[Federal Register Volume 61, Number 28 (Friday, February 9, 1996)]
[Rules and Regulations]
[Pages 5224-5245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2721]
[[Page 5223]]
_______________________________________________________________________
Part VI
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 194
Criteria for the Certification and Re-Certification of the Waste
Isolation Pilot Plant's Compliance With the 40 CFR Part 191 Disposal
Regulations; Final Rule
Federal Register / Vol. 61, No. 28 / Friday, February 9, 1996 / Rules
and Regulations
[[Page 5224]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 194
[FRL-5418-5]
RIN 2060-AE30
Criteria for the Certification and Re-Certification of the Waste
Isolation Pilot Plant's Compliance With the 40 CFR Part 191 Disposal
Regulations
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is promulgating
criteria for determining if the Waste Isolation Pilot Plant (WIPP) will
comply with EPA's environmental radiation protection standards for the
disposal of radioactive waste. If the Administrator of EPA determines
that the WIPP will comply with the standards for disposal, then the
Administrator will issue to the Secretary of Energy a certification of
compliance which will allow the emplacement of transuranic waste in the
WIPP to begin, provided that all other statutory requirements have been
met. If a certification is issued, EPA will also use this final rule to
determine if the WIPP has remained in compliance with EPA's
environmental radiation protection standards, once every five years
after the initial receipt of waste for disposal at the WIPP. This
rulemaking was mandated by the WIPP Land Withdrawal Act of 1992.
EFFECTIVE DATE: These regulations are effective April 9, 1996. The
incorporation of certain publications listed in the regulations is
approved by the Director of the Office of the Federal Register as of
April 9, 1996. A petition for judicial review of this final action must
be filed no later than April 9, 1996 pursuant to section 18 of the WIPP
Land Withdrawal Act of 1992 (Pub. L. 102-579).
FOR FURTHER INFORMATION CONTACT: Betsy Forinash, Mary Kruger or Martin
Offutt; telephone number (202)-233-9310; address: Radiation Protection
Division, Mail Code 6602J, U.S. Environmental Protection Agency,
Washington, DC 20460. Copies of the Background Information Document and
Economic Impact Analysis which accompany today's action may be obtained
at this address. The Agency has also published a document, accompanying
today's action, which responds in detail to significant public comments
that were received on the proposed rule. This document, entitled
``Response to Comments'' may be obtained by contacting Betsy Forinash.
SUPPLEMENTARY INFORMATION:
Introduction
Purpose of Today's Action
Today's action implements the Environmental Protection Agency's
(EPA) environmental radiation protection standards, 40 CFR part 191, by
applying them to the proposed disposal of transuranic radioactive waste
in the Waste Isolation Pilot Plant (WIPP). The EPA previously
promulgated 40 CFR part 191, ``Environmental Radiation Protection
Standards for Management and Disposal of Spent Nuclear Fuel, High-Level
and Transuranic Radioactive Wastes,'' to provide standards that will
apply to all sites (except Yucca Mountain) for the deep geologic
disposal of highly radioactive waste. Complete descriptions of 40 CFR
part 191 were published in the Federal Register in 1985 (50 FR 38066-
38089, Sep. 19, 1985) and 1993 (58 Fed. Reg. 66398-66416, Dec. 20,
1993). The WIPP is subject to 40 CFR part 191, and is being constructed
by the Department of Energy (DOE) near Carlsbad, New Mexico, as a
potential repository for the safe disposal of transuranic radioactive
waste. The EPA is required by the WIPP Land Withdrawal Act of 1992
(Pub. L. 102-579) to evaluate whether the WIPP will comply with
subparts B and C of 40 CFR Part 191--known as the ``disposal
regulations''--and to issue or deny a certification of compliance. The
Department of Energy is required to submit an application to EPA that
will be the basis of EPA's evaluation of whether a certification of the
WIPP's compliance with the disposal regulations should be issued. The
Department of Energy may not begin to emplace transuranic waste
underground for disposal at the WIPP until such time as a certification
of compliance has been issued and all other requirements of section
7(b) of the WIPP Land Withdrawal Act have been satisfied. With today's
rulemaking, the Agency establishes criteria by which to judge whether
the WIPP is in compliance with the ``disposal regulations'' and sets
forth procedural requirements for this determination.
Today's action, 40 CFR part 194, also applies to the periodic re-
certification of the WIPP's compliance with the disposal regulations.
The process of periodic re-certification, established by section 8(f)
of the WIPP Land Withdrawal Act, calls for EPA to determine whether the
WIPP continues to be in compliance with the disposal regulations,
assuming that an initial certification of compliance has been issued.
The Secretary of Energy must submit to the Administrator of EPA
documentation of the WIPP's continued compliance with the disposal
regulations, every five years after the initial receipt of transuranic
waste for disposal at the WIPP, until the end of the decommissioning
phase. The Agency will use the criteria set forth in today's rulemaking
in determining whether or not the WIPP will have continued to be in
compliance.
The WIPP was authorized in 1980, under section 213 of the
Department of Energy National Security and Military Applications of the
Nuclear Energy Authorization Act of 1980 (Pub. L. 96-164, 93 Stat.
1259, 1265), ``for the express purpose of providing a research and
development facility to demonstrate the safe disposal of radioactive
wastes resulting from the defense activities and programs of the United
States.'' The waste proposed for disposal in the WIPP, transuranic
radioactive waste (TRU waste), is waste consisting of materials such as
rags, equipment, tools, protective gear and sludges which have become
contaminated during atomic energy defense activities. The WIPP Land
Withdrawal Act defines transuranic waste to be waste containing more
than 100 nano-curies per gram of alpha-emitting radio-isotopes, with
half-lives greater than twenty years and atomic number greater than 92,
per gram of waste. The Act further stipulates that radioactive waste
shall not be transuranic waste if such waste also meets the definition
of high-level radioactive waste, has been specifically exempted from
the disposal regulations with the concurrence of the Administrator, or
has been approved for an alternate method of disposal by the Nuclear
Regulatory Commission. The radioactive component of transuranic waste
consists of man-made elements created during the process of nuclear
fission, chiefly isotopes of plutonium.
Statutory and Regulatory Basis
Today's action, 40 CFR part 194, was mandated by Congress in
section 8(c) of the WIPP Land Withdrawal Act. The criteria promulgated
in this action implement only those subparts of 40 CFR part 191 that
apply to the disposal of transuranic radioactive waste. As stated in
the Code of Federal Regulations, Appendix C of 40 CFR part 191 is
guidance for the implementation of the regulations contained in 40 CFR
part 191 that is not binding on the implementing agency, which is EPA
with respect to the WIPP. Appendix C was designed to apply to all
geologic
[[Page 5225]]
repositories for the disposal of highly radioactive wastes, not
necessarily to the specific site characteristics of the WIPP and not
only to transuranic waste. As a result, the Agency found in developing
today's action that only some of the guidance contained in Appendix C
had specific relevance to the WIPP. Today's action has been guided by
only those aspects of Appendix C that the Agency has determined, based
on technical and policy considerations, to be applicable to the WIPP.
Today's action, 40 CFR part 194, does not amend 40 CFR part 191.
With the Energy Policy Act of 1992, Congress mandated the development
of regulations to replace 40 CFR part 191 for the Yucca Mountain site
only, but the entire standard, 40 CFR part 191, remains applicable to
the WIPP. See 106 Stat. 2921, section 801(a)(1). Subpart A of 40 CFR
part 191 applies to the management of spent nuclear fuel, high-level
and transuranic radioactive wastes at sites designated for the disposal
of these wastes. Section 9(a) of the WIPP Land Withdrawal Act
stipulates that the Secretary of Energy shall comply with respect to
the WIPP with Subpart a of 40 CFR part 191. The Agency has not
implemented these requirements in today's action, 40 CFR part 194, but
intends to issue guidance for their application to the WIPP at a future
date.
Compliance With Other Environmental Laws and Regulations
The WIPP is regulated under the Resource Conservation and Recovery
Act (RCRA) and is subject to both the Part B licensing requirements and
the land disposal restrictions of that statute. The WIPP must comply
with other environmental laws, including, among other statutes, the
Clean Air Act (40 U.S.C. 7401 et seq.), the Toxic Substances Control
Act (15 U.S.C. 2601 et seq.) and the Comprehensive Environmental
Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9601 et
seq.). This action does not affect the need for DOE to comply with
these and all other applicable environmental laws with respect to the
WIPP.
Public Involvement in Today's Rulemaking
The Agency has taken significant steps to involve the public in the
rulemaking for today's action. The EPA published an Advanced Notice of
Proposed Rulemaking (ANPR) in February, 1993 (58 FR 8029) which
solicited public comment on eight issues central to the development of
this final rule. The EPA again solicited public comment on a
preliminary draft of the proposed rule, in January, 1994. The Agency
published a notice of proposed rule on January 30, 1995, which
announced the start of a public comment period of 90 days (60 FR 5766).
The Agency convened a technical workshop in February, 1995, for the
express purpose of soliciting the views of both scientific experts and
the public on issues germane to the rulemaking. In March, 1995, the
Agency held public hearings in three cities in New Mexico to solicit
public input on the notice of proposed rule. On August 1, 1995, the
Agency re-opened the comment period on the notice of proposed rule for
an additional 45 days (60 FR 39131). During the entire comment period
on the proposed rule, the Agency received over 100 written public
comments. The Agency has responded to significant comments received on
the notice of proposed rule from both written submissions and from
testimony at the public hearings, including late written comments
received soon after the close of the second part of the comment period,
in a document published concurrently with today's action. In September,
1995, EPA conducted a public meeting of the WIPP Review Committee of
the National Advisory Council for Environmental Policy and Technology
(NACEPT) on three issues relevant to today's action. During this
meeting, members of the public provided formal presentations and oral
comments to the committee. See 60 FR 43470-43471 (Aug. 21, 1995).
Summary of the Final Rule
The supporting rationale for today's action, found in the following
summary and discussion of principal changes, is further explained in
the Background Information Document and the Response to Comments which
accompany today's action, copies of which may be obtained as described
in the start of this notice. Those sections of the final rule which
have remained unchanged since the rule's proposal are also further
explained in the notice of proposed rule (60 FR 5766-5791).
Subpart A: General Provisions
Subpart A of the final rule establishes provisions related to the
structure of the final rule itself, including: Purpose, scope and
applicability; definitions; substitution of alternative provisions for
those promulgated in today's final rule; and procedures which shall be
followed in communications and written reports submitted by the
Secretary of Energy to the Administrator. Further provisions are set
forth which incorporate by reference several publications. Publications
so incorporated shall have the same legal force and effect as the other
requirements of the final rule.
Section 194.4 of subpart A permits the Agency to specify conditions
on the issuance of a certification and to issue a modification,
suspension or revocation of a certification. The Agency would, for
example, specify conditions in the event that the necessary confidence
in the WIPP's compliance could be achieved by the implementation of
additional measures, or if EPA determines that the WIPP will comply
with the disposal regulations if certain terms of the application were
to be changed.
The Agency would consider issuing a modification, suspension or
revocation whenever the disposal activities or disposal system change
such that significant information contained in the most recent
compliance application were no longer to remain true. Such a situation
may occur if (1) DOE plans to make a significant change to the disposal
system or disposal activities, or (2) DOE discovers that a significant
change has occurred in the disposal system or disposal activities; in
either case DOE must inform the Administrator in writing. If DOE finds
the latter condition to be true, then DOE must determine if a release
of waste from the disposal system has occurred or is expected to occur
that would cause the numerical requirements of the disposal regulations
to be exceeded. Releases which might occur during management
operations, covered under subpart A of 40 CFR part 191, which do not
relate to compliance with the disposal regulations would not
necessitate this investigation. However, if DOE conducts this
investigation and determines that such a release has occurred or is
likely to occur, then DOE shall notify the Administrator of this fact
and immediately cease emplacing waste in the WIPP. In such situations,
the Administrator will determine which of three actions--modification,
suspension or revocation--will be appropriate. Any modifications and
revocations issued by EPA would affect the certification issued
pursuant to section 8(d)(1) of the WIPP Land Withdrawal Act and must be
conducted by rulemaking under section 553 of the Administrative
Procedure Act. See 5 U.S.C. 553. A suspension may be issued at any time
at the Administrator's discretion so as to promptly address any
potential threat to public health. A suspension shall remain in place
until such time as DOE shall have effected remediations as necessary to
re-establish the WIPP's compliance with the disposal regulations or
until EPA will
[[Page 5226]]
have modified or revoked the certification. DOE shall not restart
emplacing waste in the WIPP until the Administrator notifies DOE in
writing that the suspension has been lifted.
Subpart B: Compliance Certification and Re-certification Applications
Subpart B of the final rule sets forth requirements for the format
and content of compliance applications. Section 194.11 of the final
rule stipulates that DOE must submit a complete compliance application
before the one-year, statutory review period shall commence. See Pub.
L. 102-579, section 8(d)(1). Should DOE's initial submission be
incomplete, the Administrator will explain the nature of the deficiency
and will request DOE to submit further information until the
Administrator has notified the Secretary that all materials necessary
for a complete application have been received. This process will ensure
that the Agency's one-year period will be devoted exclusively to a
substantive, meaningful review. This provision applies as well to the
compliance applications periodically submitted by DOE for re-
certification of compliance. Once the Administrator has notified the
Secretary of Energy that a complete compliance application for re-
certification has been received, the Agency will commence the six month
review period as provided for in section 8(f) of the WIPP Land
Withdrawal Act. Section 194.12 requires that 30 copies of the
compliance applications and any accompanying materials shall be
submitted to the Administrator. Section 194.13 requires that compliance
applications be accompanied by any referenced materials, unless such
materials are generally available.
Section 194.14 of the final rule lists those elements which the
Agency requires to be in a complete compliance application. In general,
compliance applications must include information relevant to
demonstrating compliance with each of the individual sections of the
final rule. The Agency intends to publish the final version of the
Compliance Application Guidance (CAG) at a later date to provide
detailed guidance on the submission of a complete compliance
application.
Section 194.15 of the final rule specifies that DOE must submit any
additional information that will have been gathered during the elapsed
five-year period and that is relevant to compliance with the disposal
regulations. To facilitate the Agency's review of compliance
applications for re-certification, today's final rule stipulates that
DOE will not have to re-submit information that will have been included
in previous compliance applications, provided that the information will
have remained true and accurate. The current compliance application
should clearly reference such information so that the Agency's review
of the section in question can be accomplished expeditiously.
Subpart C: Compliance Certification and Re-certification
Subpart C establishes the requirements that apply to the
performance assessments and compliance assessments that will be used to
demonstrate compliance with the numerical requirements of the disposal
regulations. In addition, subpart C implements the six assurance
requirements of the disposal regulations and also establishes seven
general requirements in Secs. 194.21 through 194.27 which must be met
by all portions of and all activities associated with compliance
applications.
Section 194.21, inspections, provides EPA with right of inspection
of all activities at the WIPP and all activities located off-site which
provide information included in compliance applications. The Agency
will conduct periodic inspections, both announced and unannounced, to
verify the adequacy of information included in the compliance
applications. The Agency may conduct its own laboratory tests, in
parallel with those conducted by DOE, so as to confirm the adequacy of
the techniques employed at those facilities. The Agency may also
inspect any relevant records kept by DOE, including those records
required to be generated pursuant to today's action.
Section 194.22, quality assurance (QA), sets requirements that
apply to data and information collected as part of the WIPP program.
The Agency requires quality assurance programs to be implemented, as
soon as practicable after April 9, 1996, that meet the requirements of
the American Society of Mechanical Engineers (ASME) ``Quality Assurance
Program Requirements for Nuclear Facilities'' (NQA-1-1989), ASME's
``Quality Assurance Requirements of Computer Software for Nuclear
Facility Applications'' (part 2.7 of NQA-2a-1990 addendum to ASME NQA-
2-1989), and ASME's ``Quality Assurance Requirements for the Collection
of Scientific and Technical Information on Site Characterization of
High-Level Nuclear Waste Repositories,'' (NQA-3-1989 edition),
excluding sections 2.1(b), 2.1(c) and 17.1. Section 194.5 of the final
rule incorporates these three publications by reference. The Agency
believes that ASME's standards offer the most comprehensive and
specific set of requirements for nuclear facilities and has therefore
used these standards in place of establishing new requirements.
Paragraph (a)(2) of Sec. 194.22 requires that DOE must implement a
quality assurance program that meets the above three sets of ASME's
requirements for seven specific program elements of the WIPP and for
any other system, structure, component, or activity important to the
containment of waste in the disposal system.
Data that were collected prior to the implementation of the above
programs must also satisfy quality assurance requirements. Any
compliance application must demonstrate, subject to the approval of the
Administrator or the Administrator's authorized representative, that
such data were qualified using one or more of the following four
methodologies: (1) Use of a methodology that is substantially
equivalent in effect to the three sets of ASME's requirements; (2) peer
review that is compatible with NUREG-1297; (3) corroborating data; or
(4) confirmatory testing. The Agency believes that each of these latter
three methods provides a means of inferring the quality of the existing
data by subjecting some aspect of that data to additional scrutiny.
Peer review involves a critical evaluation by an independent review
group of the adequacy with which the experiments used to acquire this
data were planned and conducted. The use of corroborating data
evaluates the degree to which the existing data agree with data
generated from similar work that has already been published in
scientific journals, along with an appraisal of the latter's quality.
Confirmatory testing involves repeating a small portion of the
experiments, using quality assurance methods that meet the requirements
of ASME's standards, and comparing the resulting data to the data in
question. In the last two alternate methodologies, the level of
agreement between the existing data and the corroborating or
confirmatory data provides an objective measure to assess the quality
of the existing data, if only in part. All quality assurance programs,
both for existing data and data that has yet to be collected, must
assess the accuracy, precision, representativeness, completeness and
comparability of data. To verify that the quality assurance programs
satisfy the requirements of this section, the Administrator will
conduct inspections which may include surveillance, audits and
management systems reviews.
Section 194.23, models and computer codes, sets requirements for
the models and computer codes used in
[[Page 5227]]
performance assessments and compliance assessments. Compliance
applications must demonstrate that performance assessments and
compliance assessments make a logical progression from conceptual
models to mathematical models to numerical models and finally to
computer models and codes. Compliance applications must provide
information on and descriptions of models and computer codes which will
permit the Agency to conduct a review of the modeling approach,
theoretical bases, and the methodology employed in developing the list
of processes and events used to support the compliance application.
Compliance applications must include evidence that all computer codes
comply with the requirements of part 2.7 of ASME's NQA-2a-1990
addendum.
The Agency intends to conduct detailed reviews of the computer
codes used in performance and compliance assessments, since it is the
results of computer codes themselves that will be compared to the
numerical requirements found at section 13 of 40 CFR part 191.
Compliance applications must provide: Descriptions of the theoretical
backgrounds for each model and the method of analysis or assessment; a
line-by-line listing of codes, which may be submitted in electronic
format; a discussion of the treatment of correlation between
parameters; and other information necessary to permit the Agency to
conduct its review. Upon request, DOE must provide the Agency with the
means to conduct its own simulations. The final rule requires that any
computer files and hardware that will be necessary for performing
simulations shall be made available within 30 days of a request from
the Administrator or the Administrator's authorized representative.
Section 194.24, waste characterization, has been revised in the
final rule. A discussion of the rationale for the changes is contained
below in the section of the supplementary information, ``Principal
changes in the final rule.'' The final rule requires DOE to identify
and describe quantitative information on those physical, chemical and
radiologic characteristics of the waste that can influence disposal
system performance. The Agency does not expect or require that every
drum of transuranic waste be opened in an effort to provide an
exhaustive characterization of the contents. Rather, the Agency expects
that DOE will sample drums of waste to the extent necessary and will
combine the results with other information such as process knowledge to
determine the waste characteristics. The level of accuracy needed in
waste characterization is determined by the degree of accuracy assumed
in the compliance application. A waste characteristic, as defined in
the final rule, is a physical or chemical parameter that serves as a
quantitative input to performance assessments or compliance
assessments, examples of which are solubility and compactibility. DOE
must conduct an analysis to identify and assess the impact on long-term
performance of those waste characteristics which influence the
containment of waste in the disposal system. This section of the final
rule lists specific characteristics which must, at a minimum, be
included in the analysis.
The final rule requires DOE to establish limits on the quantities
of different ``waste components,'' such as cellulosics, metals or
activity in curies, that may be proposed for disposal and emplaced in
the WIPP. A waste component is distinguished from a waste
characteristic in that the former is an amount of a type of waste
present in the total inventory-- expressed as a volume, mass or weight
(or curies, in the case of activity)--whereas the latter is any
parameter that describes the physical, chemical or radiologic
properties and behavior of some or all of the containers of waste. For
example, a container of waste might contain a given quantity of
chelating agents, which are a waste component. An example of a
corresponding waste characteristic is the solubility in brine of the
radionuclides in a container. The final rule requires that DOE
establish upper or lower limits, as appropriate, on the total amount of
each waste component that may be emplaced for disposal in the WIPP. A
lower limit might be specified for gas-gettering waste components, and
an upper limit might be specified for cellulosics. The final rule
requires that these upper and lower limits be established based on the
total inventory proposed for disposal such that the results of a
performance assessment will comply with the containment requirements of
40 CFR 191.13 when these values are used.
Performance assessments and compliance assessments must use the
values for each waste characteristic as each would exist in the
disposal system assuming that an amount of each waste component, equal
to that component's upper or lower limit, as appropriate, were emplaced
in the WIPP. As waste is emplaced in the WIPP, a running total must be
kept of each waste component. The final rule requires that the quantity
of each waste component that has been emplaced in the repository shall
not cause the upper limits to be exceeded or, as appropriate, shall not
preclude the total emplaced quantity of any waste component from
eventually reaching its lower limit. Compliance with the lower limits
shall be demonstrated by DOE using information on the waste loading
scheme, the total amount of that waste component that has been emplaced
in the disposal system to date, the total amount of that waste
component listed in the total waste inventory described in the current
compliance application, and the amount of that waste component that
still has yet to be generated. DOE must establish a system of controls
to verify that this requirement will be met and shall submit
documentation demonstrating this with any compliance application.
Section 194.24 also requires that performance assessments and
compliance assessments shall be conducted in accordance with the waste
loading procedures and schemes that will be employed. If a waste
loading scheme is not included in the compliance application, the
performance assessments and compliance assessments must assume that the
containers of waste are randomly emplaced in the WIPP. Thus, for
example, DOE shall not assume that the waste components and
characteristics are evenly distributed throughout the repository unless
a proposed loading scheme that would cause this to occur has been
included in the current compliance application.
The final rule extends the requirements of Sec. 194.22, on quality
assurance, to process knowledge acquired and used during waste
characterization activities. The final rule specifies that the total
inventory of waste proposed for disposal in the WIPP must comply with
the limitations on transuranic waste found in the WIPP Land Withdrawal
Act. The final rule enables the Administrator to use audits and
inspections to verify compliance with the waste characterization
section.
Section 194.25 of the final rule specifies requirements on future
state assumptions. The Agency recognizes the inherently conjectural
nature of specifications on future states and wishes to minimize such
speculation in compliance applications. The Agency has found no
acceptable methodology that could make reliable predictions of the
future state of society, science, languages or other characteristics of
future mankind. The Agency does believe that established scientific
methods could make plausible predictions regarding the future state of
three classes of natural processes,
[[Page 5228]]
namely geologic, hydrogeologic and climatic conditions. Hence, the
final rule requires that performance assessments and compliance
assessments shall include dynamic analyses of geologic, hydrogeologic
and climatic processes and events that will evolve over the 10,000-year
regulatory time frame. DOE shall assume that all other present day
conditions will exist in their present state for the entire 10,000-year
regulatory time frame.
Section 194.26 sets requirements that apply to expert judgment.
Typically, expert judgment is used to elicit two types of information:
(1) Numerical values for parameters (variables) which are measurable
only by experiments that cannot be conducted due to limitations of
time, money and physical situation; and (2) essentially unknowable
information, such as which features should be incorporated into passive
institutional controls that will deter human intrusion into the
repository. Quality assurance must be applied to expert judgment to
verify that the procedures for conducting and documenting the expert
elicitation have been followed. The final rule prohibits expert
judgment from being used in place of experimental data unless DOE can
provide a justification explaining why the necessary experiments could
not be conducted. Expert judgment may substitute for experimental data
in those instances where limitations of time, resources or physical
setting would have precluded the successful and timely collection of
data.
The compliance application must provide documentation which
demonstrates that the experts have the necessary qualifications for
addressing the questions and issues put before them. Compliance
applications must explain the connection between the question posed to
the expert panel and the manner in which the final report of the panel
is used in the compliance application. These requirements have been
included to prevent any misuse of expert judgment as might result from
the use of the results of one elicitation process in answer to a new
and separate question that was not posed to the experts and for which,
if asked, the experts might have provided a different answer.
The final rule places requirements on the composition of the expert
panel, including the fraction of panel members who are not employed by
DOE. At least two-thirds of the experts sitting on an expert panel
shall not be employed directly by DOE or its contractors. University
professors with grants from DOE for research not related to the WIPP
will not be considered employees or contractors of DOE, nor will the
New Mexico Environmental Evaluation Group and the National Academy of
Sciences' Board on Radioactive Waste Management and WIPP Panel. In
exceptional instances, DOE may use as few as one-third non-DOE
employees if a sufficient number of non-DOE employees cannot be found.
DOE must submit documentation which demonstrates that a sufficient
number of non-DOE experts were not available. In the proposed rule, the
Agency had set this minimum at one-half of the expert panel's
membership. However, because of the pervasive effort of DOE in the
fields of highly radioactive waste disposal and actinide chemistry, the
Agency has lessened this requirement in the final rule in striving to
balance the importance of technical expertise with the need for the
advice to be impartial.
The section on expert judgment requires that the public be given
the opportunity to present information to the expert panel to allow the
public's views to be incorporated in the expert judgment process. This
requirement will help prevent an inappropriately narrow spectrum of
background information from being presented to the experts which might
have slanted the outcome of the elicitation process. This section also
requires that the elicitation process be well documented so as to
demonstrate a logical progression from the first statement of the issue
given to the panel members to the combination and presentation in the
final report of the elicited results.
Section 194.27, peer review, has been revised in the final rule.
The rationale for these changes is discussed in the section of the
supplementary information, ``Principal changes in the final rule.''
Given that decisions in the field of highly radioactive waste disposal
are inherently first-of-a-kind, the Agency is requiring peer review so
that others working in the field can confirm the adequacy of these
decisions and interpretations. The final rule requires DOE to conduct
peer review of three specific elements of the WIPP program. In
specific, the Agency has required peer review of the conceptual models
that DOE selects and develops, waste characterization assessments and
the study of engineered barriers. The requirement for peer review of
conceptual models will enrich DOE's process of selecting and developing
conceptual models with a broad spectrum of scientific viewpoints. Waste
characterization is a field in which many new and precedent-setting
techniques will be employed in areas in which no standardized practice
exists. Peer review of waste characterization is indicated due to the
importance of a knowledge of the physical, chemical and radiological
state of the waste in predictions of the long term performance of the
disposal system. This section, Sec. 194.27, requires peer review to be
conducted of the study of engineered barriers so as to ensure that the
best possible information is provided to DOE on the selection of
engineered barriers. Additionally, this section requires compliance
applications to include documentation of any peer review activities
that DOE may have conducted apart from those required by this rule,
including those activities which are similar to peer review, such as
the reviews conducted by the WIPP Panel of the National Academy of
Sciences.
The Agency is requiring that peer review which occurs subsequent to
the promulgation of today's action must be conducted according to the
guidelines of NUREG-1297. The final rule incorporates this publication
by reference, as specified in Sec. 194.5. The specific requirements in
NUREG-1297 that discuss for which activities peer review should be
conducted do not apply, nor do they supersede the requirements of the
final rule. Peer review which has been conducted prior to today's
action must be documented in compliance applications. Such past peer
review activities must conform to either NUREG-1297 or to an alternate
set of criterion which are substantially equivalent in effect to NUREG-
1297 and which have been approved by the Administrator.
Sections 194.31 through 194.34 of the final rule implement the
numerical containment requirements of 40 CFR 191.13. Section 194.31,
which provides instructions for setting the release limits of appendix
A of 40 CFR part 191, has been revised from the proposed rule. The
rationale for this change is explained in the section, ``Principal
changes in the final rule.'' Section 194.31 now specifies that the
release limits are to be determined based on the total activity, in
curies, of transuranic waste present at the time of disposal (as
defined in 40 CFR 191.2). If the activity of a waste container is
assayed prior to this time, then the known rates of decay for the
radionuclides in the container should be used to calculate the activity
of the waste as it will exist at the anticipated time of disposal.
Section 194.32 stipulates that performance assessments shall
include both natural and man-made processes and events which can have
an effect on the disposal system. Performance assessments need not
include those processes and events which have a
[[Page 5229]]
probability of less than 1 in 10,000 of occurring during the 10,000-
year regulatory time frame. For the purposes of this screening
requirement, processes and events must be analyzed in the most general
formulation possible; for example, the probability of dissolution must
be set equal to the probability of all types of dissolution occurring
anywhere in the Delaware Basin during the regulatory time frame.
Performance assessments should, however, conduct separate analyses of
the different dissolution fronts which occur in the Delaware Basin so
as to account for the different hydrogeologic characteristics of each.
With respect to man-made processes and events, performance
assessments must include the effects of drilling events and excavation
mining. Some natural resources in the vicinity of the WIPP can be
extracted by mining. These natural resources lie within the geologic
formations found at shallower depths than the tunnels and shafts of the
repository and do not lie vertically above the repository. Were mining
of these resources to occur, this could alter the hydrologic properties
of overlying formations--including the most transmissive layer in the
disposal system, the Culebra dolomite--so as to either increase or
decrease ground-water travel times to the accessible environment. For
the purposes of modeling these hydrologic properties, this change can
be well represented by making corresponding changes in the values for
the hydraulic conductivity. The Agency has conducted a review of the
data and scientific literature discussing the effects mining can induce
in the hydrologic properties of a formation. Based on its review of
available information, the Agency expects that mining can, in some
instances, increase the hydraulic conductivity of overlying formations
by as much as a factor of 1,000, although smaller or even negligible
changes can also be expected to occur. Thus, the final rule requires
DOE to consider the effects of mining in performance assessments. In
order to consider the effects of mining in performance assessments, DOE
may use the location-specific values of hydraulic conductivity,
established for the different spatial locations within the Culebra
dolomite, and treat them as sampled parameters with each having a range
of values varying between unchanged and increased 1,000-fold relative
to the value that would exist in the absence of mining.
The Agency recognizes that other numerical changes to the hydraulic
conductivity values may be more appropriate for use in representing the
effects of mining. Compliance applications must include a discussion of
the rationale and experimental data which support the hydraulic
conductivity values chosen and the effects of mining on the range of
these values. The Agency further recognizes that some parameter other
than hydraulic conductivity might be demonstrated to incorporate,
equally or perhaps better, the potential effects of mining in
performance assessments. DOE may elect to use another parameter,
provided that DOE can demonstrate that the use of this other parameter
is equally or more appropriate than hydraulic conductivity in
reflecting the potential effects of mining on the disposal system.
Pursuant to Sec. 194.34 of the final rule, performance assessments must
randomly sample across the full range of values that have been
established for all uncertain variables, including the hydraulic
conductivity of the Culebra dolomite established as discussed above.
The final rule specifies those assumptions and methods that shall
be used in performance assessments to account for the effects of
mining. As with drilling, the historical record of the past 100 years'
mining activity in the Delaware Basin provides a reasonable basis for
predicting the nature of future mining activity. Accordingly, the
Agency examined the records of past mining of mineral resources in the
Delaware Basin, using data supplied by the U.S. Bureau of Land
Management. The Agency found that the areal extent of mining in the
immediate vicinity of WIPP over the past 100 years covered roughly one
percent of the land area of the entire Delaware Basin and used this
information to predict the likelihood that a mining event would occur
in succeeding centuries. Accordingly, the final rule requires
performance assessments to assume that, in each century after closure
of the repository, there will be a 1 in 100 chance that a single mining
event will occur within the controlled area. As explained later in this
section, the assumed mining event would remove all of the existing
mineral deposits lying within the controlled area that are of similar
quality and type to those minerals currently extracted in the Delaware
Basin. For each century during the regulatory time frame, performance
assessments should determine whether this mining event will occur,
based on the 1 in 100 probability, proceeding one century at a time
from the start of the 10,000-year period. If a positive determination
is made, then performance assessments must assume that the single
mining event occurs at the start of that century and further assume
that no mining will occur thereafter. The Department may elect to use
an alternate method for calculating the point in time at which mining
will occur, provided that such method would not, on average, predict
that mining will occur at times later than those calculated using the
method in the final rule.
The final rule specifies that mining should be assumed to occur
within the controlled area, with the size and shape of the mine
conforming to existing mineral deposits that are similar in type and
quality to those extracted in the Delaware Basin. The Agency based this
requirement on a consideration of the physical nature of mining
activities. First, the Agency assumed that the size and shape of a mine
will be dictated by the size and shape of the mineral deposits that are
to be extracted with no two mines being alike. The mineral deposits
that will be mined in the future may consist of minerals of current
economic interest, or of materials not useful or valuable in present-
day terms. Without knowledge of what these future resources might be,
any attempt to predict the size and shape of the associated mineral
deposits would be speculative, as would any attempt to determine the
size and shape of the mines used to extract them. The Agency further
recognized that individual mines are of highly irregular shape and
there is every reason to believe that deposits of minerals that are
mined in the future will also vary in size and be highly irregular in
shape. The Agency believes that no logical mathematical scheme exists
that could be used to predict the potentially wide variety of sizes and
highly irregular shapes. In light of the speculativeness and
mathematical difficulty, the Agency has chosen to use existing mineral
deposits as ``stand-ins'' to be used to determine the size and shape of
the unknown mineral deposits that might be mined in the future. Thus,
the final rule requires performance assessments to assume that all the
presently known mineral resources lying within the controlled area will
be extracted at the single point in time determined by the method in
the final rule, discussed above. No further mining will be assumed to
occur, since the available mineral deposits will have been depleted.
The type of minerals that shall be assumed to be extracted are those
mineral deposits that are similar in quality and type to those that are
currently extracted in the Delaware Basin.
[[Page 5230]]
Performance assessments may assume that the likelihood of mining
may be decreased by PICs and active institutional controls, to the
extent that can be justified in the compliance application and to a
degree identical to that assumed for drilling. The requirements of
sections 41 and 43 of the final rule therefore will apply to the
consideration of mining in performance assessments.
Section 194.33, consideration of drilling events, has been revised
since the proposed rule. The rationale for the new provisions is
explained in the section below, entitled ``Principle changes in the
final rule.'' Section 194.2 includes two definitions relevant to the
consideration of drilling events. ``Deep drilling'' denotes those
drilling events that reach or exceed a depth 2150 feet below the
surface where such drilling occurred. ``Shallow drilling'' denotes
those drilling events that do not reach to a depth 2150 feet below the
surface where such drilling occurred. Sections 194.32 and 194.33 of the
final rule require that performance assessments include the effects of
both deep drilling and shallow drilling, whether such drilling has
occurred prior to the time at which the compliance application is
prepared, can be reasonably expected to occur in the near future based
on existing leases, or can be expected to occur in the future during
the 10,000-year regulatory time frame.
The future rates of both deep drilling and shallow drilling shall
each be set equal to the rate at which deep drilling and shallow
drilling, respectively, have occurred in the Delaware Basin during the
100-year period immediately prior to the time the current compliance
application is prepared. The Delaware Basin is defined, in Sec. 194.2,
to be the surface and subsurface features which lie inside the
innermost edge of the Capitan Reef and, where the Capitan Reef is
absent to the south, the features which lie to the north of a straight
line connecting the southeastern point of the Davis Mountains and the
southwestern point of the Glass Mountains.
Performance assessments must add together all releases of
radionuclides which are predicted to occur during the 10,000-year
regulatory time frame to arrive at the cumulative releases from the
disposal systems; the containment requirements of 40 CFR 191.13 apply
to cumulative releases of waste and not the individual events which
cause the releases. Further, boreholes drilled after closure of the
repository shall be assumed to affect the properties of the disposal
system for the remainder of the 10,000-year regulatory time frame. When
analyzing the effects of all later boreholes, performance assessments
must account for the effect that these existing boreholes will have had
on the hydrogeologic properties of the disposal system and on the
creation of new pathways for releases. In today's final rule, the
Agency requires that performance assessments and compliance assessments
must include--among other processes and events--the effects on the
disposal system of drilling and all types of resource extraction
activities, including inter alia solution mining and fluid injection,
that will have occurred prior to the time at which the compliance
application is prepared or that may be expected to occur soon afterward
based on existing plans and leases for drilling.
In the case of shallow drilling only, DOE may, if justified, derive
the drilling rate from the historical rates of shallow drilling for
only those resources in the Delaware Basin which are of similar quality
and type to those found in the controlled area. For example, if only
non-potable water can be found within the controlled area, then the
rate of drilling for water may be set equal to the historical rate of
drilling for non-potable water in the Delaware Basin over the past 100
years.
Section 194.33 requires performance assessments to make several
specific assumptions about future deep drilling and shallow drilling.
These assumptions include that drilling will occur randomly in space
and time and may occur at different rates for each resource, and that
drilling practices will remain as those of today and may vary depending
on the resource. Performance assessments should assume that the
permeability of sealed boreholes will be affected by natural processes,
and should assume that the fraction of boreholes that will be sealed by
man equals the fraction of boreholes which are currently sealed in the
Delaware Basin.
The Agency recognizes that drill operators currently employ
different techniques in the exploration and development of each
resource. Hence, performance assessments shall conduct a separate
analysis of the effects that future drilling for each different
resource--the act creating a borehole--will have on the disposal
system. Each separate analysis should set the future rate of drilling
for the particular resource equal to the historical rate at which that
resource has been drilled for in the Delaware Basin during the past 100
years. The analyses of the consequences of each type of drilling might
remain conceptually similar, but vary with regard to assumptions made
on size and depth of boreholes, quantity of drilling fluid used, or any
other characteristic specific to that type of resource. Analyses of the
consequences of future drilling events may be confined only to the
drilling activity and the subsequent effect of the borehole's presence
and need not include an analysis of extraction and recovery activities
which would occur subsequently.
In determining the drilling rate or the amount of waste released
from such drilling, performance assessments should not assume that
drill operators would detect the waste and then cease the current
drilling operations or otherwise mitigate the consequences of their
actions. Similarly, drill operators should not be assumed to cease
further exploration and development of resources as a result of the
driller's detecting the waste.
Section 194.34 requires that the results of performance assessments
be expressed as complementary, cumulative distributions functions
(CCDFs). The CCDFs shall be generated using random sampling techniques
which draw upon the full range of values established for each uncertain
parameter, which may include physical and chemical waste
characteristics. Parameters of lesser sensitivity in performance
assessments may be held constant, provided that such constant values
can be justified as sufficiently conservative. The quantitative
requirements of this section state that there must be a 0.95
probability that, at values of cumulative release of 1 and 10, the
maximum CCDF generated exceeds the 99th percentile of the population of
CCDFs. The values of cumulative release are calculated according to
Note 6 of Table 1, Appendix A of 40 CFR part 191. Additionally, the
mean of the population of CCDFs must meet the requirements of section
13 of 40 CFR part 191 with at least a 95 percent level of statistical
confidence. In demonstrating compliance with these standards, the
infinite number of CCDFs denoted by the term, population of CCDFs, need
not be generated. By generating only a finite number of CCDFs and
applying statistical theory, the relationships between the finite group
of computer-generated CCDFs, the population of CCDFs and the numerical
requirements of this section can be established.
Subpart C of today's action also implements the six assurance
requirements of section 14 of 40 CFR part 191. The assurance
requirements were included in the disposal regulations to provide the
confidence needed for long-term compliance with
[[Page 5231]]
the containment requirements of section 13 of 40 CFR part 191.
Section 194.41 of today's final rule requires a description of the
active institutional controls that will be implemented at the WIPP.
This description shall be sufficient to support any assumptions made on
their effectiveness in performance assessments and compliance
assessments. However, in no case shall active institutional controls be
assumed to be in effect for more than 100 years after the time of
disposal.
Section 194.42 of the final rule, monitoring, has been revised from
the proposed rule. The rationale for these changes is provided below,
in ``Principal changes in the final rule.'' Any unpredicted detection
of movement of radionuclides toward the accessible environment would be
cause for concern that a release of waste in excess of what is
permitted under the disposal regulations is likely to occur. This
section specifies requirements for monitoring in both the pre-closure
and post-closure periods, as necessary to verify that the WIPP complies
with the disposal regulations. In the event that an initial
certification has been granted, the results of monitoring during the
pre-closure period will be used by the Agency to verify that the
information contained in the initial compliance application has
remained true and accurate; this information would be used by the
Agency during both the initial five-year period after the start of
emplacement of waste and during the reviews made for the periodic re-
certifications of compliance. The final rule has included a provision
which requires DOE to conduct an analysis of parameters that will be
used in the development of pre-closure and post-closure monitoring
plans. The analysis should consider the importance of the parameter
with respect to both the containment of waste in the disposal system
and the practicability of performing such monitoring, including its
technical feasibility and the cost.
Section 194.43 implements the assurance requirements on passive
institutional controls (PICs). The final rule specifies that DOE must
include a detailed description of the PICs that will be employed and
lists the information that the PICs are required, at a minimum, to
convey. Additionally, the final rule allows the Department to reduce
the likelihood of future human intrusion that is used in performance
assessments by a proposed amount corresponding to the predicted effect
of PICs. See generally 47 FR 58196, 58201 (Dec. 29, 1982); 50 FR 38066,
38080 (Sept. 19, 1985). Thus, DOE may propose in its compliance
application to reduce the rate of human intrusion by a fractional
amount, extending over a technically supportable period of time, and
must justify this using the plans for the implementation for PICs and
associated evidence of their effectiveness. This credit may take the
form of a constant reduction in the rate of human intrusion lasting
several hundred years or may be a reduction in the rate which tapers
off in size over several hundred years. Such credit cannot be assumed
to eliminate completely the possibility of human intrusion, even for a
short period of time after the active institutional controls at the
WIPP are assumed to be ineffective. During the rulemaking on
certification, the Agency could determine that the description of the
PICs does not adequately justify the degree of proposed credit assumed
by DOE and therefore disallow some or all of the credit proposed by DOE
in the compliance application.
Having considered the public comments regarding PICs, the Agency
believes that such credit could be no more than approximately 700 years
past the time of disposal. Thus, the final rule limits to several
hundred years the amount of credit that EPA may grant for PICs. Any
determination that a specific numerical credit would be appropriate for
a much longer period of time would be unduly speculative and therefore
inappropriate.
Today's action should not be construed to approve or award any
amount of credit for PICs, as such a determination cannot be made in
advance of the rulemaking on certification of compliance. The Agency is
deferring any decisions on credit for PICs planned for the WIPP until
such time as the compliance application has been received and a
rulemaking for certification has been completed. This restates the
Agency's prior assertion, made in the promulgation of the final
disposal regulations in 1985:
Specific judgments about the chances and consequences of
intrusion should be made by the implementing agencies (EPA for the
WIPP) when more information about particular disposal sites and
passive control systems is available. See 50 FR 38080.
In developing this section of the final rule, 40 CFR 194.43, the
Agency considered the treatment of PICs in the disposal regulations,
the input received in public forums and the public comments received on
the proposed rule. The disposal regulations established the foundation
of today's action on the role of passive institutional controls.
Section 191.14(c) of the disposal regulations require that disposal
sites be designated by the most permanent markers, records, and other
passive institutional controls practicable to indicate the dangers of
the wastes and their location. In adopting these provisions of the
disposal regulations, the Agency expressly assumed that passive
institutional controls ``should reduce the chance of inadvertent
intrusion compared to the likelihood if no markers and records were in
place.'' See 50 FR 38080. With respect to performance assessments, the
Agency examined whether PICs should be taken into account to some
degree when estimating the likelihood of inadvertent human intrusion
and concluded that ``a limited role for passive institutional controls
would be appropriate when projecting the long-term performance of mined
geologic repositories to judge compliance with (the containment
requirements of 40 CFR part 191).'' At the same time, the Agency
explicitly determined that PICs should not be assumed to completely
prevent the possibility of inadvertent human intrusion. See 50 FR
38080.
In the proposed rule, 40 CFR part 194, the Agency specifically
requested comment on the requirements on PICs. The Agency conducted a
public discussion of PICs in a technical workshop in Washington, DC, in
February, 1995. In September, 1995, EPA consulted the WIPP Review
Committee of the National Advisory Council for Environmental Policy and
Technology (NACEPT) on three issues, including PICs, in a public
meeting in New Mexico. See 60 FR 43470-43471 (Aug. 21, 1995). The
Committee agreed that PICs would be likely to decrease the likelihood
of inadvertent intrusion into the WIPP but expressed concern about the
availability of a rigorous method by which to determine the appropriate
reduction due to PICs in the future likelihood of inadvertent
intrusion. Some members of the Committee stated that, if credit were to
be approved, the size of the credit should not reflect that PICs would
be effective for more than a small fraction of the 10,000 year
regulatory time frame.
Many public comments received on the proposed rule expressed
skepticism about whether PICs would be effective for the entire 10,000
year regulatory time frame or for even a fraction thereof. Other
comments stated the belief that civilizations living 1,000 to 10,000
years from now would, in fact, be capable of understanding the records
and markers that were left behind at the WIPP. Still other comments
asserted that, in allowing for the possibility of credit, the Agency
had revised the intent of the
[[Page 5232]]
assurance requirements, one of which being the requirement for the
implementation of PICs. Specifically, comments stated that the
assurance requirements were not intended to be considered when
determining compliance with the numerical containment requirements
found at 40 CFR 191.13.
The provisions of the final rule entertaining possible credit for
PICs are within EPA's authority. In adopting the assurance requirements
in 40 CFR part 191, EPA expressly limited the credit for active
institutional controls. EPA prohibited performance assessments from
considering any contributions from active institutional controls for
more than 100 years after disposal. See 40 CFR 191.14(a). EPA declined
to similarly limit the effect of PICs in reducing the likelihood of
human intrusion. 50 FR 38080. By contrast, EPA contemplated that PICs
may discourage the likelihood of human intrusion for some period of
time longer than active institutional controls. However, EPA indicated
that it generally believed it was inappropriate to rely on PICs for
extended periods of time. See 50 FR 38080. Based on the public comments
and consistent with EPA's general view that it is inappropriate to rely
on PICs for very long periods of time, EPA is constraining in the final
rule the length of time that EPA could consider granting credit for
PICs to several hundred years. EPA's decision about the actual efficacy
of PICs proposed for the WIPP will be based on DOE's compliance
application but may not exceed this limit.
Further, the degree to which PICs might reduce the future drilling
rate can be reliably determined only through informed judgment. The
Agency agrees with the NACEPT Committee that no rigorous and non-
speculative method is available to determine the appropriate amount of
credit for PICs. Thus, DOE's proposed reduction in the likelihood of
human intrusion due to PICs would probably be conducted through an
expert judgment process that considers the specific PICs to be
implemented at the WIPP by DOE. The expert judgment performed
specifically to determine the effect of PICs must satisfy the
requirements of section 26 of today's action, on expert judgment. For
example, this section requires that the range of professions
represented on the expert panel must cover the complete spectrum of
knowledge that will be necessary to address the question given to the
experts. In the case of PICs, the Agency would expect that experts
would be selected not only from professions such as archeology, but
from professions which are concerned with the exploration and
development of natural resources such as oil and natural gas.
Section 194.44 of the final rule implements the assurance
requirement on engineered barriers. This section requires that DOE
conduct a study of available options for engineered barriers at the
WIPP and submit this study and evidence of its use with the compliance
application. Consistent with the requirement, found at 40 CFR 191.13,
that DOE analyze the performance of the complete disposal system, any
engineered barriers that are ultimately implemented at the WIPP must be
considered by the Department and, ultimately, EPA when evaluating
compliance with both the containment requirements of 40 CFR 191.13 and
the assurance requirement of 40 CFR 191.14(d).
Section 194.45 implements the assurance requirement that the
disposal system be sited such that the benefits of the natural barriers
of the disposal system compensate for the increased probability of
disruptions of the disposal system resulting from exploration and
development of nearby natural resources. This assurance requirement
will be met if performance assessments comply with the numerical
containment requirements of section 13 of 40 CFR part 191, provided
that the potential effects of human intrusion at the WIPP will have
been appropriately considered.
Section 194.46 implements the assurance requirement that the
removal of waste remain possible for a reasonable period of time after
disposal. The final rule has eliminated the requirement for the
development of a plan for the removal of waste which had been contained
in the proposed rule. In place of the requirement for a removal plan,
EPA is including in the final rule a requirement that DOE perform an
evaluation to demonstrate that the removal of waste will remain
feasible for a reasonable period of time after disposal.
Sections 194.51 through 194.55 provide the criteria that must be
met in order to demonstrate that the WIPP will comply with the ground-
water requirements of subpart C of 40 CFR part 191 and the individual
protection requirements of section 15 of 40 CFR part 191. Section
194.51 and 194.52 specify the assumptions that must be incorporated
into compliance assessments in the analyses of annual committed
effective dose equivalent received by individuals, used in determining
compliance with the individual protection requirements. Compliance
assessments should separately analyze the doses received by individuals
from each pathway. Compliance assessments should assume that the
protected individual resides at the single geographic point where the
maximum dose would be received, calculated by the sum of all pathways.
Section 194.53 lists the assumptions that compliance assessments
must include when analyzing the doses received through underground
sources of drinking water (USDWs), used in determining compliance with
subpart C of 40 CFR part 191. Doses can be received from any USDW
outside of the controlled area, provided that a connective pathway
could be expected to be established via ground-water travel between the
disposal system and that USDW. The Agency expects that USDWs which lie
closer to the disposal system will have a greater chance of being
affected by releases of waste. The Agency therefore does not intend for
DOE to expend resources analyzing doses received from USDWs located
large distances from the disposal system. The calculations of doses
received from USDWs should assume that drinking water is withdrawn
directly from the contaminated USDW and consumed at a rate of two
liters per day.
Section 194.54 defines the scope of compliance assessments.
Compliance assessments should be conducted of the undisturbed
performance of the disposal system, which, by the definition in section
12 of 40 CFR part 191, denotes that the disposal system is not
disrupted by human intrusion or the occurrence of unlikely natural
events. Section 194.55 requires that compliance assessments include
calculations or ``estimates'' of three quantities: (1) The annual
committed effective dose received from all pathways, an analysis which
corresponds to the requirements of section 15 of 40 CFR part 191; (2)
dose equivalents received from USDWs; and (3) concentrations of
radionuclides present in USDWs, the latter two of which correspond to
subpart C of 40 CFR part 191. To generate a ``range'' of estimates,
compliance assessments must make repeated calculations, with each
iteration employing a different set of randomly selected values for
each uncertain parameter. Parameters of lesser sensitivity in
compliance assessments may be held constant, provided that these values
can be justified as being sufficiently conservative. The final rule
requires that there be a 0.95 probability that the maximum estimate of
each set so generated exceeds the 99th percentile of
[[Page 5233]]
the population of estimates. The mean and the median of the population
of each set of estimates must meet the requirements of section 15 and
subpart C of 40 CFR part 191, as applicable, with at least a 95 percent
level of statistical confidence.
Subpart D: Public Participation
Subpart D of today's action establishes procedures that EPA will
use to involve the public in the decisions on certification and re-
certification and requires EPA to publish notices of its actions in the
Federal Register. Subpart D includes new provisions which require the
Agency to involve the public in decisions to modify or revoke a
certification. Section 194.65 requires that EPA publish a notice in the
Federal Register announcing the Agency's proposed decision on the
modification or revocation of the certification. The notice of proposed
rulemaking must solicit comment on the proposed decision. Section
194.66 requires the Administrator to publish a notice of final
rulemaking in the Federal Register, announcing whether the Agency has
revoked, modified or taken no action to change the certification.
Section 194.67 requires that EPA maintain a public docket with all
information used in making the decisions on certification, re-
certification, and modification and revocation of the certification.
Principal Changes in the Final Rule
In addition to the principal changes described below, today's
action contains other minor modifications to the proposed rule. Further
discussion of the rationale and information supporting significant
changes found in today's action is contained in the Background
Information Document and the Response to Comments, which may obtained
as explained in the start of this notice.
Scope of Performance Assessments and Consideration of Drilling Events
In Secs. 194.32 and 194.33 of the final rule, the Agency has
provided further clarification on which activities fall within the
scope of human intrusion. (Section 194.33 had been titled
``Consideration of human initiated processes and events'' in the
proposed rule.) The final rule requires that the effects of deep
drilling, shallow drilling and excavation mining must be included in
performance assessments. In the proposed rule, the Agency had excluded
excavation mining from consideration (60 FR 5774; January 30, 1995).
The Agency received several public comments recommending that
performance assessments should be required to include the effects of
future mining during the regulatory time frame in order to account for
the presence of potash in the vicinity of the repository. The Agency
has re-evaluated the proposed exclusion of mining, in light of these
public comments. The Agency believes that, while there is uncertainty
surrounding the potential effects of mining, mining could nonetheless
alter the hydrogeologic properties of certain formations that lie at
shallower depths than the mined portion of the repository. Thus, the
final rule requires performance assessments to consider the possible
effects of excavation mining on the disposal system. As discussed
previously, DOE may address this requirement by considering the changes
that mining would induce in the hydraulic conductivity of the disposal
system. Additionally, the requirements of the final rule specify the
method for determining the size and shape, location and point in time
at which mining occurs. The Agency specified these items to provide
clarification on how mining should be considered and to avoid unbounded
speculation that would result from the high uncertainty regarding
whether, where and how mining would occur in the Land Withdrawal area.
EPA's decision was based on a desire to include mining in performance
assessment in a realistic fashion without recourse to such
unconstrained speculation. To this end, the final rule has specified
that mining will continue at the same rate as it has over the past 100
years, that the area to be mined is the area that contains mineral
deposits of similar type and quality to those that are currently
extracted in the Delaware Basin, and that only the major impacts on the
disposal system of mining need be considered. EPA believes this is
consistent with the future states assumptions of section 25 as they
apply to the future activities of man.
The Agency has added definitions of deep drilling and shallow
drilling in Sec. 194.2. Both types of drilling shall include
exploratory and developmental wells. The addition of these definitions
was prompted by commenters who noted that the definitions of human
intrusion and ``human activity'' that were in the proposed rule had
caused confusion by distinguishing their meanings on the basis of the
depth at which drilling occurs. In the final rule, the Agency has
removed these definitions from the final rule and instead makes use of
the defined terms, deep drilling and shallow drilling in order to
provide greater clarity.
Commenters also requested that the final rule require analysis of
disposal of brine that accumulates during the extraction of oil and of
secondary recovery of oil performed using water-flood injection. The
Agency considered this comment in the larger context of the nature of
potential human intrusions during the next 10,000 years and what
assumptions might hold true during that time. The Agency believes that
no one resource will last for the entire 10,000 years and therefore has
concluded that the techniques for extraction of any one resource--such
as water-flood injection for oil recovery--are unlikely to be in use
during much of the 10,000-year regulatory time frame. With respect to
drilling rates, the Agency reasoned that while the resources drilled
for today may not be the same as those drilled for in the future, the
present rates at which these boreholes are drilled can nonetheless
provide an estimate of the future rate at which boreholes will be
drilled. The Agency does expect that drilling will never completely
cease; while some resources may become depleted over time and, while
the rate of extraction of those resources may decrease, the increased
rate of drilling for newly discovered resources will compensate for
this decline. In effect, when used for the purpose of determining the
future drilling rate, today's drilling activities act as surrogates for
the unknown resources that will be drilled for in the future. With
respect to the consequence and releases due to future drilling,
present-day drilling activities provide the only available basis for
making assumptions in performance assessments. Future extraction of any
resource will likely necessitate drilling a hole for its recovery.
However, because there is doubt as to whether the resources associated
with today's specialized extraction techniques and fluid injection will
remain available for 10,000 years, the final rule does not require that
performance assessments assume that such extraction activities will
occur during the entire regulatory time frame, but does require that
the effects of the drilling events themselves be analyzed. The
techniques include, for example, water-flood injection for secondary
recovery of oil, solution mining and the disposal by injection of brine
accumulated during recovery of oil.
The Agency recognizes, however, that resource extraction and fluid
injection activities which are currently performed in the Delaware
Basin can alter the hydrogeologic properties of the initial state of
the disposal system. The final
[[Page 5234]]
rule requires that performance assessments and compliance assessments
analyze the effects of all types of fluid-injection and all boreholes
which can have an effect on the disposal system and which have been or
will have been drilled prior to or soon after disposal. These boreholes
shall be assumed to affect the properties of the disposal system for
the entire 10,000-year regulatory time frame. Predictions about such
future activities shall be strictly limited to the expected use of
existing leases.
Today's final rule eliminates the proposed cap on the rate of deep
drilling into the disposal system of 62.5 boreholes per square
kilometer per 10,000 years as well as the proposed lower limit of 25
boreholes per square kilometer per 10,000 years. The Agency received
numerous public comments objecting to the use of upper and lower limits
on the rate of deep drilling. The Agency has concluded that the rate of
drilling into the disposal system used in performance assessments
covering the 10,000-year regulatory time frame should be derived solely
from the historical record of drilling in the region surrounding the
WIPP. In the proposed rule, the Agency had specified that the past 50
years of records on drilling shall be used to establish the rates for
shallow drilling and deep drilling, the latter being subject to upper
and lower caps. While developing the final rule, the Agency recognized
that drilling activity has been at a maximum during the past 50 years,
whereas during the past 100 years, a broader spectrum of high and low
drilling rates can be found. In the long-term future, it can be
expected that the drilling rate will consist of periods of high and low
drilling activity, which makes the past 100 years a more appropriate
period for calculating the drilling rate. In addition, more detailed
examination of the available records in Texas and New Mexico since the
time of the proposed rule has shown that accurate data on drilling
activity dates back 100 years, rather than 50 years as was believed
initially. The final rule therefore specifies that the rates of both
shallow drilling and deep drilling are to be set based on data from the
100 year period ending at the time DOE prepares the compliance
application.
Today's final rule includes a definition of the term ``Delaware
Basin,'' used in the regulation to be that area over which the past
drilling rate is to be averaged in order to establish the rate of
drilling used in performance assessments. In the proposed rule, the
Agency had solicited comment on how to define the Delaware Basin. Many
comments were received, with the bulk of the discussion focusing on
whether the Capitan Reef should be included in the definition. In
arriving at the definition in the final rule, the Agency considered the
geologic and hydrogeologic characteristics of the formations which
contain the WIPP versus those of the Capitan Reef. The Capitan Reef is
more permeable to the flow of water and was formed from organic
material which differs from the salt formations which immediately
surround the WIPP. The Agency had stated its intention to define the
Delaware Basin to be the largest contiguous area that has similar
geologic properties. Because of the differences, noted above, between
the Capitan Reef and the interior formations, the Agency has chosen to
define the Delaware Basin to be those surface and subsurface formations
which lie inside the inner-most edge of the Capitan Reef. Where the
Capitan Reef is absent to the south, the Delaware Basin includes those
features which lie to the north of a straight line connecting the
southeastern point of the Davis Mountains and the southwestern point of
the Glass Mountains.
Waste Characterization
Numerous public comments were received on the proposed Sec. 194.24,
waste characterization. Commenters stated that this section required
greater clarity in order to be implemented effectively at the WIPP. The
final rule retains the use of ``waste characteristics'' to provide a
description of the waste. The term, waste categories, has been
eliminated in the final rule. The final rule uses the term, ``waste
components,'' to denote an amount of a type of waste--expressed as a
volume, mass or weight (or curies, in the case of activity)--such as
chelating agents and cellulosics. The waste categories in the proposed
rule were to be established based on the assumption that wastes with
similar waste characteristics would behave similarly in the disposal
system. The Agency believes that using instead the term ``waste
components'' provides a less abstract scheme for classifying waste
which could be more easily implemented. In particular, the Agency
believes that, for a given container of waste, DOE could more readily
identify how much of each waste component is present rather than how
much of each waste category is present. The final rule requires that
these limits be established such that the results of performance
assessments and compliance assessments will comply with the numerical
requirements of 40 CFR Part 191 when the maximum or minimum values for
each waste component are used, as appropriate.
To assist in establishing the waste characteristics and waste
components and quantitative values of each, the final rule requires
that compliance applications include an analysis to identify and assess
the impact on long-term performance of those waste characteristics
which influence the containment of waste in the disposal system. An
analysis must also be conducted of waste components to determine which
of these will influence the waste characteristics identified as having
an influence on containment. This section of the final rule specifies
those waste characteristics and waste components which, at a minimum,
the respective analyses must investigate.
Peer Review
Section 194.26, peer review, has been narrowed in scope in the
final rule. The Agency received many public comments stating that the
requirements on peer review were stated too broadly such that an
inordinate and unmanageable number of peer reviews would be required.
Additionally, commenters noted that many of the activities that the
proposed rule had required to be peer reviewed were subject to specific
quality assurance requirements under Sec. 194.22. Public comments noted
that, in this instance, the proposed peer review requirements would be
redundant with the quality assurance requirements. Such activities
would include the computer codes and the data used to support all
models--conceptual, mathematical and numerical--and computer codes.
The Agency consulted the WIPP Review Committee of NACEPT at the
September, 1995 meeting and sought its advice on how to address peer
review. The Committee suggested that peer review of quality assurance
programs would be unnecessary, since, by requiring DOE to adhere to a
program that meets the requirements of three sets of ASME's standards,
today's action would already be sufficient to control the quality
assurance process. The Agency agrees with both the Committee and with
similar public comment and has eliminated the requirement for peer
review of quality assurance programs and plans. The Committee also
stated that peer review could be used both to insure that analyses use
the correct model of repository behavior and to evaluate the subjective
uncertainty in whether the appropriate conceptual model was selected.
In the case of WIPP, unanimous agreement does not exist on the nature
of the conceptual models of natural processes such as dissolution
[[Page 5235]]
which can have an effect on the disposal system. To subject these
issues to wider scrutiny, the final rule specifies that peer review
must be conducted of the conceptual models selected and developed by
DOE.
Application of Release Limits
Section 194.31 of the final rule specifies that the release limits
of Appendix A of 40 CFR part 191 shall be determined based on the total
activity, in curies, of transuranic waste present at the time of
disposal. Public comment was divided between those who recommended
setting release limits at 100 years, as in the proposed rule, and those
who recommended the time of disposal. The Agency solicited the views of
the WIPP Review Committee of NACEPT on the subject of release limits in
the meeting held in September, 1995. Some committee members noted that
radionuclides such as plutonium 238 would quickly decay to less than
half their original number in under 100 years and thus would not pose a
threat for more than a small fraction of the 10,000-year regulatory
time frame. Hence, some members of the committee recommended the option
of setting the release limits at later times so that the release limits
would be based on longer-lived radionuclides. Doing so would more
accurately reflect the long-term hazards presented by the waste.
Some committee members also recommended that the Agency should base
its decision on the original intent of the disposal regulations. The
Agency believes that the disposal regulations were designed to avoid
the undue influence of short-lived radionuclides on the size of the
release limits. The disposal regulations accomplished this purpose in
Appendix A by eliminating the contribution of radionuclides having
half-lives of less than twenty years. The Agency has therefore chosen
in the final rule to determine release limits based on the total
activity, in curies, of transuranic waste present at the time of
disposal.
Monitoring
The monitoring requirements have been modified to provide clearer
direction for the development of a post-closure monitoring plan.
Several commenters suggested that, by requiring that post-closure
monitoring be conducted in a manner ``compatible'' with RCRA, DOE might
be forced to implement two over-lapping monitoring programs in order to
comply with both RCRA hazardous waste regulations and 40 CFR part 194.
Other commenters noted that, in the event that RCRA monitoring at the
WIPP were to be modified or eliminated, the requirement in 40 CFR Part
194 as proposed would be correspondingly reduced. To provide clearer
direction on the performance of post-closure monitoring, the Agency has
made two changes in the final rule. First, to eliminate potential
overlap, the Agency is requiring that post-closure monitoring be
required to be ``complementary'' with RCRA, so that information yielded
by the one monitoring program would not be duplicated by the other. The
Agency is requiring in the final rule that post-closure monitoring be
conducted, to the extent practicable when considering technical
feasibility and cost, of those parameters which are important to the
containment of waste in the disposal system. Such parameters shall be
identified in a required analysis that will assess which parameters are
important to the containment of waste and which therefore should be
included in post-closure (and pre-closure) monitoring.
Rulemaking Analyses
Executive Order 12866
Under Executive Order 12866, (58 FR 51,735 October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action''
because it raises novel policy issues which arise from legal mandates.
As such, this action was submitted to OMB for review. Changes made in
response to OMB suggestions or recommendations will be documented in
the public record.
Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the Administrator certifies that this rule will not have
a significant economic impact on a substantial number of small
entities. Today's final rule sets forth requirements which apply only
to Federal agencies and the Administrator therefore certifies that no
small entities will be affected.
Paperwork Reduction Act
The EPA has determined that this proposed rule contains no
information collection requirements as defined by the Paperwork
Reduction Act (44 U.S.C. 3501 et seq).
Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local and tribal
governments and the private sector. Today's rule contains no Federal
mandates (under the regulatory provisions of Title II of the UMRA) for
State, local or tribal governments or the private sector. The rule
implements requirements specifically set forth by the Congress in the
Waste Isolation Pilot Plant Land Withdrawal Act (Pub. L. 102-579).
List of Subjects in 40 CFR Part 194
Administrative practice and procedure, Environmental protection,
Incorporation by reference Nuclear materials, Radionuclides, Plutonium,
Radiation protection, Uranium, Transuranics, Waste treatment and
disposal.
Dated: February 1, 1996.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, 40 CFR part 194 is added
as set forth below.
PART 194--CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF
THE WASTE ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART
191 DISPOSAL REGULATIONS
Subpart A--General Provisions
Sec.
194.1 Purpose, scope, and applicability.
194.2 Definitions.
194.3 Communications.
194.4 Conditions of compliance certification.
194.5 Publications incorporated by reference.
[[Page 5236]]
194.6 Alternative provisions.
194.7 Effective date.
Subpart B--Compliance Certification and Re-certification Applications
194.11 Completeness and accuracy of compliance applications.
194.12 Submission of compliance applications.
194.13 Submission of reference materials.
194.14 Content of compliance certification application.
194.15 Content of compliance re-certification application(s).
Subpart C--Compliance Certification and Re-certification General
Requirements
General Requirements
194.21 Inspections.
194.22 Quality assurance.
194.23 Models and computer codes.
194.24 Waste characterization.
194.25 Future state assumptions.
194.26 Expert judgment.
194.27 Peer review.
Containment Requirements
194.31 Application of release limits.
194.32 Scope of performance assessments.
194.33 Consideration of drilling events in performance assessments.
194.34 Results of performance assessments.
Assurance Requirements
194.41 Active institutional controls.
194.42 Monitoring.
194.43 Passive institutional controls.
194.44 Engineered barriers.
194.45 Consideration of the presence of resources.
194.46 Removal of waste.
Individual and Ground-water Protection Requirements
194.51 Consideration of protected individual.
194.52 Consideration of exposure pathways.
194.53 Consideration of underground sources of drinking water.
194.54 Scope of compliance assessments.
194.55 Results of compliance assessments.
Subpart D--Public Participation
194.61 Advance notice of proposed rulemaking for certification.
194.62 Notice of proposed rulemaking for certification.
194.63 Final rule for certification.
194.64 Documentation of continued compliance.
194.65 Notice of proposed rulemaking for modification or
revocation.
194.66 Final rule for modification or revocation.
194.67 Dockets.
Authority: The Waste Isolation Pilot Plant Land Withdrawal Act
of 1992, Pub.L. 102-579, 106 Stat. 4777; Atomic Energy Act of 1954,
as amended, 42 U.S.C. 2011-2296; Reorganization Plan No. 3 of 1970,
5 U.S.C. app.1; Nuclear Waste Policy Act of 1982, as amended, 42
U.S.C. 10101-10270.
Subpart A--General Provisions
Sec. 194.1 Purpose, scope and applicability.
This part specifies criteria for the certification or any re-
certification, or subsequent actions relating to the terms or
conditions of certification of the Department of Energy's Waste
Isolation Pilot Plant's compliance with the disposal regulations found
at part 191 of this chapter and pursuant to section 8(d)(1) and section
8(f), respectively, of the WIPP LWA. The compliance certification
application submitted pursuant to section 8(d)(1) of the WIPP LWA and
any compliance re-certification application submitted pursuant to
section 8(f) of the WIPP LWA shall comply with the requirements of this
part.
Sec. 194.2 Definitions.
Unless otherwise indicated in this part, all terms have the same
meaning as in part 191 of this chapter.
Certification means any action taken by the Administrator pursuant
to section 8(d)(1) of the WIPP LWA.
Compliance application(s) means the compliance certification
application submitted to the Administrator pursuant to section 8(d)(1)
of the WIPP LWA or any compliance re-certification applications
submitted to the Administrator pursuant to section 8(f) of the WIPP
LWA.
Compliance assessment(s) means the analysis conducted to determine
compliance with Sec. 191.15, and part 191, subpart C of this chapter.
Delaware Basin means those surface and subsurface features which
lie inside the boundary formed to the north, east and west of the
disposal system by the innermost edge of the Capitan Reef, and formed,
to the south, by a straight line drawn from the southeastern point of
the Davis Mountains to the most southwestern point of the Glass
Mountains.
Deep drilling means those drilling events in the Delaware Basin
that reach or exceed a depth of 2,150 feet below the surface relative
to where such drilling occurred.
Department means the United States Department of Energy.
Disposal regulations means part 191, subparts B and C of this
chapter.
Management systems review means the qualitative assessment of a
data collection operation or organization(s) to establish whether the
prevailing quality management structure, policies, practices, and
procedures are adequate to ensure that the type and quality of data
needed are obtained.
Modification means action(s) taken by the Administrator that alters
the terms or conditions of certification pursuant to section 8(d)(1) of
the WIPP LWA. Modification of any certification shall comply with this
part and part 191 of this chapter.
Population of CCDFs means all possible complementary, cumulative
distribution functions (CCDFs) that can be generated from all disposal
system parameter values used in performance assessments.
Population of estimates means all possible estimates of radiation
doses and radionuclide concentrations that can be generated from all
disposal system parameter values used in compliance assessments.
Quality assurance means those planned and systematic actions
necessary to provide adequate confidence that the disposal system will
comply with the disposal regulations set forth in part 191 of this
chapter. Quality assurance includes quality control, which comprises
those actions related to the physical characteristics of a material,
structure, component, or system that provide a means to control the
quality of the material, structure, component, or system to
predetermined requirements.
Re-certification means any action taken by the Administrator
pursuant to section 8(f) of the WIPP LWA.
Regulatory time frame means the time period beginning at disposal
and ending 10,000 years after disposal.
Revocation means any action taken by the Administrator to terminate
the certification pursuant to section 8(d)(1) of the WIPP LWA.
Secretary means the Secretary of Energy.
Shallow drilling means those drilling events in the Delaware Basin
that do not reach a depth of 2,150 feet below the surface relative to
where such drilling occurred.
Suspension means any action taken by the Administrator to withdraw,
for a limited period of time, the certification pursuant to section
8(d)(1) of the WIPP LWA.
Waste means the radioactive waste, radioactive material and
coincidental material subject to the requirements of part 191 of this
chapter.
Waste characteristic means a property of the waste that has an
impact on the containment of waste in the disposal system.
Waste component means an ingredient of the total inventory of the
waste that influences a waste characteristic.
WIPP means the Waste Isolation Pilot Plant, as authorized pursuant
to section 213 of the Department of Energy National Security and
Military
[[Page 5237]]
Applications of Nuclear Energy Authorization Act of 1980 (Pub.L. 96-
164; 93 Stat. 1259, 1265).
WIPP LWA means the Waste Isolation Pilot Plant Land Withdrawal Act
of 1992 (Pub.L. 102-579, 106 Stat. 4777).
Sec. 194.3 Communications.
(a) Compliance application(s) shall be:
(1) Addressed to the Administrator; and
(2) Signed by the Secretary.
(b) Communications and reports concerning the criteria in this part
shall be:
(1) Addressed to the Administrator or the Administrator's
authorized representative; and
(2) Signed by the Secretary or the Secretary's authorized
representative.
Sec. 194.4 Conditions of compliance certification.
(a) Any certification of compliance issued pursuant to section
8(d)(1) of the WIPP LWA may include such conditions as the
Administrator finds necessary to support such certification.
(b) Whether stated therein or not, the following conditions shall
apply in any such certification:
(1) The certification shall be subject to modification, suspension
or revocation by the Administrator. Any suspension of the certification
shall be done at the discretion of the Administrator. Any modification
or revocation of the certification shall be done by rule pursuant to 5
U.S.C. 553. If the Administrator revokes the certification, the
Department shall retrieve, as soon as practicable and to the extent
practicable, any waste emplaced in the disposal system.
(2) Any time after the Administrator issues a certification, the
Administrator or the Administrator's authorized representative may
submit a written request to the Department for information to enable
the Administrator to determine whether the certification should be
modified, suspended or revoked. Unless otherwise specified by the
Administrator or the Administrator's authorized representative, the
Department shall submit such information to the Administrator or the
Administrator's authorized representative within 30 calendar days of
receipt of the request.
(3) Any time after the Administrator issues a certification, the
Department shall report any planned or unplanned changes in activities
or conditions pertaining to the disposal system that differ
significantly from the most recent compliance application.
(i) The Department shall inform the Administrator, in writing,
prior to making such a planned change in activity or disposal system
condition.
(ii) In the event of an unplanned change in activity or condition,
the Department shall immediately cease emplacement of waste in the
disposal system if the Department determines that one or more of the
following conditions is true:
(A) The containment requirements established pursuant to
Sec. 191.13 of this chapter have been or are expected to be exceeded;
(B) Releases from already-emplaced waste lead to committed
effective doses that are or are expected to be in excess of those
established pursuant to Sec. 191.15 of this chapter. For purposes of
this paragraph (b)(3)(ii)(B), emissions from operations covered
pursuant to part 191, subpart A of this chapter are not included; or
(C) Releases have caused or are expected to cause concentrations of
radionuclides or estimated doses due to radionuclides in underground
sources of drinking water in the accessible environment to exceed the
limits established pursuant to part 191, subpart C of this chapter.
(iii) If the Department determines that a condition described in
paragraph (b)(3)(ii) of this section has occurred or is expected to
occur, the Department shall notify the Administrator, in writing,
within 24 hours of the determination. Such notification shall, to the
extent practicable, include the following information:
(A) Identification of the location and environmental media of the
release or the expected release;
(B) Identification of the type and quantity of waste (in activity
in curies of each radionuclide) released or expected to be released;
(C) Time and date of the release or the estimated time of the
expected release;
(D) Assessment of the hazard posed by the release or the expected
release; and
(E) Additional information requested by the Administrator or the
Administrator's authorized representative.
(iv) The Department may resume emplacement of waste in the disposal
system upon written notification that the suspension has been lifted by
the Administrator.
(v) If the Department discovers a condition or activity that
differs significantly from what is indicated in the most recent
compliance application, but does not involve conditions or activities
listed in paragraph (b)(3)(ii) of this section, then the difference
shall be reported, in writing, to the Administrator within 10 calendar
days of its discovery.
(vi) Following receipt of notification, the Administrator will
notify the Secretary in writing whether any condition or activity
reported pursuant to paragraph (b)(3) this section:
(A) Does not comply with the terms of the certification; and, if it
does not comply,
(B) Whether the compliance certification must be modified,
suspended or revoked. The Administrator or the Administrator's
authorized representative may request additional information before
determining whether modification, suspension or revocation of the
compliance certification is required.
(4) Not later than six months after the Administrator issues a
certification, and at least annually thereafter, the Department shall
report to the Administrator, in writing, any changes in conditions or
activities pertaining to the disposal system that were not required to
be reported by paragraph (b)(3) of this section and that differ from
information contained in the most recent compliance application.
Sec. 194.5 Publications incorporated by reference.
(a) The following publications are incorporated into this part by
reference:
(1) U.S. Nuclear Regulatory Commission, NUREG-1297 ``Peer Review
for High-Level Nuclear Waste Repositories,'' published February 1988;
incorporation by reference (IBR) approved for Secs. 194.22, 194.23 and
194.27.
(2) American Society of Mechanical Engineers (ASME) Nuclear Quality
Assurance (NQA) Standard, NQA-1-1989 edition, ``Quality Assurance
Program Requirements for Nuclear Facilities;'' IBR approved for
Sec. 194.22.
(3) ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition
``Quality Assurance Requirements for Nuclear Facility Applications;''
IBR approved for Sec. 194.22 and Sec. 194.23.
(4) ASME NQA-3-1989 edition, ``Quality Assurance Program
Requirements for the Collection of Scientific and Technical Information
for Site Characterization of High-Level Nuclear Waste Repositories''
(excluding section 2.1 (b) and (c)); IBR approved for Sec. 194.22.
(b) The publications listed in paragraph (a) of this section were
approved for incorporation by reference by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be inspected or obtained from the Air Docket, Docket No. A-92-56,
room M1500 (LE131),
[[Page 5238]]
U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC
20460, or copies may be inspected at the Office of the Federal
Register, 800 N. Capitol Street NW, 7th floor, Suite 700, Washington,
DC, or copies may be obtained from the following addresses:
(1) For ASME standards, contact American Society of Mechanical
Engineers, 22 Law Drive, P.O. Box 2900, Fairfield, NJ 07007-2900, phone
1-800-843-2763.
(2) For Nuclear Regulatory Commission documents, contact Division
of Information Support Services, Distribution Service, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, or contact National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161, phone 703-487-4650.
Sec. 194.6 Alternative provisions.
The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute
for any of the provisions of this part alternative provisions chosen
after:
(a) The alternative provisions have been proposed for public
comment in the Federal Register together with information describing
how the alternative provisions comport with the disposal regulations,
the reasons why the existing provisions of this part appear
inappropriate, and the costs, risks and benefits of compliance in
accordance with the alternative provisions;
(b) A public comment period of at least 120 days has been completed
and public hearings have been held in New Mexico;
(c) The public comments received have been fully considered; and
(d) A notice of final rulemaking is published in the Federal
Register.
Sec. 194.7 Effective date.
The criteria in this part shall be effective on April 9, 1996. The
incorporation by reference of certain publications listed in the
criteria is approved by the Director of the Federal Register as of
April 9, 1996.
Subpart B--Compliance Certification and Re-certification
Applications
Sec. 194.11 Completeness and accuracy of compliance applications.
Information provided to the Administrator in support of any
compliance application shall be complete and accurate. The
Administrator's evaluation for certification pursuant to section
8(d)(1)(B) of the WIPP LWA and evaluation for recertification pursuant
to section 8(f)(2) of the WIPP LWA shall not begin until the
Administrator has notified the Secretary, in writing, that a complete
application in accordance with this part has been received.
Sec. 194.12 Submission of compliance applications.
Unless otherwise specified by the Administrator or the
Administrator's authorized representative, 30 copies of any compliance
application, any accompanying materials, and any amendments thereto
shall be submitted in a printed form to the Administrator.
Sec. 194.13 Submission of reference materials.
Information may be included by reference into compliance
application(s), provided that the references are clear and specific and
that, unless otherwise specified by the Administrator or the
Administrator's authorized representative, 10 copies of the referenced
information are submitted to the Administrator. Referenced materials
which are widely available in standard textbooks or reference books
need not be submitted.
Sec. 194.14 Content of compliance certification application.
Any compliance application shall include:
(a) A current description of the natural and engineered features
that may affect the performance of the disposal system. The description
of the disposal system shall include, at a minimum, the following
information:
(1) The location of the disposal system and the controlled area;
(2) A description of the geology, geophysics, hydrogeology,
hydrology, and geochemistry of the disposal system and its vicinity and
how these conditions are expected to change and interact over the
regulatory time frame. Such description shall include, at a minimum:
(i) Existing fluids and fluid hydraulic potential, including brine
pockets, in and near the disposal system; and
(ii) Existing higher permeability anhydrite interbeds located at or
near the horizon of the waste.
(3) The presence and characteristics of potential pathways for
transport of waste from the disposal system to the accessible
environment including, but not limited to: Existing boreholes, solution
features, breccia pipes, and other potentially permeable features, such
as interbeds.
(4) The projected geophysical, hydrogeologic and geochemical
conditions of the disposal system due to the presence of waste
including, but not limited to, the effects of production of heat or
gases from the waste.
(b) A description of the design of the disposal system including:
(1) Information on materials of construction including, but not
limited to: Geologic media, structural materials, engineered barriers,
general arrangement, and approximate dimensions; and
(2) Computer codes and standards that have been applied to the
design and construction of the disposal system.
(c) Results of assessments conducted pursuant to this part.
(d) A description of input parameters associated with assessments
conducted pursuant to this part and the basis for selecting those input
parameters.
(e) Documentation of measures taken to meet the assurance
requirements of this part.
(f) A description of waste acceptance criteria and actions taken to
assure adherence to such criteria.
(g) A description of background radiation in air, soil and water in
the vicinity of the disposal system and the procedures employed to
determine such radiation.
(h) One or more topographic map(s) of the vicinity of the disposal
system. The contour interval shall be sufficient to show clearly the
pattern of surface water flow in the vicinity of the disposal system.
The map(s) shall include standard map notations and symbols, and, in
addition, shall show boundaries of the controlled area and the location
of any active, inactive, and abandoned injection and withdrawal wells
in the controlled area and in the vicinity of the disposal system.
(i) A description of past and current climatologic and meteorologic
conditions in the vicinity of the disposal system and how these
conditions are expected to change over the regulatory time frame.
(j) The information required elsewhere in this part or any
additional information, analyses, tests, or records determined by the
Administrator or the Administrator's authorized representative to be
necessary for determining compliance with this part.
Sec. 194.15 Content of compliance re-certification application(s).
(a) In submitting documentation of continued compliance pursuant to
section 8(f) of the WIPP LWA, the previous compliance application shall
be updated to provide sufficient information for the Administrator to
determine whether or not the WIPP continues to be in compliance with
the disposal regulations. Updated documentation shall include:
(1) All additional geologic, geophysical, geochemical, hydrologic,
and meteorologic information;
[[Page 5239]]
(2) All additional monitoring data, analyses and results;
(3) All additional analyses and results of laboratory experiments
conducted by the Department or its contractors as part of the WIPP
program;
(4) An identification of any activities or assumptions that deviate
from the most recent compliance application;
(5) A description of all waste emplaced in the disposal system
since the most recent compliance certification or re-certification
application. Such description shall consist of a description of the
waste characteristics and waste components identified in
Secs. 194.24(b)(1) and 194.24(b)(2);
(6) Any significant information not previously included in a
compliance certification or re-certification application related to
whether the disposal system continues to be in compliance with the
disposal regulations; and
(7) Any additional information requested by the Administrator or
the Administrator's authorized representative.
(b) To the extent that information required for a re-certification
of compliance remains valid and has been submitted in previous
certification or re-certification application(s), such information need
not be duplicated in subsequent applications; such information may be
summarized and referenced.
Subpart C--Compliance Certification and Re-certification
General Requirements
Sec. 194.21 Inspections.
(a) The Administrator or the Administrator's authorized
representative(s) shall, at any time:
(1) Be afforded unfettered and unannounced access to inspect any
area of the WIPP, and any locations performing activities that provide
information relevant to compliance application(s), to which the
Department has rights of access. Such access shall be equivalent to
access afforded Department employees upon presentation of credentials
and other required documents.
(2) Be allowed to obtain samples, including split samples, and to
monitor and measure aspects of the disposal system and the waste
proposed for disposal in the disposal system.
(b) Records (including data and other information in any form) kept
by the Department pertaining to the WIPP shall be made available to the
Administrator or the Administrator's authorized representative upon
request. If requested records are not immediately available, they shall
be delivered within 30 calendar days of the request.
(c) The Department shall, upon request by the Administrator or the
Administrator's authorized representative, provide permanent, private
office space that is accessible to the disposal system. The office
space shall be for the exclusive use of the Administrator or the
Administrator's authorized representative(s).
(d) The Administrator or the Administrator's authorized
representative(s) shall comply with applicable access control measures
for security, radiological protection, and personal safety when
conducting activities pursuant to this section.
Sec. 194.22 Quality assurance.
(a)(1) As soon as practicable after April 9, 1996, the Department
shall adhere to a quality assurance program that implements the
requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part
2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding
Section 2.1 (b) and (c), and Section 17.1). (Incorporation by reference
as specified in Sec. 194.5.)
(2) Any compliance application shall include information which
demonstrates that the quality assurance program required pursuant to
paragraph (a)(1) of this section has been established and executed for:
(i) Waste characterization activities and assumptions;
(ii) Environmental monitoring, monitoring of the performance of the
disposal system, and sampling and analysis activities;
(iii) Field measurements of geologic factors, ground water,
meteorologic, and topographic characteristics;
(iv) Computations, computer codes, models and methods used to
demonstrate compliance with the disposal regulations in accordance with
the provisions of this part;
(v) Procedures for implementation of expert judgment elicitation
used to support applications for certification or re-certification of
compliance;
(vi) Design of the disposal system and actions taken to ensure
compliance with design specifications;
(vii) The collection of data and information used to support
compliance application(s); and
(viii) Other systems, structures, components, and activities
important to the containment of waste in the disposal system.
(b) Any compliance application shall include information which
demonstrates that data and information collected prior to the
implementation of the quality assurance program required pursuant to
paragraph (a)(1) of this section have been qualified in accordance with
an alternate methodology, approved by the Administrator or the
Administrator's authorized representative, that employs one or more of
the following methods: Peer review, conducted in a manner that is
compatible with NUREG-1297, ``Peer Review for High-Level Nuclear Waste
Repositories,'' published February 1988 (incorporation by reference as
specified in Sec. 194.5); corroborating data; confirmatory testing; or
a quality assurance program that is equivalent in effect to ASME NQA-1-
1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989
edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c)
and Section 17.1). (Incorporation by reference as specified in
Sec. 194.5.)
(c) Any compliance application shall provide, to the extent
practicable, information which describes how all data used to support
the compliance application have been assessed for their quality
characteristics, including:
(1) Data accuracy, i.e., the degree to which data agree with an
accepted reference or true value;
(2) Data precision, i.e., a measure of the mutual agreement between
comparable data gathered or developed under similar conditions
expressed in terms of a standard deviation;
(3) Data representativeness, i.e., the degree to which data
accurately and precisely represent a characteristic of a population, a
parameter, variations at a sampling point, or environmental conditions;
(4) Data completeness, i.e., a measure of the amount of valid data
obtained compared to the amount that was expected; and
(5) Data comparability, i.e., a measure of the confidence with
which one data set can be compared to another.
(d) Any compliance application shall provide information which
demonstrates how all data are qualified for use in the demonstration of
compliance.
(e) The Administrator will verify appropriate execution of quality
assurance programs through inspections, record reviews and record
keeping requirements, which may include, but may not be limited to,
surveillance, audits and management systems reviews.
Sec. 194.23 Models and computer codes.
(a) Any compliance application shall include:
[[Page 5240]]
(1) A description of the conceptual models and scenario
construction used to support any compliance application.
(2) A description of plausible, alternative conceptual model(s)
seriously considered but not used to support such application, and an
explanation of the reason(s) why such model(s) was not deemed to
accurately portray performance of the disposal system.
(3) Documentation that:
(i) Conceptual models and scenarios reasonably represent possible
future states of the disposal system;
(ii) Mathematical models incorporate equations and boundary
conditions which reasonably represent the mathematical formulation of
the conceptual models;
(iii) Numerical models provide numerical schemes which enable the
mathematical models to obtain stable solutions;
(iv) Computer models accurately implement the numerical models;
i.e., computer codes are free of coding errors and produce stable
solutions;
(v) Conceptual models have undergone peer review according to
Sec. 194.27.
(b) Computer codes used to support any compliance application shall
be documented in a manner that complies with the requirements of ASME
NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition.
(Incorporation by reference as specified in Sec. 194.5.)
(c) Documentation of all models and computer codes included as part
of any compliance application performance assessment calculation shall
be provided. Such documentation shall include, but shall not be limited
to:
(1) Descriptions of the theoretical backgrounds of each model and
the method of analysis or assessment;
(2) General descriptions of the models; discussions of the limits
of applicability of each model; detailed instructions for executing the
computer codes, including hardware and software requirements, input and
output formats with explanations of each input and output variable and
parameter (e.g., parameter name and units); listings of input and
output files from a sample computer run; and reports on code
verification, benchmarking, validation, and quality assurance
procedures;
(3) Detailed descriptions of the structure of computer codes and
complete listings of the source codes;
(4) Detailed descriptions of data collection procedures, sources of
data, data reduction and analysis, and code input parameter
development;
(5) Any necessary licenses; and
(6) An explanation of the manner in which models and computer codes
incorporate the effects of parameter correlation.
(d) The Administrator or the Administrator's authorized
representative may verify the results of computer simulations used to
support any compliance application by performing independent
simulations. Data files, source codes, executable versions of computer
software for each model, other material or information needed to permit
the Administrator or the Administrator's authorized representative to
perform independent simulations, and access to necessary hardware to
perform such simulations, shall be provided within 30 calendar days of
a request by the Administrator or the Administrator's authorized
representative.
Sec. 194.24 Waste characterization.
(a) Any compliance application shall describe the chemical,
radiological and physical composition of all existing waste proposed
for disposal in the disposal system. To the extent practicable, any
compliance application shall also describe the chemical, radiological
and physical composition of to-be-generated waste proposed for disposal
in the disposal system. These descriptions shall include a list of
waste components and their approximate quantities in the waste. This
list may be derived from process knowledge, current non-destructive
examination/assay, or other information and methods.
(b) The Department shall submit in the compliance certification
application the results of an analysis which substantiates:
(1) That all waste characteristics influencing containment of waste
in the disposal system have been identified and assessed for their
impact on disposal system performance. The characteristics to be
analyzed shall include, but shall not be limited to: Solubility;
formation of colloidal suspensions containing radionuclides; production
of gas from the waste; shear strength; compactability; and other waste-
related inputs into the computer models that are used in the
performance assessment.
(2) That all waste components influencing the waste characteristics
identified in paragraph (b)(1) of this section have been identified and
assessed for their impact on disposal system performance. The
components to be analyzed shall include, but shall not be limited to:
metals; cellulosics; chelating agents; water and other liquids; and
activity in curies of each isotope of the radionuclides present.
(3) Any decision to exclude consideration of any waste
characteristic or waste component because such characteristic or
component is not expected to significantly influence the containment of
the waste in the disposal system.
(c) For each waste component identified and assessed pursuant to
paragraph (b) of this section, the Department shall specify the
limiting value (expressed as an upper or lower limit of mass, volume,
curies, concentration, etc.), and the associated uncertainty (i.e.,
margin of error) for each limiting value, of the total inventory of
such waste proposed for disposal in the disposal system. Any compliance
application shall:
(1) Demonstrate that, for the total inventory of waste proposed for
disposal in the disposal system, WIPP complies with the numeric
requirements of Sec. 194.34 and Sec. 194.55 for the upper or lower
limits (including the associated uncertainties), as appropriate, for
each waste component identified in paragraph (b)(2) of this section,
and for the plausible combinations of upper and lower limits of such
waste components that would result in the greatest estimated release.
(2) Identify and describe the method(s) used to quantify the limits
of waste components identified in paragraph (b)(2) of this section.
(3) Provide information which demonstrates that the use of process
knowledge to quantify components in waste for disposal conforms with
the quality assurance requirements found in Sec. 194.22.
(4) Provide information which demonstrates that a system of
controls has been and will continue to be implemented to confirm that
the total amount of each waste component that will be emplaced in the
disposal system will not exceed the upper limiting value or fall below
the lower limiting value described in the introductory text of
paragraph (c) of this section. The system of controls shall include,
but shall not be limited to: Measurement; sampling; chain of custody
records; record keeping systems; waste loading schemes used; and other
documentation.
(5) Identify and describe such controls delineated in paragraph
(c)(4) of this section and confirm that they are applied in accordance
with the quality assurance requirements found in Sec. 194.22.
(d) The Department shall include a waste loading scheme in any
compliance application, or else performance assessments conducted
[[Page 5241]]
pursuant to Sec. 194.32 and compliance assessments conducted pursuant
to Sec. 194.54 shall assume random placement of waste in the disposal
system.
(e) Waste may be emplaced in the disposal system only if the
emplaced components of such waste will not cause:
(1) The total quantity of waste in the disposal system to exceed
the upper limiting value, including the associated uncertainty,
described in the introductory text to paragraph (c) of this section; or
(2) The total quantity of waste that will have been emplaced in the
disposal system, prior to closure, to fall below the lower limiting
value, including the associated uncertainty, described in the
introductory text to paragraph (c) of this section.
(f) Waste emplacement shall conform to the assumed waste loading
conditions, if any, used in performance assessments conducted pursuant
to Sec. 194.32 and compliance assessments conducted pursuant to
Sec. 194.54.
(g) The Department shall demonstrate in any compliance application
that the total inventory of waste emplaced in the disposal system
complies with the limitations on transuranic waste disposal described
in the WIPP LWA.
(h) The Administrator will use inspections and records reviews,
such as audits, to verify compliance with this section.
Sec. 194.25 Future state assumptions.
(a) Unless otherwise specified in this part or in the disposal
regulations, performance assessments and compliance assessments
conducted pursuant the provisions of this part to demonstrate
compliance with Sec. 191.13, Sec. 191.15 and part 191, subpart C shall
assume that characteristics of the future remain what they are at the
time the compliance application is prepared, provided that such
characteristics are not related to hydrogeologic, geologic or climatic
conditions.
(b) In considering future states pursuant to this section, the
Department shall document in any compliance application, to the extent
practicable, effects of potential future hydrogeologic, geologic and
climatic conditions on the disposal system over the regulatory time
frame. Such documentation shall be part of the activities undertaken
pursuant to Sec. 194.14, Content of compliance certification
application; Sec. 194.32, Scope of performance assessments; and
Sec. 194.54, Scope of compliance assessments.
(1) In considering the effects of hydrogeologic conditions on the
disposal system, the Department shall document in any compliance
application, to the extent practicable, the effects of potential
changes to hydrogeologic conditions.
(2) In considering the effects of geologic conditions on the
disposal system, the Department shall document in any compliance
application, to the extent practicable, the effects of potential
changes to geologic conditions, including, but not limited to:
Dissolution; near surface geomorphic features and processes; and
related subsidence in the geologic units of the disposal system.
(3) In considering the effects of climatic conditions on the
disposal system, the Department shall document in any compliance
application, to the extent practicable, the effects of potential
changes to future climate cycles of increased precipitation (as
compared to present conditions).
Sec. 194.26 Expert judgment.
(a) Expert judgment, by an individual expert or panel of experts,
may be used to support any compliance application, provided that expert
judgment does not substitute for information that could reasonably be
obtained through data collection or experimentation.
(b) Any compliance application shall:
(1) Identify any expert judgments used to support the application
and shall identify experts (by name and employer) involved in any
expert judgment elicitation processes used to support the application.
(2) Describe the process of eliciting expert judgment, and document
the results of expert judgment elicitation processes and the reasoning
behind those results. Documentation of interviews used to elicit
judgments from experts, the questions or issues presented for
elicitation of expert judgment, background information provided to
experts, and deliberations and formal interactions among experts shall
be provided. The opinions of all experts involved in each elicitation
process shall be provided whether the opinions are used to support
compliance applications or not.
(3) Provide documentation that the following restrictions and
guidelines have been applied to any selection of individuals used to
elicit expert judgments:
(i) Individuals who are members of the team of investigators
requesting the judgment or the team of investigators who will use the
judgment were not selected; and
(ii) Individuals who maintain, at any organizational level, a
supervisory role or who are supervised by those who will utilize the
judgment were not selected.
(4) Provide information which demonstrates that:
(i) The expertise of any individual involved in expert judgment
elicitation comports with the level of knowledge required by the
questions or issues presented to that individual; and
(ii) The expertise of any expert panel, as a whole, involved in
expert judgment elicitation comports with the level and variety of
knowledge required by the questions or issues presented to that panel.
(5) Explain the relationship among the information and issues
presented to experts prior to the elicitation process, the elicited
judgment of any expert panel or individual, and the purpose for which
the expert judgment is being used in compliance applications(s).
(6) Provide documentation that the initial purpose for which expert
judgment was intended, as presented to the expert panel, is consistent
with the purpose for which this judgment was used in compliance
application(s).
(7) Provide documentation that the following restrictions and
guidelines have been applied in eliciting expert judgment:
(i) At least five individuals shall be used in any expert
elicitation process, unless there is a lack or unavailability of
experts and a documented rationale is provided that explains why fewer
than five individuals were selected.
(ii) At least two-thirds of the experts involved in an elicitation
shall consist of individuals who are not employed directly by the
Department or by the Department's contractors, unless the Department
can demonstrate and document that there is a lack or unavailability of
qualified independent experts. If so demonstrated, at least one-third
of the experts involved in an elicitation shall consist of individuals
who are not employed directly by the Department or by the Department's
contractors.
(c) The public shall be afforded a reasonable opportunity to
present its scientific and technical views to expert panels as input to
any expert elicitation process.
Sec. 194.27 Peer review.
(a) Any compliance application shall include documentation of peer
review that has been conducted, in a manner required by this section,
for:
(1) Conceptual models selected and developed by the Department;
(2) Waste characterization analyses as required in Sec. 194.24(b);
and
(3) Engineered barrier evaluation as required in Sec. 194.44.
[[Page 5242]]
(b) Peer review processes required in paragraph (a) of this
section, and conducted subsequent to the promulgation of this part,
shall be conducted in a manner that is compatible with NUREG-1297,
``Peer Review for High-Level Nuclear Waste Repositories,'' published
February 1988. (Incorporation by reference as specified in Sec. 194.5.)
(c) Any compliance application shall:
(1) Include information that demonstrates that peer review
processes required in paragraph (a) of this section, and conducted
prior to the implementation of the promulgation of this part, were
conducted in accordance with an alternate process substantially
equivalent in effect to NUREG-1297 and approved by the Administrator or
the Administrator's authorized representative; and
(2) Document any peer review processes conducted in addition to
those required pursuant to paragraph (a) of this section. Such
documentation shall include formal requests, from the Department to
outside review groups or individuals, to review or comment on any
information used to support compliance applications, and the responses
from such groups or individuals.
Containment Requirements
Sec. 194.31 Application of release limits.
The release limits shall be calculated according to part 191,
appendix A of this chapter, using the total activity, in curies, that
will exist in the disposal system at the time of disposal.
Sec. 194.32 Scope of performance assessments.
(a) Performance assessments shall consider natural processes and
events, mining, deep drilling, and shallow drilling that may affect the
disposal system during the regulatory time frame.
(b) Assessments of mining effects may be limited to changes in the
hydraulic conductivity of the hydrogeologic units of the disposal
system from excavation mining for natural resources. Mining shall be
assumed to occur with a one in 100 probability in each century of the
regulatory time frame. Performance assessments shall assume that
mineral deposits of those resources, similar in quality and type to
those resources currently extracted from the Delaware Basin, will be
completely removed from the controlled area during the century in which
such mining is randomly calculated to occur. Complete removal of such
mineral resources shall be assumed to occur only once during the
regulatory time frame.
(c) Performance assessments shall include an analysis of the
effects on the disposal system of any activities that occur in the
vicinity of the disposal system prior to disposal and are expected to
occur in the vicinity of the disposal system soon after disposal. Such
activities shall include, but shall not be limited to, existing
boreholes and the development of any existing leases that can be
reasonably expected to be developed in the near future, including
boreholes and leases that may be used for fluid injection activities.
(d) Performance assessments need not consider processes and events
that have less than one chance in 10,000 of occurring over 10,000
years.
(e) Any compliance application(s) shall include information which:
(1) Identifies all potential processes, events or sequences and
combinations of processes and events that may occur during the
regulatory time frame and may affect the disposal system;
(2) Identifies the processes, events or sequences and combinations
of processes and events included in performance assessments; and
(3) Documents why any processes, events or sequences and
combinations of processes and events identified pursuant to paragraph
(e)(1) of this section were not included in performance assessment
results provided in any compliance application.
Sec. 194.33 Consideration of drilling events in performance
assessments.
(a) Performance assessments shall examine deep drilling and shallow
drilling that may potentially affect the disposal system during the
regulatory time frame.
(b) The following assumptions and process shall be used in
assessing the likelihood and consequences of drilling events, and the
results of such process shall be documented in any compliance
application:
(1) Inadvertent and intermittent intrusion by drilling for
resources (other than those resources provided by the waste in the
disposal system or engineered barriers designed to isolate such waste)
is the most severe human intrusion scenario.
(2) In performance assessments, drilling events shall be assumed to
occur in the Delaware Basin at random intervals in time and space
during the regulatory time frame.
(3) The frequency of deep drilling shall be calculated in the
following manner:
(i) Identify deep drilling that has occurred for each resource in
the Delaware Basin over the past 100 years prior to the time at which a
compliance application is prepared.
(ii) The total rate of deep drilling shall be the sum of the rates
of deep drilling for each resource.
(4) The frequency of shallow drilling shall be calculated in the
following manner:
(i) Identify shallow drilling that has occurred for each resource
in the Delaware Basin over the past 100 years prior to the time at
which a compliance application is prepared.
(ii) The total rate of shallow drilling shall be the sum of the
rates of shallow drilling for each resource.
(iii) In considering the historical rate of all shallow drilling,
the Department may, if justified, consider only the historical rate of
shallow drilling for resources of similar type and quality to those in
the controlled area.
(c) Performance assessments shall document that in analyzing the
consequences of drilling events, the Department assumed that:
(1) Future drilling practices and technology will remain consistent
with practices in the Delaware Basin at the time a compliance
application is prepared. Such future drilling practices shall include,
but shall not be limited to: The types and amounts of drilling fluids;
borehole depths, diameters, and seals; and the fraction of such
boreholes that are sealed by humans; and
(2) Natural processes will degrade or otherwise affect the
capability of boreholes to transmit fluids over the regulatory time
frame.
(d) With respect to future drilling events, performance assessments
need not analyze the effects of techniques used for resource recovery
subsequent to the drilling of the borehole.
Sec. 194.34 Results of performance assessments.
(a) The results of performance assessments shall be assembled into
``complementary, cumulative distribution functions'' (CCDFs) that
represent the probability of exceeding various levels of cumulative
release caused by all significant processes and events.
(b) Probability distributions for uncertain disposal system
parameter values used in performance assessments shall be developed and
documented in any compliance application.
(c) Computational techniques, which draw random samples from across
the entire range of the probability distributions developed pursuant to
paragraph (b) of this section, shall be used in generating CCDFs and
shall be documented in any compliance application.
[[Page 5243]]
(d) The number of CCDFs generated shall be large enough such that,
at cumulative releases of 1 and 10, the maximum CCDF generated exceeds
the 99th percentile of the population of CCDFs with at least a 0.95
probability. Values of cumulative release shall be calculated according
to Note 6 of Table 1, Appendix A of Part 191 of this chapter.
(e) Any compliance application shall display the full range of
CCDFs generated.
(f) Any compliance application shall provide information which
demonstrates that there is at least a 95 percent level of statistical
confidence that the mean of the population of CCDFs meets the
containment requirements of Sec. 191.13 of this chapter.
Assurance Requirements
Sec. 194.41 Active institutional controls.
(a) Any compliance application shall include detailed descriptions
of proposed active institutional controls, the controls' location, and
the period of time the controls are proposed to remain active.
Assumptions pertaining to active institutional controls and their
effectiveness in terms of preventing or reducing radionuclide releases
shall be supported by such descriptions.
(b) Performance assessments shall not consider any contributions
from active institutional controls for more than 100 years after
disposal.
Sec. 194.42 Monitoring.
(a) The Department shall conduct an analysis of the effects of
disposal system parameters on the containment of waste in the disposal
system and shall include the results of such analysis in any compliance
application. The results of the analysis shall be used in developing
plans for pre-closure and post-closure monitoring required pursuant to
paragraphs (c) and (d) of this section. The disposal system parameters
analyzed shall include, at a minimum:
(1) Properties of backfilled material, including porosity,
permeability, and degree of compaction and reconsolidation;
(2) Stresses and extent of deformation of the surrounding roof,
walls, and floor of the waste disposal room;
(3) Initiation or displacement of major brittle deformation
features in the roof or surrounding rock;
(4) Ground water flow and other effects of human intrusion in the
vicinity of the disposal system;
(5) Brine quantity, flux, composition, and spatial distribution;
(6) Gas quantity and composition; and
(7) Temperature distribution.
(b) For all disposal system parameters analyzed pursuant to
paragraph (a) of this section, any compliance application shall
document and substantiate the decision not to monitor a particular
disposal system parameter because that parameter is considered to be
insignificant to the containment of waste in the disposal system or to
the verification of predictions about the future performance of the
disposal system.
(c) Pre-closure monitoring. To the extent practicable, pre-closure
monitoring shall be conducted of significant disposal system
parameter(s) as identified by the analysis conducted pursuant to
paragraph (a) of this section. A disposal system parameter shall be
considered significant if it affects the system's ability to contain
waste or the ability to verify predictions about the future performance
of the disposal system. Such monitoring shall begin as soon as
practicable; however, in no case shall waste be emplaced in the
disposal system prior to the implementation of pre-closure monitoring.
Pre-closure monitoring shall end at the time at which the shafts of the
disposal system are backfilled and sealed.
(d) Post-closure monitoring. The disposal system shall, to the
extent practicable, be monitored as soon as practicable after the
shafts of the disposal system are backfilled and sealed to detect
substantial and detrimental deviations from expected performance and
shall end when the Department can demonstrate to the satisfaction of
the Administrator that there are no significant concerns to be
addressed by further monitoring. Post-closure monitoring shall be
complementary to monitoring required pursuant to applicable federal
hazardous waste regulations at parts 264, 265, 268, and 270 of this
chapter and shall be conducted with techniques that do not jeopardize
the containment of waste in the disposal system.
(e) Any compliance application shall include detailed pre-closure
and post-closure monitoring plans for monitoring the performance of the
disposal system. At a minimum, such plans shall:
(1) Identify the parameters that will be monitored and how baseline
values will be determined;
(2) Indicate how each parameter will be used to evaluate any
deviations from the expected performance of the disposal system; and
(3) Discuss the length of time over which each parameter will be
monitored to detect deviations from expected performance.
Sec. 194.43 Passive institutional controls.
(a) Any compliance application shall include detailed descriptions
of the measures that will be employed to preserve knowledge about the
location, design, and contents of the disposal system. Such measures
shall include:
(1) Identification of the controlled area by markers that have been
designed and will be fabricated and emplaced to be as permanent as
practicable;
(2) Placement of records in the archives and land record systems of
local, State, and Federal governments, and international archives, that
would likely be consulted by individuals in search of unexploited
resources. Such records shall identify:
(i) The location of the controlled area and the disposal system;
(ii) The design of the disposal system;
(iii) The nature and hazard of the waste;
(iv) Geologic, geochemical, hydrologic, and other site data
pertinent to the containment of waste in the disposal system, or the
location of such information; and
(v) The results of tests, experiments, and other analyses relating
to backfill of excavated areas, shaft sealing, waste interaction with
the disposal system, and other tests, experiments, or analyses
pertinent to the containment of waste in the disposal system, or the
location of such information.
(3) Other passive institutional controls practicable to indicate
the dangers of the waste and its location.
(b) Any compliance application shall include the period of time
passive institutional controls are expected to endure and be
understood.
(c) The Administrator may allow the Department to assume passive
institutional control credit, in the form of reduced likelihood of
human intrusion, if the Department demonstrates in the compliance
application that such credit is justified because the passive
institutional controls are expected to endure and be understood by
potential intruders for the time period approved by the Administrator.
Such credit, or a smaller credit as determined by the Administrator,
cannot be used for more than several hundred years and may decrease
over time. In no case, however, shall passive institutional controls be
assumed to eliminate the likelihood of human intrusion entirely.
Sec. 194.44 Engineered barriers.
(a) Disposal systems shall incorporate engineered barrier(s)
designed to prevent or substantially delay the movement of water or
radionuclides toward the accessible environment.
[[Page 5244]]
(b) In selecting any engineered barrier(s) for the disposal system,
the Department shall evaluate the benefit and detriment of engineered
barrier alternatives, including but not limited to: Cementation,
shredding, supercompaction, incineration, vitrification, improved waste
canisters, grout and bentonite backfill, melting of metals, alternative
configurations of waste placements in the disposal system, and
alternative disposal system dimensions. The results of this evaluation
shall be included in any compliance application and shall be used to
justify the selection and rejection of each engineered barrier
evaluated.
(c)(1) In conducting the evaluation of engineered barrier
alternatives, the following shall be considered, to the extent
practicable:
(i) The ability of the engineered barrier to prevent or
substantially delay the movement of water or waste toward the
accessible environment;
(ii) The impact on worker exposure to radiation both during and
after incorporation of engineered barriers;
(iii) The increased ease or difficulty of removing the waste from
the disposal system;
(iv) The increased or reduced risk of transporting the waste to the
disposal system;
(v) The increased or reduced uncertainty in compliance assessment;
(vi) Public comments requesting specific engineered barriers;
(vii) The increased or reduced total system costs;
(viii) The impact, if any, on other waste disposal programs from
the incorporation of engineered barriers (e.g., the extent to which the
incorporation of engineered barriers affects the volume of waste);
(ix) The effects on mitigating the consequences of human intrusion.
(2) If, after consideration of one or more of the factors in
paragraph (c)(1) of this section, the Department concludes that an
engineered barrier considered within the scope of the evaluation should
be rejected without evaluating the remaining factors in paragraph
(c)(1) of this section, then any compliance application shall provide a
justification for this rejection explaining why the evaluation of the
remaining factors would not alter the conclusion.
(d) In considering the ability of engineered barriers to prevent or
substantially delay the movement of water or radionuclides toward the
accessible environment, the benefit and detriment of engineered
barriers for existing waste already packaged, existing waste not yet
packaged, existing waste in need of re-packaging, and to-be-generated
waste shall be considered separately and described.
(e) The evaluation described in paragraphs (b), (c) and (d) of this
section shall consider engineered barriers alone and in combination.
Sec. 194.45 Consideration of the presence of resources.
Any compliance application shall include information that
demonstrates that the favorable characteristics of the disposal system
compensate for the presence of resources in the vicinity of the
disposal system and the likelihood of the disposal system being
disturbed as a result of the presence of those resources. If
performance assessments predict that the disposal system meets the
containment requirements of Sec. 191.13 of this chapter, then the
Agency will assume that the requirements of this section and
Sec. 191.14(e) of this chapter have been fulfilled.
Sec. 194.46 Removal of waste.
Any compliance application shall include documentation which
demonstrates that removal of waste from the disposal system is feasible
for a reasonable period of time after disposal. Such documentation
shall include an analysis of the technological feasibility of mining
the sealed disposal system, given technology levels at the time a
compliance application is prepared.
Individual and Ground-water Protection Requirements
Sec. 194.51 Consideration of protected individual.
Compliance assessments that analyze compliance with Sec. 191.15 of
this chapter shall assume that an individual resides at the single
geographic point on the surface of the accessible environment where
that individual would be expected to receive the highest dose from
radionuclide releases from the disposal system.
Sec. 194.52 Consideration of exposure pathways.
In compliance assessments that analyze compliance with Sec. 191.15
of this chapter, all potential exposure pathways from the disposal
system to individuals shall be considered. Compliance assessments with
part 191, subpart C and Sec. 191.15 of this chapter shall assume that
individuals consume 2 liters per day of drinking water from any
underground source of drinking water in the accessible environment.
Sec. 194.53 Consideration of underground sources of drinking water.
In compliance assessments that analyze compliance with part 191,
subpart C of this chapter, all underground sources of drinking water in
the accessible environment that are expected to be affected by the
disposal system over the regulatory time frame shall be considered. In
determining whether underground sources of drinking water are expected
to be affected by the disposal system, underground interconnections
among bodies of surface water, ground water, and underground sources of
drinking water shall be considered.
Sec. 194.54 Scope of compliance assessments.
(a) Any compliance application shall contain compliance assessments
required pursuant to this part. Compliance assessments shall include
information which:
(1) Identifies potential processes, events, or sequences of
processes and events that may occur over the regulatory time frame;
(2) Identifies the processes, events, or sequences of processes and
events included in compliance assessment results provided in any
compliance application; and
(3) Documents why any processes, events, or sequences of processes
and events identified pursuant to paragraph (a)(1) of this section were
not included in compliance assessment results provided in any
compliance application.
(b) Compliance assessments of undisturbed performance shall include
the effects on the disposal system of:
(1) Existing boreholes in the vicinity of the disposal system, with
attention to the pathways they provide for migration of radionuclides
from the site; and
(2) Any activities that occur in the vicinity of the disposal
system prior to or soon after disposal. Such activities shall include,
but shall not be limited to: Existing boreholes and the development of
any existing leases that can be reasonably expected to be developed in
the near future, including boreholes and leases that may be used for
fluid injection activities.
Sec. 194.55 Results of compliance assessments.
(a) Compliance assessments shall consider and document uncertainty
in the performance of the disposal system.
(b) Probability distributions for uncertain disposal system
parameter values used in compliance assessments shall be developed and
documented in any compliance application.
[[Page 5245]]
(c) Computational techniques which draw random samples from across
the entire range of values of each probability distribution developed
pursuant to paragraph (b) of this section shall be used to generate a
range of:
(1) Estimated committed effective doses received from all pathways
pursuant to Sec. 194.51 and Sec. 194.52;
(2) Estimated radionuclide concentrations in USDWs pursuant to
Sec. 194.53; and
(3) Estimated dose equivalent received from USDWs pursuant to
Sec. 194.52 and Sec. 194.53.
(d) The number of estimates generated pursuant to paragraph (c) of
this section shall be large enough such that the maximum estimates of
doses and concentrations generated exceed the 99th percentile of the
population of estimates with at least a 0.95 probability.
(e) Any compliance application shall display:
(1) The full range of estimated radiation doses; and
(2) The full range of estimated radionuclide concentrations.
(f) Any compliance application shall document that there is at
least a 95 percent level of statistical confidence that the mean and
the median of the range of estimated radiation doses and the range of
estimated radionuclide concentrations meet the requirements of
Sec. 191.15 and part 191, subpart C of this chapter, respectively.
Subpart D--Public Participation
Sec. 194.61 Advance notice of proposed rulemaking for certification.
(a) Upon receipt of a compliance application submitted pursuant to
section 8(d)(1) of the WIPP LWA and Sec. 194.11, the Agency will
publish in the Federal Register an Advance Notice of Proposed
Rulemaking announcing that a compliance application has been received,
soliciting comment on such application, and announcing the Agency's
intent to conduct a rulemaking to certify whether the WIPP facility
will comply with the disposal regulations.
(b) A copy of the compliance application will be made available for
inspection in Agency dockets established pursuant to Sec. 194.67.
(c) The notice will provide a public comment period of 120 days.
(d) A public hearing concerning the notice will be held if a
written request is received by the Administrator or the Administrator's
authorized representative within 30 calendar days of the date of
publication pursuant to paragraph (a) of this section.
(e) Any comments received on the notice will be made available for
inspection in the dockets established pursuant to Sec. 194.67.
(f) Any comments received on the notice will be provided to the
Department and the Department may submit to the Agency written
responses to the comments.
Sec. 194.62 Notice of proposed rulemaking for certification.
(a) The Administrator will publish a Notice of Proposed Rulemaking
in the Federal Register announcing the Administrator's proposed
decision, pursuant to section 8(d)(1) of the WIPP LWA, whether to issue
a certification that the WIPP facility will comply with the disposal
regulations and soliciting comment on the proposal.
(b) The notice will provide a public comment period of at least 120
days.
(c) The notice will announce public hearings in New Mexico.
(d) Any comments received on the notice will be made available for
inspection in the dockets established pursuant to Sec. 194.67.
Sec. 194.63 Final rule for certification.
(a) The Administrator will publish a Final Rule in the Federal
Register announcing the Administrator's decision, pursuant to section
8(d)(1) of the WIPP LWA, whether to issue a certification that the WIPP
facility will comply with the disposal regulations.
(b) A document summarizing significant comments and issues arising
from comments received on the Notice of Proposed Rulemaking, as well as
the Administrator's response to such significant comments and issues,
will be prepared and will be made available for inspection in the
dockets established pursuant to Sec. 194.67.
Sec. 194.64 Documentation of continued compliance.
(a) Upon receipt of documentation of continued compliance with the
disposal regulations pursuant to section 8(f) of the WIPP LWA and
Sec. 194.11, the Administrator will publish a notice in the Federal
Register announcing that such documentation has been received,
soliciting comment on such documentation, and announcing the
Administrator's intent to determine whether or not the WIPP facility
continues to be in compliance with the disposal regulations.
(b) Copies of documentation of continued compliance received by the
Administrator will be made available for inspection in the dockets
established pursuant to Sec. 194.67.
(c) The notice will provide a public comment period of at least 30
days after publication pursuant to paragraph (a) of this section.
(d) Any comments received on such notice will be made available for
public inspection in the dockets established pursuant to Sec. 194.67.
(e) Upon completion of review of the documentation of continued
compliance with the disposal regulations, the Administrator will
publish a notice in the Federal Register announcing the Administrator's
decision whether or not to re-certify the WIPP facility.
Sec. 194.65 Notice of proposed rulemaking for modification or
revocation.
(a) If the Administrator determines that any changes in activities
or conditions pertaining to the disposal system depart significantly
from the most recent compliance application, the Agency will publish a
Notice of Proposed Rulemaking in the Federal Register announcing the
Administrator's proposed decision on modification or revocation, and
soliciting comment on the proposal.
(b) Any comments received on the notice will be made available for
inspection in the dockets established pursuant to Sec. 194.67.
Sec. 194.66 Final rule for modification or revocation.
(a) The Administrator will publish a Final Rule in the Federal
Register announcing the Administrator's decision on modification or
revocation.
(b) A document summarizing significant comments and issues arising
from comments received on the Notice of Proposed Rulemaking as well as
the Administrator's response to such significant comments and issues
will be prepared and will be made available for inspection in the
dockets established pursuant to Sec. 194.67.
Sec. 194.67 Dockets.
The Agency will establish and maintain dockets in the State of New
Mexico and Washington, DC. The dockets will consist of all relevant,
significant information received from outside parties and all
significant information considered by the Administrator in certifying
whether the WIPP facility will comply with the disposal regulations, in
certifying whether or not the WIPP facility continues to be in
compliance with the disposal regulations, and in determining whether
compliance certification should be modified, suspended or revoked.
[FR Doc. 96-2721 Filed 2-8-96; 8:45 am]
BILLING CODE 6560-50-P