[7590-01-P] 

NUCLEAR REGULATORY COMMISSION 

10 CFR Parts 20 and 61 

[NRC-2011-0012; NRC-2015-0003] 

RIN 3150-AI92 

LOW-LEVEL RADIOACTIVE WASTE DISPOSAL 

AGENCY: Nuclear Regulatory Commission. 

ACTION: Proposed rule. 

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its 

regulations that govern low-level radioactive waste (LLRW) disposal facilities to require new and 

revised site-specific technical analyses, to permit the development of site-specific criteria for 

LLRW acceptance based on the results of these analyses, to facilitate implementation, and to 

better align the requirements with current health and safety standards. This proposed rule 

would affect LLRW disposal licensees or license applicants that are regulated by the NRC or the 

Agreement States. 

DATES: Submit comments on the proposed rule by July 24, 2015. Submit comments specific 

to the information collection aspects of this proposed rule by May 26, 2015. Comments 

received after these dates will be considered if it is practical to do so, but the NRC is able to 

ensure consideration only for comments received on or before these dates. 

ADDRESSES: You may submit comments by any of the following methods (unless this 

document describes a different method for submitting comments on a specific subject): 
2 

• Federal rulemaking Web Site: Go to http://www.regulations.gov and search for 

Docket ID NRC-2011-0012. Address questions about NRC dockets to Carol Gallagher; 

telephone: 301-492-3668; e-mail: Carol.Gallagher@nrc.gov. For technical questions, contact 

one of the individuals listed in the FOR FURTHER INFORMATON CONTACT section of this 

document. 

• E-mail comments to: Rulemaking.Comments@nrc.gov. If you do not receive an 

automatic e-mail reply confirming receipt, then contact us at 301-415-1677. 

• Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 

301-415-1101. 

• Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, 

DC 20555-0001, ATTN: Rulemakings and Adjudications Staff. 

• Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, 

between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677. 

For additional direction on obtaining information and submitting comments, see 

“Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION 

section of this document. 

FOR FURTHER INFORMATION CONTACT: Gary Comfort, telephone: 301-415-8106, e-mail: 

Gary.Comfort@nrc.gov; or Andrew Carrera, telephone: 301-415-1078, e-mail: 

Andrew.Carrera@nrc.gov. Both of the Office of Nuclear Material Safety and Safeguards, U.S. 

Nuclear Regulatory Commission, Washington, DC 20555-0001. 

SUPPLEMENTARY INFORMATION:
3 

EXCUTIVE SUMMARY: 

A. Need for the Regulatory Action 

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations 

that govern low-level radioactive waste (LLRW) disposal facilities to require new and revised 

site-specific technical analyses and to permit the development of criteria for LLRW acceptance 

based on the results of these analyses. These amendments would ensure that LLRW streams 

that are significantly different from those considered during the development of the current 

regulations (i.e., depleted uranium and other unanalyzed waste streams) can be disposed of 

safely and meet the performance objectives for land disposal of LLRW. These amendments 

would also increase the use of site-specific information to ensure performance objectives are 

met that are designed to provide protection of public health and safety. This proposed rule 

would affect LLRW disposal licensees or license applicants that are regulated by the NRC or the 

Agreement States. 

B. Major Provisions 

Major provisions of the proposed rule include changes to: 

• Revise the existing technical analysis for protection of the general population to 

include a 1,000-year compliance period; 

• Add a new site-specific technical analysis for the protection of inadvertent intruders 

that would include a 1,000-year compliance period and a dose limit; 

• Add new analyses that would include a 10,000-year protective assurance period and 

annual dose minimization target; 

• Add a new analysis for certain long-lived LLRW that would include a post-10,000-

year performance period; 
4 

• Add new analyses that would identify and describe the features of the design and 

site characteristics that provide defense-in-depth protections; 

• Add a new requirement to update the technical analyses at closure; and 

• Add a new requirement to develop site-specific criteria for the future acceptance of 

LLRW for disposal based on either the results of these technical analyses or the existing LLRW 

classification requirements. 

C. Costs and Benefits 

 The NRC prepared a draft regulatory analysis to determine the expected quantitative 

costs and benefits of the proposed rule, as well as qualitative factors to be considered in the 

NRC’s rulemaking decision. The analysis concluded that the proposed rule would result in net 

costs to the industry and the NRC. The key findings of the analysis are as follows: 

• Cost to the Industry. The proposed rule would result in an average implementation 

cost per licensee of $1,000,000, followed by an estimated annual cost of $4,000. Overall, the 

industry will incur an estimated implementation cost of $4 million, followed by an estimated 

annual cost of $16,000. 

• Cost to the Agreement States. The proposed rule would result in additional costs to 

the Agreement States with all costs resulting from implementation. On average, each 

Agreement State would incur an estimated implementation cost of $525,000. Overall, the 

Agreement States will incur an estimated implementation cost of $2.1 million. 

• Cost to the NRC. The NRC would incur an implementation cost for drafting and 

implementing a final rulemaking based on the proposed rule. This cost is estimated to be 

$333,000. Because the NRC does not have any LLRW disposal licensees, no annual NRC cost 
5 

is expected. The NRC would also incur an estimated implementation cost of $216,000 for 

drafting a final guidance document based on the final rule. 

The regulatory analysis also considered, in a qualitative fashion, direct benefits that 

would accrue and the indirect benefits from risks that could be avoided if the NRC adopted the 

rule. The principal qualitative benefits of the proposed action would include: 1) ensuring that 

LLRW streams that are significantly different from those considered during the development of 

the current regulations can be disposed of safely and meet the performance objectives for land 

disposal of LLRW; 2) facilitating the use of site-specific information and up-to-date dosimetry 

methodology in site-specific technical analyses to ensure public health and safety is protected; 

and 3) promoting a risk-informed regulatory framework that specifies what requirements need to 

be met and provides flexibility to a licensee or applicant with regard to what information or 

approach they use to satisfy those requirements. 

 The draft regulatory analysis concludes that the proposed rule should be adopted 

because the proposed regulatory initiatives enhance public health and safety by ensuring the 

safe disposal of LLRW that was not analyzed in the regulatory basis for the original part 61 of 

Title 10 of the Code of Federal Regulations (e.g., large quantities of depleted uranium). For 

more information, please see the draft regulatory analysis (Accession No. ML14289A158 in the 

NRC's Agencywide Documents Access and Management System). 

TABLE OF CONTENTS: 

I. Obtaining Information and Submitting Comments. 

 A. Obtaining Information. 

 B. Submitting Comments. 

II. Background. 
6 

A. Existing Regulatory Framework. 

B. Low-Level Radioactive Waste Classification System. 

C. Previous Public Interactions. 

III. Discussion. 

A. What action is the NRC taking? 

B. Who would this action affect? 

C. Why do the regulatory requirements need to be revised? 

D. When would this rule become effective? 

E. What LLRW streams are affected by this proposed rule? 

F. What are site-specific technical analyses? 

1. Performance assessment. 

 2. Intruder assessment. 

 3. Performance period analyses. 

 4. Defense-in-depth analyses. 

 5. Site stability analyses. 

 G. Updated safety case and technical analyses for closure. 

H. What options were considered for selecting approach and timeframes and what 

is the NRC’s preferred option?

 1. Considerations made in developing options. 

2. Options considered. 

3. NRC proposed option. 

 I. Why are the 1,000-year compliance period and 10,000-year protective assurance 

period appropriate? 

 J. Why is a 5 milliSievert per year (500 mrem per year) target appropriate for dose 

minimization during the protective assurance period? 
7 

 K. What are waste acceptance criteria (WAC)? 

 1. Options considered. 

 2. NRC proposed option. 

L. What other changes are proposed? 

1. Adding new definitions to 10 CFR 61.2 and updating concepts in 

10 CFR 61.7. 

2. Implementing changes to appendix G to 10 CFR part 20 to conform to 

proposed LLRW acceptance requirements. 

3. Modifying the site suitability requirements in 10 CFR 61.50 to be 

consistent with the proposed analyses framework. 

4. Updating the dose calculation system used in 10 CFR part 61. 

5. Implementing the safety case in 10 CFR part 61. 

M. What guidance documents will be available? 

N. Are there any cumulative effects of regulation associated with this proposed rule? 

O. Request for additional public comments. 

P. What should I consider as I prepare my comments to submit to the NRC? 

IV. Discussion of Proposed Amendments by Section. 

V. Criminal Penalties. 

VI. Agreement State Compatibility. 

VII. Plain Writing. 

VIII. Voluntary Consensus Standards. 

IX. Draft Environmental Assessment and Draft Finding of No Significant Environmental 

Impact. 

X. Paperwork Reduction Act Statement. 

XI. Regulatory Analysis. 
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XII. Regulatory Flexibility Certification. 

XIII. Backfitting. 

I. Obtaining Information and Submitting Comments. 

A. Obtaining Information. 

 Please refer to Docket ID NRC-2011-0012 when contacting the U.S. Nuclear Regualtory 

Commission (NRC) about the availability of information for this action. You may obtain publiclyavailable information related to this action by any of the following methods: 

• Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for 

Docket ID NRC-2011-0012. 

• NRC's Agencywide Documents Access and Management System (ADAMS): 

You may obtain publicly-available documents online in the ADAMS Public Documents collection 

at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public 

Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, 

please contact the NRC’s Public Document Room (PDR) reference staff at 1-800-397-4209, 

301-415-4737, or by e-mail to pdr.resource@nrc.gov. The ADAMS accession number for each 

document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in 

the SUPPLEMENTARY INFORMATION section. 

• NRC's PDR: You may examine and purchase copies of public documents at the 

NRC’s PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 

20852. 

B. Submitting Comments. 

Please include Docket ID NRC-2011-0012 in your comment submission. 
9 

The NRC cautions you not to include identifying or contact information that you do not 

want to be publicly disclosed in your comment submission. The NRC will post all comment 

submissions at http://www.regulations.gov as well as enter the comment submissions into 

ADAMS. The NRC does not routinely edit comment submissions to remove identifying or 

contact information. 

If you are requesting or aggregating comments from other persons for submission to the 

NRC, then you should inform those persons not to include identifying or contact information that 

they do not want to be publicly disclosed in their comment submission. Your request should 

state that the NRC does not routinely edit comment submissions to remove such information 

before making the comment submissions available to the public or entering the comment into 

ADAMS. 

II. Background. 

A. Existing Regulatory Framework. 

The NRC’s licensing requirements for the disposal of commercial low-level radioactive 

waste (LLRW) in near-surface disposal facilities can be found in part 61 of Title 10 of the Code 

of Federal Regulations (10 CFR), “Licensing Requirements for Land Disposal of Radioactive 

Waste.” The NRC adopted 10 CFR part 61 on December 27, 1982 (47 FR 57446). The 

existing LLRW disposal facilities are located in and licensed by Agreement States, and those 

Agreement States have incorporated many of the requirements in current 10 CFR part 61 into 

their corresponding regulations and as license conditions. 

The current 10 CFR part 61 emphasizes an integrated systems approach to the disposal 

of commercial LLRW, including site selection, disposal facility design and operation, LLRW 

characteristics, and disposal facility closure. To reduce reliance on institutional controls, the 
10 

current 10 CFR part 61 emphasizes passive (e.g., site stability) rather than active systems to 

limit and retard the releases of LLRW to the environment. This integrated systems approach is 

similar to the defense-in-depth concept that has been well known for some time for the NRC’s 

nuclear reactor safety design and licensing activities. However, defense-in-depth is not 

explicitly discussed in the existing 10 CFR part 61 regulations. Currently, the defense-in-depth 

concept is implicitly contained in the 10 CFR part 61 regulations (e.g., requiring that the disposal 

site design complement and improve upon the ability of the site’s natural characteristics to 

ensure the performance objectives will be met; imposing concentration limits on waste that 

presents a higher hazard through the waste classification requirements; requiring the 

segregation of unstable waste from waste that presents a larger hazard and should be stable for 

proper disposal; imposing requirements on wasteform and packaging characteristics; and 

requiring the use of barriers to intrusion for wastes that will not decay to levels which present an 

acceptable hazard to an intruder within 100 years). 

Subparts of the existing 10 CFR part 61 cover general provisions and procedural 

licensing matters; performance objectives; technical requirements for near-surface disposal; 

financial assurance; state and tribal participation; and records, reports, tests, and inspections. 

The regulations cover all phases of near-surface commercial LLRW disposal from site selection 

through facility design, licensing, operations, closure, postclosure stabilization, and the end of 

active institutional controls. The overall philosophy that underlies the regulatory requirements of 

10 CFR part 61 is provided in 10 CFR 61.7, “Concepts.” 

 The following are key provisions in current 10 CFR part 61: 

• Standards for: 1) protection of the general population in 10 CFR 61.41, “Protection 

of the general population from the releases of radioactivity;” 2) protection of an inadvertent 

intruder in 10 CFR 61.42, ”Protection of individuals from inadvertent intrusion;” 3) protection of 

individuals during facility operations in 10 CFR 61.43, “Protection of individuals during 
11 

operations;” and 4) site stability in 10 CFR 61.44, “Stability of disposal site after closure.” These 

standards are collectively known as the “Performance Objectives” in subpart C of 10 CFR 

part 61. 

• Specification of the minimum geologic and geomorphic characteristics for an 

acceptable near-surface LLRW disposal site in 10 CFR 61.50, “Disposal site suitability 

requirements for land disposal.” 

• A LLRW classification system (LLRW being categorized as Class A, Class B, Class 

C, or greater-than-Class C) for commercial LLRW in 10 CFR 61.55, “Waste classification,” 

based on the concentration of certain radionuclides. 

• Specification of the LLRW characteristics in 10 CFR 61.56, “Waste characteristics,” 

that commercial LLRW forms must meet to be acceptable for disposal. 

• Requirements for caretaker oversight in the form of institutional controls of LLRW 

disposal facilities in 10 CFR 61.59, “Institutional requirements,” for a period of 100 years 

following facility closure. 

Currently, to grant a license, the NRC must conclude that there is reasonable assurance 

that the performance objectives will be met. To demonstrate that a license applicant will meet 

these performance objectives, 10 CFR part 61 license applicants need to prepare the analyses 

required by 10 CFR 61.13, “Technical analyses.” 

To demonstrate that the general population is protected from releases of radioactivity, 

license applicants are required to prepare an analysis of exposure pathways leading to potential 

radiological doses to the general population. The current 10 CFR part 61 does not impose a 

specific performance timeframe for use in the analysis to protect the general population, and 

there are currently differences among Agreement States regarding the analysis timeframe. For 

example, some Agreement States have required licensees to analyze the disposal facility for 

only 500 years, while others have required analyses to the peak dose. For certain long-lived 
12 

LLRW, a shorter timeframe for the analysis could result in a situation where the long-term 

impacts from the disposal of long-lived LLRW are not adequately identified in a licensee’s 

analysis. Conversely, the increasing uncertainties associated with very long timeframes could 

diminish the value of the information generated with technical analyses for applicants, 

regulators, and other stakeholders. The NRC has drafted this proposed rule to balance the 

consideration of the risks from disposal of long-lived LLRW with significant uncertainties that 

may be associated with long-term analyses. 

License applicants must also demonstrate that potential inadvertent intruders into the 

LLRW disposal facility will be protected. Inadvertent intruders might occupy the site at any time 

after institutional controls over the LLRW disposal facility are no longer effective and may not be 

aware of the radiation hazard from the LLRW. Under the current regulations, protection of 

inadvertent intruders is demonstrated by compliance with the LLRW classification 

(10 CFR 61.55) and segregation requirements (10 CFR 61.52, “Land disposal facility operation 

and disposal site closure”), and by providing adequate barriers to inadvertent intrusion. The 

NRC developed the LLRW classification requirements as part of the original 10 CFR part 61 

rulemaking. Explicit dose limits for an inadvertent intruder are not currently provided in 

10 CFR part 61 because an intruder dose assessment is not required, but the LLRW 

classification concentration limits for radionuclides, in tables 1 and 2 of 10 CFR 61.55, were 

based on a dose of 5 milliSieverts per year (mSv/yr) (500 millirem per year (mrem/yr)) to an 

inadvertent intruder. The LLRW classification tables were developed assuming that only a 

fraction of the LLRW being disposed would approach the LLRW classification limits (note that 

the dose to an intruder exposed to a large volume of disposed LLRW at the classification limits 

could exceed 5 mSv/yr (500 mrem/yr)). By complying with the LLRW classification and 

segregation requirements, an inadvertent intruder will be protected if the underlying 

assumptions are not violated. 
13 

In the existing 10 CFR part 61 regulations, 10 CFR 61.13(a) through (d) require the 

technical analyses needed to demonstrate that the performance objectives are met. The 

regulations in 10 CFR part 61 are risk-informed and performance-based, and ensure public 

health and safety are protected in the operation of any commercial LLRW disposal facility. 

Applicants can demonstrate how their proposals meet the respective performance objectives for 

the specific near-surface disposal method selected (47 FR 57446). The NRC is proposing to 

modify the current regulations to ensure that LLRW streams that are significantly different than 

those considered in the development of the existing 10 CFR part 61 are adequately considered 

during the licensing of LLRW disposal facilities, to require licensees to explicitly identify how 

disposal site characteristics and design provide defense-in-depth, and to ensure that the 

10 CFR part 61 performance objectives will be met for disposal of those LLRW streams. 

B. Low-Level Radioactive Waste Classification System. 

The NRC developed current 10 CFR part 61 based on assumptions regarding the types 

of LLRW likely to go into a commercial disposal facility. These were based on a survey of 

LLRW generators and the results were published in 1982 in NUREG-0945, “Final Environmental 

Impact Statement on 10 CFR Part 61, ‘Licensing Requirements for Land Disposal of 

Radioactive Waste’” (ADAMS Accession Nos. ML052590184, ML052920727, and 

ML052590187). The results of this survey ultimately formed the regulatory basis for the source 

terms used in the analysis to define the allowable isotopic concentration limits in tables 1 and 2 

of 10 CFR 61.55 that establish four classes of LLRW (Class A, Class B, Class C, and greaterthan-Class-C). Table 1 provides limiting concentrations for long-lived radionuclides and table 2 

provides limiting concentrations for short-lived radionuclides. As the LLRW class increases in 

hazard, greater controls (e.g., protection for a longer period of time or greater burial depth) are 

required in order to reduce the risk from disposal of the LLRW. Class A LLRW is the least 
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hazardous to the inadvertent intruder and requires the fewest controls, while Class C LLRW is 

more hazardous and requires additional controls. For example, Class C LLRW may require 

either greater burial depth or an engineered barrier that will prevent inadvertent intrusion for 500 

years. The additional controls for Class C LLRW reduce the radiological risk from the greater 

hazard. Low-level radioactive waste with greater-than-Class-C concentrations of radionuclides 

is generally not suitable for near-surface disposal because of the radiological risk that can result 

from disposal of this LLRW without adequate barriers or other protective measures. 

 As part of the initial 10 CFR part 61 rulemaking, the NRC considered inadvertent 

intrusion scenarios and the physical stability and isotopic concentration of the LLRW when it 

developed the 10 CFR part 61 LLRW classification system. These isotopic concentration limits 

were based on the NRC’s understanding of the characteristics and volumes of commercial 

LLRW reasonably expected for commercial disposal through the year 2000, as well as the 

potential disposal methods likely to be used. 

In the Statement of Considerations for the final rule (47 FR 57457), the Commission 

noted the following: 

[W]aste that is stable for a long period helps to ensure the long-term stability of 

the site, eliminating the need for active maintenance after the site is closed. This 

stability requirement helps to assure against water infiltration caused by failure of 

the disposal covers and, with the improved leaching properties implicit in a stable 

wasteform, minimizes the potential for radionuclide migration in groundwater. 

Stability also plays an important role in protecting an inadvertent intruder, since 

the stable wasteform is recognizable for a long period of time and minimizes any 

effects from dispersion of the waste upon intrusion. 

The Commission also noted that “to the extent practicable, wasteforms or containers 

should be designed to maintain gross physical properties and identity over 300 years, 

approximately the time required for Class B waste to decay to innocuous levels . . . ” 

(47 FR 57457). 

In addition to determining the acceptability of LLRW for disposal in a near-surface land 
15 

disposal facility, the LLRW classification system is also integral to determining Federal and 

State responsibilities for LLRW and requirements for transfers of LLRW intended for disposal. 

The Low-Level Radioactive Waste Policy Act of 1980 (as amended in 1985) defines Federal 

and State responsibilities for the disposal of LLRW based on 10 CFR 61.55, as in effect on 

January 26, 1983. Specifically, the Act assigns responsibility for disposal of Class A, Class B, 

and Class C commercial LLRW to the States and responsibility for disposal of commercial 

LLRW with concentrations that exceed the limits for Class C LLRW to the Federal Government. 

Appendix G to 10 CFR part 20, “Requirements for Transfers of Low-Level Radioactive 

Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests” (60 FR 15664; 

March 27, 1995), imposes manifest requirements on shipments of LLRW consigned for 

disposal. Manifests for LLRW shipments must identify the LLRW classification and a 

certification that the LLRW is “...properly classified, described, packaged, marked, and 

labeled....” 

C. Previous Public Interactions. 

On May 3, 2011, the NRC published preliminary proposed rule language (76 FR 24831) 

and an associated regulatory basis document, “Technical Analysis Supporting Definition of 

Period of Performance for Low-level Waste Disposal“ (ADAMS Accession No. ML111030586) 

for public comment. The NRC staff conducted a public meeting on May 18, 2011, in Rockville, 

Maryland, to discuss the preliminary proposed rule language and its associated regulatory basis 

document. A summary and transcript of this meeting can be found in ADAMS under Accession 

No. ML111570329. The comment period ended on June 18, 2011, and the NRC received 15 

comment letters from public interest groups, industry, and government organizations. 

As a result of additional direction from the Commission in a SRM-COMWDM-11-

0002/COMGEA-11-0002, “Revisions to Part 61,” dated January 19, 2012 (ADAMS Accession 
16 

No. ML120190360), the NRC staff published, for public comment (77 FR 72997; December 7, 

2012), a second version of the preliminary proposed rule language (ADAMS Accession No. 

ML12311A444) and an associated regulatory basis document, “Regulatory Basis for Proposed 

Revisions to Low-Level Waste Disposal Requirements (10 CFR part 61)” (ADAMS Accession 

No. ML12356A242). The comment period ended on January 7, 2013, and the NRC received an 

additional 24 comment letters from public interest groups, industry, and government 

organizations. Since these early comment periods were outside of the formal proposed rule 

notice-and-comment rulemaking process, the NRC staff did not and does not plan to prepare 

formal responses to the comments received on the preliminary documents. However, the NRC 

staff did consider these comments in the development of the proposed rule and some of the 

comments did result in modifications to the preliminary proposed rule language. 

The NRC staff also briefed the Advisory Committee on Reactor Safeguards (ACRS), 

Radiation Protection and Nuclear Materials Subcommittee, on June 23 and August 17, 2011, 

and the full committee on July 13 and September 8, 2011. The NRC staff again briefed the 

ACRS, Radiation Protection and Nuclear Materials Subcommittee, on April 9, 2013, and the full 

committee on July 10, 2013. Summaries and transcripts of these meetings can be found at the 

ACRS’ Web site, http://www.nrc.gov/about-nrc/organization/acrsfuncdesc.html

Based on early comments and interactions with the ACRS, the NRC staff revised the 

preliminary proposed rule language. 

III. Discussion. 

A. What action is the NRC taking? 

The NRC is proposing to amend 10 CFR part 61 to require LLRW disposal licensees or 

license applicants to prepare a safety case that includes a defense-in-depth analysis and new 
17 

and revised site-specific technical analyses to ensure that LLRW streams that are significantly 

different from the LLRW streams considered in the current 10 CFR part 61 regulatory basis can 

be disposed of safely and meet the performance objectives in subpart C of 10 CFR part 61. 

These new and revised analyses would also more easily identify any additional measures that 

would be prudent to implement for continued disposal of radioactive LLRW at a particular 

facility. 

The NRC is also proposing to amend 10 CFR part 61 to require LLRW disposal facility 

licensees or license applicants to develop site-specific criteria for the acceptability of LLRW for 

disposal. These amendments maintain the existing LLRW classification system, but permit 

disposal facility licensees or license applicants to account for facility design, disposal practices, 

and site characteristics to determine criteria for accepting future shipments of LLRW for disposal 

at their site. Because licensees or license applicants are required to develop site-specific 

criteria for the acceptability of LLRW for disposal, the NRC is also proposing to amend 

appendix G of 10 CFR part 20, “Standards for Protection Against Radiation,” to conform to the 

proposed requirements for LLRW acceptance. The NRC is also proposing additional 

amendments to the regulations to facilitate implementation and better align the requirements 

with current health and safety standards. 

Table 1 compares the proposed new and revised technical analyses to the current 

10 CFR part 61 requirements. The inadvertent intruder assessment would be a new 

requirement under 10 CFR 61.13 to demonstrate compliance with the performance objective to 

protect inadvertent intruders at 10 CFR 61.42. The inadvertent intruder assessment would have 

to demonstrate that the annual dose would not exceed a proposed 5 mSv (500 mrem) limit over 

a newly defined 1,000-year compliance period. A performance assessment would also be 

required for the protection of the general population from releases of radioactivity. This analysis 

would update the current exposure-pathway analysis to use a more modern performance-
18 

assessment methodology that would better align 10 CFR part 61 with the Commission’s policy 

regarding the use of probabilistic risk assessment methods in nuclear regulatory analysis (60 

FR 42622; August 16 1995). The performance assessment would also use a newly defined 

1,000-year compliance period. The performance assessment would retain the current 0.25 mSv 

(25 mrem) annual dose limit and the as low as reasonably achievable (ALARA) concept, but the 

dose methodology would be consistent with the dose methodology specified in the standards for 

radiation protection set forth in the current 10 CFR part 20. 

Given the significant uncertainties inherent in demonstrating compliance with the 

performance objectives over a long timeframe, a protective assurance period analysis would be 

required to demonstrate that the annual dose would be minimized below 5 mSv (500 mrem) or a 

level that is supported as reasonably achievable based on technological and economic 

considerations from the end of the compliance period through 10,000 years. Further, this 

analysis would need to consider new site features and processes occurring at the site that are 

different than what is considered during the compliance period. 

Finally, a qualitative analysis covering a performance period of 10,000 years or more 

after site closure will also be required in 10 CFR 61.13 for those sites disposing of long-lived 

waste or if necessitated by site-specific conditions. This analysis would be required to assess 

how the disposal facility and site characteristics limit the potential long-term radiological 

impacts, consistent with available data and current scientific understanding, for the protection of 

the general population and the inadvertent intruder. 

Defense-in-depth is an integral part of the safety case presented by the disposal 

applicant or licensee. Therefore, the defense-in-depth analyses are required in each one of the 

periods that are analyzed, as noted in Table 1. 
19 

Table 1 - Comparison Table of Current and Proposed 10 CFR Part 61 Regulations 

Protection of 

the general 

population from 

releases of 

radioactivity 

(10 CFR 61.41) 

Protection of 

individual from 

inadvertent 

intrusion 

(10 CFR 61.42) 

Stability of the 

disposal site 

after closure 

Long-term 

analyses 

(10 CFR 61.44) 

Defense-inDepth 

Current 

10 CFR Part 61 

regulations 

- Pathway 

analysis 

- Undefined 

period of 

performance 

- 0.25 mSv (25 

mrem) annual 

whole body dose 

limit for the 

protection of the 

general 

population from 

releases of 

radioactivity 

- ALARA 

concept 

- Comply with 

10 CFR 61.55 

LLRW 

classification and 

segregation 

requirements 

- Provide 

adequate 

barriers to 

inadvertent 

intrusion 

- Undefined 

period of 

performance 

- No annual 

dose limit 

Analyses of 

active natural 

processes that 

demonstrate that 

there will not be 

a need for 

ongoing active 

maintenance of 

the disposal site 

following closure 

Implicit in 

Subpart D 

technical 

requirements 

Proposed 10 

CFR Part 61 

regulations 

Within 1,000 Years Following Closure of Disposal Facility (Compliance 

Period) 

- Performance 

assessment that 

estimates peak 

annual dose that 

occurs within 

1,000 years 

following closure 

of disposal 

facility 

- 0.25 mSv (25 

mrem) annual 

dose limit for the 

protection of the 

general 

population from 

the releases of 

- Comply with 

LLRW 

acceptance 

criteria 

- Provide 

adequate 

barriers to 

inadvertent 

intrusion 

- Intruder 

assessment that 

estimates peak 

annual dose that 

occurs within 

1,000 years 

Analyses of 

active natural 

processes that 

demonstrate that 

long-term 

stability of the 

site can be 

ensured and that 

there will not be 

a need for 

ongoing active 

maintenance of 

the disposal site 

following closure 

Analyses that 

demonstrate the 

proposed 

disposal system 

includes 

defense-in-depth 

protections 
20 

radioactivity that 

occurs within 

1,000 years 

following closure 

of disposal 

facility 

- ALARA 

concept 

following closure 

of disposal 

facility 

- 5 mSv (500 

mrem) annual 

dose limit 

 

Between 1,000 and 10,000 Years Following Closure of Disposal Facility 

(Protective Assurance Period) 

- Performance 

assessment that 

estimates peak 

annual dose that 

occurs between 

1,000 and 

10,000 years 

following closure 

of disposal 

facility 

- Annual dose 

shall be below 5 

mSv (500 mrem) 

or a level that is 

reasonably 

achievable 

based on 

technological 

and economic 

considerations 

for the protection 

of the general 

population from 

releases of 

radioactivity that 

may occur 

between 1,000 

and 10,000 

years following 

closure of 

disposal facility 

- Intruder 

assessment that 

estimates peak 

annual dose that 

occurs between 

1,000 and 

10,000 years 

following closure 

of disposal 

facility 

- Annual dose 

shall be below 5 

mSv (500 mrem) 

or a level that is 

reasonably 

achievable 

based on 

technological 

and economic 

considerations 

for the protection 

of the 

inadvertent 

intruders from 

exposures that 

may occur 

between 1,000 

and 10,000 

years following 

closure of 

disposal facility 

- Analyses of 

active natural 

processes that 

demonstrate that 

long-term 

stability of the 

site can be 

ensured and that 

there will not be 

a need for 

ongoing active 

maintenance of 

the disposal site 

following closure 

- Analyses that 

demonstrate the 

proposed 

disposal system 

includes 

defense-in-depth 

protections 

 

After 10,000 Years Following Closure of Disposal Facility (Performance 

Period) 
21 

- Analyses for 

10,000 or more 

years following 

closure of 

disposal facility 

that 

demonstrates 

releases will be 

minimized to the 

extent 

reasonably 

achievable for 

the protection of 

the general 

population 

- Analyses only 

apply for 

disposal sites 

containing longlived 

radionuclides 

exceeding 

concentrations 

listed in table A 

of 

10 CFR 61.13(e), 

or if necessitated 

by site-specific 

conditions 

- Analyses that 

demonstrate how 

the facility has 

been designed to 

limit long-term 

releases. 

- Analyses for 

10,000 or more 

years following 

closure of 

disposal facility 

that 

demonstrates 

exposures will be 

minimized to the 

extent 

reasonably 

achievable for 

the protection of 

inadvertent 

intruders 

- Analyses only 

apply for 

disposal sites 

containing longlived 

radionuclides 

exceeding 

concentrations 

listed in table A 

of 

10 CFR 61.13(e), 

or if necessitated 

by site-specific 

conditions 

- Analyses that 

demonstrate how 

the facility has 

been designed to 

limit long-term 

exposures to an 

inadvertent 

intruder 

 - Analyses that 

demonstrate the 

proposed 

disposal system 

includes 

defense-in-depth 

protections 

B. Who would this action affect? 

This proposed rule would affect existing and future LLRW disposal facilities that are 

regulated by the NRC or an Agreement State. 
22 

C. Why do the regulatory requirements need to be revised? 

Recently, the industry and the NRC have identified new LLRW streams that were not 

envisioned during the development of 10 CFR part 61. These LLRW streams include depleted 

uranium (DU) from enrichment facilities, LLRW from the U.S. Department of Energy (DOE) 

operations, and blended LLRW streams in quantities greater than previously expected. In 

addition, new technologies might result in the generation of different LLRW streams not 

previously evaluated during the development of the current 10 CFR part 61 regulations. 

The renewed interest in licensing new uranium enrichment facilities in the United States 

has brought disposal of DU LLRW to the forefront of commercial LLRW disposal issues. In the 

regulatory basis supporting the development of current 10 CFR part 61, the NRC did not 

consider the relatively high concentrations and large quantities of DU LLRW that are generated 

by enrichment facilities. Additionally, the NRC did not anticipate that the DOE would dispose of 

large quantities of DU LLRW or any other defense-related LLRW in commercial disposal 

facilities. With the existing DOE DU stockpile at the Paducah and Portsmouth Gaseous 

Diffusion Plants, and the recent licensing of the Louisiana Energy Services National Enrichment 

Facility and the United States Enrichment Corporation American Centrifuge Plant, the DOE and 

the industry might need to dispose of more than 109

 kilograms (1 million metric tons) of DU 

LLRW. 

In a 2008 analysis provided in SECY-08-0147, “Response to Commission Order 

CLI-05-20 Regarding Depleted Uranium,” dated October 7, 2008 (ADAMS Accession No. 

ML081820762), involving a land disposal scenario for large quantities of DU, the NRC staff 

identified conditions that would likely not meet the current performance objectives in 

10 CFR 61.41 and 10 CFR 61.42, if large quantities of DU were disposed under those 

conditions (e.g., shallow disposal, such as that commonly associated with Class A LLRW, or 

disposal at humid sites with a potable ground water supply). The NRC staff determined that the 
23 

disposal of large quantities of DU as Class A LLRW, with no additional restrictions, could result 

in inadvertent intruders receiving a dose greater than 5 mSv/yr (500 mrem/yr) for both acute and 

chronic exposure scenarios. The estimated dose would result from pathways such as 

inadvertent ingestion of uranium-contaminated soil and inhalation of radon gas (a member of 

the uranium decay chain). These results are consistent with those found in an earlier analysis 

of possible DU disposal in an LLRW disposal facility discussed in a Sandia National 

Laboratories report titled, “Performance Assessment of the Proposed Disposal of Depleted 

Uranium as Class A Low-Level Waste” (ADAMS Accession No. ML101890179). 

 The blending of different classes of LLRW could also result in LLRW streams with 

concentrations that are inconsistent with the assumptions used to develop tables 1 and 2 of 

10 CFR 61.55. Blending of LLRW would enable some materials that would otherwise have 

been disposed of as a higher class (e.g., Class B or Class C LLRW) to be blended with a lower 

class (e.g., Class A LLRW) or lower concentration LLRW of the same class. The result of the 

blending process would be to create large volumes of blended LLRW that have concentrations 

near the LLRW classification limits. The NRC did not evaluate the disposal of large volumes of 

LLRW with concentrations near the LLRW classification limits in the final regulatory basis for the 

current 10 CFR part 61. The LLRW concentration values published in the draft regulatory basis 

for the current 10 CFR part 61 were based on the assumption that all LLRW would be disposed 

at the LLRW classification limit. However, the final LLRW classification tables were developed 

with the assumption that only a fraction of the LLRW being disposed would approach the LLRW 

classification limit. In SECY-10-0043, “Blending of Low-Level Radioactive Waste,” dated April 7, 

2010 (ADAMS Accession No. ML090410246), the NRC staff noted that large-scale blending of 

Class B and Class C concentrations of LLRW with Class A to produce a Class A mixture could 

result in a dose to an inadvertent intruder that is above 5 mSv/yr (500 mrem/yr) (i.e., the dose 

limit used in developing the current LLRW classification in 10 CFR 61.55(a)). 
24 

Other unanticipated LLRW streams may also need to be considered for future disposal 

at LLRW disposal facilities. For example, the Energy Policy Act of 2005 expanded the NRC’s 

regulatory authority under the Atomic Energy Act of 1954, as amended (AEA), to include 

discrete sources of naturally occurring radioactive material (including radium-226) that might be 

produced, extracted, or converted as a byproduct material. The regulatory basis for the current 

10 CFR part 61 considered only a small quantity of radium-226 bearing LLRW in the 

development of the 10 CFR part 61 LLRW classification system.1

 More recently, consistent with 

the National Defense Authorization Act for Fiscal Year 2013,2

 LLRW 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 

performance objectives in 10 CFR part 61. Because the types of LLRW streams requiring 

disposal at a LLRW disposal facility have expanded over time, the NRC has concluded that 

rulemaking is necessary to better ensure that a broad spectrum of LLRW types and volumes are 

disposed of in a manner that is protective of public health and safety and the surrounding 

environment. 

Further, as part of its regulatory effectiveness strategy described in NUREG-1614, 

Volume 6, “Strategic Plan Fiscal Years 2014-2018” (ADAMS Accession No. ML14246A439), the 

Commission strives, through its regulatory processes, to use risk-informed and performancebased approaches, where appropriate, to enhance the effectiveness and efficiency of the 

regulatory framework. The NRC concluded that amending the regulations to permit licensees or 

license applicants to develop criteria for LLRW acceptance from the results of the site-specific 

 

1

 For example, the equivalent of 0.5 nanocuries/gram of radium-226 contained in about 68 kg (about 150 pounds) 

of natural uranium ore (at equilibrium with its daughter products) was considered for the purposes of designating 

Class A LLRW (47 FR 57453–57454).

2

 National Defense Authorization Act for Fiscal Year 2013. Subtitle F, Sec 3173. Improving the reliability of 

Domestic Isotope Supply. H.R. 4310 (112th).
25 

technical analyses as an alternative to the LLRW classification requirements allows for 

increased use of site-specific information to develop risk insights to support the safe disposal of 

LLRW. The new amendments also provide flexibility to determine how licensees can best meet 

the performance objectives for the specific design and operational practices of their disposal 

facility, as well as the specific environmental characteristics of their site. 

Finally, the concept of “defense-in-depth” is currently not explicit in 10 CFR part 61. On 

February 11, 2011 (ADAMS Accession No. ML110680621), the NRC Chairman, Gregory B. 

Jaczko, created a Risk Management Task Force (RMTF), to develop a strategic vision and 

options for adopting a more comprehensive and holistic risk-informed, performance-based 

regulatory approach for reactors, materials, waste, fuel cycle, and transportation that would 

continue to ensure the safe and secure use of nuclear material. The RMTF issued NUREG2150, “A Proposed Risk Management Regulatory Framework,” dated April 30, 2012 (ADAMS 

Accession No. ML12109A277). Three recommendations for LLRW were proposed in NUREG2150. One of these recommendations was that the NRC should develop an explicit 

characterization of how defense-in-depth, within the proposed risk management framework, 

applies to the LLRW program and build this into current and future staff guidance documents 

and into training and development activities for the staff. This proposed rule would add a 

defense-in-depth requirement in 10 CFR part 61 to address the LLRW recommendations in 

NUREG-2150. 

When would this rule become effective? 

For the NRC licensees and license applicants, the rule would become effective 1 year 

after the final rule is published in the Federal Register. The Agreement States will have 3 years 

from the published date of the Federal Register notice for the final rule to adopt compatible 
26 

regulations. 

D. What LLRW streams are affected by this proposed rule? 

 The NRC considered a number of options in developing this proposed rule. The agency 

decided that requiring a safety case comprised of a collection of information that demonstrates 

the safety of a land disposal facility and includes site-specific technical analyses and defense-indepth protections for all LLRW inventories would be the most comprehensive approach. This 

approach would ensure that as LLRW streams are generated, analyses would be performed to 

determine if the performance objectives would be met for disposal of all isotopic concentrations 

and volumes of LLRW. Under the proposed rule, all sites would be required to complete 

performance assessments and intruder assessments for the compliance period and the 

protective assurance period. In addition, land disposal sites with long-lived LLRW, or land 

disposal sites with site-specific conditions that would necessitate it, would be required to 

complete performance period analyses for the performance period. 

E. What are site-specific technical analyses? 

This rulemaking would require licensees and license applicants to prepare a 

performance assessment, a new intruder assessment, and new defense-in-depth analyses to 

demonstrate that its disposal site and design meet the performance objectives. Licensees and 

license applicants under 10 CFR part 61 would be required to prepare the following as part of 

their site-specific technical analyses: a) a revised analysis, called a performance assessment, 

to demonstrate the protection of the general population from releases of radioactivity 

(10 CFR 61.41); b) a new analysis, called an intruder assessment, to demonstrate the 

protection of inadvertent intruders (10 CFR 61.42); c) performance period analyses to evaluate 

how the disposal system may mitigate the long-term risk from disposal of long-lived LLRW 
27 

(10 CFR 61.13(e)); and d) new analyses that demonstrate the disposal site includes defense-indepth protections. The site-specific technical analyses would be required to be updated at 

facility closure, to provide assurance of compliance with the performance objectives for the 

disposal of LLRW streams that were not analyzed in the original 10 CFR part 61 regulatory 

basis. 

 

1. Performance assessment. 

The first performance objective of subpart C of 10 CFR part 61, which provides 

protection of the general population from releases of radioactivity, would continue to be 

demonstrated with a technical analysis that would be revised and renamed in 10 CFR 61.13 as 

a “performance assessment.”3

 A performance assessment, as described in NUREG-1636, 

“Regulatory Perspectives on Model Validation in High-Level Radioactive Waste Management 

Programs: A Joint NRC/SKI White Paper” (ADAMS Accession No. ML012260054), would be a 

systematic analysis that addresses what can happen, how likely it is to happen, what the 

resulting impacts are, and how these impacts compare to regulatory standards. The essential 

elements of a performance assessment for a LLRW disposal site are the same as the essential 

elements of a performance assessment for a HLW repository described in “Risk Assessment: A 

Survey of Characteristics, Applications, and Methods Used by Federal Agencies for Engineered 

Systems” (ADAMS Accession No. ML040090236). The essential elements of a performance 

assessment for a LLRW disposal site are: a) a description of the site and engineered system, 

b) an understanding of events likely to affect long-term facility performance, c) a description of 

processes controlling the movement of radionuclides from LLRW disposal units to the general 

environment, d) a computation of doses to members of the general population, and e) an 

 

3

 The current 10 CFR part 61 refers to a “technical analysis.”
28 

evaluation of uncertainties in the computational results. 

Many features, events, and processes can influence the ability of a LLRW disposal 

facility to limit releases of radioactivity to the environment. Disposal system behavior is 

influenced by the LLRW disposal facility design, the characteristics of the LLRW, and the 

geologic and environmental characteristics of the disposal site. A performance assessment 

evaluates the projected behavior of an LLRW disposal system and the uncertainties in the 

projected performance of the system. The performance assessment identifies the specific 

characteristics of the disposal site (e.g., hydrology, meteorology, geochemistry, biology, 

geomorphology); degradation, deterioration, or alteration processes of the engineered barriers 

(including the wasteform and container) and natural system; and interactions between the 

disposal site characteristics and engineered barriers that might affect the performance of the 

LLRW disposal system. The performance assessment examines the effects of these processes 

and interactions on the ability of the LLRW disposal system to limit LLRW releases, and 

calculates the annual dose to a member of the public for comparison with the appropriate 

performance objective. 

Currently, the descriptions of the technical information, technical analysis, and 

requirement to demonstrate compliance with the protection of the general population from 

releases of radioactivity can be found in 10 CFR 61.12, “Specific technical information,” 

10 CFR 61.13(a), and 10 CFR 61.41, respectively, although these analyses are not called a 

“performance assessment.” In addition, these technical analyses do not have a prescribed 

compliance period. The original guidance documents associated with these requirements can 

be found in NUREG-1300, "Environmental Standard Review Plan for the Review of a License 

Application for a Low-Level Radioactive Waste Disposal Facility" (ADAMS Accession No. 

ML053010347); NUREG-1199, Revision 2, "Standard Format and Content of a License 

Application for a Low-Level Radioactive Waste Disposal Facility" (ADAMS Accession No. 
29 

ML022550605); and NUREG-1200, Revision 3, "Standard Review Plan for the Review of a 

License Application for a Low-Level Radioactive Waste Disposal Facility” (ADAMS Accession 

No. ML061370484). 

Proposed 10 CFR 61.41 would require licensees or license applicants to complete a 

performance assessment to estimate peak dose within the compliance period following closure 

of the disposal facility. The proposed compliance period is defined as 1,000 years following 

closure of the facility. 

After the compliance period, licensees or license applicants would be required to provide 

analyses of the disposal facility performance from the end of the compliance period to 10,000 

years. This period of time is referred to the protective assurance period. The analysis for the 

protective assurance period is an extension of the performance assessment to the timeframe 

following the compliance period. From a technical standpoint, the analysis for the protective 

assurance period is likely to be very similar to the compliance period performance assessment, 

but, given the uncertainty in projecting the performance of the disposal site over long time 

periods, uses a different metric (i.e., minimize releases and keep annual doses below 5 mSv/yr 

(500 mrem/yr) or to a level that is supported as reasonably achievable based on technological 

and economic considerations). The metric for the protective assurance analyses is different 

from the dose limits provided for the compliance period. The protective assurance analyses are 

being proposed as a minimization process (i.e., optimization) with guidance provided on the 

goals to use in the minimization process. The NRC is seeking feedback on the proposed 

approach. 

The definition of compliance and protective assurance periods would add important 

technical parameters to the current technical analyses. Appropriate time periods are important 

for the evaluation of LLRW streams that were not considered in the original 10 CFR part 61 

rulemaking as well as for evaluation of long-lived LLRW that were considered in the original 
30 

rulemaking. The NRC believes that the results of a performance assessment would assist in 

demonstrating that the protection of the general population from releases of radioactivity can be 

achieved. The proposed 10 CFR 61.41, new definitions, technical analyses requirements, and 

concepts are risk-informed and flexible. Proposed 10 CFR 61.41 uses a risk-informed 

regulatory framework that specifies what requirements need to be met and provides flexibility to 

a licensee or applicant with regard to what information or approach they use to satisfy those 

requirements. The NRC believes that the proposed approach is warranted because of the sitespecific nature of LLRW disposal, which can rely on different designs operating at different sites. 

The proposed amendments formally introduce the concept of features, events, and 

processes (FEPs), which ensure appropriate comprehensiveness of any site-specific technical 

analysis. For the protective assurance period, the performance assessment would need to 

reflect new FEPs different from the compliance period that address significant uncertainties 

inherent in the long timeframes only if scientific information compelling such changes is 

available. The NRC staff has developed a draft guidance document, NUREG-2175, “Guidance 

for Conducting Technical Analyses for 10 CFR Part 61,” to facilitate the development of 

information and analyses that will support licensees or license applicants in addressing the 

regulatory requirements. This draft guidance document is being made available for public 

comment concurrent with this proposed rule. (See Docket ID NRC-2015-0003 in the Proposed 

Rules section of this issue of the Federal Register.) 

2. Intruder assessment. 

In 10 CFR part 61, the NRC recognizes that it is possible, though unlikely, that an 

inadvertent intruder might occupy a disposal site in the future and engage in normal pursuits 

without knowing that they are receiving radiation exposure. Therefore, the second performance 
31 

objective in subpart C of 10 CFR part 61 is the protection of inadvertent intruders. Currently, 

10 CFR part 61 does not require a site-specific analysis to demonstrate the protection of an 

inadvertent intruder. Instead, the safety of an inadvertent intruder is demonstrated by 

compliance with the LLRW classification system and the disposal requirements imposed for 

each class of LLRW. The connection between the LLRW classification system and protection of 

an inadvertent intruder is reflected in the LLRW classification tables in 10 CFR 61.55. The 

regulatory basis for the current 10 CFR part 61, published in NUREG-0945, contains an 

analysis of a reference disposal facility that evaluates the impacts of LLRW disposal on an 

inadvertent intruder. This analysis supported the concentration-based LLRW classification 

tables developed for 10 CFR 61.55. 

Consistent with the development of the LLRW classification system, the technical 

analysis requirements currently found in 10 CFR 61.13(b) specify that the analyses of the 

protection of inadvertent intruders must include a demonstration that there is reasonable 

assurance that the LLRW classification and segregation requirements will be met and that 

adequate barriers to inadvertent intrusion will be provided. The regulations ensure the safety of 

the inadvertent intruder through the LLRW classification system and the LLRW disposal 

requirements imposed for each class of LLRW. However, as they are presently written, the 

regulations do not explicitly require an analysis of inadvertent intruder doses. Differences 

between LLRW disposal inventories, disposal practices, and the underlying assumptions used 

to develop the LLRW classification tables in 10 CFR 61.55 can result in varying doses with 

respect to the protection of an inadvertent intruder. Therefore, the new proposed regulatory 

provisions require licensees and license applicants to conduct an analysis of inadvertent 

intruder doses. 

 The proposed revisions would add a requirement for licensees and license applicants to 

conduct a site-specific intruder assessment to demonstrate compliance with 10 CFR 61.42. The 
32 

proposed intruder assessment would quantitatively estimate the radiological exposure of an 

inadvertent intruder at an LLRW disposal facility following an assumed loss of institutional 

controls at the end of the active institutional control period. The results of the intruder 

assessment would then be compared to the performance objective in 10 CFR 61.42. The 

intruder assessment would identify the intruder barriers, examine the capability of the barriers, 

and address the effects of uncertainty on the performance of the barriers. The capabilities of 

the barriers to inhibit contact with the disposed LLRW or limit the radiological exposure of an 

inadvertent intruder and the time period over which the capability persists must be 

demonstrated and a technical basis must be provided. In performing the proposed intruder 

assessment, licensees would be expected to employ a methodology similar to that used for a 

performance assessment, but the intruder assessment would assume that an inadvertent 

intruder occupies the LLRW disposal site after closure, engages in normal activities, and is 

unknowingly exposed to radiation from the LLRW. 

With the intruder assessment requirement, the NRC is proposing to specify an intruder 

dose limit for the compliance period and protective assurance period as described in the original 

10 CFR part 61 analysis to develop the LLRW classification tables. The regulatory basis for 

10 CFR part 61 assumed that inadvertent intrusion occurred following a cessation of a caretaker 

or active institutional control period. Institutional control of the site was expected to occur 

beyond the active institutional control period, although it could not be assured because of the 

long timeframes involved. Therefore, an intruder was assumed to occupy the LLRW disposal 

facility and engage in normal activities, such as agriculture or dwelling construction. The 

analysis assumed that the intruder directly contacted the disposed LLRW, and was exposed to 

radionuclides through inhalation of contaminated soil and air, direct radiation, and ingestion of 

contaminated food and water. The NRC based the LLRW classification tables in 10 CFR 61.55 

on radionuclide concentrations that would yield a 5 mSv/yr (500 mrem/yr) dose. 
33 

The dose limit used to develop the current LLRW classification tables was selected from 

a range of values that were consistent with exposure guidelines of different orders of magnitude: 

0.25 mSv/yr (25 mrem/yr), 5 mSv/yr (500 mrem/yr), and 50 mSv/yr (5,000 mrem/yr). In 

NUREG-0945, the NRC selected the 5 mSv/yr (500 mrem/yr) dose based primarily on safety as 

reflected in the effective dose limit in 10 CFR part 20 at that time and public opinion gained 

through the four regional workshops held on the preliminary draft of 10 CFR part 61. The NRC 

continues to believe that this dose limit provides an acceptable level of protection to an 

inadvertent intruder. The NRC is proposing to add an annual intruder dose limit to 

10 CFR 61.42 to ensure protection of any inadvertent intruder who occupies the disposal site or 

contacts the LLRW at any time after active institutional controls are removed. 

Given the uncertainty in projecting performance of disposal sites over long time periods 

such as those beyond the compliance period, the amendments proposed in 10 CFR 61.42 

would require that annual doses be minimized, as estimated by an intruder assessment, for the 

protective assurance period. The minimization target is for annual doses to be below 5 mSv/yr 

(500 mrem/yr) or a level that is supported as reasonably achievable based on technological and 

economic considerations. The NRC is seeking feedback on the proposed approach, especially 

with regard to whether a 5 milliSievert (500 mrem) annual dose target is appropriate for the 

protective assurance period and whether it is appropriate to require licensees or license 

applicants to consider alternative levels to minimize exposures to an inadvertent intruder. 

Given the uncertainty in predicting human behavior into the distant future and to limit 

associated speculation, the NRC is proposing to change the definition of the inadvertent intruder 

to limit the scenarios to reasonably foreseeable activities that are realistic and consistent with 

activities in and around the disposal site at the time of closure. 

As discussed in Section M of this document, the NRC has prepared a draft guidance 

document that describes acceptable approaches for determining reasonably foreseeable 
34 

intruder activities that are consistent with activities in and around the disposal site at the time of 

closure to be assessed in the intruder assessment. The draft guidance describes how licensees 

or license applicants can take credit for physical characteristics (e.g., water quality) and societal 

information (e.g., land use patterns) related to the disposal facility to limit speculation about the 

types of activities in which an inadvertent intruder might engage. 

The proposed approach, consistent with the current approach, is to assume that the 

active institutional controls will fail after the end of the active institutional control period. The 

NRC does not believe that controls will fail, but rather that the durability of the controls cannot 

be assured. In addition, the NRC is not assuming the probability is 100 percent that contact 

with the LLRW by an intruder will occur. As in the current regulation, engineered barriers and 

disposal practices, such as greater disposal depth, are to be considered in the intruder 

assessment. For example, with a protective cover of at least 5 m (16 feet) thickness, 

consideration of a scenario in which a dwelling foundation is excavated in a disposal unit would 

not be reasonable. A 5 mSv (500 mrem) dose limit for the intruder, compared to a 0.25 mSv 

(25 mrem) annual dose limit for the public during the compliance period in 10 CFR 61.41, 

demonstrates the NRC expectation that the intruder scenario is unlikely. As previously stated, 

the NRC is making available the draft guidance document (see Docket ID NRC-2015-0003) for 

public comment concurrent with the publication of this proposed rule and is seeking comments 

on whether the approaches described in the guidance are adequate or if further specification for 

inadvertent intruder scenarios in the proposed rule is necessary. 

As previously indicated, the current 10 CFR part 61 provides LLRW classification and 

segregation requirements. The NRC considered, based on comments received on the 

preliminary proposed rule language (76 FR 24831), whether additional requirements such as 

minimum depth of disposal were needed for large quantities of long-lived LLRW (e.g., DU). The 

NRC proposes that a more risk-informed approach would be to require an intruder assessment 
35 

that would allow the actual disposal depth and form of LLRW to be considered in the analysis. 

3. Performance period analyses. 

The current regulations in 10 CFR part 61 limit radiological risks from land disposal of 

LLRW regardless of the half-life of the LLRW. To ensure protection of public health and safety, 

10 CFR part 61 includes regulations regarding analyses, LLRW classification, site-selection, 

LLRW characteristics, and other requirements. A long-term analysis (e.g., longer than 10,000 

years) was not necessary under 10 CFR part 61, as originally written, because the NRC 

developed LLRW classification limits for long-lived radionuclides. The regulatory system was 

designed to ensure the short- and long-term impacts were limited by regulatory requirements 

such as the LLRW classification system. The NRC is now proposing additional analyses to 

ensure that LLRW streams that are significantly different from those considered in the original 

10 CFR part 61 regulatory basis (e.g., large quantities of DU) can be disposed of safely and that 

the performance objectives will be met or LLRW disposal will be prohibited. The use of a threetiered analyses system with different performance metrics for each tier should allow licensees or 

applicants to perform risk-informed assessments of the land disposal of LLRW for the protection 

of public health and safety. The analyses-based approach to regulation is more risk-informed 

than the concentration-based approach used in the current 10 CFR part 61 regulations. The 

concentration-based approach cannot be easily adjusted to differing site conditions because 

concentration limits were derived based on conservative assumptions. 

The long-term analyses, termed “performance period analyses” as set forth in 

10 CFR 61.13(e), would require licensees or license applicants to prepare long-term analyses 

(i.e., after the compliance and protective assurance periods) that assess how the disposal 

facility and site characteristics limit the potential long-term radiological impacts, consistent with 

available data and current scientific understanding. The proposed performance period analyses 
36 

will only be required for land disposal sites with long-lived LLRW that contains radionuclides 

with average concentrations exceeding the values listed in the proposed table A of 

10 CFR 61.13(e), “Average Concentrations of Long-lived Radionuclides Requiring Performance 

Period Analyses,” or if necessitated by site-specific conditions. The average concentrations, as 

explained in greater detail in the associated draft guidance document, are disposal siteaveraged concentrations. Disposal site-averaged concentrations can include the volume of the 

LLRW, uncontaminated materials used to stabilize LLRW or reduce void space within LLRW 

packages, the volume of uncontaminated materials placed within the disposal units, and the 

volume of engineered or natural materials used to construct the disposal units. For the purpose 

of determining if performance period analyses are necessary, the disposal site-averaged 

concentrations should be based on the total volume of LLRW averaged over the total volume of 

all disposal units. For radionuclides where the concentrations are based on mass and not 

volume, the average density of the different materials within the disposal units can be used. 

The averaging calculations are explained in further detail in the draft guidance document. 

The metric for the performance period analyses would be to minimize releases to the 

public to the extent reasonably achievable. The NRC considered a variety of approaches for 

metrics to evaluate the performance period analyses. The aforementioned metric was selected 

because it would allow socioeconomic information to be considered in a risk-informed manner. 

Considering the timeframes involved, uncertainties may be considerable and therefore the 

precision typically assigned to a dose limit is not warranted. Whereas the calculated dose in a 

numerical model may be precise, the significance of that dose to a future generation is 

unknowable in the present. Although a dose limit is not prescribed, it is recommended that 

doses or concentrations and fluxes of radionuclides in the environment are calculated as they 

are appropriate to use to compare alternatives using a common metric. The NRC believes the 

value of information an applicant would provide to describe its actions to mitigate long-term 
37 

impacts to future generations is higher than the value of long-term dose estimates. The 

minimization of releases and barrier analyses for the performance period can demonstrate how 

an applicant is proposing to limit impacts to future generations. The draft guidance document 

discusses in more detail an acceptable approach to performing the analyses for the 

performance period. 

The proposed performance period analyses must identify and describe the features of 

the design and site characteristics that will demonstrate that the performance objectives set 

forth in 10 CFR 61.41(c) and 10 CFR 61.42(c) will be met. These analyses would also help 

determine whether any additional measures are needed at a disposal site to ensure the 

protection of the general population and the inadvertent intruder from disposal of long-lived 

LLRW with average concentrations exceeding the values listed in the proposed table A of 

10 CFR 61.13(e), or if necessitated by site-specific conditions, and to determine whether 

limitations on the disposal of some LLRW streams at certain sites may be needed to properly 

manage the disposal of LLRW. 

An ending time for the performance period analyses is not specified in the proposed 

regulation. A number of factors influenced this decision. First, the analyses may demonstrate 

the time when the peak impact is likely to occur such that further calculation beyond this time is 

unnecessary. Because long-term impacts are going to be driven by site-specific characteristics 

and the particular LLRW that is disposed, the timing of peak impacts may differ substantially 

from site to site. A licensee or license applicant must demonstrate that impacts are minimized 

to the extent reasonably achievable, ensuring that facilities and disposal cells are not 

under-designed. Second, the analyses that are developed for the performance period may 

differ from traditional projections of long-term radiological doses. Performance period analyses 

may demonstrate that the performance period metrics have been satisfied irrespective of peak 

radiological impacts. The proposed approach is based on the position that there are many 
38 

uncertainties in the risks imposed on future generations, especially from processes or events 

other than LLRW disposal. In addition, there is uncertainty in the projected radiological risk to 

future populations from LLRW disposal, which may be based on a number of assumptions 

about the behavior and characteristics of future society. The proposed approach focuses on a 

demonstration of how the natural and engineered barriers of the disposal system could limit 

releases of material rather than the radiological impact to an individual or group. The NRC is 

seeking feedback on the proposed approach, especially with regard to whether a dose limit is 

needed for the long-term analyses or whether the proposed metric combined with barrier 

analyses is more appropriate. 

4. Defense-in-depth analyses. 

 The defense-in-depth principle has served as a cornerstone of the NRC’s deterministic 

regulatory framework for nuclear reactors, and it provides an important tool for making 

regulatory decisions, with regard to complex facilities, in the face of significant uncertainties. 

The NRC also has applied the concept of defense-in-depth elsewhere in its regulations to 

ensure safety of licensed facilities through requirements for multiple, independent layers, and, 

where possible, redundant safety systems. Traditionally, the reliance on independence and 

redundancy of barriers has been used to provide assurance of safety when reliable, quantitative 

assessments of barrier reliability are unavailable. The NRC maintains, as it has in other 

regulations for disposal, such as for high-level radioactive waste, that the application of the 

defense-in-depth concept to a LLRW land disposal facility is appropriate and reasonable. 

Therefore, The NRC is now proposing additional analyses to ensure that the land disposal 

facility includes defense-in-depth protections. 

However, implementation of defense-in-depth protections, in the context of a LLRW land 

disposal facility, should be consistent with the NRC’s goal of achieving a regulatory program 
39 

and associated requirements that are risk-informed and performance-based. While waste is 

being disposed, and before a LLRW land disposal facility is closed, defense-in-depth protections 

would typically be comparable to other operating nuclear fuel cycle facilities licensed by the 

NRC. Application of defense-in-depth principles for regulation of disposal facility performance 

for long time periods following closure, however, must account for the difference between a 

closed land disposal facility and an operating facility with active safety systems and the potential 

for active control and intervention. A closed land disposal facility is essentially a passive 

system, and assessment of its safety over long timeframes is best evaluated through 

consideration of the relative likelihood of threats to its integrity and performance. Although it is 

relatively easy to identify multiple, independent and redundant layers that comprise the 

engineered features and site characteristics, the capabilities of any of these design features and 

site characteristics may not be either independent or totally redundant. The NRC continues to 

believe that multiple layers of defense must each make a definite contribution to the isolation of 

the waste, so that the NRC may find, with reasonable assurance, that no single layer of defense 

will be exclusively relied upon to achieve the overall safety objectives over timeframes of 

hundreds to thousands of years. Disposal of LLRW is also predicated on the expectation that a 

portion of the site in combination with engineered features will minimize the migration of 

radionuclides away from the disposal site. However, the capabilities of site characteristics and 

engineered features over the long timeframes are subject to interpretation and include many 

uncertainties. These uncertainties can be quantified generally and are addressed by requiring 

the use of a multiple layers. Similarly, although the composition and configuration of engineered 

features, as well as their capacity to limit releases or function as intruder barriers, may be 

defined with a degree of precision in the near-term that may not be possible for site 

characteristics, it is recognized that except for a few archaeologic analogues, there is no 

experience base for the performance of complex, engineered structures over periods longer 
40 

than a few hundred years. Therefore, the NRC expects that licensees will rely on both the 

characteristics and the engineered features, in combination, to provide reasonable assurance 

that the overall performance of the disposal site will be adequate over long time periods. 

5. Site stability analyses. 

Currently, 10 CFR 61.50, which is also being revised in this rulemaking, requires that 

LLRW disposal sites not be susceptible to erosion, flooding, seismicity, or other disruptive 

events or processes to such a degree or frequency that compliance with the 10 CFR part 61 

performance objectives cannot be demonstrated with reasonable assurance. Currently, 10 CFR 

61.44 also includes a performance objective for stability at the disposal site after closure. It 

states that the disposal facility must be sited, designed, used, operated, and closed to achieve 

long-term stability of the disposal site and to eliminate, to the extent practicable, the need for 

ongoing active maintenance of the disposal site following closure. To demonstrate with 

areasonable assurance that the 10 CFR 61.44 performance objective will be met, licensees 

must conduct site stability analyses. 

Site stability analyses focus on stability of the wasteform, stability of the engineered 

disposal facility, and geologic/geomorphic stability of the disposal site. For disposal of 

traditional LLRW (i.e., range and type of LLRW that was analyzed in the current 10 CFR part 

61), site stability analyses will likely focus on the former two areas. For disposal of large 

quantities of long-lived waste, the focus will likely be on the latter two areas. The extent of the 

site stability analyses will be strongly influenced by the type of waste to be disposed. Stability of 

wasteforms, disposal units, engineered barriers (such as cover systems), disposal site, disposal 

facility, and disposal system may all be within the scope of the stability assessment. However, 

the current 10 CFR 61.44 performance objective does not specify an analysis timeframe for the 

site stability analyses. Without an analysis timeframe, the applicability of the stability 
41 

requirement would be subject to different interpretations. 

The NRC proposes to revise 10 CFR 61.44 to specify that stability of the disposal site 

must be demonstrated for the compliance and protective assurance periods. This change was 

necessary to clarify that the post-closure site stability requirements apply to the compliance and 

protective assurance periods created in this proposed rule. 

F. Updated safety case and technical analyses for closure. 

Currently, 10 CFR 61.28, “Contents of application for closure,” requires licensees to 

submit an application to amend the license for closure. This application must include 1) a final 

revision and specific details of the disposal site closure plan, and 2) an environmental report or 

a supplement to an environmental report. Currently, 10 CFR 61.28 does not require licensees 

to prepare updated site-specific technical analyses. The proposed rule would require licensees 

to include updated safety case and technical analyses in their applications to amend their 

licenses for closure, to provide greater assurance of compliance with the performance 

objectives that ensure the safe disposal of LLRW streams significantly different from those 

considered in the original 10 CFR part 61 regulatory basis (i.e., large quantities of depleted 

uranium). In particular, 10 CFR 61.28 would be revised to require licensees to also prepare 

updated performance period analyses required by proposed 10 CFR 61.13, 10 CFR 61.41, and 

10 CFR 61.42. The NRC believes that this change, coupled with current 10 CFR 61.28(c) which 

is not being amended by this rulemaking, may require licensees to take additional action prior to 

closure to ensure that the LLRW that has been disposed of will meet the performance 

objectives. 

G. What options were considered for selecting approach and timeframes and what is 

the NRC’s preferred option? 
42 

1. Considerations made in developing options.

Currently, 10 CFR 61.7 discusses a number of timeframes that licensees or license 

applicants should consider in selecting a site, designing stable wasteforms or containers, 

controlling access to the site, and developing intruder barriers. The timeframes discussed are 

provided within the context of a LLRW management system that attempts to ensure that LLRW 

decays to innocuous levels prior to public exposure to radiation. The concentrations and 

quantities of long-lived LLRW for disposal would be limited thereby limiting potential exposures. 

For instance, 10 CFR 61.7(a)(2) indicates that in choosing a disposal site, site characteristics 

should be considered for the indefinite future and evaluated for at least a 500-year timeframe. 

However, 10 CFR part 61 does not provide a value for the time period4

 to demonstrate 

compliance with the performance objectives. The existing regulatory basis for 10 CFR part 61 

in NUREG-0945 and the related guidance in NUREG-1573, “A Performance Assessment 

Methodology for Low-Level Radioactive Waste Disposal Facilities: Recommendations of NRC's 

Performance Assessment Working Group” (ADAMS Accession No. ML003770778), recognize 

the need to use an analysis timeframe commensurate with the persistence of the hazard of the 

source. In selecting an analysis timeframe, the general practice is to consider the 

characteristics of the LLRW, the analysis framework (e.g., assumed scenarios, receptors, and 

pathways), societal uncertainties, and uncertainty in predicting the behavior of natural systems 

over time. Both technical factors (e.g., the characteristics and persistence of the radiological 

hazard attributed to the LLRW) and socioeconomic factors (e.g., transgenerational equity) 

should be considered.5

 The purpose of completing a performance assessment of a LLRW 

disposal facility is to ensure that public health and safety are protected with an acceptable 

 

4

 Different terminology has historically been used to refer to the timeframe assessed for regulatory compliance or 

other analyses, including “performance period,” “time of compliance,” “compliance period,” and other variants. 5

 International Commission on Radiological Protection (ICRP), “Radiation Protection Recommendations as Applied 

to the Disposal of Long-lived Solid Radioactive Waste,” ICRP Publication 81, Annals of the ICRP, Vol. 28, No. 4, 

ICRP Publication 81, 2000.
43 

degree of confidence. 

The NRC evaluated what other countries and international agencies use to manage the 

radiological risks from the disposal of long-lived LLRW. Some organizations impose a 

requirement to identify impacts from the disposal of long-lived LLRW using technical analyses. 

Results of the analyses are used to impose appropriate restrictions on LLRW disposal, if 

necessary. Almost every country that the NRC looked at places restrictions on how much 

LLRW can be disposed of in the near surface or does not allow near-surface disposal of longlived LLRW. Most countries place explicit numerical limits on concentrations of long-lived alphaemitting LLRW. These concentration limits are set by regulators based on generic technical 

analyses or policy decisions. The concentration limits are not developed based on the results of 

site-specific technical analyses. Site-specific technical analyses are performed, but only for 

LLRW that satisfies the generic limits. This approach is very similar to what was done for the 

initial development of 10 CFR part 61. The current requirements in 10 CFR part 61 supplement 

technical analyses with LLRW concentration limits and other disposal requirements, such as 

minimum disposal depth for certain types of LLRW. The development of concentrations limits 

by generic analysis or policy works well for countries that only have one disposal site. However, 

if numerous sites are regulated in this manner the concentration limits must be based on the 

most limiting conditions in order to assure that public health and safety is protected. 

In general, different international programs have used regulatory approaches that vary 

considerably in methodology used to achieve protection of future generations from the disposal 

of LLRW. However, countries and international safety organizations consistently apply limiting 

conditions on the near-surface disposal of LLRW (e.g., prohibit disposal, or impose 

concentration limits, disposal depth requirements, flux limits, and/or long-term analyses). 

Performance assessments are used to understand how a system (e.g., a disposal facility and 

natural environment) may perform. They are used to understand the potential impacts of 
44 

uncertainties on public health and safety decisions that decision makers need to consider. The 

many sources of uncertainty associated with projecting the future risks from disposal of LLRW 

include, but are not limited to, natural, engineering, and societal sources. The selection of 

analyses timeframes or an approach to selection of analyses timeframes for the evaluation of 

the disposal of LLRW should consider the different sources of uncertainty and how the 

uncertainties may impact projected future radiological risk. The uncertainties influence how the 

projected future radiological risks are interpreted by decision makers. The staff evaluated these 

uncertainties and their impact on intergenerational decision making through review of the work 

by the National Academy of Public Administration, the Organization for Economic Co-Operation 

and Development, and others. 

2. Options considered. 

The NRC has considered a variety of options for selection of the analysis timeframe for 

the assessment of LLRW disposal.6

 These options were based on two different approaches to 

waste management: 

• Analyses-based approach to safety, and 

• Design- and control-based approach to safety. 

These two approaches are not mutually-exclusive and each can contain elements of the 

other approach. Traditionally, for the disposal of LLRW, analyses-based approaches projecting 

performance of the disposal facility into the future have been used. Disposal of municipal and 

industrial waste that is non-radioactive have used the design- and control-based approach to 

 

6

 The NRC developed a position paper on the analyses timeframe for LLRW disposal and a revised regulatory 

basis that provides more detail than the summary provided here. For more information, refer to the NRC’s “Technical 

Analysis Supporting Definition of Period of Performance for Low-level Waste Disposal,” issued in April 2011, and 

“Regulatory Basis for Proposed Revisions to Low-Level Waste Disposal Requirements (10 CFR Part 61),” issued in 

December 2012. 
45 

safety. The primary decision is what specific regulatory requirements are needed to ensure that 

public health and safety will be protected. 

Analyses-based approach: A variety of different options were considered with respect to the 

analyses-based approaches. A key consideration of these approaches is the obligation of the 

current generation to protect future generations from the disposal of LLRW. Though this section 

discusses the NRC’s options for analyses timeframes, the technical analyses should be 

considered in context with all the requirements of the regulation. The primary decision variables 

with respect to analyses timeframes considered by the NRC were: 

• How many tiers should be used for the analyses? 

• What should be the duration of the tiers? 

• What limits should be prescribed to each tier? 

Table 2 provides a summary of the analyses-based approaches considered by the NRC. A 

more in-depth discussion of the advantages and disadvantages of each approach can be found 

in the NRC’s “Technical Analysis Supporting Definition of Period of Performance for Low-level 

Waste Disposal,” and “Regulatory Basis for Proposed Revisions to Low-Level Waste Disposal 

Requirements (10 CFR Part 61)”. 

Table 2 - Summary of Timeframes Considered for Analyses-based Approaches 

Tiers Approach Duration Limits 

Single Current – no 

change 

Variable, from 500 years to peak 

dose as currently implemented 

by Agreement States 

25 mrem/yr 

Single Peak dose 

approach 

Determined by specific waste 

and site characteristics 

25 mrem/yr 

Single Concentration limits A few thousand 25 mrem/yr, 

Concentration limits 

Single Limited duration 1,000 years or less 25 mrem/yr 
46 

Two Risk-informed 

analysis 

Tier 1: up to 10,000 years 

Tier 2: undefined 

Tier 1: 25 mrem/yr 

Tier 2: minimize releases 

to the extent reasonably 

achievable 

Two Risk-informed 

analysis with longterm dose limit 

Tier 1: 10,000 years 

Tier 2: undefined 

Tier 1: 25 mrem/yr 

Tier 2: 100 mrem/yr 

Two Site specific Tier 1: a few hundred to 10,000 

years 

Tier 2: site-specific 

Tier 1: 25 mrem/yr 

Tier 2: site-specific 

Three Uncertainty 

limitation 

Tier 1: 1,000 years 

Tier 2: 10,000 years 

Tier 3: undefined 

Tier 1: 25 mrem/yr 

Tier 2: minimize releases 

using a target of keeping 

doses below 500 mrem/yr 

Tier 3: minimize releases 

to the extent reasonably 

achievable 

Three Uncertainty 

informed 

Durations not defined but 

examples are provided in 

“Technical Analysis Supporting 

Definition of Period of 

Performance for Low-level 

Waste Disposal” 

Limits not defined but 

examples are provided in 

“Technical Analysis 

Supporting Definition of 

Period of Performance for 

Low-level Waste Disposal”

Single Tier Options: The regulatory requirements for a single-tier approach would involve 

specifying the timeframe of the analyses as well as an associated metric to be met during the 

timeframe. Variants of the single tier approach considered by the NRC included the following: 

a) Current – no change approach: In this approach, a compliance period is not specified 

for the assessment of the performance objectives. All four currently operating commercial 

low-level waste disposal facilities are located in Agreement States, and they all have different 

requirements for the compliance period. No additional action would be required by the NRC to 

maintain the current approach. 

b) Peak dose approach: This approach would require the calculation of peak dose for 

the compliance determination regardless of when the peak occurs (which could be greater than 

10,000 years if large amounts of DU are disposed at the site). If regulatory limits are met, this 

approach ensures that all future generations would be provided with the same level of protection 
47 

as the current generation. It would also ensure that the burden from the disposal of LLRW by 

the present generation is not deferred to any future generations, no matter how distant in the 

future. 

c) Regulator-derived concentration limits approach: This approach would involve using 

a single tier for the analyses of up to a few thousand years, complemented with regulatorderived concentration and quantity limits for long-lived isotopes. This approach is used by some 

other countries. The NRC believes this approach can be effective at mitigating the impact of 

long-term uncertainties while avoiding unnecessary speculation and ensuring protection of 

public health and safety for present and future generations. The challenge of using this 

approach is that it would be difficult to take into account different site, disposal facility, and other 

characteristics when determining regulator-derived concentration and quantity limits for longlived isotopes. The NRC believes that this approach could work well for a single LLRW disposal 

site (which is most common in foreign nations), but would be difficult to implement in a riskinformed manner for numerous disposal sites. To ensure protection of public health and safety, 

the limits that would be derived using this approach may need to be set at values derived for the 

most limiting conditions (e.g., site and design) and may be inappropriately restrictive for some 

sites. 

d) Limited duration approach: This approach would assign a 1,000-year compliance 

period to the analysis using a single tier. No limits would be prescribed for impacts that would 

occur after this period. Proposed guidance would indicate that it may be useful to evaluate 

longer-term impacts and consider modifications to the disposal system, if practical. A challenge 

with this approach is that, without limits on the disposal of long-lived isotopes, the dose 

estimated in a 1,000-year analysis timeframe may not be close in magnitude to the peak dose 

even for disposal of traditional LLRW. Another shortcoming of this approach is that a 

performance assessment could demonstrate that the performance objectives would be met 
48 

within the first 1,000 years but then be exceeded by a large margin afterwards. In fact, this 

result would be expected, especially for the disposal of DU where the maximum dose achieved 

within 1,000 years is only about 1/1000th of the peak dose. Because Agreement States have 

selected different compliance periods, staff anticipates that the lack of a standard approach with 

respect to long-term impacts (after 1,000 years) will likely result in differences in interpretation 

among Agreement States. The approach would also create ambiguity with respect to the 

Commission’s objectives for the management of long-term impacts. The decisions for additional 

action under this approach will be subjective, with case-by-case decisions being made by 

different regulators using different metrics. 

Two Tier Options: The regulatory requirements for a two-tier approach would involve 

specification of a duration for the analyses for each tier as well as an associated metric to be 

met for each tier. Variants of the two-tier approach considered by the NRC included the 

following: 

a) Risk-informed analyses approach: This approach sets standards for the analyses 

timeframes to ensure consistency, but then affords flexibility to licensees with respect to the 

technical analyses used to demonstrate compliance with the subpart C performance objectives. 

To ensure the long-term protection of public health and safety from the disposal of LLRW, the 

risk-informed analyses approach would be characterized by: 

• A compliance period of up to 10,000 years. 

• A second tier (i.e., performance period) that would only be applicable when facilityaveraged LLRW concentrations exceed certain values, or if necessitated by site-specific 

conditions. The concentrations would be developed by the NRC. 

The analyses for the second tier would include: 1) a screening process to identify if 

performance period analyses are necessary, and 2) performance period analyses, if applicable. 
49 

The performance requirement for the performance period analyses would be to minimize 

releases to the extent reasonably achievable. The analyses that could be used for the second 

tier would be described in guidance. The regulations would describe the analyses at a 

high-level. 

Under this two-tiered approach, licensees or license applicants of LLRW disposal 

facilities that dispose of short-lived LLRW or limited quantities of long-lived LLRW would perform 

their compliance analyses, and no additional analyses would be required. If LLRW has average 

concentrations exceeding the values developed by the NRC, or if necessitated by site-specific 

conditions, then the licensees or license applicants would have to perform analyses for the 

second tier. Guidance would describe the use of a conservative screening analysis or, if 

desired, a site-specific technical analysis for the second tier. The screening analysis would be 

based on a conservative approach (e.g., peak in-growth of progeny, no retardation during 

transport, defined scenarios) to manage long-term uncertainties and ensure that public health 

and safety is protected. If the screening analysis results showed the performance objectives 

would not be met, then inventory limits would be established based on the screening analysis or 

quantitative performance period analyses could be performed to demonstrate that public health 

and safety will be protected. Using this framework, the analyses would be risk-informed. 

b) Risk-informed analysis with long-term dose limits approach: This approach is 

conceptually similar to the previous two-tiered approach but differs in that a dose limit for the 

second tier (i.e., post 10,000 years) of the analysis would be specified in the regulation 

(e.g.,1 mSv (100 mrem)) to align the requirement with regulatory precedent in similar programs 

(e.g., high-level waste disposal at Yucca Mountain, LLRW disposal staff guidance). 

c) Site-specific approach: A final option using a two-tiered approach would be described 

as involving a compliance period of somewhere between a few hundred to 1,000 years, which 

would cover what the NRC believes is a reasonably foreseeable period for estimating future 
50 

human activities. If uncertainty associated with the societal component of the problem is 

managed by specifying reasonably conservative scenarios, then the compliance period could be 

as long as 10,000 years. The time period for the second tier of this approach would not be 

defined in the regulation, instead it would be determined on a site-specific basis. Under this 

option a dose limit could be established for the second tier or an alternative metric could be 

used. 

Three Tier Options: 

a) Uncertainty limitation approach: This three-tiered approach involves a compliance 

period, a protective assurance period, and a performance period. 

The compliance period would be defined as 1,000 years following closure of the disposal 

facility. The period of 1,000 years was selected to cover the reasonably foreseeable future 

during which there would be a high degree of confidence that the requirements could be 

realistically met. Further, the compliance period would limit speculation on future human 

activities, as well as waste- and site-performance. The NRC would limit the impact of 

uncertainty on the compliance period decision making by limiting the duration of the compliance 

period. 

The NRC recognizes that there is merit in considering timeframes longer than 1,000 

years for some types of waste. Therefore, this approach would also establish a protective 

assurance period which would ensure that the disposal of LLRW would not present an 

unacceptable risk to future generations by minimizing radiation doses from the end of the 

compliance period until 10,000 years. The minimization process would be designed to ensure 

that radiological doses are maintained below 5 millisieverts (500 mrem) per year, or to a level 

that is reasonably achievable based on technological and economic considerations. The use of 

a protective assurance period with a minimization target rather than a dose limit would 
51 

recognize the uncertainty in estimating future social patterns, living conditions, and 

environmental conditions in and around a disposal facility. The standard for the second tier is 

more similar to ALARA or optimization than a strict dose limit. The types of questions a 

licensee, license applicant, or regulator may consider when applying this approach would 

include but are not limited to: 

• What are the projected doses? 

• What other technologies are available to reduce those projected doses (e.g. different 

wasteforms, engineered covers)? 

• If the doses are projected to be above 5 mSv/yr (500 mrem/yr), can they be reduced 

using technology in an economically justifiable manner? 

• Could the waste stream be disposed at a different site? Is this site not suitable for 

this waste (i.e., excess instability)? 

The third tier of the approach is the performance period. The performance period would 

be used to evaluate the performance of the site after the protective assurance period and 

ensure that disposal system’s ability to mitigate long-term risks associated with the disposal of 

long-lived LLRW is evaluated. The performance period would only apply if a facility is projected 

to contain sufficient long-lived radioactivity that could pose an unacceptable risk beyond 10,000 

years. 

b) Uncertainty informed approach: This approach would provide decision points and 

regulatory limits that would consider major sources of uncertainty associated with the projection 

of radiological risk from the disposal of LLRW. This approach would be divided into three 

timeframes—compliance period, assessment period, and performance period—and is referred 

to as the Compliance, Assessment, and Performance approach (CAP). 

The compliance period would be defined as the period of time when the disposal facility 

performance could be estimated quantitatively with relative confidence. Societal uncertainties, 
52 

though large, would not prevent the performance calculations from providing meaningful 

information. 

The assessment period would be the period of time after the compliance period where 

performance of the disposal facility would be assessed quantitatively and the results would be 

interpreted semi-quantitatively considering the increasing uncertainties in natural and 

engineered system components. The assessment period would be used to evaluate the relative 

performance of natural and engineered barriers. 

The performance period would be the period of time after the assessment period where 

performance of the disposal facility would be evaluated qualitatively or quantitatively, as 

appropriate, because numerous and significant sources of uncertainty could significantly 

influence the results. 

The objective of the CAP approach is to balance the need to consider radiological risks 

to future generations, even over long periods of time, with the uncertainties that could impact 

the interpretation of the results of the performance calculations. For LLRW inventories with 

long-lived radionuclides and with in-growth of more mobile progeny, the CAP approach is one 

way to ensure that the long-term risks would be incorporated into decision making. This threetiered approach would ensure that the potential long-term radiological risks are communicated 

to decision makers while properly reflecting the uncertainties associated with the calculations. 

In the NRC’s “Technical Analysis Supporting Definition of Period of Performance for Low-level 

Waste Disposal,” examples were given for defining the tiers and providing associated dose 

limits, however, specific values for each variable were not selected. 

Design- and control-based approach: The NRC considered an approach to managing longlived LLRW that requires periodic review and reassessment (e.g., perpetual institutional control, 

monitoring, and maintenance), as is done with facilities that dispose of industrial metals. 
53 

Currently, 10 CFR part 61 contemplates that involvement of a disposal site operator will follow a 

well-defined timeline. The more open-ended process associated with the disposal of industrial 

metals is viewed as a disadvantage to adoption of this type of approach. 

Under current 10 CFR part 61, after satisfactory disposal site closure, licenses are 

transferred to the State or Federal Government, one of which is required to own the disposal 

site. A 5-year period during which the licensee would remain at the disposal site to ensure that 

the site is stable and ready for institutional control is required, though the Commission would be 

able to prescribe longer periods of time to demonstrate that the disposal site is stable, if 

warranted.7

 The disposal site is transferred to the State or Federal Government after this 

period. 

3. NRC proposed option. 

The NRC proposed option is an approach to analyses timeframes that is based on a 

three-tiered conceptual framework. The proposed option includes a compliance period of 1,000 

years applicable to both a performance assessment used to demonstrate compliance with 

10 CFR 61.41 and to an intruder assessment used to demonstrate compliance with 

10 CFR 61.42. 

The second tier of the proposed option includes a 10,000 year protective assurance 

period, during which doses, as estimated by technical analyses, would be minimized. The 

objective of the minimization process would be to keep doses below 500 mrem/yr or to a level 

that is reasonably achievable based on technological and economic considerations. Should 

doses exceed the minimzation target, changes to the disposal site design, inventory limits, or 

alternative methods of disposal would be needed to ensure doses are minimized to avoid 

 

7

 10 CFR 61.29. 
54 

unacceptable consequences unless those changes can be shown to not be technically or 

economically practical. Given the significant uncertainties inherent in these long timeframes, 

the performance assessment should reflect changes in features, events, and processes of the 

natural environment such as climatology, geology, and geomorphology only if scientific 

information compelling such changes from the compliance period is available. The NRC is not 

proposing that features, events, and processes that are dynamic be arbitrarily fixed as static. 

Rather that the scope of the features, events, and processes considered does not need to be 

expanded unless information is available to do so. 

The third tier of the proposed option includes a performance period of undefined duration 

during which a licensee must demonstrate that effort has been made to minimize releases to the 

extent reasonably achievable. This metric for the third tier would afford the flexibility for 

consideration of long-term radiological doses, cost-benefit type of analyses, and concentration 

and fluxes of radionuclides in the environment. The duration is undefined to allow for 

consideration of site- and waste-specific factors as well as different methods to demonstrate 

that the requirements have been met. This approach was informed by the views expressed by 

various members of the public about the consideration of long-term uncertainties. Conditions 

have been established to determine when the performance period analyses should be 

performed, therefore risk-informing the approach. In order to determine if performance period 

analyses are necessary, it is proposed that a licensee or license applicant compare LLRW 

disposal site-averaged concentrations of long-lived radionuclides to values provided in the 

proposed table A of 10 CFR 61.13(e). This requirement would ensure that the analyses are 

performed only when dictated by the radiological characteristics of the LLRW or if necessitated 

by site-specific conditions. The concentration values are primarily, but not solely, based on the 

Class A LLRW concentration values from table 1 of 10 CFR 61.55. Unlike the existing table 1, 

the proposed table A includes non-transuranic long-lived isotopes, as well as transuranic long-
55 

lived isotopes. It is appropriate to include the non-transuranic isotopes in the performance 

period analyses if they could potentially be disposed of in significant concentrations and 

quantities. The radiological risk is estimated using the dose conversion factors of individual 

isotopes at the concentration provided (10 nanoCuries per gram (nCi/g)). The dose conversion 

factors for all isotopes have variability; there are different values of dose conversion factors for 

different solubility classes of an isotope as well as different values of dose conversion factors for 

different isotopes. When deriving the 10 nCi/g concentration value for transuranic isotopes in 

Class A LLRW, the NRC applied the same conversion of concentration to dose for all of these 

isotopes. The dose conversion factors for non-transuranic isotopes are generally comparable to 

the transuranic isotopes, and the NRC believes it is appropriate to simplify the variability similar 

to what was done in the original rulemaking. This simplification results in a single concentration 

value for all long-lived alpha emitting radionuclides rather than a table of values for different 

isotopes. The concentrations provided in the proposed table A of 10 CFR 61.13(e) are only 

used to determine if performance period analyses are necessary. As explained in detail in the 

draft guidance document, the complexity of the analyses would be driven by the projected 

impacts. The results of the performance period analyses would determine if any resultant 

actions are necessary (e.g., establish inventory limits). 

The specification of certain LLRW for which the performance period calculations apply to 

eliminates the need for all licensees or license applicants to develop performance period 

analyses. However, the language “or if necessitated by site-specific conditions” is needed 

because it is difficult to determine an absolute threshold for all sites below which the projected 

radiological risk, especially for 10 CFR 61.41, would be acceptably low. The risk to the public 

from the land disposal of LLRW can be driven by many variables, including but not limited to, 

concentration of LLRW, quantity of LLRW, disposal facility design, hydrogeology, release 

pathways, and receptor location and behavior. It is technically challenging to reduce this multi-
56 

dimension problem into one-dimension (i.e., concentrations) in a risk-informed manner. The 

approach proposed in this rule attempts to address this issue by providing disposal siteaveraged concentrations for which the long-term radiological risk is expected to be suitably low 

for most facilities, but would afford flexibility for additional analyses if warranted by site-specific 

conditions. The draft guidance document describes the types of conditions that may warrant 

performance period analyses even with the disposal of low concentrations of long-lived LLRW. 

The reasons for selecting this option are: 

• The tiered analysis that is required allows for tailoring of the analysis to the problem. 

• The 1,000 year compliance period, appropriate for the disposal of short-lived LLRW, 

would ensure consistency among Agreement State regulators. 

• By providing a 1,000 year compliance period, it would limit speculation and limit the 

impact of uncertainties on the compliance period decision making. 

• By providing a protective assurance period, it would ensure that radiological impacts 

are minimized up to 10,000 years after closure. The miminization process would strive to 

maintain doses below 5 mSv/yr (500 mrem/yr) thereby providing protection to the public from 

the disposal of long-lived LLRW. 

• By providing a goal rather than a limit for the second tier (i.e., between 1,000 and 

10,000 years), it would recognize the uncertainty about future society and environmental 

characteristics and allow consideration of economic and technological arguments to justify that 

doses are minimized to a level that is reasonably achievable. It may be economically and 

technically justifiable to reduce doses well below the target. 

• Selective constraints are provided while affording regulatory flexibility, where 

warranted. 
57 

H. Why are the 1,000-year compliance period and 10,000-year protective assurance 

period appropriate? 

The NRC’s perspective is that impacts should be reliably calculated for the compliance 

period. The NRC is proposing to manage the increasing uncertainties associated with long 

timeframes by limiting the timeframe of the analyses and the scope of the analyses. Licensing 

decisions should be based on information that is reasonable, reliable, and knowable based on 

current understanding. The proposed approach limits the consideration of uncertainties 

associated with long timeframes. 

One of the factors underlying the proposed approach was the DU LLRW stream. The 

DU radiological characteristics are somewhat unique in that DU is very long-lived and there is 

potentially a large quantity of DU that needs to be disposed. In addition, the hazard of DU 

increases over very long periods of time because of the slow decay of uranium and the ingrowth of progeny. The time at which the concentration of radionuclides in the LLRW is within 

one order of magnitude of the peak concentration is sensitive to the assumed isotopic mass 

fractions in the initial LLRW. For depleted uranium this time is approximately 10,000 years or 

longer. The recommended approach is suitable for depleted uranium because though the 

impacts after 1,000 years would not be part of a compliance decision, they would be considered 

in the licensing process and a licensee must demonstrate that the impacts have been minimized 

after 1,000 years. 

Performing analyses that ensure public health and safety are protected when disposing 

of long-lived LLRW, and considering the information from the analyses in the decision-making 

process, is a risk-informed approach. However, it is not a risk-informed approach to disregard 

potential long-term impacts in the decision-making process because of large uncertainties 

without applying other regulatory requirements to ensure public health and safety will be 

protected. It would also not be a risk-informed approach to apply expensive and burdensome 
58 

requirements on the present generation to offset hypothetical and unknown risks to generations 

long into the future. The proposed three tiered approach balances these competing influences 

by having a 1,000 year compliance period, followed by site-specific technical analyses 

(minimization) for the period up to 10,000 years, and additional analyses beyond 10,000 years, 

when sufficient quantities and concentrations of long-lived LLRW would be disposed of. In the 

analyses performed in 2008 as part of the development of SECY-08-0147, the NRC staff 

estimated that concentrated, long-lived LLRW (e.g., DU) could be disposed of in the nearsurface but only in either limited quantities or under certain conditions. Without specifying 

regulatory requirements to either identify when the conditions for disposal are appropriate or to 

prevent disposal under inappropriate conditions, there may be instances when the performance 

objectives will not be met. Most other concentrated, long-lived LLRW in significant quantities 

may need some type of restrictions for near surface disposal. The proposed approach is to use 

site-specific technical analyses to identify what restrictions are necessary. Because waste 

disposal is a proposed future action, when all else fails or is too uncertain, inventory limits can 

be used to mitigate future risks. 

 

I. Why is a 5 milliSievert per year (500 mrem per year) target appropriate for dose 

minimization during the protective assurance period? 

Given the significant uncertainties inherent in demonstrating compliance with the 

performance objectives over a very long timeframe and to ensure a reasonable analysis, the 

analyses would be required to demonstrate that the annual dose should be minimized below 5 

mSv (500 mrem) or a level that is supported as reasonably achievable based on technological 

and economic considerations from the end of the compliance period through 10,000 years. This 

500 mrem/yr minimization target was chosen to limit releases to values that have been 

previously established by the NRC in 10 CFR part 20. For example, paragraph (e) in 10 CFR 
59 

20.1403, “Criteria for license termination under restricted conditions,” and paragraph (d) in 10 

CFR 20.1301, “Dose limits for individual members of the public,” require annual dose limits of 

5 milliSievert (500 mrem) in limited cases. This approach is designed to provide a target for 

minimization that takes into account the significant uncertainties over these long periods of time. 

As discussed in the guidance document, the minimization process most likely will result in 

projected impacts that are significantly lower then this mimization target. The NRC is seeking 

feedback on the proposed approach, especially with regard to whether a 5 milliSievert (500 

mrem) annual dose goal is appropriate for the protective assurance period and whether it is 

appropriate to consider alternative, higher levels based on technological and economic 

considerations. 

J. What are waste acceptance criteria (WAC)? 

The NRC’s current WAC can be found in subpart D of 10 CFR part 61, which specifies 

technical requirements for land disposal facilities for commercial LLRW. The technical 

requirements specify the classes and characteristics of LLRW that are acceptable for 

near-surface disposal, as well as other requirements. Currently, 10 CFR 61.55 provides the 

primary criteria related to LLRW acceptance and identifies the classes of LLRW acceptable for 

near-surface disposal (i.e., the LLRW classification system). Section 61.56 identifies the 

minimum characteristics for all classes of LLRW and characteristics intended to provide stability 

of certain LLRW (i.e., Class B and Class C LLRW). Additionally, 10 CFR 61.52(a) specifies 

requirements for near-surface LLRW disposal facility operation, including segregation and 

intruder barrier requirements for various classes of LLRW. Section 61.58 currently allows for 

other provisions for the classification and characteristics of LLRW on a case-by-case basis if, 

after evaluation, the Commission finds reasonable assurance of compliance with the 

performance objectives. 
60 

The LLRW classification system is well integrated with the requirements for LLRW 

characteristics and disposal facility operation. This integration stemmed from the generic nature 

of the original regulatory basis for 10 CFR part 61. The integrated requirements are intended to 

ensure that the performance objectives are met. 

In addition to reviewing other regulatory approaches, the NRC also considered the 

original regulatory basis for 10 CFR part 61 in the development of the proposed revisions to 

10 CFR 61.58. The principle basis used for setting the current 10 CFR part 61 classification 

limits, LLRW characteristic requirements, and operational requirements was limiting exposures 

to a potential inadvertent intruder at a reference LLRW disposal facility. Other considerations, 

such as long-term environmental impacts, LLRW disposal facility stability, institutional control 

costs, and financial impacts to small entities, were also considered. The NRC developed the 

LLRW classification system in 10 CFR part 61 from an analysis performed in 1981 of a 

representative LLRW disposal facility that was operated consistent with then-current practices 

and considered a projected set of LLRW streams (46 FR 38081; July 24, 1981). Specifically, 

the LLRW class limits were derived from an analysis that considered a combination of factors 

including radionuclide characteristics and concentrations, the wasteform, the methods of 

emplacement, and to some extent, the site characteristics. These factors influenced the 

concentration of radionuclides transferred from the disposed LLRW to the access points for the 

intruder scenarios. These factors are dependent upon the LLRW disposed, methods of 

emplacement, engineering design, and site characteristics, which can vary from facility to 

facility. 

For example, one of the factors the NRC considered is site characteristics, which plays a 

role in the movement of radionuclides between environmental media (e.g., soil to air). The 

movement of radionuclides depend on the environmental conditions at the location of the LLRW 

disposal facility. The reference LLRW disposal facility used in the original regulatory basis was 
61 

not intended to represent any particular location, but rather, it was used to reflect the typical 

environmental conditions within its region. The NRC chose the southeastern region because, at 

the time, most of the LLRW was produced in the eastern portion of the nation and was projected 

to be disposed regionally. Today, only one of the four operating LLRW disposal sites is located 

in the eastern United States; the other three are located in the arid or semi-arid western United 

States. The Southeastern region was selected for the reference facility location because the 

environmental characteristics of the reference LLRW disposal facility were expected to be 

conservative compared to more arid site locations. 

Regardless of whether the assumptions regarding the LLRW, operational practices, 

facility design, or site characteristics of the reference LLRW disposal facility are consistent with 

current facilities, the NRC believes that the 10 CFR part 61 LLRW classification system remains 

protective of public health and safety for the LLRW streams that were analyzed in the 

development of the regulations because of the reasonably conservative nature of the analysis 

used to develop the LLRW classification system. However, inconsistency between actual site 

conditions and practices at an LLRW disposal facilities and the generic assumptions used to 

develop the LLRW classification system may cause the radionuclide concentration limits to be 

either overly restrictive or permissive. If radionuclide concentration limits are overly restrictive 

based on actual site characteristics, facility design, and operational practices, the LLRW 

classification system would ensure the safe disposal of LLRW, but it would impose unnecessary 

regulatory burdens on licensees and LLRW generators. Whereas, if the generic concentration 

limits at a LLRW disposal facility are overly permissive based on actual site characteristics, 

facility design, and operational practices, the LLRW classification system alone may not 

adequately ensure the protection of public health and safety. If the Commission found that the 

LLRW classification requirements were overly permissive at a particular disposal facility, it could 

impose additional requirements to ensure that the 10 CFR part 61 performance objectives 
62 

would be met. Therefore, it’s the 10 CFR part 61 performance objectives that ultimately ensure 

protection of public health and safety. However, the inconsistency between the generic 

assumptions and current practices highlights the need for flexibility to develop site-specific 

WAC. The site-specific WAC would provide assurance that public health and safety can be 

protected, while offering the possibility for the relief of unnecessary regulatory burdens for 

facilities with superior site characteristics, design, and operational practices. The specifics of 

WAC background information, other regulatory approaches regarding LLRW acceptance 

practices, technical considerations, and public comments are discussed further in Section 5.2, 

“Flexibility for Site-Specific Waste Acceptance Criteria,” of the regulatory basis document issued 

in December 2012. 

In addition to considering the original regulatory basis for 10 CFR part 61, the NRC also 

performed a review of other regulatory approaches, domestic and international, regarding LLRW 

acceptance practices to develop the proposed revisions to 10 CFR 61.58. In general, practices 

vary but are constrained between specification of criteria by the regulatory agency and 

development of site-specific WAC by LLRW disposal facility operators. In all cases, the 

regulatory authority maintains oversight of disposal, including approval of the LLRW acceptance 

requirements. 

1. Options considered. 

The NRC considered three options for revising the regulatory framework associated with 

waste acceptance criteria for the near-surface disposal of LLRW. In the first option, the NRC 

considered maintaining the current approach for determining LLRW acceptability, namely the 

generic LLRW classification system. The NRC staff also considered a second option, in which 

the current LLRW classification system is replaced with criteria allowing flexibility for licensees 

or license applicants to determine site-specific WAC. Finally, the NRC considered a third option 
63 

that would add flexibility to establish site-specific WAC to the existing LLRW classification 

system. These options are summarized as follows: 

Option 1. No change from current approach. The regulations in 10 CFR part 61 

currently provide general criteria for LLRW acceptability for near surface disposal through the 

classification and LLRW characteristics requirements set forth in 10 CFR 61.55 and 

10 CFR 61.56. Because of the conservative nature of the assumptions used in the original 

10 CFR Part 61 regulatory basis to develop the LLRW classification, the LLRW classification 

system is expected to be protective of public health and safety as long as LLRW disposal 

facilities operate within the regulatory basis of the original 10 CFR part 61 regulations. 

However, new practices that differ from the assumptions of the original analyses create 

uncertainty regarding the protectiveness of the LLRW classification system. For instance, new 

LLRW streams that were not considered during the development of 10 CFR part 61 are being 

considered for disposal (e.g., large quantities of concentrated DU and LLRW resulting from the 

production of medical isotopes). Also, current LLRW disposal facility design and operational 

practices can differ from the generic assumptions employed in the development of the LLRW 

classification system (e.g., disposal of LLRW containers in concrete vaults). 

Currently, 10 CFR part 61 allows for alternative provisions for LLRW acceptability (i.e., 

LLRW classification and characterization) on a case-by-case basis through 10 CFR 61.58. 

Section 61.58 allows the Commission, either upon request or upon its own initiative, to authorize 

alternate provisions for classification or characteristics of LLRW. The requirements for LLRW 

classification and characteristics are found in 10 CFR 61.55 and 10 CFR 61.56, respectively. 

Such alternative provisions could be authorized after an evaluation showing that the specific 

LLRW disposal facility, and disposal method being proposed, would provide reasonable 

assurance of compliance with the performance objectives. Agreement States that regulate 

LLRW facilities would apply their own regulatory provisions in these situations. 
64 

At present, only one of the four Agreement States that has an operating near-surface 

LLRW disposal facility has adopted a corresponding regulation to 10 CFR 61.58. Currently, 

Agreement States are not required to adopt 10 CFR 61.58, therefore, the Agreement State 

compatibility designation for 10 CFR 61.58 must be changed in order to require Agreement 

States to adopt an alternative provision for LLRW classification and characteristics. Agreement 

State compatibility designation for 10 CFR 61.58 is discussed further in Section VI, “Agreement 

State Compatibility,” of this notice. 

Option 2. Site-specific waste acceptance approach. Another possible approach to 

provide flexibility for licensees or license applicants to determine site-specific WAC would be for 

the NRC to abandon the existing LLRW classification system and replace it with requirements 

for developing site-specific WAC from the results of the site-specific technical analyses. This 

approach would require LLRW disposal facilities to define the acceptability of LLRW. In defining 

LLRW streams with acceptable radionuclide concentrations or activities and wasteforms, LLRW 

disposal facilities would be required to use the results of the site-specific technical analyses set 

forth in the proposed 10 CFR 61.13. Under the site-specific LLRW acceptance approach, 

licensees and license applicants would also need to develop strategies for characterizing LLRW 

and methods to certify that LLRW meets acceptance criteria that are commensurate with the 

analyses used to derive the site-specific WAC.

Removal of the current LLRW classification system from 10 CFR part 61 would present 

challenges because the LLRW classification requirements are well integrated with other 

requirements of 10 CFR part 61. For instance, license requirements for the operation of a 

LLRW disposal facility may reference the LLRW classes of 10 CFR 61.55. Therefore, complete 

replacement of the LLRW classification system would likely expand the effect of the rule 

revisions beyond the intended scope of this rulemaking. 

Further, removal of the LLRW classification system from 10 CFR part 61 would not result 
65 

in total abandonment of the system because the classification of LLRW is referenced in the 

Low-Level Radioactive Waste Policy Act of 1980 (as amended in 1985). The Low-Level 

Radioactive Waste Policy Act of 1980 (as amended in 1985) establishes Federal and State 

responsibilities for the disposal of LLRW based on the LLRW classification system in 10 CFR 

part 61 as it existed on January 26, 1983. Specifically, Section 3 of the Low-Level Radioactive 

Waste Policy Act of 1980 (as amended in 1985) states that the responsibilities of each State 

shall include the disposal of LLRW generated within the State (other than by the Federal 

Government) that consists of, or contains, Class A, Class B, or Class C LLRW, as defined by 

10 CFR 61.55, in effect on January 26, 1983. Likewise, the Low-Level Radioactive Waste 

Policy Act of 1980 (as amended in 1985) states that the Federal Government responsibilities 

shall include LLRW with concentrations of radionuclides that exceed the Class C limits 

established in 10 CFR 61.55 in effect on January 26, 1983. 

Because the Low-Level Radioactive Waste Policy Act of 1980 (as amended in 1985) 

relies on 10 CFR part 61 as it existed in 1983, removing the LLRW classification system from 

10 CFR part 61 would not change the assignment of responsibilities for the disposal of 

commercial LLRW to the States and Federal Government. Therefore, the existing LLRW 

classification system would remain relevant to assigning responsibilities to the States and 

Federal Government, regardless of its presence in 10 CFR part 61. 

Removal of the LLRW classification system from 10 CFR part 61, however, may create 

confusion among stakeholders about how responsibility is assigned. One possible approach to 

avoid confusion would be to maintain a version of the LLRW classification system in an 

appendix to 10 CFR part 61, for the sole purpose of aiding in the determination of Federal and 

State responsibilities for the disposal of LLRW. Alternatively, the LLRW classification 

requirements could be included in appendix G to 10 CFR part 20, where LLRW is manifested for 

shipment. The purpose of appendix G to 10 CFR part 20 is to address the various regulatory 
66 

information needs for the transfer and disposal of LLRW. These informational needs, which 

were identified in the Statement of Consideration that accompanies the final rule (60 FR 15664) 

include, among others, access to information needed for assessments to demonstrate 

compliance with the performance objectives in 10 CFR part 61. This includes information 

necessary for the States and Compacts to carry out their responsibilities. Therefore, preserving 

the LLRW classification requirements in appendix G to 10 CFR part 20 would minimize 

confusion for shippers to provide accurate information that allows the States and Compacts to 

carry out their responsibilities. 

The NRC is assuming that changes to the Low-Level Radioactive Waste Policy Act of 

1980 (as amended in 1985) will not be made to accommodate any revisions to the 

10 CFR part 61 regulations. Instead, as previously noted, the NRC has developed a proposal 

that would implement this option without requiring changes to the Low-Level Radioactive Waste 

Policy Act of 1980 (as amended in 1985). 

Option 3. Hybrid waste acceptance approach. A third approach that the NRC 

considered would be to allow licensees or license applicants to develop site-specific WAC from 

the results of the technical analyses or from the requirements of the existing LLRW classification 

system. This proposed approach would still require licensees or license applicants to determine 

the acceptability of LLRW. In defining LLRW streams with acceptable radionuclide 

concentrations or activities and wasteforms, licensees or license applicants would be allowed to 

use either the results of the site-specific technical analyses set forth in 10 CFR 61.13, or the 

LLRW classification requirements in 10 CFR 61.55. Beyond the radionuclide limits and 

acceptable LLRW characteristics, licensees or license applicants would, as discussed 

previously in the site-specific waste acceptance approach, need to develop strategies for 

characterizing LLRW and methods to certify that LLRW meets acceptance criteria. 

For licensees that choose to develop WAC based on the LLRW classification system in 
67 

10 CFR 61.55, this approach would not result in a significant additional burden to their current 

operating practices since they are currently using acceptance practices with essentially the 

same type of criteria. Licensees typically develop these site-specific WAC from the existing 

10 CFR part 61 requirements and the NRC guidance.8

 These licensees would still be required 

to demonstrate through the technical analyses set forth in 10 CFR 61.13 that they will meet the 

performance objectives. The required analyses may demonstrate that additional mitigation 

should be performed for certain LLRW streams, particularly those that were not considered in 

the development of the LLRW classification system. 

Because the hybrid waste acceptance approach would not alter the LLRW classification 

requirements in 10 CFR part 61, the approach also would maintain consistency between the 

LLRW classification requirements in 10 CFR part 61 and the assignment of Federal and State 

responsibilities in the Low-Level Radioactive Waste Policy Act of 1980 (as amended in 1985), 

for the disposal of commercial LLRW. For instance, States may choose to permit the 

acceptance of LLRW designated as a Federal responsibility (e.g., greater-than-Class-C LLRW) 

under the Low-Level Radioactive Waste Policy Act of 1980 (as amended in 1985), if the results 

of the site-specific technical analyses demonstrate that greater-than-Class-C LLRW would be 

acceptable for disposal at a specific disposal facility. Further, under the existing 10 CFR part 61 

regulations, though States are responsible for disposal of LLRW with concentrations less than 

the upper limits for Class C, some States have exercised flexibility to further limit disposal of 

certain LLRW for which they are responsible at specific LLRW disposal facilities. The NRC 

proposes not to alter this flexibility under this proposed approach. In all cases, the regulatory 

authority maintains oversight of disposal, including approval of the LLRW acceptance 

requirements. 

 

8

 NRC, “Branch Technical Position on Concentration Averaging and Encapsulation,” January 17, 1995, Division of 

Waste Management.
68 

The NRC also considered whether licensees and license applicants should have the 

flexibility to consider alternative active institutional control periods to derive site-specific WAC, 

under both the site-specific waste acceptance and hybrid waste acceptance approaches. To 

allow this flexibility when developing site-specific WAC, the NRC would need to revise 

10 CFR 61.59 to permit licensees or license applicants to develop site-specific WAC for periods 

beyond 100 years. 

During the original development of 10 CFR part 61, in NUREG-0782, “Draft 

Environmental Impact Statement (EIS) on 10 CFR Part 61 ‘Licensing Requirements for Land 

Disposal of Radioactive Waste’” (ADAMS Accession No. ML052590348), the NRC considered a 

range of time periods for active institutional controls but decided that 100 years is an 

appropriate period for determining how long the government would be able to ensure custodial 

care for a near-surface disposal facility. When the public commented that longer times would 

be appropriate, the NRC determined that, while the longevity of government may reasonably be 

assumed to extend beyond 100 years, the limit is tied to the possibility of bureaucratic error, 

which is more difficult to assess. For example, the government could, at some future date, 

unintentionally permit activities on the site as a result of an incomplete records search. The 

NRC indicated that it saw no compelling reason to abandon a 100-year institutional control 

period. Further, the institutional control period is a regulatory component of defense-in-depth by 

limiting the period of time over which oversight would need to be effective. Federal regulations 

for disposal of a variety of waste, including municipal and hazardous wastes, allow for a wide 

range of institutional control periods. International approaches for LLRW disposal vary for the 

period over which institutional controls are assumed to function, but generally they are limited to 

300 years or less. Therefore, allowing unlimited flexibility would appear to be inconsistent with 

current international practice regarding the longevity of institutional controls. 

Since the 100-year time duration is an integral assumption in the analyses that originally 
69 

derived the radionuclide concentration limits set forth in 10 CFR 61.55, the hybrid waste 

acceptance approach would also need to maintain the current 100-year limit for licensees or 

license applicants that continue to use the LLRW classification system. The NRC maintains its 

earlier assessment and sees no new compelling reason to consider a revision to 10 CFR 61.59. 

Therefore, the NRC proposes to maintain the 100-year limit set out in 10 CFR 61.59. 

2. NRC proposed option. 

In the proposed rule, the NRC is proposing the hybrid waste acceptance approach 

(Option 3) as the regulatory LLRW acceptance framework for the near-surface disposal of 

LLRW. The hybrid waste acceptance approach provides a framework for the use of either the 

generic LLRW classification system specified in 10 CFR 61.55 or the results of the technical 

analyses required in 10 CFR 61.13. Either approach, when combined with the other revisions 

recommended for this rulemaking, would provide reasonable assurance that public health and 

safety would be protected. The hybrid waste acceptance approach would provide a framework 

for determining LLRW acceptability at a disposal facility while achieving the following: 

• providing flexibility to develop site-specific WAC; 

• minimizing revisions to 10 CFR part 61; 

• maintaining consistency with the Low-Level Radioactive Waste Policy Act of 1980 

(as amended in 1985); 

• limiting additional regulatory burden on licensees and license applicants; 

• providing States flexibility to exercise their regulatory authority within a national 

framework; and 

• maintaining consistency with the range of domestic and international practices for the 

disposal of LLRW. 
70 

The implementation of the hybrid waste acceptance approach would require revisions to 

10 CFR part 61 that allow land disposal facilities flexibility to establish site-specific WAC based 

either on the LLRW classification system specified in 10 CFR 61.55 or the results of the 

analyses required in 10 CFR 61.13 for any land disposal facility. The use of the LLRW 

classification system would be limited to a near surface disposal facility because the LLRW 

classification requirements were originally developed as technical requirements for disposal in a 

near-surface LLRW disposal facility. The revisions would specify the minimum content of the 

WAC and the proposed 10 CFR 61.52(a)(12) would limit the disposal facility to disposing only 

LLRW that meet the WAC. 

The revisions would also require licensees or license applicants to develop approaches 

and methods for generators to characterize LLRW, to certify that LLRW meets acceptance 

criteria in order to demonstrate compliance with the WAC, and to annually review the content 

and implementation of the LLRW acceptance program. Requiring licensees and license 

applicants to specify acceptable methods to characterize LLRW, ensures that generators 

appropriately characterize the LLRW and that the data are sufficient to demonstrate that the 

disposal facility’s WAC are met. Certification requirements ensure an appropriate administrative 

process developed by the licensees or license applicants is used by generators to demonstrate 

that the WAC are met, that necessary records are maintained, and that certified LLRW is 

managed to maintain its certification. Resource burdens associated with administrative and 

recordkeeping processes used to demonstrate compliance with disposal facility’s WAC 

requirements are further discussed in Section X, “Paperwork Reduction Act Statement,” of this 

document and the accompanying draft regulatory analysis. 

Additionally, implementation of the hybrid waste acceptance approach requires revisions 

to specific manifesting requirements specified in sections I, II, and III of appendix G to 10 CFR 

part 20 and the related guidance in NUREG/BR-0204, “Instructions for Completing NRC’s 
71 

Uniform Low-Level Radioactive Waste Manifest” (ADAMS Accession No. ML071870172), that 

provide information considered important for demonstrating compliance with the performance 

objectives and for States and Compacts to carry out their responsibilities under the Low-Level 

Radioactive Waste Policy Act of 1980 (as amended in 1985). The proposed revisions to 

appendix G to 10 CFR part 20 ensure that specific manifesting requirements, which were 

previously linked directly to the LLRW classification requirements, are revised to maintain 

consistency with the proposed requirements for LLRW acceptance in 10 CFR part 61. The 

proposed revisions to appendix G to 10 CFR part 20 also ensure that information important for 

States and Compacts to carry out their responsibilities under the Low-Level Radioactive Waste 

Policy Act of 1980 (as amended in 1985) will continue to be reported. 

K. What other changes are proposed? 

The NRC is proposing additional changes to the 10 CFR part 61 regulations to facilitate 

implementation and better align the requirements with current health and safety standards. 

These changes would include: 1) adding new definitions to 10 CFR 61.2, “Definitions,” and 

updating concepts in 10 CFR 61.7; 2) implementing changes to appendix G to 10 CFR part 20, 

to conform to proposed LLRW acceptance requirements; 3) modifying site suitability 

requirements in 10 CFR 61.50, to be consistent with the proposed analyses framework; and 

4) Updating the dose calculation system used in 10 CFR part 61. 

1. Adding new definitions to 10 CFR 61.2 and updating concepts in 10 CFR 61.7. 

Currently, 10 CFR 61.2 defines common terms used in 10 CFR part 61 and 10 CFR 61.7 

provides conceptual information for the disposal facility LLRW classification and near-surface 

disposal, and licensing process for LLRW disposal facilities. These concepts include 
72 

descriptions of: a) the parameters for near-surface disposal in engineered facilities and the 

layout of land and buildings necessary to carry out the disposal; b) the safety objectives for 

near-surface LLRW disposal, which emphasize the stability of the wasteforms and disposal 

sites; and c) the licensing processes that the licensees or license applicants go through during 

the preoperational, operational, and site closure periods. 

The NRC proposes to add definitions and concepts to 10 CFR 61.2 and 10 CFR 61.7, 

respectively, to support the site-specific technical analyses and LLRW acceptance 

requirements. These terms and concepts are needed to provide consistency and facilitate 

implementation of the proposed 10 CFR part 61 regulations. 

The NRC is proposing to add definitions for “compliance period,” “defense-in-depth,” 

“intruder assessment,” “long-lived waste,” “performance assessment,” “performance period,” 

“protective assurance period,” and “safety case” to facilitate implementation of the proposed 

requirements for site-specific analyses. The definitions for the various analyses and time 

periods are necessary to support the requirements for the performance objectives and technical 

analyses. Three specific definitions deserve to be discussed in greater detail are “long-lived 

waste” because the proposed performance period analyses are only necessary for the disposal 

of long-lived LLRW, “defense-in-depth” because licensees will be required to demonstrate how 

the disposal facility relies upon multiple independent and redundant layers, and “safety case” 

because the requirements are central to demonstrating that public health and safety will be 

adequately protected at present and in the foreseeable future. 

The performance period analyses are designed to be completed if a facility will be 

disposing of long-lived LLRW. The proposed “long-lived waste” definition contains three 

components. The first component is a radionuclide that does not decay sufficiently over the 

compliance period. The reason the NRC is expressing this as a percentage of initial activity of a 

radionuclide that remains after 10,000 years, instead of a half-life value such as 3,000 years as 
73 

suggested by some members of the public, is to ensure that stakeholders understand that the 

“long-lived waste” definition is conditional on the analyses framework. If the analysis framework 

were to be changed in the future or if a different framework was used, for instance, in a different 

country, a half-life of 3,000 years may or may not be appropriate. The second component is a 

long-lived radionuclide parent that produces short-lived radionuclide progeny. The second 

component is designed to ensure that the analysis includes radionuclide progeny, such as those 

resulting from the uranium decay series. The third component is a short-lived radionuclide 

parent that results in long-lived radionuclide progeny. Examples would include the curium 

decay series or the isotope Am-241 which produces Np-237, a long-lived radionuclide that can 

be fairly mobile in the environment. The inventory of LLRW at the time of disposal can differ 

considerably from the inventory at future times. The “long-lived waste” definition is designed to 

take this into account. 

The concept of defense-in-depth has been implicitly used in LLRW regulations in the 

past, but it has not previously been explicitly defined in 10 CFR part 61. Defense-in-depth is 

implicitly provided through the various regulatory requirements. For instance, while 10 CFR 

61.59 imposes land ownership and institutional control requirements that are intended to limit 

the potential for intrusion into a closed disposal facility, licensees may not take credit for these 

protections beyond 100 years when assessing whether the performance objectives will be met. 

The NRC's defense-in-depth approach to risk management ensures that safety is not wholly 

dependent on any single element of the design, construction, maintenance or operation of a 

regulated facility. With the potential disposal of DU and other long-lived LLRW in shallow land 

disposal facilities, defense-in-depth takes on additional importance and it is now being defined 

and explicitly used in this proposed revision to 10 CFR part 61 to provide assurance that safe 

disposal can be achieved in light of the significant uncertainties associated with projecting doses 

far into the future. Defense-in-depth for a land disposal facility includes, but is not limited to, the 
74 

use of remote siting, consideration of waste forms and radionuclide content, engineered 

features, and natural geologic features of the disposal site. 

Regarding the proposed definition for “safety case,” licensing decisions are based on 

whether there is reasonable assurance that the performance objectives can be met. The 

technical analyses are used to demonstrate that the performance objectives can be met. These 

analyses together with defense-in-depth protections and the supporting evidence and reasoning 

for the strength and reliability of these analyses and protections form the “safety case” for 

licensing a LLRW facility. The safety case must make a convincing conclusion that public 

health and safety will be adequately protected from the disposal of LLRW (including long-lived 

LLRW). A clear case for the safety of a disposal facility would also enhance communication 

among stakeholders. 

2. Implementing changes to appendix G to 10 CFR part 20 to conform to proposed LLRW 

acceptance requirements. 

Appendix G to 10 CFR part 20 imposes manifest requirements on shipments of LLRW 

consigned for disposal. The purpose of the requirements in appendix G to 10 CFR part 20 is to 

address various regulatory information needs for the transfer of LLRW. These information 

needs, which were identified in the Statement of Consideration accompanying the current 

regulations (60 FR 15664), include access to information needed for the analyses to 

demonstrate compliance with the performance objectives and that the States and Compacts 

believe is necessary to carry out their responsibilities. In particular, manifests for LLRW 

shipments must identify the LLRW classification and certify that the LLRW is “...properly 

classified, described, packaged, marked, and labeled....” Therefore, the NRC is proposing 

changes to these requirements to conform to the proposed addition of the LLRW acceptance 

requirements in 10 CFR 61.58. 
75 

To meet these needs, the requirements in appendix G to 10 CFR part 20 require 

shippers to properly classify, describe, package, mark, and label LLRW that will be transferred 

and is intended for disposal. Further, shippers must certify that these actions have been 

completed in accordance with the applicable requirements, including those in 10 CFR part 61 

for LLRW classification (i.e., 10 CFR 61.55), characteristics (i.e., 10 CFR 61.56), and labeling 

(i.e., 10 CFR 61.57). Therefore, the NRC is also proposing to amend the regulations at 

appendix G to 10 CFR part 20 to conform to the flexibility afforded by the proposal to determine 

site-specific WAC. 

Specifically, sections I.C.12 and I.D.4 of appendix G to 10 CFR part 20 currently 

require the shipper of LLRW consigned to a LLRW disposal facility to identify the LLRW 

classification per 10 CFR 61.55 and to state if it meets the structural stability requirements of 

10 CFR 61.56(b) on the uniform manifest. Because the proposed revisions to 10 CFR 61.58 

allow a licensee or license applicant to use the classification system to develop site-specific 

WAC, shipping manifest requirements related to LLRW classification will be retained so that 

States and Compacts continue to receive information allowing them to carry out their 

responsibilities as defined by the Low-Level Radioactive Waste Policy Act of 1980 (as amended 

in 1985). 

Information on LLRW acceptability at a disposal facility is essential to demonstrate 

compliance with the performance objectives. Therefore, the NRC proposes adding a 

requirement to section II of appendix G to 10 CFR part 20 to specify in the uniform manifest 

whether the LLRW being shipped to a disposal facility conforms to the facility’s WAC. The 

addition of this requirement would also require a revision of NRC Form 541, “Uniform Low-Level 

Radioactive Waste Manifest–Container and Waste Description,” to conform to this new 

requirement and the accompanying guidance NUREG/BR-0204, Revision 2. 

Further, the proposed requirements for LLRW acceptance would require revisions to the 
76 

certification requirements of section II of appendix G to 10 CFR part 20. Section II requires 

LLRW generators, processors, or collectors to certify that the transported LLRW is properly 

classified. Since the proposed 10 CFR part 61 requirements would require licensees and 

license applicants to develop criteria for LLRW acceptability using either the existing LLRW 

classification system or the results of site-specific analyses, this certification requirement would 

be updated so that shippers are certifying that LLRW consigned to a disposal facility meets the 

facility’s waste acceptance criteria for LLRW acceptability. 

The proposed 10 CFR part 61 requirements for LLRW acceptability would also require 

revisions to section III of appendix G to 10 CFR part 20. Section III of appendix G to 10 CFR 

part 20 imposes requirements on the control and tracking of LLRW transferred to a disposal 

facility. Specifically, current sections III.A.1 through 3 and III.C.3 through 5 require the LLRW to 

be classified according to 10 CFR 61.55 and meet the LLRW characteristics requirements in 

10 CFR 61.56. The container must be labeled with the appropriate LLRW class, and the 

licensee who transfers the LLRW must implement a quality assurance program to assure 

compliance with 10 CFR 61.55 and 10 CFR 61.56. Since the proposed 10 CFR part 61 

requirements would require licensees or license applicants to develop criteria for LLRW 

acceptability using either the existing LLRW classification system or the results of site-specific 

technical analyses, these requirements would be revised so that shippers are preparing, 

labeling, and providing quality assurance in accordance with the disposal facility operator’s 

criteria for LLRW acceptability. 

3. Modifying the site suitability requirements in 10 CFR 61.50 to be consistent with the 

proposed analyses framework. 

The site suitability requirements in 10 CFR 61.50 specify the minimum characteristics a 

disposal site must possess to be acceptable for use as a near-surface disposal facility. The 
77 

primary factors considered for disposal site suitability are isolation of LLRW—which is 

dependent on the radiological characteristics of the LLRW—and 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. The concept of site characteristics is explained in 10 

CFR 61.7. Site characteristics should be considered in terms of the indefinite future, take into 

account the radiological characteristics of the LLRW, and be evaluated for at least a 

500-year timeframe. Site characteristics and site suitability requirements play an integral role in 

ensuring that the site is appropriate for the type of LLRW proposed for disposal. When the site 

suitability requirements were originally developed, it was envisioned that LLRW would primarily 

contain short-lived radionuclides with low concentrations of long-lived radionuclides. The NRC 

developed the LLRW classification framework around this concept. However, the regulation at 

10 CFR 61.55(a)(6) allows long-lived LLRW not currently listed in table 1 or 2 of 10 CFR 61.55 

to be disposed in the near surface as Class A LLRW. 

In the proposed revision, it is recognized that not all LLRW may decay to relatively 

innocuous levels within 500 years and so a technical analysis would be required to determine if 

site-specific restriction of disposal of LLRW is necessary. The regulation at 10 CFR 61.50 

would be revised to clarify the interpretation of site characteristics. The site suitability 

characteristics have not been changed, but have been reorganized to distinguish the 

hydrological site characteristics from other characteristics. The hydrological site characteristics 

have been separated to clarify that for 500 years the hydrological site characteristics must be 

met regardless of the results of any technical analyses. Historically, most of the problems 

encountered in LLRW disposal resulted from water impacting the LLRW disposal system. A site 

that is unlikely to satisfy the hydrological site characteristics (e.g., disposal of LLRW in the zone 

of water table fluctuation, flooding) in the next 500 years is unlikely to be defensibly 

characterized and modeled. If the site cannot be defensibly characterized and modeled, the 
78 

radiological risk from the disposal of LLRW cannot be reliably projected. The short-lived 

radionuclides that are disposed of can result in significant impacts if they are improperly 

managed. Therefore, the hydrological site characteristics are treated differently than the other 

site characteristics. After 500 years for hydrological characteristics and for all timeframes for 

other characteristics, it is appropriate to consider if the characteristics will limit the ability of the 

licensee or applicant to meet the 10 CFR part 61 subpart C performance objectives. 

Historically, the other characteristics have not been associated to a significant degree with 

problems encountered in LLRW disposal. Therefore it is anticipated that it is less likely that the 

other characteristics will be associated with performance issues compared to the hydrological 

characteristics. The proposed revisions to 10 CFR 61.50 clarify the requirements for site 

suitability. Stability is a cornerstone of waste disposal. Future instability of a waste disposal site 

may provide the basis to limit or prohibit disposal of certain types of waste if the stability of the 

disposal site cannot be ensured. Future instability of a disposal facility may prohibit accurate 

characterization and performance assessment modeling. 

4. Updating the dose calculation system used in 10 CFR part 61. 

Currently, 10 CFR 61.41 requires that concentrations of radioactive material released to 

the general environment “not result in an annual dose exceeding an equivalent of 0.25 mSv 

(25 mrem) to the whole body, 0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to 

any other organ of any member of the public.” The objective of modeling in a performance 

assessment that would be used to evaluate compliance with 10 CFR 61.41 is described in 

NUREG-1573, and provides estimates of doses to humans from radioactive releases from an 

LLRW disposal facility after it has been closed. 

Currently, 10 CFR part 20 provides for the use of current NRC health physics practices 

for NRC licensees. In May 1991, the NRC updated 10 CFR part 20 based on a dosimetric 
79 

modeling and effective dose equivalent approach described in the International Commission on 

Radiological Protection (ICRP) Publications 26 and 30.9

 In 1991, the 10 CFR part 20 standards 

were updated to the total effective dose equivalent (TEDE) approach, consistent with the 

Federal radiation protection guidance signed by the President on January 20, 1987 (56 FR 

23360), for occupational exposure to implement the ICRP recommendations found in 

Publication 26. The current 10 CFR part 61 dose limits, and several others within the 

regulations, stem from a method of calculating and limiting doses that date back to the late 

1950s and were based on recommendations in ICRP Publication 2.10 The NRC proposes to 

revise the 10 CFR part 61 regulations to require licensee to use the dose calculation 

methodology found in ICRP Publication 26 and allow the use of more up-to-date ICRP 

recommendations for dosimetry modeling purposes. 

The topic of using updated dosimetry has been raised before. In the matter of the 

NRC’s site-specific regulations for a geologic repository for high-level radioactive waste at 

Yucca Mountain, for example, the Commission was aware of the potential for future updates to 

the ICRP’s recommendations that might be available following promulgation of its regulations in 

10 CFR part 63, “Disposal of High-Level Radioactive Wastes in a Geologic Repository at Yucca 

Mountain, Nevada.” As a consequence, rather than index the site-specific regulations to a 

particular version of the ICRP, the Commission alternatively allowed the DOE to use “... the 

most current and appropriate ...” dosimetry in its performance assessment calculations, without 

specifying which particular version or edition of that guidance to employ. Any updated radiation 

and organ or tissue weighting factors, however, would need to have been incorporated by the 

 

9

 ICRP, “Recommendations of the International Commission on Radiological Protection,” Annals of the ICRP, 

Vol. 1, No. 3, 1977, (ICRP Publication 26); ICRP, “Limits for Intakes of Radionuclides by Workers,” Annals of the 

ICRP (Part 1), Vol. 2, Nos. 3-4, 1979, (ICRP Publication 30). 10 ICRP, “Report of ICRP Committee II on Permissible Dose for Internal Radiation (1959), with Bibliography for 

Biological, Mathematical and Physical Data,” Health Physics, Vol. 3, [1959], (Reprinted in 1975 as ICRP Publication 

2).
80 

U.S. Environmental Protection Agency (EPA) into Federal radiation protection guidance. The 

Commission also stated that, “Additionally, as scientific models and methodologies for 

estimating doses are updated, the DOE may use the most current and appropriate (e.g., those 

accepted by the ICRP) scientific models and methodologies to calculate the TEDE. The 

weighting factors used in the calculation of the TEDE must be consistent with the methodology 

used to perform the calculation” (74 FR 10828; March 13, 2009). The specific language in 

current 10 CFR 63.102(o), “Concepts,” reads, in part, as follows: 

After the effective date of this regulation, the Commission may allow [a licensee] 

to use updated factors, which have been issued by consensus scientific 

organizations and incorporated by EPA [U.S. Environmental Protection Agency] 

into Federal radiation guidance. Additionally, as scientific models and 

methodologies for estimating doses are updated, [a licensee] may use the most 

current and appropriate (e.g., those accepted by the International Commission on 

Radiological Protection) scientific models and methodologies to calculate the 

TEDE. The weighting factors used in the calculation of TEDE must be consistent 

with the methodology used to perform the calculation. 

The topic of using updated methodology and terminology was also addressed by the 

Commission in SRM-SECY-12-0064, “Recommendations for Policy and Technical Direction to 

Revise Radiation Protection Regulations and Guidance,” dated December 17, 2012 (ADAMS 

Accession No. ML12352A133). The Commission approved the staff’s development of the 

regulatory basis for a revision to 10 CFR part 20 to align with the most recent methodology and 

terminology for dose assessment. The Commission further directed that appropriate steps 

should be undertaken to assure that conforming changes are made as soon as practical to 

make these methods consistent throughout all NRC regulations. 

During the development of the regulatory basis that supports this rulemaking, the 

majority of the public commenters supported the proposal to allow licensees or license 

applicants the flexibility to use the latest ICRP dose methodologies in a site-specific 

performance assessment. However, some people questioned the value and the safety 

significance in removing critical organ dose limits in updating the dose limits in 10 CFR 61.41. 
81 

The benefit of updating the dose limit to an effective dose, whether it is the TEDE or a 

more current effective dose methodology, is that it provides a holistic and consistent evaluation 

of the risks of radiation, whether the worker or member of the public is exposed from external 

radiation, inhalation, ingestion, or some combination of these. Because an effective dose 

methodology compares, and more importantly, sums the doses from different organs, exposure 

routes, and radionuclides, an overall risk is evaluated. This was not possible with the critical 

organ system provided by the ICRP Publication 2. When the ICRP Publication 2 was 

developed, organ weighting factors were unknown. The doses to different organs, in the critical 

organ system, do not account for the radiosensitivity of the organ, nor did the system use the 

wider range of organs and tissues evaluated with modern approaches. A holistic approach 

provides a large benefit in LLRW disposal dose assessment because of the range of 

radionuclides that co-mingled within the LLRW. Each radionuclide has its own predominant 

exposure pathway and dose rate, depending on the manner in which a member of the public 

may get exposed. Without a holistic method that sums the total exposures across exposure 

pathways and radionuclides, a risk-informed, performance-based decision is harder to make, as 

the doses between scenarios or situations would not be comparable especially when one is 

trying to optimize the resources to provide maximum protection within the disposal system. 

The critical organ dose approach was developed to limit doses from the intake of 

radioactive materials. In the critical organ dose approach, doses to a limited number of 

individual organ systems were calculated based on models of the movement of elements within 

the human body. For example, iodine collects mainly in the thyroid, ingested uranium provides 

doses largely to the bones and kidneys, ingested cesium provides doses to multiple organ 

systems with total body or liver being the critical organ.11 However, the potential result of a 

 

11 Battelle Pacific Northwest Laboratories, “Age-Specific Radiation Dose Commitment Factors for a One-Year 
82 

dose to a specific organ was not well-known at the time. Without this radiosensitivity 

information, doses could not be added together to evaluate the overall risk to the individual from 

radionuclides present in multiple organs. In addition, any external dose was only added to the 

“whole body” critical organ (which is not directly comparable to the TEDE in the ICRP 

Publication 26 or later publications). Because of the uncertainty, limits for the public were 

developed that gave each of the organs equal weighting, except the thyroid (for which some 

data was available). In the final rule for 10 CFR part 20 (56 FR 23360), the NRC responded to 

comments about proposed appendix B as follows: 

The former ICRP-2 “critical organ” concept based the limiting intake upon 

controlling the dose rate to the organ receiving the highest dose rate (the “critical 

organ”). The doses to organs other than the critical organ did not have to be 

evaluated, even if these doeses [sic] were close to the estimated dose to the 

critical organ. 

The TEDE approach, recommended in ICRP Publication 26, and subsequently updated 

by ICRP Publication 60 and ICRP Publication 103, uses a different approach to limiting the risk 

from radiation. Because more information on the risk associated with dose to specific organs 

exists, it is possible to calculate the overall increased risk of stochastic effects (e.g., cancer) to 

an individual. Each of the major organ or tissue systems and the six remaining highest organs 

or tissues were assigned weighting factors based on the age and gender averaged risk for each 

organ or tissue. The internal dose to each organ system from an intake of a radionuclide, or 

mixture of radionuclides, is calculated, multiplied by the appropriate weighting factor, and then 

the results are summed to give a risk-weighted “effective dose.” To calculate the TEDE, the 

external dose is added to the risk-weighted effective dose. This radiation protection system 

therefore reflects the doses to all principal organs or tissues that are irradiated, not just the one 

organ that receives the highest dose, as was done in 10 CFR part 20 before 1991. 

 

Chronic Intake,” NUREG-0172, NRC, November 1977 (Adams Accession No. ML14083A242).
83 

In the TEDE approach, the dose to individual organs also needs to be considered to 

ensure that deterministic effects do not occur. For this reason, an organ limit of 0.5 Sv (50 rem) 

is applied in addition to the TEDE dose limit for workers of 50 mSv (5 rem). Because the dose 

limit in 10 CFR part 20 for a member of the public is 50 times less than the occupational limit, 

the same concern for deterministic effects in organs does not occur. As noted in appendix B to 

10 CFR part 20, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of 

Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release 

to Sewerage,” consideration of nonstochastic effects is unnecessary at the dose levels 

established for members of the public because the organ dose can never reach the organ limit 

for the nonstochastic effects of 0.5 Sv/year (50 rem/year), without the TEDE dose being greater 

than the public dose limit (or any fraction of the public dose limit stated in 10 CFR 61.41(a)). 

Therefore, in modifying a dose limit such as 10 CFR 61.41(a) to be consistent with 10 CFR part 

20, organ dose limits are unnecessary. The TEDE approach protects all the organ systems and 

provides adequate protection to members of the public, from both individual radionuclides, as 

well as multiple radionuclides through all exposure routes (i.e., external, inhalation, and 

ingestion). In addition, the proposed regulations in 10 CFR 61.41(b) and 10 CFR 61.42(b) do 

provide a pathway for a licensee to exceed the proposed minimization target of 5 milliSieverts 

per year (500 millirems per year) by demonstrating a level that is supported as reasonably 

achievable based on technological and economic considerations. However, the NRC does not 

anticipate that technological and economic considerations could justify a target that would 

necessitate the consideration of nonstochastic effects. 

The NRC considered the following three options to revise the 10 CFR part 61 regulations 

to allow the use of more up-to-date ICRP recommendations for dosimetry modeling purposes: 

Option 1. No change from current approach. The NRC considered allowing the rule to 

remain silent on this matter and address the issue in the accompanying LLRW performance 
84 

assessment guidance. 

Option 2. Edition-specific approach. The NRC considered requiring a dose calculation 

approach found in ICRP Publication 26 and specifying in the regulations which version of the 

ICRP the licensees or license applicants should implement in any 10 CFR part 61 license 

application. 

Option 3. Edition-neutral approach. The NRC considered requiring a dose calculation 

approach found in ICRP Publication 26 and adopting an edition-neutral approach, to allow the 

use of more up-to-date ICRP recommendations, for dosimetry modeling purposes. 

The NRC is proposing to adopt option 3, the edition-neutral approach, for the revision of 

the 10 CFR part 61 regulations, to allow the use of more up-to-date ICRP recommendations for 

dosimetry modeling purposes. The NRC favors this approach because it has already approved 

and implemented this particular type of regulatory approach in its 10 CFR part 63 regulations. 

As the ICRP’s recommendations have historically been updated more frequently than the 

Commission’s LLRW regulations, adopting an edition-neutral approach in the regulations would 

obviate the need for updating 10 CFR part 61 at some future date in response to some 

comparable update to Federal radiation protection guidance and the associated ICRP 

recommendations provided that the guidance and the ICRP recommendation continue to ensure 

the Agency’s approach to adequate protection. Licensees would need to use the dose 

calculation method required in 10 CFR part 20 (currently based on ICRP Publication 26). Since 

10 CFR part 61 would not refer to a specific dose calculation method, the general radiation 

protection regulations of 10 CFR part 20 would apply. 

5. Implementing the safety case in 10 CFR part 61. 

Licensees are responsible for demonstrating that their land disposal facilties are 

constructed, operated, and closed safely. To this end, 10 CFR part 61 establishes requirements 
85 

that licensees must meet to demonstrate that a land disposal facility will be constructed, 

operated, and closed so as to provide reasonable assurance that public health and safety and 

the environment will be protected. While the NRC believes that the existing requirements 

specified in 10 CFR 61.10 through 10 CFR 61.16, together with the performance objectives of 

subpart C and the technical requirements of subpart D, ensure that a licensee demonstrates the 

safety of a land disposal facility, the regulations do not explicitly establish requirements for the 

development of a safety case. 

The safety case concept in the context of radioactive waste disposal, which has been 

developed internationally, is generally regarded as a collection of arguments and evidence to 

demonstrate the safety and performance of a disposal facility. A safety case for a land disposal 

facility covers the suitability of the site and the design, construction and operation of the facility, 

as well as the assessment of radiation risks and assurance of the adequacy and quality of all of 

the safety related work associated with the disposal facility. The purpose of a safety case is to 

provide a sufficient level of detail regarding the description of all safety relevant aspects of the 

site, the design of the facility, and the managerial control measures and regulatory controls to 

inform the decision whether to grant a license for the disposal of LLRW and provide the public 

assurance that the facility will be designed, constructed, operated, and closed safely.12 

The NRC believes that the current 10 CFR part 61 implicitly includes components of the 

safety case concept. For instance, an important component of the international safety case 

concept is the safety assessment, which consists of the assessment of radiological impacts as 

well as an analysis of site and engineering aspects and operational safety. Currently, the 

NRC’s regulations at 10 CFR 61.13 require analyses that achieve the intent of a safety 

assessment. 

 

12 IAEA Safety Standards Series No. SSG-23. The Safety Case And Safety Assessment For The Disposal Of 

Radioactive Waste Specific Safety Guide International Atomic Energy Agency Vienna, 2012. 
86 

The safety case, as specified in the proposed requirements, would include the same 

type of information currently required to be submitted as part of a license application. To 

explicitly ensure that a robust safety case is made for each disposal facility, the NRC is 

proposing requirements that licensees prepare a safety case that demonstrates the assessment 

of the safety of a land disposal facility. In explicitly specifying a requirement for a safety case, 

the NRC is proposing to require the incorporation of the safety assessment and defense-indepth components into the safety case. 

The revised regulations would incorporate the 10 CFR 61.13 analyses into the licensee’s 

safety case. Further, the proposed regulations also would require new defense-in-depth 

analyses in 10 CFR 61.13 which would add an explicit assessment of defense-in-depth 

provisions to the proposed safety case. Finally, the NRC envisions that the safety case for a 

land disposal facility would evolve over time as new information is gained during the various 

phases of the facility’s development and operation. Therefore, the NRC expects that the safety 

case will be updated as new information that could significantly impact safety of the facility is 

learned and is proposing that the application for closure of a licensed land disposal facility must 

include a final revision to the safety case. 

 

L. What guidance document will be available? 

As previously noted, the NRC is making available for public comment a draft guidance 

document, “Guidance for Conducting Technical Analyses for 10 CFR Part 61” (Docket ID NRC2015-0003), concurrent with this proposed rule. The draft guidance document is intended to 

supplement existing guidance on performance assessment (e.g., NUREG-1573, “A 

Performance Assessment Methodology for Low-Level Radioactive Waste Disposal Facilities—

Recommendations of NRC's Performance Assessment Working Group,” issued in October 

2000; and NUREG-1854, “NRC Staff Guidance for Activities Related to U.S. Department of 
87 

Energy Waste Determinations—Draft Report for Interim Use,” issued in August 2007) and to 

provide additional guidance on the new requirements that would be added to 10 CFR part 61 by 

this rulemaking. The draft guidance covers performance assessment topics such as source 

term, radionuclide transport, consideration of uncertainty, and model support. It also represents 

detailed guidance on conducting technical analyses, such as intruder assessment, analysis of 

site stability after closure of the disposal site, a performance period analysis for the disposal site 

beyond the compliance period, and an analysis demonstrating the disposal facility includes 

defense-in-depth protections. Additionally, the document contains guidance on acceptable 

approaches for determining WAC based on the results of the site-specific analyses, establishing 

LLRW characterization methods, and implementing a certification program. The document also 

contains guidance on conducting 

risk-informed, performance-based analyses; general technical analysis considerations, such as 

the incorporation of features, events, and processes into performance assessments; as well as 

other considerations, such as setting inventory limits, mitigation techniques, and demonstration 

of defense-in-depth. 

M. Are there any cumulative effects of regulation associated with this proposed rule? 

In the SRM to SECY-11-0032, “Consideration of the Cumulative Effects of Regulation in 

the Rulemaking Process” (ADAMS Accession No. ML112840466), dated October 11, 2011, the 

Commission provided direction to the staff on issues related to the implementation of the 

cumulative effects of regulation process enhancements. The concept of cumulative effects of 

regulation describes the challenges that licensees, or other impacted entities (such as State 

partners) face while implementing new regulatory positions, programs, and requirements (e.g., 

rules, generic letters, backfits, or inspections). Cumulative effects of regulation is an 

organizational effectiveness challenge that results from a licensee or impacted entity 
88 

implementing a number of complex positions, programs or requirements within a limited 

implementation period and with available resources (which may include limited available 

expertise to address a specific issue). Cumulative effects of regulation can potentially distract 

licensees from executing other primary duties that ensure safety or security. The NRC is 

specifically requesting comment on the cumulative effects of this rulemaking. In developing 

comments on cumulative effects of regulation, consider the following questions: 

1) In light of any current or projected cumulative effects of regulation challenges, does 

the proposed rule’s effective date provide sufficient time to implement the new proposed 

requirements, including changes to programs, procedures, and the facility? 

2) If current or projected cumulative effects of regulation challenges exist, what should 

be done to address this situation (e.g., if more time is required to implement the new 

requirements, what period of time would be sufficient)? 

3) Do other (NRC or other agency) regulatory actions (e.g., orders, generic 

communications, license amendment requests, or inspection findings of a generic nature) 

influence the implementation of the proposed requirements? 

4) Are there unintended consequences? Does the proposed rule create conditions that 

would be contrary to the proposed rule’s purpose and objectives? If so, what are the 

consequences and how should they be addressed? 

5) Is the cost and benefit estimate developed in the regulatory analysis sufficient? 

N. Request for additional public comments. 

The NRC is requesting public comment on the following questions: 

• Is the proposed three-tiered approach (a compliance period, followed by a protective 

assurance period, followed by a performance period, if applicable) appropriate? 

• Is 500 mrem/yr an appropriate analytical threshold for the protective assurance 
89 

period? 

• Should there be a quantitative goal or dose limit associated with the performance 

period analysis, and if so, what should that goal or dose limit be? 

• Is Compatibility Category B appropriate for the compliance period, protective 

assurance period, and the waste acceptance criteria? 

P. What should I consider as I prepare my comments to submit to the NRC? 

When submitting your comments, remember to: 

• Identify the rulemaking with the Regulation Identifier Number (RIN 3150-AI92) and 

NRC Docket ID (NRC-2011-0012). 

• Explain why you agree or disagree with the proposed revisions, and suggest 

alternatives and substitute language to the proposed changes. 

• Describe any assumptions and provide any technical information or data that support 

your comments. 

• If you estimate potential costs or burdens, explain how you arrived at your estimate 

in sufficient detail to allow for it to be reproduced. 

• Provide specific examples to illustrate your concerns, and suggest alternatives. 

• Explain your views as clearly as possible. 

• Make sure to submit your comments by the comment period deadline. 

• The NRC is particularly interested in your comments concerning the issues raised in 

Section Ill, Discussion, of this notice. In addition, the NRC is requesting comment on the 

information in the following sections of this document: 1) Section VI, Agreement State 

Compatibility; 2) Section VII, Plain Writing; 3) Section IX, Draft Environmental Assessment and 

Draft Finding of No Significant Environmental Impact; 4) Section X, Paperwork Reduction Act 
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Statement; 5) Section XI, Regulatory Analysis; and 6) Section XII, Regulatory Flexibility 

Certification. 

IV. Discussion of Proposed Amendments by Section. 

Section 20.1003 Definitions. 

Section 20.1003 defines common terms used in 10 CFR part 20. The NRC is proposing 

to revise the term “waste” to capture waste streams resulting 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, 

consistent with the National Defense Authorization Act for Fiscal Year 2013. 

10 CFR Part 20, Appendix G, Section II Certification. 

Currently, section II of appendix G to 10 CFR part 20, requires LLRW generators, 

processors, or collectors to certify that the transported LLRW is properly classified. Since 

10 CFR 61.58 would require licensees to develop criteria for LLRW acceptability, using either 

the existing LLRW classification system or the results of site-specific technical analyses, the 

NRC proposes to revise the requirements in section II so that shippers are certifying that LLRW 

consigned to a disposal facility meets the facility’s criteria for LLRW acceptability. Section II 

would also be revised to enhance its readability. 

10 CFR Part 20, Appendix G, Section III Control and Tracking. 

Currently, section III of appendix G to 10 CFR part 20 places requirements on the control 

and tracking of LLRW transferred to a disposal facility. Currently, sections III.A and III.C only 
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require the LLRW to be classified according to 10 CFR 61.55 and meet the LLRW characteristic 

requirements in 10 CFR 61.56, and does not provide requirements for compliance with the WAC 

of the proposed 10 CFR 61.58. Since the amended rule would require site-specific technical 

analyses, and then have LLRW disposal licensees develop criteria for LLRW acceptability using 

either the existing LLRW classification system or the results of site-specific technical analyses, 

the NRC proposes to revise the requirements in sections III.A.1, III.A.2, III.A.3, III.C.3, III.C.4, 

and III.C.5, to ensure that shippers prepare, label, and provide quality assurance in accordance 

with the disposal facility operator’s criteria for LLRW acceptability, if applicable. 

Section 61.2 Definitions. 

Section 61.2 defines common terms used in 10 CFR part 61. The NRC is proposing to 

make the following revisions: 1) revise the definitions of “site closure and stabilization” and 

“stability” to correct misspellings; 2) revise the definition of “inadvertent intruder” to include the 

phrase “reasonably foreseeable” to limit speculation of the analyses; and 3) revise the term 

“waste” to capture waste streams resulting 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, consistent with the 

National Defense Authorization Act for Fiscal Year 2013. The NRC is also proposing to add 

definitions for “compliance period,” “defense-in-depth,” “intruder assessment,” “long-lived 

waste,” “performance assessment,” “performance period,” “protective assurance period,” and 

“safety case” to facilitate implementation of the proposed requirements for site-specific 

analyses. For more information on “compliance period,” “defense-in-depth,” “intruder 

assessment,” “long-lived waste,” “performance assessment,” “protective assurance analysis,” 

“protective assurance period,” and “safety case,” see Section III, Discussion, of this document. 
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Section 61.7 Concepts. 

Currently, 10 CFR 61.7 provides conceptual information for the licensing of a disposal 

facility, the LLRW classification system, and near-surface disposal. Paragraph 61.7(a) 

describes the parameters for near-surface LLRW disposal in engineered facilities and the layout 

of land and buildings necessary to carry out the disposal. Paragraph 61.7(b) describes the 

safety objectives for near-surface LLRW disposal and emphasizes the stability of the 

wasteforms and disposal sites. Paragraph 61.7(c) describes the licensing processes that the 

applicant and licensee must complete during the preoperational, operational, and site closure 

periods. 

The NRC proposes to revise 10 CFR 61.7(a)(1) and 10 CFR 61.7(a)(2) to enhance 

readability. An additional sentence would be added to clarify that the additional technical criteria 

may be developed on a case-by-case basis for land disposal techniques that are not explicitly 

considered in 10 CFR part 61. 

The NRC proposes to redesignate paragraphs (b)(1), (b)(2) through (b)(5), and (c) as 

paragraphs (b),(f), and (g), respectively. The NRC proposes to revise redesignated paragraphs 

(b), (f), and (g) to enhance the readability of these paragraphs. Additionally, paragraph (b) 

would be revised to describe the performance objectives of the 10 CFR part 61 regulations. 

Paragraph (f)(1) would be revised to clarify that for long-lived waste 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 

associated with long-term stability of the disposal site. Some waste, depending on its 

radiological characteristics, may not be suitable for disposal if uncertainties cannot be 

adequately addressed with technical analyses. Paragraph (f)(2) would be revised to clarify that 

the effective life of these intruder barriers should be at least 500 years and an additional 

sentence would be added to clarify that the disposal of LLRW above the Class C limit will be 
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evaluated on a case-by-case basis with the technical analyses required in 10 CFR 61.13. 

Paragraph (f)(3) would be revised to clarify that waste that will not decay to levels which present 

an acceptable hazard to an intruder within 100 years is typically designated as Class C waste. 

Also paragraph (f) would provide conceptual information on the requirement for enhanced 

controls or limitations at a particular LLRW disposal facility to provide reasonable assurance that 

the LLRW will not present an unacceptable risk over the compliance period. Paragraph (g) 

would be revised to include the concept of a safety case in the licensing process. 

The NRC proposes to add new paragraphs (b), (c), (d), and (e) to 10 CFR 61.7. 

Proposed 10 CFR 61.7(c) would provide conceptual information for demonstrating compliance 

with the performance objectives of the technical analyses, which include a performance 

assessment and an intruder assessment, and performance period analyses for waste containing 

significant concentrations and quantities of long-lived radionuclides. Additionally, proposed 

paragraph (c)(5) would provide conceptual information on the requirement for the use of dose 

methodology that is consistent with those set forth in 10 CFR part 20 and would also describe 

the flexibility of the licensees’ ability to consistently use the latest dose methodology to 

demonstrate compliance with the performance objectives. 

Proposed 10 CFR 61.7(d) would provide conceptual information on the role of defensein-depth protections with respect to LLRW disposal. Proposed 10 CFR 61.7(e) would provide 

conceptual information for demonstrating compliance with the performance objectives through a 

determination of criteria for the acceptance of LLRW. 

Section 61.8 Information collection requirements: OMB approval. 

Currently, 10 CFR 61.8 (b) lists sections that contain the approved information collection 

requirements in 10 CFR Part 61. 
94 

The NRC proposes to revise 10 CFR 61.8(b) to include 10 CFR 61.41 and 61.42. 

Section 61.10 Content of application. 

Currently, 10 CFR 61.10 identifies the contents that an application for a land disposal 

facility must contain. This information includes the general information, specific technical 

information, institutional information, and financial information set forth in 10 CFR 61.11 through 

61.16 and an environmental report. 

The NRC is proposing to divide this section into two paragraphs, assigned as 

paragraphs (a) and (b). Paragraph (a) would retain the current rule language. Paragraph (b) 

would be added to convey that the information provided in an application comprises the safety 

case, supports the licensee’s demonstration that the disposal facility will be constructed and 

operated safely, and provides reasonable assurance that the disposal site will be capable of 

meeting the performance objectives. 

Section 61.12 Specific technical information. 

Currently, 10 CFR 61.12 lists specific technical information that must be included in an 

application for a 10 CFR part 61 disposal facility license. This information is needed to 

demonstrate that the performance objectives of 10 CFR part 61, subpart C, and the applicable 

technical requirements of 10 CFR part 61, subpart D, “Technical requirements for land disposal 

facilities,” would be met. The specific technical information includes a description of natural and 

demographic disposal site characteristics as determined by disposal site selection and 

characterization activities. 

 The NRC proposes to revise the introductory text of this section to enhance its 

readability and identify that the specific technical information supports the safety case. The 

NRC also proposes to revise 10 CFR 61.12(a) to include geochemistry and geomorphology in 
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the description of the natural and demographic disposal site characteristics. Geochemical and 

geomorphological characteristics need to be included in the description because they play a role 

in the transportation of long-lived radionuclides and the long-term erosion of the disposal site, 

respectively. Paragraphs 61.12(e) and (g) would be revised to enhance the readability of these 

sections. Proposed 10 CFR 61.12(i) would require applicants to include the criteria for 

acceptance of LLRW for disposal, and 10 CFR 61.12(j) would require applicants to include the 

development of technical analyses to the description of the quality assurance program. 

Section 61.13 Technical analyses. 

Currently, 10 CFR 61.13 lists technical information that must be included in an 

application for a 10 CFR part 61 disposal facility license to demonstrate that the performance 

objectives of subpart C of 10 CFR part 61 would be met. 

Currently, 10 CFR 61.13 does not specify the safety case and does not indicate how 

existing licensees would be captured in the requirements to conduct the 10 CFR 61.13 sitespecific technical analyses. The NRC proposes to revise the introductory text of 10 CFR 61.13 

to specify the requirements for technical analyses as one element of the safety case and to 

clarify that licensees must conduct the analyses set forth in 10 CFR 61.13 to demonstrate that 

the performance objectives of subpart C will be met. Licensees with licenses for land disposal 

facilities in effect on the effective date of this subpart must submit these analyses at the next 

license renewal or within 5 years of the effective date of this subpart, whichever comes first. 

Currently, 10 CFR 61.13(a) does not require considerations of features, events, and 

processes that can influence the ability of the LLRW disposal facility to limit the releases of 

radioactivity to the environment; these features, events, and processes are important elements 

of a performance assessment. The NRC proposes to revise 10 CFR 61.13(a) to require a 

licensee or applicant prepare a performance assessment to demonstrate compliance with the 
96 

proposed dose limit in 10 CFR 61.41(a) during the compliance period and a dose goal in 10 

CFR 61.41(b) during the protective assurance period. The performance assessment would be 

required to consider features, events, and processes which can influence the ability of the 

disposal facility to meet the performance objectives, evaluate environmental pathways, account 

for uncertainty, consider alternative conceptual models, and identify and differentiate the roles 

performed by site characteristics and design features of the disposal facility. Further, the 

proposed revisions to 10 CFR 61.13(a) would require that the performance assessment used to 

demonstrate compliance with a new 10 CFR 61.41(b) during the protective assurance period 

reflect new features, events, and processes different from those in the compliance period only if 

scientific information compelling such changes is available. 

In addition, the NRC proposes a new subparagraph 10 CFR 61.13(a)(4) to further clarify 

that the performance assessment must reflect new features, events, and processes different 

from the compliance period that address significant uncertainties inherent in the long timeframes 

associated with demonstrating compliance with § 61.41(b) only if scientific information 

compelling such changes is available. 

Currently, 10 CFR 61.13(b) requires an applicant to prepare analyses that demonstrate 

there is reasonable assurance an applicant will meet the LLRW classification and segregation 

requirements and that it will provide adequate barriers to inadvertent intrusion. The NRC 

proposes to revise 10 CFR 61.13(b) to require a site-specific intruder assessment to 

demonstrate the protection of inadvertent intruders. The intruder assessment would be required 

to assume an intruder occupies the site and engages in normal activities that are consistent with 

activities in and around the site at the time of closure, identify adequate intruder barriers and 

provide a basis for the time period that they are effective, and account for uncertainty and 

variability. The NRC also proposes to revise the term “analyses of the protection of individuals 

from inadvertent intrusion” to “inadvertent intruder analyses.” This paragraph would also be 
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revised to enhance its readability. 

Currently, 10 CFR 61.13(d) requires an applicant to prepare analyses that demonstrate 

long-term stability of the site and the need for ongoing active maintenance after closure. 

However, the analyses are not currently required to provide reasonable assurance that longterm stability of the disposal site can be ensured. The NRC is proposing to require that the 

analyses also provide reasonable assurance that long-term stability of the disposal site can be 

ensured. 

The NRC proposes to add a new paragraph (e) to 10 CFR 61.13 to require licensees 

and applicants to prepare performance period analyses that assess how the disposal facility and 

site characteristics limit the potential long-term radiological impacts, consistent with available 

data and current scientific understanding. The analyses would be required for LLRW disposal 

facilities with long-lived LLRW that contains radionuclides with average concentrations 

exceeding the values listed in proposed table A of 10 CFR 61.13(e), or if necessitated by 

site-specific conditions. The analyses would identify and describe the features of the design 

and site characteristics that will demonstrate that the performance objectives set forth in 

10 CFR 61.41(b) and 10 CFR 61.42(b) will be met. The NRC also proposes to include table A 

in this paragraph to facilitate the implementation of this requirement. 

Finally, the NRC proposes to add a new paragraph (f) to 10 CFR 61.13 to require 

licensees and applicants to prepare analyses that demonstrate the land disposal facility includes 

defense-in-depth protections. The analyses would identify and describe the features of the 

design and site characteristics that provide multiple independent and redundant layers of 

defense so that no single layer, no matter how robust, is exclusively relied upon during 

operations of the facility and after closure during the compliance period, protective assurance 

period, or performance period. 
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Section 61.23 Standards for issuance of a license. 

Currently, 10 CFR 61.23 lists standards that must be met for the Commission to issue a 

license for receipt, possession, and disposal of LLRW containing or contaminated with source, 

special nuclear, or byproduct material. 

The NRC proposes to revise 10 CFR 61.23(b), (c), (d), and (e) to include the proposed 

WAC in the list of standards for issuance of a license. In addition, the NRC proposes to add a 

new paragraph (m) to 10 CFR 61.23 that adds a safety case as one of the standards for 

issuance of a license. 

Section 61.25 Changes. 

Currently, 10 CFR 61.25 provides restrictions on the licensee to make changes in the 

LLRW disposal facility procedures described in the license application. 

The NRC proposes to revise 10 CFR 61.25(a) to correct a misspelling, and 

10 CFR 61.25(b) to include a provision restricting changes to the WAC. 

Section 61.28 Contents of application for closure. 

Currently, 10 CFR 61.28 lists items that must be included in an application for closure. 

These items include 1) a requirement for a final revision and specific details of the disposal site 

closure plan, and 2) an environmental (or a supplemental) report. 

Proposed revisions to 10 CFR 61.28(a) would add a requirement to submit a final 

revision to the safety case, which would be required in the proposed revisions in 10 CFR 61.10, 

and require licensees to provide updated site-specific technical analyses, which would be 

required in the proposed revisions in 10 CFR 61.13, using the details of the final closure plan 

and LLRW inventory as would be required in the proposed revisions in 10 CFR 61.13. Under 

current 10 CFR 61.28(c), which is not being amended by this rulemaking, the NRC can only 
99 

authorize closure of the LLRW disposal facility if there is reasonable assurance that the longterm performance objectives of subpart C will be met. As a result of the proposed revision to 

10 CFR 61.28(a), licensees may be required to take additional action prior to closure to ensure 

that the LLRW that has already been disposed, including large quantities of depleted uranium 

and other LLRW streams that were not analyzed in the original 10 CFR part 61 regulatory basis, 

will meet the long-term performance objectives of subpart C. 

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

Currently, 10 CFR 61.41 specifies a dose limit (organ and whole body equivalent) for 

protection of the general population from the releases of radioactivity and requires licensees to 

exercise reasonable effort to keep all doses ALARA. 

The NRC proposes to revise 10 CFR 61.41 by adding paragraphs (a), (b), and (c). 

Proposed 10 CFR 61.41(a) would retain the dose limits and the ALARA concept during the 

compliance period, and would be updated to use a dose methodology that is consistent with the 

dose methodology used in 10 CFR part 20. Compliance with the proposed 10 CFR 61.41(a) 

would be demonstrated through analyses that meet the requirements specified in the proposed 

10 CFR 61.13(a). 

Proposed 10 CFR 61.41(b) would require that the licensee minimize releases of 

radioactivity from a disposal facility to the general environment during the protective assurance 

period. Proposed 10 CFR 61.41(b) would specify that an annual dose, established on the 

license, shall be below 5 milliSieverts (500 millirems) or a level that is supported as reasonably 

achievable based on technological and economic considerations in the information submitted for 

review and approval by the Commission. Compliance with this paragraph must be 

demonstrated through analyses that meet the requirements specified in 10 CFR 61.13(a). 

Proposed 10 CFR 61.41(c) would require that the licensee make an effort to minimize 
100 

releases of radioactivity from a disposal facility to the general environment to the extent 

reasonably achievable at any time during the performance period. Compliance with the 

proposed 10 CFR 61.41(c) would be demonstrated through analyses that meet the 

requirements specified in the proposed 10 CFR 61.13(e). 

Section 61.42 Protection of inadvertent intruders. 

Currently, 10 CFR 61.42 requires the facility to be designed, operated, and closed to 

ensure the protection of any inadvertent intruder after the lifting of institutional controls. 

The NRC proposes to revise 10 CFR 61.42 by adding new paragraphs (a), (b), and (c). 

Proposed 10 CFR 61.42(a) would retain the current regulatory language and would be updated 

to add an annual dose limit of 5 mSv/yr (500 mrem/yr) for the intruder assessment during the 

compliance period. Compliance with the proposed 10 CFR 61.42(a) paragraph would be 

demonstrated through analyses that meet the requirements specified in the proposed 

10 CFR 61.13(b). 

Proposed 10 CFR 61.42(b) would require that the licensee minimize exposures to any 

inadvertent intruder during the protective assurance period. Proposed 10 CFR 61.42(b) would 

also specify that an annual dose, established on the license, shall be below 5 milliSieverts (500 

millirems) or a level that is supported as reasonably achievable based on technological and 

economic considerations in the information submitted for review and approval by the 

Commission. Compliance with this paragraph must be demonstrated through analyses that 

meet the requirements specified in 10 CFR 61.13(b). 

Proposed 10 CFR 61.42(c) would require that the licensee make an effort to minimize 

exposures to any inadvertent intruder to the extent reasonably achievable at any time during 

the performance period. Compliance with the proposed 10 CFR 61.42(c) would be 

demonstrated through analyses that meet the requirements specified in the proposed 
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10 CFR 61.13(e). 

Section 61.44 Stability of the disposal site after closure. 

Currently, 10 CFR 61.44 requires the disposal facility to be sited, designed, used, 

operated, and closed to achieve long-term stability of the disposal site and to eliminate to the 

extent practicable the need for ongoing active maintenance of the disposal site following closure 

so that only surveillance, monitoring, or minor custodial care are required. 

The NRC proposes to revise 10 CFR 61.44 to specify that stability of the disposal site 

must be demonstrated for the compliance and protective assurance periods. 

Section 61.50 Disposal site suitability requirements for land disposal. 

Currently, 10 CFR 61.50 specifies site suitability requirements for the minimum 

characteristics a disposal site must possess to be acceptable for use as a near-surface LLRW 

disposal facility. Site suitability requirements play an integral role in ensuring that the site is 

appropriate for the type of LLRW proposed for disposal. 

The NRC proposes to revise 10 CFR 61.50 to clarify the interpretation of site 

characteristics. The technical content of the site suitability characteristics would not be 

changed. However, the site suitability characteristics would be reorganized to distinguish the 

hydrological site characteristics from other characteristics. 

Section 61.51 Disposal site design for land disposal. 

Currently, 10 CFR 61.51 specifies disposal design requirements for a near-surface 

LLRW disposal facility. Site design requirements play an integral role in ensuring that the site is 

appropriate for the type of LLRW proposed for disposal. 

The NRC proposes to revise 10 CFR 61.51(a)(1) to clarify that site design features must 
102 

be directed toward providing defense-in-depth protections in addition to long-term isolation and 

avoidance of continuing active maintenance after site closure. 

Section 61.52 Land disposal facility operation and disposal site closure. 

Currently, 10 CFR 61.52 imposes requirements to ensure the integrity of the LLRW, the 

proper marking of the disposal unit boundary, and the proper maintenance of the buffer zone. 

The NRC proposes to revise 10 CFR 61.52(a)(3) and (a)(8) to enhance its readability 

and to conform to the proposed new requirements in 10 CFR 61.52(a)(12) and (a)(13). 

The NRC proposes to add new paragraphs (a)(12) and (a)(13). Proposed 

10 CFR 61.52(a)(12) would only allow the disposal of LLRW meeting the disposal facility’s 

LLRW acceptance criteria, and proposed 10 CFR 61.52(a)(13) would require licensees to 

prepare updated site-specific analyses using the details of the final closure plan and LLRW 

inventory. 

Section 61.55 Waste classification. 

The NRC proposes to revise 10 CFR 61.55(a)(6) to enhance its readability. The change 

would not alter the meaning or intent of this regulation. 

Section 61.56 Waste characteristics. 

Currently, 10 CFR 61.56(a) lists minimum requirements for all classes of LLRW, 

intended to facilitate handling at the disposal site and provide protection of health and safety of 

personnel at the disposal site. 

The NRC proposes to revise 10 CFR 61.56(a) to replace the phrase “all classes of 

wastes” with the phrase “all waste” which includes all classes of LLRW and WAC. 
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Section 61.57 Labeling. 

Currently, 10 CFR 61.57 requires the listing of LLRW class in accordance with 

10 CFR 61.55 and does not reference the proposed WAC. 

The NRC proposes to revise 10 CFR 61.57 to include any information required by the 

land disposal facility’s criteria for LLRW acceptance developed according to 10 CFR 61.58. 

Section 61.58 Waste acceptance. 

Currently, 10 CFR 61.58 grants exemptions for the classification and characterization of 

LLRW, on a case-by-case basis, if the Commission finds reasonable assurance of compliance 

with the performance objectives. In the proposed rule, the alternative requirements in 

10 CFR 61.58 would be replaced by the proposed LLRW acceptance requirements. 

The NRC proposes to retitle and revise 10 CFR 61.58 to specify the minimum content of 

the WAC and require disposal facility licensees to develop approaches for generators to 

characterize LLRW and methods for generators to certify that such LLRW meets the 

acceptance criteria for demonstration compliance with the site-specific WAC. Proposed 

10 CFR 61.58 would also require licensees to annually review their LLRW acceptance plan and 

to comply with 10 CFR 61.20 when modifying their approved WAC. Additionally, the new 

regulatory language would indicate that the NRC would incorporate, where consistent with State 

and Federal law, the WAC into existing licenses. 

Section 61.80 Maintenance of records, reports, and transfers. 

Currently, 10 CFR 61.80 requires the licensee to keep records on the LLRW received for 

disposal, to provide annual reports of site and financial activities, and to comply with specified 

provisions of 10 CFR parts 30, 40, and 70 for any transfer by the licensee of byproduct, source, 

or special nuclear material. 
104 

The NRC proposes to restructure 10 CFR 61.80(i)(2) to meet codification requirements 

of the Office of the Federal Register. In 10 CFR 61.80(i)(1), the erroneous reference to 

10 CFR 60.4 would be corrected to reference 10 CFR 61.4. 

The NRC also proposes to add a new paragraph (m) to 10 CFR 61.80. This addition 

would require licensees and license applicants to maintain their provisions for LLRW 

acceptance and audits and other reviews of program content and implementation. 

V. Criminal Penalties. 

For the purpose of Section 223 of the AEA, the NRC is proposing to amend 10 CFR part 

61 under one or more of Sections 161b., 161i., or 161o. of the AEA. Willful violations of the rule 

would be subject to criminal enforcement. 

VI. Agreement State Compatibility. 

Under the “Policy Statement on Adequacy and Compatibility of Agreement State 

Programs” approved by the Commission on June 30, 1997, and published in the Federal 

Register (62 FR 46517; September 3, 1997), this proposed rule would be a matter of 

compatibility between the NRC and the Agreement States, which would ensure consistency 

between the Agreement State requirements and the NRC requirements. The NRC staff 

analyzed the proposed rule in accordance with the procedure established in Part III, 

“Categorization Process for NRC Program Elements,” of the Handbook for Management 

Directive 5.9, “Adequacy and Compatibility of Agreement State Programs” (see

http://www.nrc.gov/reading-rm/doc-collections/management-directives/). 

The NRC program elements (including regulations) are placed into four compatibility 

categories (see the proposed compatibility table in this section). In addition, the NRC program 
105 

elements can be identified as having particular health and safety significance or as being 

reserved solely to the NRC. Compatibility Category A applies to those program elements that 

are basic radiation protection standards and scientific terms and definitions that are necessary 

to understand radiation protection concepts. An Agreement State should adopt Compatibility 

Category A program elements in an essentially identical manner to provide uniformity in the 

regulation of agreement material on a nationwide basis. Compatibility Category B includes 

those program elements that apply to activities that have direct and significant effects in multiple 

jurisdictions. An Agreement State should adopt Compatibility Category B program elements in 

an essentially identical manner. Compatibility Category C includes those program elements that 

do not meet the criteria of Compatibility Categories A or B, but reflect essential objectives that 

an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that 

would jeopardize an orderly pattern in the regulation of agreement material on a nationwide 

basis. An Agreement State should adopt the essential objectives of the Compatibility Category 

C program elements. Compatibility Category D applies to those program elements that do not 

meet any of the criteria of Compatibility Categories A, B, or C and, therefore, do not need to be 

adopted by Agreement States for compatibility. 

Health and Safety (H&S) program elements are elements that are not required for 

compatibility, but are identified as having a particular health and safety role (i.e., adequacy) in 

the regulation of agreement material within the State. Although not required for compatibility, 

the State should adopt program elements in this H&S category based on those elements that 

embody the essential objectives of the NRC program elements because of particular health and 

safety considerations. Compatibility Category NRC contains those program elements that 

address areas of regulation that cannot be relinquished to Agreement States under the Atomic 

Energy Act or 10 CFR. These program elements are not adopted by Agreement States. 

Proposed definition “compliance period” in 10 CFR 61.2 would be assigned to 
106 

Compatibility Category B. The NRC believes the program elements of this definition need to be 

adopted to ensure a consistent regulatory approach across the Nation and inconsistent 

definitions of this term would have direct and significant transboundary implications. Proposed 

definition “defense-in-depth” in 10 CFR 61.2 would be assigned to Compatibility Category H&S. 

The NRC believes the essential objectives of this definition need to be adopted to ensure 

consistent application of 10 CFR 61.41 and 10 CFR 61.42. Proposed definition of “intruder 

assessment” in 10 CFR 61.2 would be assigned to Compatibility Category H&S. The NRC 

believes that the H&S compatibility designation of this definition is appropriate to support 

paragraphs 61.13(a) and 61.13(b). Proposed definition of “long-lived waste” in 10 CFR 61.2 

would be assigned to Compatibility Category B because inconsistent definitions of this term 

could have direct and significant effects in multiple jurisdictions. Proposed definition 

“performance period” in 10 CFR 61.2 would be assigned to Compatibility Category C. The NRC 

believes the essential objectives of this definition need to be adopted to ensure consistent 

application of 10 CFR 61.41 and 10 CFR 61.42. Proposed definition of “performance 

assessment” in 10 CFR 61.2 would be assigned to Compatibility Category H&S. The NRC 

believes that the H&S compatibility designation of this definition is appropriate to support 

paragraphs 61.13(a) and 61.13(b). Proposed definition “protective assurance period” in 10 CFR 

61.2 would be assigned to Compatibility Category B. The NRC believes the program elements 

of this definition need to be adopted to ensure a consistent regulatory approach across the 

Nation and inconsistent definitions of this term would have direct and significant transboundary 

implications. Proposed definition “safety case” in 10 CFR 61.2 would be assigned to 

Compatibility Category H&S. The NRC believes the essential objectives of this definition need 

to be adopted to ensure consistent application of 10 CFR 61.40. The compatibility category of 

other amended definitions in 10 CFR 61.2 would remain unchanged. 

Paragraphs 61.7(c)(1), (c)(2), (c)(4), (c)(5), (c)(6)(d), (e), and (f)(4) would be assigned to 
107 

Compatibility Category H&S to be consistent with the designation of the rest of 10 CFR 61.7. 

The compatibility category of other amended paragraphs in 10 CFR 61.7 would remain 

unchanged. 

The NRC is proposing to retain the existing Compatibility Category D for paragraph 

61.10(a) because this paragraph provides a list of contents of an application that would not be 

applicable for all Agreement States (i.e., an environmental report). Paragraph 61.10(b) would 

be assigned to Compatibility Category H&S. The NRC believes the safety case information of 

this paragraph needs to be included in the application for operating license for the protection of 

health and safety but is not required for compatibility with the national program. 

Section 61.12 in its entirety would be reassigned from Compatibility Category D to 

Compatibility Category H&S. The NRC believes that all the requirements in 10 CFR 61.12 

should be designated as Compatibility Category H&S to support the demonstration of the 

subpart C performance objectives. The NRC believes that the absence of these provisions 

could create a situation that could result in individual exposures that exceed the basic radiation 

protection standards of the subpart C performance objectives. 

Section 61.13, in its entirety, would be reassigned from Compatibility Category H&S to 

Compatibility Category C. The NRC believes the essential objectives of this section need to be 

adopted to ensure consistent application of of 10 CFR 61.40. 

Proposed paragraph 61.23(m) would be assigned to Compatibility Category H&S. The 

compatibility category of other amended paragraphs in 10 CFR 61.23 would remain unchanged. 

Section 61.28 in its entirety would also be reassigned from Compatibility Category D to 

Compatibility Category H&S. The NRC believes that all the all information in this paragraph has 

to be included in the application for closure. The NRC believes that the presence of these 

provisions are necessary for the Commission to make a final decision on the amendment 
108 

authorizing a disposal site closure, based on protection of health and safety but is not required 

for compatibility with the national program. 

The NRC is proposing to retain the existing Compatibility Category A for paragraph 

61.41(a) because this paragraph provides a basic radiation protection standard. Paragraph 

61.41(b) would be assigned to Compatibility Category B. The NRC believes the program 

elements of this paragraph need to be adopted to ensure a consistent regulatory approach 

across the Nation and inconsistent application of this paragraph would have direct and 

significant transboundary implications. Paragraph 61.41(c) would be assigned to Compatibility 

Category C because the NRC believes that the Agreement States need to adopt the essential 

objectives of this paragraph. 

Similarly, the NRC is proposing to designate paragraph 61.42(a) as Compatibility 

Category A (instead of Compatibility Category H&S, which is the current compatibility level for 

10 CFR 61.42) because of the prescribed annual dose limit of 5 mSv (500 mrem) for the 

protection of an inadvertent intruder. Paragraph 61.42(b) would be assigned to Compatibility 

Category B. The NRC believes the program elements of this paragraph need to be adopted to 

ensure a consistent regulatory approach across the Nation and inconsistent application of this 

paragraph would have direct and significant transboundary implications. Paragraph 61.42(c) 

would be assigned to Compatibility Category C because the NRC also believes that the 

essential objectives of this paragraph need to be adopted by the Agreement States. 

Paragraphs 61.52(a)(12) and (a)(13) would be assigned to Compatibility Category H&S. 

The compatibility categories of 10 CFR 61.52(a)(3) and (a)(8) would remain unchanged. 

At present, only one of the four Agreement States that has an operating near-surface 

LLRW disposal facility has adopted a corresponding regulation to 10 CFR 61.58. Currently, 

Agreement States are not required to adopt 10 CFR 61.58, therefore, the compatibility 

designation for this section must be changed in order to require Agreement States to adopt an 
109 

alternative provision for LLRW classification and characteristics. Therefore, the NRC is retitling, 

revising and reclassifying the compatibility for 10 CFR 61.58. Section 61.58 would be assigned 

to Compatibility Category B because the NRC believes the program elements of this section 

need to be adopted to ensure a consistent regulatory approach across the Nation and 

inconsistent application of this section would have direct and significant transboundary 

implications. 

Paragraph 61.80(m) would be assigned to Compatibility Category C. The compatibility 

category of 10 CFR 61.80(i)(1) and (i)(2) would remain unchanged. 

The compatibility categories of the remaining sections (10 CFR 20.1003; appendix G to 

10 CFR part 20, sections II and III; and 10 CFR 61.8, 61.25, 61.44, 61.50, 61.51, 61.55, 61.56, 

and 61.57) would remain unchanged. 

The NRC invites comment on the compatibility category designations in this proposed 

rule and suggests that commenters refer to the Handbook for NRC Management Directive 5.9 

for more information. Comments on the proposed compatibility categories need to be received 

by the end of the public comment period. 

The following table lists the parts and sections that would be revised and their 

corresponding categorization under the “Policy Statement on Adequacy and Compatibility of 

Agreement State Programs.” 

Proposed Compatibility Table for 10 CFR Part 20, Appendix G 

10 CFR 

Part 20, 

Appendix G 

Proposed 

Rule Section 

Change Subject Compatibility 

Existing New 
110 

20.1003 Amend Definition Waste. B B 

II Amend Certification. D D 

III.A Amend Control and Tracking. D D 

III.C Amend Control and Tracking. D D 

Proposed Compatibility Table for 10 CFR Part 61 

10 CFR Part 

61 Proposed 

Rule Section 

Change Subject Compatibility 

Existing New 

61.2 New Definition-Compliance period. - B 

61.2 New Definition-Defense-in-depth. - H&S 

61.2 Amend Definition-Inadvertent intruder. C C 

61.2 New Definition-Intruder assessment. - H&S 

61.2 New Definition-Long-lived waste. - B 

61.2 New Definition-Performance assessment. - H&S 

61.2 New Definition-Performance period. - C 

61.2 New Definition-Protective assurance period. - B 

61.2 New Definition-Safety case. - H&S 

61.2 Amend Definition-Site closure and stabilization. D D 

61.2 Amend Definition-Stability. D D 

61.2 Amend Definition-Waste. B B 

61.7(a)(1) Amend Concepts. H&S H&S 

61.7(a)(2) Amend Concepts. H&S H&S 

61.7(b) Amend Concepts. (Previously 61.7(b)(1)) H&S H&S 

61.7(c)(1) New Concepts. - H&S 

61.7(c)(2) New Concepts. - H&S 

61.7(c)(3) Amend Concepts. (Previously 61.7(b)(3)) H&S H&S 

61.7(c)(4) New Concepts. - H&S 

61.7(c)(5) New Concepts. - H&S 

61.7(c)(6) New Concepts. - H&S 

61.7(d) New Concepts. - H&S 

61.7(e) New Concepts. - H&S 

61.7(f)(1) Amend Concepts. (Previously 61.7(b)(2)) H&S H&S 

61.7(f)(2) Amend Concepts. (Previously 61.7(b)(4)) H&S H&S 

61.7(f)(3) Amend Concepts. (Previously 61.7(b)(5)) H&S H&S 

61.7(f)(4) New Concepts. - H&S 

61.7(g)(1) Amend Concepts. (Previously 61.7(c)(1) H&S H&S 

61.7(g)(2) Amend Concepts. (Previously 61.7(c)(2) H&S H&S 

61.7(g)(3) Amend Concepts. (Previously 61.7(c)(3) H&S H&S 

61.7(g)(4) Amend Concepts. (Previously 61.7(c)(4) H&S H&S 

61.8 Amend Information collection requirements: D D 
111 

Office of Management and Budget 

approval. 

61.10(a) Amend Content of application. D D 

61.10(b) New Content of application. - H&S 

61.12(a) 

Amend/ 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(b) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(c) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(d) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(e) 

Amend/Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(f) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(g) 

Amend/Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(h) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(i) 

Amend/Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(j) 

Amend/Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(k) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(l) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 
112 

61.12(m) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.12(n) 

Revised 

Compatibility 

Category 

Specific technical information. D H&S 

61.13(a) 

Amend/ 

Revised 

Compatibility 

Category 

Technical analyses. H&S C 

61.13(b) 

Amend/ 

Revised 

Compatibility 

Category 

Technical analyses. H&S C 

61.13(c) 

Amend/ 

Revised 

Compatibility 

Category 

Technical analyses. H&S C 

61.13(d) 

Amend/ 

Revised 

Compatibility 

Category 

Technical analyses. H&S C 

61.13(e) New Technical analyses. - C 

61.13(f) New Technical analyses. - C 

61.23(b) Amend Standards for issuance of a license. H&S H&S 

61.23(c) Amend Standards for issuance of a license. H&S H&S 

61.23(d) Amend Standards for issuance of a license. H&S H&S 

61.23(e) Amend Standards for issuance of a license. H&S H&S 

61.23(m) New Standards for issuance of a license. - H&S 

61.25(a) Amend Changes. D D 

61.25(b) Amend Changes. D D 

61.28(a)(2) Amend Contents of application closure. D D 

61.41(a) Amend Protection of the general population from 

releases of radioactivity. 

A A 

61.41(b) New Protection of the general population from 

releases of radioactivity. 

- B 

61.41(c) New Protection of the general population from 

releases of radioactivity. 

- C 

61.42(a) Amend Protection of individuals from inadvertent 

intrusion. 

H&S A 
113 

61.42(b) New Protection of individuals from inadvertent 

intrusion. 

- B 

61.42(c) New Protection of individuals from inadvertent 

intrusion. 

- C 

61.44 Amend Stability of the disposal site after closure. H&S H&S 

61.50 Amend Disposal site suitability requirements for 

land disposal. 

H&S H&S 

61.51(a) Amend Disposal site design for land disposal. H&S H&S 

61.52(a)(3) Amend Land disposal facility operation and 

disposal site closure. 

H&S H&S 

61.52(a)(8) Amend Land disposal facility operation and 

disposal site closure. 

H&S H&S 

61.52(a)(12) New Land disposal facility operation and 

disposal site closure. 

- H&S 

61.52(a)(13) New Land disposal facility operation and 

disposal site closure. 

- H&S 

61.55(a)(6) Amend Waste classification. B B 

61.56(a) Amend Waste characteristics. H&S H&S 

61.57 Amend Labeling. H&S H&S 

61.58 

Retitled, 

revised and 

Revised 

Compatibility 

Category 

Waste acceptance 

(Previously titled Alternative 

requirements for waste classification and 

characteristics) 

D B 

61.80(i)(1) Amend Maintenance of records, reports, and 

transfers. 

C C 

61.80(i)(2) Amend Maintenance of records, reports, and 

transfers. 

C C 

61.80(m) New Maintenance of records, reports, and 

transfers. 

- C 

VII. Plain Writing. 

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write 

documents in a clear, concise, and well-organized manner. The NRC has written this document 

to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain 

Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests 
114 

comment on the proposed rule with respect to the clarity and effectiveness of the language 

used. 

VIII. Voluntary Consensus Standards. 

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) 

requires that Federal agencies use technical standards that are developed or adopted by 

voluntary consensus standards bodies unless the use of such a standard is inconsistent with 

applicable law or otherwise impractical. In this proposed rule, the NRC is proposing to amend 

its regulations that govern LLRW disposal facilities to require new and revised site-specific 

technical analyses and to permit the development of criteria for LLRW acceptance based on the 

results of these analyses. These amendments would ensure that LLRW streams that are 

significantly different from those considered in the regulatory basis for the current regulations 

can be disposed of safely and meet the performance objectives for land disposal of LLRW. 

These amendments would also increase the use of site-specific information to ensure public 

health and safety is protected. Additionally, the NRC is also proposing amendments to facilitate 

implementation and better align the requirements with current health and safety standards. The 

NRC is not aware of any voluntary consensus standards that address the proposed subject 

matter of this proposed rule. The NRC will consider using a voluntary consensus standard if an 

appropriate standard is identified. If a voluntary consensus standard is identified for 

consideration, the submittal should explain why the standard should be used. 
115 

IX. Draft Environmental Assessment and Draft Finding of No Significant Environmental 

Impact. 

A. The Proposed Action and the Need for the Proposed Action. 

The proposed action is to add new, and amend some of the existing, requirements in 

10 CFR part 61. The NRC is proposing to amend its regulations that apply to LLRW disposal 

facilities to require new and revised site-specific technical analyses, to permit the development 

of criteria for LLRW acceptance based on the results of these analyses, and to require the 

application for closure to include updates to the safety case and the technical analyses. These 

amendments would ensure that LLRW streams that are significantly different from those 

considered in the regulatory basis for the current regulations can be disposed of safely and 

meet the performance objectives for land disposal of LLRW. These amendments would also 

increase the use of site-specific information to ensure public health and safety is protected. 

These amendments would revise the existing technical analysis for protection of the general 

population (i.e., performance assessment) to include a 1,000-year compliance period; add a 

new site-specific technical analysis for the protection of inadvertent intruders (i.e., intruder 

assessment) that would include a 1,000-year compliance period and a dose limit; add new 

analyses (i.e., performance assessment and intruder assessment) that would include a 10,000-

year protective assurance period and dose minimization target; new analyses that demonstrate 

the disposal site includes defense-in-depth protections for the compliance period, protective 

assurance period, and performance period; add a new analysis for certain long-lived LLRW (i.e., 

performance period analysis) that would include a post-10,000 year performance period; and 

revise the application for closure to include updates to the safety case and the technical 

analyses. The NRC would also be adding a new requirement to develop criteria for the 

acceptance of LLRW for disposal based on either the results of these technical analyses or the 
116 

existing LLRW classification requirements. Additionally, the NRC is proposing amendments to 

facilitate implementation and better align the requirements with current health and safety 

standards. 

B. Environmental Impact of the Proposed Action. 

The proposed action is to add new, and amend some of the existing, requirements in 10 

CFR part 61. The proposed rulemaking would modify the analyses that licensees need to 

perform to demonstrate compliance with the subpart C performance objectives and to permit the 

development of criteria for LLRW acceptance based on the results of these analyses. These 

amendments would not authorize the construction of LLRW disposal facilities and do not 

authorize the disposal of additional LLRW in existing facilities. Licensees and applicants would 

need to request and receive separate regulatory approval before construction of new disposal 

facilities or disposal of additional LLRW in existing facilities. Consequently, because this 

rulemaking will not result in any physical impacts to the environment the NRC has determined 

that the proposed action would result in no significant environmental impacts. 

C. Alternatives to the Proposed Action. 

As an alternative to the proposed action, the NRC staff considered the “no-action” 

alternative. Under this alternative, the NRC would not modify 10 CFR part 61, no performance 

period analyses would be required, no period of compliance and no protective assurance period 

would be specified, no intruder assessment would be required, and development of waste 

acceptance plan would not be required. However, requiring new and revised site-specific 

technical analyses to demonstrate compliance with the subpart C performance objectives and 

development of LLRW site-specific acceptance criteria for LLRW acceptance would ensure the 

safe disposal of waste streams not previously analyzed in the development of part 61 and would 
117 

provide assurance that these waste streams comply with the subpart C performance objectives. 

Further, these analyses would identify any additional measures that would be prudent to 

implement, and these amendments would improve the efficiency of the regulations by making 

changes to facilitate implementation and better align the requirements with current health and 

safety standards. Not taking the proposed action would not provide the added assurance that 

disposal of the LLRW streams not considered in the original 10 CFR part 61 regulatory basis 

comply with the subpart C performance objectives. Therefore, the NRC has decided to reject 

the no-action alternative and publish the proposed rule for public comment. 

D. Alternative Use of Resources. 

This action would not result in any irreversible commitments of resources. 

E. Agencies and Persons Contacted and Resources Used. 

The NRC sent a copy of this proposed rule containing this draft environmental 

assessment and the proposed rule to all State Liaison Officers and requested their comments 

on the assessment. Aside from those sources referenced in this notice, the NRC staff did not 

use any additional sources and did not contact any additional persons or agencies to develop 

this environmental assessment. 

F. Draft Finding of No Significant Impact. 

The Commission has preliminarily determined under the National Environmental Policy 

Act and the Commission’s regulations in subpart A, “National Environmental Policy 

Act—Regulations Implementing Section 102(2),” of 10 CFR part 51, “Environmental Protection 

Regulations for Domestic Licensing and Related Regulatory Functions,” that the proposed 

amendments to 10 CFR part 61 described in this document would not be a major Federal action 
118 

significantly affecting the quality of the human environment, and therefore, an environmental 

impact statement would not be required. The amendments would require LLRW disposal facility 

licensees and license applicants to conduct new and updated site-specific technical analyses 

and safety case to demonstrate compliance with the performance objectives in 10 CFR part 61 

and develop criteria for LLRW acceptance based on the results of these analyses, which would 

ensure the safe disposal of LLRW. The amendments would also make additional changes to 

the regulations to facilitate implementation and better align the requirements with current health 

and safety standards. The amendments would be primarily procedural and administrative in 

nature and would have no significant impact on the quality of the human environment. 

The preliminary determination of this draft environmental assessment is that there would 

be no significant impact to the quality of the human environment from this proposed action. The 

NRC is, however, seeking public comment on this draft environmental assessment and draft 

finding of no significant impact. Comments on the draft environmental assessment and draft 

finding of no significant impact may be submitted to the NRC by any of the methods provided in 

the ADDRESSES section of this document. 

X. Paperwork Reduction Act Statement. 

This proposed rule contains new or amended collections of information subject to the 

Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This proposed rule has been 

submitted to the Office of Management and Budget (OMB) for review and approval of the 

information collections. 

Type of submission, new or revision: Revision. 
119 

The title of the information collection: 10 CFR parts 20 and 61, “Low Level Radioactive 

Waste Disposal.” 

The form number if applicable: NRC Forms 540 and 541. 

How often the collection is required or requested: On occasion. 

Who will be required or asked to respond: Current and future LLRW disposal facilities 

that are regulated by the NRC or an Agreement State. 

An estimate of the number of annual responses: 0. 

The estimated number of annual respondents: 0. 

An estimate of the total number of hours needed annually to comply with the information 

requirement or request: New applicants and current LLRW disposal facility licensees seeking to 

amend their licenses to address the requirements in these amendments will incur a reporting 

burden to submit performance period analyses, compliance period analyses, and LLRW 

acceptance plans beginning approximately 4 years from publication of the final rule. The 

estimated one-time reporting burden per licensee to perform these analyses is 22,200 hours. 

An additional 80 hours of annual recordkeeping per licensee would be required once its LLRW 

acceptance plan has been submitted. However, the NRC does not expect to receive any 

license applications or license closure applications within the OMB information collection period 

of 3 years following publication of the final rule, and no current licensees are anticipated to 

amend their licenses within the information collection period; therefore, there is no estimated 
120 

annual burden (0 hours) for the next 3 years. 

Abstract: The NRC is proposing to amend its regulations to require LLRW disposal 

facilities to conduct site-specific technical analyses to demonstrate compliance with the 

performance objectives of 10 CFR part 61. The intent of the rule is to ensure performance 

objectives are met at disposal sites for safe disposal of LLRW that was not analyzed in the 

original 10 CFR part 61 regulatory basis (i.e., large quantities of depleted uranium). The 

site-specific technical analyses would include compliance period analyses with both a 

performance assessment and an intruder assessment, analyses for the protective assurance 

period that include both a performance assessment and an intruder assessment, performance 

period analyses to evaluate how the disposal system could mitigate the risk from long-lived 

LLRW, new analyses that demonstrate the disposal site includes defense-in-depth protections, 

and an LLRW acceptance plan identifying the WAC for the disposal facility. In addition, 

licensees must review their LLRW acceptance plan annually and update the safety case and 

analyses as part of the application for closure. 

The NRC Forms 540 and 541 would be updated to allow licensees to indicate the use of 

LLRW acceptance criteria. 

The U.S. Nuclear Regulatory Commission is seeking public comment on the potential 

impact of the information collections contained in this proposed rule and on the following issues: 

1. Is the proposed information collection necessary for the proper performance of the 

functions of the NRC, including whether the information will have practical utility? 

2. Is the estimate of the burden of the proposed information collection accurate? 

3. Is there a way to enhance the quality, utility, and clarity of the information to be 

collected? 

4. How can the burden of the proposed information collection on respondents be 
121 

minimized, including the use of automated collection techniques or other forms of information 

technology? 

A copy of the OMB clearance package and proposed rule is available in ADAMS under 

Accession No. ML14289A143 or may be viewed free of charge at the NRC’s PDR, One White 

Flint North, 11555 Rockville Pike, Room O-1 F21, Rockville, Maryland, 20852. You may obtain 

information and comment submissions related to the OMB clearance package by searching on 

http://www.regulations.gov under Docket ID NRC-2011-0012. 

You may submit comments on any aspect of these proposed information collections, 

including suggestions for reducing the burden and on the previously stated issues, by the 

following methods: 

• Federal rulemaking Web Site: Go to http://www.regulations.gov and search for 

Docket ID NRC-2011-0012. 

• Mail comments to: FOIA, Privacy, and Information Collections Branch, Office of 

Information Services, Mail Stop: T-5 F53, U.S. Nuclear Regulatory Commission, Washington, 

DC 20555-0001 or to Vlad Dorjets, Desk Officer, Office of Information and Regulatory Affairs 

(3150-0135, 3150-0164, and 3150-0166), NEOB-10202, Office of Management and Budget, 

Washington, DC 20503; telephone: 202-395-1741, e-mail: vladik.dorjets@omb.eop.gov. 

Submit comments by May 26, 2015. Comments received after this date will be 

considered if it is practical to do so, but the NRC staff is able to ensure consideration only for 

comments received on or before this date.

Public Protection Notification. 

The NRC may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless the document requesting or requiring the collection displays a 

currently valid OMB control number. 
122 

XI. Regulatory Analysis. 

The Commission has prepared a draft regulatory analysis on this proposed regulation, 

and it is available in ADAMS under Accession No. ML14289A158. The draft regulatory analysis 

examines the costs and benefits of the alternatives considered by the Commission. 

The Commission requests public comment on the draft regulatory analysis. Comments 

on the draft analysis may be submitted to the NRC by any of the methods provided in the 

ADDRESSES section of this document. 

XII. Regulatory Flexibility Certification. 

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the 

Commission certifies that this rule would not, if adopted, have a significant economic impact on 

a substantial number of small entities. The LLRW licensees and license applicants impacted by 

this rule do not fall within the scope of the definition of “small entities” given in the Regulatory 

Flexibility Act or the standards established by the NRC in 10 CFR 2.810, “NRC size standard.” 

The NRC is seeking public comment on the potential impact of the proposed rule on 

small entities. The NRC particularly desires comments from licensees who qualify as small 

businesses, specifically as to how the proposed rule would affect them and how the rule may be 

tiered or otherwise modified to impose less stringent requirements on small entities while still 

adequately protecting the public health and safety and common defense and security. 

Comments on how the rule could be modified to take into account the differing needs of small 

entities should specifically discuss: 

a) The size of the business and how the proposed rule would result in a significant 
123 

economic burden upon it as compared to a larger organization in the same business 

community; 

b) How the proposed rule could be modified to take into account the business’s differing 

needs or capabilities; 

c) The benefits that would accrue, or the detriments that would be avoided, if the NRC 

adopts the commenter’s suggestion; 

d) How the proposed rule, as modified, would more closely equalize the impact of NRC 

regulations as opposed to providing special advantages to any individuals or groups; and 

e) How the proposed rule, as modified, would still adequately protect the public health 

and safety and common defense and security. 

 Comments should be submitted by any of the methods provided in the ADDRESSES 

section of this document. 

XIII. Backfitting. 

A backfit analysis is not required for this rule. The NRC’s backfit provisions appear in 

the regulations at 10 CFR 50.109, 52.39, 52.63, 52.83, 52.98, 52.145, 52.171, 70.76, 72.62, and 

76.76. The requirements in this proposed rule do not involve any provisions that would impose 

backfits on nuclear power plant licensees as defined in 10 CFR part 50, “Domestic Licensing of 

Production and Utilization Facilities,” or in 10 CFR part 52, “Licenses, Certifications, and 

Approvals for Nuclear Power Plants,” or on licensees under 10 CFR part 70, “Domestic 

Licensing of Special Nuclear Material,” 10 CFR part 72, “Licensing Requirements for the 

Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste, and 

Reactor-Related Greater Than Class C Waste,” and 10 CFR part 76, “Certification of Gaseous 

Diffusion Plants.” 
124 

List of Subjects 

10 CFR Part 20 

 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear 

power plants and reactors, Occupational safety and health, Packaging and containers, 

Radiation protection, Reporting and recordkeeping requirements, Source material, Special 

nuclear material, Waste treatment and disposal. 

10 CFR Part 61 

 Criminal penalties, Low-level waste, Nuclear materials, Reporting and recordkeeping 

requirements, Waste treatment and disposal. 

 

 For the reasons set out in the preamble and under the authority of the Atomic Energy 

Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 

552 and 553 , the NRC is proposing to adopt the following amendments to 10 CFR parts 20 and 

61. 

PART 20 -- STANDARDS FOR PROTECTION AGAINST RADIATION 

1. The authority citation for 10 CFR part 20 continues to read as follows: 

Authority: Atomic Energy Act secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 223, 234 

1701 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2273, 2282, 2297f), 

Energy Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846); Government 
125 

Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005 sec. 

651(e), Pub. L. No. 109-58, 119 Stat. 549 (2005) (42 U.S.C. 2014, 2021, 2021b, 2111). 

2. In § 20.1003, revise the definition of “Waste” to read as follows: 

§ 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. 

* * * * * 

3. In appendix G to part 20: 

a. Revise section II; and 

b. Revise paragraphs III.A.1, III.A.2, III.A.3, III.C.3, III.C.4, and III.C.5. 

The revisions read as follows: 
126 

Appendix G to Part 20 -- Requirements for Transfers of Low-Level Radioactive Waste 

Intended for Disposal at Licensed Land Disposal Facilities and Manifests 

* * * * * 

II. * * * 

An authorized representative of the waste generator, processor, or collector shall certify 

by signing and dating the shipment manifest that the transported materials meet the waste 

acceptance criteria for disposal for a specific site; are properly classified, described, packaged, 

marked, and labeled; and are in proper condition for transportation according to the applicable 

regulations of the U.S. Department of Transportation and the Commission. A collector who 

signs the certification is certifying that nothing has been done to the collected waste that would 

invalidate the waste generator's certification. 

III. * * * 

A. * * * 

1. Prepare all wastes according to the land disposal facility’s criteria for waste 

acceptance developed in accordance with § 61.58 of this chapter; 

2. Label each disposal container (or transport package if potential radiation hazards 

preclude labeling of the individual disposal container) of waste in accordance with § 61.57 of 

this chapter; 

3. Conduct a quality assurance program to assure compliance with the land disposal 

facility’s criteria for waste acceptance that has been developed in accordance with § 61.58 of 

this chapter (the program must include management evaluation of audits); 

* * * * * 

C. * * * 
127 

3. Prepare all wastes according to the land disposal facility’s criteria for waste 

acceptance developed in accordance with § 61.58 of this chapter; 

4. Label each package of waste in accordance with § 61.57 of this chapter; 

5. Conduct a quality assurance program to assure compliance with the land disposal 

facility’s criteria for waste acceptance that has been developed in accordance with § 61.58 of 

this chapter (the program shall include management evaluation of audits); 

* * * * * 

PART 61 -- LICENSING REQUIREMENTS FOR LAND DISPOSAL RADIOACTIVE WASTE 

4. The authority citation for 10 CFR part 61 continues to read as follows: 

Authority: Atomic Energy Act secs. 53, 57, 62, 63, 65, 81, 161, 181, 182, 183, 223, 

234 (42 U.S.C. 2073, 2077, 2092, 2093, 2095, 2111, 2201, 2231, 2232, 2233, 2273, 2282); 

Energy Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846), sec. 211, Pub. L. 

95-601, sec. 10, as amended by Pub. L. 102-486, sec. 2902 (42 U.S.C. 5851). Pub. L. 95-601, 

sec. 10, 14, 92 Stat. 2951, 2953 (42 U.S.C. 2021a, 5851); Government Paperwork Elimination 

Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, sec. 651(e), Pub. L. 109-58, 

119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111). 

 5. In § 61.2: 

 a. Add the definitions of “Compliance period” and “Defense-in-depth”; 

 b. Revise the definition of “Inadvertent intruder”; 

 c. Add the definitions of “Intruder assessment,” “Long-lived waste,” “Performance 

assessment,” “Performance period,” “Protective assurance period,” and “Safety case”; and 

 d. Revise the definitions of “Site closure and stabilization,” “Stability,” and “Waste.” 
128 

 The revisions and additions read as follows: 

§ 61.2 Definitions. 

* * * * * 

Compliance period is the time out to 1,000 years after closure of the disposal facility. 

* * * * * 

Defense-in-depth means the use of multiple independent and redundant layers of 

defense such that no single layer, no matter how robust, is exclusively relied upon. Defense-indepth for a land disposal facility includes, but is not limited to, the use of siting, waste forms and 

radionuclide content, engineered features, and natural geologic features of the disposal site. 

* * * * * 

Inadvertent intruder means a person who might occupy the disposal site after closure 

and engage in normal activities, such as agriculture, dwelling construction, resource exploration 

or exploitation (e.g., well drilling) or other reasonably foreseeable pursuits that might 

unknowingly expose the person to radiation from the waste included in or generated from a lowlevel radioactive waste facility. 

* * * * * 

Intruder assessment is an analysis that: 

(1) Assumes an inadvertent intruder occupies the site and engages in normal activities 

or other reasonably foreseeable pursuits that are realistic and consistent with expected activities 
129 

in and around the disposal site at the time of site closure and that might unknowingly expose the 

person to radiation from the waste; 

(2) examines the capabilities of intruder barriers to inhibit an inadvertent intruder’s 

contact with the waste or to limit the inadvertent intruder’s exposure to radiation; and 

(3) estimates an inadvertent intruder’s potential annual dose, considering associated 

uncertainties. 

* * * * * 

Long-lived waste means waste containing radionuclides: 

(1) Where more than 10 percent of the initial activity of a radionuclide remains after 

10,000 years (e.g., long-lived parent), 

(2) Where the peak activity from progeny occurs after 10,000 years (e.g., long-lived 

parent – short-lived progeny), or 

(3) where more than 10 percent of the peak activity of a radionuclide (including progeny) 

within 10,000 years remains after 10,000 years (e.g., short-lived parent – long-lived progeny). 

* * * * * 

Performance assessment is an analysis that 

(1) Identifies the features, events, and processes that might affect the disposal system; 

(2) Examines the effects of these features, events, and processes on the performance of 

the disposal system; and 

(3) Estimates the annual dose to any member of the public caused by all significant 

features, events, and processes. 

* * * * * 
130 

Performance period is the timeframe established for considering waste and site 

characteristics to evaluate the performance of the site after the protective assurance period. 

* * * * * 

Protective assurance period is the period from the end of the compliance period through 

10,000 years following closure of the site.

* * * * * 

Safety case is a collection of information that demonstrates the assessment of the safety 

of a waste disposal facility. This includes technical analyses, such as the performance 

assessment and intruder assessment, but also includes information on defense-in-depth and 

supporting evidence and reasoning on the strength and reliability of the technical analyses and 

the assumptions made therein. The safety case also includes description of the safety relevant 

aspects of the site, the design of the facility, and the managerial control measures and 

regulatory controls. 

* * * * * 

Site closure and stabilization means those actions that are taken upon completion of operations 

that prepare the disposal site for custodial care and that assure that the disposal site will remain 

stable and will not need ongoing active maintenance.* * * 

 * * 

Stability means structural stability. 

* * * * * 
131 

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. 

* * * * * 

 6. Revise § 61.7 to read as follows: 

§ 61.7 Concepts.

(a) The disposal facility. (1) Part 61 is intended to apply to land disposal of radioactive 

waste and not to other methods such as sea or extraterrestrial disposal. Part 61 contains 

procedural requirements and performance objectives applicable to any method of land disposal. 

It contains specific technical requirements for near-surface disposal of radioactive waste, a 

subset of land disposal, which involves disposal in the uppermost portion of the earth, 

approximately 30 meters. Near-surface disposal includes disposal in engineered facilities that 

may be built totally or partially above-grade provided that such facilities have protective covers. 

Near-surface disposal does not include disposal facilities that are partially or fully above-grade 

with no protective cover, which are referred to as “above-ground disposal.” Burial deeper than 

30 meters may also be satisfactory. Technical requirements for alternative methods may be 
132 

added in the future. Alternative methods of disposal may be approved on a case-by-case basis 

as needed under § 61.6. 

(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 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. 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. An early warning allows a licensee to 

perform any mitigation that might be necessary. In choosing a disposal site, site characteristics 

should be considered in terms of the indefinite future, take into account the radiological 

characteristics of the waste, and be evaluated for at least a 500-year timeframe to provide 

assurance that the performance objectives can be met. 

(b) Performance objectives. Disposal of radioactive waste in land disposal facilities has 

the following safety objectives: protection of the general population from releases of 

radioactivity, protection of inadvertent intruders, protection of individuals during operations, and 

ensuring stability of the site after closure. Achieving these objectives depends upon many 

factors including the design of the land disposal facility, operational procedures, characteristics 

of the environment surrounding the land disposal facility, and the radioactive waste acceptable 

for disposal. 

(c) Technical analyses. (1) Demonstrating compliance with the performance objectives 

requires assessments of the site-specific factors including engineering design, operational 

practices, site characteristics, and radioactive waste acceptable for disposal. Technical 

analyses assess the impact of site-specific factors on the performance of the disposal facility 
133 

and the site environment both during the operational period, as in the analysis for protection of 

individuals during operations and, importantly for disposal of radioactive waste, over the longer 

term, as in the analyses for protection of the general population from releases of radioactivity, 

protection of inadvertent intruders, and stability of the disposal site after closure. 

(2) A performance assessment is an analysis that is required to demonstrate protection 

of the general population from releases of radioactivity. A performance assessment identifies 

the specific characteristics of the disposal site (e.g., hydrology, meteorology, geochemistry, 

biology, and geomorphology); degradation, deterioration, or alteration processes of the 

engineered barriers (including the waste form and container); and interactions between the site 

characteristics and engineered barriers that might affect performance of the disposal site. A 

performance assessment examines the effects of these processes and interaction on the ability 

of the disposal site to limit waste releases and estimates the annual dose to a member of the 

public for comparison with the appropriate performance objective of subpart C of this part. 

(3) Inadvertent intruders might occupy the site in the future and engage in normal 

pursuits without knowing that they were receiving radiation exposure. Protection of inadvertent 

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 dose 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. These regulations incorporate both types of protective controls. 

(4) The intruder assessment must demonstrate protection of inadvertent intruders 

through the assessment of potential radiological exposures should an inadvertent intruder 

occupy the disposal site following a loss of institutional controls after closure. The intruder can 

be exposed to radioactivity that has been released into the environment as a result of 

disturbance of the waste or from radiation emitted from waste that is still contained in the 
134 

disposal site. The results of the intruder assessment are compared with the appropriate 

performance objective of subpart C of this part. An intruder assessment can employ a similar 

methodology to that used for a performance assessment, but the intruder assessment must 

assume that an inadvertent intruder occupies the disposal site following a loss of institutional 

controls after closure, and engages in activities that unknowingly expose the intruder to 

radiation from the waste. 

(5) Implementation of dose methodology. The dose methodology used to demonstrate 

compliance with the performance objectives of this part shall be consistent with the dose 

methodology specified in the standards for radiation protection set forth in part 20 of this 

chapter. After the effective date of these regulations, applicants and licensees may use 

updated factors incorporated by the U.S. Environmental Protection Agency into Federal 

radiation protection guidance or may use the most current scientific models and methodologies 

(e.g., those accepted by the International Commission on Radiological Protection) appropriate 

for site-specific circumstances to calculate the dose. The weighting factors used in the 

calculation of the dose must be consistent with the methodology used to perform the calculation. 

(6) Waste with significant concentrations and quantities of long-lived radionuclides may 

require special processing, design, or site conditions for disposal. Demonstrating protection of 

the general population from releases of radioactivity and inadvertent intruders from the disposal 

of this waste requires an assessment of long-term impacts. Performance period analyses are 

used to evaluate the suitability of this waste for disposal on a case-by-case basis. In general, 

for disposal facilities with limited quantities of long-lived waste, performance period analyses are 

not necessary to demonstrate protection of the general population from releases of radioactivity 

and protection of inadvertent intruders. However, there may be site-specific conditions that 

require licensees to assess disposal facilities beyond the compliance period even when 
135 

long-lived waste is limited. These conditions should be evaluated on a case-by-case basis to 

determine whether analyses beyond the compliance period would be required. 

(d) Defense-in-depth. With respect to waste disposal, defense-in-depth is the use of 

multiple independent and redundant layers of defense to compensate for uncertainties in the 

estimation of long-term performance. Defense-in-depth protections, commensurate with the 

risks, are intended to ensure that no single layer, no matter how robust, is exclusively relied 

upon by the disposal system to provide protection of the public and environment from radiation 

that may be released from the facility to the environment. Defense-in-depth protections, such 

as siting, wasteforms, radiological source-term, engineered features, and natural system 

features of the disposal site, combined with technical analyses and scientific judgment form the 

safety case for licensing a low-level waste disposal facility. The insights derived from technical 

analyses include supporting evidence and reasoning on the strength and reliability of the layers 

of defense relied upon in the safety case. These insights provide input for making regulatory 

decisions. 

(e) Waste acceptance. Demonstrating compliance with the performance objectives also 

requires a determination of criteria for the acceptance of waste. The criteria can be determined 

from the results of the technical analyses that demonstrate compliance with the performance 

objectives for any land disposal facility or, for a near-surface disposal facility, the waste 

classification requirements of subpart D of this part. 

(f) Waste classification and near-surface disposal. (1) A cornerstone of the waste 

classification system is stability of both the waste and disposal site, which minimizes the access 

of water to waste that has been emplaced and covered. Limiting the access of water to the 

waste minimizes the migration of radionuclides, which may avoid the need for long-term active 

maintenance and reduces the potential for release of radioactivity into the environment. While 

stability is desirable, it is not necessary from a health and safety standpoint for most waste 
136 

because the waste does not contain sufficient radioactivity to be of concern. This lower-activity 

waste (e.g., ordinary trash-type waste) tends to be unstable. If unstable waste is disposed with 

the waste requiring stability, the deterioration of unstable waste could lead to the failure of the 

system. The failure of the system could permit water to penetrate the disposal unit, which may 

cause problems with the waste that requires stability. Therefore, to avoid placing requirements 

for a stable waste form on relatively innocuous waste, these wastes have been classified as 

Class A waste. Unstable Class A waste will be disposed of in separate disposal units at the 

disposal site. However, stable Class A waste may be disposed of with other classes of waste. 

Wastes that must be stable for proper disposal are classified 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. The stability of the 

disposal site for the disposal of long-lived waste may be more uncertain and require more 

robust technical evaluation of the processes that are unlikely to affect the ability of the disposal 

system to isolate short-lived waste. For long-lived waste 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 associated with 

long-term stability of the disposal site. Some waste, depending on its radiological 

characteristics, may not be suitable for disposal if uncertainties cannot be adequately addressed 

with technical analyses. 

(2) Institutional control of access to the site is required for up to 100 years. This permits 

the disposal of Class A and B waste without special provisions for intrusion protection, since 

these wastes contain types and quantities of radionuclides that generally will decay during the 

100-year period and will present an acceptable hazard to the intruder. However, waste that is 

Class A under 10 CFR 61.55(a)(6) may not decay to acceptable levels in 100 years. For waste 

classified under 10 CFR 61.55(a)(6), safety is provided by limiting the quantities and 
137 

concentrations of the material consistent with the disposal site design. Safe disposal of waste 

classified under 10 CFR 61.55(a)(6) is demonstrated by the technical analyses and compliance 

with the performance objectives. The government landowner administering the active 

institutional control program has flexibility in controlling site access, which may include allowing 

productive uses of the land provided the integrity and long-term performance of the site are not 

affected. 

(3) Waste that will not decay to levels that present an acceptable hazard to an intruder 

within 100 years is typically designated as Class C waste. Class C waste must be stable and 

be 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 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 so that at the end of the 500-year period, the remaining 

radioactivity will be at a level that does not pose an unacceptable hazard to an inadvertent 

intruder or to 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. Disposal of this waste will be evaluated on a 

case-by-case basis with the technical analyses required in § 61.13. 

(4) Regardless of the classification, some waste may require enhanced controls or 

limitations at a particular land disposal facility. A performance assessment and an intruder 

assessment are used to identify these enhanced controls and limitations, which are site- and 

waste-specific. Enhanced controls or limitations could include additional limits on waste 

concentration or total activity, more robust intruder barriers, deeper burial depth, and 
138 

waste-specific stability requirements. These enhanced controls or limitations could mitigate the 

uncertainty associated with the evolutionary effects of the natural environment and the disposal 

facility performance over the compliance period. 

(g) The licensing process. (1) During the preoperational phase, the potential applicant 

goes through 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 disposal site characteristics the potential 

applicant obtains data on which to base an analysis of the disposal site's suitability. The 

potential applicant uses these data and analyses to develop a safety case that describes the 

safety relevant aspects of the site, the design of the facility, and the managerial control 

measures and regulatory controls. The safety case demonstrates the level of protection of 

people and the environment and provides reasonable assurance that the performance 

objectives will be met. Along with these data and analyses, the applicant submits other more 

general information to the Commission in the form of an application for a license for land 

disposal. The Commission's review of the application is in accordance with administrative 

procedures established by rule and may involve participation by affected State governments or 

Indian tribes. While the proposed disposal site must be owned by a State or the Federal 

Government before the Commission will issue a license, it may be privately owned during the 

preoperational phase if suitable arrangements have been made with a State or the Federal 

Government to take ownership in fee of the land before the license is issued. 

(2) During the operational phase, the licensee carries out disposal activities in 

accordance with the requirements of these regulations and any conditions on 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. When disposal operations are to cease, the 
139 

licensee applies for an amendment to the site 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 

is not required during the period of institutional control. 

(3) During the period when the final site closure and stabilization activities are being 

carried out, the licensee is in a disposal site closure phase. Following that, for a period of 5 

years, the licensee must remain at the disposal site for a period of postclosure observation and 

maintenance to assure that the disposal site is stable and ready for institutional control. The 

period of postclosure observation and maintenance is used to ensure that the final site closure 

and stabilization activities have not resulted in unintended instability at the 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. 

(4) After a finding of satisfactory disposal site closure, the Commission will transfer the 

license to the State or Federal Government that owns the disposal site. If the U.S. Department 

of Energy is the Federal agency administering the land on behalf of the Federal Government 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 owner will carry 

out a program of monitoring to assure continued satisfactory disposal site performance, perform 

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 control, the license will be terminated by the Commission. 

7. In § 61.8, revise paragraph (b) to read as follows: 
140 

§ 61.8 Information collection requirements: OMB approval.

* * * * * 

(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. 

* * * * * 

8. Revise § 61.10 to read as follows: 

§ 61.10 Content of application.

(a) 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, institutional information, and financial 

information as set forth in §§ 61.11 through 61.16. An environmental report prepared in 

accordance with subpart A of part 51 of this chapter must accompany the application. 

(b) The information provided in an application comprises the safety case and supports 

the licensee’s demonstration that the disposal facility will be constructed and operated safely 

and provides reasonable assurance that the disposal site will be capable of isolating waste and 

limiting releases to the environment. 

9. In § 61.12, revise the introductory text and paragraphs (a), (e), (g), (i), and (j) to 

read as follows: 
141 

§ 61.12 Specific technical information.

The specific technical information, which supports the safety case, must include the 

following to 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 of the disposal site and vicinity. 

* * * * * 

(e) A description of codes and standards that the applicant has applied to the design and 

that will apply to construction of the land disposal facilities. 

* * * * * 

(g) A description of the disposal site closure plan, including those design features that 

are intended to facilitate disposal site closure and eliminate the need for ongoing active 

maintenance. 

* * * * * 

(i) A description of the kind, amount, and specifications of the radioactive material 

proposed to be received, possessed, and disposed of at the land disposal facility, including the 

criteria for acceptance of waste for disposal. 

(j) A description of the quality assurance program, tailored to low-level radioactive waste 

disposal, developed and applied by the applicant for: 
142 

(1) The determination of natural disposal site characteristics; 

(2) The development of technical analyses; and 

(3) Quality assurance during the design, construction, operation, and closure of the land 

disposal facility and the receipt, handling, and emplacement of waste. 

* * * * * 

10. In § 61.13: 

a. Revise the introductory text and paragraphs (a), (b), and (d); and 

b. Add paragraphs (e) and (f). 

The revisions and additions read as follows: 

§ 61.13 Technical analyses. 

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. The technical 

analyses are one of the elements of the safety case. Licensees with licenses for land disposal 

facilities in effect on the effective date of this subpart must submit these analyses at the next 

license renewal or within 5 years of the effective date of this subpart, whichever comes first. 

(a) A performance assessment that demonstrates that there is reasonable assurance 

that the exposure to humans from the release of radioactivity will meet the performance 

objective set forth in § 61.41. A performance assessment shall: 

(1) 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 with 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 inclusion or exclusion of specific features, events, and processes must be provided. 
143 

(2) Evaluate specific features, events, and processes in detail if their omission would 

significantly affect meeting the performance objective specified in § 61.41. 

(3) Consider the likelihood of disruptive or other unlikely features, events, or processes 

for comparison with the limits set forth in § 61.41. 

 (4) Reflect new features, events, and processes different from the compliance period 

that address significant uncertainties inherent in the long timeframes associated with 

demonstrating compliance with § 61.41(b) only if scientific information compelling such changes 

is available. 

(5) Provide a technical basis for either inclusion or exclusion of degradation, 

deterioration, or alteration processes (e.g., of the engineered barriers, waste form, site 

characteristics) and interactions between the disposal facility and site characteristics that might 

affect the facility’s ability to meet the performance objective in § 61.41. 

(6) Provide a technical basis for models used in the performance assessment such as 

comparisons made with outputs of detailed process-level models or empirical observations 

(e.g., laboratory testing, field investigations, and natural analogs). 

(7) Evaluate pathways including air, soil, groundwater, surface water, plant uptake, and 

exhumation by burrowing animals. 

(8) Account for uncertainties and variability in the projected behavior of the disposal 

system (e.g., disposal facility, natural system, and environment). 

(9) Consider alternative conceptual models of features and processes that are consistent 

with available data and current scientific understanding, and evaluate the effects that alternative 

conceptual models have on the understanding of the performance of the disposal facility. 

(10) Identify and differentiate between the roles performed by the natural disposal site 

characteristics and design features of the disposal facility in limiting releases of radioactivity to 

the general population. 
144 

(b) Inadvertent intruder analyses that demonstrate there is reasonable assurance that: 

(1) the waste acceptance criteria developed in accordance with § 61.58 will be met, 

(2) adequate barriers to inadvertent intrusion will be provided, and 

(3) any inadvertent intruder will not be exposed to doses that exceed the limits set forth 

in § 61.42 as part of the intruder assessment. An intruder assessment shall: 

(i) Assume that an inadvertent intruder occupies the disposal site at any time after the 

period of institutional controls ends, and engages in normal activities including agriculture, 

dwelling construction, resource exploration or exploitation (e.g., well drilling), or other 

reasonably foreseeable pursuits that are consistent with activities in and around the site at the 

time of closure and that unknowingly expose the intruder to radiation from the waste. 

(ii) Identify adequate barriers to inadvertent intrusion that inhibit contact with the waste or 

limit exposure to radiation from the waste, and provide a basis for the time period over which 

barriers are effective. 

(iii) Account for uncertainties and variability. 

* * * * * 

(d) 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 long-term stability of the disposal site can be 

ensured and that there will not be a need for ongoing active maintenance of the disposal site 

following closure. 

(e) Analyses that assess how the disposal site limits the potential long-term radiological 

impacts, consistent with available data and current scientific understanding. The analyses shall 
145 

be required for disposal sites with waste that contains radionuclides with average 

concentrations exceeding the values listed in table A of this paragraph, or if necessitated by 

site-specific conditions. For wastes containing mixtures of radionuclides found in table A, the 

total concentration shall be determined by the sum of fractions rule described in paragraph 

61.55(a)(7). The analyses must identify and describe the features of the design and site 

characteristics that will demonstrate that the performance objectives set forth in §§ 61.41(c) and 

61.42(c) will be met. 

Table A - Average Concentrations of Long-lived Radionuclides Requiring Performance 

Period Analyses 

Radionuclide Concentration (Ci/m3

)

1

C-14 0.8 

C-14 in activated metal 8 

Ni-59 in activated metal 22 

Nb-94 in activated metal 0.02 

Tc-99 0.3 

I-129 0.008 

Long-lived alpha-emitting nuclides2 103

Pu-241 3503 

Cm-242 2,0003

1

 Values derived from § 61.55 Class A limits. 

2

 Includes alpha-emitting transuranic nuclides as well as other long-lived alpha-emitting 

nuclides. 

3

 Units are nanocuries per gram. 

(f) Analyses that demonstrate the proposed disposal facility includes defense-in-depth 

protections. 

11. In § 61.23: 

a. Revise paragraphs (b), (c), (d), and (e); and 

b. Add paragraph (m). 
146 

The revisions and additions read as follows:

§ 61.23 Standards for issuance of a license. 

* * * * * 

(b) The applicant’s proposed disposal site, disposal design, waste acceptance criteria, 

land disposal facility operations (including equipment, facilities, and procedures), disposal site 

closure, and postclosure institutional control demonstrate that they are adequate to protect the 

public health and safety 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. 

(c) The applicant’s proposed disposal site, disposal site design, waste acceptance 

criteria, land disposal facility operations (including equipment, facilities, and procedures), 

disposal site closure, and postclosure institutional control demonstrate that they are adequate to 

protect the public health and safety because they provide reasonable assurance that individual 

inadvertent intruders are protected in accordance with the performance objective in § 61.42. 

(d) The applicant’s proposed waste acceptance criteria and land disposal facility 

operations (including equipment, facilities, and procedures) demonstrate that they are adequate 

to protect the public health and safety because they provide reasonable assurance that the 

standards for radiation protection set out in part 20 of this chapter will be met. 

(e) The applicant’s proposed disposal site, disposal site design, waste acceptance 

criteria, land disposal facility operations, disposal site closure, and postclosure institutional 

control demonstrate that they are adequate to protect the public health and safety because they 

provide reasonable assurance that long-term stability of the disposed waste and the disposal 
147 

site will be achieved and will eliminate to the extent practicable the need for ongoing active 

maintenance of the disposal site following closure. 

* * * * * 

(m) The applicant’s safety case is adequate to support the licensing decision. 

* * * * * 

12. In § 61.25, revise paragraphs (a) and (b) to read as follows: 

§ 61.25 Changes. 

(a) Except as provided for in specific license conditions, the licensee shall 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 

authorized 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 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 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 that may not be changed without 60 days prior notice 

to the Commission. Features and procedures falling in this paragraph (a)(3) may not be 
148 

changed without prior Commission approval if the Commission so orders, after having received 

the required notice. 

(b) Amendments authorizing waste acceptance criteria changes, site closure, license 

transfer, or license termination shall be included in paragraph (a)(1) of this section. 

* * * * * 

13. In § 61.28, revise paragraphs (a) introductory text and (a)(2) to read as follows: 

§ 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 shall submit an application to amend the license for closure. This closure 

application must include a final revision of the safety case and specific details of the disposal 

site closure plan included as part of the license application submitted under § 61.12(g) that 

includes each of the following: 

* * * * * 

 (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, including revised analyses for § 61.13 using the details of the 

final closure plan and waste inventory.

* * * * * 

14. Revise § 61.41 to read as follows: 
149 

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

(a) Concentrations of radioactive material that may be released to the general 

environment in ground water, surface water, air, soil, plants, or animals must not result in an 

annual dose exceeding an equivalent of 0.25 milliSievert (25 millirems) to any member of the 

public within the compliance period. Reasonable effort should be made to maintain releases of 

radioactivity in effluents to the general environment as low as is reasonably achievable during 

the compliance period. Compliance with this paragraph must be demonstrated through 

analyses that meet the requirements specified in § 61.13(a). 

(b) Concentrations of radioactive material that may be released to the general 

environment in ground water, surface water, air, soil, plants, or animals shall be minimized 

during the protective assurance period. The annual dose, established on the license, shall be 

below 5 milliSieverts (500 millirems) or a level that is supported as reasonably achievable based 

on technological and economic considerations in the information submitted for review and 

approval by the Commission. Compliance with this paragraph must be demonstrated through 

analyses that meet the requirements specified in § 61.13(a). 

(c) Effort shall be made to minimize releases of radioactivity from a disposal facility to 

the general environment to the extent reasonably achievable at any time during the 

performance period. Compliance with this paragraph must be demonstrated through analyses 

that meet the requirements specified in § 61.13(e). 

15. Revise § 61.42 to read as follows: 

§ 61.42 Protection of inadvertent intruders. 
150 

(a) Design, operation, and closure of the land disposal facility must ensure protection of 

any inadvertent intruder into the disposal site who occupies the site or contacts 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 analyses that meet the 

requirements specified in § 61.13(b). 

(b) Design, operation, and closure of the land disposal facility shall minimize exposures 

to any inadvertent intruder into the disposal site at any time during the protective assurance 

period. The annual dose, established on the license, shall be below 5 milliSieverts (500 

millirems) or a level that is supported as reasonably achievable based on technological and 

economic considerations in the information submitted for review and approval by the 

Commission. Compliance with this paragraph must be demonstrated through analyses that 

meet the requirements specified in § 61.13(b). 

(c) Effort shall be made to minimize exposures to any inadvertent intruder to the extent 

reasonably achievable at any time during the performance period. Compliance with this 

paragraph must be demonstrated through analyses that meet the requirements specified in § 

61.13(e). 

16. Revise § 61.44 to read as follows: 

§ 61.44 Stability of the disposal site after closure. 

The disposal facility must be sited, designed, used, operated, and closed to achieve 

long-term stability of the disposal site for the compliance and protective assurance periods and 

to eliminate to the extent practicable the need for ongoing active maintenance of the disposal 

site following closure so that only surveillance, monitoring, or minor custodial care are required. 
151 

17. Revise § 61.50 to read as follows: 

§ 61.50 Disposal site suitability requirements for land disposal. 

(a) Disposal site suitability for near-surface disposal. The purpose of this section is to 

specify the minimum characteristics a disposal site must possess to be acceptable for the 

disposal of radioactive waste in the near surface. 

(1) To the extent practicable, the disposal site shall be capable of being characterized, 

modeled, analyzed, and monitored. 

(2) The hydrologic characteristics that a site must have for 500 years following closure of 

the land disposal facility to be acceptable for the disposal of radioactive waste in the near 

surface include: 

(i) Waste disposal shall not take place in a poorly drained site or a site subject to 

flooding or frequent ponding, or in a 100-year flood plain, coastal high-hazard area or wetland, 

as defined in Executive Order 11988, “Floodplain Management Guidelines.” 

(ii) Upstream drainage areas must be minimized to decrease the amount of runoff which 

could erode or inundate waste disposal units. 

(iii) The disposal site must provide sufficient depth to the water table that ground water 

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. 
152 

(iv) The hydrogeologic unit used for disposal shall not discharge ground water to the 

surface within the disposal site. 

(3) After 500 years, the hydrologic characteristics specified in paragraph (2) of this 

section shall not significantly affect the ability of the disposal site to meet the performance 

objectives of subpart C of this part. 

(4) Other characteristics of the site shall not significantly affect the ability of the disposal 

site to meet the performance objectives of subpart C of this part, or preclude defensible 

modeling and estimation of longer-term impacts. The characteristics include: 

(i) 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. 

(ii) 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. 

(iii) Areas must be avoided where tectonic processes such as faulting, folding, seismic 

activity, or volcanism 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 

preclude defensible modeling and prediction of long-term impacts. 

(iv) Areas must be avoided where surface geologic processes such as mass wasting, 

erosion, slumping, landsliding, 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 preclude defensible modeling and prediction of long-term impacts. 

(v) The disposal site must not be located where nearby facilities or activities could 

adversely impact the ability of the site to meet the performance objectives of subpart C of this 

part or significantly mask the environmental monitoring program. 
153 

(b) Disposal site suitability requirements for land disposal other than near-surface 

(reserved). [Reserved] 

18. In § 61.51, revise paragraph (a)(1) to read as follows: 

§ 61.51 Disposal site design for land disposal. 

(a) * * * 

(1) Site design features must be directed toward defense-in-depth, long-term isolation 

and avoidance of the need for continuing active maintenance after site closure. 

* * * * * 

19. In § 61.52, revise paragraphs (a)(3) and (a)(8) and add paragraphs (a)(12) and (13) 

to read as follows:

§ 61.52 Land disposal facility operation and disposal site closure. 

(a) * * * 

(3) All wastes shall be disposed of in accordance with the requirements of paragraphs 

(a)(4) through (13) of this section. 

* * * * * 

(8) 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 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. 

* * * * * 
154 

(12) Only waste meeting the acceptance criteria shall be disposed of at the disposal site. 

(13) Waste will be disposed of consistent with the description provided in § 61.12(f) and 

the technical analyses required by § 61.13. 

* * * * * 

20. In § 61.55, revise paragraph (a)(6) to read as follows: 

§ 61.55 Waste classification. 

(a) * * * 

(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. 

* * * * * 

21. In § 61.56, revise paragraph (a) to read as follows: 

§ 61.56 Waste characteristics. 

(a) The following requirements are minimum requirements for all waste and are intended 

to facilitate handling at the disposal site and provide protection of health and safety of personnel 

at the disposal site. 

* * * * * 
155 

22. Revise § 61.57 to read as follows: 

§ 61.57 Labeling. 

Each package of waste must be clearly labeled to identify any information required by 

the land disposal facility’s criteria for waste acceptance developed according to § 61.58. Each 

package of waste disposed in a land disposal facility with waste acceptance criteria developed 

in accordance with the waste classification requirements must indicate whether it is Class A 

waste, Class B waste, or Class C waste, in accordance with § 61.55. 

23. Revise § 61.58 to read as follows: 

§ 61.58 Waste acceptance. 

(a) Waste acceptance criteria. Each applicant shall provide, for approval by the 

Commission, criteria for the acceptance of waste for disposal that provide reasonable 

assurance of compliance with the performance objectives of subpart C of this part. Waste 

acceptance criteria shall specify, at a minimum, the following: 

(1) Allowable activities and concentrations of specific radionuclides. Allowable activities 

and concentrations shall be developed from the technical analyses required by either § 61.13 

for any land disposal facility or the waste classification requirements set forth in § 61.55 for a 

near-surface disposal facility. 

(2) Acceptable wasteform characteristics and container specifications. The 

characteristics and specifications shall meet the minimum requirements for waste 

characteristics set forth in § 61.56(a) for all waste, and the requirements in § 61.56(b) for waste 

that requires stability to demonstrate compliance with the performance objectives of subpart C 

of this part. 
156 

(3) Restrictions or prohibitions on waste, materials, or containers that might affect the 

facility’s ability to meet the performance objectives in subpart C of this part. 

(b) Waste characterization. Each applicant shall provide, for Commission approval, 

acceptable methods for characterizing the waste for acceptance. The methods shall identify the 

characterization parameters and acceptable uncertainty in the characterization data. The 

following information, at a minimum, shall be required to characterize waste: 

(1) Physical and chemical characteristics; 

(2) Volume, including the waste and any stabilization or absorbent media; 

(3) Weight of the container and contents; 

(4) 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. Each applicant shall provide, for Commission approval, a 

program to certify that waste meets the acceptance criteria prior to shipment to the disposal 

facility. The certification program shall: 

(1) Designate authority to certify and receive waste for disposal at the disposal facility. 

(2) Provide procedures for certifying that waste meets the waste acceptance criteria. 

(3) Specify documentation required for waste acceptance including waste 

characterization, shipment (including the requirements set forth in appendix G of 10 CFR part 

20), and certification. 

(4) Identify records, reports, tests, and inspections that are necessary to comply with the 

requirements in § 61.80. 
157 

(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) Licensees with licenses for land disposal facilities in effect on the effective date of 

this subpart shall comply with the requirements of paragraphs (a), (b), and (c) of this section at 

the next license renewal or within 5 years of the effective date of this subpart, whichever comes 

first. 

(e) For license applicants, the waste acceptance criteria will be incorporated into the 

facility license. For licensees with licenses for land disposal facilities in effect on the effective 

date of this subpart, upon Commission approval and if otherwise consistent with applicable 

State and Federal law, the NRC will issue an amendment to the license incorporating the waste 

acceptance criteria in to the existing license. 

(f) Each licensee shall annually review the content and implementation of the waste 

acceptance criteria, waste characterization methods, and certification program. 

(g) Applications for modification of approved waste acceptance criteria must be filed in 

accordance with § 61.20. 

(h) In determining whether waste acceptance criteria will be approved, the Commission 

will apply the criteria set forth in § 61.23. 

24. In § 61.80, revise paragraphs (i)(1) and (2) and add paragraph (m) to read as 

follows: 

§ 61.80 Maintenance of records, reports, and transfers. 

* * * * * 
158 

(i)(1) Each licensee authorized to dispose of waste materials received from other 

persons under this part shall submit annual reports to the Director, Office of Nuclear 

Material Safety and Safeguards, by an appropriate method listed in § 61.4, with a copy 

to the appropriate NRC Regional Office shown in appendix D to 10 CFR part 20. 

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

preceding year. 

(2) The reports shall 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 of 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. 

* * * * * 

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

(1) Provisions for waste acceptance including the waste acceptance criteria, 

characterization methods, and certification program. 
159 

(2) Audits and other reviews of program content and implementation. The licensee shall 

retain records of audits and other reviews for 3 years after the record is made. 

 Dated at Rockville, Maryland, this 16th day of March, 2015. 

 

 For the Nuclear Regulatory Commission. 

 

 /RA/ 

 Annette L. Vietti-Cook, 

 Secretary of the Commission.