ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 194
RIN 2060-AE30
Criteria for the Certification and Determination of the Waste
Isolation Pilot Plant's Compliance with Environmental Standards for
the Management and Disposal of Spent Nuclear Fuel, High-Level and
Transuranic Radioactive Wastes
AGENCY: Environmental Protection Agency (EPA)
ACTION: Proposed rule.
SUMMARY: The Environmental Protection Agency (EPA) is proposing
criteria for certifying and determining whether the Department of
Energy's Waste Isolation Pilot Plant (WIPP) complies with disposal
standards set forth in 40 CFR part 191 (Environmental Standards for
the Management and Disposal of Spent Nuclear Fuel, High-Level and
Transuranic Radioactive Wastes). EPA is required to promulgate
these criteria under the 1992 Waste Isolation Pilot Plant Land
Withdrawal Act (WIPP LWA) . These criteria will be used by the Agency
in ascertaining whether the WIPP disposal system complies with the
disposal standards.
DATES: Comments on today's proposal must be received within 90 days
from this publication. Public hearings on today's proposal will
be held in New Mexico.
ADDRESSES: Comments should be submitted, in duplicate, to: Docket
No. A-92-56, Air Docket, room M-1500 (LE-131), U.S. Environmental
Protection Agency, 401 M Street, S.W., Washington, D.C. 20460. See
additional docket information in the Supplementary Information.
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The effective date of these compliance criteria, once finalized,
will be 30 calendar days after date of publication of the final rule
in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Mary Kruger or Martin Offutt;
telephone number (202) 233-9310; address: Criteria and Standards
Division, Mail Code 6602J, U.S. Environmental Protection Agency,
401 M Street, S.W., Washington, B.C. 20460. An addendum to the
supplementary information provided in today's notice is located in
Docket No. A-92-56. For copies of this addendum and the Background
Information Document and Economic Impact Analysis prepared for this
proposed rule, contact Mary Kruger at the above phone number and
address.
SUPPLEMENTARY INFORMATION: As discussed below, the scope of today' s
proposal is limited to proposed criteria for certifying and
determining whether the Waste Isolation Pilot Plant (WIPP) in New
Mexico complies with the disposal standards set forth in 40 CFR part
191. Accordingly, comments should be similarly limited in scope;
e.g., comments should not address the Agency's recently promulgated
radioactive waste disposal standards--40 CFR part 191 (58 FR 66398,
December 20, 1993)--or whether WIPP should be used as a disposal
facility.
The U.S. Department of Energy (DOE) is developing the Waste
Isolation Pilot Plant (WIPP) near Carlsbad in southeastern New Mexico
as a potential deep geologic repository for the disposal of defense
transuranic (TRU) radioactive waste currently being stored on Federal
reservations in Washington, Ohio, Idaho, New Mexico, Tennessee, South
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Carolina, Nevada and Colorado. TRU waste consists of materials
containing one or more elements having atomic numbers greater than
92, in concentrations greater than 100 nanocuries of alpha-emitting
TRU isotopes per gram of waste, with half-lives greater than twenty
years. Most TRU waste consists of items that have become
contaminated as a result of activities associated with the production
of nuclear weapons, e.g., rags, equipment, tools, and organic and
inorganic sludges. TRU waste is often mixed with hazardous chemical
constituents.
Before beginning disposal of radioactive waste at the WIPP,
DOE must demonstrate that the WIPP complies with the Environmental
Protection Agency's (EPA) radioactive waste standards at 40 CFR part
191 (Environmental Standards for the Management and Disposal of Spent
Nuclear Fuel, High-Level and Transuranic Radioactive Wastes).
On October 30, 1992, the Waste Isolation Pilot Plant Land
Withdrawal Act (WIPP LWA) was enacted (Pub. L. 102-579). The WIPP
LWA contains numerous provisions pertaining to EPA's role in
overseeing DOE's activities at the WIPP, including requirements for
the development and implementation of the 40 CFR part 191 disposal
standards as they are applied to the WIPP. Specifically, section
8 (a) of the WIPP LWA reinstated all of the remanded disposal standards
except those aspects of the individual and ground-water protection
requirements which the court found problematic in NRDC v. U.S. EPA.
The WIPP LWA requires EPA to certify and determine whether or
not the WIPP will comply with the Agency's final radioactive waste
disposal standards. "Certification" refers to any initial
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certification of compliance of DOE's application for the WIPP with
subparts B and C of 40 CFR part 191 (see section 8(d) of the WIPP
LWA). "Determination" refers to any subsequent decisions by the
Agency (required every 5 years by the WIPP LWA) of whether the WIPP
continues to be in compliance with subparts B and C of 40 CFR part
191 (see section 8(f) of the WIPP LWA). In order to certify or
determine compliance, the Agency will be issuing criteria for
assessing compliance with the final disposal standards, as required
by section 8(c) of the WIPP LWA. On February 11, 1993, as a first
step in the development of compliance criteria, EPA issued an Advance
Notice of Proposed Rulemaking (ANPR) soliciting comments on issues
associated with the development of compliance criteria. (58 FR
8029.) The next step in the evolution of these criteria is occurring
today with the issuance of proposed compliance criteria.
Objective and Implementation of Today's Proposed Criteria
Under authority of the WIPP LWA, the Agency is proposing criteria
for certifying and determining whether the Department of Energy's
(DOE) Waste Isolation Pilot Plant (WIPP) will comply with the Agency' s
radioactive waste disposal standards set forth in 40 CFR part 191.
The WIPP LWA specifies that underground emplacement of transuranic
wastes for disposal at the WIPP may not commence unless and until
EPA certifies that the WIPP facility will comply with 40 CFR part
191, subparts B and C. If the Agency certifies compliance, the WIPP
LWA requires EPA to subsequently conduct periodic determinations
of continued compliance throughout waste disposal operations at the
WIPP. Criteria contained in today's notice address any initial
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certification of compliance as well as any subsequent determinations
of continued compliance. When final compliance criteria are
promulgated as Agency regulations, EPA will be responsible for
assuring that the requirements are properly implemented.
Importantly, today's proposal is limited to consideration of
the WIPP' s compliance with the disposal regulations found in subparts
B and C of 40 CFR part 191 (which include containment requirements,
assurance requirements, individual protection requirements, and
ground-water protection requirements). These compliance criteria
do not address compliance with the management and storage regulations
found in subpart A of 40 CFR part 191. The Agency plans to issue
guidance addressing implementation of subpart A at a later date.
The Agency also wishes to make clear that today's proposal does
not address compliance with all of the requirements of the WIPP LWA.
Rather, today's proposal is limited to those requirements of the
WIPP LWA which pertain to the WIPP's compliance with the disposal
standards in 40 CFR part 191. For example, today's proposal does
not address the WIPP's compliance with EPA regulations developed
pursuant to the Resource Conservation and Recovery Act (RCRA) or
any other environmental laws or regulations. EPA intends to address
compliance with the balance of these additional laws and regulations
through compliance plans being developed by EPA's Region VI. For
more information regarding the Region's activities, please write
to EPA Region VI, 1445 Ross Avenue, Dallas, Texas, 75202-2733; Attn:
Chuck Byrum.
EPA has prepared a document entitled "Implementation Strategy
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for the Waste Isolation Pilot Plant Land Withdrawal Act of 1992"
(EPA 402-R-93-002, March 1993) which explains in more detail the
Agency's roles and responsibilities under the WIPP LWA. For more
information concerning the Implementation Strategy Document, please
write to the Policy and Public Information Section, Office of
Radiation and Indoor Air, U.S. EPA, Mail Code 6602J, 401 M St., S.W.,
Washington, B.C. 20460 or call the EPA WIPP Information Line at
Additional Docket Information
The Agency is currently maintaining the following public
information dockets: 1) Docket No. A-92-56, located in room 1500
(first floor in Waterside Mall near the Washington Information
Center), U.S. Environmental Protection Agency, 401 M Street, S.W.,
Washington, B.C. 20460 (open from 8 : 00 a .m. to 4 : 00 p .m. on weekdays) ;
2) EPA's docket in the Government Publications Department of the
Zimmerman Library of the University of New Mexico located in
Albuquerque, New Mexico (open from 8:00 a.m. to 9:00 p.m. on Monday
through Thursday, 8:00 a.m. to 5:00 p.m. on Friday, 9:00 a.m. to
5:00 p.m. on Saturday, and 1:00 p.m. to 9:00 p.m. on Sunday); 3)
EPA's docket in the Fogelson Library of the College of Santa Fe in
Santa Fe, New Mexico located at 1600 St. Michaels Drive (open from
8:00 a.m. to 12:00 midnight on Monday through Thursday, 8:00 a.m.
to 5:00 p.m. on Friday, 9:00 a.m. to 5:00 p.m. on Saturday, 1:00
p.m. to 9:00 p.m. on Sunday); and 4) EPA's docket in the Municipal
Library of Carlsbad, New Mexico located at 101 S. Halegueno (open
from 10:00 a.m. to 9:00 p.m. on Monday through Thursday, 10:00 a.m.
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to 6:00 p.m. on Friday and Saturday, and 1:00 p.m. to 5:00 p.m. on
Sunday) . As provided in 40 CFR part 2 , a reasonable fee may be charged
for photocopying docket materials.
Description Of Proposed Criteria
The proposed criteria consist of four subparts. Each of these
subparts is discussed in more detail below.
Subpart A--General Provisions
Subpart A is chiefly concerned with identifying the purpose,
scope and applicability of the criteria, defining terms, setting
forth requirements regarding communications, addressing conditions
of compliance certification and determinations, incorporating
publications by reference, and providing for alternative provisions
if future information indicates a need to modify the criteria. The
specific provisions of Subpart A are discussed below.
Purpose, Scope, and Applicability
Under Section 7 (b) of the WIPP LWA, the DOE cannot dispose of
transuranic waste at the WIPP until the EPA certifies that the WIPP
is in compliance with the Agency's radioactive waste disposal
standards set forth in 40 CFR part 191. In addition, under Section
8(f) of the WIPP LWA, not later than five years after initial receipt
of waste for disposal at the WIPP, and every five years thereafter
until the end of the decommissioning phase (as defined in section
2 of the WIPP LWA), DOE is required to submit to the Administrator
documentation of continued compliance with the Agency's disposal
standards. EPA is proposing to specify that these criteria will
apply to any certification of compliance or determination of
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continued compliance under these sections of the WIPP LWA. The
Administrator will review any compliance applications (hereinafter,
the term "compliance applications" refers to applications for
certification of compliance under section 8(d) of the WIPP LWA as
well as applications for determinations of continued compliance under
section 8(f) of the WIPP LWA) and will utilize these criteria to
ascertain whether such applications demonstrate compliance with
subparts B and C of 40 CFR part 191. The Administrator's
certification or determination of compliance for the WIPP facility
will depend on satisfying the specific requirements of each section
of these criteria.
Definitions
In an effort to be consistent with the disposal standards set
forth in 40 CFR part 191, the Agency is proposing that, unless
otherwise indicated, all terms in the criteria have the same meaning
as terms found in the disposal regulations. Communications
The Agency is proposing to specify that any compliance
applications shall be addressed to the Administrator and shall be
signed by the Secretary. Any other communications concerning
compliance applications for the WIPP shall, likewise, be addressed
to the Administrator and shall be signed by the Secretary or the
Secretary's authorized representative.
Conditions of compliance certification and determination
EPA is proposing that any certification or determination issued
by the Agency pursuant to the WIPP LWA may include any conditions
that the Administrator finds necessary to support a compliance
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certification or determination. In addition, EPA is proposing that
any certification or determination of compliance be potentially
subject to modification, suspension, or revocation for cause. The
Agency believes that such conditions are necessary in order to guard
against the possibility that the disposal system does not perform
as expected (i.e., according to predictions contained in compliance
applications).
Any certification or determination of the WIPP's compliance
will be based upon the information contained in any compliance
application submitted to the Administrator and upon other available
information relevant to the application. So long as the contents
of the application remain valid, the current certification or
determination will remain valid. However, if the information
contained in the application becomes invalid due to unanticipated
developments, then the basis for the certification or determination
may no longer be valid, and modification, suspension, or revocation
of the certification or determination may be in order. Any
modification, suspension, or revocation of a compliance
certification will be subject to Agency rulemaking.
EPA is proposing to include these conditions because the Agency
believes it is important to have a mechanism which enables a
certification or determination to be modified, suspended, or revoked
if new information comes to light which suggests that the WIPP is
no longer performing or may no longer perform as predicted. It would
not be prudent to wait until submission of documentation of continued
compliance (potentially up to five years later) before taking steps
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to mitigate against potential malfunctioning of the disposal system.
Delay would allow a situation which could result in a violation
continuing to exist or, perhaps, worsen. Hence, EPA is proposing
these conditions in order to be able to take action quickly to address
serious issues raised as to whether the WIPP is in compliance with
the disposal regulations.
The Agency is not specifying, in today's proposal, the
particular actions which may be required to be undertaken if
modification or suspension were invoked. EPA has not done so because
the Agency believes that it is inappropriate to specify particular
actions prior to knowing the precise circumstances in which the
actions would be undertaken. Since all of the scenarios in which
the conditions might be invoked would be difficult to predict,
specification of the actions necessary to mitigate against the
consequences of all such scenarios becomes even more difficult.
EPA, therefore, is proposing that decisions about the appropriate
actions shall be based upon the nature and gravity of the given
scenario at the time it occurs. In some cases this might entail
instituting remedial actions or even removal of waste, while in other
cases it might simply involve temporarily halting waste emplacement.
Thus, actions will be evaluated on a case by case basis. The Agency
solicits comment on this approach.
While the Agency is not specifying the particular actions which
may be required in the event of a modification or suspension, the
Agency is proposing that, in the event of a revocation (where
presumably all attempts at remedial action have failed), the
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Department shall retrieve, to the extent practicable, any waste
emplaced in the disposal system. The Agency solicits comment on
this proposal.
The Agency is proposing that upon written request of the
Administrator (after any certification or determination of
compliance has been issued) , the Department shall submit information
to enable the Administrator to determine whether cause exists to
modify, revoke, or suspend any certification or determination.
Moreover, the EPA is proposing that the Department shall provide
the requested information to the Administrator within 30 days of
receipt of the Administrator's request. By requiring such a quick
response time, the Agency can be assured that if circumstances arise
which warrant suspension, modification, or revocation, the potential
consequences of such circumstances can be mitigated early and safety
can, therefore, be increased. As an additional measure to
ensure that the Administrator is kept apprised of any developments
at the WIPP which might warrant modification, suspension, or
revocation of any certification or determination of compliance, the
Agency is proposing that the Department report, within ten days of
discovery, any significant changes in conditions pertaining to the
disposal system that depart from the application and which formed
the basis of any certification or determination. Moreover, the
Agency is requiring that a written report of all changes in conditions
and/or activities pertaining to the disposal system that depart from
the application and which formed the basis of any certification or
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determination be submitted to the Agency at least once every six
months. If the Department plans to intentionally make any
significant changes in conditions or activities pertaining to the
disposal system, all such changes must be approved by the
Administrator prior to being made. The Administrator will consider
whether the planned change will invalidate the terms of the
certification or determination in assessing whether approval should
be given.
EPA is proposing to require the reporting of changes in WIPP
conditions or activities once every six months to assure that the
Agency is kept apprised of such changes but in a manner which is
not overly burdensome to the Department in submitting the information
or to the Agency in reviewing it.
EPA is also proposing to require that if the Department
determines that a release of waste from the disposal system in excess
of what is permitted under the disposal regulations has occurred
or is likely to occur, the Department shall immediately suspend
emplacement of waste in the disposal system and notify the
Administrator within 24 hours of discovery of such a release.
Following such notification, the Administrator may request
additional information and will determine whether to modify, suspend,
or revoke any previously issued certification or determination of
compliance. The EPA is proposing this requirement to ensure that
the Administrator is quickly apprised of any changes in the disposal
system's performance from the projections included in any compliance
applications.
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Publications incorporated by reference
EPA is proposing that the following four documents be
incorporated by reference: (1) the Nuclear Regulatory Commission's
NUREG 1297 "Peer Review for High-Level Nuclear Waste Repositories";
(2) The American Society of Mechanical Engineers' (ASME) NQA-1-1989
edition "Quality Assurance Program Requirements for Nuclear
Facilities"; (3) ASME NQA-2a-1990 addenda (part 2.7) to ASME
NQA-2-1989 edition "Quality Assurance Requirements of Computer
Software for Nuclear Facility Applications" ; and (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." The Agency is proposing
to incorporate all of these documents because EPA believes that each
is appropriate for use at the WIPP. More detailed information about
the contents of each document is provided below in the sections
dedicated to the particular topic covered by the various documents.
Documents incorporated by reference are also available for
inspection in the Office of the Federal Register.
Alternative provisions
Although the Agency believes that the criteria being proposed
today are appropriate based upon current knowledge and information,
the possibility that future information may indicate necessary
modifications to the criteria can not be ruled out.
In recognition of this possibility, today's proposed criteria
set forth procedures under which the Administrator may develop
modifications to this part, should the need arise. Any such
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modifications would proceed through the notice-and-comment
rulemaking process under the Administrative Procedure Act (5 U.S.C.
553) . The proposed criteria stipulate that such a rulemaking would
require a public comment period of at least 120 days, including public
hearings in New Mexico.
Subpart B--Compliance Certification and Determination
Applications
Subpart B of the proposed compliance criteria addresses: 1) the
completeness and accuracy of compliance applications; 2) the filing
and distribution requirements for such applications and any
associated reference materials; 3) the contents of a complete
application; and 4) the criteria for updating certification
applications. Each of these sections is discussed below.
Completeness and accuracy of compliance applications
The Agency proposes to require that any applications submitted
to the Administrator for a certification or determination of
compliance be complete and accurate. Since the statutory review
period for applications is only one year for certification and six
months for determinations, it is essential that all of that time
be devoted to substantive evaluation of the information contained
in the applications. Therefore, the Agency is proposing that the
statutory review periods not begin until the Administrator has
determined that the application is complete, accurate, and in
accordance with the compliance criteria. The Administrator will
notify the Secretary in writing once this determination is made.
Submission of compliance applications
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In order to meet EPA's needs for reviewing and docketing any
compliance applications, the Agency proposes to require that 30 paper
copies of applications be filed with the Administrator (one original
and 29 printed copies), unless otherwise specified by the
Administrator. This number of copies is necessary because the Agency
plans to place copies of compliance applications in various public
dockets and the complexity of the application material will require
multiple reviewers. The phrase "unless otherwise specified by the
Administrator" is meant to allow for the possibility of alternative
requirements for submission of compliance applications in the event
that new submission methods are developed; e.g., electronic
submission requirements.
Submission of reference materials
The Agency recognizes that compliance applications will likely
include references to other sources of information. Accordingly,
today's proposal requires submission to the Administrator of ten
paper copies of any referenced material unless otherwise specified
by the Administrator. This is necessary due to the limited time
period for review and due to the needs of multiple reviewers,
including the public. Again, the phrase "unless otherwise specified
by the Administrator" signals that the Administrator may require
an alternative method for submission of reference materials if a
more appropriate system (e.g., an electronic submission system) is
developed. Regardless of what system is ultimately used,
submissions need not include referenced material from standard
textbooks (e.g., physics or chemical handbooks).
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Content of compliance certification applications
The Agency is proposing to specify information which must
be included in any compliance certification application. The
proposed criteria require descriptions of the WIPP disposal system
and surrounding environment, and the components and results of
long-term compliance assessments. The items listed, however, are
not intended to be an exhaustive identification of the necessary
elements of a complete application. Rather, the proposed criteria
identify what the Agency considers to be major elements of a complete
compliance application. Note that other major submission
requirements are discussed elsewhere in the criteria and are too
numerous to list here (such as documentation requirements for use
of expert judgment and for waste characterization).
In the future, the Agency will be issuing a detailed guide as
a supplement to the 40 CFR part 194 compliance criteria. This guide
will provide additional detailed information on the expected format
and content of a complete compliance application. The Agency is not
including such a detailed itemization in today's proposal because
EPA needs more information about factors important to the disposal
system's ability to contain waste before such detailed submission
requirements can be identified.
As an example of the type of information which may be necessary
for inclusion in a complete application, but which EPA is not
specifying in today' s proposal due to the fact that there is currently
an incomplete understanding of its effect on the disposal system,
is an analysis and identification of higher permeability marker beds
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in the host rock. (Marker beds are stratified units with distinctive
characteristics making them an easily recognized geologic horizon.)
At present, there is some information about the existence of these
marker beds in the host rock, but little knowledge about how they
may affect the transport of radionuclides and the flow of ground
water. As further study is done of these marker beds, it is possible
that they may be discovered to have a great impact on the WIPP's
ability to comply with the disposal standards of 40 CFR part 191.
It is also possible that they will be discovered to have little
or no impact. Depending on the results of further study, then, EPA
will decide whether information about the higher permeability beds
needs to be included in compliance applications and if so, how much
information. EPA solicits comment on this approach. Content of
compliance determination application(s)
As required by section 8(f) of the WIPP Land Withdrawal Act,
DOE must submit documentation of continued compliance every five
years after any initial certification is granted for the WIPP until
the end of the decommissioning phase, when all shafts and rooms at
the WIPP are backfilled and sealed. To avoid duplication of
information already submitted to the Administrator as part of any
previous compliance applications, EPA proposes to require that only
relevant new information be submitted as documentation of continued
compliance. This documentation must update the information
contained in previous applications and apprise the Agency of new
developments regarding the WIPP disposal system and its performance.
Information included in previous applications may be summarized
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and referenced.
Subpart C--Compliance Certification and Determination
Subpart C sets forth general and specific requirements for
certifying and determining compliance with the provisions of the
disposal regulations found in subparts B and C of 40 CFR part 191.
The provisions of Subpart C are discussed in detail below.
General Requirements
Inspections
Today's proposal provides for EPA inspections to help ensure
that WIPP-related activities and pertinent records described in any
compliance applications are implemented as described. Inspections,
including, random, unannounced inspections of WIPP-related
activities and records, will assist EPA in assuring the validity
of information used to support compliance applications. In
conducting such inspections, EPA will comply with applicable access
control measures for security, radiological protection and personal
safety, but shall otherwise have unfettered access to WIPP-related
activities and records.
To facilitate EPA's ability to inspect as warranted, EPA is
proposing that, upon request, the Department provide the
Administrator's inspectors with rent-free office space convenient
to the WIPP disposal system. Additionally, records shall be made
immediately available to Agency inspectors where possible, and in
no circumstances shall the furnishing of records be extended beyond
30 days from the initial request.
As an additional matter, the Agency believes that on occasion,
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EPA personnel may need to conduct sampling and analysis or monitoring
of the disposal system. Such sampling may include split sampling,
in which portions of samples taken by the DOE shall be furnished
to EPA for analysis. Through split sampling, EPA can independently
verify the results of DOE analyses. Moreover, by taking such
samples, EPA will be better equipped to evaluate the quality of data
being produced, as well as gain a better understanding of the disposal
system.
EPA proposes that its inspection privileges be broad enough
to allow the Agency to inspect activities that may provide information
used to support compliance application(s) and are deemed by the
Administrator or the Administrator's authorized representative to
be relevant to a compliance certification or determination. This
may include, but is not necessarily limited to, examination of quality
assurance procedures, waste characterization activities,
experimental programs, computer operations, and data collection
activities, insofar as all of these items may affect the WIPP's
ability to comply with the 40 CFR part 191 disposal regulations.
Significantly, under today's proposal, EPA inspections would be
limited to locations to which the Department has rights of access
but would not be limited to activities which occur at the WIPP
facility. As discussed above, if an activity can potentially affect
the WIPP's ability to comply with the Agency's disposal regulations,
it shall be subject to potential inspection by EPA personnel. For
instance, EPA may inspect WIPP-destined waste generation and storage
sites because waste characterization activities often occur at these
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sites.
Quality Assurance
To help assure that calculations of compliance with 40 CFR part
191, subparts B and C, are based upon sound data and information,
the Agency proposes to include compliance criteria addressing quality
assurance (QA). EPA is proposing that the Department implement a
QA program that meets the requirements of the American Society of
Mechanical Engineer's (ASME) "Quality Assurance Program Requirements
for Nuclear Facilities" (NQA-1-1989 Edition), ASME's "Quality
Assurance Requirements of Computer Software for Nuclear Facility
Applications" (NQA-2a-1990 addenda, part 2.7 to ASME NQA-2-1989
edition), and ASME's "Quality Assurance Program Requirements for
the Collection of Scientific and Technical Information on Site
Characterization of High-Level Nuclear Waste Repositories"
(NQA-3-1989 edition--excluding Section 2.1(b) and (c)). EPA is
proposing to use the ASME standards referenced above because it
appears they offer the most comprehensive and specific set of QA
requirements for all compliance-related elements of the disposal
system. EPA solicits comment on whether these standards are the
most appropriate to use for this purpose.
With respect to data collected prior to the implementation of
the ASME standards, EPA is proposing that such data be acceptable
for the purpose of supporting any applications for compliance
certification if it can be demonstrated to have been collected: (1)
under a QA program that is equivalent in scope and implementation
to the NQA series, or (2) through a method otherwise approved by
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the Administrator for use at the WIPP. Today's proposal does not
include any specific criteria identifying how such equivalence should
be demonstrated, nor is there any specification about what the Agency
will consider in approving QA plans. The Agency intends to issue
guidance on this topic in the future.
The Agency is proposing to allow a flexible approach on quality
assurance for data collected prior to implementation of the ASME
NQA series because the Agency recognizes that unless a method exists
for qualifying such "old data, " the efforts in collecting such "old
data" will be wasted. It is likely that a large portion of the data
submitted in support of an application for certification of
compliance will be "old data." To prohibit the inclusion of such
data if the data can be demonstrated to be of equivalent quality
to "new data," or is sufficiently reliable for approval by the
Administrator, would be unreasonable because data that are
sufficiently reliable should be included in the analysis . The Agency
solicits comment on this approach.
The ASME NQA-1-1989 edition sets forth requirements for the
"establishment and execution of quality assurance programs for the
siting, design, construction, operation, and decommissioning of
nuclear facilities."
The NQA-2(a)-1990 addenda (part 2.7) to ASME NQA-2-1989 edition
standard is directed toward establishing requirements for "the
development, procurement, maintenance, and use of computer software,
as applied to the design, construction, operation, modification,
repair, and maintenance of nuclear facilities." More specifically,
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it applies to computer software "used to produce or manipulate data
which is used directly in the design, analysis, and operation of
structures, systems, and components."
The NQA-3-1989 edition standard sets forth quality assurance
requirements for "the collection of scientific and technical
information for site characterization of high-level nuclear waste
repositories." The requirements apply to "activities which could
affect the quality of scientific and technical information collected
as part of the site characterization phase of high-level nuclear
waste repositories... [which include] as a minimum: (a) readiness
reviews; (b) peer reviews; (c) data and sample management; (d) data
collection and analysis; (e) coring; (f) sampling; (g) in situ
testing; and (h) scientific investigations."
EPA is proposing criteria which require submission of
information which demonstrates that QA programs have been established
and executed for aspects of the WIPP disposal system important to
the containment of waste in the disposal system. QA programs must
address elements such as models used to support applications for
certification of compliance, waste characterization, monitoring,
field measurements, design of the disposal system (and actions taken
to ensure compliance with design specification), use of expert
judgment, and other factors important to the containment of
radionuclides in the disposal system. EPA solicits comment on the
appropriateness of the items listed above and on any other items
which should be specifically included in such a list. The Agency
also is proposing that applications for certification of compliance
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address how quality indicators such as data accuracy, precision,
representativeness, completeness, comparability, and
reproducibility have been or will be achieved in the collection of
compliance data and information.
As a final matter, the Agency is proposing to conduct its own
examination of DOE QA programs and plans through select inspections,
management system reviews, and audits. This is to help assure that
QA plans are implemented appropriately.
Models and computer codes
Computer models are needed to assess whether the WIPP disposal
system will comply with the 40 CFR part 191 disposal regulations.
In order for these computer models to perform their functions with
acceptable accuracy, they must be based upon appropriate conceptual,
mathematical, and numerical models.
In order to ensure that the conceptual, mathematical, numerical,
and computer models used to support compliance applications are
appropriate for use in certifying whether the WIPP complies with
the disposal regulations, EPA proposes to require that detailed
information about these models be submitted to the Agency as part
of any compliance certification applications. EPA proposes to
assess the appropriateness of the models and any computer codes used
to represent them based on the following factors: whether conceptual
models reasonably represent the disposal system; whether
mathematical models incorporate equations and boundary conditions
which reasonably represent mathematical formulations of the
conceptual models; whether numerical models provide numerical
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schemes which enable mathematical models to obtain stable
solutions; whether computer models accurately implement the
numerical models (i.e., are free of coding errors and produce stable
and accurate solutions); and whether the models, data, and computer
codes have been properly peer reviewed. EPA solicits comment on
these factors and whether other factors should be included. For
instance, should EPA require information which demonstrates that
there is agreement between the model results and any measured and
observed data? Or, if it can be demonstrated that models and computer
codes are sufficiently conservative, is such demonstration
unnecessary?
In addition, EPA is proposing to require that the American
Society of Mechanical Engineer's NQA-2a-1990 addenda (part 2.7 to
ASME NQA-2-1989 edition) be used to help ensure that models and codes
are fully and clearly documented.
In order to determine whether the conceptual models used to
support a compliance certification application offer the best
representation of the disposal system, EPA is proposing to require
a complete listing and description of conceptual models considered
but not used to support such application. In addition, EPA is
proposing to require a complete listing of conceptual model(s)
considered but not used to support compliance certification
applications, a description of such model(s), and an explanation
of the reason (s) why such model (s) was/were not used. An examination
of conceptual models requires an assessment as to whether the theories
represented in conceptual models are appropriate and whether other
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theories may be more or equally appropriate. For this reason, EPA
is proposing that the DOE identify and describe all conceptual models
that the Department considered and provide justification why some
were selected and others were not. The Agency solicits comments
on this approach and on whether any particular theories should be
represented in conceptual models used to support compliance
certification applications.
EPA is proposing to require that documentation include such
items as: descriptions of the theoretical backgrounds of each model,
the method of analysis and assessment, scenario construction, data
collection procedures, and code structures and source codes. In
addition, the Agency is proposing that user's manuals be submitted
that include the following information: discussions of the limits
of applicability of each model; detailed instructions for running
the codes including hardware and software requirements; input and
output formats with detailed explanations of each input and output
variable and parameter; listings of input and output files with a
sample computer run; reports on code verification, benchmarking,
validation and quality assurance procedures. The Agency is also
proposing to require the submission of programmer's manuals and any
necessary licenses. Programmer's manuals typically include such
things as the mathematical formulations included in the model,
computational algorithms and modeling structures.
In addition, because the WIPP disposal system is very complex,
it is likely that some of its characteristics correlate to one
another. If this correlation is not reflected in modeling efforts,
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then the models may fail to portray the realities of the system and
significant errors in performance assessment results can occur.
Covariance, a measurement of the tendency of random variables to
vary together, is used to evaluate this possibility. Therefore,
EPA is proposing that information be provided which indicates whether
and how models and codes handle covariance of model input parameters.
If models do not consider covariance, EPA would expect to be provided
with an explanation of why covariance was not considered and the
potential impact of instead treating variables independently. EPA
solicits comments on this approach and on the alternatives of (1)
requiring covariance to be included in models and codes and, (2)
requiring covariance to be included unless justification can be
provided that the independent treatment of variables would cause
models to predict greater releases than if covariance is taken into
account.
Finally, EPA proposes that copies of the models and software,
data files, source codes, licenses, or other materials necessary
to run the models on EPA's own computers (or on DOE computers if
EPA computers are unable to run the models) be provided to the Agency
within 30 days of a request by the Administrator or the
Administrator's authorized representative. Additional
requirements for models are covered in the quality assurance and
peer review sections of today's proposal.
Waste Characterization
In order to make meaningful predictions about the performance
of the WIPP over long periods of time, it is necessary to have a
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good understanding of the characteristics of the waste proposed to
be emplaced in the disposal system. The potential for releasing
radionuclides from the disposal system can be directly affected by
the chemical, radiological, and physical composition of the waste.
These factors, therefore, can affect the ability of the WIPP to
comply with the 40 CFR part 191 disposal standards and, consequently,
must be examined as part of any certification or determination of
compliance.
Currently, the waste inventory to be potentially disposed of
at the WIPP consists of: 1) a large volume of stored ("existing")
waste with varying degrees of adequacy of accompanying documentation
regarding its composition and properties; and 2) an estimated larger
volume of "to-be-generated" waste about which there is uncertain
knowledge of its expected composition and properties.
For the purpose of gaining a complete understanding of the waste
proposed for disposal at the WIPP, EPA is proposing to require
submittal of a detailed description of the waste's chemical,
physical, and radiological contents including a description of the
activity in curies of each radionuclide contained in such waste .
Such description shall be used in assessing compliance with
subparts B and C of 40 CFR part 191.
To identify waste characteristics important to the containment
of waste in the disposal system, EPA is proposing that DOE undertake
a study to determine the effect of various characteristics on the
performance of the disposal system. The characteristics studied
shall include, but need not be limited to: (1) waste form; (2) free
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liquid content and liquid saturation; (3) pyrophoric and explosive
material content, and (4) characteristics affecting the
solubilization and mobilization of radionuclides, formation of
colloidal suspensions containing radionuclides, production of gas
from the waste, nuclear criticality, and generation of heat in the
disposal system. The impact of non-radioactive hazardous components
of the waste should also be assessed as such components have the
capacity to influence radionuclide transport. The results of this
study shall be provided to EPA along with documentation of the
methodology and information describing the importance of particular
characteristics of the waste. These results shall dictate the
breadth of characterization to be performed.
Once the waste characteristics that are important to the
disposal system's ability to isolate radionuclides have been
identified, the waste shall be categorized based on those
characteristics that would be expected to make all waste within a
particular category behave similarly in the disposal system. For
example, if the curie content of a given radionuclide in the waste
is determined to be important to the disposal system's ability to
contain radionuclides, it might be used as part of a system of
categorization. Waste having a high curie content of that nuclide
could comprise one category, while waste having a low curie content
of that nuclide could comprise another category. Similarly, if a
given waste form is found to be important, categories could be made
for various waste forms such as sludges and solids. EPA proposes
that a detailed description shall be provided which identifies the
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characteristics of each category of waste established.
A variety of methods for characterizing waste exists including
sampling and analysis, radioassay, and examination of waste
generation documentation and associated records (often referred to
as "process knowledge"). Today's proposal does not specify any
particular method for characterizing the waste. Nevertheless,
regardless of which method or combination of methods is selected
for waste characterization activities, the Agency is proposing to
require that each method be identified and described. Moreover,
the uncertainty associated with each method shall be identified,
and if information about the processes and materials that generated
the waste is used as a basis for waste characterization, the DOE
shall be required to substantiate such characterization.
The manner in which the Agency proposes that waste
characterization shall be accomplished is explained below. The DOE
will examine each important characteristic of the waste and determine
a value or range of values for that characteristic. Since DOE must
demonstrate that the WIPP complies with the containment, individual,
and ground-water protection requirements of 40 CFR part 191 for the
whole range of values for each waste characteristic, the larger the
range, the greater the uncertainty associated with a claim that WIPP
complies. DOE can reduce the range of values for each characteristic
through enhanced information gathering until the range is small
enough such that DOE is reasonably confident that the resulting
probability for compliance will meet the containment, individual,
and ground-water protection requirements of 40 CFR part 191. Thus,
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DOE has a great deal of flexibility in the amount of characterization
required. However, whatever value or range of values DOE selects
for each characteristic must be considered in compliance assessments
of the WIPP. In assessing compliance, DOE shall consider all
combinations of waste characteristics and the resulting impact on
the disposal system's behavior.
EPA is proposing that waste not be emplaced in the repository
unless its characteristics fall within the ranges of values for those
characteristics used in compliance assessments. To assure that only
waste whose characteristics fall within the given range of values
is emplaced, the Agency is proposing that a system of controls be
established, including measurements, sampling, and record-keeping
for the waste, such that the actual characteristics of waste will
be identified before the waste is emplaced in the WIPP. Compliance
applications shall provide an identification and description of these
controls along with an analysis of the uncertainty associated with
them.
As a final measure to assure proper waste characterization,
the Agency is proposing that EPA audits and inspections will be used
to verify the waste characterization requirements of this part.
Future state assumptions
Demonstrating compliance with 40 CFR part 191, subparts B and
C, involves the use of computer models based on conceptual models
which project, over an extended period of time, the transport of
radionuclides from the disposal system to the accessible environment
and resulting radiation doses to individual members of the public.
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Because of the long-term nature of these evaluations, uncertainty
of values for many parameters important to the analysis may be very
large. Environmental conditions and living habits of future
populations and individuals may change in significant and
unforeseeable ways over the lengthy timeframes that will be analyzed
for compliance.
In light of the difficulty of assigning appropriate values with
confidence, the Agency is proposing to specify certain assumptions
about the future for use in long-term modeling. The Agency is
proposing that, unless otherwise specified, any certification of
compliance shall assume that characteristics of the future remain
what they are today. EPA believes such an approach will enable
compliance assessment to focus on more predictable and more
significant features of disposal system performance. For instance,
EPA is proposing that such an approach not be used to characterize
the long-term geologic, hydrologic, or climatologic conditions of
the system and its vicinity.
With regard to consideration of climatic conditions, the Agency
is proposing to require predictions about climate, but within a
specified framework. Specifically, EPA is proposing to limit the
consideration of climate effects to the effects of increased and
decreased precipitation on the disposal system. This would include
predictions of temperature, which affects evapotranspiration, and
other factors.
With respect to human technology and behavior, EPA has
tentatively concluded that it would be fruitless to attempt any
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predictions about the future that would be useful over 10,000 years.
The one constant in human history is change--in social organization,
economic activity, and technology. Thus, at first glance it seems
highly anomalous to assume that future states will be like the
present. However, as noted, EPA believes that there is no reasonable
way to predict in any definitive way what changes will take place
in the future. In effect, then, EPA is proposing to employ present
conditions as default values for future states because it has no
better choices, and because this approach at least has the advantage
of providing readily ascertainable and verifiable values.
The Agency solicits comment on its approach to future states
assumptions and the Agency's treatment of geology, hydrology, and
climate considerations. Suggestions of alternatives to the proposed
approach are also solicited.
Expert judgment
EPA recognizes that expert judgment may be used to support
disposal system compliance analyses. EPA is proposing that use of
expert judgment be limited to those situations where data is not
reasonably attainable through data collection or experimentation.
To assure that the Agency is aware of all cases in which expert
judgment is used, EPA is proposing that any compliance certification
application clearly identify all instances in which such judgment
is used and the names and professional affiliations of experts
involved. Moreover, documentation shall be included which describes
the process for expert judgment elicitation, the results of expert
elicitation, and the reasoning behind those results. Documentation
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shall also be provided of interviews used to elicit judgments from
experts, deliberations and formal interactions among experts,
background information provided to experts, and the questions or
issues presented for elicitation of expert judgment. Access to this
information will help the Agency assess the quality and
appropriateness of expert judgment as well as DOE's interpretation
and use of that judgment.
Although EPA has not specified any particular methods for expert
judgment elicitation in today's proposal, the Agency does believe
that some restrictions and guidelines for the selection of
individuals for expert judgment are appropriate. The restrictions
which EPA is proposing today include prohibitions on: selecting
individuals who are members of the team of investigators requesting
the judgment or the team of investigators who will use the judgment;
selecting individuals who maintain a supervisory role or who are
supervised by (directly or indirectly) those who will utilize the
judgment; and selecting a membership of which no more than one-third
consists of individuals who are employed directly by the Department
or its contractors (unless it can be shown that this is impracticable
because of a lack or unavailability of qualified independent experts,
in which case at least one-half of the membership must be non-DOE
personnel). University professors with grants from the Department
not related to work on the WIPP and the New Mexico Environmental
Evaluation Group are not considered employees or contractors of the
Department for purposes of this part. Additionally, compliance
applications shall provide information which demonstrates that the
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expertise of any individuals involved in expert judgment is
consistent with the level of knowledge required by the question or
issue presented to that individual.
Furthermore, the Agency is requiring that at least five
individuals be used in any expert elicitation process, unless a lack
or unavailability of experts can be demonstrated. Also, any
compliance certification application shall include a discussion
explaining the relationship between the information presented, the
questions asked, the judgment of any expert panel or individual,
and the purpose for which the expert judgment is being used. The
Agency is proposing all of the above requirements to assure that
expert judgment is elicited in a manner that is as objective and
informed as possible.
As a final means of helping to assure the appropriateness of
expert judgment, EPA is proposing that the elicitation process afford
an opportunity for presentation to the experts of the scientific
and technical views of outside groups and individuals. This
provision is being proposed in today's notice because the Agency
believes it will help to provide experts involved in elicitations
with a fuller range of information and view points upon which to
base their judgments.
The Agency considered several different approaches to the use
of expert elicitation and concluded that though each was appropriate
for a specific type of situation, none were appropriate for all types
of situations. For example, one approach identified would require
that the average of all values elicited by an expert panel be used
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as the final judgment. This maybe appropriate if the issue presented
to an expert panel lends itself to meaningful averaging of values.
For instance, if an expert panel is asked to determine the rate
of rainfall in the Delaware Basin over 10,000 years, the range of
answers that would be obtained from the various experts would be
expressed in numbers that could be meaningfully averaged. However,
if an expert panel is asked to determine whether the possibility
of a meteor hitting the WIPP site is likely, the answers would be
expressed in terms of yes or no, which cannot be meaningfully
averaged. Hence, depending on the situation, this approach may not
be appropriate.
Given the above, EPA believes that it may not be useful to specify
a particular method. However, the Agency solicits comments on
alternative approaches to incorporating the results of expert
judgment elicitations into compliance assessment.
Peer review
Peer review is widely used as a means of validating technical
data, processes and assumptions. Peer review involves a group of
experts who are convened to review work conducted by their peers
to determine whether the work was performed appropriately and in
keeping with the purpose intended.
Since a large part of compliance applications will consist of
data and descriptions of methods for producing data, EPA believes
that peer review can be helpful as a means of validating the
information contained in such applications. Therefore, the Agency
proposes that peer review be used to support compliance applications.
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Specifically, EPA proposes to require peer review of any information
contained in any compliance certification application regarding the
evaluation of engineered barriers, consideration of processes and
events that may affect the disposal system's performance, quality
assurance programs and plans, models and computer codes and including
data used to support them, and waste characterization activities.
Peer review can build additional confidence in the soundness of
these important aspects of a compliance certification.
EPA proposes that peer review be conducted in a manner which
is compatible with the Nuclear Regulatory Commission's NUREG-1297
"Peer Review for High-Level Nuclear Waste Repositories," which is
incorporated by reference in today's proposal. This document
provides guidance on the definition of peer review, the acceptability
of peers, and the conduct and documentation of peer review.
Containment requirements
The Agency's disposal regulations found in 40 CFR part 191
include requirements for containment of radionuclides. These
containment requirements specify numerical requirements limiting
the cumulative release of radionuclides over 10,000 years. The
specific release limits are found in Appendix A of the disposal
regulations. The containment requirements specify that there be
less than one chance in ten of cumulative releases exceeding the
limits specified in Appendix A and less than one chance in 1,000
of cumulative releases exceeding ten times those limits.
Application of release limits.
The containment requirements of 40 CFR part 191 specify that
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releases from a disposal system to the accessible environment can
not exceed release limits set forth in Appendix A, Table 1.
Information about the curie content will be needed for calculation
of the release limits. However, because the curie content of the
waste inventory will vary over time due to natural ingrowth and decay
of radionuclides, a question arises concerning when the curie content
of the waste should be fixed for purposes of calculating the release
limits.
The EPA is proposing that the expected curie activity 100 years
after disposal of the waste in the WIPP be used in calculating
applicable release limits. The Agency is proposing this approach
because EPA believes that 100 years represents a long enough period
of time for most of the radioactive material with short half-lives
to decay to low levels. The remaining activity after the 100-year
period will largely be the result of radioactivity from waste with
long half-lives. Such waste may pose the most danger to human health
and the environment and, therefore, should be the focus of attention.
The Agency solicits comment on the appropriateness of the
above-mentioned approach and on alternative time frames for fixing
the curie content.
Scope of performance assessments
In today's notice, the Agency is proposing criteria which
indicate that performance assessments shall consider both natural
and human-initiated processes and events that may affect the disposal
system. However, EPA is also proposing that performance assessments
need not consider processes, events, or sequences of processes and
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events (sometimes referred to as "scenarios") that have less than
one chance in 10,000 of occurring over 10,000 years.
EPA is proposing the above requirements because section 13 of
40 CFR part 191 requires the implementing agencies to evaluate
compliance through performance assessments. One method of
displaying results of performance assessments required under section
13 of 40 CFR part 191 is to assemble "complementary cumulative
distribution functions" (CCDF). CCDFs are assembled by first
calculating the probability of each release scenario and associating
a consequence (e.g., release of radionuclides) with each probability.
Once the paired probability and consequence estimates are made,
they are combined into the CCDF by ranking them in the order of
decreasing consequences. The first point on the curve would
represent the large consequence of a low probability scenario. The
second point on the curve would represent the probability of the
first scenario added to the probability of a second scenario. Since
the probability of scenarios occurring is cumulative, scenarios with
probabilities lower than one chance in 1,000 must be incorporated
into probability distributions assembled under section 13 of 40 CFR
part 191 to see if the results are significant with regard to
compliance assessment.
Importantly, not all scenarios considered by the Department
will necessarily be included in calculations of compliance with the
40 CFR part 191 disposal standards. Some scenarios maybe eliminated
from incorporation into performance assessments because assumptions
will be made about such scenarios which indicate that the probability
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or consequences of such scenarios are outside of the scope of the
requirements of 40 CFR part 191. In an effort to understand which
scenarios were considered in performance assessments, EPA is
proposing that information be provided which identifies all potential
processes, events, or sequences of processes and events that may
occur during the regulatory time frame and that may affect the
disposal system, as well as information which identifies those
processes, events, or sequences of processes and events actually
included in performance assessment results.
Consideration of Human-Initiated Processes and Events
Compliance with the containment requirements of 40 CFR part
191 requires consideration of the effects of human-initiated
processes and events on the disposal system. The Agency believes
that the most productive consideration of inadvertent
human-initiated processes and events concerns those realistic
possibilities that may be usefully mitigated by disposal system
design, site selection, or use of passive institutional controls.
Therefore, the Agency is proposing that inadvertent and intermittent
drilling for resources (other than those resources provided by the
waste in the disposal system or any engineered barriers designed
to isolate such waste) be the most severe scenario for human-initiated
processes and events.
Further, the Agency is limiting the consideration of
human-initiated processes and events to drilling events because
mining events were not included in EPA's analyses that supported
the final rule of 40 CFR part 191 as promulgated in 1985.
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The Agency has chosen to divide human-initiated processes and
events into two distinct categories, "human intrusion" and "human
activity," and is proposing a separate process to establish the
drilling rate for each. "Human intrusion" includes those drilling
events that reach the level of the waste in the disposal system or
below. Such events would include, but would not be limited to,
exploration for and development of oil and natural gas resources.
The second category of human-initiated processes and events, "human
activity," includes all drilling events that may affect the disposal
system, but do not reach the level of the waste in the disposal system.
Such drilling events may include, but would not be limited to,
exploration for potash, withdrawal of water -- whether for purposes
of drinking, irrigating or controlling dust -- and drilling for other
resources. Note that a given resource may exist at levels above
and below the level of the waste in the disposal system and may
therefore be included in establishing the rates for both human
intrusion and human activity.
EPA is proposing that consideration be given to the record of
human-initiated processes and events in the Delaware Basin over the
past 50 years. The Agency believes that the 50-year time frame is
appropriate because it represents a period during which information
regarding human-initiated processes and events in the Delaware Basin
can be reasonably obtained.
Importantly, by making assumptions about the frequency of
human-initiated processes and events in the vicinity of the WIPP
and holding them constant throughout the future, scenarios in which
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such events cease because, for instance, resources eventually become
depleted would no longer be considered. However, the Agency
recognizes that as one resource becomes depleted, the decrease in
exploratory or production operations may be compensated for by the
increase in drilling operations for another. Rather than engage
in speculation about which resources will become more valuable in
the future, and which will become depleted, EPA believes it is
preferable to assume that current rates of drilling for each
individual resource will remain constant. The Agency solicits
comment on this approach.
As stated above, the Delaware Basin is being proposed as the
area for examination of the record of human-initiated processes and
events. The Delaware Basin is an elongated depression that extends
from just north of Carlsbad, New Mexico, southward into Texas. The
Agency solicits comment on how, precisely, the Delaware Basin should
be defined. The Agency believes that the Delaware Basin is an
appropriate region because the WIPP is situated within it and, as
a region, it represents the largest contiguous area which shares
similar geologic and hydrologic conditions with the WIPP site.
However, EPA solicits comments on whether a different area should
be used (such as a subset of the Delaware Basin).
It is important to note that the Agency is proposing to require
a separate examination of each type of human-initiated process and
event. The reason for this requirement is to account for the fact
that each type of drilling has a distinct rate and unique properties,
resulting in a different effect on the disposal system for each type
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of drilling. For example, oil drilling is conducted at a different
depth, rate and with a different drilling technique than water
drilling and is, therefore, more likely to penetrate the repository
than water drilling. Accordingly, the analyses for each resource
must be conducted individually.
In assessing the consequences of human-initiated processes and
events, the Agency is proposing that such processes and events be
assumed to occur at random intervals in time and space throughout
the regulatory time frame. The consequences of each human-initiated
process and event shall be calculated in terms of the projected impact
on the WIPP disposal system. If more than one human-initiated
process or event is predicted to occur, the consequences of any
processes and events which occur subsequent to initial ones shall
take into account any impacts on the disposal system from such
previous disruptions. This is done to take into account the fact
that every drilling event introduces potential changes to the
disposal system. For example, a disposal system with man-made
pathways interconnecting aquifers underlying the disposal system
with ground water above the disposal system may react differently
than a disposal system that has never been disturbed. In other words,
the cumulative consequences of all human-initiated processes and
events shall be taken into account in performance assessment results.
For the purpose of performance assessments, the Agency is
proposing different criteria for establishing the frequency of "human
intrusion" and the frequency of "human activity". While both are
based on the historical record of resource exploration over the past
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50 years in the Delaware Basin, an upper and lower limit is placed
on the rate of human intrusion. The rate of human activity, however,
is not limited to a set range.
Specifically, the rate of human intrusion is determined by first
identifying and examining past occurrences of human intrusion in
the Delaware Basin over the past 50 years for all resources.
The sum of the individual rates of human intrusion for each
resource then becomes the rate of human intrusion to be used in
performance assessments, provided that the sum is not less than 25
and not greater than 62.5 boreholes per square kilometer per 10,000
years. In the event that the calculated total rate is less than
25, then the rate of human intrusion to be used in performance
assessments should be adjusted upward proportionally to yield a total
rate of 25 boreholes per square kilometer per 10,000 years. Thus,
if the oil drilling rate is 8 and the natural gas drilling rate is
2, both values are adjusted upward by a factor of 2.5 to yield a
rate of 20 for oil and 5 for natural gas. Likewise, if the calculated
total rate exceeds 62 .5, then the rate of each type of human intrusion
should be adjusted downward proportionally to yield a maximum rate
of 62.5 boreholes per square kilometer per 10,000 years to be used
in performance assessments.
By placing an upper and lower limit on the rate of human
intrusion, the Agency is adhering to the assumptions that the Agency
made in developing the technical basis used for formulating the
containment requirements of the final disposal regulations as
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promulgated in 1985. As part of the development of the disposal
regulations, the Agency estimated the range of future human intrusion
and human activity for the general case of a repository in bedded
salt, the geologic setting of the WIPP. Assumptions were made about
the presence near a repository of different types of resources --
including oil, gas, minerals and water -- though it was assumed that
the most significant resources present would be oil and gas. Using
drilling data from the contiguous 48 states as a rough guide, the
Agency estimated that a region of bedded salt would experience 25
to 62.5 boreholes per square kilometer per 10,000 years. Because
the depths at which oil and gas, the only significant resources
assumed to be present, are located typically exceed 10,000 feet the
estimated range applies only to the rate of human intrusion. Thus,
by proposing a human intrusion range of 25 to 62.5 boreholes per
square kilometer per 10,000 years, the Agency is grounding the
criteria on the same basis as 40 CFR part 191. Discussion of the
assumptions as developed for the 1985 final rule of 40 CFR part 191
can be found in "Technical Support of Standards for High-Level
Radioactive Waste Management, Volume D" (EPA 520/4-79-007D) and
"Addendum to Volumes C and D" (EPA 520/4-79-007E).
The Agency is proposing that, should the Department wish to
forego the process of analyzing the historical rates of human
intrusion events in the Delaware Basin, the Department shall assume
the maximum rate of 62.5 boreholes per square kilometer per 10,000
years. The Agency is further proposing that the rate of human
intrusion may be reduced in accordance with the criteria found in
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§194.41, active institutional controls, and §194.43(c), passive
institutional controls. A complete discussion of reduction of the
human intrusion rate can be found in the discussion of those two
portions of the criteria.
For consideration of "human activity" in performance
assessments, the Agency is proposing that the historical record of
drilling be examined, but without placing pre-set limits on the rates .
Specifically, the rate of human activity is determined by first
identifying and examining past occurrences of human activity in the
Delaware Basin over the past 50 years for all resources. The sum
of the individual rates for each resource then becomes the rate of
human activity to be used in performance assessment.
The Agency is placing no limits on the rate of human activity,
in contrast to the treatment of the rate of human intrusion. This
divergent treatment is consistent with the final rule of 40 CFR part
191, which was based on an estimate of 25 to 62.5 boreholes per square
kilometer per 10,000 years for the general case of a repository in
bedded salt in the vicinity of few resources other than oil and natural
gas. Because the depths at which oil and natural gas reserves are
located typically exceed 10,000 feet, the estimated range of 25 to
62.5 boreholes per square kilometer per 10,000 years applies to the
case of human intrusion only. Hence, no limit, upper or lower, is
placed on the rate of human activity.
The Agency recognizes that for some resources such as water,
the use of that resource may depend upon the quality of the specific
reservoir of that resource that is being exploited. A given
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reservoir of water, for example, may not be of potable quality but
may still be usefully withdrawn for controlling dust. Therefore it
may be possible to show that certain resources found within the
controlled area differ in quality from the same resource as found
in rest of the Delaware Basin. For such resources, it could
potentially be demonstrated that the resource would normally be
exploited for different purposes at a different rate within the
controlled area, and further that there is reason to believe that
such practices would continue. The Agency is proposing that if such
a case can be made in compliance applications, then when examining
the historical record of human activity associated with that
resource, only that human activity that has been associated with
resources of quality similar to that found within the controlled
area need be considered. Consider a hypothetical example in which
the water resources in the controlled area were found not to be of
potable quality, and this were demonstrated and documented in the
application for certification of compliance. Then, when examining
the history of drilling for water in the Delaware Basin, the
Department would need only consider boreholes created for water uses
other than drinking, e.g., irrigation and control of dust.
The Agency is further proposing that the rate of human activity
may be reduced in accordance with the criteria found in §194.41,
active institutional controls, and in §194.43(c), passive
institutional controls. A complete discussion of reduction of the
human activity rate can be found under the discussion of those two
portions of the criteria.
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In assessing the consequences of human-initiated processes and
events, the Agency is proposing that assumptions pertaining to
characteristics of such processes and events be based on
characteristics associated with current practice in the Delaware
Basin. This approach is consistent with the approach the Agency
is proposing for future state assumptions. For example, assumptions
related to the type and amount of any drilling fluids, borehole
depths, diameters, and seals should be assumed to remain consistent
with the current practice in the Delaware Basin. For the specific
case of borehole seals, EPA is further proposing that boreholes shall
be assumed to be sealed at the rate boreholes have been sealed over
the past 50 years in the Delaware Basin and that natural processes
will degrade or otherwise affect the permeability of boreholes over
the regulatory time frame.
The Agency has chosen in today's proposal to differ from the
Appendix C "Guidance for Implementation" which accompanied 40 CFR
Part 191 because EPA believes that the approach outlined above for
assessing the likelihood and consequences of human-initiated
processes and events is more appropriate for the WIPP than the method
discussed in the guidance. Today's proposal is specific to the WIPP;
the guidance, on the other hand, is generic. Moreover, the guidance
only took into account drilling frequencies for oil and gas. The
Agency believes that other human activities, such as drilling for
potash and drilling for water, are equally important for
consideration at the WIPP, as they too have the potential to affect
the disposal system. Therefore, today's proposal requires
consideration of all human actions that could affect a waste disposal
system. However, the Agency solicits comment on its proposed
approach and the appropriateness of differing from the Appendix C
guidance.
Results of Performance Assessments
The Agency proposes to establish criteria for assessing the
results of performance assessments required under the containment
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requirements of 40 CFR part 191. The Agency is proposing to require
that the results of performance assessments be displayed as
complementary cumulative distribution functions or "CCDFs." These
CCDFs would display the releases of radionuclides over 10,000 years
after disposal--summed and normalized according to Table 1, Note
6 of 40 CFR part 191--on the horizontal axis and the probability
of releases occurring on the vertical axis.
In conducting performance assessments, there will be many
parameter values that can affect the results of such assessments.
For instance, gas generation by the waste, radionuclide
solubilities, permeability of the host rock, and the porosity and
transmissivity of surrounding aquifers entail parameter values that
can affect the results of such performance assessments . These values
may be difficult to quantify particularly over a 10,000-year period.
Therefore, the Agency is proposing to require the development of
probability distributions for parameter values in order to represent
the probability of different values of the parameter occurring.
The Agency is further proposing to require that, in generating
CCDFs, computational techniques be developed that sample randomly
across the full range of probability distributions developed for
uncertain disposal system parameter values used in performance
assessments. In so doing, it is possible to convey the influence
of parameter uncertainty upon the resulting CCDFs. Random sampling
techniques can select a predetermined number of values from a
parameter's probability distribution, the collection of which will
represent the range of the distribution in successive stages of
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calculation.
The Agency is proposing to require that the entire range or
"family" of CCDFs generated as a result of these sampling techniques
be included in compliance applications. By requiring that all CCDFs
be submitted, the Agency can evaluate whether given the conditions
that exist at the disposal system, the disposal system could fail
to comply with section 13 of 40 CFR part 191 in some of the CCDFs.
By noting the number of total CCDFs generated that fail to comply,
the Agency will gain insight into the performance of the disposal
system over the 10,000-year time frame.
The Agency is proposing to place statistical criteria on the
number of CCDFs generated. The Agency is proposing to require that
the number of CCDFs generated be large enough such that the maximum
CCDF generated exceeds the 99th percentile of the population of CCDFs
with at least a 0.95 probability. A 95% confidence level is commonly
recognized as being a good indicator of statistical acceptability.
The Agency believes that the effect of this approach will be that
the number of CCDFs generated will be large enough to ensure that
a full range of realizations have been generated. EPA estimates
that this will require several hundred realizations, although the
number submitted in compliance with this requirement may ultimately
be larger or smaller.
The Agency is proposing to require that the mean CCDF of the
population of CCDFs meets the requirements of section 13(a) of 40
CFR part 191 with at least a 95 percent level of statistical
confidence. The mean CCDF is calculated from a "family" of CCDFs
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whose parameters have an associated uncertainty to them, as discussed
above. As a result, the mean will have its own associated
uncertainty. This uncertainty around the location of the mean
reduces the level of assurance with which we can state that the mean
CCDF is in compliance with section 13 of 40 CFR part 191. One way
of attaining statistical confidence in the mean is to determine how
reproducible the mean is if recalculated. For example, first
generate an ensemble of a certain number of CCDFs and calculate the
mean. Next, generate an entirely new ensemble of the same number
of CCDFs and compare the mean calculated for this new set to that
of the first set. If the number of CCDFs generated is a statistically
representative portion of the infinite population of CCDFs, then
the two calculated means will likely agree. By placing a statistical
confidence requirement on the mean of the CCDFs, the Agency hopes
to ensure that a mean that is in compliance would upon recalculation
from a new ensemble of CCDFs, still be in compliance. The Agency
is proposing to require a 95 percent level of statistical confidence
that the mean meets the requirements but solicits comment on other
levels of confidence which may be more appropriate.
Before selecting the mean as the compliance indicator, the
Agency examined three options. The first option, the mean CCDF or
expected value, was selected because of its ability to convey a sense
of the whole ensemble of CCDFs generated. In calculating the mean,
all CCDFs--those representing best case results, those representing
worst case results, and everything in between--are included. Since
it cannot be known which CCDF represents actual performance over
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the 10,000 year regulatory period, it is deemed wise to include the
influence of all generated CCDFs.
The Agency also examined the median CCDF. The median CCDF would
be indicative of the central tendency of the majority of the CCDFs
and would not exhibit the influence of high or low consequence CCDFs
as strongly as the mean CCDF. Specifically, the influence of high
consequence CCDFs that do not meet the requirements of section 13 (a)
of 40 CFR part 191 would be discounted by the median. In the Agency' s
view, this makes the median CCDF less suitable as a compliance
indicator.
The Agency also examined the possibility of using a percentile
value as a compliance indicator. The Agency has considered and
rejected percentile values at or below 50 on grounds that such values
would not provide adequate confidence of achieving the desired
protection of public health. As for higher values, the Agency
believes that it would be extremely difficult to justify any specific
higher value.
The Agency solicits comment on the appropriateness of the mean
or some other CCDF as a basis for compliance. The Agency solicits
comments on using some possible combination of CCDFs as a basis for
compliance; e.g., requiring that the mean and the median meet the
requirements of section 13(a) of 40 CFR part 191.
Another issue upon which the Agency solicits comment is on the
alternative of basing compliance on one single realization, rather
than on a multitude of them as discussed above and then using that
realization to determine compliance with the containment
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requirements. Instead of sampling from a given range of variables
for each parameter and generating a new realization curve each time
this is done, it has been suggested that all possible values for
each parameter should be selected in creating a single curve. In
this way, all the information is folded into one realization which
either complies or does not. The advantage in this technique is
that the issue of the appropriateness of the mean, median, or other
percentile is obviated. The disadvantage is that it is difficult
to see exactly which parameters caused the curve to behave in a
particular way.
Regardless of the method ultimately used to determine compliance
with the numerical requirements of section 13 of 40 CFR part 191,
a "reasonable expectation of compliance" with the containment
requirements cannot be achieved until a demonstration has been made
that the qualitative requirements set forth in sections 21 through
27 of today' s proposal have also been met. A "reasonable expectation
of compliance" with the containment requirements shall not be based
solely upon a statistical estimate of radionuclide releases to the
accessible environment. Instead, the Agency will consider the full
record of information submitted in compliance applications and will
examine the methods and assumptions which were used to support the
development of radionuclide release estimates. For example, the
EPA will consider such factors as the reasonableness of the processes
and events incorporated into performance assessments, the
appropriateness of any expert elicitation used to provide input to
models, the adequacy of peer review, and the quality of other data
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inputs. Only after a demonstration has been made that all of the
requirements set forth in sections 21 through 27 of today's proposal
have been met and that the numerical requirements of section 13 of
40 CFR part 191 have been satisfied, will a "reasonable expectation"
of compliance with the containment requirements be achieved.
Assurance requirements
In addition to the numerical requirements set forth in the
Agency's radioactive waste disposal standards, section 14 of the
standards contains a set of qualitative requirements to help assure
that the desired level of protection is achieved. These assurance
requirements address: 1) active institutional controls; 2)
monitoring; 3) passive institutional controls; 4) engineered
barriers; 5) consideration of the presence of resources; and 6)
removal of waste.
Active institutional controls
According to the disposal standards:
Active institutional controls over disposal sites should
be maintained for as long a period of time as is practicable
after disposal; however, performance assessments that
assess the isolation of the wastes from the accessible
environment shall not consider any contributions from
active institutional controls for more than 100 years after
disposal.
As defined in 40 CFR part 191, "active institutional control"
means: " (1) controlling access to a disposal site by any means other
than passive institutional controls; (2) performing maintenance
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operations or remedial actions at a site; (3) controlling or cleaning
up releases from a site; or (4) monitoring parameters related to
disposal system performance." With the above requirements in
mind, today's proposal requires that any application for
certification of compliance contain detailed descriptions of
proposed active institutional controls, their location and the period
of time they are proposed to remain active. Any credit assumed for
reduced human activity in the vicinity of the WIPP or reduced releases
of radionuclides must be supported by such descriptions but, as
indicated in the disposal standards, in no case shall it be assumed
that active institutional controls will be effective in preventing
or reducing releases beyond 100 years after disposal.
Monitoring
Since the predictions associated with long-term compliance with
the disposal standards of 40 CFR part 191 are inherently uncertain,
final disposal standards issued in 1985 included a provision
requiring monitoring of disposal systems to help assure that they
are performing as predicted. The proposed disposal standards issued
in 1982 had not included such a requirement. However, several
commenters (including most of the States) urged addition of a
requirement for long-term monitoring of a repository after disposal
to guard against unexpected failures. Accordingly, further
information was sought on this idea. The Agency surveyed the
capabilities and expectations of long-term monitoring approaches.
As explained in the preamble to the 1985 disposal standards (50
FR 38081, September 19, 1985):
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Evaluating this information led the Agency to several
conclusions:
(1) Perhaps most importantly, the techniques used for monitoring
after disposal must not jeopardize the long-term isolation
capabilities of the disposal system. Furthermore, plans to
conduct monitoring after disposal should never become an excuse
to relax the care with which systems to isolate these wastes
must be selected, designed, constructed, and operated.
(2) Monitoring for radionuclide releases to the accessible
environment is not likely to be productive. Even a poorly
performing geologic repository is very unlikely to allow
measurable releases to the accessible environment for several
hundreds of years or more, particularly in view of the engineered
controls needed to comply with 10 CFR Part 60. A monitoring
system based only on detecting radionuclide releases--a system
which would almost certainly not be detecting anything for
several times the history of the United States--is not likely
to be maintained for long enough to be of much use.
(3) Within the above constraints, however, there are likely
to be monitoring approaches which may, in a relatively
short time, significantly improve confidence that a
repository is performing as intended. Two examples are
of particular interest. One involves the concept of
monitoring ground-water sources at a variety of distances
for benign tracers intentionally released to the ground
water in the repository; this approach can evaluate the
delay involved in ground-water movement from the
repository to the environment and can serve to validate
expectations of the performance expected from the system' s
natural barriers. Another concept involves monitoring
the small uplift of the land surface over the repository
in order to validate predictions of the system's thermal
behavior. Both of these approaches can be carried out
without enhancing pathways for the wastes to escape from
the repository.
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Based on these conclusions and the public comments on this question,
the Agency included a provision (in the assurance requirements of
the final disposal standards) for long-term monitoring after
disposal: "Disposal systems shall be monitored after disposal to
detect substantial and detrimental deviations from expected
performance. This monitoring shall be done with techniques that
do not jeopardize the isolation of the wastes and shall be conducted
until there are no significant concerns to be addressed by further
monitoring."
Accordingly, EPA is proposing criteria for complying with the
monitoring requirements in the disposal standards. EPA is proposing
that monitoring programs be designed to detect the movement of
radionuclides toward the accessible environment at the earliest
practicable time. Such monitoring programs shall be consistent with
monitoring required under applicable federal hazardous waste
regulations and shall be done with techniques that do not jeopardize
the containment of waste in the disposal system. Due to the long-term
nature of the potential hazard associated with disposal of
transuranic radioactive waste, any unpredicted detection of movement
of radionuclides away from the disposal system and toward the
accessible environment would be cause for concern that an exceedance
of what is permitted under the disposal regulations is likely to
occur. If releases are detected early enough, remedial action can
be implemented before radionuclides reach the accessible
environment.
EPA is proposing in today's criteria that any compliance
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certification application include a detailed plan for monitoring
the performance of the WIPP after disposal. At a minimum, this plan
shall: identify parameters that will be monitored and how baseline
states will be determined; indicate how each parameter will be used
to evaluate the performance of the disposal system; and discuss the
length of time over which each parameter will be monitored to detect
deviations from expected performance.
Radionuclide monitoring programs should be consistent with
applicable federal hazardous waste monitoring programs in order to
minimize duplication of monitoring efforts. The Agency solicits
comments on this approach.
In addition to monitoring after closure of the disposal system
(i.e., when all of the shafts to the repository are backfilled and
sealed), EPA proposes that, to the extent practicable, pre-closure
monitoring of parameters which may affect the long-term performance
of the disposal system after closure shall also be conducted. The
Agency believes that such monitoring can provide important
information about the disposal system and that such information can
contribute to a better understanding of how the disposal system is
likely to perform after closure. Furthermore, such information can
be used to verify assumptions (about the disposal system) which form
the basis of a compliance assessment.
The Agency is proposing to require that, as a part of the
pre-closure monitoring plan for the WIPP, monitoring of parameters
which can affect the containment of waste in the disposal system
shall be conducted to the extent practicable. The Agency
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believes that the following parameters can affect the containment
capability of the WIPP: brine quantity, flux, composition, and
spatial distribution; gas quantity and composition; and temperature
distribution. Since there may be additional disposal system
parameters important to the containment of waste, EPA is proposing
that DOE undertake a study to determine the effect of various disposal
system parameters on the performance of the disposal system. Such
study shall consider whether a disposal system parameter should be
monitored because the parameter either provides information
regarding the disposal system' s ability to contain waste or regarding
the ability to predict the future performance of the disposal system.
The parameters studied shall include, but need not be limited to:
backfilled mechanical state including porosity, permeability, and
degree of compaction and reconsolidation; extent of deformation of
the surrounding roof, walls, and floor of the disposal room; and
initiation or displacement of major brittle deformation features
in the roof or surrounding rock. The results of the study shall
be provided to EPA along with documentation of the methodology and
information describing the importance of each disposal system
parameter studied. The results of such study shall dictate the
breadth of monitoring of disposal system parameters.
The parameters specifically mentioned above and in the
proposed criteria were identified as important to the containment
capability of the WIPP by the Agency in its comments to the Department
(dated October 19, 1989) regarding the Test Phase Plan for the WIPP.
In those comments, EPA recommended that the Department implement
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monitoring systems in disposal rooms that would be "indicative of
waste system performance" (Recommendation 7) . In response to EPA's
comments, the DOE agreed to conduct a feasibility study on underground
monitoring of the WIPP.
EPA solicits comment on whether monitoring should be required
for the specific parameters listed above, on whether additional or
other parameters should be specified, and on the feasibility of
continuing such monitoring after disposal (i.e., after the repository
has been backfilled and sealed) . Additionally, the Agency solicits
comment on whether EPA should require the use of specific monitoring
methods.
Passive institutional controls
The assurance requirements of 40 CFR part 191 require that
"disposal systems shall be designated by the most permanent markers,
records, and other passive institutional controls practicable to
indicate the dangers of the wastes and their location." Section
14 (c) of 40 CFR part 191. The standards define "passive
institutional controls" as "(1) permanent markers placed at a
disposal site, (2) public records and archives, (3) government
ownership and regulations regarding land or resource use, and (4)
other methods of preserving knowledge about the location, design
and contents of a disposal system."
In light of the requirement for use of passive institutional
controls set forth in 40 CFR part 191, the Agency is proposing that
any application for certification of compliance include detailed
descriptions of the measures that will be employed to preserve
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knowledge about the location, design, and contents of the disposal
system. At a minimum, it is proposed that such measures will include:
(1) identification of the controlled area by markers that have been
designed, fabricated and emplaced to be as permanent as practicable;
and (2) placement of records in the archives and land record systems
of local, state, and federal government agencies, and international
archives, that would be likely to be consulted by individuals in
search of unexploited resources.
The Agency proposes that the type of information contained in
records shall include: the location of the controlled area and the
disposal system; the design of the disposal system; the nature and
hazard of the waste; geologic, geochemical, hydrologic, other site
date pertinent to the containment of waste in the disposal system,
and the results of tests, experiments, and other analyses relating
to backfill of excavated areas, shaft sealing, waste interaction
with the disposal system, and any other tests, experiments, or
analyses pertinent to the containment of waste in the disposal system.
EPA solicits comments on the appropriateness of this list and on
whether additional or other items should be specified. Any
application for certification of compliance shall include detailed
descriptions of the proposed controls as well as information
regarding the period of time those controls are expected to endure
and be understood.
A question arises with regard to the extent to which the Agency
should allow performance assessments to consider contributions from
passive institutional controls in reducing the likelihood of
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human-initiated processes and events that may affect the disposal
system. While the disposal regulations address contributions from
active institutional controls (see above discussion of active
institutional controls), they do not specifically address
contributions from passive institutional controls. The Agency may
be willing to consider such contributions if a persuasive case can
be made that the passive institutional controls can be expected to
endure and act as a deterrent to potential intruders . In no instance,
however, will passive institutional controls be assumed to eliminate
the likelihood of human-initiated processes and events entirely.
Furthermore, contributions from passive institutional controls may
vary over time. For example, the effectiveness of passive
institutional controls may decrease over the regulatory time frame.
The Agency solicits comment on the extent--if any--to which
contributions from passive institutional controls should be
considered in performance assessments.
Because of the uncertainty concerning the effectiveness of
passive institutional controls in terms of influencing human
activity, EPA must carefully scrutinize information about such
controls. The Agency has considered the fact that markers exist
in the world today that are thousands of years old. This would tend
to support the view that passive institutional controls can survive
for very long periods of time. Nevertheless, it is possible that
markers have been created in the past and were destroyed or
disintegrated. The actual percentage of surviving markers is thus
unknown. It could be very small, meaning that an unrealistically
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large number of markers would have to be placed at the WIPP in order
to assure survival. Further uncertainty in the effectiveness of
markers derives from the possibility that even if markers survive,
it does not mean they will necessarily be understood by future
generations.
Institutional controls have been known to fail. The New Mexico
Environmental Evaluation Group (EEC) has documented instances in
the recent past where institutional controls have failed at the WIPP.
According to EEC, both the DOE and the Department of the Interior's
Bureau of Land Management "failed to implement the procedures
described by the DOE as crucial to protecting the site from
inadvertent human intrusion in twenty-two of the twenty-five
applications to drill oil and gas wells filed while a Memorandum
of Understanding was legally binding and the WIPP facility was in
a state of full readiness to receive waste." (EEC letter to EPA
dated February 23, 1994) . This indicates that even today, and even
with governmental entities responsible for implementation of
controls, such controls are not, necessarily, reliable. The unknown
nature of future societies and governmental institutions compounds
the uncertainty.
Engineered barriers
The assurance requirements of 40 CFR part 191 require that
disposal systems "use different types of barriers to isolate the
wastes from the accessible environment." Additionally, the disposal
standards mandate that "Both engineered and natural barriers shall
be used. " 40 CFR part 191 defines the term "barrier" as "any material
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or structure that prevents or substantially delays movement of water
or radionuclides toward the accessible environment. For example,
a barrier may be a geologic structure, a canister, a waste form with
physical and chemical characteristics that significantly decrease
the mobility of radionuclides, or a material placed over and around
waste, provided that the material or structure substantially delays
movement of water or radionuclides."
If selected and designed properly, engineered barriers can
significantly reduce the potential for waste migration away from
the disposal system. They can be an effective mechanism for
improving the performance of the WIPP and for reducing the uncertainty
inherent in long-term projections about the ability of the disposal
system to comply with the quantitative requirements of 40 CFR part
191.
While the disposal standards require use of engineered barriers,
they do not specify how many or what kinds of engineered barriers
must be used. The Agency is, therefore, proposing criteria for
selecting engineered barriers.
In today's notice, EPA is proposing that DOE complete a study
of engineered barrier alternatives and their benefits and costs.
The results of such study shall be used to justify both the selection
and rejection of engineered barriers at the WIPP. Moreover, the
study shall be peer reviewed. For example, EPA believes that the
National Academy of Sciences may be able to provide an appropriate
forum for peer review of the study envisioned in today's proposed
criteria. The Agency believes that the credibility of the study
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of engineered barrier alternatives and resulting selection of
engineered barriers for the WIPP disposal system is critically
important.
The specific engineered barriers proposed to be evaluated
include, but are 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. These specific
engineered barriers were selected by the Agency because they have
already begun to be considered by DOE' s Engineered Alternatives Task
Force (EATF) (see July, 1991 EATF Report on Engineered Alternatives
for the WIPP, DOE/WIPP 91-007) and appear to represent potentially
promising alternatives. EPA solicits comment on the appropriateness
of specifying the above-mentioned engineered barriers as the subject
of the study and on whether alternative barriers should be specified.
The Agency is proposing that the following factors be considered
in benefit/cost analysis of the above-mentioned engineered barriers:
the ability of the engineered barrier to prevent or substantially
delay the movement of water or radionuclides toward the accessible
environment; the impact on worker exposures to radiation (at the
WIPP and off-site) both during and after incorporation of engineered
barriers; the increased ease or difficulty in removing the waste
from the disposal system; the increased or reduced risk of
transporting the waste to the disposal system; the increased or
reduced uncertainty in compliance assessment; the increased or
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reduced public confidence in the performance of the disposal system;
the increased or reduced total system costs; the impact, if any,
on other waste disposal programs from the incorporation of engineered
barriers; and the effect on mitigating the consequences of
human-initiated processes and events.
It would be inappropriate to limit the study only to the impact
of engineered barriers on the performance of the WIPP. If this were
done, the possibility would exist that an engineered barrier may
be selected, for example, which marginally improves the disposal
system's performance, yet results in much higher environmental risks
at treatment sites. This increase in risk would contravene the
Agency's objective of protecting human health and the environment.
EPA solicits comment on this approach to selecting engineered
barriers and on whether an alternative list of factors should be
specified for consideration.
The Agency proposes that the benefit/cost study described above
include separate analyses for different categories of waste
potentially destined for disposal at the WIPP. The Agency believes
that benefits and costs of engineered barriers can differ depending
on whether they are applied to existing waste that is already
packaged, existing waste that is not yet packaged or is in need of
re-packaging, or to-be-generated waste. Therefore, the Agency is
proposing that these different categories of waste be analyzed
separately.
Finally, EPA is proposing that engineered barrier alternatives
be considered both alone and in combination. In this way, assurance
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can be had that the full range of alternative applications of
engineered barrier systems has been considered.
Importantly, today's proposal requires the results of the
benefit/cost study to be included in any compliance application and
for the results to be used to justify the selection or rejection
of any engineered barrier. This will help the Agency understand
why particular barriers were selected while others were not, as well
as help the Agency to evaluate the appropriateness of such selections .
The Agency solicits comments on other potential approaches to
the treatment of engineered barriers in the WIPP compliance criteria.
In particular, the Agency is interested in receiving comment on
the option of specifying a performance standard for engineered
barriers similar to that specified by the Nuclear Regulatory
Commission in 10 CFR part 60 regulations for disposal of high-level
radioactive waste. Under this approach, a maximum radionuclide
release rate would be established for the engineered barrier system.
Engineered barriers selected for the disposal system would have
to contain radionuclide releases within the established rate.
Consideration of the presence of resources
Section 14 of 40 CFR part 191 includes the following requirement:
"Places where there has been mining for resources, or where there
is a reasonable expectation of exploration for scarce or easily
accessible resources, or where there is a significant concentration
of any material that is not widely available from other sources,
should be avoided in selecting disposal sites. Resources to be
considered shall include minerals, petroleum or natural gas, valuable
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geologic formations, and ground waters that are either irreplaceable
because there is no alternative source of drinking water available
for substantial populations or that are vital to the preservation
of unique and sensitive ecosystems. Such places shall not be used
for disposal of the wastes covered by this part unless the favorable
characteristics of such places compensate for their greater
likelihood of being disturbed in the future."
EPA is proposing that any application for certification of
compliance shall include information which demonstrates that the
favorable characteristics of the WIPP compensate for the presence
of resources and the likelihood of human-initiated processes and
events as a result of the presence of those resources. If, after
full consideration of the potential effects of resource recovery
activities the WIPP is still predicted to meet the requirements of
40 CFR part 191, then the Agency will assume that the requirements
of this part and section 14 (e) of 40 CFR part 191 have been fulfilled.
The Agency solicits comment on this approach.
Removal of waste
Another assurance requirement included in the 40 CFR part 191
disposal standards involves the removal of waste from the disposal
system. Specifically, 40 CFR part 191 mandates that: "Disposal
systems shall be selected so that removal of most of the wastes is
not precluded for a reasonable period of time after disposal." In
order to address this requirement, EPA is proposing criteria to
require a plan for removing waste from the disposal system using
the best technology available at the time of application.
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Individual and Ground-Water Protection Requirements
The Agency incorporated requirements in 40 CFR part 191 for
the protection of individuals and ground-water. The individual
protection requirements of 40 CFR part 191 limit annual committed
effective doses of radiation to members of the public to no more
than 15 millirem. The ground-water protection requirements limit
releases to ground water to no more than the limits set by the maximum
contaminant level for radionuclides (MCL) established in 40 CFR part
141 under section 1412 of the Safe Drinking Water Act (SDWA), 42
U.S.C. 300g-l. Both of these requirements are concerned with human
exposure to radionuclides from disposal systems and, like the
containment requirements of 40 CFR part 191, both limit such exposure
for 10,000 years.
The proposed criteria address the following issues: the
definition of a protected individual, the consideration of exposure
pathways, the consideration of underground sources of drinking water,
the scope of compliance assessments, and the basis for a determination
of compliance with these requirements (results of compliance
assessments).
With regard to identifying protected individuals, the Agency
is proposing to require that assessments regarding individual
exposures to radiation from the disposal system be based upon the
assumption that individuals reside at the point on the surface of
the accessible environment where they would be expected to receive
the highest exposure from radionuclide releases from the disposal
system. This helps ensure that the individual most likely to receive
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the highest exposure from the disposal system is accounted for and
protected.
In assessing individual doses, the Agency proposes to require
consideration of all potential pathways (associated with undisturbed
performance) for radionuclide transport. The pathways which need
to be considered include land-surface pathways (including direct
radiation exposure), surface or ground-water pathways, and air
pathways, as well as combinations of the above. Furthermore,
consistent with the Agency's approach under the Safe Drinking Water
Act (42 U.S.C.A. sections 300 (f) to 300J-26), it should be assumed
that individuals consume two liters of water per day from any
underground source of drinking water in the accessible environment.
EPA is proposing today that any underground sources of drinking
water in the accessible environment which are likely to be affected
by the disposal system over 10,000 years be considered in WIPP
compliance applications. Such consideration should include an
analysis of the interconnection and commingling of bodies of ground
water with underground sources of drinking water, as well as
ground-water flow rates and direction.
According to 40 CFR part 191, calculations of compliance with
the individual and ground-water protection requirements must
consider the undisturbed performance of the disposal system. 40
CFR part 191 defines "undisturbed performance" as: "the predicted
behavior of a disposal system, including consideration of the
uncertainties in predicted behavior, if the disposal system is not
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disrupted by human-intrusion or the occurrence of unlikely natural
events." The Agency solicits comment on whether there is a need
for further clarification of the analysis of undisturbed performance,
e.g.; is there a need to identify what constitutes an "unlikely"
natural event or what probability of occurrence renders an event
"likely" or "unlikely?".
EPA is proposing that any application for certification of
compliance shall include information which identifies the processes,
events, or sequences of processes and events considered in compliance
analyses. Moreover, EPA is proposing that documentation be provided
which justifies the inclusion/non-inclusion of particular processes,
events, or sequences of processes and events in compliance assessment
results.
Once the processes, events, or sequences of processes and events
have been identified, they shall be incorporated into compliance
assessments of the disposal system. The disposal standards require
compliance assessments to include consideration of the uncertainties
associated with the undisturbed performance of the disposal system.
To do this, it is necessary to identify all disposal system
parameters that can affect the performance of the WIPP, as well as
to identify the uncertainty associated with each parameter.
When the disposal system parameters and their accompanying
uncertainty have been identified, EPA is proposing that probability
distributions be developed for each such parameter. A probability
distribution is a function which assigns a probability of occurrence
to each value for a given parameter.
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The Agency is proposing that, in compiling compliance assessment
results, computational techniques be used which draw random samples
from across the full range of probability distributions for parameter
values used in compliance assessments. This will help assure that
all possible values of a parameter have been considered in compiling
compliance assessment results.
EPA is proposing that the range of estimated radiation doses
to individuals (as generated through use of the computational
techniques referred to above), and the range of estimated
radionuclide concentrations in ground water must be large enough
such that the maximum estimate generated exceeds the 99th percentile
of the population of estimates with at least a 95% probability.
The "population of estimates" refers to the set of all possible
estimates that can be generated from all disposal system parameter
values used in compliance assessments . A single estimate, in effect,
samples this population. This is similar to the requirement for
the number of CCDFs which must be generated for purposes of compliance
with the containment requirements. The Agency is proposing to
include this provision for the purpose of ensuring that there is
a 95% probability that 99% of all possible values have been exceeded
by the maximum estimate generated.
In order to assure that all pertinent information is provided
to the Agency, EPA is proposing to require that compliance
applications display the full range of estimated radiation doses
and the full range of estimated radionuclide concentrations.
Finally, the Agency is proposing to require that any compliance
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certification application provide information which demonstrates
that there is at least a 95% level of statistical confidence that
the mean and the median of the full range of estimated radiation
doses and of the full range of estimated radionuclide concentrations
meet the requirements set forth in sections 15 and 16 of 40 CFR part
191. The mean estimate provides a measure of compliance that
expresses the average impacts of the disposal system on individuals
and ground water as well as the probabilities of uncertain disposal
system parameter values. The median estimate provides a measure
of compliance that expresses the central tendency of a population
of estimates. Specifically, the median represents the point that
a calculated estimate would be equally likely to fall above or below.
Insofar as both statistics contain useful information, the Agency
is proposing an approach that assures that both meet the limits of
the individual and ground-water protection requirements.
The Agency solicits comments on the above approach for
evaluating the results of compliance assessment.
Subpart D--Public Participation
The Agency intends to involve the public throughout the Agency' s
regulatory oversight at the WIPP. Accordingly, today's proposal
contains a set of criteria for public participation in any compliance
certification or determination.
In today's proposal, the Agency is proposing to continue to
maintain the four public information dockets listed in the
Supplementary Information section of this part. All materials
relevant to any compliance certification or determination or to any
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decision regarding modifications, suspensions, or revocations of
such compliance certifications and determinations will be placed
in the proposed dockets.
The Agency believes that maintaining dockets is useful because
they can greatly increase communication between EPA and all
interested parties. The Agency intends to maintain all dockets in
conformance with EPA's "Uniform Rulemaking Docket Guidance" to the
extent practicable. This guidance is widely used within the Agency
and helps to ensure that public participation in Agency rulemakings
is optimized.
The Agency also proposes to hold public hearings on proposed
compliance criteria within the State of New Mexico. These hearings
will provide an opportunity for members of the public, beyond
submission of written comments, to express their views to EPA in
the rulemaking process.
With respect to applications for compliance certification, the
Agency is proposing that, upon receipt of an application for
certification of compliance, it will publish a notice in the Federal
Register announcing that an application for certification of
compliance has been received and soliciting comment on that
application. This notice in the Federal Register will be an Advance
Notice of Proposed Rulemaking (ANPR), as it will also announce the
Agency's intent to conduct a rulemaking to certify whether the WIPP
will comply with the disposal regulations. The Agency is proposing
this approach in order to afford the public an opportunity for early
input into EPA' s certification decision. The alternative might have
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been simply putting the application in the docket and receiving
comments from the public through a more informal means. However,
the Agency believes that this approach would not necessarily lead
to as much public input relevant to its decision. Hence, the more
formal approach is proposed.
Upon completion of a review of the application for certification
of compliance, the Agency also proposes to publish in the Federal
Register a Notice of Proposed Rulemaking announcing the
Administrator's proposed decision on whether the WIPP facility will
comply with the disposal regulations and soliciting comment on such
proposal. The notice will provide a comment period of at least 120
days and will announce the opportunity for public hearings in New
Mexico (including times and procedures for registering to testify).
The Agency will publish a Notice of Final Rule in the Federal
Register announcing the Administrator's decision on certifying
whether the WIPP facility will comply with the disposal regulations.
Additionally, a document summarizing major comments and issues
arising from comments received on the Notice of Proposed Rulemaking,
as well as the Administrator's response to such comments and issues,
will be prepared and made available for inspection in Agency dockets.
Similar to the process outlined above for applications for
compliance certification (and for the same reasons), when EPA
receives documentation of continued compliance as required under
8 (f) of the WIPP LWA, the Agency will publish a notice in the Federal
Register announcing the Administrator's intent to determine whether
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the WIPP facility continues to be in compliance with the disposal
regulations. Copies of any documentation received will be made
available for inspection in Agency dockets and comments will be
solicited for at least 30 days after receipt. Once the Agency has
considered all comments received, the Administrator will make a
determination regarding WIPP' s continued compliance and publish that
decision in the Federal Register.
Questions for Comment
The Agency is requesting comment on today's proposed criteria
for the certification and determination of the WIPP's compliance
with the 40 CFR part 191 disposal standards and on the proposed
approaches taken. EPA generally invites comment on whether today's
proposal addresses all issues related to the any EPA certification
or determination of WIPP's compliance with the disposal regulations
in 40 CFR part 191.
Regulatory Analyses
Executive Order 12866
Under Executive Order 12866 [58 Federal Register 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
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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 arising out of 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
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires
each Federal agency to consider the effects of their regulations
on small entities and to examine alternatives that may reduce these
effects. The nature of this action is to propose criteria for the
certification of compliance of the WIPP with the Agency' s radioactive
waste disposal standards set forth in 40 CFR part 191. Since the
preparation of applications for
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Criteria for the Certification and Determination of the Waste
Isolation Pilot Plant's Compliance with Environmental Standards for
the Management and Disposal of Spent Nuclear Fuel, High-Level and
Transuranic Radioactive Wastes, Page 80 of 127.
compliance will only be conducted by DOE, and since any ensuing
disposal and information gathering activities will only be carried
out by DOE, the Agency certifies that this regulation will not have
a significant impact on a substantial number of
small entities.
Paperwork Reduction Act
The EPA has determined that this proposed rule contains no
information requirements as defined by the Paperwork Reduction Act
(42 U.S.C. 3501 et sea).
List of Subjects in 40 CFR part 194
Environmental protection, Nuclear energy, Nuclear wastes,
Nuclear weapons, Plutonium, Radiation, Radiation protection,
Radionuclides, Uranium, Transuranics, Waste treatment and disposal.
Dated:
Carol M. Browner
Administrator
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A new Part 194 is hereby proposed to be added to Title 40, Code
of Federal Regulations, as follows:
PART 194--CRITERIA FOR THE CERTIFICATION AND DETERMINATION OF
THE WASTE ISOLATION PILOT PLANT' S COMPLIANCE WITH ENVIRONMENTAL
STANDARDS FOR THE MANAGEMENT AND DISPOSAL OF SPENT NUCLEAR FUEL,
HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES
Subpart A--General Provisions
Sec.
194.01 Purpose, scope, and applicability.
194.02 Definitions.
194.03 Communications.
194.04 Conditions of compliance certification and
determination.
194.05 Publications incorporated by reference.
194.06 Alternative provisions.
Subpart B--Compliance Certification and Determination
Applications
194.11 Completeness and accuracy of compliance
appli
catio
ns.
194.12 Submission of compliance applications.
194.13 Submission of reference materials.
194.14 Content of compliance certification application.
194.15 Content of compliance determination
appli
catio
n(s) .
Subpart C--Compliance Certification and Determination
GENERAL REQUIREMENTS
194.21 Inspections.
194.22 Quality assurance.
194.23 Models and computer codes.
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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 human-initiated processes and
events.
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.
194.62 Notice of proposed rulemaking.
194.63 Notice of final rule.
194.64 Documentation of continued compliance.
194.65 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.l; Nuclear Waste Policy Act of 1982,
as amended, 42 U.S.C. 10101-10270.
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Subpart A--General Provisions
§ 194.01 Purpose, scope and applicability.
This part specifies criteria for any certification or
determination of compliance, under section 8(d) and section
8(f) of the WIPP LWA, with the disposal regulations at 40 CFR
part 191. Any compliance application submitted under section
8 (d) of the WIPP LWA and any compliance application submitted
under section 8(f) of the WIPP LWA must comply with the
requirements of this part.
§ 194.02 Definitions.
Unless otherwise indicated in this part, all terms have the
same meaning as in 40 CFR part 191.
Certification means any action taken by the Administrator
under section 8(d) of the WIPP LWA.
Compliance application(s) means any application submitted
to the Administrator under section 8 (d) of the WIPP LWA or any
application(s) submitted to the Administrator under section
8(f) of the WIPP LWA.
Compliance assessment(s) means the analysis conducted to
determine compliance with section 15 and subpart C of 40 CFR
part 191.
Determination means any action taken by the Administrator
pursuant to 8(f) of the WIPP LWA.
Disposal regulations means subparts B and C of 40 CFR part
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191.
Human activity means those drilling events that may affect
the disposal system, but do not necessarily reach the level
of the waste in the disposal system.
Human intrusion means those drilling events that reach the
level of the waste in the disposal system.
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 for ensuring that the
type and quality of data needed are obtained.
Modification means action (s) taken by the Administrator that
has the effect of altering the terms or conditions of
certification under section 8(d) of the WIPP LWA or that has
the effect of altering the terms or conditions of a determination
under section 8(f) of the WIPP LWA.
Population of CCDFs means all possible CCDFs that can be
generated from all disposal system parameter values used in
performance assessments.
Population of estimates means all possible estimates that
can be generated from all disposal system parameter values used
in compliance assessments.
Quality assurance means all those planned and systematic
actions necessary to provide adequate confidence that the
disposal system will perform satisfactorily in service.
Quality assurance includes quality control, which comprises
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those quality assurance actions related to the physical
characteristics of a material, structure, component, or system
which provide a means to control the quality of the material,
structure, component, or system to predetermined requirements.
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 or withdraw the effectiveness of a certification under
section 8(d) of the WIPP LWA or to terminate or withdraw the
effectiveness of a determination under section 8(f) of the WIPP
LWA.
Secretary means the Secretary of the Department of Energy.
Suspension means any action taken by the Administrator to
withdraw, for a limited period of time, the effectiveness of
certification under section 8 (d) of the WIPP LWA or to withdraw,
for a limited period of time, the effectiveness of a
determination under section 8(f) of the WIPP LWA.
Waste means the radioactive waste and radioactive material
subject to the requirements of 40 CFR part 191.
WIPP means the Waste Isolation Pilot Plant project authorized
under section 213 of the Department of Energy National Security
and Military 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 (Pub.L. 102-579, 106 Stat. 4777) .
§ 194.03 Communications.
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(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, where indicated, the
Administrator's authorized representative; and
(2) Signed by the Secretary or the Secretary's authorized
representative.
§ 194.04 Conditions of compliance certification and
determination.
(a) Any certification or determination issued pursuant to
the WIPP LWA may include such conditions as the Administrator
finds to be necessary to support such certification or
determination(s).
(b) Whether stated therein or not, the following shall be
conditions in any certification or determination:
(1) The certification or determination shall be subject
to modification, suspension, or revocation, by the
Administrator. Any modification, suspension, or revocation
of the certification shall be done by rule. If the
Administrator revokes the certification, the Department shall
retrieve, to the extent practicable, any waste emplaced in the
disposal system.
(2) Upon written request of the Administrator any time after
the Administrator has issued a certification or determination
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of compliance, the Department shall submit information to enable
the Administrator to determine whether the certification or
determination should be modified, suspended, or revoked.
Unless otherwise specified by the Administrator, the Department
shall submit such information to the Administrator within 30
calendar days of receipt of the Administrator's request.
(3) Not later than six months after the Administrator has
issued any certification or determination of compliance, and
at least every six months thereafter, the Department shall
report to the Administrator, in writing, any changes in
conditions or activities pertaining to the disposal system that
depart from the application and that formed the basis of such
certification or determination of compliance.
(4) Any time after the Administrator has issued a
certification or determination of compliance, the Department
shall report any changes in activities pertaining to the
disposal system that depart significantly from the application
and that formed the basis of such certification or determination
of compliance. The Department shall inform the Administrator,
in writing, prior to making a planned change . The Administrator
will determine whether the planned change invalidates the terms
of the certification or determination. Any significant change
must be approved by the Administrator prior to being made and
the Administrator will determine whether the change requires
further action. Further action may include modification,
suspension, or revocation of the compliance certification or
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determination. (5) If the Department discovers that a
condition pertaining to the disposal system differs
significantly from that indicated in the application that formed
the basis of a certification or determination of compliance,
the difference must be reported, in writing, to the
Administrator within 10 calendar days of its discovery. The
Administrator will determine whether the report requires
further action. Further action may include modification,
suspension, or revocation of the compliance certification or
determination.
(6) If the Department determines that a release of waste
from the disposal system to the accessible environment in excess
of what is permitted under the disposal regulations has occurred
or is likely to occur, the Department shall:
(i) Immediately suspend emplacement of waste in the
disposal system, and
(ii) Notify the Administrator, in writing, within 24 hours
of the determination that such a release has occurred or is
likely to occur. Such notification shall include, but need
not be limited to, the following information to the extent
possible:
(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;
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(C) Time and date of the release or the approximate 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 and deemed
by the Administrator or the Administrator's authorized
representative to be relevant to a modification, suspension
or revocation of a certification or determination of compliance .
(iii) Following receipt of the notification, the
Administrator:
(A) May request additional information; and
(B) Will determine whether emplacement of waste in the
disposal system may continue and whether to modify, suspend,
or revoke any previously issued certification or determination
of compliance.
§ 194.05 Publications incorporated by reference.
(a) The following publications are incorporated in this
part by reference:
(1) NUREG 1297 "Peer Review for High-Level Nuclear Waste
Repositories."
(2) ASME NQA-1-1989 edition "Quality Assurance Program
Requirements for Nuclear Facilities."
(3) ASME NQA-2a-1990 addenda (part 2.7) to ASME NQA-2-1989
edition "Quality Assurance Requirements of Computer Software
for Nuclear Facility Applications."
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(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."
(b) The references listed in paragraph (a) of this section
are available for inspection at the Office of the Federal
Register. These incorporations by reference were approved by
the Director of the Federal Register. These publications are
incorporated as they exist on the date of promulgation of this
part.
§ 194.06 Alternative provisions.
The Administrator may, by rule, 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 compliance with the
existing provisions of this part appears inappropriate, 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, during which an opportunity for public hearings in
New Mexico has been provided; and
(c) The public comments received have been fully considered
in developing the final version of alternative provisions.
Subpart B--Compliance Certification and Determination
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Applications
§ 194.11 Completeness and accuracy of compliance
applications.
Information provided to the Administrator in support of any
compliance application(s) shall be complete and accurate. The
Administrator's evaluation for certification under section
8(d)(1)(B) of the WIPP LWA and evaluation for determination
under 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.
§ 194.12 Submission of compliance applications.
Unless otherwise specified by the Administrator, 30 copies
of any compliance application(s), any accompanying materials,
and any amendments thereto shall be submitted in a printed form
to the Administrator.
§ 194.13 Submission of reference materials.
Information may be incorporated by reference in compliance
application(s): Provided, That the references are clear and
specific and that 10 copies of the referenced information are
submitted to the Administrator. Referenced materials which
are widely available in standard textbooks need not be
submitted.
§ 194.14 Content of compliance certification application.
Any application for certification of compliance with the
disposal regulations shall include:
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(a) A description of the disposal system and those features
that may affect disposal system performance. The description
of the disposal system shall include 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;
(3) The presence and characteristics of potential pathways
for transport of waste from the disposal system to the accessible
environment including, but not necessarily limited to, solution
features, breccia pipes, and other potentially permeable
features including but not necessarily limited to interbeds;
and
(4) The projected geophysical, hydrologic 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 relative to materials of construction
(including, but not necessarily limited to, geologic media,
structural materials, engineered barriers, general
arrangement, and approximate dimensions); and
(2) Codes and standards that have been applied to the design
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and construction of the disposal system.
(c) Results of assessments conducted pursuant to the
disposal regulations.
(d) A description of input parameters associated with
assessments conducted pursuant to the disposal regulations and
the basis for selecting those input parameters.
(e) Evidence that disposal of waste in the disposal system
meets the requirements of §191.14.
(f) A description of any 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.
(h) One or more topographic map(s) of the vicinity of the
disposal system. Contours must be shown on the map. The
contour interval must be sufficient to clearly show the pattern
of surface water flow in the vicinity of the disposal system.
The map(s) shall clearly show the following:
(1) Scale and date;
(2) Floodplain area;
(3) Surface waters including intermittent streams;
(4) Surrounding land uses, i.e.,residential, commercial,
industrial, agricultural, recreational;
(5) A wind rose, i.e., wind speeds and directions;
(6) Orientation of the map, i.e., north arrow;
(7) Boundaries of the controlled area;
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(8) Location of proposed active and passive institutional
controls;
(9) Location of any active, inactive, and abandoned
injection and withdrawal wells in the controlled area and in
the vicinity of the disposal system; and
(10) Location of proposed monitoring stations or wells.
(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 and interact
over the regulatory time frame.
(j) Any additional information required elsewhere in this
part or determined by the Administrator or the Administrator's
authorized representative to be necessary for a decision whether
to certify or determine compliance.
§ 194 .15 Content of compliance determination application (s) .
(a) In submitting documentation of continued compliance
pursuant to section 8(f) of the WIPP LWA, the most recent
previous application(s) for compliance certification or
determination shall be updated so as 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) Additional geologic, geophysical, geochemical,
hydrologic, and meteorologic information.
(2) Monitoring results.
(3) An evaluation of the conformance of the disposal system
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components with design.
(4) A description of any waste emplaced in the disposal
system since the most recent previous compliance certification
or determination application. Such description shall consist
of a description of the waste characteristics identified in
§194.24(a)(ii).
(5) Any additional information that the Administrator or
the Administrator's authorized representative identifies as
necessary to determine whether or not the disposal system
continues to be in compliance with the disposal regulations.
(b) To the extent that information required for a
determination of compliance remains valid and has been submitted
in previous certification or determination application (s) , such
information need not be duplicated in subsequent applications;
such information may be summarized and referenced.
Subpart C--Compliance Certification and Determination
GENERAL REQUIREMENTS
§ 194.21 Inspections.
(a) (1) The Administrator or the Administrator' s authorized
representative (s) shall be afforded unfettered and unannounced
access to inspect any area of the WIPP and locations performing
activities that may provide information used to support any
compliance application(s) to which the Department has rights
of access.
(2) The Administrator or the Administrator's authorized
representative(s) shall be afforded access, pursuant to
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paragraph (a) (1) of this section, equivalent to access afforded
Department employees upon presentation of credentials and other
documents as may be required by law.
(b) Records kept by the Department pertaining to aspects
of the disposal system that could affect the containment of
waste in the disposal system shall be made available to the
Administrator or the Administrator's authorized
representative (s) upon request. If requested records are not
immediately available, they shall be made available to the
Administrator or the Administrator's authorized
representative(s) within 30 calendar days of a request from
the Administrator or the Administrator's authorized
representative(s).
(c) The Department shall, upon request by the Administrator
or the Administrator's authorized representative(s), provide
private, rent-free office space for the exclusive use of the
Administrator or the Administrator's authorized
representative(s). The office space shall be convenient and
have full access to the disposal system.
(d) The Administrator or the Administrator's authorized
representative (s) shall 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 and deemed by the Administrator or the
Administrator's authorized representative to be relevant to
a compliance certification or determination.
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(e) In conducting activities pursuant to this section, the
Administrator or the Administrator's authorized
representative(s) will comply with applicable access control
measures for security, radiological protection and personal
safety.
§ 194.22 Quality assurance.
(a) (1) The Department shall implement a quality assurance
program that meets 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) ) .
(2) Any application for certification of compliance shall
include information which demonstrates that the quality
assurance program implemented under paragraph (a)(1) of this
section has been established and executed for:
(i) Waste characterization activities and assumptions;
(ii) Environmental monitoring, monitoring the performance
of the disposal system, sampling, and analysis activities;
(iii) Field measurements of geological factors, ground
water, meteorology, and topography;
(iv) Computations, codes, models and methods used to
demonstrate compliance with the disposal regulations;
(v) Expert judgment elicitation used to support applications
for certification or determination 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
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compliance application(s); and
(viii) Other systems, structures, components, and activities
important to the containment of waste in the disposal system.
(b) Any application for certification of compliance shall
include information which demonstrates that data and
information collected prior to implementation of the quality
assurance program under paragraph (a) of this section has been
qualified in accordance with:
(1) a quality assurance program equivalent in scope and
implementation 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)); or
(2) an alternative method approved by the Administrator for
use at the WIPP.
(c) Any application for certification of compliance shall
provide information which addresses how the following quality
indicators for the collection of data and information used to
support a compliance application have been and will continue
to be achieved:
(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
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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;
(5) Data comparability, i.e., a measure of the confidence
with which one data set can be compared to another;
(6) Data reproducibility, i.e. a measure of the variability
among measurements of the same sample at different laboratories;
(7) Data validation, i.e., a systematic process for reviewing
a body of data against a set of criteria to provide assurance
that the data are adequate for their intended use; and
(8) Data verification, i.e., a systematic process for
reviewing a body of data generated by one source against a body
of data generated by another source.
(d) The Administrator will verify appropriate execution
of quality assurance programs through inspections which include
surveillances, audits, and management systems reviews.
§ 194.23 Models and computer codes.
(a) Any application for certification of compliance shall
include:
(1) A complete listing and description of the models used
to support such application. The description shall be
sufficiently complete to permit technical review of the purpose
of modeling, the modeling approach, method of analysis and the
assumptions underlying such analyses.
(2) A complete listing of conceptual model(s) considered
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but not used to support such application, a description of such
model (s) , and an explanation of the reason (s) why such model (s)
was/were not used to support such application.
(3) Information which demonstrates that:
(i) conceptual models reasonably represent 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 and accurate solutions; and
(v) models, computer codes, and observed and measured data
used to confirm models and computer codes have undergone peer
review according to §194.27.
(b) Models and computer codes used to support any application
for certification of compliance shall be fully and clearly
documented in a manner that complies with the requirements of
ASME NQA-2a-1990 addenda (part 2.7) to ASME NQA-2-1989 edition.
(c) Documentation for models and computer codes shall
include:
(1) A description of the theoretical backgrounds of each
model, the method of analysis or assessment, scenario
construction, and data collection procedures;
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(2) Detailed descriptions of the structure of computer
codes and complete listings of the source codes;
(3) Users' manuals that include general descriptions of the
models, discussions of the limits of applicability of each
model, detailed instructions for running the computer codes
including hardware and software requirements, input and output
formats with detailed explanations of each input and output
variable and parameter, listings of input and output files from
a sample computer run, and reports on code verification,
benchmarking, validation and quality assurance procedures;
(4) Programmers' manuals;
(5) Any necessary licenses; and
(6) An explanation of how models and computer codes handle
covariance.
(d) The Administrator or the Administrator's authorized
representative may verify the results of computer simulations
used to support any application for certification of compliance
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.
§ 194.24 Waste characterization.
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(a) (1) Any application for certification of compliance shall
identify, in detail, the chemical, radiological and physical
characteristics of all waste proposed for disposal in the
disposal system. Such identification shall provide
information about waste characteristics as they exist or, in
the case of to-be-generated waste, as they are expected to exist
upon emplacement in the disposal system.
(2) Information about the following characteristics of waste
proposed for disposal in the disposal system shall be provided:
(i) Activity in curies of each radionuclide; and
(ii) Any other characteristic(s) important to the
containment of waste in the disposal system as identified by
the study conducted under paragraph (a)(3) of this section.
(3) The Department shall conduct a study of the effects of
waste characteristics on the containment of waste in the
disposal system and shall include the results of such study
in any application for certification of compliance. The
characteristics studied shall include, but need not be limited
to:
(i) Waste form;
(ii) Free liquid content and liquid saturation;
(iii) Pyrophoric and explosive materials; and
(iv) Characteristics affecting the solubilization and
mobilization of radionuclides, formation of colloidal
suspensions containing radionuclides, production of gas from
the waste, nuclear criticality, and generation of heat in the
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disposal system.
(4) For all waste characteristics studied pursuant to
paragraph (a)(3) of this section, any application for
certification of compliance shall document and substantiate
any decision not to provide information on a particular waste
characteristic because that characteristic is considered to
be unimportant to the containment of waste in the disposal
system.
(5) Categories of waste shall be established, by the
Department, based on characteristics of the waste that would
be expected to behave similarly in the disposal system.
(b) The information provided under paragraph (a) of this
section:
(1) shall consist of a value or range of values for
characteristics listed under paragraph (a) (2) of this section;
and
(2) shall consist of a value or range of values for
characteristics identified as important to the containment of
waste in the disposal system by the study required under
paragraph (a)(3) of this section; and
(3) shall describe in detail the characteristics of each
category of waste established under paragraph (a)(5) of this
section; and
(4) may specify the maximum amount of each category of waste
that will be placed in any waste container or location in the
disposal system.
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(c) (1) Any application for certification of compliance shall
identify and describe the method(s) used to determine waste
characteristics and the uncertainty associated with such
method(s).
(2) Any application for certification of compliance shall
provide information which substantiates any determination of
waste characteristics based on knowledge of the processes and
materials that generated the waste.
(d) Any application for certification of compliance shall
provide information which demonstrates that the disposal system
complies with the disposal regulations for all combinations
of waste whose contents fall within the range of characteristics
provided pursuant to paragraph (b) of this section.
(e)(1) Waste may only be emplaced in the disposal system
if the characteristics of such waste fall within the range of
values provided under paragraph (b) of this section and if the
amount of each category of waste placed in any waste container
or location in the disposal system does not exceed any maximum
specified under paragraph (b)(4) of this section.
(2) Any application for certification of compliance shall
provide information which demonstrates that a system of controls
which includes but is not necessarily limited to measurements,
sampling, chain of custody records and other record-keeping
is and will continue to be implemented to assure that only waste
containers whose contents fall within the range of
characteristics provided under paragraph (b) of this section
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are emplaced in the disposal system. Any application for
certification of compliance shall identify and describe such
controls and the uncertainty associated with them.
(f) The Administrator will use audits and inspections to
verify the waste characterization requirements of this part.
§ 194.25 Future state assumptions.
(a) Unless otherwise specified in this part or in the
disposal regulations, certifications or determinations of
compliance with the disposal regulations shall assume that
characteristics of the future remain what they are today:
Provided, That such characteristics are not related to
geologic, hydrologic, or climatic conditions.
(b) In considering the effects of climatic conditions on
the disposal system, certifications and determinations of
compliance with the disposal regulations shall consider the
effects of increased and decreased precipitation and
evaporation on the disposal system over the regulatory time
frame.
§ 194.26 Expert judgment.
(a) Expert judgment, by an individual expert or panel of
experts, may be used to support any application for
certification of compliance: Provided, That expert judgment
does not substitute for information that could reasonably be
obtained through data collection or experimentation.
(b) Any application for certification of compliance shall
identify any expert judgments used to support the application
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and shall identify experts (by name and by professional
affiliation) involved in any expert judgment elicitation
processes used to support the application.
(c) Any application for certification of compliance shall
describe the process of eliciting expert judgment, and shall
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.
(d) Any application for certification of compliance shall
provide information which demonstrates that the following
restrictions and guidelines have been applied to any selection
of individuals used to elicit expert judgments:
(1) Individuals who are members of the team of investigators
requesting the judgment or the team of investigators who will
use the judgment shall not be selected; and
(2) Individuals who maintain, at any organizational level,
a supervisory role or who are supervised by those who will
utilize the judgment shall not be selected.
(e) Any application for certification of compliance shall
provide information which demonstrates that 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.
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(f) Any application for certification of compliance shall
include an explanation of the relationship between the
information presented, the questions or issues presented, the
judgment of any expert panel or individual, and the purpose
for which the expert judgment is being used.
(g) Any application for certification of compliance shall
provide information which demonstrates that the following
restrictions and guidelines have been applied in eliciting
expert judgment:
(1) 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 which explains
why fewer than five individuals were selected.
(2) 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;
however, in no case shall more than one-half of the experts
involved in an elicitation consist of individuals employed
directly by the Department or by the Department's contractors.
(h) Groups and individuals (including those not directly
employed by the Department or by the Department's contractors)
shall be afforded an opportunity to present their scientific
and technical views as input to any expert elicitation process.
§ 194.27 Peer review.
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(a) Any application for certification of compliance shall
include information which demonstrates that peer review has
been conducted to evaluate the adequacy of:
(1) The evaluation, required under this part, of engineered
barriers for the disposal system;
(2) Consideration of processes and events that may affect
the disposal system;
(3) Quality assurance programs and plans;
(4) Models and computer codes;
(5) Data used to support models and computer codes; and
(6) Waste characterization.
(b) Peer review processes used in certifying or determining
compliance with the disposal regulations shall be conducted
in a manner which is compatible with NUREG-1297 "Peer Review
for High-Level Nuclear Waste Repositories."
CONTAINMENT REQUIREMENTS
§ 194.31 Application of release limits.
The expected curie activity 100 years after disposal of the
waste proposed for disposal in the disposal system shall be
used in calculating applicable release limits under Appendix
A of 40 CFR 191, Table 1, Note 1(e) .
§ 194.32 Scope of performance assessments.
(a) Performance assessments shall consider both natural and
human-initiated processes and events that may affect the
disposal system.
(b) Performance assessments need not consider processes,
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events, or sequences of processes and events that have less
than one chance in 10,000 of occurring over 10,000 years.
(c) Any application for certification of compliance shall
include information which:
(1) identifies potential processes, events or sequences of
processes and events that may occur during the regulatory
timeframe and may affect the disposal system;
(2) identifies the processes, events or sequences of
processes and events included in performance assessment results
provided in any application for certification of compliance;
and
(3) documents why any processes, events or sequences of
processes and events identified under paragraph (c) (1) of this
section were not included in performance assessment results
provided in any application for certification of compliance.
§ 194.33 Consideration of human-initiated processes and
events.
(a) A separate examination of each type of human-initiated
process and event shall be conducted. Analyses shall be limited
to those types of human-initiated processes and events that
may potentially affect the disposal system.
(b) The following process shall be used in assessing the
likelihood and consequences of human-initiated processes and
events and the results of such process shall be documented in
any application for certification of compliance:
(1) Inadvertent and intermittent drilling for resources
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(other than those resources provided by the waste in the disposal
system or any engineered barriers designed to isolate such
waste) is the most severe scenario for human-initiated processes
and events.
(2) Human-initiated processes and events occur at random
intervals in time and space throughout the regulatory time
frame.
(3) Two categories of human-initiated processes and events
shall be considered:
(i) Human intrusion, which shall include those drilling
events that reach the level of the waste in the disposal system,
and
(ii) Human activity, which shall include those drilling
events that may affect the disposal system, but do not
necessarily reach the level of the waste in the disposal system.
(4) The frequency of human intrusion shall be calculated
in the following manner:
(i) Identify each type of human intrusion in the Delaware
Basin over the past 50 years.
(ii) The total rate of human intrusion shall be the sum
of the rates of each type of human intrusion. However, in no
event shall the total rate of human intrusion be less than
25/km2/10, 000 yrs or more than 62 . 5/km2/10 , 000 yrs .
(iii) In lieu of conducting the analysis in paragraphs
(b)(4)(i) and (b)(4)(ii) of historical rates, a rate of 62.5
may be assumed.
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(iv) The rate may then be reduced in accordance with §194.41
and §194.43(c).
(5) The frequency of human activity shall be calculated
in the following manner:
(i) Identify each type of human activity in the Delaware
Basin over the past 50 years.
(ii) The total rate of human activity shall be the sum of
the rates of each type of human activity.
(iii) In considering the historical rate of all human
activity, the Department may, if justified, consider only the
historical rate of human activity for resources of similar type
and quality of resources in the controlled area.
(iv) The rate may then be reduced in accordance with §194.41
and §194.43(c).
(6) In assessing the consequences of human-initiated
processes and events, performance assessments shall assume that
the future characteristics of those processes and events
including, but not limited to, the types and amounts of drilling
fluids, and borehole depths, diameters, and seals will remain
consistent with current practice in the Delaware Basin.
(b) In assessing the consequences of human-initiated
processes and events, performance assessments shall assume
that:
(1) Boreholes will be sealed at the rate boreholes have been
sealed over the past 50 years in the Delaware Basin; and
(2) Natural processes will degrade or otherwise affect the
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permeability of boreholes over the regulatory time frame.
§ 194.34 Results of performance assessments.
(a)(1) 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.
(2) Probability distributions for uncertain disposal system
parameter values used in performance assessments shall be
developed.
(3) Computational techniques which draw random samples from
across all of the probability distributions developed under
paragraph (a)(2) of this section shall be used in generating
CCDFs.
(b) The number of CCDFs generated must be large enough such
that the maximum CCDF generated exceeds the 99th percentile
of the population of CCDFs with at least a 0.95 probability.
(c) Any application for certification of compliance shall
display the full range of CCDFs generated.
(d) Any application for certification of compliance shall
provide information which demonstrates that there is at least
a 95% level of statistical confidence that the mean of the
population of CCDFs meets the requirements of section 13(a)
of 40 CFR part 191.
ASSURANCE REQUIREMENTS
§ 194.41 Active institutional controls.
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(a) Any application for certification of compliance 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) Assessments to determine compliance with the disposal
regulations shall not consider any contributions from active
institutional controls for more than 100 years after disposal.
§ 194.42 Monitoring.
(a) (i) Disposal systems shall be monitored after disposal
to detect substantial and detrimental deviations from expected
performance at the earliest practicable time and shall be
consistent with monitoring required under applicable federal
hazardous waste regulations at 40 CFR parts 264, 265, 268, and
270. These monitoring programs shall be done with techniques
that do not jeopardize the containment of waste in the disposal
system.
(ii) Any application for certification of compliance shall
include a detailed plan for monitoring the performance of the
disposal system. At a minimum, such plan shall:
(1) Identify parameters that will be monitored and how
baseline states will be determined;
(2) Indicate how each parameter will be used to evaluate
the performance of the disposal system; and
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(3) Discuss the length of time over which each parameter
will be monitored to detect deviations from expected
performance.
(b)(i) To the extent practicable, pre-closure monitoring
of the following disposal system parameters shall be conducted:
(1) Brine quantity, flux, composition, and spatial
distribution;
(2) Gas quantity and composition;
(3) Temperature distribution; and
(4) Any other disposal system parameter(s) important to the
containment of waste in the disposal system as identified by
the study conducted under (b) (ii) . A disposal system parameter
shall be considered important 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 after the Administrator's
certification of compliance; however, in no case shall waste
be emplaced in the disposal system prior to the implementation
of such monitoring. Monitoring shall end when the last
container of waste is emplaced in the disposal system but before
shafts of the disposal system are backfilled and sealed.
(ii) The Department shall conduct a study of the effects
of disposal system parameters on the containment of waste in
the disposal system and shall include the results of such study
in any application for certification of compliance. The
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disposal system parameters studied shall include, but need not
be limited to:
(1) Backfilled mechanical state including porosity,
permeability, and degree of compaction and reconsolidation;
(2) 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; and
(4) Subsidence and other effects of human activity in the
vicinity of the disposal system.
(iii) For all disposal system parameters studied pursuant
to paragraph (4)(ii) of this section, any application for
certification of compliance shall document and substantiate
the decision not to monitor a particular disposal system
parameter because that parameter is considered to be unimportant
to the containment of waste in the disposal system and to the
verification of predictions about the future performance of
the disposal system.
§ 194.43 Passive institutional controls.
(a) Any application for certification of compliance shall
include detailed descriptions of the measures that will be
employed to preserve knowledge about the location, design, and
contents of the disposal system. At a minimum, such measures
shall include:
(1) Identification of the controlled area by markers that
have been designed, fabricated, and emplaced to be as permanent
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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;
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.
(b) Any application for certification of compliance shall
include detailed descriptions of the proposed passive
institutional controls and the period of time those controls
are expected to endure and be understood.
(c) Any application for certification of compliance may
include a proposed credit (which may vary over the regulatory
time frame) for reducing the rate of human-initiated processes
and events calculated using the procedures enumerated in
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§194.33. The Administrator shall allow such credit, or a
smaller credit, to be taken if the Department demonstrates that
such credit is justified because the passive institutional
controls can be expected to endure, be understood, and act as
a deterrent to potential intruders throughout the regulatory
time frame. In no case, however, shall passive institutional
controls be assumed to eliminate the likelihood of
human-initiated processes and events entirely.
§ 194.44 Engineered barriers.
(a) Disposal systems shall incorporate engineered barriers
designed to prevent or substantially delay the movement of water
or radionuclides toward the accessible environment.
(b) In selecting engineered barriers for the disposal system,
the Department shall evaluate the benefit and detriment of
engineered barrier alternatives including but not limited to
such engineered barriers as 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 application
for certification of compliance 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:
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(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) the increased or reduced public confidence in the
performance of the disposal system;
(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-initiated processes and events.
(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 should be rejected without evaluating
the remaining factors in paragraph (c) (1) of this section, then
any application for certification of compliance shall provide
a justification for this rejection explaining why the evaluation
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of the remaining factors would not alter the conclusion.
(d) In considering the benefit and detriment of
incorporation of engineered barriers, 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 shall consider engineered barriers alone
and in combination.
§ 194.45 Consideration of the presence of resources.
Any application for certification of compliance 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 future human-initiated processes and
events as a result of the presence of those resources.
§ 194.46 Removal of waste.
Any application for certification of compliance shall
include a plan for removal of waste from the disposal system.
The plan shall incorporate the best technology available, at
the time of application, for removing such waste.
INDIVIDUAL AND GROUND-WATER PROTECTION REQUIREMENTS
§ 194.51 Consideration of protected individual.
Certifications or determinations of compliance with section
15 and subpart C of 40 CFR part 191 shall assume that an
individual resides at the location in the accessible environment
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where that individual would be expected to receive the highest
exposure from radionuclide releases from the disposal system.
§ 194.52 Consideration of exposure pathways.
In certifying or determining compliance with section 15 and
subpart C of 40 CFR part 191, all potential exposure pathways,
associated with undisturbed performance, from the disposal
system to individuals shall be considered. Certifications or
determinations of compliance with section 15 and subpart C of
40 CFR part 191 shall assume that individuals consume 2 liters
per day of drinking water from any underground source of drinking
water in the accessible environment.
§ 194.53 Consideration of underground sources of drinking
water.
In certifying or determining compliance with subpart C of
40 CFR part 191, all underground sources of drinking water in
the accessible environment likely to be affected by the disposal
system over the regulatory time frame shall be considered.
In determining whether underground sources of drinking water
are likely to be affected by the disposal system,
interconnections between bodies of surface water, ground water,
and underground sources of drinking water shall be considered.
§ 194.54 Scope of compliance assessments.
Any application for certification of compliance shall
include information which:
(a) identifies potential processes, events or sequences of
processes and events that may occur over the regulatory time
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frame;
(b) identifies the processes, events or sequences of
processes and events included in compliance assessment results
provided in any application for certification of compliance;
and
(c) documents why any processes, events or sequences of
processes and events identified under paragraph (a) of this
section were not included in compliance assessment results
provided in any application for certification of compliance.
§ 194.55 Results of compliance assessments.
(a)(1) Compliance assessments shall consider uncertainty
in the undisturbed performance of a disposal system.
(2) Probability distributions for uncertain disposal
system parameter values used in compliance assessments shall
be developed.
(3) Computational techniques which draw random samples from
across all of the probability distributions developed under
paragraph (2) of this section shall be used to generate a range
of:
(i) Estimated radiation doses; and
(ii) Estimated radionuclide concentrations.
(b) Each of the ranges generated under paragraph (a)(3)
of this section must be large enough such that the maximum
estimate generated exceeds the 99th percentile of the population
of estimates with at least a 0.95 probability.
(c) Any application for certification of compliance shall
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display:
(1) The full range of estimated radiation doses; and
(2) The full range of estimated radionuclide concentrations.
(d) Any application for certification of compliance shall
provide information which demonstrates that there is at least
a 95% 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 sections 15 and 16 of 40 CFR part 191.
Subpart D--Public Participation
§ 194.61 Advance notice of proposed rulemaking.
(a) Upon receipt of an application for certification of
compliance, the Agency will publish in the Federal Register
an Advance Notice of Proposed Rulemaking announcing that an
application for certification of compliance 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 application for certification of compliance
will be made available for inspection in Agency dockets.
(c) The notice will provide a public comment period of at
least 120 days.
(d) A public hearing concerning the notice will be held if
a written request for a hearing is received within 30 calendar
days of the date of publication under paragraph (a) of this
section. Written requests shall be directed to the
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Administrator and the Administrator's authorized
representative.
(e) Any comments received on the notice will be made available
for inspection in the dockets established under section 65 of
this part.
(f) Any comments received on the notice will be provided
to the Department and the Department may submit written
responses to the comments within 120 days of receipt.
§ 194.62 Notice of proposed rulemaking.
(a) Upon completion of review of the application for
certification of compliance, the Administrator will publish
a Notice of Proposed Rulemaking in the Federal Register
announcing the Administrator's proposed decision on whether
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 the opportunity for public
hearings in New Mexico and provide information on the timing
and location of such hearings and procedures for registering
to testify.
(d) Any comments received on the notice will be made available
for inspection in the dockets established under section 65 of
this part.
§ 194.63 Notice of final rule.
(a) The Administrator will publish a Notice of Final Rule
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in the Federal Register announcing the Administrator' s decision
on certifying whether the WIPP facility will comply with the
disposal regulations.
(b) A document summarizing major comments and issues arising
from comments received on the Notice of Proposed Rulemaking
as well as the Administrator's response to such comments and
issues will be prepared and will be made available for inspection
in the dockets established under section 65 of this part.
§ 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, 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 under section 65 of this part.
(c) The notice will provide a public comment period of at
least 30 days after publication under paragraph (a) of this
section.
(d) Any comments received on such notice will be made
available for public inspection in the dockets established under
§194.65.
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(e) Upon completion of a review of documentation of continued
compliance with the disposal regulations, the Administrator
will publish a notice in the Federal Register announcing the
Administrator's decision determining whether or not the WIPP
facility continues to be in compliance with the disposal
regulations.
§ 194.65 Dockets.
The Agency will establish and maintain dockets in the State
of New Mexico and Washington, B.C.. The dockets will consist
of all relevant information received from outside parties and
all information considered by the Administrator in certifying
whether the WIPP facility will comply with the disposal
regulations, in determining whether or not the WIPP facility
continues to be in compliance with the disposal regulations,
and in determining whether compliance certification or
determination(s) should be modified, suspended, or revoked.
BILLING CODE 6560-50-P
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