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DOE G 435.1-1 Chapter 3, Transuranic Waste Requirements

Functional areas: Environmental Management, Radioactive Waste Management, Safety and Security

The guide provides criteria for determining if a waste is to be managed in accordance with DOE M 435.1-1, Chapter III, Transuranic Waste Requirements. Chapters have been combined into one document.
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Section 1

Chapter III Transuranic Waste Requirements IMPLEMENTATION GUIDE for use with DOE M 435.1-1 (This page intentionally left blank.) DOE G 435.1-1 III-1 7-09-99 Chapter III - Transuranic Waste Requirements III. A. Definition of Transuranic Waste. Transuranic waste is radioactive waste containing more than 100 nanocuries (3700 becquerels) of alpha-emitting transuranic isotopes per gram of waste, with half-lives greater than 20 years, except for: (1) High-level radioactive waste; (2) Waste that the Secretary of Energy has determined, with the concurrence of the Administrator of the Environmental Protection Agency, does not need the degree of isolation required by the 40 CFR Part 191 disposal regulations; or (3) Waste that the Nuclear Regulatory Commission has approved for disposal on a case-by-case basis in accordance with 10 CFR Part 61. Objective: The objective of this requirement is to provide the criteria for determining if a waste is to be managed in accordance with DOE M 435.1-1, Chapter III, Transuranic Waste Requirements. Additionally, it is necessary to determine if a waste meets the definition of transuranic waste to enable the Department of Energy to comply with provisions in the Waste Isolation Pilot Plant Land Withdrawal Act of 1992, as amended. Discussion: Basis. This definition of transuranic waste is the definition used in the Waste Isolation Pilot Plant (WIPP) Land Withdrawal Act of 1992, as amended. This definition is functionally equivalent to that in 40 CFR Part 191, Environmental Radiation Protection Standards for Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes. The WIPP Land Withdrawal Act of 1992, as amended, defines transuranic waste and limits disposal at WIPP to transuranic waste resulting from atomic energy defense activities which meets this definition. Interpretation and Application. In order to ensure consistent application, various terms used in the definition need to be clarified. First, the limit above which a waste is determined to be transuranic waste is based on an activity of 100 nanocuries (nCi) (3700 becquerels (Bq)) per gram of waste. The activity to be counted in making this determination is only that from the isotopes that would qualify a waste as transuranic waste as described in the following paragraphs. In other words, one would not include the activity from short-lived fission products (i.e., non-alpha emitters with half-lives less than 20 years) in calculating the concentration. The mass over which III-2 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements the activity is divided in making the waste determination is the waste matrix. This includes the waste material itself as well as any stabilization media that must be added to meet waste acceptance criteria for mobility, physical form, structural stability or free liquids. The mass of added shielding, the container, or any rigid liners is not included in the calculation. The term transuranic means those elements with an atomic number greater than that of uranium (i.e., atomic number >92). Therefore, uranium wastes do not qualify as transuranic waste by virtue of their uranium concentration. The transuranic radionuclides that are to be considered in making a transuranic waste determination must decay by emission of alpha particles and also must have a half-life greater than 20 years. Consistent with this portion of the definition, there are radionuclides with atomic numbers greater than 92 that would not cause a waste to be called transuranic waste.

Section 2

Example: A waste is contaminated with americium-242 which predominantly decays by emission of a beta particle and has a 16-hour half-life. Even though americium-242 has an atomic number greater than 92, it cannot be considered in determining the waste type because it is not an alpha emitter and does not have a 20-year half life. Given the definition provided in the public law and its application pursuant to DOE M 435.1-1, the determination of transuranic waste should be made at the time of waste certification, that is, each time the waste is transferred to another person or facility (see guidance for DOE M 435.1-1, Section III.J). Example 1: A waste is contaminated with curium-244 which is an alpha-emitter and has an atomic number greater than 92. Over a period of about 200 years, a sufficient inventory of curium-244 will decay to greater than 100 nCi/g of plutonium-240, an alpha emitter with a 6,750-year half-life. Regardless of the decay product, the curium-244 content of the waste is not relevant to the determination of whether the waste is transuranic because the curium has an 18.11-year half-life and the determination is made at the time the waste is certified as meeting a facility’s waste acceptance criteria. However, even if the waste is determined to be a low-level waste, the method of disposal must be commensurate with the long-term hazard associated with the plutonium-240 decay product. Example 2: A waste is generated and placed in bags within 55-gallon drums. The waste has been characterized and certified as transuranic waste in accordance with the waste acceptance criteria of the facility receiving the waste. This same waste, if required to undergo solidification to enable shipment and disposal, could be re-certified after treatment by the treating facility as low-level waste, in the event that radioassay found DOE G 435.1-1 III-3 7-09-99 Chapter III - Transuranic Waste Requirements that the solidification process reduced the concentration of relevant radioisotopes to less than 100 nCi (3700 Bq) per gram of waste matrix. In the previous example, the waste form would be altered by the addition of solidifying agents that would be considered in the radioassay. In either of the two cases in the previous example, the determination would not consider the waste container or its rigid liner. Even if a waste container fails and has to be overpacked, the mass of the failed container does not need to be included in the transuranic waste determination. Example: A 55-gallon drum is damaged, has leaked, and requires overpacking. The concentration determination would include the weights of the original waste matrix and interior bags, but not the weight of the failed drum. It is also conceivable that a low-level waste could become sufficiently concentrated that it becomes a transuranic waste. Example: A waste with a relatively high concentration of transuranic radionuclides (but less than 100 nCi (3700 Bq) per gram) is transferred to a treatment facility as low-level waste. The thermal treatment of the waste reduces the mass of the waste matrix enough that the resulting transuranic concentration exceeds 100 nCi (3700 Bq) per gram. If no additional treatment (e.g., stabilization) were necessary, the resulting waste would be categorized as transuranic waste.

Section 3

Determining whether waste exceeds the 100 nCi/g (3700 Bq/g) shall be in accordance with the requirements and guidance issued by the Carlsbad Area Office in the Transuranic Waste Characterization Quality Assurance Program Plan, Waste Acceptance Criteria for the Waste Isolation Pilot Plant, and/or other controlling documents. Waste which does not exceed the 100 nCi/g limit is to be managed in accordance with the low-level waste requirements of DOE M 435.1-1. Dilution of a transuranic waste stream to reclassify the waste as low-level waste (i.e., reducing the concentration to less than or equal to 100 nCi (3700 Bq) per gram) is not permitted by the Department. While it is recognized that in the course of stabilizing a waste stream some changes in waste concentration may occur, actions to dilute a waste stream below the concentration limits for transuranic waste are prohibited. It is also recognized that actions taken to process a waste stream for safety or technological reasons that are justified, may result in the waste being reclassified after processing as low-level waste. Example: Due to the moisture content of a transuranic waste sludge, the waste does not meet the WIPP WAC. The site evaluates several treatment options taking into consideration factors such as worker exposure, waste minimization, cost and complexity III-4 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements of the treatment process and disposal facility waste acceptance requirements. The treatment process selected involves adding grout to the transuranic waste sludge to eliminate free liquids resulting in a solidified waste form that contains transuranic radionuclides in concentrations less than 100 nCi (3700 Bq) per gram and meets the waste acceptance criteria for a low-level waste disposal facility. There are three exceptions to the definition of transuranic waste: the high-level waste exception; the degree of isolation exception; and the NRC-approved disposal exception. High-Level Waste Exception. The definition of transuranic waste includes exceptions for some wastes that would otherwise be considered transuranic waste. The first exception to the definition of transuranic waste is waste that meets the definition of high-level waste (see Definition of High- Level Waste guidance). Because high-level waste is generated by reprocessing spent nuclear fuel, much high-level waste contains concentrations of greater than 100 nCi (3700 Bq) per gram alpha- emitting radionuclides with half-lives greater than 20 years. Separate requirements apply to management of high-level waste, both within and external to DOE. This exception serves to distinguish high-level waste, as defined in DOE M 435.1-1, Chapter II, from transuranic waste. Example: Waste in underground storage tanks at the Hanford Site contains long-lived, alpha-emitting plutonium and neptunium isotopes in excess of 100 nCi (3700 Bq) per gram. However, the waste is not categorized as transuranic waste because it is highly radioactive waste from reprocessing spent nuclear fuel; i.e., it is high-level waste. Degree of Isolation Exception. The second exception to the definition of transuranic waste is waste that is determined to not need the degree of isolation that is provided by implementation of the disposal requirements of 40 CFR Part 191. This allows the Secretary of Energy to make a determination to remove these wastes from the transuranic waste definition based on an evaluation of a proposed disposal concept. Such a determination would have to be submitted to and concurred with by the EPA Administrator.

Section 4

Example: A site is contemplating on-site disposal of a small quantity of a unique waste contaminated with greater than 100 nCi (3700 Bq) per gram of transuranic alpha-emitters with greater than 20-year half-lives. Site personnel submit a rationale for applying standards other than those for transuranic waste disposal, a conceptual disposal design, and a preliminary radiological impacts analysis to the cognizant Headquarters Program Office. The Program Office confers with the Offices of Environmental Management and Environment, Safety, and Health on the proposal. The Headquarters staff agrees with the site’s approach, so the Office of Environment, Safety, and Health arranges a meeting with the Environmental Protection Agency. The meeting results in an agreement on the analyses that need to be conducted and the radiological performance measures that apply. Site personnel conduct the analyses, which project DOE G 435.1-1 III-5 7-09-99 Chapter III - Transuranic Waste Requirements that the performance measures will be met. The analyses are reviewed by Headquarters staff, then by EPA staff. Following resolution of any concerns, the Secretary of Energy determines, and the EPA Administrator concurs, that the waste does not need to be considered transuranic waste, but can be disposed of as low-level waste. NRC-Approved Disposal Exception. Under the current regulatory regime, this exception does not affect DOE’s management of defense transuranic waste that is to be disposed of at WIPP. This exception gives the Nuclear Regulatory Commissioning (NRC) the latitude to not apply the disposal standards of 40 CFR Part 191 to waste which meets the concentration limits of transuranic waste if the waste is disposed of in an NRC-licensed facility. Waste generated by commercial activities could have concentrations of radionuclides that would result in categorization as transuranic waste. As long as the waste is not high-level waste, it could be accepted as Greater-than-Class-C low-level waste per the waste classification system in 10 CFR 61.55. In accordance with the Low-Level Radioactive Waste Policy Act, as amended, the Department is responsible for disposal of Greater-than-Class-C waste; however, disposal of Greater-than-Class C waste generated by an NRC licensee is to be in a facility licensed by the NRC. The NRC issued a final rule requiring the disposal of Greater-than-Class C low-level radioactive waste in a geologic repository, unless disposal has been approved elsewhere (54 FR 22578, codified at 10 CFR Part 61). The rulemaking clarified that only the requirements governing disposal of high-level radioactive waste in geologic repositories (10 CFR Part 60) would be relevant to disposal of Greater-than-Class C waste in a geologic repository. Although the NRC has indicated that the disposal of Greater-than-Class C waste in near-surface disposal facilities is generally not acceptable, the requirements of 10 CFR Part 61 would be applicable to the disposal of commercially generated (NRC licensed) Greater-than-Class C waste in “intermediate” disposal facilities. The exception to the definition allows NRC to authorize such waste to be disposed without necessarily invoking the additional requirements of 40 CFR Part 191. Supplemental References: 1. Cowan, 1996. Stephen P. Cowan to Distribution, memorandum, Implementation Guidance Concerning “Atomic Energy Defense Activities” as Used in the Waste Isolation Pilot Plant Land Withdrawal Act, U.S. Department of Energy, October 17, 1996.

Section 5

2. NRC. Disposal of High-Level Radioactive Wastes in Geologic Repositories, 10 CFR Part 60, U.S. Nuclear Regulatory Commission, Washington, D.C. 3. NRC. Licensing Requirements for Land Disposal of Radioactive Waste, 10 CFR Part 61. U.S. Nuclear Regulatory Commission, Washington, D.C. III-6 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements 4. Waste Isolation Pilot Plant Land Withdrawal Act of 1992, as amended, October 30, 1992. 5. Low-Level Radioactive Waste Policy Amendments Act of 1985, as amended, January 15, 1986. 6. CAO, 1998. U.S. Department of Energy, Transuranic Waste Characterization Quality Assurance Program Plan, Revision 1, CAO-94-1010, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, December 18, 1998. 7. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, Revision 5, DOE/WIPP-069, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996. 8. NRC, 1989. “Final rule, 10 CFR Part 61, Disposal of Radioactive Waste,” Federal Register, Vol. 54, No. 100, U.S. Nuclear Regulatory Commission, Washington, D.C., May 25, 1989. 9. EPA, 1985. “Final rule, 40 CFR Part 191, Environmental Radiation Protection Standards for Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes,” Federal Register, Vol. 50, No. 182, U.S. Environmental Protection Agency, Washington, D.C., September 19, 1985. DOE G 435.1-1 III-7 7-09-99 Chapter III - Transuranic Waste Requirements III. B. Management of Specific Wastes. The following provide for management of specific wastes as transuranic waste in accordance with the requirements in this Chapter: (1) Mixed Transuranic Waste. Transuranic waste determined to contain both a hazardous component subject to the Resource Conservation and Recovery Act (RCRA), as amended, and a radioactive component subject to the Atomic Energy Act of 1954, as amended, shall be managed in accordance with the requirements of RCRA and DOE O 435.1, Radioactive Waste Management, and this Manual. (2) TSCA-Regulated Waste. Transuranic waste containing polychlorinated biphenyls, asbestos, or other such regulated toxic components shall be managed in accordance with requirements derived from the Toxic Substances Control Act, as amended, DOE O 435.1, Radioactive Waste Management, and this Manual. (3) Pre-1970 Transuranic Waste. Transuranic waste disposed of prior to implementation of the 1970 Atomic Energy Commission Immediate Action Directive regarding retrievable storage of transuranic waste is not subject to the requirements of DOE O 435.1, Radioactive Waste Management, and this Manual. Objective: The objective of this requirement is to ensure that DOE transuranic waste is managed in accordance with the applicable requirements of external regulations, specifically those of the Resource Conservation and Recovery Act and the Toxic Substances Control Act, that address non-radiological hazards, in addition to being managed in accordance with the requirements of DOE O 435.1 and the Radioactive Waste Management Manual, DOE M 435.1-1. Discussion: The Radioactive Waste Management Manual, DOE M 435.1-1, contains requirements for managing the radioactive character of transuranic waste. Through the safety and hazards analysis process used in developing the Manual, non-radiological hazards associated with managing certain wastes were identified. During development of the requirements necessary to control the identified hazards, it was concluded that sufficient external regulations, promulgated pursuant to Resource Conservation and Recovery Act (RCRA) and Toxic Substances Control Act (TSCA), exist for controlling the non-radiological hazard.

Section 6

III-8 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements In managing transuranic waste which are subject to RCRA and TSCA requirements, personnel should be aware of the requirements for storage and disposal of the waste. The ability to dispose of RCRA and TSCA waste that has a radioactive component is limited. The expectation is that certain mixed wastes can be disposed of at WIPP without treatment (refer to the Waste Acceptance Criteria for the Waste Isolation Pilot Plant). Currently, no disposal facilities are available for TSCA-regulated transuranic wastes. Therefore, to the extent practical, waste generators should avoid generating mixed or TSCA-regulated transuranic waste, and generators and waste managers should avoid actions (e.g., commingling wastes with different regulatory requirements) that result in transuranic waste with no path to disposal (see guidance for DOE M 435.1-1, Section I.2.F.(19)). Example: According to the Waste Acceptance Criteria for the Waste Isolation Pilot Plant, PCBs in concentrations greater than 50 ppm cannot be accepted for disposal. Therefore, in performing work involving PCBs (e.g., activities creating waste or waste management such as packaging) care should be taken to avoid commingling PCB contaminated materials with transuranic or mixed transuranic waste. Commingling the wastes could potentially result in a larger volume of waste with no path to disposal. Careful control and segregation of the PCB-contaminated material would result in a relatively small volume of waste that cannot be disposed of and the rest of the waste being eligible for disposal at WIPP. RCRA and State Hazardous Waste Regulations. Resource Conservation and Recovery Act required the Environmental Protection Agency to promulgate regulations for management of hazardous waste. The Act also provides for states to promulgate and implement hazardous waste regulatory programs that are at least as protective as the Federal program. The hazardous waste requirements that personnel must follow in managing (i.e., generating, transporting, treating, storing or disposing) mixed transuranic waste and in closing affected facilities are primarily in 40 CFR Parts 260 through 270, or authorized state regulations. A variety of guidance manuals and information relevant to the management of the hazardous component of mixed transuranic waste has been prepared both by the state regulatory agencies and the Environmental Protection Agency (see, for example, U.S. Environmental Protection Agency, Catalog of Hazardous and Solid Waste Publications, EPA530-B-96-007, September, 1996). These guidance documents should be consulted when developing management programs for mixed transuranic waste. Hazardous waste regulations promulgated by States with RCRA authority may be more restrictive than the Federal regulations. The more restrictive requirements may include more waste than the Federal requirements or may impose another state’s definition of hazardous waste when waste is received from that state. Waste management personnel therefore need to be aware of the requirements of the regulations in their own state as well as the implications of the regulations in states to which they intend to transfer waste. DOE G 435.1-1 III-9 7-09-99 Chapter III - Transuranic Waste Requirements

Section 7

Example 1: In a state that invokes requirements equivalent to the EPA hazardous waste regulations, waste oil that meets the radiological criteria for being transuranic waste would not be managed as mixed waste. However, if the oil was to be shipped to another state in which the state-passed regulations had expanded the definition of hazardous waste to include waste oil, the waste would have to be packaged, manifested, transported and stored as a mixed waste. Example 2: If the direction of waste transfer in the above example were reversed, a different situation could arise. The waste would be declared a mixed waste in the state of origin because the state regulations had a broader definition of hazardous waste. The state to which it was to be shipped did not specifically regulate waste oil as a hazardous waste. However, it may be that the state regulations require that waste be considered to be categorized as it was in the state of origin. Then the waste would still be considered mixed waste even after it was shipped to the state that did not explicitly regulate waste oils. The RCRA requirements prohibit storage of hazardous (including mixed) waste restricted from land disposal except for purposes of accumulating sufficient quantities to facilitate recovery, treatment, or disposal. Capabilities and capacities to treat DOE mixed waste to the land disposal restriction treatment standards do not exist. Congress addressed this issue in 1992 with passage of the Federal Facility Compliance Act of 1992 (FFCA). The FFCA required the Department to prepare site-specific treatment plans to address treatment of mixed waste to meet the land disposal restrictions at each facility at which DOE generates or stores mixed waste. To meet the requirement, site-specific treatment plans were developed, and through agreements or consent orders, commitments to schedules to treat or otherwise meet the land disposal restrictions were made. In accordance with the WIPP Land Withdrawal Act of 1992, as amended, transuranic mixed waste that is to be disposed at the Waste Isolation Pilot Plant (WIPP) is exempt from having to comply with the treatment standards and is not subject to the land disposal restrictions of 40 CFR Part 268. Therefore, management of most of the transuranic waste addressed in the agreements or consent orders is predicated on the assumption that mixed transuranic waste will be disposed at WIPP without treatment. Waste that is not eligible for disposal at WIPP, i.e., waste that cannot meet the Waste Acceptance Criteria for the Waste Isolation Pilot Plant, must comply with RCRA treatment and disposal requirements, the Federal Facility Compliance Act of 1992, and consent orders and agreements with the States or EPA. This highlights the importance of avoiding actions in generating or managing waste that result in a waste not being acceptable for disposal at WIPP. Personnel should consult the site-specific treatment plans and agreements or consent orders as part of the life-cycle planning performed in accordance with Waste Generation Planning (DOE M 435.1-1, Section III.H). PCB, Asbestos, and Other TSCA Wastes. Transuranic wastes contaminated with PCBs do not meet the definition of mixed waste, however, the situation is similar to RCRA in that there are III-10 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements

Section 8

external requirements promulgated under the authority of the Toxic Substances Control Act that need to be complied with in addition to the requirements of DOE O 435.1 and DOE M 435.1-1. Waste managers responsible for managing PCB-containing products should consult the EPA requirements at 40 CFR Part 761. The regulations impose requirements for the destruction, storage awaiting destruction, and disposal of PCBs. Unlike mixed wastes, there are no provisions to accommodate PCBs (exceeding 50 ppm) at WIPP. If transuranic waste contaminated with PCBs cannot be treated to reduce the PCB concentration to less than 50 ppm, then it is one of the wastes that currently has no path to disposal (see General Requirements, Section I.2.F.(19)). Waste managers responsible for managing materials containing asbestos should consult the EPA requirements at 40 CFR Part 61, Subpart M. These regulations impose requirements for the removal of asbestos during demolition and renovation and disposal of asbestos-containing waste. This regulation includes cross-references to several other regulations governing management of asbestos that may also apply. Planning for management of transuranic wastes that include a component which is regulated under TSCA is addressed in the Complex-Wide Transuranic Waste Management Program and the appropriate Site-Wide Waste Management Programs (see DOE M 435.1-1, Sections I.2.B.(1) and I.2.F.(1)). The DOE M 435.1-1 requirements imposed on the radioactive component of RCRA or TSCA waste should not create a duplication of management activities that can be satisfied by compliance with a RCRA or TSCA requirement. Also, documentation required by RCRA or TSCA requirements which provides the same or similar information as required by DOE M 435.1-1 can be used to satisfy the DOE M 435.1-1 requirement. Example: Mixed transuranic waste is being sent from one site to another for storage. The Uniform Hazardous Waste Manifest is prepared as required by 40 CFR Part 262. It is determined that the manifest satisfies the need to document the transfer of ownership of the waste, the transfer date, and physical location of the waste. If the waste acceptance requirements of the facility receiving the waste allow it, the manifest may also provide the necessary information on the chemical and physical characteristics of the waste. Compliance with these requirements is demonstrated if RCRA, state-hazardous, and TSCA- regulated radioactive wastes are being managed in compliance with applicable requirements and agreements or in accordance with a consent order, and consistent with the Transuranic Waste Requirements of DOE M 435.1-1. Pre-1970 Transuranic Waste. A definition for transuranic waste was first put into operational use by the Department’s predecessor in 1970. At that time, the decision was made to store waste exceeding the transuranic waste limit. Waste disposed of prior to implementation of the 1970 Atomic Energy Commission Immediate Action Directive regarding retrievable storage of transuranic waste is not subject to the requirements of the Radioactive Waste Management DOE G 435.1-1 III-11 7-09-99 Chapter III - Transuranic Waste Requirements

Section 9

Manual. This interpretation is consistent with the decision of the Environmental Protection Agency as documented in the preamble to 40 CFR Part 191 (50 FR 38066). The Agency stated that the disposal standards do not apply to transuranic waste that already has been disposed of because the selection of disposal system site, design, and operational techniques are no longer available options. Therefore, “the Agency believes it appropriate that these disposal standards only apply to disposal occurring after the standards have been promulgated.” Transuranic waste consists of waste generated by DOE activities that has been placed in retrievable storage since 1970, and waste that will continue to be generated as a result of plutonium stabilization and management activities, environmental restoration (including remediation of some sites where transuranic waste was previously buried), decontamination and decommissioning, waste management, and testing and research. Transuranic waste that was disposed of prior to 1970, retrieved as part of environmental restoration activities, may be managed in accordance with the requirements of the Radioactive Waste Management Manual. Supplemental References: 1. EPA. 40 CFR Parts 260-270, U.S. Environmental Protection Agency, Washington, D.C. 2. EPA. Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions, 40 CFR Part 761, U.S. Environmental Protection Agency, Washington, DC. 3. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, Revision 5, DOE/WIPP-069, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996. 4. EPA, 1996. U.S. Environmental Protection Agency Catalog of Hazardous and Solid Waste Publications, EPA530-B-96-007, U.S. Environmental Protection Agency, Washington, D.C., September 1996. 5. Federal Facility Compliance Act of 1992, as amended, October 6, 1992. 6. Resource Conservation and Recovery Act of 1976, as amended, October 21, 1986. 7. Toxic Substances Control Act, as amended, October 11, 1976. 8. EPA, 1973. National Emission Standards for Hazardous Air Pollutants – National Emission Standard for Asbestos, 40 CFR Part 61, Subpart M, U.S. Environmental Protection Agency, Washington, D.C., April 6, 1973. III-12 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements 9. AEC, 1970. Policy Statement Regarding Solid Waste Burial, Immediate Action Directive, IAD No. 0511-21, U.S. Atomic Energy Commission, Washington, D.C., March 20, 1970. DOE G 435.1-1 III-13 7-09-99 Chapter III - Transuranic Waste Requirements III. C. Complex-Wide Transuranic Waste Management Program. A complex-wide program and plan shall be developed as described under Responsibilities, 2.B and 2.D, in Chapter I of this Manual. Objective: The objective of this requirement is to ensure the development, documentation, and implementation of a complex-wide transuranic waste management program. The complex-wide program and plan establishes the framework within which individual site programs operate. Discussion:

Section 10

The Department’s management of transuranic waste occurs at over 15 sites that generate and store waste, as well as at the Waste Isolation Pilot Plant which is to serve as the central repository for most of the waste. A complex-wide program and plan establish the overall mission for the Department’s management of transuranic waste and to provide a framework within which the individual site programs operate. The Radioactive Waste Management Manual, DOE M 435.1-1, Section I.2.B assigns the Assistant Secretary for Environmental Management the responsibility for developing and maintaining complex-wide, waste-type programs. The Manual, DOE M 435.1-1, Section I.2.D also assigns the Deputy Assistant Secretary for Waste Management the responsibility for developing and implementing complex-wide, waste-type program plans. The Complex-Wide Transuranic Waste Management Program and Plan are to be developed following the guidance provided for DOE M 435.1-1, Sections I.2.B and I.2.D. Compliance with this requirement is demonstrated by the presence of a Complex-Wide Transuranic Waste Management Program which includes the appropriate interfaces, technical information, data inputs, and other elements described in Chapter I of this Manual. Supplemental References: 1. CAO, 1997. The National TRU Waste Management Plan, Revision 1, DOE/NTP-96- 1204, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, December 18, 1997. III-14 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements III. D. Radioactive Waste Management Basis. Transuranic waste facilities, operations, and activities shall have a radioactive waste management basis consisting of physical and administrative controls to ensure the protection of workers, the public, and the environment. The following specific waste management controls shall be part of the radioactive waste management basis: (1) Generators. The waste certification program. (2) Treatment Facilities. The waste acceptance requirements and the waste certification program. (3) Storage Facilities. The waste acceptance requirements and the waste certification program. (4) Disposal Facilities. The performance assessment, disposal authorization statement, waste acceptance requirements, and monitoring plan. Objective: The objective of this requirement is to ensure that the hazards associated with transuranic waste management facilities, operations, and activities have been identified, their potential impacts analyzed, and appropriate controls documented, implemented, and maintained for the protection of workers, the public, and the environment. Discussion: As described in the guidance for DOE M 435.1-1, Section I.2.F.(2), the Manual requires the radioactive waste management basis to provide for development and documentation of controls to ensure the safe and efficient management of radioactive waste. Requiring an approved radioactive waste management basis for the initiation of new, or continuation of existing, radioactive waste management activities should prevent the operation of facilities without the appropriate controls. The required elements of the radioactive waste management basis vary with the type of waste management operation or facility and the types of hazards associated with the facility. The term “controls,” used here and elsewhere in the discussion of a radioactive waste management basis, refers to processes, procedures, equipment, instruments, and other items intended to curb the likelihood of, or consequences from, a problem that could arise from managing radioactive waste. Controls include such things as placards, alarms, tools, shielding, training, checklists, duplication of critical steps, redundant monitoring, analysis, sampling and testing, etc. The items required for a radioactive waste management basis listed above for the four types of transuranic waste management facilities, operations, and activities is not a complete list of those items which should

Section 11

DOE G 435.1-1 III-15 7-09-99 Chapter III - Transuranic Waste Requirements be included in a radioactive waste management basis. Several processes, procedures, and documents that are required by other directives and requirements provide for radioactive waste management controls that should be considered part of the radioactive waste management basis. The guidance on DOE M 435.1-1, Section I.2.F.(2) discusses this aspect of the radioactive waste management basis in detail. Example: Site X has a transuranic waste storage facility in which they store waste to be shipped to the Waste Isolation Pilot Plant. The Field Element Manager is responsible for ensuring that it operates in accordance with an approved radioactive waste management basis. The DOE staff reviews the waste acceptance requirements, the storage facility’s waste certification program, plus the facility-specific procedures implementing the site's radiological control program, health and safety plan, training program, quality assurance program, and record-keeping plan. Based on the staff’s review, they report to the Field Element Manager that an adequate radioactive waste management basis has been developed and recommend approval. Also, as discussed in the Section I.2.F.(2) guidance, if a transuranic waste management facility already operates under an approved Authorization Basis, it may not need any additional controls to demonstrate that it has a radioactive waste management basis. In this case, the Authorization Basis documentation is reviewed and evaluated to determine whether it sufficiently covers the requirements needed for a radioactive waste management basis. The Field Element Manager has the responsibility to ensure the transuranic waste management facilities under his or her authority have a radioactive waste management basis. Example: Site personnel are developing the radioactive waste management basis for the Site Q Transuranic Waste Management Facility which provides non-destructive characterization, selected treatment and repackaging, and storage capabilities for transuranic waste. The site personnel identify the following documents and programs which include descriptions of the controls for safely managing waste at the facility: C Radiological Control Program C Site Health and Safety Plan C Safety Analysis Report (SAR) C Operational Safety Requirements/Technical Safety Requirements C Basis for Interim Operations C Technical Standards C Unreviewed Safety Questions Evaluation C DOE Safety Evaluation Report C Listing of documents that are to be Configuration Managed but are not Authorization Basis Documents (including the waste acceptance criteria and certification program documents). III-16 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Following an analysis of the information contained in the above documents, the staff concludes that the complete set of operational requirements relied on by the site to ensure that the public, workers, and the environment are protected from hazards associated with management of transuranic waste at the facility are in place. A statement is prepared that documents that the radioactive waste management basis is covered by the Authorization Basis for the facility.

Section 12

For a facility that generates transuranic waste, the radioactive waste management basis is to include the program for certifying that waste meets the waste acceptance requirements of the facility(ies) to which the waste will be sent. The waste certification program is reviewed against the applicable requirements of DOE M 435.1-1 and approved in accordance with the Radioactive Waste Generator Requirements (DOE M 435.1-1, Section I.2.F.(7)) before becoming part of the radioactive waste management basis. As discussed in guidance on DOE M 435.1-1, Section I.2.F.(2), several other processes and procedures contribute to a complete radioactive waste management basis at a generating facility. Example: A small laboratory facility at Site R generates transuranic waste. The radioactive waste management basis for the facility is established through review and approval of the laboratory’s waste certification procedure, and a review confirming the adequacy of the following: the Radiological Control Program, the Health and Safety Plan, the Training Program, and the site waste transfer procedure. This is documented in a radioactive waste management basis statement for the laboratory. Facilities that store or treat transuranic waste are to have approved waste acceptance requirements (see DOE M 435.1-1, Section III.G) prior to the issuance of a radioactive waste management basis. The waste acceptance requirements will usually suffice as documentation of the radiological, physical, and chemical limitations on waste that can be safely received at the facility, provided they are developed correctly with consideration of the hazards of the waste to be managed, and are kept up to date. Controls on the radiological, physical and chemical limitations need to include considerations of the potential effects of radiolysis. A facility that stores or treats waste is generally expected to have a waste certification program. Waste from these facilities will have to be certified as meeting the waste acceptance requirements of the facility to which it will be transferred and the facilities have the potential for generating radioactive waste (e.g., secondary processing streams from treatment, monitoring and sampling, radioactive release cleanup). Consequently, storage and treatment facilities should also have an approved waste certification program as part of their radioactive waste management basis. An exception to the need for a waste certification program can be justified based on there being no known path to disposal for the waste or based on the expectation that a long time will elapse DOE G 435.1-1 III-17 7-09-99 Chapter III - Transuranic Waste Requirements (e.g., more than a year) before the certification program has been reviewed and accepted by the receiving facility. Example: A transuranic waste storage facility is used for storing defense transuranic waste that will be shipped to the Waste Isolation Pilot Plant and non-defense transuranic waste. According to the schedule for receipt of waste at WIPP, shipments from the site will not occur for six years. The certification program for the defense waste is not scheduled to be reviewed by WIPP for two years. Because there is no disposal facility to which the non-defense waste can be sent, it is not possible for the storage facility to develop a certification program for that waste (i.e., there are no waste acceptance requirements for a disposal facility to which waste can be certified). The Field Element Manager should proceed with ensuring the development of and approving a radioactive waste management basis for the facility even though fully authorized certification programs do not exist. In this case, an interim certification program for the defense waste may be included as part of the radioactive waste management basis (interim because it has not been reviewed by WIPP personnel). The radioactive waste management basis would be updated after the certification program is reviewed and accepted by WIPP personnel.

Section 13

The radioactive waste management basis for transuranic waste disposal facilities is to be based on documented controls similar to those discussed for treatment or storage facilities, but with additional limitations based on the performance assessment required by 40 CFR Part 191 and any conditions associated with authorizing operation of the facility (e.g, the conditions of compliance certification resulting from the Environmental Protection Agency review of DOE’s compliance certification application per 40 CFR Part 194) and by the disposal authorization statement issued following approval of the performance assessment. In addition, the radioactive waste management basis should include the development and implementation of a monitoring program designed to evaluate performance of the facility (see guidance for DOE M 435.1-1, Section III.Q). The results of the 40 CFR Part 191 performance assessment and the safety analyses required by DOE 5480.23 provide the basis on which the quantities and concentrations of radionuclides that can be accepted for disposal will be identified and documented in the waste acceptance requirements. The responsibility for the radioactive waste management basis for transuranic waste disposal facilities resides with the Field Element Manager. However, a review may be required by another organization before the issuance and documentation of the radioactive waste management basis. In the case of the Waste Isolation Pilot Plant, the review was performed by the Environmental Protection Agency and was documented in a compliance certification. If another transuranic waste disposal facility is constructed, a performance assessment will need to be prepared. Review of the performance assessment will be in accordance with either external III-18 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements requirements (if regulations similar to those for WIPP certification are promulgated) or a process imposed by the Department. Staff responsible for establishing a disposal facility radioactive waste management basis should combine the results of the review of the performance assessment (and compliance certification application if applicable) with their own findings on the waste acceptance requirements and monitoring plans as the basis for documenting the radioactive waste management basis for the disposal facility. Guidance for DOE M 435.1-1 Sections III.G (waste acceptance requirements) and III.Q (monitoring) provides details on what information needs to be addressed to meet the requirements and serve as part of the radioactive waste management basis. For transuranic waste disposal facilities other than WIPP, a disposal authorization statement is to be issued by Headquarters following the review and approval of the performance assessment as required by DOE M 435.1-1, Section I.2.E.(1). The Waste Isolation Pilot Plant met the requirement for a disposal authorization statement when the Secretary of Energy provided notification to Congress that the Department of Energy would open WIPP for disposal operations pursuant to section 7(b)(3) of the Waste Isolation Pilot Plant Land Withdrawal Act of 1992, as amended. In the notification, the Secretary determined that the Waste Isolation Pilot Plant was in compliance with all requirements of section 9(a)(1) of the Waste Isolation Pilot Plant Land Withdrawal Act of 1992, as amended.

Section 14

Contents of a Disposal Authorization Statement. The disposal authorization statement will clearly indicate the transuranic waste disposal facility and design that is being authorized to operate. The statement will refer to the performance assessment reviewed as the basis for the authorization and state the primary features of the disposal facility important for understanding the authorization of operations of the facility. Conditions and limitations for operations of the facility are clearly indicated in the disposal authorization statement. These include quantities, limitations, references, or codification of assumptions contained in the performance assessment. The conditions include any limitations or allowances required based on independent analysis of the disposal configuration and conditions being examined in the evaluations. The conditions also include any other limitations, responsibilities, or commitments that were needed to resolve issues during the review of the performance assessment or which will serve to answer questions that need to be resolved during the first years of operation of the disposal facility. As part of the radioactive waste management basis, site personnel should implement a system or process for tracking the waste inventory at a storage, treatment, or disposal facility. Tracking the waste inventory is a means of ensuring that radionuclide limits established in accordance with a safety analysis or performance assessment will not be exceeded. In addition, a system or process for accurately tracking waste received at a facility can facilitate providing information to the complex-wide management data system (see guidance Section I.2.D.(2)). DOE G 435.1-1 III-19 7-09-99 Chapter III - Transuranic Waste Requirements Compliance with this requirement is demonstrated if, the radioactive waste management basis is documented and signed by the Field Element manager or a designee (see DOE M 435.1-1, Section I.1.A, Delegation of Authority) for each transuranic waste management facility, operation, or activity. Using a graded approach, it may be possible to include multiple activities under a single radioactive waste management basis, but it should be possible to objectively identify which activities are covered. Further, the radioactive waste management basis includes or references the controls that are established on a facility-specific basis to address the unique waste management requirements and circumstances for each facility, operation, and/or activity. Example: A storage facility that stores mixed and non-mixed transuranic waste has approved waste acceptance requirements and a waste certification program that enables transuranic waste to be shipped to the Waste Isolation Pilot Plant for disposal. The mixed transuranic waste is to remain in storage pending WIPP receiving a RCRA Part B permit. The radioactive waste management basis statement references the waste certification process and the waste acceptance requirement documentation, which in turn invoke the waste acceptance requirements of WIPP. In addition to citing site-wide programs and plans (radiological control, health and safety, training, etc.) the radioactive waste management basis statement also cites the RCRA permit issued for storage of mixed transuranic waste and the facility operating procedure for segregating mixed and non-mixed waste within the facility. Supplemental References:

Section 15

1. EPA. Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes, 40 CFR Part 191, U.S. Environmental Protection Agency, Washington D.C. 2. EPA. Criteria for the Certification or Re-Certification of the Waste Isolation Pilot Plant’s Compliance with the 40 CFR Part 191 Disposal Regulations, 40 CFR Part 194, U.S. Environmental Protection Agency, Washington, D.C. 3. DOE, 1992. Nuclear Safety Analysis Reports, DOE 5480.23, U.S. Department of Energy, Washington, D.C., April 10, 1992. III-20 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements III. E. Contingency Actions. The following requirements are in addition to those in Chapter I of this Manual. (1) Contingency Storage. For off-normal or emergency situations involving liquid transuranic waste storage or treatment, spare capacity with adequate capabilities shall be maintained to receive the largest volume of liquid contained in any one storage tank or treatment facility. Tanks or other facilities that are designated transuranic waste contingency storage shall be maintained in an operational condition when waste is present and shall meet the requirements of DOE O 435.1, Radioactive Waste Management, and this Manual. (2) Transfer Equipment. Pipelines and auxiliary facilities necessary for the transfer of liquid waste to contingency storage shall be maintained in an operational condition when waste is present and shall meet the requirements of DOE O 435.1, Radioactive Waste Management, and this Manual. Objective: The objective of this requirement is to ensure the impacts on the public, workers, or environment are mitigated in the event that a leak develops in a tank storing transuranic waste or in a facility processing transuranic waste. The mitigation is provided by ensuring spare waste storage capacity is a required part of a site’s emergency management program. To meet this objective, there needs to be both capacity to handle the largest volume of any single storage tank or liquid waste in process, and the capability to transfer the waste. Discussion: This requirement shall be implemented through and included in site emergency management programs that are required by DOE O 151.1, Comprehensive Emergency Management System. The directive DOE O 151.1 is referenced in DOE M 435.1-1, Chapter I and considered necessary for the safe management of radioactive waste. The Comprehensive Emergency Management System requires the development of a complex-wide system for preparing for and managing emergencies. At the site level, personnel are to establish an Operational Emergency Base Program that provides the framework for responding to events involving, among other subjects, health and safety, and the environment. The program requires a qualitative hazards survey to identify the emergency conditions, describe the potential impacts, and summarize the planning and preparedness requirements that apply. DOE G 435.1-1 III-21 7-09-99 Chapter III - Transuranic Waste Requirements During the development of the requirements of DOE M 435.1-1, Radioactive Waste Management Manual, a waste management hazard and safety analysis identified the loss of containment of a storage tank or waste processing facility containing radioactive liquids as a hazard requiring mitigation. In addition to requiring facility designs to maintain waste confinement (see DOE M 435.1, Section III.M.(2)), the ability to respond to leaks or other off-normal conditions if they occur was also considered necessary. Consequently, the requirements to have adequate spare capacity and the ability to transfer waste to the spare capacity were established.

Section 16

Operating procedures are developed and utilized for transfer of liquid transuranic waste to contingency storage. The procedures should address maximum operational capacities and limits for components of the operational system (e.g., spare storage capacity available in tanks). The procedures should define and address all possible emergency transfer scenarios needed to comply with this requirement. Contingency Storage. Contingency storage is to be provided for both stored liquid transuranic waste and for liquid transuranic waste treatment facilities. In the case of storage tanks, adequate volumetric capacity must be available to receive the largest volume of waste stored in any single tank. In the case of a treatment facility, adequate volumetric capacity must be available to allow all in-process liquids in the facility to be moved into storage in the event of emergency or off- normal conditions. A number of factors are considered in maintaining spare capacity. First, the requirement includes a provision that the spare capacity has “adequate capabilities.” Therefore, the spare capacity must have the necessary features and functionality as dictated by the design and safety analysis for the facility and wastes of concern. Features to be taken into account include appropriate materials of construction, shielding, ventilation and filtration, heat dissipation, liquid level monitoring, and mixing. Similarly, if the waste that may need to be transferred is regulated by some external regulation (e.g., RCRA), the tank(s) that would be used for spare capacity should be properly permitted. The requirement specifies that the contingency storage provided is to meet the requirements of DOE O 435.1 and DOE M 435.1-1. Of prime interest is the ability of contingency storage and associated facilities to meet the requirements for confinement in Facility Design, DOE M 435.1-1, Section III.M.(2). Additionally, compliance with the requirements for instrumentation and control systems, ventilation, and monitoring systems is very important for tanks or facilities that will be used for contingency storage. Meeting these requirements, in combination, ensures that the use of existing tanks or other facilities for contingency storage minimizes the potential impacts of off- normal or emergency situations involving liquid transuranic waste. Spare capacity may be provided by a single tank or by the combined available volume in multiple tanks. In cases where radiation fields are sufficiently low, spare capacity could be provided by III-22 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements portable tanks, tankers (i.e,. railroad cars), or tank trucks. Due to the potential for airborne radioactive material, impoundments or bermed areas open to the air should not be used for spare storage capacity unless a safety analysis shows that the risk to workers and the public is low. Example: Liquid radioactive waste is stored in six underground storage tanks with a design capacity of 250,000 gallons each. The waste in the all tanks has the same chemical and radiological characteristics. One tank contains 200,000 gallons and each of the others contain about 100,000 gallons. Capabilities exist to retrieve waste and transfer it among the six tanks. This system meets the requirement because the largest volume of 200,000 gallons can be distributed between any two of the other tanks.

Section 17

Transfer Equipment. The ability to perform the transfer is just as important as having the capacity. Equipment necessary to transfer each tank or treatment facility volume of liquid transuranic waste in the event of a leak or other off-normal condition is to be identified and documented. Example: Liquid radioactive waste is stored in six underground tanks with the volumes and characteristics described in the previous example. Although there are transfer lines to any of the tanks from a central diversion box, the tanks were constructed without the capability to retrieve the waste. This situation does not comply with the requirement. Although there is adequate capacity, the ability to transfer the waste does not exist. In addition, equipment necessary to transfer the contents of each tank is tested and inspected as part of a routine maintenance program (see DOE M 435.1-1, I.1.E.(9)). Special attention should be given to including in the maintenance program equipment and transfer lines that are not routinely used in managing liquid wastes. Inspection and testing includes the following minimum items: • leak testing of pipelines; • ensuring the availability of any jumpers necessary for completing waste transfer; • confirming that instrument panels, control panels, valves, pumps and any necessary ventilation equipment is supplied with the necessary electrical power, air (for pneumatically-controlled items), steam, and water; and • performing functional tests of instruments, controls, valves, pumps, and ventilation equipment. The capability to perform an emergency transfer of liquid transuranic waste is to be maintained at all times. Therefore, every shift must include or have immediate access to qualified individuals DOE G 435.1-1 III-23 7-09-99 Chapter III - Transuranic Waste Requirements and the equipment necessary to perform transfers in a timely manner, unless analysis of the hazards associated with the leaking waste demonstrates that immediate transfer is unnecessary. Example: A large shielding block is in place over a jumper pit that needs to be accessed during an emergency transfer of liquid waste. The block can only be moved by a crane. Therefore, implementation of this requirement entails making sure that the crane is always operationally available (in a matter of hours rather than days) and every shift has a individual qualified to operate the crane and remove the block. Spare capacity may be shared by different waste types, however mixing radioactive wastes of different types should be evaluated and is generally not acceptable. Example 1: A tank farm contains both high activity liquid low-level waste and liquid transuranic waste in separate tanks. A spare empty tank is maintained and available for emergency transfers of either waste. Example 2: A tank farm contains both high-level waste and liquid transuranic waste in separate tanks. If the spare capacity were provided by excess capacity in tanks that contain high-level waste, use of the capacity for transuranic waste would be undesirable. Transferring transuranic waste into a tank containing high-level waste, would result in a mixture that would no longer be eligible for disposal at the Waste Isolation Pilot Plant which, by law, cannot dispose of high-level waste. Therefore, waste managers should identify different spare capacity to accommodate the two different waste types.

Section 18

Compliance with these requirements is demonstrated by having adequate spare capacity and transfer equipment exists for emergency transfers of all liquid transuranic waste. In addition, the capability to perform emergency transfers is demonstrated by having waste transfer routings identified, operational procedures to direct transfers, staff trained to the procedures, and records showing that the spare capacity and transfer capability are kept in operating condition. Supplemental References: 1. DOE, 1995. Comprehensive Emergency Management System, DOE O 151.1, U.S. Department of Energy, Washington, D.C., September 25, 1995. III-24 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements III. F. Corrective Actions. The following requirements are in addition to those in Chapter I of this Manual. (1) Order Compliance. Corrective actions shall be implemented whenever necessary to ensure the requirements of DOE O 435.1, Radioactive Waste Management, and this Manual are met. Objective: The objective of this requirement is to ensure that actions will be taken to preclude, minimize, or mitigate hazards whenever a situation arises at a transuranic waste management facility that could threaten worker or public safety, or the environment. Discussions: The Radioactive Waste Management Manual, DOE M 435.1-1, Section I.2.G, states that all personnel have a responsibility to identify conditions that require corrective actions to achieve compliance with the Order and Manual requirements or to address health and safety conditions that pose an imminent or possible danger. That responsibility is to ensure that conditions that pose an imminent or potential danger to the environment, or to the health and safety of workers or the public are identified and corrected. If necessary, activities are to be curtailed or shutdown to ensure that the public, workers, and the environment are protected until corrective actions are implemented to mitigate the identified hazard. Corrective actions are activities which, when implemented, will address and correct noncompliant or hazardous conditions. Corrective actions can include improvements to documentation (e.g., procedures, plans, authorization basis documents), training and qualification programs or procedures, physical and process design changes, changes to operating conditions, or a combination of these activities. Corrective Action System. A corrective action system exists for addressing noncompliant or hazardous conditions for transuranic waste management facilities, operations, and activities. The system for addressing corrective actions may be an integral portion of the site’s quality assurance program. Corrective actions in response to quality assurance program assessments are addressed in the Implementation Guide for Use with Independent and Management Assessment Requirements of 10 CFR 830.120 and DOE O 414.1 Quality Assurance. The corrective action system provides for documenting noncompliant or hazardous conditions, identifying the organizations or individuals responsible for developing and implementing corrective action plans, providing corrective action status, and tracking progress through final implementation of the actions. The corrective action system is instituted as a fundamental part of the systematic DOE G 435.1-1 III-25 7-09-99 Chapter III - Transuranic Waste Requirements

Section 19

evaluation of radioactive waste activities that is implemented by the Site-Wide Radioactive Waste Management Program (see guidance for DOE M 435.1-1, Section I.2.F.(1)). A problem requiring corrective action could range from a minor deviation from a procedure that has minimal safety or public health implications, to a situation that poses an immediate threat to health and safety from an uncontrolled release of large quantities of radioactive material. For situations where a problem could pose an immediate risk to a worker, member of the public, or damage to the environment, immediate shutdown of the process or facility may be appropriate as the first step in addressing the problem (see guidance for DOE M 435.1-1, Section III.F.(2). Example: An employee performing a routine container inspection in a storage facility notices that there are drums in an area designated for “WIPP-ready packages” that do not have a tamper indicating device on the container closure. The worker records his observation in the inspection log and notifies the building manager. The manager directs that a corrective action plan be prepared. The plan includes an evaluation of the conditions that resulted in the package being improperly controlled and recommends changes in procedures and training to the new procedures to prevent any recurrences. A notice is sent to staff responsible for receiving and handling waste containers and to generator organizations reiterating the requirement for tamper indicating devices. In addition, a follow-up review is schedule for 60 days after the plan is approved. If a facility or activity can be allowed to operate while a noncompliant or hazardous condition exists, the allowance and any associated limitations must be defined as part of the facility’s or activity’s radioactive waste management basis, identified as a configuration controlled item in a configuration management plan or included in a revision or modification to an operating procedure or similar controlled documentation. The corrective action system should provide for preventing the use of systems or facilities (e.g., through lockout), or procedures (through cancellation) in cases where it is determined that use of the system, facility, or procedure impacts safety. Example: In the above example, the facility manager imposes a 2 week moratorium on receiving additional transuranic waste at the facility or certifying transuranic waste as meeting the Waste Acceptance Criteria for the Waste Isolation Pilot Plant. The manager expects that during the two week time period, the underlying problem can be identified and interim measures implemented to prevent a recurrence until the corrective action plan is fully implemented. Compliance with this requirement is demonstrated if a corrective action system exists which addresses noncompliant or hazardous situations associated with transuranic waste management and in a systematic fashion, and allows identification of problems by all personnel. III-26 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Supplemental References: 1. DOE, 1996. Implementation Guide for Use with Independent and Management Assessment Requirements of 10 CFR 830.120 and DOE O 414.1 Quality Assurance, DOE G 414.1-1, U.S. Department of Energy, Washington D.C., August 1996. III. F.(2) Operations Curtailment. Operations shall be curtailed or facilities shut down for failure to establish, maintain, or operate consistent with an approved radioactive waste management basis.

Section 20

Objective: The objective of this requirement is to limit the operation of waste management activities and facilities as necessary to avoid creation of near- or long-term safety or environmental hazards. Discussion: The Radioactive Waste Management Manual, DOE M 435.1-1, requires that a radioactive waste management basis be established for each transuranic waste management facility, operation, or activity. The radioactive waste management basis documents the conclusion that the potential hazards from management of radioactive waste have been sufficiently evaluated and that adequate controls are in place to provide assurance that the public, workers, and the environment are being protected. Field Element Managers are responsible for ensuring a radioactive waste management basis is developed, reviewed, approved, and maintained for each DOE radioactive waste management facility, operation, or activity (DOE M 435.1-1, Section I.2.F.(2)). The guidance for that requirement should be consulted for additional details on the development, review, and approval of a radioactive waste management basis. Also, additional discussion concerning the radioactive waste management basis for transuranic waste generator, treatment, storage, and disposal facilities is discussed under guidance for DOE M 435.1-1, Section III.D. As part of his/her responsibilities for maintaining the radioactive waste management basis for transuranic waste management facilities, operations, and activities under his/her authority, the Field Element Manager evaluates the compliance of the facilities, operations, and activities with the constraints and controls documented in the radioactive waste management basis by ensuring that routine assessments are conducted. If the Field Element Manager determines, either through routine assessment or by virtue of an occurrence or off normal event, that an operation, activity, or facility is not operating in compliance with an approved radioactive waste management basis, it must be curtailed or shut down. The action taken is commensurate with the hazards associated with the noncompliance and with the continued operation of the facility. DOE G 435.1-1 III-27 7-09-99 Chapter III - Transuranic Waste Requirements This requirement is to be implemented in a graded manner. Actions to be taken are based on assessments of adherence to radioactive waste management bases, and can range from shutdown of an operation or facility to placing limits or constraints on what activities can be performed or how the activities are to be performed. Shutdown of a facility involves stopping all operations in the facility except surveillance or monitoring activities necessary to maintain the facility in a safe standby condition. Shutdown is considered appropriate when there is either a potential imminent threat to safety or environmental protection, or a blatant failure to establish or comply with a radioactive waste management basis. Alternatively, there may be cases where a facility, operation, or activity assessment determines that the radioactive waste management basis is no longer current or has been violated, but there is no imminent threat to public, worker, or environmental protection. In such a case, the Field Element Manager may decide that shutdown of the facility is not necessary. It may be sufficient to impose certain limits until the radioactive waste management basis is made current. The limits imposed may prohibit the generation, receipt, or processing of certain waste streams, or may involve constraints on the processes that may be performed.

Section 21

The action taken in response to the failure to establish a radioactive waste management basis is to be clearly documented in a formal communication (e.g., letter, memorandum). Such communication needs to identify the reason for the shutdown or curtailment, and identify what is necessary to initiate restart. Generally, development of a corrective action that is implemented through the corrective action system discussed in the preceding section would be appropriate for responding to a shutdown or curtailment of activities. In concert with Core Requirement #6 of the Integrated Safety Management System, “Feedback and Improvement,” the Field Element Manager should use the audits and assessments to identify opportunities for improvement in the implementation of an activity or facility’s radioactive waste management basis. Identified improvement actions should be shared with like organizations and tracked by management to determine whether they are yielding the anticipated improvements. Communicating the results of assessment upward in the DOE and contractor organization will allow the findings to reach the management level with the authority necessary to effect improvements. Compliance with this requirement is demonstrated by documented evidence of systematic, routine reviews to determine whether waste management activities and facilities under are operating in accordance with an approved radioactive waste management basis. In addition, the documentation should show that limitations (which may include shutdown) have been placed on activities and operations that do not have or are operating outside the conditions of an approved radioactive waste management basis. III-28 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Supplemental References: 1. DOE, 1996. Safety Management System Policy, DOE P 450.4, U.S. Department of Energy, Washington, D.C. October 15, 1996. 2. DOE, 1997. Line Environment, Safety and Health Oversight, DOE P 450.5, U.S. Department of Energy, Washington, D.C., June 26, 1997. 3. DOE, 1997. Safety Management Functions, Responsibilities, and Authorities Policy, DOE P 411.1, U.S. Department of Energy, Washington, D.C., January 1, 1997. 4. DOE, 1997. Manual of Safety Management Functions, Responsibilities, and Authorities, DOE M 411.1-1, U.S. Department of Energy, Washington, D.C., October 8, 1997. DOE G 435.1-1 III-29 7-09-99 Chapter III - Transuranic Waste Requirements III. G. Waste Acceptance. The following requirements are in addition to those in Chapter I of this Manual. (1) Technical and Administrative. Waste acceptance requirements for all transuranic waste storage, treatment, or disposal facilities, operations, and activities shall specify, at a minimum, the following: (a) Allowable activities and/or concentrations of specific radionuclides; (b) Acceptable waste form and/or container requirements that ensure the chemical and physical stability of waste under conditions that might be encountered during transportation, storage, treatment, or disposal; (c) Restrictions or prohibitions on waste, materials, or containers that may adversely affect waste handlers or compromise facility or waste container performance; (d) Requirement to identify transuranic waste as defense or non-defense, and limitations on acceptance; and (e) The basis, procedures, and levels of authority required for granting exceptions to the waste acceptance requirements, which shall be contained in each facility’s waste acceptance documentation. Each exception request shall be documented, including its disposition as approved or not approved.

Section 22

Objective: The objectives of the waste acceptance requirements are to ensure that transuranic waste which is received at a facility contains only the radionuclides that the facility can safely manage, and only in concentrations and/or total activities which are compatible with the work to be undertaken in the facility; ensure that transuranic waste which is to be received at a facility is in a form or package that will maintain its integrity and retain acceptable configuration under the conditions that are expected to be encountered during the management steps the waste will undergo; ensure that no transuranic waste received at a facility contains materials that will compromise the safety or integrity of the facility under the expected operating conditions; and ensure that formal procedures exist and a decision process is clear concerning the granting of exceptions to waste acceptance requirements. III-30 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Discussion: As discussed in the guidance for DOE M 435.1-1, Section I.2.F.(6), the waste acceptance requirements establish the conditions for waste that facilities can safely receive. Therefore, the acceptance requirements for a transuranic waste storage, treatment, or disposal facility include all requirements that transuranic waste must meet to be acceptable for receipt, and for the subsequent storage, treatment, or disposal, as appropriate. In conducting the analyses for development of the DOE M 435.1-1 requirements, minimum acceptance requirements that must be specified in the waste acceptance documentation for storage, treatment, and disposal facilities in order for transuranic waste to be safely handled were identified. Guidance on subrequirement (a) is provided below under Radionuclide Content or Concentration. Guidance on subrequirements (b) and (c) is provided under Waste Form and Package Criteria and Prohibitions. Guidance on subrequirement (d) is provided under Defense/Non-Defense Waste. Guidance on subrequirement (e) is provided under Exceptions. Development of Waste Acceptance Requirements. A facility receiving waste for storage, treatment, or disposal is required to document the waste acceptance requirements for the facility. These requirements have their foundation in facility design capabilities such as volume, handling weight, allowable contents, and radiological limits (i.e., criticality, radiation, contamination). Other requirements may include any number of regulations promulgated by the EPA, NRC, DOT, the host state, and DOE itself. The designer and operator of the facility receiving waste are likely to be most knowledgeable and understanding of the requirements and limitations of the facility and, therefore, are in the best position to establish the waste acceptance requirements or criteria that must be met for waste sent to the facility. Although there are exceptions, most transuranic waste in the Department is to be disposed at WIPP. The exceptions include waste that cannot meet the waste acceptance criteria of WIPP or are otherwise ineligible (e.g., non-defense waste). Personnel responsible for transuranic waste storage or treatment facilities which manage waste destined for WIPP need to consider the WIPP waste acceptance criteria in developing acceptance criteria for their facilities.

Section 23

A transuranic waste management facility at a site may have its own specific stand-alone waste acceptance requirements. Or a site may have general waste acceptance requirements applicable to all transuranic waste management facilities at the site, with separate facilities adding facility- specific acceptance requirements to the site waste acceptance requirements as necessary. This practice may be particularly effective at sites with many facilities which manage small quantities of waste with multiple locations for staging, storage, and/or central management of waste. At such facilities, most of the process and procedural waste acceptance requirements could be in one document applicable to the whole site, which would be supplemented with specific technical requirements for acceptance at each of the separate management locations. If activities across DOE G 435.1-1 III-31 7-09-99 Chapter III - Transuranic Waste Requirements various facilities are similar, they could share the same supplemental waste acceptance requirements documents. Likewise, if several activities are carried out at locations that are close to one another, or are managed by the same entity, then one supplemental technical document may be prepared to cover those activities. The waste acceptance requirements and documentation for a facility receiving waste for storage, treatment, or disposal is prepared using a graded approach commensurate with the hazards associated with the management of the waste in the facility and the complexity of the activities to be conducted in the facility. The waste acceptance requirements for a facility which receives large quantities of transuranic waste from many generators, or with highly variable contents, or both, may need to address many hazards and consequently be more detailed. By contrast, a storage facility which will only pass-through properly packaged waste directly to a disposal facility without any additional processing or packaging may only need a minimal set of requirements. Perhaps only a few administrative requirements would be necessary for proper receipt of waste at such a storage facility, along with assurance that waste received at the storage facility meets the disposal facility technical waste acceptance requirements. Example 1: The Waste Isolation Pilot Plant is to receive defense transuranic waste generated by many different processes and from many different sites. In addition, the transportation of contact-handled transuranic waste to WIPP is to be in TRUPACT II containers. The requirements for acceptance of waste at WIPP are extensive and require a high degree of rigor. The waste acceptance requirements are addressed in a number of interrelated documents. These documents include the Waste Acceptance Criteria for the Waste Isolation Pilot Plant, the Generator Site Certification Guide, the Quality Assurance Program Description, and the Transuranic Waste Characterization Quality Assurance Program Plan. Example 2: At a DOE site, several facilities are used for storage of transuranic waste. A single waste acceptance requirements document which contains the necessary administrative requirements for all of the storage facilities is prepared as an umbrella document at the site. For each storage facility, a supplemental technical procedure which contains the technical criteria specific to the facility (e.g., inventory limits based on safety evaluations) and which invokes the umbrella document for the administrative processes and forms is prepared. This combination of documents provides the necessary waste acceptance criteria for waste to be received at the facilities.

Section 24

Legislation, regulations, performance assessments, safety analysis reports, technical safety requirements, criticality analyses, and other appropriate safety or authorization basis documents are to be used to establish the waste acceptance criteria for facilities receiving transuranic waste for storage, treatment, or disposal. These documents and analyses provide the basis for radioactivity (concentration and inventory) limits, waste categories (e.g., contact-handled or III-32 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements remote-handled), waste form and/or packaging stability requirements, allowable chemical content, allowable free liquid content, and any other necessary waste package or form requirements to ensure that the facilities’ design, performance, and operating bases are not compromised. Radionuclide Content or Concentration. Radiological limits for storage, treatment, and disposal facilities may be derived from a number of technical as well as administrative sources. In developing radionuclide limits, personnel need to consider legislative and/or regulatory limitations, the disposal facility performance assessment, safety analysis reports, and criticality analyses. In addition to establishing general radiological limits (e.g., a contact dose rate), these sources identify specific radionuclides whose concentration or total activity must be limited in the waste acceptance criteria in order to remain within the bounds for safe and legal facility operation. The operating definition of transuranic waste is taken from Federal legislation (see guidance for DOE M 435.1-1, Section III.A). The definition is significant to transuranic waste management because the designated disposal facility for defense transuranic waste, WIPP can only accept waste that meets that definition. Storage and treatment facilities need to include appropriate waste acceptance requirements that require identification of transuranic waste to facilitate its eventual transfer for WIPP disposal. The results of a long-term performance assessment analysis may provide information on critical radionuclides that are most important to the long-term performance of the disposal facility. The waste acceptance criteria for the disposal facility are to translate the results of the performance assessment analyses into limits on the receipt of waste at the facility or on the operation of the facility. Example: The performance assessment of WIPP is based on an assumed final inventory of transuranic and other radionuclides. Although the performance assessment indicated that facility performance was not sensitive to radionuclide inventory, in the Compliance Certification Application WIPP committed to tracking the cumulative inventory of radionuclides of interest. Therefore, the waste acceptance criteria require sites to report the inventory or concentration of these radionuclides of interest. Although performance assessments are not required for storage or treatment facilities, personnel developing waste acceptance criteria for these types of facilities should consider the radiological limits of WIPP. In most cases, transuranic waste will eventually be transferred to WIPP for disposal, so WIPP waste acceptance criteria should be factored into the waste acceptance requirements of the storage or treatment facility to ensure a situation is not created in which the waste does not have a path to disposal.

Section 25

Example: A transuranic storage facility accepts a high dose rate transuranic waste from a generator. Due to the dose rate, the waste is managed and stored as remote-handled DOE G 435.1-1 III-33 7-09-99 Chapter III - Transuranic Waste Requirements waste. However, when placed into storage, the waste does not meet the WIPP waste acceptance criteria, thus creating a future management issue. As an alternative, the waste acceptance criteria could be revised to not allow acceptance of transuranic waste that does not meet the WIPP waste acceptance criteria. The generator would be compelled to work with the waste management organizations to determine how to manage or process the waste at the source in order to meet the disposal criteria of available facilities (transuranic and/or low-level waste). The safety analysis report or safety evaluation prepared for a transuranic waste management facility may identify specific radionuclides that warrant specific attention from a worker safety standpoint, and may require special handling if received and managed at the facility. Example: A storage facility that manages mixed transuranic waste is subject to RCRA Part B permit requirements for routine inspection of the waste. An analysis of worker radiation exposure associated with inspection of the storage configuration indicates that several radionuclides need to be controlled below certain concentrations to maintain doses to workers as low as reasonably achievable. The waste acceptance requirements for the facility reflect the allowable concentrations from the safety analyses as maxima for waste that can be accepted for storage in the facility. Any criticality analyses conducted in accordance with the criticality safety program in conformance with DOE M 435.1-1, Section I.1.E.(4) may also result in limitations on acceptance of fissile radionuclides. These limitations need to be included in the waste acceptance requirements, as appropriate. Similarly, for transuranic waste, the TRUPACT II Safety Analysis Report for Packaging establishes limits on the amount of fissile material that is allowed to be transported in the TRUPACT II. These limits need to be considered in the development of waste acceptance criteria to avoid the need to repackage waste to transfer it to the next step in the waste management process. These limits are reflected in the Waste Acceptance Criteria for the Waste Isolation Pilot Plant. Waste Form and Package Criteria and Prohibitions. Generally, waste acceptance requirements specify that wastes received at the facility are in a physically/chemically stable form. As used in this requirement, stability refers to the physical and chemical properties of waste that are necessary for it to be handled safely at a facility and to undergo the management steps normally performed at that facility. Such stability is dependent on the waste management steps to be performed with the waste (e.g., treat, store) and the time to complete the management step (e.g., time until treatment or length of expected storage period). Therefore, waste acceptance requirements must specify the physical and chemical stability that correspond to the specific operations and activities of a particular facility. Waste acceptance requirements for a transuranic waste treatment facility need to specify the physical and chemical precautions and conditions under which untreated waste can be received at the facility so that facility safety and effective

Section 26

III-34 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements operations will not be compromised. Any physical or chemical stabilization of waste prior to transfer to a facility receiving waste for storage, treatment, or disposal needs to be done according to a systematic process that may include consideration of bench-scale testing and verification that the process is producing satisfactory results. Example: A facility that is in the process of cleaning out transuranic radionuclide- contaminated glove boxes determines that operational efficiencies will be realized in the form of fewer drums, less storage space, and fewer transuranic waste shipments if they compact the cleanout waste into 55-gallon drums. The organization responsible for operating the compactor establish a set of waste acceptance criteria for waste that can be received from the cleanout activities. The criteria, based on expected ability to fit 25 boxes in a drum, specify: waste must be packages in 1 cubic foot cardboard boxes; no more than 5% of the volume of a box can be incompressible waste; the long axis of incompressible waste must be oriented in a horizontal plane; boxes must be free of removable external contamination; the dose rate from any box must be less than 10 mrem/hr; there must be less than 8 plutonium-239 fissile-gram equivalents per box; there must be less than 3 plutonium-239 equivalent curies per box; waste must be less than 50 ppm polychlorinated biphenyls, and the waste must be characterized for RCRA constituents. Based on these criteria, the compactor facility can provide 55-gallon drums that meet the on-site storage facility’s requirements, and subsequently, the WIPP requirements. The waste acceptance requirements are to specify waste streams, classes, or categories of waste requiring application of specific physical, chemical, or structural stabilization methods, as determined by the results of safety analyses or long-term performance assessments. Acceptable waste forms, containers, and packages are specified by the waste acceptance requirements. The waste acceptance requirements need to list any specific packages and containers pre-approved as acceptable for the transuranic waste management facilities, as well as acceptable overpacks. The waste acceptance requirements need to identify any of the following specific technical requirements that must be included to ensure that waste received at any storage, treatment, or disposal facility is consistent with the operating basis of the facility: • the acceptable limits for waste package external surface dose rate for both contact and remote handled packages; • the acceptable limits for waste package surface contamination; • the allowable heat generation rates; • the acceptable limits for free liquid content, specified on a per package basis; DOE G 435.1-1 III-35 7-09-99 Chapter III - Transuranic Waste Requirements • the acceptable limits for maximum void space, specified on a per package basis; • the necessary labeling and marking, including information about bar coding or other tracking system used at the facility receiving the waste and the application of the system by generators; • any specific radionuclides or chemical or hazardous materials that are prohibited from acceptance at the facility. This may include pyrophoric materials, explosives, or materials that might cause violent reactions during storage, treatment, or disposal;

Section 27

• any specific requirements associated with acceptance of mixed transuranic waste, including any additional restrictions or limitations on the waste or specifications for handling mixed waste containers; • any specific requirements associated with acceptance of special transuranic waste needing out-of-the ordinary attention for receipt, handling, storage, treatment, or disposal, (e.g., sealed sources), including any additional restrictions or limitations on the waste or specifications for handling the waste containers; • any package protection requirements needed for transport and receipt to provide needed physical protection of the packages to prevent breaching and so that the certified status of the waste is preserved; and • the necessary shipping arrangements for transport to the facility receiving waste, including any electronic data bases or scheduling system used. Example 1: Waste acceptance criteria for the Waste Isolation Pilot Plant have been developed based on applicable requirements, e.g., statutory requirements, other environmental compliance requirements, operational and safety analysis requirements, and transportation requirements. Development of waste acceptance requirements based on these sources ensures that waste received at WIPP complies with applicable regulations and can be safely managed at the site. The requirements include technical requirements addressing container properties, physical properties, nuclear properties, chemical properties, and gas generation; and administrative requirements for data that need to be provided with waste shipments. Example 2: A transuranic waste containing spent solvents regulated by RCRA is transferred from a storage facility to a treatment facility for treatment. The treatment facility personnel must establish the limits, if any, on the concentration of solvents for which the treatment process was designed and qualified, and limitations or prohibitions III-36 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements on other materials that may adversely affect the processing. The waste treatment process is to produce a treated waste product that (1) has been reduced in transuranic contaminant concentrations such that it may be disposed of as mixed low-level waste or (2) is acceptable for disposal at the WIPP as mixed transuranic waste. In either case, the final treated waste form must also meet the disposal facility waste acceptance criteria. In order to ensure that the treatment process product will meet applicable requirements, the treatment facility must document the limitations in the waste acceptance criteria that the organization supplying the waste must meet. By doing so, the treatment facility can safely process the waste, treat it successfully, and produce a product that can be disposed of. Defense/Non-Defense Waste. The WIPP Land Withdrawal Act of 1992, as amended, limits the waste that can be accepted for disposal at WIPP to transuranic waste generated by atomic energy defense activities. In order to ensure compliance with the statutory constraint, and to facilitate identification of waste that can be disposed of at WIPP, all transuranic waste acceptance criteria must include a requirement for waste to be identified as defense or non-defense. At a minimum, the waste acceptance criteria should require identification of waste as defense or non-defense to be part of the certification program (see Waste Certification guidance for DOE M 435.1-1, Section III.J) and be included in the documentation used to transfer responsibility to personnel at the facility receiving the waste for storage, treatment, or disposal. The requirement applies to all transuranic waste and to all waste management facilities to ensure that the defense or non-defense identity of waste is not lost during waste generation and subsequent processing operations.

Section 28

Example: The waste acceptance criteria for a transuranic waste storage facility has a waste transfer form that is to be used for each transfer of waste to the facility. The form, which the waste acceptance criteria requires to be used to document the certification that waste meets the waste acceptance criteria, includes identification of the waste as defense or non-defense as a mandatory piece of data. In addition, the waste acceptance criteria require that waste packages be marked to indicate the waste as being defense or non- defense. The waste acceptance criteria identifies three acceptable means of marking waste packages, color of the package, labeling, or through bar coding. The Departmental interpretation is that the term “atomic energy defense activities” used in the WIPP Land Withdrawal Act of 1992, as amended, has the same meaning as the same term used in the Nuclear Waste Policy Act of 1982, as amended. The term “atomic energy defense activities” permits WIPP to dispose of defense transuranic waste resulting from all of the noncivilian activities and programs of DOE, including weapons production, naval reactors, defense research and development, associated defense environmental restoration and waste management and other defense- DOE G 435.1-1 III-37 7-09-99 Chapter III - Transuranic Waste Requirements related activities, as defined more specifically in the Nuclear Waste Policy Act, from which the term was borrowed. (Nordhaus, 1996) As the Nuclear Waste Policy Act of 1982, as amended, states, the term “atomic energy defense activity” means any activity of the Secretary [of Energy] performed in whole or in part in carrying out any of the following functions: (a) naval reactors development; (b) weapons activities, including defense inertial confinement fusion; (c) verification and control technology; (d) defense nuclear materials production; (e) defense nuclear waste and materials by-product management; (f) defense nuclear materials security and safeguards and security investigations; and (g) defense research and development. This definition of atomic energy defense activity does not include transuranic waste generated from DOE’s civilian atomic energy activities. Exceptions. Waste acceptance requirements are established to ensure that facilities can safely manage waste received for storage, treatment, or disposal. Thus, exceptions or deviations to waste acceptance criteria cannot be routine and must be carefully reviewed and documented. The procedures for granting exceptions need to clearly state the entire process for requesting an exception, describe acceptable bases for granting exceptions, and identify any additional information that is needed to supplement the documentation normally provided for waste transfers. The approval process needs to be clearly spelled out including identification of the officials who have the authority to approve the exception.

Section 29

Example: The waste acceptance requirements for a transuranic waste storage facility establishes a per package limit on fissile material. The limit was developed based on criticality and safety analyses which assumed all of the packages in the facility could potentially contain the specified amount of fissile material. A generator has a waste package that slightly exceeds the limit. The waste acceptance requirements specify the that the generator needs to identify the criterion for which an exception is being requested and provide relevant information about the waste package or waste stream for which an exception is being sought. It further identifies to whom the request for an exception is to be submitted. At the storage facility, there are documented procedures indicating the process to be followed for evaluating the exception request and identifying the facility manager as the approval authority. In this case, an analysis is performed indicating that because of the small inventory of fissile material in the facility, an exception can be granted. Documentation supporting this decision includes notification to the generator that the exception is granted, copies of the analyses performed to III-38 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements support the decision, and additional controls on waste that can be accepted in the facility during the time the particular waste remains in storage (i.e., limits may have to be placed on the per package content of other waste or on the total number of packages that the facility could accept). Compliance with these requirements is demonstrated if waste acceptance requirements are documented, contain clear and precise criteria specifying the radionuclide limits in the form of contents or concentrations that can be accepted, the limitations and prohibitions on waste forms and packages that can be received, and the limits, prohibitions, or instructions concerning any other technical information so that the waste is compatible with the safety basis of the facility, and which will result in acceptable waste at subsequent steps in managing the transuranic waste. Waste acceptance requirements are to also contain a clear description of the process and bases for obtaining an exception or deviation to the acceptance criteria for transuranic waste to be received at the facility. Supplemental References: 1. CAO, 1997. Generator Site Certification Guide, Revision 1, DOE/CAO-95-2119, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, August 1997. 2. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, Revision 5, DOE/WIPP-069, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996. 3. CAO, 1996. Quality Assurance Program Document, Revision 1, CAO-94-1012, U.S. Department of Energy, Carlsbad Area Office, Carlsbad NM, 1996. 4. CAO, 1998. U.S. Department of Energy, Transuranic Waste Characterization Quality Assurance Program Plan, Revision 1, CAO-94-1010, U.S. Department of Energy, Carlsbad Area Office, Carlsbad NM, December 18, 1998. 5. CAO, 1998. TRUPACT-II Operating and Maintenance Instructions, Revision 1, DOE/WIPP-93-1001, U.S. Department of Energy, Carlsbad Area Office, Carlsbad NM, May 1998. 6. Nordhaus, 1996. Robert R. Nordhaus, to Al Alm, memorandum, Interpretation of the Term “Atomic Defense Activities” as Used in the Waste Isolation Pilot Plant Land Withdrawal Act, U.S. Department of Energy, Washington, D.C., September 9, 1996.

Section 30

DOE G 435.1-1 III-39 7-09-99 Chapter III - Transuranic Waste Requirements III. G.(2) Evaluation and Acceptance. The receiving facility shall evaluate waste for acceptance, including confirmation that technical and administrative requirements have been met. A process for the disposition of non-conforming wastes shall be established. Objective: The objective of this requirement is to establish a process by which personnel at a facility receiving transuranic waste for storage, treatment, or disposal determine that the waste being transferred is acceptable in accordance with the waste acceptance requirements, and for that process to specifically address management of waste that does not conform with all of the requirements when it is received at the facility. Discussion: This requirement makes it the responsibility of officials at a facility to which waste is transferred to confirm that waste is in compliance with the established waste acceptance requirements and also provides a mechanism by which the officials confirm that waste can be accepted and safely managed at the facility. Evaluation and Acceptance. The methodology for implementing the evaluation and acceptance of transuranic waste needs to be flexible and defined on a facility-specific basis. The complete process and procedures, including the responsibilities of generating facilities, need to be clearly documented so that both the generator and the facility receiving the waste understand the process that will be used. As with implementation of other parts of DOE M 435.1-1, this requirement is implemented using the graded approach. Facilities receiving transuranic from many generators and/or offsite generators may need to implement more detailed waste evaluation and acceptance processes than a facility receiving waste from a small number of onsite generators. The evaluation and confirmation process consists of one or more of the following approaches, and is designed to demonstrate that the waste presented meets the waste acceptance requirements of the facility receiving waste for storage, treatment, or disposal: • Testing, sampling, and analysis of the contents of a representative sample of waste packages as they are received at the facility; • Testing and analysis of a number of samples taken at the generator facility; • Detailed review of sampling and analysis data generated by the sending facility or an independent laboratory employed by the generating facility; III-40 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements • Audit, review, or surveillance of the sender’s waste characterization activities and processes and waste certification programs. Testing, sampling, and analysis of the contents of a representative sample of waste packages upon receipt is complicated by the fact that additional risk is posed if a technique such as opening of drums and obtaining grab samples is used. Therefore, consideration needs to be given to implementing non-destructive examination technologies if receipt sampling and analysis is the preferred approach. Likewise, analysis of samples taken at the generator’s site may involve additional risk, and also may be expensive to implement. If this method is employed, samples which are representative, either statistically or correlated with generator profiles, need to be obtained for analysis to validate this method as accurate. This sampling would include packages from the generators sending the largest volume of waste to the facility or packages containing the critical radionuclides as identified in the waste acceptance requirements.

Section 31

Example: The waste acceptance process for a storage facility that receives waste from multiple generators involves assay to confirm the waste is transuranic, and sample collection and analysis to confirm its RCRA status. The process calls for assaying and sampling one waste package of every 100 from established waste streams and one of every 10 for new waste streams or for waste streams from generators who have a history of poor compliance with the waste acceptance criteria. The use of a detailed review of the sampling and analysis data gathered by others would include an evaluation of the methodologies used for collecting the sample, maintaining the integrity of the sample and data (e.g., through a chain of custody), and performing the radioanalyses. As above, the samples collected would need to be representative of the waste, either statistically or with a bias towards large generators or generators of significant radionuclides (i.e., those that are most limiting for the storage, treatment, or disposal facility). The use of assessments (audits, reviews, or surveillances) to verify compliance of the waste generators’ certification programs with acceptance requirements would need to be conducted on a regular schedule commensurate with the frequency of waste generation and shipments. The documentation of the verification process would include organization and authorities; frequency of assessments; methods to be employed; the information that will be documented as a result; and the qualifications of personnel. Example: At the Waste Isolation Pilot Plant, there are no plans for sampling waste packages upon receipt. Instead, WIPP has instituted a program in which generator site waste certification programs are reviewed to determine whether they will produce waste packages meeting the waste acceptance criteria. A Generator Site Certification Guide describes what is entailed in obtaining an approved site certification program. Once a site has developed its program, representatives from WIPP evaluate it, and if determined DOE G 435.1-1 III-41 7-09-99 Chapter III - Transuranic Waste Requirements to be acceptable, approve it. After a site’s certification program has been approved, WIPP personnel rely on the combination of site certification that waste packages comply with the site’s approved program and their own review of transfer documentation and processes to assure that waste meets the waste acceptance criteria. Site certification programs are re-evaluated annually to confirm that they are still adequate. Non-Conforming Waste. Facilities receiving waste for storage, treatment, or disposal must have a documented process to be used in the event a non-conforming waste is received. A non- conforming waste is a waste container or shipment which is certified by the generator as meeting the waste acceptance requirements of the receiving facility, but which is found to be in violation of the acceptance criteria during the facility’s waste receipt and inspection process. Facility procedures need to address how non-conforming waste will be segregated from acceptable waste, the process for notifying the sender of the non-conformance, and the acceptable methods for dispositioning the non-conforming waste. The process includes prior notice to the sender of the actions to be taken by the facility receiving the waste and the sender’s obligations, particularly regarding the cost of the actions, to support the disposition of the non-conforming waste.

Section 32

Example: A transuranic waste storage facility’s waste acceptance procedures require that non-conforming waste be segregated from conforming waste and isolated by a rope barrier pending resolution of the non-conformance. The procedures further require notification of the generator of the non-conformance and a resolution to be negotiated with the generator. The process requires consideration of risk and cost in determining the proper resolution. Compliance with these requirements is demonstrated if there is a procedure or process for evaluating and accepting incoming waste which ensures the acceptance criteria of the facility receiving the waste are met by one or a combination of: (1) testing, sampling, and analysis of representative samples of incoming waste upon receipt; (2) testing, sampling, and analysis of samples of waste taken at the generator facility; (3) evaluation of testing, sampling, and analysis of data provided by the generator; or (4) audits, reviews, or surveillances of generator waste certification programs and characterization activities. Additionally, acceptable waste acceptance requirements for a storage, treatment, or disposal facility will have documented procedures and actions to be taken if a waste that does not conform to the waste acceptance criteria is received at the facility. Supplemental References: 1. CAO, 1997. Generator Site Certification Guide, Revision 1, DOE/CAO-95-2119, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, August 1997. III-42 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements 2. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, Revision 5, DOE/WIPP-069, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996. DOE G 435.1-1 III-43 7-09-99 Chapter III - Transuranic Waste Requirements III. H. Waste Generation Planning. The following requirements are in addition to those in Chapter I of this Manual. (1) Life-Cycle Planning. Prior to waste generation, planning shall be performed to address the entire life cycle for all transuranic waste streams. Objective: The objective of this requirement is to provide for the disposal of all transuranic waste that is generated in the future by ensuring that prior to generating a new transuranic waste stream, the specific waste management facilities necessary for safe management of the waste from the time it is generated up to and including its disposal are identified; plans are developed for resolving issues that prevent disposal, and for safe, long-term storage for transuranic waste with no path to disposal; and sites are discouraged from generating transuranic waste that does not have an identified path to disposal. Discussion: The Department intends on disposing of stored and future defense transuranic waste (the majority of DOE transuranic waste) that meets waste acceptance requirements at WIPP. The subject requirement is based on a recognition that protection of the public, workers, and the environment is best assured if transuranic waste is generated with cognizance of its final disposition and of the waste management facilities that are needed until the waste is disposed. In developing DOE O 435.1 and DOE M 435.1-1, the safety and hazards analysis identified long-term storage of waste, and potential loss of characterization data from generators and the subsequent need for recharacterization as weaknesses to be mitigated. Therefore, as part of the generator planning requirements in DOE M 435.1-1, Section I.2.F.(7), specific requirements are identified for planning the management of waste prior to its generation, and for approval to generate transuranic waste streams with no identified path to disposal.

Section 33

Life cycle planning for all transuranic waste. Planning prior to generating transuranic waste is primarily intended to address newly-generated waste streams. Life-cycle planning for waste that has been generated and continues to be generated is documented through the Site-Wide Waste Management Program required in DOE M 435.1-1, Section I.2.F.(1). The following discussion describes the types of life cycle planning need. The information needed is influenced by the fact that, on the implementation date of the Order, the transuranic waste will be in one of three stages of its life-cycle: (1) waste generated in the past (in storage); (2) waste being generated at present; and (3) wastes not yet generated (future wastes); and will either have an identified path to disposal, or will not. III-44 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Therefore, from a waste generation planning perspective, there are six different “states” of transuranic waste, depending on when the waste was or is generated and whether it has or will have a path to disposal. The following paragraphs explain the recommended life cycle information for these different transuranic wastes. Transuranic Waste With a Path to Disposal Generated currently - The life-cycle information for currently generated transuranic waste with an identified path to disposal includes a description of the management steps for the waste as discussed in guidance for the Site-Wide Radioactive Waste Management Program. Generated in the future (from a new process) - The life-cycle information for transuranic waste with an identified path to disposal that is generated from a new process includes a description of the management steps for the waste as discussed in guidance for the Site-Wide Radioactive Waste Management Program. Generated in the past (in storage) - In addition to the basic information on management steps, life cycle information for transuranic waste with a path to disposal that is in storage (due to budget constraints, delays due to regulatory matters or management decisions, or for other reasons) includes a schedule for achieving disposal. For transuranic waste in earthen-covered storage, the retrieval plan required by the storage requirements (DOE M 435.1-1, Section III.N) can be used to meet this requirement provided it has a schedule. Transuranic Waste Without a Path to Disposal Generated in the past (in storage) - The life-cycle information for transuranic waste in storage as of the issuance of DOE O 435.1 for which there is not an identified path to disposal includes the basic information on the management steps for the waste which can be identified, a discussion of the issues that hinder disposal of the waste, and the plans and schedule for achieving resolution of the issues. Generated in the future (from a new process) - The life-cycle information for transuranic waste without an identified path to disposal which is generated from a new process includes the basic information on the management steps for the waste which can be identified, a discussion of the issues that hinder disposal of the waste, and the plans and schedule for achieving resolution of the issues. This information will be assembled in the course of getting the generation of the waste approved in accordance with the process required in DOE M 435.1-1, Section I.2.F.(19), and is also discussed in the next section of this guidance. DOE G 435.1-1 III-45 7-09-99

Section 34

Chapter III - Transuranic Waste Requirements Generated currently - The life-cycle information for transuranic waste without an identified path to disposal includes the basic information on the management steps for the waste which can be identified, a discussion of the issues that hinder disposal of the waste, and the plans and schedule for achieving resolution of the issues. The intent of the requirement is not to ensure that these waste streams receive approval for generation in accordance with General Requirement I.2.F.(19). However, the life-cycle planning information needs to address the continued generation of this waste. The life-cycle planning information for continuing to generate a no path forward waste needs to include consideration of the necessity to generate the waste, an understanding of what prevents disposal of the waste, the needed capacity and capabilities for continued storage of the waste, and the plans for future disposal of the waste. Discussions would also be included on any alternatives to the process that generates the no path forward waste that have been considered. Providing the life cycle information discussed above for waste streams already being generated is relatively straightforward. For most transuranic wastes, the information already exists and has been utilized for other documents such as the Programmatic Environmental Impact Statement and the Baseline Disposition Maps. To the extent that existing documentation includes the specified information, they may be used to meet the life cycle planning requirement. Example: A transuranic waste generating facility operating at Site A continues to operate with no alterations. The facility generates the same transuranic waste streams it has been generating for years, and none of them are waste streams without a path to disposal. The life-cycle information about transuranic waste generated at this facility is included in the current waste inventories and capacities section of the Site A Radioactive Waste Management Plan, and no technical or programmatic issues are included in the Plan concerning these waste streams. Waste generator planning prior to generation. Planning, prior to generating transuranic waste (subrequirement H.(1)), is intended to address transuranic waste streams that do not already exist. Transuranic waste streams that are first generated after issuance of the Order are subject to this requirement. Waste generator planning is a component of the waste generator program required in I.2.F.(7) of the General Requirements Chapter of DOE M 435.1-1. Waste generator planning activities need to be integrated in the generator program with waste characterization, certification, and transfer activities. Example: A previously operating high-level waste treatment facility has been shut down for eighteen months and is to be restarted. Based on past experience, it is known that contamination control activities in the building will result in the generation of a transuranic waste stream. As part of the generation planning in support of the restart, plant personnel must evaluate the life-cycle of all of the waste streams (high-level, III-46 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements

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transuranic and low-level) that will come from the facility. For the transuranic waste, personnel confirm that there is a facility that can accept the waste for storage and that because the waste is from a defense-related activity, it is eligible for disposal at the Waste Isolation Pilot Plant. Based on the WIPP waste acceptance criteria and communications with WIPP personnel, the determination is made that the waste will meet the waste acceptance criteria and that adequate capacity will be available. From the perspective of transuranic waste life-cycle planning there are no issues associated with the restart. Generator planning addresses the life-cycle of the waste to disposal, including all interim steps of waste management. This can be accomplished by preparing a waste stream profile and reviewing it with the facility(ies) that will manage the waste. The waste stream profile format used needs to be consistent with the needs of the storage, treatment, and/or disposal facilities that will be involved in managing the waste stream. An example of a waste stream profile form is included as Figure III.H.1 at the end of this section of guidance. The waste generator confirms with each storage, treatment, and disposal facility that will be used, that based on the current knowledge of the waste stream characteristics, and planned facility capacity, the waste stream can be managed by the facility. It is therefore conceivable that a generator may have to interface with multiple facilities (e.g., a storage and/or treatment facility in addition to the disposal facility) to ensure that the waste can be managed. Example: In the previous example, the treatment facility confirmed with the storage facility that based on the expected generation rate of the transuranic waste and the expected commencement of shipments of waste to WIPP that there was sufficient storage capacity to handle the transuranic waste stream. The determination of whether a transuranic waste stream has an identified path to disposal is based on the availability and capacity of existing or planned facilities and operations. A planned facility is considered to be available if it has been authorized (e.g., a line item in a Congressional appropriation or equivalent approval for design and construction). A facility is not considered available if it is not authorized to accept or manage a particular waste type or concentration. If a planned facility is designated in the planning information, then the planning information also needs to address the schedule for when the facility will be operational, and the management steps that will be taken for waste designated for that facility until it becomes operational. For purposes of planning for disposal of a transuranic waste stream, a facility or capabilities that are part of a program or strategic plan, but have not been authorized are not considered available. If a planned or available facility is canceled, the generator site needs to revise the planning for the life-cycle of the transuranic waste, an alternate path to disposal needs to be identified and documented, or approval to generate the transuranic waste needs to be obtained from the cognizant Field Element Manager as required by DOE M 435.1-1, Section I.2.F.(19). DOE G 435.1-1 III-47 7-09-99 Chapter III - Transuranic Waste Requirements

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The generator is responsible for ensuring that transuranic waste is not generated unless the life-cycle management, including disposal of the waste, has been considered. However, as discussed below, it is not the objective of this requirement to prohibit, under all conditions, the generation of transuranic waste that does not have an identified path to disposal. In meeting the DOE O 435.1 planning requirements, it is appropriate for waste management organizations to provide assistance to the generator in determining the waste management path, particularly in cases where the waste management organization may utilize offsite treatment, storage, or disposal facilities. Compliance with this planning requirement is demonstrated by the individual sites establishing a process for evaluating the life-cycle of low-level waste prior to its generation, including the identification of low-level wastes with no path to disposal and appropriate records justifying the newly generated low-level waste stream(s), and site personnel possessing planning information showing the location(s) where low-level waste will be stored, treated, and/or disposed along with a confirmation that the personnel managing the facilities agree that the low-level waste may be managed at those facilities. Supplemental References: 1. DOE, 1998. Accelerating Cleanup: Paths to Closure, DOE/EM-0362, U.S. Department of Energy, Washington, D.C., June 1998. III. H.(2) Waste With No Identified Path to Disposal. Transuranic waste streams with no identified path to disposal shall be generated only in accordance with approved conditions which, at a minimum, shall address: (a) Programmatic need to generate the waste; (b) Characteristics and issues preventing the disposal of the waste; (c) Safe storage of the waste until disposal can be achieved; and (d) Activities and plans for achieving final disposal of the waste. Objective: The objective of this requirement is to ensure that prior to generation of a new transuranic waste streams with no path to disposal, the need to generate the waste is carefully considered and plans III-48 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements for safe long-term storage and for resolving issues that prevent disposal of the wastes are developed. Discussion: There are instances where programmatic needs may necessitate the generation of transuranic waste without an identified path to disposal. In these instances, the Field Element Manager must ensure development of a process for identifying generation of transuranic waste with no path to disposal and approving the conditions under which such transuranic waste can be generated (DOE M 435.1-1, Section 1.2.F.(19)). The process of identifying waste with no path to disposal and establishing conditions for its generation is intended to raise to the attention of DOE management that a long-term commitment is being made with the generation of such a waste, including prolonged storage of this waste and resolving those issues that prevent the waste from being disposed. Example: Through generation planning it is determined that an Office of Science project will generate a small volume of non-defense transuranic waste. The generator contacts the waste management organization and learns that because the waste is non-defense it is not eligible for WIPP disposal. Working together, generator and waste management personnel determine there is no way to avoid creating the waste if the project proceeds, however, the waste management organization does have long-term storage capacity available. The Field Element Manager determines that due to the importance of the project, and based on plans that the Department is pursuing to resolve disposal of non-defense transuranic waste that generating the transuranic waste is acceptable.

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The minimum conditions for generating a waste without an identified path to disposal are identified in this requirement. They include various evaluations and considerations that involve both the waste generating and waste management organizations. The decision to proceed with the activity generating the wastes is made considering the factors discussed below. Programmatic need to generate the waste. There must be a clear identification of the programmatic mission being served that results in the generation of transuranic waste with no identified path to disposal. Alternate means of accomplishing the mission without generating the waste should be discussed. These could include use of alternative materials to achieve the mission, use of different processes, or substitution of chemicals other than the ones originally to be used. Characteristics and issues preventing the disposal of the waste. The reasons that the transuranic waste cannot be disposed of must be identified. These may be technical or programmatic reasons. For example, if a waste needs to be treated in order to meet a disposal facility waste acceptance criteria and an appropriate treatment facility is not available, the lack of treatment would be DOE G 435.1-1 III-49 7-09-99 Chapter III - Transuranic Waste Requirements identified as the reason the waste does not have a path to disposal. Identifying the characteristics and issues preventing disposal is necessary to support the development of plans for achieving disposal. Safe storage of the waste until disposal can be achieved. Since the waste cannot be disposed of pending the resolution of programmatic or technical issues, facilities must be available for safe storage. In order to evaluate the ability to provide for the storage of the waste, there needs to be an estimate of the amount of the waste that will be generated, as well as an estimate of the time necessary to keep the waste in storage. Identification of the requirements for safe storage and acceptable storage facilities is a prerequisite to generating the waste so that unique or risky aspects that may make long-term storage problematic can be identified. In addition, treatment necessary to comply with RCRA, if applicable, should be identified. Activities and plans for achieving final disposal of the waste. The decision to generate waste with no identified path to disposal must be based on a plan to eventually achieve disposal. The plan to achieve disposal of the waste needs to identify the activities being pursued to resolve issues preventing disposal and a schedule for their resolution. The activities described may be fairly detailed if the problems are technical and involve only one waste stream at a site. In other cases involving programmatic issues, or which involve several waste streams at several sites, the activities and schedules to resolve issues may be less certain because they are dependent on other internal or external organizations. For example, resolution of the issue of disposal of non-defense transuranic waste may require action external to DOE (e.g., legislation). Sites should defer to the complex-wide plans for addressing disposal of non-defense transuranic waste in lieu of developing individual plans and schedules.

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Example 1: Approval is given to generate transuranic waste with no path to disposal. The waste is not acceptable for disposal at WIPP because it is reactive (EPA hazardous waste code D003). The approval to generate the waste is based on the generator providing plans to develop the treatment capabilities necessary to make the waste acceptable for WIPP disposal. These plans should be detailed, identifying the schedule for conducting the studies, tests, and engineering, as well as regulatory activities, necessary to allow the waste to be treated. Example 2: A non-defense transuranic waste which is otherwise acceptable for WIPP disposal may require a programmatic decision by DOE Headquarters and legislative action to resolve disposal issues. The site plan for addressing this issue should identify the data collection and options analyses to be performed by the site and address how they fit with the actions being taken by the Complex-Wide Transuranic Waste Management Program (see DOE M 435.1-1, Section III.C). III-50 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements If the assumptions for the planned management of the waste are adversely impacted (e.g., as a result of testing, design, funding profile, DOE policy) they should be updated. Minor updates to the assumptions and changes to the planned management of the waste would not be a basis for re- evaluating the generation of the waste as long as the overall plan remains essentially unchanged. However, major changes to the plan (e.g., changes in decisions for developing a treatment facility or disposal facility to handle the waste) must result in a re-evaluation of the acceptability of continuing to generate the transuranic waste. All changes in plans for resolving issues preventing disposal should be forwarded to the Headquarters Office of Waste Management so their impact on the Complex-Wide Transuranic Waste Management Program can reflected in the program plan (see DOE M 435.1-1, Section I.2.D.(1)). Compliance with requirement is demonstrated by the waste generation organization having documentation concerning the decision to generate a transuranic waste stream that does not have an identified path to disposal. This documentation needs to include the cognizant Field Element Manager or designee approval to generate the waste, an explanation of the need for the process that generates the transuranic waste, a discussion of the reason it cannot be disposed of, the proposed management plan for the waste, and an up-to-date schedule of activities being pursued to resolve constraints to the disposal of the subject waste. Consistent with the use of a graded approach for applying DOE M 435.1-1 requirements, the schedule and plans for disposing of non- defense waste can defer to the complex-wide resolution of the issue. Supplemental References: 1. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, DOE/WIPP-069, Revision 5, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996. DOE G 435.1-1 III-51 7-09-99 Chapter III - Transuranic Waste Requirements WASTE STREAM PROFILE FORM Page 1 of 3 Waste Stream Profile Number: Generator site name: Technical contact: Generator site EPA ID : Technical contact phone number: Did your facility generate this waste? ~~ Yes ~~ No If no, provide the name and EPA ID of the original generator:

Section 39

Waste Stream Information ID: Summary Category: Waste Stream Name : Description from the TWBIR (if available): Defense TRU Waste?: ~~ Yes ~~ No CH-TRU or RH-TRU?: ~~ CH ~~ RH Concentration of PCBs: Number of SWBs Number of Drums Number of Canisters Data package numbers supporting this waste stream characterization: List applicable EPA Hazardous Waste Numbers: List the concentrations of VOCs listed in Table 4-2: List average isotope ratios: List the weight fraction of CRP: Acceptable Knowledge Information For the following, enter supporting documentation used (i.e., references and dates) Required Program Information C Map of site: C Facility mission description: C Description of operations that generate waste: C Waste identification/categorization schemes: C Types and quantities of waste generated: C Correlation of waste streams generated from the same building and process, as appropriate: C Waste certification procedures: Figure III.H.1. Example Transuranic Waste Stream Profile Form III-52 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements WASTE STREAM PROFILE FORM Page 2 of 3 Required Waste Stream Information C Area(s) and building(s) from which the waste stream was generated: C Waste stream volume and time period of generation: C Waste generating process description for each building: C Process flow diagrams: C Material inputs or other information identifying chemical/radionuclide content and physical waste form: C Which Defense Activity generated the waste: (check one) ~~ Weapons activities including defense inertial confinement fusion ~~ Naval Reactors development ~~ Verification and control technology ~~ Defense research and development ~~ Defense nuclear waste and material by products management ~~ Defense nuclear materials production ~~ Defense nuclear waste and materials security and safeguards and security investigations Supplemental Documentation C Process design documents: C Standard operating procedures: C Safety Analysis Reports: C Waste packaging logs: C Test plans/research project reports: C Site data bases: C Information from site personnel: C Standard industry documents: C Previous analytical data: C Material safety data sheets: C Sampling and analysis data from comparable/surrogate Waste: C Laboratory notebooks: Figure III.H.1. Example Transuranic Waste Stream Profile Form (cont.) DOE G 435.1-1 III-53 7-09-99 Chapter III - Transuranic Waste Requirements WASTE STREAM PROFILE FORM Page 3 of 3 Sampling and Analysis Information (1) For the following, when applicable, enter procedure title(s), number(s) and date(s). C Radiography: C Visual Examination: C Headspace Gas Analysis VOCs: Homogeneous Solids/Soils/Gravel Sample Analysis Metals: PCBs: VOCs: Nonhalogenated VOCs: Semi-VOCs: Other (specify): Waste Stream Profile Form certification: I hereby certify that I have reviewed the information in this Waste Stream Profile Form and it is complete and accurate to the best of my knowledge. I understand that this information will be made available to regulatory agencies and that there are significant penalties for submitting false information, including the possibility of fines and imprisonment for knowing violations. Signature of site project manager Printed name and title Date

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Note: (1) If radiography, visual examination, headspace gas analysis, and/or homogeneous solids/soils/gravel sample analysis were used to determine EPA Hazardous Waste Codes attach signed summary reports documenting this determination. Figure III.H.1. Example Transuranic Waste Stream Profile Form (cont.) III-54 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements III. I. Waste Characterization. Transuranic waste shall be characterized using direct or indirect methods, and the characterization documented in sufficient detail to ensure safe management and compliance with the waste acceptance requirements of the facility receiving the waste. Objective: The objective of this requirement is to ensure that sufficient knowledge of transuranic waste’s characteristics (e.g., chemical, physical, radiological) is available to protect workers handling the waste and to support effective decision-making for its management. This information is to be maintained from generation, through storage and treatment in sufficient detail to ensure that the requirements of subsequent treatment and storage facilities, transportation regulations, and the disposal requirements for transuranic waste will be met. Discussion: The Radioactive Waste Management Manual assigns the Field Element Manager the responsibility of ensuring development, approval, and implementation of a program that addresses the responsibilities of waste generators, including waste characterization (DOE M 435.1-1, Section I.2.F.(7)). The characterization data acquired during generation, storage, and after treatment of transuranic waste need to be reliable and in sufficient detail to ensure subsequent management can be conducted safely and to meet the waste acceptance requirements of all subsequent receiving facilities. Accurate characterization of transuranic waste is essential to: 1) waste planning by generators, as required by DOE M 435.1-1, Section III.H; 2) waste certification by generators and other senders of waste, as required by DOE M 435.1-1, Section III.J; 3) waste transfers by generators and other senders of waste, as required by DOE M 435.1 Section III.K; and; 4) waste evaluation and acceptance by receivers of waste, as required by DOE M 435.1-1, Section III.G. In conducting the analyses for development of the DOE M 435.1-1, characterization was identified as necessary to ensuring the safe management of waste from generation through disposal. Waste characterization is defined (DOE M 435.1-1, Definitions) as: “The identification of waste composition and properties, such as by review of acceptable knowledge (which includes process knowledge), or by nondestructive examination, nondestructive assay, or sampling and analysis, to comply with applicable storage, treatment, handling, transportation, and disposal requirements.” DOE G 435.1-1 III-55 7-09-99 Chapter III - Transuranic Waste Requirements Accurate waste characterization is necessary so that the waste and waste containers are compatible and worker handling of waste containers can be performed safely. All information necessary for personnel to safely handle a container of transuranic waste needs to be known at all times during the life-cycle of the waste.

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Waste characterization is a tool for gathering information that supports defensible decisions regarding safety, process, environmental and compliance matters in the management of transuranic waste. The significance of the waste management decision will guide the graded application of this requirement, as well as the more detailed characterization requirements addressed in subsequent sections of this guidance. These subsequent sections address application of a data quality objectives process to guide characterization (Section III.I.(1)) and minimum characterization requirements (Section III.I.(2)). Use of Direct and Indirect Methods. Waste managers are to characterize transuranic waste using an appropriate combination of direct and indirect methods. The appropriate method for characterizing waste depends on the parameter being measured, the hazards associated with acquiring the information, and the amount and quality of the data needed as determined through a data quality objectives or similar process. Direct methods of characterizing waste can be used to established certain physical and chemical attributes as well as radiological characteristics. The most common direct methods for characterizing the chemical and/or radiological characteristics are sampling and laboratory analyses and certain nondestructive evaluation techniques (e.g., real-time radiography). Direct characterization methods are conducted in accordance with the quality assurance program and plan governing the site and laboratory facilities. Indirect methods of characterization use non-destructive examination techniques and acceptable knowledge to replace, supplement, and/or initially provide data that might otherwise be collected by direct, intrusive characterization of the waste. In the safety and hazard analysis performed in support of development of DOE M 435.1-1, the use of indirect methods was identified as an appropriate means of characterizing waste and at the same time complying with the as low as reasonably achievable (ALARA) principle for keeping radiation exposures to a minimum. An additional benefit of characterizing transuranic waste by the use of indirect methods is the avoidance of the generation of waste associated with sample materials, and laboratory equipment and expendables. In order for indirect methods of transuranic waste characterization to serve their purpose of providing information necessary for the safe management of waste, the data need to be sufficiently accurate. The level of accuracy is determined through application of data quality objectives, or comparable process. Consistent with the data quality objectives, correlations demonstrating that data provided by indirect methods are representative of the actual waste may need to be III-56 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements supported through the application of direct methods. The methodology could employ a number of techniques, some of which involve some direct sampling and analysis of the waste stream. The following guidance paragraphs discuss different indirect methods. Similar to the EPA and NRC guidance on characterizing mixed waste, DOE endorses the use of indirect methods such as the use of “acceptable” or “waste knowledge” for characterizing physical, chemical, RCRA-regulated, and radioactive components of waste. The term “acceptable knowledge” (or “waste knowledge”) includes process knowledge; records of analyses performed prior to the effective date of a requirement; or a combination of process knowledge and previous records, supplemented with chemical analyses (NRC/EPA, 1997). Process knowledge refers to detailed information on processes that generate waste subject to this requirement or information on processes similar to those which generated the waste being characterized.

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Acceptable knowledge characterization of transuranic waste is based on an understanding of the materials and processes used to generate the waste, or analytical data obtained from the process or waste stream or both. Acceptable knowledge also includes information regarding the source of the waste stream, the physical form and materials comprising the waste, the chemical constituents of the waste, and the nature of the radioactivity present. Acceptable knowledge may be used to describe transuranic waste if the source information is consistent, defensible, and auditable. While the development of a process for identifying and documenting transuranic waste acceptable knowledge is not dictated by this requirement, the following guidance provides an overview of elements of an acceptable process for assembling acceptable knowledge documentation: C Acceptable knowledge is compiled in an auditable record. C Correlations within waste streams in terms of time of generation, waste generating processes, analytical data, and site-specific facilities are clearly described. C A reference list of applicable documents, databases, quality control protocols, and other sources of information that support the acceptable knowledge information is prepared. C Procedures which outline the methodology that is to be used to identify and assemble auditable acceptable knowledge records, including the origin of the documentation, how the assembled information was or will be used, and any limitations associated with the information. Characterization data gained through acceptable knowledge must be within the acceptable range of certainty and precision identified by the data quality objectives or similar process. Additionally, the effects of time-dependent processes must either be negligible or predictable. If acceptable DOE G 435.1-1 III-57 7-09-99 Chapter III - Transuranic Waste Requirements knowledge is supported by the collection, analysis, and comparison of statistically valid samples with the acceptable knowledge records, periodicity of sampling and analysis should correlate with the nature of any changes in the process creating the waste or with changes that are being documented in characterization data. Non-destructive examination and assay techniques use methods such as passive-active neutron assay, high resolution gamma ray spectroscopy, and thermal neutron capture to non-destructively collect data relating to the radionuclide constituents in the waste. Acceptable performance of assay techniques is determined through measurement of known standards and comparison to established quality assurance objectives of the applicable characterization program. A process, similar to the one discussed above regarding acceptable knowledge, needs to be established and documented in site procedures that outline the exact nature of the acceptable use of non- destructive examination techniques for providing characterization information on waste. Another indirect method of providing radionuclide characterization data is through the use of a known relationship, or scaling factors, between a measured radionuclide or a dose rate and the radionuclide(s) of interest. As discussed above for acceptable knowledge and non-destructive examination techniques, use of scaling factors must be correlated with actual data.

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The use of scaling factors is generally established by an initial characterization that provides a statistical basis for use of the scaling factors. As with any indirect method, the characterization program needs to include confirmatory measurements. The frequency of the confirmatory measurements is to be based on the consistency of the process generating the waste. Additionally, the history of previous confirmatory measurements may also influence the frequency of future confirmatory measurements with results that are very consistent providing justification for less frequent confirmatory measurements. Example: A waste stream from an actinide processing building is sampled and analyzed and determined to be composed of three primary nuclides: Pu-239, Am-241, and Pu- 238. The samples are found to contain the three radionuclides in essentially the same ratio. The process is known to be uniform and is therefore expected to generate similar concentrations in the waste stream as the facility is operated. Therefore, the contents of future waste containers are routinely characterized based on a gamma energy analysis which detects gamma radiation from the Am-241 and Pu-238. The characterization program requires the collection and full analysis of samples once a month to confirm that the ratio of the three radionuclides falls within an acceptable range (based on application of the data quality objectives process). Characterization Documentation. The requirement states that characterization data shall be documented in sufficient detail to enable the waste acceptance requirements of the receiving III-58 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements facility to be met. The following elements are considered essential to this process for acquiring and controlling characterization data: Organization(s) and Responsibilities - Identification of the organizations involved and responsible for characterization of transuranic waste. Quality Assurance - Characterization data need to be subjected to a quality assurance program and the program that applies needs to be identified and documented. Procedures - The process for obtaining waste characterization data is formalized in procedures which describe to the user the steps that are to be followed and the administrative process for ensuring the data are of the quality needed. Topics that need to be proceduralized include the processes for sampling, packaging, transportation, laboratory analysis, and data control. Procurement/Purchasing Controls - The procurement and/or purchasing of items or services that are significant to characterizing transuranic waste are controlled and documented. Such procurement includes the purchase of sampling equipment and sample transport containers, as well as services such as laboratory analyses (onsite or offsite). As dictated by the type of procurement, the documentation needs to include (or reference) the technical specifications for the item/service being procured, identification of quality assurance requirements including any required inspections, specifications of documentation requirements (e.g., certification of compliance or conformance, laboratory analytical results), and a statement ensuring access to the provider’s facilities as necessary to perform audits and inspections. The characterization data need to be traceable through the provider’s process of generating them and verifying their accuracy.

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Document/Data Change Control - Records that contain characterization data, whether they have been generated through sampling and analysis, nondestructive assay, or acceptable knowledge, need to be controlled. In addition, the waste characterization procedures and quality assurance program documentation are subject to document control. Document and data control need to include review, approval, and distribution to designated recipients (users), and a controlled process for making revisions to documents or data. Existing document and data control programs at a site may be adequate to provide the necessary controls for documents related to transuranic waste characterization data, but will need to be reviewed to ensure the objectives of DOE M 435.1-1 requirements are met. Training - Characterization data are generated and managed only by personnel that are properly trained to recognize the significance of the data. Generally, training of laboratory personnel will be adequate to support transuranic waste characterization, but needs to be DOE G 435.1-1 III-59 7-09-99 Chapter III - Transuranic Waste Requirements reviewed versus the goals of the characterization. Other staff managing and using characterization data need to understand what is to be done with the data (i.e., what decisions are to be made) once data are collected. Records - Waste characterization records include those that are necessary to meet the waste acceptance requirements of receiving facilities, and as specified by the waste certification program DOE M 435.1-1, Section III.J. As noted above, existing programs at a site may provide the framework within which the elements of waste characterization can be addressed (e.g., quality assurance, training, document control). The waste acceptance requirements of a facility to which the waste is sent also may impose additional requirements on what is to be included in the waste characterization data. The waste acceptance requirements for the receiving facility include specific quality assurance, administrative, or documentation requirements so that waste characterization data are acceptable to the facility. Example: A site is preparing to transfer waste to WIPP for disposal. The waste characterization program at the site normally generates data on the physical, chemical, and radiological characteristics of the waste. However, additional requirements have been established for the characterization of transuranic waste in order to transfer it to the WIPP for disposal. In addition to what is normally thought of as characterization data (chemical and radiological), the waste acceptance criteria require, among other information, the waste packages to be characterized in terms of their thermal power and decay heat. Compliance with this requirement is demonstrated by a program for documenting and the existence of records that document the process for acquiring and verifying the validity of transuranic waste characterization data acquired through the use of direct or indirect methods. Supplemental References: 1. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, DOE/WIPP-069, Revision 5, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996. 2. EPA, 1994. Guidance for the Data Quality Objectives Process, EPA QA/G-4, U.S. Environmental Protection Agency, Washington, D.C., September 1994. 3. NRC/EPA, 1997. “Joint NRC/EPA Guidance on Testing Requirements for Mixed Radioactive and Hazardous Waste,” Federal Register, Vol. 62, No. 224, U.S.

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III-60 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Environmental Protection Agency and U.S. Nuclear Regulatory Commission, November 20, 1997. III. I.(1) Data Quality Objectives. The data quality objectives process, or a comparable process, shall be used for identifying characterization parameters and acceptable uncertainty in characterization data. Objective: The objective of this requirement is to invoke a process for determining the type, quantity, and quality of characterization data needed to support the safe management of transuranic waste so as to ensure that needed data are acquired, the data meet the objectives they are being collected for, and resources are not wasted on unnecessary, incomplete or unusable data collection efforts. Discussion: The type, quantity, and quality of characterization data obtained for the safe management of transuranic waste need to be consistent with the purpose for which the characterization information will be used. The uses of transuranic waste characterization data include complying with storage, treatment, and disposal facilities’ waste acceptance requirements; determining radiation shielding and other protective measures; evaluating compliance with processing requirements; and meeting legislative or regulatory commitments. This requirement is included in DOE M 435.1 to ensure that the appropriate characterization data to support the safe management of transuranic waste are generated. The requirement is intended to promote a structured process for the collection and use of transuranic waste characterization data and to avoid the collection of data that is neither necessary nor defensible. Input from various waste management organizations and interested groups is necessary to establish a clear understanding of the characterization data needs and the level of data quality that is acceptable for making transuranic waste management decisions. The current requirement invokes the use of a structured process for determining the type, quantity, and quality of characterization data needed. Such a process, called a data quality objectives process, has been developed by the Environmental Protection Agency and is documented in Guidance for the Data Quality Objectives Process. Application of the EPA process and use of the guidance for the use of the data quality objectives process is an acceptable method of meeting this requirement. However, use of other comparable processes that employ a structured approach to yield similar results is also acceptable. DOE G 435.1-1 III-61 7-09-99 Chapter III - Transuranic Waste Requirements The objectives of applying a structured process such as the data quality objectives process are to: C manage and control the risks of making incorrect decisions; C determine the data required to support making specific decisions; C determine the type and quality of required data; C allow stakeholders, decision makers, data users, and relevant technical experts to participate in planning and assessment; C determine the quantity, location, and type of samples required; C quantify the uncertainty in data through development of statistical sampling plans; and C reduce overall costs by identifying resource-efficient sample collection and analytical methods by optimizing the sample and analysis plans.

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The data quality objective process is a strategic planning approach based on the scientific method that is used to prepare for a data collection activity. The value of using this process to develop transuranic waste characterization parameters is that it reduces radiation exposure and saves resources by making characterization data collection operations more resource-effective; enables characterization data users and others to participate in characterization data planning; and provides a structured method for defining characterization data performance requirements, i.e., quality. To foster the development and implementation of an effective data quality objectives or similar process, individuals are assigned responsibility for specific activities for each application of the process. Key activities of the process include: • preparing the data quality objectives documentation; • identifying stakeholders; • identifying technical experts; • ensuring opportunities for input and coordinating stakeholder and technical experts into the data quality objective process; • reviewing and commenting on the developed data quality objectives; and III-62 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements • approving the data quality objectives documents. A more detailed description of the assignment of specific responsibilities for implementing a data quality objectives or similar process is presented in the Hanford “Data Quality Objectives Procedure” (see reference 2). The data quality objectives process consists of seven steps. The output from each step influences the choices that will be made later in the process. Even though the data quality objectives process is depicted as a linear sequence of steps, in practice it is iterative; the outputs from one step may lead to a reconsideration of prior steps. This iteration is encouraged since it will ultimately lead to a more efficient data collection design. During the first six steps of the process, a team of process-cognizant personnel develop decision performance criteria (i.e., data quality objectives) that will be used to develop the data collection design. The final step of the process involves developing the data collection design based on the data quality objectives developed in the first six steps. The first six steps need to be completed before the team attempts to develop the data collection design because the design is dependent on a clear understanding of the first six steps taken as a whole. Following is a listing and brief description of each of the seven steps. This is followed by an example of how the data quality objectives process can be applied to transuranic waste characterization. 1. State the Problem – Concisely describe the problem to be studied. Review prior studies and existing information to gain a sufficient understanding to define the problem. 2. Identify the Decision – Identify what questions the study will attempt to resolve, and what actions may result. 3. Identify the Inputs to the Decision – Identify the information that needs to be obtained and the measurements that need to be taken to resolve the decision statement. 4. Define the Study Boundaries – Specify the time periods and spatial area to which decisions will apply. Determine when and where data should be collected. 5. Develop a Decision Rule – Define the statistical parameter of interest, specify the action level, and integrate the previous data quality objective outputs into a single statement that describes the logical basis for choosing among alternative actions.

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DOE G 435.1-1 III-63 7-09-99 Chapter III - Transuranic Waste Requirements 6. Specify Tolerable Limits on Decision Errors – Define the decision maker’s tolerable decision error rates based on a consideration of the consequences of making an incorrect decision. 7. Optimize the Design – Evaluate information from the previous steps and generate alternative data collection designs. Choose the most resource-effective design that meets all data quality objectives. Example: In order to comply with current legislation, the Waste Isolation Pilot Plant has established a waste acceptance criterion that transuranic waste must exceed 100 nCi (3700 Bq) of alpha-emitting transuranic nuclides per gram of waste. At the CST Site waste management personnel worked with the WIPP staff, site laboratory personnel, and members of the local citizens advisory board to address the transuranic waste determination issue. The question is formulated as, what are the analytical criteria waste must meet in order to be categorized as transuranic waste? The answer to this question makes a significant difference in cost and in the amount of waste that will be shipped to WIPP, and conversely, the amount of waste that will be designated as low-level waste and disposed of near surface. From the perspective of worker protection, it was recognized that a non-intrusive analysis technique was preferred. The CST Site personnel anticipated that most of the waste would be around 200 nCi/g (7400 Bq/g) so they opted for a two-tiered characterization approach which employs a fast, inexpensive protocol to make an initial screening of waste and a slower, more expensive protocol to characterize waste that fails the initial screening. The data quality objective is: Waste containers will be categorized as transuranic waste if the results of the non-destructive analysis exceed the minimum detectable concentration for a particular assay system and protocol, and the results exceed 100 nCi/g. Waste containers will be initially analyzed using a system and protocol that has a minimum detectable concentration of 150 nCi/g. If the result does not exceed 150 nCi/g, the waste container will be analyzed using a system and protocol with a minimum detectable concentration of no more than 50 nCi/g. Applying this data quality objective, a waste container is assayed as having 175 nCi/g using the first system (150 nCi/g minimum detectable concentration) and categorized as transuranic waste. Another waste container assayed as having 125 nCi/g using the first system. Even though the assay exceeds 100 nCi/g, the categorization would be indeterminate because the assayed value is less than the minimum detectable concentration. An assay of the container using the second system (50 nCi/g minimum detectable concentration) yields a result of 110 nCi/g. Based on the second measurement the waste is categorized as transuranic. III-64 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements The above description of the use of the data quality objectives process, and the example, are provided as an introduction to the process. A more detailed description of the process can be found in the referenced EPA guide. The data quality objectives process is most useful during the planning stages of identifying transuranic waste characterization and uncertainty parameters, i.e., before the data are needed and collected. The value of the process is diminished significantly if the characterization data have already been collected because there is a tendency to make the questions that need to be answered fit the available data. The application of the data quality objectives process is applied in a graded manner, i.e., the depth of detail and the magnitude of the resources expended in implementing the process should be commensurate with the relative importance of the characterization data in terms of the decisions to be made and protection of the public, workers and the environment.

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The intent of this requirement is not that waste streams with characterization processes already in place and accepted by storage, treatment, and disposal facilities be recharacterized using the Data Quality Objectives Process, or a comparable process, or that the characterization processes be revised using the Data Quality Objectives Process, or a comparable process. The intent is that, as new waste streams are identified and generated, the Data Quality Objectives Process, or a comparable process, be used for identifying characterization parameters and acceptable uncertainty in characterization data. If the characterization parameters of an existing waste stream characterization process are to be significantly modified, then the Data Quality Objectives Process, or a comparable process, should be used. Compliance with this requirement is demonstrated by the documented use of a data quality objectives or a comparable process for determining the type, quantity, and quality of characterization data needed to safely manage transuranic waste. Supplemental References: 1. EPA, 1994. Guidance for the Data Quality Objectives Process, EPA QA/G-4, U.S. Environmental Protection Agency, Washington, D.C., September 1994. 2. WHC, 1996. Data Quality Objectives Procedure, WHC-IP-1216, Revision 1, Westinghouse Hanford Company, January 31, 1996, (included as Appendix A in draft Manual HNF-SD-WM-PROC-021, Revision 0, Lockheed Martin Hanford Corporation, January 2, 1997). III. I.(2) Minimum Waste Characterization. Characterization data shall, at a minimum, include the following information relevant to the management of the waste: DOE G 435.1-1 III-65 7-09-99 Chapter III - Transuranic Waste Requirements (a) Physical and chemical characteristics; (b) Volume, including the waste and any stabilization or absorbent media; (c) Weight of the container and contents; (d) Identities, activities, and concentrations of major radionuclides; (e) Characterization date; (f) Generating source; (g) Packaging date; and (h) Any other information which may be needed to prepare and maintain the disposal facility performance assessment or demonstrate compliance with applicable performance objectives. Objective: The objective of this requirement is to establish minimum transuranic waste data that have been determined to be necessary for safe and effective management during the life cycle of the waste. Discussion: In the process of developing DOE O 435.1 and DOE M 435.1-1, the safety and hazard analysis indicated that certain characterization data were critical because several consequences could be avoided or minimized if certain basic information was accurately known about transuranic waste. This requirement identifies those critical characterization data points that must be known for safe handling and proper management. The sections below provide guidance on each of these specific characteristics. Physical and Chemical Characteristics. Physical characteristics support handling and packaging activities. Parameters include a description of the material, its density, consistency, and appearance. Chemical characteristics impact handling, storage, containment, and can impact treatment processes. These characteristics determine the compatibility of the waste with other waste and the waste container, as well as its compatibility with proposed treatment processes. Parameters include pH, reactivity, chemical compounds present, and the presence of hazardous

Section 49

III-66 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements and/or toxic constituents. Physical and chemical characteristics can be determined directly by visual examination and/or sampling and analysis. Physical characteristics can be determined directly, indirectly by use of acceptable knowledge and/or by non-destructive examination techniques such as computer tomography or real-time radiography. Chemical characteristics can also be determined by use of acceptable knowledge. Volume and Weight. Volume and weight information is necessary for proper control of storage and disposal facility capacities as well as proper payload control for transportation and handling systems. Typical parameters include: C container volume, measured as the external volume of the waste container which represents the volume that will be occupied in a storage or disposal facility (e.g., 55 gallon drum or 120 cu ft (for a 4 x 5 x 6 box)); C actual waste volume, including stabilization media; C container weight; i.e., the total weight of the container and all of its contents (waste, shielding, stabilization media) that would have to be handled; C identification of the stabilization medium, if used; and C waste container utilization factor, measured as the percentage of the packaging volume that is filled with waste, including stabilization media. This parameter does not require an individual calculation be made of stabilization or absorbent media volume, but that those media be included in the total waste volume calculation. These characteristics are generally determined by acceptable knowledge (e.g., container size, stabilization medium) or by measurement (e.g., weight). Radionuclide Data. Radionuclide information allows for proper control of thermal loads for storage and disposal facilities, determination of personnel safety procedures, control of total activity limits for transportation, storage, and disposal, and also determination of the waste type. Parameters which constitute radionuclide information may include the following: C total activity in the container, in curies; C identity and activity per unit mass of the major radionuclides. For purposes of this guidance, major radionuclides are those which affect the determination that a waste is transuranic waste and any others determined to be of importance to the receiving facility (e.g., by safety analysis, performance assessment, etc.); DOE G 435.1-1 III-67 7-09-99 Chapter III - Transuranic Waste Requirements C radiation dose levels at the surface of the container; and C container external surface contamination levels. These characteristics can be determined directly by smear survey or radiochemical analysis of the waste, or indirectly by waste package non-destructive assay, radiation survey, and/or by documentation of nuclear materials accountability information or individual assays performed on components contained in the container. Date and Generating Source. Date and generating source information helps to determine the validity of currently held documentation on the waste, which, in turn, will determine the need for additional sampling or analysis. Parameters include characterization date, packaging date, DOE site, building location of the process which generated the waste, and the generating process, if available.

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Performance Assessment and Compliance Data. Additional data about waste that are important to performance or evaluating performance of the disposal facility, or to complying with laws, applicable regulations, or authorizing conditions (e.g., of a permit) may also need to be collected. The specific data needed will, by necessity, be identified by the disposal facility operator. Parameters which need to be included with waste characterization data may be identified by the analysts developing the disposal facility performance assessment, specified through conditions imposed on the site through the review and approval of the performance assessment, or derived from internal regulatory compliance evaluations. Examples of the types of data that may be needed are the presence and amounts of chelating agents which can enhance the transport of radionuclides from the disposal facility, or the presence and concentrations of specific chemicals which are not acceptable above specific limits (e.g., reporting polychlorinated biphenyls concentrations versus a limit of 50 ppm). All of these data may not be required for a particular phase in the management of the waste’s life cycle. The specific data needed will be determined by the waste acceptance criteria of a particular receiving facility. Example: Experimental work in a laboratory generates a liquid transuranic waste stream that is transferred via a pipeline to a central storage tank. Although the minimum characterization requirements include “weight of the container and contents,” this is not relevant to this waste stream and the characterization data in the waste acceptance requirements for the central storage tank do not include packaging weight. Compliance with this requirement is demonstrated by the existence of a program or procedures for determining and records that document characterization of transuranic waste consistent with the minimum characterization data requirements. III-68 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements Supplemental References: None. DOE G 435.1-1 III-69 7-09-99 Chapter III - Transuranic Waste Requirements III. J. Waste Certification. A waste certification program shall be developed, documented, and implemented to ensure that the waste acceptance requirements of facilities receiving transuranic waste for storage, treatment, or disposal are met. Objective: The objective of this requirement is to ensure that waste transferred to a facility for storage, treatment, or disposal meets the receiving facility’s waste acceptance requirements, to reduce the likelihood that transferred wastes contain unacceptable materials or characteristics, and to avoid hazards that would occur from the transportation and handling of waste packages which do not meet acceptance requirements. Certification also ensures that the storage, treatment, or disposal facilities receiving the waste operate within limits established through safety analyses and/or performance assessments. Discussion:

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The Radioactive Waste Management Manual, General Requirements, assigns the Field Element Manager the responsibility of ensuring development and approval of a program that addresses the responsibilities of waste generators (DOE M 435.1-1, Section I.2.F.(7)). The generator requirements are to address hazards associated with a waste management facility receiving unexpected volumes or types of waste, or receiving waste that may not meet the waste acceptance requirements of the facility to which it is transferred. The generator requirements address generation planning, waste characterization, waste certification, and waste transfer. As discussed in this guidance, a certification program is to be established by generators of radioactive waste to provide a mechanism for confirming that waste is in compliance with the waste acceptance criteria of the facility to which the waste is being transferred. The certification program is required by any organization or facility that transfers waste to another facility. Example: The Transuranic Waste Storage Facility has transuranic waste that it has received for storage over the last 10 years. Facility personnel plan to continue to receive transuranic waste and store it until it can be transferred to WIPP. The organization responsible for the storage facility must have a certification program through which facility personnel confirm the waste meets the acceptance criteria for WIPP . Since the storage facility does not change the characteristics of the waste package, the facility waste acceptance requirement should ensure that the waste they receive is acceptable for WIPP disposal. In this particular example, the certification program would have to be in accordance with the Generator Site Certification Guide (CAO, 1997). III-70 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements The certification program is part of the waste generator program that is approved by the Field Element Manager or designee. The certification program requires that an authorized official confirms compliance with the waste acceptance requirements of the facility to which waste is being transferred. Additional guidance correlated to the specific waste certification requirements of the Transuranic Waste Requirements Chapter is provided below. Program Development and Documentation. The waste certification program should consist of a documented, structured process that works in concert with the DOE M 435.1 requirements for waste acceptance (Section III.G) and waste transfer (Section III.K) to control the transfer of waste to a storage, treatment, or disposal facility. Development of the waste certification program involves defining and documenting controls for those items and activities that affect certifying that a waste and its packaging meets the waste acceptance criteria of the receiving facility. The documentation should include the following: Organizations and Responsibilities - Certification program documentation needs to identify the organizations and officials involved in the certification process and the responsibilities of each. Officials who are authorized to certify waste are identified in the documentation. Quality Assurance - The certification program is subject to quality assurance. The quality assurance controls that apply to waste certification activities needs to be identified and documented. The use of an existing quality assurance program under which the certification activities will be performed is acceptable and appropriate.

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Procedures - The process for certifying waste is formalized in procedures. The procedures need to describe to the user the steps that are to be followed and the administrative process for ensuring waste containers are certified. The procedures require a signed statement certifying waste meets the appropriate criteria. The procedures also document the steps necessary for complying with the applicable transportation requirements (e.g., requirements from a safety analysis report for packaging and/or from Title 49, Code of Federal Regulations). Procurement/Purchasing Controls - The procurement and/or purchase of items or services that are significant to certifying that waste meets the waste acceptance criteria of a receiving facility need to be documented. Such procurement may include the purchase of materials such as waste containers or laboratory services (onsite or offsite). As dictated by the type of procurement, the documentation should include (or reference) the technical specifications for the item/service being procured; identification of quality assurance requirements including any required testing or inspections; specification of documentation to be provided on delivery (e.g., fabrication inspection and/or test records; a certificate of compliance or conformance, laboratory analytical results); and a statement ensuring access DOE G 435.1-1 III-71 7-09-99 Chapter III - Transuranic Waste Requirements to the provider’s facilities as necessary to perform audits and inspections. The certification program ensures that the procurement documentation is reviewed and approved by an official with knowledge of the need, intent, and requirements for the procurement. The program also provides for documented verification commensurate with the relative importance and complexity of the items or services being procured. Document Control - The principal documents that constitute the certification program needs to be subject to document control. Program documentation will identify which documents are to be controlled. The waste certification program description, waste certification procedures, and quality assurance program documentation need to all be subject to document control. Document control includes review and approval, distribution to designated recipients (users), and a controlled process for making changes to the documents. Existing document control programs at a site may provide the necessary controls for documents that are part of the waste certification program. Training - The certification program needs to identify the training requirements for the various individuals who are involved in the program. At a minimum, the program will require training of the official who certifies that the waste meets the waste acceptance criteria of the facility(ies) to which it is being transferred. In addition, individuals will need to be trained in the procedures that control the part of the certification process with which they are involved. Records - The certification program documentation needs to describe the management of certification records (see guidance for subparagraph (1) of this Waste Certification requirement).

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Example: A site generates a small amount of transuranic waste that is sent to a central facility managed by a waste management organization. The generating organization works with the receiving facility to define the waste certification program for the site. Through a review of the existing site procedures, site personnel determine that the waste certification program can operate under the existing site quality assurance program, document control program, procurement process, and records management program. However, they determine that the site training program does not adequately address the certification process. Consequently, the waste managers work with the training department to develop a training module that explains the purpose and process of waste certification. The certification program documentation would identify these other programs as applicable, specify the facilities from which waste would be transferred, designate the officials responsible for waste certification at those facilities and their training requirements, and develop procedures (within the document control program) that ensure compliance with the waste acceptance criteria. Within the III-72 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements existing programs, site personnel would identify the records to be maintained and retention times, technical specifications and receipt requirements for obtaining waste packaging materials, and requirements for analytical data. Operating within the parameters defined by the program, the waste generators would be able to certify waste for transfer to the onsite receiving facility. As noted in the preceding example, existing programs at a site may provide the framework within which elements of the waste certification program can be addressed (e.g., quality assurance, training, document control). The waste acceptance requirements of the facility to which the waste is to be sent may impose additional requirements on what is to be included in the waste certification program. Whether the waste acceptance requirements of the facility to which waste is transferred mandate a waste certification program (e.g., a commercial facility), the organization transferring the waste is responsible for developing and implementing a certification program to provide internal assurance that the waste acceptance requirements will be met. Implementation. The waste certification program is implemented through the use of the documented controls, processes, and procedures. The key document in a waste certification program is the certification statement or equivalent. The certification statement is the documentation signed by a designated official that certifies that the waste meets the appropriate requirements. The list below, derived from the Waste Acceptance Criteria for the Waste Isolation Pilot Plant, is a generic listing of the topics that are recommended for consideration in development of certification statements. 1. Container and Physical Properties - container type or description - labeling/markings - weight - vents - liquids 2. Nuclear/Radiological Properties - fissile content - transuranic activity - other radioactivity - dose rate - surface contamination - thermal power DOE G 435.1-1 III-73 7-09-99 Chapter III - Transuranic Waste Requirements 3. Chemical Properties - mixed waste - polychlorinated biphenyls - other hazardous constituents - pyrophorics - explosives - corrosives - compressed gases - volatile organic compounds

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4. Packaging/Shipping Data - packaging - shipping information Graded Approach. A graded approach is used in implementing the waste certification program. The above list is recommended for the intersite transfer of transuranic waste. Intersite transfers involve certifying that the waste is in compliance with the requirements for the receiving facility itself, and also in compliance with Department of Transportation requirements. However, even though the above list should be considered, it may be shortened and simplified for onsite transfers where the organizational relationships and knowledge of waste and waste generating activities may reduce the information that needs to be documented and transferred with each individual waste container or shipment. For onsite transfers, much of the information may already be available to the receiving facility. Onsite transportation of waste should be certified as meeting Department of Transportation requirements or site-specific requirements for transportation. Example: For onsite transfers the receiving facility/organization may already have a waste stream profile provided by the generator facility/organization. Because of the existence of the waste stream profile, the certification may be as simple as an individual trained to the waste packaging and certification procedures signing a waste pick-up request that provides the radionuclide inventory of the waste packages being transferred and the waste stream identification number. The waste acceptance requirements of the facility receiving the waste (see DOE M 435.1-1, Section III.G) may dictate additional items which must be part of the certification statement. Even if such information is not dictated by the receiving facility, the waste acceptance criteria should be used to identify key elements to include on the waste certification statement. Compliance with the development and documentation portion of the certification requirement is demonstrated by a waste certification plan that identifies the organizations involved, assigns III-74 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements responsibilities for implementing the program, and describes or references the quality assurance, training, procurement controls, records management, and procedures to be used by the program. Acceptable performance for implementing the program is demonstrated when the appropriate personnel are trained, and have and follow the procedures that govern their part of the waste certification process. Acceptable performance also requires that the waste certification plan and procedures are current and controlled in accordance with a document control program, and records related to certification (e.g., certification statements, training records, procurement records, characterization records, container records) are generated and managed in accordance with the established site program. Supplemental References: 1. CAO, 1997. Generator Site Certification Guide, Revision 1, DOE/CAO-95-2119, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1997. 2. DOT. Shippers-General Requirements for Shipments and Packagings, 49 CFR Part 173, U.S. Department of Transportation, Washington, D.C. 3. CAO, 1996. Waste Acceptance Criteria for the Waste Isolation Pilot Plant, Revision 5, DOE/WIPP-069, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, April 1996.

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III. J.(1) Certification Program. The waste certification program shall designate the officials who have the authority to certify and release waste for shipment; and specify what documentation is required for waste generation, characterization, shipment, and certification. The program shall provide requirements for auditability, retrievability, and storage of required documentation and specify the records retention period. Objective: The objective of this requirement is to ensure waste certification programs are developed that clearly identify the documentation required for certifying waste, specify personnel with the authority to make the certification, and provide a traceable and verifiable record of and basis for certification. DOE G 435.1-1 III-75 7-09-99 Chapter III - Transuranic Waste Requirements Discussion: Officials who have the authority to certify that waste meets the waste acceptance requirements of the receiving facility must be designated by a cognizant manager. To avoid having personnel who are not knowledgeable of waste acceptance and transfer requirements authorizing the release of waste, the program needs to identify, by title or name, the officials who are authorized to certify. The official(s) are qualified by virtue of position, responsibilities, and training to make this certification. The official(s) have sufficient familiarity with the waste being generated and have been trained relative to the acceptance criteria of the facility receiving the waste for storage, treatment or disposal (and applicable transportation requirements) to be able to certify in writing that the waste is acceptable for transfer. The official(s) need to also have authorization from the facility receiving the waste to transfer the waste (see DOE M 435.1-1, Section III.K). Implementation of this element should be tailored to specific site needs and situations. Example: Onsite transfers from multiple laboratories or processes to a central waste management facility may involve training multiple personnel (e.g., one for each laboratory or process) who have the authority to certify waste as meeting the onsite waste acceptance requirements. However, for the transfer of waste from the central waste management facility to an offsite facility, there may be a designated official at the site who has been trained relative to the acceptance criteria of the offsite storage, treatment, or disposal facility waste acceptance criteria and transportation requirements that is authorized to certify the waste as ready for shipment. The waste certification program needs to specifically identify the documentation to be produced to support the certification that waste meets the waste acceptance criteria of the receiving facility. The required documentation may include the following: Waste Stream Profile (or record relating the waste to a previous profile). The waste stream profile is a description of the waste stream, generally identifying the source, physical and chemical description, and upper limits on radionuclides. Radionuclide Characterization Data. Radionuclide characterization data include the concentration and/or inventory of radionuclides as determined by characterization (see guidance for DOE M 435.1-1, Section III.I, Waste Characterization). EPA Uniform Hazardous Waste Manifest. The EPA manifest is required by 40 CFR Part 262 for the transfer of a hazardous or mixed waste.

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Waste Container Data and Integrity Maintenance Documentation. Container data include information about the container dimensions, other physical attributes, and III-76 DOE G 435.1-1 7-09-99 Chapter III - Transuranic Waste Requirements procurement information. Integrity documentation includes the records of ownership and transfer of waste containers and data. (See guidance for Waste Transfer, DOE M 435.1-1, Section III.K). Radiological Survey Results (or documentation referencing a survey record). Survey results include the determination of the surface contamination of the waste container and the external dose rate. Bill of Lading. A document indicating the contents of a shipment. Real-Time Radiography Results. The results of radiography performed to detect unallowed material in the waste package (e.g., liquids, compressed gas cylinders). Certification Statement. The statement required by DOE M 435.1-1 to document that waste is in compliance with the acceptance criteria of the facility to which the waste is being transferred. Authorization to Transfer. Documentation indicating that an official from the facility to which the waste is to be transferred has authorized transfer of the waste to the facility. As noted for other elements of this requirement, the organization developing the certification program uses a graded approach in determining which of these documents are needed. Regardless of the extent of the required documentation, the certification statement can serve as a checklist that all of the waste acceptance criteria have been considered and the waste is in compliance. An example of a certification statement for waste to be shipped to WIPP is provided at the end of this section of guidance (Figure III.J.1). In order to ensure that information is available if or when it is needed in the future, the waste certification program should identify which records are to be maintained and how they are to be maintained. The certification program documentation may include specific records management requirements, or may simply invoke an existing acceptable records management program. Although no minimum record retention times are established in DOE M 435.1-1, certain records may need to be maintained indefinitely. Whereas hazardous waste regulations require only a three-year retention period, DOE disposal facilities should plan on maintaining pertinent records at least through the operations, closure, and post-closure monitoring periods, and consider making them part of any local land use records. The pertinent records would be those which identify physical, chemical, and radiological characteristics of the waste and the certification of that information. Generating, storage, or treatment facility waste management records may not be required beyond the life of the facility or operation, provided pertinent information has been supplied to the facility where the waste will be disposed. DOE G 435.1-1 III-77 7-09-99 Chapter III - Transuranic Waste Requirements Example: Personnel at a storage facility maintain records describing when they received waste, what the waste was (characterization and container data provided by the generator), and to whom the waste was eventually transferred. Once the waste is disposed of and the waste characterization and container information is in the possession of the organization responsible for the disposal facility, the organization responsible for the storage facility disposes of its records. To meet the requirement for auditability and retrievability, the method of records storage and retention needs to allow a person to trace shipmen

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