ENVIRONMENTAL PROTECTION AGENCY



40 CFR Part 194



RIN 2060-AE30



Criteria for the Certification and Determination of the Waste



Isolation Pilot Plant's Compliance with Environmental Standards for



the Management and Disposal of Spent Nuclear Fuel, High-Level and



Transuranic Radioactive Wastes



AGENCY: Environmental Protection Agency (EPA)



ACTION: Proposed rule.



SUMMARY: The Environmental Protection Agency (EPA) is proposing



criteria for certifying and determining whether the Department of



Energy's Waste Isolation Pilot Plant  (WIPP) complies with disposal



standards set forth in 40 CFR part 191 (Environmental Standards for



the Management and Disposal of Spent Nuclear Fuel, High-Level and



Transuranic Radioactive Wastes).   EPA is required to promulgate



these criteria under the 1992 Waste Isolation Pilot Plant Land



Withdrawal Act  (WIPP LWA) .   These  criteria will be used by the Agency



in ascertaining whether the WIPP  disposal system complies with the



disposal standards.



DATES: Comments on today's proposal must be  received within 90 days



from this publication.  Public hearings on today's proposal will



be held in New Mexico.



ADDRESSES: Comments should be submitted, in duplicate, to:  Docket



No. A-92-56, Air Docket, room M-1500  (LE-131),  U.S. Environmental



Protection Agency,  401 M Street, S.W., Washington, D.C. 20460.  See



additional docket information in the Supplementary Information.

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     The effective date of these compliance criteria, once finalized,



will be 30 calendar days after date of publication of the final rule



in the Federal Register.



FOR FURTHER INFORMATION CONTACT: Mary Kruger or Martin Offutt;



telephone number (202) 233-9310; address:  Criteria and Standards



Division, Mail Code 6602J,  U.S. Environmental Protection Agency,



401 M Street,  S.W.,  Washington, B.C. 20460.  An addendum to the



supplementary information provided in today's notice is located in



Docket No. A-92-56.   For copies of this addendum and the Background



Information Document and Economic Impact Analysis prepared for this



proposed rule, contact Mary Kruger at the above phone number and



address.



SUPPLEMENTARY INFORMATION:   As discussed below, the scope of today' s



proposal is limited to proposed criteria for certifying and



determining whether the Waste Isolation Pilot Plant (WIPP)  in New



Mexico complies with the disposal standards  set forth in 40 CFR part



191.  Accordingly,  comments should be similarly limited in scope;



e.g., comments should not address the Agency's recently promulgated



radioactive waste disposal  standards--40 CFR part 191  (58 FR 66398,



December 20, 1993)--or whether WIPP should be used as a disposal



facility.



     The U.S.  Department of Energy  (DOE) is developing the Waste



Isolation Pilot Plant (WIPP) near Carlsbad in southeastern New Mexico



as a potential deep geologic repository for the disposal of defense



transuranic (TRU) radioactive waste currently being stored on Federal



reservations in Washington,  Ohio, Idaho, New Mexico, Tennessee, South

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Carolina, Nevada and Colorado.  TRU waste consists of materials



containing one or more  elements having atomic numbers greater than



92, in concentrations greater than 100 nanocuries of alpha-emitting



TRU isotopes per gram of waste, with half-lives greater than twenty



years.  Most TRU waste consists of items that have become



contaminated as a result of activities associated with the production



of nuclear weapons, e.g., rags,  equipment,  tools,  and organic and



inorganic sludges.   TRU waste is often mixed with hazardous chemical



constituents.



     Before beginning disposal of radioactive waste at the WIPP,



DOE must demonstrate that the  WIPP complies with the Environmental



Protection Agency's (EPA) radioactive waste standards at 40 CFR part



191 (Environmental Standards for the Management and Disposal of Spent



Nuclear Fuel, High-Level and Transuranic Radioactive Wastes).



    On October 30, 1992,  the Waste Isolation Pilot Plant Land



Withdrawal Act (WIPP LWA)  was  enacted (Pub. L. 102-579).  The WIPP



LWA contains numerous provisions pertaining to EPA's role in



overseeing DOE's activities at the WIPP,  including requirements for



the development and implementation of the 40 CFR part 191 disposal



standards as they are applied to the WIPP.   Specifically,  section



8 (a) of the WIPP LWA reinstated  all of the remanded disposal standards



except those aspects of the individual and ground-water protection



requirements which the  court found problematic in NRDC v. U.S. EPA.



  The WIPP LWA  requires EPA to certify and determine whether or



not the WIPP will comply  with  the Agency's final radioactive waste



disposal standards.  "Certification" refers to any initial

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certification of compliance of DOE's  application for the WIPP with



subparts B and C of 40 CFR part 191  (see section 8(d)  of the WIPP



LWA).   "Determination" refers to any subsequent decisions by the



Agency (required every 5 years by the WIPP LWA)  of whether the WIPP



continues to be in compliance with  subparts  B and C of 40 CFR part



191 (see section 8(f)  of the WIPP LWA).   In order to certify or



determine compliance,  the Agency will be issuing criteria for



assessing compliance with the final disposal  standards, as required



by section 8(c)  of the WIPP LWA.  On  February 11, 1993, as a first



step in the development of compliance criteria, EPA issued an Advance



Notice of Proposed Rulemaking (ANPR)  soliciting comments on issues



associated with the development of compliance criteria.  (58 FR



8029.)  The next step in the evolution of these criteria  is occurring



today with the issuance of proposed compliance criteria.



     Objective and Implementation of Today's Proposed Criteria



     Under authority of the WIPP LWA, the Agency is proposing criteria



for certifying and determining whether the Department  of Energy's



(DOE)  Waste Isolation Pilot Plant (WIPP) will comply with the Agency' s



radioactive waste disposal  standards  set  forth  in 40 CFR part 191.



 The WIPP LWA specifies that underground emplacement of transuranic



wastes for disposal at the WIPP may not  commence unless and until



EPA certifies that the WIPP facility will comply with 40 CFR part



191, subparts B and C.   If the Agency certifies compliance, the WIPP



LWA requires EPA to subsequently conduct periodic determinations



of continued compliance throughout waste  disposal operations at the



WIPP.   Criteria contained in today's notice address any initial

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certification of compliance as well as any subsequent determinations



of continued compliance.  When final compliance criteria are



promulgated as Agency regulations,  EPA will be responsible for



assuring that the requirements are properly implemented.



     Importantly,  today's proposal is limited to consideration of



the WIPP' s compliance with the disposal regulations found in subparts



B and C of 40 CFR part 191 (which include containment requirements,



assurance requirements,  individual protection requirements, and



ground-water protection requirements).   These compliance criteria



do not address compliance with the management and storage regulations



found in subpart A of 40 CFR part 191.   The Agency plans to issue



guidance addressing implementation of subpart A at a later date.



     The Agency also wishes to make clear that today's proposal does



not address  compliance with all of the requirements of the WIPP LWA.



 Rather, today's proposal is limited to those requirements of the



WIPP LWA which pertain to the WIPP's compliance with the disposal



standards in 40 CFR part 191.  For example, today's proposal does



not address the WIPP's compliance with EPA regulations developed



pursuant to the Resource Conservation and Recovery Act  (RCRA)  or



any other environmental laws or regulations.  EPA intends to address



compliance with the balance of these additional laws and regulations



through compliance plans being developed by EPA's Region VI.  For



more information regarding the Region's activities,  please write



to EPA Region VI,  1445 Ross Avenue, Dallas,  Texas, 75202-2733; Attn:



Chuck Byrum.



     EPA has prepared a  document entitled  "Implementation Strategy

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for the Waste Isolation Pilot Plant Land Withdrawal Act of 1992"



(EPA 402-R-93-002, March 1993) which explains in more detail the



Agency's roles and responsibilities under the WIPP LWA.  For more



information concerning the Implementation Strategy Document, please



write to the Policy and Public Information Section, Office of



Radiation and Indoor Air, U.S.  EPA, Mail Code 6602J, 401 M St., S.W.,



Washington, B.C. 20460 or call the EPA WIPP Information Line at
     Additional Docket Information



     The Agency is currently maintaining the following public



information dockets: 1) Docket No. A-92-56, located in room 1500



(first floor in Waterside Mall near the Washington Information



Center), U.S.  Environmental Protection Agency, 401 M Street, S.W.,



Washington, B.C. 20460 (open from 8 : 00 a .m. to 4 : 00 p .m. on weekdays) ;



2) EPA's docket in the Government Publications Department of the



Zimmerman Library of the University of New Mexico located in



Albuquerque, New Mexico (open from 8:00 a.m. to  9:00 p.m. on Monday



through Thursday, 8:00 a.m. to 5:00 p.m. on Friday,  9:00 a.m. to



5:00 p.m. on Saturday, and 1:00 p.m. to 9:00 p.m. on Sunday); 3)



EPA's docket in the Fogelson Library of the College of Santa Fe in



Santa Fe, New Mexico located at  1600 St. Michaels Drive  (open from



8:00 a.m. to 12:00 midnight on Monday through Thursday,  8:00 a.m.



to 5:00 p.m. on Friday, 9:00 a.m. to 5:00 p.m.  on Saturday, 1:00



p.m. to 9:00 p.m.  on Sunday); and 4) EPA's  docket in the Municipal



Library of Carlsbad, New Mexico located at 101 S. Halegueno  (open



from 10:00 a.m.  to 9:00 p.m. on Monday  through Thursday,  10:00 a.m.

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to 6:00 p.m.  on Friday and  Saturday, and 1:00 p.m. to 5:00 p.m. on



Sunday) .   As provided in 40 CFR part 2 , a reasonable fee may be charged



for photocopying docket materials.



     Description Of Proposed Criteria



     The proposed criteria consist of four  subparts.  Each of these



subparts is discussed in more detail below.



     Subpart A--General Provisions



     Subpart A is chiefly concerned with identifying the purpose,



scope and applicability of the criteria,  defining terms,  setting



forth requirements regarding  communications, addressing conditions



of compliance certification and determinations,  incorporating



publications by reference, and providing for alternative provisions



if future information  indicates a need to modify the criteria.  The



specific provisions of Subpart A are discussed below.



     Purpose, Scope, and Applicability



     Under Section 7 (b)  of  the WIPP LWA, the DOE cannot dispose of



transuranic waste at the WIPP until the EPA certifies that the WIPP



is in compliance with the Agency's radioactive waste disposal



standards set forth in 40 CFR part 191.  In addition, under Section



8(f)  of the WIPP LWA, not later than five years after initial receipt



of waste for disposal  at the  WIPP, and every five years thereafter



until the end of the decommissioning phase (as defined in section



2 of the WIPP LWA),  DOE  is  required to submit to the Administrator



documentation of continued compliance with the Agency's disposal



standards.  EPA is proposing to specify that these criteria will



apply to any certification of compliance or determination of






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continued compliance under these sections of the WIPP LWA.  The



Administrator will review any compliance applications (hereinafter,



the term "compliance applications" refers to applications for



certification of compliance under section 8(d)  of the WIPP LWA as



well as applications for determinations of continued compliance under



section 8(f) of the WIPP LWA) and will utilize these criteria to



ascertain whether such applications demonstrate compliance with



subparts B and C of 40 CFR part 191.  The Administrator's



certification or determination of  compliance for the WIPP facility



will depend on satisfying the specific requirements of each section



of these criteria.



     Definitions



     In an effort to be  consistent with the disposal standards set



forth in 40 CFR part 191,  the Agency is proposing that,  unless



otherwise indicated,  all terms in the criteria have the same meaning



as terms found in the disposal regulations.       Communications



     The Agency is  proposing to specify that any compliance



applications shall  be addressed to the Administrator and shall be



signed by the Secretary.  Any other communications concerning



compliance applications  for the WIPP shall, likewise, be addressed



to the Administrator and shall be signed by the Secretary or the



Secretary's authorized representative.



     Conditions of  compliance certification and determination



     EPA is proposing that any certification or determination issued



by the Agency pursuant to the WIPP LWA may include any conditions



that the Administrator finds necessary to support a compliance

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certification or determination.   In addition, EPA is proposing that



any certification or determination of compliance be potentially



subject to modification,  suspension,  or revocation for cause.  The



Agency believes that such conditions are necessary in order to guard



against the possibility that the disposal system does not perform



as expected (i.e., according to predictions contained in compliance



applications).



     Any certification or determination of the WIPP's compliance



will be based upon the information contained in any compliance



application submitted to the Administrator and upon other available



information relevant to the application.   So long as the contents



of the application remain valid, the current certification or



determination will remain valid.  However, if the information



contained in the application becomes invalid due to unanticipated



developments, then the basis for the certification or determination



may no longer be valid, and modification,  suspension, or revocation



of the certification or determination may be in order.  Any



modification, suspension,  or revocation of a compliance



certification will be subject to Agency rulemaking.



     EPA is proposing to include these conditions because the Agency



believes it is important to have a mechanism which enables a



certification or determination to be modified, suspended, or revoked



if new information comes to light which suggests that the WIPP is



no longer performing or may no longer perform as predicted.  It would



not be prudent to wait until submission of documentation of continued



compliance (potentially up  to five years later) before  taking steps

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to mitigate against potential malfunctioning of the disposal system.



 Delay would allow a situation which could result in a violation



continuing to exist or, perhaps, worsen.  Hence, EPA is proposing



these conditions in order to be able to take action quickly to address



serious issues raised as to  whether  the  WIPP is in compliance with



the disposal regulations.



     The Agency is not specifying,  in today's proposal, the



particular actions which may be required to be undertaken if



modification or suspension were invoked.  EPA has not done so because



the Agency believes that it  is inappropriate to specify particular



actions prior to knowing the precise circumstances in which the



actions would be undertaken.  Since all of the scenarios in which



the conditions might be invoked would be difficult to predict,



specification of the actions necessary to mitigate against the



consequences of all such scenarios becomes even more difficult.



EPA, therefore,  is proposing that decisions about the appropriate



actions shall be based upon the nature and gravity of the given



scenario at the time it occurs.   In some cases this might entail



instituting remedial actions or even removal of waste, while in other



cases it might simply involve temporarily halting waste emplacement.



 Thus, actions will be evaluated on a case by case basis.   The Agency



solicits comment on this approach.



     While the Agency is not  specifying the particular actions which



may be required in the event of a modification or suspension,  the



Agency is proposing that, in the event of a revocation  (where



presumably all attempts at remedial action have failed), the






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Department shall retrieve, to the extent practicable, any waste



emplaced in the disposal system.  The Agency solicits comment on



this proposal.








     The Agency is proposing that upon written request of the



Administrator  (after any certification or determination of



compliance has been issued) ,  the Department shall submit information



to enable the Administrator to determine whether cause exists to



modify, revoke, or suspend any certification or determination.



Moreover, the EPA is proposing that the Department shall provide



the requested information to the Administrator within 30 days of



receipt of the Administrator's request.   By requiring such a quick



response time, the Agency can be assured that  if  circumstances arise



which warrant  suspension, modification, or revocation,  the potential



consequences of such circumstances can be mitigated early and safety



can, therefore, be increased.       As an additional measure to



ensure that the Administrator  is  kept apprised  of any developments



at the WIPP which might warrant modification, suspension, or



revocation of any certification or determination of compliance, the



Agency is proposing that the Department report, within ten days of



discovery, any significant changes in conditions pertaining to the



disposal system that depart from the application and which formed



the basis of any certification or determination.   Moreover,  the



Agency is requiring that a written report of all changes in conditions



and/or activities pertaining to the disposal system that depart from



the application and which formed the basis of any certification or






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determination be submitted to the Agency at least once every six



months.  If the Department plans to intentionally make any



significant changes in conditions or activities pertaining to the



disposal system, all such changes must be approved by the



Administrator prior to being made.  The Administrator will consider



whether the planned change will invalidate the terms of the



certification or determination in assessing whether approval should



be given.



     EPA is proposing to require the reporting of changes in WIPP



conditions or activities once every six months to assure that the



Agency is kept apprised of such changes but in a manner which is



not overly burdensome to the Department in submitting the information



or to the Agency in reviewing it.



     EPA is also proposing to require that if the Department



determines that  a release of waste from the disposal system in excess



of what is permitted under the disposal regulations has occurred



or is likely to occur,  the Department shall immediately suspend



emplacement of waste in the disposal system and notify the



Administrator within 24 hours of discovery of such a release.



Following such notification, the Administrator may request



additional information and will determine whether to modify, suspend,



or revoke any previously issued certification or determination of



compliance.  The EPA is proposing this requirement to ensure that



the Administrator is quickly apprised of any changes in the disposal



system's performance from the projections included in any compliance



applications.





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     Publications incorporated by reference



     EPA is proposing that the following four documents be



incorporated by reference:  (1)  the Nuclear Regulatory Commission's



NUREG 1297  "Peer Review for High-Level Nuclear Waste Repositories";



(2)  The American Society of Mechanical Engineers'  (ASME) NQA-1-1989



edition "Quality Assurance Program Requirements for Nuclear



Facilities"; (3) ASME NQA-2a-1990 addenda (part 2.7)  to ASME



NQA-2-1989 edition "Quality Assurance Requirements of Computer



Software for Nuclear Facility Applications" ; and (4) ASME NQA-3-1989



edition "Quality Assurance  Program Requirements for the Collection



of Scientific and Technical Information for Site Characterization



of High-Level Nuclear Waste Repositories."  The Agency is proposing



to incorporate  all of these  documents because EPA believes that each



is appropriate  for use at the WIPP.  More detailed  information about



the  contents of each document is provided below in the sections



dedicated to the particular topic covered by the various documents.



 Documents incorporated by reference are also available for



inspection in the Office of the Federal Register.



     Alternative provisions



     Although the Agency believes that  the criteria being proposed



today are appropriate based upon current knowledge and information,



the  possibility that future information may indicate necessary



modifications to the criteria can not be ruled out.



     In recognition of this possibility,  today's proposed criteria



set  forth procedures under which the Administrator may develop



modifications to this part, should the need arise.  Any such






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modifications would proceed through the notice-and-comment



rulemaking process under the Administrative Procedure Act  (5 U.S.C.



553) .   The proposed criteria stipulate that such a rulemaking would



require a public comment period of at least 120 days, including public



hearings in New Mexico.



     Subpart B--Compliance Certification and Determination



Applications



    Subpart B of the proposed compliance criteria addresses: 1) the



completeness and accuracy of compliance applications; 2) the filing



and distribution requirements for such applications and any



associated reference materials; 3)  the contents of a complete



application; and 4) the criteria for updating certification



applications.  Each of these sections is discussed below.



     Completeness and accuracy of compliance applications



     The Agency proposes to require that any applications submitted



to the Administrator for a certification or determination of



compliance be complete and accurate.  Since the statutory review



period for applications  is  only one  year for certification and six



months for determinations,  it is essential that all of that time



be devoted to substantive evaluation of the information contained



in the applications.  Therefore, the Agency is proposing that the



statutory review periods not begin until the Administrator has



determined that the application is complete,  accurate, and in



accordance with the compliance criteria.  The Administrator will



notify the Secretary in writing once this determination is made.



     Submission of compliance applications





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     In order to meet EPA's needs for reviewing and docketing any



compliance applications, the Agency proposes to require that 30 paper



copies of applications be filed with the Administrator (one original



and 29 printed copies),  unless otherwise specified by the



Administrator.  This number of copies is necessary because the Agency



plans to place copies of compliance applications in various public



dockets and the complexity of the application material will require



multiple reviewers.   The phrase  "unless otherwise specified by the



Administrator" is meant to allow for the possibility of alternative



requirements for submission of compliance applications in the event



that new submission methods are developed; e.g.,  electronic



submission requirements.



     Submission of reference materials



     The Agency recognizes that compliance applications will likely



include references to other sources of information.   Accordingly,



today's proposal requires submission to the Administrator of ten



paper copies of any  referenced material unless otherwise specified



by the Administrator.  This is necessary due to the limited time



period for review and due to the needs of multiple reviewers,



including the public.  Again, the phrase "unless otherwise specified



by the Administrator" signals that the Administrator may require



an alternative method for submission of reference materials if a



more appropriate system  (e.g., an electronic  submission  system) is



developed.  Regardless  of what system is ultimately used,



submissions need not include referenced material from standard



textbooks  (e.g.,  physics or chemical handbooks).






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     Content of compliance certification applications



       The Agency is proposing to specify information which must



be included in any compliance certification application.  The



proposed criteria require descriptions of the WIPP disposal system



and surrounding environment,  and the components and results of



long-term compliance assessments.  The items listed,  however, are



not intended to be an exhaustive identification of the necessary



elements of a complete application.  Rather, the proposed criteria



identify what the Agency considers to be major elements of a complete



compliance application.   Note that other major submission



requirements are discussed elsewhere in the criteria and are too



numerous to list here (such as documentation requirements for use



of expert judgment and for waste characterization).



     In the future,  the  Agency will  be issuing a detailed guide as



a supplement to the 40 CFR part 194 compliance criteria.   This guide



will provide additional detailed information on the expected format



and content of a complete compliance application. The Agency is not



including such a detailed itemization in today's proposal because



EPA needs more information about  factors important to the disposal



system's ability to contain waste before such detailed submission



requirements can be identified.



     As an example of the type of information which may be necessary



for inclusion in a complete application,  but which EPA is not



specifying in today' s proposal due to  the fact that there is currently



an incomplete understanding of its effect on the disposal system,



is an analysis and identification  of higher permeability marker beds






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in the host rock.   (Marker beds are stratified units with distinctive



characteristics making them an easily recognized geologic horizon.)



 At present,  there is  some information about the existence of these



marker beds in the host rock,  but little knowledge about how they



may affect the transport of radionuclides and the flow of ground



water.   As further study is done of these marker beds, it is possible



that they may be discovered to have a great impact on the WIPP's



ability to comply with the disposal standards of 40 CFR part 191.



 It is also possible that they will be discovered to have little



or no impact.   Depending  on the results of further study, then, EPA



will decide whether  information about  the higher permeability beds



needs to be included in compliance applications and  if so, how much



information.  EPA solicits comment on this approach.   Content of



compliance determination application(s)



     As required by section 8(f)  of the WIPP Land Withdrawal Act,



DOE must submit documentation of continued compliance every five



years after any initial certification is granted for the WIPP until



the end of the decommissioning phase,  when  all shafts and rooms at



the WIPP are backfilled and sealed.  To avoid duplication of



information already submitted to the Administrator as part of any



previous compliance applications, EPA proposes to require that only



relevant new information be submitted as documentation of continued



compliance.  This documentation must update the information



contained in previous applications and apprise the Agency of  new



developments regarding the WIPP disposal system and its performance.



 Information included in previous applications may be summarized





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and referenced.



     Subpart C--Compliance Certification and Determination



   Subpart C sets forth general and specific requirements for



certifying and determining compliance with the provisions of the



disposal regulations found in subparts B and  C of 40 CFR part 191.



 The provisions of Subpart C are discussed in detail below.



     General Requirements



     Inspections



     Today's proposal provides for EPA inspections to help ensure



that WIPP-related activities and pertinent records described in any



compliance applications are implemented as described.  Inspections,



including, random, unannounced inspections of WIPP-related



activities and records,  will assist EPA in assuring the validity



of information used to support compliance applications.  In



conducting such inspections, EPA will comply with applicable access



control measures for security, radiological protection and personal



safety, but shall otherwise have unfettered access to WIPP-related



activities and records.



     To facilitate EPA's ability to inspect as warranted,  EPA is



proposing that, upon request, the Department provide the



Administrator's inspectors with rent-free office space convenient



to the WIPP disposal system.   Additionally, records shall be made



immediately available to Agency inspectors where possible,  and in



no circumstances shall the furnishing of records be extended beyond



30 days from the initial request.



     As an additional matter, the Agency believes  that on occasion,






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EPA personnel may need to conduct sampling and analysis or monitoring



of the disposal system.   Such sampling may include split sampling,



in which portions of samples taken by the DOE shall be furnished



to EPA for analysis.  Through split sampling,  EPA can independently



verify the results of DOE analyses.  Moreover, by taking such



samples, EPA will be better equipped to evaluate the quality of data



being produced, as well as gain a better understanding of the disposal



system.



     EPA proposes that its inspection privileges be broad enough



to allow the Agency to inspect activities that may provide information



used to support compliance application(s)  and are deemed by the



Administrator or the Administrator's authorized representative to



be relevant to a compliance certification or determination.   This



may include, but is not necessarily limited to, examination of quality



assurance procedures, waste characterization activities,



experimental programs, computer operations,  and data collection



activities,  insofar as all of these items may affect the WIPP's



ability to comply with the 40 CFR part 191 disposal regulations.



Significantly,  under today's proposal,  EPA inspections would be



limited to locations to which the Department has rights of access



but would not be limited to activities which occur at the WIPP



facility.  As discussed above, if an activity can potentially affect



the WIPP's ability to comply with the Agency's  disposal regulations,



it shall be  subject to potential inspection by EPA personnel.  For



instance, EPA may inspect WIPP-destined waste generation and storage



sites because waste characterization activities often occur at these






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sites.



     Quality Assurance



     To help assure that calculations of compliance with 40 CFR part



191, subparts B and C, are based upon sound data and information,



the Agency proposes to include compliance criteria addressing quality



assurance (QA).   EPA is proposing that the Department implement a



QA program that meets the requirements of the American Society of



Mechanical Engineer's  (ASME)  "Quality Assurance Program Requirements



for Nuclear Facilities" (NQA-1-1989 Edition), ASME's "Quality



Assurance Requirements of Computer Software for Nuclear Facility



Applications" (NQA-2a-1990 addenda, part 2.7 to ASME NQA-2-1989



edition), and ASME's "Quality Assurance Program Requirements for



the Collection of Scientific and Technical Information on Site



Characterization of High-Level Nuclear Waste Repositories"



(NQA-3-1989 edition--excluding Section 2.1(b) and (c)).  EPA is



proposing to use the ASME standards referenced above because it



appears they offer the most comprehensive and specific set of QA



requirements for all compliance-related elements of the disposal



system.  EPA solicits comment on whether these standards are the



most appropriate to use for this purpose.



     With respect to data  collected prior to  the implementation of



the ASME standards,  EPA is proposing that such data be acceptable



for the purpose of supporting any applications for compliance



certification if it  can be demonstrated to have been collected:  (1)



under a QA program that is equivalent in scope and implementation



to the NQA series, or (2)  through a method otherwise approved by






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the Administrator for use at the WIPP.  Today's proposal does not



include any specific criteria identifying how such equivalence should



be demonstrated, nor is there any specification about what the Agency



will consider in approving QA plans.  The Agency intends to issue



guidance on this topic in the future.



     The Agency is proposing to allow a flexible approach on quality



assurance for data collected prior to implementation of the ASME



NQA series because the Agency recognizes  that unless a method exists



for qualifying such "old data, "   the efforts in collecting such "old



data" will be wasted.   It is likely that  a large portion of the data



submitted in support of an application for certification of



compliance will be "old data."  To prohibit the inclusion of such



data if the data can be demonstrated to be of equivalent quality



to "new data," or is sufficiently reliable for approval by the



Administrator, would be unreasonable because data that are



sufficiently reliable should be included in the analysis .   The Agency



solicits comment on this approach.



     The ASME NQA-1-1989 edition sets forth requirements for the



"establishment and execution of quality  assurance programs for the



siting, design, construction, operation, and decommissioning of



nuclear facilities."



     The NQA-2(a)-1990 addenda (part 2.7) to ASME NQA-2-1989 edition



standard is directed toward establishing requirements for "the



development, procurement, maintenance, and use of computer software,



as applied to the design, construction,  operation, modification,



repair, and maintenance of nuclear facilities."   More specifically,





                                21

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it applies to computer software "used to produce or manipulate data



which is used directly in the design, analysis, and operation of



structures, systems, and components."



     The NQA-3-1989 edition standard sets forth quality assurance



requirements for "the collection of scientific and technical



information for site characterization of high-level nuclear waste



repositories."   The requirements apply to "activities which could



affect the quality of scientific and technical information collected



as part of the site characterization phase of high-level nuclear



waste repositories... [which include] as a minimum:  (a) readiness



reviews; (b) peer reviews;  (c) data and sample management;  (d) data



collection and analysis; (e) coring; (f) sampling;  (g) in situ



testing; and (h)  scientific investigations."



     EPA is proposing criteria which require submission of



information which demonstrates that QA programs have been established



and executed for   aspects of the WIPP disposal  system  important to



the containment of  waste in the disposal system.  QA programs must



address elements  such as models used to support applications for



certification of  compliance, waste characterization,  monitoring,



field measurements,  design of the disposal system (and actions taken



to ensure compliance with design specification),  use of expert



judgment, and  other factors important to the containment of



radionuclides in  the disposal system.   EPA solicits comment on the



appropriateness of the items listed above and on any other items



which should be specifically included in such a list.   The Agency



also is proposing that applications for certification of compliance





                               22

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address how quality indicators such as data accuracy,  precision,



representativeness, completeness, comparability,  and



reproducibility have been or will be achieved in the collection of



compliance data and information.



     As a final matter,  the  Agency  is proposing to conduct its own



examination of  DOE QA programs and plans through select inspections,



management system reviews, and audits.   This is  to help assure that



QA plans are implemented appropriately.



     Models and computer codes



     Computer models are needed to assess whether the WIPP disposal



system will comply with the 40 CFR part 191 disposal regulations.



 In order for these computer models to perform their functions with



acceptable accuracy, they must be based upon appropriate conceptual,



mathematical, and numerical models.



     In order to ensure that the conceptual, mathematical, numerical,



and computer models used to support compliance  applications are



appropriate for use in certifying whether the WIPP complies with



the disposal regulations,  EPA proposes to require that detailed



information about these models be submitted to  the Agency as part



of any compliance certification applications.   EPA proposes to



assess the appropriateness of the models and any  computer codes used



to represent them based on the following factors: whether conceptual



models reasonably represent the disposal system;  whether



mathematical models incorporate equations and boundary conditions



which reasonably represent mathematical formulations of the



conceptual models; whether numerical models provide numerical






                                23

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schemes which enable  mathematical models to obtain stable



solutions; whether computer models accurately implement the



numerical models (i.e., are free of coding errors and produce stable



and accurate solutions); and whether the models,  data, and computer



codes have been properly peer reviewed.  EPA solicits comment on



these factors and whether other factors should be included.  For



instance, should EPA require information which demonstrates that



there is agreement between the model results and any measured and



observed data?   Or, if it can be demonstrated that models and computer



codes are sufficiently conservative, is such demonstration



unnecessary?



     In addition, EPA is proposing to require that the American



Society of Mechanical Engineer's NQA-2a-1990 addenda (part 2.7 to



ASME NQA-2-1989  edition) be used to help ensure that models and codes



are fully and clearly documented.



     In order to determine whether the conceptual models used to



support a compliance certification application offer the best



representation of the disposal system,  EPA is proposing  to require



a complete listing and description of  conceptual models considered



but not used to support such application.  In addition,  EPA is



proposing to require  a complete listing  of  conceptual model(s)



considered but not used to support compliance certification



applications, a description of such model(s),  and an explanation



of the reason (s)  why such model (s) was/were not used.  An examination



of conceptual models requires an assessment as to whether the theories



represented in conceptual  models are appropriate and whether other





                                24

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theories may be more or equally appropriate.  For this reason, EPA



is proposing that the DOE identify and describe all conceptual models



that the Department considered and provide justification why some



were selected and others were not.  The Agency solicits comments



on this approach and on whether any particular theories should be



represented in conceptual models used to support compliance



certification applications.



     EPA is proposing to require that documentation include such



items as: descriptions of the theoretical backgrounds of each model,



the method of analysis and  assessment, scenario construction, data



collection procedures,  and code structures and source codes.  In



addition,  the Agency is proposing that user's manuals be submitted



that include the following information:  discussions of the limits



of applicability of each model;  detailed instructions for running



the codes including hardware and software requirements;  input and



output formats with detailed explanations of each input and output



variable and parameter;  listings of input and output files with a



sample computer run; reports on code verification,  benchmarking,



validation and quality assurance procedures.   The Agency is also



proposing to require the submission of programmer's manuals and any



necessary licenses.  Programmer's manuals typically include such



things as the mathematical formulations included in the model,



computational algorithms and modeling structures.



     In addition, because the WIPP disposal system is very complex,



it is likely that some of its characteristics correlate to one



another.  If this correlation is not reflected in modeling efforts,






                               25

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then the models may fail to portray the realities of the system and



significant errors in performance assessment results can occur.



Covariance, a measurement of the tendency of random variables to



vary together, is used to evaluate this possibility.   Therefore,



EPA is proposing that information be provided which indicates whether



and how models and codes handle covariance of model input parameters.



 If models do not consider covariance, EPA would expect to be provided



with an explanation of why covariance was not considered and the



potential impact of instead treating variables independently.  EPA



solicits comments on this approach and on the alternatives of  (1)



requiring covariance to be included in models and codes and, (2)



requiring covariance to be included unless justification can be



provided that the independent treatment of variables would cause



models to predict  greater releases than if covariance  is taken into



account.



     Finally, EPA proposes that copies of  the models and  software,



data files, source codes,  licenses,  or other materials necessary



to run the models on EPA's own computers  (or on DOE computers if



EPA computers are unable to run the models)  be provided to the Agency



within 30 days of a request by the Administrator or the



Administrator's authorized representative.  Additional



requirements for models are covered in the quality assurance and



peer review sections of today's proposal.



     Waste Characterization



     In order to make  meaningful predictions about the performance



of the WIPP over long periods of time, it is necessary to have a






                                26

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good understanding of the characteristics of the waste proposed to



be emplaced in the disposal system.  The potential for releasing



radionuclides from the disposal  system can be directly affected by



the chemical,  radiological,  and  physical composition of the waste.



 These factors, therefore, can affect the ability of the WIPP to



comply with the 40 CFR part 191 disposal standards and, consequently,



must be examined as part of any certification or determination of



compliance.



     Currently, the waste inventory to be potentially disposed of



at the WIPP consists of: 1)  a large volume of stored ("existing")



waste with varying degrees of adequacy of accompanying documentation



regarding its composition and properties; and 2)  an estimated larger



volume of "to-be-generated" waste about which there is  uncertain



knowledge of its expected composition and properties.



     For the purpose of gaining a complete understanding of the waste



proposed for disposal at the WIPP, EPA is proposing to require



submittal of a detailed  description of the waste's chemical,



physical, and radiological contents including a description of the



activity in curies of each radionuclide contained in such waste  .



 Such  description shall be used in assessing compliance with



subparts B and C of 40 CFR part 191.



     To identify   waste characteristics important to the containment



of waste in the disposal system,  EPA is proposing that DOE undertake



a study to determine the effect of various characteristics on the



performance of the disposal system.  The characteristics studied



shall include,  but need not be limited to:  (1)  waste form;  (2) free





                                27

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liquid content and liquid saturation;  (3) pyrophoric and explosive



material content, and (4) characteristics  affecting the



solubilization and mobilization of radionuclides,  formation of



colloidal suspensions containing radionuclides,  production of gas



from the waste,  nuclear  criticality,  and  generation of heat in the



disposal system.   The impact of non-radioactive hazardous components



of the waste should also be assessed as such components have the



capacity to influence  radionuclide  transport.  The results of this



study shall be provided to EPA along with documentation of the



methodology and information describing the importance of particular



characteristics of the waste.  These results shall dictate the



breadth of characterization to be performed.



     Once the waste characteristics that are important to the



disposal system's ability to isolate radionuclides have been



identified, the waste shall be categorized based on those



characteristics that would be expected to make all waste within a



particular category behave similarly in the disposal system.  For



example, if the curie  content of  a  given  radionuclide in the waste



is determined to be important to the disposal system's ability to



contain radionuclides, it might be used as part of a system of



categorization.  Waste having a high curie content of that nuclide



could comprise one category, while waste having a low curie content



of that nuclide could comprise another category.   Similarly, if a



given waste form is found to be important, categories could be made



for various waste forms such as sludges and solids.   EPA proposes



that a detailed description shall be provided which identifies the






                                28

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characteristics of each category of waste established.



     A variety of methods for characterizing waste exists including



sampling and analysis,  radioassay,  and examination of waste



generation documentation and associated records  (often referred to



as "process knowledge").  Today's proposal does not specify any



particular method for characterizing the waste.  Nevertheless,



regardless of which method or combination of methods is selected



for waste characterization activities, the Agency is proposing to



require that each method be identified and described.  Moreover,



the uncertainty associated with each method shall be identified,



and if information about the processes and materials that generated



the waste is used as a basis for waste characterization,  the DOE



shall be required to substantiate such characterization.



     The manner in which the Agency proposes that waste



characterization shall be accomplished is  explained below.  The DOE



will examine each important characteristic of the waste and determine



a value or range of values for that characteristic.  Since DOE must



demonstrate that the WIPP complies with the containment, individual,



and ground-water protection  requirements of 40 CFR part 191 for the



whole range of values for each waste characteristic, the larger the



range, the greater the uncertainty associated with a claim that WIPP



complies.  DOE can reduce the range of values for each characteristic



through enhanced information gathering until the range is small



enough such that DOE is reasonably confident that the resulting



probability for compliance will meet the containment, individual,



and ground-water protection  requirements of 40 CFR part 191.   Thus,






                                29

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DOE has a great deal of flexibility in the amount of characterization



required.  However,  whatever value or range of values DOE selects



for each characteristic must be considered in compliance assessments



of the WIPP.  In assessing compliance,  DOE shall consider all



combinations of waste characteristics and the resulting impact on



the disposal system's behavior.



     EPA is proposing that waste  not be emplaced in the repository



unless its characteristics fall within the ranges of values for those



characteristics used in compliance assessments.  To assure that only



waste whose characteristics fall within the given range of values



is emplaced, the Agency is proposing that a system of controls be



established, including measurements,  sampling, and record-keeping



for the  waste, such that the actual characteristics of waste will



be identified before the waste is emplaced in the WIPP.  Compliance



applications shall provide an identification and description of these



controls along with an analysis of the uncertainty associated with



them.



     As  a final measure to assure proper waste characterization,



the Agency  is proposing that EPA audits and inspections will be used



to verify the waste characterization requirements of this part.



     Future state assumptions



     Demonstrating compliance with 40 CFR part 191, subparts B and



C, involves the use of computer models  based on conceptual models



which project, over an extended period  of time,  the transport of



radionuclides from the disposal system to the accessible environment



and resulting radiation doses to  individual members of the public.






                               30

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 Because of the long-term nature of these evaluations, uncertainty



of values for many parameters important to the analysis may be very



large.  Environmental conditions and living habits of future



populations and individuals may change in significant and



unforeseeable ways over the lengthy timeframes that will be analyzed



for compliance.



     In light of the difficulty of assigning appropriate values with



confidence, the Agency is proposing to specify certain assumptions



about the future for use in long-term modeling.   The Agency is



proposing that, unless otherwise specified, any certification of



compliance shall assume that characteristics of the future remain



what they are today.  EPA believes such an approach will enable



compliance assessment to focus  on more predictable and more



significant features of disposal system performance.   For instance,



EPA is proposing that  such  an approach not be used to characterize



the long-term geologic, hydrologic,  or climatologic conditions of



the system and its vicinity.



     With regard to consideration of climatic conditions, the Agency



is proposing to require predictions about climate, but within a



specified framework.  Specifically,  EPA is proposing to limit the



consideration of climate effects to the effects of increased and



decreased precipitation on the disposal system.   This  would include



predictions of temperature, which affects evapotranspiration, and



other factors.



     With respect to human technology and behavior, EPA has



tentatively concluded that it would be fruitless to attempt any






                                31

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predictions about the future that would be useful over 10,000 years.



 The one constant in human history is change--in social organization,



economic activity,  and technology.   Thus,  at  first glance it seems



highly anomalous to assume that future states will be like the



present.   However,  as noted, EPA believes that  there is no reasonable



way to predict in any definitive way what changes will take place



in the future.   In  effect, then, EPA is proposing to employ present



conditions as default values for future states because it has no



better choices,  and because this approach at least has the advantage



of providing readily ascertainable and verifiable values.



     The Agency solicits comment on its approach to future states



assumptions and the Agency's treatment of geology, hydrology, and



climate considerations.   Suggestions of alternatives to the proposed



approach are also solicited.



     Expert judgment



     EPA recognizes that expert judgment may be used to support



disposal system compliance analyses.  EPA is  proposing that use of



expert judgment be limited to those situations where data is not



reasonably attainable through data collection or experimentation.



     To assure that the Agency is aware of all cases in which expert



judgment is used, EPA is proposing that any compliance certification



application clearly identify all instances in which such judgment



is used and the names and professional affiliations of experts



involved.  Moreover, documentation shall be included which describes



the process for expert judgment elicitation,  the  results of expert



elicitation,  and the reasoning behind those results.  Documentation






                                32

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shall also be provided of  interviews used to elicit judgments from



experts, deliberations and formal interactions among experts,



background information provided to experts,  and the questions  or



issues presented for elicitation of expert judgment.   Access to this



information will help the Agency assess the quality and



appropriateness of expert  judgment as well as DOE's interpretation



and use of that judgment.



     Although EPA has not specified any particular methods for expert



judgment elicitation in today's proposal,  the Agency does believe



that some restrictions and guidelines  for the selection of



individuals for expert judgment are appropriate.   The restrictions



which EPA is proposing today include prohibitions  on:  selecting



individuals who are members of the team of investigators requesting



the judgment or the team of investigators who will use the judgment;



selecting individuals who maintain a supervisory role or who are



supervised by  (directly or indirectly)  those who will utilize  the



judgment; and selecting a membership of which no more than one-third



consists of individuals who are employed directly by the Department



or its contractors (unless it can be shown that this is impracticable



because of a lack or unavailability of qualified independent experts,



in which case at least one-half of the membership  must be non-DOE



personnel).  University professors with grants  from the Department



not related to work on the WIPP and the New Mexico Environmental



Evaluation Group are not considered employees or contractors of the



Department for purposes of this part.   Additionally,  compliance



applications shall provide information which demonstrates that  the






                               33

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expertise of any individuals involved in expert judgment is



consistent with the level  of knowledge required by the question or



issue presented to that individual.



     Furthermore,  the Agency is requiring that at least five



individuals be used in any expert elicitation process,  unless a lack



or unavailability of experts can be demonstrated.  Also, any



compliance certification application shall include a discussion



explaining the relationship between the information presented, the



questions asked, the judgment of any expert panel or individual,



and the purpose for which the expert judgment is being used.   The



Agency is proposing all of the above requirements to assure that



expert judgment is elicited in a manner that is as objective and



informed as possible.



     As a final means of helping to assure the appropriateness of



expert judgment, EPA is proposing that the elicitation process afford



an opportunity for presentation to the experts of the scientific



and technical views of outside groups and individuals.  This



provision is being proposed in today's notice because the Agency



believes it will help to provide experts involved in elicitations



with a fuller range of information and view points upon which to



base their judgments.



     The Agency considered several  different approaches  to the use



of expert elicitation and concluded  that though each was appropriate



for a specific type of situation, none were appropriate for all types



of situations.  For example, one approach identified would require



that the average of all  values  elicited by an expert panel be used





                               34

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as the final judgment.  This maybe appropriate if the issue presented



to an expert panel  lends  itself to meaningful averaging of values.



 For instance,  if an expert panel is asked to determine the rate



of rainfall in the Delaware Basin over 10,000 years,  the range of



answers that would be obtained from the various experts would be



expressed in numbers that could be meaningfully averaged.  However,



if an expert panel is asked to determine whether the possibility



of a meteor hitting the WIPP site is likely, the answers would be



expressed in terms of yes or no,  which cannot be meaningfully



averaged.  Hence, depending on the situation, this approach may not



be appropriate.



     Given the above,  EPA believes that it may not be useful to specify



a particular method.   However,  the Agency solicits comments on



alternative approaches to incorporating the results of expert



judgment elicitations into compliance assessment.



     Peer review



     Peer review is widely used as a means of validating technical



data, processes and assumptions.   Peer review involves a group of



experts who are convened to review work conducted by their peers



to determine whether the work was performed appropriately and in



keeping with the purpose intended.



     Since a large  part of  compliance applications will consist of



data and descriptions of methods for producing data,  EPA believes



that peer review can be helpful  as a means of validating the



information contained in  such applications.  Therefore, the Agency



proposes that peer review be used to support compliance applications.






                               35

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 Specifically, EPA proposes to require peer review of any information



contained in any compliance certification application regarding the



evaluation of engineered barriers,  consideration of processes and



events that may affect the disposal system's performance,  quality



assurance programs and plans, models and computer codes and including



data used to support them, and waste characterization activities.



 Peer review can build additional confidence in the soundness of



these important aspects of a compliance certification.



     EPA proposes that peer review be conducted in a manner which



is compatible with the Nuclear Regulatory Commission's  NUREG-1297



"Peer Review for High-Level Nuclear Waste Repositories,"  which is



incorporated by reference in today's proposal.   This document



provides guidance on the definition of peer review, the acceptability



of peers, and the conduct and documentation of  peer review.



     Containment requirements



     The Agency's disposal regulations found in 40 CFR  part 191



include requirements for containment of radionuclides.   These



containment requirements specify numerical requirements limiting



the cumulative release of radionuclides over 10,000 years.  The



specific release limits are found in Appendix A of the  disposal



regulations.  The containment requirements specify that there be



less than one chance in ten of cumulative releases exceeding the



limits specified in Appendix A and less than one chance in 1,000



of cumulative releases exceeding ten times those limits.



     Application of release limits.



     The containment requirements of 40 CFR part 191 specify that






                                36

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releases from a disposal system to the accessible environment can



not exceed release limits set forth in Appendix A,  Table 1.



Information about the curie  content will be needed for calculation



of the release limits.  However,  because the curie content of the



waste inventory will vary over time due to natural ingrowth and decay



of radionuclides, a question arises concerning when the curie content



of the waste should be fixed  for purposes of calculating the release



limits.



      The EPA is proposing that the expected curie activity 100 years



after disposal of the waste in the WIPP be used in calculating



applicable release limits.   The Agency is proposing this approach



because EPA believes  that 100 years represents  a long enough period



of time for most  of the  radioactive material with short half-lives



to decay to low levels.   The remaining activity after the 100-year



period will largely be the result  of radioactivity from waste with



long half-lives.   Such waste may pose the most danger to human health



and the environment and,  therefore, should be the focus of attention.



     The Agency solicits comment on the appropriateness of the



above-mentioned approach and on alternative time frames for fixing



the curie content.



     Scope of performance assessments



     In today's notice,  the Agency is proposing criteria which



indicate that performance assessments shall  consider both natural



and human-initiated processes and events that may affect the disposal



system.   However, EPA is also proposing that performance assessments



need not consider processes,  events, or sequences of processes and





                               37

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events (sometimes referred to as "scenarios")  that have less than



one chance in 10,000 of occurring over 10,000 years.



    EPA is proposing the above requirements because section 13 of



40 CFR part 191 requires the implementing agencies to evaluate



compliance through performance assessments.  One method of



displaying results of performance assessments required under section



13 of 40 CFR part 191 is to assemble "complementary cumulative



distribution functions" (CCDF).   CCDFs are assembled by first



calculating the probability of each release scenario and associating



a consequence (e.g.,  release of radionuclides) with each probability.



 Once the paired probability and consequence estimates are made,



they are combined into the CCDF by ranking them in the order of



decreasing consequences.  The first point on the curve would



represent the large  consequence of a low probability scenario.  The



second point on the curve would represent the probability of the



first scenario  added to the probability of a second scenario.   Since



the probability of scenarios occurring is cumulative,  scenarios with



probabilities lower than one chance in 1,000 must be incorporated



into probability distributions assembled under section 13 of 40 CFR



part 191 to see if the results are significant with regard to



compliance assessment.



     Importantly, not all scenarios considered by the Department



will necessarily be  included in calculations of compliance with the



40 CFR part 191 disposal standards.   Some scenarios maybe eliminated



from incorporation into performance assessments because assumptions



will be made about such scenarios which indicate that the probability






                                38

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or consequences of such scenarios are outside of the scope of the



requirements of 40 CFR part  191.   In  an effort to understand which



scenarios were considered in performance assessments,  EPA is



proposing that information be provided which identifies all potential



processes, events, or sequences of processes and events that may



occur during the regulatory time frame and that may affect the



disposal system, as well as information which identifies those



processes, events, or sequences of processes and events actually



included in performance assessment results.



     Consideration of Human-Initiated Processes and Events



     Compliance with the containment requirements of 40 CFR part



191 requires consideration of the effects of human-initiated



processes and events on the disposal system.  The Agency believes



that the most productive consideration of inadvertent



human-initiated processes and events concerns those realistic



possibilities that may be usefully mitigated by disposal system



design,  site selection, or use of passive institutional controls.



 Therefore, the Agency is proposing that inadvertent and intermittent



drilling for resources (other than those resources provided by the



waste in the disposal system or any engineered barriers designed



to isolate such waste) be the most severe scenario for human-initiated



processes and events.



     Further, the Agency is limiting the consideration of



human-initiated processes and events to drilling events because



mining events were not included in EPA's analyses that supported



the final rule of 40 CFR part 191 as promulgated in 1985.






                                39

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     The Agency has chosen to divide human-initiated processes and



events into two distinct categories,  "human intrusion" and "human



activity," and is proposing a separate process to establish the



drilling rate for each.   "Human  intrusion" includes those drilling



events that reach the level of the waste in the disposal system or



below.  Such events would include,  but would not be limited to,



exploration for and development of oil and natural gas resources.



 The second category of human-initiated processes and events, "human



activity," includes all drilling events that may affect  the disposal



system, but do not reach the level of the waste in the disposal system.



 Such drilling events may include,  but would not be limited to,



exploration for potash, withdrawal of water -- whether  for purposes



of drinking, irrigating or controlling dust -- and drilling for other



resources.  Note that a  given resource may exist at levels above



and below the level of the waste in the disposal system and may



therefore be included in establishing the rates for both human



intrusion and human activity.



     EPA is proposing that consideration be given  to the record of



human-initiated processes and events in the Delaware Basin over the



past 50 years. The Agency believes that the 50-year time frame is



appropriate because it represents a period during which information



regarding human-initiated processes and events in the Delaware Basin



can be reasonably obtained.



     Importantly, by making assumptions about the frequency of



human-initiated processes and events in the vicinity of the WIPP



and holding them constant throughout the future, scenarios in which






                                40

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such events cease because,  for instance, resources eventually become



depleted would no longer be considered.  However,  the Agency



recognizes that as one resource becomes depleted,  the decrease in



exploratory or production operations  may be compensated for by the



increase in drilling operations  for another.  Rather than engage



in speculation about which resources will become more valuable in



the future,  and which will become depleted, EPA believes it is



preferable to assume that current rates of drilling for each



individual resource will remain constant.  The Agency solicits



comment on this approach.



     As stated above, the Delaware Basin is being proposed as the



area for examination of the record of human-initiated processes and



events.  The Delaware Basin is an elongated depression that extends



from just north of Carlsbad,  New Mexico,  southward into Texas.   The



Agency solicits comment on how, precisely, the Delaware Basin should



be defined.   The Agency believes that the Delaware Basin is an



appropriate region because the WIPP is situated within it and,  as



a region, it represents the largest contiguous area which shares



similar geologic and hydrologic conditions with the WIPP site.



However, EPA solicits comments on whether a different area should



be used  (such as a subset of the Delaware Basin).



     It is important  to note that the Agency is proposing to require



a separate examination of  each type of human-initiated process and



event.  The reason for this  requirement  is  to account for the fact



that each type of drilling has a distinct rate and unique properties,



resulting in a different effect on the disposal system for each type





                                41

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of drilling.   For example, oil drilling is conducted at a different



depth, rate and with a different drilling technique than water



drilling and is,  therefore, more likely to penetrate the repository



than water drilling.  Accordingly,  the analyses for each resource



must be conducted individually.



     In assessing the consequences of human-initiated processes and



events, the Agency is proposing that such processes and events be



assumed to occur at random intervals in time and space throughout



the regulatory time frame.   The consequences of each human-initiated



process and event shall be calculated in terms of the projected impact



on the WIPP disposal system.  If more than one human-initiated



process or event is predicted to occur, the consequences of any



processes and events which occur subsequent to initial ones shall



take into account any impacts on the disposal system from such



previous disruptions.  This is done to take into account the fact



that every drilling event introduces potential changes to the



disposal system.  For example,  a disposal system with man-made



pathways interconnecting aquifers underlying the disposal system



with ground water above the disposal system may react differently



than a disposal system that has never been disturbed.  In other words,



the cumulative consequences of all human-initiated processes and



events shall be taken into account in performance assessment results.



     For the purpose of performance assessments, the Agency is



proposing different criteria for establishing the frequency of "human



intrusion" and the frequency of "human activity".  While both are



based on the historical record of resource exploration over the past





                                42

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50 years in the Delaware  Basin,  an upper and lower limit is placed



on the rate of human intrusion.  The rate of human activity, however,



is not limited to a set range.



     Specifically,  the rate of human intrusion is determined by first



identifying and examining past occurrences of human intrusion in



the Delaware Basin over the past 50  years for all resources.



     The sum of the individual rates of human intrusion for each



resource then becomes the rate of human intrusion to be used in



performance assessments,  provided that  the sum  is not less than 25



and not  greater than 62.5 boreholes per  square kilometer per 10,000



years.   In the event that the calculated total rate is less than



25, then the rate of human intrusion to be used in performance



assessments should be adjusted upward proportionally to yield a total



rate of  25 boreholes  per  square  kilometer per 10,000 years.   Thus,



if the oil drilling rate  is 8 and the natural gas drilling rate is



2, both  values are adjusted upward by a factor of 2.5 to yield a



rate of 20 for oil and 5 for natural gas.  Likewise, if the calculated



total rate exceeds 62 .5, then the rate of each type of human intrusion



should be adjusted  downward proportionally to yield a maximum rate



of 62.5  boreholes per square kilometer per 10,000 years to be used



in performance assessments.








     By  placing an upper and lower limit on the rate of human



intrusion, the  Agency is adhering to the assumptions that the Agency



made in  developing the technical basis  used for formulating the



containment requirements of the final disposal regulations as






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promulgated in 1985.  As part of the development of the disposal



regulations, the Agency estimated the range of future human intrusion



and human activity for the general case of a repository in bedded



salt, the geologic setting of  the WIPP.  Assumptions were made about



the presence near a repository of different types of resources --



including oil,  gas, minerals and water -- though it was assumed that



the most significant resources present would be oil  and gas.  Using



drilling data from the contiguous 48 states as a rough guide,  the



Agency estimated that a region of bedded salt would experience 25



to 62.5 boreholes per square kilometer per 10,000 years.   Because



the depths at which oil and gas, the only significant resources



assumed to be present, are located typically exceed 10,000  feet the



estimated range applies only  to the  rate of human intrusion. Thus,



by proposing a human intrusion range of 25 to 62.5 boreholes per



square kilometer per 10,000 years, the Agency is grounding the



criteria on the same basis as 40 CFR part 191.   Discussion of the



assumptions as developed for  the 1985 final rule  of 40 CFR part 191



can be found in "Technical Support of Standards  for High-Level



Radioactive Waste Management, Volume D" (EPA 520/4-79-007D) and



"Addendum to Volumes C and D"  (EPA 520/4-79-007E).



     The Agency is proposing that, should the Department wish to



forego the process of analyzing the historical rates of human



intrusion events  in  the Delaware Basin, the Department shall assume



the maximum rate  of  62.5 boreholes per square kilometer per 10,000



years.  The Agency is further proposing that the rate  of human



intrusion may be reduced in accordance with the  criteria found in





                                44

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194.41, active institutional controls,  and 194.43(c),  passive



institutional controls.   A complete discussion of reduction of the



human intrusion rate can be found in the discussion of those two



portions of the criteria.



     For consideration of "human activity" in performance



assessments, the Agency  is proposing that  the historical record of



drilling be examined, but without placing pre-set limits on the rates .



 Specifically, the rate  of human activity is determined by first



identifying and examining past occurrences of human  activity in the



Delaware Basin over the  past 50 years for all resources.  The sum



of the individual rates  for each resource  then becomes the rate of



human activity to be used in performance assessment.



     The Agency is placing no limits on the rate of human activity,



in contrast to the treatment of  the  rate of human intrusion.   This



divergent treatment  is consistent with the  final rule of 40 CFR part



191, which was based  on an estimate of 25 to  62.5 boreholes  per square



kilometer per 10,000 years for  the  general case of a repository in



bedded salt in the vicinity of few resources other than oil and natural



gas.  Because the depths at which oil  and  natural gas reserves are



located typically exceed 10,000 feet,  the  estimated range of 25 to



62.5 boreholes per square kilometer per 10,000 years applies to the



case of human intrusion  only.   Hence,  no limit, upper or lower, is



placed on the rate of  human activity.



     The Agency recognizes that for some resources such as water,



the use of that resource  may depend upon the quality of the specific



reservoir of that resource that is being exploited.  A given






                                45

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reservoir of water,  for example, may not be of potable quality but



may still be usefully withdrawn for controlling dust. Therefore it



may be possible to show that certain resources found within the



controlled area differ in quality from the same resource as found



in rest of the Delaware Basin.   For such resources, it could



potentially be demonstrated that the resource would normally be



exploited for different purposes at a different rate within the



controlled area, and further that there is reason to believe that



such practices would continue.  The Agency  is proposing that  if such



a case can be made in compliance applications, then when examining



the historical record of human activity associated with that



resource, only that  human activity that has been associated with



resources of quality similar to that found within the controlled



area need be considered.   Consider a hypothetical example in which



the water resources  in the controlled  area were found not to be of



potable quality, and this were demonstrated and documented in the



application for certification of compliance.  Then, when examining



the history of drilling for water in the Delaware Basin, the



Department would need only consider boreholes created for water uses



other than drinking,  e.g., irrigation and control of dust.



     The Agency is further proposing that the rate of human activity



may be reduced in accordance with the criteria found in 194.41,



active institutional controls, and in 194.43(c), passive



institutional controls.  A complete discussion of reduction of the



human activity rate  can be found under the discussion of those two



portions of the criteria.






                               46

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     In assessing the consequences of human-initiated processes and

events, the Agency is proposing that assumptions pertaining to

characteristics of such processes and events be based on

characteristics associated with current practice in the Delaware

Basin.  This approach is consistent with the approach the Agency

is proposing for future state assumptions.   For example, assumptions

related to the type and amount of any drilling fluids,  borehole

depths, diameters, and seals should be assumed to remain consistent

with the current practice  in the Delaware Basin.  For the specific

case of borehole seals, EPA is further proposing that boreholes shall

be assumed to  be sealed at the  rate boreholes have been sealed over

the past 50 years in  the Delaware  Basin and that natural processes

will degrade or otherwise affect the permeability of boreholes over

the regulatory time frame.

     The Agency has chosen in  today's proposal to differ from the
Appendix C "Guidance for Implementation"  which accompanied 40 CFR
Part 191 because EPA  believes  that the approach outlined above for
assessing the likelihood and consequences of human-initiated
processes and  events is more appropriate for the WIPP than the method
discussed in the guidance.  Today's proposal is specific to the WIPP;
the guidance,  on the other hand, is generic.   Moreover, the guidance
only took into account  drilling frequencies for oil and gas.   The
Agency believes that other human activities, such as drilling for
potash and drilling for water, are equally important for
consideration at the  WIPP, as they too have the potential to affect
the disposal system.   Therefore,  today's proposal requires
consideration of all human actions that could affect a waste disposal
system.  However, the Agency solicits comment on its proposed
approach and the appropriateness of differing from the Appendix C
guidance.


     Results of Performance Assessments

     The Agency proposes to establish criteria for assessing the

results of performance  assessments required under the containment
                                47

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requirements of 40 CFR part 191.  The Agency is proposing to require



that the results of performance assessments be displayed as



complementary cumulative distribution functions or "CCDFs."  These



CCDFs would display the releases of radionuclides over 10,000 years



after disposal--summed and normalized according to Table 1, Note



6 of 40 CFR part 191--on the horizontal axis and the probability



of releases occurring on the vertical axis.



     In conducting performance assessments, there will be many



parameter values that can affect the results of such assessments.



 For instance, gas generation by the waste, radionuclide



solubilities, permeability of the host rock, and the porosity and



transmissivity of surrounding aquifers entail parameter values that



can affect the results of such performance assessments .  These values



may be difficult to quantify particularly over a 10,000-year period.



 Therefore, the Agency is proposing to require the development of



probability distributions for parameter values in order to represent



the probability of different values of the parameter occurring.



     The Agency is further proposing to require that, in generating



CCDFs, computational techniques be developed that sample randomly



across the full range of probability distributions developed for



uncertain disposal system parameter values used in performance



assessments.   In so doing,  it  is  possible  to convey the influence



of parameter uncertainty upon the resulting  CCDFs.  Random sampling



techniques can select a predetermined number of values from a



parameter's probability distribution, the collection of which will



represent the range of the distribution in successive stages of






                                48

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calculation.



     The Agency is proposing to require that the entire range or



"family" of CCDFs generated as a result of these sampling techniques



be included in compliance applications.   By requiring that all CCDFs



be submitted,  the  Agency can evaluate whether given the conditions



that exist at the disposal system,  the disposal system could fail



to comply with section 13 of 40 CFR part  191 in some of the CCDFs.



 By noting the number of total CCDFs  generated that fail to comply,



the Agency will gain insight into the performance of the disposal



system over the 10,000-year time frame.



     The Agency is proposing to place statistical criteria on the



number of CCDFs generated.   The Agency is proposing to require that



the number of CCDFs generated be large enough such that the maximum



CCDF generated exceeds the 99th percentile of the population of CCDFs



with at least a 0.95 probability.   A 95% confidence level is commonly



recognized as being a  good indicator of statistical acceptability.



 The Agency believes that the effect of  this approach will be that



the number of CCDFs generated will be large enough to ensure that



a full range of realizations have been generated.   EPA estimates



that this will require several hundred realizations, although the



number submitted in compliance with this requirement may ultimately



be larger or smaller.



     The Agency is proposing to require that the mean CCDF of the



population of CCDFs meets the requirements of  section 13(a)  of 40



CFR part 191 with at least a 95 percent level  of statistical



confidence.  The  mean CCDF is calculated from a "family" of CCDFs






                               49

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whose parameters have an associated uncertainty to them, as discussed



above.  As a result, the mean will have its own associated



uncertainty.  This uncertainty around the location of the mean



reduces the level of assurance with which we can state that the mean



CCDF is in compliance with section 13 of 40 CFR part 191.  One way



of attaining statistical confidence in the mean is  to determine how



reproducible the mean is if recalculated.   For example,  first



generate an ensemble of a certain number of CCDFs and calculate the



mean.  Next, generate an entirely new ensemble of the same number



of CCDFs and compare the mean calculated for this new set to that



of the first set.   If the number of CCDFs generated is a statistically



representative portion of the infinite population of CCDFs,  then



the two calculated means will likely agree.  By placing a statistical



confidence requirement on the mean of the CCDFs,  the Agency hopes



to ensure that a mean that  is in compliance  would upon recalculation



from a new ensemble of CCDFs,  still  be in compliance.   The Agency



is proposing to require a 95 percent level of statistical confidence



that the mean meets the requirements but solicits comment on other



levels of confidence which may be more appropriate.



     Before selecting the mean as the compliance indicator,  the



Agency examined three options.   The  first  option,  the mean CCDF or



expected value, was selected because of its  ability to convey a sense



of the whole ensemble of CCDFs generated.   In calculating the mean,



all CCDFs--those representing best case  results, those representing



worst case results, and everything in between--are included.  Since



it cannot be known which CCDF represents actual performance over






                                50

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the 10,000 year regulatory period, it is deemed wise to include the



influence of all generated CCDFs.



     The Agency also examined the median CCDF.  The median CCDF would



be indicative of the central tendency  of the majority of the CCDFs



and would not exhibit the influence of high or low consequence CCDFs



as strongly as the  mean  CCDF.  Specifically, the influence of high



consequence CCDFs that do not meet the requirements of section 13 (a)



of 40 CFR part 191 would be discounted by the median.   In the Agency' s



view,  this makes the median CCDF less suitable as a compliance



indicator.



     The Agency also examined the possibility of using a percentile



value as a compliance indicator.  The Agency has considered and



rejected percentile values at or below 50 on grounds that such values



would not provide adequate confidence of achieving the desired



protection of public health.  As for higher values,  the Agency



believes that it would be extremely difficult to justify any specific



higher value.



     The Agency solicits comment on the appropriateness of the mean



or some other CCDF  as a  basis for compliance.  The Agency solicits



comments on using some possible combination of  CCDFs as a basis for



compliance; e.g., requiring that the mean and the median meet the



requirements of section 13(a)  of 40 CFR part 191.



     Another issue  upon  which the Agency solicits  comment is on the



alternative of basing compliance on  one single realization,  rather



than on a multitude of them  as discussed above and then using that



realization to determine compliance with the containment






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requirements.  Instead of sampling from a given range of variables



for each parameter and generating a new realization curve each time



this is done, it has been suggested that all possible values for



each parameter should be selected in creating a single curve.  In



this way, all the information  is  folded into one realization which



either complies or does not.  The advantage in this technique is



that the issue of  the appropriateness of the mean, median, or other



percentile is obviated.  The disadvantage is that it is difficult



to see exactly which parameters caused the curve to behave in a



particular way.



     Regardless of the method ultimately used to determine compliance



with the numerical requirements of section 13 of 40 CFR part 191,



a "reasonable expectation of compliance" with the containment



requirements cannot  be achieved until a demonstration has been made



that the qualitative requirements set  forth in sections 21 through



27 of today' s proposal have also been met.  A "reasonable expectation



of compliance" with  the containment requirements shall not be based



solely upon a statistical estimate of  radionuclide releases to the



accessible environment.   Instead,  the Agency will consider the full



record of information submitted in compliance applications and will



examine the methods  and assumptions which were used to support the



development of radionuclide release estimates.  For example, the



EPA will consider such factors as the reasonableness of the processes



and events incorporated into performance assessments,  the



appropriateness of any  expert  elicitation used to provide input to



models, the adequacy of peer review, and the quality of other data





                                52

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inputs.  Only after a demonstration has been made that all of the



requirements set forth in sections 21 through 27 of today's proposal



have been met and that  the  numerical requirements of section 13 of



40 CFR part 191 have been satisfied, will a "reasonable expectation"



of compliance with the containment requirements be achieved.



     Assurance requirements



     In addition to the numerical requirements set forth in the



Agency's radioactive waste disposal standards, section 14 of the



standards contains a set of qualitative requirements to help assure



that the desired level  of protection is achieved.  These assurance



requirements address:  1)  active institutional controls;  2)



monitoring;  3) passive institutional controls; 4) engineered



barriers; 5)  consideration of the presence of resources; and 6)



removal of waste.



     Active institutional controls



    According to the disposal standards:



     Active institutional controls over disposal  sites should



     be maintained for as long a period of time as is practicable



     after disposal; however, performance assessments that



     assess the isolation of the wastes from the accessible



     environment shall not consider any contributions from



     active institutional controls for more than 100 years after



     disposal.



     As defined in 40  CFR part 191, "active institutional control"



means: " (1) controlling access to a disposal site by any means other



than passive institutional controls;   (2)  performing maintenance






                                53

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operations or remedial actions at a site;  (3) controlling or cleaning



up releases from a site; or  (4)  monitoring parameters related to



disposal system performance."      With the above requirements in



mind, today's proposal requires that any application for



certification of compliance contain detailed descriptions of



proposed active institutional controls, their location and the period



of time they are proposed to remain active.   Any credit assumed for



reduced human activity in the vicinity of the WIPP or reduced releases



of radionuclides must be supported by such descriptions but, as



indicated in the disposal standards, in no case shall  it be assumed



that active institutional controls will  be effective in preventing



or reducing releases beyond 100 years after disposal.



     Monitoring



     Since the predictions associated with long-term compliance with



the disposal standards of 40 CFR part 191 are inherently uncertain,



 final disposal standards issued in 1985 included a provision



requiring monitoring of disposal systems to help assure that they



are performing as predicted.   The proposed disposal standards issued



in 1982 had not included such a requirement.  However, several



commenters  (including most  of the States)  urged addition of a



requirement for long-term monitoring of a repository after disposal



to guard against unexpected failures.  Accordingly,  further



information was sought on this idea.  The Agency surveyed the



capabilities and expectations of long-term monitoring approaches.



 As explained in the preamble to the 1985 disposal standards (50



FR 38081, September 19,  1985):





                                54

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 Evaluating  this  information  led  the Agency  to  several
 conclusions:
 (1) Perhaps most importantly,  the techniques used for monitoring
 after  disposal must  not  jeopardize the  long-term  isolation
 capabilities  of  the  disposal system.  Furthermore,  plans  to
 conduct monitoring after disposal should never become an excuse
 to  relax  the  care  with which systems  to isolate these  wastes
 must be selected,  designed,  constructed,  and operated.
(2)  Monitoring for  radionuclide releases to  the accessible
     environment is not likely to be productive.  Even a poorly
 performing  geologic  repository is very  unlikely to allow
 measurable  releases  to the accessible environment  for  several
 hundreds of years or more, particularly in view of the engineered
 controls  needed  to comply  with 10 CFR Part  60.  A monitoring
 system based only on  detecting radionuclide releases--a system
 which  would almost certainly not be detecting  anything for
 several times the  history of the United  States--is not  likely
 to  be  maintained for long  enough to be  of much use.
(3) Within the  above constraints, however, there are  likely

     to be monitoring approaches which may, in a relatively

 short  time, significantly  improve confidence that a

 repository  is performing as  intended.   Two  examples are

 of  particular interest.  One involves the concept of

 monitoring  ground-water sources at a variety of  distances

 for benign  tracers intentionally released to the  ground

 water  in  the  repository; this approach  can  evaluate the

 delay  involved in  ground-water movement from the

 repository  to the  environment and can serve to validate

 expectations of the performance expected  from the system' s

 natural barriers.  Another concept involves monitoring

 the small uplift of  the land surface  over the repository

 in  order to validate predictions of  the  system's thermal

 behavior.   Both  of these approaches can be  carried out

 without enhancing  pathways for the wastes to escape from

 the repository.
                           55

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Based on these conclusions and the public comments on this question,



the Agency included a provision (in the assurance requirements of



the final disposal standards) for long-term monitoring after



disposal:   "Disposal systems shall be monitored after disposal to



detect substantial and detrimental deviations from expected



performance.   This monitoring shall be done with techniques that



do not jeopardize the isolation of the wastes and shall be conducted



until there are no significant concerns to be addressed by further



monitoring."



     Accordingly,  EPA is proposing  criteria  for complying with the



monitoring requirements in the disposal standards.   EPA is proposing



that monitoring programs be designed to detect the movement of



radionuclides toward the accessible environment at the earliest



practicable time.   Such monitoring programs shall be consistent with



monitoring required under applicable federal hazardous waste



regulations and shall be done with techniques that do not jeopardize



the containment of waste in the disposal system.  Due to the long-term



nature of the potential hazard associated with disposal of



transuranic radioactive waste, any unpredicted detection of movement



of radionuclides away from the disposal system and toward the



accessible environment would be cause for concern that an exceedance



of what is permitted under the disposal regulations is likely to



occur.  If releases are  detected early enough, remedial action can



be implemented before radionuclides reach the accessible



environment.



     EPA is proposing in today's criteria that any compliance






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certification application include a detailed plan for monitoring



the performance of the WIPP after disposal.  At a minimum, this plan



shall: identify parameters that will be monitored and how baseline



states will be  determined; indicate how each parameter will be used



to evaluate the performance of the disposal system; and discuss the



length of time over which each parameter will be monitored to detect



deviations from expected performance.



Radionuclide monitoring programs should be consistent with



applicable federal hazardous  waste monitoring programs in order to



minimize duplication of monitoring efforts.  The Agency solicits



comments on this approach.



     In addition to monitoring after closure of  the disposal system



(i.e., when all of the shafts to the repository are backfilled and



sealed),  EPA proposes that, to the  extent practicable,  pre-closure



monitoring of parameters which may affect  the long-term performance



of the disposal system after  closure shall also be conducted.  The



Agency believes that such monitoring can provide important



information about the disposal system and that such information can



contribute to a better understanding of how the disposal system is



likely to perform after closure.   Furthermore,  such information can



be used to verify assumptions  (about the disposal system) which form



the basis of a compliance assessment.



     The Agency is proposing to require that,  as a part of the



pre-closure monitoring plan for the WIPP, monitoring of parameters



which can affect the containment of waste in the disposal system



shall be conducted to the extent practicable.       The Agency





                               57

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believes that the following parameters can affect the containment



capability of the WIPP: brine quantity, flux,  composition,  and



spatial distribution; gas quantity and composition; and temperature



distribution.  Since there may be additional disposal system



parameters important to the containment of waste, EPA is proposing



that DOE undertake a study to determine the effect of various disposal



system parameters on the performance of the disposal system.  Such



study shall consider whether a disposal system parameter should be



monitored because the parameter either provides information



regarding the disposal system' s ability to contain waste or regarding



the ability to predict the future performance of the disposal system.



 The parameters studied shall include,  but need not be limited to:



backfilled mechanical state including porosity,  permeability,  and



degree of compaction and reconsolidation; extent of deformation of



the surrounding roof, walls, and floor of the disposal room; and



initiation or displacement of major brittle deformation features



in the roof or surrounding rock.  The results of the study shall



be provided to EPA along with documentation of the methodology and



information describing the importance of  each disposal system



parameter studied.  The results of such study shall dictate the



breadth of monitoring of disposal system parameters.



     The  parameters specifically mentioned above and in the



proposed criteria were identified as important to the containment



capability of the WIPP by the Agency in its comments to the Department



(dated October 19, 1989) regarding the Test Phase Plan for the WIPP.



 In those comments,  EPA recommended that  the Department implement






                                58

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monitoring systems in disposal rooms that would be "indicative of



waste system performance"  (Recommendation 7) .   In response to EPA's



comments, the DOE agreed to conduct a feasibility study on underground



monitoring of the WIPP.



     EPA solicits comment on whether monitoring  should be required



for the specific parameters listed above, on whether additional or



other parameters should be specified,  and on the feasibility of



continuing such monitoring after disposal (i.e., after the repository



has been backfilled and sealed) .   Additionally,  the Agency solicits



comment on whether EPA should require the use of specific monitoring



methods.



     Passive institutional controls



     The assurance requirements of 40 CFR part 191 require that



"disposal systems shall be designated by the most  permanent markers,



records, and other passive institutional controls practicable to



indicate the dangers of the wastes and their location."  Section



14  (c) of 40 CFR part 191.  The standards define "passive



institutional controls"  as "(1)  permanent markers placed at a



disposal site,   (2)  public records and archives,   (3)  government



ownership and regulations regarding land or resource use,  and (4)



other methods of preserving knowledge about the location,  design



and contents of a disposal system."



     In light of the requirement for use of passive institutional



controls set forth in 40 CFR part 191,  the Agency is proposing that



any application for certification of compliance include detailed



descriptions of the measures that will be employed to preserve






                                59

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knowledge about the location,  design, and contents of the disposal



system.  At a minimum, it is proposed that such measures will include:



(1)  identification of the controlled area by markers  that have been



designed, fabricated and emplaced to be as permanent as practicable;



and (2) placement of records  in the archives and land  record systems



of local, state, and federal  government  agencies, and international



archives, that would be likely to be consulted by individuals in



search of unexploited resources.



     The Agency proposes  that  the type  of information contained in



records shall  include: the location of  the controlled area and the



disposal system; the design  of the disposal system;  the nature and



hazard of the  waste;  geologic, geochemical, hydrologic, other site



date pertinent to the containment of waste in the disposal system,



and the results of tests,  experiments,  and other analyses relating



to backfill of excavated areas,  shaft sealing,  waste interaction



with the disposal system, and any other tests,  experiments,  or



analyses pertinent to the containment of waste in the disposal system.



 EPA solicits  comments on the appropriateness of this list and on



whether additional or other items should be specified.  Any



application for certification  of compliance shall include detailed



descriptions of the proposed controls as well as information



regarding the  period of time those controls are expected to endure



and be understood.



     A question arises with regard to the extent to which the Agency



should allow performance assessments to  consider contributions from



passive institutional controls in reducing the likelihood of






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human-initiated processes and events that may affect the disposal



system.  While the disposal  regulations address contributions from



active institutional controls (see above discussion of active



institutional controls),  they do not specifically address



contributions from passive institutional controls.  The Agency may



be willing to consider such  contributions  if a persuasive case can



be made that the passive  institutional controls can be expected to



endure and act as a deterrent to potential intruders .   In no instance,



however, will passive institutional controls be assumed to eliminate



the likelihood of human-initiated processes and events entirely.



Furthermore, contributions from  passive institutional controls may



vary over time.  For example, the effectiveness of passive



institutional controls may decrease over the regulatory time frame.



 The Agency solicits comment on the extent--if any--to which



contributions from passive institutional controls should be



considered in performance assessments.



     Because of the uncertainty concerning the effectiveness of



passive institutional controls in terms of influencing human



activity, EPA must carefully scrutinize information about such



controls.  The Agency has considered the fact that markers exist



in the world today that are thousands of years old.   This would tend



to support the view that passive  institutional controls can survive



for very long periods of time.   Nevertheless,  it is possible that



markers have been created in the past and were destroyed or



disintegrated.  The actual percentage of surviving markers is thus



unknown.  It could be very small, meaning that an unrealistically






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large number of markers would have to be placed at the WIPP in order



to assure survival.  Further uncertainty in the effectiveness of



markers derives from the  possibility that even if markers survive,



it does not mean they will necessarily be understood by future



generations.



     Institutional controls have been known to fail.   The New Mexico



Environmental Evaluation Group (EEC)  has documented instances in



the recent past where institutional controls have failed at the WIPP.



 According to EEC, both the DOE and the Department of  the Interior's



Bureau of Land Management "failed to implement the procedures



described by the DOE as crucial to protecting the site from



inadvertent human intrusion in twenty-two of the twenty-five



applications to drill oil and gas wells filed while a Memorandum



of Understanding was legally binding and the WIPP facility was in



a state of full readiness to receive waste."  (EEC letter to EPA



dated February 23,  1994) .  This indicates that even today, and even



with governmental entities responsible for implementation of



controls, such controls are not, necessarily,  reliable.   The unknown



nature of future  societies and governmental institutions compounds



the uncertainty.



     Engineered barriers



     The assurance requirements of 40 CFR part 191 require that



disposal systems "use different types of barriers to isolate the



wastes from the accessible environment."  Additionally,  the disposal



standards mandate that "Both  engineered and natural barriers shall



be used. "  40 CFR part 191 defines the term "barrier" as "any material





                               62

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or structure that prevents or substantially delays movement of water



or radionuclides toward the accessible environment.  For example,



a barrier may be a geologic structure, a canister, a waste form with



physical and chemical characteristics that significantly decrease



the mobility of  radionuclides, or a material placed over and around



waste, provided  that the material or structure substantially delays



movement of water or radionuclides."



     If selected and designed properly,  engineered barriers can



significantly reduce the potential for waste migration away from



the disposal system.   They can be an effective mechanism for



improving the performance of the WIPP and for reducing the uncertainty



inherent in long-term projections about the ability of the disposal



system to comply with  the quantitative requirements of 40 CFR part



191.



     While the disposal standards require use of engineered barriers,



they do not specify how many or what kinds of engineered barriers



must be used.   The Agency is,  therefore,  proposing criteria for



selecting engineered barriers.



     In today's  notice,  EPA is proposing that DOE complete a study



of engineered barrier alternatives and their benefits and costs.



The results of such study shall be used to justify both the selection



and rejection of engineered barriers at the WIPP.  Moreover,  the



study shall be peer reviewed.   For example, EPA believes that the



National Academy of Sciences may  be able to provide an appropriate



forum for peer review of the study envisioned in today's proposed



criteria.  The Agency believes that the credibility of the study






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of engineered barrier alternatives and resulting selection of



engineered barriers for the WIPP disposal system is critically



important.



     The specific engineered barriers proposed to be evaluated



include, but are not limited to: cementation,  shredding,



supercompaction, incineration,  vitrification,  improved waste



canisters,  grout and bentonite backfill,  melting of metals,



alternative configurations of waste placements in the disposal



system, and alternative disposal system dimensions.  These specific



engineered barriers were selected by the Agency because they have



already begun to be considered by DOE' s Engineered Alternatives Task



Force (EATF)  (see July, 1991 EATF Report on Engineered Alternatives



for the WIPP, DOE/WIPP 91-007)  and appear to represent potentially



promising alternatives.   EPA solicits comment on the appropriateness



of specifying the above-mentioned engineered barriers as the subject



of the study and on whether alternative barriers should be specified.



     The Agency is proposing that the  following factors be considered



in benefit/cost analysis of the above-mentioned engineered barriers:



the ability of  the engineered barrier to prevent or substantially



delay the movement of  water or  radionuclides toward the accessible



environment;  the impact on worker exposures to radiation (at the



WIPP and off-site) both during and after incorporation of engineered



barriers; the increased ease or difficulty in removing the waste



from the disposal system; the increased or reduced risk of



transporting the waste to the disposal system; the increased or



reduced uncertainty in compliance assessment;  the increased or





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reduced public confidence in the performance of the disposal system;



the increased or reduced total system costs; the impact,  if any,



on other waste disposal programs from the incorporation of engineered



barriers; and the effect on mitigating the consequences of



human-initiated processes and events.



     It would be inappropriate to limit the study only to the impact



of engineered barriers on the performance of the WIPP.   If this were



done,  the possibility would exist that an engineered barrier may



be selected, for example, which marginally improves the disposal



system's performance, yet results in much higher environmental risks



at treatment sites.  This increase in risk would contravene the



Agency's objective of protecting human health and the environment.



 EPA solicits comment on this approach to selecting engineered



barriers and on whether an alternative list of factors should be



specified for consideration.



     The Agency proposes that the benefit/cost study described above



include separate analyses for different categories of waste



potentially destined for disposal at the WIPP.   The Agency believes



that benefits and costs of engineered barriers can differ depending



on whether they are applied to existing waste that is already



packaged, existing waste that is not  yet packaged or is in need of



re-packaging, or to-be-generated waste.   Therefore,  the Agency is



proposing that these different categories of waste be analyzed



separately.



     Finally, EPA is proposing that engineered barrier alternatives



be considered both alone and in combination.  In this way, assurance






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can be had that the full range of alternative applications of



engineered barrier systems has been considered.



     Importantly,  today's proposal requires the results of the



benefit/cost study to be included in any compliance application and



for the results to be used to justify the selection or rejection



of any engineered barrier.  This will help the Agency understand



why particular barriers were selected while others were not, as well



as help the Agency to evaluate the appropriateness of such selections .



     The Agency solicits comments on other potential approaches to



the treatment of engineered barriers in the WIPP compliance criteria.



 In particular,  the Agency is interested in receiving comment on



the option of specifying a performance standard for engineered



barriers similar to that specified by the Nuclear Regulatory



Commission in 10 CFR part 60 regulations for disposal of high-level



radioactive waste.  Under this approach,  a maximum radionuclide



release rate would be established for the engineered barrier system.



 Engineered barriers selected for the disposal system would have



to contain radionuclide releases within the established rate.



     Consideration of the presence of resources



     Section 14 of 40 CFR part 191 includes the following requirement:



"Places where there has been mining for resources,  or where there



is a reasonable expectation of exploration for scarce or easily



accessible resources, or where there is  a significant concentration



of any material that is not widely available from other sources,



should be avoided in selecting disposal sites.  Resources to be



considered shall include minerals, petroleum or natural gas, valuable






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geologic formations, and ground waters that are either irreplaceable



because there is no alternative  source of drinking water available



for substantial populations or that are vital to the preservation



of unique and sensitive  ecosystems.  Such places shall not be used



for disposal of the wastes covered by this part unless the favorable



characteristics of such places compensate for their greater



likelihood of being disturbed in the future."



     EPA is proposing that any application for certification of



compliance shall include information which demonstrates that the



favorable characteristics of the WIPP compensate for the presence



of resources and the likelihood of human-initiated processes and



events as a result of the presence of those resources.   If, after



full consideration of the potential effects of resource recovery



activities the WIPP is still  predicted to meet the requirements of



40 CFR part 191,  then the Agency will assume that the requirements



of this part and section 14 (e)  of  40 CFR part 191 have been fulfilled.



 The Agency solicits comment on this approach.



     Removal of waste



     Another assurance  requirement  included in the 40 CFR part 191



disposal standards involves the  removal of waste from the disposal



system.  Specifically,  40 CFR part 191 mandates that:  "Disposal



systems shall be selected so  that removal of most of the wastes is



not precluded for a reasonable period of time after disposal."  In



order to address this requirement,  EPA is proposing criteria to



require a plan for removing waste from the disposal system using



the best technology available at the time of application.





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     Individual and Ground-Water Protection Requirements



     The Agency incorporated requirements in 40 CFR part 191 for



the protection of individuals and ground-water.  The individual



protection requirements of 40 CFR part 191 limit annual committed



effective doses of radiation to members of the public to no more



than 15 millirem.  The ground-water protection requirements limit



releases to ground water to no more than the limits set by the maximum



contaminant level for radionuclides (MCL) established in 40 CFR part



141 under section 1412 of the Safe Drinking Water Act  (SDWA),  42



U.S.C. 300g-l.   Both of  these requirements are concerned with human



exposure to radionuclides from disposal systems and, like the



containment requirements of 40 CFR part 191, both limit such exposure



for 10,000 years.



     The proposed criteria address the following issues:  the



definition of a protected individual,  the consideration  of exposure



pathways, the consideration of underground sources of drinking water,



the scope of compliance assessments,  and the basis for a determination



of compliance with these requirements (results of compliance



assessments).



     With regard to identifying protected individuals,  the Agency



is proposing to require that assessments regarding individual



exposures to radiation from the disposal system be based upon the



assumption that individuals reside at the point on the surface of



the accessible environment  where they would be expected to receive



the highest exposure from radionuclide releases from the disposal



system.  This helps ensure that the individual most likely to receive






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the highest exposure from the  disposal  system is accounted for and



protected.



     In assessing individual doses,  the Agency proposes to require



consideration of all potential pathways  (associated with undisturbed



performance) for radionuclide transport.   The pathways which need



to be considered include land-surface pathways (including direct



radiation exposure), surface or ground-water pathways,  and air



pathways, as well as combinations of the above.   Furthermore,



consistent with the Agency's approach under the Safe Drinking Water



Act (42 U.S.C.A.  sections 300 (f)  to  300J-26), it should be assumed



that individuals consume two liters of water per day from any



underground source of drinking water in the accessible environment.








     EPA is proposing today that any underground sources of drinking



water in the accessible environment which are likely to be affected



by the disposal system over 10,000 years be considered in WIPP



compliance applications.  Such consideration should include an



analysis of the interconnection and commingling of bodies of ground



water with underground sources of drinking water,  as well as



ground-water flow rates and direction.



     According to 40 CFR part  191, calculations of compliance with



the individual and ground-water protection requirements must



consider the undisturbed performance of the disposal system.  40



CFR part 191 defines "undisturbed performance" as:  "the predicted



behavior of a disposal system, including consideration of the



uncertainties in predicted behavior,  if the disposal system is not






                               69

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disrupted by human-intrusion or the occurrence of unlikely natural



events."  The Agency solicits comment on whether there is a need



for further clarification of the analysis of undisturbed performance,



e.g.; is there a need to identify what constitutes an "unlikely"



natural event or what probability of occurrence renders an event



"likely" or "unlikely?".



     EPA is proposing that any application for certification of



compliance shall include information which identifies the processes,



events, or sequences of processes and events considered in compliance



analyses.  Moreover, EPA is proposing that documentation be provided



which justifies the inclusion/non-inclusion of particular processes,



events, or sequences of processes and events in compliance assessment



results.



     Once the processes, events, or sequences of processes and events



have been identified, they shall be  incorporated into compliance



assessments of the disposal system.   The disposal standards require



compliance assessments to include consideration of the uncertainties



associated with the undisturbed performance of  the disposal system.



 To do this, it  is necessary to identify all disposal system



parameters that  can  affect the performance  of  the WIPP, as well as



to identify the  uncertainty associated with each parameter.



     When the disposal system parameters and their accompanying



uncertainty have been identified, EPA is proposing that probability



distributions be developed for each such parameter.  A probability



distribution is a function which assigns a probability of occurrence



to each value for a given parameter.






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     The Agency is proposing that,  in compiling compliance assessment



results, computational techniques be used which draw random samples



from across the full range of probability distributions for parameter



values used in compliance assessments.   This  will help assure that



all possible values of a parameter have been considered in compiling



compliance assessment results.



     EPA is proposing that the range of estimated radiation doses



to individuals (as generated through use of the computational



techniques referred to above), and the range of estimated



radionuclide concentrations in ground water must be large enough



such that the maximum estimate generated exceeds the 99th percentile



of the population of estimates with at least a 95% probability.



The "population of estimates"  refers to the set of all possible



estimates that can be generated from  all  disposal system parameter



values used in compliance assessments .   A single estimate, in effect,



samples this population.   This is similar to the requirement for



the number of CCDFs which must be generated for purposes of compliance



with the containment requirements.  The Agency is proposing to



include this provision for the purpose of ensuring that there is



a 95% probability that 99% of all possible values have been exceeded



by the maximum estimate generated.



     In order to  assure that all pertinent information is provided



to the Agency, EPA is proposing to require that compliance



applications display the  full  range of estimated radiation doses



and the full range of estimated radionuclide concentrations.



     Finally,  the Agency is proposing to require that any compliance





                               71

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certification application provide information which demonstrates



that there is at least a 95% level of statistical confidence that



the mean and the median of the full range of estimated radiation



doses and of the full range of estimated radionuclide concentrations



meet the requirements set forth in sections 15 and 16 of 40 CFR part



191.  The mean estimate provides a measure of compliance that



expresses the average impacts of the disposal system on individuals



and ground water as well as the probabilities of uncertain disposal



system parameter values.  The median estimate provides a measure



of compliance that expresses the central tendency of a population



of estimates.  Specifically, the median represents the point that



a calculated estimate would be equally likely to fall above or below.



 Insofar as both statistics contain useful information, the Agency



is proposing an approach that  assures  that both meet the limits of



the individual and ground-water protection requirements.



     The Agency solicits comments on the above approach for



evaluating the results of compliance assessment.



     Subpart D--Public Participation



     The Agency intends to involve the public throughout the Agency' s



regulatory oversight at the WIPP.  Accordingly,  today's proposal



contains a  set of criteria for public participation in any compliance



certification or determination.



     In today's proposal, the Agency is proposing to continue to



maintain the four public information dockets listed in the



Supplementary Information section of this part.   All materials



relevant to any compliance certification or determination or to any






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decision regarding modifications, suspensions, or revocations of



such compliance certifications and determinations will be placed



in the proposed dockets.



     The Agency believes that maintaining dockets is useful because



they can greatly increase communication between EPA and all



interested parties.   The Agency intends  to maintain all dockets in



conformance with EPA's "Uniform Rulemaking Docket Guidance" to the



extent practicable.   This guidance is widely used within the Agency



and helps to ensure that public participation in Agency rulemakings



is optimized.



     The Agency also proposes to hold public hearings on proposed



compliance criteria within the State of New Mexico.  These hearings



will provide an opportunity for members of the public, beyond



submission of written comments, to express their views to EPA in



the rulemaking process.



     With respect to applications for compliance certification, the



Agency is proposing that, upon receipt of an application for



certification of compliance, it will  publish a notice in the Federal



Register announcing that an application for certification of



compliance has been received and soliciting comment on that



application.  This notice in the Federal  Register will be an Advance



Notice of Proposed Rulemaking (ANPR),  as it will also announce the



Agency's intent to conduct a rulemaking to certify whether the WIPP



will comply with the disposal regulations.  The Agency is proposing



this approach  in order to afford the public an opportunity for early



input into EPA' s certification decision.   The alternative might have






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been simply putting the application in the docket and receiving



comments from the public through a more informal means.  However,



the Agency believes that this approach would not necessarily lead



to as much public input relevant  to its decision.  Hence, the more



formal approach is proposed.



     Upon completion of a review of the application for certification



of compliance, the Agency also proposes to publish in the Federal



Register a Notice of Proposed Rulemaking announcing the



Administrator's proposed decision on whether the WIPP facility will



comply with the disposal regulations and soliciting comment on such



proposal.  The notice will provide a comment period of at least 120



days and will announce the opportunity for public hearings in New



Mexico (including times and procedures for registering to testify).








     The Agency will publish a Notice  of  Final Rule in the Federal



Register announcing the Administrator's decision on certifying



whether the WIPP facility will comply with the disposal regulations.



 Additionally, a document summarizing major comments and issues



arising from comments received on  the Notice of Proposed Rulemaking,



as well as the Administrator's response to such comments and issues,



will be prepared and made available for  inspection in Agency dockets.



     Similar to the process outlined above for applications for



compliance certification (and for the same reasons),  when EPA



receives documentation of continued compliance as required under



8 (f)  of the WIPP LWA, the Agency will publish a notice in the Federal



Register announcing the Administrator's intent to determine whether





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the WIPP facility continues to be in compliance with the disposal

regulations.  Copies of any documentation received will be made

available for inspection in Agency dockets and comments will be

solicited for at least 30 days after receipt.  Once the Agency has

considered all comments received, the Administrator will make a

determination regarding WIPP' s continued compliance and publish that

decision in the Federal Register.

     Questions for Comment

     The Agency is requesting  comment on today's proposed criteria

for the certification and determination of the WIPP's compliance

with the 40 CFR part 191 disposal standards and on the proposed

approaches taken.   EPA generally invites comment on whether today's

proposal addresses all issues  related to the any EPA certification

or determination of WIPP's compliance with the disposal regulations

in 40 CFR part 191.

     Regulatory Analyses

     Executive Order 12866

     Under Executive Order 12866 [58 Federal Register 51, 735 (October

4, 1993)] the Agency must determine whether the regulatory action

is "significant" and therefore subject to OMB review and the

requirements of the Executive Order.  The Order defines "significant

regulatory action" as one that is likely to result in a rule that

may:

     (1) have an annual effect on the economy of $100 million or
     more or adversely affect in a material way the economy, a sector
     of the economy,  productivity, competition, jobs,  the
     environment,  public health or safety, or State, local, or tribal
     governments or communities;
     (2) create a  serious inconsistency or otherwise interfere with

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     an action taken or planned by another agency;
     (3)  materially alter the budgetary impact of entitlements,
     grants, user fees, or loan programs or the rights and obligations
     of recipients thereof; or
     (4)  raise novel legal or policy issues arising out of legal

     mandates, the President's priorities, or the principles set

     forth in the Executive Order.

     Pursuant to the terms of Executive Order 12866, it has been

determined that this rule is a "significant regulatory action"

because it raises novel policy issues arising out of legal mandates.

 As such,  this action was submitted to OMB for review.  Changes made

in response  to OMB suggestions or recommendations will be documented

in the public record.

     Regulatory Flexibility Act

     The Regulatory Flexibility Act (5 U.S.C.  601 et seq.) requires

each Federal agency to consider the effects of their regulations

on small  entities and to examine alternatives  that may reduce these

effects.   The nature of this action is  to  propose  criteria for the

certification of compliance of the WIPP with the Agency' s radioactive

waste disposal standards set forth in 40 CFR part 191.   Since the

preparation of applications for
                                76

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Criteria for the Certification and Determination of the Waste
Isolation Pilot Plant's Compliance with Environmental Standards for
the Management and Disposal of Spent Nuclear Fuel, High-Level and
Transuranic Radioactive Wastes, Page 80 of 127.


compliance will only be conducted by DOE, and since any ensuing

disposal and information gathering activities will only be carried

out by DOE,   the Agency certifies that this regulation will not have

a significant impact on a substantial number of

small entities.

     Paperwork Reduction Act

     The EPA has determined that this proposed rule contains no

information requirements as defined by  the Paperwork Reduction Act

(42 U.S.C. 3501 et sea).

     List of Subjects in 40 CFR part 194

     Environmental protection, Nuclear energy,  Nuclear wastes,

Nuclear weapons, Plutonium, Radiation,  Radiation protection,

Radionuclides, Uranium, Transuranics, Waste treatment and disposal.



Dated:
Carol M. Browner

Administrator
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     A new Part 194 is hereby proposed to be added to Title 40, Code

of Federal Regulations, as follows:



     PART 194--CRITERIA FOR THE CERTIFICATION AND DETERMINATION OF

     THE WASTE ISOLATION PILOT PLANT' S COMPLIANCE WITH ENVIRONMENTAL

     STANDARDS FOR THE MANAGEMENT AND DISPOSAL OF SPENT NUCLEAR FUEL,

     HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES


     Subpart A--General Provisions

     Sec.
     194.01    Purpose, scope,  and applicability.
     194.02    Definitions.
     194.03    Communications.
     194.04    Conditions of compliance certification and
                determination.
     194.05    Publications incorporated by reference.
     194.06    Alternative provisions.

     Subpart B--Compliance Certification and Determination
     Applications

     194.11    Completeness and accuracy of compliance

                                                            appli
                                                            catio
                                                            ns.
     194.12    Submission of compliance applications.
     194.13    Submission of reference materials.
     194.14    Content of compliance certification application.
     194.15    Content of compliance determination

                                                            appli
                                                            catio
                                                            n(s)  .

     Subpart C--Compliance Certification and Determination

                   GENERAL REQUIREMENTS

     194.21    Inspections.
     194.22    Quality assurance.
     194.23    Models and computer codes.

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194.24    Waste characterization.
194.25    Future state assumptions.
194.26    Expert judgment.
194.27    Peer review.

            CONTAINMENT REQUIREMENTS

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

             ASSURANCE REQUIREMENTS

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

        INDIVIDUAL AND GROUND-WATER PROTECTION REQUIREMENTS

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

Subpart D--Public Participation

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

Authority:  The Waste Isolation Pilot Plant Land Withdrawal

Act of 1992, Pub.L. 102-579, 106 Stat.  4777;  Atomic Energy Act

of 1954,  as amended,  42 U.S.C.  2011-2296; Reorganization Plan

No. 3 of 1970,  5 U.S.C. app.l; Nuclear Waste Policy Act  of 1982,

as amended, 42 U.S.C. 10101-10270.
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Subpart A--General Provisions








  194.01  Purpose, scope and applicability.








   This part specifies criteria for any certification or



determination of compliance, under section 8(d)  and section



8(f)  of the WIPP LWA,  with  the disposal regulations at 40 CFR



part 191.  Any compliance application submitted under section



8 (d)  of the WIPP LWA and  any compliance application submitted



under section 8(f) of the WIPP LWA must comply with the



requirements of this part.



  194.02  Definitions.



   Unless otherwise indicated in this part,  all terms have the



same meaning as in 40 CFR part 191.



   Certification means any action taken by the Administrator



under section 8(d) of the WIPP LWA.



   Compliance application(s) means any application submitted



to the Administrator under  section 8 (d)  of the WIPP LWA or any



application(s) submitted to the Administrator under section



8(f)  of the WIPP LWA.



   Compliance assessment(s) means the analysis conducted to



determine compliance with section 15 and subpart C of 40 CFR



part 191.



   Determination means any action taken by the Administrator



pursuant to 8(f) of the WIPP LWA.



   Disposal regulations means  subparts  B  and C of 40 CFR part






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191.



   Human activity means those  drilling events that may affect



the disposal system, but do not necessarily reach the level



of the waste in the disposal system.



   Human intrusion means those drilling events that reach the



level of the waste in the disposal system.



   Management systems review means the qualitative assessment



of a data collection operation or organization(s) to establish



whether the prevailing quality management structure, policies,



practices,  and procedures are adequate for ensuring that the



type and quality of data needed are obtained.



   Modification means action (s) taken by the Administrator that



has the effect of altering the terms or conditions of



certification under section 8(d) of the WIPP LWA or that has



the effect of altering the terms or conditions of a determination



under section 8(f) of the WIPP LWA.



   Population of CCDFs means all possible CCDFs that can be



generated from all  disposal system parameter values used in



performance assessments.



   Population of estimates means all possible estimates that



can be generated from all disposal system parameter values used



in compliance assessments.



   Quality assurance means all those planned and systematic



actions necessary to provide adequate confidence that the



disposal system will perform satisfactorily in service.



Quality assurance includes quality control,  which comprises






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those quality assurance actions related to the physical



characteristics of a material, structure,  component, or system



which provide a means  to  control the quality of the material,



structure, component,  or system to predetermined requirements.



   Regulatory time frame means the time period beginning at



disposal and ending 10,000 years after disposal.



   Revocation means any action taken by the Administrator to



terminate or withdraw the effectiveness of a certification under



section 8(d)  of the WIPP LWA or to terminate or withdraw the



effectiveness of a determination under section 8(f)  of the WIPP



LWA.



   Secretary means the Secretary of the Department of Energy.



   Suspension means any action taken by the Administrator to



withdraw, for a limited period of time,  the effectiveness of



certification under section 8 (d) of the WIPP LWA or to withdraw,



for a limited period of time, the effectiveness of a



determination under section 8(f)  of the WIPP LWA.



   Waste means the radioactive waste and radioactive material



subject to the requirements of 40 CFR part 191.



   WIPP means the Waste Isolation Pilot Plant project authorized



under section 213 of the Department of Energy National Security



and Military Applications of Nuclear Energy Authorization Act



of 1980  (Pub.L. 96-164; 93 Stat. 1259, 1265).



   WIPP LWA means the Waste Isolation Pilot Plant Land



Withdrawal Act  (Pub.L. 102-579,  106 Stat. 4777) .



  194.03  Communications.





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   (a) Compliance application(s) shall be:



   (1) Addressed to the Administrator; and



   (2) Signed by the Secretary.



   (b) Communications and reports concerning the criteria in



this part shall be:



   (1) Addressed to the Administrator or,  where  indicated, the



Administrator's authorized representative; and



   (2) Signed by the Secretary or the Secretary's authorized



representative.



  194.04  Conditions of compliance certification and



determination.



   (a)  Any certification or determination issued pursuant to



the WIPP LWA may include such conditions  as the Administrator



finds to be necessary to support such certification or



determination(s).



   (b)  Whether stated therein or not, the following shall be



conditions in any certification or determination:



   (1)  The certification or determination shall be subject



to modification, suspension, or revocation, by the



Administrator.  Any modification, suspension, or revocation



of the certification shall be done by rule.  If the



Administrator revokes the certification,  the Department shall



retrieve, to the extent practicable, any waste emplaced in the



disposal system.



   (2)  Upon written request of the Administrator any time after



the Administrator has issued a certification or determination






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of compliance, the Department shall submit information to enable



the Administrator to determine whether the certification or



determination should be modified, suspended,  or revoked.



Unless otherwise specified by the Administrator,  the Department



shall submit such information to the Administrator within 30



calendar days of receipt of the Administrator's request.



   (3)  Not later than six months after the Administrator has



issued any certification or determination of compliance, and



at least every six months thereafter, the Department shall



report to the Administrator,  in writing,  any changes in



conditions or activities pertaining to the disposal system that



depart from the application and that  formed the basis of such



certification or determination of compliance.



   (4)  Any time after the Administrator has issued a



certification or determination of compliance, the Department



shall report any changes in activities pertaining to the



disposal system that depart significantly from the application



and that formed the basis of such certification or determination



of compliance.   The Department shall inform the Administrator,



in writing, prior to making a planned change .  The Administrator



will  determine whether the planned change invalidates the terms



of the certification or determination. Any significant change



must  be approved by  the Administrator prior to being made and



the Administrator will determine whether the change requires



further action.  Further action may include modification,



suspension, or revocation of  the compliance certification or






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determination.     (5)  If the Department discovers that a



condition pertaining to the disposal system differs



significantly from that indicated in the application that formed



the basis of a certification or determination of compliance,



the difference must be reported,  in writing, to the



Administrator within 10 calendar days of its discovery.  The



Administrator will determine whether the report requires



further action.  Further action may include modification,



suspension, or revocation of the compliance certification or



determination.



   (6)  If the Department determines that a release of waste



from the disposal system to the accessible environment in excess



of what is permitted under the disposal regulations has occurred



or is likely to occur, the Department shall:



   (i)  Immediately suspend emplacement of waste in the



disposal system, and



   (ii)   Notify the Administrator, in writing,  within 24 hours



of the determination that such a release has occurred or is



likely to occur.  Such notification shall include, but need



not be limited to, the following information to the extent



possible:



   (A)  Identification of the location and environmental media



of the release or the expected release;



   (B)  Identification of the type and quantity of waste (in



activity in curies of  each radionuclide)  released or expected



to be released;






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   (C)  Time and date of the release or the approximate time



of the expected release;



   (D)  Assessment of the hazard posed by the release or the



expected release; and



   (E)  Additional information requested by the Administrator



or the Administrator's authorized representative and deemed



by the Administrator or the Administrator's authorized



representative to be relevant to a modification, suspension



or revocation of a certification or determination of compliance .



   (iii)   Following receipt of the notification, the



Administrator:



   (A) May request additional information; and



   (B) Will determine whether emplacement of waste in the



disposal system may continue and whether to modify, suspend,



or revoke any previously issued certification or determination



of compliance.



  194.05   Publications incorporated by reference.



   (a)  The following publications are incorporated in this



part by reference:



   (1)  NUREG 1297 "Peer Review for High-Level Nuclear Waste



Repositories."



   (2)  ASME NQA-1-1989 edition "Quality Assurance Program



Requirements for Nuclear Facilities."



   (3) ASME NQA-2a-1990 addenda (part  2.7) to ASME NQA-2-1989



edition "Quality Assurance Requirements of Computer Software



for Nuclear Facility Applications."






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   (4)  ASME NQA-3-1989 edition "Quality Assurance Program



Requirements for the Collection of Scientific and Technical



Information for Site Characterization of High-Level Nuclear



Waste Repositories."



   (b)   The references listed in paragraph (a)  of this section



are available for inspection at the Office of the Federal



Register.  These incorporations by reference were approved by



the Director of  the  Federal Register.  These publications are



incorporated as  they exist on the date of promulgation of this



part.



  194.06   Alternative provisions.



   The Administrator may, by rule, substitute for any of the



provisions of this part alternative provisions chosen after:



   (a)  The alternative provisions have been proposed for public



comment in the Federal Register together with information



describing how the alternative provisions comport with the



disposal regulations,  the reasons why compliance with the



existing provisions of this part appears inappropriate,  the



costs,  risks and benefits of compliance in  accordance with the



alternative provisions;



   (b)  A public comment period of at least 120 days has been



completed, during which an opportunity for public hearings in



New Mexico has been provided;  and



   (c)  The public comments received have  been fully considered



in developing the final version of alternative provisions.



Subpart B--Compliance Certification and Determination






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Applications



  194.11  Completeness and accuracy of compliance



applications.



   Information provided to the Administrator in support of any



compliance application(s) shall be complete and accurate.   The



Administrator's evaluation for certification under section



8(d)(1)(B) of the WIPP LWA and evaluation for determination



under section 8(f)(2) of the WIPP LWA shall not begin until



the Administrator has notified the Secretary,  in writing, that



a complete application in accordance with this Part has been



received.



   194.12   Submission of compliance applications.



    Unless otherwise specified by the Administrator, 30 copies



of any compliance application(s),  any accompanying materials,



and any amendments thereto shall be submitted in a printed form



to the Administrator.



  194.13  Submission of reference materials.



   Information may be incorporated by reference in compliance



application(s):  Provided,  That the references are clear and



specific and that 10 copies of  the referenced information are



submitted to the Administrator.  Referenced materials which



are widely available  in standard textbooks need not be



submitted.



  194.14  Content of compliance certification application.



   Any application for certification of compliance with the



disposal regulations  shall include:






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   (a)   A description of the disposal system and those features



that may affect disposal  system performance.  The description



of the disposal system shall  include the following information:



   (1)   The location of the disposal system and  the controlled



area;



   (2)   A description of the geology, geophysics, hydrogeology,



hydrology, and geochemistry of the disposal system and its



vicinity and how these conditions are expected to change and



interact over the regulatory time frame;



   (3)   The presence and characteristics of potential pathways



for transport of waste from the disposal system to the accessible



environment including, but not necessarily limited to, solution



features, breccia pipes,  and other potentially permeable



features including but not necessarily limited to interbeds;



and



   (4)   The projected geophysical,  hydrologic and geochemical



conditions of  the disposal system due to the presence of waste



including, but not limited to,  the effects of production of



heat or gases from the waste.



   (b)   A description of the design of the disposal system



including:



   (1)   Information relative to materials of construction



(including, but not necessarily limited to, geologic media,



structural materials, engineered barriers, general



arrangement, and approximate dimensions); and



   (2)   Codes and standards that have been applied to the design






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and construction of the disposal system.



   (c)  Results of assessments conducted pursuant to the



disposal regulations.



   (d) A description of input parameters associated with



assessments conducted pursuant to the disposal regulations and



the basis for selecting those input parameters.



   (e)  Evidence that disposal of waste in the disposal system



meets the requirements of 191.14.



   (f)  A description of any waste acceptance criteria and



actions taken to assure adherence to such criteria.



   (g)  A description of background radiation in air, soil,



and water in the vicinity of the disposal system and the



procedures employed to determine such.



   (h)  One or more topographic  map(s)  of  the vicinity of the



disposal system.  Contours must be shown on  the map.  The



contour interval must be sufficient to clearly show the pattern



of surface water flow in the vicinity of the  disposal system.



 The map(s) shall clearly show the following:



   (1)  Scale and date;



   (2)  Floodplain area;



   (3)  Surface waters including intermittent streams;



   (4)  Surrounding land uses,  i.e.,residential,  commercial,



industrial, agricultural, recreational;



   (5)  A wind rose, i.e., wind speeds and directions;



   (6)  Orientation of the map,  i.e., north  arrow;



   (7)  Boundaries of the controlled area;






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   (8)   Location of proposed active and passive institutional



controls;



   (9)   Location of any active, inactive, and abandoned



injection and withdrawal wells in the controlled area and in



the vicinity of the disposal system;  and



   (10)   Location of proposed monitoring stations or wells.



   (i)   A description of past and current climatologic and



meteorologic conditions in the vicinity of the disposal system



and how these conditions are expected to change and interact



over the regulatory time frame.



   (j)   Any additional information required elsewhere in this



part or  determined by the Administrator or the Administrator's



authorized representative to be necessary for a decision whether



to certify or determine compliance.



  194 .15  Content of compliance determination application (s) .



   (a)   In submitting documentation of continued compliance



pursuant to section 8(f) of the WIPP LWA, the most recent



previous application(s) for compliance certification or



determination shall be updated so as to provide sufficient



information for the Administrator to determine whether or not



the WIPP continues to be in compliance with the disposal



regulations.  Updated documentation shall include:



   (1)   Additional geologic, geophysical, geochemical,



hydrologic, and meteorologic information.



   (2)   Monitoring results.



   (3)   An evaluation of the conformance of the disposal system






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components with design.



   (4)   A description of any waste emplaced in the disposal



system since the most recent previous compliance certification



or determination application.   Such description shall consist



of a description of the waste characteristics identified in



194.24(a)(ii).



   (5)   Any additional information that the Administrator or



the Administrator's authorized representative identifies as



necessary to determine whether or not the disposal system



continues to be in compliance with the disposal regulations.



   (b)  To the extent that information required for a



determination of compliance remains valid and has been submitted



in previous certification or determination application (s) , such



information need not be duplicated in subsequent applications;



such information may be summarized and referenced.



Subpart C--Compliance Certification and Determination



                    GENERAL REQUIREMENTS



  194.21  Inspections.



   (a)  (1)  The Administrator or the Administrator' s authorized



representative (s) shall be afforded unfettered and unannounced



access to inspect any area of the WIPP and locations performing



activities that may provide information used to support any



compliance application(s) to which the Department has rights



of access.



   (2)   The Administrator or the Administrator's authorized



representative(s) shall be afforded access,  pursuant to





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paragraph (a) (1) of this section, equivalent to access afforded



Department employees upon presentation of credentials and other



documents as may be required by law.



   (b)  Records kept by the Department pertaining to aspects



of the disposal system that could affect the containment of



waste in the disposal system shall be made available to the



Administrator or the Administrator's authorized



representative (s)  upon request.   If  requested records are not



immediately available, they shall be made available to the



Administrator or the Administrator's authorized



representative(s)  within 30 calendar days of a request from



the Administrator or the Administrator's authorized



representative(s).



   (c)  The Department shall, upon request by the Administrator



or the Administrator's authorized representative(s),  provide



private, rent-free office space for the exclusive use of the



Administrator or the Administrator's authorized



representative(s).   The office space shall be convenient and



have full access to the disposal system.



   (d)  The Administrator or the Administrator's authorized



representative (s) shall be allowed to obtain samples, including



split samples and to monitor and measure  aspects of the



disposal system and the waste proposed for disposal in the



disposal system and deemed by the Administrator or the



Administrator's authorized representative to be relevant to



a compliance certification or determination.






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   (e)  In conducting activities pursuant to this section, the



Administrator or the Administrator's authorized



representative(s) will comply with applicable access control



measures for security, radiological protection and personal



safety.



  194.22  Quality assurance.



   (a) (1)  The Department shall implement  a quality assurance



program that meets the requirements of ASME NQA-1-1989 edition,



ASME NQA-2a-1990 addenda  (part 2.7) to ASME NQA-2-1989 edition,



and ASME NQA-3-1989 edition (excluding Section 2 .1 (b) and (c) ) .



   (2)  Any application for certification  of compliance  shall



include information which demonstrates that the  quality



assurance program implemented under paragraph (a)(1)  of this



section has been established and executed for:



   (i) Waste characterization activities and assumptions;



   (ii) Environmental monitoring, monitoring the performance



of the disposal system,  sampling, and analysis activities;



   (iii) Field measurements of geological factors, ground



water, meteorology, and  topography;



   (iv) Computations, codes, models and methods  used to



demonstrate compliance with the disposal regulations;



   (v) Expert judgment elicitation used to support applications



for certification or determination of compliance;



   (vi) Design of the disposal system and actions taken to ensure



compliance with design specifications;



   (vii) The collection of data and information used to support






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compliance application(s);  and



   (viii)  Other systems,  structures, components, and activities



important to the containment  of waste  in the disposal system.



   (b)  Any application for certification of compliance shall



include information which demonstrates that data and



information collected prior to implementation of the quality



assurance program under paragraph  (a) of this  section has been



qualified in accordance with:



   (1)  a quality assurance program equivalent in scope and



implementation to ASME NQA-1-1989 edition, ASME NQA-2a-1990



addenda (part 2.7) to ASME NQA-2-1989 edition, and ASME



NQA-3-1989 edition (excluding Section 2.1(b)  and  (c)); or



   (2)  an alternative method approved by the Administrator for



use at the WIPP.



   (c)  Any application for certification of compliance shall



provide information which addresses  how the following quality



indicators for the collection of data  and  information used to



support a compliance application have been and will continue



to be achieved:



   (1)  Data accuracy, i.e. ,  the degree  to which data agree with



an accepted reference or true value;



   (2)  Data precision, i.e., a measure of the mutual agreement



between comparable data gathered or developed under similar



conditions expressed in terms of a standard deviation;



   (3)  Data representativeness, i.e., the degree to which data



accurately and precisely represent a characteristic of a






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population, a parameter, variations at a sampling point, or



environmental conditions;



   (4)  Data completeness, i.e. ,  a measure of the amount of valid



data obtained compared to the amount that was expected;



   (5)  Data comparability, i.e.,  a measure of the confidence



with which one data set can be compared to another;



   (6)  Data reproducibility, i.e. a measure of the variability



among measurements of the same sample at different laboratories;



   (7)  Data validation, i.e., a systematic process for reviewing



a body of data against a set of criteria to provide assurance



that the data are adequate for their intended use; and



   (8)  Data verification, i.e., a systematic process for



reviewing a body of data generated by one source against a body



of data generated by another source.



   (d)   The Administrator will verify appropriate execution



of quality assurance programs through inspections which include



surveillances, audits, and management systems reviews.



  194.23     Models and computer codes.



   (a)  Any application for certification of compliance shall



include:



   (1)   A complete listing and description of the models used



to support such application.   The description shall be



sufficiently complete to permit technical review of the purpose



of modeling,  the modeling approach,  method of analysis and the



assumptions underlying such analyses.



   (2)  A complete listing   of   conceptual model(s) considered






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but not used to support such application, a description of such



model (s) ,  and an explanation of the reason (s) why such model (s)



was/were not used to support such application.



    (3)  Information which demonstrates that:



    (i)  conceptual models reasonably represent the disposal



system;



    (ii)  mathematical models incorporate equations and



boundary conditions which reasonably represent the mathematical



formulation of the conceptual models;



    (iii)   numerical models provide numerical schemes which



enable the mathematical models to obtain stable solutions;



    (iv) computer models accurately implement the numerical



models; i.e., computer codes are free of coding errors and



produce stable and accurate solutions; and



    (v)   models, computer codes, and observed and measured data



used to confirm models and computer codes have undergone peer



review according to 194.27.



    (b)  Models and computer codes used to support any application



for certification of compliance shall be fully and clearly



documented in a manner that complies with the requirements of



ASME NQA-2a-1990 addenda  (part 2.7) to ASME NQA-2-1989 edition.



    (c)  Documentation for models and computer codes shall



include:



    (1)  A description of the theoretical backgrounds of each



model,  the method of analysis or assessment, scenario



construction, and data collection procedures;






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   (2)  Detailed descriptions of the structure of  computer



codes and complete listings of the source codes;



   (3) Users'  manuals that include general descriptions of the



models, discussions of the limits of applicability of each



model, detailed instructions for running the computer codes



including hardware and software requirements,  input and output



formats with detailed explanations of each input and output



variable and parameter, listings of input and output files from



a sample computer run,  and reports on code verification,



benchmarking,  validation and quality assurance procedures;



   (4)  Programmers'  manuals;



   (5)  Any necessary licenses; and



   (6)  An explanation of how models and computer codes handle



covariance.



   (d) The Administrator or the Administrator's authorized



representative may verify the results of computer simulations



used to support any application for certification of compliance



by performing independent simulations.   Data files,  source



codes, executable versions of computer software for each model,



 other material or information needed to permit the



Administrator or the Administrator' s authorized representative



to perform independent simulations,  and access to  necessary



hardware to perform such simulations,  shall be provided within



30 calendar days of a request by the Administrator or the



Administrator's authorized representative.



  194.24    Waste characterization.






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   (a) (1) Any application for certification of compliance shall



 identify, in detail,  the  chemical, radiological and physical



characteristics  of all waste proposed for disposal in the



disposal system.  Such identification  shall provide



information about waste characteristics as they exist or, in



the case of to-be-generated waste, as they are expected to exist



upon emplacement in the disposal system.



   (2)  Information about the  following characteristics of waste



proposed for disposal in the  disposal system shall be provided:



   (i)  Activity in curies of each radionuclide; and



   (ii)  Any other characteristic(s) important to the



containment of waste in the disposal system as identified by



the study conducted under paragraph (a)(3)  of this section.



   (3)  The Department shall  conduct a  study of the effects of



waste characteristics on the containment of waste in the



disposal system and shall include the results of such study



in any application for certification of compliance.  The



characteristics studied shall include, but need not be limited



to:



   (i)  Waste form;



   (ii)  Free liquid content and liquid saturation;



   (iii) Pyrophoric and explosive materials; and



   (iv)  Characteristics affecting the solubilization and



mobilization of radionuclides,  formation of colloidal



suspensions containing radionuclides,  production of gas from



the waste, nuclear  criticality,  and generation of heat in the






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disposal system.



   (4)  For all waste characteristics studied pursuant to



paragraph (a)(3) of this section, any application for



certification of compliance shall document and substantiate



any decision not to provide information on a particular waste



characteristic because that characteristic is considered to



be unimportant to the containment of waste in the disposal



system.



   (5)  Categories of waste shall be established, by the



Department,  based on characteristics of the waste that would



be expected to behave similarly in the disposal system.



   (b)  The information provided under paragraph (a)  of this



section:



   (1)  shall consist of a value or range of values for



characteristics listed under paragraph (a) (2)  of  this section;



and



   (2)  shall consist of a value or range of values for



characteristics identified as  important to the containment of



waste in the disposal system by the study required under



paragraph (a)(3) of this section; and



   (3)  shall describe in detail the characteristics of each



category of waste established under paragraph (a)(5)  of this



section; and



   (4)  may specify the maximum amount of each category of waste



that will be placed in any waste  container or location in the



disposal system.






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   (c) (1)  Any application for certification of compliance shall



identify and describe the method(s) used to determine waste



characteristics and the uncertainty associated with such



method(s).



   (2)  Any application for certification of compliance shall



provide information which substantiates any determination of



waste characteristics based on knowledge of  the processes and



materials that generated the waste.



   (d)  Any application for certification of compliance shall



provide information which demonstrates that the disposal system



complies with the disposal regulations for all combinations



of waste whose contents fall within the range of characteristics



provided pursuant to paragraph (b)  of this section.



   (e)(1)  Waste may only be emplaced in the disposal system



if the characteristics of such waste  fall within the range of



values provided under paragraph (b)  of this section and if the



amount of  each category of waste placed in any waste container



or location in the disposal system does not exceed  any maximum



specified under paragraph  (b)(4)  of this section.



   (2)  Any application for certification of compliance shall



provide information which demonstrates that a system of controls



which includes but  is not necessarily limited to measurements,



sampling,  chain of custody records  and other record-keeping



is and will continue to be implemented to assure that only waste



containers whose contents fall within the range of



characteristics provided under paragraph (b) of this section






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are emplaced in the disposal system.  Any application for



certification of compliance shall identify and describe such



controls and  the uncertainty associated with them.



   (f)  The Administrator will use audits and inspections to



verify the waste characterization requirements of this part.



  194.25   Future state assumptions.



   (a)   Unless otherwise specified in this part or in the



disposal regulations, certifications or determinations of



compliance with the disposal regulations shall assume that



characteristics of the future remain what they are today:



Provided,  That such characteristics are not related to



geologic, hydrologic, or climatic conditions.



   (b)   In considering the effects of climatic conditions on



the disposal system, certifications and determinations of



compliance with the disposal regulations shall consider the



effects of increased and decreased precipitation and



evaporation on the disposal system over the regulatory time



frame.



  194.26   Expert judgment.



   (a)  Expert judgment,  by an individual expert or panel of



experts, may be used to support any application for



certification of compliance:  Provided, That expert judgment



does not substitute for information that could reasonably be



obtained through data collection or experimentation.



   (b)  Any application for certification of compliance shall



identify any expert judgments used to support the application





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and shall identify experts (by name and by professional



affiliation)  involved in any expert judgment elicitation



processes used to support the application.



   (c)  Any application for certification of compliance shall



describe the process of eliciting expert judgment,  and shall



document the results of expert judgment elicitation processes



and the reasoning behind those results.  Documentation of



interviews used to elicit  judgments from experts, the questions



or issues presented for elicitation of expert judgment,



background information provided  to experts, and deliberations



and formal interactions among experts shall be provided.



   (d)  Any application for certification of compliance shall



provide information which demonstrates that the following



restrictions and guidelines have been applied to any selection



of individuals used to elicit expert judgments:



   (1)  Individuals who are members of the team of investigators



requesting the judgment or the team of investigators who will



use the judgment shall not be selected; and



   (2)  Individuals  who maintain,  at any organizational level,



a supervisory role or who are supervised by those who will



utilize the judgment shall not be selected.



   (e)  Any application for certification of compliance shall



provide information which demonstrates that the expertise of



any individual involved in expert judgment elicitation comports



with the level of knowledge required by the questions or issues



presented to that individual.






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   (f)  Any application for certification of compliance shall



include an explanation of the relationship between the



information presented,  the questions or issues presented, the



judgment of any expert panel or individual, and the purpose



for which the expert judgment is being used.



   (g)  Any application for certification of compliance shall



provide information which demonstrates that the following



restrictions and guidelines have been applied in eliciting



expert judgment:



   (1)  At least five individuals shall be used in any expert



elicitation process: Unless, there is a lack or unavailability



of experts and a documented rationale is provided which explains



why fewer than five individuals were selected.



   (2)  At least two-thirds of the experts involved in an



elicitation shall consist of individuals who are not employed



directly by the Department or by the Department's contractors:



Unless, The Department can demonstrate and document that there



is a lack or unavailability of qualified independent experts;



however, in no case shall more than one-half of the experts



involved in an elicitation consist of individuals employed



directly by the Department or by the Department's contractors.



   (h)  Groups and individuals (including those not directly



employed by the Department or by the Department's contractors)



shall be afforded an opportunity to present their scientific



and technical views as input to any expert elicitation process.



  194.27   Peer review.






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   (a) Any application for certification of compliance shall



include information which demonstrates that peer review has



been conducted to evaluate the adequacy of:



   (1) The evaluation, required under this part, of engineered



barriers for the disposal system;



   (2) Consideration of processes and events that may affect



the disposal system;



   (3) Quality assurance programs and plans;



   (4) Models and computer codes;



   (5) Data used to support models and computer codes; and



   (6) Waste characterization.



   (b) Peer review processes used in certifying or determining



compliance with the disposal regulations shall be conducted



in a manner which is compatible with NUREG-1297 "Peer Review



for High-Level Nuclear Waste Repositories."



                  CONTAINMENT REQUIREMENTS



  194.31   Application of release limits.



   The expected curie activity 100 years after disposal of the



waste proposed for disposal in the disposal system shall be



used in calculating applicable release limits under Appendix



A of 40 CFR 191, Table 1, Note 1(e) .



  194.32   Scope of performance assessments.



   (a) Performance assessments shall consider both natural and



human-initiated processes and events that may affect the



disposal system.



   (b) Performance assessments need not consider processes,






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events, or sequences of processes and events that have less



than one chance in 10,000 of occurring over 10,000 years.



   (c)  Any application for certification of compliance shall



include information which:



   (1)  identifies potential  processes, events or sequences of



processes and events that may occur during the regulatory



timeframe and may affect the disposal system;



   (2)  identifies the processes, events or sequences of



processes and events included in performance assessment results



provided in any application for certification of compliance;



and



   (3)  documents why any processes, events or sequences of



processes and events identified under paragraph (c) (1) of this



section were not included in performance assessment results



provided in any application for certification of compliance.



  194.33    Consideration of human-initiated processes and



events.



   (a)   A separate examination of each type of human-initiated



process and event shall be conducted.   Analyses shall be limited



to those types of human-initiated processes and events that



may potentially affect the disposal system.



   (b)  The following process shall be used in assessing the



likelihood and consequences of human-initiated processes and



events and the  results  of such process shall be documented in



any application for certification of compliance:



   (1)   Inadvertent and intermittent drilling for resources






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(other than those resources provided by the waste in the disposal



system or any engineered barriers designed to isolate such



waste) is the most severe scenario for human-initiated processes



and events.



   (2)  Human-initiated processes and events occur at random



intervals in time and space throughout the regulatory time



frame.



   (3) Two categories of human-initiated  processes  and events



shall be considered:



   (i)  Human intrusion, which shall include those drilling



events that reach the level of the waste in the disposal system,



and



   (ii)  Human activity, which shall include those drilling



events that  may affect the disposal system, but do not



necessarily reach the level of the waste in the disposal system.



   (4)  The  frequency of human intrusion shall be calculated



in the following manner:



   (i)  Identify each type  of  human intrusion in the Delaware



Basin over the past 50 years.



   (ii)  The total rate of human intrusion shall be the sum



of the rates of  each type of human  intrusion.  However, in no



event shall  the total rate of human intrusion be less than



25/km2/10, 000  yrs or more than 62 . 5/km2/10 , 000 yrs .



   (iii)   In lieu of conducting the analysis in paragraphs



(b)(4)(i)  and (b)(4)(ii) of historical rates, a rate of 62.5



may be assumed.





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   (iv)  The rate may then be reduced in accordance with 194.41



and 194.43(c).



   (5)   The frequency of human activity shall be calculated



in the following manner:



   (i)   Identify each type of human activity in the Delaware



Basin over the past 50 years.



   (ii)  The total rate of  human activity  shall be the sum of



the rates of each type of human activity.



   (iii)   In considering the historical rate of all human



activity, the Department may,  if justified, consider only the



historical rate of human activity for resources of  similar type



and quality of resources in the controlled area.



   (iv)  The rate may then be reduced in accordance with 194.41



and 194.43(c).



   (6)  In assessing the consequences of human-initiated



processes and events, performance assessments shall assume that



the future characteristics of those processes and events



including, but not limited to, the types and amounts of drilling



fluids, and borehole depths,  diameters, and seals will remain



consistent with current practice in the Delaware Basin.



   (b)   In assessing the consequences of human-initiated



processes and events, performance assessments shall assume



that:



   (1)  Boreholes will be sealed at the rate boreholes have been



sealed over the past 50 years in the Delaware Basin;  and



   (2)  Natural processes will degrade or otherwise affect the






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permeability of boreholes over the regulatory time frame.



  194.34    Results of performance assessments.



   (a)(1) The results of performance assessments shall be



assembled into "complementary cumulative distribution



functions" (CCDFs)  that represent the probability of exceeding



various levels of cumulative release caused by all significant



processes and events.



   (2)  Probability  distributions for uncertain disposal system



parameter values used in performance assessments shall be



developed.



   (3)  Computational techniques which draw random samples from



across all of the probability distributions developed under



paragraph (a)(2)  of this section shall be used in generating



CCDFs.



   (b)  The number of CCDFs generated must be large enough such



that the maximum CCDF generated exceeds the 99th percentile



of the population of CCDFs with at least a 0.95 probability.



   (c)  Any application for certification of compliance shall



display the full range of CCDFs generated.



   (d)  Any application for certification of compliance shall



provide information which demonstrates that there is at least



a 95% level of statistical confidence that the mean of the



population of CCDFs meets the requirements of section 13(a)



of 40 CFR part 191.



                   ASSURANCE REQUIREMENTS



  194.41   Active institutional controls.






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   (a)  Any application for certification of compliance shall



include detailed descriptions of proposed active institutional



controls, the controls' location, and the period of time the



controls are proposed to remain active.  Assumptions pertaining



to active institutional controls and their effectiveness in



terms of preventing or reducing radionuclide releases shall



be supported by such descriptions.



   (b)   Assessments to determine compliance with the disposal



regulations shall not consider any contributions from active



institutional controls for more than 100  years after disposal.



  194.42   Monitoring.



   (a) (i)  Disposal systems shall be monitored after disposal



to detect substantial and detrimental deviations from expected



performance at the earliest practicable time and shall be



consistent with monitoring required under applicable federal



hazardous waste regulations  at 40 CFR parts 264, 265, 268, and



270.   These monitoring programs  shall be done with techniques



that do  not jeopardize the containment of waste in the disposal



system.



   (ii)  Any application for  certification of compliance shall



include a detailed plan for  monitoring the performance of the



disposal system.  At a minimum,  such plan shall:



   (1)  Identify parameters that will be monitored and how



baseline states will be determined;



   (2)  Indicate how each parameter will be used to evaluate



the performance of the disposal system;  and






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   (3)  Discuss the length of time over which each parameter



will be monitored to detect deviations from expected



performance.



   (b)(i)  To the extent practicable, pre-closure monitoring



of the following disposal system parameters shall be conducted:



   (1)  Brine quantity, flux, composition, and spatial



distribution;



   (2)  Gas quantity and composition;



   (3)  Temperature distribution; and








   (4)  Any other disposal system parameter(s)  important to the



containment of waste in the disposal system as identified by



the study conducted under (b) (ii) .  A disposal system parameter



shall be considered important if it affects the system's ability



to contain waste or the ability to verify predictions about



the future performance of the disposal system.   Such monitoring



shall begin as soon as practicable after the Administrator's



certification of compliance; however, in no case shall waste



be emplaced in the disposal system prior to the implementation



of such monitoring.  Monitoring shall end when the last



container of waste is emplaced in the disposal system but before



shafts of the disposal system are backfilled and sealed.



   (ii)  The Department shall conduct a study of the effects



of disposal system parameters on the containment of waste in



the disposal  system and shall include  the results of such study



in any application for certification of compliance.   The






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disposal system parameters studied shall include,  but need not



be limited to:



   (1)  Backfilled mechanical state including porosity,



permeability, and degree of compaction and reconsolidation;



   (2)  Extent of deformation of the surrounding roof,  walls,



and floor of the waste disposal room;



   (3)  Initiation or displacement of major brittle deformation



features in the roof or surrounding rock; and



   (4)  Subsidence and other effects of human activity in the



vicinity of the disposal system.



   (iii) For all disposal system parameters studied pursuant



to paragraph  (4)(ii)  of this section, any application for



certification of compliance shall document and substantiate



the decision not to monitor a particular disposal system



parameter because that parameter is considered to be unimportant



to the containment  of waste  in  the disposal system and to the



verification of predictions about the future performance of



the disposal system.



  194.43   Passive institutional controls.



   (a)  Any application for certification of compliance shall



include detailed descriptions of the measures that will be



employed to preserve knowledge about the location, design, and



contents of the disposal  system.   At  a minimum, such measures



shall include:



   (1)   Identification of the controlled area by markers that



have been designed, fabricated,  and emplaced to be  as permanent





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as practicable;



   (2)   Placement of records in the archives and land record



systems of local, State, and Federal governments, and



international archives, that would likely be consulted by



individuals in search of unexploited resources.  Such records



shall identify:



   (i)  The location of the controlled area and the disposal



system;



   (ii)  The design of the disposal system;



   (iii)   The nature and hazard of the waste;



   (iv)  Geologic, geochemical, hydrologic, and other site data



pertinent to the containment of waste  in the disposal system;



and



   (v)   The results of  tests, experiments,  and other analyses



relating to backfill of excavated  areas, shaft sealing, waste



interaction with the disposal system,  and  other tests,



experiments, or analyses pertinent to the containment of waste



in the disposal system.



   (b)  Any application for certification of compliance shall



include detailed descriptions of the proposed passive



institutional controls and the period of time those controls



are expected to endure and be understood.



   (c)  Any application for certification of compliance may



include a proposed credit  (which may vary over the regulatory



time frame)  for reducing the rate of human-initiated processes



and events calculated using the procedures enumerated in






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194.33.  The Administrator shall allow such credit,  or a



smaller credit, to be taken if the Department demonstrates that



such credit is justified because the passive institutional



controls can be expected to  endure, be understood, and act as



a deterrent to potential intruders throughout the regulatory



time frame.  In no  case,  however, shall passive institutional



controls be assumed to eliminate the likelihood of



human-initiated processes and events entirely.



  194.44   Engineered barriers.



   (a) Disposal systems  shall incorporate engineered barriers



designed to prevent or substantially delay the movement of water



or radionuclides toward the accessible environment.



   (b) In selecting engineered barriers for the disposal system,



the Department shall evaluate the benefit and detriment of



engineered barrier alternatives including but not limited to



such engineered barriers as cementation, shredding,



supercompaction,  incineration,  vitrification, improved waste



canisters,  grout and bentonite backfill, melting of metals,



alternative configurations of waste placements in the disposal



system, and alternative disposal system dimensions.   The



results of  this evaluation shall be included in any application



for certification of compliance and shall be used to justify



the selection and rejection of each engineered barrier



evaluated.



   (c) (1)  In conducting the evaluation of engineered barrier



alternatives, the following shall be considered:





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   (i)  the ability of the engineered barrier to prevent or



substantially delay the movement of water or waste



toward the accessible environment;



   (ii)  the impact on worker exposure to radiation both during



and after incorporation of engineered barriers;



   (iii) the increased ease or difficulty of removing the waste



from the disposal system;



   (iv)  the increased or reduced risk of transporting the waste



to the disposal system;



   (v)  the increased or reduced uncertainty in compliance



assessment;



   (vi)  the increased or reduced public confidence in the



performance of the disposal system;



   (vii) the increased or reduced total system costs;



   (viii) the  impact, if any, on other waste disposal programs



from the incorporation of engineered barriers (e.g. ,  the extent



to which the incorporation of engineered barriers affects the



volume of waste);



   (ix)  the effects on mitigating the consequences of



human-initiated processes and events.



   (2)  If, after consideration of one or more of the factors



in paragraph (c)(1)  of  this section,  the Department concludes



that an engineered barrier should be rejected without evaluating



the remaining  factors in paragraph (c) (1) of this section, then



any application for certification of  compliance shall provide



a justification for this rejection explaining why the evaluation






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of the remaining factors would not alter the conclusion.



   (d)  In considering the benefit and detriment of



incorporation of engineered barriers, the benefit and detriment



of engineered barriers for existing waste already packaged,



existing waste not yet packaged, existing waste in need of



re-packaging, and to-be-generated waste shall be considered



separately and described.



   (e) The evaluation shall consider engineered barriers alone



and in combination.



  194.45   Consideration of the presence of resources.



   Any application for certification of compliance shall



include information that demonstrates that the favorable



characteristics of the disposal system compensate for the



presence of resources in the vicinity of the disposal system



and the likelihood of future human-initiated processes and



events as a result of the presence of those resources.



  194.46   Removal of waste.



   Any application for certification of compliance shall



include a plan for removal  of waste from the disposal system.



 The plan shall incorporate the  best technology available, at



the time of application, for removing such waste.



     INDIVIDUAL AND GROUND-WATER PROTECTION REQUIREMENTS



  194.51    Consideration of protected individual.



   Certifications or determinations of compliance with section



15 and subpart C of 40 CFR part 191 shall assume that an



individual resides at the location in the accessible environment






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where that individual would be expected to receive the highest



exposure from radionuclide releases  from  the disposal system.



  194.52    Consideration of exposure pathways.



   In certifying or determining compliance with section 15 and



subpart C of  40 CFR part 191,  all potential exposure pathways,



associated with undisturbed performance,  from the disposal



system to individuals shall be considered.  Certifications or



determinations of compliance  with  section 15 and subpart C of



40 CFR part 191 shall assume that individuals consume 2 liters



per day of drinking water from any underground source of drinking



water in the accessible environment.



  194.53     Consideration of underground sources of drinking



water.



   In certifying or determining compliance with subpart C of



40 CFR part 191,  all underground sources  of drinking water in



the accessible environment likely to be affected by the disposal



system over the regulatory time frame shall be considered.



In determining whether underground sources of drinking water



are likely to be affected by the disposal system,



interconnections between bodies of  surface water, ground water,



and underground sources  of drinking water  shall  be considered.



  194.54   Scope of compliance assessments.



   Any application for certification of compliance shall



include information which:



   (a) identifies potential processes,  events or sequences of



processes and events that may occur over the regulatory time





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frame;



   (b) identifies the processes, events or sequences of



processes and events included in compliance assessment results



provided in any application for certification of compliance;



and



   (c) documents why any processes, events or sequences of



processes and events identified under paragraph (a) of this



section were not included in compliance assessment results



provided in any application for certification of compliance.



  194.55   Results of compliance assessments.



   (a)(1)  Compliance assessments shall consider uncertainty



in the undisturbed performance of a disposal system.



   (2) Probability distributions for  uncertain disposal



system parameter values used in compliance assessments shall



be developed.



   (3) Computational techniques which draw random samples from



across all of the probability distributions developed under



paragraph (2)  of this section shall  be used to generate a range



of:



   (i) Estimated radiation doses; and



   (ii)  Estimated radionuclide concentrations.



   (b)  Each of the ranges generated under paragraph (a)(3)



of this section must be large enough such that the maximum



estimate generated exceeds the 99th percentile of the population



of estimates with at least a 0.95 probability.



   (c) Any application for certification of compliance shall






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display:



   (1) The full range of estimated radiation doses; and



   (2) The full range of estimated radionuclide concentrations.



   (d) Any application for certification of compliance shall



provide information which demonstrates that  there is at least



a 95% level of statistical confidence that the mean and the



median of the  range of estimated radiation doses and the range



of estimated radionuclide concentrations meet the requirements



of sections 15 and 16 of 40 CFR part 191.



Subpart D--Public Participation



  194.61   Advance notice of proposed rulemaking.



   (a) Upon receipt of an application for certification of



compliance,  the Agency will publish in the Federal Register



an Advance Notice of Proposed Rulemaking announcing that an



application for certification of compliance has been received,



soliciting comment on such application, and announcing the



Agency's intent to conduct a rulemaking to certify whether the



WIPP facility will comply with the disposal regulations.



   (b) A copy of the application for certification of compliance



will be made available for inspection in Agency dockets.



   (c) The notice will provide a public comment period of at



least 120 days.



   (d) A public hearing concerning  the notice will  be held if



a written request  for a hearing is received within 30 calendar



days of the date of publication under paragraph (a) of this



section.  Written requests shall be directed to the






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Administrator and the Administrator's authorized



representative.



   (e) Any comments received on the notice will be made available



for inspection in the dockets  established under section 65 of



this part.



   (f) Any comments received on the notice will be provided



to the Department and the Department may submit written



responses to the comments within 120 days of receipt.



  194.62   Notice of proposed rulemaking.



   (a)  Upon completion of review of the application for



certification of compliance, the Administrator will publish



a Notice of Proposed Rulemaking in the Federal Register



announcing the Administrator's proposed decision on whether



the WIPP facility will comply with the disposal regulations



and soliciting comment on the proposal.



   (b) The notice will provide a public comment period of at



least 120 days.



   (c) The notice will announce the opportunity for public



hearings in New Mexico and provide information on the timing



and  location of such hearings and procedures for registering



to testify.



   (d) Any comments received on the notice will be made available



for inspection in the dockets  established under section 65 of



this part.



  194.63   Notice of final rule.



   (a) The Administrator will publish a Notice of Final Rule






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in the Federal Register announcing the Administrator' s decision



on certifying whether the WIPP facility will comply with the



disposal regulations.



   (b)  A document summarizing major comments and issues arising



from comments received on the Notice of Proposed Rulemaking



as well as the Administrator's response to such comments and



issues will be prepared and will be made available for inspection



in the dockets established under section 65 of this part.



  194.64    Documentation of continued compliance.



   (a)  Upon receipt of documentation of continued compliance



with the disposal regulations pursuant  to section 8(f) of the



WIPP LWA, the Administrator will publish a notice in the Federal



Register announcing that such documentation has been received,



soliciting comment on such documentation,  and announcing the



Administrator's intent to determine whether or not the WIPP



facility continues to be in compliance with the disposal



regulations.



   (b)  Copies of documentation of continued compliance received



by the Administrator will  be made available for inspection in



the dockets established under section 65 of this part.



   (c)  The notice will provide a public comment period of at



least 30 days after publication under paragraph (a) of this



section.



   (d)  Any comments received on such notice will be made



available for public inspection in the dockets established under



194.65.





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   (e) Upon completion of a review of documentation of continued



compliance with the disposal regulations, the Administrator



will publish a notice in the Federal Register announcing the



Administrator's decision determining whether or not the WIPP



facility continues to be in compliance with the disposal



regulations.



  194.65    Dockets.



   The Agency will establish and maintain dockets in the State



of New Mexico and Washington,  B.C.. The dockets will consist



of all relevant information received from outside parties and



all information considered by the Administrator  in certifying



whether the WIPP facility will comply with the disposal



regulations,  in determining whether or not the WIPP facility



continues to be in compliance with the disposal regulations,



and in determining whether compliance certification or



determination(s) should be modified, suspended, or revoked.








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