[Federal Register Volume 60, Number 19 (Monday, January 30, 1995)]
[Proposed Rules]
[Pages 5766-5791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1657]



      

[[Page 5765]]

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Part II





Environmental Protection Agency





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40 CFR Part 194



Criteria for the Certification and Determination of the Waste Isolation 
Pilot Plant's Compliance With Environmental Standards for the 
Management and Disposal of Spent Nuclear Fuel, High-Level and 
Transuranic Radioactive Wastes; Proposed Rule

  Federal Register / Vol. 60, No. 19 / Monday, January 30, 1995 / 
Proposed Rules   
[[Page 5766]] 

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 194

[FRL-5142-4]
RIN 2060-AE30


Criteria for the Certification and Determination of the Waste 
Isolation Pilot Plant's Compliance With Environmental Standards for the 
Management and Disposal of Spent Nuclear Fuel, High-Level and 
Transuranic Radioactive Wastes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing 
criteria for certifying and determining whether the Department of 
Energy's Waste Isolation Pilot Plant (WIPP) complies with disposal 
standards set forth in 40 CFR part 191 (Environmental Standards for the 
Management and Disposal of Spent Nuclear Fuel, High-Level and 
Transuranic Radioactive Wastes). EPA is required to promulgate these 
criteria under the 1992 Waste Isolation Pilot Plant Land Withdrawal Act 
(WIPP LWA). These criteria will be used by the Agency in ascertaining 
whether the WIPP disposal system complies with the disposal standards.

DATES: Comments on today's proposal must be received by May 1, 1995. 
Public hearings on today's proposal will be held in New Mexico. A 
separate annoucement will be published in the Federal Register to 
provide public hearing information.

ADDRESSES: Comments should be submitted, in duplicate, to: Docket No. 
A-92-56, Air Docket, room M-1500 (LE-131), U.S. Environmental 
Protection Agency, 401 M Street SW., Washington, DC 20460. See 
additional docket information in the Supplementary Information.

FOR FURTHER INFORMATION CONTACT: Mary Kruger or Martin Offutt; 
telephone number (202) 233-9310; address: Criteria and Standards 
Division, Mail Code 6602J, U.S. Environmental Protection Agency, 401 M 
Street SW., Washington, DC 20460. An addendum to the supplementary 
information provided in today's notice is located in Docket No. A-92-
56. For copies of this addendum and the Background Information Document 
and Economic Impact Analysis prepared for this proposed rule, contact 
Mary Kruger at the above phone number and address.

SUPPLEMENTARY INFORMATION: As discussed below, the scope of today's 
proposal is limited to proposed criteria for certifying and determining 
whether the Waste Isolation Pilot Plant (WIPP) in New Mexico complies 
with the disposal standards set forth in 40 CFR part 191. Accordingly, 
comments should be similarly limited in scope; e.g., comments should 
not address the Agency's recently promulgated radioactive waste 
disposal standards--40 CFR part 191 (58 FR 66398, December 20, 1993)--
or whether WIPP should be used as a disposal facility.
    The U.S. Department of Energy (DOE) is developing the Waste 
Isolation Pilot Plant (WIPP) near Carlsbad in southeastern New Mexico 
as a potential deep geologic repository for the disposal of defense 
transuranic (TRU) radioactive waste currently being stored on Federal 
reservations in Washington, Ohio, Idaho, New Mexico, Tennessee, South 
Carolina, Nevada and Colorado. TRU waste consists of materials 
containing one or more elements having atomic numbers greater than 92, 
in concentrations greater than 100 nanocuries of alpha-emitting TRU 
isotopes per gram of waste, with half-lives greater than 20 years. Most 
TRU waste consists of items that have become contaminated as a result 
of activities associated with the production of nuclear weapons, e.g., 
rags, equipment, tools, and organic and inorganic sludges. TRU waste is 
often mixed with hazardous chemical constituents.
    Before beginning disposal of radioactive waste at the WIPP, DOE 
must demonstrate that the WIPP complies with the Environmental 
Protection Agency's (EPA) radioactive waste standards at 40 CFR part 
191 (Environmental Standards for the Management and Disposal of Spent 
Nuclear Fuel, High-Level and Transuranic Radioactive Wastes).
    On October 30, 1992, the Waste Isolation Pilot Plant Land 
Withdrawal Act (WIPP LWA) was enacted (Pub. L. 102-579). The WIPP LWA 
contains numerous provisions pertaining to EPA's role in overseeing 
DOE's activities at the WIPP, including requirements for the 
development and implementation of the 40 CFR part 191 disposal 
standards as they are applied to the WIPP. Specifically, section 8(a) 
of the WIPP LWA reinstated all of the remanded disposal standards 
except those aspects of the individual and ground-water protection 
requirements which the court found problematic in NRDC v. U.S. EPA. The 
WIPP LWA requires EPA to certify and determine whether or not the WIPP 
will comply with the Agency's final radioactive waste disposal 
standards. ``Certification'' refers to any initial certification of 
compliance of DOE's application for the WIPP with subparts B and C of 
40 CFR part 191 (see section 8(d) of the WIPP LWA). ``Determination'' 
refers to any subsequent decisions by the Agency (required every 5 
years by the WIPP LWA) of whether the WIPP continues to be in 
compliance with subparts B and C of 40 CFR part 191 (see section 8(f) 
of the WIPP LWA). In order to certify or determine compliance, the 
Agency will be issuing criteria for assessing compliance with the final 
disposal standards, as required by section 8(c) of the WIPP LWA. On 
February 11, 1993, as a first step in the development of compliance 
criteria, EPA issued an Advance Notice of Proposed Rulemaking (ANPR) 
soliciting comments on issues associated with the development of 
compliance criteria. (58 FR 8029.) The next step in the evolution of 
these criteria is occurring today with the issuance of proposed 
compliance criteria.

Objective and Implementation of Today's Proposed Criteria

    Under authority of the WIPP LWA, the Agency is proposing criteria 
for certifying and determining whether the Department of Energy's (DOE) 
Waste Isolation Pilot Plant (WIPP) will comply with the Agency's 
radioactive waste disposal standards set forth in 40 CFR part 191. The 
WIPP LWA specifies that underground emplacement of transuranic wastes 
for disposal at the WIPP may not commence unless and until EPA 
certifies that the WIPP facility will comply with 40 CFR part 191, 
subparts B and C. If the Agency certifies compliance, the WIPP LWA 
requires EPA to subsequently conduct periodic determinations of 
continued compliance throughout waste disposal operations at the WIPP. 
Criteria contained in today's notice address any initial certification 
of compliance as well as any subsequent determinations of continued 
compliance. When final compliance criteria are promulgated as Agency 
regulations, EPA will be responsible for assuring that the requirements 
are properly implemented.
    Importantly, today's proposal is limited to consideration of the 
WIPP's compliance with the disposal regulations found in subparts B and 
C of 40 CFR part 191 (which include containment requirements, assurance 
requirements, individual protection requirements, and ground-water 
protection requirements). These compliance criteria do not address 
compliance with the management and storage regulations found in subpart 
A [[Page 5767]] of 40 CFR part 191. The Agency plans to issue guidance 
addressing implementation of subpart A at a later date.
    The Agency also wishes to make clear that today's proposal does not 
address compliance with all of the requirements of the WIPP LWA. 
Rather, today's proposal is limited to those requirements of the WIPP 
LWA which pertain to the WIPP's compliance with the disposal standards 
in 40 CFR part 191. For example, today's proposal does not address the 
WIPP's compliance with EPA regulations developed pursuant to the 
Resource Conservation and Recovery Act (RCRA) or any other 
environmental laws or regulations. EPA intends to address compliance 
with the balance of these additional laws and regulations through 
compliance plans being developed by EPA's Region VI. For more 
information regarding the Region's activities, please write to EPA 
Region VI, 1445 Ross Avenue, Dallas, Texas 75202-2733; Attn: Chuck 
Byrum.
    EPA has prepared a document entitled ``Implementation Strategy for 
the Waste Isolation Pilot Plant Land Withdrawal Act of 1992'' (EPA 402-
R-93-002, March 1993) which explains in more detail the Agency's roles 
and responsibilities under the WIPP LWA. For more information 
concerning the Implementation Strategy Document, please write to the 
Policy and Public Information Section, Office of Radiation and Indoor 
Air, U.S. EPA, Mail Code 6602J, 401 M St., S.W., Washington, D.C. 20460 
or call the EPA WIPP Information Line at 1-800-331-WIPP.

Additional Docket Information

    The Agency is currently maintaining the following public 
information dockets: (1) Docket No. A-92-56, located in room 1500 
(first floor in Waterside Mall near the Washington Information Center), 
U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, 
D.C. 20460 (open from 8:00 a.m. to 4:00 p.m. on weekdays); (2) EPA's 
docket in the Government Publications Department of the Zimmerman 
Library of the University of New Mexico located in Albuquerque, New 
Mexico (open from 8:00 a.m. to 9:00 p.m. on Monday through Thursday, 
8:00 a.m. to 5:00 p.m. on Friday, 9:00 a.m. to 5:00 p.m. on Saturday, 
and 1:00 p.m. to 9:00 p.m. on Sunday); (3) EPA's docket in the Fogelson 
Library of the College of Santa Fe in Santa Fe, New Mexico located at 
1600 St. Michaels Drive (open from 8:00 a.m. to 12:00 midnight on 
Monday through Thursday, 8:00 a.m. to 5:00 p.m. on Friday, 9:00 a.m. to 
5:00 p.m. on Saturday, 1:00 p.m. to 9:00 p.m. on Sunday); and (4) EPA's 
docket in the Municipal Library of Carlsbad, New Mexico located at 101 
S. Halegueno (open from 10:00 a.m. to 9:00 p.m. on Monday through 
Thursday, 10:00 a.m. to 6:00 p.m. on Friday and Saturday, and 1:00 p.m. 
to 5:00 p.m. on Sunday). As provided in 40 CFR part 2, a reasonable fee 
may be charged for photocopying docket materials.

Description of Proposed Criteria

    The proposed criteria consist of four subparts. Each of these 
subparts is discussed in more detail below.

Subpart A--General Provisions

    Subpart A is chiefly concerned with identifying the purpose, scope 
and applicability of the criteria, defining terms, setting forth 
requirements regarding communications, addressing conditions of 
compliance certification and determinations, incorporating publications 
by reference, and providing for alternative provisions if future 
information indicates a need to modify the criteria. The specific 
provisions of Subpart A are discussed below.

Purpose, Scope, and Applicability

    Under Section 7(b) of the WIPP LWA, the DOE cannot dispose of 
transuranic waste at the WIPP until the EPA certifies that the WIPP is 
in compliance with the Agency's radioactive waste disposal standards 
set forth in 40 CFR part 191. In addition, under Section 8(f) of the 
WIPP LWA, not later than five years after initial receipt of waste for 
disposal at the WIPP, and every five years thereafter until the end of 
the decommissioning phase (as defined in section 2 of the WIPP LWA), 
DOE is required to submit to the Administrator documentation of 
continued compliance with the Agency's disposal standards. EPA is 
proposing to specify that these criteria will apply to any 
certification of compliance or determination of continued compliance 
under these sections of the WIPP LWA. The Administrator will review any 
compliance applications (hereinafter, the term ``compliance 
applications'' refers to applications for certification of compliance 
under section 8(d) of the WIPP LWA as well as applications for 
determinations of continued compliance under section 8(f) of the WIPP 
LWA) and will utilize these criteria to ascertain whether such 
applications demonstrate compliance with subparts B and C of 40 CFR 
part 191. The Administrator's certification or determination of 
compliance for the WIPP facility will depend on satisfying the specific 
requirements of each section of these criteria.

Definitions

    In an effort to be consistent with the disposal standards set forth 
in 40 CFR part 191, the Agency is proposing that, unless otherwise 
indicated, all terms in the criteria have the same meaning as terms 
found in the disposal regulations.

Communications

    The Agency is proposing to specify that any compliance applications 
shall be addressed to the Administrator and shall be signed by the 
Secretary. Any other communications concerning compliance applications 
for the WIPP shall, likewise, be addressed to the Administrator and 
shall be signed by the Secretary or the Secretary's authorized 
representative.

Conditions of Compliance Certification and Determination

    EPA is proposing that any certification or determination issued by 
the Agency pursuant to the WIPP LWA may include any conditions that the 
Administrator finds necessary to support a compliance certification or 
determination. In addition, EPA is proposing that any certification or 
determination of compliance be potentially subject to modification, 
suspension, or revocation for cause. The Agency believes that such 
conditions are necessary in order to guard against the possibility that 
the disposal system does not perform as expected (i.e., according to 
predictions contained in compliance applications).
    Any certification or determination of the WIPP's compliance will be 
based upon the information contained in any compliance application 
submitted to the Administrator and upon other available information 
relevant to the application. So long as the contents of the application 
remain valid, the current certification or determination will remain 
valid. However, if the information contained in the application becomes 
invalid due to unanticipated developments, then the basis for the 
certification or determination may no longer be valid, and 
modification, suspension, or revocation of the certification or 
determination may be in order. Any modification, suspension, or 
revocation of a compliance certification will be subject to Agency 
rulemaking.
    EPA is proposing to include these conditions because the Agency 
believes it is important to have a mechanism which enables a 
certification or determination to be modified, suspended, or revoked if 
new information comes to light which suggests that the WIPP is no 
longer [[Page 5768]] performing or may no longer perform as predicted. 
It would not be prudent to wait until submission of documentation of 
continued compliance (potentially up to five years later) before taking 
steps to mitigate against potential malfunctioning of the disposal 
system. Delay would allow a situation which could result in a violation 
continuing to exist or, perhaps, worsen. Hence, EPA is proposing these 
conditions in order to be able to take action quickly to address 
serious issues raised as to whether the WIPP is in compliance with the 
disposal regulations.
    The Agency is not specifying, in today's proposal, the particular 
actions which may be required to be undertaken if modification or 
suspension were invoked. EPA has not done so because the Agency 
believes that it is inappropriate to specify particular actions prior 
to knowing the precise circumstances in which the actions would be 
undertaken. Since all of the scenarios in which the conditions might be 
invoked would be difficult to predict, specification of the actions 
necessary to mitigate against the consequences of all such scenarios 
becomes even more difficult. EPA, therefore, is proposing that 
decisions about the appropriate actions shall be based upon the nature 
and gravity of the given scenario at the time it occurs. In some cases 
this might entail instituting remedial actions or even removal of 
waste, while in other cases it might simply involve temporarily halting 
waste emplacement. Thus, actions will be evaluated on a case by case 
basis. The Agency solicits comment on this approach.
    While the Agency is not specifying the particular actions which may 
be required in the event of a modification or suspension, the Agency is 
proposing that, in the event of a revocation (where presumably all 
attempts at remedial action have failed), the Department shall 
retrieve, to the extent practicable, any waste emplaced in the disposal 
system. The Agency solicits comment on this proposal.
    The Agency is proposing that upon written request of the 
Administrator (after any certification or determination of compliance 
has been issued), the Department shall submit information to enable the 
Administrator to determine whether cause exists to modify, revoke, or 
suspend any certification or determination. Moreover, the EPA is 
proposing that the Department shall provide the requested information 
to the Administrator within 30 days of receipt of the Administrator's 
request. By requiring such a quick response time, the Agency can be 
assured that if circumstances arise which warrant suspension, 
modification, or revocation, the potential consequences of such 
circumstances can be mitigated early and safety can, therefore, be 
increased. As an additional measure to ensure that the Administrator is 
kept apprised of any developments at the WIPP which might warrant 
modification, suspension, or revocation of any certification or 
determination of compliance, the Agency is proposing that the 
Department report, within ten days of discovery, any significant 
changes in conditions pertaining to the disposal system that depart 
from the application and which formed the basis of any certification or 
determination. Moreover, the Agency is requiring that a written report 
of all changes in conditions and/or activities pertaining to the 
disposal system that depart from the application and which formed the 
basis of any certification or determination be submitted to the Agency 
at least once every six months. If the Department plans to 
intentionally make any significant changes in conditions or activities 
pertaining to the disposal system, all such changes must be approved by 
the Administrator prior to being made. The Administrator will consider 
whether the planned change will invalidate the terms of the 
certification or determination in assessing whether approval should be 
given.
    EPA is proposing to require the reporting of changes in WIPP 
conditions or activities once every six months to assure that the 
Agency is kept apprised of such changes but in a manner which is not 
overly burdensome to the Department in submitting the information or to 
the Agency in reviewing it.
    EPA is also proposing to require that if the Department determines 
that a release of waste from the disposal system in excess of what is 
permitted under the disposal regulations has occurred or is likely to 
occur, the Department shall immediately suspend emplacement of waste in 
the disposal system and notify the Administrator within 24 hours of 
discovery of such a release. Following such notification, the 
Administrator may request additional information and will determine 
whether to modify, suspend, or revoke any previously issued 
certification or determination of compliance. The EPA is proposing this 
requirement to ensure that the Administrator is quickly apprised of any 
changes in the disposal system's performance from the projections 
included in any compliance applications.

Publications Incorporated by Reference

    EPA is proposing that the following four documents be incorporated 
by reference: (1) The Nuclear Regulatory Commission's NUREG 1297 ``Peer 
Review for High-Level Nuclear Waste Repositories''; (2) The American 
Society of Mechanical Engineers' (ASME) NQA-1-1989 edition ``Quality 
Assurance Program Requirements for Nuclear Facilities''; (3) ASME NQA-
2a-1990 addenda (part 2.7) to ASME NQA-2-1989 edition ``Quality 
Assurance Requirements of Computer Software for Nuclear Facility 
Applications''; and (4) ASME NQA-3-1989 edition ``Quality Assurance 
Program Requirements for the Collection of Scientific and Technical 
Information for Site Characterization of High-Level Nuclear Waste 
Repositories.'' The Agency is proposing to incorporate all of these 
documents because EPA believes that each is appropriate for use at the 
WIPP. More detailed information about the contents of each document is 
provided below in the sections dedicated to the particular topic 
covered by the various documents. Documents incorporated by reference 
are also available for inspection in the Office of the Federal 
Register.

Alternative Provisions

    Although the Agency believes that the criteria being proposed today 
are appropriate based upon current knowledge and information, the 
possibility that future information may indicate necessary 
modifications to the criteria can not be ruled out.
    In recognition of this possibility, today's proposed criteria set 
forth procedures under which the Administrator may develop 
modifications to this part, should the need arise. Any such 
modifications would proceed through the notice-and-comment rulemaking 
process under the Administrative Procedure Act (5 U.S.C. 553). The 
proposed criteria stipulate that such a rulemaking would require a 
public comment period of at least 120 days, including public hearings 
in New Mexico.

Subpart B--Compliance Certification and Determination Applications

    Subpart B of the proposed compliance criteria addresses: (1) The 
completeness and accuracy of compliance applications; (2) the filing 
and distribution requirements for such applications and any associated 
reference materials; (3) the contents of a complete application; and 
(4) the criteria for updating certification [[Page 5769]] applications. 
Each of these sections is discussed below.

Completeness and Accuracy of Compliance Applications

    The Agency proposes to require that any applications submitted to 
the Administrator for a certification or determination of compliance be 
complete and accurate. Since the statutory review period for 
applications is only one year for certification and six months for 
determinations, it is essential that all of that time be devoted to 
substantive evaluation of the information contained in the 
applications. Therefore, the Agency is proposing that the statutory 
review periods not begin until the Administrator has determined that 
the application is complete, accurate, and in accordance with the 
compliance criteria. The Administrator will notify the Secretary in 
writing once this determination is made.

Submission of Compliance Applications

    In order to meet EPA's needs for reviewing and docketing any 
compliance applications, the Agency proposes to require that 30 paper 
copies of applications be filed with the Administrator (one original 
and 29 printed copies), unless otherwise specified by the 
Administrator. This number of copies is necessary because the Agency 
plans to place copies of compliance applications in various public 
dockets and the complexity of the application material will require 
multiple reviewers. The phrase ``unless otherwise specified by the 
Administrator'' is meant to allow for the possibility of alternative 
requirements for submission of compliance applications in the event 
that new submission methods are developed; e.g., electronic submission 
requirements.

Submission of Reference Materials

    The Agency recognizes that compliance applications will likely 
include references to other sources of information. Accordingly, 
today's proposal requires submission to the Administrator of ten paper 
copies of any referenced material unless otherwise specified by the 
Administrator. This is necessary due to the limited time period for 
review and due to the needs of multiple reviewers, including the 
public. Again, the phrase ``unless otherwise specified by the 
Administrator'' signals that the Administrator may require an 
alternative method for submission of reference materials if a more 
appropriate system (e.g., an electronic submission system) is 
developed. Regardless of what system is ultimately used, submissions 
need not include referenced material from standard textbooks (e.g., 
physics or chemical handbooks).

Content of Compliance Certification Applications

    The Agency is proposing to specify information which must be 
included in any compliance certification application. The proposed 
criteria require descriptions of the WIPP disposal system and 
surrounding environment, and the components and results of long-term 
compliance assessments. The items listed, however, are not intended to 
be an exhaustive identification of the necessary elements of a complete 
application. Rather, the proposed criteria identify what the Agency 
considers to be major elements of a complete compliance application. 
Note that other major submission requirements are discussed elsewhere 
in the criteria and are too numerous to list here (such as 
documentation requirements for use of expert judgment and for waste 
characterization).
    In the future, the Agency will be issuing a detailed guide as a 
supplement to the 40 CFR part 194 compliance criteria. This guide will 
provide additional detailed information on the expected format and 
content of a complete compliance application. The Agency is not 
including such a detailed itemization in today's proposal because EPA 
needs more information about factors important to the disposal system's 
ability to contain waste before such detailed submission requirements 
can be identified.
    As an example of the type of information which may be necessary for 
inclusion in a complete application, but which EPA is not specifying in 
today's proposal due to the fact that there is currently an incomplete 
understanding of its effect on the disposal system, is an analysis and 
identification of higher permeability marker beds in the host rock. 
(Marker beds are stratified units with distinctive characteristics 
making them an easily recognized geologic horizon.) At present, there 
is some information about the existence of these marker beds in the 
host rock, but little knowledge about how they may affect the transport 
of radionuclides and the flow of ground water. As further study is done 
of these marker beds, it is possible that they may be discovered to 
have a great impact on the WIPP's ability to comply with the disposal 
standards of 40 CFR part 191. It is also possible that they will be 
discovered to have little or no impact. Depending on the results of 
further study, then, EPA will decide whether information about the 
higher permeability beds needs to be included in compliance 
applications and if so, how much information. EPA solicits comment on 
this approach.

Content of Compliance Determination Application(s)

    As required by section 8(f) of the WIPP Land Withdrawal Act, DOE 
must submit documentation of continued compliance every five years 
after any initial certification is granted for the WIPP until the end 
of the decommissioning phase, when all shafts and rooms at the WIPP are 
backfilled and sealed. To avoid duplication of information already 
submitted to the Administrator as part of any previous compliance 
applications, EPA proposes to require that only relevant new 
information be submitted as documentation of continued compliance. This 
documentation must update the information contained in previous 
applications and apprise the Agency of new developments regarding the 
WIPP disposal system and its performance. Information included in 
previous applications may be summarized and referenced.

Subpart C--Compliance Certification and Determination

    Subpart C sets forth general and specific requirements for 
certifying and determining compliance with the provisions of the 
disposal regulations found in subparts B and C of 40 CFR part 191. The 
provisions of Subpart C are discussed in detail below.

General Requirements

Inspections

    Today's proposal provides for EPA inspections to help ensure that 
WIPP-related activities and pertinent records described in any 
compliance applications are implemented as described. Inspections, 
including, random, unannounced inspections of WIPP-related activities 
and records, will assist EPA in assuring the validity of information 
used to support compliance applications. In conducting such 
inspections, EPA will comply with applicable access control measures 
for security, radiological protection and personal safety, but shall 
otherwise have unfettered access to WIPP-related activities and 
records.
    To facilitate EPA's ability to inspect as warranted, EPA is 
proposing that, upon request, the Department provide the 
Administrator's inspectors with rent-free office space convenient to 
the WIPP disposal system. Additionally, records shall be made 
immediately [[Page 5770]] available to Agency inspectors where 
possible, and in no circumstances shall the furnishing of records be 
extended beyond 30 days from the initial request.
    As an additional matter, the Agency believes that on occasion, EPA 
personnel may need to conduct sampling and analysis or monitoring of 
the disposal system. Such sampling may include split sampling, in which 
portions of samples taken by the DOE shall be furnished to EPA for 
analysis. Through split sampling, EPA can independently verify the 
results of DOE analyses. Moreover, by taking such samples, EPA will be 
better equipped to evaluate the quality of data being produced, as well 
as gain a better understanding of the disposal system.
    EPA proposes that its inspection privileges be broad enough to 
allow the Agency to inspect activities that may provide information 
used to support compliance application(s) and are deemed by the 
Administrator or the Administrator's authorized representative to be 
relevant to a compliance certification or determination. This may 
include, but is not necessarily limited to, examination of quality 
assurance procedures, waste characterization activities, experimental 
programs, computer operations, and data collection activities, insofar 
as all of these items may affect the WIPP's ability to comply with the 
40 CFR part 191 disposal regulations. Significantly, under today's 
proposal, EPA inspections would be limited to locations to which the 
Department has rights of access but would not be limited to activities 
which occur at the WIPP facility. As discussed above, if an activity 
can potentially affect the WIPP's ability to comply with the Agency's 
disposal regulations, it shall be subject to potential inspection by 
EPA personnel. For instance, EPA may inspect WIPP-destined waste 
generation and storage sites because waste characterization activities 
often occur at these sites.

Quality Assurance

    To help assure that calculations of compliance with 40 CFR part 
191, subparts B and C, are based upon sound data and information, the 
Agency proposes to include compliance criteria addressing quality 
assurance (QA). EPA is proposing that the Department implement a QA 
program that meets the requirements of the American Society of 
Mechanical Engineer's (ASME) ``Quality Assurance Program Requirements 
for Nuclear Facilities'' (NQA-1-1989 Edition), ASME's ``Quality 
Assurance Requirements of Computer Software for Nuclear Facility 
Applications'' (NQA-2a-1990 addenda, part 2.7 to ASME NQA-2-1989 
edition), and ASME's ``Quality Assurance Program Requirements for the 
Collection of Scientific and Technical Information on Site 
Characterization of High-Level Nuclear Waste Repositories'' (NQA-3-1989 
edition--excluding Section 2.1 (b) and (c)). EPA is proposing to use 
the ASME standards referenced above because it appears they offer the 
most comprehensive and specific set of QA requirements for all 
compliance-related elements of the disposal system. EPA solicits 
comment on whether these standards are the most appropriate to use for 
this purpose.
    With respect to data collected prior to the implementation of the 
ASME standards, EPA is proposing that such data be acceptable for the 
purpose of supporting any applications for compliance certification if 
it can be demonstrated to have been collected: (1) Under a QA program 
that is equivalent in scope and implementation to the NQA series, or 
(2) through a method otherwise approved by the Administrator for use at 
the WIPP. Today's proposal does not include any specific criteria 
identifying how such equivalence should be demonstrated, nor is there 
any specification about what the Agency will consider in approving QA 
plans. The Agency intends to issue guidance on this topic in the 
future.
    The Agency is proposing to allow a flexible approach on quality 
assurance for data collected prior to implementation of the ASME NQA 
series because the Agency recognizes that unless a method exists for 
qualifying such ``old data,'' the efforts in collecting such ``old 
data'' will be wasted. It is likely that a large portion of the data 
submitted in support of an application for certification of compliance 
will be ``old data.'' To prohibit the inclusion of such data if the 
data can be demonstrated to be of equivalent quality to ``new data,'' 
or is sufficiently reliable for approval by the Administrator, would be 
unreasonable because data that are sufficiently reliable should be 
included in the analysis. The Agency solicits comment on this approach.
    The ASME NQA-1-1989 edition sets forth requirements for the 
``establishment and execution of quality assurance programs for the 
siting, design, construction, operation, and decommissioning of nuclear 
facilities.''
    The NQA-2(a)-1990 addenda (part 2.7) to ASME NQA-2-1989 edition 
standard is directed toward establishing requirements for ``the 
development, procurement, maintenance, and use of computer software, as 
applied to the design, construction, operation, modification, repair, 
and maintenance of nuclear facilities.'' More specifically, it applies 
to computer software ``used to produce or manipulate data which is used 
directly in the design, analysis, and operation of structures, systems, 
and components.''
    The NQA-3-1989 edition standard sets forth quality assurance 
requirements for ``the collection of scientific and technical 
information for site characterization of high-level nuclear waste 
repositories.'' The requirements apply to ``activities which could 
affect the quality of scientific and technical information collected as 
part of the site characterization phase of high-level nuclear waste 
repositories * * * [which include] as a minimum: (a) Readiness reviews; 
(b) peer reviews; (c) data and sample management; (d) data collection 
and analysis; (e) coring; (f) sampling; (g) in situ testing; and (h) 
scientific investigations.''
    EPA is proposing criteria which require submission of information 
which demonstrates that QA programs have been established and executed 
for aspects of the WIPP disposal system important to the containment of 
waste in the disposal system. QA programs must address elements such as 
models used to support applications for certification of compliance, 
waste characterization, monitoring, field measurements, design of the 
disposal system (and actions taken to ensure compliance with design 
specification), use of expert judgment, and other factors important to 
the containment of radionuclides in the disposal system. EPA solicits 
comment on the appropriateness of the items listed above and on any 
other items which should be specifically included in such a list. The 
Agency also is proposing that applications for certification of 
compliance address how quality indicators such as data accuracy, 
precision, representativeness, completeness, comparability, and 
reproducibility have been or will be achieved in the collection of 
compliance data and information.
    As a final matter, the Agency is proposing to conduct its own 
examination of DOE QA programs and plans through select inspections, 
management system reviews, and audits. This is to help assure that QA 
plans are implemented appropriately.

Models and Computer Codes

    Computer models are needed to assess whether the WIPP disposal 
system will comply with the 40 CFR part 191 disposal regulations. In 
order for these computer models to perform their 
[[Page 5771]] functions with acceptable accuracy, they must be based 
upon appropriate conceptual, mathematical, and numerical models.
    In order to ensure that the conceptual, mathematical, numerical, 
and computer models used to support compliance applications are 
appropriate for use in certifying whether the WIPP complies with the 
disposal regulations, EPA proposes to require that detailed information 
about these models be submitted to the Agency as part of any compliance 
certification applications. EPA proposes to assess the appropriateness 
of the models and any computer codes used to represent them based on 
the following factors: Whether conceptual models reasonably represent 
the disposal system; whether mathematical models incorporate equations 
and boundary conditions which reasonably represent mathematical 
formulations of the conceptual models; whether numerical models provide 
numerical schemes which enable mathematical models to obtain stable 
solutions; whether computer models accurately implement the numerical 
models (i.e., are free of coding errors and produce stable and accurate 
solutions); and whether the models, data, and computer codes have been 
properly peer reviewed. EPA solicits comment on these factors and 
whether other factors should be included. For instance, should EPA 
require information which demonstrates that there is agreement between 
the model results and any measured and observed data? Or, if it can be 
demonstrated that models and computer codes are sufficiently 
conservative, is such demonstration unnecessary?
    In addition, EPA is proposing to require that the American Society 
of Mechanical Engineer's NQA-2a-1990 addenda (part 2.7 to ASME NQA-2-
1989 edition) be used to help ensure that models and codes are fully 
and clearly documented.
    In order to determine whether the conceptual models used to support 
a compliance certification application offer the best representation of 
the disposal system, EPA is proposing to require a complete listing and 
description of conceptual models considered but not used to support 
such application. In addition, EPA is proposing to require a complete 
listing of conceptual model(s) considered but not used to support 
compliance certification applications, a description of such model(s), 
and an explanation of the reason(s) why such model(s) was/were not 
used. An examination of conceptual models requires an assessment as to 
whether the theories represented in conceptual models are appropriate 
and whether other theories may be more or equally appropriate. For this 
reason, EPA is proposing that the DOE identify and describe all 
conceptual models that the Department considered and provide 
justification why some were selected and others were not. The Agency 
solicits comments on this approach and on whether any particular 
theories should be represented in conceptual models used to support 
compliance certification applications.
    EPA is proposing to require that documentation include such items 
as: Descriptions of the theoretical backgrounds of each model, the 
method of analysis and assessment, scenario construction, data 
collection procedures, and code structures and source codes. In 
addition, the Agency is proposing that user's manuals be submitted that 
include the following information: discussions of the limits of 
applicability of each model; detailed instructions for running the 
codes including hardware and software requirements; input and output 
formats with detailed explanations of each input and output variable 
and parameter; listings of input and output files with a sample 
computer run; reports on code verification, benchmarking, validation 
and quality assurance procedures. The Agency is also proposing to 
require the submission of programmer's manuals and any necessary 
licenses. Programmer's manuals typically include such things as the 
mathematical formulations included in the model, computational 
algorithms and modeling structures.
    In addition, because the WIPP disposal system is very complex, it 
is likely that some of its characteristics correlate to one another. If 
this correlation is not reflected in modeling efforts, then the models 
may fail to portray the realities of the system and significant errors 
in performance assessment results can occur. Covariance, a measurement 
of the tendency of random variables to vary together, is used to 
evaluate this possibility. Therefore, EPA is proposing that information 
be provided which indicates whether and how models and codes handle 
covariance of model input parameters. If models do not consider 
covariance, EPA would expect to be provided with an explanation of why 
covariance was not considered and the potential impact of instead 
treating variables independently. EPA solicits comments on this 
approach and on the alternatives of (1) requiring covariance to be 
included in models and codes and, (2) requiring covariance to be 
included unless justification can be provided that the independent 
treatment of variables would cause models to predict greater releases 
than if covariance is taken into account.
    Finally, EPA proposes that copies of the models and software, data 
files, source codes, licenses, or other materials necessary to run the 
models on EPA's own computers (or on DOE computers if EPA computers are 
unable to run the models) be provided to the Agency within 30 days of a 
request by the Administrator or the Administrator's authorized 
representative. Additional requirements for models are covered in the 
quality assurance and peer review sections of today's proposal.

Waste Characterization

    In order to make meaningful predictions about the performance of 
the WIPP over long periods of time, it is necessary to have a good 
understanding of the characteristics of the waste proposed to be 
emplaced in the disposal system. The potential for releasing 
radionuclides from the disposal system can be directly affected by the 
chemical, radiological, and physical composition of the waste. These 
factors, therefore, can affect the ability of the WIPP to comply with 
the 40 CFR part 191 disposal standards and, consequently, must be 
examined as part of any certification or determination of compliance.
    Currently, the waste inventory to be potentially disposed of at the 
WIPP consists of: (1) A large volume of stored (``existing'') waste 
with varying degrees of adequacy of accompanying documentation 
regarding its composition and properties; and (2) an estimated larger 
volume of ``to-be-generated'' waste about which there is uncertain 
knowledge of its expected composition and properties.
    For the purpose of gaining a complete understanding of the waste 
proposed for disposal at the WIPP, EPA is proposing to require 
submittal of a detailed description of the waste's chemical, physical, 
and radiological contents including a description of the activity in 
curies of each radionuclide contained in such waste. Such description 
shall be used in assessing compliance with subparts B and C of 40 CFR 
part 191.
    To identify waste characteristics important to the containment of 
waste in the disposal system, EPA is proposing that DOE undertake a 
study to determine the effect of various characteristics on the 
performance of the disposal system. The characteristics studied shall 
include, but need not be limited to: (1) waste form; (2) free liquid 
content and liquid saturation; (3) [[Page 5772]] pyrophoric and 
explosive material content, and (4) characteristics affecting the 
solubilization and mobilization of radionuclides, formation of 
colloidal suspensions containing radionuclides, production of gas from 
the waste, nuclear criticality, and generation of heat in the disposal 
system. The impact of non-radioactive hazardous components of the waste 
should also be assessed as such components have the capacity to 
influence radionuclide transport. The results of this study shall be 
provided to EPA along with documentation of the methodology and 
information describing the importance of particular characteristics of 
the waste. These results shall dictate the breadth of characterization 
to be performed.
    Once the waste characteristics that are important to the disposal 
system's ability to isolate radionuclides have been identified, the 
waste shall be categorized based on those characteristics that would be 
expected to make all waste within a particular category behave 
similarly in the disposal system. For example, if the curie content of 
a given radionuclide in the waste is determined to be important to the 
disposal system's ability to contain radionuclides, it might be used as 
part of a system of categorization. Waste having a high curie content 
of that nuclide could comprise one category, while waste having a low 
curie content of that nuclide could comprise another category. 
Similarly, if a given waste form is found to be important, categories 
could be made for various waste forms such as sludges and solids. EPA 
proposes that a detailed description shall be provided which identifies 
the characteristics of each category of waste established.
    A variety of methods for characterizing waste exists including 
sampling and analysis, radioassay, and examination of waste generation 
documentation and associated records (often referred to as ``process 
knowledge''). Today's proposal does not specify any particular method 
for characterizing the waste. Nevertheless, regardless of which method 
or combination of methods is selected for waste characterization 
activities, the Agency is proposing to require that each method be 
identified and described. Moreover, the uncertainty associated with 
each method shall be identified, and if information about the processes 
and materials that generated the waste is used as a basis for waste 
characterization, the DOE shall be required to substantiate such 
characterization.
    The manner in which the Agency proposes that waste characterization 
shall be accomplished is explained below. The DOE will examine each 
important characteristic of the waste and determine a value or range of 
values for that characteristic. Since DOE must demonstrate that the 
WIPP complies with the containment, individual, and ground-water 
protection requirements of 40 CFR part 191 for the whole range of 
values for each waste characteristic, the larger the range, the greater 
the uncertainty associated with a claim that WIPP complies. DOE can 
reduce the range of values for each characteristic through enhanced 
information gathering until the range is small enough such that DOE is 
reasonably confident that the resulting probability for compliance will 
meet the containment, individual, and ground-water protection 
requirements of 40 CFR part 191. Thus, DOE has a great deal of 
flexibility in the amount of characterization required. However, 
whatever value or range of values DOE selects for each characteristic 
must be considered in compliance assessments of the WIPP. In assessing 
compliance, DOE shall consider all combinations of waste 
characteristics and the resulting impact on the disposal system's 
behavior.
    EPA is proposing that waste not be emplaced in the repository 
unless its characteristics fall within the ranges of values for those 
characteristics used in compliance assessments. To assure that only 
waste whose characteristics fall within the given range of values is 
emplaced, the Agency is proposing that a system of controls be 
established, including measurements, sampling, and recordkeeping for 
the waste, such that the actual characteristics of waste will be 
identified before the waste is emplaced in the WIPP. Compliance 
applications shall provide an identification and description of these 
controls along with an analysis of the uncertainty associated with 
them.
    As a final measure to assure proper waste characterization, the 
Agency is proposing that EPA audits and inspections will be used to 
verify the waste characterization requirements of this part.

Future State Assumptions

    Demonstrating compliance with 40 CFR part 191, subparts B and C, 
involves the use of computer models based on conceptual models which 
project, over an extended period of time, the transport of 
radionuclides from the disposal system to the accessible environment 
and resulting radiation doses to individual members of the public. 
Because of the long-term nature of these evaluations, uncertainty of 
values for many parameters important to the analysis may be very large. 
Environmental conditions and living habits of future populations and 
individuals may change in significant and unforeseeable ways over the 
lengthy timeframes that will be analyzed for compliance.
    In light of the difficulty of assigning appropriate values with 
confidence, the Agency is proposing to specify certain assumptions 
about the future for use in long-term modeling. The Agency is proposing 
that, unless otherwise specified, any certification of compliance shall 
assume that characteristics of the future remain what they are today. 
EPA believes such an approach will enable compliance assessment to 
focus on more predictable and more significant features of disposal 
system performance. For instance, EPA is proposing that such an 
approach not be used to characterize the long-term geologic, 
hydrologic, or climatologic conditions of the system and its vicinity.
    With regard to consideration of climatic conditions, the Agency is 
proposing to require predictions about climate, but within a specified 
framework. Specifically, EPA is proposing to limit the consideration of 
climate effects to the effects of increased and decreased precipitation 
on the disposal system. This would include predictions of temperature, 
which affects evapotranspiration, and other factors.
    With respect to human technology and behavior, EPA has tentatively 
concluded that it would be fruitless to attempt any predictions about 
the future that would be useful over 10,000 years. The one constant in 
human history is change--in social organization, economic activity, and 
technology. Thus, at first glance it seems highly anomalous to assume 
that future states will be like the present. However, as noted, EPA 
believes that there is no reasonable way to predict in any definitive 
way what changes will take place in the future. In effect, then, EPA is 
proposing to employ present conditions as default values for future 
states because it has no better choices, and because this approach at 
least has the advantage of providing readily ascertainable and 
verifiable values.
    The Agency solicits comment on its approach to future states 
assumptions and the Agency's treatment of geology, hydrology, and 
climate considerations. Suggestions of alternatives to the proposed 
approach are also solicited.

Expert Judgment

    EPA recognizes that expert judgment may be used to support disposal 
system [[Page 5773]] compliance analyses. EPA is proposing that use of 
expert judgment be limited to those situations where data is not 
reasonably attainable through data collection or experimentation.
    To assure that the Agency is aware of all cases in which expert 
judgment is used, EPA is proposing that any compliance certification 
application clearly identify all instances in which such judgment is 
used and the names and professional affiliations of experts involved. 
Moreover, documentation shall be included which describes the process 
for expert judgment elicitation, the results of expert elicitation, and 
the reasoning behind those results. Documentation shall also be 
provided of interviews used to elicit judgments from experts, 
deliberations and formal interactions among experts, background 
information provided to experts, and the questions or issues presented 
for elicitation of expert judgment. Access to this information will 
help the Agency assess the quality and appropriateness of expert 
judgment as well as DOE's interpretation and use of that judgment.
    Although EPA has not specified any particular methods for expert 
judgment elicitation in today's proposal, the Agency does believe that 
some restrictions and guidelines for the selection of individuals for 
expert judgment are appropriate. The restrictions which EPA is 
proposing today include prohibitions on: selecting individuals who are 
members of the team of investigators requesting the judgment or the 
team of investigators who will use the judgment; selecting individuals 
who maintain a supervisory role or who are supervised by (directly or 
indirectly) those who will utilize the judgment; and selecting a 
membership of which no more than one-third consists of individuals who 
are employed directly by the Department or its contractors (unless it 
can be shown that this is impracticable because of a lack or 
unavailability of qualified independent experts, in which case at least 
one-half of the membership must be non-DOE personnel). University 
professors with grants from the Department not related to work on the 
WIPP and the New Mexico Environmental Evaluation Group are not 
considered employees or contractors of the Department for purposes of 
this part. Additionally, compliance applications shall provide 
information which demonstrates that the expertise of any individuals 
involved in expert judgment is consistent with the level of knowledge 
required by the question or issue presented to that individual.
    Furthermore, the Agency is requiring that at least five individuals 
be used in any expert elicitation process, unless a lack or 
unavailability of experts can be demonstrated. Also, any compliance 
certification application shall include a discussion explaining the 
relationship between the information presented, the questions asked, 
the judgment of any expert panel or individual, and the purpose for 
which the expert judgment is being used. The Agency is proposing all of 
the above requirements to assure that expert judgment is elicited in a 
manner that is as objective and informed as possible.
    As a final means of helping to assure the appropriateness of expert 
judgment, EPA is proposing that the elicitation process afford an 
opportunity for presentation to the experts of the scientific and 
technical views of outside groups and individuals. This provision is 
being proposed in today's notice because the Agency believes it will 
help to provide experts involved in elicitations with a fuller range of 
information and view points upon which to base their judgments.
    The Agency considered several different approaches to the use of 
expert elicitation and concluded that though each was appropriate for a 
specific type of situation, none were appropriate for all types of 
situations. For example, one approach identified would require that the 
average of all values elicited by an expert panel be used as the final 
judgment. This may be appropriate if the issue presented to an expert 
panel lends itself to meaningful averaging of values. For instance, if 
an expert panel is asked to determine the rate of rainfall in the 
Delaware Basin over 10,000 years, the range of answers that would be 
obtained from the various experts would be expressed in numbers that 
could be meaningfully averaged. However, if an expert panel is asked to 
determine whether the possibility of a meteor hitting the WIPP site is 
likely, the answers would be expressed in terms of yes or no, which 
cannot be meaningfully averaged. Hence, depending on the situation, 
this approach may not be appropriate.
    Given the above, EPA believes that it may not be useful to specify 
a particular method. However, the Agency solicits comments on 
alternative approaches to incorporating the results of expert judgment 
elicitations into compliance assessment.

Peer Review

    Peer review is widely used as a means of validating technical data, 
processes and assumptions. Peer review involves a group of experts who 
are convened to review work conducted by their peers to determine 
whether the work was performed appropriately and in keeping with the 
purpose intended.
    Since a large part of compliance applications will consist of data 
and descriptions of methods for producing data, EPA believes that peer 
review can be helpful as a means of validating the information 
contained in such applications. Therefore, the Agency proposes that 
peer review be used to support compliance applications. Specifically, 
EPA proposes to require peer review of any information contained in any 
compliance certification application regarding the evaluation of 
engineered barriers, consideration of processes and events that may 
affect the disposal system's performance, quality assurance programs 
and plans, models and computer codes and including data used to support 
them, and waste characterization activities. Peer review can build 
additional confidence in the soundness of these important aspects of a 
compliance certification.
    EPA proposes that peer review be conducted in a manner which is 
compatible with the Nuclear Regulatory Commission's NUREG-1297 ``Peer 
Review for High-Level Nuclear Waste Repositories,'' which is 
incorporated by reference in today's proposal. This document provides 
guidance on the definition of peer review, the acceptability of peers, 
and the conduct and documentation of peer review.

Containment Requirements

    The Agency's disposal regulations found in 40 CFR part 191 include 
requirements for containment of radionuclides. These containment 
requirements specify numerical requirements limiting the cumulative 
release of radionuclides over 10,000 years. The specific release limits 
are found in Appendix A of the disposal regulations. The containment 
requirements specify that there be less than one chance in ten of 
cumulative releases exceeding the limits specified in Appendix A and 
less than one chance in 1,000 of cumulative releases exceeding ten 
times those limits.

Application of Release Limits

    The containment requirements of 40 CFR part 191 specify that 
releases from a disposal system to the accessible environment can not 
exceed release limits set forth in Appendix A, Table 1. Information 
about the curie content will be needed for calculation of the release 
limits. However, because the curie content of the waste inventory will 
vary over time due to natural ingrowth and decay of radionuclides, a 
question arises concerning when the curie content of [[Page 5774]] the 
waste should be fixed for purposes of calculating the release limits.
    The EPA is proposing that the expected curie activity 100 years 
after disposal of the waste in the WIPP be used in calculating 
applicable release limits. The Agency is proposing this approach 
because EPA believes that 100 years represents a long enough period of 
time for most of the radioactive material with short half-lives to 
decay to low levels. The remaining activity after the 100-year period 
will largely be the result of radioactivity from waste with long half-
lives. Such waste may pose the most danger to human health and the 
environment and, therefore, should be the focus of attention.
    The Agency solicits comment on the appropriateness of the above-
mentioned approach and on alternative time frames for fixing the curie 
content.

Scope of Performance Assessments

    In today's notice, the Agency is proposing criteria which indicate 
that performance assessments shall consider both natural and human-
initiated processes and events that may affect the disposal system. 
However, EPA is also proposing that performance assessments need not 
consider processes, events, or sequences of processes and events 
(sometimes referred to as ``scenarios'') that have less than one chance 
in 10,000 of occurring over 10,000 years.
    EPA is proposing the above requirements because section 13 of 40 
CFR part 191 requires the implementing agencies to evaluate compliance 
through performance assessments. One method of displaying results of 
performance assessments required under section 13 of 40 CFR part 191 is 
to assemble ``complementary cumulative distribution functions'' (CCDF). 
CCDFs are assembled by first calculating the probability of each 
release scenario and associating a consequence (e.g., release of 
radionuclides) with each probability. Once the paired probability and 
consequence estimates are made, they are combined into the CCDF by 
ranking them in the order of decreasing consequences. The first point 
on the curve would represent the large consequence of a low probability 
scenario. The second point on the curve would represent the probability 
of the first scenario added to the probability of a second scenario. 
Since the probability of scenarios occurring is cumulative, scenarios 
with probabilities lower than one chance in 1,000 must be incorporated 
into probability distributions assembled under section 13 of 40 CFR 
part 191 to see if the results are significant with regard to 
compliance assessment.
    Importantly, not all scenarios considered by the Department will 
necessarily be included in calculations of compliance with the 40 CFR 
part 191 disposal standards. Some scenarios may be eliminated from 
incorporation into performance assessments because assumptions will be 
made about such scenarios which indicate that the probability or 
consequences of such scenarios are outside of the scope of the 
requirements of 40 CFR part 191. In an effort to understand which 
scenarios were considered in performance assessments, EPA is proposing 
that information be provided which identifies all potential processes, 
events, or sequences of processes and events that may occur during the 
regulatory time frame and that may affect the disposal system, as well 
as information which identifies those processes, events, or sequences 
of processes and events actually included in performance assessment 
results.

Consideration of Human-Initiated Processes and Events

    Compliance with the containment requirements of 40 CFR part 191 
requires consideration of the effects of human-initiated processes and 
events on the disposal system. The Agency believes that the most 
productive consideration of inadvertent human-initiated processes and 
events concerns those realistic possibilities that may be usefully 
mitigated by disposal system design, site selection, or use of passive 
institutional controls. Therefore, the Agency is proposing that 
inadvertent and intermittent drilling for resources (other than those 
resources provided by the waste in the disposal system or any 
engineered barriers designed to isolate such waste) be the most severe 
scenario for human-initiated processes and events.
    Further, the Agency is limiting the consideration of human-
initiated processes and events to drilling events because mining events 
were not included in EPA's analyses that supported the final rule of 40 
CFR part 191 as promulgated in 1985.
    The Agency has chosen to divide human-initiated processes and 
events into two distinct categories, ``human intrusion'' and ``human 
activity,'' and is proposing a separate process to establish the 
drilling rate for each. ``Human intrusion'' includes those drilling 
events that reach the level of the waste in the disposal system or 
below. Such events would include, but would not be limited to, 
exploration for and development of oil and natural gas resources. The 
second category of human-initiated processes and events, ``human 
activity,'' includes all drilling events that may affect the disposal 
system, but do not reach the level of the waste in the disposal system. 
Such drilling events may include, but would not be limited to, 
exploration for potash, withdrawal of water--whether for purposes of 
drinking, irrigating or controlling dust--and drilling for other 
resources. Note that a given resource may exist at levels above and 
below the level of the waste in the disposal system and may therefore 
be included in establishing the rates for both human intrusion and 
human activity.
    EPA is proposing that consideration be given to the record of 
human-initiated processes and events in the Delaware Basin over the 
past 50 years. The Agency believes that the 50-year time frame is 
appropriate because it represents a period during which information 
regarding human-initiated processes and events in the Delaware Basin 
can be reasonably obtained.
    Importantly, by making assumptions about the frequency of human-
initiated processes and events in the vicinity of the WIPP and holding 
them constant throughout the future, scenarios in which such events 
cease because, for instance, resources eventually become depleted would 
no longer be considered. However, the Agency recognizes that as one 
resource becomes depleted, the decrease in exploratory or production 
operations may be compensated for by the increase in drilling 
operations for another. Rather than engage in speculation about which 
resources will become more valuable in the future, and which will 
become depleted, EPA believes it is preferable to assume that current 
rates of drilling for each individual resource will remain constant. 
The Agency solicits comment on this approach.
    As stated above, the Delaware Basin is being proposed as the area 
for examination of the record of human-initiated processes and events. 
The Delaware Basin is an elongated depression that extends from just 
north of Carlsbad, New Mexico, southward into Texas. The Agency 
solicits comment on how, precisely, the Delaware Basin should be 
defined. The Agency believes that the Delaware Basin is an appropriate 
region because the WIPP is situated within it and, as a region, it 
represents the largest contiguous area which shares similar geologic 
and hydrologic conditions with the WIPP site. However, EPA solicits 
comments on whether a different area should be used (such as a subset 
of the Delaware Basin).
    It is important to note that the Agency is proposing to require a 
separate [[Page 5775]] examination of each type of human-initiated 
process and event. The reason for this requirement is to account for 
the fact that each type of drilling has a distinct rate and unique 
properties, resulting in a different effect on the disposal system for 
each type of drilling. For example, oil drilling is conducted at a 
different depth, rate and with a different drilling technique than 
water drilling and is, therefore, more likely to penetrate the 
repository than water drilling. Accordingly, the analyses for each 
resource must be conducted individually.
    In assessing the consequences of human-initiated processes and 
events, the Agency is proposing that such processes and events be 
assumed to occur at random intervals in time and space throughout the 
regulatory time frame. The consequences of each human-initiated process 
and event shall be calculated in terms of the projected impact on the 
WIPP disposal system. If more than one human-initiated process or event 
is predicted to occur, the consequences of any processes and events 
which occur subsequent to initial ones shall take into account any 
impacts on the disposal system from such previous disruptions. This is 
done to take into account the fact that every drilling event introduces 
potential changes to the disposal system. For example, a disposal 
system with man-made pathways interconnecting aquifers underlying the 
disposal system with ground water above the disposal system may react 
differently than a disposal system that has never been disturbed. In 
other words, the cumulative consequences of all human-initiated 
processes and events shall be taken into account in performance 
assessment results.
    For the purpose of performance assessments, the Agency is proposing 
different criteria for establishing the frequency of ``human 
intrusion'' and the frequency of ``human activity''. While both are 
based on the historical record of resource exploration over the past 50 
years in the Delaware Basin, an upper and lower limit is placed on the 
rate of human intrusion. The rate of human activity, however, is not 
limited to a set range.
    Specifically, the rate of human intrusion is determined by first 
identifying and examining past occurrences of human intrusion in the 
Delaware Basin over the past 50 years for all resources.
    The sum of the individual rates of human intrusion for each 
resource then becomes the rate of human intrusion to be used in 
performance assessments, provided that the sum is not less than 25 and 
not greater than 62.5 boreholes per square kilometer per 10,000 years. 
In the event that the calculated total rate is less than 25, then the 
rate of human intrusion to be used in performance assessments should be 
adjusted upward proportionally to yield a total rate of 25 boreholes 
per square kilometer per 10,000 years. Thus, if the oil drilling rate 
is 8 and the natural gas drilling rate is 2, both values are adjusted 
upward by a factor of 2.5 to yield a rate of 20 for oil and 5 for 
natural gas. Likewise, if the calculated total rate exceeds 62.5, then 
the rate of each type of human intrusion should be adjusted downward 
proportionally to yield a maximum rate of 62.5 boreholes per square 
kilometer per 10,000 years to be used in performance assessments.
    By placing an upper and lower limit on the rate of human intrusion, 
the Agency is adhering to the assumptions that the Agency made in 
developing the technical basis used for formulating the containment 
requirements of the final disposal regulations as promulgated in 1985. 
As part of the development of the disposal regulations, the Agency 
estimated the range of future human intrusion and human activity for 
the general case of a repository in bedded salt, the geologic setting 
of the WIPP. Assumptions were made about the presence near a repository 
of different types of resources--including oil, gas, minerals and 
water--though it was assumed that the most significant resources 
present would be oil and gas. Using drilling data from the contiguous 
48 states as a rough guide, the Agency estimated that a region of 
bedded salt would experience 25 to 62.5 boreholes per square kilometer 
per 10,000 years. Because the depths at which oil and gas, the only 
significant resources assumed to be present, are located typically 
exceed 10,000 feet the estimated range applies only to the rate of 
human intrusion. Thus, by proposing a human intrusion range of 25 to 
62.5 boreholes per square kilometer per 10,000 years, the Agency is 
grounding the criteria on the same basis as 40 CFR part 191. Discussion 
of the assumptions as developed for the 1985 final rule of 40 CFR part 
191 can be found in ``Technical Support of Standards for High-Level 
Radioactive Waste Management, Volume D'' (EPA 520/4-79-007D) and 
``Addendum to Volumes C and D'' (EPA 520/4-79-007E).
    The Agency is proposing that, should the Department wish to forego 
the process of analyzing the historical rates of human intrusion events 
in the Delaware Basin, the Department shall assume the maximum rate of 
62.5 boreholes per square kilometer per 10,000 years. The Agency is 
further proposing that the rate of human intrusion may be reduced in 
accordance with the criteria found in Sec. 194.41, active institutional 
controls, and Sec. 194.43(c), passive institutional controls. A 
complete discussion of reduction of the human intrusion rate can be 
found in the discussion of those two portions of the criteria.
    For consideration of ``human activity'' in performance assessments, 
the Agency is proposing that the historical record of drilling be 
examined, but without placing pre-set limits on the rates. 
Specifically, the rate of human activity is determined by first 
identifying and examining past occurrences of human activity in the 
Delaware Basin over the past 50 years for all resources. The sum of the 
individual rates for each resource then becomes the rate of human 
activity to be used in performance assessment.
    The Agency is placing no limits on the rate of human activity, in 
contrast to the treatment of the rate of human intrusion. This 
divergent treatment is consistent with the final rule of 40 CFR part 
191, which was based on an estimate of 25 to 62.5 boreholes per square 
kilometer per 10,000 years for the general case of a repository in 
bedded salt in the vicinity of few resources other than oil and natural 
gas. Because the depths at which oil and natural gas reserves are 
located typically exceed 10,000 feet, the estimated range of 25 to 62.5 
boreholes per square kilometer per 10,000 years applies to the case of 
human intrusion only. Hence, no limit, upper or lower, is placed on the 
rate of human activity.
    The Agency recognizes that for some resources such as water, the 
use of that resource may depend upon the quality of the specific 
reservoir of that resource that is being exploited. A given reservoir 
of water, for example, may not be of potable quality but may still be 
usefully withdrawn for controlling dust. Therefore it may be possible 
to show that certain resources found within the controlled area differ 
in quality from the same resource as found in rest of the Delaware 
Basin. For such resources, it could potentially be demonstrated that 
the resource would normally be exploited for different purposes at a 
different rate within the controlled area, and further that there is 
reason to believe that such practices would continue. The Agency is 
proposing that if such a case can be made in compliance applications, 
then when examining the historical record of human activity associated 
with that resource, only that human activity that has been associated 
with resources of quality similar to that found within the 
[[Page 5776]] controlled area need be considered. Consider a 
hypothetical example in which the water resources in the controlled 
area were found not to be of potable quality, and this were 
demonstrated and documented in the application for certification of 
compliance. Then, when examining the history of drilling for water in 
the Delaware Basin, the Department would need only consider boreholes 
created for water uses other than drinking, e.g., irrigation and 
control of dust.
    The Agency is further proposing that the rate of human activity may 
be reduced in accordance with the criteria found in Sec. 194.41, active 
institutional controls, and in Sec. 194.43(c), passive institutional 
controls. A complete discussion of reduction of the human activity rate 
can be found under the discussion of those two portions of the 
criteria.
    In assessing the consequences of human-initiated processes and 
events, the Agency is proposing that assumptions pertaining to 
characteristics of such processes and events be based on 
characteristics associated with current practice in the Delaware Basin. 
This approach is consistent with the approach the Agency is proposing 
for future state assumptions. For example, assumptions related to the 
type and amount of any drilling fluids, borehole depths, diameters, and 
seals should be assumed to remain consistent with the current practice 
in the Delaware Basin. For the specific case of borehole seals, EPA is 
further proposing that boreholes shall be assumed to be sealed at the 
rate boreholes have been sealed over the past 50 years in the Delaware 
Basin and that natural processes will degrade or otherwise affect the 
permeability of boreholes over the regulatory time frame.
    The Agency has chosen in today's proposal to differ from the 
Appendix C ``Guidance for Implementation'' which accompanied 40 CFR 
part 191 because EPA believes that the approach outlined above for 
assessing the likelihood and consequences of human-initiated processes 
and events is more appropriate for the WIPP than the method discussed 
in the guidance. Today's proposal is specific to the WIPP; the 
guidance, on the other hand, is generic. Moreover, the guidance only 
took into account drilling frequencies for oil and gas. The Agency 
believes that other human activities, such as drilling for potash and 
drilling for water, are equally important for consideration at the 
WIPP, as they too have the potential to affect the disposal system. 
Therefore, today's proposal requires consideration of all human actions 
that could affect a waste disposal system. However, the Agency solicits 
comment on its proposed approach and the appropriateness of differing 
from the Appendix C guidance.

Results of Performance Assessments

    The Agency proposes to establish criteria for assessing the results 
of performance assessments required under the containment requirements 
of 40 CFR part 191. The Agency is proposing to require that the results 
of performance assessments be displayed as complementary cumulative 
distribution functions or ``CCDFs.'' These CCDFs would display the 
releases of radionuclides over 10,000 years after disposal--summed and 
normalized according to Table 1, Note 6 of 40 CFR part 191--on the 
horizontal axis and the probability of releases occurring on the 
vertical axis.
    In conducting performance assessments, there will be many parameter 
values that can affect the results of such assessments. For instance, 
gas generation by the waste, radionuclide solubilities, permeability of 
the host rock, and the porosity and transmissivity of surrounding 
aquifers entail parameter values that can affect the results of such 
performance assessments. These values may be difficult to quantify 
particularly over a 10,000-year period. Therefore, the Agency is 
proposing to require the development of probability distributions for 
parameter values in order to represent the probability of different 
values of the parameter occurring.
    The Agency is further proposing to require that, in generating 
CCDFs, computational techniques be developed that sample randomly 
across the full range of probability distributions developed for 
uncertain disposal system parameter values used in performance 
assessments. In so doing, it is possible to convey the influence of 
parameter uncertainty upon the resulting CCDFs. Random sampling 
techniques can select a predetermined number of values from a 
parameter's probability distribution, the collection of which will 
represent the range of the distribution in successive stages of 
calculation.
    The Agency is proposing to require that the entire range or 
``family'' of CCDFs generated as a result of these sampling techniques 
be included in compliance applications. By requiring that all CCDFs be 
submitted, the Agency can evaluate whether given the conditions that 
exist at the disposal system, the disposal system could fail to comply 
with section 13 of 40 CFR part 191 in some of the CCDFs. By noting the 
number of total CCDFs generated that fail to comply, the Agency will 
gain insight into the performance of the disposal system over the 
10,000-year time frame.
    The Agency is proposing to place statistical criteria on the number 
of CCDFs generated. The Agency is proposing to require that the number 
of CCDFs generated be large enough such that the maximum CCDF generated 
exceeds the 99th percentile of the population of CCDFs with at least a 
0.95 probability. A 95% confidence level is commonly recognized as 
being a good indicator of statistical acceptability. The Agency 
believes that the effect of this approach will be that the number of 
CCDFs generated will be large enough to ensure that a full range of 
realizations have been generated. EPA estimates that this will require 
several hundred realizations, although the number submitted in 
compliance with this requirement may ultimately be larger or smaller.
    The Agency is proposing to require that the mean CCDF of the 
population of CCDFs meets the requirements of section 13(a) of 40 CFR 
part 191 with at least a 95 percent level of statistical confidence. 
The mean CCDF is calculated from a ``family'' of CCDFs whose parameters 
have an associated uncertainty to them, as discussed above. As a 
result, the mean will have its own associated uncertainty. This 
uncertainty around the location of the mean reduces the level of 
assurance with which we can state that the mean CCDF is in compliance 
with section 13 of 40 CFR part 191. One way of attaining statistical 
confidence in the mean is to determine how reproducible the mean is if 
recalculated. For example, first generate an ensemble of a certain 
number of CCDFs and calculate the mean. Next, generate an entirely new 
ensemble of the same number of CCDFs and compare the mean calculated 
for this new set to that of the first set. If the number of CCDFs 
generated is a statistically representative portion of the infinite 
population of CCDFs, then the two calculated means will likely agree. 
By placing a statistical confidence requirement on the mean of the 
CCDFs, the Agency hopes to ensure that a mean that is in compliance 
would upon recalculation from a new ensemble of CCDFs, still be in 
compliance. The Agency is proposing to require a 95 percent level of 
statistical confidence that the mean meets the requirements but 
solicits comment on other levels of confidence which may be more 
appropriate.
    Before selecting the mean as the compliance indicator, the Agency 
[[Page 5777]] examined three options. The first option, the mean CCDF 
or expected value, was selected because of its ability to convey a 
sense of the whole ensemble of CCDFs generated. In calculating the 
mean, all CCDFs--those representing best case results, those 
representing worst case results, and everything in between--are 
included. Since it cannot be known which CCDF represents actual 
performance over the 10,000 year regulatory period, it is deemed wise 
to include the influence of all generated CCDFs.
    The Agency also examined the median CCDF. The median CCDF would be 
indicative of the central tendency of the majority of the CCDFs and 
would not exhibit the influence of high or low consequence CCDFs as 
strongly as the mean CCDF. Specifically, the influence of high 
consequence CCDFs that do not meet the requirements of section 13(a) of 
40 CFR part 191 would be discounted by the median. In the Agency's 
view, this makes the median CCDF less suitable as a compliance 
indicator.
    The Agency also examined the possibility of using a percentile 
value as a compliance indicator. The Agency has considered and rejected 
percentile values at or below 50 on grounds that such values would not 
provide adequate confidence of achieving the desired protection of 
public health. As for higher values, the Agency believes that it would 
be extremely difficult to justify any specific higher value.
    The Agency solicits comment on the appropriateness of the mean or 
some other CCDF as a basis for compliance. The Agency solicits comments 
on using some possible combination of CCDFs as a basis for compliance; 
e.g., requiring that the mean and the median meet the requirements of 
section 13(a) of 40 CFR part 191.
    Another issue upon which the Agency solicits comment is on the 
alternative of basing compliance on one single realization, rather than 
on a multitude of them as discussed above and then using that 
realization to determine compliance with the containment requirements. 
Instead of sampling from a given range of variables for each parameter 
and generating a new realization curve each time this is done, it has 
been suggested that all possible values for each parameter should be 
selected in creating a single curve. In this way, all the information 
is folded into one realization which either complies or does not. The 
advantage in this technique is that the issue of the appropriateness of 
the mean, median, or other percentile is obviated. The disadvantage is 
that it is difficult to see exactly which parameters caused the curve 
to behave in a particular way.
    Regardless of the method ultimately used to determine compliance 
with the numerical requirements of section 13 of 40 CFR part 191, a 
``reasonable expectation of compliance'' with the containment 
requirements cannot be achieved until a demonstration has been made 
that the qualitative requirements set forth in sections 21 through 27 
of today's proposal have also been met. A ``reasonable expectation of 
compliance'' with the containment requirements shall not be based 
solely upon a statistical estimate of radionuclide releases to the 
accessible environment. Instead, the Agency will consider the full 
record of information submitted in compliance applications and will 
examine the methods and assumptions which were used to support the 
development of radionuclide release estimates. For example, the EPA 
will consider such factors as the reasonableness of the processes and 
events incorporated into performance assessments, the appropriateness 
of any expert elicitation used to provide input to models, the adequacy 
of peer review, and the quality of other data inputs. Only after a 
demonstration has been made that all of the requirements set forth in 
sections 21 through 27 of today's proposal have been met and that the 
numerical requirements of section 13 of 40 CFR part 191 have been 
satisfied, will a ``reasonable expectation'' of compliance with the 
containment requirements be achieved.

Assurance Requirements

    In addition to the numerical requirements set forth in the Agency's 
radioactive waste disposal standards, section 14 of the standards 
contains a set of qualitative requirements to help assure that the 
desired level of protection is achieved. These assurance requirements 
address: (1) Active institutional controls; (2) monitoring; (3) passive 
institutional controls; (4) engineered barriers; (5) consideration of 
the presence of resources; and (6) removal of waste.

Active Institutional Controls

    According to the disposal standards:

    Active institutional controls over disposal sites should be 
maintained for as long a period of time as is practicable after 
disposal; however, performance assessments that assess the isolation 
of the wastes from the accessible environment shall not consider any 
contributions from active institutional controls for more than 100 
years after disposal.

    As defined in 40 CFR part 191, ``active institutional control'' 
means: ``(1) Controlling access to a disposal site by any means other 
than passive institutional controls; (2) performing maintenance 
operations or remedial actions at a site; (3) controlling or cleaning 
up releases from a site; or (4) monitoring parameters related to 
disposal system performance.''
    With the above requirements in mind, today's proposal requires that 
any application for certification of compliance contain detailed 
descriptions of proposed active institutional controls, their location 
and the period of time they are proposed to remain active. Any credit 
assumed for reduced human activity in the vicinity of the WIPP or 
reduced releases of radionuclides must be supported by such 
descriptions but, as indicated in the disposal standards, in no case 
shall it be assumed that active institutional controls will be 
effective in preventing or reducing releases beyond 100 years after 
disposal.

Monitoring

    Since the predictions associated with long-term compliance with the 
disposal standards of 40 CFR part 191 are inherently uncertain, final 
disposal standards issued in 1985 included a provision requiring 
monitoring of disposal systems to help assure that they are performing 
as predicted. The proposed disposal standards issued in 1982 had not 
included such a requirement. However, several commenters (including 
most of the States) urged addition of a requirement for long-term 
monitoring of a repository after disposal to guard against unexpected 
failures. Accordingly, further information was sought on this idea. The 
Agency surveyed the capabilities and expectations of long-term 
monitoring approaches. As explained in the preamble to the 1985 
disposal standards (50 FR 38081, September 19, 1985):

    Evaluating this information led the Agency to several 
conclusions:
    (1) Perhaps most importantly, the techniques used for monitoring 
after disposal must not jeopardize the long-term isolation 
capabilities of the disposal system. Furthermore, plans to conduct 
monitoring after disposal should never become an excuse to relax the 
care with which systems to isolate these wastes must be selected, 
designed, constructed, and operated.
    (2) Monitoring for radionuclide releases to the accessible 
environment is not likely to be productive. Even a poorly performing 
geologic repository is very unlikely to allow measurable releases to 
the accessible environment for several hundreds of years or more, 
particularly in view of the engineered controls needed to comply 
with 10 CFR Part 60. A monitoring system based only on 
[[Page 5778]] detecting radionuclide releases--a system which would 
almost certainly not be detecting anything for several times the 
history of the United States--is not likely to be maintained for 
long enough to be of much use.
    (3) Within the above constraints, however, there are likely to 
be monitoring approaches which may, in a relatively short time, 
significantly improve confidence that a repository is performing as 
intended. Two examples are of particular interest. One involves the 
concept of monitoring ground-water sources at a variety of distances 
for benign tracers intentionally released to the ground water in the 
repository; this approach can evaluate the delay involved in ground-
water movement from the repository to the environment and can serve 
to validate expectations of the performance expected from the 
system's natural barriers. Another concept involves monitoring the 
small uplift of the land surface over the repository in order to 
validate predictions of the system's thermal behavior. Both of these 
approaches can be carried out without enhancing pathways for the 
wastes to escape from the repository.

    Based on these conclusions and the public comments on this 
question, the Agency included a provision (in the assurance 
requirements of the final disposal standards) for long-term monitoring 
after disposal: ``Disposal systems shall be monitored after disposal to 
detect substantial and detrimental deviations from expected 
performance. This monitoring shall be done with techniques that do not 
jeopardize the isolation of the wastes and shall be conducted until 
there are no significant concerns to be addressed by further 
monitoring.''
    Accordingly, EPA is proposing criteria for complying with the 
monitoring requirements in the disposal standards. EPA is proposing 
that monitoring programs be designed to detect the movement of 
radionuclides toward the accessible environment at the earliest 
practicable time. Such monitoring programs shall be consistent with 
monitoring required under applicable federal hazardous waste 
regulations and shall be done with techniques that do not jeopardize 
the containment of waste in the disposal system. Due to the long-term 
nature of the potential hazard associated with disposal of transuranic 
radioactive waste, any unpredicted detection of movement of 
radionuclides away from the disposal system and toward the accessible 
environment would be cause for concern that an exceedance of what is 
permitted under the disposal regulations is likely to occur. If 
releases are detected early enough, remedial action can be implemented 
before radionuclides reach the accessible environment.
    EPA is proposing in today's criteria that any compliance 
certification application include a detailed plan for monitoring the 
performance of the WIPP after disposal. At a minimum, this plan shall: 
Identify parameters that will be monitored and how baseline states will 
be determined; indicate how each parameter will be used to evaluate the 
performance of the disposal system; and discuss the length of time over 
which each parameter will be monitored to detect deviations from 
expected performance. Radionuclide monitoring programs should be 
consistent with applicable federal hazardous waste monitoring programs 
in order to minimize duplication of monitoring efforts. The Agency 
solicits comments on this approach.
    In addition to monitoring after closure of the disposal system 
(i.e., when all of the shafts to the repository are backfilled and 
sealed), EPA proposes that, to the extent practicable, pre-closure 
monitoring of parameters which may affect the long-term performance of 
the disposal system after closure shall also be conducted. The Agency 
believes that such monitoring can provide important information about 
the disposal system and that such information can contribute to a 
better understanding of how the disposal system is likely to perform 
after closure. Furthermore, such information can be used to verify 
assumptions (about the disposal system) which form the basis of a 
compliance assessment.
    The Agency is proposing to require that, as a part of the pre-
closure monitoring plan for the WIPP, monitoring of parameters which 
can affect the containment of waste in the disposal system shall be 
conducted to the extent practicable. The Agency believes that the 
following parameters can affect the containment capability of the WIPP: 
Brine quantity, flux, composition, and spatial distribution; gas 
quantity and composition; and temperature distribution. Since there may 
be additional disposal system parameters important to the containment 
of waste, EPA is proposing that DOE undertake a study to determine the 
effect of various disposal system parameters on the performance of the 
disposal system. Such study shall consider whether a disposal system 
parameter should be monitored because the parameter either provides 
information regarding the disposal system's ability to contain waste or 
regarding the ability to predict the future performance of the disposal 
system. The parameters studied shall include, but need not be limited 
to: Backfilled mechanical state including porosity, permeability, and 
degree of compaction and reconsolidation; extent of deformation of the 
surrounding roof, walls, and floor of the disposal room; and initiation 
or displacement of major brittle deformation features in the roof or 
surrounding rock. The results of the study shall be provided to EPA 
along with documentation of the methodology and information describing 
the importance of each disposal system parameter studied. The results 
of such study shall dictate the breadth of monitoring of disposal 
system parameters.
    The parameters specifically mentioned above and in the proposed 
criteria were identified as important to the containment capability of 
the WIPP by the Agency in its comments to the Department (dated October 
19, 1989) regarding the Test Phase Plan for the WIPP. In those 
comments, EPA recommended that the Department implement monitoring 
systems in disposal rooms that would be ``indicative of waste system 
performance'' (Recommendation 7). In response to EPA's comments, the 
DOE agreed to conduct a feasibility study on underground monitoring of 
the WIPP.
    EPA solicits comment on whether monitoring should be required for 
the specific parameters listed above, on whether additional or other 
parameters should be specified, and on the feasibility of continuing 
such monitoring after disposal (i.e., after the repository has been 
backfilled and sealed). Additionally, the Agency solicits comment on 
whether EPA should require the use of specific monitoring methods.

Passive Institutional Controls

    The assurance requirements of 40 CFR part 191 require that 
``disposal systems shall be designated by the most permanent markers, 
records, and other passive institutional controls practicable to 
indicate the dangers of the wastes and their location.'' Section 14(c) 
of 40 CFR part 191. The standards define ``passive institutional 
controls'' as ``(1) permanent markers placed at a disposal site, (2) 
public records and archives, (3) government ownership and regulations 
regarding land or resource use, and (4) other methods of preserving 
knowledge about the location, design and contents of a disposal 
system.''
    In light of the requirement for use of passive institutional 
controls set forth in 40 CFR part 191, the Agency is proposing that any 
application for certification of compliance include detailed 
descriptions of the measures that will be employed to preserve 
knowledge about the location, design, [[Page 5779]] and contents of the 
disposal system. At a minimum, it is proposed that such measures will 
include: (1) Identification of the controlled area by markers that have 
been designed, fabricated and emplaced to be as permanent as 
practicable; and (2) placement of records in the archives and land 
record systems of local, state, and Federal Government agencies, and 
international archives, that would be likely to be consulted by 
individuals in search of unexploited resources.
    The Agency proposes that the type of information contained in 
records shall include: The location of the controlled area and the 
disposal system; the design of the disposal system; the nature and 
hazard of the waste; geologic, geochemical, hydrologic, other site data 
pertinent to the containment of waste in the disposal system, and the 
results of tests, experiments, and other analyses relating to backfill 
of excavated areas, shaft sealing, waste interaction with the disposal 
system, and any other tests, experiments, or analyses pertinent to the 
containment of waste in the disposal system. EPA solicits comments on 
the appropriateness of this list and on whether additional or other 
items should be specified. Any application for certification of 
compliance shall include detailed descriptions of the proposed controls 
as well as information regarding the period of time those controls are 
expected to endure and be understood.
    A question arises with regard to the extent to which the Agency 
should allow performance assessments to consider contributions from 
passive institutional controls in reducing the likelihood of human-
initiated processes and events that may affect the disposal system. 
While the disposal regulations address contributions from active 
institutional controls (see above discussion of active institutional 
controls), they do not specifically address contributions from passive 
institutional controls. The Agency may be willing to consider such 
contributions if a persuasive case can be made that the passive 
institutional controls can be expected to endure and act as a deterrent 
to potential intruders. In no instance, however, will passive 
institutional controls be assumed to eliminate the likelihood of human-
initiated processes and events entirely. Furthermore, contributions 
from passive institutional controls may vary over time. For example, 
the effectiveness of passive institutional controls may decrease over 
the regulatory time frame. The Agency solicits comment on the extent--
if any--to which contributions from passive institutional controls 
should be considered in performance assessments.
    Because of the uncertainty concerning the effectiveness of passive 
institutional controls in terms of influencing human activity, EPA must 
carefully scrutinize information about such controls. The Agency has 
considered the fact that markers exist in the world today that are 
thousands of years old. This would tend to support the view that 
passive institutional controls can survive for very long periods of 
time. Nevertheless, it is possible that markers have been created in 
the past and were destroyed or disintegrated. The actual percentage of 
surviving markers is thus unknown. It could be very small, meaning that 
an unrealistically large number of markers would have to be placed at 
the WIPP in order to assure survival. Further uncertainty in the 
effectiveness of markers derives from the possibility that even if 
markers survive, it does not mean they will necessarily be understood 
by future generations.
    Institutional controls have been known to fail. The New Mexico 
Environmental Evaluation Group (EEG) has documented instances in the 
recent past where institutional controls have failed at the WIPP. 
According to EEG, both the DOE and the Department of the Interior's 
Bureau of Land Management ``failed to implement the procedures 
described by the DOE as crucial to protecting the site from inadvertent 
human intrusion in twenty-two of the twenty-five applications to drill 
oil and gas wells filed while a Memorandum of Understanding was legally 
binding and the WIPP facility was in a state of full readiness to 
receive waste.'' (EEG letter to EPA dated February 23, 1994). This 
indicates that even today, and even with governmental entities 
responsible for implementation of controls, such controls are not, 
necessarily, reliable. The unknown nature of future societies and 
governmental institutions compounds the uncertainty.

Engineered Barriers

    The assurance requirements of 40 CFR part 191 require that disposal 
systems ``use different types of barriers to isolate the wastes from 
the accessible environment.'' Additionally, the disposal standards 
mandate that ``Both engineered and natural barriers shall be used.'' 40 
CFR part 191 defines the term ``barrier'' as ``any material or 
structure that prevents or substantially delays movement of water or 
radionuclides toward the accessible environment. For example, a barrier 
may be a geologic structure, a canister, a waste form with physical and 
chemical characteristics that significantly decrease the mobility of 
radionuclides, or a material placed over and around waste, provided 
that the material or structure substantially delays movement of water 
or radionuclides.''
    If selected and designed properly, engineered barriers can 
significantly reduce the potential for waste migration away from the 
disposal system. They can be an effective mechanism for improving the 
performance of the WIPP and for reducing the uncertainty inherent in 
long-term projections about the ability of the disposal system to 
comply with the quantitative requirements of 40 CFR part 191.
    While the disposal standards require use of engineered barriers, 
they do not specify how many or what kinds of engineered barriers must 
be used. The Agency is, therefore, proposing criteria for selecting 
engineered barriers.
    In today's notice, EPA is proposing that DOE complete a study of 
engineered barrier alternatives and their benefits and costs. The 
results of such study shall be used to justify both the selection and 
rejection of engineered barriers at the WIPP. Moreover, the study shall 
be peer reviewed. For example, EPA believes that the National Academy 
of Sciences may be able to provide an appropriate forum for peer review 
of the study envisioned in today's proposed criteria. The Agency 
believes that the credibility of the study of engineered barrier 
alternatives and resulting selection of engineered barriers for the 
WIPP disposal system is critically important.
    The specific engineered barriers proposed to be evaluated include, 
but are not limited to: Cementation, shredding, supercompaction, 
incineration, vitrification, improved waste canisters, grout and 
bentonite backfill, melting of metals, alternative configurations of 
waste placements in the disposal system, and alternative disposal 
system dimensions. These specific engineered barriers were selected by 
the Agency because they have already begun to be considered by DOE's 
Engineered Alternatives Task Force (EATF) (see July, 1991 EATF Report 
on Engineered Alternatives for the WIPP, DOE/WIPP 91-007) and appear to 
represent potentially promising alternatives. EPA solicits comment on 
the appropriateness of specifying the above-mentioned engineered 
barriers as the subject of the study and on whether alternative 
barriers should be specified.
    The Agency is proposing that the following factors be considered in 
benefit/cost analysis of the above-mentioned engineered barriers: the 
ability of the engineered barrier to [[Page 5780]] prevent or 
substantially delay the movement of water or radionuclides toward the 
accessible environment; the impact on worker exposures to radiation (at 
the WIPP and off-site) both during and after incorporation of 
engineered barriers; the increased ease or difficulty in removing the 
waste from the disposal system; the increased or reduced risk of 
transporting the waste to the disposal system; the increased or reduced 
uncertainty in compliance assessment; the increased or reduced public 
confidence in the performance of the disposal system; the increased or 
reduced total system costs; the impact, if any, on other waste disposal 
programs from the incorporation of engineered barriers; and the effect 
on mitigating the consequences of human-initiated processes and events.
    It would be inappropriate to limit the study only to the impact of 
engineered barriers on the performance of the WIPP. If this were done, 
the possibility would exist that an engineered barrier may be selected, 
for example, which marginally improves the disposal system's 
performance, yet results in much higher environmental risks at 
treatment sites. This increase in risk would contravene the Agency's 
objective of protecting human health and the environment. EPA solicits 
comment on this approach to selecting engineered barriers and on 
whether an alternative list of factors should be specified for 
consideration.
    The Agency proposes that the benefit/cost study described above 
include separate analyses for different categories of waste potentially 
destined for disposal at the WIPP. The Agency believes that benefits 
and costs of engineered barriers can differ depending on whether they 
are applied to existing waste that is already packaged, existing waste 
that is not yet packaged or is in need of repackaging, or to-be-
generated waste. Therefore, the Agency is proposing that these 
different categories of waste be analyzed separately.
    Finally, EPA is proposing that engineered barrier alternatives be 
considered both alone and in combination. In this way, assurance can be 
had that the full range of alternative applications of engineered 
barrier systems has been considered.
    Importantly, today's proposal requires the results of the benefit/
cost study to be included in any compliance application and for the 
results to be used to justify the selection or rejection of any 
engineered barrier. This will help the Agency understand why particular 
barriers were selected while others were not, as well as help the 
Agency to evaluate the appropriateness of such selections.
    The Agency solicits comments on other potential approaches to the 
treatment of engineered barriers in the WIPP compliance criteria. In 
particular, the Agency is interested in receiving comment on the option 
of specifying a performance standard for engineered barriers similar to 
that specified by the Nuclear Regulatory Commission in 10 CFR part 60 
regulations for disposal of high-level radioactive waste. Under this 
approach, a maximum radionuclide release rate would be established for 
the engineered barrier system. Engineered barriers selected for the 
disposal system would have to contain radionuclide releases within the 
established rate.

Consideration of the Presence of Resources

    Section 14 of 40 CFR part 191 includes the following requirement: 
``Places where there has been mining for resources, or where there is a 
reasonable expectation of exploration for scarce or easily accessible 
resources, or where there is a significant concentration of any 
material that is not widely available from other sources, should be 
avoided in selecting disposal sites. Resources to be considered shall 
include minerals, petroleum or natural gas, valuable geologic 
formations, and ground waters that are either irreplaceable because 
there is no alternative source of drinking water available for 
substantial populations or that are vital to the preservation of unique 
and sensitive ecosystems. Such places shall not be used for disposal of 
the wastes covered by this part unless the favorable characteristics of 
such places compensate for their greater likelihood of being disturbed 
in the future.''
    EPA is proposing that any application for certification of 
compliance shall include information which demonstrates that the 
favorable characteristics of the WIPP compensate for the presence of 
resources and the likelihood of human-initiated processes and events as 
a result of the presence of those resources. If, after full 
consideration of the potential effects of resource recovery activities 
the WIPP is still predicted to meet the requirements of 40 CFR part 
191, then the Agency will assume that the requirements of this part and 
section 14(e) of 40 CFR part 191 have been fulfilled. The Agency 
solicits comment on this approach.

Removal of Waste

    Another assurance requirement included in the 40 CFR part 191 
disposal standards involves the removal of waste from the disposal 
system. Specifically, 40 CFR part 191 mandates that: ``Disposal systems 
shall be selected so that removal of most of the wastes is not 
precluded for a reasonable period of time after disposal.'' In order to 
address this requirement, EPA is proposing criteria to require a plan 
for removing waste from the disposal system using the best technology 
available at the time of application.

Individual and Ground-Water Protection Requirements

    The Agency incorporated requirements in 40 CFR part 191 for the 
protection of individuals and ground-water. The individual protection 
requirements of 40 CFR part 191 limit annual committed effective doses 
of radiation to members of the public to no more than 15 millirem. The 
ground-water protection requirements limit releases to ground water to 
no more than the limits set by the maximum contaminant level for 
radionuclides (MCL) established in 40 CFR part 141 under section 1412 
of the Safe Drinking Water Act (SDWA), 42 U.S.C. 300g-1. Both of these 
requirements are concerned with human exposure to radionuclides from 
disposal systems and, like the containment requirements of 40 CFR part 
191, both limit such exposure for 10,000 years.
    The proposed criteria address the following issues: the definition 
of a protected individual, the consideration of exposure pathways, the 
consideration of underground sources of drinking water, the scope of 
compliance assessments, and the basis for a determination of compliance 
with these requirements (results of compliance assessments).
    With regard to identifying protected individuals, the Agency is 
proposing to require that assessments regarding individual exposures to 
radiation from the disposal system be based upon the assumption that 
individuals reside at the point on the surface of the accessible 
environment where they would be expected to receive the highest 
exposure from radionuclide releases from the disposal system. This 
helps ensure that the individual most likely to receive the highest 
exposure from the disposal system is accounted for and protected.
    In assessing individual doses, the Agency proposes to require 
consideration of all potential pathways (associated with undisturbed 
performance) for radionuclide transport. The pathways which need to be 
considered include land-surface pathways (including direct radiation 
exposure), surface or ground-water pathways, and air pathways, as well 
as [[Page 5781]] combinations of the above. Furthermore, consistent 
with the Agency's approach under the Safe Drinking Water Act (42 
U.S.C.A. sections 300(f) to 300j-26), it should be assumed that 
individuals consume two liters of water per day from any underground 
source of drinking water in the accessible environment.
    EPA is proposing today that any underground sources of drinking 
water in the accessible environment which are likely to be affected by 
the disposal system over 10,000 years be considered in WIPP compliance 
applications. Such consideration should include an analysis of the 
interconnection and commingling of bodies of ground water with 
underground sources of drinking water, as well as ground-water flow 
rates and direction.
    According to 40 CFR part 191, calculations of compliance with the 
individual and ground-water protection requirements must consider the 
undisturbed performance of the disposal system. 40 CFR part 191 defines 
``undisturbed performance'' as: ``the predicted behavior of a disposal 
system, including consideration of the uncertainties in predicted 
behavior, if the disposal system is not disrupted by human-intrusion or 
the occurrence of unlikely natural events.'' The Agency solicits 
comment on whether there is a need for further clarification of the 
analysis of undisturbed performance, e.g.; is there a need to identify 
what constitutes an ``unlikely'' natural event or what probability of 
occurrence renders an event ``likely'' or ``unlikely?''.
    EPA is proposing that any application for certification of 
compliance shall include information which identifies the processes, 
events, or sequences of processes and events considered in compliance 
analyses. Moreover, EPA is proposing that documentation be provided 
which justifies the inclusion/non-inclusion of particular processes, 
events, or sequences of processes and events in compliance assessment 
results.
    Once the processes, events, or sequences of processes and events 
have been identified, they shall be incorporated into compliance 
assessments of the disposal system. The disposal standards require 
compliance assessments to include consideration of the uncertainties 
associated with the undisturbed performance of the disposal system. To 
do this, it is necessary to identify all disposal system parameters 
that can affect the performance of the WIPP, as well as to identify the 
uncertainty associated with each parameter.
    When the disposal system parameters and their accompanying 
uncertainty have been identified, EPA is proposing that probability 
distributions be developed for each such parameter. A probability 
distribution is a function which assigns a probability of occurrence to 
each value for a given parameter.
    The Agency is proposing that, in compiling compliance assessment 
results, computational techniques be used which draw random samples 
from across the full range of probability distributions for parameter 
values used in compliance assessments. This will help assure that all 
possible values of a parameter have been considered in compiling 
compliance assessment results.
    EPA is proposing that the range of estimated radiation doses to 
individuals (as generated through use of the computational techniques 
referred to above), and the range of estimated radionuclide 
concentrations in ground water must be large enough such that the 
maximum estimate generated exceeds the 99th percentile of the 
population of estimates with at least a 95% probability. The 
``population of estimates'' refers to the set of all possible estimates 
that can be generated from all disposal system parameter values used in 
compliance assessments. A single estimate, in effect, samples this 
population. This is similar to the requirement for the number of CCDFs 
which must be generated for purposes of compliance with the containment 
requirements. The Agency is proposing to include this provision for the 
purpose of ensuring that there is a 95% probability that 99% of all 
possible values have been exceeded by the maximum estimate generated.
    In order to assure that all pertinent information is provided to 
the Agency, EPA is proposing to require that compliance applications 
display the full range of estimated radiation doses and the full range 
of estimated radionuclide concentrations.
    Finally, the Agency is proposing to require that any compliance 
certification application provide information which demonstrates that 
there is at least a 95% level of statistical confidence that the mean 
and the median of the full range of estimated radiation doses and of 
the full range of estimated radionuclide concentrations meet the 
requirements set forth in sections 15 and 16 of 40 CFR part 191. The 
mean estimate provides a measure of compliance that expresses the 
average impacts of the disposal system on individuals and ground water 
as well as the probabilities of uncertain disposal system parameter 
values. The median estimate provides a measure of compliance that 
expresses the central tendency of a population of estimates. 
Specifically, the median represents the point that a calculated 
estimate would be equally likely to fall above or below. Insofar as 
both statistics contain useful information, the Agency is proposing an 
approach that assures that both meet the limits of the individual and 
ground-water protection requirements.
    The Agency solicits comments on the above approach for evaluating 
the results of compliance assessment.

Subpart D--Public Participation

    The Agency intends to involve the public throughout the Agency's 
regulatory oversight at the WIPP. Accordingly, today's proposal 
contains a set of criteria for public participation in any compliance 
certification or determination.
    In today's proposal, the Agency is proposing to continue to 
maintain the four public information dockets listed in the 
Supplementary Information section of this part. All materials relevant 
to any compliance certification or determination or to any decision 
regarding modifications, suspensions, or revocations of such compliance 
certifications and determinations will be placed in the proposed 
dockets.
    The Agency believes that maintaining dockets is useful because they 
can greatly increase communication between EPA and all interested 
parties. The Agency intends to maintain all dockets in conformance with 
EPA's ``Uniform Rulemaking Docket Guidance'' to the extent practicable. 
This guidance is widely used within the Agency and helps to ensure that 
public participation in Agency rulemakings is optimized.
    The Agency also proposes to hold public hearings on proposed 
compliance criteria within the State of New Mexico. These hearings will 
provide an opportunity for members of the public, beyond submission of 
written comments, to express their views to EPA in the rulemaking 
process.
    With respect to applications for compliance certification, the 
Agency is proposing that, upon receipt of an application for 
certification of compliance, it will publish a notice in the Federal 
Register announcing that an application for certification of compliance 
has been received and soliciting comment on that application. This 
notice in the Federal Register will be an Advance Notice of Proposed 
Rulemaking (ANPR), as it will also announce the Agency's intent to 
conduct a rulemaking to certify whether [[Page 5782]] the WIPP will 
comply with the disposal regulations. The Agency is proposing this 
approach in order to afford the public an opportunity for early input 
into EPA's certification decision. The alternative might have been 
simply putting the application in the docket and receiving comments 
from the public through a more informal means. However, the Agency 
believes that this approach would not necessarily lead to as much 
public input relevant to its decision. Hence, the more formal approach 
is proposed.
    Upon completion of a review of the application for certification of 
compliance, the Agency also proposes to publish in the Federal Register 
a Notice of Proposed Rulemaking announcing the Administrator's proposed 
decision on whether the WIPP facility will comply with the disposal 
regulations and soliciting comment on such proposal. The notice will 
provide a comment period of at least 120 days and will announce the 
opportunity for public hearings in New Mexico (including times and 
procedures for registering to testify).
    The Agency will publish a Notice of Final Rule in the Federal 
Register announcing the Administrator's decision on certifying whether 
the WIPP facility will comply with the disposal regulations. 
Additionally, a document summarizing major comments and issues arising 
from comments received on the Notice of Proposed Rulemaking, as well as 
the Administrator's response to such comments and issues, will be 
prepared and made available for inspection in Agency dockets.
    Similar to the process outlined above for applications for 
compliance certification (and for the same reasons), when EPA receives 
documentation of continued compliance as required under 8(f) of the 
WIPP LWA, the Agency will publish a notice in the Federal Register 
announcing the Administrator's intent to determine whether the WIPP 
facility continues to be in compliance with the disposal regulations. 
Copies of any documentation received will be made available for 
inspection in Agency dockets and comments will be solicited for at 
least 30 days after receipt. Once the Agency has considered all 
comments received, the Administrator will make a determination 
regarding WIPP's continued compliance and publish that decision in the 
Federal Register.

Questions for Comment

    The Agency is requesting comment on today's proposed criteria for 
the certification and determination of the WIPP's compliance with the 
40 CFR part 191 disposal standards and on the proposed approaches 
taken. EPA generally invites comment on whether today's proposal 
addresses all issues related to any EPA certification or determination 
of WIPP's compliance with the disposal regulations in 40 CFR part 191.

Effective Date

    The effective date of these compliance criteria, once finalized, 
will be 30 calendar days after date of publication of the final rule in 
the Federal Register.

Regulatory Analyses

Executive Order 12866

    Under Executive Order 12866 (58 FR 51735 (October 4, 1993)) the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may:

    (1) Have an annual effect on the economy of $100 million or more 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with 
an action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.

    Pursuant to the terms of Executive Order 12866, it has been 
determined that this rule is a ``significant regulatory action'' 
because it raises novel policy issues arising out of legal mandates. As 
such, this action was submitted to OMB for review. Changes made in 
response to OMB suggestions or recommendations will be documented in 
the public record.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires each 
Federal agency to consider the effects of their regulations on small 
entities and to examine alternatives that may reduce these effects. The 
nature of this action is to propose criteria for the certification of 
compliance of the WIPP with the Agency's radioactive waste disposal 
standards set forth in 40 CFR Part 191. Since the preparation of 
applications for compliance will only be conducted by DOE, and since 
any ensuing disposal and information gathering activities will only be 
carried out by DOE, the Agency certifies that this regulation will not 
have a significant impact on a substantial number of small entities.

Paperwork Reduction Act

    The EPA has determined that this proposed rule contains no 
information requirements as defined by the Paperwork Reduction Act (42 
U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 194

    Environmental protection, Administrative practice and procedure, 
Nuclear materials, Plutonium, Radiation protection, Radionuclides, 
Uranium, Transuranics, Waste treatment and disposal.

    Dated: January 11, 1995.
Carol M. Browner,
Administrator.

    A new part 194 is hereby proposed to be added to title 40, Code of 
Federal Regulations, as follows:

PART 194--CRITERIA FOR THE CERTIFICATION AND DETERMINATION OF THE 
WASTE ISOLATION PILOT PLANT'S COMPLIANCE WITH ENVIRONMENTAL 
STANDARDS FOR THE MANAGEMENT AND DISPOSAL OF SPENT NUCLEAR FUEL, 
HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES

Subpart A--General Provisions

Sec.
194.1  Purpose, scope, and applicability.
194.2  Definitions.
194.3  Communications.
194.4  Conditions of compliance certification and determination.
194.5  Publications incorporated by reference.
194.6  Alternative provisions.

Subpart B--Compliance Certification and Determination 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 determination application(s).

Subpart C--Compliance Certification and Determination

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. [[Page 5783]] 

Containment Requirements

194.31  Application of release limits.
194.32  Scope of performance assessments.
194.33  Consideration of human-initiated processes and events.
194.34  Results of performance assessments.

Assurance Requirements

194.41  Active institutional controls.
194.42  Monitoring.
194.43  Passive institutional controls.
194.44  Engineered barriers.
194.45  Consideration of the presence of resources.
194.46  Removal of waste.

Individual and Ground-Water Protection Requirements

194.51  Consideration of protected individual.
194.52  Consideration of exposure pathways.
194.53  Consideration of underground sources of drinking water.
194.54  Scope of compliance assessments.
194.55  Results of compliance assessments.

Subpart D--Public Participation

194.61  Advance notice of proposed rulemaking.
194.62  Notice of proposed rulemaking.
194.63  Final rule.
194.64  Documentation of continued compliance.
194.65  Dockets.

    Authority: The Waste Isolation Pilot Plant Land Withdrawal Act 
of 1992, Pub.L. 102-579, 106 Stat. 4777; 5 U.S.C.app.1; 42 U.S.C. 
2011-2296; 42 U.S.C. 10101-10270.

Subpart A--General Provisions


Sec. 194.1  Purpose, scope and applicability.

    This part specifies criteria for any certification or determination 
of compliance, under section 8(d) and section 8(f) of the Waste 
Isolation Pilot Plant Land Withdrawal Act of 1992 (WIPP LWA), with the 
disposal regulations at 40 CFR part 191. Any compliance application 
submitted under section 8(d) of the WIPP LWA and any compliance 
application submitted under section 8(f) of the WIPP LWA must comply 
with the requirements of this part.


Sec. 194.2   Definitions.

    Unless otherwise indicated in this part, all terms have the same 
meaning as in 40 CFR part 191.
    Certification means any action taken by the Administrator under 
section 8(d) of the WIPP LWA.
    Compliance application(s) means any application submitted to the 
Administrator under section 8(d) of the WIPP LWA or any application(s) 
submitted to the Administrator under section 8(f) of the WIPP LWA.
    Compliance assessment(s) means the analysis conducted to determine 
compliance with section 15 and subpart C of 40 CFR part 191.
    Determination means any action taken by the Administrator pursuant 
to 8(f) of the WIPP LWA.
    Disposal regulations means subparts B and C of 40 CFR part 191.
    Human activity means those drilling events that may affect the 
disposal system, but do not necessarily reach the level of the waste in 
the disposal system.
    Human intrusion means those drilling events that reach the level of 
the waste in the disposal system.
    Management systems review means the qualitative assessment of a 
data collection operation or organization(s) to establish whether the 
prevailing quality management structure, policies, practices, and 
procedures are adequate for ensuring that the type and quality of data 
needed are obtained.
    Modification means action(s) taken by the Administrator that has 
the effect of altering the terms or conditions of certification under 
section 8(d) of the WIPP LWA or that has the effect of altering the 
terms or conditions of a determination under section 8(f) of the WIPP 
LWA.
    Population of CCDFs means all possible CCDFs that can be generated 
from all disposal system parameter values used in performance 
assessments.
    Population of estimates means all possible estimates that can be 
generated from all disposal system parameter values used in compliance 
assessments.
    Quality assurance means all those planned and systematic actions 
necessary to provide adequate confidence that the disposal system will 
perform satisfactorily in service. Quality assurance includes quality 
control, which comprises those quality assurance actions related to the 
physical characteristics of a material, structure, component, or system 
which provide a means to control the quality of the material, 
structure, component, or system to predetermined requirements.
    Regulatory time frame means the time period beginning at disposal 
and ending 10,000 years after disposal.
    Revocation means any action taken by the Administrator to terminate 
or withdraw the effectiveness of a certification under section 8(d) of 
the WIPP LWA or to terminate or withdraw the effectiveness of a 
determination under section 8(f) of the WIPP LWA.
    Secretary means the Secretary of the Department of Energy.
    Suspension means any action taken by the Administrator to withdraw, 
for a limited period of time, the effectiveness of certification under 
section 8(d) of the WIPP LWA or to withdraw, for a limited period of 
time, the effectiveness of a determination under section 8(f) of the 
WIPP LWA.
    Waste means the radioactive waste and radioactive material subject 
to the requirements of 40 CFR part 191.
    WIPP means the Waste Isolation Pilot Plant project authorized under 
section 213 of the Department of Energy National Security and Military 
Applications of Nuclear Energy Authorization Act of 1980 (Pub. L. 96-
164; 93 Stat. 1259, 1265).
    WIPP LWA means the Waste Isolation Pilot Plant Land Withdrawal Act 
(Pub. L. 102-579, 106 Stat. 4777).


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, where indicated, the 
Administrator's authorized representative; and
    (2) Signed by the Secretary or the Secretary's authorized 
representative.


Sec. 194.4  Conditions of compliance certification and determination.

    (a) Any certification or determination issued pursuant to the WIPP 
LWA may include such conditions as the Administrator finds to be 
necessary to support such certification or determination(s).
    (b) Whether stated therein or not, the following shall be 
conditions in any certification or determination:
    (1) The certification or determination shall be subject to 
modification, suspension, or revocation, by the Administrator. Any 
modification, suspension, or revocation of the certification shall be 
done by rule. If the Administrator revokes the certification, the 
Department shall retrieve, to the extent practicable, any waste 
emplaced in the disposal system.
    (2) Upon written request of the Administrator any time after the 
Administrator has issued a certification or determination of 
compliance, the Department shall submit information to enable the 
Administrator to determine whether the certification or determination 
should be modified, suspended, or revoked. Unless otherwise specified 
by the Administrator, the Department shall submit such information to 
the Administrator within 30 calendar days of receipt of the 
Administrator's request.
    (3) Not later than six months after the Administrator has issued 
any [[Page 5784]] certification or determination of compliance, and at 
least every six months thereafter, the Department shall report to the 
Administrator, in writing, any changes in conditions or activities 
pertaining to the disposal system that depart from the application and 
that formed the basis of such certification or determination of 
compliance.
    (4) Any time after the Administrator has issued a certification or 
determination of compliance, the Department shall report any changes in 
activities pertaining to the disposal system that depart significantly 
from the application and that formed the basis of such certification or 
determination of compliance. The Department shall inform the 
Administrator, in writing, prior to making a planned change. The 
Administrator will determine whether the planned change invalidates the 
terms of the certification or determination. Any significant change 
must be approved by the Administrator prior to being made and the 
Administrator will determine whether the change requires further 
action. Further action may include modification, suspension, or 
revocation of the compliance certification or determination.
    (5) If the Department discovers that a condition pertaining to the 
disposal system differs significantly from that indicated in the 
application that formed the basis of a certification or determination 
of compliance, the difference must be reported, in writing, to the 
Administrator within 10 calendar days of its discovery. The 
Administrator will determine whether the report requires further 
action. Further action may include modification, suspension, or 
revocation of the compliance certification or determination.
    (6) If the Department determines that a release of waste from the 
disposal system to the accessible environment in excess of what is 
permitted under the disposal regulations has occurred or is likely to 
occur, the Department shall:
    (i) Immediately suspend emplacement of waste in the disposal 
system, and
    (ii) Notify the Administrator, in writing, within 24 hours of the 
determination that such a release has occurred or is likely to occur. 
Such notification shall include, but need not be limited to, the 
following information to the extent possible:
    (A) Identification of the location and environmental media of the 
release or the expected release;
    (B) Identification of the type and quantity of waste (in activity 
in curies of each radionuclide) released or expected to be released;
    (C) Time and date of the release or the approximate time of the 
expected release;
    (D) Assessment of the hazard posed by the release or the expected 
release; and
    (E) Additional information requested by the Administrator or the 
Administrator's authorized representative and deemed by the 
Administrator or the Administrator's authorized representative to be 
relevant to a modification, suspension or revocation of a certification 
or determination of compliance.
    (iii) Following receipt of the notification, the Administrator:
    (A) May request additional information; and
    (B) Will determine whether emplacement of waste in the disposal 
system may continue and whether to modify, suspend, or revoke any 
previously issued certification or determination of compliance.


Sec. 194.5  Publications incorporated by reference.

    (a) The following publications are incorporated in this part by 
reference:
    (1) NUREG 1297 ``Peer Review for High-Level Nuclear Waste 
Repositories.''
    (2) ASME NQA-1-1989 edition ``Quality Assurance Program 
Requirements for Nuclear Facilities.''
    (3) ASME NQA-2a-1990 addenda (part 2.7) to ASME NQA-2-1989 edition 
``Quality Assurance Requirements of Computer Software for Nuclear 
Facility Applications.''
    (4) ASME NQA-3-1989 edition ``Quality Assurance Program 
Requirements for the Collection of Scientific and Technical Information 
for Site Characterization of High-Level Nuclear Waste Repositories.''
    (b) The publications listed in paragraph (a) of this section were 
approved 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, 401 M Street, SW., Washington, DC 
20460 or copies may be inspected at the Office of the Federal Register, 
800 N. Capitol Street NW., 7th floor, suite 700, Washington, DC.


Sec. 194.6  Alternative provisions.

    The Administrator may, by rule, substitute for any of the 
provisions of this part alternative provisions chosen after:
    (a) The alternative provisions have been proposed for public 
comment in the Federal Register together with information describing 
how the alternative provisions comport with the disposal regulations, 
the reasons why compliance with the existing provisions of this part 
appears inappropriate, the costs, risks and benefits of compliance in 
accordance with the alternative provisions;
    (b) A public comment period of at least 120 days has been 
completed, during which an opportunity for public hearings in New 
Mexico has been provided; and
    (c) The public comments received have been fully considered in 
developing the final version of alternative provisions.

Subpart B--Compliance Certification and Determination Applications


Sec. 194.11  Completeness and accuracy of compliance applications.

    Information provided to the Administrator in support of any 
compliance application(s) shall be complete and accurate. The 
Administrator's evaluation for certification under section 8(d)(1)(B) 
of the WIPP LWA and evaluation for determination under section 8(f)(2) 
of the WIPP LWA shall not begin until the Administrator has notified 
the Secretary, in writing, that a complete application in accordance 
with this Part has been received.


Sec. 194.12  Submission of compliance applications.

    Unless otherwise specified by the Administrator, 30 copies of any 
compliance application(s), any accompanying materials, and any 
amendments thereto shall be submitted in a printed form to the 
Administrator.


Sec. 194.13  Submission of reference materials.

    Information may be referenced in compliance application(s): 
Provided, That the references are clear and specific and that 10 copies 
of the referenced information are submitted to the Administrator. 
Referenced materials which are widely available in standard textbooks 
need not be submitted.


Sec. 194.14  Content of compliance certification application.

    Any application for certification of compliance with the disposal 
regulations shall include:
    (a) A description of the disposal system and those features that 
may affect disposal system performance. The description of the disposal 
system shall include the following information:
    (1) The location of the disposal system and the controlled area; 
[[Page 5785]] 
    (2) A description of the geology, geophysics, hydrogeology, 
hydrology, and geochemistry of the disposal system and its vicinity and 
how these conditions are expected to change and interact over the 
regulatory time frame;
    (3) The presence and characteristics of potential pathways for 
transport of waste from the disposal system to the accessible 
environment including, but not necessarily limited to, solution 
features, breccia pipes, and other potentially permeable features 
including but not necessarily limited to interbeds; and
    (4) The projected geophysical, hydrologic and geochemical 
conditions of the disposal system due to the presence of waste 
including, but not limited to, the effects of production of heat or 
gases from the waste.
    (b) A description of the design of the disposal system including:
    (1) Information relative to materials of construction (including, 
but not necessarily limited to, geologic media, structural materials, 
engineered barriers, general arrangement, and approximate dimensions); 
and
    (2) Codes and standards that have been applied to the design and 
construction of the disposal system.
    (c) Results of assessments conducted pursuant to the disposal 
regulations.
    (d) A description of input parameters associated with assessments 
conducted pursuant to the disposal regulations and the basis for 
selecting those input parameters.
    (e) Evidence that disposal of waste in the disposal system meets 
the requirements of Sec. 191.14.
    (f) A description of any waste acceptance criteria and actions 
taken to assure adherence to such criteria.
    (g) A description of background radiation in air, soil, and water 
in the vicinity of the disposal system and the procedures employed to 
determine such.
    (h) One or more topographic map(s) of the vicinity of the disposal 
system. Contours must be shown on the map. The contour interval must be 
sufficient to clearly show the pattern of surface water flow in the 
vicinity of the disposal system. The map(s) shall clearly show the 
following:
    (1) Scale and date;
    (2) Floodplain area;
    (3) Surface waters including intermittent streams;
    (4) Surrounding land uses, i.e., residential, commercial, 
industrial, agricultural, recreational;
    (5) A wind rose, i.e., wind speeds and directions;
    (6) Orientation of the map, i.e., north arrow;
    (7) Boundaries of the controlled area;
    (8) Location of proposed active and passive institutional controls;
    (9) Location of any active, inactive, and abandoned injection and 
withdrawal wells in the controlled area and in the vicinity of the 
disposal system; and
    (10) Location of proposed monitoring stations or wells.
    (i) A description of past and current climatologic and meteorologic 
conditions in the vicinity of the disposal system and how these 
conditions are expected to change and interact over the regulatory time 
frame.
    (j) Any additional information required elsewhere in this part or 
determined by the Administrator or the Administrator's authorized 
representative to be necessary for a decision whether to certify or 
determine compliance.


Sec. 194.15  Content of compliance determination application(s).

    (a) In submitting documentation of continued compliance pursuant to 
section 8(f) of the WIPP LWA, the most recent previous application(s) 
for compliance certification or determination shall be updated so as to 
provide sufficient information for the Administrator to determine 
whether or not the WIPP continues to be in compliance with the disposal 
regulations. Updated documentation shall include:
    (1) Additional geologic, geophysical, geochemical, hydrologic, and 
meteorologic information.
    (2) Monitoring results.
    (3) An evaluation of the conformance of the disposal system 
components with design.
    (4) A description of any waste emplaced in the disposal system 
since the most recent previous compliance certification or 
determination application. Such description shall consist of a 
description of the waste characteristics identified in 
Sec. 194.24(a)(ii).
    (5) Any additional information that the Administrator or the 
Administrator's authorized representative identifies as necessary to 
determine whether or not the disposal system continues to be in 
compliance with the disposal regulations.
    (b) To the extent that information required for a determination of 
compliance remains valid and has been submitted in previous 
certification or determination application(s), such information need 
not be duplicated in subsequent applications; such information may be 
summarized and referenced.

Subpart C--Compliance Certification and Determination

General Requirements


Sec. 194.21  Inspections.

    (a)(1) The Administrator or the Administrator's authorized 
representative(s) shall be afforded unfettered and unannounced access 
to inspect any area of the WIPP and locations performing activities 
that may provide information used to support any compliance 
application(s) to which the Department has rights of access.
    (2) The Administrator or the Administrator's authorized 
representative(s) shall be afforded access, pursuant to paragraph 
(a)(1) of this section, equivalent to access afforded Department 
employees upon presentation of credentials and other documents as may 
be required by law.
    (b) Records kept by the Department pertaining to aspects of the 
disposal system that could affect the containment of waste in the 
disposal system shall be made available to the Administrator or the 
Administrator's authorized representative(s) upon request. If requested 
records are not immediately available, they shall be made available to 
the Administrator or the Administrator's authorized representative(s) 
within 30 calendar days of a request from the Administrator or the 
Administrator's authorized representative(s).
    (c) The Department shall, upon request by the Administrator or the 
Administrator's authorized representative(s), provide private, rent-
free office space for the exclusive use of the Administrator or the 
Administrator's authorized representative(s). The office space shall be 
convenient and have full access to the disposal system.
    (d) The Administrator or the Administrator's authorized 
representative(s) shall be allowed to obtain samples, including split 
samples and to monitor and measure aspects of the disposal system and 
the waste proposed for disposal in the disposal system and deemed by 
the Administrator or the Administrator's authorized representative to 
be relevant to a compliance certification or determination.
    (e) In conducting activities pursuant to this section, the 
Administrator or the Administrator's authorized representative(s) will 
comply with applicable access control measures for security, 
radiological protection and personal safety.


Sec. 194.22  Quality assurance.

    (a)(1) The Department shall implement a quality assurance program 
[[Page 5786]] that meets the requirements of ASME NQA-1-1989 edition, 
ASME NQA-2a-1990 addenda (part 2.7) to ASME NQA-2-1989 edition, and 
ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c)).
    (2) Any application for certification of compliance shall include 
information which demonstrates that the quality assurance program 
implemented under paragraph (a)(1) of this section has been established 
and executed for:
    (i) Waste characterization activities and assumptions;
    (ii) Environmental monitoring, monitoring the performance of the 
disposal system, sampling, and analysis activities;
    (iii) Field measurements of geological factors, ground water, 
meteorology, and topography;
    (iv) Computations, codes, models and methods used to demonstrate 
compliance with the disposal regulations;
    (v) Expert judgment elicitation used to support applications for 
certification or determination of compliance;
    (vi) Design of the disposal system and actions taken to ensure 
compliance with design specifications;
    (vii) The collection of data and information used to support 
compliance application(s); and
    (viii) Other systems, structures, components, and activities 
important to the containment of waste in the disposal system.
    (b) Any application for certification of compliance shall include 
information which demonstrates that data and information collected 
prior to implementation of the quality assurance program under 
paragraph (a) of this section has been qualified in accordance with:
    (1) A quality assurance program equivalent in scope and 
implementation to ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda 
(part 2.7) to ASME NQA-2-1989 edition, and ASME NQA 3-1989 edition 
(excluding Section 2.1 (b) and (c)); or
    (2) An alternative method approved by the Administrator for use at 
the WIPP.
    (c) Any application for certification of compliance shall provide 
information which addresses how the following quality indicators for 
the collection of data and information used to support a compliance 
application have been and will continue to be achieved:
    (1) Data accuracy, i.e., the degree to which data agree with an 
accepted reference or true value;
    (2) Data precision, i.e., a measure of the mutual agreement between 
comparable data gathered or developed under similar conditions 
expressed in terms of a standard deviation;
    (3) Data representativeness, i.e., the degree to which data 
accurately and precisely represent a characteristic of a population, a 
parameter, variations at a sampling point, or environmental conditions;
    (4) Data completeness, i.e., a measure of the amount of valid data 
obtained compared to the amount that was expected;
    (5) Data comparability, i.e., a measure of the confidence with 
which one data set can be compared to another;
    (6) Data reproducibility, i.e., a measure of the variability among 
measurements of the same sample at different laboratories;
    (7) Data validation, i.e., a systematic process for reviewing a 
body of data against a set of criteria to provide assurance that the 
data are adequate for their intended use; and
    (8) Data verification, i.e., a systematic process for reviewing a 
body of data generated by one source against a body of data generated 
by another source.
    (d) The Administrator will verify appropriate execution of quality 
assurance programs through inspections which include surveillances, 
audits, and management systems reviews.


Sec. 194.23  Models and computer codes.

    (a) Any application for certification of compliance shall include:
    (1) A complete listing and description of the models used to 
support such application. The description shall be sufficiently 
complete to permit technical review of the purpose of modeling, the 
modeling approach, method of analysis and the assumptions underlying 
such analyses.
    (2) A complete listing of conceptual model(s) considered but not 
used to support such application, a description of such model(s), and 
an explanation of the reason(s) why such model(s) was/were not used to 
support such application.
    (3) Information which demonstrates that:
    (i) Conceptual models reasonably represent the disposal system;
    (ii) Mathematical models incorporate equations and boundary 
conditions which reasonably represent the mathematical formulation of 
the conceptual models;
    (iii) Numerical models provide numerical schemes which enable the 
mathematical models to obtain stable solutions;
    (iv) Computer models accurately implement the numerical models; 
i.e., computer codes are free of coding errors and produce stable and 
accurate solutions; and
    (v) Models, computer codes, and observed and measured data used to 
confirm models and computer codes have undergone peer review according 
to Sec. 194.27.
    (b) Models and computer codes used to support any application for 
certification of compliance shall be fully and clearly documented in a 
manner that complies with the requirements of ASME NQA-2a-1990 addenda 
(part 2.7) to ASME NQA-2-1989 edition.
    (c) Documentation for models and computer codes shall include:
    (1) A description of the theoretical backgrounds of each model, the 
method of analysis or assessment, scenario construction, and data 
collection procedures;
    (2) Detailed descriptions of the structure of computer codes and 
complete listings of the source codes;
    (3) Users' manuals that include general descriptions of the models, 
discussions of the limits of applicability of each model, detailed 
instructions for running the computer codes including hardware and 
software requirements, input and output formats with detailed 
explanations of each input and output variable and parameter, listings 
of input and output files from a sample computer run, and reports on 
code verification, benchmarking, validation and quality assurance 
procedures;
    (4) Programmers' manuals;
    (5) Any necessary licenses; and
    (6) An explanation of how models and computer codes handle 
covariance.
    (d) The Administrator or the Administrator's authorized 
representative may verify the results of computer simulations used to 
support any application for certification of compliance by performing 
independent simulations. Data files, source codes, executable versions 
of computer software for each model, other material or information 
needed to permit the Administrator or the Administrator's authorized 
representative to perform independent simulations, and access to 
necessary hardware to perform such simulations, shall be provided 
within 30 calendar days of a request by the Administrator or the 
Administrator's authorized representative.


Sec. 194.24  Waste characterization.

    (a)(1) Any application for certification of compliance shall 
identify, in detail, the chemical, radiological and physical 
characteristics of all waste proposed for disposal in the disposal 
system. Such identification shall provide information about waste 
characteristics as they exist or, in the case of to-be-generated waste, 
as they are expected to exist upon emplacement in the disposal system. 
[[Page 5787]] 
    (2) Information about the following characteristics of waste 
proposed for disposal in the disposal system shall be provided:
    (i) Activity in curies of each radionuclide; and
    (ii) Any other characteristic(s) important to the containment of 
waste in the disposal system as identified by the study conducted under 
paragraph (a)(3) of this section.
    (3) The Department shall conduct a study of the effects of waste 
characteristics on the containment of waste in the disposal system and 
shall include the results of such study in any application for 
certification of compliance. The characteristics studied shall include, 
but need not be limited to:
    (i) Waste form;
    (ii) Free liquid content and liquid saturation;
    (iii) Pyrophoric and explosive materials; and
    (iv) Characteristics affecting the solubilization and mobilization 
of radionuclides, formation of colloidal suspensions containing 
radionuclides, production of gas from the waste, nuclear criticality, 
and generation of heat in the disposal system.
    (4) For all waste characteristics studied pursuant to paragraph 
(a)(3) of this section, any application for certification of compliance 
shall document and substantiate any decision not to provide information 
on a particular waste characteristic because that characteristic is 
considered to be unimportant to the containment of waste in the 
disposal system.
    (5) Categories of waste shall be established, by the Department, 
based on characteristics of the waste that would be expected to behave 
similarly in the disposal system.
    (b) The information provided under paragraph (a) of this section:
    (1) Shall consist of a value or range of values for characteristics 
listed under paragraph (a)(2) of this section; and
    (2) Shall consist of a value or range of values for characteristics 
identified as important to the containment of waste in the disposal 
system by the study required under paragraph (a)(3) of this section; 
and
    (3) Shall describe in detail the characteristics of each category 
of waste established under paragraph (a)(5) of this section; and
    (4) May specify the maximum amount of each category of waste that 
will be placed in any waste container or location in the disposal 
system.
    (c)(1) Any application for certification of compliance shall 
identify and describe the method(s) used to determine waste 
characteristics and the uncertainty associated with such method(s).
    (2) Any application for certification of compliance shall provide 
information which substantiates any determination of waste 
characteristics based on knowledge of the processes and materials that 
generated the waste.
    (d) Any application for certification of compliance shall provide 
information which demonstrates that the disposal system complies with 
the disposal regulations for all combinations of waste whose contents 
fall within the range of characteristics provided pursuant to paragraph 
(b) of this section.
    (e)(1) Waste may only be emplaced in the disposal system if the 
characteristics of such waste fall within the range of values provided 
under paragraph (b) of this section and if the amount of each category 
of waste placed in any waste container or location in the disposal 
system does not exceed any maximum specified under paragraph (b)(4) of 
this section.
    (2) Any application for certification of compliance shall provide 
information which demonstrates that a system of controls which includes 
but is not necessarily limited to measurements, sampling, chain of 
custody records and other record-keeping is and will continue to be 
implemented to assure that only waste containers whose contents fall 
within the range of characteristics provided under paragraph (b) of 
this section are emplaced in the disposal system. Any application for 
certification of compliance shall identify and describe such controls 
and the uncertainty associated with them.
    (f) The Administrator will use audits and inspections to verify the 
waste characterization requirements of this part.


Sec. 194.25  Future state assumptions.

    (a) Unless otherwise specified in this part or in the disposal 
regulations, certifications or determinations of compliance with the 
disposal regulations shall assume that characteristics of the future 
remain what they are today: Provided, That such characteristics are not 
related to geologic, hydrologic, or climatic conditions.
    (b) In considering the effects of climatic conditions on the 
disposal system, certifications and determinations of compliance with 
the disposal regulations shall consider the effects of increased and 
decreased precipitation and evaporation on the disposal system over the 
regulatory time frame.


Sec. 194.26  Expert judgment.

    (a) Expert judgment, by an individual expert or panel of experts, 
may be used to support any application for certification of compliance: 
Provided, That expert judgment does not substitute for information that 
could reasonably be obtained through data collection or 
experimentation.
    (b) Any application for certification of compliance shall identify 
any expert judgments used to support the application and shall identify 
experts (by name and by professional affiliation) involved in any 
expert judgment elicitation processes used to support the application.
    (c) Any application for certification of compliance shall describe 
the process of eliciting expert judgment, and shall document the 
results of expert judgment elicitation processes and the reasoning 
behind those results. Documentation of interviews used to elicit 
judgments from experts, the questions or issues presented for 
elicitation of expert judgment, background information provided to 
experts, and deliberations and formal interactions among experts shall 
be provided.
    (d) Any application for certification of compliance shall provide 
information which demonstrates that the following restrictions and 
guidelines have been applied to any selection of individuals used to 
elicit expert judgments:
    (1) Individuals who are members of the team of investigators 
requesting the judgment or the team of investigators who will use the 
judgment shall not be selected; and
    (2) Individuals who maintain, at any organizational level, a 
supervisory role or who are supervised by those who will utilize the 
judgment shall not be selected.
    (e) Any application for certification of compliance shall provide 
information which demonstrates that the expertise of any individual 
involved in expert judgment elicitation comports with the level of 
knowledge required by the questions or issues presented to that 
individual.
    (f) Any application for certification of compliance shall include 
an explanation of the relationship between the information presented, 
the questions or issues presented, the judgment of any expert panel or 
individual, and the purpose for which the expert judgment is being 
used.
    (g) Any application for certification of compliance shall provide 
information which demonstrates that the following restrictions and 
guidelines have been applied in eliciting expert judgment:
    (1) At least five individuals shall be used in any expert 
elicitation process: [[Page 5788]] Unless, there is a lack or 
unavailability of experts and a documented rationale is provided which 
explains why fewer than five individuals were selected.
    (2) At least two-thirds of the experts involved in an elicitation 
shall consist of individuals who are not employed directly by the 
Department or by the Department's contractors: Unless, The Department 
can demonstrate and document that there is a lack or unavailability of 
qualified independent experts; however, in no case shall more than one-
half of the experts involved in an elicitation consist of individuals 
employed directly by the Department or by the Department's contractors.
    (h) Groups and individuals (including those not directly employed 
by the Department or by the Department's contractors) shall be afforded 
an opportunity to present their scientific and technical views as input 
to any expert elicitation process.


Sec. 194.27  Peer review.

    (a) Any application for certification of compliance shall include 
information which demonstrates that peer review has been conducted to 
evaluate the adequacy of:
    (1) The evaluation, required under this part, of engineered 
barriers for the disposal system;
    (2) Consideration of processes and events that may affect the 
disposal system;
    (3) Quality assurance programs and plans;
    (4) Models and computer codes;
    (5) Data used to support models and computer codes; and
    (6) Waste characterization.
    (b) Peer review processes used in certifying or determining 
compliance with the disposal regulations shall be conducted in a manner 
which is compatible with NUREG-1297 ``Peer Review for High-Level 
Nuclear Waste Repositories.''

Containment Requirements


Sec. 194.31  Application of release limits.

    The expected curie activity 100 years after disposal of the waste 
proposed for disposal in the disposal system shall be used in 
calculating applicable release limits under Appendix A of 40 CFR part 
191, Table 1, Note 1(e).


Sec. 194.32  Scope of performance assessments.

    (a) Performance assessments shall consider both natural and human-
initiated processes and events that may affect the disposal system.
    (b) Performance assessments need not consider processes, events, or 
sequences of processes and events that have less than one chance in 
10,000 of occurring over 10,000 years.
    (c) Any application for certification of compliance shall include 
information which:
    (1) Identifies potential processes, events or sequences of 
processes and events that may occur during the regulatory timeframe and 
may affect the disposal system;
    (2) Identifies the processes, events or sequences of processes and 
events included in performance assessment results provided in any 
application for certification of compliance; and
    (3) Documents why any processes, events or sequences of processes 
and events identified under paragraph (c)(1) of this section were not 
included in performance assessment results provided in any application 
for certification of compliance.


Sec. 194.33  Consideration of human-initiated processes and events.

    (a) A separate examination of each type of human-initiated process 
and event shall be conducted. Analyses shall be limited to those types 
of human-initiated processes and events that may potentially affect the 
disposal system.
    (b) The following process shall be used in assessing the likelihood 
and consequences of human-initiated processes and events and the 
results of such process shall be documented in any application for 
certification of compliance:
    (1) Inadvertent and intermittent drilling for resources (other than 
those resources provided by the waste in the disposal system or any 
engineered barriers designed to isolate such waste) is the most severe 
scenario for human-initiated processes and events.
    (2) Human-initiated processes and events occur at random intervals 
in time and space throughout the regulatory time frame.
    (3) Two categories of human-initiated processes and events shall be 
considered:
    (i) Human intrusion, which shall include those drilling events that 
reach the level of the waste in the disposal system, and
    (ii) Human activity, which shall include those drilling events that 
may affect the disposal system, but do not necessarily reach the level 
of the waste in the disposal system.
    (4) The frequency of human intrusion shall be calculated in the 
following manner:
    (i) Identify each type of human intrusion in the Delaware Basin 
over the past 50 years.
    (ii) The total rate of human intrusion shall be the sum of the 
rates of each type of human intrusion. However, in no event shall the 
total rate of human intrusion be less than 25/km2/10,000 yrs or 
more than 62.5/km2/10,000 yrs.
    (iii) In lieu of conducting the analysis in paragraphs (b)(4)(i) 
and (b)(4)(ii) of historical rates, a rate of 62.5 may be assumed.
    (iv) The rate may then be reduced in accordance with Sec. 194.41 
and Sec. 194.43(c).
    (5) The frequency of human activity shall be calculated in the 
following manner:
    (i) Identify each type of human activity in the Delaware Basin over 
the past 50 years.
    (ii) The total rate of human activity shall be the sum of the rates 
of each type of human activity.
    (iii) In considering the historical rate of all human activity, the 
Department may, if justified, consider only the historical rate of 
human activity for resources of similar type and quality of resources 
in the controlled area.
    (iv) The rate may then be reduced in accordance with Sec. 194.41 
and Sec. 194.43(c).
    (6) In assessing the consequences of human-initiated processes and 
events, performance assessments shall assume that the future 
characteristics of those processes and events including, but not 
limited to, the types and amounts of drilling fluids, and borehole 
depths, diameters, and seals will remain consistent with current 
practice in the Delaware Basin.
    (b) In assessing the consequences of human-initiated processes and 
events, performance assessments shall assume that:
    (1) Boreholes will be sealed at the rate boreholes have been sealed 
over the past 50 years in the Delaware Basin; and
    (2) Natural processes will degrade or otherwise affect the 
permeability of boreholes over the regulatory time frame.


Sec. 194.34  Results of performance assessments.

    (a)(1) The results of performance assessments shall be assembled 
into ``complementary cumulative distribution functions'' (CCDFs) that 
represent the probability of exceeding various levels of cumulative 
release caused by all significant processes and events.
    (2) Probability distributions for uncertain disposal system 
parameter values used in performance assessments shall be developed.
    (3) Computational techniques which draw random samples from across 
all of the probability distributions developed under paragraph (a)(2) 
of this section shall be used in generating CCDFs. [[Page 5789]] 
    (b) The number of CCDFs generated must be large enough such that 
the maximum CCDF generated exceeds the 99th percentile of the 
population of CCDFs with at least a 0.95 probability.
    (c) Any application for certification of compliance shall display 
the full range of CCDFs generated.
    (d) Any application for certification of compliance shall provide 
information which demonstrates that there is at least a 95% level of 
statistical confidence that the mean of the population of CCDFs meets 
the requirements of section 13(a) of 40 CFR part 191.

Assurance Requirements


Sec. 194.41  Active institutional controls.

    (a) Any application for certification of compliance shall include 
detailed descriptions of proposed active institutional controls, the 
controls' location, and the period of time the controls are proposed to 
remain active. Assumptions pertaining to active institutional controls 
and their effectiveness in terms of preventing or reducing radionuclide 
releases shall be supported by such descriptions.
    (b) Assessments to determine compliance with the disposal 
regulations shall not consider any contributions from active 
institutional controls for more than 100 years after disposal.


Sec. 194.42  Monitoring.

    (a)(1) Disposal systems shall be monitored after disposal to detect 
substantial and detrimental deviations from expected performance at the 
earliest practicable time and shall be consistent with monitoring 
required under applicable federal hazardous waste regulations at 40 CFR 
parts 264, 265, 268, and 270. These monitoring programs shall be done 
with techniques that do not jeopardize the containment of waste in the 
disposal system.
    (2) Any application for certification of compliance shall include a 
detailed plan for monitoring the performance of the disposal system. At 
a minimum, such plan shall:
    (i) Identify parameters that will be monitored and how baseline 
states will be determined;
    (ii) Indicate how each parameter will be used to evaluate the 
performance of the disposal system; and
    (iii) Discuss the length of time over which each parameter will be 
monitored to detect deviations from expected performance.
    (b)(1) To the extent practicable, pre-closure monitoring of the 
following disposal system parameters shall be conducted:
    (i) Brine quantity, flux, composition, and spatial distribution;
    (ii) Gas quantity and composition;
    (iii) Temperature distribution; and
    (iv) Any other disposal system parameter(s) important to the 
containment of waste in the disposal system as identified by the study 
conducted under paragraph (b)(2) of this section. A disposal system 
parameter shall be considered important if it affects the system's 
ability to contain waste or the ability to verify predictions about the 
future performance of the disposal system. Such monitoring shall begin 
as soon as practicable after the Administrator's certification of 
compliance; however, in no case shall waste be emplaced in the disposal 
system prior to the implementation of such monitoring. Monitoring shall 
end when the last container of waste is emplaced in the disposal system 
but before shafts of the disposal system are backfilled and sealed.
    (2) The Department shall conduct a study of the effects of disposal 
system parameters on the containment of waste in the disposal system 
and shall include the results of such study in any application for 
certification of compliance. The disposal system parameters studied 
shall include, but need not be limited to:
    (i) Backfilled mechanical state including porosity, permeability, 
and degree of compaction and reconsolidation;
    (ii) Extent of deformation of the surrounding roof, walls, and 
floor of the waste disposal room;
    (iii) Initiation or displacement of major brittle deformation 
features in the roof or surrounding rock; and
    (iv) Subsidence and other effects of human activity in the vicinity 
of the disposal system.
    (3) For all disposal system parameters studied pursuant to 
paragraph (b)(2) of this section, any application for certification of 
compliance shall document and substantiate the decision not to monitor 
a particular disposal system parameter because that parameter is 
considered to be unimportant to the containment of waste in the 
disposal system and to the verification of predictions about the future 
performance of the disposal system.


Sec. 194.43  Passive institutional controls.

    (a) Any application for certification of compliance shall include 
detailed descriptions of the measures that will be employed to preserve 
knowledge about the location, design, and contents of the disposal 
system. At a minimum, such measures shall include:
    (1) Identification of the controlled area by markers that have been 
designed, fabricated, and emplaced to be as permanent as practicable;
    (2) Placement of records in the archives and land record systems of 
local, State, and Federal governments, and international archives, that 
would likely be consulted by individuals in search of unexploited 
resources. Such records shall identify:
    (i) The location of the controlled area and the disposal system;
    (ii) The design of the disposal system;
    (iii) The nature and hazard of the waste;
    (iv) Geologic, geochemical, hydrologic, and other site data 
pertinent to the containment of waste in the disposal system; and
    (v) The results of tests, experiments, and other analyses relating 
to backfill of excavated areas, shaft sealing, waste interaction with 
the disposal system, and other tests, experiments, or analyses 
pertinent to the containment of waste in the disposal system.
    (b) Any application for certification of compliance shall include 
detailed descriptions of the proposed passive institutional controls 
and the period of time those controls are expected to endure and be 
understood.
    (c) Any application for certification of compliance may include a 
proposed credit (which may vary over the regulatory time frame) for 
reducing the rate of human-initiated processes and events calculated 
using the procedures enumerated in Sec. 194.33. The Administrator shall 
allow such credit, or a smaller credit, to be taken if the Department 
demonstrates that such credit is justified because the passive 
institutional controls can be expected to endure, be understood, and 
act as a deterrent to potential intruders throughout the regulatory 
time frame. In no case, however, shall passive institutional controls 
be assumed to eliminate the likelihood of human-initiated processes and 
events entirely.


Sec. 194.44  Engineered barriers.

    (a) Disposal systems shall incorporate engineered barriers designed 
to prevent or substantially delay the movement of water or 
radionuclides toward the accessible environment.
    (b) In selecting engineered barriers for the disposal system, the 
Department shall evaluate the benefit and detriment of engineered 
barrier alternatives including but not limited to such engineered 
barriers as cementation, shredding, supercompaction, incineration, 
vitrification, improved waste canisters, grout and bentonite backfill, 
melting of metals, alternative [[Page 5790]] configurations of waste 
placements in the disposal system, and alternative disposal system 
dimensions. The results of this evaluation shall be included in any 
application for certification of compliance and shall be used to 
justify the selection and rejection of each engineered barrier 
evaluated.
    (c) (1) In conducting the evaluation of engineered barrier 
alternatives, the following shall be considered:
    (i) The ability of the engineered barrier to prevent or 
substantially delay the movement of water or waste toward the 
accessible environment;
    (ii) The impact on worker exposure to radiation both during and 
after incorporation of engineered barriers;
    (iii) The increased ease or difficulty of removing the waste from 
the disposal system;
    (iv) The increased or reduced risk of transporting the waste to the 
disposal system;
    (v) The increased or reduced uncertainty in compliance assessment;
    (vi) The increased or reduced public confidence in the performance 
of the disposal system;
    (vii) The increased or reduced total system costs;
    (viii) The impact, if any, on other waste disposal programs from 
the incorporation of engineered barriers (e.g., the extent to which the 
incorporation of engineered barriers affects the volume of waste);
    (ix) The effects on mitigating the consequences of human-initiated 
processes and events.
    (2) If, after consideration of one or more of the factors in 
paragraph (c)(1) of this section, the Department concludes that an 
engineered barrier should be rejected without evaluating the remaining 
factors in paragraph (c)(1) of this section, then any application for 
certification of compliance shall provide a justification for this 
rejection explaining why the evaluation of the remaining factors would 
not alter the conclusion.
    (d) In considering the benefit and detriment of incorporation of 
engineered barriers, the benefit and detriment of engineered barriers 
for existing waste already packaged, existing waste not yet packaged, 
existing waste in need of re-packaging, and to-be-generated waste shall 
be considered separately and described.
    (e) The evaluation shall consider engineered barriers alone and in 
combination.


Sec. 194.45  Consideration of the presence of resources.

    Any application for certification of compliance shall include 
information that demonstrates that the favorable characteristics of the 
disposal system compensate for the presence of resources in the 
vicinity of the disposal system and the likelihood of future human-
initiated processes and events as a result of the presence of those 
resources.


Sec. 194.46  Removal of waste.

    Any application for certification of compliance shall include a 
plan for removal of waste from the disposal system. The plan shall 
incorporate the best technology available, at the time of application, 
for removing such waste.

Individual and Ground-Water Protection Requirements


Sec. 194.51  Consideration of protected individual.

    Certifications or determinations of compliance with section 15 and 
subpart C of 40 CFR part 191 shall assume that an individual resides at 
the location in the accessible environment where that individual would 
be expected to receive the highest exposure from radionuclide releases 
from the disposal system.


Sec. 194.52  Consideration of exposure pathways.

    In certifying or determining compliance with section 15 and subpart 
C of 40 CFR part 191, all potential exposure pathways, associated with 
undisturbed performance, from the disposal system to individuals shall 
be considered. Certifications or determinations of compliance with 
section 15 and subpart C of 40 CFR part 191 shall assume that 
individuals consume 2 liters per day of drinking water from any 
underground source of drinking water in the accessible environment.


Sec. 194.53  Consideration of underground sources of drinking water.

    In certifying or determining compliance with subpart C of 40 CFR 
part 191, all underground sources of drinking water in the accessible 
environment likely to be affected by the disposal system over the 
regulatory time frame shall be considered. In determining whether 
underground sources of drinking water are likely to be affected by the 
disposal system, interconnections between bodies of surface water, 
ground water, and underground sources of drinking water shall be 
considered.


Sec. 194.54  Scope of compliance assessments.

    Any application for certification of compliance shall include 
information which:
    (a) Identifies potential processes, events or sequences of 
processes and events that may occur over the regulatory time frame;
    (b) Identifies the processes, events or sequences of processes and 
events included in compliance assessment results provided in any 
application for certification of compliance; and
    (c) Documents why any processes, events or sequences of processes 
and events identified under paragraph (a) of this section were not 
included in compliance assessment results provided in any application 
for certification of compliance.


Sec. 194.55  Results of compliance assessments.

    (a)(1) Compliance assessments shall consider uncertainty in the 
undisturbed performance of a disposal system.
    (2) Probability distributions for uncertain disposal system 
parameter values used in compliance assessments shall be developed.
    (3) Computational techniques which draw random samples from across 
all of the probability distributions developed under paragraph (a)(2) 
of this section shall be used to generate a range of:
    (i) Estimated radiation doses; and
    (ii) Estimated radionuclide concentrations.
    (b) Each of the ranges generated under paragraph (a)(3) of this 
section must be large enough such that the maximum estimate generated 
exceeds the 99th percentile of the population of estimates with at 
least a 0.95 probability.
    (c) Any application for certification of compliance shall display:
    (1) The full range of estimated radiation doses; and
    (2) The full range of estimated radionuclide concentrations.
    (d) Any application for certification of compliance shall provide 
information which demonstrates that there is at least a 95% level of 
statistical confidence that the mean and the median of the range of 
estimated radiation doses and the range of estimated radionuclide 
concentrations meet the requirements of sections 15 and 16 of 40 CFR 
part 191.

Subpart D--Public Participation


Sec. 194.61  Advance notice of proposed rulemaking.

    (a) Upon receipt of an application for certification of compliance, 
the Agency will publish in the Federal Register an Advance Notice of 
Proposed Rulemaking announcing that an application for certification of 
compliance has been received, soliciting comment on such application, 
and announcing the Agency's intent to [[Page 5791]] conduct a 
rulemaking to certify whether the WIPP facility will comply with the 
disposal regulations.
    (b) A copy of the application for certification of compliance will 
be made available for inspection in Agency dockets.
    (c) The notice will provide a public comment period of at least 120 
days.
    (d) A public hearing concerning the notice will be held if a 
written request for a hearing is received within 30 calendar days of 
the date of publication under paragraph (a) of this section. Written 
requests shall be directed to the Administrator and the Administrator's 
authorized representative.
    (e) Any comments received on the notice will be made available for 
inspection in the dockets established under section 65 of this part.
    (f) Any comments received on the notice will be provided to the 
Department and the Department may submit written responses to the 
comments within 120 days of receipt.


Sec. 194.62  Notice of proposed rulemaking.

    (a) Upon completion of review of the application for certification 
of compliance, the Administrator will publish a Notice of Proposed 
Rulemaking in the Federal Register announcing the Administrator's 
proposed decision on whether the WIPP facility will comply with the 
disposal regulations and soliciting comment on the proposal.
    (b) The notice will provide a public comment period of at least 120 
days.
    (c) The notice will announce the opportunity for public hearings in 
New Mexico and provide information on the timing and location of such 
hearings and procedures for registering to testify.
    (d) Any comments received on the notice will be made available for 
inspection in the dockets established under section 65 of this part.


Sec. 194.63  Final rule.

    (a) The Administrator will publish a Final Rule in the Federal 
Register announcing the Administrator's decision on certifying whether 
the WIPP facility will comply with the disposal regulations.
    (b) A document summarizing major comments and issues arising from 
comments received on the Notice of Proposed Rulemaking as well as the 
Administrator's response to such comments and issues will be prepared 
and will be made available for inspection in the dockets established 
under section 65 of this part.


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, the 
Administrator will publish a notice in the Federal Register announcing 
that such documentation has been received, soliciting comment on such 
documentation, and announcing the Administrator's intent to determine 
whether or not the WIPP facility continues to be in compliance with the 
disposal regulations.
    (b) Copies of documentation of continued compliance received by the 
Administrator will be made available for inspection in the dockets 
established under section 65 of this part.
    (c) The notice will provide a public comment period of at least 30 
days after publication under paragraph (a) of this section.
    (d) Any comments received on such notice will be made available for 
public inspection in the dockets established under Sec. 194.65.
    (e) Upon completion of a review of documentation of continued 
compliance with the disposal regulations, the Administrator will 
publish a notice in the Federal Register announcing the Administrator's 
decision determining whether or not the WIPP facility continues to be 
in compliance with the disposal regulations.


Sec. 194.65  Dockets.

    The Agency will establish and maintain dockets in the State of New 
Mexico and Washington, DC. The dockets will consist of all relevant 
information received from outside parties and all information 
considered by the Administrator in certifying whether the WIPP facility 
will comply with the disposal regulations, in determining whether or 
not the WIPP facility continues to be in compliance with the disposal 
regulations, and in determining whether compliance certification or 
determination(s) should be modified, suspended, or revoked.

[FR Doc. 95-1657 Filed 1-27-95; 8:45 am]
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