United States Office of EPA 402-R-95-014
Environmental Protection Radiation
Agency and Indoor Air
Compliance Application Guidance
for 40 CFR Part 194
March 29, 1996
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Compliance Application Guidance
for 40 CFR Part 194
Disclaimer
This Compliance Application Guidance (CAG) is a companion to the EPA final rule
published on February 9, 1996, 61 Fed. Reg. 5224-5245 (to be codified at 40 CFR part 194).
The February 9, 1996 final rule establishes the binding "compliance criteria" that will govern
EPA's certification, pursuant to section 8(d) of the Waste Isolation Pilot Plant (WIPP) Land
Withdrawal Act (Pub. L. No. 102-579), of the WIPP facility's compliance with EPA's final
radioactive waste disposal regulations (40 CFR part 191). The CAG is intended solely as
guidance. The CAG does not establish compliance criteria or any other binding rights and
duties. The CAG summarizes and explains the final rule to assist the Department of Energy
in the preparation and compilation of the WIPP Compliance Certification Application (CCA)
and to assist in EPA's review of the CCA for completeness. Any inconsistencies between the
CAG and the February 9, 1996 final rule are wholly inadvertent and, in all circumstances, the
final rule is dispositive of any inconsistencies.
If you have any questions contact:
Agnes Ortiz
US EPA (6602J)
401 M St., SW
Washington, DC 20460
phone: (202)-233-9310
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Introduction
The Compliance Application Guidance (CAG) is a companion to the final rule
published at
61 FR 5224, February 9,1996, "Criteria for the Certification and Re-Certification of the Waste
Isolation Pilot Plant's (WIPP) Compliance With the 40 CFR Part 191 Disposal Regulations"
(to be codified at 40 CFR Part 194).
The CAG summarizes and explains the February 9, 1996 final rule. The United States
Environmental Protection Agency (EPA) developed this guidance to assist the United States
Department of Energy (DOE) with the preparation of any Compliance Certification
Application (CCA) for the WIPP and, in turn, to assist in EPA's review of the CCA for
completeness and generally to enhance the readability and accessibility of the CCA for EPA
and public scrutiny. It is EPA's intent that this guidance will facilitate the understanding that
DOE and the public have of the specific information that is expected to be included in a
complete application for certification of compliance. Examples used for clarification in this
guidance should not be considered exhaustive or definitive, since they are provided merely to
facilitate DOE's understanding of the types of information EPA is expecting.
EPA's final compliance criteria for the WIPP provide for EPA to determine that the
CCA is "complete" as a preliminary step in its more extensive administrative review of the
CCA. A completeness determination is a threshold determination that the application
warrants further scrutiny, so that EPA, DOE, and the public do not invest major resources in a
rulemaking proceeding for an incomplete document. The completeness determination does
not represent final agency action. EPA will make a final decision about the CCA only when it
ultimately certifiespursuant to rulemaking procedures which will include public notice and
ample opportunity for public commentwhether or not the WIPP facility will comply with the
final disposal regulations.
Upon receipt of a full CCA from DOE, EPA will publish an Advance Notice of
Proposed Rulemaking in the Federal Register that announces receipt of the application and
initiates a public comment period. A copy of the application will be made available for public
inspection in the Agency WIPP dockets, written public comments will be accepted, and, if
sufficient interest is expressed, a hearing will be held in New Mexico. The public comment
period will allow all interested parties to provide comments to EPA on the application.
Subsequently, EPA will publish a Notice of Proposed Rulemaking in the Federal Register and
provide a public comment period of at least 120 days, during which it will hold public
hearings in New Mexico. EPA's Final Rulemaking Notice will be accompanied by a
document summarizing significant comments and issues and providing EPA's responses.
EPA provided public notice and opportunity for public comment on a prior draft of
this document. See 60 FR 53921, October 18, 1995. EPA was unable to provide additional
opportunity for public comment on this guidance document after the issuance of the final
compliance criteria (40 CFR Part 194), as some commenters had requested. EPA endeavored
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to
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issue this guidance expeditiously after issuance of the final compliance criteria, because DOE
is currently preparing the CCA.
The CAG summarizes and explains EPA's expectations of the format and content of
the CCA, based on the February 9, 1996 final rule (hereafter referred to as "40 CFR Part 194).
The technical and legal requirements pertaining to the CCA are addressed by 40 CFR Parts
191 and 194. The CAG's format follows that of 40 CFR Part 194, restating the rule language
in italics, followed by the specific guidance for that section in standard type. Only those
portions of 40 CFR Part 194 (and, by reference, applicable portions of 40 CFR Part 191) for
which DOE is required to submit specific information to EPA, are addressed. Portions of 40
CFR Part 194 which are applicable only to EPA, such as Subpart D, were excluded from this
guidance.
The information DOE presents in any compliance application must conform to the
requirements of 40 CFR Part 194.
General Recommendations for Format
1. The application should include information (i.e., a matrix or cross-walk) that identifies
where the specific requirements of 40 CFR Part 194 have been addressed (i.e., 40 CFR
Section 194.42 Chapter X, pages xxx). EPA does not intend that DOE should
submit duplicative information if such information is needed to establish compliance
with more than one requirement. In such instances, the Agency indicates in this
document how it would like any compliance application to present the information and
appropriate cross-references. DOE may decide how avoidance of duplication is best
achieved.
2. Text should be augmented with graphical representations having sufficient scale and
clarity to portray the intended subject matter accurately. The text should reference the
source of the information (e.g., published or unpublished reports, field data, laboratory
tests, expert judgment, modeling results).
3. DOE should prepare an executive summary to accompany the application that
discusses major issues and presents the final compliance results.
4. Units should be listed in Systeme Internationale (SI) terminology where possible, with
English units listed parenthetically.
5. The application should provide readily identified links between text, references,
appendices, and other information used in the compliance demonstration.
6. The application should provide a subject index as part of the application. This index
should contain key words and the sections and pages on which they are discussed in
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the application. If the information is in an appendix, it should be so noted along with
the section and page number. The following is an example of what should be in the
subject index:
Topic Section Page(s)
Computer codes 5.7 pp. 5-70 to 5-80
6.2-6.6 pp. 6-45 to 6-99
Appendix CODES pp. 1-250
Culebra Dolomite 2.4.3 pp. 2-56 to 2-58
2.7.2 pp. 2-99
6.4.1 pp. 6-105 to 6-111
Appendix ABC pp. 34-67
Gas generation 2.9.2 pp. 2-200
6.6.3 pp. 6-145 to 6-159
Appendix GG pp. 99-112
Matrix of 191 and 194 requirements 1.1 pp. 1-10
Quality Assurance 5.1-5.15 pp. 5-1 to 5-144
QAPD 5.2 pp. 5-5 to 5-40
Input parameters 5.8 pp. 5-81 to 5-99
Appendix PARAM pp. 1-99
Computer codes 5.7 pp. 5-70 to 5-80
7. Information in the application related to analyses should be presented so that EPA may
confirm the analyses. For example, the application should provide examples as
appropriate to explain calculations. If the example calculations are complex, they may
be placed in an appendix and appropriately cross-referenced in the main text.
8. The terms in the application must adhere to the definitions established by 40 CFR
Parts 191 and 194. DOE should not redefine terms.
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Subpart AGeneral Provisions
§194.1 Purpose, scope and applicability.
This part specifies criteria for the certification or any re-certification, or subsequent
actions relating to the terms or conditions of certification of the Department of Energy's
Waste Isolation Pilot Plant's compliance with the disposal regulations found at part 191 of
this chapter and pursuant to section 8(d)(l) and section 8(J), respectively, of the WIPP LWA.
The compliance certification application submitted pursuant to section 8(d)(l) of the WIPP
LWA and any compliance re-certification application submitted pursuant to section 8(j) of the
WIPP LWA shall comply with the requirements of this part.
§194.2 Definitions.
See Appendix A: Definitions of 40 CFR Parts 191 and 194.
§194.3 Communications.
(a) Compliance application(s) shall be:
(1) Addressed to the Administrator; and
(2) Signed by the Secretary.
(b) Communications and reports concerning the criteria in this part shall be:
(1) Addressed to the Administrator or the Administrator's authorized representative;
and
(2) Signed by the Secretary or the Secretary's authorized representative.
Any compliance application should be signed by the Secretary and any subsequent
communications regarding the application should be signed by either the Secretary or
the Secretary's authorized representative.
Any compliance application, and any other communications and/or reports concerning
compliance with 40 CFR Part 194, unless otherwise specified, should be addressed to
the Administrator, at the following address:
United States Environmental Protection Agency
Administrator
Office of the Administrator (A-100)
401 M Street, S.W.
Washington, D.C. 20460
§194.4 Conditions of compliance certification.
(a) Any certification of compliance issued pursuant to section 8(d)(l) of the WIPP
LWA may include such conditions as the Administrator finds necessary to support such
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certification.
(b) Whether stated therein or not, the following conditions shall apply in any such
certification:
(1) The certification shall be subject to modification, suspension or revocation by the
Administrator. Any suspension of the certification shall be done at the discretion of the
Administrator. Any modification or revocation of the certification shall be done by rule
pursuant to 5 U.S.C. 553. If the Administrator revokes the certification, the Department shall
retrieve, as soon as practicable and to the extent practicable, any waste emplaced in the
disposal system.
(2) Any time after the Administrator issues a certification, the Administrator or the
Administrator's authorized representative may submit a written request to the Department for
information to enable the Administrator to determine whether the certification should be
modified, suspended or revoked. Unless otherwise specified by the Administrator or the
Administrator's authorized representative, the Department shall submit such information to
the Administrator or the Administrator's authorized representative within 30 calendar days of
receipt of the request.
(3) Any time after the Administrator issues a certification, the Department shall report
any planned or unplanned changes in activities or conditions pertaining to the disposal
system that differ significantly from the most recent compliance application.
(i) The Department shall inform the Administrator, in writing, prior to making such a
planned change in activity or disposal system condition.
(ii) In the event of an unplanned change in activity or condition, the Department shall
immediately cease emplacement of waste in the disposal system if the Department determines
that one or more of the following conditions is true:
(A) The containment requirements established pursuant to § 191.13 of this chapter
have been or are expected to be exceeded;
(B) Releases from air eady-emplaced waste lead to committed effective doses that are
or are expected to be in excess of those established pursuant to § 191.15 of this chapter. For
purposes of this subparagraph (b)(3)(ii)(B), emissions from operations covered pursuant to
part 191, subpart A of this chapter are not included; or
(C) Releases have caused or are expected to cause concentrations ofradionuclides or
estimated doses due to radionuclides in underground sources of drinking water in the
accessible environment to exceed the limits established pursuant to part 191, subpart C of this
chapter.
(Hi) If the Department determines that a condition described in paragraph (b)(3)(ii) of
this section has occurred or is expected to occur, the Department shall notify the
Administrator, in writing, within 24 hours of the determination. Such notification shall, to the
extent practicable, include the following information:
(A) Identification of the location and environmental media of the release or the
expected release;
(B) Identification of the type and quantity of waste (in activity in curies of each
radionuclide) released or expected to be released;
(C) Time and date of the release or the estimated time of the expected release;
(D) Assessment of the hazard posed by the release or the expected release; and
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(E) Additional information requested by the Administrator or the Administrator's
authorized representative.
(iv) The Department may resume emplacement of waste in the disposal system upon
written notification that the suspension has been lifted by the Administrator.
(v) If the Department discovers a condition or activity that differs significantly from
what is indicated in the most recent compliance application, but does not involve conditions
or activities listed in paragraph (b)(3)(ii) of this section, then the difference shall be reported,
in writing, to the Administrator within 10 calendar days of its discovery.
(vi) Following receipt of notification, the Administrator will notify the Secretary in
writing whether any condition or activity reported pursuant to paragraph (b)(3) this section:
(A) Does not comply with the terms of the certification; and, if it does not comply,
(B) Whether the compliance certification must be modified, suspended or revoked.
The Administrator or the Administrator's authorized representative may request additional
information before determining whether modification, suspension or revocation of the
compliance certification is required.
(4) Not later than six months after the Administrator issues a certification, and at least
annually thereafter, the Department shall report to the Administrator, in writing, any changes
in conditions or activities pertaining to the disposal system that were not required to be
reported by paragraph (b)(3) of this section and that differ from information contained in the
most recent compliance application.
No information is required in a compliance application to fulfill this section of 40 CFR
Part 194.
§194.5 Publications incorporated by reference.
(a) The follow ing publications are incorporated into this part by reference:
(1) U.S. Nuclear Regulatory Commission, NUREG-1297 "Peer Review for High-Level
Nuclear Waste Repositories, " published February 1988; incorporation by reference (IBR)
approved for § 194.22, § 194.23 and § 194.27.
(2) American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance
(NQA) Standard, NQA-1-1989 edition, "Quality Assurance Program Requirements for
Nuclear Facilities;" IBR approved for § 194.22.
(3) ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition "Quality
Assurance Requirements for Nuclear Facility Applications;" IBR approved for § 194.22 and §
194.23.
(4) ASME NQA-3-1989 edition, "Quality Assurance Program Requirements for the
Collection of Scientific and Technical Information for Site Characterization ofHigh-Level
Nuclear Waste Repositories" [excluding section 2.1(b) and (c)]; IBR approved for § 194.22.
(b) The publications listed in paragraph (a) of this section were approved for
incorporation by reference by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFRpart 51. Copies may be inspected or obtained from the Air Docket,
Docket No. A-92-56, room Ml500 (LEI31), U.S. Environmental Protection Agency, 401M
Street, SW, Washington, DC 20460, or copies may be inspected at the Office of the Federal
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Register. SOON. Capitol Street NW, 7th floor, Suite 700, Washington, DC, or copies may be
obtained from the following addresses:
(1) For ASME standards, contact American Society of Mechanical Engineers, 22 Law
Drive, P.O. Box 2900, Fair field, NJ'07007-2900, phone 1-800-843-2763.
(2) For Nuclear Regulatory Commission documents, contact Division of Information
Support Services, Distribution Service, U.S. Nuclear Regulatory Commission, Washington,
DC 20555, or contact National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161, phone 703-487-4650.
No information is required in a compliance application to fulfill this section of 40 CFR
Part 194.
§194.6 Alternative provisions.
The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute for any of the
provisions of this part alternative provisions chosen after:
(a) The alternative provisions have been proposed for public comment in the Federal
Register together with information describing how the alternative provisions comport with the
disposal regulations, the reasons why the existing provisions of this part appear
inappropriate, and the costs, risks and benefits of compliance in accordance with the
alternative provisions;
(b) A public comment period of at least 120 days has been completed and public
hearings have been held in New Mexico;
(c) The public comments received have been fully considered; and
(d) A notice of final rulemaking is published in the Federal Register.
No information is required in a compliance application to fulfill this section of 40 CFR
Part 194.
§194.7 Effective date.
The criteria in this part shall be effective on April 9, 1996. The incorporation by
reference of certain publications listed in the criteria is approved by the Director of the
Federal Register as of April 9, 1996.
No information is required in a compliance application to fulfill this section of 40 CFR
Part 194.
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Subpart BCompliance Certification and Re-certification Applications
§194.11 Completeness and accuracy of compliance applications.
Information provided to the Administrator in support of any compliance application
shall be complete and accurate. The Administrator's evaluation for certification pursuant to
section 8(d)(l)(B) of the WIPP LWA and evaluation for re-certification pursuant to section
8(f)(2) of the WIPP LWA shall not begin until the Administrator has notified the Secretary, in
writing, that a complete application in accordance with this part has been received.
The concept of "completeness" is an administrative tool that EPA will use to screen any
compliance certification application (CCA) received from DOE as a preliminary step in the
more extensive technical review of the CAA. EPA intends to use the CAG to guide its
determination whether DOE has submitted a "complete" CCA for the WIPP. However, the
CAG is not legally binding for either EPA or DOE. The summarized information, clarifying
information, interpretations, and examples contained in the CAG are based on the regulatory
requirements established by 40 CFR Parts 191 and 194. Any inconsistencies between the
CAG and these rules are inadvertent and, in all circumstances, 40 CFR Parts 191 and 194 are
dispositive of any inconsistencies.
EPA's determination of completeness will focus on two questions: (1) Does the information
provided address the specific requirements for compliance with 40 CFR Part 194? and (2) Is
the information provided in what appears to be sufficient detail and format to enable the
Agency to review the technical adequacy of the application? However, even if the application
is determined to be complete, at any point during EPA's review of the application additional
information may be requested to assist the Agency in determining compliance in accordance
with §194.140).
The determination of completeness (or incompleteness) will be made by the Administrator,
who will then inform DOE in writing of any such decision, pursuant to the provisions of this
section of the compliance criteria. Any such written notification(s) to DOE will also be
placed in the docket for public examination.
§194.12 Submission of compliance applications.
Unless otherwise specified by the Administrator or the Administrator's authorized
representative, 30 copies of any compliance application, any accompanying materials, and
any amendments thereto shall be submitted in a printed form to the Administrator.
DOE should provide 30 copies of the application.
EPA will provide DOE with information on an appropriate format for electronic submission
of the application and the number of paper copies needed.
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§194.13 Submission of reference materials.
Information may be included by reference into compliance application(s), provided
that the references are clear and specific and that, unless otherwise specified by the
Administrator or the Administrator's authorized representative, 10 copies of the referenced
information are submitted to the Administrator. Referenced materials which are widely
available in standard textbooks or reference books need not be submitted.
EPA will provide DOE with information on an appropriate format for electronic submission
of references and the number of paper copies needed.
§194.14 Content of compliance certification application.
Any compliance application shall include:
(a) A current description of the natural and engineered features that may affect the
performance of the disposal system. The description of the disposal system shall include, at a
minimum, the following information:
(1) The location of the disposal system and the controlled area.
EPA expects that any compliance application will specify the:
physical setting;
size;
county;
township and range;
roads;
longitude and latitude;
appropriate graphics (maps, at a minimum); and
boundaries of the disposal system and controlled area.
(2) A description of the geology, geophysics, hydrogeology, hydrology and
geochemistry of the disposal system and its vicinity and how these conditions are expected to
change and interact over the regulatory time frame. Such description shall include, at a
minimum:
(i) Existing fluids and fluid hydraulic potential, including brine pockets, in and near
the disposal system; and
(ii) Existing higher permeability anhydrite interbeds located at or near the horizon of
the waste.
Geologic and geophysical characteristics include regional and site:
geologic history;
stratigraphy;
lithology;
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structural geology and geotectonics (e.g., geologic structure, tectonic history,
lineaments, fault or fracture zones, earthquake occurrence, subsidence);
seismic history (e.g., earthquake activity, relation of epicenters with geologic
structures and/or geologic setting);
geomorphology and topography (e.g., geomorphic units and processes, such as
secondary topographic features caused by erosion);
soil characteristics in the controlled area that affect infiltration and runoff (e.g.,
hydraulic conductivity, infiltration capacity); and
natural resources (e.g., type, occurrence, location, extent of minerals, hydrocarbons
and water, such as potash, oil, gas, irrigation water). See also §194.33 and §194.45.
Hydrologic, hydrogeologic, and geochemical descriptions are expected to include:
For all geologic units in the disposal system, general hydraulic characteristics:
hydraulic conductivity;
storage coefficients;
transmissivity;
permeability;
thickness;
matrix and fracture characteristics; and
hydraulic gradients.
For geological units that could be expected to transmit radionuclides to the accessible
environment during the regulatory time frame:
regional and site-specific recharge and discharge areas;
groundwater flow patterns, including horizontal flow (e.g., potentiometric surface,
flow direction, effect of density on flow direction) and the estimated vertical flow
into transmissive units;
general physical characteristics (e.g., fracturing, porositytotal, effective,
interstitial, and fractureand saturated thickness);
general transport characteristics (e.g., logitudinal and transverse dispersivity,
tortuosity, matrix and fracture characteristics, retardation (physical and chemical)
and a discussion of the characterization method(s) used);
flow boundaries, magnitudes and flow rates;
depth to water table (where applicable); and
geochemistry and geochemical history (e.g., total dissolved solids, mineral content
and distribution, fluid density, salinity).
EPA expects that any application will provide information on general hydrological,
hydrogeological and geochemical characteristics of the geological units in the disposal
system. In the description of the hydrogeology, hydrology and geochemistry, the application
should discuss the geological units that could be expected to transmit radionuclides to the
accessible environment during the regulatory time frame. For those geological units which
are not expected to transmit water, EPA recommends that the application discuss the basic
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hydrological properties that support this expectation.
(3) The presence and characteristics of potential pathways for transport of waste from
the disposal system to the accessible environment including, but not limited to: Existing
boreholes, solution features, breccia pipes, and other potentially permeable features, such as
interbeds.
(4) The projected geophysical, hydrogeologic and geochemical conditions due to the
presence of waste including, but not limited to, the effects of production of heat or gases from
the waste.
EPA recommends that this information be presented in any compliance application as part of
the waste information or the screening of events and processes. The information for this
requirement should be appropriately cross-referenced in all of the sections in which it is
discussed. See also §194.24, §194.32, and §194.54.
(b) A description of the design of the disposal system including:
A complete description of the disposal system design should include the designs, with
supporting documentation that demonstrates that the designs can be implemented and that
they will function in the manner for which they were designed. See §194.15(b).
{!) Information on materials of construction including, but not limited to: Geologic
media, structural materials, engineered barriers, general arrangement, and approximate
dimensions; and
(2) Computer codes and standards that have been applied to the design and
construction of the disposal system.
(c) Results of assessments conducted pursuant to the disposal regulations.
See §194.23, §194.24, §194.34, §194.42, §194.44, and §194.55 for relevant guidance.
(d) A description of input parameters associated with assessments conducted pursuant
to this part and the basis for selecting those input parameters.
EPA recommends that input parameter descriptions be linked to the appropriate discussions of
models and data. See §194.23, §194.34, and §194.55.
(e) Documentation of measures taken to meet the assurance requirements of this part.
See the guidance for assurance requirements at §194.41 through §194.46.
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(f) A description of waste acceptance criteria and actions taken to assure adherence to
such criteria.
See the guidance for §194.24(c)(4).
(g) A description of background radiation in air, soil and water in the vicinity of the
disposal system and the procedures employed to determine such radiation.
EPA expects the description to include background radiation in:
air;
soil; and
water.
EPA expects the procedures employed to determine such radiation to include:
locations in which the measurements were made;
dates on which the measurements were made;
standard statistics, such as mean and standard deviation;
discussion of problems (if any) encountered in the measurement process;
identification of the instrument used and lower limit of detection for the
instrumentation; and
documentation that the measurements were quality assured.
(h) One or more topographic map(s) of the vicinity of the disposal system. The
contour interval shall be sufficient to show clearly the pattern of surface water flow in the
vicinity of the disposal system. The map(s) shall include standard map notations and
symbols, and, in addition, shall show boundaries of the controlled area and the location of
any active, inactive, and abandoned injection and withdrawal wells in the controlled area and
in the vicinity of the disposal system.
EPA expects that:
the contour interval will be sufficient to show clearly the pattern of surface water flow
in the vicinity of the disposal system;
the map(s) will include:
standard map notations and symbols;
boundaries of the controlled area; and
the location of any active, inactive, and abandoned injection and withdrawal wells
in the controlled area and in the vicinity of the disposal system.
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EPA recommends that sufficient topographic and/or other maps be included, and that any
information on the maps be discussed in the text of the application, so that any information on
the maps will be clear to the reviewer.
(i) A description of past and current climatologic and meteorologic conditions in the
vicinity of the disposal system and how these conditions are expected to change over the
regulatory time frame.
EPA recommends that any compliance application list recent estimates, using existing written
records, of climatologic and meteorologic conditions in the vicinity of the disposal system in
tabular form, and briefly discuss the following:
record of annual and monthly precipitation averages;
record of monthly temperature averages and extremes;
wind speed and direction information that forms the basis for the exposure pathway
modeling; and
an estimate of evapotranspiration.
EPA expects any compliance application to discuss the past climatologic and meteorologic
conditions for the vicinity of the disposal system including:
climate changes, including past glaciation events; and
past precipitation and temperature averages and variability, estimated from the
geologic record, or other means.
EPA expects that any compliance application will include a discussion of how climatologic
and meteorologic conditions are expected to change during the 10,000-year regulatory time
period.
EPA further expects any compliance application to state how climatologic and meteorologic
changes were incorporated into the conceptual models used and how they were used in the
performance and compliance assessments, including:
potential changes and rates of change in precipitation, air temperatures, and resulting
changes in potential evapotranspiration from the present;
potential precipitation patterns that may evolve in the future as a result of climatic and
geologic changes; and
potential increased/decreased recharge to the disposal system.
For additional guidance, see §194.25, §194.32, §194.34, §194.54 and §194.55.
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(j) The information required elsewhere in this part or any additional information,
analyses, tests, or records determined by the Administrator or the Administrator's authorized
representative to be necessary for determining compliance with this part.
Even if the application is determined to be complete, at any point during EPA's review of the
application additional information may be requested to assist the Agency in determining
compliance in accordance with §194.14(j) .
§194.15 Content of compliance re-certification application(s).
(a) In submitting documentation of continued compliance pursuant to section 8(f) of
the WIPP LWA, the previous compliance application shall be updated to provide sufficient
information for the Administrator to determine whether or not the WIPP continues to be in
compliance with the disposal regulations. Updated documentation shall include:
(1) All additional geologic, geophysical, geochemical, hydrologic, and meteorologic
information;
(2) All additional monitoring data, analyses and results;
(3) All additional analyses and results of laboratory experiments conducted by the
Department or its contractors as part of the WIPP program;
(4) An identification of any activities or assumptions that deviate from the most recent
compliance application;
(5) A description of all waste emplaced in the disposal system since the most recent
compliance certification or re-certification application. Such description shall consist of a
description of the waste characteristics and waste components identified in § §194.24(b)(l)
and 194.24(b)(2);
(6) Any significant information not previously included in a compliance certification
or re-certification application related to whether the disposal system continues to be in
compliance with the disposal regulations; and
(7) Any additional information requested by the Administrator or the Administrator's
authorized representative.
(b) To the extent that information required for a re-certification of compliance
remains valid and has been submitted in previous certification or re-certification
application(s), such information need not be duplicated in subsequent applications; such
information may be summarized and referenced.
Section 8(f) of the WIPP Land Withdrawal Act requires DOE to submit documentation of
continued compliance with 40 CFR Part 191 every five years after the emplacement of waste
begins, if the initial certification is granted, and until completion of the decommissioning
phase. EPA expects the documentation to include any new information related to the disposal
system that was obtained during the five-year period after the emplacement of waste began, or
since the time of the most recent recertification.
EPA expects any compliance recertification application to include:
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information which updates the previous compliance certification or recertification;
a short summary of information provided in previous compliance applications;
updated computer codes; and
a list of changes which may affect the predicted radionuclide releases from the
disposal system. Possible changes include:
if the waste were emplaced so that high-curie waste is grouped together instead of
equally distributed;
changes resulting from monitoring the disposal system, or data collected from
continuing experiments, that alter the parameter values used in the models;
changes/improvements in the disposal system design, with documentation that the
changes improve performance and that they will function in the manner for which
they were designed; and
updated information from continuing studies.
If the computer codes are modified, DOE must submit updated codes and code listings. This
should be accompanied by the appropriate performance and compliance assessments.
See also §194.4, §194.23, §194.32, and §194.54.
EPA recommends that DOE continue geologic, geophysical, hydrogeologic, geochemical,
hydrologic, and meteorological studies of the site and the surrounding area as appropriate.
Any data, results, and interpretations yielded by such studies must be included in any
compliance recertification application. EPA must be notified immediately of any significant
information pursuant to §194.4.
EPA expects any compliance recertification application to include updated monitoring
information as follows:
pre-closure monitoring results collected during the five-year recertification period, and
a discussion of the data quality acceptability;
the implications of the results;
whether the results change or challenge the conceptual or computer model of the
disposal system, or a portion of the disposal system; and
whether, as a result of any changes, the projection of the system's performance
should be revised. See also §194.23.
EPA expects any compliance recertification application to include updated waste
emplacement information as follows:
information regarding the wastes that were emplaced during the five-year period
immediately following the time at which waste emplacement began, or the most recent
compliance recertification.
If assumptions about the waste or other aspects of the disposal system change, it is expected
that any compliance recertification application will contain the appropriate analyses
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describing such assumptions. EPA must be notified immediately of any significant
information pursuant to §194.4.
EPA expects the waste emplacement information to include the following:
the location and distribution of emplaced waste by waste components required for
waste characterization. See also §194.24;
confirmation that the location and distribution of waste conform to assumptions used
in performance assessments. See also §194.23, §194.32, §194.33, §194.34, §194.54,
and §194.55;
waste characteristics of waste emplaced and a demonstration that they continue to fall
within the requirements established under §194.24.
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Subpart C -- Compliance Certification and Re-Certification General Requirements
§194.21 Inspections.
(a) The Administrator or the Administrator's authorized representative(s) shall, at any
time:
(1) Be afforded unfettered and unannounced access to inspect any area of the WIPP,
and any locations performing activities that provide information relevant to compliance
application(s), to which the Department has rights of access. Such access shall be equivalent
to access afforded Department employees upon presentation of credentials and other required
documents.
EPA expects any compliance application to include:
a list of locations and facilities covered by this part. The list should include points of
contact, phone numbers, etc.
(2) Be allowed to obtain samples, including split samples, and to monitor and
measure aspects of the disposal system and the waste proposed for disposal in the disposal
system.
(b) Records (including data and other information in any form) kept by the
Department pertaining to the WIPP shall be made available to the Administrator or the
Administrator's authorized representative upon request. If requested records are not
immediately available, they shall be delivered within 30 calendar days of the request.
EPA expects any compliance application to include:
a complete list of the location of records, such as quality assurance records, data
acquisition records, and other information used to support the compliance application.
This list should be in the form of a table(s), cross-reference(s), or matrix, as
appropriate. See §194.14.
(c) The Department shall, upon request by the Administrator or the Administrator's
authorized representative, provide permanent, private office space that is accessible to the
disposal system. The office space shall be for the exclusive use of the Administrator or the
Administrator's authorized representative (s).
(d) The Administrator or the Administrator's authorized representative (s) shall
comply with applicable access control measures for security, radiological protection, and
personal safety when conducting activities pursuant to this section.
No information is required in a compliance application to fulfill this section of 40 CFR
Part 194.
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§194.22 Quality Assurance.
(a)(l) As soon as practicable after April 9, 1996, the Department shall adhere to a
quality assurance program that implements the requirements ofASME NQA-1-1989 edition,
ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition, andASME NQA-3-
1989 edition [excluding Section 2.1(b) and (c), and Section 17.1]. (Incorporation by
reference as specified in § 194.5.
EPA expects any compliance application to include:
DOE top tier QA documents for WIPP to demonstrate commitment to NQA-1 (1989),
NQA-2, part 2.7 (1990), and NQA-3 (1989) standards;
DOE principle contractor top tier QA documents, and a list of top tier QA documents
of all non-principle and/or subcontractors performing listed quality affecting activities
(see§194.22(a)(2)); and
the effective date of top-tier document conformance with the NQA requirements for
DOE and each listed contractor and subcontractor.
(2) Any compliance application shall include information which demonstrates that the
quality assurance program required pursuant to paragraph (a)(l) of this section has been
established and executed for:
(i) Waste characterization activities and assumptions;
(ii) Environmental monitoring, monitoring of the performance of the disposal system,
and sampling and analysis activities;
(Hi) Field measurements of geologic factors, ground water, meteorologic, and
topographic characteristics;
(iv) Computations, computer codes, models and methods used to demonstrate
compliance with the disposal regulations in accordance with the provisions of this part;
(v) Procedures for implementation of expert judgment elicitation used to support
applications for certification or re-certification of compliance;
(vi) Design of the disposal system and actions taken to ensure compliance with design
specifications;
(vii) The collection of data and information used to support compliance
application(s); and
(viii) Other systems, structures, components, and activities important to the
containment of waste in the disposal system.
For each of the eight areas listed above, EPA expects any compliance application to:
provide a list of quality affecting activities and items that are important to the
demonstration of compliance;
discuss the rationale used in preparation/development of the list;
provide (and make available for field review) objective evidence to support proper
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implementation of the rationale;
describe the process for selection of applicable NQA requirements and the means of
implementation of these requirements;
describe the means used to assess the flow down (or traceability) of applicable NQA
requirements from top tier documents to implementing procedures for the listed
activities;
describe the nature and location of objective evidence which substantiates the
traceability;
provide the grading criteria and describe the nature and location of objective evidence
which substantiates proper grading criteria application (if the graded QA approach has
been applied to the requirements of any of the listed activities);
provide the effective dates (month and year) of QA implementation conforming to
NQA for each listed activity or item, and describe the nature and location of objective
evidence which supports this determination (e.g., audit report, closeout of corrective
action, etc.). A tabular format is suggested;
describe the DOE and principal contractor QA assessments (audits) and corrective
action programs by providing:
principal rules for auditors (i.e. management procedures) for these programs;
a list of principal activities that have been done (i.e. audits, surveillance,
management reviews, tracking and closeout of corrective actions, and follow-up
audits);
schedules of principal activities;
the nature and location of objective evidence which supports a determination that
these program elements are effectively implemented; and
documentation of how the QA records (i.e. QA personnel training, QA audit
reports, and tracking of deficiencies records) are maintained and providing the
locations where the QA records are maintained.
The descriptions of listed activities and objective evidence of QA implementation should be
sufficiently detailed to allow EPA to evaluate the DOE QA audit and corrective action
programs through selection of a sample of activities, procedures, training records, etc., and
verification of records in the field.
b) Any compliance application shall include information which demonstrates that
data and information collected prior to the implementation of the quality assurance program
required pursuant to paragraph (a)(l) of this section have been qualified in accordance with
an alternate methodology, approved by the Administrator or the Administrator's authorized
representative, that employs one or more of the following methods: "Peer review, conducted
in a manner that is compatible with NUREG-1297, "Peer Review for High-Level Nuclear
Waste Repositories, " published February 1988 (incorporation by reference as specified in §
194.5); corroborating data; confirmatory testing; or a quality assurance program that is
equivalent in effect to ASMENQA-1-1989 edition, ASMENQA-2a-1990 addenda, part 2.7, to
ASMENQA-2-1989 edition, andASMENQA-3-1989 edition (excluding Section 2.1(b) and (c)
and Section 17.1). (Incorporation by reference as specified in § 194.5.)
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EPA expects any compliance application to:
provide a list which identifies pre-existing data records packages which are used in the
compliance demonstration and list the locations of these data records packages;
provide the rationale and alternate methodologies used in qualifying each listed
package;
describe the QA requirements and the process for developing the qualification of
existing data (QED) alternate methodologies, which may include the use of equivalent
QA procedures, peer review procedures, corroborating data procedure, and
confirmatory testing procedures;
provide the QED governing documents that include procedures and management plans
for independent review, peer review, use of corroborating data, etc;
describe the nature and location of QA records generated during the conduct of QED
(i.e., independent review team conclusions, qualification of independent personnel,
review records, QED final decisions, auditing records, and deficiencies correction
records);
describe other records such as scientific notebooks, roadmaps, checklists, peer review
process documentation and records, documentation of corroborating data, final
decision and approval of qualified data records packages, data interpretations,
parameter value determination process records; and
describe the nature and location of objective evidence which demonstrates that QA
requirements have been effectively implemented in the QED process.
(c) Any compliance application shall provide, to the extent practicable, information
which describes how all data used to support the compliance application have been assessed
for their quality characteristics, including:
(1) Data accuracy, i.e., the degree to which data agree with an accepted reference or
true value;
(2) Data precision, i.e., a measure of the mutual agreement between comparable data
gathered or developed under similar conditions expressed in terms of a standard deviation;
(3) Data representativeness, i.e., the degree to which data accurately and precisely
represent a characteristic of a population, a parameter, variations at a sampling point, or
environmental conditions;
(4) Data completeness, i.e., a measure of the amount of valid data obtained compared
to the amount that was expected; and
(5) Data comparability, i.e., a measure of the confidence with which one data set can
be compared to another.
EPA expects any compliance application to:
specify, for each set of measured or published data, the level of quality indicators
required to be for its intended use in the WIPP compliance demonstration (see
guidance for §194.22(d)). When practicable, it must be expressed in terms of the data
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quality indicators on the list at §194.22(c). Alternatively, it is acceptable to specify the
degree of uncertainty that is tolerable in the data to attain the required degree of
confidence in the results of the compliance demonstration. EPA will consider this
information in evaluating the effectiveness of alternative methods for QED.
(d) Any compliance application shall provide information which demonstrates how all
data are qualified for use in the demonstration of compliance.
EPA expects any compliance application to:
describe the use of each data set in the demonstration of compliance (e.g., construction
of the distribution of an input parameter, selection of a particular conceptual model,
basis of assumptions about the waste inventory which are used in the PA, etc.).
describe how each data set was qualified. A tabular format is suggested; and
provide objective evidence to demonstrate that the intended use of each data set was
considered during the qualification process.
DOE should provide documentation to demonstrate the traceability of data, from collection
through data interpretation, to determination of parameter values and PA input parameters
which are based upon measured or published data. EPA will consider this information in its
evaluation of the effectiveness of alternative methodologies for QED.
(e) The Administrator will verify appropriate execution of quality assurance programs
through inspections, record reviews and record keeping requirements, which may include, but
may not be limited to, surveillance, audits and management systems reviews.
EPA may request additional documentation to verify QA implementation in selected program
areas. Also, additional QA audits or other activities may be conducted in specific topic areas,
if EPA identifies an area that is not clearly addressed in the compliance application
documentation.
EPA may conduct a field inspection of selected records to verify DOE's QA implementation.
Records which are cited by DOE as objective evidence must be made available for review. If
classified material is involved, EPA will provide reviewers with clearances.
In the event that DOE cannot demonstrate the effectiveness of its Q A assessment and
corrective action programs, EPA will conduct independent QA audits of activities.
§194.23 Models and computer codes.
(a) Any compliance application shall include:
(1) A description of the conceptual models and scenario construction used to support
any compliance application.
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EPA expects any compliance application to include:
a description of the conceptual models used; and
a description of the scenario construction development.
Conceptual models provide a broad overview of the disposal system, including processes that
may occur during the regulatory time frame at the WIPP, and they incorporate simplifying
assumptions regarding the behavior of the disposal system. EPA expects that the
documentation of conceptual models will discuss site and other characteristics, such as
processes active on the site. The conceptual models used at WIPP should represent those
characteristics and attributes of the WIPP disposal system that reasonably describe the
disposal system's performance. EPA expects that conceptual models will be considered
broadly, with conceptual models for the natural and engineered aspects of the WIPP and
subsystem component models that describe in more detail each part of the total disposal
system. See Figure 1. For example, the shaft seal subsystem consists of many individual
components that make-up the total shaft seal system, and the process of gas generation
consists of many individual components, such as the corrosion of metal drums and the
interaction of cellulosic material and brine.
EPA expects any compliance application to use this broad conceptualization to identify the
subsystem conceptual models. Both the overall site conceptual model and the subsystem
conceptual models are expected to be peer reviewed. See §194.23(a)(3)(v) and §194.27.
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FIGURE - 1 CONCEPTUAL MODEL
OVERALL
CONCEPTUAL
MODEL
SUBSYSTEM
A
SUBSYSTEM
B
SUBSYSTEM
C
SUBSYSTEM
A
COMPONENT
1
SUBSYSTEM
B
COMPONENT
1
SUBSYSTEM
C
COMPONENT
1
SUBSYSTEM
A
COMPONENT
2
SUBSYSTEM
B
COMPONENT
2
SUBSYSTEM
C
COMPONENT
2
SUBSYSTEM
C
COMPONENT
3
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Each conceptual model selected should be discussed in sufficient detail to allow EPA to
follow the logical development of each selected conceptual model, from characteristics
learned following characterization and other activities that describe the disposal system and its
subsystems, to the final conceptual models used.
As well as being a product, conceptual models also are an important part of the scenario
construction (see §194.32). EPA expects scenario construction to be documented in sufficient
detail to EPA to understand the relationship between the scenarios selected and why other
scenarios were rejected.
(2) A description of plausible, alternative conceptual model(s) seriously considered
but not used to support such application, and an explanation of the reason(s) why such
model(s) was not deemed to accurately portray performance of the disposal system.
EPA expects any compliance application to include:
a description of plausible alternative conceptual models considered but not used; and
an explanation of why these models were not used.
The description of rejected, plausible, alternative, conceptual models is not expected to be as
comprehensive as that for the models actually used, but should adequately document why the
models were not utilized.
Examples of plausible, alternative models are those used to describe ground water flow in the
Culebra Dolomite (matrix, dual porosity, channeling) and flow in the Salado (clay,
reconsolidation, Darcey flow).
(3) Documentation that:
(i) Conceptual models and scenarios reasonably represent possible future states of
the disposal system;
EPA expects any compliance application to include a demonstration that:
the conceptual models and scenarios reasonably represent the disposal system.
See §194.32 and §194.54 for additional guidance.
(ii) Mathematical models incorporate equations and boundary conditions which
reasonably represent the mathematical formulation of the conceptual models;
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EPA expects any compliance application to include:
a discussion of the development of mathematical models based on the conceptual
models.
(Hi) Numerical models provide numerical schemes which enable the mathematical
models to obtain stable solutions;
EPA expects any compliance application to include:
a discussion(s) of the numerical models developed from the mathematical models; and
information which demonstrates the numerical models produce stable solutions.
(iv) Computer models accurately implement the numerical models; i.e., computer
codes are free of coding errors and produce stable solutions;
EPA expects any compliance application to include a demonstration that:
the computer models (codes) developed from numerical models are accurate;
the computer codes are free of coding errors; and
the computer codes produce stable solutions.
EPA recommends that the description of conceptual models show the connection between the
system characteristics learned during site characterization and other activities, events, and
processes that are represented in the conceptual models developed (see §194.32(e)). The
information should also be reflected in the mathematical representation of conceptual models
and numerical models, including initial and boundary conditions that are coded into the
computer software that implements these models.
(v) Conceptual models have undergone peer review according to § 194.27.
EPA expects any compliance application to include:
a demonstration that the conceptual model(s) selected by DOE were peer reviewed and
documented in accordance with §194.27.
EPA expects that peer review of conceptual models will evaluate the various subsystems of
the site conceptual models. EPA expects each of these subsystems to be evaluated for its
adequacy as a part of the conceptual model(s).
The fundamental question that peer review should answer is, "Do the final conceptual
model(s) and the subsystem components used in the compliance application represent a
reasonable approximation of the actual disposal system?" The results of the peer review
process should be
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documented according to the requirements of §194.27 to show clearly the subsystem
components that were evaluated and the results of the peer review.
EPA expects any compliance application to include:
documentation that demonstrates that the requirements of NUREG-1297, Section IV.5
have been fulfilled. Such documentation includes:
a listing of the reviewers;
acceptability requirements for each reviewer;
a discussion of the conceptual models peer reviewed;
individual statements by peer reviewers reflecting dissenting views;
an evaluation of data and information used to develop conceptual models,
including attributes of the disposal system learned during site characterization
activities, such as room creep closure or disturbed rock zone characteristics;
an evaluation of the validity of conceptual model assumptions;
an evaluation of alternate conceptual models;
an evaluation of the uncertainty in the conceptual models and a discussion of
consequences if the conceptual model chosen is inappropriate for the site;
a statement indicating the adequacy of the conceptual models used for the disposal
system;
a statement of the accuracy of the results based on the conceptual models
employed; and
a discussion of the validity of the conclusions drawn based on the conceptual
models.
(b) Computer codes used to support any compliance application shall be documented
in a manner that complies with the requirements ofASMENQA-2a-1990 addenda, part 2.7,
to ASME NQA-2-1989 edition. (Incorporation by reference as specified in § 194.5.}
EPA expects any compliance application to include:
a demonstration that the computer codes are documented in compliance with quality
assurance requirements of ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-
1989 edition Section 6.
The development of computer codes should adhere to the quality assurance requirements
specified in §194.22 and should be documented according to the requirements of ASME
NQA-2a-1990 addenda, part 2.7, Section 6. EPA expects this documentation to include
plan(s) for quality assurance software, software requirements documentation, software design
and implementation documentation, software verification and validation documentation, and
user documentation.
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(c) Documentation of all models and computer codes included as part of any
compliance application performance assessment calculation shall be provided. Such
documentation shall include, but shall not be limited to:
(1) Descriptions of the theoretical backgrounds of each model and the method of
analysis or assessment;
EPA expects any compliance application to include:
a description of the theoretical background of each model; and
a description of the method of analysis or assessment.
(2) General descriptions of the models; discussions of the limits of applicability of
each model; detailed instructions for executing the computer codes, including hardware and
software requirements, input and output for mats with explanations of each input and output
variable and parameter (e.g., parameter name and units); listings of input and output files
from a sample computer run; and reports on code verification, benchmarking, validation, and
quality assurance procedures;
EPA expects any compliance application to include:
a general description of each model;
a description of limits of applicability of each model;
detailed instructions for executing the computer codes;
hardware and software requirements;
input and output formats with explanations of each input and output variable and
parameter;
listings of input and output files from sample computer runs; and
reports on code verification, benchmarking, validation, and quality assurance
procedures.
EPA expects this documentation to present the general description of each model and describe
any limiting assumptions or conditions placed on each model developed. These limitations,
assumptions, or conditions should be presented with sufficient detail to allow the reviewer to
understand their impact on the performance and accuracy of model results.
(3) Detailed descriptions of the structure of computer codes and complete listings of
the source codes;
EPA expects any compliance application to include:
detailed descriptions of the structure of computer codes; and
a complete listing of the source codes.
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EPA expects the documentation of computer codes to describe the structure of computer
codes with sufficient detail to allow EPA to understand how software subroutines are linked
and how the code structure operates to provide accurate solutions of the conceptual models.
EPA recommends the usage of flowcharts to assist the reviewer's understanding of the
linkage of code structure, code subroutines, and each computer code.
(4) Detailed descriptions of data collection procedures, sources of data, data
reduction and analysis, and code input parameter development;
EPA expects any compliance application to include a:
detailed listing of the code input parameters;
listing of the input parameters that were sampled;
description of the parameters, including units;
listing of the model(s) and code(s) in which the parameter was used and the computer
code (i.e., material and parameter) name(s) of the parameter that was sampled;
discussion of any correlations between sampled parameters;
discussion of the importance of the sampled parameter relative to final releases;
discussion of how correlations between sampled parameters are addressed in
performance assessments;
description of data collection procedures;
description of sources of data;
description of data reduction and analysis;
description of code input parameter development;
discussion of the linkage between the input parameter information and the data used to
develop the input information;
listing of the sources of data used (e.g., experimentally derived, standard textbook
values, and results of other computer codes); and
data reduction/analysis used for performance assessment (PA) calculations, including
an explanation of quality assurance activities. See §194.22 and §194.34(b) for
additional guidance.
(5) Any necessary licenses; and
EPA expects any compliance application to include:
any computer code licenses necessary to execute or use computer codes documented
in any compliance application.
(6) An explanation of the manner in which models and computer codes incorporate
the effects of parameter correlation.
EPA expects any application to include:
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a discussion that explains how the effects of parameter correlation are incorporated;
an explanation of the mathematical functions that describe these relationships; and
a description of the potential impact on the sampling of uncertain parameters. See
§194.34(b) for additional guidance.
EPA expects the effects of parameter correlation to be documented for both conceptual
models and the formulation of computer codes. Sufficiently detailed instructions for the
successful execution of the computer codes are expected to be provided with:
a description of hardware and software requirements;
complete input and output parameter formats, as part of the execution instructions;
a complete listing and explanation of input and output files, that may be used for
running sample computer runs;
reports on code verification, benchmarking, and validation procedures; and
evidence of adherence to the quality assurance procedures required in §194.22.
(d) The Administrator or the Administrator's authorized representative may verify the
results of computer simulations used to support any compliance application by performing
independent simulations. Data files, source codes, executable versions of computer software
for each model, other material or information needed to permit the Administrator or the
Administrator's authorized representative to perform independent simulations, and access to
necessary hardware to perform such simulations, shall be provided within 30 calendar days
of a request by the Administrator or the Administrator's authorized representative.
EPA expects any compliance application to identify points of contact to facilitate this
process.
§194.24 Waste Characterization.
(a) Any compliance application shall describe the chemical, radiological and physical
composition of all existing waste proposed for disposal in the disposal system. To the extent
practicable, any compliance application shall also describe the chemical, radiological and
physical composition of to-be-generated waste proposed for disposal in the disposal system.
These descriptions shall include a list of waste components and their approximate quantities
in the waste. This list may be derived from process knowledge, current non-destructive
examination/assay, or other information and methods.
EPA expects any compliance application to:
provide a description (chemical, radiological, physical) of existing waste;
list approximate quantities of waste components in each description; and
provide similar descriptions for to-be-generated waste, to the extent practicable.
The physical description of waste may include: the types of items, articles, and materials
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present in the waste (including void space); a description of physical forms and initial liquids
present in the category (both free and bound); and the types and properties of the containers to
be used for disposal.
The chemical description may include: process chemicals likely to be present in the waste; all
added components (neutralizers, stabilizers, solidifiers, etc.) including approximate total
quantities; and the chemical properties of other items present that could impact performance.
The radiological description may include: the species and quantities of the radioisotopes
present in the waste; information on the expected distribution of curie loading by container;
the surface radiation levels of containers, including types of radiation; and the classification of
the waste material, such as contact-handled or remote-handled transuranic waste.
The waste description may be rather lengthy, due to the heterogeneous nature of transuranic
waste and the presence of numerous components that are present in quantity and have the
potential to affect solubility, gas generation, criticality, etc. EPA expects that the waste
description will be detailed enough to enable EPA to have confidence that no component that
is present in transuranic waste and has significant potential to influence releases of
radionuclides has been overlooked. It is expected that the description will be semi-
quantitative, based upon both waste measurement data and process knowledge that are readily
available at the waste generator sites and well documented, best-judgement estimates of what
will be generated in the future.
(b) The Department shall submit in the compliance certification application the
results of an analysis which substantiates:
(1) That all waste characteristics influencing containment of waste in the disposal
system have been identified and assessed for their impact on disposal system performance.
The characteristics to be analyzed shall include, but shall not be limited to: solubility;
formation of colloidal suspensions containing radionuclides; production of gas from the
waste; shear strength; comparability; and other waste-related inputs into the computer
models that are used in the performance assessment.
(2) That all waste components influencing the waste characteristics identified in
paragraph (b)(l) of this section have been identified and assessed for their impact on
disposal system performance. The components to be analyzed shall include, but shall not be
limited to: metals; cellulosics; chelating agents; water and other liquids; and activity in
curies of each isotope of the radionuclides present.
(3) Any decision to exclude consideration of any waste characteristic or waste
component because such characteristic or component is not expected to significantly
influence the containment of the waste in the disposal system.
EPA expects any compliance application to provide a waste characterization analysis that
includes:
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a detailed description of the analysis performed;
a list of waste characteristics retained as a result of the analysis;
a list of waste components influencing these characteristics that are retained as a result
of the analysis;
identification of all waste related inputs into computer models;
a list of all waste characteristics and components (tabular format suggested) that were
considered and excluded, including the rationale for exclusion.
EPA expects that DOE will present rationales, logical arguments, applications of screening
procedures, results of bounding or sensitivity analyses, etc., beginning from the description
required by §194.24(a) and leading to the selection of the important or significant waste
components that will be limited and controlled to assure compliance with the disposal
regulations. The identification of significant waste characteristics is an important step in this
process, and EPA expects to see a list of all potential processes considered that involve waste
and disposal system interactions. It should be obvious that any measured or assumed waste
property that is used either directly or indirectly in performance assessments should be present
on the list of waste characteristics and components, and that any significant waste
characteristic or component is addressed in performance assessments.
In accordance with §194.27, a description of the scope of peer review of the waste
characterization analysis is expected to be provided, along with a discussion of reviews of
technical issues, evaluations and recommendations as to the adequacy of the analysis, and
follow-up actions. Also, objective evidence supporting decisions (peer review process
documentation, conclusions, etc.) and the location of the evidence should be cited.
(c) For each waste component identified and assessed pursuant to paragraph (b) of
this section, the Department shall specify the limiting value (expressed as an upper or lower
limit of mass, volume, curies, concentration, etc.), and the associated uncertainty (i.e., margin
of error) for each limiting value, of the total inventory of such waste proposed for disposal in
the disposal system.
EPA expects any compliance application to:
specify the limiting value of the waste component;
note whether the limiting value is an upper or lower limiting value; and
provide the associated uncertainty with each waste component limiting value.
EPA expects the waste related inputs to computer models identified pursuant to §194.24(b)(l)
to be clearly related to the waste components identified under §194.24(b)(2). Further, this
relationship should result in the specification of delimiting values for each of the waste
components (maxima or minima, as appropriate), so that there is a clear connection between
the waste related code inputs used to model performance and the components of the waste
inventory.
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For example, actinide solubility is modeled using assumptions about various components of
the inventory (chelating agents, buffers, acids, bases, salts, etc.) that may influence solubility.
Fulfillment of this requirement for the waste characteristic of actinide solubility would
involve the specification of the limiting value for solubility, with the range of the components
affecting solubility that are expected to be part of the total inventory.
Any compliance application shall:
(1) Demonstrate that, for the total inventory of waste proposed for disposal in the
disposal system, W1PP complies with the numeric requirements of § 194.34 and § 194.55 for
the upper or lower limits (including the associated uncertainties), as appropriate, for each
waste component identified in paragraph (b)(2) of this section, and for the plausible
combinations of upper and lower limits of such waste components that would result in the
greatest estimated release.
EPA expects any compliance application to provide:
a description of the plausible combinations of upper and lower limits of waste and
their associated uncertainties;
a rationale for the selection of these combinations;
the results of a modeling run of the code, using values to input parameters
corresponding to values of waste components fixed at the limiting values;
a demonstration that the results of the analysis show that the disposal system complies
with the numeric requirements under these conditions; and
documentation that the combination of the selected limits results in the greatest
estimated release.
(2) Identify and describe the method(s) used to quantify the limits of waste
components identified in paragraph (b)(2) of this section.
EPA expects any compliance application to specify:
the method which is/will be used to quantify each waste component (e.g., process
knowledge, non-destructive assay, non-destructive examination, visual inspection,
statistical sampling and analysis, etc.);
how each method will be used to quantify the amounts of listed waste components
prior to disposal;
the procedure followed and the scale to which the method is applied (e.g., individual
waste container, batch, statistical sample of drums, etc.);
the instrumentation used and its sensitivity; and
the parameter measured and how it is related to the waste component in question.
EPA also expects any compliance application to:
describe how the data obtained by each method meet or exceed any quality assurance
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indicators or data quality indicators that have been assumed or derived relative to
waste related inputs to the modeling of compliance.
Discussions of quantification methods may be referenced in documentation of existing quality
assurance or methods documentation.
EPA expects any compliance application to:
demonstrate the ability to quantify each of the listed waste components (for purposes
of control, at the precision and accuracy adequate to assure that limiting values will
not be exceeded in the inventory shipped to WIPP). See additional requirements at
§194.24(c)(5).
(3) Provide information which demonstrates that the use of process knowledge
to quantify components in waste for disposal conforms with the quality assurance
requirements found in §194.22.
EPA expects any compliance application to:
provide information, including standardized guidance or directives, training
documents, etc., used in connection with control of the use of process knowledge;
cite (and make available for field review) objective evidence substantiating the degree
of implementation of quality assurance (such as audit reports, status of corrective
actions, etc.) for each generator site that is approved to use process knowledge for
characterization; and
provide an implementation plan for application of quality assurance requirements to
process knowledge at remaining sites.
Refer to 194.22(a)(2)(i). "Waste characterization assumptions" means the use of process
knowledge qualitatively or quantitatively to characterize transuranic waste for purposes of
demonstrating compliance with 40 CFR Part 191, or for purposes of meeting waste
acceptance criteria prior to shipment of waste to WIPP. EPA expects that this activity will be
performed under a quality assurance program as required in 194.22(a)(l).
(4) Provide information which demonstrates that a system of controls has been and
will continue to be implemented to confirm that the total amount of each waste component
that will be emplaced in the disposal system will not exceed the upper limiting value or fall
below the lower limiting value described in the introductory text of paragraph (c) of this
section. The
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system of controls shall include, but shall not be limited to: measurement; sampling; chain of
custody records; record keeping systems; waste loading schemes used; and other
documentation.
EPA expects any compliance application to:
describe the system for maintaining centralized control over the waste characterization
activities and the authorization of grants to generator sites to characterize and ship
waste to WIPP;
describe the mechanism for maintaining chain of custody over waste and waste
records from the point of characterization to the point of disposal;
describe controls currently in place for receipt of waste at the WIPP, including:
provisions for records and shipment surveys, acceptance and emplacement of waste,
and provisions for dealing with non-conforming waste/waste records; and cite
applicable procedures;
describe the record keeping/accounting system for controlling limited waste
components for verification of emplacement of waste; and
provide the current WIPP Waste Acceptance Criteria (WIPPWAC) document and
identify all (WIPPWAC) requirements or controls that are relevant to compliance with
40 CFR Part 194 (i.e., those criteria specifically related to performance). See
§194.14(f).
EPA expects any evidence that substantiates compliance to be provided as part of any
compliance application, or when cited, to be available for inspection. This includes evidence
that substantiates that waste components for which inventory limits were set in accordance
with §194.24(c) are monitored, controlled, and accounted for in a systematic and traceable
manner in the waste proposed for disposal at the WIPP, including waste that undergoes
treatment or repackaging, remote-handled and contact-handled wastes, and to-be-generated
waste.
(5) Identify and describe such controls delineated in paragraph (c)(4) of this section
and confirm that they are applied in accordance with the quality assurance requirements
found in § 194.22.
EPA expects any compliance application to:
describe all Performance Demonstration Programs (PDPs) used to certify the
measurements capability and comparability of waste generation sites;
provide all governing documents for PDPs;
cite (and make available for field review) objective evidence of the status of current
implementation of PDPs (schedule of past and planned tests, reports on test rounds
conducted, etc.);
provide or cite (and make available for field review) standardized Methods Manuals,
Sampling and Analysis Procedures manuals, etc., which are used to standardize waste
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characterization methodologies, if not provided under §194.24(c)(2).
cite (and make available for field review) objective evidence (e.g., audit reports,
certification reports, etc.) of the status of current implementation methods/procedures.
See §194.22(a)(2) for guidance regarding quality assurance for waste characterization
activities. EPA expects to see documentation of quality assurance for waste characterization
activities from the point of generation (for to-be-generated waste) to the point of emplacement
and disposal at the WIPP.
(d) The Department shall include a waste loading scheme in any compliance
application, or else performance assessments conducted pursuant to § 194.32 and
compliance assessments conducted pursuant to § 194.54 shall assume random placement of
waste in the disposal system.
EPA expects any compliance application to:
provide a final plan for waste loading that addresses the emplacement of waste and
implements any assumptions about the distribution of such waste that were used in the
descriptions of performance assessments, and provide a cross-reference to waste
distribution assumptions made in performance assessments; and
address the requirement of §194.24(f) in the emplacement plan by describing how the
planned distribution will be achieved, with specification of acceptance criteria for
implementation and the controls that will be in place to assure proper implementation
of the plan.
(e) Waste may be emplaced in the disposal system only if the emplaced components of
such waste will not cause:
(1) The total quantity of waste in the disposal system to exceed the upper limiting
value, including the associated uncertainty, described in the introductory text to paragraph
(c) of this section; or
(2) The total quantity of waste that will have been emplaced in the disposal system,
prior to closure, to fall below the lower limiting value, including the associated uncertainty,
described in the introductory text to paragraph (c) of this section.
This requirement is applicable to all waste proposed for emplacement in the WIPP. Any
compliance application should demonstrate how this requirement will be addressed in its
response to §194.24(c)(4). This requirement should also be addressed in recertification
applications.
(f) Waste emplacement shall conform to the assumed waste loading conditions, if any,
used in performance assessments conducted pursuant to § 194.32 and compliance
assessments conducted pursuant to § 194.54.
See discussion at §194.24(d). If random placement is assumed in performance assessments,
documentation should be submitted that addresses how it will be achieved in actual
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emplacement.
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(g) The Department shall demonstrate in any compliance application that the total
inventory of waste emplaced in the disposal system complies with the limitations on
transuranic waste disposal described in the W1PP LWA.
EPA expects any compliance application to:
describe the inventory of waste proposed for disposal at the WIPP in terms of the units
specified in the limitations of the LWA, in addition to limits of important waste
components; and
describe how these limitations will be assured through implementation of the required
system of controls.
(h) The Administrator will use inspections and records reviews, such as audits, to
verify compliance with this section.
See §194.21.
§194.25 Future State Assumptions.
(a) Unless otherwise specified in this part or in the disposal regulations, performance
assessments and compliance assessments conducted pursuant the provisions of this part to
demonstrate compliance with § 191.13, § 191.15, and part 191, subpart C shall assume that
characteristics of the future remain what they are at the time the compliance application is
prepared, provided that such characteristics are not related to hydrogeologic, geologic or
climatic conditions.
EPA expects any compliance application to:
identify and explain future state assumptions in reference to performance assessments
and compliance assessments and clearly cross-reference where appropriate;
provide a list showing where future state assumptions have been applied;
document the scenarios in which the exempted characteristics (hydrogeologic,
geologic or climatic) may interact and influence the assumptions; and
indicate the potential variations, if any, in the assumed characteristics at the time of
initiation.
(b) In considering future states pursuant to this section, the Department shall
document in any compliance application, to the extent practicable, effects of potential future
hydrogeologic, geologic and climatic conditions on the disposal system over the regulatory
time frame. Such documentation shall be part of the activities undertaken pursuant to §
194.14, Content of compliance certification application; § 194.32, Scope of performance
assessments; and § 194.54, Scope of compliance assessments.
(1) In considering the effects of hydrogeologic conditions on the disposal system, the
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Department shall document in any compliance application, to the extent practicable, the
effects of potential changes to hydrogeologic conditions.
EPA expects any compliance application to include:
the potential impact of increased precipitation on recharge location and capacity,
hydraulic gradient and characteristics in the Culebra member of the Rustler Formation
and the Dewey Lake Formation;
likely uncertainties associated with analyses conducted in accordance with
§194.25(b)(l);and
other potential changes to hydrogeologic conditions.
EPA expects the effects of hydrogeologic conditions to be considered as part of the analyses
in compliance and performance assessments. See §194.32, §194.34, §194.54 and §194.55.
(2) In considering the effects of geologic conditions on the disposal system, the
Department shall document in any compliance application, to the extent practicable, the
effects of potential changes to geologic conditions, including, but not limited to: Dissolution;
near surface geomorphic features and processes; and related subsidence in the geologic units
of the disposal system.
EPA expects any compliance application to:
list the assumptions on which the geologic conditions in the disposal system are
projected to change;
list the changes in geologic conditions that are projected to change in both disturbed
and undisturbed cases over the 10,000-year regulatory period;
discuss how conditions are projected to change;
document uncertainties in the analyses; and
address other potential changes to geologic conditions.
EPA expects the effects of geologic conditions to be considered as part of the analyses in
compliance and performance assessments. See §194.32, §194.34, §194.54 and §194.55.
(3) In considering the effects of climatic conditions on the disposal system, the
Department shall document in any compliance application, to the extent practicable, the
effects of potential changes to future climate cycles of increased precipitation (as compared to
present conditions).
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EPA expects any compliance application to contain:
a list of potential scenarios that are likely to be affected by climatic changesin the
form of increased precipitation and evaporationover the 10,000-year regulatory
period;
a description of how these scenarios are likely to be affected;
a discussion of the potential impact of climatic changes on the geologic conditions
identified in §194.25 (b)(2); and
other potential changes to climatic conditions.
EPA expects the effects of climatic conditions to be considered as part of the analyses in
compliance and performance assessments. See §194.32, §194.34, §194.54 and §194.55.
§194.26 Expert Judgment.
(a) Expert judgment, by an individual expert or panel of experts, may be used to
support any compliance application, provided that expert judgment does not substitute for
information that could reasonably be obtained through data collection or experimentation.
(b) Any compliance application shall:
(1) Identify any expert judgments used to support the application and shall identify
experts (by name and employer) involved in any expert judgment elicitation processes used to
support the application.
EPA expects any compliance application to:
identify those places in the application where the results of any expert judgment
elicitation were incorporated;
explain why data were not obtained, either by experimentation or from the results of
previous experiments; and
include an estimate of the time and level of effort that would have been required to
obtain data experimentally, if applicable.
(2) Describe the process of eliciting expert judgment, and document the results of
expert judgment elicitation processes and the reasoning behind those results. Documentation
of interviews used to elicit judgments from experts, the questions or issues presented for
elicitation of expert judgment, background information provided to experts, and deliberations
and formal interactions among experts shall be provided. The opinions of all experts
involved in each elicitation process shall be provided whether the opinions are used to
support compliance applications or not.
EPA expects any compliance application to include:
documentation of all interviews with expert panel members conducted during the
formal elicitation process;
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any written material distributed to expert panel members by a facilitator;
copies of written summaries of the responses that are given to the other experts
(applies to the Delphi method) in cases where the responses of the experts were
elicited individually by a facilitator;
documentation of any interactive sessions among the experts themselves; and
documentation of all presentations of technical evidence.
(3) Provide documentation that the following restrictions and guidelines have been
applied to any selection of individuals used to elicit expert judgments:
(i) Individuals who are members of the team of investigators requesting the judgment
or the team of investigators who will use the judgment were not selected; and
(ii) Individuals who maintain, at any organizational level, a supervisory role or who
are supervised by those who will utilize the judgment were not selected.
(4) Provide information which demonstrates that:
(i) The expertise of any individual involved in expert judgment elicitation comports
with the level of knowledge required by the questions or issues presented to that individual;
and
(ii) The expertise of any expert panel, as a whole, involved in expert judgment
elicitation comports with the level and variety of knowledge required by the questions or
issues presented to that panel.
As part of the documentation requested by these rules, EPA recommends that any application
include a curriculum vitae of each expert panel member that lists, at a minimum:
past and present professional or contractual affiliations;
publications and abstracts;
work and educational experience;
a history of research grants and monetary awards from DOE, including documentation
of any honoraria received; and,
a chart of the expert's employing organization that demonstrates the expert's affiliation
with any individuals within the organization who perform work relevant to the WIPP.
(5) Explain the relationship among the information and issues presented to experts
prior to the elicitation process, the elicited judgment of any expert panel or individual, and
the purpose for which the expert judgment is being used in compliance application(s).
(6) Provide documentation that the initial purpose for which expert judgment was
intended, as presented to the expert panel, is consistent with the purpose for which this
judgment was used in compliance application(s).
EPA expects any compliance application to include:
documentation of the question presented to the experts, including a copy of any
statement of the issue and any similar statement sent to the nominating and selection
committees; and,
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a discussion of the relationship of the final result of the expert judgment process to the
statement of the issue presented to the experts, as incorporated into the compliance
application.
(7) Provide documentation that the following restrictions and guidelines have been
applied in eliciting expert judgment:
(i) At least five individuals shall be used in any expert elicitation process, unless there
is a lack or unavailability of experts and a documented rationale is provided that explains
why fewer than five individuals were selected.
(ii) At least two-thirds of the experts involved in an elicitation shall consist of
individuals who are not employed directly by the Department or by the Department's
contractors, unless the Department can demonstrate and document that there is a lack or
unavailability of qualified independent experts. If so demonstrated, at least one-third of the
experts involved in an elicitation shall consist of individuals who are not employed directly by
the Department or by the Department's contractors.
EPA expects the documentation of efforts made to solicit experts not employed by DOE or its
contractors to include:
a list of all non-DOE employees and non-DOE contractors who were sent letters of
nomination or were otherwise solicited for participation on the panel; and
documentation of all responses to letters of solicitation by those potential participants.
(c) The public shall be afforded a reasonable opportunity to present its scientific and
technical views to expert panels as input to any expert elicitation process.
EPA expects any compliance application to include:
documentation and descriptions of the methods used to solicit participation of the
public, including outside groups and individuals; and
copies of any publicly available notices that solicited presentations from the public.
§194.27 Peer review.
(a) Any compliance application shall include documentation of peer review that has
been conducted, in a manner required by this section, for:
(1) Conceptual models selected and developed by the Department;
(2) Waste characterization analyses as required in § 194.24(b); and
(3) Engineered barrier evaluation as required in § 194.44.
For guidance on the technical scope of peer reviews for §194.27(a)(l-3), see §194.23,
§194.24, and §194.44.
Documentation of peer reviews should be presented in a consistent manner. EPA
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recommends that the documentation of peer reviews be compiled in a chapter separate from
the chapters addressing conceptual models, waste characterization, and engineered barriers, in
accordance with §194.27(a). Decisions involving peer review should be clearly indicated in
the topical chapters and cross-referenced with the peer review reports as appropriate.
Peer review of the evaluation of engineered barriers should incorporate all alternatives
considered, whether DOE has selected or rejected them for use at the WIPP. Peer review
should consider alternate engineered barriers rejected in the manner described in
§194.44(c)(2).
(b) Peer review processes required in paragraph (a) of this section, and conducted
subsequent to the promulgation of this part, shall be conducted in a manner that is
compatible with NUREG-1297, "Peer Review for High-Level Nuclear Waste Repositories, "
published February 1988. (Incorporation by reference as specified in § 194.5.)
As defined by NUREG-1297, a "peer review" is an in-depth critique of assumptions,
calculations, extrapolations, alternate interpretations, methodology, and acceptance criteria
employed, and of conclusions drawn in the original work, performed by peers who are
independent of the work being reviewed. Peer review reports should clearly demonstrate:
the structure of the peer review group for any given issue, including how relevant
technical disciplines were represented;
the technical qualifications of peer reviewers to review a given issue;
the independence of the peer reviewers from the original work, including the rationale
why someone with greater independence was not selected, if necessary;
the process of the peer review, including how a given issue was presented to peer
reviewers;
the conclusions the peer reviewers reached, including dissenting views if they exist;
and
how DOE incorporated those conclusions.
(c) Any compliance application shall:
(1) Include information that demonstrates that peer review processes required in
paragraph (a), and conducted prior to the implementation of the promulgation of this part,
were conducted in accordance with an alternate process substantially equivalent in effect to
NUREG-1297 and approved by the Administrator or the Administrator's authorized
representative; and
In order to determine substantial equivalence to NUREG-1297, it is particularly important that
EPA receive documentation of the technical qualifications and independence of the peer
reviewers.
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(2) Document any peer review processes conducted in addition to those required
pursuant to paragraph (a) of this section. Such documentation shall include formal requests,
from the Department to outside review groups or individuals, to review or comment on any
information used to support compliance applications, and the responses from such groups or
individuals.
EPA recommends that peer reviews conducted prior to the implementation 40 CFR Part 194,
as well as any peer reviews in addition to those required in §194.27(a), be documented in a
manner similar to that described in the guidance for §194.27(b). EPA does not consider an
internal technical review to be equivalent to a peer review.
§194. 31 Application of release limits.
The release limits shall be calculated according to part 191, appendix A of this
chapter, using the total activity, in curies, that will exist in the disposal system at the time of
disposal.
EPA expects any compliance application to provide:
estimated curies of each radionuclide in the disposal system at the time of disposal;
a description of the process used to determine the activity of each radionuclide (see
§194.24);
the current estimate of the activity (in curies) of each radionuclide;
the estimated upper limit of the activity (in curies) of each radionuclide (see § 194.24);
a description of the procedure used to estimate the units of waste proposed for disposal
(according to the transuranic waste described in Note l(e) of Appendix A to
40 CFR Part 191);
example calculations of release limits; and
identification of the relative contribution of each radionuclide to the normalized
release.
§194.32 Scope of performance assessments.
(a) Performance assessments shall consider natural processes and events, mining,
deep drilling, and shallow drilling that may affect the disposal system during the regulatory
time frame.
EPA recognizes that performance assessments and/or other modeling may indicate that some
items are not necessary to demonstrate compliance. In those instances, any compliance
application should include justification why the particular items are not important to a
reasonable expectation of compliance. See §194.32(e)(l) for additional guidance.
(b) Assessments of mining effects may be limited to changes in the hydraulic
conductivity of the hydrogeologic units of the disposal system from excavation mining for
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natural resources. Mining shall be assumed to occur with a one in 100 probability in each
century of the regulatory time frame. Performance assessments shall assume that mineral
deposits of those resources, similar in quality and type to those resources currently extracted
from the Delaware Basin, will be completely removed from the controlled area during the
century in which such mining is randomly calculated to occur. Complete removal of such
mineral resources shall be assumed to occur only once during the regulatory time frame.
EPA expects any compliance application to include a discussion of:
the method used to implement or incorporate the probability of mining in each
century;
how the mining rate effects are incorporated in performance assessments, including
example calculations;
how institutional control credit(s) were applied in the performance assessments (see
§194.41 and §194.43), including the time period that credit for institutional controls is
assumed in the performance assessments;
the change in random sampling of hydraulic conductivity (using a probability
distribution with a range of 1 to 1000);
how mining is incorporated into performance assessments;
evidence that the randomly sampled change in hydraulic conductivity was multiplied
equally in all projected mined-out areas;
the identity and extent of minable mineral resources currently extracted in the
Delaware Basin; and
the identity of minable, mineral resources in the controlled area, and the extent to
which the resources are similar in quality and type to those resources currently
extracted from the Delaware Basin.
EPA also expects any compliance application to include:
graphics to illustrate the expected extent of the resources used in the performance
assessment.
No distribution need be developed to determine the century in which mining occurs. Instead,
the Department should employ a scheme that examines each century separately and
determines probabilistically whether mining occurs within that century based on a likelihood
of 1 in 100. One determination or "iteration" would be conducted for each century, starting
with the first century after the time of disposal and proceeding chronologically until making a
positive determination that mining has occurred. For example, within each iteration, an
integer from 1 to 100 would be selected, at random, with each integer equally likely to be
chosen. If the integer "1" (one) is randomly selected, then mining is assumed to occur in the
century corresponding to that iteration, with the first iteration corresponding to the first
century, the second iteration corresponding to the second century and so forth. If after the
end of 100 iterations, the integer "1" has not been selected, then mining should be assumed
not to occur within the particular sequence or combination of processes and events under
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consideration.
As an example, the first iteration might result in the integer "33" being selected, signifying
that mining does not occur in the first century. Proceeding to the second iteration, the integer
"15" is selected, signifying that mining does not occur in the second century. In the third
iteration, the integer "1" is selected, signifying that mining occurs at the start of the third
century after disposal. This set of iterations would therefore be complete. A new set of
iterations would be conducted when calculating the consequences of a different sequence or
combination of processes and events.
The probability of 1 in 100 is subject to modification by passive institutional controls and
active institutional controls in the first few hundred years after the time of disposal. If active
institutional controls and passive institutional controls were predicted collectively to reduce
the likelihood of mining by a factor of 3 in the first century, then this condition should be
incorporated into the appropriate iteration. For example, the probability of mining in the first
century would be adjusted to be 1 in 300 to reflect this factor of 3. Therefore, when
conducting the iteration corresponding to the first century, a random integer would be selected
from 1 to 300, with each integer being equally likely. If the outcome is the integer "1" (one),
then mining should be assumed to occur at the start of the first century after disposal.
Otherwise, the second iteration should be performed using the appropriate probability,
continuing further iterations as necessary until either a "1" is generated or 100 iterations have
been performed.
EPA recommends the discussion of mining assessments be limited to changes of 1 to 1000
times the hydraulic conductivity in the Culebra Dolomite. EPA recognizes that other
numerical changes to the hydraulic conductivity values may be more appropriate for use in
representing the effects of mining, and that some parameter other than hydraulic conductivity
might be demonstrated to incorporate, equally or better, the potential effects of mining in
performance assessments. DOE may elect to use an additional parameter, but any compliance
application should demonstrate that the use of this other parameter is as or more appropriate
than hydraulic conductivity in reflecting the potential effects of mining on the disposal
system.
If an approach different than the hydraulic conductivity is developed and selected by DOE,
then EPA expects that the different approach (i.e., conceptual model) will be peer reviewed
and documented according to §194.27.
(c) Performance assessments shall include an analysis of the effects on the disposal
system of any activities that occur in the vicinity of the disposal system prior to disposal and
are expected to occur in the vicinity of the disposal system soon after disposal. Such activities
shall include, but shall not be limited to, existing boreholes and the development of any
existing leases that can be reasonably expected to be developed in the near future, including
boreholes and leases that may be used for fluid injection activities.
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EPA expects any compliance application to:
provide an analysis of the effects of any activities on the disposal system;
identify the activities that occur, or are expected to occur, in the vicinity of WIPP soon
after disposal, including the extraction of mineral resources similar in quality and type
to those currently extracted;
discuss the potential effects of such activities identified to occur, or expected to occur,
in the vicinity of WIPP soon after disposal;
discuss potential effects of existing boreholes;
discuss the process by which the expected lives of the oil and gas fields in existing
leases were estimated; and
identify existing leases that are being developed, or that can be reasonably expected to
be developed in the near future, in the vicinity of the controlled area.
EPA recommends that the terms "near future" and "soon after disposal" for oil and gas
drilling be considered to consist of the expected lives of the oil and gas fields in existing
leases that can be reasonably expected to be developed in the vicinity of the WIPP.
For mining, the terms "near future" and "soon after disposal" should be applied to the
estimated lives of existing mines and plans for new mines in the vicinity of WIPP. EPA
recommends that DOE use minable reserves in estimating mine lives and the extent of
potential mining. When establishing the rate of growth for mines, DOE should consider both
the historical growth of mines and the potential for new mines that may be developed in the
vicinity of WIPP.
(d) Performance assessments need not consider processes and events that have less
than one chance in 10,000 of occurring over 10,000 years.
EPA expects any compliance application to:
list the processes, events or sequences of processes and events that were not included
in performance assessment results; and
discuss the reasons why processes, events or sequences of processes and events were
not included in performance assessment results.
(e) Any compliance application(s) shall include information which:
(1) Identifies all potential processes, events or sequences and combinations of
processes and events that may occur during the regulatory time frame and may affect the
disposal system;
See §194.25 and §194.14.
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EPA expects any compliance application to:
identify any human-initiated processes and events that may occur during the regulatory
time frame;
identify potential natural processes and events that may occur during the regulatory
time frame and how they may affect the disposal system;
identify the sequences and combinations of potential processes and events that may
occur during the regulatory time frame and may affect the disposal system;
discuss how the events and processes were identified (e.g., through the use of a
comprehensive list with a derivation of the list);
discuss the screening criteria and the procedure(s) used to include and eliminate
processes and events;
discuss the application of the screening criteria to the processes and events that may
occur during the regulatory time frame and may affect the disposal system;
discuss the effects of potential changes to geologic conditions, including, but not
limited to:
dissolution;
near surface geomorphic processes; and
related subsidence in the geologic units of the disposal system;
evaluate and discuss near future fluid injection activities and other existing boreholes
as part of the performance assessment;
identify existing leases in the vicinity of the disposal system with boreholes that are
being used for fluid injection activities;
identify existing leases in the vicinity of the disposal system that can be reasonably
expected to be developed (e.g., for fluid injection activities) in the near future; and
link site, waste, laboratory and other characterization information to the potential
processes, events or sequences and combinations of processes and events, and the
conceptual models. It is expected such linkage will be accomplished through
appropriate discussions in the text and the use of cross-references.
(2) Identifies the processes, events or sequences and combinations of processes and
events included in performance assessments; and
EPA expects any compliance application to include the performance assessment evaluations
of:
mining;
deep drilling; and
shallow drilling.
EPA expects any compliance application to:
list and discuss the events and processes and the combinations of potential processes,
events or sequences and combinations of processes and events, that could have an
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effect on radionuclide transport to the accessible environment and that are included in
the performance assessment;
discuss the effect of the sequence of processes and events on the disposal system on
the performance assessment calculations; for example, the relative timing of mining
and a deep drilling event that intersects the waste may affect the amount of
radionuclides that may reach the accessible environment during the regulatory time
frame;
specify the models and codes in which the individual potential processes, events or
sequences and combinations of processes and events are included. As a hypothetical
example: Gas generation is a process associated with the waste that could affect room
closure and releases from a drilling event: Gas generation is discussed in the
conceptual models found in chapter x.x.x and the computer models discussed in
chapter x.x.x;
indicate that events and processes incorporated into the performance assessment are
reflected in the appropriate portions of the application; for example, incorporation of
the process of gas generation in the waste (if it occurs) into performance assessment
modeling should be identified and discussed in any compliance assessment and cross-
referenced appropriately;
provide documentation that the conceptual models used in performance assessments
were peer reviewed (see §194.23 and §194.27);
discuss the final combinations of events and processes in the context of the final
conceptual scenarios used in performance assessments (see §194.23); and
discuss how the retained potential processes, events or sequences and combinations of
processes and events were constructed into the scenarios used in performance
assessments.
It is expected that the general classes of scenarios (e.g., undisturbed processes, events, or
sequences and combinations of processes and events; drilling events; mining events; and the
combination of drilling and mining events) used in performance assessments will be discussed
separately. For disturbed scenarios constructed for use in performance assessments, it is
expected that the discussion will refer to the undisturbed scenarios, and focus on those
elements (e.g., processes and events) that differ from the undisturbed scenarios.
(3) Documents why any processes, events or sequences and combinations of
processes and events identified pursuant to paragraph (e)(l) of this section were not included
in performance assessment results provided in any compliance application.
EPA expects any compliance application to provide:
a list of events and processes or sequences and combinations of processes and events
that may occur during the regulatory time frame;
the rationale for each process and event or sequences and combinations of processes
and events screened out; and
evidence that the screening process was quality assured for the individual potential
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processes, events, or sequences and combinations of processes and events.
§194.33 Consideration of drilling events in performance assessments.
(a) Performance assessments shall examine deep drilling and shallow drilling that
may potentially affect the disposal system during the regulatory time frame.
EPA expects any compliance application to:
discuss how deep drilling is conducted for each resource;
discuss how shallow drilling is conducted for each resource; and
demonstrate that boreholes drilled after closure of the disposal system have been
evaluated for their effect on the properties of the disposal system, and show the
manner in which they were evaluated.
(b) The following assumptions and process shall be used in assessing the likelihood
and consequences of drilling events, and the results of such process shall be documented in
any compliance application:
(1) Inadvertent and intermittent intrusion by drilling for resources (other than those
resources provided by the waste in the disposal system or engineered barriers designed to
isolate such waste) is the most severe human intrusion scenario.
EPA expects any compliance application to:
demonstrate that exploratory and development wells were included in the analysis of
inadvertent and intermittent intrusion by drilling for resources and the manner in
which they were evaluated.
(2) In performance assessments, drilling events shall be assumed to occur in the
Delaware Basin at random intervals in time and space during the regulatory time frame.
EPA expects any compliance application to:
provide documentation that drilling events were assumed to occur in the Delaware
Basin at random intervals in time and space during the regulatory time frame; and
discuss the method and assumptions (e.g., Poisson process) and their application to the
drilling issue.
(3) The frequency of deep drilling shall be calculated in the following manner:
(i) Identify deep drilling that has occurred for each resource in the Delaware Basin
over the past 100 years prior to the time at which a compliance application is prepared.
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EPA expects any compliance application to:
identify the resources for which deep drilling is used;
estimate the number of deep drilling events for each resource that has occurred over
the past 100 years;
discuss the methodology used to calculate the frequency of the deep drilling rate; and
identify the sources of information used to estimate the number of deep drilling events.
(ii) The total rate of deep drilling shall be the sum of the rates of deep drilling for
each resource.
EPA expects any compliance application to:
identify the total rate of deep drilling.
(4) The frequency of shallow drilling shall be calculated in the following manner:
(i) Identify shallow drilling that has occurred for each resource in the Delaware
Basin over the past 100 years prior to the time at which a compliance application is
prepared.
EPA expects any compliance application to:
identify the resources for which shallow drilling is used;
estimate the number of shallow drilling events for each resource that has occurred over
the past 100 years;
discuss the methodology used to calculate the frequency of the shallow drilling rate;
and
identify the sources of information used to estimate the number of shallow drilling
events.
(ii) The total rate of shallow drilling shall be the sum of the rates of shallow drilling
for each resource.
EPA expects any compliance application to:
identify the total rate of shallow drilling.
(iii) In considering the historical rate of all shallow drilling, the Department may, if
justified, consider only the historical rate of shallow drilling for resources of similar type and
quality to those in the controlled area.
If DOE, in its consideration of the historical rate of shallow drilling, considers only resources
of similar type and quality to those in the controlled area, any compliance application should:
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include a discussion of resources in the controlled area and their type and quality;
discuss the use of resources of similar type and quality in the Delaware Basin; and
list the sources used to estimate the type and quality of resources and the nature of the
use of similar resources in the Delaware Basin.
If DOE does not limit consideration of shallow drilling to only resources of similar type and
quality to those in the controlled area, compliance applications need not address the quality of
the resources in the controlled area.
(c) Performance assessments shall document that in analyzing the consequences of
drilling events, the Department assumed that:
(1) Future drilling practices and technology will remain consistent with practices in
the Delaware Basin at the time a compliance application is prepared. Such future drilling
practices shall include, but shall not be limited to: The types and amounts of drilling fluids;
borehole depths, diameters, and seals; and the fraction of such boreholes that are sealed by
humans;
EPA expects any compliance application to identify:
current drilling practices in the Delaware Basin;
the current drilling practices that affect performance assessments;
types and amounts of drilling fluids;
borehole depths typically used;
borehole diameters typically used;
seals typically used;
the fraction of boreholes sealed by humans today; and
the source(s) of the above information.
(2) Natural processes will degrade or otherwise affect the capability of boreholes to
transmit fluids over the regulatory time frame.
EPA expects any compliance application to:
identify the processes that are expected to affect boreholes over time;
discuss the portions of the borehole over which particular processes are expected to
act. For example, creeping of the salt is one process that could affect a borehole in the
salt section, while other processes may affect other portions of a borehole;
discuss the effects that natural degradation are expected to have on the capability of
boreholes to transmit fluids; and
identify the models in which borehole degradation is addressed.
(d) With respect to future drilling events, performance assessments need not analyze
the effects of techniques used for resource recovery subsequent to the drilling of the borehole.
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EPA expects that the discussion of drilling will be in its own section in any compliance
application. This section in the application should cross-reference the specific parts of the
application that use this information or have closely related information, such as the
discussion that addresses the requirements for models and codes in §194.23.
§194.34 Results of performance assessments.
(a) The results of performance assessments shall be assembled into "complementary,
cumulative distribution functions "(CCDFs) that represent the probability of exceeding
various levels of cumulative release caused by all significant processes and events.
EPA expects any compliance application to:
demonstrate that the results of performance assessments were assembled into CCDFs;
and
demonstrate that the CCDFs represent the probability of exceeding various levels of
cumulative release caused by all significant processes and events; and
demonstrate that all significant processes and events were incorporated into the
CCDFs that are presented.
(b) Probability distributions for uncertain disposal system parameter values used in
performance assessments shall be developed and documented in any compliance application.
For additional guidance, see §194.23 and §194.55.
EPA expects any compliance application to:
discuss the sources used and the methods by which each of the probability
distributions were developed (e.g., experimental data, field data, etc.);
identify the functional form of the probability distribution (e.g., lognormal, uniform)
used for the sampled parameters;
describe the statistics of each probability distribution, including the values for the
lower and upper ranges, mean (geometric mean when appropriate), and median;
identify the importance of the sampled parameter relative to final releases; and
demonstrate that the data used to develop the input parameter probability distribution
were qualified and controlled in accordance with §194.22.
(c) Computational techniques, which draw random samples from across the entire
range of the probability distributions developed pursuant to paragraph (b) of this section,
shall be used in generating CCDFs and shall be documented in any compliance application.
EPA expects any compliance application to:
discuss the computational techniques used for random sampling; and
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demonstrate that sampling occurred across the entire range of each parameter.
(d) The number ofCCDFs generated shall be large enough such that, at cumulative
releases of 1 and 10, the maximum CCDF generated exceeds the 99th percentile of the
population of CCDFs with at least a 0.95 probability. Values of cumulative release shall be
calculated according to Note 6 of Table 1, Appendix A of Part 191 of this chapter.
EPA expects any compliance application to:
identify the number of CCDFs generated;
discuss how DOE determined the number of CCDFs to be generated;
list the probabilities of exceeding cumulative releases of 1 and 10 for each CCDF
generated; and
demonstrate that the maximum CCDFs generated, at cumulative releases of 1 and 10,
exceeds the 99th percentile with at least a 0.95 probability, with a discussion that
includes examples of calculations.
(e) Any compliance application shall display the full range of CCDFs generated.
EPA expects any compliance application to:
display the full range of CCDFs generated;
present the appropriate information so that EPA may confirm the DOE's performance
assessment analyses, including steps used to arrive at the result and the data values that
are represented by the CCDFs; and
include descriptive statistics such as the range, mean, median, etc., for the range of
CCDFs at cumulative releases of 1 and 10.
(f) Any compliance application shall provide information which demonstrates that
there is at least a 95 percent level of statistical confidence that the mean of the population of
CCDFs meets the containment requirements of § 191.13 of this chapter.
EPA expects any compliance application to:
present the appropriate information, including steps used to arrive at the result and the
data used in the analysis, so that EPA can confirm that the mean of the population of
CCDFs meets the containment requirements of 40 CFR 191.13 with a 95 percent level
of statistical confidence;
identify the mean of the sample of CCDFs generated for the cumulative releases at 1
and 10 as specified in 40 CFR 191.13; and
identify the values of the CCDFs associated with a 95 percent level of statistical
confidence of the mean of the population for the cumulative releases at 1 and 10 as
specified in 40 CFR 191.13.
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§194.41 Active Institutional Controls.
(a) Any compliance application shall include detailed descriptions of proposed active
institutional controls, the controls' location, and the period of time the controls are proposed
to remain active. Assumptions pertaining to active institutional controls and their
effectiveness in terms of preventing or reducing radionuclide releases shall be supported by
such descriptions.
EPA expects any compliance application to include:
descriptions of active controls;
the location of active controls;
the period of time active controls are proposed to remain active;
assumptions pertaining to the effectiveness of active controls (in terms of preventing
or reducing radionuclide releases);
the justification for assumed credit; and
the methodology for determining assumed credit.
A graphic representation may be used to illustrate the assumed effectiveness of active controls
over time.
(b) Performance assessments shall not consider any contributions from active
institutional controls for more than 100 years after disposal.
Since EPA may allow up to 100 years credit for active institutional controls, EPA expects that
DOE's implementation plan for such controls will clearly articulate why credit is warranted
for the proposed time frame. For example, if DOE assumes the full 100 years of credit, the
information provided in any compliance application relative to active institutional controls is
expected to support that assumption.
§194.42 Monitoring.
(a) The Department shall conduct an analysis of the effects of disposal system
parameters on the containment of waste in the disposal system and shall include the results of
such analysis in any compliance application. The results of the analysis shall be used in
developing plans for pre-closure and post-closure monitoring required pursuant to
paragraphs (c) and (d) of this section. The disposal system parameters analyzed shall
include, at a minimum:
(1) Properties of backfilled material, including porosity, permeability, and degree of
compaction and reconsolidation;
(2) Stresses and extent of deformation of the surrounding roof, walls, and floor of the
waste disposal room;
(3) Initiation or displacement of major brittle deformation features in the roof or
surrounding rock;
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(4) Ground water flow and other effects of human intrusion in the vicinity of the
disposal system;
(5) Brine quantity, flux, composition, and spatial distribution;
(6) Gas quantity and composition; and
(7) Temperature distribution.
EPA expects any compliance application to:
describe the methodology of the analysis of the effects of disposal system parameters
on the containment of waste;
describe the results of the above analysis of disposal system parameters on
containment of waste;
explain why DOE has selected or rejected characteristics for pre- and post-closure
monitoring;
provide a complete list of parameters evaluated in the analysis, including at a
minimum:
properties of backfilled material;
stress and extent of deformation;
initiation or displacement of major brittle deformation features;
ground water flow and other effects of human intrusion;
brine quality, flux, composition, and spacial distribution;
gas quantity and composition; and
temperature distribution.
(b) For all disposal system parameters analyzed pursuant to paragraph (a) of this
section, any compliance application shall document and substantiate the decision not to
monitor a particular disposal system parameter because that parameter is considered to be
insignificant to the containment of waste in the disposal system or to the verification of
predictions about the future performance of the disposal system.
EPA expects any compliance application to include:
documentation that substantiates decisions not to monitor a particular disposal system
parameter analyzed pursuant to §194.42(a).
(c) Pre-closure monitoring. To the extent practicable, pre-closure monitoring shall
be conducted of significant disposal system parameter (s) as identified by the analysis
conducted pursuant to paragraph (a) of this section. A disposal system parameter shall be
considered significant if it affects the system's ability to contain waste or the ability to verify
predictions about the future performance of the disposal system. Such monitoring shall begin
as soon as practicable; however, in no case shall waste be emplacedin the disposal system
prior to the implementation of pre-closure monitoring. Pre-closure monitoring shall end at
the time at which the shafts of the disposal system are backfilled and sealed.
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EPA expects any compliance application to include:
a description of disposal system parameters identified to be monitored during pre-
closure;
an explanation of parameters considered significant and documentation that
substantiates any decision not to monitor a disposal system parameter analyzed
pursuant to §194.2(a) because it is not deemed to be significant;
an explanation of why monitoring is not practicable for parameters found to be
significant, but not chosen for monitoring;
a discussion and explanation of when pre-closure monitoring is to begin; and
a discussion and explanation of when pre-closure monitoring will end.
Results of pre-closure monitoring could be used to verify inputs to the performance
assessment models that predict disposal system behavior over time. Any monitoring to be
conducted should be detailed in a monitoring plan in accordance with §194.42(e). For
example, panel rooms may be instrumented during the pre-closure phase to measure
parameters that affect both the long-term performance of the disposal system and the
predictions made by performance assessments.
(d) Post-closure monitoring. The disposal system shall, to the extent practicable, be
monitored as soon as practicable after the shafts of the disposal system are backfilled and
sealed to detect substantial and detrimental deviations from expected performance and shall
end when the Department can demonstrate to the satisfaction of the Administrator that there
are no significant concerns to be addressed by further monitoring. Post-closure monitoring
shall be complementary to monitoring required pursuant to applicable federal hazardous
waste regulations at parts 264, 265, 268, and 270 of this chapter and shall be conducted with
techniques that do not jeopardize the containment of waste in the disposal system.
EPA expects any compliance application to:
include an explanation when post-closure monitoring will commence;
include a description of the post-closure monitoring to be conducted;
document how the monitoring will be effective to detect substantial and detrimental
deviations from expected performance;
identify the monitoring to be conducted pursuant to applicable hazardous waste
regulations for 40 CFR Parts 264, 265, 268 and 270;
describe how post-closure monitoring is complementary to applicable federal
hazardous waste regulations at parts 264, 265, 268, and 270 of this chapter; and
explain how the monitoring techniques do not jeopardize the containment of waste in
the disposal system.
(e) Any compliance application shall include detailed pre-closure and post-closure
monitoring plans for monitoring the performance of the disposal system. At a minimum, such
plans shall:
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(1) Identify the parameters that will be monitored and how baseline values will be
determined;
(2) Indicate how each parameter will be used to evaluate any deviations from the
expected performance of the disposal system; and
(3) Discuss the length of time over which each parameter will be monitored to detect
deviations from expected performance.
EPA expects any compliance application to include:
a pre-closure plan that identifies:
a description of the monitoring plan required before waste is emplaced and any
monitoring to be performed after panel rooms are filled during pre-closure
operations;
the parameters to be monitored;
how the baseline for each parameter will be determined;
how monitoring results of each parameter will be used to evaluate the performance
of the disposal system;
approximately when monitoring for each parameter is planned to begin; and
how long each parameter will be monitored.
a post-closure plan that identifies:
the parameters to be monitored;
how the baseline for each parameter will be determined;
how monitoring results of each parameter will be used to evaluate the performance
of the disposal system;
approximately when monitoring for each parameter is planned to begin; and
how long each parameter will be monitored.
EPA expects the discussion of the monitoring plan to include descriptions of:
the environmental media (i.e., air, soil, groundwater, surface water, sediment,
subsurface gas), biota (i.e., vegetation and/or small mammals), or microbiota to be
monitored; and
the proposed monitoring network (sampling locations) and a justification of its design.
The design of the monitoring network should take into account potential spatial and temporal
changes in the disposal system and any releases that may affect long-term performance of the
disposal system. Spatially, the plan should allow for sufficient samples to be collected to
define adequately the extent of any relevant release and account for changes in the
dimensions of the disposal system over time. The plan should consider the potential for
spreading of a relevant release plume with time and for concentration variations due to
physical and chemical processes, such as retardation and degradation.
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EPA expects any compliance application to identify:
background sampling stations and their locations;
sampling method and equipment; and
the type and number of samples to be collected.
The plan should specify whether the samples collected will be grab, composite, or integrated.
A grab sample is an individual sample taken at a specific location at a specific time. A
composite sample is a combination of more than one sample collected at various sampling
locations and/or different times. An integrated sample is a continuously collected single
sample taken to describe a population in which one or more parameters vary with time or
space.
EPA expects any compliance application to identify:
sample preservation and handling;
chain of custody;
analytical methods;
detection limits;
the monitoring schedule, including the proposed initiation date and the frequency with
which monitoring will be conducted (schedule of the occurrence of monitoring
events); and
data evaluation and presentation methods (statistics).
All monitoring should follow properly documented and implemented Quality Assurance and
Quality Control procedures, as described in §194.22. Monitoring is subject to inspection by
EPA, in accordance with §194.21.
§194.43 Passive Institutional Controls.
(a) Any compliance application shall include detailed descriptions of the measures
that will be employed to preserve knowledge about the location, design, and contents of the
disposal system.
EPA expects any compliance application to include:
detailed descriptions of passive controls; and
locations of passive controls.
EPA expects any compliance application will describe how the Passive Institutional Controls
(PICs) planned for implementation will describe the disposal system's:
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location;
design; and
contents.
Such measures shall include:
(1) Identification of the controlled area by markers that have been designed, and will
be fabricated and emplaced to be as permanent as practicable;
EPA expects any compliance application to include:
a time line for implementation/construction and emplacement of markers; and
a description of the markers (e.g., size, materials, etc.).
(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.
EPA expects any compliance application to identify the:
location of archives of local, State, and Federal governments (to include Native
American governments as well) in which records will be placed;
location of land record systems of local, State and Federal governments in which
records will be placed;
location of international archives in which records will be placed;
time line for implementation and emplacement of records; and
the practices employed by each archive and repository for maintaining records and
making them accessible to the public.
Such records shall identify:
(i) The location of the controlled area and the disposal system;
(ii) The design of the disposal system;
(Hi) The nature and hazard of the waste;
(iv) Geologic, geochemical, hydrologic, and other site data pertinent to the
containment of waste in the disposal system, or the location of such information; and
(v) The results of tests, experiments, and other analyses relating to backfill of
excavated areas, shaft sealing, waste inter action with the disposal system, and other tests,
experiments, or analyses pertinent to the containment of waste in the disposal system, or the
location of such information.
EPA expects any compliance application to describe how records will identify:
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the location of the controlled area and the disposal system;
the design of the disposal system, as identified in accordance with § 194.14(b);
nature and hazard of the waste, as identified in accordance with § 194.24(a);
geologic data;
geochemical data;
hydrologic data;
other site data;
analyses relating to backfill of excavated areas;
analyses relating to shaft sealing;
analyses relating to waste interaction with the disposal system; and
other tests, experiments, or analyses pertinent to the containment of waste in the
disposal system.
EPA believes that such information could reasonably be identified in archives by
incorporating relevant parts of compliance applications into records planned for archiving.
DOE may choose simply to state the location of the information contained in
§194.43(a)(2)(iv) and (v) above; however, EPA recommends that actual location(s) be easily
accessible to future "individuals."
(3) Other passive institutional controls practicable to indicate the dangers of the
waste and its location.
EPA expects any compliance application to identify and describe:
other practicable passive controls proposed for use at the WIPP.
(b) Any compliance application shall include the period of time passive institutional
controls are expected to endure and be understood.
EPA expects any compliance application to include:
the period of time passive controls are expected to endure and be understood;
the basis for estimating the time period; and
any assumptions pertaining to the effectiveness of passive controls.
(c) The Administrator may allow the Department to assume passive institutional
control credit, in the form of reduced likelihood of human intrusion, if the Department
demonstrates in the compliance application that such credit is justified because the passive
institutional controls are expected to endure and be understood by potential intruders for the
time period approved by the Administrator. Such credit, or a smaller credit as determined by
the Administrator, cannot be used for more than several hundred years and may decrease
over time. In no case, however,
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shall passive institutional controls be assumed to eliminate the likelihood of human intrusion
entirely.
EPA may allow up to approximately 700 years of credit for passive institutional controls in
performance assessments. If DOE proposes a credit, EPA expects that DOE's implementation
plan for such controls will clearly articulate why credit is warranted for the proposed time
frame. For example, if DOE assumes credit for as long as 700 years after disposal, the
information provided in the compliance application relative to PICs is expected to support that
assumption. Under no circumstance may passive controls be assumed to eliminate human
intrusion entirely.
If DOE assumes credit for passive controls, EPA expects any compliance application to
identify:
the estimated effectiveness of passive controls over time, in terms of reducing the
likelihood of potential human intrusion; for example, a graphic representation
illustrating how credit will diminish over time;
the methodology employed to estimate the effectiveness of passive controls; and
justification for the proposed credit, based on how well the controls are expected to
endure and be understood.
If any credit is assumed for passive controls, credit should begin at the time of disposal (i.e.,
when the shafts of the disposal system are backfilled and sealed), although some of the credit
may not be needed in light of credit for active institutional controls.
EPA will make its determination regarding credit for passive controls based on the two
aspects of PICs identified in §194.43(c): that they are expected to endure for the proposed
period, and that they are expected to be understood by potential intruders for the proposed
period. EPA expects that DOE's justification of the proposed credit will clearly address these
two aspects. The first aspect, the period of time for which the markers "are expected to
endure," is likely to require a deterministic analysis, based on scientific data, that takes into
account assumptions like those outlined in the CAG for §194.43(a)(l).
The second aspect, the period of time for which the markers will "be understood by potential
intruders," is likely to require qualitative analysis and discussion. EPA expects that DOE will
establish a framework of assumptions for PICs that is a prudent extrapolation of the future
state assumptions established in §194.25. For example, §194.25 may allow DOE to assume,
for the purpose of developing the performance assessment models., that particular
governmental regulations will remain in force. Such an assumption would be inappropriate,
however, in the justification of credit for PICs. Instead, DOE may choose to assume that
while some form of governmental regulation exists, the exact form and content of any
regulation cannot be identified with certainty. In other words, DOE may not a priori rely on
the future states assumption in this context. Rather, DOE must demonstratebased on the
particular measures at issue and documented, reasoned justificationwhy any assumptions
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made in these circumstances are sound.
EPA believes that there are certain societal "common denominators," such as the existence of
some form of government and some level of regulatory control over the exploration for and
development of resources, that could be considered in the discussion of PICs. These common
denominators are patterns of human behavior that may be detected throughout history and
around the world. The degree to which the PICs implemented at the WIPP rely on common
denominators will determine the degree to which the PICs are effective at being understood
by potential intruders in the future. Other examples of common denominators (but by no
means a comprehensive list) are: the ability of pictures to convey meaning, the curiosity of
humans, the expectation that some people will avoid, ignore or be ignorant of governmental
controls, the use of the written word to transmit information and concepts, and story-telling or
the generational "passing down" of history.
Explicit application of future state assumptions to passive controls i.e., the assumption that
all present-day societal and demographic factors will remain constant will not be considered
by EPA to justify adequately the design of PICs or the estimation of credit.
§194.44 Engineered Barriers.
(a) Disposal systems shall incorporate engineered barrier(s) designed to prevent or
substantially delay the movement of water or radionuclides toward the accessible
environment.
EPA expects (a) barrier(s) to be selected that will address uncertainties identified in the
evaluation of disposal system performance and will reduce those uncertainties. Examples of
key disposal system parameters that could be addressed by the incorporation of an engineered
barrier are the shear strength and mobility of the waste. The desired reduction in uncertainty
could be accomplished by including a barrier with predictable, tested, and demonstrated
performance characteristics that may be emplaced in a manner consistent with the desired
performance. The development of engineered barriers related to input parameters for use in
the performance assessment modeling codes must be documented in accordance with the
requirements established in §194.23(c)(4).
EPA expects any compliance application to:
specify the method for incorporating the engineered barriers;
provide a qualitative evaluation and justification of the barrier's ability to prevent or
substantially delay the movement of water or radionuclides toward the accessible
environment;
clearly explain how inclusion of the selected engineered barrier(s) contributes to
system performance; and
qualitatively discuss the reduction in uncertainty associated with engineered barrier
performance in relation to total system performance.
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(b) In selecting any engineered barrier(s) for the disposal system, the Department
shall evaluate the benefit and detriment of engineered barrier alternatives, including but not
limited to: cementation, shredding, supercompaction, incineration, vitrification, improved
waste canisters, grout and bentonite backfill, melting of metals, alternative configurations of
waste placements in the disposal system, and alternative disposal system dimensions. The
results of this evaluation shall be included in any compliance application and shall be used to
justify the selection and rejection of each engineered barrier evaluated.
EPA expects any compliance application to include documentation of an evaluation of
benefits and detriments of the following barriers:
cementation;
shredding;
supercompaction;
incineration;
vitrification;
improved waste canisters;
grout and bentonite backfill;
melting of metals;
alternative configurations of waste placements in the disposal system;
alternative disposal system dimensions; and
other barriers or combinations of barriers.
EPA expects the evaluation of engineered barriers to contain the following elements:
a list of all barriers to be considered;
clearly defined screening criteria;
a justification for "screening out" any barriers;
a list of all barriers to be evaluated;
an evaluation against the factors listed in §194.44(c)(l);
a justification for not completing the full evaluation of any barrier; and
a final, comparable benefit/detriment evaluation in matrix or tabular form.
EPA expects the evaluation of engineered barriers to have a broad scope that encompasses all
current waste isolation technologies suitable for use at the WIPP, as well as any that are under
development, and: (1) could reasonably be expected to reach fruition during the operating life
of the WIPP facility; (2) have enough data available to allow comparison with current
methods; and (3) are developed to the point that the other system factors listed in §194.44(c)
can be evaluated. EPA expects barriers to be evaluated consistently so that they may be
compared.
In performing the peer review of the evaluation of engineered barriers described in
§194.44(b), as required in §194.27(a), the following issues should be included in the technical
scope of the review: (1) the adequacy of the scope of alternatives considered; (2) the
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adequacy and appropriate application of the screening criteria; (3) the factors against which
the barriers were evaluated meet the regulatory requirements and are sufficient to allow
evaluation of the barriers; (4) the barriers were adequately evaluated; and (5) in the selection
of a barrier and subsequent parameter development, that the parameters were appropriately
developed to support PA (this portion may be covered under the peer review of models and
codes (see §194.23(a)(3)(v)), as required by §194.27(a).
(c)(l) In conducting the evaluation of engineered barrier alternatives, the following
shall be considered, to the extent practicable:
(i) The ability of the engineered barrier to prevent or substantially delay the
movement of water or waste toward the accessible environment;
(ii) The impact on worker exposure to radiation both during and after incorporation
of engineered barriers;
(Hi) The increased ease or difficulty of removing the waste from the disposal system;
(iv) The increased or reduced risk of transporting the waste to the disposal system;
(v) The increased or reduced uncertainty in compliance assessment;
(vi) Public comments requesting specific engineered barriers;
(vii) The increased or reduced total system costs;
(viii) The impact, if any, on other waste disposal programs from the incorporation of
engineered barriers (e.g., the extent to which the incorporation of engineered barriers affects
the volume of waste);
(ix) The effects on mitigating the consequences of human intrusion.
(2) If, after consideration of one or more of the factors in paragraph (c)(l) of this
section, the Department concludes that an engineered barrier considered within the scope of
the evaluation should be rejected without evaluating the remaining factors in paragraph
(c)(l) of this section, then any compliance application shall provide a justification for this
rejection explaining why the evaluation of the remaining factors would not alter the
conclusion.
EPA expects any compliance application to:
demonstrate that all engineered barriers identified in accordance with §194.44(b) were
considered based on the following factors:
the ability of the engineered barrier to prevent or substantially delay the movement
of water or waste toward the accessible environment;
the impact on worker exposure to radiation both during and after incorporation of
engineered barriers;
the increased ease or difficulty of 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;
public comments requesting specific engineered barriers;
the increased or reduced total system costs;
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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); and
the effects on mitigating the consequences of human intrusion;
or:
justify for each barrier why consideration of such factors was not "practicable;"
or:
justify why a barrier was rejected prior to completion of the consideration of all nine
factors identified in §194.44(c)(2);
or
use a combination.
(d) In considering the ability of engineered barriers to prevent or substantially delay
the movement of water or radionuclides toward the accessible environment, the benefit and
detriment of engineered barriers for existing waste already packaged, existing waste not yet
packaged, existing waste in need of re-packaging, and to-be-generated waste shall be
considered separately and described.
EPA expects a clear distinction between these four types of waste:
existing waste already packaged;
existing waste not yet packaged;
existing waste in need of re-packaging; and
to-be-generated waste.
EPA expects any compliance application to:
clearly delineate the effects of the four waste groupings ("existing waste already
packaged, existing waste not yet packaged, existing waste in need of re-packaging,
and to-be-generated waste") on the evaluation of benefits and detriments and reflect
the effects in the barrier(s) selected.
(e) The evaluation described in paragraphs (b), (c) and (d) of this section shall
consider engineered barriers alone and in combination.
EPA recognizes that some engineered barriers (i.e., shredding) may have little benefit alone,
but may be greatly enhanced when performed in combination with other options (e.g.,
cementation).
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EPA expects DOE to carry out evaluations of combinations of engineered barriers that are the
most beneficial regarding the factors listed in §194.44(c)(l) above.
§194.45 Consideration of the presence of resources.
Any compliance applications shall include information that demonstrates that the
favorable characteristics of the disposal system compensate for the presence of resources in
the vicinity of the disposal system and the likelihood of the disposal system being disturbed as
a result of the presence of those resources. If performance assessments predict that the
disposal system meets the containment requirements of § 191.13 of this chapter, then the
Agency will assume that the requirements of this section and § 191.14(e) of this chapter have
been fulfilled.
EPA expects any compliance application to:
document that the effects of mining and drilling over the regulatory time frame have
been incorporated into performance assessments according to the requirements of
§194.32, §194.33, and §194.43;
document that performance assessments incorporate the effects on the disposal system
of any activities that occur in the vicinity of the disposal system or are expected to
occur in the vicinity of the disposal system soon after disposal, according to the
requirements of §194.32; and
document whether the results of performance assessments demonstrate compliance
with the containment requirements of § 191.13.
EPA expects that detailed information on these and other related topics such as descriptions
of the conceptual or computer models used for human intrusion in performance assessments,
maps showing the locations of various resources, and data bases of drilling information will
be presented and discussed in other sections of any compliance application. It is acceptable
not to reiterate such information contained in other sections of the compliance application
provided that clear cross-references are provided so that EPA may confirm that the analysis
has been accomplished as described in the bullets above. At a minimum, any compliance
application should address this assurance requirement by clearly stating whether the above
conditions have been met, and by providing specific references to where detailed information
on incorporation of human intrusion into performance assessments can be found elsewhere in
the application.
§194.46 Removal of Waste.
Any compliance application shall include documentation which demonstrates that
removal of waste is feasible for a reasonable period of time after disposal. Such
documentation shall include an analysis of the technological feasibility of mining the sealed
disposal system, given technology levels at the time a compliance application is prepared.
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EPA expects the required analysis to include:
a sequence of procedures or steps which would need to be accomplished in order for
waste to be removed from the disposal system after closure;
a discussion of how the sequence described above could be implemented, including
descriptions of how currently available equipment and technologies could be utilized;
and
an estimate of how long after disposal it would be technologically feasible to remove
the waste, based on the disposal system design and closure, and using the system and
equipment described in the application.
EPA expects that further information related to removal of waste such as descriptions of the
design of the disposal system, use of engineered barriers, and conceptual or computer models
used to predict performance of closure seals will be discussed in greater detail in other
sections of any compliance application (e.g., §194.14, §194.23, §194.44). EPA expects such
information to be clearly cited (where used as the basis for stating a conclusion) and cross-
referenced.
§194.51 Consideration of protected individual.
Compliance assessments that analyze compliance with § 191.15 of this chapter shall
assume that an individual resides at the single geographic point on the surface of the
accessible environment where that individual would be expected to receive the highest dose
from radionuclide releases from the disposal system.
For guidance regarding documentation of compliance assessments, see §194.54 and §194.55.
EPA expects that, in determining the location of the maximally exposed individual,
compliance assessments will:
present information on doses from individual pathways; and
show the sum of the doses from all pathways.
The location of the maximally exposed individual would be the location with the largest dose
from all pathways. EPA expects any compliance application to:
identify this location and the position of the individual relative to the controlled area
and the disposal system, using map coordinates.
For the air pathway, the location of the maximally exposed individual may be within the
controlled area. However, the location of the protected individual is restricted to outside the
controlled area for the ground water pathway. For additional guidance on consideration of
exposure pathway, see §194.52.
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EPA expects any compliance application to:
discuss the methods used to identify the location of the maximally exposed individual;
and
document the results of the modeling used to determine the location.
Intermediate and final calculations should be provided so that EPA may confirm the analyses.
§194.52 Consideration of exposure pathways.
In compliance assessments that analyze compliance with § 191.15 of this chapter, all
potential exposure pathways from the disposal system to individuals shall be considered.
Compliance assessments with part 191, subpart C and § 191.15 of this chapter shall assume
that individuals consume 2 liters per day of drinking water from any underground source of
drinking water in the accessible environment.
For guidance regarding documentation of compliance assessments, see §194.54 and §194.55.
EPA expects compliance assessments to:
identify and consider all potential exposure pathways associated with undisturbed
performance.
Several different radionuclide release pathways should be postulated, each potentially
resulting in different exposures.
DOE should construct exposure pathways and use exposure parameter values that are
consistent with pathways and values already in use by EPA for conducting risk assessments.
If default exposure parameters are used, they should be referenced clearly. However, 40 CFR
191.15 does not require that DOE perform risk assessments or dose-to-risk conversions.
EPA expects that compliance assessments will:
discuss the assumptions, methodologies, and results of analyses of exposure pathways.
Items such as dose coefficients that may be found in readily obtainable documents need not
be reproduced, but appropriate references for such items should be indicated in the
application in the event that they are used. Enough information should be provided in the
application so that EPA may confirm pathways analyses.
Detailed information on exposure parameters and dose conversions must be provided to the
extent necessary to support the assumptions and models used in compliance assessments.
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Simplified models may be used to estimate radiation doses to individuals. Such models
would be adequate to demonstrate compliance if it can be shown that the simplified models
are more conservative than more detailed and complex models are expected to be.
§194.53 Consideration of underground sources of drinking water.
In compliance assessments that analyze compliance with part 191, subpart C of this
chapter, all underground sources of drinking water in the accessible environment that are
expected to be affected by the disposal system over the regulatory time frame shall be
considered. In determining whether underground sources of drinking water are expected to
be affected by the disposal system, underground interconnections among bodies of surface
water, ground water, and underground sources of drinking water shall be considered.
For guidance regarding documentation of compliance assessments, see §194.54 and §194.55.
EPA expects that compliance assessments will:
discuss the assumptions and approaches (e.g., modeling of ground-water flow, total
dissolved solids per liter) used to consider USDWs, as well as the uncertainty
associated with the analyses. Enough information should be provided so that EPA
may recreate the analyses.
indicate the estimated concentrations of radionuclides in affected USDWs in the
accessible environment, and show that MCLs for radionuclides in USDWs in the
accessible environment will not be exceeded during the regulatory time period.
Detailed information on the location and nature of USDWs must be provided to the extent
necessary to support the assumptions used in compliance assessments. Simplified models
may be used to estimate radionuclide concentrations in groundwater. Such models would be
adequate to demonstrate compliance if it can be shown that the simplified models are more
conservative than more detailed and complex models would be expected to be.
EPA expects that compliance applicationsto the extent necessary to support models and
assumptions used in compliance assessmentswill:
identify and characterize any USDWs in the accessible environment expected to be
affected by the disposal system. Their location should be shown on maps with
information such as cross-sections and plan views with township, range, and estimated
latitude and longitude of the center of the USDW.
describe why any USDWs in the vicinity of the disposal system that are not included
in the analyses are not expected to be affected by the disposal system over the
regulatory time frame.
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document current and potential groundwater flow rates and direction, to determine if
interconnections specified in §194.53 could result in the migration of radionuclides
from the disposal system to the accessible environment within the 10,000 year
regulatory time period. Information assembled to satisfy §194.14(a)(3) may be used to
support the fulfillment of this requirement, if clearly and appropriately cross-
referenced.
§194.54 Scope of compliance assessments.
Since much of the information for compliance assessments may be the same as that used for
performance assessments, an application may discuss common information in one location.
The application should identify the common information and cross-reference the specific
topics, so that the flow of the information is not disrupted or confused.
(a) Any compliance application shall contain compliance assessments required
pursuant to this part. Compliance assessments shall include information which:
(1) Identifies potential processes, events, or sequences of processes and events that
may occur over the regulatory time frame;
EPA expects any compliance application to:
identify potential processes, events, or sequences of processes and events that may
occur over the regulatory time frame (see §194.14 and §194.25).
(2) Identifies the processes, events, or sequences of processes and events included in
compliance assessment results provided in any compliance application; and
EPA expects any compliance application to:
list, in the compliance assessment discussion, the potential process, events or
sequences of processes and events that may occur over the regulatory time frame and
which are included in the compliance assessment;
identify and explain how the screening criteria of "unlikely natural events" is
addressed; and
identify and reference the appropriate discussions in the performance assessment
section, if the performance assessment's discussion of processes, events or sequences
of processes and events is used for compliance assessment purposes (see §194.32).
The processes, events, or sequences of processes and events for this section are limited to
undisturbed performance, where undisturbed performance (from 40 CFR Part 191) means the
predicted behavior of a disposal system, including consideration of the uncertainties in
predicted behavior, if the disposal system is not disrupted by human intrusion or the
occurrence of unlikely natural events.
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(3) Documents why any processes, events, or sequences of processes and events
identified pursuant to paragraph (a)(l) of this section were not included in compliance
assessment results provided in any compliance application.
EPA expects any compliance application to:
list the processes, events, or sequences of processes and events that were considered
but not included in compliance assessment analyses; and
discuss the reasons why processes, events, or sequences of processes and events were
not included in compliance assessment results.
(b) Compliance assessments of undisturbed performance shall include the effects on
the disposal system of:
(1) Existing boreholes in the vicinity of the disposal system, with attention to the
pathways they provide for migration ofradionuclidesfrom the site; and
EPA expects any compliance application to include:
evidence that the compliance assessment calculations include the effects of existing
boreholes in the vicinity of the disposal system, and explain how existing boreholes
were considered.
(2) Any activities that occur in the vicinity of the disposal system prior to or soon after
disposal. Such activities shall include, but shall not be limited to: existing boreholes and the
development of any existing leases that can be reasonably expected to be developed in the
near future, including boreholes and leases that may be used for fluid injection activities.
EPA expects any compliance application to:
identify any activities that occur in the vicinity of the disposal system prior to or soon
after disposal; and
demonstrate which processes, events or sequences of processes and events were
included in the compliance assessment calculations, including, but not limited to:
existing boreholes; and
the development of any existing leases that can be reasonably expected to be
developed in the near future, including boreholes that may be used for fluid
injection activities (see §194.32).
§194.55 Results of compliance assessments.
(a) Compliance assessments shall consider and document uncertainty in the
performance of the disposal system.
EPA expects any compliance application to:
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identify where compliance assessment uncertainty is documented;
document the uncertainty in the performance of the disposal system for compliance
assessment purposes; and
discuss how the uncertainty is considered in the compliance assessment.
(b) Probability distributions for uncertain disposal system parameter values used in
compliance assessments shall be developed and documented in any compliance application.
EPA expects any compliance application to:
identify the probability distributions used for compliance assessments. Cross-
reference to performance assessment probability distributions is acceptable, but
performance assessment probability distributions that are not used in the compliance
assessment should be noted. See §194.34;
describe the parameters, including units;
identify the model(s) and code(s) in which each parameter was used and the computer
code (i.e., material and parameter) name(s) of the parameter that was sampled;
identify any correlations between sampled parameters;
discuss how correlations between sampled parameters are addressed in performance
assessments;
identify the functional form of the probability distribution (e.g., lognormal, uniform)
used for the sampled parameters;
fully describe the statistics of each probability distribution, including the values for the
lower and upper ranges, mean (geometeric mean when appropriate), and median;
identify the importance of the sampled parameter relative to final releases, and to the
intermediate results calculated by the codes that use the parameter. For example, a
parameter may have an important role in a particular process, but may not have as
significant an effect on the results of compliance assessments. EPA recommends that
this information be presented in a table, as well as briefly discussed in the text;
demonstrate that the data used to develop the input parameter probability distribution
have been qualified and controlled in accordance with §194.22; and
discuss the linkage between the input parameter information and the data used to
develop the input information.
(c) Computational techniques which draw random samples from across the entire
range of values of each probability distribution developed pursuant to paragraph (b) of this
section shall be used to generate a range of:
(1) Estimated committed effective doses received from all pathways pursuant to §
194.51 and § 194.52;
EPA expects any compliance application to:
indicate the methodology used to estimate committed effective doses received from all
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pathways in accordance with §194.51 and §194.52;
provide information so that EPA may confirm the analyses; and
list and discuss estimated committed effective doses.
(2) Estimatedradionuclide concentrations in USDWspursuant to § 194.53; and
EPA expects any compliance application to:
identify underground sources of drinking water in the vicinity of WIPP;
discuss potential pathways by which radionuclides could travel to an underground
source of drinking water;
discuss why any underground sources of drinking water in the vicinity of WIPP would
not be expected to be affected; and
identify the radionuclide concentrations in the USDWs in the accessible environment
that are expected to be affected by the disposal system over the regulatory time frame.
(3) Estimated dose equivalent received from USDWs pursuant to § 194.52 and §
194.53.
EPA expects any compliance application to:
discuss the method for estimating the dose from any USDW that is expected to be
affected by the disposal system;
identify the estimated dose; and
provide information so that EPA may confirm the analyses.
(d) The number of estimates generated pursuant to paragraph (c) of this section shall
be large enough such that the maximum estimates of doses and concentrations generated
exceed the 99th percentile of the population of estimates with at least a 0.95 probability.
EPA expects any compliance application to:
discuss the method used to calculate that the maximum estimates of doses and
concentrations exceed the 99th percentile of the population of estimates with at least a
0.95 probability;
list and discuss the sample size used for the analyses;
identify the estimate of doses and concentrations at the 99th percentile in the
calculated sample; and
provide information so that EPA may confirm the analyses.
(e) Any compliance application shall display:
(1) The full range of estimated radiation doses; and
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EPA expects any compliance application to:
list the lower and upper values of the estimated doses, along with other descriptive
statistics, such as the mean, median, and standard deviation;
list and discuss the sample size used to develop the full range of estimated doses;
identify the time period for which the doses apply;
provide information so that EPA may confirm the analyses.
(2) The full range of estimated radionuclide concentrations.
EPA expects any compliance application to:
list the lower and upper values of the estimated radionuclide concentrations, along
with other descriptive statistics, such as the mean, median, and standard deviation;
list and discuss the sample size used to develop the full range of estimated
radionuclide concentrations;
identify the time period for which the doses were calculated;
identify the location (estimated spatial coordinates) for which the estimates apply; and
provide information so that EPA may confirm the analyses.
(f) Any compliance application shall document that there is at least a 95 percent level
of statistical confidence that the mean and the median of the range of estimated radiation
doses and the range of estimated radionuclide concentrations meet the requirements of §
191.15 and part 191, subpart C of this chapter, respectively.
EPA expects any compliance application to:
provide information so that EPA may confirm the analyses, including steps used to
arrive at the result and the data used in the analyses; and
provide descriptive statistics, including the lower and upper limits of the range, the
mean, and the median of estimated doses and radionuclide concentrations.
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Appendix A Definitions from Parts 191 and 194
The following definitions have been excerpted from the respective portions of 40 CFR Parts
191 and 194 and they are reproduced here for convenience. Unless otherwise indicated in Part
194.02, all terms have the same meaning as in part 191.02, 191.12 of this chapter.
40 CFR Part 191.02 Definitions
(a) Agency means the Environmental Protection Agency.
(b) Administrator means the Administrator of the Environmental Protection Agency.
(c) Commission means the Nuclear Regulatory Commission.
(d) Department means the Department of Energy.
(e) NWPA means the Nuclear Waste Policy Act of 1982 (Pub. L 97-425).
(f) Agreement State means any State with which the Commission or the Atomic
Energy Commission has entered into an effective agreement under subsection 274b of the
Atomic Energy Act of 1954, as amended (68 Stat. 919).
(g) Spent nuclear fuel means fuel that has been withdrawn from a nuclear reactor
following irradiation, the constituent elements of which have not been separated by
reprocessing.
(h) High-level radioactive waste., as used in this part, means high-level radioactive
waste as defined in the Nuclear Waste Policy Act of 1982 (Pub. Law 97-425).
(i) Transuranic radioactive waste, as used in this part, means waste containing more
than 100 nanocuries of alpha-emitting transuranic isotopes, with half-lives greater than twenty
years, per gram of waste, except for: (1) High-level radioactive wastes; (2) wastes that the
Department has determined, with the concurrence of the Administrator, do not need the
degree of isolation required by this part; or (3) wastes that the Commission has approved for
disposal on a case-by-case basis in accordance with 10 CFR part 61.
(j) Radioactive waste, as used in this part, means the high-level and transuranic
radioactive waste covered by this part.
(k) Storage means retention of spent nuclear fuel or radioactive wastes with the intent
and capability to readily retrieve such fuel or waste for subsequent use, processing, or
disposal.
(1) Disposal means permanent isolation of spent nuclear fuel or radioactive waste from
the accessible environment with no intent of recovery, whether or not such isolation permits
the recovery of such fuel or waste. For example, disposal of waste in a mined geologic
repository occurs when all of the shafts to the repository are backfilled and sealed.
(m) Management means any activity, operation, or process (except for transportation)
conducted to prepare spent nuclear fuel or radioactive waste for storage or disposal, or the
activities associated with placing such fuel or waste in a disposal system.
(n) Site means an area contained within the boundary of a location under the effective
control of persons possessing or using spent nuclear fuel or radioactive waste that are
involved in any activity, operation, or process covered by this part.
(o) General environment means the total terrestrial, atmospheric, and aquatic
environments outside sites within which any activity, operation, or process associated with the
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management and storage of spent nuclear fuel or radioactive waste is conducted.
(p) Member of the public means any individual except during the time when that
individual is a worker engaged in any activity, operation, or process that is covered by the
Atomic Energy Act of 1954, as amended.
(q) Critical organ means the most exposed human organ or tissue exclusive of the
integumentary system (skin) and the cornea.
40 CFR Part 191.12 Definitions
Accessible environment means: (1) The atmosphere: (2) land surfaces; (3) surface
waters; (4) oceans; and (5) all of the lithosphere that is beyond the controlled area.
Active institutional control means: (1) Controlling access to a disposal site by any
means other than passive institutional controls; (2) performing maintenance 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.
Annual committed effective dose means the committed effective dose resulting from a
one-year intake of radionuclides released plus the annual effective dose caused by direct
radiation from facilities or activities subject to subparts B and C of this part.
Aquifer means an underground geological formation, group of formations, or part of a
formation that is capable of yielding a significant amount of water to a well or spring.
Barrier means any material 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.
Controlled area means: (1) A surface location, to be identified by passive institutional
controls, that encompasses no more than 100 square kilometers and extends horizontally no
more than five kilometers in any direction from the outer boundary of the original location of
the radioactive wastes in a disposal system: and (2) the subsurface underlying such a surface
location.
Disposal system means any combination of engineered and natural barriers that isolate
spent nuclear fuel or radioactive waste after disposal.
Dose equivalent means the product of absorbed dose and appropriate factors to
account for differences in biological effectiveness due to the quality of radiation and its
spatial distribution in the body; the unit of dose equivalent is the "rem" ("sievert" in SI units).
Effective dose means the sum over specified tissues of the products of the dose
equivalent received following an exposure of, or an intake of radionuclides into, specified
tissues of the body, multiplied by appropriate weighting factors. This allows the various
tissue-specific health risks to be summed into an overall health risk. The method used to
calculate effective dose is described in Appendix B of this part.
Ground water means water below the land surface in a zone of saturation.
Heavy metal means all uranium, plutonium, or thorium placed into a nuclear reactor.
Implementing agency means:
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(1) The Commission for facilities licensed by the Commission;
(2) The Agency for those implementation responsibilities for the Waste Isolation Pilot
Plant, under this part, given to the Agency by the Waste Isolation Pilot Plant Land
Withdrawal Act (Pub. L. 102-579, 106 Stat. 4777) which, for the purposes of this part, are:
(i) Determinations by the Agency that the Waste Isolation Pilot Plant is in compliance
with sub part A of this part;
(ii) Issuance of criteria for the certifications of compliance with subparts B and C of
this part of the Waste Isolation Pilot Plant's compliance with subparts B and C of this part;
(iii) Certifications of compliance with subparts B and C of this part of the Waste
Isolation Pilot Plant's compliance with subparts B and C of this part;
(iv) If the initial certification is made, periodic recertification of the Waste Isolation
Pilot Plant's continued compliance with subparts B and C of this part;
(v) Review and comment on performance assessment reports of the Waste Isolation
Pilot Plant; and,
(vi) Concurrence by the Agency with the Department's determination under
§ 191.02(1) that certain wastes do not need the degree of isolation required by subparts B and
C of this part; and,
(3) The Department of Energy for any other disposal facility and all other
implementation responsibilities for the Waste Isolation Pilot Plant, under this part, not given
to the Agency.
International System of Units is the version of the metric system which has been
established by the International Bureau of Weights and Measures and is administered in the
United States by the National Institute of Standards and Technology. The abbreviation for
this system is "SI."
Lithosphere means the solid part of the Earth below the surface, including any ground
water contained within it.
Passive institutional control means: (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.
Performance assessment means an analysis that: (1) Identifies the processes and
events that might affect the disposal system; (2) examines the effects of these processes and
events on the performance of the disposal system; and (3) estimates the cumulative releases of
radionuclides, considering the associated uncertainties, caused by all significant processes and
events. These estimates should be incorporated into an overall probability distribution of
cumulative release to the extent practicable.
Radioactive material means matter composed of or containing radionuclides, with
radiological half-lives greater than 20 years, subject to the Atomic Energy Act of 1954, as
amended.
SI unit means a unit of measure in the International System of Units.
Sievert is the SI unit of effective dose and is equal to 100 rem or one joule per
kilogram. The abbreviation is "Sv."
Undisturbed performance means the predicted behavior of a disposal system,
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including consideration of the uncertainties in predicted behavior, if the disposal system is not
disrupted by human intrusion or the occurrence of unlikely natural events
Waste, as used in this part, means any spent nuclear fuel or radioactive waste isolated
in a disposal system.
Waste form means the materials comprising the radioactive components of waste and
any encapsulating or stabilizing matrix.
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40 CFR Part 194.02 Definitions
Certification means any action taken by the Administrator pursuant to section 8(d)(l)
oftheWIPPLWA.
Compliance application^) means the compliance certification application submitted to
the Administrator pursuant to section 8(d)(l) of the WIPP LWA or any compliance re-
certification applications submitted to the Administrator pursuant to section 8(f) of the WIPP
LWA.
Compliance assessments) means the analysis conducted to determine compliance with
§ 191.15, and part 191, subpart C of this chapter.
Delaware Basin means those surface and subsurface features which lie inside the
boundary formed to the north, east and west of the disposal system by the innermost edge of
the Capitan Reef, and formed, to the south, by a straight line drawn from the southeastern
point of the Davis Mountains to the most southwestern point of the Glass Mountains.
Deep drilling means those drilling events in the Delaware Basin that reach or exceed a
depth of 2,150 feet below the surface relative to where such drilling occurred.
Department means the United States Department of Energy.
Disposal regulations means part 191, subparts B and C of this chapter.
Management systems review means the qualitative assessment of a data collection
operation or organization(s) to establish whether the prevailing quality management structure,
policies, practices, and procedures are adequate to ensure that the type and quality of data
needed are obtained.
Modification means action(s) taken by the Administrator that alters the terms or
conditions of certification pursuant to section 8(d)(l) of the WIPP LWA. Modification of any
certification shall comply with this part and part 191 of this chapter.
Population of CCDFs means all possible complementary, cumulative distribution
functions (CCDFs) that can be generated from all disposal system parameter values used in
performance assessments.
Population of estimates means all possible estimates of radiation doses and
radionuclide concentrations that can be generated from all disposal system parameter values
used in compliance assessments.
Quality assurance means those planned and systematic actions necessary to provide
adequate confidence that the disposal system will comply with the disposal regulations set
forth in part 191 of this chapter. Quality assurance includes quality control, which comprises
those actions related to the physical characteristics of a material, structure, component, or
system that provide a means to control the quality of the material, structure, component, or
system to predetermined requirements.
Re-certification means any action taken by the Administrator pursuant to section 8(f)
oftheWIPPLWA.
Regulatory time frame means the time period beginning at disposal and ending 10,000
years after disposal.
Revocation means any action taken by the Administrator to terminate the certification
pursuant to section 8(d)(l) of the WIPP LWA.
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Secretary means the Secretary of Energy.
Shallow drilling means those drilling events in the Delaware Basin that do not reach a
depth of 2,150 feet below the surface relative to where such drilling occurred.
Suspension means any action taken by the Administrator to withdraw, for a limited
period of time, the certification pursuant to section 8(d)(l) of the WIPP LWA.
Waste means the radioactive waste, radioactive material and coincidental material
subject to the requirements of part 191 of this chapter.
Waste characteristic means a property of the waste that has an impact on the
containment of waste in the disposal
system.
Waste component means an ingredient of the total inventory of the waste that
influences a waste characteristic.
WIPP means the Waste Isolation Pilot Plant, as authorized pursuant to section 213 of
the Department of Energy National Security and Military Applications of Nuclear Energy
Authorization Act of 1980 (Pub.L. 96-164; 93 Stat. 1259, 1265).
WIPP LWA means the Waste Isolation Pilot Plant Land Withdrawal Act of 1992
(Pub.L. 102-579, 106 Stat. 4777).
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