[Federal Register Volume 61, Number 28 (Friday, February 9, 1996)]
[Rules and Regulations]
[Pages 5224-5245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2721]




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Part VI





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 194



Criteria for the Certification and Re-Certification of the Waste 
Isolation Pilot Plant's Compliance With the 40 CFR Part 191 Disposal 
Regulations; Final Rule

  Federal Register / Vol. 61, No. 28 / Friday, February 9, 1996 / Rules 
and Regulations   

[[Page 5224]]


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 194

[FRL-5418-5]
RIN 2060-AE30


Criteria for the Certification and Re-Certification of the Waste 
Isolation Pilot Plant's Compliance With the 40 CFR Part 191 Disposal 
Regulations

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is promulgating 
criteria for determining if the Waste Isolation Pilot Plant (WIPP) will 
comply with EPA's environmental radiation protection standards for the 
disposal of radioactive waste. If the Administrator of EPA determines 
that the WIPP will comply with the standards for disposal, then the 
Administrator will issue to the Secretary of Energy a certification of 
compliance which will allow the emplacement of transuranic waste in the 
WIPP to begin, provided that all other statutory requirements have been 
met. If a certification is issued, EPA will also use this final rule to 
determine if the WIPP has remained in compliance with EPA's 
environmental radiation protection standards, once every five years 
after the initial receipt of waste for disposal at the WIPP. This 
rulemaking was mandated by the WIPP Land Withdrawal Act of 1992.

EFFECTIVE DATE: These regulations are effective April 9, 1996. The 
incorporation of certain publications listed in the regulations is 
approved by the Director of the Office of the Federal Register as of 
April 9, 1996. A petition for judicial review of this final action must 
be filed no later than April 9, 1996 pursuant to section 18 of the WIPP 
Land Withdrawal Act of 1992 (Pub. L. 102-579).

FOR FURTHER INFORMATION CONTACT: Betsy Forinash, Mary Kruger or Martin 
Offutt; telephone number (202)-233-9310; address: Radiation Protection 
Division, Mail Code 6602J, U.S. Environmental Protection Agency, 
Washington, DC 20460. Copies of the Background Information Document and 
Economic Impact Analysis which accompany today's action may be obtained 
at this address. The Agency has also published a document, accompanying 
today's action, which responds in detail to significant public comments 
that were received on the proposed rule. This document, entitled 
``Response to Comments'' may be obtained by contacting Betsy Forinash.

SUPPLEMENTARY INFORMATION:

Introduction

Purpose of Today's Action

    Today's action implements the Environmental Protection Agency's 
(EPA) environmental radiation protection standards, 40 CFR part 191, by 
applying them to the proposed disposal of transuranic radioactive waste 
in the Waste Isolation Pilot Plant (WIPP). The EPA previously 
promulgated 40 CFR part 191, ``Environmental Radiation Protection 
Standards for Management and Disposal of Spent Nuclear Fuel, High-Level 
and Transuranic Radioactive Wastes,'' to provide standards that will 
apply to all sites (except Yucca Mountain) for the deep geologic 
disposal of highly radioactive waste. Complete descriptions of 40 CFR 
part 191 were published in the Federal Register in 1985 (50 FR 38066-
38089, Sep. 19, 1985) and 1993 (58 Fed. Reg. 66398-66416, Dec. 20, 
1993). The WIPP is subject to 40 CFR part 191, and is being constructed 
by the Department of Energy (DOE) near Carlsbad, New Mexico, as a 
potential repository for the safe disposal of transuranic radioactive 
waste. The EPA is required by the WIPP Land Withdrawal Act of 1992 
(Pub. L. 102-579) to evaluate whether the WIPP will comply with 
subparts B and C of 40 CFR Part 191--known as the ``disposal 
regulations''--and to issue or deny a certification of compliance. The 
Department of Energy is required to submit an application to EPA that 
will be the basis of EPA's evaluation of whether a certification of the 
WIPP's compliance with the disposal regulations should be issued. The 
Department of Energy may not begin to emplace transuranic waste 
underground for disposal at the WIPP until such time as a certification 
of compliance has been issued and all other requirements of section 
7(b) of the WIPP Land Withdrawal Act have been satisfied. With today's 
rulemaking, the Agency establishes criteria by which to judge whether 
the WIPP is in compliance with the ``disposal regulations'' and sets 
forth procedural requirements for this determination.
    Today's action, 40 CFR part 194, also applies to the periodic re-
certification of the WIPP's compliance with the disposal regulations. 
The process of periodic re-certification, established by section 8(f) 
of the WIPP Land Withdrawal Act, calls for EPA to determine whether the 
WIPP continues to be in compliance with the disposal regulations, 
assuming that an initial certification of compliance has been issued. 
The Secretary of Energy must submit to the Administrator of EPA 
documentation of the WIPP's continued compliance with the disposal 
regulations, every five years after the initial receipt of transuranic 
waste for disposal at the WIPP, until the end of the decommissioning 
phase. The Agency will use the criteria set forth in today's rulemaking 
in determining whether or not the WIPP will have continued to be in 
compliance.
    The WIPP was authorized in 1980, under section 213 of the 
Department of Energy National Security and Military Applications of the 
Nuclear Energy Authorization Act of 1980 (Pub. L. 96-164, 93 Stat. 
1259, 1265), ``for the express purpose of providing a research and 
development facility to demonstrate the safe disposal of radioactive 
wastes resulting from the defense activities and programs of the United 
States.'' The waste proposed for disposal in the WIPP, transuranic 
radioactive waste (TRU waste), is waste consisting of materials such as 
rags, equipment, tools, protective gear and sludges which have become 
contaminated during atomic energy defense activities. The WIPP Land 
Withdrawal Act defines transuranic waste to be waste containing more 
than 100 nano-curies per gram of alpha-emitting radio-isotopes, with 
half-lives greater than twenty years and atomic number greater than 92, 
per gram of waste. The Act further stipulates that radioactive waste 
shall not be transuranic waste if such waste also meets the definition 
of high-level radioactive waste, has been specifically exempted from 
the disposal regulations with the concurrence of the Administrator, or 
has been approved for an alternate method of disposal by the Nuclear 
Regulatory Commission. The radioactive component of transuranic waste 
consists of man-made elements created during the process of nuclear 
fission, chiefly isotopes of plutonium.

Statutory and Regulatory Basis

    Today's action, 40 CFR part 194, was mandated by Congress in 
section 8(c) of the WIPP Land Withdrawal Act. The criteria promulgated 
in this action implement only those subparts of 40 CFR part 191 that 
apply to the disposal of transuranic radioactive waste. As stated in 
the Code of Federal Regulations, Appendix C of 40 CFR part 191 is 
guidance for the implementation of the regulations contained in 40 CFR 
part 191 that is not binding on the implementing agency, which is EPA 
with respect to the WIPP. Appendix C was designed to apply to all 
geologic 

[[Page 5225]]
repositories for the disposal of highly radioactive wastes, not 
necessarily to the specific site characteristics of the WIPP and not 
only to transuranic waste. As a result, the Agency found in developing 
today's action that only some of the guidance contained in Appendix C 
had specific relevance to the WIPP. Today's action has been guided by 
only those aspects of Appendix C that the Agency has determined, based 
on technical and policy considerations, to be applicable to the WIPP.
    Today's action, 40 CFR part 194, does not amend 40 CFR part 191. 
With the Energy Policy Act of 1992, Congress mandated the development 
of regulations to replace 40 CFR part 191 for the Yucca Mountain site 
only, but the entire standard, 40 CFR part 191, remains applicable to 
the WIPP. See 106 Stat. 2921, section 801(a)(1). Subpart A of 40 CFR 
part 191 applies to the management of spent nuclear fuel, high-level 
and transuranic radioactive wastes at sites designated for the disposal 
of these wastes. Section 9(a) of the WIPP Land Withdrawal Act 
stipulates that the Secretary of Energy shall comply with respect to 
the WIPP with Subpart a of 40 CFR part 191. The Agency has not 
implemented these requirements in today's action, 40 CFR part 194, but 
intends to issue guidance for their application to the WIPP at a future 
date.

Compliance With Other Environmental Laws and Regulations

    The WIPP is regulated under the Resource Conservation and Recovery 
Act (RCRA) and is subject to both the Part B licensing requirements and 
the land disposal restrictions of that statute. The WIPP must comply 
with other environmental laws, including, among other statutes, the 
Clean Air Act (40 U.S.C. 7401 et seq.), the Toxic Substances Control 
Act (15 U.S.C. 2601 et seq.) and the Comprehensive Environmental 
Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9601 et 
seq.). This action does not affect the need for DOE to comply with 
these and all other applicable environmental laws with respect to the 
WIPP.

Public Involvement in Today's Rulemaking

    The Agency has taken significant steps to involve the public in the 
rulemaking for today's action. The EPA published an Advanced Notice of 
Proposed Rulemaking (ANPR) in February, 1993 (58 FR 8029) which 
solicited public comment on eight issues central to the development of 
this final rule. The EPA again solicited public comment on a 
preliminary draft of the proposed rule, in January, 1994. The Agency 
published a notice of proposed rule on January 30, 1995, which 
announced the start of a public comment period of 90 days (60 FR 5766). 
The Agency convened a technical workshop in February, 1995, for the 
express purpose of soliciting the views of both scientific experts and 
the public on issues germane to the rulemaking. In March, 1995, the 
Agency held public hearings in three cities in New Mexico to solicit 
public input on the notice of proposed rule. On August 1, 1995, the 
Agency re-opened the comment period on the notice of proposed rule for 
an additional 45 days (60 FR 39131). During the entire comment period 
on the proposed rule, the Agency received over 100 written public 
comments. The Agency has responded to significant comments received on 
the notice of proposed rule from both written submissions and from 
testimony at the public hearings, including late written comments 
received soon after the close of the second part of the comment period, 
in a document published concurrently with today's action. In September, 
1995, EPA conducted a public meeting of the WIPP Review Committee of 
the National Advisory Council for Environmental Policy and Technology 
(NACEPT) on three issues relevant to today's action. During this 
meeting, members of the public provided formal presentations and oral 
comments to the committee. See 60 FR 43470-43471 (Aug. 21, 1995).

Summary of the Final Rule

    The supporting rationale for today's action, found in the following 
summary and discussion of principal changes, is further explained in 
the Background Information Document and the Response to Comments which 
accompany today's action, copies of which may be obtained as described 
in the start of this notice. Those sections of the final rule which 
have remained unchanged since the rule's proposal are also further 
explained in the notice of proposed rule (60 FR 5766-5791).

Subpart A: General Provisions

    Subpart A of the final rule establishes provisions related to the 
structure of the final rule itself, including: Purpose, scope and 
applicability; definitions; substitution of alternative provisions for 
those promulgated in today's final rule; and procedures which shall be 
followed in communications and written reports submitted by the 
Secretary of Energy to the Administrator. Further provisions are set 
forth which incorporate by reference several publications. Publications 
so incorporated shall have the same legal force and effect as the other 
requirements of the final rule.
    Section 194.4 of subpart A permits the Agency to specify conditions 
on the issuance of a certification and to issue a modification, 
suspension or revocation of a certification. The Agency would, for 
example, specify conditions in the event that the necessary confidence 
in the WIPP's compliance could be achieved by the implementation of 
additional measures, or if EPA determines that the WIPP will comply 
with the disposal regulations if certain terms of the application were 
to be changed.
    The Agency would consider issuing a modification, suspension or 
revocation whenever the disposal activities or disposal system change 
such that significant information contained in the most recent 
compliance application were no longer to remain true. Such a situation 
may occur if (1) DOE plans to make a significant change to the disposal 
system or disposal activities, or (2) DOE discovers that a significant 
change has occurred in the disposal system or disposal activities; in 
either case DOE must inform the Administrator in writing. If DOE finds 
the latter condition to be true, then DOE must determine if a release 
of waste from the disposal system has occurred or is expected to occur 
that would cause the numerical requirements of the disposal regulations 
to be exceeded. Releases which might occur during management 
operations, covered under subpart A of 40 CFR part 191, which do not 
relate to compliance with the disposal regulations would not 
necessitate this investigation. However, if DOE conducts this 
investigation and determines that such a release has occurred or is 
likely to occur, then DOE shall notify the Administrator of this fact 
and immediately cease emplacing waste in the WIPP. In such situations, 
the Administrator will determine which of three actions--modification, 
suspension or revocation--will be appropriate. Any modifications and 
revocations issued by EPA would affect the certification issued 
pursuant to section 8(d)(1) of the WIPP Land Withdrawal Act and must be 
conducted by rulemaking under section 553 of the Administrative 
Procedure Act. See 5 U.S.C. 553. A suspension may be issued at any time 
at the Administrator's discretion so as to promptly address any 
potential threat to public health. A suspension shall remain in place 
until such time as DOE shall have effected remediations as necessary to 
re-establish the WIPP's compliance with the disposal regulations or 
until EPA will 

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have modified or revoked the certification. DOE shall not restart 
emplacing waste in the WIPP until the Administrator notifies DOE in 
writing that the suspension has been lifted.

Subpart B: Compliance Certification and Re-certification Applications

    Subpart B of the final rule sets forth requirements for the format 
and content of compliance applications. Section 194.11 of the final 
rule stipulates that DOE must submit a complete compliance application 
before the one-year, statutory review period shall commence. See Pub. 
L. 102-579, section 8(d)(1). Should DOE's initial submission be 
incomplete, the Administrator will explain the nature of the deficiency 
and will request DOE to submit further information until the 
Administrator has notified the Secretary that all materials necessary 
for a complete application have been received. This process will ensure 
that the Agency's one-year period will be devoted exclusively to a 
substantive, meaningful review. This provision applies as well to the 
compliance applications periodically submitted by DOE for re-
certification of compliance. Once the Administrator has notified the 
Secretary of Energy that a complete compliance application for re-
certification has been received, the Agency will commence the six month 
review period as provided for in section 8(f) of the WIPP Land 
Withdrawal Act. Section 194.12 requires that 30 copies of the 
compliance applications and any accompanying materials shall be 
submitted to the Administrator. Section 194.13 requires that compliance 
applications be accompanied by any referenced materials, unless such 
materials are generally available.
    Section 194.14 of the final rule lists those elements which the 
Agency requires to be in a complete compliance application. In general, 
compliance applications must include information relevant to 
demonstrating compliance with each of the individual sections of the 
final rule. The Agency intends to publish the final version of the 
Compliance Application Guidance (CAG) at a later date to provide 
detailed guidance on the submission of a complete compliance 
application.
    Section 194.15 of the final rule specifies that DOE must submit any 
additional information that will have been gathered during the elapsed 
five-year period and that is relevant to compliance with the disposal 
regulations. To facilitate the Agency's review of compliance 
applications for re-certification, today's final rule stipulates that 
DOE will not have to re-submit information that will have been included 
in previous compliance applications, provided that the information will 
have remained true and accurate. The current compliance application 
should clearly reference such information so that the Agency's review 
of the section in question can be accomplished expeditiously.

Subpart C: Compliance Certification and Re-certification

    Subpart C establishes the requirements that apply to the 
performance assessments and compliance assessments that will be used to 
demonstrate compliance with the numerical requirements of the disposal 
regulations. In addition, subpart C implements the six assurance 
requirements of the disposal regulations and also establishes seven 
general requirements in Secs. 194.21 through 194.27 which must be met 
by all portions of and all activities associated with compliance 
applications.
    Section 194.21, inspections, provides EPA with right of inspection 
of all activities at the WIPP and all activities located off-site which 
provide information included in compliance applications. The Agency 
will conduct periodic inspections, both announced and unannounced, to 
verify the adequacy of information included in the compliance 
applications. The Agency may conduct its own laboratory tests, in 
parallel with those conducted by DOE, so as to confirm the adequacy of 
the techniques employed at those facilities. The Agency may also 
inspect any relevant records kept by DOE, including those records 
required to be generated pursuant to today's action.
    Section 194.22, quality assurance (QA), sets requirements that 
apply to data and information collected as part of the WIPP program. 
The Agency requires quality assurance programs to be implemented, as 
soon as practicable after April 9, 1996, that meet the requirements of 
the American Society of Mechanical Engineers (ASME) ``Quality Assurance 
Program Requirements for Nuclear Facilities'' (NQA-1-1989), ASME's 
``Quality Assurance Requirements of Computer Software for Nuclear 
Facility Applications'' (part 2.7 of NQA-2a-1990 addendum to ASME NQA-
2-1989), and ASME's ``Quality Assurance Requirements for the Collection 
of Scientific and Technical Information on Site Characterization of 
High-Level Nuclear Waste Repositories,'' (NQA-3-1989 edition), 
excluding sections 2.1(b), 2.1(c) and 17.1. Section 194.5 of the final 
rule incorporates these three publications by reference. The Agency 
believes that ASME's standards offer the most comprehensive and 
specific set of requirements for nuclear facilities and has therefore 
used these standards in place of establishing new requirements. 
Paragraph (a)(2) of Sec. 194.22 requires that DOE must implement a 
quality assurance program that meets the above three sets of ASME's 
requirements for seven specific program elements of the WIPP and for 
any other system, structure, component, or activity important to the 
containment of waste in the disposal system.
    Data that were collected prior to the implementation of the above 
programs must also satisfy quality assurance requirements. Any 
compliance application must demonstrate, subject to the approval of the 
Administrator or the Administrator's authorized representative, that 
such data were qualified using one or more of the following four 
methodologies: (1) Use of a methodology that is substantially 
equivalent in effect to the three sets of ASME's requirements; (2) peer 
review that is compatible with NUREG-1297; (3) corroborating data; or 
(4) confirmatory testing. The Agency believes that each of these latter 
three methods provides a means of inferring the quality of the existing 
data by subjecting some aspect of that data to additional scrutiny. 
Peer review involves a critical evaluation by an independent review 
group of the adequacy with which the experiments used to acquire this 
data were planned and conducted. The use of corroborating data 
evaluates the degree to which the existing data agree with data 
generated from similar work that has already been published in 
scientific journals, along with an appraisal of the latter's quality. 
Confirmatory testing involves repeating a small portion of the 
experiments, using quality assurance methods that meet the requirements 
of ASME's standards, and comparing the resulting data to the data in 
question. In the last two alternate methodologies, the level of 
agreement between the existing data and the corroborating or 
confirmatory data provides an objective measure to assess the quality 
of the existing data, if only in part. All quality assurance programs, 
both for existing data and data that has yet to be collected, must 
assess the accuracy, precision, representativeness, completeness and 
comparability of data. To verify that the quality assurance programs 
satisfy the requirements of this section, the Administrator will 
conduct inspections which may include surveillance, audits and 
management systems reviews.
    Section 194.23, models and computer codes, sets requirements for 
the models and computer codes used in 

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performance assessments and compliance assessments. Compliance 
applications must demonstrate that performance assessments and 
compliance assessments make a logical progression from conceptual 
models to mathematical models to numerical models and finally to 
computer models and codes. Compliance applications must provide 
information on and descriptions of models and computer codes which will 
permit the Agency to conduct a review of the modeling approach, 
theoretical bases, and the methodology employed in developing the list 
of processes and events used to support the compliance application. 
Compliance applications must include evidence that all computer codes 
comply with the requirements of part 2.7 of ASME's NQA-2a-1990 
addendum.
    The Agency intends to conduct detailed reviews of the computer 
codes used in performance and compliance assessments, since it is the 
results of computer codes themselves that will be compared to the 
numerical requirements found at section 13 of 40 CFR part 191. 
Compliance applications must provide: Descriptions of the theoretical 
backgrounds for each model and the method of analysis or assessment; a 
line-by-line listing of codes, which may be submitted in electronic 
format; a discussion of the treatment of correlation between 
parameters; and other information necessary to permit the Agency to 
conduct its review. Upon request, DOE must provide the Agency with the 
means to conduct its own simulations. The final rule requires that any 
computer files and hardware that will be necessary for performing 
simulations shall be made available within 30 days of a request from 
the Administrator or the Administrator's authorized representative.
    Section 194.24, waste characterization, has been revised in the 
final rule. A discussion of the rationale for the changes is contained 
below in the section of the supplementary information, ``Principal 
changes in the final rule.'' The final rule requires DOE to identify 
and describe quantitative information on those physical, chemical and 
radiologic characteristics of the waste that can influence disposal 
system performance. The Agency does not expect or require that every 
drum of transuranic waste be opened in an effort to provide an 
exhaustive characterization of the contents. Rather, the Agency expects 
that DOE will sample drums of waste to the extent necessary and will 
combine the results with other information such as process knowledge to 
determine the waste characteristics. The level of accuracy needed in 
waste characterization is determined by the degree of accuracy assumed 
in the compliance application. A waste characteristic, as defined in 
the final rule, is a physical or chemical parameter that serves as a 
quantitative input to performance assessments or compliance 
assessments, examples of which are solubility and compactibility. DOE 
must conduct an analysis to identify and assess the impact on long-term 
performance of those waste characteristics which influence the 
containment of waste in the disposal system. This section of the final 
rule lists specific characteristics which must, at a minimum, be 
included in the analysis.
    The final rule requires DOE to establish limits on the quantities 
of different ``waste components,'' such as cellulosics, metals or 
activity in curies, that may be proposed for disposal and emplaced in 
the WIPP. A waste component is distinguished from a waste 
characteristic in that the former is an amount of a type of waste 
present in the total inventory-- expressed as a volume, mass or weight 
(or curies, in the case of activity)--whereas the latter is any 
parameter that describes the physical, chemical or radiologic 
properties and behavior of some or all of the containers of waste. For 
example, a container of waste might contain a given quantity of 
chelating agents, which are a waste component. An example of a 
corresponding waste characteristic is the solubility in brine of the 
radionuclides in a container. The final rule requires that DOE 
establish upper or lower limits, as appropriate, on the total amount of 
each waste component that may be emplaced for disposal in the WIPP. A 
lower limit might be specified for gas-gettering waste components, and 
an upper limit might be specified for cellulosics. The final rule 
requires that these upper and lower limits be established based on the 
total inventory proposed for disposal such that the results of a 
performance assessment will comply with the containment requirements of 
40 CFR 191.13 when these values are used.
    Performance assessments and compliance assessments must use the 
values for each waste characteristic as each would exist in the 
disposal system assuming that an amount of each waste component, equal 
to that component's upper or lower limit, as appropriate, were emplaced 
in the WIPP. As waste is emplaced in the WIPP, a running total must be 
kept of each waste component. The final rule requires that the quantity 
of each waste component that has been emplaced in the repository shall 
not cause the upper limits to be exceeded or, as appropriate, shall not 
preclude the total emplaced quantity of any waste component from 
eventually reaching its lower limit. Compliance with the lower limits 
shall be demonstrated by DOE using information on the waste loading 
scheme, the total amount of that waste component that has been emplaced 
in the disposal system to date, the total amount of that waste 
component listed in the total waste inventory described in the current 
compliance application, and the amount of that waste component that 
still has yet to be generated. DOE must establish a system of controls 
to verify that this requirement will be met and shall submit 
documentation demonstrating this with any compliance application.
    Section 194.24 also requires that performance assessments and 
compliance assessments shall be conducted in accordance with the waste 
loading procedures and schemes that will be employed. If a waste 
loading scheme is not included in the compliance application, the 
performance assessments and compliance assessments must assume that the 
containers of waste are randomly emplaced in the WIPP. Thus, for 
example, DOE shall not assume that the waste components and 
characteristics are evenly distributed throughout the repository unless 
a proposed loading scheme that would cause this to occur has been 
included in the current compliance application.
    The final rule extends the requirements of Sec. 194.22, on quality 
assurance, to process knowledge acquired and used during waste 
characterization activities. The final rule specifies that the total 
inventory of waste proposed for disposal in the WIPP must comply with 
the limitations on transuranic waste found in the WIPP Land Withdrawal 
Act. The final rule enables the Administrator to use audits and 
inspections to verify compliance with the waste characterization 
section.
    Section 194.25 of the final rule specifies requirements on future 
state assumptions. The Agency recognizes the inherently conjectural 
nature of specifications on future states and wishes to minimize such 
speculation in compliance applications. The Agency has found no 
acceptable methodology that could make reliable predictions of the 
future state of society, science, languages or other characteristics of 
future mankind. The Agency does believe that established scientific 
methods could make plausible predictions regarding the future state of 
three classes of natural processes, 

[[Page 5228]]
namely geologic, hydrogeologic and climatic conditions. Hence, the 
final rule requires that performance assessments and compliance 
assessments shall include dynamic analyses of geologic, hydrogeologic 
and climatic processes and events that will evolve over the 10,000-year 
regulatory time frame. DOE shall assume that all other present day 
conditions will exist in their present state for the entire 10,000-year 
regulatory time frame.
    Section 194.26 sets requirements that apply to expert judgment. 
Typically, expert judgment is used to elicit two types of information: 
(1) Numerical values for parameters (variables) which are measurable 
only by experiments that cannot be conducted due to limitations of 
time, money and physical situation; and (2) essentially unknowable 
information, such as which features should be incorporated into passive 
institutional controls that will deter human intrusion into the 
repository. Quality assurance must be applied to expert judgment to 
verify that the procedures for conducting and documenting the expert 
elicitation have been followed. The final rule prohibits expert 
judgment from being used in place of experimental data unless DOE can 
provide a justification explaining why the necessary experiments could 
not be conducted. Expert judgment may substitute for experimental data 
in those instances where limitations of time, resources or physical 
setting would have precluded the successful and timely collection of 
data.
    The compliance application must provide documentation which 
demonstrates that the experts have the necessary qualifications for 
addressing the questions and issues put before them. Compliance 
applications must explain the connection between the question posed to 
the expert panel and the manner in which the final report of the panel 
is used in the compliance application. These requirements have been 
included to prevent any misuse of expert judgment as might result from 
the use of the results of one elicitation process in answer to a new 
and separate question that was not posed to the experts and for which, 
if asked, the experts might have provided a different answer.
    The final rule places requirements on the composition of the expert 
panel, including the fraction of panel members who are not employed by 
DOE. At least two-thirds of the experts sitting on an expert panel 
shall not be employed directly by DOE or its contractors. University 
professors with grants from DOE for research not related to the WIPP 
will not be considered employees or contractors of DOE, nor will the 
New Mexico Environmental Evaluation Group and the National Academy of 
Sciences' Board on Radioactive Waste Management and WIPP Panel. In 
exceptional instances, DOE may use as few as one-third non-DOE 
employees if a sufficient number of non-DOE employees cannot be found. 
DOE must submit documentation which demonstrates that a sufficient 
number of non-DOE experts were not available. In the proposed rule, the 
Agency had set this minimum at one-half of the expert panel's 
membership. However, because of the pervasive effort of DOE in the 
fields of highly radioactive waste disposal and actinide chemistry, the 
Agency has lessened this requirement in the final rule in striving to 
balance the importance of technical expertise with the need for the 
advice to be impartial.
    The section on expert judgment requires that the public be given 
the opportunity to present information to the expert panel to allow the 
public's views to be incorporated in the expert judgment process. This 
requirement will help prevent an inappropriately narrow spectrum of 
background information from being presented to the experts which might 
have slanted the outcome of the elicitation process. This section also 
requires that the elicitation process be well documented so as to 
demonstrate a logical progression from the first statement of the issue 
given to the panel members to the combination and presentation in the 
final report of the elicited results.
    Section 194.27, peer review, has been revised in the final rule. 
The rationale for these changes is discussed in the section of the 
supplementary information, ``Principal changes in the final rule.'' 
Given that decisions in the field of highly radioactive waste disposal 
are inherently first-of-a-kind, the Agency is requiring peer review so 
that others working in the field can confirm the adequacy of these 
decisions and interpretations. The final rule requires DOE to conduct 
peer review of three specific elements of the WIPP program. In 
specific, the Agency has required peer review of the conceptual models 
that DOE selects and develops, waste characterization assessments and 
the study of engineered barriers. The requirement for peer review of 
conceptual models will enrich DOE's process of selecting and developing 
conceptual models with a broad spectrum of scientific viewpoints. Waste 
characterization is a field in which many new and precedent-setting 
techniques will be employed in areas in which no standardized practice 
exists. Peer review of waste characterization is indicated due to the 
importance of a knowledge of the physical, chemical and radiological 
state of the waste in predictions of the long term performance of the 
disposal system. This section, Sec. 194.27, requires peer review to be 
conducted of the study of engineered barriers so as to ensure that the 
best possible information is provided to DOE on the selection of 
engineered barriers. Additionally, this section requires compliance 
applications to include documentation of any peer review activities 
that DOE may have conducted apart from those required by this rule, 
including those activities which are similar to peer review, such as 
the reviews conducted by the WIPP Panel of the National Academy of 
Sciences.
    The Agency is requiring that peer review which occurs subsequent to 
the promulgation of today's action must be conducted according to the 
guidelines of NUREG-1297. The final rule incorporates this publication 
by reference, as specified in Sec. 194.5. The specific requirements in 
NUREG-1297 that discuss for which activities peer review should be 
conducted do not apply, nor do they supersede the requirements of the 
final rule. Peer review which has been conducted prior to today's 
action must be documented in compliance applications. Such past peer 
review activities must conform to either NUREG-1297 or to an alternate 
set of criterion which are substantially equivalent in effect to NUREG-
1297 and which have been approved by the Administrator.
    Sections 194.31 through 194.34 of the final rule implement the 
numerical containment requirements of 40 CFR 191.13. Section 194.31, 
which provides instructions for setting the release limits of appendix 
A of 40 CFR part 191, has been revised from the proposed rule. The 
rationale for this change is explained in the section, ``Principal 
changes in the final rule.'' Section 194.31 now specifies that the 
release limits are to be determined based on the total activity, in 
curies, of transuranic waste present at the time of disposal (as 
defined in 40 CFR 191.2). If the activity of a waste container is 
assayed prior to this time, then the known rates of decay for the 
radionuclides in the container should be used to calculate the activity 
of the waste as it will exist at the anticipated time of disposal.
    Section 194.32 stipulates that performance assessments shall 
include both natural and man-made processes and events which can have 
an effect on the disposal system. Performance assessments need not 
include those processes and events which have a 

[[Page 5229]]
probability of less than 1 in 10,000 of occurring during the 10,000-
year regulatory time frame. For the purposes of this screening 
requirement, processes and events must be analyzed in the most general 
formulation possible; for example, the probability of dissolution must 
be set equal to the probability of all types of dissolution occurring 
anywhere in the Delaware Basin during the regulatory time frame. 
Performance assessments should, however, conduct separate analyses of 
the different dissolution fronts which occur in the Delaware Basin so 
as to account for the different hydrogeologic characteristics of each.
    With respect to man-made processes and events, performance 
assessments must include the effects of drilling events and excavation 
mining. Some natural resources in the vicinity of the WIPP can be 
extracted by mining. These natural resources lie within the geologic 
formations found at shallower depths than the tunnels and shafts of the 
repository and do not lie vertically above the repository. Were mining 
of these resources to occur, this could alter the hydrologic properties 
of overlying formations--including the most transmissive layer in the 
disposal system, the Culebra dolomite--so as to either increase or 
decrease ground-water travel times to the accessible environment. For 
the purposes of modeling these hydrologic properties, this change can 
be well represented by making corresponding changes in the values for 
the hydraulic conductivity. The Agency has conducted a review of the 
data and scientific literature discussing the effects mining can induce 
in the hydrologic properties of a formation. Based on its review of 
available information, the Agency expects that mining can, in some 
instances, increase the hydraulic conductivity of overlying formations 
by as much as a factor of 1,000, although smaller or even negligible 
changes can also be expected to occur. Thus, the final rule requires 
DOE to consider the effects of mining in performance assessments. In 
order to consider the effects of mining in performance assessments, DOE 
may use the location-specific values of hydraulic conductivity, 
established for the different spatial locations within the Culebra 
dolomite, and treat them as sampled parameters with each having a range 
of values varying between unchanged and increased 1,000-fold relative 
to the value that would exist in the absence of mining.
    The Agency recognizes that other numerical changes to the hydraulic 
conductivity values may be more appropriate for use in representing the 
effects of mining. Compliance applications must include a discussion of 
the rationale and experimental data which support the hydraulic 
conductivity values chosen and the effects of mining on the range of 
these values. The Agency further recognizes that some parameter other 
than hydraulic conductivity might be demonstrated to incorporate, 
equally or perhaps better, the potential effects of mining in 
performance assessments. DOE may elect to use another parameter, 
provided that DOE can demonstrate that the use of this other parameter 
is equally or more appropriate than hydraulic conductivity in 
reflecting the potential effects of mining on the disposal system. 
Pursuant to Sec. 194.34 of the final rule, performance assessments must 
randomly sample across the full range of values that have been 
established for all uncertain variables, including the hydraulic 
conductivity of the Culebra dolomite established as discussed above.
    The final rule specifies those assumptions and methods that shall 
be used in performance assessments to account for the effects of 
mining. As with drilling, the historical record of the past 100 years' 
mining activity in the Delaware Basin provides a reasonable basis for 
predicting the nature of future mining activity. Accordingly, the 
Agency examined the records of past mining of mineral resources in the 
Delaware Basin, using data supplied by the U.S. Bureau of Land 
Management. The Agency found that the areal extent of mining in the 
immediate vicinity of WIPP over the past 100 years covered roughly one 
percent of the land area of the entire Delaware Basin and used this 
information to predict the likelihood that a mining event would occur 
in succeeding centuries. Accordingly, the final rule requires 
performance assessments to assume that, in each century after closure 
of the repository, there will be a 1 in 100 chance that a single mining 
event will occur within the controlled area. As explained later in this 
section, the assumed mining event would remove all of the existing 
mineral deposits lying within the controlled area that are of similar 
quality and type to those minerals currently extracted in the Delaware 
Basin. For each century during the regulatory time frame, performance 
assessments should determine whether this mining event will occur, 
based on the 1 in 100 probability, proceeding one century at a time 
from the start of the 10,000-year period. If a positive determination 
is made, then performance assessments must assume that the single 
mining event occurs at the start of that century and further assume 
that no mining will occur thereafter. The Department may elect to use 
an alternate method for calculating the point in time at which mining 
will occur, provided that such method would not, on average, predict 
that mining will occur at times later than those calculated using the 
method in the final rule.
    The final rule specifies that mining should be assumed to occur 
within the controlled area, with the size and shape of the mine 
conforming to existing mineral deposits that are similar in type and 
quality to those extracted in the Delaware Basin. The Agency based this 
requirement on a consideration of the physical nature of mining 
activities. First, the Agency assumed that the size and shape of a mine 
will be dictated by the size and shape of the mineral deposits that are 
to be extracted with no two mines being alike. The mineral deposits 
that will be mined in the future may consist of minerals of current 
economic interest, or of materials not useful or valuable in present-
day terms. Without knowledge of what these future resources might be, 
any attempt to predict the size and shape of the associated mineral 
deposits would be speculative, as would any attempt to determine the 
size and shape of the mines used to extract them. The Agency further 
recognized that individual mines are of highly irregular shape and 
there is every reason to believe that deposits of minerals that are 
mined in the future will also vary in size and be highly irregular in 
shape. The Agency believes that no logical mathematical scheme exists 
that could be used to predict the potentially wide variety of sizes and 
highly irregular shapes. In light of the speculativeness and 
mathematical difficulty, the Agency has chosen to use existing mineral 
deposits as ``stand-ins'' to be used to determine the size and shape of 
the unknown mineral deposits that might be mined in the future. Thus, 
the final rule requires performance assessments to assume that all the 
presently known mineral resources lying within the controlled area will 
be extracted at the single point in time determined by the method in 
the final rule, discussed above. No further mining will be assumed to 
occur, since the available mineral deposits will have been depleted. 
The type of minerals that shall be assumed to be extracted are those 
mineral deposits that are similar in quality and type to those that are 
currently extracted in the Delaware Basin.

[[Page 5230]]

    Performance assessments may assume that the likelihood of mining 
may be decreased by PICs and active institutional controls, to the 
extent that can be justified in the compliance application and to a 
degree identical to that assumed for drilling. The requirements of 
sections 41 and 43 of the final rule therefore will apply to the 
consideration of mining in performance assessments.
    Section 194.33, consideration of drilling events, has been revised 
since the proposed rule. The rationale for the new provisions is 
explained in the section below, entitled ``Principle changes in the 
final rule.'' Section 194.2 includes two definitions relevant to the 
consideration of drilling events. ``Deep drilling'' denotes those 
drilling events that reach or exceed a depth 2150 feet below the 
surface where such drilling occurred. ``Shallow drilling'' denotes 
those drilling events that do not reach to a depth 2150 feet below the 
surface where such drilling occurred. Sections 194.32 and 194.33 of the 
final rule require that performance assessments include the effects of 
both deep drilling and shallow drilling, whether such drilling has 
occurred prior to the time at which the compliance application is 
prepared, can be reasonably expected to occur in the near future based 
on existing leases, or can be expected to occur in the future during 
the 10,000-year regulatory time frame.
    The future rates of both deep drilling and shallow drilling shall 
each be set equal to the rate at which deep drilling and shallow 
drilling, respectively, have occurred in the Delaware Basin during the 
100-year period immediately prior to the time the current compliance 
application is prepared. The Delaware Basin is defined, in Sec. 194.2, 
to be the surface and subsurface features which lie inside the 
innermost edge of the Capitan Reef and, where the Capitan Reef is 
absent to the south, the features which lie to the north of a straight 
line connecting the southeastern point of the Davis Mountains and the 
southwestern point of the Glass Mountains.
    Performance assessments must add together all releases of 
radionuclides which are predicted to occur during the 10,000-year 
regulatory time frame to arrive at the cumulative releases from the 
disposal systems; the containment requirements of 40 CFR 191.13 apply 
to cumulative releases of waste and not the individual events which 
cause the releases. Further, boreholes drilled after closure of the 
repository shall be assumed to affect the properties of the disposal 
system for the remainder of the 10,000-year regulatory time frame. When 
analyzing the effects of all later boreholes, performance assessments 
must account for the effect that these existing boreholes will have had 
on the hydrogeologic properties of the disposal system and on the 
creation of new pathways for releases. In today's final rule, the 
Agency requires that performance assessments and compliance assessments 
must include--among other processes and events--the effects on the 
disposal system of drilling and all types of resource extraction 
activities, including inter alia solution mining and fluid injection, 
that will have occurred prior to the time at which the compliance 
application is prepared or that may be expected to occur soon afterward 
based on existing plans and leases for drilling.
    In the case of shallow drilling only, DOE may, if justified, derive 
the drilling rate from the historical rates of shallow drilling for 
only those resources in the Delaware Basin which are of similar quality 
and type to those found in the controlled area. For example, if only 
non-potable water can be found within the controlled area, then the 
rate of drilling for water may be set equal to the historical rate of 
drilling for non-potable water in the Delaware Basin over the past 100 
years.
    Section 194.33 requires performance assessments to make several 
specific assumptions about future deep drilling and shallow drilling. 
These assumptions include that drilling will occur randomly in space 
and time and may occur at different rates for each resource, and that 
drilling practices will remain as those of today and may vary depending 
on the resource. Performance assessments should assume that the 
permeability of sealed boreholes will be affected by natural processes, 
and should assume that the fraction of boreholes that will be sealed by 
man equals the fraction of boreholes which are currently sealed in the 
Delaware Basin.
    The Agency recognizes that drill operators currently employ 
different techniques in the exploration and development of each 
resource. Hence, performance assessments shall conduct a separate 
analysis of the effects that future drilling for each different 
resource--the act creating a borehole--will have on the disposal 
system. Each separate analysis should set the future rate of drilling 
for the particular resource equal to the historical rate at which that 
resource has been drilled for in the Delaware Basin during the past 100 
years. The analyses of the consequences of each type of drilling might 
remain conceptually similar, but vary with regard to assumptions made 
on size and depth of boreholes, quantity of drilling fluid used, or any 
other characteristic specific to that type of resource. Analyses of the 
consequences of future drilling events may be confined only to the 
drilling activity and the subsequent effect of the borehole's presence 
and need not include an analysis of extraction and recovery activities 
which would occur subsequently.
    In determining the drilling rate or the amount of waste released 
from such drilling, performance assessments should not assume that 
drill operators would detect the waste and then cease the current 
drilling operations or otherwise mitigate the consequences of their 
actions. Similarly, drill operators should not be assumed to cease 
further exploration and development of resources as a result of the 
driller's detecting the waste.
    Section 194.34 requires that the results of performance assessments 
be expressed as complementary, cumulative distributions functions 
(CCDFs). The CCDFs shall be generated using random sampling techniques 
which draw upon the full range of values established for each uncertain 
parameter, which may include physical and chemical waste 
characteristics. Parameters of lesser sensitivity in performance 
assessments may be held constant, provided that such constant values 
can be justified as sufficiently conservative. The quantitative 
requirements of this section state that there must be a 0.95 
probability that, at values of cumulative release of 1 and 10, the 
maximum CCDF generated exceeds the 99th percentile of the population of 
CCDFs. The values of cumulative release are calculated according to 
Note 6 of Table 1, Appendix A of 40 CFR part 191. Additionally, the 
mean of the population of CCDFs must meet the requirements of section 
13 of 40 CFR part 191 with at least a 95 percent level of statistical 
confidence. In demonstrating compliance with these standards, the 
infinite number of CCDFs denoted by the term, population of CCDFs, need 
not be generated. By generating only a finite number of CCDFs and 
applying statistical theory, the relationships between the finite group 
of computer-generated CCDFs, the population of CCDFs and the numerical 
requirements of this section can be established.
    Subpart C of today's action also implements the six assurance 
requirements of section 14 of 40 CFR part 191. The assurance 
requirements were included in the disposal regulations to provide the 
confidence needed for long-term compliance with 

[[Page 5231]]
the containment requirements of section 13 of 40 CFR part 191.
    Section 194.41 of today's final rule requires a description of the 
active institutional controls that will be implemented at the WIPP. 
This description shall be sufficient to support any assumptions made on 
their effectiveness in performance assessments and compliance 
assessments. However, in no case shall active institutional controls be 
assumed to be in effect for more than 100 years after the time of 
disposal.
    Section 194.42 of the final rule, monitoring, has been revised from 
the proposed rule. The rationale for these changes is provided below, 
in ``Principal changes in the final rule.'' Any unpredicted detection 
of movement of radionuclides toward the accessible environment would be 
cause for concern that a release of waste in excess of what is 
permitted under the disposal regulations is likely to occur. This 
section specifies requirements for monitoring in both the pre-closure 
and post-closure periods, as necessary to verify that the WIPP complies 
with the disposal regulations. In the event that an initial 
certification has been granted, the results of monitoring during the 
pre-closure period will be used by the Agency to verify that the 
information contained in the initial compliance application has 
remained true and accurate; this information would be used by the 
Agency during both the initial five-year period after the start of 
emplacement of waste and during the reviews made for the periodic re-
certifications of compliance. The final rule has included a provision 
which requires DOE to conduct an analysis of parameters that will be 
used in the development of pre-closure and post-closure monitoring 
plans. The analysis should consider the importance of the parameter 
with respect to both the containment of waste in the disposal system 
and the practicability of performing such monitoring, including its 
technical feasibility and the cost.
    Section 194.43 implements the assurance requirements on passive 
institutional controls (PICs). The final rule specifies that DOE must 
include a detailed description of the PICs that will be employed and 
lists the information that the PICs are required, at a minimum, to 
convey. Additionally, the final rule allows the Department to reduce 
the likelihood of future human intrusion that is used in performance 
assessments by a proposed amount corresponding to the predicted effect 
of PICs. See generally 47 FR 58196, 58201 (Dec. 29, 1982); 50 FR 38066, 
38080 (Sept. 19, 1985). Thus, DOE may propose in its compliance 
application to reduce the rate of human intrusion by a fractional 
amount, extending over a technically supportable period of time, and 
must justify this using the plans for the implementation for PICs and 
associated evidence of their effectiveness. This credit may take the 
form of a constant reduction in the rate of human intrusion lasting 
several hundred years or may be a reduction in the rate which tapers 
off in size over several hundred years. Such credit cannot be assumed 
to eliminate completely the possibility of human intrusion, even for a 
short period of time after the active institutional controls at the 
WIPP are assumed to be ineffective. During the rulemaking on 
certification, the Agency could determine that the description of the 
PICs does not adequately justify the degree of proposed credit assumed 
by DOE and therefore disallow some or all of the credit proposed by DOE 
in the compliance application.
    Having considered the public comments regarding PICs, the Agency 
believes that such credit could be no more than approximately 700 years 
past the time of disposal. Thus, the final rule limits to several 
hundred years the amount of credit that EPA may grant for PICs. Any 
determination that a specific numerical credit would be appropriate for 
a much longer period of time would be unduly speculative and therefore 
inappropriate.
    Today's action should not be construed to approve or award any 
amount of credit for PICs, as such a determination cannot be made in 
advance of the rulemaking on certification of compliance. The Agency is 
deferring any decisions on credit for PICs planned for the WIPP until 
such time as the compliance application has been received and a 
rulemaking for certification has been completed. This restates the 
Agency's prior assertion, made in the promulgation of the final 
disposal regulations in 1985:

    Specific judgments about the chances and consequences of 
intrusion should be made by the implementing agencies (EPA for the 
WIPP) when more information about particular disposal sites and 
passive control systems is available. See 50 FR 38080.
    In developing this section of the final rule, 40 CFR 194.43, the 
Agency considered the treatment of PICs in the disposal regulations, 
the input received in public forums and the public comments received on 
the proposed rule. The disposal regulations established the foundation 
of today's action on the role of passive institutional controls. 
Section 191.14(c) of the disposal regulations require that disposal 
sites be designated by the most permanent markers, records, and other 
passive institutional controls practicable to indicate the dangers of 
the wastes and their location. In adopting these provisions of the 
disposal regulations, the Agency expressly assumed that passive 
institutional controls ``should reduce the chance of inadvertent 
intrusion compared to the likelihood if no markers and records were in 
place.'' See 50 FR 38080. With respect to performance assessments, the 
Agency examined whether PICs should be taken into account to some 
degree when estimating the likelihood of inadvertent human intrusion 
and concluded that ``a limited role for passive institutional controls 
would be appropriate when projecting the long-term performance of mined 
geologic repositories to judge compliance with (the containment 
requirements of 40 CFR part 191).'' At the same time, the Agency 
explicitly determined that PICs should not be assumed to completely 
prevent the possibility of inadvertent human intrusion. See 50 FR 
38080.

    In the proposed rule, 40 CFR part 194, the Agency specifically 
requested comment on the requirements on PICs. The Agency conducted a 
public discussion of PICs in a technical workshop in Washington, DC, in 
February, 1995. In September, 1995, EPA consulted the WIPP Review 
Committee of the National Advisory Council for Environmental Policy and 
Technology (NACEPT) on three issues, including PICs, in a public 
meeting in New Mexico. See 60 FR 43470-43471 (Aug. 21, 1995). The 
Committee agreed that PICs would be likely to decrease the likelihood 
of inadvertent intrusion into the WIPP but expressed concern about the 
availability of a rigorous method by which to determine the appropriate 
reduction due to PICs in the future likelihood of inadvertent 
intrusion. Some members of the Committee stated that, if credit were to 
be approved, the size of the credit should not reflect that PICs would 
be effective for more than a small fraction of the 10,000 year 
regulatory time frame.
    Many public comments received on the proposed rule expressed 
skepticism about whether PICs would be effective for the entire 10,000 
year regulatory time frame or for even a fraction thereof. Other 
comments stated the belief that civilizations living 1,000 to 10,000 
years from now would, in fact, be capable of understanding the records 
and markers that were left behind at the WIPP. Still other comments 
asserted that, in allowing for the possibility of credit, the Agency 
had revised the intent of the 

[[Page 5232]]
assurance requirements, one of which being the requirement for the 
implementation of PICs. Specifically, comments stated that the 
assurance requirements were not intended to be considered when 
determining compliance with the numerical containment requirements 
found at 40 CFR 191.13.
    The provisions of the final rule entertaining possible credit for 
PICs are within EPA's authority. In adopting the assurance requirements 
in 40 CFR part 191, EPA expressly limited the credit for active 
institutional controls. EPA prohibited performance assessments from 
considering any contributions from active institutional controls for 
more than 100 years after disposal. See 40 CFR 191.14(a). EPA declined 
to similarly limit the effect of PICs in reducing the likelihood of 
human intrusion. 50 FR 38080. By contrast, EPA contemplated that PICs 
may discourage the likelihood of human intrusion for some period of 
time longer than active institutional controls. However, EPA indicated 
that it generally believed it was inappropriate to rely on PICs for 
extended periods of time. See 50 FR 38080. Based on the public comments 
and consistent with EPA's general view that it is inappropriate to rely 
on PICs for very long periods of time, EPA is constraining in the final 
rule the length of time that EPA could consider granting credit for 
PICs to several hundred years. EPA's decision about the actual efficacy 
of PICs proposed for the WIPP will be based on DOE's compliance 
application but may not exceed this limit.
    Further, the degree to which PICs might reduce the future drilling 
rate can be reliably determined only through informed judgment. The 
Agency agrees with the NACEPT Committee that no rigorous and non-
speculative method is available to determine the appropriate amount of 
credit for PICs. Thus, DOE's proposed reduction in the likelihood of 
human intrusion due to PICs would probably be conducted through an 
expert judgment process that considers the specific PICs to be 
implemented at the WIPP by DOE. The expert judgment performed 
specifically to determine the effect of PICs must satisfy the 
requirements of section 26 of today's action, on expert judgment. For 
example, this section requires that the range of professions 
represented on the expert panel must cover the complete spectrum of 
knowledge that will be necessary to address the question given to the 
experts. In the case of PICs, the Agency would expect that experts 
would be selected not only from professions such as archeology, but 
from professions which are concerned with the exploration and 
development of natural resources such as oil and natural gas.
    Section 194.44 of the final rule implements the assurance 
requirement on engineered barriers. This section requires that DOE 
conduct a study of available options for engineered barriers at the 
WIPP and submit this study and evidence of its use with the compliance 
application. Consistent with the requirement, found at 40 CFR 191.13, 
that DOE analyze the performance of the complete disposal system, any 
engineered barriers that are ultimately implemented at the WIPP must be 
considered by the Department and, ultimately, EPA when evaluating 
compliance with both the containment requirements of 40 CFR 191.13 and 
the assurance requirement of 40 CFR 191.14(d).
    Section 194.45 implements the assurance requirement that the 
disposal system be sited such that the benefits of the natural barriers 
of the disposal system compensate for the increased probability of 
disruptions of the disposal system resulting from exploration and 
development of nearby natural resources. This assurance requirement 
will be met if performance assessments comply with the numerical 
containment requirements of section 13 of 40 CFR part 191, provided 
that the potential effects of human intrusion at the WIPP will have 
been appropriately considered.
    Section 194.46 implements the assurance requirement that the 
removal of waste remain possible for a reasonable period of time after 
disposal. The final rule has eliminated the requirement for the 
development of a plan for the removal of waste which had been contained 
in the proposed rule. In place of the requirement for a removal plan, 
EPA is including in the final rule a requirement that DOE perform an 
evaluation to demonstrate that the removal of waste will remain 
feasible for a reasonable period of time after disposal.
    Sections 194.51 through 194.55 provide the criteria that must be 
met in order to demonstrate that the WIPP will comply with the ground-
water requirements of subpart C of 40 CFR part 191 and the individual 
protection requirements of section 15 of 40 CFR part 191. Section 
194.51 and 194.52 specify the assumptions that must be incorporated 
into compliance assessments in the analyses of annual committed 
effective dose equivalent received by individuals, used in determining 
compliance with the individual protection requirements. Compliance 
assessments should separately analyze the doses received by individuals 
from each pathway. Compliance assessments should assume that the 
protected individual resides at the single geographic point where the 
maximum dose would be received, calculated by the sum of all pathways.
    Section 194.53 lists the assumptions that compliance assessments 
must include when analyzing the doses received through underground 
sources of drinking water (USDWs), used in determining compliance with 
subpart C of 40 CFR part 191. Doses can be received from any USDW 
outside of the controlled area, provided that a connective pathway 
could be expected to be established via ground-water travel between the 
disposal system and that USDW. The Agency expects that USDWs which lie 
closer to the disposal system will have a greater chance of being 
affected by releases of waste. The Agency therefore does not intend for 
DOE to expend resources analyzing doses received from USDWs located 
large distances from the disposal system. The calculations of doses 
received from USDWs should assume that drinking water is withdrawn 
directly from the contaminated USDW and consumed at a rate of two 
liters per day.
    Section 194.54 defines the scope of compliance assessments. 
Compliance assessments should be conducted of the undisturbed 
performance of the disposal system, which, by the definition in section 
12 of 40 CFR part 191, denotes that the disposal system is not 
disrupted by human intrusion or the occurrence of unlikely natural 
events. Section 194.55 requires that compliance assessments include 
calculations or ``estimates'' of three quantities: (1) The annual 
committed effective dose received from all pathways, an analysis which 
corresponds to the requirements of section 15 of 40 CFR part 191; (2) 
dose equivalents received from USDWs; and (3) concentrations of 
radionuclides present in USDWs, the latter two of which correspond to 
subpart C of 40 CFR part 191. To generate a ``range'' of estimates, 
compliance assessments must make repeated calculations, with each 
iteration employing a different set of randomly selected values for 
each uncertain parameter. Parameters of lesser sensitivity in 
compliance assessments may be held constant, provided that these values 
can be justified as being sufficiently conservative. The final rule 
requires that there be a 0.95 probability that the maximum estimate of 
each set so generated exceeds the 99th percentile of 

[[Page 5233]]
the population of estimates. The mean and the median of the population 
of each set of estimates must meet the requirements of section 15 and 
subpart C of 40 CFR part 191, as applicable, with at least a 95 percent 
level of statistical confidence.

Subpart D: Public Participation

    Subpart D of today's action establishes procedures that EPA will 
use to involve the public in the decisions on certification and re-
certification and requires EPA to publish notices of its actions in the 
Federal Register. Subpart D includes new provisions which require the 
Agency to involve the public in decisions to modify or revoke a 
certification. Section 194.65 requires that EPA publish a notice in the 
Federal Register announcing the Agency's proposed decision on the 
modification or revocation of the certification. The notice of proposed 
rulemaking must solicit comment on the proposed decision. Section 
194.66 requires the Administrator to publish a notice of final 
rulemaking in the Federal Register, announcing whether the Agency has 
revoked, modified or taken no action to change the certification. 
Section 194.67 requires that EPA maintain a public docket with all 
information used in making the decisions on certification, re-
certification, and modification and revocation of the certification.

Principal Changes in the Final Rule

    In addition to the principal changes described below, today's 
action contains other minor modifications to the proposed rule. Further 
discussion of the rationale and information supporting significant 
changes found in today's action is contained in the Background 
Information Document and the Response to Comments, which may obtained 
as explained in the start of this notice.

Scope of Performance Assessments and Consideration of Drilling Events

    In Secs. 194.32 and 194.33 of the final rule, the Agency has 
provided further clarification on which activities fall within the 
scope of human intrusion. (Section 194.33 had been titled 
``Consideration of human initiated processes and events'' in the 
proposed rule.) The final rule requires that the effects of deep 
drilling, shallow drilling and excavation mining must be included in 
performance assessments. In the proposed rule, the Agency had excluded 
excavation mining from consideration (60 FR 5774; January 30, 1995). 
The Agency received several public comments recommending that 
performance assessments should be required to include the effects of 
future mining during the regulatory time frame in order to account for 
the presence of potash in the vicinity of the repository. The Agency 
has re-evaluated the proposed exclusion of mining, in light of these 
public comments. The Agency believes that, while there is uncertainty 
surrounding the potential effects of mining, mining could nonetheless 
alter the hydrogeologic properties of certain formations that lie at 
shallower depths than the mined portion of the repository. Thus, the 
final rule requires performance assessments to consider the possible 
effects of excavation mining on the disposal system. As discussed 
previously, DOE may address this requirement by considering the changes 
that mining would induce in the hydraulic conductivity of the disposal 
system. Additionally, the requirements of the final rule specify the 
method for determining the size and shape, location and point in time 
at which mining occurs. The Agency specified these items to provide 
clarification on how mining should be considered and to avoid unbounded 
speculation that would result from the high uncertainty regarding 
whether, where and how mining would occur in the Land Withdrawal area. 
EPA's decision was based on a desire to include mining in performance 
assessment in a realistic fashion without recourse to such 
unconstrained speculation. To this end, the final rule has specified 
that mining will continue at the same rate as it has over the past 100 
years, that the area to be mined is the area that contains mineral 
deposits of similar type and quality to those that are currently 
extracted in the Delaware Basin, and that only the major impacts on the 
disposal system of mining need be considered. EPA believes this is 
consistent with the future states assumptions of section 25 as they 
apply to the future activities of man.
    The Agency has added definitions of deep drilling and shallow 
drilling in Sec. 194.2. Both types of drilling shall include 
exploratory and developmental wells. The addition of these definitions 
was prompted by commenters who noted that the definitions of human 
intrusion and ``human activity'' that were in the proposed rule had 
caused confusion by distinguishing their meanings on the basis of the 
depth at which drilling occurs. In the final rule, the Agency has 
removed these definitions from the final rule and instead makes use of 
the defined terms, deep drilling and shallow drilling in order to 
provide greater clarity.
    Commenters also requested that the final rule require analysis of 
disposal of brine that accumulates during the extraction of oil and of 
secondary recovery of oil performed using water-flood injection. The 
Agency considered this comment in the larger context of the nature of 
potential human intrusions during the next 10,000 years and what 
assumptions might hold true during that time. The Agency believes that 
no one resource will last for the entire 10,000 years and therefore has 
concluded that the techniques for extraction of any one resource--such 
as water-flood injection for oil recovery--are unlikely to be in use 
during much of the 10,000-year regulatory time frame. With respect to 
drilling rates, the Agency reasoned that while the resources drilled 
for today may not be the same as those drilled for in the future, the 
present rates at which these boreholes are drilled can nonetheless 
provide an estimate of the future rate at which boreholes will be 
drilled. The Agency does expect that drilling will never completely 
cease; while some resources may become depleted over time and, while 
the rate of extraction of those resources may decrease, the increased 
rate of drilling for newly discovered resources will compensate for 
this decline. In effect, when used for the purpose of determining the 
future drilling rate, today's drilling activities act as surrogates for 
the unknown resources that will be drilled for in the future. With 
respect to the consequence and releases due to future drilling, 
present-day drilling activities provide the only available basis for 
making assumptions in performance assessments. Future extraction of any 
resource will likely necessitate drilling a hole for its recovery. 
However, because there is doubt as to whether the resources associated 
with today's specialized extraction techniques and fluid injection will 
remain available for 10,000 years, the final rule does not require that 
performance assessments assume that such extraction activities will 
occur during the entire regulatory time frame, but does require that 
the effects of the drilling events themselves be analyzed. The 
techniques include, for example, water-flood injection for secondary 
recovery of oil, solution mining and the disposal by injection of brine 
accumulated during recovery of oil.
    The Agency recognizes, however, that resource extraction and fluid 
injection activities which are currently performed in the Delaware 
Basin can alter the hydrogeologic properties of the initial state of 
the disposal system. The final 

[[Page 5234]]
rule requires that performance assessments and compliance assessments 
analyze the effects of all types of fluid-injection and all boreholes 
which can have an effect on the disposal system and which have been or 
will have been drilled prior to or soon after disposal. These boreholes 
shall be assumed to affect the properties of the disposal system for 
the entire 10,000-year regulatory time frame. Predictions about such 
future activities shall be strictly limited to the expected use of 
existing leases.
    Today's final rule eliminates the proposed cap on the rate of deep 
drilling into the disposal system of 62.5 boreholes per square 
kilometer per 10,000 years as well as the proposed lower limit of 25 
boreholes per square kilometer per 10,000 years. The Agency received 
numerous public comments objecting to the use of upper and lower limits 
on the rate of deep drilling. The Agency has concluded that the rate of 
drilling into the disposal system used in performance assessments 
covering the 10,000-year regulatory time frame should be derived solely 
from the historical record of drilling in the region surrounding the 
WIPP. In the proposed rule, the Agency had specified that the past 50 
years of records on drilling shall be used to establish the rates for 
shallow drilling and deep drilling, the latter being subject to upper 
and lower caps. While developing the final rule, the Agency recognized 
that drilling activity has been at a maximum during the past 50 years, 
whereas during the past 100 years, a broader spectrum of high and low 
drilling rates can be found. In the long-term future, it can be 
expected that the drilling rate will consist of periods of high and low 
drilling activity, which makes the past 100 years a more appropriate 
period for calculating the drilling rate. In addition, more detailed 
examination of the available records in Texas and New Mexico since the 
time of the proposed rule has shown that accurate data on drilling 
activity dates back 100 years, rather than 50 years as was believed 
initially. The final rule therefore specifies that the rates of both 
shallow drilling and deep drilling are to be set based on data from the 
100 year period ending at the time DOE prepares the compliance 
application.
    Today's final rule includes a definition of the term ``Delaware 
Basin,'' used in the regulation to be that area over which the past 
drilling rate is to be averaged in order to establish the rate of 
drilling used in performance assessments. In the proposed rule, the 
Agency had solicited comment on how to define the Delaware Basin. Many 
comments were received, with the bulk of the discussion focusing on 
whether the Capitan Reef should be included in the definition. In 
arriving at the definition in the final rule, the Agency considered the 
geologic and hydrogeologic characteristics of the formations which 
contain the WIPP versus those of the Capitan Reef. The Capitan Reef is 
more permeable to the flow of water and was formed from organic 
material which differs from the salt formations which immediately 
surround the WIPP. The Agency had stated its intention to define the 
Delaware Basin to be the largest contiguous area that has similar 
geologic properties. Because of the differences, noted above, between 
the Capitan Reef and the interior formations, the Agency has chosen to 
define the Delaware Basin to be those surface and subsurface formations 
which lie inside the inner-most edge of the Capitan Reef. Where the 
Capitan Reef is absent to the south, the Delaware Basin includes those 
features which lie to the north of a straight line connecting the 
southeastern point of the Davis Mountains and the southwestern point of 
the Glass Mountains.

Waste Characterization

    Numerous public comments were received on the proposed Sec. 194.24, 
waste characterization. Commenters stated that this section required 
greater clarity in order to be implemented effectively at the WIPP. The 
final rule retains the use of ``waste characteristics'' to provide a 
description of the waste. The term, waste categories, has been 
eliminated in the final rule. The final rule uses the term, ``waste 
components,'' to denote an amount of a type of waste--expressed as a 
volume, mass or weight (or curies, in the case of activity)--such as 
chelating agents and cellulosics. The waste categories in the proposed 
rule were to be established based on the assumption that wastes with 
similar waste characteristics would behave similarly in the disposal 
system. The Agency believes that using instead the term ``waste 
components'' provides a less abstract scheme for classifying waste 
which could be more easily implemented. In particular, the Agency 
believes that, for a given container of waste, DOE could more readily 
identify how much of each waste component is present rather than how 
much of each waste category is present. The final rule requires that 
these limits be established such that the results of performance 
assessments and compliance assessments will comply with the numerical 
requirements of 40 CFR Part 191 when the maximum or minimum values for 
each waste component are used, as appropriate.
    To assist in establishing the waste characteristics and waste 
components and quantitative values of each, the final rule requires 
that compliance applications include an analysis to identify and assess 
the impact on long-term performance of those waste characteristics 
which influence the containment of waste in the disposal system. An 
analysis must also be conducted of waste components to determine which 
of these will influence the waste characteristics identified as having 
an influence on containment. This section of the final rule specifies 
those waste characteristics and waste components which, at a minimum, 
the respective analyses must investigate.

Peer Review

    Section 194.26, peer review, has been narrowed in scope in the 
final rule. The Agency received many public comments stating that the 
requirements on peer review were stated too broadly such that an 
inordinate and unmanageable number of peer reviews would be required. 
Additionally, commenters noted that many of the activities that the 
proposed rule had required to be peer reviewed were subject to specific 
quality assurance requirements under Sec. 194.22. Public comments noted 
that, in this instance, the proposed peer review requirements would be 
redundant with the quality assurance requirements. Such activities 
would include the computer codes and the data used to support all 
models--conceptual, mathematical and numerical--and computer codes.
    The Agency consulted the WIPP Review Committee of NACEPT at the 
September, 1995 meeting and sought its advice on how to address peer 
review. The Committee suggested that peer review of quality assurance 
programs would be unnecessary, since, by requiring DOE to adhere to a 
program that meets the requirements of three sets of ASME's standards, 
today's action would already be sufficient to control the quality 
assurance process. The Agency agrees with both the Committee and with 
similar public comment and has eliminated the requirement for peer 
review of quality assurance programs and plans. The Committee also 
stated that peer review could be used both to insure that analyses use 
the correct model of repository behavior and to evaluate the subjective 
uncertainty in whether the appropriate conceptual model was selected. 
In the case of WIPP, unanimous agreement does not exist on the nature 
of the conceptual models of natural processes such as dissolution 

[[Page 5235]]
which can have an effect on the disposal system. To subject these 
issues to wider scrutiny, the final rule specifies that peer review 
must be conducted of the conceptual models selected and developed by 
DOE.

Application of Release Limits

    Section 194.31 of the final rule specifies that the release limits 
of Appendix A of 40 CFR part 191 shall be determined based on the total 
activity, in curies, of transuranic waste present at the time of 
disposal. Public comment was divided between those who recommended 
setting release limits at 100 years, as in the proposed rule, and those 
who recommended the time of disposal. The Agency solicited the views of 
the WIPP Review Committee of NACEPT on the subject of release limits in 
the meeting held in September, 1995. Some committee members noted that 
radionuclides such as plutonium 238 would quickly decay to less than 
half their original number in under 100 years and thus would not pose a 
threat for more than a small fraction of the 10,000-year regulatory 
time frame. Hence, some members of the committee recommended the option 
of setting the release limits at later times so that the release limits 
would be based on longer-lived radionuclides. Doing so would more 
accurately reflect the long-term hazards presented by the waste.
    Some committee members also recommended that the Agency should base 
its decision on the original intent of the disposal regulations. The 
Agency believes that the disposal regulations were designed to avoid 
the undue influence of short-lived radionuclides on the size of the 
release limits. The disposal regulations accomplished this purpose in 
Appendix A by eliminating the contribution of radionuclides having 
half-lives of less than twenty years. The Agency has therefore chosen 
in the final rule to determine release limits based on the total 
activity, in curies, of transuranic waste present at the time of 
disposal.

Monitoring

    The monitoring requirements have been modified to provide clearer 
direction for the development of a post-closure monitoring plan. 
Several commenters suggested that, by requiring that post-closure 
monitoring be conducted in a manner ``compatible'' with RCRA, DOE might 
be forced to implement two over-lapping monitoring programs in order to 
comply with both RCRA hazardous waste regulations and 40 CFR part 194. 
Other commenters noted that, in the event that RCRA monitoring at the 
WIPP were to be modified or eliminated, the requirement in 40 CFR Part 
194 as proposed would be correspondingly reduced. To provide clearer 
direction on the performance of post-closure monitoring, the Agency has 
made two changes in the final rule. First, to eliminate potential 
overlap, the Agency is requiring that post-closure monitoring be 
required to be ``complementary'' with RCRA, so that information yielded 
by the one monitoring program would not be duplicated by the other. The 
Agency is requiring in the final rule that post-closure monitoring be 
conducted, to the extent practicable when considering technical 
feasibility and cost, of those parameters which are important to the 
containment of waste in the disposal system. Such parameters shall be 
identified in a required analysis that will assess which parameters are 
important to the containment of waste and which therefore should be 
included in post-closure (and pre-closure) monitoring.

Rulemaking Analyses

Executive Order 12866

    Under Executive Order 12866, (58 FR 51,735 October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that this rule is a ``significant regulatory action'' 
because it raises novel policy issues which arise from legal mandates. 
As such, this action was submitted to OMB for review. Changes made in 
response to OMB suggestions or recommendations will be documented in 
the public record.

Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 
U.S.C. 605(b), the Administrator certifies that this rule will not have 
a significant economic impact on a substantial number of small 
entities. Today's final rule sets forth requirements which apply only 
to Federal agencies and the Administrator therefore certifies that no 
small entities will be affected.

Paperwork Reduction Act

    The EPA has determined that this proposed rule contains no 
information collection requirements as defined by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq).

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local and tribal 
governments and the private sector. Today's rule contains no Federal 
mandates (under the regulatory provisions of Title II of the UMRA) for 
State, local or tribal governments or the private sector. The rule 
implements requirements specifically set forth by the Congress in the 
Waste Isolation Pilot Plant Land Withdrawal Act (Pub. L. 102-579).

List of Subjects in 40 CFR Part 194

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

    Dated: February 1, 1996.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, 40 CFR part 194 is added 
as set forth below.

PART 194--CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF 
THE WASTE ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART 
191 DISPOSAL REGULATIONS

Subpart A--General Provisions

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

[[Page 5236]]

194.6  Alternative provisions.
194.7  Effective date.
Subpart B--Compliance Certification and Re-certification Applications
194.11  Completeness and accuracy of compliance applications.
194.12  Submission of compliance applications.
194.13  Submission of reference materials.
194.14  Content of compliance certification application.
194.15  Content of compliance re-certification application(s).
Subpart C--Compliance Certification and Re-certification General 
Requirements

General Requirements

194.21  Inspections.
194.22  Quality assurance.
194.23  Models and computer codes.
194.24  Waste characterization.
194.25  Future state assumptions.
194.26  Expert judgment.
194.27  Peer review.

Containment Requirements

194.31  Application of release limits.
194.32  Scope of performance assessments.
194.33  Consideration of drilling events in performance assessments.
194.34  Results of performance assessments.

Assurance Requirements

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

Individual and Ground-water Protection Requirements

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

Subpart D--Public Participation

194.61  Advance notice of proposed rulemaking for certification.
194.62  Notice of proposed rulemaking for certification.
194.63  Final rule for certification.
194.64  Documentation of continued compliance.
194.65  Notice of proposed rulemaking for modification or 
revocation.
194.66  Final rule for modification or revocation.
194.67  Dockets.

    Authority: The Waste Isolation Pilot Plant Land Withdrawal Act 
of 1992, Pub.L. 102-579, 106 Stat. 4777; Atomic Energy Act of 1954, 
as amended, 42 U.S.C. 2011-2296; Reorganization Plan No. 3 of 1970, 
5 U.S.C. app.1; Nuclear Waste Policy Act of 1982, as amended, 42 
U.S.C. 10101-10270.

Subpart A--General Provisions


Sec. 194.1  Purpose, scope and applicability.

    This part specifies criteria for the certification or any re-
certification, or subsequent actions relating to the terms or 
conditions of certification of the Department of Energy's Waste 
Isolation Pilot Plant's compliance with the disposal regulations found 
at part 191 of this chapter and pursuant to section 8(d)(1) and section 
8(f), respectively, of the WIPP LWA. The compliance certification 
application submitted pursuant to section 8(d)(1) of the WIPP LWA and 
any compliance re-certification application submitted pursuant to 
section 8(f) of the WIPP LWA shall comply with the requirements of this 
part.


Sec. 194.2  Definitions.

    Unless otherwise indicated in this part, all terms have the same 
meaning as in part 191 of this chapter.
    Certification means any action taken by the Administrator pursuant 
to section 8(d)(1) of the WIPP LWA.
    Compliance application(s) means the compliance certification 
application submitted to the Administrator pursuant to section 8(d)(1) 
of the WIPP LWA or any compliance re-certification applications 
submitted to the Administrator pursuant to section 8(f) of the WIPP 
LWA.
    Compliance assessment(s) means the analysis conducted to determine 
compliance with Sec. 191.15, and part 191, subpart C of this chapter.
    Delaware Basin means those surface and subsurface features which 
lie inside the boundary formed to the north, east and west of the 
disposal system by the innermost edge of the Capitan Reef, and formed, 
to the south, by a straight line drawn from the southeastern point of 
the Davis Mountains to the most southwestern point of the Glass 
Mountains.
    Deep drilling means those drilling events in the Delaware Basin 
that reach or exceed a depth of 2,150 feet below the surface relative 
to where such drilling occurred.
    Department means the United States Department of Energy.
    Disposal regulations means part 191, subparts B and C of this 
chapter.
    Management systems review means the qualitative assessment of a 
data collection operation or organization(s) to establish whether the 
prevailing quality management structure, policies, practices, and 
procedures are adequate to ensure that the type and quality of data 
needed are obtained.
    Modification means action(s) taken by the Administrator that alters 
the terms or conditions of certification pursuant to section 8(d)(1) of 
the WIPP LWA. Modification of any certification shall comply with this 
part and part 191 of this chapter.
    Population of CCDFs means all possible complementary, cumulative 
distribution functions (CCDFs) that can be generated from all disposal 
system parameter values used in performance assessments.
    Population of estimates means all possible estimates of radiation 
doses and radionuclide concentrations that can be generated from all 
disposal system parameter values used in compliance assessments.
    Quality assurance means those planned and systematic actions 
necessary to provide adequate confidence that the disposal system will 
comply with the disposal regulations set forth in part 191 of this 
chapter. Quality assurance includes quality control, which comprises 
those actions related to the physical characteristics of a material, 
structure, component, or system that provide a means to control the 
quality of the material, structure, component, or system to 
predetermined requirements.
    Re-certification means any action taken by the Administrator 
pursuant to section 8(f) of the WIPP LWA.
    Regulatory time frame means the time period beginning at disposal 
and ending 10,000 years after disposal.
    Revocation means any action taken by the Administrator to terminate 
the certification pursuant to section 8(d)(1) of the WIPP LWA.
    Secretary means the Secretary of Energy.
    Shallow drilling means those drilling events in the Delaware Basin 
that do not reach a depth of 2,150 feet below the surface relative to 
where such drilling occurred.
    Suspension means any action taken by the Administrator to withdraw, 
for a limited period of time, the certification pursuant to section 
8(d)(1) of the WIPP LWA.
    Waste means the radioactive waste, radioactive material and 
coincidental material subject to the requirements of part 191 of this 
chapter.
    Waste characteristic means a property of the waste that has an 
impact on the containment of waste in the disposal system.
    Waste component means an ingredient of the total inventory of the 
waste that influences a waste characteristic.
    WIPP means the Waste Isolation Pilot Plant, as authorized pursuant 
to section 213 of the Department of Energy National Security and 
Military

[[Page 5237]]

Applications of Nuclear Energy Authorization Act of 1980 (Pub.L. 96-
164; 93 Stat. 1259, 1265).
    WIPP LWA means the Waste Isolation Pilot Plant Land Withdrawal Act 
of 1992 (Pub.L. 102-579, 106 Stat. 4777).


Sec. 194.3  Communications.

    (a) Compliance application(s) shall be:
    (1) Addressed to the Administrator; and
    (2) Signed by the Secretary.
    (b) Communications and reports concerning the criteria in this part 
shall be:
    (1) Addressed to the Administrator or the Administrator's 
authorized representative; and
    (2) Signed by the Secretary or the Secretary's authorized 
representative.


Sec. 194.4  Conditions of compliance certification.

    (a) Any certification of compliance issued pursuant to section 
8(d)(1) of the WIPP LWA may include such conditions as the 
Administrator finds necessary to support such certification.
    (b) Whether stated therein or not, the following conditions shall 
apply in any such certification:
    (1) The certification shall be subject to modification, suspension 
or revocation by the Administrator. Any suspension of the certification 
shall be done at the discretion of the Administrator. Any modification 
or revocation of the certification shall be done by rule pursuant to 5 
U.S.C. 553. If the Administrator revokes the certification, the 
Department shall retrieve, as soon as practicable and to the extent 
practicable, any waste emplaced in the disposal system.
    (2) Any time after the Administrator issues a certification, the 
Administrator or the Administrator's authorized representative may 
submit a written request to the Department for information to enable 
the Administrator to determine whether the certification should be 
modified, suspended or revoked. Unless otherwise specified by the 
Administrator or the Administrator's authorized representative, the 
Department shall submit such information to the Administrator or the 
Administrator's authorized representative within 30 calendar days of 
receipt of the request.
    (3) Any time after the Administrator issues a certification, the 
Department shall report any planned or unplanned changes in activities 
or conditions pertaining to the disposal system that differ 
significantly from the most recent compliance application.
    (i) The Department shall inform the Administrator, in writing, 
prior to making such a planned change in activity or disposal system 
condition.
    (ii) In the event of an unplanned change in activity or condition, 
the Department shall immediately cease emplacement of waste in the 
disposal system if the Department determines that one or more of the 
following conditions is true:
    (A) The containment requirements established pursuant to 
Sec. 191.13 of this chapter have been or are expected to be exceeded;
    (B) Releases from already-emplaced waste lead to committed 
effective doses that are or are expected to be in excess of those 
established pursuant to Sec. 191.15 of this chapter. For purposes of 
this paragraph (b)(3)(ii)(B), emissions from operations covered 
pursuant to part 191, subpart A of this chapter are not included; or
    (C) Releases have caused or are expected to cause concentrations of 
radionuclides or estimated doses due to radionuclides in underground 
sources of drinking water in the accessible environment to exceed the 
limits established pursuant to part 191, subpart C of this chapter.
    (iii) If the Department determines that a condition described in 
paragraph (b)(3)(ii) of this section has occurred or is expected to 
occur, the Department shall notify the Administrator, in writing, 
within 24 hours of the determination. Such notification shall, to the 
extent practicable, include the following information:
    (A) Identification of the location and environmental media of the 
release or the expected release;
    (B) Identification of the type and quantity of waste (in activity 
in curies of each radionuclide) released or expected to be released;
    (C) Time and date of the release or the estimated time of the 
expected release;
    (D) Assessment of the hazard posed by the release or the expected 
release; and
    (E) Additional information requested by the Administrator or the 
Administrator's authorized representative.
    (iv) The Department may resume emplacement of waste in the disposal 
system upon written notification that the suspension has been lifted by 
the Administrator.
    (v) If the Department discovers a condition or activity that 
differs significantly from what is indicated in the most recent 
compliance application, but does not involve conditions or activities 
listed in paragraph (b)(3)(ii) of this section, then the difference 
shall be reported, in writing, to the Administrator within 10 calendar 
days of its discovery.
    (vi) Following receipt of notification, the Administrator will 
notify the Secretary in writing whether any condition or activity 
reported pursuant to paragraph (b)(3) this section:
    (A) Does not comply with the terms of the certification; and, if it 
does not comply,
    (B) Whether the compliance certification must be modified, 
suspended or revoked. The Administrator or the Administrator's 
authorized representative may request additional information before 
determining whether modification, suspension or revocation of the 
compliance certification is required.
    (4) Not later than six months after the Administrator issues a 
certification, and at least annually thereafter, the Department shall 
report to the Administrator, in writing, any changes in conditions or 
activities pertaining to the disposal system that were not required to 
be reported by paragraph (b)(3) of this section and that differ from 
information contained in the most recent compliance application.


Sec. 194.5  Publications incorporated by reference.

    (a) The following publications are incorporated into this part by 
reference:
    (1) U.S. Nuclear Regulatory Commission, NUREG-1297 ``Peer Review 
for High-Level Nuclear Waste Repositories,'' published February 1988; 
incorporation by reference (IBR) approved for Secs. 194.22, 194.23 and 
194.27.
    (2) American Society of Mechanical Engineers (ASME) Nuclear Quality 
Assurance (NQA) Standard, NQA-1-1989 edition, ``Quality Assurance 
Program Requirements for Nuclear Facilities;'' IBR approved for 
Sec. 194.22.
    (3) ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition 
``Quality Assurance Requirements for Nuclear Facility Applications;'' 
IBR approved for Sec. 194.22 and Sec. 194.23.
    (4) ASME NQA-3-1989 edition, ``Quality Assurance Program 
Requirements for the Collection of Scientific and Technical Information 
for Site Characterization of High-Level Nuclear Waste Repositories'' 
(excluding section 2.1 (b) and (c)); IBR approved for Sec. 194.22.
    (b) The publications listed in paragraph (a) of this section were 
approved for incorporation by reference by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be inspected or obtained from the Air Docket, Docket No. A-92-56, 
room M1500 (LE131), 

[[Page 5238]]
U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC 
20460, or copies may be inspected at the Office of the Federal 
Register, 800 N. Capitol Street NW, 7th floor, Suite 700, Washington, 
DC, or copies may be obtained from the following addresses:
    (1) For ASME standards, contact American Society of Mechanical 
Engineers, 22 Law Drive, P.O. Box 2900, Fairfield, NJ 07007-2900, phone 
1-800-843-2763.
    (2) For Nuclear Regulatory Commission documents, contact Division 
of Information Support Services, Distribution Service, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555, or contact National 
Technical Information Service, 5285 Port Royal Road, Springfield, VA 
22161, phone 703-487-4650.


Sec. 194.6  Alternative provisions.

    The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute 
for any of the provisions of this part alternative provisions chosen 
after:
    (a) The alternative provisions have been proposed for public 
comment in the Federal Register together with information describing 
how the alternative provisions comport with the disposal regulations, 
the reasons why the existing provisions of this part appear 
inappropriate, and the costs, risks and benefits of compliance in 
accordance with the alternative provisions;
    (b) A public comment period of at least 120 days has been completed 
and public hearings have been held in New Mexico;
    (c) The public comments received have been fully considered; and
    (d) A notice of final rulemaking is published in the Federal 
Register.


Sec. 194.7  Effective date.

    The criteria in this part shall be effective on April 9, 1996. The 
incorporation by reference of certain publications listed in the 
criteria is approved by the Director of the Federal Register as of 
April 9, 1996.

Subpart B--Compliance Certification and Re-certification 
Applications


Sec. 194.11  Completeness and accuracy of compliance applications.

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


Sec. 194.12  Submission of compliance applications.

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


Sec. 194.13  Submission of reference materials.

    Information may be included by reference into compliance 
application(s), provided that the references are clear and specific and 
that, unless otherwise specified by the Administrator or the 
Administrator's authorized representative, 10 copies of the referenced 
information are submitted to the Administrator. Referenced materials 
which are widely available in standard textbooks or reference books 
need not be submitted.


Sec. 194.14  Content of compliance certification application.

    Any compliance application shall include:
    (a) A current description of the natural and engineered features 
that may affect the performance of the disposal system. The description 
of the disposal system shall include, at a minimum, the following 
information:
    (1) The location of the disposal system and the controlled area;
    (2) A description of the geology, geophysics, hydrogeology, 
hydrology, and geochemistry of the disposal system and its vicinity and 
how these conditions are expected to change and interact over the 
regulatory time frame. Such description shall include, at a minimum:
    (i) Existing fluids and fluid hydraulic potential, including brine 
pockets, in and near the disposal system; and
    (ii) Existing higher permeability anhydrite interbeds located at or 
near the horizon of the waste.
    (3) The presence and characteristics of potential pathways for 
transport of waste from the disposal system to the accessible 
environment including, but not limited to: Existing boreholes, solution 
features, breccia pipes, and other potentially permeable features, such 
as interbeds.
    (4) The projected geophysical, hydrogeologic and geochemical 
conditions of the disposal system due to the presence of waste 
including, but not limited to, the effects of production of heat or 
gases from the waste.
    (b) A description of the design of the disposal system including:
    (1) Information on materials of construction including, but not 
limited to: Geologic media, structural materials, engineered barriers, 
general arrangement, and approximate dimensions; and
    (2) Computer codes and standards that have been applied to the 
design and construction of the disposal system.
    (c) Results of assessments conducted pursuant to this part.
    (d) A description of input parameters associated with assessments 
conducted pursuant to this part and the basis for selecting those input 
parameters.
    (e) Documentation of measures taken to meet the assurance 
requirements of this part.
    (f) A description of waste acceptance criteria and actions taken to 
assure adherence to such criteria.
    (g) A description of background radiation in air, soil and water in 
the vicinity of the disposal system and the procedures employed to 
determine such radiation.
    (h) One or more topographic map(s) of the vicinity of the disposal 
system. The contour interval shall be sufficient to show clearly the 
pattern of surface water flow in the vicinity of the disposal system. 
The map(s) shall include standard map notations and symbols, and, in 
addition, shall show boundaries of the controlled area and the location 
of any active, inactive, and abandoned injection and withdrawal wells 
in the controlled area and in the vicinity of the disposal system.
    (i) A description of past and current climatologic and meteorologic 
conditions in the vicinity of the disposal system and how these 
conditions are expected to change over the regulatory time frame.
    (j) The information required elsewhere in this part or any 
additional information, analyses, tests, or records determined by the 
Administrator or the Administrator's authorized representative to be 
necessary for determining compliance with this part.


Sec. 194.15  Content of compliance re-certification application(s).

    (a) In submitting documentation of continued compliance pursuant to 
section 8(f) of the WIPP LWA, the previous compliance application shall 
be updated to provide sufficient information for the Administrator to 
determine whether or not the WIPP continues to be in compliance with 
the disposal regulations. Updated documentation shall include:
    (1) All additional geologic, geophysical, geochemical, hydrologic, 
and meteorologic information; 

[[Page 5239]]

    (2) All additional monitoring data, analyses and results;
    (3) All additional analyses and results of laboratory experiments 
conducted by the Department or its contractors as part of the WIPP 
program;
    (4) An identification of any activities or assumptions that deviate 
from the most recent compliance application;
    (5) A description of all waste emplaced in the disposal system 
since the most recent compliance certification or re-certification 
application. Such description shall consist of a description of the 
waste characteristics and waste components identified in 
Secs. 194.24(b)(1) and 194.24(b)(2);
    (6) Any significant information not previously included in a 
compliance certification or re-certification application related to 
whether the disposal system continues to be in compliance with the 
disposal regulations; and
    (7) Any additional information requested by the Administrator or 
the Administrator's authorized representative.
    (b) To the extent that information required for a re-certification 
of compliance remains valid and has been submitted in previous 
certification or re-certification application(s), such information need 
not be duplicated in subsequent applications; such information may be 
summarized and referenced.

Subpart C--Compliance Certification and Re-certification

General Requirements


Sec. 194.21  Inspections.

    (a) The Administrator or the Administrator's authorized 
representative(s) shall, at any time:
    (1) Be afforded unfettered and unannounced access to inspect any 
area of the WIPP, and any locations performing activities that provide 
information relevant to compliance application(s), to which the 
Department has rights of access. Such access shall be equivalent to 
access afforded Department employees upon presentation of credentials 
and other required documents.
    (2) Be allowed to obtain samples, including split samples, and to 
monitor and measure aspects of the disposal system and the waste 
proposed for disposal in the disposal system.
    (b) Records (including data and other information in any form) kept 
by the Department pertaining to the WIPP shall be made available to the 
Administrator or the Administrator's authorized representative upon 
request. If requested records are not immediately available, they shall 
be delivered within 30 calendar days of the request.
    (c) The Department shall, upon request by the Administrator or the 
Administrator's authorized representative, provide permanent, private 
office space that is accessible to the disposal system. The office 
space shall be for the exclusive use of the Administrator or the 
Administrator's authorized representative(s).
    (d) The Administrator or the Administrator's authorized 
representative(s) shall comply with applicable access control measures 
for security, radiological protection, and personal safety when 
conducting activities pursuant to this section.


Sec. 194.22  Quality assurance.

    (a)(1) As soon as practicable after April 9, 1996, the Department 
shall adhere to a quality assurance program that implements the 
requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part 
2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding 
Section 2.1 (b) and (c), and Section 17.1). (Incorporation by reference 
as specified in Sec. 194.5.)
    (2) Any compliance application shall include information which 
demonstrates that the quality assurance program required pursuant to 
paragraph (a)(1) of this section has been established and executed for:
    (i) Waste characterization activities and assumptions;
    (ii) Environmental monitoring, monitoring of the performance of the 
disposal system, and sampling and analysis activities;
    (iii) Field measurements of geologic factors, ground water, 
meteorologic, and topographic characteristics;
    (iv) Computations, computer codes, models and methods used to 
demonstrate compliance with the disposal regulations in accordance with 
the provisions of this part;
    (v) Procedures for implementation of expert judgment elicitation 
used to support applications for certification or re-certification of 
compliance;
    (vi) Design of the disposal system and actions taken to ensure 
compliance with design specifications;
    (vii) The collection of data and information used to support 
compliance application(s); and
    (viii) Other systems, structures, components, and activities 
important to the containment of waste in the disposal system.
    (b) Any compliance application shall include information which 
demonstrates that data and information collected prior to the 
implementation of the quality assurance program required pursuant to 
paragraph (a)(1) of this section have been qualified in accordance with 
an alternate methodology, approved by the Administrator or the 
Administrator's authorized representative, that employs one or more of 
the following methods: Peer review, conducted in a manner that is 
compatible with NUREG-1297, ``Peer Review for High-Level Nuclear Waste 
Repositories,'' published February 1988 (incorporation by reference as 
specified in Sec. 194.5); corroborating data; confirmatory testing; or 
a quality assurance program that is equivalent in effect to ASME NQA-1-
1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 
edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c) 
and Section 17.1). (Incorporation by reference as specified in 
Sec. 194.5.)
    (c) Any compliance application shall provide, to the extent 
practicable, information which describes how all data used to support 
the compliance application have been assessed for their quality 
characteristics, including:
    (1) Data accuracy, i.e., the degree to which data agree with an 
accepted reference or true value;
    (2) Data precision, i.e., a measure of the mutual agreement between 
comparable data gathered or developed under similar conditions 
expressed in terms of a standard deviation;
    (3) Data representativeness, i.e., the degree to which data 
accurately and precisely represent a characteristic of a population, a 
parameter, variations at a sampling point, or environmental conditions;
    (4) Data completeness, i.e., a measure of the amount of valid data 
obtained compared to the amount that was expected; and
    (5) Data comparability, i.e., a measure of the confidence with 
which one data set can be compared to another.
    (d) Any compliance application shall provide information which 
demonstrates how all data are qualified for use in the demonstration of 
compliance.
    (e) The Administrator will verify appropriate execution of quality 
assurance programs through inspections, record reviews and record 
keeping requirements, which may include, but may not be limited to, 
surveillance, audits and management systems reviews.


Sec. 194.23  Models and computer codes.

    (a) Any compliance application shall include: 
    
[[Page 5240]]

    (1) A description of the conceptual models and scenario 
construction used to support any compliance application.
    (2) A description of plausible, alternative conceptual model(s) 
seriously considered but not used to support such application, and an 
explanation of the reason(s) why such model(s) was not deemed to 
accurately portray performance of the disposal system.
    (3) Documentation that:
    (i) Conceptual models and scenarios reasonably represent possible 
future states of the disposal system;
    (ii) Mathematical models incorporate equations and boundary 
conditions which reasonably represent the mathematical formulation of 
the conceptual models;
    (iii) Numerical models provide numerical schemes which enable the 
mathematical models to obtain stable solutions;
    (iv) Computer models accurately implement the numerical models; 
i.e., computer codes are free of coding errors and produce stable 
solutions;
    (v) Conceptual models have undergone peer review according to 
Sec. 194.27.
    (b) Computer codes used to support any compliance application shall 
be documented in a manner that complies with the requirements of ASME 
NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition. 
(Incorporation by reference as specified in Sec. 194.5.)
    (c) Documentation of all models and computer codes included as part 
of any compliance application performance assessment calculation shall 
be provided. Such documentation shall include, but shall not be limited 
to:
    (1) Descriptions of the theoretical backgrounds of each model and 
the method of analysis or assessment;
    (2) General descriptions of the models; discussions of the limits 
of applicability of each model; detailed instructions for executing the 
computer codes, including hardware and software requirements, input and 
output formats with explanations of each input and output variable and 
parameter (e.g., parameter name and units); listings of input and 
output files from a sample computer run; and reports on code 
verification, benchmarking, validation, and quality assurance 
procedures;
    (3) Detailed descriptions of the structure of computer codes and 
complete listings of the source codes;
    (4) Detailed descriptions of data collection procedures, sources of 
data, data reduction and analysis, and code input parameter 
development;
    (5) Any necessary licenses; and
    (6) An explanation of the manner in which models and computer codes 
incorporate the effects of parameter correlation.
    (d) The Administrator or the Administrator's authorized 
representative may verify the results of computer simulations used to 
support any compliance application by performing independent 
simulations. Data files, source codes, executable versions of computer 
software for each model, other material or information needed to permit 
the Administrator or the Administrator's authorized representative to 
perform independent simulations, and access to necessary hardware to 
perform such simulations, shall be provided within 30 calendar days of 
a request by the Administrator or the Administrator's authorized 
representative.


Sec. 194.24  Waste characterization.

    (a) Any compliance application shall describe the chemical, 
radiological and physical composition of all existing waste proposed 
for disposal in the disposal system. To the extent practicable, any 
compliance application shall also describe the chemical, radiological 
and physical composition of to-be-generated waste proposed for disposal 
in the disposal system. These descriptions shall include a list of 
waste components and their approximate quantities in the waste. This 
list may be derived from process knowledge, current non-destructive 
examination/assay, or other information and methods.
    (b) The Department shall submit in the compliance certification 
application the results of an analysis which substantiates:
    (1) That all waste characteristics influencing containment of waste 
in the disposal system have been identified and assessed for their 
impact on disposal system performance. The characteristics to be 
analyzed shall include, but shall not be limited to: Solubility; 
formation of colloidal suspensions containing radionuclides; production 
of gas from the waste; shear strength; compactability; and other waste-
related inputs into the computer models that are used in the 
performance assessment.
    (2) That all waste components influencing the waste characteristics 
identified in paragraph (b)(1) of this section have been identified and 
assessed for their impact on disposal system performance. The 
components to be analyzed shall include, but shall not be limited to: 
metals; cellulosics; chelating agents; water and other liquids; and 
activity in curies of each isotope of the radionuclides present.
    (3) Any decision to exclude consideration of any waste 
characteristic or waste component because such characteristic or 
component is not expected to significantly influence the containment of 
the waste in the disposal system.
    (c) For each waste component identified and assessed pursuant to 
paragraph (b) of this section, the Department shall specify the 
limiting value (expressed as an upper or lower limit of mass, volume, 
curies, concentration, etc.), and the associated uncertainty (i.e., 
margin of error) for each limiting value, of the total inventory of 
such waste proposed for disposal in the disposal system. Any compliance 
application shall:
    (1) Demonstrate that, for the total inventory of waste proposed for 
disposal in the disposal system, WIPP complies with the numeric 
requirements of Sec. 194.34 and Sec. 194.55 for the upper or lower 
limits (including the associated uncertainties), as appropriate, for 
each waste component identified in paragraph (b)(2) of this section, 
and for the plausible combinations of upper and lower limits of such 
waste components that would result in the greatest estimated release.
    (2) Identify and describe the method(s) used to quantify the limits 
of waste components identified in paragraph (b)(2) of this section.
    (3) Provide information which demonstrates that the use of process 
knowledge to quantify components in waste for disposal conforms with 
the quality assurance requirements found in Sec. 194.22.
    (4) Provide information which demonstrates that a system of 
controls has been and will continue to be implemented to confirm that 
the total amount of each waste component that will be emplaced in the 
disposal system will not exceed the upper limiting value or fall below 
the lower limiting value described in the introductory text of 
paragraph (c) of this section. The system of controls shall include, 
but shall not be limited to: Measurement; sampling; chain of custody 
records; record keeping systems; waste loading schemes used; and other 
documentation.
    (5) Identify and describe such controls delineated in paragraph 
(c)(4) of this section and confirm that they are applied in accordance 
with the quality assurance requirements found in Sec. 194.22.
    (d) The Department shall include a waste loading scheme in any 
compliance application, or else performance assessments conducted 

[[Page 5241]]
pursuant to Sec. 194.32 and compliance assessments conducted pursuant 
to Sec. 194.54 shall assume random placement of waste in the disposal 
system.
    (e) Waste may be emplaced in the disposal system only if the 
emplaced components of such waste will not cause:
    (1) The total quantity of waste in the disposal system to exceed 
the upper limiting value, including the associated uncertainty, 
described in the introductory text to paragraph (c) of this section; or
    (2) The total quantity of waste that will have been emplaced in the 
disposal system, prior to closure, to fall below the lower limiting 
value, including the associated uncertainty, described in the 
introductory text to paragraph (c) of this section.
    (f) Waste emplacement shall conform to the assumed waste loading 
conditions, if any, used in performance assessments conducted pursuant 
to Sec. 194.32 and compliance assessments conducted pursuant to 
Sec. 194.54.
    (g) The Department shall demonstrate in any compliance application 
that the total inventory of waste emplaced in the disposal system 
complies with the limitations on transuranic waste disposal described 
in the WIPP LWA.
    (h) The Administrator will use inspections and records reviews, 
such as audits, to verify compliance with this section.


Sec. 194.25  Future state assumptions.

    (a) Unless otherwise specified in this part or in the disposal 
regulations, performance assessments and compliance assessments 
conducted pursuant the provisions of this part to demonstrate 
compliance with Sec. 191.13, Sec. 191.15 and part 191, subpart C shall 
assume that characteristics of the future remain what they are at the 
time the compliance application is prepared, provided that such 
characteristics are not related to hydrogeologic, geologic or climatic 
conditions.
    (b) In considering future states pursuant to this section, the 
Department shall document in any compliance application, to the extent 
practicable, effects of potential future hydrogeologic, geologic and 
climatic conditions on the disposal system over the regulatory time 
frame. Such documentation shall be part of the activities undertaken 
pursuant to Sec. 194.14, Content of compliance certification 
application; Sec. 194.32, Scope of performance assessments; and 
Sec. 194.54, Scope of compliance assessments.
    (1) In considering the effects of hydrogeologic conditions on the 
disposal system, the Department shall document in any compliance 
application, to the extent practicable, the effects of potential 
changes to hydrogeologic conditions.
    (2) In considering the effects of geologic conditions on the 
disposal system, the Department shall document in any compliance 
application, to the extent practicable, the effects of potential 
changes to geologic conditions, including, but not limited to: 
Dissolution; near surface geomorphic features and processes; and 
related subsidence in the geologic units of the disposal system.
    (3) In considering the effects of climatic conditions on the 
disposal system, the Department shall document in any compliance 
application, to the extent practicable, the effects of potential 
changes to future climate cycles of increased precipitation (as 
compared to present conditions).


Sec. 194.26  Expert judgment.

    (a) Expert judgment, by an individual expert or panel of experts, 
may be used to support any compliance application, provided that expert 
judgment does not substitute for information that could reasonably be 
obtained through data collection or experimentation.
    (b) Any compliance application shall:
    (1) Identify any expert judgments used to support the application 
and shall identify experts (by name and employer) involved in any 
expert judgment elicitation processes used to support the application.
    (2) Describe the process of eliciting expert judgment, and document 
the results of expert judgment elicitation processes and the reasoning 
behind those results. Documentation of interviews used to elicit 
judgments from experts, the questions or issues presented for 
elicitation of expert judgment, background information provided to 
experts, and deliberations and formal interactions among experts shall 
be provided. The opinions of all experts involved in each elicitation 
process shall be provided whether the opinions are used to support 
compliance applications or not.
    (3) Provide documentation that the following restrictions and 
guidelines have been applied to any selection of individuals used to 
elicit expert judgments:
    (i) Individuals who are members of the team of investigators 
requesting the judgment or the team of investigators who will use the 
judgment were not selected; and
    (ii) Individuals who maintain, at any organizational level, a 
supervisory role or who are supervised by those who will utilize the 
judgment were not selected.
    (4) Provide information which demonstrates that:
    (i) The expertise of any individual involved in expert judgment 
elicitation comports with the level of knowledge required by the 
questions or issues presented to that individual; and
    (ii) The expertise of any expert panel, as a whole, involved in 
expert judgment elicitation comports with the level and variety of 
knowledge required by the questions or issues presented to that panel.
    (5) Explain the relationship among the information and issues 
presented to experts prior to the elicitation process, the elicited 
judgment of any expert panel or individual, and the purpose for which 
the expert judgment is being used in compliance applications(s).
    (6) Provide documentation that the initial purpose for which expert 
judgment was intended, as presented to the expert panel, is consistent 
with the purpose for which this judgment was used in compliance 
application(s).
    (7) Provide documentation that the following restrictions and 
guidelines have been applied in eliciting expert judgment:
    (i) At least five individuals shall be used in any expert 
elicitation process, unless there is a lack or unavailability of 
experts and a documented rationale is provided that explains why fewer 
than five individuals were selected.
    (ii) At least two-thirds of the experts involved in an elicitation 
shall consist of individuals who are not employed directly by the 
Department or by the Department's contractors, unless the Department 
can demonstrate and document that there is a lack or unavailability of 
qualified independent experts. If so demonstrated, at least one-third 
of the experts involved in an elicitation shall consist of individuals 
who are not employed directly by the Department or by the Department's 
contractors.
    (c) The public shall be afforded a reasonable opportunity to 
present its scientific and technical views to expert panels as input to 
any expert elicitation process.


Sec. 194.27  Peer review.

    (a) Any compliance application shall include documentation of peer 
review that has been conducted, in a manner required by this section, 
for:
    (1) Conceptual models selected and developed by the Department;
    (2) Waste characterization analyses as required in Sec. 194.24(b); 
and
    (3) Engineered barrier evaluation as required in Sec. 194.44. 
    
[[Page 5242]]

    (b) Peer review processes required in paragraph (a) of this 
section, and conducted subsequent to the promulgation of this part, 
shall be conducted in a manner that is compatible with NUREG-1297, 
``Peer Review for High-Level Nuclear Waste Repositories,'' published 
February 1988. (Incorporation by reference as specified in Sec. 194.5.)
    (c) Any compliance application shall:
    (1) Include information that demonstrates that peer review 
processes required in paragraph (a) of this section, and conducted 
prior to the implementation of the promulgation of this part, were 
conducted in accordance with an alternate process substantially 
equivalent in effect to NUREG-1297 and approved by the Administrator or 
the Administrator's authorized representative; and
    (2) Document any peer review processes conducted in addition to 
those required pursuant to paragraph (a) of this section. Such 
documentation shall include formal requests, from the Department to 
outside review groups or individuals, to review or comment on any 
information used to support compliance applications, and the responses 
from such groups or individuals.

Containment Requirements


Sec. 194.31  Application of release limits.

    The release limits shall be calculated according to part 191, 
appendix A of this chapter, using the total activity, in curies, that 
will exist in the disposal system at the time of disposal.


Sec. 194.32  Scope of performance assessments.

    (a) Performance assessments shall consider natural processes and 
events, mining, deep drilling, and shallow drilling that may affect the 
disposal system during the regulatory time frame.
    (b) Assessments of mining effects may be limited to changes in the 
hydraulic conductivity of the hydrogeologic units of the disposal 
system from excavation mining for natural resources. Mining shall be 
assumed to occur with a one in 100 probability in each century of the 
regulatory time frame. Performance assessments shall assume that 
mineral deposits of those resources, similar in quality and type to 
those resources currently extracted from the Delaware Basin, will be 
completely removed from the controlled area during the century in which 
such mining is randomly calculated to occur. Complete removal of such 
mineral resources shall be assumed to occur only once during the 
regulatory time frame.
    (c) Performance assessments shall include an analysis of the 
effects on the disposal system of any activities that occur in the 
vicinity of the disposal system prior to disposal and are expected to 
occur in the vicinity of the disposal system soon after disposal. Such 
activities shall include, but shall not be limited to, existing 
boreholes and the development of any existing leases that can be 
reasonably expected to be developed in the near future, including 
boreholes and leases that may be used for fluid injection activities.
    (d) Performance assessments need not consider processes and events 
that have less than one chance in 10,000 of occurring over 10,000 
years.
    (e) Any compliance application(s) shall include information which:
    (1) Identifies all potential processes, events or sequences and 
combinations of processes and events that may occur during the 
regulatory time frame and may affect the disposal system;
    (2) Identifies the processes, events or sequences and combinations 
of processes and events included in performance assessments; and
    (3) Documents why any processes, events or sequences and 
combinations of processes and events identified pursuant to paragraph 
(e)(1) of this section were not included in performance assessment 
results provided in any compliance application.


Sec. 194.33  Consideration of drilling events in performance 
assessments.

    (a) Performance assessments shall examine deep drilling and shallow 
drilling that may potentially affect the disposal system during the 
regulatory time frame.
    (b) The following assumptions and process shall be used in 
assessing the likelihood and consequences of drilling events, and the 
results of such process shall be documented in any compliance 
application:
    (1) Inadvertent and intermittent intrusion by drilling for 
resources (other than those resources provided by the waste in the 
disposal system or engineered barriers designed to isolate such waste) 
is the most severe human intrusion scenario.
    (2) In performance assessments, drilling events shall be assumed to 
occur in the Delaware Basin at random intervals in time and space 
during the regulatory time frame.
    (3) The frequency of deep drilling shall be calculated in the 
following manner:
    (i) Identify deep drilling that has occurred for each resource in 
the Delaware Basin over the past 100 years prior to the time at which a 
compliance application is prepared.
    (ii) The total rate of deep drilling shall be the sum of the rates 
of deep drilling for each resource.
    (4) The frequency of shallow drilling shall be calculated in the 
following manner:
    (i) Identify shallow drilling that has occurred for each resource 
in the Delaware Basin over the past 100 years prior to the time at 
which a compliance application is prepared.
    (ii) The total rate of shallow drilling shall be the sum of the 
rates of shallow drilling for each resource.
    (iii) In considering the historical rate of all shallow drilling, 
the Department may, if justified, consider only the historical rate of 
shallow drilling for resources of similar type and quality to those in 
the controlled area.
    (c) Performance assessments shall document that in analyzing the 
consequences of drilling events, the Department assumed that:
    (1) Future drilling practices and technology will remain consistent 
with practices in the Delaware Basin at the time a compliance 
application is prepared. Such future drilling practices shall include, 
but shall not be limited to: The types and amounts of drilling fluids; 
borehole depths, diameters, and seals; and the fraction of such 
boreholes that are sealed by humans; and
    (2) Natural processes will degrade or otherwise affect the 
capability of boreholes to transmit fluids over the regulatory time 
frame.
    (d) With respect to future drilling events, performance assessments 
need not analyze the effects of techniques used for resource recovery 
subsequent to the drilling of the borehole.


Sec. 194.34  Results of performance assessments.

    (a) The results of performance assessments shall be assembled into 
``complementary, cumulative distribution functions'' (CCDFs) that 
represent the probability of exceeding various levels of cumulative 
release caused by all significant processes and events.
    (b) Probability distributions for uncertain disposal system 
parameter values used in performance assessments shall be developed and 
documented in any compliance application.
    (c) Computational techniques, which draw random samples from across 
the entire range of the probability distributions developed pursuant to 
paragraph (b) of this section, shall be used in generating CCDFs and 
shall be documented in any compliance application. 

[[Page 5243]]

    (d) The number of CCDFs generated shall be large enough such that, 
at cumulative releases of 1 and 10, the maximum CCDF generated exceeds 
the 99th percentile of the population of CCDFs with at least a 0.95 
probability. Values of cumulative release shall be calculated according 
to Note 6 of Table 1, Appendix A of Part 191 of this chapter.
    (e) Any compliance application shall display the full range of 
CCDFs generated.
    (f) Any compliance application shall provide information which 
demonstrates that there is at least a 95 percent level of statistical 
confidence that the mean of the population of CCDFs meets the 
containment requirements of Sec. 191.13 of this chapter.

Assurance Requirements


Sec. 194.41  Active institutional controls.

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


Sec. 194.42  Monitoring.

    (a) The Department shall conduct an analysis of the effects of 
disposal system parameters on the containment of waste in the disposal 
system and shall include the results of such analysis in any compliance 
application. The results of the analysis shall be used in developing 
plans for pre-closure and post-closure monitoring required pursuant to 
paragraphs (c) and (d) of this section. The disposal system parameters 
analyzed shall include, at a minimum:
    (1) Properties of backfilled material, including porosity, 
permeability, and degree of compaction and reconsolidation;
    (2) Stresses and extent of deformation of the surrounding roof, 
walls, and floor of the waste disposal room;
    (3) Initiation or displacement of major brittle deformation 
features in the roof or surrounding rock;
    (4) Ground water flow and other effects of human intrusion in the 
vicinity of the disposal system;
    (5) Brine quantity, flux, composition, and spatial distribution;
    (6) Gas quantity and composition; and
    (7) Temperature distribution.
    (b) For all disposal system parameters analyzed pursuant to 
paragraph (a) of this section, any compliance application shall 
document and substantiate the decision not to monitor a particular 
disposal system parameter because that parameter is considered to be 
insignificant to the containment of waste in the disposal system or to 
the verification of predictions about the future performance of the 
disposal system.
    (c) Pre-closure monitoring. To the extent practicable, pre-closure 
monitoring shall be conducted of significant disposal system 
parameter(s) as identified by the analysis conducted pursuant to 
paragraph (a) of this section. A disposal system parameter shall be 
considered significant if it affects the system's ability to contain 
waste or the ability to verify predictions about the future performance 
of the disposal system. Such monitoring shall begin as soon as 
practicable; however, in no case shall waste be emplaced in the 
disposal system prior to the implementation of pre-closure monitoring. 
Pre-closure monitoring shall end at the time at which the shafts of the 
disposal system are backfilled and sealed.
    (d) Post-closure monitoring. The disposal system shall, to the 
extent practicable, be monitored as soon as practicable after the 
shafts of the disposal system are backfilled and sealed to detect 
substantial and detrimental deviations from expected performance and 
shall end when the Department can demonstrate to the satisfaction of 
the Administrator that there are no significant concerns to be 
addressed by further monitoring. Post-closure monitoring shall be 
complementary to monitoring required pursuant to applicable federal 
hazardous waste regulations at parts 264, 265, 268, and 270 of this 
chapter and shall be conducted with techniques that do not jeopardize 
the containment of waste in the disposal system.
    (e) Any compliance application shall include detailed pre-closure 
and post-closure monitoring plans for monitoring the performance of the 
disposal system. At a minimum, such plans shall:
    (1) Identify the parameters that will be monitored and how baseline 
values will be determined;
    (2) Indicate how each parameter will be used to evaluate any 
deviations from the expected performance of the disposal system; and
    (3) Discuss the length of time over which each parameter will be 
monitored to detect deviations from expected performance.


Sec. 194.43  Passive institutional controls.

    (a) Any compliance application shall include detailed descriptions 
of the measures that will be employed to preserve knowledge about the 
location, design, and contents of the disposal system. Such measures 
shall include:
    (1) Identification of the controlled area by markers that have been 
designed and will be fabricated and emplaced to be as permanent as 
practicable;
    (2) Placement of records in the archives and land record systems of 
local, State, and Federal governments, and international archives, that 
would likely be consulted by individuals in search of unexploited 
resources. Such records shall identify:
    (i) The location of the controlled area and the disposal system;
    (ii) The design of the disposal system;
    (iii) The nature and hazard of the waste;
    (iv) Geologic, geochemical, hydrologic, and other site data 
pertinent to the containment of waste in the disposal system, or the 
location of such information; and
    (v) The results of tests, experiments, and other analyses relating 
to backfill of excavated areas, shaft sealing, waste interaction with 
the disposal system, and other tests, experiments, or analyses 
pertinent to the containment of waste in the disposal system, or the 
location of such information.
    (3) Other passive institutional controls practicable to indicate 
the dangers of the waste and its location.
    (b) Any compliance application shall include the period of time 
passive institutional controls are expected to endure and be 
understood.
    (c) The Administrator may allow the Department to assume passive 
institutional control credit, in the form of reduced likelihood of 
human intrusion, if the Department demonstrates in the compliance 
application that such credit is justified because the passive 
institutional controls are expected to endure and be understood by 
potential intruders for the time period approved by the Administrator. 
Such credit, or a smaller credit as determined by the Administrator, 
cannot be used for more than several hundred years and may decrease 
over time. In no case, however, shall passive institutional controls be 
assumed to eliminate the likelihood of human intrusion entirely.


Sec. 194.44  Engineered barriers.

    (a) Disposal systems shall incorporate engineered barrier(s) 
designed to prevent or substantially delay the movement of water or 
radionuclides toward the accessible environment. 

[[Page 5244]]

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


Sec. 194.45  Consideration of the presence of resources.

    Any compliance application shall include information that 
demonstrates that the favorable characteristics of the disposal system 
compensate for the presence of resources in the vicinity of the 
disposal system and the likelihood of the disposal system being 
disturbed as a result of the presence of those resources. If 
performance assessments predict that the disposal system meets the 
containment requirements of Sec. 191.13 of this chapter, then the 
Agency will assume that the requirements of this section and 
Sec. 191.14(e) of this chapter have been fulfilled.


Sec. 194.46  Removal of waste.

    Any compliance application shall include documentation which 
demonstrates that removal of waste from the disposal system is feasible 
for a reasonable period of time after disposal. Such documentation 
shall include an analysis of the technological feasibility of mining 
the sealed disposal system, given technology levels at the time a 
compliance application is prepared.

Individual and Ground-water Protection Requirements


Sec. 194.51  Consideration of protected individual.

    Compliance assessments that analyze compliance with Sec. 191.15 of 
this chapter shall assume that an individual resides at the single 
geographic point on the surface of the accessible environment where 
that individual would be expected to receive the highest dose from 
radionuclide releases from the disposal system.


Sec. 194.52  Consideration of exposure pathways.

    In compliance assessments that analyze compliance with Sec. 191.15 
of this chapter, all potential exposure pathways from the disposal 
system to individuals shall be considered. Compliance assessments with 
part 191, subpart C and Sec. 191.15 of this chapter shall assume that 
individuals consume 2 liters per day of drinking water from any 
underground source of drinking water in the accessible environment.


Sec. 194.53  Consideration of underground sources of drinking water.

    In compliance assessments that analyze compliance with part 191, 
subpart C of this chapter, all underground sources of drinking water in 
the accessible environment that are expected to be affected by the 
disposal system over the regulatory time frame shall be considered. In 
determining whether underground sources of drinking water are expected 
to be affected by the disposal system, underground interconnections 
among bodies of surface water, ground water, and underground sources of 
drinking water shall be considered.


Sec. 194.54  Scope of compliance assessments.

    (a) Any compliance application shall contain compliance assessments 
required pursuant to this part. Compliance assessments shall include 
information which:
    (1) Identifies potential processes, events, or sequences of 
processes and events that may occur over the regulatory time frame;
    (2) Identifies the processes, events, or sequences of processes and 
events included in compliance assessment results provided in any 
compliance application; and
    (3) Documents why any processes, events, or sequences of processes 
and events identified pursuant to paragraph (a)(1) of this section were 
not included in compliance assessment results provided in any 
compliance application.
    (b) Compliance assessments of undisturbed performance shall include 
the effects on the disposal system of:
    (1) Existing boreholes in the vicinity of the disposal system, with 
attention to the pathways they provide for migration of radionuclides 
from the site; and
    (2) Any activities that occur in the vicinity of the disposal 
system prior to or soon after disposal. Such activities shall include, 
but shall not be limited to: Existing boreholes and the development of 
any existing leases that can be reasonably expected to be developed in 
the near future, including boreholes and leases that may be used for 
fluid injection activities.


Sec. 194.55  Results of compliance assessments.

    (a) Compliance assessments shall consider and document uncertainty 
in the performance of the disposal system.
    (b) Probability distributions for uncertain disposal system 
parameter values used in compliance assessments shall be developed and 
documented in any compliance application. 

[[Page 5245]]

    (c) Computational techniques which draw random samples from across 
the entire range of values of each probability distribution developed 
pursuant to paragraph (b) of this section shall be used to generate a 
range of:
    (1) Estimated committed effective doses received from all pathways 
pursuant to Sec. 194.51 and Sec. 194.52;
    (2) Estimated radionuclide concentrations in USDWs pursuant to 
Sec. 194.53; and
    (3) Estimated dose equivalent received from USDWs pursuant to 
Sec. 194.52 and Sec. 194.53.
    (d) The number of estimates generated pursuant to paragraph (c) of 
this section shall be large enough such that the maximum estimates of 
doses and concentrations generated exceed the 99th percentile of the 
population of estimates with at least a 0.95 probability.
    (e) Any compliance application shall display:
    (1) The full range of estimated radiation doses; and
    (2) The full range of estimated radionuclide concentrations.
    (f) Any compliance application shall document that there is at 
least a 95 percent level of statistical confidence that the mean and 
the median of the range of estimated radiation doses and the range of 
estimated radionuclide concentrations meet the requirements of 
Sec. 191.15 and part 191, subpart C of this chapter, respectively.

Subpart D--Public Participation


Sec. 194.61  Advance notice of proposed rulemaking for certification.

    (a) Upon receipt of a compliance application submitted pursuant to 
section 8(d)(1) of the WIPP LWA and Sec. 194.11, the Agency will 
publish in the Federal Register an Advance Notice of Proposed 
Rulemaking announcing that a compliance application has been received, 
soliciting comment on such application, and announcing the Agency's 
intent to conduct a rulemaking to certify whether the WIPP facility 
will comply with the disposal regulations.
    (b) A copy of the compliance application will be made available for 
inspection in Agency dockets established pursuant to Sec. 194.67.
    (c) The notice will provide a public comment period of 120 days.
    (d) A public hearing concerning the notice will be held if a 
written request is received by the Administrator or the Administrator's 
authorized representative within 30 calendar days of the date of 
publication pursuant to paragraph (a) of this section.
    (e) Any comments received on the notice will be made available for 
inspection in the dockets established pursuant to Sec. 194.67.
    (f) Any comments received on the notice will be provided to the 
Department and the Department may submit to the Agency written 
responses to the comments.


Sec. 194.62  Notice of proposed rulemaking for certification.

    (a) The Administrator will publish a Notice of Proposed Rulemaking 
in the Federal Register announcing the Administrator's proposed 
decision, pursuant to section 8(d)(1) of the WIPP LWA, whether to issue 
a certification that the WIPP facility will comply with the disposal 
regulations and soliciting comment on the proposal.
    (b) The notice will provide a public comment period of at least 120 
days.
    (c) The notice will announce public hearings in New Mexico.
    (d) Any comments received on the notice will be made available for 
inspection in the dockets established pursuant to Sec. 194.67.


Sec. 194.63  Final rule for certification.

    (a) The Administrator will publish a Final Rule in the Federal 
Register announcing the Administrator's decision, pursuant to section 
8(d)(1) of the WIPP LWA, whether to issue a certification that the WIPP 
facility will comply with the disposal regulations.
    (b) A document summarizing significant comments and issues arising 
from comments received on the Notice of Proposed Rulemaking, as well as 
the Administrator's response to such significant comments and issues, 
will be prepared and will be made available for inspection in the 
dockets established pursuant to Sec. 194.67.


Sec. 194.64  Documentation of continued compliance.

    (a) Upon receipt of documentation of continued compliance with the 
disposal regulations pursuant to section 8(f) of the WIPP LWA and 
Sec. 194.11, the Administrator will publish a notice in the Federal 
Register announcing that such documentation has been received, 
soliciting comment on such documentation, and announcing the 
Administrator's intent to determine whether or not the WIPP facility 
continues to be in compliance with the disposal regulations.
    (b) Copies of documentation of continued compliance received by the 
Administrator will be made available for inspection in the dockets 
established pursuant to Sec. 194.67.
    (c) The notice will provide a public comment period of at least 30 
days after publication pursuant to paragraph (a) of this section.
    (d) Any comments received on such notice will be made available for 
public inspection in the dockets established pursuant to Sec. 194.67.
    (e) Upon completion of review of the documentation of continued 
compliance with the disposal regulations, the Administrator will 
publish a notice in the Federal Register announcing the Administrator's 
decision whether or not to re-certify the WIPP facility.


Sec. 194.65  Notice of proposed rulemaking for modification or 
revocation.

    (a) If the Administrator determines that any changes in activities 
or conditions pertaining to the disposal system depart significantly 
from the most recent compliance application, the Agency will publish a 
Notice of Proposed Rulemaking in the Federal Register announcing the 
Administrator's proposed decision on modification or revocation, and 
soliciting comment on the proposal.
    (b) Any comments received on the notice will be made available for 
inspection in the dockets established pursuant to Sec. 194.67.


Sec. 194.66  Final rule for modification or revocation.

    (a) The Administrator will publish a Final Rule in the Federal 
Register announcing the Administrator's decision on modification or 
revocation.
    (b) A document summarizing significant comments and issues arising 
from comments received on the Notice of Proposed Rulemaking as well as 
the Administrator's response to such significant comments and issues 
will be prepared and will be made available for inspection in the 
dockets established pursuant to Sec. 194.67.


Sec. 194.67  Dockets.

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

[FR Doc. 96-2721 Filed 2-8-96; 8:45 am]
BILLING CODE 6560-50-P