United States
Environmental Protection
Agency
Office of
Radiation Programs
Washington, D.C 20460
EPA 520/1-85-024-2
August 1985
Radiation
High-Level and Transuranic
Radioactive Wastes
Response to Comments for
Final Rule
Volume II
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40 CFR Part 191 EPA 520/1-85-024-2
Environmental Standards for the
Management and Disposal of Spent
Nuclear Fuel, High-Level and
Transuranic Radioactive Wastes
RESPONSE TO COMMENTS
FINAL RULE FOR HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES
Volume II—Science Advisory Board Comments
August 1985
U.S Environmental Protection Agency
Office of Radiation Programs
Washington, B.C. 20460
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CONTENTS
Page
1. Introduction 1-1
2, EPA's Responses to the Science Advisory Board Subcommittee
Findings and to Public Comments on the Findings 2-1
3. EPA's Responses to Other Public Comments Regarding the SAB
Subcommittee Report 3-1
Appendix A List of Public Commenters A-l
Appendix B Acronyms B-l
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Chapter 1: INTRODUCTION
The Science Advisory Board (SAB) is the largest and most important
of EPA's advisory panels. It was first established by the Administrator
in 1974 and was re-established in 1978 by legislative mandate under the
Environmental Research, Development, and Demonstration and Authorization
Act. The SAB is the Agency's principal institutional link with the
independent scientific community. Its mission is to help ensure the
scientific accuracy, authority, and reliability of Agency products. SAB
meetings are open to the public and are announced in advance. Its find-
ings, which are advisory in nature, are made public, including its recom-
mendations for Agency action. The SAB also reports annually to Congress.
The first SAB review of an Office of Radiation Programs (ORP) proj-
ect was undertaken for this rulemaking. The Executive Committee estab-
lished a special subcommittee for this purpose, called the High-Level
Radioactive Waste Disposal Subcommittee. The Agency announced the first
meeting of the Subcommittee in the January 5, 1983 Federal Register
(48 FR 509) for the purpose of "organizing a review of the scientific and
technical bases of the proposed standards for the management of spent
fuel, and high-level and transuranic radioactive wastes, 40 CFR Part 191."
The Subcommittee held nine meetings during 1983, the final meeting being
on September 21, 1983. Since the main effect of these standards will be
in the siting and design of repositories, the main effort of the Subcom-
mittee went to reviewing the models used as the basis of the EPA analyses
supporting the disposal standards of the proposed 40 CFR Part 191. There
was extensive technical interaction between the staff of ORP and the
members of the Subcommittee. On February 17, 1984, the Subcommittee's
final report was approved by the Executive Committee and forwarded to the
Administrator.
The primary purpose of this document is to explain which recommenda-
tions and findings were incorporated into the standards or the technical
support documents and which were not. The document also provides the
Agency's rationale for those decisions.
Since it was anticipated that many of the SAB's recommendations
would be incorporated into the standards, the Agency requested public
comments on the SAB report on May 8, 1984 with an announcement of avail-
ability in the Federal Register (49 FR 19604). A total of 39 individuals
and organizations submitted comments; this document also responds to
those comments.
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In organizing this response document, it was necessary to rearrange
the presentation in the SAB Subcommittee report. More than 60 findings
and recommendations were identified in the "Executive Summary" and "Major
Findings and Recommendations" sections of the Subcommittee's report. For
ease of response and to avoid repetition, these were condensed into 46
items by combining recommendations and findings that were identical or
very similar. These items are reproduced in this document, with page
references to their appearance in the SAB report ("ES" refers to the
Executive Summary and "MFR" refers to the "Major Findings and Recommenda-
tions"). In several instances, supporting text from the SAB report has
also been reproduced to clarify the SAB comment.
These 46 items were then arranged in the order of the first appear-
ance in the report, except that a few recommendations were moved to
facilitate combined responses. Next, the public comments on the SAB
report we're placed with the appropriate recommendations. Finally, re-
sponses were written which considered both the SAB recommendations and
the corresponding public comments. It should be noted that appended to
the SAB report were the reports of the various task groups which were
formed by the Subcommittee. The recommendations of each task group are
not addressed by the Agency because only the recommendations and findings
in the main body of the report constitute the official advice and guid-
ance of the SAB to the Agency.
After evaluating the SAB report and the public comments received,
the Agency agreed with 34 of the 40 findings and recommendations that
primarily addressed technical issues, and partially agreed with two other
technical recommendations. Of the 36 technical recommendations that the
Agency agreed with in part or in full, five did not require any action by
the Agency. Thus, 3L of the primarily technical recommendations have
resulted in changes either in the final rule, in the analyses supporting
the final rule or in other Agency actions. The four technical recommenda-
tions with which the Agency disagreed are identified as SAB Findings 17,
29, 30, and 38 in this document.
Six other SAB recommendations addressed "risk management" or other
policy issues (SAB Findings 1, 2, 4, 9, 16, and 22). These were con-
sidered as suggestions comparable to those received during the public
comment periods on the proposed rule and were evaluated in the context of
the public comments received on the SAB report. The Agency agreed with
two of these six (neither of which required action on the EPA's part) and
partially agreed with two others. The Agency disagreed with Findings 2
and 22 of these six policy-related recommendations.
The transcripts of all the High-Level Radioactive Waste Disposal
Subcommittee meetings and all the public comments referred to in this
document are filed in Public Docket Number R-82-3 which is located in
EPA's Central Docket Section, West Tower Lobby, 401 M Street, SW,
Washington D.C. 20460. A reasonable fee may be charged for copying.
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Chapter 2: EPA's RESPONSES TO THE SCIENCE ADVISORY BOARD
SUBCOMMITTEE FINDINGS AND TO PUBLIC COMMENTS ON THE FINDINGS
Finding 1; "The Subcommittee supports the general form of the proposed
standards, including (a) the use of a societal objective as an upper
bound of acceptable health (cancer and genetic) effects, (b) the focus on
performance standards in terms of release limits rather than individual
exposures, (c) the reference level of the initial 10,000 year time frame
applicable to both the societal objective and the release limits, (d) the
use of a probabilistic approach, and (e) the use of qualitative assurance
requirements, as modified by the Subcommittee, but issued as Federal
Radiation Protection Guidance to other Federal agencies in lieu of in-
clusion in the proposed rule." (ES p.2)
Response: Both technical and policy issues are addressed by this summary
finding. The final rule retains the general form of the standards as
supported by the SAB Subcommittee. However, as discussed in the EPA
Response to SAB Finding 22, the qualitative assurance requirements have
been retained in the final rule (rather than issued as Federal Radiation
Protection Guidance) for disposal facilities not licensed by the Nuclear
Regulatory Commission (NRC). The assurance requirements have been with-
drawn for NRC-licensed disposal facilities in deference to equivalent
requirements that NK.C is developing for inclusion in 10 CFR Part 60.
Finding 2; "The Subcommittee recommends that the release limits speci-
fied in Table 2 of the proposed standards be increased by a factor of
ten, thereby causing a related ten fold relaxation of the proposed
societal objective (population risk of cancer)." (ES p.2, MFR p.10)
"Two members of the Subcommittee, Dr. Lash and Dr. Giletti, dissent
from this view. They believe that the Office of Radiation Programs' more
stringent standard is justified and can be met by sufficient numbers of
proposed disposal sites." [ES p.2]
"The Subcommittee notes that the proposed release limits are di-
rectly related to the societal objective of not exceeding 1,000 deaths in
10,000 years, and thus, compliance with this recommendation carries with
it a related ten fold increase in the societal objective. The relaxation
of the release limits is, in the Subcommittee's opinion, justified for
the following reasons. First, the proposed release limits in Table 2,
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and therefore the proposed societal objective, are considerably more
stringent than those standards generally required or adopted in today's
society (see for instance Table A on page 12 of (the SAB) report).
Second, in addition to the fact that some of the cancer deaths which
might result from these releases are calculated using conservative as-
sumptions that probably overestimate the number, some of these deaths
would have resulted at least in part from the unmined ore from which the
wastes were subsequently generated, and thus are substitutional rather
than additional in nature. Third, the Subcommittee believes that the
compounding of conservatism by EPA in the choice of probabilities and
specific model parameters used throughout the analysis is not warranted."
(ES p.3)
Public Comment: All 39 of the commenters addressed this finding, far
more than commented on any other single issue in the SAB report. Those
commenters (M-5, M-17, M-18, M-21, M-25, M-36, M-39) who agreed with the
recommendation said that the risk level is well below internationally-
accepted risk levels and that the models are overly conservative.
Among the commenters who disagreed, the NRC (M-37) saw no need to
increase the level from an implementation point of view. The States
(M-2, M-4, M-12, M-31) saw no compelling justification for relaxation,
especially when the SAB recognized that the levels appear achievable at
some sites; and the States argued that levels of uncertainty are so high
that they justify conservatism. The States also predicted a loss of
credibility with the public if relaxation occurs. The environmental/
public interest groups (M-3, M-9, M-10, M-ll. M-15, M-24, M-34) cited
reasons, similar to the States', for disagreeing, but added arguments
that the other levels of risk which SAB said exist are not necessarily
acceptable and that SAB overstepped its bounds by recommending policy.
The private citizens' comments (M-6, M-7, M-8, M-13, M-14, M-16, M-19,
M-20, M-22, M-23, M-26, M-27, M-28, M-29, M-30, M-32, M-33, M-38, M-40)
generally followed one or more of the themes expressed by the States and
environmental/publie interest groups with emphasis on 1) existing stan-
dards and risk levels not necessarily being acceptable, 2) the uncer-
tainties involved justifying conservatism, and 3) the loss of credibility
with the public.
One other commenter (M-35) said that the phrasing of the SAB recom-
mendation was inherently contradictory because, had the number of deaths
been significantly overestimated, then increasing the release limits
would not result in an increase in the number of estimated deaths. This
commenter suggested that the SAB reword its recommendation to make clear
that the number of deaths will not be increased due to the proposed
increase in the release limit.
Response; This recommendation primarily involves issues associated
with policy and risk management, rather than the technical aspects of the
rule. After performing revised analyses of the capabilities of mined
geologic repositories to isolate the wastes covered by these disposal
standards, the Agency continues to believe that many of the options being
considered within the national program can reasonably achieve release
limits that correspond to the level of protection associated with the
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proposed rule. Therefore, the Agency agrees with the large majority of
public comraenters that this risk objective should not be relaxed.
With regard to the three reasons offered by the SAB Subcommittee in
support of this recommendation:
1) The Agency does not believe that the Panel demonstrated that the
standards are "considerably more stringent than those generally adopted
or required in today's society." Furthermore, such comparative risk
considerations by themselves normally would not be a primary determinant
of appropriate residual risk levels when making risk management decisions
(considerations of control technologies and cost effectiveness usually
receive greater emphasis).
2) The view that some of the residual risks from high-level radio-
active waste or spent fuel disposal are substitutional for those that
would have been caused by the unmined ore is a perspective that the
Agency agrees is useful in considering the level of protection that
should be afforded future generations. In fact, this perspective is one
of the reasons that the Agency did not choose more stringent containment
requirements for the final rule (although more stringent levels of pro-
tection appear reasonably achievable at some of the sites now being
considered by DOE). However, the Agency does not believe that this fact
justifies choosing the less stringent standards recommended by the SAB.
3) Correcting some of the overestimates of the long-term risks from
mined geologic repositories, as recommended by the SAB, has reinforced
the Agency's view that the proposed level of protection can probably be
met at essentially no additional cost to the national program. As shown
in Figure 1, these changes in the Agency's technical analyses make it
appear less appropriate to relax the disposal standards, rather than more
so.
Finding 3; "EPA should also clarify the analytical framework that forms
the basis for the limits in Table 2 of the proposed standards. The
Subcommittee believes that such clarification will help to establish
clearly the relationship between the release limits and the societal
objective, and will facilitate future amendments to the standard as
knowledge increases regarding radiation health effects or radionuclide
migration in the biosphere." (ES p.3)
Response; The Agency agrees with this recommendation. The relationship
of the release limits in Table 1 of the final rule (which was Table 2 in
the proposed standards) and the associated population risks is discussed
in the preamble to the final rule, and a detailed explantion of the
analytical framework is provided in Chapter 7 of the Background Informa-
tion Document (BID) prepared for the final rule.
Finding 4; "We recommend that the probabilistic release criteria in the
draft standard be modified to read 'analysis of repository performance
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LEVEL OF PROTECTION PROVIDED BY 40 CFR PART T91
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Figure 1. Population risks from disposal in geologic repositores
(logarithmic scale, reference case).
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shall demonstrate that there is less than a 50% chance of exceeding the
Table 2 limits, modified as is appropriate. Events whose median fre-
quency is less than one in one-thousand in 10,000 years need not be
considered.'" (ES p.3, MFR p.10)
Public Comment; Three commenters (M-18, M-25, M-36) felt that the anal-
ysis of projected repository performance is often subjective and requires
expert judgment; thus, it would be very difficult to verify compliance to
a set level of confidence.
Four commenters (M-9, M-10, M-15, M-34) argued that a fifty percent
chance of exceeding the release limits would be unacceptably low to
adequately protect public health and instill public confidence. Also,
while the SAB thought that the proposed standard could unnecessarily tie
up the licensing process in legal proceedings, these commenters did not
think this was a valid consideration for this standard-setting effort.
Response; Upon reexamining the technical basis for the rule, the
Agency became aware of greater uncertainties in predicting the frequency
of fault movement and also reviewed a report by a United States Geological
Survey (USGS) scientist that developed upper bound estimates for these
frequencies in various regions of the country (USGS Open File Report
82-972). Based upon this reassessment, the Agency has relaxed the prob-
abilistic release criteria in the final rule (Section 191.13) by a factor
of ten from those in the proposed rule to better reflect the state of
confidence involved with predicting the occurence of natural disruptive
events. Thus, the final rule calls for the cumulative probability of
exceeding the final release limits (considering normal and accidental
events and processes) to be less than 0.1, and for the cumulative prob-
ability of exceeding ten times the release limits to be less than 0.001.
This revision is in the direction of the SAB recommendation; how-
ever, it does not go as far as that recommendation. In essence, the
Agency agrees with those commenters who suggested that allowing a 50
percent chance of exceeding the containment requirement release limits
would not provide adequate confidence of achieving the desired protection
of public health. The Agency also agrees with those commenters who state
that expert judgment will be an important part of the analyses done to
determine compliance with the containment requirements; this issue is
discussed as part of the response to the next SAB finding.
Finding 5; "We recommend that use of a quantitative probabilistic con-
dition on the modified Table 2 release limits be made dependent on EPA's
ability to provide convincing evidence that such a condition is practical
to meet and will not lead to serious impediments, legal or otherwise, to
the licensing of high-level-waste geologic repositories. If such evi-
dence cannot be provided, we recommend that EPA adopt qualitative cri-
teria, such as those suggested by the NRC." (ES p.3-4, MFR p.10)
Public Comment; Two commenters (M-5, M-25) agreed with the SAB recom-
mendation. One of these (M-25) does not believe EPA has given an
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adequate explanation or basis for selection of the probability levels.
One cotnmenter (M-34) disagreed with the recommendation because "legal
impediments or other problems" should not be a factor in "public health
and safety standards.11
Response; As discussed in Chapter 8 of the BID, the Agency has revised
and updated its probabilistic performance assessments of mined geologic
repositories, evaluating many of the areas that DOE is currently con-
sidering as potential locations for the first repository. These assess-
ments indicate that the revised probablistic release limits appear rea-
sonably achievable at all of the sites being considered by DOE (and with
essentially no additional cost at most of them). The Agency has also
discussed the application of these probabilistic release limits in the
licensing process with the NRC, and this has led to inclusion of a new
section [191.13(b)] in the containment requirements. This section should
ensure that the development of a disposal system that appears to provide
the desired protection is not subjected to unwarranted "impediments"
because of the inherent uncertainties in analytical projections over very
long periods of time. Finally, the final rule includes detailed "Guid-
ance for Implementation of Subpart B" as an informational appendix that
describes the Agency's assumptions and expectations about a "practical"
implementation process.
Finding 6; "We recommend that EPA retain the 10,000-year time period as
the basis for determining the adequacy of repository performance. We
believe that use of formal numerical criteria limited to this approximate
time period is a scientifically acceptable regulatory approach." (ES p. 4,
MFR p.14)
Public Comment; The three commenters (M-18, M-25, M-37) who discussed
this recommendation agreed with it.
Response; The Agency has retained the 10,000-year period for the radio-
nuclide containment requirements (Section 191.13), which are the primary
numerical criteria to determine the adequacy of disposal systems.
Finding 7; "We recommend that the process of selection of sites for
disposal systems also take into account potential releases of radio-
activity somewhat beyond 10,000 years. Particular attention should be
focused on potential releases of long-lived alpha-emitting radionuclides
and their decay products." (ES p.4, MFR p.14)
Public CoT™»ent; Three (M-3, M-5, M-25) of the four commenters agreed
with the proposition. However, one of these (M-5) wants the application
limited to the final three sites. The fourth commenter, the NRC (M-37),
while agreeing in principle, pointed out that DOE's siting guidelines
call for a 100,000-year performance assessment and argued that such a
requirement is not within EPA's jurisdiction.
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Response; The Agency agrees with the SAB recommendation, for substan-
tial amounts of radioactivity will remain in a disposal system well
beyond 10,000 years. Accordingly, EPA worked closely with both DOE and
NRG to develop a provision—calling for comparative site evaluations over
100,000 years—that has been incorporated into the DOE "Final Siting
Guidelines" (10 CFR Part 960) promulgated on November 30, 1984
(49 FR 47714). These comparative evaluations, which are described in
Section 960.3-1-5 of 10 CFR Part 960, will be one of the significant
considerations in selecting the sites for the development of repositories
from those sites characterized in accordance with the Nuclear Waste
Policy Act of 1982 (NWPA). The Agency believes that these comparative
evaluations will strongly encourage the selection of disposal sites that
provide the best isolation among the alternatives considered and that
they will meet the intent of this SAB recommendation.
Finding 8t "We recommend that EPA retain the use of a population risk
criterion as the measure of performance for the proposed standards."
(ES p.4)
"We find that the 'release limit1 approach for expressing the level
of protection required of a repository is a satisfactory way of fulfill-
ing EPA's standard-setting mandate, and should be retained by EPA."
(MFR p.10)
"We find that an approach employing 'individual dose limits' (con-
sidering some 'maximally exposed individual* or alternatively some 'aver-
age exposed individual1) would in practice make the standard difficult to
meet with high assurance for very long times for any repository concept
currently under active consideration. However, we recommend that for the
first 500 years, the EPA standard embody an extremely low likelihood that
increases in radioactivity approaching the limits allowed by the EPA
drinking water standards will occur in potable well water drawn from any
well adjacent to the site of the repository. For longer time periods, we
recommend that EPA rely on the assumption that standards similar to the
present drinking water standards will exist to protect groups of indi-
viduals." (ES pp.4-5, MFR pp.10-11)
Public Comment; All commenters (M-5, M-10, M-25, M-34, M-36) agreed with
the recommendation to retain a population risk criterion; however, two
(M-10a M-34) encouraged having an individual standard and two others
(M-5, M-36) actively discouraged an individual standard. The NRC (M-37)
agreed with the recommendation for an individual dose limit for the first
500 years. However, the main thrust of the NRC comment was to point out
that the phrase, "...any well adjacent to the site" clearly shows the SAB
intention to be that "groundwater protection requirements be applied only
to groundwaters beyond the geologic barrier which serves as part of an
overall repository system...."
Response; The Agency has retained limits on the total radionuclide
releases from a disposal system over 10,000 years as the final rule's
primary numerical performance standards; these limits are designed to
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keep risks to populations very small. In addition, the Agency has added
provisions in the final rule (Sections 191.15 and 191.16) that limit
risks to individuals for 1,000 years after disposal. For longer time
periods, the Agency believes that several of the qualitative assurance
requirements (Section 191.14) will reduce the likelihood that individuals
vill receive significant exposures from a disposal system.
Finding 9; "We recommend that EPA initiate action within the Federal
Government for the establishment of an interagency council to coordinate
the development of high-level radioactive waste disposal policy, stan-
dards, and regulatory practices and to serve as a forum for exchange of
scientific and technological information." (ES p.5, MFR p.24)
Public Comment! Four commenters agreed (M-3, M-17, M-18, M-25). In
addition," three (M-3, M-17, M-18) encouraged State membership, one (M-3)
endorsed public membership, and one (M-18) wanted local membership.
Only one commenter (M-10) disagreed because Federal agencies already
confer and "appear to reflect different agency mandates rather than a
lack of communication", and DOE should not be given a formal role in
setting standards which effect high-level waste repository licensing.
Response; Over the past several years, there have been a number of
experiments with various types of interagency coordination mechanisms
concerning high-level radioactive waste disposal policy, standards, and
regulatory practices. Based on this experience, the Agency does not
believe that there is a compelling need for a formal "coordination
organization" for these purposes. Instead, as one commenter noted, the
Federal agencies involved with high-level radioactive waste disposal
frequently interact on policy matters. Disagreements between the
agencies almost always reflect their differing responsibilities, not a
lack of communication or coordination.
On the other hand, the Agency agrees that there could be consider-
able benefit in an interagency forum to exchange scientific and tech-
nological information regarding the high-level radioactive waste program.
A Committee on Interagency Radiation Research and Policy Coordination
(CIRRPC) was formed in April 1984 under the auspices of the Office of
Science and Technology Policy, which provides the Committee chairman.
The EPA's Assistant Administrator for Air and Radiation serves as the
Vice-Chairman. The Agency will ask the Science Panel of CIRRPC to con-
sider this recommendation.
Finding 10; "We recommend that EPA support, or encourage other agencies
to support, continuing research in technical areas where major uncer-
tainties still exist, particularly in the biological effects of radia-
tion, the geochemical transport of radionuclides, and the characteriza-
tion of rock-mass deformation." (ES p.5, MFR p.25)
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Public Comment; Two commenters (M-3, M-25) agreed but one of them
(M-25) wants research to be consistent with the NWPA and not be "ex-
cessive and open-ended."
Finding 11; "We recommend that EPA encourage research leading to better
values for solubilities and retardation factors for the nuclides listed
in Table 2 of 40CFR191, plus 1-129, Cm-247, Pb-210, Zr-93, and Sb-136."
(MFR p.23)
Response (Findings 10 and 11); Although EPA has no authorities or re-
sponsibilities to conduct such research, the Agency agrees that it is
vital to the success of the national program and will recommend that the
Science Panel of CIRRPC encourage and oversee the conduct of a continuing
research program.
Finding 12; "We think, however, that EPA has made overly conservative
choices and decisions throughout the development of the technical bases
supporting the standards, leading to overestimation of the long-term
effect of disposal, and hence that the proposed standards are too re-
strictive and compliance may be difficult to verify." (ES p.6)
"In general, EPA's analytical methodology and modeling used through-
out the development of the generic repository's performance, including
releases and subsequent cancer deaths, are deemed to be conservative.
The Subcommittee makes several suggestions for specific improvements and
updating." (ES p.7)
"We find that in their analyses of releases to the accessible en-
vironment, EPA has frequently made modeling assumptions and parameter
estimates which are conservative. These values were combined in the
models, leading to computed releases to the accessible environment that
are probably overestimated. While perhaps less conservative, this bias
was also carried through in the environmental pathways analyses."
(MFR p.19)
Public Comment; Five commenters on this finding (M-5, M-18, M-25, M-35,
M-39) agreed that many of the parameter values were conservative and
would lead to cancer death estimates higher than would actually be ex-
pected to occur. One commenter (M-18) thought adoption of the
recommendation would reduce the conservatism. The agreement of one
commenter (M-39) centered on the difficulty of compliance verification.
Another commenter (M-5) agreed that costs incurred to show compliance
with the level of the standard may be high while providing no better
protection of the public and the environment.
Response; The Agency agrees that many of the assumptions made in the
technical analyses supporting the proposed rule were conservative and
tended to overestimate the population risks from mined geologic reposi-
tories. Many of these assumptions have been made less conservative in
developing the final rule. This has had two major effects. First, many
of the radionuclide release limits in the containment requirements have
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increased (without changing the population risk objective) due to changes
in the environmental pathway, dosimetry, and biological effect analyses;
in this respect, the final containment requirements are somewhat less
stringent than those in the proposed rule. Second, the lower risk esti-
mates for geologic disposal resulting from these and other changes in the
technical analyses (see Figure 1 in the response to SAB Finding 2) make
it appear much less likely that the final containment requirements are
"too restrictive" or that compliance may be "difficult to verify".
Finding 13; "In reviewing this conclusion (that the risks to future
generations will be no greater than the risks from equivalent amounts of
naturally occurring uranium ore), we found, and EPA acknowledged, that
the comparison is uncertain because of the extreme variability of uranium
ore bodies. The Subcommittee thinks that the conclusion is valid in a
very general way, if suitably qualified, but feels that it is unwise and
not scientifically defensible to use the unmined ore as the only refer-
ence for comparison." (ES p.6)
"We recommend that EPA downplay the comparison of repository re-
leases with unmined uranium ore bodies by expanding the comparison to
include the radioactivity of natural waters and ambient radiation in the
natural environment." (MFR p.15)
"We recommend that EPA emphasize more strongly that somatic and
genetic effects resulting from repository releases that meet EPA's pro-
posed standard are at least in part substitutional effects, rather than
additive to those expected from the unmined ore." (MFR p. 15)
Response; The Agency believes that it is a useful perspective to note
that the long-term risks expected from disposal of these wastes appear to
be no more than (and probably less than) the risks that future genera-
tions would have been exposed to if the uranium ore used to create the
wastes had not been mined. The Agency agrees that there are important
qualifications to this comparison. First, it can be shown only in a
general sense because there will always be large variations in the risks
predicted for both ore bodies and disposal systems. Second, it must be
emphasized that the comparison does not necessarily mean there is
"zero-risk" to future generations from the activities used to create the
wastes, for these activities present other long-term risks besides those
associated with high-level radioactive waste disposal. The Agency also
agrees that it is useful to add other perspectives on radiation expo-
sures, and the preamble to the final rule discusses the radioactivity of
natural waters and ambient radiation in the natural environment.
Finding 14; "The Subcommittee considers there are significant shortcom-
ings in the economic analyses supporting the proposed standards. Since
the mangement, storage, and disposal of high-level waste is a multi-bil-
lion dollar venture, we believe that the shortcomings are important and
should be remedied.11 (ES p.7)
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Public Comment; Both commenters (M-5, M-36) believed that a better eco-
nomic analysis is needed, however, DOE is in a much better position than
EPA to do detailed economic analyses, such as cost/benefit, differential
costs and benefits for widely different levels of protection, costs for
alternate means of disposal, and cost savings in the waste disposal
program.
Response; Updated information and other recommendations of the
SAB Subcommittee have been considered in preparing the Final Regulatory
Impact Assessment (RIA) for 40 CFR Part 191. However, as the Subcom-
mittee notes in other findings, enough information is not yet available
to support the more sophisticated economic analyses that could overcome
the limitations of the present effort.
Finding 15; "It is noteworthy that, even though the savings associated
with individual choices may seem relatively insignificant, the absolute
costs are so large that even small percentage savings are worthwhile.
The high absolute costs appear to be relatively independent of the pro-
posed standard, and simply reflect the decision to use deep mined geo-
logic disposal sites with multiple barriers. Thus, appreciable savings
are not likely to. be realized in terms of basic cost by relaxation of the
standards. However, the cost of demonstrating compliance may be very
high, and cost reductions that may be achieved by sophisticated compli-
ance demonstrations could be substantial." (ES p.7)
Public Comment; Disagrees that "relaxation of the standards" will result
in "appreciable savings". (M-3)
Response; The Agency agrees that "appreciable savings are not likely to
be realized in terms of basic cost by relaxation of the standards." With
regard to costs of determining compliance (which the Agency thinks will
be a relatively small fraction of the overall costs in any case), Sec-
tion 191.13(b) and the "Guidance for Implementation of Subpart B" section
in the final rule have been added to alleviate unwarranted complexities
in implementation.
Finding 16; "We recommend that EPA adopt a standard which provides
adequate protection with regard to societal effects; which can be met
technically for at least some known technological approaches; on which it
will be practical for NRG to make a favorable finding with reasonable
assurance; and which does not needlessly induce or lend itself to long
controversy and delay in arriving at a decision in the regulatory frame-
work and in the courts." (MFR p. 10)
Response; In general, these have always been the Agency's objectives in
developing this rule. The only caveat concerns the "finding with rea-
sonable assurance". EPA is not sure that the same concept of "reasonable
assurance" that the NRC and its predecessor have used for many years is
appropriate when applied to the large analytical uncertainties inherent
in the projections that will be needed to determine compliance with the
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disposal standards. Therefore, 40 CFR Part 191 calls for a "reasonable
expectation" of compliance with the numerical disposal standards, allow-
ing for different judgments than might be associated with the often
rigorous test of "reasonable assurance".
Finding 17: "We believe that repository designers will find it quite
difficult and perhaps excessively expensive to demonstrate with rea-
sonable or high assurance that the levels of protection sought by EPA in
the draft standard have been met." (MFR p.10)
Response: The Agency is not sure that the Subcommittee's assertion
with respect to the proposed rule is reasonable. However, it is not
EPA's intention that the numerical disposal standards must be met with a
"high" degree of confidence in a mathematical sense (for example, demon-
strating compliance with a 95% confidence level). Instead, the "Guidance
for Implementation of Subpart B" appendix published with the final rule
describes less rigorous procedures that EPA believes are appropriate for
implementation of the disposal standards. Accordingly, the Agency does
not expect that demonstrating compliance with the disposal standards will
be unreasonably difficult or expensive.
Finding 18; "We recommend that EPA, in their calculations, drop the
ambiguous terminology 'health effects' when specific reference to somatic
(cancer) and/or genetic effects can be made." (MFR p.16)
"The term 'health effects' is often used when actually referring to
cancer mortality. While cancer-related effects may predominate over
genetic related effects, it is important to recognize that both may
occur, and more specific language is therefore needed." (MFR p.16)
Response; Appropriate changes to specify "fatal cancers" or "genetic
effects ' have been made throughout all of the documents describing the
final rule and its supporting analyses.
Finding 19; "We accept EPA's use of the linear non-threshold model for
estimating health risks." (MFR p.16)
"Although other models for estimating health risk are available and
despite uncertainties about the validity of the linear non-threshold
model in particular, this model is generally accepted for radiation
protection purposes by professionals as the conservative model of
choice." (MFR p.16)
Response; None required.
Finding 20; "We recommend that EPA consider the genetic effects to all
future generations, rather than limiting them to the first generation."
(MFR p.16)
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"Somatic effects have been appropriately calculated on a generation-
by-generation basis. Genetic effects differ, however, in that they
cumulate as a result of transferral from one generation to another. Even
though genetic effects are commonly less numerous and less serious than
somatic, it is possible for the accumulated harm from genetic effects in
any generation to be as great as that from somatic effects over the
passage of 10,000 years. To make an accurate comparison with somatic
effects, it is necessary to compute genetic effects over all generations
within a given time period." (MFR p.16)
Response: The technical analyses supporting the final rule calculate the
potential equilibrium genetic effects to all generations produced by
radiation exposure from potential releases from a disposal system, rather
than just the first generation affected; This has increased the respec-
tive genetic effect estimates from those used for the proposed rule;
however, the potential genetic effects are still relatively small com-
pared to the corresponding somatic health effects (fatal cancers).
Finding 21; "We recommend that EPA consider using the concept of effec-
tive dose equivalent in setting a dose limit in Subpart A of the proposed
standard." (MFR p.16)
"In Subpart A of 40CFR191, EPA specifies dose limits of 25 mrem/yr
to whole body, 75 mrem/yr to the thyroid, or 25 mrem/yr to any other
organ. These limits are the same as those in 40CFR190, and they are
based essentially on the critical organ approach to radiation protection.
In Subpart B, however, the radionuclide release limits are derived using
a sum of dose equivalents to different body organs weighted by the
stochastic risk factors for each organ. This is the same approach as the
effective dose equivalent described in reports of the International
Commission on Radiation Protection (ICRP 26 and 30). Thus, the two
approaches to calculating doses in Subparts A and B are clearly not
consistent.11 (MFR pp. 16-17)
Response; The Agency was aware prior to proposing the rule that the
approaches reflected in Subparts A and B of the proposed rule were not
consistent and that Subpart A was based on the "critical organ" approach.
(Similar standards for airborne radionuclide emissions recently promul-
gated under the Clean Air Act (CAA), which were developed using effective
dose equivalents, are 25 raillirems/year to the whole body and 75 mil-
lirems/year to any organ.) In the final rule, Subpart A has been divided
into two sections: one for NRC-licensed waste management and storage
facilities and one for waste management and storage operations at DOE
disposal facilities that are not licensed by NRC. The section of Sub-
part A that applies to NRC-licensed facilities will be jointly imple-
mented with the existing uranium fuel cycle standards in 40 CFR Part 190,
which are based on the older "critical organ" concept. Therefore, the
two sets of standards must be equivalent for practical implementation.
Rather than amend Part 190, the Agency has chosen to have this part of
Subpart A adopt the older concept by using the same dose limits as
Part 190. The portion of the final Subpart A that applies only to non-
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NRC-licensed facilities adopts the effective dose equivalent approach by
using the same limits utilized in the CAA standards. Thus, the incon-
sistency in approach remains because of the need to be compatible with
the older standards.
Finding 22; "We recommend that the assurance requirements, as amended by
this report, be submitted as a Federal Radiation Protection Guidance
document in support of the EPA rule package." (MFR p.17)
Public Comment; Four commenters (M-5, M-17, M-36, M-37) agreed. Four
other commenters (M-2, M-10, M-12, M-15) disagreed but for various rea-
sons. Two (M-2, M-12) believe that retention of the requirement is
important but would accept their inclusion in NRC's regulations and DOE's
guidelines if they had to be dropped from 40 CFR Part 191. One (M-10)
attacked the proposal as being "beyond the Subcommittee's expertise and
mandate"; another (M-15) used the same argument but continued on to note
that there was no legal analysis or rationale for the change which would
assure the effective implementation of 40 CFR Part 191.
Response; The Agency considered the possibility of issuing the assurance
requirements as Federal Radiation Protection Guidance, rather than as
part of the standards. However, this would add significantly to the com-
plexity of this rulemaking. Furthermore, many of the commenters support-
ing the assurance requirements believe that these principles are too
important to be issued "merely" as Federal guidance and should be incor-
porated into formal regulation. Accordingly, the Agency has retained the
assurance requirements, as modified in accordance with other comments,, in
the final rule for those disposal facilities that will not be licensed by
NRC. The final assurance requirements in 40 CFR Part 191 do not apply to
NRC-licensed facilities because NRC is developing equivalent provisions
to incorporate into its 10 CFR Part 60.
Finding 23; "We recommend that EPA delete the assurance requirement for
prompt disposal of high-level and transuranic wastes." (MFR p.17)
"There is a requirement in the Nuclear Waste Policy Act for DOE to
assess the advantages of long-term storage. Temporary storage for 20-30
years is accepted practice to allow spent fuel to 'cool down'. It may
also be advantageous for ease of computation, lesser disturbance of the
geologic environment, etc., to extend the cooling period. The prompt
disposal requirement in the proposed standards appears inconsistent with
these considerations, and should be reexamined accordingly." (MFR p.18)
Response; The Agency believes that the passage of the NWPA clarifies the
nation's commitment to develop disposal facilities for high-level radio-
active wastes and spent fuel, while allowing for temporary storage facil-
ities compatible with this commitment. Therefore, the assurance require-
ment calling for prompt disposal no longer seems necessary and has been
deleted from the final rule.
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Finding 24; "We recommend that use of the concept of as 'small (low) as
reasonably achievable' (ALARA) be limited to the consideration of the
geologic characteristics of sites nominated in accordance with the
Nuclear Waste Policy Act." (MFR p.17)
Public Comment; Three commenters (M-2, M-3, M-ll) support the ALARA
concept, but disagree with the recommendation because they believe it
should apply to the entire site selection process. Another commenter
(M-35) said the ALARA philosophy should not be stated as a standard.
This commenter also stated that the Subpart A dose limits "are not con-
sistent with other EPA (or Federal) standards, and are truly de minimis."
Response; As discussed in the preamble to the final rule, the Agency
believes that the requirements for engineered barriers in 10 CFR Part 60
adequately represent considerations of "ALARA" for the engineered por-
tions of high-level radioactive waste and spent fuel disposal systems.
Furthermore, as described in response to SAB Finding 7, the provision in
the DOE site selection guidelines (10 CFR Part 960) calling for compara-
tive site evaluations should encourage choosing sites that provide the
best isolation among the alternatives considered. While continuing to
support the concept, in this case the Agency believes that the proposed
assurance requirement calling for releases to be as small as reasonably
achievable is no longer necessary and has been deleted from the final
rule.
Finding 25; "We recommend that the assurance requirement for use of
multiple barriers be revised to give more emphasis to the system as a
whole, rather than to the performance of each barrier acting alone.
Barriers should be designed so that they complement each other and help
to compensate for unexpected failures." (MFR p.17)
"The present wording of assurance requirement (c) that 'each barrier
shall separately be designed to provide substantial isolation1 has the
implication that any one barrier acting alone should enable the reposi-
tory to comply with the proposed standard. We think that it is more
important that the system of barriers as a whole be designed to com-
pensate for the unexpected weakness or failure of one or two members."
(MFR p.18)
Response; The Agency agrees, and corresponding changes have been made in
the assurance requirement included in the final rule.
Finding 26; "We recommend that EPA limit the time period during which
repository designers may take credit in their analyses for reliance upon
active institutional controls to a period of no more than 100 years, and
that suitable surveillance be required during that period. Surveillance
techniques should not compromise the integrity of the repository. The
definition of active institutional controls should be changed so that
guarding, maintaining, and taking appropriate remedial actions are all
required." (MFR p. 17 )
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Public Comment; Both of the cotnmenters (M-2, M-3) on this issue agreed
with the recommendation.
Response; The Agency agrees with these recommendations. The assurance
requirements in the final rule have been revised to limit assumptions
about reliance on active institutional controls to no more than 100
years. At the same time, continuation of such active controls (even
though they are not "relied upon") is required for as long a period as is
reasonable. Finally, a new assurance requirement calling for long-term
monitoring of disposal systems after closure has been added to the final
rule.
Finding 27; "We recommend that EPA not preclude consideration of a
potential repository site because natural resources are at or near the
site, but rather should note that the presence of such resources is a
highly unfavorable factor which should be included in the site evalua-
tion." (MFR p.17)
Public Comment; Three commenters (M-2, M-3, M-ll) believed that the SAB
is going against the intent of the NWPA and to adopt the recommendation
would be.a significant and possibly fatal weakening of the standards.
Finding 28; "No site type should be precluded on the basis of site
characteristics alone. Consideration of all factors, including engi-
neered barriers, transportation, availability of utilities and labor,
etc., may lead to different choices amongst acceptable sites and isola-
tion technologies than those dictated by site characteristics alone."
(MFR p.22)
Public Comment; The only comment here was that EPA should clarify its
intentions on this recommendation so that it is consistent with the
NWPA. (M-3)
Response (Findings 27 and 28); Because of the inherent uncertainties in
the site selection and evaluation process, and because of the desirabil-
ity of evaluating a variety of alternatives to increase the chances of
achieving exceptional environmental protection, the Agency now agrees
that automatically precluding a potential site because of one disad-
vantage is not desirable. At the same time, the Agency still believes
that proximity to important or unique resources is a serious problem
because of the potential for unplanned human intrusion, since institu-
tional controls cannot be counted on over these periods of time to pre-
vent such intrusion. Therefore, the Agency has modified the assurance
requirement in the final rule to indicate that proximity to resources
should be considered a serious disadvantage, but not an outright pro-
hibition, for site selection.
Finding 29; "We recommend- that the applicability of Subpart B of the
proposed standards be explicitly restricted by EPA to disposal in mined
geologic repositories." (MFR p.22)
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"The present wording implies that the standard is intended to cover
all methods of disposal except disposal directly into ocean sediments.
To avoid any implication that other methods of disposal were evaluated,
and therefore to avoid foreclosing other possibilities, the standard
should be limited to disposal in mined geologic media." (MFR p.23)
Public Comment; The only commenter on this finding, the NRC (M-37),
agreed with it.
Finding 30; "We recommend that assurance requirement (g) on retrievabil-
ity of waste be deleted." (MFR p.17)
Response (Findings 29 and 30): The Agency does not agree with these
recommendations. Although the Agency only evaluated mined geologic
repositories in detail in developing 40 CFR Part 191, it seems appro-
priate that alternative disposal systems should provide protection which
is at least as good as mined repositories if such alternatives are to be
utilized. Nor does the Agency believe that it would be necessary for
alternatives to provide more protection that mined repositories. Thus,
the final rule is designed to be applicable to any potential disposal
method except disposal in the ocean or ocean sediments (which is pro-
hibited by United States law). Because of this broad applicability, the
Agency also believes it is important to rule out disposal methods which
might not be reversible even very shortly after they were implemented.
The preamble to the final rule emphasizes that all mined geologic re-
positories inherently satisfy this requirement, but techniques such as
deep well injection of liquid wastes probably would not. Therefore, the
Agency has retained the assurance requirement in the final rule that
calls for the wastes to be recoverable for a reasonable period of time
after disposal.
Finding 31; "We recommend that EPA extend the definition of 'accessible
environment1 to include major sources of potable groundwater that are
beyond the controlled area, as defined by NRG in 10CFR60 (Technical
Criteria for Disposal of High-Level Radioactive Waste), and are more than
two (2) kilometers in a horizontal direction from the original location
of the radioactive wastes in a disposal system." (MFR p.19)
"This consideration is to note the specific importance of potable
groundwater as a much needed resource, particularly in the western areas
of the country. Protecting this resource, as reflected by this position,
indicates that we feel the importance of potable groundwater supplies
will not diminish in the future and may become even more important."
(MFR p.19)
Public Comment; Three commenters (M-2, M-3, M-36) agreed with the
finding, except that one (M-2) preferred the use of EPA's "controlled
area" definition.
Response; The Agency agrees that ground water resources deserve very
good protection. Accordingly, several steps have been taken in the final
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rule to enhance the protection of ground water. First, the definition of
the "accessible environment" has "been modified to include all ground
water outside of a "controlled area". This "controlled area" is not to
exceed a horizontal distance of 5 kilometers from the disposal system or
to include a total area of more than 100 square kilometers (which would
correspond to a distance of about 3 kilometers from the disposal system
if the controlled area were symmetric with respect to the repository).
Thus, the areal extent of potential ground water sources not included
within the accessible environment is only slightly larger than that
recommended by the SAB Subcommittee. The Agency did not select a dis-
tance of 2 kilometers because it could be incompatible with the NRC's
existing requirement for a 1000-year pre-emplacement ground water travel
time to the accessible environment (which was developed on the proposed
10 kilometer distance). Second, individual protection requirements (Sec-
tion 191,15) have been added to the final rule which will limit potential
exposures to people who use ground water outside of the controlled area
for 1,000 years after disposal. And third, ground water protection
requirements (Section 191.16) have been added to protect people who drink
water from certain important aquifers either inside or outside the con-
trolled area for 1,000 years after disposal.
Finding 32; "We recommend that EPA define clearly all models used in
their analyses, if not already so documented, and ensure that state-of-
the-art information is used." (MFR p.19)
Response; In those areas where extensive documentation was not already
provided, the Agency has provided it in the documents supporting the
final rule. Furthermore, all of the analyses have been revised to incor-
porate the latest information available.
Finding 33; "We recommend that EPA, in their environmental pathways
modeling, re-evaluate the assumed fraction of activity transported to the
land surface via irrigation and make provision in the models for recycl-
ing activity leached from soils and returned to the rivers." (MFR p.19)
Response; The fraction has been reduced from 0.5 to 0.1, which is the
average fraction of total surface water flow used for irrigation in the
United States.
Finding 34; "We recommend that the environmental pathways models be
modified to incorporate the time dependence of resuspended activity in
soils and of external ground-surface exposure." (MFR p.19)
Response; The environmental pathway models have been appropriately
modified to incorporate this time dependence.
Finding 35; "We recommend that EPA improve the evaluation of uncertain-
ties inherent in all aspects of the analyses, including movement to the
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the accessible environment, the modeling of exposures through various
environmental pathways, and conversion of doses to somatic and genetic
effects." (MFR p.19)
Response; The reports of the risk assessments supporting the final rule
discuss the effects of uncertainties in all areas of the analyses more
thoroughly than in the reports supporting the proposed rule.
Finding 36; "We recommend that dilution not be an acceptable practice to
avoid the regulations for disposal of material as high-level waste, but
that it be considered as a reasonable means of converting minute quan-
tities of high-level or TRU waste into material that can be disposed of
under 10CFR61 (Licensing Requirements for Land Disposal of Radioactive
Wastes)." (MFR pp.20-21)
Response; The Agency agrees with the intention of this recommendation,
but does not believe that it requires any modification to 40 CFR Part 191.
The Agency believes that the NRC has adequate plans and procedures that
will ensure appropriate disposal of such materials.
Finding 37; "We recommend that EPA perform an economic analysis (bene-
fit/cost analyses; differential costs and benefits for widely different
levels of protection; and costs for alternate means of disposal) in
addition to the cost analysis already presented. In making this analysis
EPA should use more current cost models and data now available.11 (MFR p.21)
"Given the data available at that time (early 1982), the cost anal-
ysis (see draft Regulatory Impact Analysis, EPA 520/1-82-024) is rea-
sonably comprehensive and adequate, and uses data valid in early 1982.
New data, however, are now available, e.g., Waddell et al., Engel and
White, Clark and Cole, and the Defense Waste Management Plan." (MFR p.21)
Response; The Agency has updated the cost data used In the Final Regula-
tory Impact Analysis using the references noted by the SAB Subcommittee,
and qualitative benefit/cost assessments have been made for those few
situations where significant cost impacts were identified. The Agency
does not agree that a wider range of levels of protection needs to be
considered (the current range is from 100 to 10,000 health effects over
10,000 years). This range is adequate to consider effects on mined
repositories, and it does not appear necessary to consider the appro-
priateness of mined repositories themselves, since Congress has already
focused the national program on this method through the NWPA.
Finding 38: "We recommend that EPA examine carefully the possibilities
for cost savings in the waste disposal program. Though the uncertainties
in the cost estimates are great, the absolute amounts involved are so
large that even small percentage savings could represent substantial
amounts of money." (MFR p.21)
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Response; The Agency agrees that such an examination would be useful.
However, except to consider possible effects of these standards, the
Agency is not responsible for determining the most cost effective methods
of disposal. Therefore, the Agency's only response to this recommenda-
tion consists of the cost analyses performed in the Final RIA.
Finding 39; "We recommend that EPA consider discounted, as well as
non-discounted, costs for the operational period. This will help to
disclose the significance of sequencing and delays on site selection and
engineering designs of repositories." (MFR p.21)
"Discounted cost procedures recognize that expenditures incurred
early in repository development are of greater significance than the same
amounts expended later. The relative importance of the various cost
components in waste isolation could be changed drastically by the use of
discounted dollars." (MFR pp.21-22)
Response; Both undiscounted costs and costs discounted at rates of 2 and
10 percent for each of the elements of waste disposal are displayed in
the Final RIA.
Finding 40; "For a generic, deterministic study the aggregated, simple
model used by EPA is adequate for a cost analysis. However, the cost for
actual repositories at specific sites could diverge substantially from
these generic costs." (MFR p.21)
Response; The Agency agrees with this comment; however, no assessment of
the divergence in cost is possible at this time.
Finding Al; "We recommend that EPA analyze the practicality of imple-
menting the suggested dose limits (under Subpart A) at facilities that
include operations of both the uranium fuel cycle and the management and
storage of high-level wastes." (MFR p.22)
Response; Subpart A of the final rule has been revised so that any
exposures from: 1) NRC-licensed and 2) non-NRC-licensed waste management
and storage facilities no longer have to be considered in combination.
Exposures from NRC-licensed waste management and storage facilities and
uranium fuel cycle facilities do have to be considered in combination.
Currently, however, there do not appear to be foreseeable circumstances
where such combined consideration should be impractical to implement.
Finding A2; "We recommend that EPA, in their generic analyses, utilize
different sets of geochemical parameters for high-ionic-strength environ-
ments (such as salt) and for the much lower-ionic-strength waters ex-
pected in many other lithologies." (MFR p.23)
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Response; Media-specific geochemical parameters have been adapted from
the National Academy of Sciences' (NAS) Waste Isolation Systems Panel
(WISP) report for use in the performance assessments supporting the final
rule.
Finding 43; "We recommend that EPA reassess the values it chose for
solubility and retardation factors for Am, Sn, Sr, Cs, Tc, and Np."
(MFR p.23)
Response; Different, generally less conservative values (i.e., less
likely to overestimate the risks from repositories) have been selected
for most of these radionuclides. In particular, much lower values for
the solubility of americium have resulted in substantially lower long-
term projections of risks due to inadvertent human intrusion into re-
positories.
Finding 44; "We recommend that EPA's definition of high-level radio-
active wastes be consistent with that set forth in the Nuclear Waste
Policy Act (NWPA) and coordinated with the definition used by the Nuclear
Regulatory Commission (NRC)." (MFR p.24)
Public Comment; The only comment on this recommendation was supportive
and the commenter, the NRC (M-37), noted that drafts of 40 CFR Part 191
later than the proposed rule have "contained an appropriate definition".
Response; The final rule defines "high-level radioactive waste" by
directly referencing the definition in the NWPA. The preamble to the
final rule states that the Agency will follow the anticipated rulemaking
by the NRC to further specify the details of the NWPA definition, and
that EPA will consider any appropriate modifications to the 40 CFR Part 191
definition upon NRC's completion of its rulemaking.
Finding 45; "We recommend that EPA check the definition of TRU waste to
ensure consistency, both within EPA and among EPA, DOE and NRC." (MFR p.24)
Response; The definition has been changed to allow flexibility for
conformance with NRC and DOE practices.
Finding 46; "We recommend that a suitable equivalency to the MTHM con-
cept (such as one based on number of fissions) be established for defense
wastes, and for some kinds of commerical wastes." (MFR p.24)
Response; The final rule contains procedures for determining roughly
equivalent amounts of spent fuel (or the high-level radioactive waste
produced from the spent fuel) that have received substantially different
exposures than is typical for commercial electrical power reactors.
These procedures are needed to determine appropriate release limits for
disposal systems containing such spent fuel or high-level radioactive
waste.
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Chapter 3: EPA'S RESPONSES TO OTHER PUBLIC COMMENTS REGARDING
THE SAB SUBCOMMITTEE REPORT
Public Comment; "The SAB should not have mixed policy with science."
(M-3, M-10, M-15) .
Response; The Agency agrees that it is desirable to keep policy of "risk
management" issues as separate as possible from questions of science.
However, this was particularly difficult in this case because the Agency
arranged this SAB review to run concurrently with the public comment
period on the proposed rule. As the Chairman of the Subcommittee noted
in his letter transmitting the report to the Administrator: "... given
the timing of its review in the rulemaking process, the Subcommittee
found it virtually impossible to separate scientific and technical eval-
uations from matters of policy, since they are so interdependent." To
reduce this problem in the future, the Agency will attempt to conduct its
SAB reviews of supporting technical information before the corresponding
rule is completed and available for public comment.
Public Comment; "The SAB report reflects overconfidence and overoptimism
regarding the DOE's ability to overcome the technical and institutional
obstacles to safe disposal of high-level and transuranic nuclear wastes."
(M-3)
Response; The Agency believes that the Subcommittee was well aware of
the many difficulties that DOE will likely encounter over the many years
before a disposal system is available. The Agency thinks that it is
important that such "obstacles" be satisfactorily resolved in a rea-
sonable time frame in order to proceed with disposal of these dangerous
materials.
Public Comment; "We strongly disagree with recommendation 6 of the
Assurance Requirements Subgroup that the engineered barriers be relaxed
for TRU waste." (M-3)
Response; The assurance requirement calling for both engineered barriers
and natural barriers in the final rule does not distinguish
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between high-level and transuranic radioactive wastes. Although the
wording of the assurance requirement has changed from the proposed rule,
the Agency does not believe the requirement has been significantly
changed.
Public Comment; Based on what they believe are needed changes in the
societal objective and "to perfect the proposed approach to uncertainty
and define margins of safety," that "...renoticing the standard in the
Federal Register for an additional 180-day period for public and federal
comment" is "fully justified." (M-39)
Response; Because of the recent court order mandating promulgation of
this rule by August 15, 1985, because of the importance of 40 CFR Part
191 to the orderly progress of the national program to dispose of these
materials, and because substantial opportunities for public review and
comment have already been provided, the Agency believes it is appropriate
to proceed to complete this ruletnaking at this time.
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APPENDIX A
LIST OF PUBLIC COMMENTERS
A-l
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APPENDIX A
LIST OF PUBLIC COMMENTERS
M-2 Harmon, Weiss & Jordan, Washington, D.C. on behalf of the Yakima
Indian Nation in the State of Washington.
M-3 Southwest Research and Information Center, Albuquerque, New Mexico.
M-4 Nuclear Waste Project Office, Office of the Governor of Nevada.
M-5 Edison Electric Institute, Washington, D.C.
M-6 Ronald A. Martin, Shreveport, Louisiana.
M-7 Margaret Marshall, Hereford, Texas.
M-8 Viviana Patino, Hereford, Texas.
M-9 Appalachia - Science in the Public Interest, Livingston, Kentucky.
M-10 Natural Resources Defense Council, Inc., Washington, D.C.
M-ll Hanford Oversight Committee, Seattle, Washington.
M-12 Office of the Governor of the State of Texas.
M-13 Jim Steiert, Hereford, Texas.
M-14 Lisa Blakely, Hereford, Texas.
M-15 Environmental Policy Institute, Washington, D.C.
M-16 Brandie Lee Redinger, Arlington, Virginia.
M-17 Middle South Services, New Orleans, Louisiana.
M-18 Georgia Power Company, Atlanta, Georgia.
M-19 Karl Z. Morgan, Atlanta, Georgia.
M-20 Vicki P. Harrell, Jackson, Mississippi
M-21 Hans Frauenfelder, Urbana, Illinois, for the Environmental Policy
Institute.
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M-22 Mrs. Durley E. Hanson, Richton, Mississippi.
M-23 Dorothy Gatlin Cole, Richton, Mississippi.
M-24 Perry County Citizens Against Nuclear Disposal, Inc., Richton,
Mississippi.
M-25 Carolina Power & Light Company, Raleigh, North Carolina.
M-26 Susan Mayfield, Jackson, Mississippi.
M-27 Cynthia Gavette, Jackson, Mississippi.
M-28 Virginia Munford, Jackson, Mississippi.
M-29 James Gavette, .Jackson, Mississippi.
M-30 Mrs. David R. Mann, Jackson, Mississippi.
M-31 Governor of the State of Mississippi.
M-32 David & Lucille Reeves, Macon, Mississippi.
M-33 Catherine Thompson, Columbia, Mississippi.
M-34 Citizens Against Nuclear Disposal, Biloxi, Mississippi.
M-35 Kerr-McGee Corporation, Oklahoma City, Oklahoma.
M-36 Atomic Industrial Forum, Bethesda, Maryland.
M-37 Nuclear Regulatory Commission, Washington, B.C.
M-38 David and Mary Jo Childress, Laurel, Mississippi.
M-39 American Nuclear Society, LaGrange Park, Illinois.
M-40 William C. Thompson, Hattiesburg, Mississippi.
A-3
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APPENDIX B
ACRONYMS
B-l
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APPENDIX B
ACRONYMS
BID Background Information Document
CFR Code of Federal Regulations
CIRRPC United States Committee on Interagency Radiation Research and
Policy Coordination
DOE United States Department of Energy
EPA United States Environmental Protection Agency
ES Executive Summary section of the Science Advisory Board report
ICRP International Commission on Radiological Protection
MFR Major Findings and Recommendations section of the Science
Advisory Board report
MTHM Metric tons of heavy metal
NRC United States Nuclear Regulatory Commission
NWPA Nuclear Waste Policy Act of 1982 (Public Law 97-425, 96 Stat.
2201)
ORP Office of Radiation Programs, U.S. Environmental Protection
Agency
RIA Regulatory Impact Analysis
SAB Science Advisory Board, U.S. Environmental Protection Agency
TRU Transuranic
USGS United States Geological Survey
B-2
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