ML23349A050

February 2024 ACRS Meeting - Predecisional - Documents to Support SECY-24-XXXX - Draft Rule Text Redline Strikeout

ML23349A050
Person / Time
Issue date:	12/20/2023
From:	Advisory Committee on Reactor Safeguards
To:
References
NRC-2011-0012, RIN 3150-AI92, NRC-2017-0081, NRC-2015-0003
Download: ML23349A050 (1)

Text

1 This predecisional draft document is being publicly released to support interactions with the Advisory Committee on Reactor Safeguards (ACRS). This document has not been subject to complete NRC staff review, and its contents should not be interpreted as official agency positions. The NRC staff anticipates further changes to the document.

Please note that purple text indicates proposed additions to existing rule language and red strikeout text indicates proposed deletions from existing rule language.

§ 20.1003 Definitions.

Waste means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraphs (2), (3), and (4) of the definition of Byproduct material set forth in this section. Consistent with the National Defense Authorization Act for Fiscal Year 2013, low-level radioactive waste also includes radioactive material that, notwithstanding Section 2 of the Nuclear Waste Policy Act of 1982, results from the production of medical isotopes that have been permanently removed from a reactor or subcritical assembly, for which there is no further use, and the disposal of which can meet the requirements of this part.

Appendix G to Part 20 Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests C. Disposal Container and Waste Information The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:

I.C.12. For wastes consigned to a disposal facility, the classification of the waste pursuant to § 61.55 of this chapter. Waste not meeting the structural stability requirements of § 61.56(b) of this chapter must be identified.

2 D. Uncontainerized Waste Information The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container:

I.D.4. For waste consigned to a disposal facility, the classification of the waste pursuant to

§ 61.55 of this chapter. Unless the disposal facility has established waste acceptance criteria under § 61.58 of this chapter, wWaste not meeting the structural stability requirements of

§ 61.56(b) of this chapter must be identified; E. Multi-Generator Disposal Container Information This section applies to disposal containers enclosing mixtures of waste originating from different generators. (Note: The origin of the LLW resulting from a processor's activities may be attributable to one or more generators (including waste generators) as defined in this part). It also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators.

2. For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, provide the following:

I.E.2.(d) The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in 10 CFR 61.56(b); 10 CFR 61.56(b), or the disposal facilitys waste acceptance criteria established under 10 CFR 61.58; and II. Certification An authorized representative of the waste generator, processor, or collector shall must certify by signing and dating the shipment manifest that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the Department of Transportation and the

3 Commission, and equivalent state regulations. For materials that are consigned to a land disposal facility or waste collector, the authorized representative must certify that the materials are classified per the applicable requirements of part 61 of this chapter, meet the land disposal facility's waste acceptance criteria, and are in proper condition for disposal as described in accordance with the applicable requirements in this part and in part 61 of this chapter, or equivalent state regulations. If the land disposal facility to which the material is consigned has established waste acceptance criteria under § 61.58, the authorized representative must certify that the material meets the waste acceptance criteria in accordance with the land disposal facilitys authorized waste certification program. A collector in signing the certification is certifying that nothing has been done to the collected waste which would invalidate the waste generator's certification.

III.A.1. Prepare all wastes so that the waste is classified according to § 61.55 and meets the waste characteristics requirements in § 61.56 of this chapter, or, if the land disposal facility to which the material is consigned has established waste acceptance criteria under § 61.58, prepare the waste so that it meets the land disposal facilitys waste acceptance criteria;

2. Label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste, to identify whether it is Class A waste, Class B waste, Class C waste, or greater then Class C waste, in accordance with § 61.55 of this chapter; in accordance with § 61.57 of this chapter;

3. Conduct a quality assurance program, to assure compliance with §§ 61.55 and 61.56 of this chapter (which the program must include management evaluation of audits,); to ensure compliance with both §§ 61.55 and 61.56 of this chapter or, if the land disposal facility to which the material is consigned has established waste acceptance criteria under § 61.58, to ensure the waste meets the land disposal facilitys waste acceptance criteria;

4 C.3. Prepare all wastes so that the waste is classified according to § 61.55 of this chapter and meets the waste characteristics requirements in § 61.56 of this chapter, or if the land disposal facility to which the material is consigned has established waste acceptance criteria under § 61.58, prepare the waste so that it meets the land disposal facilitys waste acceptance criteria;

4. Label each package of waste, to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with §§ 61.55 and 61.57 of this chapter;

5. Conduct a quality assurance program to assure compliance with §§ 61.55 and 61.56 of this chapter (the programwhich shall must include management evaluation of audits); to ensure compliance with both §§ 61.55 and 61.56 of this chapter, or, if the land disposal facility to which the material is consigned has established waste acceptance criteria under § 61.58, to ensure the waste meets the land disposal facilitys waste acceptance criteria;

§ 61.1 Purpose and scope.

(a) The regulations in this part establish, for land disposal of radioactive waste, the procedures, criteria, and terms and conditions upon which the Commission issues licenses for the disposal of radioactive wastes containing byproduct, source and special nuclear material received from other persons. Disposal of waste by an individual licensee is set forth in part 20 of this chapter. Applicability of the requirements in this part to Commission licenses for waste disposal facilities in effect on the effective date of this rule will be determined on a case-by-case basis and implemented through terms and conditions of the license or by orders issued by the Commission.

5 (b)(1) Licensees need not comply with the requirements in §§ 61.13(a) through 61.13(e),

61.41(a) and (b), 61.42(a) and (b), and 61.58, if the following criteria are met:

(i) The land disposal facility license was originally issued before [30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; and (ii) The licensee does not accept Greater-Than-Class C waste or a significant quantity of long-lived radionuclides. For the purposes of this paragraph, less than 10 metric tons of depleted uranium is not considered a significant quantity of long-lived radionuclides.

(2) Licensees who meet the criteria of § 61.1(b)(1)(i) and (ii) and who choose not to comply with the requirements in §§ 61.13(a) through (e), 61.41(a) and (b), 61.42(a) and (b), and 61.58 must comply with §§ 61.13(f), 61.41(c), and 61.42(c).

(cb) Except as provided in part 150 of this chapter, which addresses assumption of certain regulatory authority by Agreement States, and § 61.6, Exemptions, the regulations in this part apply to all persons in the United States. The regulations in this part do not apply to -

(1) Disposal of high-level waste as provided for in part 60 or 63 of this chapter; (2) Disposal of uranium or thorium tailings or wastes (byproduct material as defined in § 40.4 (a-

1) as provided for in part 40 of this chapter in quantities greater than 10,000 kilograms and containing more than 5 millicuries of radium-226; or (3) Disposal of licensed material as provided for in part 20 of this chapter.

(dc) This part also gives notice to all persons who knowingly provide to any licensee, applicant, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's or applicant's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of § 61.9b.

6 Subpart A - General Provisions

§ 61.2 Definitions.

As used in this part:

Active maintenance means any significant remedial activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives in §§ 61.41 and 61.42 of this part are met. Such active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

Buffer zone is a portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site. The buffer zone provides controlled space to establish monitoring locations that are intended to provide an early warning of radionuclide movement, which allows a licensee to perform mitigative or corrective action that might be necessary.

Chelating agent means amine polycarboxylic acids (e.g., ethylenediaminetetraaceticEDTA, diethylenetriaminepentaaceticDTPA), hydroxy-carboxylic acids, and polycarboxylic acids (e.g.,

citric acid, carbolic acid, and glucinicgluconic acid).

Commencement of construction means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a land disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to

7 determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of environmental values.

Commission means the Nuclear Regulatory Commission or its duly authorized representatives.

Compliance period means the time from the completion of site closure to 1,000 years after site closure for disposal sites that do not contain significant quantities of long-lived radionuclides.

For disposal sites that contain significant quantities of long-lived radionuclides, the compliance period ends 10,000 years after closure of the disposal site.

Custodial Agency means an agency of the government designated to act on behalf of the government owner of the disposal site.

Defense-in-depth means the use of multiple independent and, where possible, redundant layers of defense against release of radioactive material such that no single layer, no matter how robust, is exclusively relied upon.

Director means the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission.

Disposal means the isolation removal of radioactive wastes from the biosphere inhabited by man a person and containing his the persons food chains by emplacement in a land disposal facility.

Disposal site means that portion of a land disposal facility which is used for disposal of waste. It consists of disposal units and a buffer zone.

8 Disposal unit means a discrete portion of the disposal site into which waste is placed for disposal (e.g., a trench). For near-surface disposal the unit is usually a trench.

Engineered barrier means a man-made structure or device that is intended to improve the land disposal sitefacility's ability to meet the performance objectives in subpart C of this part.

Explosive material means any chemical compound, mixture, or device, which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

Government agency means any executive department, commission, independent establishment, or corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States; or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the government.

Hazardous waste means those wastes designated as hazardous by Environmental Protection Agency regulations in 40 CFR part 261.

Hydrogeologic unit means any soil or rock unit or zone which by virtue of its porosity or permeability, or lack thereof, has a distinct influence on the storage or movement of groundwater.

Inadvertent intruder means a person who might occupy the disposal site after closure and engage in normal agricultural and residential activities, such as agriculture, dwelling construction, drilling for water and or other reasonably foreseeable pursuits that in which the person might be unknowingly exposed the person to radiation emitted or released from the waste in the disposal units.

Inadvertent intruder assessment is an analysis that:

9 (1) Assumes an inadvertent intruder occupies the disposal site and engages in activities and other reasonably foreseeable pursuits consistent with expected activities in and around the disposal site at the time of the assessment and that might unknowingly expose the person to radiation emitted or released from the waste in the disposal units; (2) Examines the capabilities of intruder barriers to inhibit an inadvertent intruders contact with the waste in the disposal unit or to limit the inadvertent intruders exposure to radiation from the disposal unit; and (3) Estimates an inadvertent intruders potential annual dose resulting from radiation emitted or released from the waste in the disposal unit, including an evaluation of the uncertainties.

Indian Tribe means an Indian Tribe as defined in the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5301).

Intruder barrier means a sufficient depth of coveran engineered structure over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in this part, or engineered structures that provide equivalent protection to the inadvertent intruder.

Land disposal facility means the land, building, and structures, disposal sites, and equipment which are intended to be used for, or to support, the disposal of radioactive wastes. For purposes of this chapter, a geologic repository as defined in part 60 or 63 is not considered a land disposal facility.

License means a license issued under the regulations in part 61 of this chapter. Licensee means the holder of such a license.

Long-lived radionuclide means radionuclides where:

10 (1) More than 10 percent of the initial activity of the radionuclide remains after 1,000 years; (2) The peak activity from progeny occurs after 1,000 years; or (3) More than 10 percent of the peak activity of the radionuclide (including progeny) within 1,000 years remains after 1,000 years.

Model support is data and information that technically support the development of the numerical models or assessments and provide confidence in their results. Model support that involves multiple sources and types of information is generally more robust and can include laboratory or field tests, comparison to analogous systems, natural analogs, formal independent peer review, and comparison to monitoring data.

Monitoring means the collection of field observationsing and making measurements to provide data to evaluate the performance and characteristics of the disposal site.

Near-surface disposal facility means a land disposal facility in which radioactive waste is disposed of in or generally within the upper 30 meters of the earths surface.

Operational safety assessment is an assessment used to provide reasonable assurance that exposures will be controlled to meet the requirements of 10 CFR part 20, thereby meeting the performance objective for the protection of individuals during operations set forth in § 61.43 of this part. An operational safety assessment is more detailed and comprehensive as the level of hazard posed by the waste increases.

Performance assessment is an analysis used to demonstrate compliance with § 61.41(a) and (b) that identifies the features, events, and processes that could affect the performance of the disposal site; and estimates the potential dose as a result of releases caused by all significant features, events, and processes including an evaluation of the uncertainties.

11 Performance period is the timeframe established for those sites that contain significant quantities of long-lived radionuclides for considering waste and disposal site characteristics to evaluate the anticipated performance of the disposal site after the compliance period.

Performance period analyses are analyses used to demonstrate compliance with § 61.41(b) and

§ 61.42(b) by providing information, consistent with available data and current scientific understanding, that demonstrates that releases of long-lived radioactive waste from a disposal site are reduced to the extent reasonably achievable during the performance period.

Person means (1) any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, government agency other than the Commission or the Department of Energy (except that the Department of Energy is considered a person within the meaning of the regulations in this part to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission pursuant to law), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and (2) any legal successor, representative, agent, or agency of the foregoing.

Pyrophoric liquid means any liquid that ignites spontaneously in dry or moist air at or below 130

°F (54.5 °C). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard.

Included are spontaneously combustible and water-reactive materials.

Safety case is a high-level evaluation of the information and analyses that support the licensees demonstration that the land disposal facility will be constructed and operated safely. The safety

12 case, which is a component of the application, provides a summary of the safety basis that the disposal site will be capable of isolating waste and limiting releases to the environment; describes the strength and reliability of the technical analyses; and includes consideration of defense-in-depth protections and safety relevant aspects of the site, the facility design, and the managerial, engineering, regulatory, and institutional controls.

Significant quantities of long-lived radionuclides means an amount (volume or mass) and concentration accepted for disposal after [30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] that could, if released, result in the performance objectives of subpart C of this part not being met.

Site closure and stabilization means those actions that are taken upon completion of operations that prepare the disposal site for custodial care and that enassure, to the extent practical, that the disposal site will remain stable and will not need ongoing active maintenance.

Site stability assessment is an assessment used to demonstrate compliance with § 61.44 by providing reasonable assurance that long-term stability of the disposal site can be ensured and that maintenance following site closure will not be needed. Long-term stability of the disposal site includes the ability of the site to maintain structural stability from within the disposal units and to maintain stability of the surface of the site. A site stability assessment is tailored to the types of waste disposed, thereby influencing the areal extent of the assessment.

Stability means the capability of the disposal site (e.g., wasteform, disposal containers, and disposal units) to maintain its shape and properties to an extent that will not prohibit the demonstration that the disposal site will meet the performance objectives in §§ 61.41 and 61.42 of this part and will, to the extent practical, eliminate the need for active maintenance after site closure and for maintenance in any form after license terminationstructural stabillity.

13 State means any State, Territory, the District of Columbia, Puerto Rico, and any territory or possession of the United States, Puerto Rico, and the District of Columbia.

Surveillance means observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

Technical analyses means the analyses described in § 61.13 and includes the performance assessment, the intruder assessment, the operational safety assessment, and the site stability assessment, in addition to, under certain circumstances, the performance period analyses, needed to demonstrate compliance with the performance objectives of subpart C of this part.

Tribal Governing Body means a Tribal organization as that term is defined byin the Indian Self-Determination and Education Assistance Act (25 U.S.C. § 53041).

Waste means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraphs (2), (3), and (4) of the definition of Byproduct material set forth in § 20.1003 of this chapter. Consistent with the National Defense Authorization Act for Fiscal Year 2013, low-level radioactive waste also includes radioactive material that, notwithstanding Section 2 of the Nuclear Waste Policy Act of 1982, results from the production of medical isotopes that have been permanently removed from a reactor or subcritical assembly, for which there is no further use, and the disposal of which can meet the requirements of this part.

14 Waste acceptance criteria means the requirements developed through technical analyses or other methods to ensure that waste disposed in a facility will meet the established performance objectives set forth in this part.

§ 61.3 License required.

(a) No person may receive, possess, and dispose of radioactive waste containing source, special nuclear, or byproduct material at a land disposal facility unless authorized by a license issued by the Commission pursuant to this part, or unless exemption has been granted by the Commission under § 61.6 of this part.

(b) Each person shall must file an application with the Commission and obtain a license as provided in this part before commencing construction of a land disposal facility. Failure to comply with this requirement may be grounds for denial of a license.

§ 61.4 Communications.

Except where otherwise specified, all communications and reports concerning the regulations in this part and applications filed under them should be sent by mail addressed: ATTN: Document Control Desk; Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's Offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, or digital mediaCD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at https://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission,

15 Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information.

§ 61.5 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be considered binding upon the Commission.

§ 61.6 Exemptions.

The Commission may, upon application by any interested person, or upon its own initiative, grant any exemption from the requirements of the regulations in this part as it determines is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest.

§ 61.7 Concepts.

(a) The disposal facility. (1) Part 61 is intended toThe regulations in this part apply to land disposal of radioactive waste and does not include not to other methods such as sea or extraterrestrial disposal. These regulations establish Part 61 contains procedural requirements, and performance objectives, applicable to any method of land disposal. It contains and specific technical requirements applicable to the for near-surface disposal of radioactive waste, a subset category of land disposal, which involves disposal in the uppermost portion of the earth (i.e.,

approximately 30 meters below the earths surface). Near-surface disposal includes disposal in engineered facilities which may be built totally or partially above-grade provided that such facilities have protective earthen covers. Near-surface disposal does not include disposal facilities which are partially or fully above-grade with no protective earthen cover, which are is

16 referred to as above-ground disposal. Above-ground disposal is not authorized by these regulations. Burial deeper than 30 meters below the earths surface in a land disposal facility may still be considered near-surface disposal if the methods used are similaralso be satisfactory. Technical requirements for alternative methods may be added in the future.Alternative methods of disposal may be approved on a case-by-case basis as needed under § 61.6 of this part.

(2) Near-surface disposal of radioactive waste takes place at a near-surface disposal facility, which includes all of the land and buildings necessary to carry out the disposal. The disposal site is that portion of the facility which is used for disposal of waste and consists of disposal units and a buffer zone. A disposal unit is a discrete portion of the disposal site into which waste is placed for disposal. For near-surface disposal, the disposal unit is usually a trench. A buffer zone is a portion of the disposal site that is controlled by the licensee and that lies under the site and between the boundary of the disposal site and any disposal unit. It provides controlled space to establish monitoring locations which are intended to provide an early warning of radionuclide movement, and to take mitigative measures if needed. In choosing a disposal site, site characteristics should be considered in terms of the indefinite future and evaluated for at least a 500-year timeframe.

(b) Performance objectives. (1) An applicant must demonstrate that its proposed land disposal facility will meet the following four performance objectives: protection of the general population from releases of radioactivity, protection of individuals from inadvertent intrusion, protection of individuals during operations, and stability of the site after closure. These four performance objectives are further described in subpart C of this part. Achieving these objectives depends upon many factors including, but not limited to, the design of the land disposal facility, operational procedures, the type and quantity of radioactive waste intended for disposal at the facility, and site characteristics, including those of the surrounding environment. The application

17 must include technical analyses that show how the proposed land disposal facility and the receipt, storage, and disposal of waste by the applicant will meet the four subpart C performance objectives. After the application has been evaluated and approved, and the facility license issued, the licensee must continue to demonstrate compliance with these performance objectives through measures such as monitoring, radiological dose calculations, and updating the initial technical analyses included in the application, as appropriate, until the site is closed and transferred to the Federal or a State government.

(2) The technical analyses that must be included with the application include the performance assessment, the intruder assessment, and the site stability assessment required for the compliance period and, if necessary, performance period analyses. For certain types of waste, an operational safety assessment may be performed. The technical analyses evaluate the impact of the engineering design, operational practices, natural characteristics of the site, and radioactive waste acceptable for disposal, on the ability of the land disposal facility to protect both occupational workers and the general population from potential releases of radioactivity during facility operations and to protect the general population and inadvertent intruders from potential releases of radioactivity during the compliance period.

(3) Protection of inadvertent intruders from harmful exposure to radiation involves three principal controls: institutional controls to provide reasonable assurance that occupation or improper use of the site does not occur; designating the type and quantity of waste that could present an unacceptable dose to an inadvertent intruder; and disposing of this waste in a disposal unit that includes necessary controls (e.g., depth of disposal, engineered barriers) to prevent the inadvertent intruder from receiving a harmful dose of radiation.

(cb) Waste classification and near-surface disposal. (1) Disposal of radioactive waste in near-surface disposal facilities has the following safety objectives: protection of the general

18 population from releases of radioactivity, protection of individuals from inadvertent intrusion, and protection of individuals during operations. A fourth objective is to ensure stability of the site after closure.

(2) A cornerstone of the disposal system is stability of - stability of the waste and the disposal site and stability of the waste. Site stability helps ensure that potential releases of radionuclides, such as due to water infiltration, are minimized. Assessment of the stability of a disposal site for the disposal of long-lived radionuclides may require an evaluation of processes (e.g., erosion, subsidence) that are unlikely to affect the ability of the disposal site to sufficiently contain short-lived waste. For long-lived radionuclides and certain radionuclides prone to migration, a maximum disposal site inventory, based on the characteristics of the disposal site, may be established to limit potential exposure and to mitigate the uncertainties in the assessment of long-term stability of the disposal site. Some waste, depending on its radiological characteristics, may not be suitable for near-surface disposal if uncertainties cannot be adequately addressed with engineering controls and defense-in-depth protections. Defense-in-depth protections for disposal are provided through the diversity and capabilities of the components and attributes of the disposal site (e.g., wasteform, container, engineered features, depth of the disposal unit below the land surface, hydrologic and geochemical characteristics).

(2) Different classes of waste (A, B, C, and Greater-Than-Class C (GTCC)) have been developed with corresponding requirements for each class of waste. Class A waste is the least hazardous and GTCC waste is the most hazardous. Wastes may be stable or unstable, but only certain types of Class A wastes may be disposed without stabilization. Some unstable Class A wastes (e.g., biodegradable waste), depending on the radiological composition of the constituent radionuclides, require stabilization before they can be safely disposed in the near-surface. so that once emplaced and covered, the access of water to the waste can be minimized. Migration of radionuclides is thus minimized, long-term active maintenance can be

19 avoided, and potential exposures to intruders reduced. While stability is a desirable characteristic for all waste much radioactive waste does not contain sufficient amounts of radionuclides to be of great concern from these standpoints; this waste, however, tends to be unstable, such as ordinary trash type wastes. If mixed with the higher activity waste, their deterioration could lead to failure of the system and permit water to penetrate the disposal unit and cause problems with the higher activity waste. Some unstable Class A waste may be disposed of safely without stabilization; however, licensees must ensure that any interaction between unstable Class A wastes and other wastes will not result in the failure to meet the performance objectives in subpart C of this part (i.e., through segregation of unstable Class A waste). Therefore, in order to avoid placing requirements for a stable waste form on relatively innocuous waste, these wastes have been classed as Class A waste. The Class A waste will be disposed of in separate disposal units at the disposal site. However, Class A waste that is stable may be mixed with other classes of waste. Stable Class A waste may be disposed of with other classes of waste. Class B, Class C, or GTCC waste must Those higher activity wastes that should be stable for proper disposal are classed as Class B and C waste. To the extent that it is practicable, Class B and C waste forms or containers should be designed to be stable, i.e.,

maintain gross physical properties and identity, over 300 years. For certain radionuclides prone to migration, a maximum disposal site inventory based on the characteristics of the disposal site may be established to limit potential exposure.

(3) The proposed disposal site may be privately owned if the applicant commits to conveying the land in fee simple to a State or Federal agency before the transfer of the license under § 61.30; otherwise, the proposed disposal site must be located on State or Federal lands (the licensee would obtain a long-term lease). Following the cessation of operations and prior to transfer of the site, as provided in paragraph (d)(4) of this section, sufficient institutional controls must be established. The licensee must consult with the Federal or State agency that has authority to

20 administer the closed land disposal facility prior to the establishment of such institutional controls. Upon transfer of the license, the government landowner will be responsible for implementing and otherwise enforcing the institutional controls.

(4) Generally, technical analyses may not rely on the effectiveness of institutional controls for more than 100 years following transfer of control of the disposal site to the government landowner. Limiting reliance upon institutional controls to no more than 100 years permits the disposal of most types of Class A waste and all Class B waste without special provisions for inadvertent intruder protection. Such wastes contain types and quantities of radioisotopes that generally will decay during the 100-year period and therefore will present an acceptable hazard to an inadvertent intruder who may occupy the site after the 100-year period.

It is possible but unlikely that persons might occupy the site in the future and engage in normal pursuits without knowing that they were receiving radiation exposure. These persons are referred to as inadvertent intruders. Protection of such intruders can involve two principal controls: institutional control over the site after operations by the site owner to ensure that no such occupation or improper use of the site occurs; or, designating which waste could present an unacceptable risk to an intruder, and disposing of this waste in a manner that provides some form of intruder barrier that is intended to prevent contact with the waste. This regulation incorporates both types of protective controls.

(4) Institutional control of access to the site is required for up to 100 years. This permits the disposal of Class A and Class B waste without special provisions for intrusion protection, since these classes of waste contain types and quantities of radioisotopes that will decay during the 100-year period and will present an acceptable hazard to an intruder. The government landowner administering the active institutional control program has flexibility in controlling site

21 access which may include allowing productive uses of the land provided the integrity and long-term performance of the site are not affected.

(5) Waste that will not decay to levels which present an acceptable hazard to an intruder within 100 years is designated as Class C waste. Additionally, certain Class A waste, classified under

§ 61.55(a)(6), will also not decay to acceptable levels within the 100-year period. Therefore, both § 61.55(a)(6) Class A and Class C waste must be stable and be disposed at a sufficient depth or with an intruder barrier as specified in § 61.52(a)(2) so that there is reasonable assurance the inadvertent intruder will be protected. This waste is disposed of at a greater depth than the other classes of waste so that subsequent surface activities by an intruder will not disturb the waste. Where site conditions prevent deeper disposal, intruder barriers such as concrete covers may be used. The effective service life of these intruder barriers should be at least 500 years. A maximum concentration of radionuclides is specified in tables 1 and 2 of § 61.55 of this part such for all wastes so that at the end of the 500- year period, the remaining radioactivity for Class A, B, and C waste will be at a levelconcentrations that does not pose an unacceptable hazard to an inadvertent intruder or public health and safety. Waste with concentrations above these limits is generally unacceptable for near-surface disposal. There may be some instances where waste with concentrations greater than permitted for Class C would be acceptable for near-surface disposal with special processing or design. These will be evaluated on a case-by-case basis. Class C waste must also be stable.

(6) Greater-than-Class-C waste has higher concentrations of radionuclides than Class C waste and will require additional protections and analyses. Whereas protection of an inadvertent intruder from the disposal of Class C waste will be provided by a sufficient burial depth or an intruder barrier, protection of an inadvertent intruder from Greater-Than-Class-C waste will require both a sufficient burial depth and an intruder barrier.

22 (7) Regardless of the classification, some waste (e.g., depleted uranium) may need enhanced waste-specific controls or limitations at a particular land disposal facility because the waste may be more difficult to contain. One of the purposes of both the performance assessment and the inadvertent intruder assessment is to identify, as appropriate, these waste-specific enhanced controls and limitations. The types of enhanced controls or limitations could include additional limits on waste concentration or total activity, more robust intruder barriers, deeper burial depth, and enhanced stability controls. These enhanced controls or limitations could mitigate the uncertainty associated with changes to the natural environment and the disposal site performance over the compliance period. Waste with significant quantities of long-lived radionuclides may need special processing, design, or site conditions for disposal.

Demonstrating protection of both the general population and inadvertent intruders from radiological exposure from the disposed waste requires an evaluation of long-term impacts in the technical analyses.

(dc) The licensing process. (1) Prior to the issuance of the licenseDuring the preoperational phase, the potential applicant engagesgoes through in a process of disposal site selection by selecting a region of interest, examining a number of possible disposal sites within the area of interest, and narrowing the choice to the proposed site. Through a detailed investigation of the proposed disposal site characteristics, the potential applicant obtains data on which to base a determination analysis of the disposal site's suitability. The potential applicant uses these data to develop a safety case, which is a component of the application, that describes the safety relevant aspects of the site, the facility design, and the management and regulatory controls. A safety case must demonstrate that the land disposal facility will be constructed and operated safely and provide a summary of the safety basis that the disposal site will meet the performance objectives in subpart C of this part. Along with these data and analyses, the

23 applicant submits other more general information to the Commission in the form of an application for a license for land disposal.

(2) The Commission will's review and evaluate of the application and may seek is in accordance with administrative procedures established by rule and may involve participation by affected State governments or Indian Tribes in the application review process.

(32) During the operational phase, and any period of license renewal, the licensee must carryies out disposal activities in accordance with the requirements of this regulation and any the conditions ofn the license. Periodically, the authority to conduct the above ground operations and dispose of waste will be subject to a license renewal, at which time the operating history will be reviewed and a decision made to permit or deny continued operation. At the cessation of disposal operationsWhen disposal operations are to cease, the licensee must apply applies for an amendment to his the license to permit site closure. After final review of the licensee's site closure and stabilization plan, the Commission may approve the final activities necessary to prepare the disposal site so that ongoing active maintenance of the site after site closure is not required during the period of institutional control.

(43) During the period when the final disposal site closure and stabilization activities are being carried out, the licensee is in a disposal site closure phase. Following that closure of the site, for a period of 5 years, the licensee must remain in active control ofat the disposal site for purposes a period of postclosure observation and maintenance to enassure that the disposal site remains is stable and ready for the implementation of institutional controls. Although 5 years is a suggested time period, the postclosure observation and maintenance period is intended to continue for the length of time found necessary to provide reasonable assurance that the performance objectives in §§ 61.41, 61.42, and 61.44 of this part are met and to ensure that the disposal site closure and stabilization activities have not resulted in unintended instability at the

24 disposal site. The Commission may approve shorter or require longer periods if conditions warrant. At the end of this period, the licensee applies for a license transfer to the disposal site owner.

(45) After the licensee fulfillsing the requirements of § 61.30 and a finding of satisfactory disposal site closure, the Commission will transfer the license to the State or Federal government agency that is administering the site on behalf of the government landownerowns the disposal site. If the U.S. Department of Energy is the Federal agency administering the land on beahalf of the Federal governmentGovernment, the license will be terminated because the Commission lacks regulatory authority over the Department for this activity. Under the conditions of the transferred license, the State or Federal agency licensee owner will carry out a program of monitoring to enassure continued satisfactory disposal site performance, physical surveillance to restrict access to the site, and carry out minor custodial activities. During this period, productive uses of the land might be permitted if those uses do not affect the stability of the site and its ability to meet the performance objectives. At the end of the prescribed period of institutional controls, the license will be terminated by the Commission after the State or Federal agency licenseegovernment landowner fulfilled requirements found in § 61.31.

§ 61.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0135.

25 (b) The approved information collection requirements contained in this Part appear in §§ 61.3, 61.6, 61.9, 61.10, 61.11, 61.12, 61.13, 61.14, 61.15, 61.16, 61.20, 61.22, 61.24, 61.26, 61.27, 61.28, 61.30, 61.31, 61.32, 61.41, 61.42, 61.53, 61.55, 61.57, 61.58, 61.61, 61.62, 61.63, 61.72, and 61.80.

(c) In § 61.32, IAEA Design Information Questionnaire forms IAEA Design Information Questionnaire forms are approved under control number 3150-0056, and DOC/NRC Forms AP-1, AP-A, and associated forms are approved under control numbers 0694-0135.

§ 61.9 Employee protection.

(a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act.

(1) The protected activities include but are not limited to:

(i) Providing the Commission or his or herthe employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of the section or possible violations of requirements imposed under either of those statutes; (ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer;

26 (iii) Requesting the Commission to institute action against his or herthe employer for the administration or enforcement of these requirements; (iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text.

(v) Assisting or participating in, or is about to assist or participate in, these activities.

(2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation.

(3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or herthe employer (or the employer's agent),

deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended.

(b) Any employee who believes that he or she hasthey have been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.

27 (c) A violation of paragraph (a), (e), or (f) of this section by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for -

(1) Denial, revocation, or suspension of the license.

(2) Imposition of a civil penalty on the licensee, applicant, or a contractor or subcontractor of the licensee or applicant.

(3) Other enforcement action.

(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or herthe employee immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.

(e)(1) Each licensee and each applicant for a license shall must prominently post the revision of NRC Form 3, Notice to Employees, referenced in 10 CFR 19.11(c). This form must be posted at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.

(2) Copies of NRC Form 3 can be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20

28 of this chapter, via email to Forms.Resource@nrc.gov, or by visiting the NRC's online library at https://www.nrc.gov/reading-rm/doc-collections/forms/.

(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorganization Act of 1974, as amended, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from participating in protected activity as defined in paragraph (a)(1) of this section including, but not limited to, providing information to the NRC or to his or her the employer on potential violations or other matters within NRC's regulatory responsibilities.

§ 61.9a Completeness and accuracy of information.

(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall must be complete and accurate in all material respects.

(b) Each applicant or licensee shall must notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall must be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements.

29

§ 61.9b Deliberate misconduct.

(a) Any licensee, applicant for a license, employee of a licensee or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or applicant for a license, who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's or applicant's activities in this part, may not:

(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or (2) Deliberately submit to the NRC, a licensee, an applicant, or a licensee's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC.

(b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B.

(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:

(1) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or (2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor.

Subpart B - Licenses

30

§ 61.10 Content of application.

(a)(1) An application to receive from others, possess and dispose of wastes containing or contaminated with source, byproduct or special nuclear material by land disposal must consist of general information, specific technical information, technical analyses, institutional information, and financial information as set forth in §§ 61.11 through 61.16.

(2) An environmental report prepared in accordance with subpart A of part 51 of this chapter must accompany the application.

(b) The application must include the safety case, which demonstrates that the land disposal facility will be constructed and operated safely and provides a summary of the safety basis that the disposal site will meet the performance objectives in subpart C of this part and describes the defense-in-depth protections that enhance the resiliency of the facility in complying with the performance objectives specified at §§ 61.41 and 61.43.

§ 61.11 General information.

The general information must include each of the following:

(a) Identity of the applicant including:

(1) The full name, address, telephone number and description of the business or occupation of the applicant; (2) If the applicant is a partnership, the name, and address of each partner and the principal location where the partnership does business;

31 (3) If the applicant is a corporation or an unincorporated association, (i) the state where it is incorporated or organized and the principal location where it does business, and (ii) the names and addresses of its directors and principal officers; and (4) If the applicant is acting as an agent or representative of another person in filing the application, all information required under this paragraph must be supplied with respect to the other person.

(b) Qualifications of the applicant:

(1) The organizational structure of the applicant, both offsite and onsite, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise; (2) The technical qualifications, including training and experience, of the applicant and members of the applicant's staff to engage in the proposed activities. Minimum training and experience requirements for personnel filling key positions described in paragraph (b)(1) of this section must be provided; (3) A description of the applicant's personnel training program; and (4) The plan to maintain an adequate complement of trained personnel to carry out waste receipt, handling, and disposal operations in a safe manner.

(c) A description of:

(1) The location of the proposed disposal site; (2) The general character of the proposed activities;

32 (3) The types and quantities of radioactive waste to be received, possessed, and disposed of; (4) Plans for use of the land disposal facility for purposes other than disposal of radioactive wastes; and (5) The proposed facilities and equipment.

(d) Proposed schedules for construction, receipt of waste, and first emplacement of waste at the proposed land disposal facility.

§ 61.12 Specific technical information.

The specific technical information, application must include the following specific technical information needed for demonstrationto demonstrate that the performance objectives of subpart C of this part and the applicable technical requirements of subpart D of this part will be met:

(a) A description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description must include geologic, geotechnical, geochemical, geomorphological, hydrologic, meteorologic, climatologic, and biotic features, events, and processes of the disposal site and vicinity.

(b) A description of the design features of the land disposal facility, including and the disposal units. For near-surface disposal, the description must include those design features related to surface cover runoff and infiltration; evapotranspiration from the soil and vegetation overlying the cover material; infiltration reaching of water the waste; integrity of covers for disposal units; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination to the extent practicablelong-term disposal site maintenance; inadvertent intrusion; intruder barriers;

33 occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

(c) A description of the principal design criteria and their relationship to the performance objectives of subpart C to this part.

(d) A description of the design basis natural events or phenomena and their relationships to the principal design criteria. These phenomena could include earthquakes, fires, and exceptional rain events.

(e) A description of codes and standards which that the applicant has applied to the design and which that will apply to construction of the land disposal facilitiyes.

(f) A description of the proposed construction and operation of the land disposal facility. At a minimum, the application The description must describe include as a minimum the methods of construction of disposal units; waste emplacement; the procedures for and areas of waste segregation; types of intruder barriers; onsite traffic systems; and drainage systems; survey control program; methods and areas of waste storage; and methods to control surface water and groundwater access to the wastes. The description application must also describe include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other non-radiological substances that might affect meeting the performance objectives in subpart C of this part.

(g) A description of the disposal site closure plan, including those design features which are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance.

34 (h) An identification of the known natural resources at in the vicinity of the disposal site, the exploitation of which could result in inadvertent intrusion into the low-level wastes after removal of active institutional control.

(i)(1) A description of the kind, amount, classification, characteristics, and specifications of the radioactive materialwaste proposed to be received, possessed, and disposed of at the land disposal facility, including the proposed wasteform, disposal containers, and the facilitys proposed waste acceptance criteria.

(2) A description of the procedures for waste acceptance in accordance with § 61.58(a) through (c).

(j) A description of the quality assurance program, tailored to LLW disposal, developed and applied by the applicant for: (1) the identification and selection determination of the natural disposal site, including any natural features relied upon to enhance the performance of the disposal sitecharacteristics; (2) the development of technical analyses ; and (3) for quality assurance during the design and, construction of the land disposal facility; (4), the operation of the land disposal facility, including the receipt, handling, and emplacement of waste;, and (5) the site closure of the land disposal facility and the receipt, handling, and emplacement of waste.

(k) A description of the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the performance objective in § 61.41 of this part, including the control of radioactive effluents, and occupational radiation exposure to ensure compliance with the occupational and public radiation protection requirements of part 20 of this chapter and to control contamination of personnel, vehicles, equipment, buildings, and the disposal site. The radiation safety program must address bBoth routine operations and accidents must be addressed and. The program description must include procedures for dosimetry and preventing

35 and controlling the radioactive contamination of personnel, buildings, vehiclesinstrumentation, facilities, and equipment.

(l) A description of the environmental monitoring program thato provides data for anto evaluatione of the disposal site performance including potential health and environmental impacts and the plan for taking corrective measures commensurate with detected radionuclide if migration of radionuclides is indicated.

(m) A description of the administrative procedures that the applicant will apply to control activities at the land disposal facility.

(n) A description of the facility electronic recordkeeping system as required in § 61.80.

§ 61.13 Technical analyses.

This section describes the technical analyses that must be submitted as part of the application under § 61.10. The specific technical information must also include the following analyses needed to demonstrate that the performance objectives of subpart C of this part will be met:

(a) Pathways analyzed in demonstrating protection of the general population from releases of radioactivity must include air, soil, groundwater, surface water, plant uptake, and exhumation by burrowing animals. The analyses must clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate that there is reasonable assurance that the exposure to humans from the release of radioactivity will not exceed the limits set forth in § 61.41. Performance assessment. A performance assessment that demonstrates that there is reasonable assurance that the exposure to humans from radioactivity released from the disposal site will meet the protection of the general population performance

36 objective set forth in § 61.41(a) for the duration of the compliance period. The performance assessment must:

(1) Identify the natural characteristics of the disposal site (e.g., geomorphology, meteorology, hydrology, hydrogeology, geochemistry, and biology); the characteristics of the engineered barrier; and the interactions between the disposal site and engineered barriers characteristics that might affect performance of the disposal site. Identify radionuclide transport characteristics of the waste (i.e., the ease with which radionuclides can escape containment). A performance assessment must further identify and examine the effects of the eventual degradation, deterioration, or alteration of the engineered barriers (including the wasteform and container) together with the disposal site characteristics to evaluate the ability of the disposal site to limit waste releases and to provide an estimate of the annual dose to a member of the public for comparison with the appropriate subpart C performance objective.

(2) Consider features, events, and processes that might affect demonstrating compliance with § 61.41. The features, events, and processes considered must represent a range of phenomena, including those that may have beneficial effects, adverse effects, or both beneficial and adverse effects on performance, and must consider the specific technical information required in § 61.12(a) through (i). A technical basis for either the inclusion or exclusion of specific features, events, or processes must be provided.

(3) Consider the probability of disruptive features, events, or processes when estimating the consequences for comparison with the dose limits set forth in § 61.41(a).

(4) Provide model support for the models used in the performance assessment.

37 (5) Evaluate contaminant transport pathways and processes in environmental media (e.g., air, soil, groundwater, surface water) including but not limited to advection, diffusion, plant uptake, and exhumation by burrowing animals.

(6) Account for uncertainties and variability in the projected performance of the disposal site and surrounding environment, including the demographics and behaviors of human receptors.

(7) Identify and differentiate between the roles performed by the natural characteristics and the design features of the disposal site in limiting radiological releases to the general population.

(b) Inadvertent intruder assessment. An inadvertent intruder assessment that demonstrates there is reasonable assurance that any inadvertent intruder will not be exposed to a dose that exceeds the limits in the performance objective set forth in § 61.42 (a) for the duration of the compliance period. The inadvertent intruder assessment must:

(1) Assume that an inadvertent intruder occupies the disposal site and engages in agricultural and residential activities and other reasonably foreseeable pursuits that are consistent with the activities occurring in and around the site at the time of development of the inadvertent intruder assessment.

(2) Identify barriers to inadvertent intrusion that inhibit contact with the waste or limit dose exposure from the waste and provide a basis for their degree of effectiveness and the time period over which barriers are effective.

(3) Account for uncertainties and variability in the projected performance of the disposal site and surrounding environment.Analyses of the protection of individuals from inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification and

38 segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided.

(c) Analyses Operational safety assessment. An operational safety assessment of the protection of individuals during operations. The assessment must include assessments analyses of expected exposures due to routine operations and likely accidents during handling, storage, and disposal of waste. The analyses assessment must provide reasonable assurance that exposures will be controlled to meet the requirements of part 20 of this chapter, thereby meeting the performance objective set forth in § 61.43. These analyses can be qualitative and credit administrative controls and procedures. Operational safety assessments involving Greater-Than-Class-C waste must also include quantitative analyses of expected exposures due to unlikely accidents (including fire, handling events, and other credible accidents), the identification of safety features to prevent and mitigate accidents.

(d) Analyses Site stability assessment. An assessment of the long-term stability of the disposal site and the need for ongoing active maintenance after site closure. The assessment must be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses assessment must provide reasonable assurance that long-term stability of the disposal site can be ensured and that there will not be a need for ongoing active maintenance following site closure, thereby meeting the performance objective set forth in § 61.44.

(e) Performance period analyses. Analyses of how the disposal site limits the potential long-term radiological impacts during the performance period. The performance period analyses must be consistent with available data and current scientific understanding. The analyses must identify and describe disposal site design features and natural characteristics relied on to

39 demonstrate compliance with the applicable performance objectives set forth in §§ 61.41(b) and 61.42(b). In addition, the analysies must evaluate those processes likely to occur during the performance period, including degradation, deterioration, and alteration processes that affect performance.

(f) Exception criteria. For licensees who meet the criteria in § 61.1(b)(1) and choose to comply with the requirements in § 61.1(b)(2), the specific technical information must include the following analyses needed to demonstrate that the performance objectives of subpart C of this part will be met:

(1) Pathways analyzed in demonstrating protection of the general population from releases of radioactivity must include air, soil, groundwater, surface water, plant uptake, and exhumation by burrowing animals. The analyses must clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate that there is reasonable assurance that the exposure to humans from the release of radioactivity will not exceed the limits set forth in § 61.41(c).

(2) Analyses of the protection of individuals from inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification and segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided.

(3) Analyses of the protection of individuals during operations must include assessments of expected exposures due to routine operations and likely accidents during handling, storage, and disposal of waste. The analyses must provide reasonable assurance that exposures will be controlled to meet the requirements of part 20 of this chapter.

40 (4) Analyses of the long-term stability of the disposal site and the need for ongoing active maintenance after closure must be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses must provide reasonable assurance that there will not be a need for ongoing active maintenance of the disposal site following closure.

§ 61.14 Institutional information.

The institutional information must include:

(a) A certification by the Federal or State government which owns the disposal site that the Federal or State government is prepared to accept transfer of the license when the provisions of

§ 61.30 are met, and will assume responsibility for custodial care after site closure and postclosure observation and maintenance.

(b) Where the proposed disposal site is on land not owned by the Federal or a State government, the applicant must submit evidence that arrangements have been made for assumption of ownership in fee by the Federal or a State government before the Commission issues a license.

§ 61.15 Financial information.

The financial information must be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet other financial assurance requirements as specified in subpart E of this part.

§ 61.16 Other information.

41 Depending upon the nature of the wastes to be disposed of, and the design and proposed operation of the land disposal facility, additional information may be requested by the Commission including the following:

(a) Physical security measures, if appropriate. Any application to receive and possess special nuclear material in quantities subject to the requirements of part 73 of this chapter shall must demonstrate how the physical security requirements of part 73 will be met. In determining whether receipt and possession will be subject to the physical protection requirements of part 73, the applicant shall is not required to consider the quantity of special nuclear material that has been disposed of.

(b) Safety information concerning criticality, if appropriate.

(1) Any application to receive and possess special nuclear material in quantities that would be subject to the requirements of § 70.24, Criticality accident requirements, of part 70 of this chapter shall must demonstrate how the requirements of that section will be met, unless the applicant requests an exemption pursuant to § 70.24(d) of this chapter. In determining whether receipt and possession would be subject to the requirements of § 70.24 of this chapter, the applicant shall is not required to consider the quantity of special nuclear material that has been disposed of or radioactive waste containing fissile material that meets the exemption requirements specified in § 71.15(c) of this chapter.

(2) Any application to receive and possess special nuclear material shall must describe proposed procedures for avoiding accidental criticality, which address both storage of special nuclear material prior to disposal and waste emplacement for disposal. The procedure is not required to address radioactive waste containing fissile material that meets the exemption requirements specified in § 71.15(c) of this chapter.

42 (3) Any application to dispose of Greater-Than-Class-C radioactive waste containing special nuclear material in quantities that would be subject to the requirements of § 70.24, Criticality accident requirements, of this chapter must identify the disposal unit and facility design features that limit reconcentration of fissile material following disposal to ensure that the performance objectives of subpart C of this part will be met during the compliance period.

§ 61.20 Filing and distribution of application.

(a) An application for a license under this part, and any amendments thereto, must be filed with the Director, must be signed by the applicant or the applicants authorized representative under oath or affirmation, and, if the document is in paper form, must be the signed original.

(b) The applicant shall must maintain the capability to generate additional copies of the application for distribution in accordance with written instructions from the Director or the Directors designee.

(c) Fees. Application, amendment, and inspection fees applicable to a license covering the receipt and disposal of radioactive wastes in a land disposal facility are required by part 170 of this chapter.

§ 61.21 Elimination of repetition.

In its application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Commission if these references are clear and specific.

§ 61.22 Updating of application.

43 (a) The application must be as complete as possible in the light of information that is available at the time of submittal.

(b) The applicant shall must supplement its application in a timely manner, as necessary, to permit the Commission to review, prior to issuance of a license, any changes in the activities proposed to be carried out or new information regarding the proposed activities.

§ 61.23 Standards for issuance of a license.

A license for the receipt, possession, and disposal of waste containing or contaminated with source, special nuclear, or byproduct material will be issued by the Commission upon finding that the issuance of the license will not be inimical to the common defense and security and will not constitute an unreasonable risk to the health and safety of the public, and:

(a) The applicant is qualified by reason of training and experience to carry out the disposal operations requested in a manner that protects health and minimizes danger to life or property.

(b) The applicants proposed disposal site, disposal site design, waste acceptance criteria, land disposal facility operations (including equipment, facilities, and procedures), disposal site closure, and postclosure institutional controls are adequate to protect the public health and safety in that because they provide reasonable assurance that the general population will be protected from releases of radioactivity as specified in the performance objective in § 61.41, Protection of the general population from releases of radioactivity.

(c) The applicants proposed disposal site, disposal site design, waste acceptance criteria, land disposal facility operations (including equipment, facilities, and procedures), disposal site closure, and postclosure institutional controls are adequate to protect the public health and safety in that because they will provide reasonable assurance that individual inadvertent

44 intruders are protected in accordance with the performance objective in § 61.42, Protection of individuals from inadvertent intrusion.

(d) The applicants proposed waste acceptance criteria and land disposal facility operations, (including equipment, facilities, and procedures), are adequate to protect the public health and safety in that because they will provide reasonable assurance that the standards for radiation protection set out in part 20 of this chapter will be met.

(e) The applicants proposed disposal site, disposal site design, waste acceptance criteria, land disposal facility operations, disposal site closure, and postclosure institutional controls are adequate to protect the public health and safety in that because they will provide reasonable assurance that long-term stability of the disposed waste and the disposal site will be achieved and will eliminate to the extent practicable the need for ongoing active maintenance of the disposal site following closure.

(f) The application nts demonstration provides reasonable assurance that the applicable technical requirements of subpart D of this part will be met.

(g) The applicants proposal for institutional control provides reasonable assurance that institutional control will be provided for the length of time found necessary to ensure the findings in paragraphs (b) through (e) of this section and that the institutional control meets the requirements of § 61.59, Institutional requirements.

(h) The information on financial assurances meets the requirements of subpart E of this part.

(i) The applicants physical security information provides reasonable assurance that the requirements of part 73 of this chapter will be met, insofar as they are applicable to special nuclear material to be possessed before disposal under the license.

45 (j) The applicant's criticality safety procedures are adequate to protect the public health and safety and provide reasonable assurance that the requirements of § 70.24, Criticality accident requirements, of part 70 of this chapter will be met, insofar as they are applicable to special nuclear material to be possessed before disposal under the license. If the requirements of

§ 70.24 are applicable, the applicants facility design must identify, as necessary, the disposal unit and facility design considerations that limit re-concentration of fissile material to prevent a potential criticality event following disposal.

(k) Any additional information submitted as requested by the Commission pursuant to § 61.16, Other information, is adequate.

(l) The requirements of subpart A of part 51 of this chapter have been met.

(m) The applicants safety case is adequate to support the licensing decision.

§ 61.24 Conditions of licenses.

(a) A license issued under this part, or any right thereunder, may be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, only if the Commission finds, after securing full information, that the transfer is in accordance with the provisions of the Atomic Energy Act and gives its consent in writing in the form of a license amendment.

(b) The licensee shall must submit written statements under oath upon request of the Commission, at any time before termination of the license, to enable the Commission to determine whether or not the license should be modified, suspended, or revoked.

46 (c) The license will be transferred to the site owner only on the full implementation of the final closure plan as approved by the Commission, including post-closurepostclosure observation and maintenance.

(d) The licensee shall must be subject to the provisions of the Atomic Energy Act now or hereafter in effect, and to all rules, regulations, and orders of the Commission. The terms and conditions of the license are subject to amendment, revision, or modification, by reason of amendments to, or by reason of rules, regulations, and orders issued in accordance with the terms of the Atomic Energy Act.

(e) Any license may be revoked, suspended or modified in whole or in part for any material false statement in the application or any statement of fact required under Section 182 of the Act, or because of conditions revealed by any application or statement of fact or any report, record, or inspection or other means which would warrant the Commission to refuse to grant a license to the original application, or for failure to operate the facility in accordance with the terms of the license, or for any violation of, or failure to observe any of the terms and conditions of the Act, or any rule, regulation, license or order of the Commission.

(f) Each person licensed by the Commission pursuant to the regulations in this part shall must confine possession and use of materials to the locations and purposes authorized in the license.

(g) No radioactive waste may be disposed of until the Commission has inspected the land disposal facility and has found it to be in conformance with the description, design, and construction described in the application for a license.

(h) The Commission may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, additional requirements and conditions with respect to the

47 licensee's receipt, possession, and disposal of source, special nuclear or byproduct material as it deems appropriate or necessary in order to:

(1) Promote the common defense and security; (2) Protect health or to minimize danger to life or property; (3) Require reports and the keeping of records, and to provide for inspections of activities under the license that may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

(i) Any licensee who receives and possesses special nuclear material under this part in quantities that would be subject to the requirements of § 70.24 of part 70 of this chapter shall must comply with the requirements of that section. The licensee shall must not consider the quantity of special nuclear material as specified under § 61.16(b) for preventing criticality during storage of special nuclear material prior to disposal and waste emplacement for disposal, and the licensee has, as necessary, implemented design considerations that limit re concentration of fissile material as a means to prevent a potential criticality event following disposalthat has been disposed of.

(j) The authority to dispose of wastes expires on the date stated in the license except as provided in § 61.27(a) of this part.

(k) (1) Each licensee shall must notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

(i) The licensee;

48 (ii) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or (iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.

(2) This notification must indicate:

(i) The bankruptcy court in which the petition for bankruptcy was filed; and (ii) The date of the filing of the petition.

(l) The licensee must not operate the land disposal facility in a manner that would be inconsistent with the technical analyses.

(1) The licensee must evaluate whether updates to the technical analyses are warranted:

(i) at a minimum of every 5 years; (ii) if significant changes have occurred at the site; or (iii) before receiving new waste streams not analyzed in the most recent approved technical analyses.

(2) The evaluations specified in paragraph (l)(1) of this section must be retained as records in accordance with § 61.80.

§ 61.25 Changes.

(a) Except as provided for in specific license conditions, the licensee shall must not make changes in the land disposal facility or procedures described in the license application. The license will include conditions restricting subsequent changes to the facility and the procedures

49 authorized which that are important to public health and safety. These license restrictions will fall into three categories of descending importance to public health and safety as follows:

(1) those features and procedures which that may not be changed without: (i) 60 days prior notice to the Commission, (ii) 30 days notice of opportunity for a prior hearing, and (iii) prior Commission approval; (2) those features and procedures which that may not be changed without: (i) 60 days prior notice to the Commission, and (ii) prior Commission approval; and (3) those features and procedures which that may not be changed without 60 days prior notice to the Commission. Features and procedures falling in paragraph (a)(3) of this section may not be changed without prior Commission approval if the Commission so orders, after having received the required notice, so orders.

(b) Amendments authorizing waste acceptance criteria changes, site closure, license transfer, or license termination shall will be included in the license restriction described in paragraph (a)(1) of this section.

(c) Changes to the technical analyses that do not involve waste acceptance criteria changes will be included in the license restriction described in paragraph (a)(2) of this section.

(d) The Commission shall must provide a copy of the notices of opportunity for hearing provided in paragraph (a)(1) of this section to State and local officials or tribal governing bodies specified in § 2.104(c) of this chapter.

§ 61.26 Amendment of license.

(a) An application for amendment of a license must be filed in accordance with § 61.20 and shall must fully describe the changes desired.

50 (b) In determining whether an amendment to a license will be approved, the Commission will apply the criteria set forth in § 61.23.

§ 61.27 Application for renewal or closure.

(a) Any expiration date on a license applies only to the above ground activities and to the authority to dispose of waste. Failure to renew the license shall does not relieve the licensee of responsibility for carrying out site closure, postclosure observation and transfer of the license to the site owner. An application for renewal or an application for closure under § 61.28 must be filed at least 30 days prior to license expiration.

(b) Applications for renewal of a license must be filed in accordance with §§ 61.10 through 61.16 and § 61.20. Applications for closure must be filed in accordance with §§ 61.20 and 61.28. Information contained in previous applications, statements or reports filed with the Commission under the license may be incorporated by reference if the references are clear and specific.

(c) In any case in which a licensee has timely filed an application for renewal of a license, the license for continued receipt and disposal of licensed materials does not expire until the Commission has taken final action on the application for renewal.

(d) In determining whether a license will be renewed, the Commission will apply the criteria set forth in § 61.23.

§ 61.28 Contents of application for closure.

(a) Prior to final closure of the disposal site, or as otherwise directed by the Commission, the applicant licensee shall must submit an application to amend the license for site closure. This site closure application must include a final revision of the safety case and a final revision and

51 specific details of the disposal site closure plan, which updates and revises, as appropriate, the disposal site closure plan that was submitted with included as part of the license application in accordance with submitted under § 61.12(g). The final disposal site closure plan that must includes each of the following:

(1) Any additional geologic, hydrologic, or other disposal site data pertinent to the long-term containment of emplaced radioactive wastes obtained during the operational period.

(2) The results of tests, experiments, or any other analyses relating to backfill of excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments, or analysis pertinent to the long-term containment of emplaced waste within the disposal site.

(3) Any revisions to the technical analyses necessary to support site closure; such revisions must consider the waste disposed during operations and reflect significant changes to the human activities occurring in and around the site.

(34) Any plan or proposed revision of a previously submitted plans for:

(i) Decontamination and/or dismantlement of surface facilities; (ii) Backfilling of excavated areas; or (iii) Stabilization of the disposal site for post-closurepostclosure care.

(5) The total volume and mass of waste that was disposed as well as the total radioactivity in curies of each radionuclide that was disposed.

(b) An environmental report or a supplement to an environmental report prepared in accordance with subpart A of part 51 of this chapter must accompany the application.

52 (c) Upon review and consideration of an application to amend the license for closure submitted in accordance with paragraph (a) of this section, the Commission shall will issue an amendment authorizing closure if there is reasonable assurance that the long-term performance objectives of subpart C of this part will be met.

§ 61.29 Post-closurePostclosure observation and maintenance.

Following completion of closure authorized in § 61.28(c), the licensee shall must observe, monitor, and carry out necessary maintenance and repairs at the disposal site until the license is transferred by the Commission in accordance with § 61.30. Responsibility for the disposal site must be maintained by the licensee for 5 years. A shorter or longer time period for post-closurepostclosure observation and maintenance may be established and approved as part of the site closure plan, based on site-specific conditions.

§ 61.30 Transfer of license.

(a) Following closure and the period of post-closurepostclosure observation and maintenance, the licensee may apply for an amendment to transfer the license to the disposal site owner. The license amendment request will be approved and the license transferred shall be transferred whenif the Commission finds:

(1) That the closure of the disposal site has been made in conformance with the licensee's disposal site closure plan, as amended and approved as part of the license; (2) That reasonable assurance has been provided by the licensee that the performance objectives of subpart C of this part are met; (3) That any funds for care and records required by § 61.80 (e) and (f) have been transferred to the disposal site owner;

53 (4) That the post-closurepostclosure monitoring program is operational for implementation by the disposal site owner; and (5) That the Federal or State government agency which will assume responsibility for institutional control of the disposal site is prepared to assume responsibility and ensure that the institutional requirements found necessary under § 61.23(g) will be met.

§ 61.31 Termination of license.

(a) Following any period of institutional control needed to meet the requirements found necessary under § 61.23, the licensee may apply for an amendment to terminate the license.

(b) This application must be filed, and will be reviewed, in accordance with the provision of § 61.20 and of this section.

(c) A license is terminated only when the Commission finds:

(1) That the institutional control requirements found necessary under § 61.23(g) have been met; and (2) That any additional requirements resulting from new information developed during the institutional control period have been met, and that permanent monuments or markers warning against intrusion have been installed.

(3) That the records required by § 61.80 (e) and (f) have been sent to the party responsible for institutional control of the disposal site and a copy has been sent to the Commission immediately prior to license termination.

US/IAEA Safeguards Agreement

54

§ 61.32 Facility information and verification.

(a) In response to a written request by the Commission, each applicant for a license and each recipient of a license shall must submit facility information, as described in § 75.10 of this chapter, on IAEA Design Information Questionnaire forms and site information on DOC/NRC Form AP-A, and associated forms; (b) As required by the Additional Protocol, applicants and licensees specified in paragraph (a) of this section shall must submit location information described in § 75.11 of this chapter on DOC/NRC Form AP-1 and associated forms; and (c) Applicants and licensees specified in paragraph (a) of this section Shall Mmust permit verification thereof by the International Atomic Energy Agency (IAEA) and take other action as necessary to implement the US/IAEA Safeguards Agreement, as described in Part 75 of this chapter.

Subpart C - Performance Objectives

§ 61.40 General requirement.

Land disposal facilities must be sited, designed, operated, closed, and controlled after closure so that reasonable assurance exists that exposures to humans are within the limits established in the performance objectives in §§ 61.41 through 61.44.

§ 61.41 Protection of the general population from releases of radioactivity.

(a) Concentrations of radioactive material which that may be released from the disposal site to the general environment in groundwater, surface water, air, soil, plants, or animals must not result in an annual dose exceeding an a dose equivalent of 0.25 milliSievert (25 millirems) to the

55 whole body, 75 millirems to the thyroid, and 25 millirems to any other organ of any member of the public within the compliance period. Reasonable effort should be made to maintain releases of radioactivity in effluents from the disposal siteto the general environment as low as is reasonably achievable during the compliance period. Compliance with this paragraph must be demonstrated in the performance assessment.

(b) Releases of radioactivity from the disposal site must be reduced to the extent reasonably achievable during the performance period. Compliance with this paragraph must be demonstrated through performance period analyses.

(c) For licensees who meet the criteria in § 61.1(b)(1) of this part and choose to comply with the requirements in § 61.1(b)(2) of this part, concentrations of radioactive material which may be released to the general environment in groundwater, surface water, air, soil, plants, or animals must not result in an annual dose exceeding an equivalent of 25 millirems to the whole body, 75 millirems to the thyroid, and 25 millirems to any other organ of any member of the public.

Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.

§ 61.42 Protection of individuals from inadvertent intrusion.

(a) Design, operation, and closure of the land disposal facility must ensure protection of any individual inadvertently intrudinginadvertent intruder into the disposal site who occupies the site or contacts and occupying the site or contacting the waste at any time after active institutional controls over the disposal site are removed. The annual dose must not exceed 5 milliSieverts (500 millirems) to any inadvertent intruder within the compliance period. Compliance with this paragraph must be demonstrated through the inadvertent intruder assessment.

56 (b) Exposures to an inadvertent intruder must be reduced to the extent reasonably achievable during the performance period. Compliance with this paragraph must be demonstrated through the performance period analyses.

(c) For licensees who meet the criteria in § 61.1(b)(1) of this part and choose to comply with the requirements in § 61.1(b)(2) of this part, design, operation, and closure of the land disposal facility must ensure protection of any individual inadvertently intruding into the disposal site and occupying the site or contacting the waste at any time after active institutional controls over the disposal site are removed.

§ 61.43 Protection of individuals during operations.

Operations at the land disposal facility must be conducted in compliance with the standards for radiation protection set out in part 20 of this chapter, except that the annual dose to a member of the public fromfor releases of radioactivity in effluents from the land disposal facility must not exceed an annual dose equivalent of, which 0.25 milliSievert (25 millirems)shall be governed by

§ 61.41 of this part. Every reasonable effort shall must be made to maintain radiation exposures as low as is reasonably achievable. Compliance with this section must be demonstrated through the operational safety assessment.

§ 61.44 Stability of the disposal site after closure.

The land disposal facility must be sited, designed, used, operated, and closed to achieve long-term stability of the disposal site. and to During the institutional control period, eliminate to the extent practicable practical the need for ongoing active maintenance of the disposal site

57 following site closure so that only surveillance, monitoring, or minor custodial care are required.

Compliance with this section must be demonstrated through the site stability assessment.

Subpart D - Technical Requirements for Land Disposal Facilities

§ 61.50 Disposal site suitability requirements for land disposal.

(a) Disposal site suitability for near-surface disposal. (1) The purpose of this section is to specify the minimum characteristics a disposal site must have possess to be acceptable for the disposal of waste in the near surfaceuse as a near-surface disposal facility. The primary emphasis in of disposal site suitability requirements is to avoid sites with disruptive processes and events and given to foster favorable conditions that will provide reasonable assurance that the performance objectives of subpart C of this part will be met, rather than isolation of wastes, a matter having long-term impacts, and to disposal site features that ensure that the long-term performance objectives of subpart C of this part are met, as opposed to short-term convenience or benefits to site operation. The disposal site must meet the following minimum requirements:

(12) The disposal site shall must be capable of being characterized, modeled, analyzed, and monitored to the extent that the long-term performance objectives of subpart C of this part can be met.

(23) The disposal site must have the following hydrologic characteristics present for at least 500 years following closure of the land disposal facility:Within the region or state where the facility is to be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of subpart C of this part.

58 (4) Areas must be avoided having known natural resources which, if exploited, would result in failure to meet the performance objectives of subpart C of this part.

(i5) The disposal site must be generally well drained and free of areas of flooding or frequent ponding. Waste disposal shall must not take place in a poorly drained site, a site subject to flooding or frequent ponding, a 100-year flood plain, coastal high-hazard area or wetland, as defined in Executive Order 11988, Floodplain Management Guidelines., or wetlands, as defined in Executive Order 11990, Protection of Wetlands.

(ii6) Upstream drainage areas must be minimized controlled to decrease minimize the amount of runoff which could erode or inundate waste disposal units.

(iii7) The disposal site must provide sufficient depth to the water table such that waste is not disposed within a saturated zone nor a zone of water table fluctuation, perennial or otherwisethat groundwater intrusion, perennial or otherwise, into the waste will not occur. The Commission will consider an exception to this requirement to allow disposal below the water table if it can be conclusively shown that disposal site characteristics will result in molecular diffusion being the predominant means of radionuclide movement and the rate of movement will result in the performance objectives of subpart C of this part being met. In no case will waste disposal be permitted in the zone of fluctuation of the water table.

(iv8) The hydrogeologic unit or layer within which the disposal unit is located used for disposal shall must not discharge groundwater to the surface within the disposal site.

(3) After 500 years, if any of the hydrologic characteristics specified in paragraph (2) of this section are present, they must not significantly affect the ability of the disposal site to meet the performance objectives of subpart C of this part.

59 (4) The projected population growth and future developments in the vicinity of the land disposal facility are not likely to affect the ability of the land disposal facility to meet the performance objectives of subpart C of this part or to preclude defensible modeling due to large uncertainties.

(5) The land disposal facility must not be located in, or in the immediate vicinity of, an area:

(i) having known natural resources which, if exploited, would result in the failure of the disposal site to meet the performance objectives of subpart C of this part; (ii9) Areas must be avoided where tectonic processes such as faulting, folding, seismic activity, or vulcanism may occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of subpart C of this part, or may to preclude defensible modeling and prediction of long-term impactsresults due to large uncertainties; (iii10) Areas must be avoided where surface geologic processes such as mass wasting, erosion, slumping, landslidesing, or weathering occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of subpart C of this part, or may to preclude defensible modeling and prediction of long-term impactsresults due to large uncertainties; and (iv11) The disposal site must not be located where nearby facilities or activities could adversely significantly affectimpact the ability of the disposal site to meet the performance objectives of subpart C of this part or significantly mask the environmental monitoring program.

(b) Disposal site suitability requirements for land disposal other than near-surface. [Reserved]

§ 61.51 Disposal site design for land disposal.

60 (a) Disposal site design for near-surface disposal. (1) Site design features must be directed toward long-term isolation of the waste and must avoid avoidance of the need for continuing to continue active maintenance after site closure.

(2) The disposal site design and operation must be compatible with the disposal site closure and stabilization plan and lead to disposal site closure that provides reasonable assurance that the performance objectives of subpart C of this part will be met.

(3) The disposal site must be designed to complement and improve, where appropriate, the ability of the disposal site's natural characteristics to assure that the performance objectives of subpart C of this part will be met.

(4) Covers must be designed, to the extent practical, to minimize to the extent practicable water infiltration, to direct percolating or surface water away from the disposed waste, and to resist degradation by surface geologic processes and biotic activity.

(5) Surface features must direct surface water drainage away from disposal units at velocities and gradients which will not result in erosion that will require ongoing active maintenance in the future.

(6) The disposal site must be designed, to the extent practical, to minimize to the extent practicable the contact of water with waste during storage, the contact of standing water with waste during disposal, and the contact of percolating or standing water with wastes after disposal.

(b) Disposal site design for other than near-surface disposal. [Reserved]

§ 61.52 Land disposal facility operation and disposal site closure.

61 (a) Near-surface disposal facility operation and disposal site closure. (1) Wastes designated as Class A pursuant to § 61.55, must be segregated from other wastes by placing the Class A waste in disposal units which that are sufficiently separated from disposal units containing for the other waste classes so such that any interaction between Class A wastes and other wastes will not result in the failure to meet the performance objectives in subpart C of this pPart. This segregation is not necessary for Class A wastes if they meet the stability requirements in § 61.56(b) of this part.

(2) Wastes designated as Class C pursuant to § 61.55, must be disposed of so that the top of the waste is a minimum of 5 meters below the top surface of the cover or must be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for a least 500 years.

(3) Wastes designated as Greater-Than-Class C pursuant to § 61.55 and with concentrations of alpha emitting transuranic nuclides with half-lives greater than 5 years that are equal to or less than 10,000 nanocuries per gram, may be disposed in the near-surface provided that the top of the waste is a minimum of 5 meters below the top surface of the cover and must be disposed with intruder barriers that are designed to protect against an inadvertent intrusion for a least 500 years.

(4) Wastes designated as Greater-Than-Class C pursuant to § 61.55 and with concentrations of alpha emitting transuranic nuclides with half-lives greater than 5 years that exceed 10,000 nanocuries per gram must be disposed in accordance with § 61.55(a)(2)(v).

(53) All wastes meeting the criteria of paragraphs (a)(1) through (3) of this section shall must be disposed of in accordance with the requirements of paragraphs (a) (64) through (1117) of this section.

62 (64) Wastes must be emplaced in a manner that maintains the package integrity during emplacement, minimizes the void spaces between packages, and permits the void spaces to be filled.

(75) Void spaces between waste packages must be filled with earth or other material to reduce future subsidence within the fill.

(86) Waste must be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of §§ 20.1301 and 20.1302 of this chapter at the time the license is transferred pursuant to § 61.30 of this part.

(97) The boundaries and locations of each disposal unit (e.g., trenches) must be accurately located and mapped by means of a land survey. Near-surface disposal units must be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points, referenced to United States Geological Survey (USGS) or National Geodetic Survey (NGS) survey control stations, must be established on the site to facilitate surveys. The USGS or NGS control stations must provide horizontal and vertical controls as checked against USGS or NGS record files.

(108) A buffer zone of land must be maintained between any buried waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall must be of adequate dimensions to allow a licensee to carry out environmental monitoring activities specified in § 61.53(d) of this part and take mitigative measures if needed.

(119) Closure and stabilization measures as set forth in the approved site closure plan must be carried out as each disposal unit (e.g., each trench) is filled and covered.

63 (1012) Active waste disposal operations must not have an adverse effect on completed closure and stabilization measures.

(1113) Only wastes containing or contaminated with radioactive materials shall must be disposed of at the disposal site.

(14) Waste accepted for disposal at a land disposal facility must meet that facilitys waste acceptance criteria.

(15) Waste must be disposed consistent with the description provided in § 61.12(f) of this part and the licensee must not operate the land disposal facility in a manner that would be inconsistent with the technical analyses.

(16) Greater-Than-Class C waste must be disposed so as to not produce thermal effects that would significantly degrade the performance of the disposal site.

(17) Greater-Than-Class C waste must be disposed in a manner that limits the potential for a criticality event.

(18) Significant quantities of uranium must be disposed so that the top of the waste is a minimum of 5 meters below the top of the surface cover.

(b) Facility operation and disposal site closure for land disposal facilities other than near-surface. [Reserved]

§ 61.53 Environmental monitoring.

(a) At the time a license application is submitted, the applicant shall must have conducted a preoperational monitoring program to provide basic environmental data on the disposal site characteristics. The applicant shall must obtain information and data concerningabout the

64 ecology, meteorology, climate, hydrology, geology, geomorphology, geochemistry, and seismology of the disposal site. For those characteristics that are subject to seasonal variation, data must cover at least a twelve 12-month period..

(b) At the time a license application is submitted, The the licensee applicant must have plans for taking corrective measures during the lifespan of the facility if migration of radionuclides would indicate that the performance objectives of subpart C may not be met.

(c) During the land disposal facility site construction and operation, the licensee shall must maintain a monitoring program. Measurements and observations must be made and recorded to provide data to evaluate the potential health and environmental impacts during both the construction and the operation of the facility and to enable the evaluation of long-term effects and the need for mitigative measures. The monitoring system must be capable of providing early warning of releases of radionuclides from the disposal site before they leave the site boundary.

(d) After the disposal site is closed, the licensee, in accordance with § 61.29 of this part, is responsible for post-operational surveillance of the disposal site shall must maintain a monitoring system based on the operating history and the closure and stabilization of the disposal site. The monitoring system must be capable of providing early warning of releases of radionuclides from the disposal site before they leave the site boundary.

§ 61.54 Alternative requirements for design and operations.

The Commission may, upon request or on its own initiative, authorize provisions other than those set forth in §§ 61.51 through 61.53 for the segregation and disposal of waste and for the design and operation of a land disposal facility on a specific basis, if it finds reasonable assurance of compliance with the performance objectives of subpart C of this part.

65

§ 61.55 Waste classification.

(a) Classification of waste for near surface disposal -

(1) Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste formwasteform, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste formwasteform, and disposal methods are effective.

(2) Classes of waste. (i) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in § 61.56(a). If Class A waste also meets the stability requirements set forth in § 61.56(b), it is not necessary to segregate the waste for disposal.

Class A waste that does not meet the stability requirements of § 61.56(b) must be segregated from other waste.

(ii) Class B waste is waste that must meet more rigorous requirements on waste formwasteform to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in § 61.56(a) and (b). Class B wasteforms or containers, to the extent practical, must be designed to be stable (i.e., maintain gross physical properties and identity) over 300 years.

66 (iii) Class C waste is waste that not only must meet more rigorous requirements on waste formwasteform to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in § 61.56(a) and (b). Class C wasteforms or containers, to the extent practical, must be designed to be stable (i.e., maintain gross physical properties and identity) over 300 years.

(iv) Greater-Than-Class C waste is waste that not only must meet the requirements for Class C waste but also the additional requirements set forth in § 61.56(c).

(viv) Waste that is not generally acceptable for near-surface disposal is waste for which form and disposal methods are different, and in general more stringent, than those specified for Class C waste. includes Greater-Than-Class C waste with concentrations of alpha emitting transuranic nuclides with half-lives greater than 5 years exceeding 10,000 nanocuries per gram.

In the absence of specific requirements in this part, Ssuch waste must be disposed of in a geologic repository as defined in part 60 or 63 of this chapter unless proposals for disposal of such waste (e.g., specialized design and disposal methods) in a disposal site licensed pursuant to this part are approved by the Commission.

(3) Classification determined by long-lived radionuclides. If radioactive waste contains only radionuclides listed in Table 1, classification shall beis determined as follows:

(i) If the concentration does not exceed 0.1 times the value in Table 1, the waste is Class A.

(ii) If the concentration exceeds 0.1 times the value in Table 1 but does not exceed the value in Table 1, the waste is Class C.

67 (iii) If the concentration exceeds the value in Table 1, the waste is not generally acceptable for near-surface disposalGreater-Than-Class C.

(iv) For wastes containing mixtures of radionuclides listed in Table 1, the total concentration shall be is determined by the sum of fractions rule described in paragraph (a)(7) of this section.

Table 1 Radionuclide Concentration curies per cubic meter C-14 8

C-14 in activated metal 80 Ni-59 in activated metal 220 Nb-94 in activated metal 0.2 Tc-99 3

I-129 0.08 Alpha emitting transuranic nuclides with half-life greater than 5 years 1 100 Pu-241 1 3,500 Cm-242 1 20,000 1 Units are nanocuries per gram.

(4) Classification determined by short-lived radionuclides. If radioactive waste does not contain any of the radionuclides listed in Table 1, classification shall beis determined based on the concentrations shown in Table 2. However, as specified in paragraph (a)(6) of this section, if radioactive waste does not contain any nuclides listed in either Table 1 or 2, it is Class A.

(i) If the concentration does not exceed the value in Column 1, the waste is Class A.

(ii) If the concentration exceeds the value in Column 1, but does not exceed the value in Column 2, the waste is Class B.

68 (iii) If the concentration exceeds the value in Column 2, but does not exceed the value in Column 3, the waste is Class C.

(iv) If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposalGreater-Than-Class C.

(v) For wastes containing mixtures of the nuclides listed in Table 2, the total concentration shall beis determined by the sum of fractions rule described in paragraph (a)(7) of this section.

Table 2 Radionuclide Concentration, curies per cubic meter Col. 1 Col. 2 Col. 3 Total of all nuclides with less than 5 year5-year half-life 700 (1)

(1)

H-3 40 (1)

(1)

Co-60 700 (1)

(1)

Ni-63 3.5 70 700 Ni-63 in activated metal 35 700 7000 Sr-90 0.04 150 7000 Cs-137 1

44 4600 1 There are no limits established for these radionuclides in Class B or C wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall beare Class B unless the concentrations of other nuclides in Table 2 determine the waste to be Class C or Greater-Than-Class C independent of these nuclides.

(5) Classification determined by both long-and short-lived radionuclides. If radioactive waste contains a mixture of radionuclides, some of which are listed in Table 1, and some of which are listed in Table 2, classification shall beis determined as follows:

69 (i) If the concentration of a nuclide listed in Table 1 does not exceed 0.1 times the value listed in Table 1, the class shall beis that determined by the concentration of nuclides listed in Table 2.

(ii) If the concentration of a nuclide listed in Table 1 exceeds 0.1 times the value listed in Table 1 but does not exceed the value in Table 1, the waste shall beis Class C, provided the concentration of nuclides listed in Table 2 does not exceed the value shown in Column 3 of Table 2.

(iii) If the concentration of a nuclide listed in Table 1 exceeds the value in Table 1 or the value provided in Column 3 of Table 2, the waste is Greater-Than-Class C.

(6) Classification of wastes with radionuclides other than those listed in Tables 1 and 2 of this section. If radioactive waste does not contain any nuclides listed in either Table 1 or 2 of this section, it is Class A.

(7) The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each nuclide's concentration by the appropriate limit and adding the resulting values.

The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 50 Ci/m3 and Cs-137 in a concentration of 22 Ci/m3. Since the concentrations both exceed the values in Column 1, Table 2, they must be compared to Column 2 values. For Sr-90 fraction 50/150 = 0.33; for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B.

(8) Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors which relate the inferred

70 concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as nanocuries per gram.

(b) [Reserved]

§ 61.56 Waste characteristics.

(a) The following requirements are minimum requirementsapply for all classes of waste and are intended to facilitate handling at the disposal site and provide protection of health and safety of personnel at the disposal site.

(1) Waste must not be packaged for disposal in cardboard or fiberboard boxes.

(2) Liquid waste must be solidified or packaged in sufficient absorbent material to absorb twice the volume of the liquid.

(3) Solid waste containing liquid shall must contain as little free standing and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid must not exceed 1% of the volume.

(4) Waste must not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

(5) Waste must not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with paragraph (a)(7) of this section.

(6) Waste must not be pyrophoric. Pyrophoric materials contained in waste shall must be treated, prepared, and packaged to be nonflammable.

71 (7) Waste in a gaseous form must be packaged at a pressure that does not exceed 1.5 atmospheres at 20 °C. Total activity must not exceed 100 curies per container.

(8) Waste containing hazardous, biological, pathogenic, or infectious material must be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials.

(b) The requirements in this section are intended to provide stability of the waste. Stability is intended to ensure that the waste does not structurally degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since because it provides a recognizable and nondispersible waste.

(1) Waste must have structural stability. A structurally stable waste formwasteform will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste formwasteform itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.

(2) Notwithstanding the provisions in § 61.56(a) (2) and (3), liquid wastes, or wastes containing liquid, must be converted into a form that contains as little free standing and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid must not exceed 1% of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.

(3) Void spaces within the waste and between the waste and its package must be reduced to the extent practicable.

72 (c) The following requirements are additional requirements for the near-surface disposal of Greater-Than-Class C waste.

(1) Waste must not generate heat in amounts that impact the release of radioactive material from the disposal site or the long-term stability of the disposal site.

(2) Waste must not contain quantities and concentrations of fissionable radionuclides that could result in criticality.

(3) Waste must not emit radiation at levels that could lead to degradation of the disposal environment conditions, such as through radiolysis.

(4) Waste must not be dispersible.

§ 61.57 Labeling.

Each package of waste must be clearly labeled to indicate the waste class identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55 when shipped for disposal in a land disposal facility. Each package of waste also must be clearly labeled to identify any additional information required by the land disposal facilitys criteria for waste acceptance developed in accordance with § 61.58.

§ 61.58 Alternative requirements for waste classification and characteristics.Waste acceptance.

The Commission may, upon request or on its own initiative, authorize other provisions for the classification and characteristics of waste on a specific basis, if, after evaluation, of the specific characteristics of the waste, disposal site, and method of disposal, it finds reasonable assurance of compliance with the performance objectives in subpart C of this part.

73 (a) Waste acceptance criteria. Each licensee must implement waste acceptance criteria approved by the Commission, that provide reasonable assurance of compliance with the performance objectives of subpart C of this part. Waste acceptance criteria may be either generic or site specific.

(1) Generic waste acceptance criteria. Licensees may implement the generic waste acceptance criteria set forth in § 61.55 and § 61.56.

(2) Site specific waste acceptance criteria. Licensees may implement site specific waste acceptance criteria that have been approved by the Commission. Site specific waste acceptance criteria must provide safety equivalent to the requirements in § 61.56. Site specific waste acceptance criteria must specify the following:

(i) Allowable activities and concentrations of specific radionuclides. The allowable activities and concentrations for each specific radionuclide that the licensee intends to accept for disposal, developed from the technical analyses.

(ii) Acceptable wasteform characteristics and waste container specifications. The wasteform characteristics of the waste to be accepted for disposal and the specifications for all waste containers that will be deployed during operations at the facility.

(iii) Restrictions or prohibitions on waste, materials, or containers that might affect the facilitys ability to meet the performance objectives in subpart C of this part.

(b) Waste characterization. Each licensee must implement methods for characterizing the waste to be accepted for disposal that have been approved by the Commission. The methods must identify the characterization parameters and acceptable uncertainty in the characterization data.

The following information is required to characterize waste:

74 (1) Physical and chemical characteristics of the waste; (2) Waste volume, including any stabilization or absorbent media; (3) Weight of the container and contents; (4) Radionuclide identities, activities, and concentrations; (5) Characterization date; (6) Generating source; and (7) Any other information needed to characterize the waste to demonstrate that the waste acceptance criteria set forth in § 61.58(a) are met.

(c) Waste certification program. Each licensee must implement a program approved by the Commission to certify that waste, prior to shipment to the land disposal facility, meets the waste acceptance criteria developed for the facility in accordance with paragraph (a) of this section.

The certification program must:

(1) Provide procedures for designating authority to certify and receive waste for disposal at the facility.

(2) Provide procedures for certifying that the waste to be received at the facility meets the waste acceptance criteria.

(3) Specify documentation required for waste acceptance including waste characterization, shipment information (including the information described in appendix G to part 20 of this chapter), and certification.

75 (4) Identify records, reports, tests, and inspections that are necessary to comply with the requirements in § 61.80 of this part.

(5) Provide approaches for managing waste that has been certified as meeting the waste acceptance criteria in a manner that maintains its certification status.

(d) The approved waste acceptance criteria will be incorporated into the facility license.

(e) Each licensee must annually review the implementation of the waste acceptance criteria, waste characterization methods, and certification program. The review must be documented and maintained in accordance with § 61.80 of this part.

§ 61.59 Institutional requirements.

(a) Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the Federal or a State government.

(b) Institutional control. The land owner or custodial agency shall must carry out an institutional control program to physically control access to the disposal site following transfer of control of the disposal site from the disposal site operator. The institutional control program must also include, but not be limited to, carrying out an environmental monitoring program at the disposal site, periodic surveillance, minor custodial care, and other requirements as determined by the Commission; and administration of funds to cover the costs for these activities. The period of institutional controls will be determined by the Commission. For technical analyses, but institutional controls may not be relied upon for more than 100 years following transfer of control of the disposal site to the owner.

Subpart E - Financial Assurances

76

§ 61.61 Applicant qualifications and assurances.

Each applicant shall must show that it either possesses the necessary funds or has reasonable assurance of obtaining the necessary funds, or by a combination of the two, to cover the estimated costs of conducting all licensed activities over the planned operating life of the project, including costs of construction and disposal.

§ 61.62 Funding for disposal site closure and stabilization.

(a) The applicant shall must provide assurance that sufficient funds will be available to carry out disposal site closure and stabilization, including: (1) Decontamination or dismantlement of land disposal facility structures; and (2) closure and stabilization of the disposal site so that following transfer of the disposal site to the site owner, the need for ongoing active maintenance is eliminated to the extent practicable and only minor custodial care, surveillance, and monitoring are required. These assurances shall must be based on Commission-approved cost estimates reflecting the Commission-approved plan for disposal site closure and stabilization. The applicant's cost estimates must take into account total capital costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

(b) In order to avoid unnecessary duplication and expense, the Commission will accept financial sureties that have been consolidated with earmarked financial or surety arrangements established to meet requirements of other Federal or State agencies and/or local governing bodies for such decontamination, closure and stabilization. The Commission will accept this arrangement only if they are considered adequate to satisfy these requirements and that the portion of the surety which covers the closure of the disposal site is clearly identified and committed for use in accomplishing these activities.

77 (c) The licensee's surety mechanism will be annually reviewed by the Commission to assure that sufficient funds are available for completion of the closure plan, assuming that the work has to be performed by an independent contractor.

(d) The amount of surety liability should change in accordance with the predicted cost of future closure and stabilization. Factors affecting closure and stabilization cost estimates include:

inflation; increases in the amount of disturbed land; changes in engineering plans; closure and stabilization that has already been accomplished and any other conditions affecting costs. This will yield a surety that is at least sufficient at all times to cover the costs of closure of the disposal units that are expected to be used before the next license renewal.

(e) The term of the surety mechanism must be open ended unless it can be demonstrated that another arrangement would provide an equivalent level of assurance. This assurance could be provided with a surety mechanism which is written for a specified period of time (e.g., five years) yet which must be automatically renewed unless the party who issues the surety notifies the Commission and the beneficiary (the site owner) and the principal (the licensee) not less than 90 days prior to the renewal date of its intention not to renew. In such a situation the licensee must submit a replacement surety within 30 days after notification of cancellation. If the licensee fails to provide a replacement surety acceptable to the Commission, the site owner may collect on the original surety.

(f) Proof of forfeiture must not be necessary to collect the surety so that in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall must be automatically collected prior to its expiration. The conditions described above would have to be clearly stated on any surety instrument which is not open-ended, and must be agreed to by all parties. Liability under the surety mechanism must remain in effect until the

78 closure and stabilization program has been completed and approved by the Commission and the license has been transferred to the site owner.

(g) Financial surety arrangements generally acceptable to the Commission include: surety bonds, cash deposits, certificates of deposits, deposits of government securities, escrow accounts, irrevocable letters or lines of credit, trust funds, and combinations of the above or such other types of arrangements as may be approved by the Commission. However, self-insurance, or any arrangement which essentially constitutes pledging the assets of the licensee, will not satisfy the surety requirement for private sector applicants since this provides no additional assurance other than that which already exists through license requirements.

§ 61.63 Financial assurances for institutional controls.

(a) Prior to the issuance of the license, the applicant shall must provide for Commission review and approval a copy of a binding arrangement, such as a lease, between the applicant and the disposal site owner that ensures that sufficient funds will be available to cover the costs of monitoring and any required maintenance during the institutional control period. The binding arrangement will be reviewed periodically by the Commission to ensure that changes in inflation, technology and disposal facility operations are reflected in the arrangements.

(b) Subsequent changes to the binding arrangement specified in paragraph (a) of this section relevant to institutional control shall must be submitted to the Commission for approval.

Subpart F - Participation by State Governments and Indian Tribes

§ 61.70 Scope.

This subpart describes mechanisms through which the Commission will implement a formal request from a State or tribal government to participate in the review of a license application for

79 a land disposal facility. Nothing in this subpart may be construed to bar the State or tribal governing body from participating in subsequent Commission proceedings concerning the license application as provided under Federal law and regulations.

§ 61.71 State and Tribal government consultation.

Upon request of a State or tribal governing body, the Director shall must make available Commission staff to discuss with representatives of the State or tribal governing body information submitted by the applicant, applicable Commission regulations, licensing procedures, potential schedules, and the type and scope of State activities in the license review permitted by law. In addition, staff shall must be made available to consult and cooperate with the State or tribal governing body in developing proposals for participation in the license review.

§ 61.72 Filing of proposals for State and Tribal participation.

(a) A State or tribal governing body whose interest is affected by a near-surface disposal facility at the proposed site may submit to the Director a proposal for participation in the review of a license application. Proposals must be submitted within the following time periods:

(1) For the State in which the disposal facility will be located, or any State that is member of an interstate compact that includes the State in which the disposal facility is located, no later than 45 days following publication in the Federal Register of the notice of tendering of an application submitted under § 61.20.

(2) For any other State, or for a tribal governing body, no later than 120 days following publication in the Federal Register of the notice of tendering of an application submitted under § 61.20.

80 (b) Proposals for participation in the licensing process must be made in writing and must be signed by the Governor of the State or the official otherwise provided for by State or tribal law.

(c) At a minimum, proposals must contain each of the following items of information:

(1) A general description of how the State or Tribe wishes to participate in the licensing process specifically identifying those issues it wishes to review.

(2) A description of material and information which the State or Tribe plans to submit to the Commission for consideration in the licensing process. A tentative schedule referencing steps in the review and calendar dates for planned submittals should be included.

(3) A description of any work that the State or Tribe proposes to perform for the Commission in support of the licensing process.

(4) A description of State or Tribal plans to facilitate local government and citizen participation.

(5) A preliminary estimate of the types and extent of impacts which the State expects, should a disposal facility be located as proposed.

(6) If desired, any requests for educational or information services (seminars, public meetings) or other actions from the Commission such as establishment of additional Public Document Rooms or exchange of State personnel under the Intergovernmental Personnel Act.

§ 61.73 Commission approval of proposals.

(a) Upon receipt of a proposal submitted in accordance with § 61.72, the Director shall must arrange for a meeting between the representatives of the State or Tribal governing body and the Commission staff to discuss the proposal and to ensure full and effective participation by the State or Tribe in the Commission's license review.

81 (b) If requested by a State or Tribal governing body, the Director may approve all or any part of a proposal if the Director determines that:

(1) The proposed activities are within the scope of Commission statutory responsibility and the type and magnitude of impacts which the State or Tribe may bear are sufficient to justify their participation; and (2) The proposed activities will contribute productively to the licensing review.

(c) The decision of the Director will be transmitted in writing to the governor or the designated official of the Tribal governing body.

(d) Participation by a State or Indian Tribe shall must not affect their rights to participate in an adjudicatory hearing as provided by part 2 of this chapter.

Subpart G - Records, Reports, Tests, and Inspections

§ 61.80 Maintenance of records, reports, and transfers.

(a) Each licensee shall must maintain any records and make any reports in connection with the licensed activities as may be required by the conditions of the license or by the rules, regulations, and orders of the Commission.

(b) Records which are required by the regulations in this part or by license conditions must be maintained for a period specified by the appropriate regulations in this chapter or by license condition. If a retention period is not otherwise specified, these records must be maintained and transferred to the officials specified in paragraph (e) of this section as a condition of license termination unless the Commission otherwise authorizes their disposition.

82 (c) Records which must be maintained pursuant to this part may be the original or a reproduced copy or a microform if this reproduced copy or microform is capable of producing copy that is clear and legible at the end of the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall must maintain adequate safeguards against tampering with and loss of records.

(d) If there is a conflict between the Commission's regulations in this part, license condition, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the longest retention period specified takes precedence.

(e) Notwithstanding paragraphs (a) through (d) of this section, the licensee shall must record the location and the quantity of radioactive wastes contained in the disposal site and transfer these records upon license termination to the chief executive of the nearest municipality, the chief executive of the county in which the land disposal facility is located, the county zoning board or land development and planning agency, the State governor and other State, local, and Federal governmental agencies as designated by the Commission at the time of license termination.

(f) Following receipt and acceptance of a shipment of radioactive waste, the licensee shall must record the date that the shipment is received at the disposal facility, the date of disposal of the waste, a traceable shipment manifest number, a description of any engineered barrier or structural overpack provided for disposal of the waste, the location of disposal at the disposal site, the containment integrity of the waste disposal containers as received, any discrepancies between materials listed on the manifest and those received, the volume of any pallets, bracing, or other shipping or onsite generated materials that are contaminated, and are disposed of as contaminated or suspect materials, and any evidence of leaking or damaged disposal

83 containers or radiation or contamination levels in excess of limits specified in Department of Transportation and Commission regulations. The licensee shall must briefly describe any repackaging operations of any of the disposal containers included in the shipment, plus any other information required by the Commission as a license condition. The licensee shall must retain these records until the Commission transfers or terminates the license that authorizes the activities described in this section.

(g) Each licensee shall must comply with the safeguards reporting requirements of §§ 30.55, 40.64, 74.13, and 74.15 of this chapter if the quantities or activities of materials received or transferred exceed the limits of these sections. Inventory reports required by these sections are not required for materials after disposal.

(h) Each licensee authorized to dispose of radioactive waste received from other persons shall must file a copy of its financial report or a certified financial statement annually with the Commission in order to update the information base for determining financial qualifications.

(i) (1) Each licensee authorized to dispose of waste materials received from other persons under this part shall must submit annual reports to the Director, Office of Nuclear Material Safety and Safeguards, by an appropriate method listed in § 60.461.4 of this chapter, with a copy to the appropriate NRC Regional Office shown in appendix D to part 20 of this chapter.

Reports must be submitted by the end of the first calendar quarter of each year for the preceding year.

(2) The reports shall must include (i) specification of the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in airborne effluents during the preceding year, (ii) the results of the environmental monitoring program, (iii) a summary of licensee disposal unit survey and maintenance activities, (iv) a summary, by waste class, of

84 activities and quantities of radionuclides disposed of, (v) any instances in which observed site characteristics were significantly different from those described in the application for a license; and (vi) any other information the Commission may require.

(3) If the quantities of radioactive materials released during the reporting period, monitoring results, or maintenance performed are significantly different from those expected in the materials previously reviewed as part of the licensing action, the report must cover this specifically.

(j) Each licensee shall must report in accordance with the requirements of § 70.52 of this chapter.

(k) Any transfer of byproduct, source, and special nuclear materials by the licensee is subject to the requirements in §§ 30.41, 40.51, and 70.42 of this chapter. Byproduct, source and special nuclear material means materials as defined in these parts, respectively.

(l) In addition to the other requirements of this section, the licensee shall must store, or have stored, manifest and other information pertaining to receipt and disposal of radioactive waste in an electronic recordkeeping system.

(1) The manifest information that must be electronically stored is -

(i) That information required in 10 CFR part 20, appendix G to part 20 of this chapter, with the exception of shipper and carrier telephone numbers and shipper and consignee certifications; and (ii) That information required in paragraph (f) of this section.

85 (2) As specified in facility license conditions, the licensee shall must report the stored information, or subsets of this information, on a computer-readable medium.

(m) Each licensee must maintain waste acceptance records including:

(1) Records for waste acceptance including the waste acceptance criteria, characterization methods, and certification program.

(2) Audits and other reviews of program content and implementation. The licensee must retain records of audits and other reviews for 3 years after the record is made.

(n) Each licensee must maintain records of evaluations whether updates to the technical analyses are warranted, pursuant to § 61.24 (l)(1).

§ 61.81 Tests at land disposal facilities.

(a) Each licensee shall must perform, or permit the Commission to perform, any tests as the Commission deems appropriate or necessary for the administration of the regulations in this part, including tests of:

(1) Radioactive wastes and facilities used for the receipt, storage, treatment, handling and disposal of radioactive wastes.

(2) Radiation detection and monitoring instruments; and (3) Other equipment and devices used in connection with the receipt, possession, handling, treatment, storage, or disposal of radioactive waste.

(b) [Reserved]

§ 61.82 Commission inspections of land disposal facilities.

86 (a) Each licensee shall must afford to the Commission at all reasonable times opportunity to inspect radioactive waste not yet disposed of, and the premises, equipment, operations, and facilities in which radioactive wastes are received, possessed, handled, treated, stored, or disposed of.

(b) Each licensee shall must make available to the Commission for inspection, upon reasonable notice, records kept by it pursuant to the regulations in this chapter. Authorized representatives of the Commission may copy and take away copies of, for the Commission's use, any record required to be kept pursuant to this part.

§ 61.83 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of -

(1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of -

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act;

87 (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

§ 61.84 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 61 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 61 that are not issued under sections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 61.1, 61.2, 61.4, 61.5, 61.6, 61.7, 61.8, 61.10, 61.11, 61.12, 61.13, 61.14, 61.15, 61.16, 61.20, 61.21, 61.22, 61.23, 61.26, 61.30, 61.31, 61.50, 61.51, 61.54, 61.55, 61.58, 61.59, 61.61, 61.63, 61.70, 61.71, 61.72, 61.73, 61.83, and 61.84.

§ 73.67 Licensee fixed site and in-transit requirements for the physical protection of special nuclear material of moderate and low strategic significance.

(b)(1) A licensee is exempt from the requirements of this section to the extent that he possesses, uses, or transports:

88 (i) Special nuclear material which is not readily separable from other radioactive material and which has a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding, or (ii) Sealed plutonium-beryllium neutron sources totaling 500 grams or less contained plutonium at any one site or contiguous sites, or (iii) Plutonium with an isotopic concentration exceeding 80 percent in plutonium-238, or (iv) Radioactive waste under 10 CFR part 61 or Agreement State equivalent containing special nuclear material which is (a) in quantities of low strategic significance prior to disposal, (b) not readily separable from the other radioactive waste material, and (c) is in a concentration of special nuclear material that is no more than 0.01% of the mass of the other waste material.

§ 150.11 Critical mass.

(a) For the purposes of this part, special nuclear material in quantities not sufficient to form a critical mass means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all kinds of special nuclear materials in combination shall must not exceed unity. For example, the following quantities in combination would not exceed the limitation and are within the formula, as follows:

(175 (grams contained U-235 / 350) + (50 grams U-233) / 200) + (50 grams Pu / 200) = 1

89 (b) To determine whether the exemption granted in § 150.10 applies to the receipt, possession or use of special nuclear material at any particular plant or other authorized location of use, a person shall must include in the quantity computed according to paragraph (a) of this section the total quantity of special nuclear material which he the person is authorized to receive, possess or use at the plant or other location of use at any one time.

§ 150.14 Commission regulatory authority for physical protection.

(a) Persons in Agreement States possessing, using or transporting special nuclear material of low strategic significance in quantities greater than 15 grams of plutonium or uranium-233 or uranium-235 (enriched to 20 percent or more in the U-235 isotope) or any combination greater than 15 grams when computed by the equation grams = grams uranium-235 + grams plutonium

+ grams uranium-233 shall must meet the physical protection requirements of § 73.67 of 10 CFR part 73.

(b) [Reserved]

§ 150.15 Persons not exempt.

(a) Persons in Aagreement States are not exempt from the Commission's licensing and regulatory requirements with respect to the following activities:

(1) The construction and operation of any production or utilization facility. As used in this subparagraph, operation of a facility includes, but is not limited to (i) the storage and handling of radioactive wastes at the facility site by the person licensed to operate the facility, and (ii) the discharge of radioactive effluents from the facility site.

90 (2) The export from or import into the United States of byproduct, source, or special nuclear material, or of any production or utilization facility.

(3) The disposal into the ocean or sea of byproduct, source, or special nuclear waste materials, as defined in regulations or orders of the Commission. For purposes of this part, ocean or sea means any part of the territorial waters of the United States and any part of the international waters.

(4) The transfer, storage or disposal of radioactive waste material resulting from the separation in a production facility of special nuclear material from irradiated nuclear reactor fuel. This subparagraph does not apply to the transfer, storage or disposal of contaminated equipment or to radioactive waste material to be disposed at a near-surface land disposal facility.

(5) The disposal of such other byproduct, source, or special nuclear material as the Commission determines by regulation or order should, because of the hazards or potential hazards thereof, not be so disposed of without a license from the Commission.

(6) The transfer of possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from licensing and regulatory requirements of the Commission under Parts 30 and 40 of this chapter.

(7) The storage of:

(i) Spent fuel in an independent spent fuel storage installation (ISFSI) licensed under part 72 of this chapter,

91 (ii) Spent fuel and high-level radioactive waste in a monitored retrievable storage installation (MRS) licensed under part 72 of this chapter, or (iii) Greater-than-Class C waste, as defined in part 72 of this chapter, in an ISFSI or an MRS licensed under part 72 of this chapter; the GTCC waste must originate in, or be used by, a facility licensed under part 50 or part 52 of this chapter.

(iv8) Greater-than-Class C waste, as defined in part 72 of this chapter, that originates in, or is used by, a facility licensed under part 50 or part 52 of this chapter and is licensed under part 30 and/or part 70 of this chapter.

(98) The requirements for the protection of Safeguards information in § 73.21 of this chapter and the requirements in § 73.22 or § 73.23 of this chapter, as applicable.

(b) Notwithstanding any exemptions provided in this part, the Commission may from time to time by rule, regulation, or order, require that the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nuclear material shall not transfer possession or control of such product except pursuant to a license or an exemption from licensing issued by the Commission.