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3 Regulatory and Policy Framework for Waste Characterization ,; This chapter discusses the regulatory and policy framework for the characterization of contact-handIed transuranic (CH-TRU) waste destined for the Waste Isolation Pilot Plant (WIPP). A discussion of the regulatory and oversight bodies for WIPP, as well as the primary regulatory documents, is provided in this chapter and in Appendices C and D. Amendments to the authorizing basis documents,4 along with the processes for requesting and approving changes, are also discussed here. Finally, regulatory challenges for WIPP and other first-of-a-kind facilities2 conclucle this chapter. 3.1 Regulatory Bodies for WIPP The U.S. Environmental Protection Agency (EPA) and the New Mexico Environment Department (NMED) are the only agencies, other than the U.S. Department of Energy (DOE), with clirect regulatory authority over WIPP, but a number of other federal and state regulatory bodies are involved in WIPP activities, as shown in Table C.~. Of these agencies, only EPA and NMED have jurisdiction over waste characterization operations. The U.S. Nuclear Regulatory Commission (USNRC) has regulatory authority over TRU waste shipping containers. With the exception of the EPA standards for disposal (40 CFR 191), the DOE self-regulates its activities involving radiation (10 CFR 835, DOE Orders, and various internal guidance documents). DOE is also responsible for ensuring that transportation regulations for hazardous waste are met. DOE interacts with corridor states and Tribal Nations on issues relating to TRU waste transportation planning and emergency response through cooperative agreements. Corridor states are represented by the Western Governors' Association (WGA; see Sidebar 3. ~ ), the Council of State Governments-Midwestern Radioactive Materials Transportation Project, and the Southern States Energy Board. These cooperative agreements mandate regular meetings in which radiological health, emergency management, and transportation officials receive information on TRU waste program activities and discuss planning and implementation concerns with DOE representatives. Although it is not a regulator, the New Mexico Environmental Evaluation Group has had an oversight role since 1978 to help ensure the protection of public health and safely and the environment. The roles of this oversight group include the review and evaluation of all proposed stanclarcis; reviews of transportation information; audits of These documents are the New Mexico Hazardous Waste Facility Permit, the U.S. Environmental Protection Agency Certificate of Compliance for WIPP and U.S. Nuclear Regulatory Commission Certificate of Compliance for the shipping container. 2The Committee recognizes that WIPP is a unique facility for the deep geological disposal of transuranic waste and there are no plans for any other similar facilities in the United States. 27

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28 Improving the Characterization Program for Contact-Handled Transuranic Waste characterization procedures at the generating sites; and analyses of water, soil, and organic samples jointly obtained with WIPP environmental monitoring programs. 3.2 Main Regulatory Documents To continue clisposal operations, WIPP must show continuecl compliance with regulatory constraints derived from the following laws and regulations: Land Withdrawal Act (as amended), 40 CFR 191, 40 CFR 194, and 40 CFR 264.3 The CH-TRU waste characterization program consists of characterization activities to address requirements in the above laws and regulations. The characterization activities appear in the following WIPP authorization basis documents: t EPA Certificate of Compliance for WIPP, NMED Hazardous Waste Facility Permit (HWFP), and USNRC Certificate of Compliance for shipping containers, which also addresses U.S. Department of Transportation regulations. Characterization requirements are generally compiled in the Waste Acceptance Criteria, although not all requirements mentioned in the HWFP are listed. The Land Withdrawal Act, authorization basis clocuments, and Waste Acceptance Criteria are describecl briefly below; additional information is provided in Appendix C. 3.2.1 Lanc' Withdrawal Act The Land Withdrawal Act, Public Law 102-579, is the guiding legislation for WIPP (U.S. Congress, ~ 992~. In this Act, Congress established the scope and legal criteria for the WIPP facility and withdrew 41.6 square kilometers (16 square miles) of land from the U.S. Department of Interior in favor of DOE use for "entry, appropriation, and disposal." The Land Withdrawal Act also assigned EPA regulatory authority over TRU radioactive waste standards and final disposal regulations. The Land Withdrawal Act includes many other requirements and provisions pertaining to the protection of public health and the environment. Details of characterization-related requirements of the Land Withdrawal Act are provided in Appendix C. 3.2.2 EPA Certificate of Compliance In accordance with the Land Withdrawal Act, in 1996 EPA promulgatecl criteria (40 CFR 194) for the certification and recertification of the Waste Isolation Pilot Plant's compliance with 40 CFR ]9~.4 In 199S, EPA declared WIPP to be in compliance with its disposal regulations and granted the facility a certificate of compliance, herein called "EPA Certification." EPA regulates public exposure to radiation at the land withdrawal boundaries resulting from the management and storage of TRU waste at WIPP during its operational period (nominally lasting until 2033) and regulates radioactivity releases into the environment up to 10,000 years after repository closure. The EPA Certification must be reviewed every five years. Details of characterization-related requirements in the EPA Certification are provided in Appendix C. 3.2.3 NMED Hazardous Waste Facility Permit The NMED issued the WIPP HWFP in 1999 to allow DOE to dispose of TRU mixed waste in WIPP in compliance with the Resource Conservation and Recovery Act 3For additional information on these laws and regulations, see the Glossary. 4Title 40 CFR 191 lists the standards for management and disposal of spent nuclear fuel, high-level waste, and transuranic waste (see the Glossary).

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Regulatory and Policy Framework for Waste Characterization 29 (RCRA), the New Mexico Hazardous Waste Act (HWA), and EPA standards for mixed waste (40 CFR 264~.5 The primary purpose of this permit is to regulate the design, construction, maintenance, operation, and closure of WIPP in a manner that will ensure protection of human health and the environment from the hazardous components of waste. NMED regulates the releases6 of non-radiological hazardous constituents during the operational phase and for a nominal 30-years following repository closure. The HWFP contains a Waste Analysis Plan that describes waste characterization activities to be performed at generator sites before waste is shipped to WIPP. Waste characterization requirements in the Waste Analysis Plan are intended to provide a detailed chemical and physical analysis of a representative sample of the waste in accordance with RCRA. The HWFP must be renewed every 10 years. Details of characterization-related requirements in the HWFP are provided in Appendix C. 3.2~4 USNRC Certificate of Compliance for transportation packages The USNRC regulates the packaging for transportation of radioactive waste. Regulatory requirements for transportation of hazardous, including radioactive, waste are promulgated in 10 CFR 71. Each shipping container design destined for WIPP must obtain a USNRC certificate of compliance with the requirements in ~ O CFR 71. To certify a package design, DOE must submit a Safety Analysis Report for transportation packages to the USNRC. . . . .. .. . The Safety Analysis Report describes the physical characteristics of the package, the quality assurance program for package design, and the results of normal conditions testing and incident or accident conditions testing. The USNRC issued Type B (see the Glossary) certificates of compliance for the TRUPACT-~! transportation packages. Requirements for authorized contents in the TRUPACT-~! Certificate of Compliance are implemented in TRUPACT-~! Authorized Methods of Payload Control (TRAMPAC). Other USNRC-approved shipping containers are the Half- PACT and the RH 72-B, the latter for transportation of remote-handIed transuranic (RH- TRU) waste. Details of characterization-related requirements for transportation packages are provided in Appendix D. 3.2.5 Waste Acceptance Criteria The Waste Acceptance Criteria is a document written by DOE to consolidate all of the existing acceptance criteria and ensure uniformity in TRU waste documentation, transportation, handling, and disposal activities at WIPP. The Waste Acceptance Criteria set limits and criteria on the physical aspects, racliological aspects, quantity, and chemical composition of TRU waste. For example, the criteria include information on the following parameters: gas generation, waste immobilization techniques, container design and life, package weight, toxic and corrosive materials amounts and composition, free liquid content, criticality, thermal power, and concentration and amount of radioactivity. In compiling the Waste Acceptance Criteria, DOE considered current regulations from the EPA, USNRC, and transportation requirements. The Waste Acceptance Criteria 5The Resource Conservation and Recovery Act establishes a system for tracking and regulating hazardous wastes from the time of their generation through disposal. In 40 CFR 264, EPA promulgated the "Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities" (see the Glossary). EPA delegated authority over mixed waste in New Mexico to NMED (see Appendix D). 6With an exemption from Land Disposal Restriction regulations (40 CFR 268), Congress determined that WIPP waste does not need treatment prior to disposal. As a result, the NMED imposed groundwater and air monitoring requirements to ensure that any detectable release of hazardous materials remains below specified limits that have been established to protect human health and the environment.

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30 Improving the Characterization Program for Contact-Handled Transuranic Waste have been revised several times since 1980 to reflect programmatic changes approved by NMED, EPA, and USNRC. All revisions to the Waste Acceptance Criteria require review of possible environmental impacts. ~~ ~~ ~~ ~~ ~~ .~ .. ~ ~.~ ~ ~~ ~~. . Id. has::: >~, ~:~ Id ~,~ ~~ ~~ ~~ ~~ ~~' 3,>.'x~"'~ . . .~...~ ~ ... .. :~ i, i- it. ~..~ ah:: 90:: ,~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ A, . ~~ .

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Regulatory and Policy Framework for Waste Characterization 31 I Am ha~ ~ d~g on. ~U ~~ cham - ~~:i..on 9~it'83# ~~:~ ?~ ~~:::::::::::::::::::::::::: :::::::::::::: :::::::::::::::::::::::::::::::::::::::::::::::::::::::::: ::::: ::::: :: ::::: ~~ ~ ~1~ ~ ~ ~ ~~ ~ ,: ~ ~~ ~~ ~ By: ~~,~ ~~-~ ~~ ~~ ~~ ~~ ~'~2 ', ~ ~-The~m I: ACE ~ Few Ache comb Made by Why Safe b;~;~:~y `n the~$i6~-lViemorandnm~ A:~ii~f: and ~~o 161~ the ~:~ ~~i:iu'~$ ~41 ~~0 ~ ~e ~~:~ ~~~i) ~~ ~:m~ ~-~-:~men~ Go_ as amends, -fir ~e t:~d ~ all 1:~c - though thy ~~s, whether to W1FF bt to a s~ ~r Brim stHi c~n ~~Ck~x~TP~ Gary ~~r any Se~ to provide the end ~~:~ ~~ w~~ ~ :Ilie mSou~ ~~:~ imolement~cha~ last- Ilk `~ She @labonai~liRU~ ~ ~ - ~~Pmomm~ -mane ~~! t;~-e ~~s~-~:~ ~:~800~ I ~2 * ~ ~~ ~ ~ ~ ~~-~ It ~ ~31 hid bed ~ ~~oh]~:ives~ ante ~~ ~~ ~~ ester- .~ ;~ ~ ~~.~'~su~-the~i~Iow~ng~:li~03,~poSlllons:~ 'I O'er ~~ ~~mu~*/:~-~omolv~llN ~~h~-~-~le=~-~:l ~ I* DPp!~ ~qU'~me~ ~sp~ ~~ Wl;~P Cand W't~al A. em; i- ~ ~ ~ ~ ~ .~ Dad: And: ~~ Fly win ~e U~ ~~nmental PA Talent welt) ~n :~ m~dDi=~on ~ Woof s mmpltanee whiN this I*:: 1is~l =~:~:::~d cti0a in :40 Ukiii:R ~:~s :~1 add 194~ ~ -: TRU ~ - ~~i3n and ~~ Irk at OO~ s ~~n O0r ~ ~~ ~e tmel,t, Fen cln~ Of the U*~n:~-~:r - ~~s ~~mmplex* ~ ~T~e ~~ ~hou::ld no1:: be ~~:n 0m the WIPE: ~A cmO36~t~UgtpUty ~it ~:~i~ ~qu~mmen~:~ and~ntmue~ the ~ ~~ ~ ---~d un~ff~:l~ m ~~ :::::::: ::::::::: ::::: ::: ::::::::::::: ::::::::::: ::::::::::::::::::::::::::::::::::::::::: :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: The ~~ ~ ~~ ~ the ~ ctiam~iz~ion prim On WEAL age ~-~-~with~DOE:~'s~disCu%sed in~chap~-~:~'~Fihbino~:~:~:~mme~ - i~ s~.~ ~~'~ 3.3 History of Modifications to WIPP's Regulatory Documents Since the beginning of WIPP operations (1999) there have been a number of modifications of the EPA Certification, the HWFP, and the USNRC Certificate of Compliance for shipping containers. With lime and experience, changes to permits and certifications have become more focused, in particular those for the HWFP (e.g., data management and electronic quality assurance). According to DOE, these regulatory changes have been beneficial to the National TRU Waste Management Program (Kehrman, 2002~. 3.3.1 Programmatic changes relevant to EPA The EPA process for modifying the WIPP certification is clescribed in Sections 194.4, 194.65, and 194.66 of WIPP compliance criteria (40 CFR 194~. In brief, the process is as follows. There is only one level of "modification" to the certification. Any modification is done through rulemaking, with required Fe c/era/ Register notices, a comment periocl, and responses to comments. Revocation of the WIPP Certificate of Compliance would also require rulemaking. EPA can suspend the certification at its ~~.~ '~: .~- If., :~:~:~::~: ~~.~ ~~. ~ ::::: ~ ~~ : -ail ~~:~ ~~: .~. ~~:~ - ~. ~:~ . ~ ~ ~ ~ ~ ~ ~ , ~~.~. 1 ~~ 1 1 1 . 1 ~~ 1

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32 Improving the Characterization Program for Contact-Handled Transuranic Waste discretion to address immediate threats to public health or the environment whenever the disposal activities or disposal system change such that significant information contained in the most recent compliance application were no longer to remain true (e.~., . _ , . .. . . .. . .. . . . . . . .. .. ~ if releases from the disposal system were discovered that might exceed release limits). EPA may approve WIPP program changes outside the modification process. In fact, DOE is required to report to EPA any planned program changes, which are evaluated to determine whether they are significant enough to challenge the basis for the certification decision. Thus far, no changes have risen to this level. EPA has approved a number of program changes through written notifications to DOE. In the case of such written approvals, EPA has the discretion (but is not required) to publish a Fe c/e ral Register notice and/or solicit public comment, although so far it has not done so. DOE has proposed a number of programmatic changes to EPA, some of which have been approved (see below). In December 2002, DOE submitted a request to EPA to dispose of RH-TRU waste in WIPP. To date (December 2003), EPA has not issued its decision. On its own initiative, EPA has proposed the following changes to EPA's compliance criteria (40 CFR ~ 94~: Hi.. . . Change in the waste characterization program approval process. This would add flexibility and focus EPA's oversight efforts where EPA feels they would be most effective. The change would enable EPA to issue a single approval of each site's program, followed by ongoing EPA inspections and reporting of important changes by DOE. Change in the focus of EPA's public comment process. This change would highlight EPA's proposed decisions on site-specific waste characterization programs instead of focusing on plans and procedures prepared by DOE. Change in the process to ac/c/ress minor modifications of the EPA Compliance Criteria. This would streamline the process for editorial or other minor changes to 40 CFR 194. Change in the c/ocument submission process This would allow non-paper submission (such as a compact disc) of compliance applications and reference materials to facilitate review by EPA and the public. Rep/ace the term "process know/ecige" with "Acceptable Know/ecige." This would allow EPA and DOE to use the same terminology consistently. The public comment period for this rutemaking is now concluded. EPA is preparing the final rule on alternative provisions to 40 CFR 194, to be published in the spring of 2004. According to EPA, the purpose of these provisions is to add flexibility to, and clarify minor portions of, the rule while continuing to protect the public health and the environment. The rationale for modifications proposed by EPA is that the W! PP Compliance Criteria and Conditions of Certification (including requirements for inspection and approval of waste generator sites) were initially based on the best knowledge available at the time regulations were issued and DOE's Compliance Certification Application was submitted (1996~. Since the initial certification (1998) and beginning of operation (1999), EPA has gathered extensive experience implementing the requirements and has conducted many independent technical reviews and inspections of WIPP and DOE's TRU waste facilities around the United States to verify compliance with WIPP disposal regulations. Based on this experience, EPA determined that the processes dealing with inspections for the approval of TRU waste facilities in its Certification should be updated. EPA plans to apply this experience to improve its regulation of WIPP (EPA, 2002~. EPA adds that

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Regulatory and Policy Framework for Waste Characterization 33 these proposed changes wit! have no effect on the technical approach used during its independent inspections to evaluate a site's waste characterization capabilities. They also Will not lessen the requirements that the site must meet to demonstrate compliance with EPA Certification 3.3. 1. ~ Approved programmatic changes The following are notable programmatic changes submitted by DOE and approved by EPA. None of these changes required a modification of the EPA Certification. The first is a waste characterization-related change, the remaining are related to the WIPP facility: radioassay requirements used as an indicator of program performance were reduced from twice per year to once per year; magnesium oxide "mini-sacks" emplaced around the waste were eliminated; and the repository horizon was changed to a different depth. The change in radioassay requirements reduces impacts on laboratories given that the national standards provide adequate quality control. The magnesium oxide change reduces worker doses (1 0 person-rem reduction over the entire facility capacity) and the amount of magnesium oxide by 15 percent. The change in repository horizon was approved to improve repository ground conclitions, reduce risks during mining and waste handling underground, and reduce required maintenance. 3.3.2 Programmatic changes relevant to NMED The New Mexico Hazardous Waste Act authorizes the N M ED to establ ish procedures to modify a permit. EPA has identified three classes of permit modifications of hazardous waste (RCRA) permits: . . Class ~ permit modifications are minor changes that do not require NMED approval, such as typographical errors. No opportunity for public comment is allowed on Class ~ moclifications, and the public is not informed until after they are implemented by the permittees. Class 2 permit modifications are minor changes that require public notice and a 60-day public comment period before a final cletermination by NMED to approve the modification with or without changes, deny it, or reclassify it as a Class 3 permit modification. Class 3 permit modifications are modifications that substantially alter the facility or its operations. The procedure is similar to that for the original permit. Class 3 modification requires public notice, public comment for at least 60 days, development of a ciraft permit, and the opportunity for full public hearings. The processing time for this type of permit modification takes anywhere from several months to a year from issuance of the draft permit unfit a final determination by NMED. The history of Class 2 and 3 permit modifications since the release of the HWFP (1999), their outcome, and the time elapsed between submission and action dates on behalf of NMED are discussed in a recent report by the New Mexico Environmental Evaluation Group (EEG, 2003b). Out of 40 items contained in 18 Class 2 or 3 permit modification requests' 24 have been approved (as is or with modifications), 7 have been

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34 Improving the Characterization Program for Contact-Handled Transuranic Waste withdrawn, 5 have been rejected, and 47 are still in process. Among the requests in process, is the request to allow RH-TRU waste in WIPP. Major approved changes to the HWFP are described below. 3. 3. 2. ~ Approvec/ changes to the H WFP The most significant permit modifications that have been proposed by DOE and accepted by NMED are the following: allow compositing of headspace gas samples prior to analysis for waste at the Idaho National Engineering and Environmental Laboratory (enabled this site to achieve its target date of 2002 for the first 3,100 cubic meters of TRU waste shipped to WIPP); allow statistical headspace gas sampling and analysis for thermally treated waste (Rocky Flats Environmental Technology Site reports saving more than $30 million in headspace gas characterization cost for 17,300 drums of residues in pipe overpacks); determine the mix-certification rate by performing visual examination as a quality control check on radiography on a summary category group rather than individual waste streams (Rocky Flats Environmental Technology Site reports saving more than $19 million by not having to determine and implement a mix-certification rate for every waste stream); and lengthen the compliance schedule for groundwater data reports (60 additional days are allowed to obtain and validate the analytical data). 3.3.3 Programmatic changes relevant to the USNRC The USNRC public meeting process allows applicants (e.g., DOE) to meet with USNRC staff to discuss technical, licensing, and schedule issues prior to submitting an application. Based on the results of any public pre-application meeting, the applicant may decide to modify the application or not submit it. Records of the certification process for the TRUPACT-~' shipping container indicate the DOE and its contractors met with the USNRC 14 times prior to formally submitting this certification modification (USNRC, 1989). Thus far, the USNRC has not rejected any formal TRUPACT-~! certificate modification request. Meetings between DOE and the USNRC concerning shipping containers certificate modifications are open to the public for observation and comment, but there is no regulatory mechanism for public participation in the clecision.8 To date (December 2003), the USNRC has approved 16 revisions of the TRUPACT-~! Certificate of Compliance as well as ~ revision of the Half-PACT Certificate of Compliance. The following are the most significant modifications. 3.3.3. ~ Approvec/ changes to the USNRC Certification The main changes to the USNRC Certificate of Compliance for TRUPACT-~! shipping containers approved thus far are the following: additional contents such as various pipe overpacks; 7An additional Class 2 permit modification request has been submitted since the BEG report was published: DOE is proposing to eliminate headspace gas sampling for the Los Alamos National Laboratory sealed source waste (see Section 2.3.5.2~. NMED has not yet published its . . . decision. Such is not the case in USNRC rulemaking decisions (e.g., changes in 10 CFR 71~.

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Regulatory and Policy Framework for Waste Characterization 35 flammability assessment methodology; drum age criteria and prediction factors; headspace gas sampling to qualify test category waste; mixing shipping categories based on chemical compatibility; radiolytic hydrogen yields (G values9) vary with dose and type of radiation and take into account matrix depletion; and shorter shipping periods (from 60 to 5 days) to WIPP for a particular waste stream from Los Alamos National Laboratory. The 5 percent volumetric limit on flammable gas (in particular hydrogen) generation in the innermost confinement volume of shipping containers has been one of the greatest challenges for DOE. in the case of waste with high potential for flammable gas generation (see Section 2.3.~), transportation limits on amounts of radioactivity in the TRUPACT-~! container severely restrict the amount of allowed waste per shipment. WIPP has been successful in cleveloping applications to the USNRC for certificate revisions to increase payload (e.g., matrix depletion allowance) and is working toward further revisions (e.g., use of hydrogen "getters"~. A DOE initiative, recently discussed with the USNRC, is that of using a "no- consequence" container (called ARROW-PAK) as a secondary waste container that could mitigate the effect of a deflagration caused by hydrogen buildup. According to DOE, this may be the object of a proposed revision of the Certificate of Compliance but no such request has yet been submitted to the USNRC. An exemption from parts of 10 CFR 71 may be necessary to allow use of the ARROW-PAK because a flammable mixture could be present in shipping containers. 3.4 Discussion: Regulatory Challenges and Milestones for TRU Waste (:: ha racterizati on In addition to the waste characterization challenges mentioned in Chapter ~ (see Section 1.6), characterizing TRU waste presents additional challenges due to the following: 1 1 Uniqueness of the W/PP facility. WIPP is a first-of-a-kind facility and therefore its regulators have to issue non-routine permits (see Sidebar 3.2~. Compliance with severe/ regu/atory c/ocuments. WIPP must be in compliance with the three main regulatory documents: the NMED HWFP, the EPA Certificate of Compliance for the WIPP facility, and the USNRC Certificate of Compliance for shipping containers (see Section 3.2.4~. DOE must also comply with regulations promulgated by several other agencies that do not have direct regulatory oversight of WIPP activities (see Table C.1 in Appenclix C). Variabi/ity in the definition of waste stream. Waste is categorized into waste streams based on how it is produced, its waste categories, and waste matrix cocles, depending on the agencies. In the EPA Certificate of Compliance certification application, DOE identified 569 waste streams based on historical knowledge, while EPA sorted WIPP waste inventor by volume in 10 waste categones, and NMED identified ~ ~ Waste Matrix Code Groups (see definition of waste stream in the GIossary). 9For a definition of G value, see the Glossary. Lathe term "non-routine permit" is used here to describe any regulatory document such as permit, license, or certification that is issued on a one-of-a-kind operation or facility that does not have a specific license guide, regulatory guide, or regulation section. A non-routine permit is based on the basic principles of the regulations and normal health and safety practices.

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Regulatory and Policy Framework for Waste Characterization . ~ . 37 15, 2006. The Idaho Settlement Agreement with DOE stipulated that the Idaho National Engineering and Environmental Laboratory must ship at least 3,100 cubic meters of TRU waste out of the State of Idaho by December 31, 2002 (this was called the "31 00 Projects. Comp/iance with the ALARA (as low as reasonably achievab/eJ principle. Under federal law, DOE has the responsibility and authority to self-regulate and has issued 10 CFR 835 to protect worker health and safely in every DOE facility. Various requirements include the application of the ALARA principle. This principle states that DOE must keep workers' radiation exposures as far below the regulatory dose limits as reasonably achievable. Moreover, DOE must ensure that all waste is managed in a manner that is protective of worker and public health and safely, and of the environment, as specified in DOE's Order 435. ~ . Comp/iance with DOE internal drivers. Timeliness and cost of cleanup are two internal DOE drivers. DOE managers are under pressure to complete site cleanup and send waste to WIPP "faster, better, cheaper." Comp/iance with WGA agreements. These agreements are essential to transportation of TRU waste from the Western States to WIPP (see Sidebar 3.~). The challenges of regulating a unique facility, such as WIPP, are discussed below. 3.4.1 WIPP as a First-of-a-Kincl Facility One of the major regulatory challenges for WIPP is its unique nature. WIPP is the first U.S. geologic repository for transuranic and mixed radioactive waste, and as such, regulating the geologic disposal of TRU waste in it is a unique endeavor. In particular, demonstrating compliance with radioactive waste disposal regulations over ~ 0,000 years (the regulatory compliance period) is a difficult task for both DOE and EPA. In the absence of an established licensing or permitting path, the waste characterization program was negotiated between DOE and EPA over a period of two decades. Many of the most conservative requirements were originally proposed by DOE on the basis of existing requirements for the transportation of radioactive waste. For instance, DOE introduced rigorous measures in its waste characterization program, including ~ 00 percent sampling, redundant testing, and extensive confirmation of existing data for the purpose of compensating for the absence of experience in handling this aged waste. Furthermore, explosives, combustible materials, corrosive materials, and chemically reactive materials all prohibited items in the HWFP- are also prohibited by the U.S. Department of Transportation from being transported in the same shipping container as radioactive waste. WIPP regulators (EPA and NIXED) declared the facility in compliance with the relevant regulations when they issued the Certificate of Compliance and the Hazardous Waste Facility Permit in 1998 and 1999, respectively. Because of the unique nature of WIPP, its Certificate of Compliance and the HWFP for WIPP are considered non-routine regulatory documents. As shown in Sidebar 3.2, the general pattern of licensing of a facility not specifically addressed by existing regulations is to begin in a conservative fashion (i.e., the regulator applies rigorous licensing requirements to such a facility until the permittee demonstrates what safety or process items are most representative of the operation being licensed and provide adequate protection). Equally important (or perhaps even more important) are what items have the most potential to create accidents or incidents. By starting with a conservative approach, the applicant can acquire operational experience while ensuring worker and public protection. At the same 33The limits for radiation doses to workers were first established in 10 CFR 835.

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38 Improving the Characterization Program for Contact-Handled Transuranic Waste time, the information necessary to determine those items that ensure adequate protection of health and safely can be determined. Generally, the permittee has the right to request an amendment to the permit that may change the scope of activities or kinds and amounts of radioactive material or hazardous waste to be processed, provided the applicant can support the request with adequate justification for the amendment. This has been the case with NMED's Hazardous Waste Facility Permit and with the EPA and USNRC Certificates of Compliance. 3.5 Discussion: Experience with the Permit Moctification Process DOE has successfully submitted modification requests for its HWFP, EPA, and USNRC permits to streamline characterization activities and make the process more cost- and time-effective. As shown above, the permit modification process differs depending on the regulatory agency (EPA, USNRC, or NMED). With the EPA and USNRC the process involves frequent interactions between the regulator and the applicant before a certification modification request is submitted. This approach shortens the time and increases the efficiency of the process. It also decreases the probability of rejection once the modification request has been submitted. The HWFP modification process is different because it does not stipulate interaction between DOE and NMED before the permit modification request is formally submitted. As required by regulations [40 CFR 270.42(b)~6~(ii)], all Class 2 permit modification requests submitted thus far have been either approved, denied, or reclassified as Class 3 modifications within 120 days after receipt by NMED. Only one Class 3 permit modification request has been approved to date (for headspace drum age criteria; see Section 4.~), for which the entire process took anywhere from 613 days (DOE's estimate) to 81 0 days (NMED's estimate, based on receipt of the Class ~ permit modification on November ~ 8, 2000, to issuance of the revised permit on February 6, 2003~. The long delay in receiving approval for this request is due to the following: 1) misclassification of the permit modification request by DOE; 2) the public participation process mandated by regulation; and 3) delays in processing the application by NMED. DOE initially submitted the request as a Class ~ permit modification, which was verbally rejected by NMED within two days of receipt as an inappropriate classification. DOE submitted the same request as a Class 2 permit modification, which after public comment was rejected by NMED. DOE revised the permit modification request and submitted it again as a Class 2 which, after public comment, was determined by NMED to require a draft permit and was thus reclassified as a Class 3 request. NMED took considerable time to develop a draft permit based on public comment and its own technical evaluation. After issuance of a draft permit for public comment, NMED held a public hearing on the permit modification request and, after allowing for full public participation, issued a ruling and revised the draft permit based on all public comment. The policy and societal impacts of changes to the characterization program are discussed in Sections 5.5 and 5.6.