[Code of Federal Regulations]
[Title 40, Volume 24]
[Revised as of July 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR194]
[Page 36-58]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 194_CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF THE WASTE
ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS
Subpart A_General Provisions
Sec.
194.1 Purpose, scope, and applicability.
194.2 Definitions.
194.3 Communications.
194.4 Conditions of compliance certification.
194.5 Publications incorporated by reference.
194.6 Alternative provisions.
194.7 Effective date.
194.8 Approval process for waste shipment from waste generator sites for
disposal at the WIPP.
Subpart B_Compliance Certification and Re-certification Applications
194.11 Completeness and accuracy of compliance applications.
194.12 Submission of compliance applications.
194.13 Submission of reference materials.
194.14 Content of compliance certification application.
194.15 Content of compliance re-certification application(s).
Subpart C_Compliance Certification and Re-certification
General Requirements
194.21 Inspections.
194.22 Quality assurance.
194.23 Models and computer codes.
194.24 Waste characterization.
194.25 Future state assumptions.
194.26 Expert judgment.
194.27 Peer review.
Containment Requirements
194.31 Application of release limits.
194.32 Scope of performance assessments.
194.33 Consideration of drilling events in performance assessments.
194.34 Results of performance assessments.
Assurance Requirements
194.41 Active institutional controls.
194.42 Monitoring.
194.43 Passive institutional controls.
194.44 Engineered barriers.
194.45 Consideration of the presence of resources.
194.46 Removal of waste.
Individual and Ground-water Protection Requirements
194.51 Consideration of protected individual.
194.52 Consideration of exposure pathways.
194.53 Consideration of underground sources of drinking water.
194.54 Scope of compliance assessments.
194.55 Results of compliance assessments.
Subpart D_Public Participation
194.61 Advance notice of proposed rulemaking for certification.
194.62 Notice of proposed rulemaking for certification.
194.63 Final rule for certification.
194.64 Documentation of continued compliance.
194.65 Notice of proposed rulemaking for modification or revocation.
194.66 Final rule for modification or revocation.
194.67 Dockets.
Appendix A to Part 194--Certification of the Waste Isolation Pilot
Plant's
[[Page 37]]
Compliance with the 40 CFR Part 191 Disposal Regulations and
the 40 CFR Part 194 Compliance Criteria
Authority: Pub. L. 102-579, 106 Stat. 4777, as amended by Pub. L.
104-201,110 Stat. 2422; Reorganization Plan No. 3 of 1970, 35 FR 15623,
Oct. 6, 1970, 5 U.S.C. app. 1; Atomic Energy Act of 1954, as amended, 42
U.S.C. 2011-2296 and 10101-10270.
Source: 61 FR 5235, Feb. 9, 1996, unless otherwise noted.
Subpart A_General Provisions
Sec. 194.1 Purpose, scope, and applicability.
This part specifies criteria for the certification or any re-
certification, or subsequent actions relating to the terms or conditions
of certification of the Department of Energy's Waste Isolation Pilot
Plant's compliance with the disposal regulations found at part 191 of
this chapter and pursuant to section 8(d)(1) and section 8(f),
respectively, of the WIPP LWA. The compliance certification application
submitted pursuant to section 8(d)(1) of the WIPP LWA and any compliance
re-certification application submitted pursuant to section 8(f) of the
WIPP LWA shall comply with the requirements of this part.
Sec. 194.2 Definitions.
Unless otherwise indicated in this part, all terms have the same
meaning as in part 191 of this chapter.
Acceptable knowledge means any information about the process used to
generate waste, material inputs to the process, and the time period
during which the waste was generated, as well as data resulting from the
analysis of waste, conducted prior to or separate from the waste
certification process authorized by EPA's Certification Decision, to
show compliance with Condition 3 of the certification decision (appendix
A of this part).
Administrator's authorized representative means the director in
charge of radiation programs at the Agency.
Certification means any action taken by the Administrator pursuant
to section 8(d)(1) of the WIPP LWA.
Compliance application(s) means the compliance certification
application submitted to the Administrator pursuant to section 8(d)(1)
of the WIPP LWA or any compliance re-certification applications
submitted to the Administrator pursuant to section 8(f) of the WIPP LWA.
Compliance assessment(s) means the analysis conducted to determine
compliance with Sec. 191.15, and part 191, subpart C of this chapter.
Delaware Basin means those surface and subsurface features which lie
inside the boundary formed to the north, east and west of the disposal
system by the innermost edge of the Capitan Reef, and formed, to the
south, by a straight line drawn from the southeastern point of the Davis
Mountains to the most southwestern point of the Glass Mountains.
Deep drilling means those drilling events in the Delaware Basin that
reach or exceed a depth of 2,150 feet below the surface relative to
where such drilling occurred.
Department means the United States Department of Energy.
Disposal regulations means part 191, subparts B and C of this
chapter.
Management systems review means the qualitative assessment of a data
collection operation or organization(s) to establish whether the
prevailing quality management structure, policies, practices, and
procedures are adequate to ensure that the type and quality of data
needed are obtained.
Minor alternative provision means an alternative provision to the
Compliance Criteria that only clarifies an existing regulatory
provision, or does not substantively alter the existing regulatory
requirements.
Modification means action(s) taken by the Administrator that alters
the terms or conditions of certification pursuant to section 8(d)(1) of
the WIPP LWA. Modification of any certification shall comply with this
part and part 191 of this chapter.
Population of CCDFs means all possible complementary, cumulative
distribution functions (CCDFs) that can be generated from all disposal
system parameter values used in performance assessments.
Population of estimates means all possible estimates of radiation
doses and radionuclide concentrations that can be generated from all
disposal system
[[Page 38]]
parameter values used in compliance assessments.
Quality assurance means those planned and systematic actions
necessary to provide adequate confidence that the disposal system will
comply with the disposal regulations set forth in part 191 of this
chapter. Quality assurance includes quality control, which comprises
those actions related to the physical characteristics of a material,
structure, component, or system that provide a means to control the
quality of the material, structure, component, or system to
predetermined requirements.
Re-certification means any action taken by the Administrator
pursuant to section 8(f) of the WIPP LWA.
Regulatory time frame means the time period beginning at disposal
and ending 10,000 years after disposal.
Revocation means any action taken by the Administrator to terminate
the certification pursuant to section 8(d)(1) of the WIPP LWA.
Secretary means the Secretary of Energy.
Shallow drilling means those drilling events in the Delaware Basin
that do not reach a depth of 2,150 feet below the surface relative to
where such drilling occurred.
Suspension means any action taken by the Administrator to withdraw,
for a limited period of time, the certification pursuant to section
8(d)(1) of the WIPP LWA.
Waste means the radioactive waste, radioactive material and
coincidental material subject to the requirements of part 191 of this
chapter.
Waste characteristic means a property of the waste that has an
impact on the containment of waste in the disposal system.
Waste component means an ingredient of the total inventory of the
waste that influences a waste characteristic.
WIPP means the Waste Isolation Pilot Plant, as authorized pursuant
to section 213 of the Department of Energy National Security and
Military 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).
[61 FR 5235, Feb. 9, 1996, as amended at 63 FR 27404, May 18, 1998; 69
FR 42580, July 16, 2004]
Sec. 194.3 Communications.
(a) Compliance application(s) shall be:
(1) Addressed to the Administrator; and
(2) Signed by the Secretary.
(b) Communications and reports concerning the criteria in this part
shall be:
(1) Addressed to the Administrator or the Administrator's authorized
representative; and
(2) Signed by the Secretary or the Secretary's authorized
representative.
Sec. 194.4 Conditions of compliance certification.
(a) Any certification of compliance issued pursuant to section
8(d)(1) of the WIPP LWA may include such conditions as the Administrator
finds necessary to support such certification.
(b) Whether stated therein or not, the following conditions shall
apply in any such certification:
(1) The certification shall be subject to modification, suspension
or revocation by the Administrator. Any suspension of the certification
shall be done at the discretion of the Administrator. Any modification
or revocation of the certification shall be done by rule pursuant to 5
U.S.C. 553. If the Administrator revokes the certification, the
Department shall retrieve, as soon as practicable and to the extent
practicable, any waste emplaced in the disposal system.
(2) Any time after the Administrator issues a certification, the
Administrator or the Administrator's authorized representative may
submit a written request to the Department for information to enable the
Administrator to determine whether the certification should be modified,
suspended or revoked. Unless otherwise specified by the Administrator or
the Administrator's authorized representative, the Department shall
submit such information to the Administrator or the Administrator's
authorized representative
[[Page 39]]
within 30 calendar days of receipt of the request.
(3) Any time after the Administrator issues a certification, the
Department shall report any planned or unplanned changes in activities
or conditions pertaining to the disposal system that differ
significantly from the most recent compliance application.
(i) The Department shall inform the Administrator, in writing, prior
to making such a planned change in activity or disposal system
condition.
(ii) In the event of an unplanned change in activity or condition,
the Department shall immediately cease emplacement of waste in the
disposal system if the Department determines that one or more of the
following conditions is true:
(A) The containment requirements established pursuant to Sec.
191.13 of this chapter have been or are expected to be exceeded;
(B) Releases from already-emplaced waste lead to committed effective
doses that are or are expected to be in excess of those established
pursuant to Sec. 191.15 of this chapter. For purposes of this paragraph
(b)(3)(ii)(B), emissions from operations covered pursuant to part 191,
subpart A of this chapter are not included; or
(C) Releases have caused or are expected to cause concentrations of
radionuclides or estimated doses due to radionuclides in underground
sources of drinking water in the accessible environment to exceed the
limits established pursuant to part 191, subpart C of this chapter.
(iii) If the Department determines that a condition described in
paragraph (b)(3)(ii) of this section has occurred or is expected to
occur, the Department shall notify the Administrator, in writing, within
24 hours of the determination. Such notification shall, to the extent
practicable, include the following information:
(A) Identification of the location and environmental media of the
release or the expected release;
(B) Identification of the type and quantity of waste (in activity in
curies of each radionuclide) released or expected to be released;
(C) Time and date of the release or the estimated time of the
expected release;
(D) Assessment of the hazard posed by the release or the expected
release; and
(E) Additional information requested by the Administrator or the
Administrator's authorized representative.
(iv) The Department may resume emplacement of waste in the disposal
system upon written notification that the suspension has been lifted by
the Administrator.
(v) If the Department discovers a condition or activity that differs
significantly from what is indicated in the most recent compliance
application, but does not involve conditions or activities listed in
paragraph (b)(3)(ii) of this section, then the difference shall be
reported, in writing, to the Administrator within 10 calendar days of
its discovery.
(vi) Following receipt of notification, the Administrator will
notify the Secretary in writing whether any condition or activity
reported pursuant to paragraph (b)(3) this section:
(A) Does not comply with the terms of the certification; and, if it
does not comply,
(B) Whether the compliance certification must be modified, suspended
or revoked. The Administrator or the Administrator's authorized
representative may request additional information before determining
whether modification, suspension or revocation of the compliance
certification is required.
(4) Not later than six months after the Administrator issues a
certification, and at least annually thereafter, the Department shall
report to the Administrator, in writing, any changes in conditions or
activities pertaining to the disposal system that were not required to
be reported by paragraph (b)(3) of this section and that differ from
information contained in the most recent compliance application.
Sec. 194.5 Publications incorporated by reference.
(a) The following publications are incorporated into this part by
reference:
(1) U.S. Nuclear Regulatory Commission, NUREG-1297 ``Peer Review for
[[Page 40]]
High-Level Nuclear Waste Repositories,'' published February 1988;
incorporation by reference (IBR) approved for Sec. Sec. 194.22, 194.23
and 194.27.
(2) American Society of Mechanical Engineers (ASME) Nuclear Quality
Assurance (NQA) Standard, NQA-1-1989 edition, ``Quality Assurance
Program Requirements for Nuclear Facilities;'' IBR approved for Sec.
194.22.
(3) ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition
``Quality Assurance Requirements for Nuclear Facility Applications;''
IBR approved for Sec. 194.22 and Sec. 194.23.
(4) ASME NQA-3-1989 edition, ``Quality Assurance Program
Requirements for the Collection of Scientific and Technical Information
for Site Characterization of High-Level Nuclear Waste Repositories''
(excluding section 2.1 (b) and (c)); IBR approved for Sec. 194.22.
(b) The publications listed in paragraph (a) of this section were
approved for incorporation by reference by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be inspected or obtained from the Air Docket, Docket No. A-92-56,
room M1500 (LE131), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460, or copies may be inspected
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html. or copies may be obtained from
the following addresses:
(1) For ASME standards, contact American Society of Mechanical
Engineers, 22 Law Drive, P.O. Box 2900, Fairfield, NJ 07007-2900, phone
1-800-843-2763.
(2) For Nuclear Regulatory Commission documents, contact Division of
Information Support Services, Distribution Service, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, or contact National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161, phone 703-487-4650.
[61 FR 5235, Feb. 9, 1996, as amended at 65 FR 47325, Aug. 2, 2000; 69
FR 18803, Apr. 9, 2004]
Sec. 194.6 Alternative provisions.
The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute
for any of the provisions of this part alternative provisions, or minor
alternative provisions, in accordance with the following procedures:
(a) Alternative provisions may be substituted after:
(1) 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;
(2) A public comment period of at least 120 days has been completed
and public hearings have been held in New Mexico;
(3) The public comments received have been fully considered; and
(4) A notice of final rulemaking is published in the Federal
Register.
(b) Minor alternative provisions may be substituted after:
(1) The minor alternative provisions have been proposed for public
comment in the Federal Register together with information describing how
they comport with the disposal regulations, the reasons why the existing
provisions of this part appear inappropriate, and the benefit of
compliance in accordance with the minor alternative provision;
(2) A public comment period of at least 30 days has been completed
for the minor alternative provisions and the public comments received
have been fully considered;
(3) A notice of final rulemaking is published in the Federal
Register for the minor alternative provisions.
[69 FR 42581, July 16, 2004]
Sec. 194.7 Effective date.
The criteria in this part shall be effective on April 9, 1996. The
incorporation by reference of certain publications listed in the
criteria is approved by the Director of the Federal Register as of April
9, 1996.
[[Page 41]]
Sec. 194.8 Approval process for waste shipment from waste generator
sites for disposal at the WIPP.
(a) Quality Assurance Programs at Waste Generator Sites. The Agency
will determine compliance with requirements for site-specific quality
assurance programs as set forth below:
(1) Upon submission by the Department of a site-specific quality
assurance program plan the Agency will evaluate the plan to determine
whether it establishes the applicable Nuclear Quality Assurance (NQA)
requirements of Sec. 194.22(a)(1) for the items and activities of
Sec. Sec. 194.22(a)(2)(i), 194.24(c)(3) and 194.24(c)(5). The program
plan and other documentation submitted by the Department will be placed
in the dockets described in Sec. 194.67.
(2) The Agency will conduct a quality assurance audit or an
inspection of a Department quality assurance audit at the relevant site
for the purpose of verifying proper execution of the site-specific
quality assurance program plan. The Agency will publish a notice in the
Federal Register announcing a scheduled inspection or audit. In that or
another notice, the Agency will also solicit public comment on the
quality assurance program plan and appropriate Department documentation
described in paragraph (a)(1) of this section. A public comment period
of at least 30 days will be allowed.
(3) The Agency's written decision regarding compliance with the
requisite quality assurance requirements at a waste generator site will
be conveyed in a letter from the Administrator's authorized
representative to the Department. No such compliance determination shall
be granted until after the end of the public comment period described in
paragraph (a)(2) of this section. A copy of the Agency's compliance
determination letter will be placed in the public dockets in accordance
with Sec. 194.67. The results of any inspections or audits conducted by
the Agency to evaluate the quality assurance programs described in
paragraph (a)(1) of this section will also be placed in the dockets
described in Sec. 194.67.
(4) Subsequent to any positive determination of compliance as
described in paragraph (a)(3) of this section, the Agency intends to
conduct inspections, in accordance with Sec. Sec. 194.21 and 194.22(e),
to confirm the continued compliance of the programs approved under
paragraphs (a)(2) and (a)(3) of this section. The results of such
inspections will be made available to the public through the Agency's
public dockets, as described in Sec. 194.67.
(b) Waste characterization programs at transuranic waste sites. The
Agency will establish compliance with Condition 3 of the certification
using the following process:
(1) DOE will implement waste characterization programs and processes
in accordance with Sec. 194.24(c)(4) 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 Sec. 194.24(c).
Waste characterization processes will include the collection and use of
acceptable knowledge; destructive and/or nondestructive techniques for
identifying and measuring waste components; and the validation, control,
and transmittal to the WIPP Waste Information System database of waste
characterization data, in accordance with Sec. 194.24(c)(4).
(2) The Agency will verify the compliance of waste characterization
programs and processes identified in paragraph (b)(1) of this section at
sites without EPA approval prior to October 14, 2004, using the
following process:
(i) DOE will notify EPA by letter that a transuranic waste site is
prepared to ship waste to the WIPP and has established adequate waste
characterization processes and programs. DOE also will provide the
relevant waste characterization program plans and documentation. EPA may
request additional information from DOE.
(ii) EPA will conduct a baseline compliance inspection at the site
to verify that adequate waste characterization program plans and
technical procedures have been established, and that those plans and
procedures are effectively implemented. The inspection will include a
demonstration or test by the site of the waste characterization
processes identified in paragraph (b)(1) of this section. If an
inspection does not lead to approval, we will send an
[[Page 42]]
inspection report to DOE identifying deficiencies and place the report
in the public docket described in Sec. 194.67. More than one inspection
may be necessary to resolve compliance issues.
(iii) The Agency will announce in the Federal Register a proposed
Baseline Compliance Decision to accept the site's compliance with Sec.
194.24(c)(4). We will place the inspection report(s) and any supporting
documentation in the public docket described in Sec. 194.67. The site
inspection report supporting the proposal will describe any limitations
on approved waste streams or waste characterization processes. It will
also identify (through tier designations in accordance with paragraph
(b)(4) of this section) what changes to the approved waste
characterization processes must be reported to and approved by EPA
before they can be implemented. In the notice, we will solicit public
comment (for a minimum of 45 days) on the proposed Baseline Compliance
Decision, including any limitations and the tier designations for future
changes or expansions to the site's waste characterization program.
(iv) Our written decision regarding compliance with the requirements
for waste characterization programs and processes described in paragraph
(b)(1) of this section will be conveyed in a letter from the
Administrator's authorized representative to DOE. EPA will not issue a
compliance decision until after the end of the public comment period
described in paragraph (b)(2)(iii) of this section. EPA's compliance
decision will respond to significant and timely-received comments. A
copy of our compliance decision will be placed in the public docket
described in Sec. 194.67. DOE will comply with any requirements
identified in the compliance decision and the accompanying inspection
report.
(3) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iv) of this section, the Agency intends to
conduct inspections, in accordance with Sec. 194.24(h), to confirm the
continued compliance of approved waste characterization programs and
processes at transuranic waste sites. EPA will make the results of these
inspections available to the public in the dockets described in Sec.
194.67.
(4) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iv) of this section, the Department must
report changes or expansions to the approved waste characterization
program at a site in accordance with the tier designations established
in the Baseline Compliance Decision.
(i) For changes or expansions to the waste characterization program
designated as ``Tier 1,'' the Department shall provide written
notification to the Agency. The Department shall not ship for disposal
at WIPP any waste that has been characterized using the new or revised
processes, equipment, or waste streams until EPA has provided written
approval of such new or revised systems.
(ii) For changes or expansions to the waste characterization program
designated as ``Tier 2,'' the Department shall provide written
notification to the Agency. Waste characterized using the new or revised
processes, equipment, or waste streams may be disposed at WIPP without
written EPA approval.
(iii) EPA may conduct inspections in accordance with Sec. 194.24(h)
to evaluate the implementation of Tier 1 and Tier 2 changes or
expansions to the waste characterization program at a site.
(iv) Waste characterization program changes or expansions that are
not identified as either ``Tier 1'' or ``Tier 2'' will not require
written notification by the Department to the Agency before
implementation or before shipping waste for disposal at WIPP.
(5) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iii) of this section, EPA may revise the
tier designations for approving changes or expansions to the waste
characterization program at a site using the following process:
(i) The Agency shall announce the proposed tier changes in a letter
to the Department. The letter will describe the Agency's reasons for the
proposed change in tier designation(s). The letter and any supporting
inspection report(s) or other documentation will be placed in the
dockets described in Sec. 194.67.
[[Page 43]]
(ii) If the revised designation entails more stringent notification
and approval requirements (e.g., from Tier 2 to Tier 1, or from
undesignated to Tier 2), the change shall become effective immediately
and the site shall operate under the more stringent requirements without
delay.
(iii) If the revised designated entails less stringent notification
and approval requirements, (e.g., from Tier 1 to Tier 2, or from Tier 2
to undesignated), EPA will solicit comments from the public for a
minimum of 30 days. The site will continue to operate under the more
stringent approval requirements until the public comment period is
closed and EPA notifies DOE in writing of the Agency's final decision.
(6) A waste generator site that EPA approved for characterizing and
disposing transuranic waste at the WIPP under this section prior to
October 14, 2004, may continue characterizing and disposing such waste
at the WIPP under paragraph (c) of this section until EPA has conducted
a baseline compliance inspection and provided a Baseline Compliance
Decision under paragraph (b)(2) of this section.
(i) Until EPA provides a Baseline Compliance Decision for such a
site, EPA may approve additional transuranic waste streams for disposal
at WIPP under the provisions of paragraph (c) of this section. Prior to
the effective date of EPA's Baseline Compliance Decision for such a
site, EPA will continue to conduct inspections of the site in accordance
with Sec. 194.24(c).
(ii) EPA shall conduct a baseline compliance inspection and issue a
Baseline Compliance Decision for such previously approved sites in
accordance with the provisions of paragraph (b) of this section, except
that the site shall not be required to provide written notification of
readiness as described in paragraph (b)(2)(i) of this section.
(c) Waste characterization programs at waste generator sites with
prior approval. For a waste generator site that EPA approved for
characterizing and disposing transuranic waste at the WIPP under this
section prior to October 14, 2004, the Agency will determine compliance
with the requirements for use of process knowledge and a system of
controls at waste generator sites as set in this paragraph (c).
Approvals for a site to characterize and dispose of transuranic waste at
WIPP will proceed according to this section only until EPA has conducted
a baseline compliance inspection and provided a Baseline Compliance
Decision for a site under paragraph (b)(2) of this section.
(1) For each waste stream or group of waste streams at a site, the
Department must:
(i) Provide information on how process knowledge will be used for
waste characterization of the waste stream(s) proposed for disposal at
the WIPP; and
(ii) Implement a system of controls at the site, in accordance with
Sec. 194.24(c)(4), 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 Sec. 194.24(c). The
implementation of such a system of controls shall include a
demonstration that the site has procedures in place for adding data to
the WIPP Waste Information System (``WWIS''), and that such information
can be transmitted from that site to the WWIS database; and a
demonstration that measurement techniques and control methods can be
implemented in accordance with Sec. 194.24(c)(4) for the waste
stream(s) proposed for disposal at the WIPP.
(2) The Agency will conduct an audit or an inspection of a
Department audit for the purpose of evaluating the use of process
knowledge and the implementation of a system of controls for each waste
stream or group of waste streams at a waste generator site. The Agency
will announce a scheduled inspection or audit by the Agency with a
notice in the Federal Register. In that or another notice, the Agency
will also solicit public comment on the relevant waste characterization
program plans and Department documentation, which will be placed in the
dockets described in Sec. 194.67. A public comment period of at least
30 days will be allowed.
(3) The Agency's written decision regarding compliance with the
requirements for waste characterization programs described in paragraph
(b)(1) of this section for one or more waste
[[Page 44]]
streams from a waste generator site will be conveyed in a letter from
the Administrator's authorized representative to the Department. No such
compliance determination shall be granted until after the end of the
public comment period described in paragraph (b)(2) of this section. A
copy of the Agency's compliance determination letter will be placed in
the public dockets in accordance with Sec. 194.67. The results of any
inspections or audits conducted by the Agency to evaluate the plans
described in paragraph (b)(1) of this section will also be placed in the
dockets described in Sec. 194.67.
(4) Subsequent to any positive determination of compliance as
described in paragraph (b)(3) of this section, the Agency intends to
conduct inspections, in accordance with Sec. Sec. 194.21 and 194.24(h),
to confirm the continued compliance of the programs approved under
paragraphs (b)(2) and (b)(3) of this section. The results of such
inspections will be made available to the public through the Agency's
public dockets, as described in Sec. 194.67.
[63 FR 27404, May 18, 1998, as amended at 69 FR 42581, July 16, 2004]
Subpart B_Compliance Certification and Re-certification Applications
Sec. 194.11 Completeness and accuracy of compliance applications.
Information provided to the Administrator in support of any
compliance application shall be complete and accurate. The
Administrator's evaluation for certification pursuant to section
8(d)(1)(B) of the WIPP LWA and evaluation for recertification pursuant
to section 8(f)(2) of the WIPP LWA shall not begin until the
Administrator has notified the Secretary, in writing, that a complete
application in accordance with this part has been received.
Sec. 194.12 Submission of compliance applications.
Unless otherwise specified by the Administrator or the
Administrator's authorized representative, 5 copies of any compliance
application(s), any accompanying materials, and any amendments thereto
shall be submitted in a printed form to the Administrator's authorized
representative. These paper copies are intended for the official docket
in Washington, DC, as well as the four informational dockets in
Albuquerque and Santa Fe, New Mexico. In addition, DOE shall submit 10
copies of the complete application in alternative format (e.g., compact
disk) or other approved format, as specified by the Administrator's
authorized representative.
[69 FR 42582, July 16, 2004]
Sec. 194.13 Submission of reference materials.
Information may be included by reference into compliance
applications(s), provided that the references are clear specific and
that unless, otherwise specified by the Administrator or the
Administrator's authorized representative, 5 copies of reference
information are submitted to the Administrator's authorized
representative. These paper copies are intended for the official docket
in Washington, DC, as well as the four informational dockets in
Albuquerque and Santa Fe, New Mexico. Reference materials that are
widely available in standard text books or reference books need not to
be submitted. Whenever possible, DOE shall submit 10 copies of reference
materials in alternative format (e.g., compact disk) or other approved
format, as specified by the Administrator's authorized representative.
[69 FR 42582, July 16, 2004]
Sec. 194.14 Content of compliance certification application.
Any compliance application shall include:
(a) A current description of the natural and engineered features
that may affect the performance of the disposal system. The description
of the disposal system shall include, at a minimum, the following
information:
(1) The location of the disposal system and the controlled area;
(2) A description of the geology, geophysics, hydrogeology,
hydrology, and geochemistry of the disposal system and its vicinity and
how these conditions are expected to change and interact over the
regulatory time frame.
[[Page 45]]
Such description shall include, at a minimum:
(i) Existing fluids and fluid hydraulic potential, including brine
pockets, in and near the disposal system; and
(ii) Existing higher permeability anhydrite interbeds located at or
near the horizon of the waste.
(3) The presence and characteristics of potential pathways for
transport of waste from the disposal system to the accessible
environment including, but not limited to: Existing boreholes, solution
features, breccia pipes, and other potentially permeable features, such
as interbeds.
(4) The projected geophysical, hydrogeologic and geochemical
conditions of the disposal system due to the presence of waste
including, but not limited to, the effects of production of heat or
gases from the waste.
(b) A description of the design of the disposal system including:
(1) Information on materials of construction including, but not
limited to: Geologic media, structural materials, engineered barriers,
general arrangement, and approximate dimensions; and
(2) Computer codes and standards that have been applied to the
design and construction of the disposal system.
(c) Results of assessments conducted pursuant to this part.
(d) A description of input parameters associated with assessments
conducted pursuant to this part and the basis for selecting those input
parameters.
(e) Documentation of measures taken to meet the assurance
requirements of this part.
(f) A description of waste acceptance criteria and actions taken to
assure adherence to such criteria.
(g) A description of background radiation in air, soil and water in
the vicinity of the disposal system and the procedures employed to
determine such radiation.
(h) One or more topographic map(s) of the vicinity of the disposal
system. The contour interval shall be sufficient to show clearly the
pattern of surface water flow in the vicinity of the disposal system.
The map(s) shall include standard map notations and symbols, and, in
addition, shall show boundaries of the controlled area and the location
of any active, inactive, and abandoned injection and withdrawal wells in
the controlled area and in the vicinity of the disposal system.
(i) A description of past and current climatologic and meteorologic
conditions in the vicinity of the disposal system and how these
conditions are expected to change over the regulatory time frame.
(j) The information required elsewhere in this part or any
additional information, analyses, tests, or records determined by the
Administrator or the Administrator's authorized representative to be
necessary for determining compliance with this part.
Sec. 194.15 Content of compliance re-certification application(s).
(a) In submitting documentation of continued compliance pursuant to
section 8(f) of the WIPP LWA, the previous compliance application shall
be updated to provide sufficient information for the Administrator to
determine whether or not the WIPP continues to be in compliance with the
disposal regulations. Updated documentation shall include:
(1) All additional geologic, geophysical, geochemical, hydrologic,
and meteorologic information;
(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 Sec. Sec.
194.24(b)(1) and 194.24(b)(2);
(6) Any significant information not previously included in a
compliance certification or re-certification application related to
whether the disposal system continues to be in compliance with the
disposal regulations; and
(7) Any additional information requested by the Administrator or the
[[Page 46]]
Administrator's authorized representative.
(b) To the extent that information required for a re-certification
of compliance remains valid and has been submitted in previous
certification or re-certification application(s), such information need
not be duplicated in subsequent applications; such information may be
summarized and referenced.
Subpart C_Compliance Certification and Re-certification
General Requirements
Sec. 194.21 Inspections.
(a) The Administrator or the Administrator's authorized
representative(s) shall, at any time:
(1) Be afforded unfettered and unannounced access to inspect any
area of the WIPP, and any locations performing activities that provide
information relevant to compliance application(s), to which the
Department has rights of access. Such access shall be equivalent to
access afforded Department employees upon presentation of credentials
and other required documents.
(2) Be allowed to obtain samples, including split samples, and to
monitor and measure aspects of the disposal system and the waste
proposed for disposal in the disposal system.
(b) Records (including data and other information in any form) kept
by the Department pertaining to the WIPP shall be made available to the
Administrator or the Administrator's authorized representative upon
request. If requested records are not immediately available, they shall
be delivered within 30 calendar days of the request.
(c) The Department shall, upon request by the Administrator or the
Administrator's authorized representative, provide permanent, private
office space that is accessible to the disposal system. The office space
shall be for the exclusive use of the Administrator or the
Administrator's authorized representative(s).
(d) The Administrator or the Administrator's authorized
representative(s) shall comply with applicable access control measures
for security, radiological protection, and personal safety when
conducting activities pursuant to this section.
Sec. 194.22 Quality assurance.
(a)(1) As soon as practicable after April 9, 1996, the Department
shall adhere to a quality assurance program that implements the
requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part
2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding
Section 2.1 (b) and (c), and Section 17.1). (Incorporation by reference
as specified in Sec. 194.5.)
(2) Any compliance application shall include information which
demonstrates that the quality assurance program required pursuant to
paragraph (a)(1) of this section has been established and executed for:
(i) Waste characterization activities and assumptions;
(ii) Environmental monitoring, monitoring of the performance of the
disposal system, and sampling and analysis activities;
(iii) Field measurements of geologic factors, ground water,
meteorologic, and topographic characteristics;
(iv) Computations, computer codes, models and methods used to
demonstrate compliance with the disposal regulations in accordance with
the provisions of this part;
(v) Procedures for implementation of expert judgment elicitation
used to support applications for certification or re-certification of
compliance;
(vi) Design of the disposal system and actions taken to ensure
compliance with design specifications;
(vii) The collection of data and information used to support
compliance application(s); and
(viii) Other systems, structures, components, and activities
important to the containment of waste in the disposal system.
(b) Any compliance application shall include information which
demonstrates that data and information collected prior to the
implementation of the quality assurance program required pursuant to
paragraph (a)(1) of this section have been qualified in accordance with
an alternate methodology, approved by the Administrator or the
Administrator's authorized representative, that employs one or more
[[Page 47]]
of the following methods: Peer review, conducted in a manner that is
compatible with NUREG-1297, ``Peer Review for High-Level Nuclear Waste
Repositories,'' published February 1988 (incorporation by reference as
specified in Sec. 194.5); corroborating data; confirmatory testing; or
a quality assurance program that is equivalent in effect to ASME NQA-1-
1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989
edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c)
and Section 17.1). (Incorporation by reference as specified in Sec.
194.5.)
(c) Any compliance application shall provide, to the extent
practicable, information which describes how all data used to support
the compliance application have been assessed for their quality
characteristics, including:
(1) Data accuracy, i.e., the degree to which data agree with an
accepted reference or true value;
(2) Data precision, i.e., a measure of the mutual agreement between
comparable data gathered or developed under similar conditions expressed
in terms of a standard deviation;
(3) Data representativeness, i.e., the degree to which data
accurately and precisely represent a characteristic of a population, a
parameter, variations at a sampling point, or environmental conditions;
(4) Data completeness, i.e., a measure of the amount of valid data
obtained compared to the amount that was expected; and
(5) Data comparability, i.e., a measure of the confidence with which
one data set can be compared to another.
(d) Any compliance application shall provide information which
demonstrates how all data are qualified for use in the demonstration of
compliance.
(e) The Administrator will verify appropriate execution of quality
assurance programs through inspections, record reviews and record
keeping requirements, which may include, but may not be limited to,
surveillance, audits and management systems reviews.
Sec. 194.23 Models and computer codes.
(a) Any compliance application shall include:
(1) A description of the conceptual models and scenario construction
used to support any compliance application.
(2) A description of plausible, alternative conceptual model(s)
seriously considered but not used to support such application, and an
explanation of the reason(s) why such model(s) was not deemed to
accurately portray performance of the disposal system.
(3) Documentation that:
(i) Conceptual models and scenarios reasonably represent possible
future states of the disposal system;
(ii) Mathematical models incorporate equations and boundary
conditions which reasonably represent the mathematical formulation of
the conceptual models;
(iii) Numerical models provide numerical schemes which enable the
mathematical models to obtain stable solutions;
(iv) Computer models accurately implement the numerical models;
i.e., computer codes are free of coding errors and produce stable
solutions;
(v) Conceptual models have undergone peer review according to Sec.
194.27.
(b) Computer codes used to support any compliance application shall
be documented in a manner that complies with the requirements of ASME
NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition.
(Incorporation by reference as specified in Sec. 194.5.)
(c) Documentation of all models and computer codes included as part
of any compliance application performance assessment calculation shall
be provided. Such documentation shall include, but shall not be limited
to:
(1) Descriptions of the theoretical backgrounds of each model and
the method of analysis or assessment;
(2) General descriptions of the models; discussions of the limits of
applicability of each model; detailed instructions for executing the
computer codes, including hardware and software requirements, input and
output formats with explanations of each input and output variable and
parameter (e.g., parameter name and units); listings of input and output
files from a sample computer run; and reports on code verification,
benchmarking, validation, and quality assurance procedures;
[[Page 48]]
(3) Detailed descriptions of the structure of computer codes and
complete listings of the source codes;
(4) Detailed descriptions of data collection procedures, sources of
data, data reduction and analysis, and code input parameter development;
(5) Any necessary licenses; and
(6) An explanation of the manner in which models and computer codes
incorporate the effects of parameter correlation.
(d) The Administrator or the Administrator's authorized
representative may verify the results of computer simulations used to
support any compliance application by performing independent
simulations. Data files, source codes, executable versions of computer
software for each model, other material or information needed to permit
the Administrator or the Administrator's authorized representative to
perform independent simulations, and access to necessary hardware to
perform such simulations, shall be provided within 30 calendar days of a
request by the Administrator or the Administrator's authorized
representative.
Sec. 194.24 Waste characterization.
(a) Any compliance application shall describe the chemical,
radiological and physical composition of all existing waste proposed for
disposal in the disposal system. To the extent practicable, any
compliance application shall also describe the chemical, radiological
and physical composition of to-be-generated waste proposed for disposal
in the disposal system. These descriptions shall include a list of waste
components and their approximate quantities in the waste. This list may
be derived from process knowledge, current non-destructive examination/
assay, or other information and methods.
(b) The Department shall submit in the compliance certification
application the results of an analysis which substantiates:
(1) That all waste characteristics influencing containment of waste
in the disposal system have been identified and assessed for their
impact on disposal system performance. The characteristics to be
analyzed shall include, but shall not be limited to: Solubility;
formation of colloidal suspensions containing radionuclides; production
of gas from the waste; shear strength; compactability; and other waste-
related inputs into the computer models that are used in the performance
assessment.
(2) That all waste components influencing the waste characteristics
identified in paragraph (b)(1) of this section have been identified and
assessed for their impact on disposal system performance. The components
to be analyzed shall include, but shall not be limited to: metals;
cellulosics; chelating agents; water and other liquids; and activity in
curies of each isotope of the radionuclides present.
(3) Any decision to exclude consideration of any waste
characteristic or waste component because such characteristic or
component is not expected to significantly influence the containment of
the waste in the disposal system.
(c) For each waste component identified and assessed pursuant to
paragraph (b) of this section, the Department shall specify the limiting
value (expressed as an upper or lower limit of mass, volume, curies,
concentration, etc.), and the associated uncertainty (i.e., margin of
error) for each limiting value, of the total inventory of such waste
proposed for disposal in the disposal system. Any compliance application
shall:
(1) Demonstrate that, for the total inventory of waste proposed for
disposal in the disposal system, WIPP complies with the numeric
requirements of Sec. 194.34 and Sec. 194.55 for the upper or lower
limits (including the associated uncertainties), as appropriate, for
each waste component identified in paragraph (b)(2) of this section, and
for the plausible combinations of upper and lower limits of such waste
components that would result in the greatest estimated release.
(2) Identify and describe the method(s) used to quantify the limits
of waste components identified in paragraph (b)(2) of this section.
(3) Provide information that demonstrates that the use of acceptable
knowledge to quantify components in waste for disposal conforms with the
[[Page 49]]
quality assurance requirements of Sec. 194.22.
(4) Provide information which demonstrates that a system of controls
has been and will continue to be implemented to confirm that the total
amount of each waste component that will be emplaced in the disposal
system will not exceed the upper limiting value or fall below the lower
limiting value described in the introductory text of paragraph (c) of
this section. The system of controls shall include, but shall not be
limited to: Measurement; sampling; chain of custody records; record
keeping systems; waste loading schemes used; and other documentation.
(5) Identify and describe such controls delineated in paragraph
(c)(4) of this section and confirm that they are applied in accordance
with the quality assurance requirements found in Sec. 194.22.
(d) The Department shall include a waste loading scheme in any
compliance application, or else performance assessments conducted
pursuant to Sec. 194.32 and compliance assessments conducted pursuant
to Sec. 194.54 shall assume random placement of waste in the disposal
system.
(e) Waste may be emplaced in the disposal system only if the
emplaced components of such waste will not cause:
(1) The total quantity of waste in the disposal system to exceed the
upper limiting value, including the associated uncertainty, described in
the introductory text to paragraph (c) of this section; or
(2) The total quantity of waste that will have been emplaced in the
disposal system, prior to closure, to fall below the lower limiting
value, including the associated uncertainty, described in the
introductory text to paragraph (c) of this section.
(f) Waste emplacement shall conform to the assumed waste loading
conditions, if any, used in performance assessments conducted pursuant
to Sec. 194.32 and compliance assessments conducted pursuant to Sec.
194.54.
(g) The Department shall demonstrate in any compliance application
that the total inventory of waste emplaced in the disposal system
complies with the limitations on transuranic waste disposal described in
the WIPP LWA.
(h) The Administrator will use inspections and records reviews, such
as audits, to verify compliance with this section.
[61 FR 5235, Feb. 9, 1996, as amended at 69 FR 42583, July 16, 2004]
Sec. 194.25 Future state assumptions.
(a) Unless otherwise specified in this part or in the disposal
regulations, performance assessments and compliance assessments
conducted pursuant the provisions of this part to demonstrate compliance
with Sec. 191.13, Sec. 191.15 and part 191, subpart C shall assume
that characteristics of the future remain what they are at the time the
compliance application is prepared, provided that such characteristics
are not related to hydrogeologic, geologic or climatic conditions.
(b) In considering future states pursuant to this section, the
Department shall document in any compliance application, to the extent
practicable, effects of potential future hydrogeologic, geologic and
climatic conditions on the disposal system over the regulatory time
frame. Such documentation shall be part of the activities undertaken
pursuant to Sec. 194.14, Content of compliance certification
application; Sec. 194.32, Scope of performance assessments; and Sec.
194.54, Scope of compliance assessments.
(1) In considering the effects of hydrogeologic conditions on the
disposal system, the Department shall document in any compliance
application, to the extent practicable, the effects of potential changes
to hydrogeologic conditions.
(2) In considering the effects of geologic conditions on the
disposal system, the Department shall document in any compliance
application, to the extent practicable, the effects of potential changes
to geologic conditions, including, but not limited to: Dissolution; near
surface geomorphic features and processes; and related subsidence in the
geologic units of the disposal system.
(3) In considering the effects of climatic conditions on the
disposal system, the Department shall document in
[[Page 50]]
any compliance application, to the extent practicable, the effects of
potential changes to future climate cycles of increased precipitation
(as compared to present conditions).
Sec. 194.26 Expert judgment.
(a) Expert judgment, by an individual expert or panel of experts,
may be used to support any compliance application, provided that expert
judgment does not substitute for information that could reasonably be
obtained through data collection or experimentation.
(b) Any compliance application shall:
(1) Identify any expert judgments used to support the application
and shall identify experts (by name and employer) involved in any expert
judgment elicitation processes used to support the application.
(2) Describe the process of eliciting expert judgment, and document
the results of expert judgment elicitation processes and the reasoning
behind those results. Documentation of interviews used to elicit
judgments from experts, the questions or issues presented for
elicitation of expert judgment, background information provided to
experts, and deliberations and formal interactions among experts shall
be provided. The opinions of all experts involved in each elicitation
process shall be provided whether the opinions are used to support
compliance applications or not.
(3) Provide documentation that the following restrictions and
guidelines have been applied to any selection of individuals used to
elicit expert judgments:
(i) Individuals who are members of the team of investigators
requesting the judgment or the team of investigators who will use the
judgment were not selected; and
(ii) Individuals who maintain, at any organizational level, a
supervisory role or who are supervised by those who will utilize the
judgment were not selected.
(4) Provide information which demonstrates that:
(i) The expertise of any individual involved in expert judgment
elicitation comports with the level of knowledge required by the
questions or issues presented to that individual; and
(ii) The expertise of any expert panel, as a whole, involved in
expert judgment elicitation comports with the level and variety of
knowledge required by the questions or issues presented to that panel.
(5) Explain the relationship among the information and issues
presented to experts prior to the elicitation process, the elicited
judgment of any expert panel or individual, and the purpose for which
the expert judgment is being used in compliance applications(s).
(6) Provide documentation that the initial purpose for which expert
judgment was intended, as presented to the expert panel, is consistent
with the purpose for which this judgment was used in compliance
application(s).
(7) Provide documentation that the following restrictions and
guidelines have been applied in eliciting expert judgment:
(i) At least five individuals shall be used in any expert
elicitation process, unless there is a lack or unavailability of experts
and a documented rationale is provided that explains why fewer than five
individuals were selected.
(ii) At least two-thirds of the experts involved in an elicitation
shall consist of individuals who are not employed directly by the
Department or by the Department's contractors, unless the Department can
demonstrate and document that there is a lack or unavailability of
qualified independent experts. If so demonstrated, at least one-third of
the experts involved in an elicitation shall consist of individuals who
are not employed directly by the Department or by the Department's
contractors.
(c) The public shall be afforded a reasonable opportunity to present
its scientific and technical views to expert panels as input to any
expert elicitation process.
Sec. 194.27 Peer review.
(a) Any compliance application shall include documentation of peer
review that has been conducted, in a manner required by this section,
for:
(1) Conceptual models selected and developed by the Department;
(2) Waste characterization analyses as required in Sec. 194.24(b);
and
[[Page 51]]
(3) Engineered barrier evaluation as required in Sec. 194.44.
(b) Peer review processes required in paragraph (a) of this section,
and conducted subsequent to the promulgation of this part, shall be
conducted in a manner that is compatible with NUREG-1297, ``Peer Review
for High-Level Nuclear Waste Repositories,'' published February 1988.
(Incorporation by reference as specified in Sec. 194.5.)
(c) Any compliance application shall:
(1) Include information that demonstrates that peer review processes
required in paragraph (a) of this section, and conducted prior to the
implementation of the promulgation of this part, were conducted in
accordance with an alternate process substantially equivalent in effect
to NUREG-1297 and approved by the Administrator or the Administrator's
authorized representative; and
(2) Document any peer review processes conducted in addition to
those required pursuant to paragraph (a) of this section. Such
documentation shall include formal requests, from the Department to
outside review groups or individuals, to review or comment on any
information used to support compliance applications, and the responses
from such groups or individuals.
Containment Requirements
Sec. 194.31 Application of release limits.
The release limits shall be calculated according to part 191,
appendix A of this chapter, using the total activity, in curies, that
will exist in the disposal system at the time of disposal.
Sec. 194.32 Scope of performance assessments.
(a) Performance assessments shall consider natural processes and
events, mining, deep drilling, and shallow drilling that may affect the
disposal system during the regulatory time frame.
(b) Assessments of mining effects may be limited to changes in the
hydraulic conductivity of the hydrogeologic units of the disposal system
from excavation mining for natural resources. Mining shall be assumed to
occur with a one in 100 probability in each century of the regulatory
time frame. Performance assessments shall assume that mineral deposits
of those resources, similar in quality and type to those resources
currently extracted from the Delaware Basin, will be completely removed
from the controlled area during the century in which such mining is
randomly calculated to occur. Complete removal of such mineral resources
shall be assumed to occur only once during the regulatory time frame.
(c) Performance assessments shall include an analysis of the effects
on the disposal system of any activities that occur in the vicinity of
the disposal system prior to disposal and are expected to occur in the
vicinity of the disposal system soon after disposal. Such activities
shall include, but shall not be limited to, existing boreholes and the
development of any existing leases that can be reasonably expected to be
developed in the near future, including boreholes and leases that may be
used for fluid injection activities.
(d) Performance assessments need not consider processes and events
that have less than one chance in 10,000 of occurring over 10,000 years.
(e) Any compliance application(s) shall include information which:
(1) Identifies all potential processes, events or sequences and
combinations of processes and events that may occur during the
regulatory time frame and may affect the disposal system;
(2) Identifies the processes, events or sequences and combinations
of processes and events included in performance assessments; and
(3) Documents why any processes, events or sequences and
combinations of processes and events identified pursuant to paragraph
(e)(1) of this section were not included in performance assessment
results provided in any compliance application.
Sec. 194.33 Consideration of drilling events in performance
assessments.
(a) Performance assessments shall examine deep drilling and shallow
drilling that may potentially affect the disposal system during the
regulatory time frame.
(b) The following assumptions and process shall be used in assessing
the likelihood and consequences of drilling
[[Page 52]]
events, and the results of such process shall be documented in any
compliance application:
(1) Inadvertent and intermittent intrusion by drilling for resources
(other than those resources provided by the waste in the disposal system
or engineered barriers designed to isolate such waste) is the most
severe human intrusion scenario.
(2) In performance assessments, drilling events shall be assumed to
occur in the Delaware Basin at random intervals in time and space during
the regulatory time frame.
(3) The frequency of deep drilling shall be calculated in the
following manner:
(i) Identify deep drilling that has occurred for each resource in
the Delaware Basin over the past 100 years prior to the time at which a
compliance application is prepared.
(ii) The total rate of deep drilling shall be the sum of the rates
of deep drilling for each resource.
(4) The frequency of shallow drilling shall be calculated in the
following manner:
(i) Identify shallow drilling that has occurred for each resource in
the Delaware Basin over the past 100 years prior to the time at which a
compliance application is prepared.
(ii) The total rate of shallow drilling shall be the sum of the
rates of shallow drilling for each resource.
(iii) In considering the historical rate of all shallow drilling,
the Department may, if justified, consider only the historical rate of
shallow drilling for resources of similar type and quality to those in
the controlled area.
(c) Performance assessments shall document that in analyzing the
consequences of drilling events, the Department assumed that:
(1) Future drilling practices and technology will remain consistent
with practices in the Delaware Basin at the time a compliance
application is prepared. Such future drilling practices shall include,
but shall not be limited to: The types and amounts of drilling fluids;
borehole depths, diameters, and seals; and the fraction of such
boreholes that are sealed by humans; and
(2) Natural processes will degrade or otherwise affect the
capability of boreholes to transmit fluids over the regulatory time
frame.
(d) With respect to future drilling events, performance assessments
need not analyze the effects of techniques used for resource recovery
subsequent to the drilling of the borehole.
Sec. 194.34 Results of performance assessments.
(a) The results of performance assessments shall be assembled into
``complementary, cumulative distribution functions'' (CCDFs) that
represent the probability of exceeding various levels of cumulative
release caused by all significant processes and events.
(b) Probability distributions for uncertain disposal system
parameter values used in performance assessments shall be developed and
documented in any compliance application.
(c) Computational techniques, which draw random samples from across
the entire range of the probability distributions developed pursuant to
paragraph (b) of this section, shall be used in generating CCDFs and
shall be documented in any compliance application.
(d) The number of CCDFs generated shall be large enough such that,
at cumulative releases of 1 and 10, the maximum CCDF generated exceeds
the 99th percentile of the population of CCDFs with at least a 0.95
probability. Values of cumulative release shall be calculated according
to Note 6 of Table 1, appendix A of part 191 of this chapter.
(e) Any compliance application shall display the full range of CCDFs
generated.
(f) Any compliance application shall provide information which
demonstrates that there is at least a 95 percent level of statistical
confidence that the mean of the population of CCDFs meets the
containment requirements of Sec. 191.13 of this chapter.
Assurance Requirements
Sec. 194.41 Active institutional controls.
(a) Any compliance application shall include detailed descriptions
of proposed active institutional controls, the controls' location, and
the period of
[[Page 53]]
time the controls are proposed to remain active. Assumptions pertaining
to active institutional controls and their effectiveness in terms of
preventing or reducing radionuclide releases shall be supported by such
descriptions.
(b) Performance assessments shall not consider any contributions
from active institutional controls for more than 100 years after
disposal.
Sec. 194.42 Monitoring.
(a) The Department shall conduct an analysis of the effects of
disposal system parameters on the containment of waste in the disposal
system and shall include the results of such analysis in any compliance
application. The results of the analysis shall be used in developing
plans for pre-closure and post-closure monitoring required pursuant to
paragraphs (c) and (d) of this section. The disposal system parameters
analyzed shall include, at a minimum:
(1) Properties of backfilled material, including porosity,
permeability, and degree of compaction and reconsolidation;
(2) Stresses and extent of deformation of the surrounding roof,
walls, and floor of the waste disposal room;
(3) Initiation or displacement of major brittle deformation features
in the roof or surrounding rock;
(4) Ground water flow and other effects of human intrusion in the
vicinity of the disposal system;
(5) Brine quantity, flux, composition, and spatial distribution;
(6) Gas quantity and composition; and
(7) Temperature distribution.
(b) For all disposal system parameters analyzed pursuant to
paragraph (a) of this section, any compliance application shall document
and substantiate the decision not to monitor a particular disposal
system parameter because that parameter is considered to be
insignificant to the containment of waste in the disposal system or to
the verification of predictions about the future performance of the
disposal system.
(c) Pre-closure monitoring. To the extent practicable, pre-closure
monitoring shall be conducted of significant disposal system
parameter(s) as identified by the analysis conducted pursuant to
paragraph (a) of this section. A disposal system parameter shall be
considered significant if it affects the system's ability to contain
waste or the ability to verify predictions about the future performance
of the disposal system. Such monitoring shall begin as soon as
practicable; however, in no case shall waste be emplaced in the disposal
system prior to the implementation of pre-closure monitoring. Pre-
closure monitoring shall end at the time at which the shafts of the
disposal system are backfilled and sealed.
(d) Post-closure monitoring. The disposal system shall, to the
extent practicable, be monitored as soon as practicable after the shafts
of the disposal system are backfilled and sealed to detect substantial
and detrimental deviations from expected performance and shall end when
the Department can demonstrate to the satisfaction of the Administrator
that there are no significant concerns to be addressed by further
monitoring. Post-closure monitoring shall be complementary to monitoring
required pursuant to applicable federal hazardous waste regulations at
parts 264, 265, 268, and 270 of this chapter and shall be conducted with
techniques that do not jeopardize the containment of waste in the
disposal system.
(e) Any compliance application shall include detailed pre-closure
and post-closure monitoring plans for monitoring the performance of the
disposal system. At a minimum, such plans shall:
(1) Identify the parameters that will be monitored and how baseline
values will be determined;
(2) Indicate how each parameter will be used to evaluate any
deviations from the expected performance of the disposal system; and
(3) Discuss the length of time over which each parameter will be
monitored to detect deviations from expected performance.
Sec. 194.43 Passive institutional controls.
(a) Any compliance application shall include detailed descriptions
of the
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measures that will be employed to preserve knowledge about the location,
design, and contents of the disposal system. Such measures shall
include:
(1) Identification of the controlled area by markers that have been
designed and will be fabricated and emplaced to be as permanent as
practicable;
(2) Placement of records in the archives and land record systems of
local, State, and Federal governments, and international archives, that
would likely be consulted by individuals in search of unexploited
resources. Such records shall identify:
(i) The location of the controlled area and the disposal system;
(ii) The design of the disposal system;
(iii) The nature and hazard of the waste;
(iv) Geologic, geochemical, hydrologic, and other site data
pertinent to the containment of waste in the disposal system, or the
location of such information; and
(v) The results of tests, experiments, and other analyses relating
to backfill of excavated areas, shaft sealing, waste interaction with
the disposal system, and other tests, experiments, or analyses pertinent
to the containment of waste in the disposal system, or the location of
such information.
(3) Other passive institutional controls practicable to indicate the
dangers of the waste and its location.
(b) Any compliance application shall include the period of time
passive institutional controls are expected to endure and be understood.
(c) The Administrator may allow the Department to assume passive
institutional control credit, in the form of reduced likelihood of human
intrusion, if the Department demonstrates in the compliance application
that such credit is justified because the passive institutional controls
are expected to endure and be understood by potential intruders for the
time period approved by the Administrator. Such credit, or a smaller
credit as determined by the Administrator, cannot be used for more than
several hundred years and may decrease over time. In no case, however,
shall passive institutional controls be assumed to eliminate the
likelihood of human intrusion entirely.
Sec. 194.44 Engineered barriers.
(a) Disposal systems shall incorporate engineered barrier(s)
designed to prevent or substantially delay the movement of water or
radionuclides toward the accessible environment.
(b) In selecting any engineered barrier(s) for the disposal system,
the Department shall evaluate the benefit and detriment of engineered
barrier alternatives, including but not limited to: Cementation,
shredding, supercompaction, incineration, vitrification, improved waste
canisters, grout and bentonite backfill, melting of metals, alternative
configurations of waste placements in the disposal system, and
alternative disposal system dimensions. The results of this evaluation
shall be included in any compliance application and shall be used to
justify the selection and rejection of each engineered barrier
evaluated.
(c)(1) In conducting the evaluation of engineered barrier
alternatives, the following shall be considered, to the extent
practicable:
(i) The ability of the engineered barrier to prevent or
substantially delay the movement of water or waste toward the accessible
environment;
(ii) The impact on worker exposure to radiation both during and
after incorporation of engineered barriers;
(iii) The increased ease or difficulty of removing the waste from
the disposal system;
(iv) The increased or reduced risk of transporting the waste to the
disposal system;
(v) The increased or reduced uncertainty in compliance assessment;
(vi) Public comments requesting specific engineered barriers;
(vii) The increased or reduced total system costs;
(viii) The impact, if any, on other waste disposal programs from the
incorporation of engineered barriers (e.g., the extent to which the
incorporation of engineered barriers affects the volume of waste);
(ix) The effects on mitigating the consequences of human intrusion.
(2) If, after consideration of one or more of the factors in
paragraph (c)(1)
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of this section, the Department concludes that an engineered barrier
considered within the scope of the evaluation should be rejected without
evaluating the remaining factors in paragraph (c)(1) of this section,
then any compliance application shall provide a justification for this
rejection explaining why the evaluation of the remaining factors would
not alter the conclusion.
(d) In considering the ability of engineered barriers to prevent or
substantially delay the movement of water or radionuclides toward the
accessible environment, the benefit and detriment of engineered barriers
for existing waste already packaged, existing waste not yet packaged,
existing waste in need of re-packaging, and to-be-generated waste shall
be considered separately and described.
(e) The evaluation described in paragraphs (b), (c) and (d) of this
section shall consider engineered barriers alone and in combination.
Sec. 194.45 Consideration of the presence of resources.
Any compliance application shall include information that
demonstrates that the favorable characteristics of the disposal system
compensate for the presence of resources in the vicinity of the disposal
system and the likelihood of the disposal system being disturbed as a
result of the presence of those resources. If performance assessments
predict that the disposal system meets the containment requirements of
Sec. 191.13 of this chapter, then the Agency will assume that the
requirements of this section and Sec. 191.14(e) of this chapter have
been fulfilled.
Sec. 194.46 Removal of waste.
Any compliance application shall include documentation which
demonstrates that removal of waste from the disposal system is feasible
for a reasonable period of time after disposal. Such documentation shall
include an analysis of the technological feasibility of mining the
sealed disposal system, given technology levels at the time a compliance
application is prepared.
Individual and Ground-water Protection Requirements
Sec. 194.51 Consideration of protected individual.
Compliance assessments that analyze compliance with Sec. 191.15 of
this chapter shall assume that an individual resides at the single
geographic point on the surface of the accessible environment where that
individual would be expected to receive the highest dose from
radionuclide releases from the disposal system.
Sec. 194.52 Consideration of exposure pathways.
In compliance assessments that analyze compliance with Sec. 191.15
of this chapter, all potential exposure pathways from the disposal
system to individuals shall be considered. Compliance assessments with
part 191, subpart C and Sec. 191.15 of this chapter shall assume that
individuals consume 2 liters per day of drinking water from any
underground source of drinking water in the accessible environment.
Sec. 194.53 Consideration of underground sources of drinking water.
In compliance assessments that analyze compliance with part 191,
subpart C of this chapter, all underground sources of drinking water in
the accessible environment that are expected to be affected by the
disposal system over the regulatory time frame shall be considered. In
determining whether underground sources of drinking water are expected
to be affected by the disposal system, underground interconnections
among bodies of surface water, ground water, and underground sources of
drinking water shall be considered.
Sec. 194.54 Scope of compliance assessments.
(a) Any compliance application shall contain compliance assessments
required pursuant to this part. Compliance assessments shall include
information which:
(1) Identifies potential processes, events, or sequences of
processes and events that may occur over the regulatory time frame;
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(2) Identifies the processes, events, or sequences of processes and
events included in compliance assessment results provided in any
compliance application; and
(3) Documents why any processes, events, or sequences of processes
and events identified pursuant to paragraph (a)(1) of this section were
not included in compliance assessment results provided in any compliance
application.
(b) Compliance assessments of undisturbed performance shall include
the effects on the disposal system of:
(1) Existing boreholes in the vicinity of the disposal system, with
attention to the pathways they provide for migration of radionuclides
from the site; and
(2) Any activities that occur in the vicinity of the disposal system
prior to or soon after disposal. Such activities shall include, but
shall not be limited to: Existing boreholes and the development of any
existing leases that can be reasonably expected to be developed in the
near future, including boreholes and leases that may be used for fluid
injection activities.
Sec. 194.55 Results of compliance assessments.
(a) Compliance assessments shall consider and document uncertainty
in the performance of the disposal system.
(b) Probability distributions for uncertain disposal system
parameter values used in compliance assessments shall be developed and
documented in any compliance application.
(c) Computational techniques which draw random samples from across
the entire range of values of each probability distribution developed
pursuant to paragraph (b) of this section shall be used to generate a
range of:
(1) Estimated committed effective doses received from all pathways
pursuant to Sec. 194.51 and Sec. 194.52;
(2) Estimated radionuclide concentrations in USDWs pursuant to Sec.
194.53; and
(3) Estimated dose equivalent received from USDWs pursuant to Sec.
194.52 and Sec. 194.53.
(d) The number of estimates generated pursuant to paragraph (c) of
this section shall be large enough such that the maximum estimates of
doses and concentrations generated exceed the 99th percentile of the
population of estimates with at least a 0.95 probability.
(e) Any compliance application shall display:
(1) The full range of estimated radiation doses; and
(2) The full range of estimated radionuclide concentrations.
(f) Any compliance application shall document that there is at least
a 95 percent level of statistical confidence that the mean and the
median of the range of estimated radiation doses and the range of
estimated radionuclide concentrations meet the requirements of Sec.
191.15 and part 191, subpart C of this chapter, respectively.
Subpart D_Public Participation
Sec. 194.61 Advance notice of proposed rulemaking for certification.
(a) Upon receipt of a compliance application submitted pursuant to
section 8(d)(1) of the WIPP LWA and Sec. 194.11, the Agency will
publish in the Federal Register an Advance Notice of Proposed Rulemaking
announcing that a compliance application has been received, soliciting
comment on such application, and announcing the Agency's intent to
conduct a rulemaking to certify whether the WIPP facility will comply
with the disposal regulations.
(b) A copy of the compliance application will be made available for
inspection in Agency dockets established pursuant to Sec. 194.67.
(c) The notice will provide a public comment period of 120 days.
(d) A public hearing concerning the notice will be held if a written
request is received by the Administrator or the Administrator's
authorized representative within 30 calendar days of the date of
publication pursuant to paragraph (a) of this section.
(e) Any comments received on the notice will be made available for
inspection in the dockets established pursuant to Sec. 194.67.
(f) Any comments received on the notice will be provided to the
Department and the Department may submit to the Agency written responses
to the comments.
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Sec. 194.62 Notice of proposed rulemaking for certification.
(a) The Administrator will publish a Notice of Proposed Rulemaking
in the Federal Register announcing the Administrator's proposed
decision, pursuant to section 8(d)(1) of the WIPP LWA, whether to issue
a certification that the WIPP facility will comply with the disposal
regulations and soliciting comment on the proposal.
(b) The notice will provide a public comment period of at least 120
days.
(c) The notice will announce public hearings in New Mexico.
(d) Any comments received on the notice will be made available for
inspection in the dockets established pursuant to Sec. 194.67.
Sec. 194.63 Final rule for certification.
(a) The Administrator will publish a Final Rule in the Federal
Register announcing the Administrator's decision, pursuant to section
8(d)(1) of the WIPP LWA, whether to issue a certification that the WIPP
facility will comply with the disposal regulations.
(b) A document summarizing significant comments and issues arising
from comments received on the Notice of Proposed Rulemaking, as well as
the Administrator's response to such significant comments and issues,
will be prepared and will be made available for inspection in the
dockets established pursuant to Sec. 194.67.
Sec. 194.64 Documentation of continued compliance.
(a) Upon receipt of documentation of continued compliance with the
disposal regulations pursuant to section 8(f) of the WIPP LWA and Sec.
194.11, the Administrator will publish a notice in the Federal Register
announcing that such documentation has been received, soliciting comment
on such documentation, and announcing the Administrator's intent to
determine whether or not the WIPP facility continues to be in compliance
with the disposal regulations.
(b) Copies of documentation of continued compliance received by the
Administrator will be made available for inspection in the dockets
established pursuant to Sec. 194.67.
(c) The notice will provide a public comment period of at least 30
days after publication pursuant to paragraph (a) of this section.
(d) Any comments received on such notice will be made available for
public inspection in the dockets established pursuant to Sec. 194.67.
(e) Upon completion of review of the documentation of continued
compliance with the disposal regulations, the Administrator will publish
a notice in the Federal Register announcing the Administrator's decision
whether or not to re-certify the WIPP facility.
Sec. 194.65 Notice of proposed rulemaking for modification or
revocation.
(a) If the Administrator determines that any changes in activities
or conditions pertaining to the disposal system depart significantly
from the most recent compliance application, the Agency will publish a
Notice of Proposed Rulemaking in the Federal Register announcing the
Administrator's proposed decision on modification or revocation, and
soliciting comment on the proposal.
(b) Any comments received on the notice will be made available for
inspection in the dockets established pursuant to Sec. 194.67.
Sec. 194.66 Final rule for modification or revocation.
(a) The Administrator will publish a Final Rule in the Federal
Register announcing the Administrator's decision on modification or
revocation.
(b) A document summarizing significant comments and issues arising
from comments received on the Notice of Proposed Rulemaking as well as
the Administrator's response to such significant comments and issues
will be prepared and will be made available for inspection in the
dockets established pursuant to Sec. 194.67.
Sec. 194.67 Dockets.
The Agency will establish and maintain dockets in the State of New
Mexico and Washington, DC. The dockets will consist of all relevant,
significant information received from outside parties and all
significant information
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considered by the Administrator in certifying whether the WIPP facility
will comply with the disposal regulations, in certifying whether or not
the WIPP facility continues to be in compliance with the disposal
regulations, and in determining whether compliance certification should
be modified, suspended or revoked.
Appendix A to Part 194--Certification of the Waste Isolation Pilot
Plant's Compliance With the 40 CFR Part 191 Disposal Regulations and the
40 CFR Part 194 Compliance Criteria
In accordance with the provisions of the WIPP Compliance Criteria of
this part, the Agency finds that the Waste Isolation Pilot Plant
(``WIPP'') will comply with the radioactive waste disposal regulations
at part 191, subparts B and C, of this chapter. Therefore, pursuant to
Section 8(d)(2) of the WIPP Land Withdrawal Act (``WIPP LWA''), as
amended, the Administrator certifies that the WIPP facility will comply
with the disposal regulations. In accordance with the Agency's authority
under Sec. 194.4(a), the certification of compliance is subject to the
following conditions:
Condition 1: Sec. 194.14(b), Disposal system design, panel closure
system. The Department shall implement the panel seal design designated
as Option D in Docket A-93-02, Item II-G-1 (October 29, 1996, Compliance
Certification Application submitted to the Agency). The Option D design
shall be implemented as described in Appendix PCS of Docket A-93-02,
Item II-G-1, with the exception that the Department shall use Salado
mass concrete (consistent with that proposed for the shaft seal system,
and as described in Appendix SEAL of Docket A-93-02, Item II-G-1)
instead of fresh water concrete.
Condition 2: Sec. 194.22: Quality Assurance. The Secretary shall
not allow any waste generator site other than the Los Alamos National
Laboratory to ship waste for disposal at the WIPP until the Agency
determines that the site has established and executed a quality
assurance program, in accordance with Sec. Sec. 194.22(a)(2)(i),
194.24(c)(3) and 194.24(c)(5) for waste characterization activities and
assumptions. The Agency will determine compliance of site-specific
quality assurance programs at waste generator sites using the process
set forth in Sec. 194.8.
Condition 3: Sec. 194.24: Waste Characterization. The Secretary may
allow shipment for disposal at the WIPP of legacy debris waste at the
Los Alamos National Laboratory (``LANL'') that can be characterized
using the systems and processes inspected by the Agency and documented
in Docket A-93-02, Item II-I-70. The Secretary shall not allow shipment
of any waste from any additional LANL waste stream(s) or from any waste
generator site other than LANL for disposal at the WIPP until the Agency
has approved the processes for characterizing those waste streams for
shipment using the process set forth in Sec. 194.8.
Condition 4: Sec. 194.43, Passive institutional controls.
(a) Not later than the final recertification application submitted
prior to closure of the disposal system, the Department shall provide,
to the Administrator or the Administrator's authorized representative:
(1) a schedule for implementing passive institutional controls that
has been revised to show that markers will be fabricated and emplaced,
and other measures will be implemented, as soon as possible following
closure of the WIPP. Such schedule should describe how testing of any
aspect of the conceptual design will be completed prior to or soon after
closure, and what changes to the design of passive institutional
controls may be expected to result from such testing.
(2) documentation showing that the granite pieces for the proposed
monuments and information rooms described in Docket A-93-02, Item II-G-
1, and supplementary information may be: quarried (cut and removed from
the ground) without cracking due to tensile stresses from handling or
isostatic rebound; engraved on the scale required by the design;
transported to the site, given the weight and dimensions of the granite
pieces and the capacity of existing rail cars and rail lines; loaded,
unloaded, and erected without cracking based on the capacity of
available equipment; and successfully joined.
(3) documentation showing that archives and record centers will
accept the documents identified and will maintain them in the manner
identified in Docket A-93-02, Item II-G-1.
(4) documentation showing that proposed recipients of WIPP
information other than archives and record centers will accept the
information and make use of it in the manner indicated by the Department
in Docket A-93-02, Item II-G-1 and supplementary information.
(b) Upon receipt of the information required under paragraph (a) of
this condition, the Agency will place such documentation in the public
dockets identified in Sec. 194.67. The Agency will determine if a
modification to the compliance certification in effect is necessary. Any
such modification will be conducted in accordance with the requirements
at Sec. Sec. 194.65 and 194.66.
[63 FR 27405, May 18, 1998]
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