related point is that discounting would
not allow for a comparison of media, i.e., it is easier to compare large whole
numbers than fractions very near zero. A second and more compelling reason for not
discounting is that it is not appropriate. Costs and health effects are not directly
compared within the framework of a cost-benefit analysis nor do we have "true" costs
and benefits since by definition these must be measured against a reference case. As
noted previously, this does not exist for this analysis. What are presented are
absolute costs and absolute health effects.
T5. General
Comment T5.A1: The government is using an economically based safety standard rather
than a health-based standard. (D-57)
Response:
Protecting public health and the environment is EPA's primary concern. While EPA
does take economic factors into account, it was not considered a compelling factor in
this rulemaking. The EPA determined that the impact is minimal by adopting a 15
mrem CED/yr dose standard and finds the lifetime risk represented by this level of
exposure to present an acceptable risk, as discussed in the preamble to the final rule.
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Comment T5JB.1: Since EPA is developing a "generally applicable standard" additional
issues should be addressed. In particular, releases of C-14 gas should be addressed, even
though it is generally not a concern with TRU waste. (A-05)
Comment T5.B2: Limits on the release of carbon-14 should be deleted. (D-85)
Comment T5.B3: The C-14 release limit should be deleted because it is based on a deficient
analysis which failed to consider gaseous releases under quiescent conditions. (D-67,74,77)
Response (Comments T5.B1 through 3):
The quantity limits on the release of carbon-14 are a part of the containment
requirements which were reinstated by the Congress. It is a policy decision made by
EPA not to reopen, at this time, portions of the standards which have been reinstated
by the WIPP LWA.
The issue of gaseous releases was the subject of an EPA Science Advisory Board
study and may be an issue considered in the forthcoming study being conducted by
the National Academy of Sciences. That study has been mandated by the Energy
Policy Act of 1992 for the purpose of advising EPA on devising standards for Yucca
Mountain. In addition, EPA may reconsider the issue whenever 40 CFR Part 191 is
reconsidered.
3-12
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APPENDIX A
LIST OF COMMENTERS
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APPENDIX A
LIST OF COMMENTERS
Public hearings on the proposed 40 CFR Part 191 were conducted in New Mexico as follows:
February 23, 1993 in Carlsbad; February 24, 1993 in Albuquerque; and February 25 and 26 in
Santa Fe. The following is a list of those who testified and, where appropriate, the
organizations they represented.
Carlsbad Hearing
C-01 Arlen Hunt, DOE WIPP Site Project Manager
C-02 Clifford Stroud, Carlsbad Dept. of Development
C-03 Chuck Bernhard, Carlsbad Dept. of Development
Albuquerque Hearing
A-01 Mark Matthews, DOE WIPP Integration Office Deputy Project Manager
A-02 Charles Hyder
A-03 Roger Anderson, Scientists Review Panel
A-04 Dori Bunting
A-05 James D. Werner, Natural Resources Defense Council
A-06 Don Hancock, Southwest Research and Information Center
A-07 Harry Willson
A-08 Joseph Shunkamolah
A-09 JLouise Kahn
A-10 Jim McConnell
A-11 Rose Shaw, Southwest Organizing Project
A-3
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A-12 Pablo Marquez
A-13 Angela Weibock
A-14 Jerry Messick
A-15 Janna Holland
A-16 Barbara Forshay
A-17 Arthur Apodaca
A-18 Mario Villeda
A-19 Tim Forrest
A-20 Evelyn Kennerly
A-21 Gloria Williams
A-22 Phyllis Hoge
A-23 Elizabeth Byer
A-24 Mary Morell
A-25 Robert Neill, New Mexico Environmental Evaluation Group
A-26 Don Schrader
A-27 Bob Anderson
A-28 Rita Getty
A-29 John Leahigh
A-30 Pat Marcelo
A-31 Lee Sims
A-32 Alva Morrison, Water Information Network
A-33 Andres Valdez, New Mexico Vecinos United
A-4
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A-34 Susan Gorman, Rio Grande Chapter of the Sierra Club
A-35 Geraldine Amato
A-36 Barbara Pfaff
A-37 Eric Lane, People's Emergency Response Committee
A-38 Bruce Trigg
A-39 Janet Greenwald
A-40 Julia Heinzelman
A-41 Emmett Garrity
A-42 Sylvianna Diaz D'Oville
A-43 Sue Chavez
A-44 Doug Darien
A-45 Dan Moore
A-46 Karen Navarro
A-47 Glenda Voigt
A-48 Penny Bradfield
A-49 Garland Harris
A-50 Reyna Juarez
A-51 Chuck Goodmarker
A-52 Sylvanna Seidel
A-53 Robyn Seidel
A-54 Dan Kerlinsky, N.M. Physicians for Social Responsibility
A-55 BobAly
A-5
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A-56 Susan Pearce
A-57 Aspen Evans
A-58 Mimi Leland
A-59 Pere Gormley
A-60 Jeff Radford, Business People Concerned about WIPP
A-61 Lisa Cover
A-62 JackUhrich
A-63 Allan Moskowitz
A-64 Deborah Orozco
A-65 Michele Witzki
A-66 Stephanie Daw
A-67 David Hofer
A-68 Amy Silverman
A-69 Ari Maslow
A-70 Kent Gormley
A-71 Cordelia Friedman
A-72 Thomas Metcalf
A-73 Lorraine Evans
A-74 Jocelyn Brown
A-75 Jim Morrison
A-6
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Santa Fe Hearing - Day 1
S-01 Eli Maestas, DOE WIPP Integration Office
S-02 Tom Udall, New Mexico Attorney General
S-03 Margaret Carde, Concerned Citizens for Nuclear Safety
S-04 Sasha Pyle
S-05 Bonnie Bonneau
S-06 Robin Laughlin
S-07 Stephanie Lee
S-08 Dan Gibson
S-09 Amy Hamouda
S-10 Ted Seeley
S-ll Jean Nichols
S-12 Kathy Lage
S-13 Thomas Hatcher
S-14 Ditto Nowakoski
S-15 Deborah Reade
S-16 Len Maki
S-17 Marilyn Winter-Tamkin
S-18 Mary Lou Cook
S-19 Jason Salzman, Greenpeace
S-20 Doug Doran
S-21 Bonney Hughes, Religious Society of Friends
A-7
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S-22 T. Quinn Evans
S-23 Don Hancock, Southwest Research and Information Center
S-24 Stanley E. Logan
S-25 Kenneth Jacks
S-26 Jenny Schatzle
S-27 Baltazar Aragon
S-28 Richard Deyo
S-29 Elliott Skinner
S-30 Mary-Charlotte Domandi
S-31 Linda Hibbs
S-32 John Ussery
S-33 Patricia Theodore
S-34 Bob Samuel
S-35 Jim Brogan
S-36 Bill Gould
S-37 Anhara Lovato
S-38 Florence May Gonzalez
S-39 Maureen Havey
S-40 Lynne Stroud
S-41 John Brito
S-42 Edward Baca, ASME Local 2238
S-43 Bill Doyle
A-8
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S-44 Ann Dasburg
S-45 Dolores Pierson
S-46 Helen Thompson
S-47 Elizabeth Dunham
S-48 Scott Estep
S-49 Medora Raborg
S-50 Kirsten Hartman
S-51 Dawn Harris
S-52 Mary Riseley
S-53 Liberty Goodwin
S-54 Leslie O'Toole
S-55 Jay Coughlin
S-56 Peter Cummings
S-57 Julie Daniel, Business Against WIPP
S-58 Penny McMullen, Sisters of Loretto
S-59 Michael Collins
S-60 David Fine
S-61 Robert March
S-62 Carmen Ruiz
S-63 Richard Schmidt
S-64 Marvin Mattis
S-65 Naomi Mattis, Letters from the People
A-9
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S-66 Ellen Roddick
S-67 Florence Dance
S-68 Joni Arends
S-69 John Stroud
S-70 Alan Liddell
S-71 Trish Tanner
S-72 Nelson Denman
S-73 Gary Gallup
S-74 Ed Winter-Tamkin
S-75 A. Mona
S-76 Don Brayfield
S-77 Thomas A. Morgan
S-78 Penelope Place
S-79 Mansi Kern
S-80 Susan Myers
S-81 B. Watt
Santa Fe Hearing - Day 2
S-82 Marcia Summers
S-83 Joan Halifax
S-84 David Coffey
S-85 Jonas Skardis
S-86 Stanley Paytiamo, Pueblo of Acoma
A-10
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S-87 Dominique Mazeaud
S-88 Christina Brown
S-89 Laura Clarke
S-90 Sandy Clarke
S-91 Reba Lee
S-92 Judith M. Espinosa, New Mexico Environment Department
S-93 Nelson Foss
S-94 Lola Moonfrog
S-95 Karin Salzmann
S-96 Virginia Miller
S-97 Ed Romero
S-98 Shama Beach
S-99 Peter Tadd
S-100 Alexis Clemens
S-101 Edwin Treitler
S-102 Jean McFarland
S-103 Norah Pierson
S-104 Eric Larson
S-105 Carrie Hitch
S-106 Mike Castro
S-107 Richard Schmidt
S-108 Patricia Strout
S-109 Naomi Mattis
A-ll
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Written comments on the proposed 40 CFR Part 191 were received into Docket Number R-89-
01. Comments were logged during the comment period in the order they were received. The
following is a list of those who wrote and, where appropriate, the organizations they
represented.
D-01 George Greer & Requa Tolbert, Santa Fe, New Mexico
D-02 Anna Katherine, Santa Fe, New Mexico
D-03 Llyn Peabody, Santa Fe, New Mexico
D-04 Janet Degan, Santa Fe, New Mexico
D-05 Helen Thompson, Rowe, New Mexico
D-06 Lea Shepperson, Albuquerque, New Mexico
D-07 Robert M. Bernstein, M.D.
D-08 Retta Johnston, Santa Fe, New Mexico
D-09 Charles Hyder
D-10 Cliff Hall, Squash Blossom, Alamogordo, New Mexico
D-ll Dolores Pierson, Santa Fe, New Mexico
D-12 Bettie Witt, Roswell, New Mexico
D-13 Frances Tyson, Las Vegas, New Mexico
D-14 Sheila M. Stevens
D-15 James M. Hardin, Derwood, Maryland
D-16 Bonnie Bonneau, El Prado, New Mexico
D-17 Dee Homans, Andrew D., H. Howans, Santa Fe, New Mexico
D-18 Raymond Singer, Santa Fe, New Mexico
D-19 Abraham Ellis Goldminz & Irene Judith Goldminz, Carlsbad, New Mexico
D-20 Enimy Koponen, Ojo Sarco, New Mexico
A-12
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D-21 Coalition for the Sensible Management and Disposal of Radioactive Waste, signed by
Pamela Aycock
D-22 New Mexico Environmental Evaluation Group, Robert H. Neill
D-23 U.S. Department of Energy, presented at public hearings by Arlen Hunt and Eli Maestas
D-24 New Mexico Attorney General, Tom Udall
D-25 Gladys R. Winblad, Albuquerque, New Mexico
D-26 Georgia Power Company, signed by J.T. Beckham, Jr.
D-27 Cliff Stroud, Carlsbad Dept. of Development
D-28 Roger Y. Anderson, Scientists Review Panel
D-29 Elizabeth Dunham, Santa Fe, New Mexico
D-30 Centerior Energy, Perry Nuclear Power Plant, signed by Robert A. Stratman
D-31 Bob E. Watt (Human Intrusion), Los Alamos, New Mexico
D-32 Bob E. Watt (WIPP Test Phase), Los Alamos, New Mexico
D-33 Bob E. Watt (WIPP EIS), Los Alamos, New Mexico
D-34 Susan Myers, Santa Fe, New Mexico
D-35 Mansi Kern
D-36 Richard Schmidt, Ranches de Taos, New Mexico
D-37 Penelope McMullen, Sister of Loretto
D-38 Florence May Gonzalez, Santa Fe, New Mexico
D-39 Anhara Lovato
D-40 Patricia Theodore, Concerned Citizens for Nuclear Safety
D-41 John W. Ussery, El Rito, New Mexico
D-42 Linda Hibbs, Santa Fe, New Mexico
D-43 Richard Deyo, Santa Fe, New Mexico
A-13
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D-44 Stanley E. Logan, Santa Fe, New Mexico
D-45 Bonney Hughes, Religious Society of Friends
D-46 Doug Doran, Citizens for Alternatives to Radioactive Dumping
D-47 Jason Salzman, Greenpeace
D-48 Leonard M. Maki, Santa Fe, New Mexico
D-49 Judith M. Espinosa, New Mexico Environment Department
D-50 Dominique Mazeaud, Santa Fe, New Mexico
D-51 Lola Moonfrog, Santa Fe, New Mexico
D-52 Stanley Paytiamo, Pueblo of Acoma
D-53 Margaret Carde, Concerned Citizens for Nuclear Safety
D-54 Marcia Summers, New Mexico
D-55 Norah Pierson, Santa Fe, New Mexico
D-56 Da Vid, The Human Ecology Party
D-57 Patricia Strout
D-58 U.S. Nuclear Regulatory Commission, draft comments signed by Magaret V. Federline
and Daniel J. Fehringer
D-59 Richard Deyo
D-60 Don Hancock
D-61 Naomi Mattis Document
D-62 Albuquerque Hearing Submissions from commenters A-02, 05, 25, 32, 34, 60, 72, 73,
74,75
D-63 Concerned Citizens of Cerrillos, signed by Ross Lockridge, president
D-64 Lon Murphy, Portland, Oregon
D-65 Mary Burton Riseley, Santa Fe, New Mexico
A-14
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D-66 Hannah Riseley-White, Santa Fe, New Mexico
D-67 Southern Nuclear Operating Company, signed by J.D. Woodard
D-68 Environmental Defense Institute, signed by Chuck Broscious
D-69 David Okrent, University of California, Los Angeles
D-70 Retta Johnston, Santa Fe, New Mexico
D-71 Attorney General of New Mexico, signed by Tom Udall and the Attorneys General of
Arkansas, Minnesota, Nevada, and Texas
D-72 Basia Miller, Santa Fe, New Mexico
D-73 Susan Butkovich, Santa Fe, New Mexico
D-74 Nuclear Management and Resources Council, signed by Thomas E. Tipton
D-75 Nevada Division of Environmental Protection
D-76 Natural Resources Defense Council, signed by Thomas B. Cochran, James D. Werner,
and David P. O'Very
D-77 Edison Electric Institute, signed by David L. Swanson
D-78 U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards
signed by Robert M. Bemero
D-79 Kenneth Jacks, Santa Fe, New Mexico
D-80 Nevada Agency for Nuclear Projects, Nuclear Waste Project Office, signed by
Robert R. Loux
D-81 Southwest Research and Information Center, signed by Don Hancock
D-82 Westinghouse Electric Corporation, signed by S.A. Green
D-83 Sierra Club, signed by Anne Ehrlich
D-84 Victor Ferkiss, Corrales, New Mexico
D-85 Yankee Atomic Electric Company, signed by D.W. Edwards
D-86 New Mexico Environmental Evaluation Group, signed by Robert H. Neill
A-15
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D-87 U.S. Department of Energy, signed by Paul D. Grimm
D-88 Citizens for Alternatives to Radioactive Dumping, Albuquerque, New Mexico
D-89 State of New Mexico, Radioactive Waste Consultation Task Force, signed by
Anita Lockwood
A-16
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APPENDIX B
ACRONYMS
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APPENDIX B
LIST OF ACRONYMS
AEA Atomic Energy Act of 1954, as amended
CFR Code of Federal Regulations
DOE U.S. Department of Energy
EPA U.S. Environmental Protection Agency
FR Federal Register
HLW High-Level Waste
ICRP International Commission on Radiological Protection
MCL Maximum Contaminant Levels
NRC U.S. Nuclear Regulatory Commission
NWPA Nuclear Waste Policy Act
RCRA Resource Conservation and Recovery Act
SDWA Safe Drinking Water Act
TDS Total Dissolved Solids
TRU Transuranic
UIC Underground Injection Control
USC United States Code
USDW Underground Source of Drinking Water
WIPP Waste Isolation Pilot Plant
WIPP LWA Waste Isolation Pilot Plant Land Withdrawal Act
B-3
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