Vol. 80 Thursday, 

No. 58 March 26, 2015 

Part II 

Nuclear Regulatory Commission 

10 CFR Parts 20 and 61 

Low-Level Radioactive Waste Disposal; Proposed Rule 

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16082 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

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 lowlevel 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): 

• 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; 

email: Carol.Gallagher@nrc.gov. For 

technical questions, contact one of the 

individuals listed in the FOR FURTHER

INFORMATON CONTACT section of this 

document. 

• Email comments to: 

Rulemaking.Comments@nrc.gov. If you 

do not receive an automatic email 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, 

email: Gary.Comfort@nrc.gov; or 

Andrew Carrera, telephone: 301–415– 

1078, email: 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: 

Excutive Summary 

A. Need for the Regulatory Action 

The U.S. Nuclear Regulatory 

Commission (NRC) is proposing to 

amend its regulations that govern lowlevel 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 longlived LLRW that would include a post10,000-year performance period; 

• 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 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 

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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 

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? 

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 

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 publiclyavailable 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 

email 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. 

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 nearsurface 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 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, defensein-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 

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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 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 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. 

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 

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in tables 1 and 2 of 10 CFR 61.55 that 

establish four classes of LLRW (Class A, 

Class B, Class C, and greater-than-ClassC). 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 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-thanClass-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 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 LowLevel 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 

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 LowLevel 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 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 

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16086 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

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-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 longterm 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. 

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-in-depth 

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 radioactivity that occurs within 

1,000 years following closure of disposal facility.

—ALARA concept. 

—Comply with LLRW acceptance criteria.

—Provide adequate barriers to 

inadvertent intrusion.

—Intruder assessment that estimates peak annual dose 

that occurs within 1,000 

years following closure of 

disposal facility.

—5 mSv (500 mrem) annual 

dose limit.

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. 

Between 1,000 and 10,000 Years Following Closure of Disposal Facility (Protective Assurance Period). 

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TABLE 1—COMPARISON TABLE OF CURRENT AND PROPOSED 10 CFR PART 61 REGULATIONS—Continued 

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-in-depth 

—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). 

—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 sitespecific 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 sitespecific 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. 

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 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 

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16088 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

1For 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). 

2National Defense Authorization Act for Fiscal 

Year 2013. Subtitle F, Sec. 3173. Improving the 

reliability of Domestic Isotope Supply. H.R. 4310 

(112th). 

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)). 

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 riskinformed and performance-based 

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 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-indepth’’ 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 riskinformed, 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 NUREG–2150, ‘‘A 

Proposed Risk Management Regulatory 

Framework,’’ dated April 30, 2012 

(ADAMS Accession No. ML12109A277). 

Three recommendations for LLRW were 

proposed in NUREG–2150. One of these 

recommendations was that the NRC 

should develop an explicit 

characterization of how defense-indepth, 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-indepth 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 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-in-depth 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 sitespecific conditions that would 

necessitate it, would be required to 

complete performance period analyses 

for the performance period. 

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Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 16089 

3The current 10 CFR part 61 refers to a ‘‘technical 

analysis.’’ 

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 (10 

CFR 61.13(e)); and (d) new analyses that 

demonstrate the disposal site includes 

defense-in-depth protections. The sitespecific 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 

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. 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 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 riskinformed and flexible. Proposed 10 CFR 

61.41 uses a risk-informed regulatory 

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16090 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

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 site-specific 

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 

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 

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. 

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 

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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 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 riskinformed approach would be to require 

an intruder assessment 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 halflife of the LLRW. To ensure protection 

of public health and safety, 10 CFR part 

61 includes regulations regarding 

analyses, LLRW classification, siteselection, 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 analysesbased approach to regulation is more 

risk-informed than the concentrationbased 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 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 site-averaged 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 longmstockstill on DSK4VPTVN1PROD with PROPOSALS2

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term 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 longterm 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 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 defensein-depth protections. 

However, implementation of defensein-depth protections, in the context of a 

LLRW land disposal facility, should be 

consistent with the NRC’s goal of 

achieving a regulatory program and 

associated requirements that are riskinformed 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 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 longterm 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 

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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. 

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 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? 

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 longlived 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 

period 4 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 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 long-lived 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. Sitespecific 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 longterm analyses). Performance 

assessments are used to understand how 

a system (e.g., a disposal facility and 

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6The 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. 

natural environment) may perform. 

They are used to understand the 

potential impacts of 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 designand control-based approach to 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. 

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 lowlevel 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. 

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(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 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 regulator-derived 

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 long-lived 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 risk-informed 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 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 facility-averaged 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. 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 shortlived 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 riskinformed. 

(b) Risk-informed analysis with longterm 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 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 

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7 10 CFR 61.29. 

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 

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 longlived 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, 

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 three-tiered 

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 long-lived 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. Currently, 10 CFR 

part 61 contemplates that involvement 

of a disposal site operator will follow a 

well-defined timeline. The more openended 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 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 

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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-lived isotopes. 

It is appropriate to include the nontransuranic 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-dimension problem into onedimension (i.e., concentrations) in a 

risk-informed manner. The approach 

proposed in this rule attempts to 

address this issue by providing disposal 

site-averaged 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 sitespecific 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 shortlived 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. 

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 in-growth 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 

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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 longterm 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 

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 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 nearsurface 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 nearsurface 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. 

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 

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 

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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 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 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. 

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 sitespecific 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 sitespecific 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 

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8NRC, ‘‘Branch Technical Position on 

Concentration Averaging and Encapsulation’’, 

January 17, 1995, Division of Waste Management. 

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 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 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 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-thanClass-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. 

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 

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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-indepth 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 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 sitespecific 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. 

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 nearsurface 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 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. 

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16102 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

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 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 sitespecific 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 

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 halflife 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 shortlived 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, defensein-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 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-indepth 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. 

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. 

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Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 16103 

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 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 

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 sitespecific 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 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 

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16104 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

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). 

11Battelle Pacific Northwest Laboratories, ‘‘AgeSpecific Radiation Dose Commitment Factors for a 

One-Year Chronic Intake,’’ NUREG–0172, NRC, 

November 1977 (Adams Accession No. 

ML14083A242). 

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 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 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. 

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 comingled 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 riskinformed, 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 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 

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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 riskweighted ‘‘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. 

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 

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 editionneutral 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 upto-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 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 

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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. 

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. 

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 NRC–2015– 

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 

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-indepth protections. Additionally, the 

document contains guidance on 

acceptable approaches for determining 

WAC based on the results of the sitespecific 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 

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 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: 

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Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 16107 

• 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 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 

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-indepth,’’ ‘‘intruder assessment,’’ ‘‘longlived waste,’’ ‘‘performance 

assessment,’’ ‘‘protective assurance 

analysis,’’ ‘‘protective assurance 

period,’’ and ‘‘safety case,’’ see Section 

III, Discussion, of this document. 

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 longterm 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 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 

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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 longlived 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 defense-in-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. 

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 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 site-specific 

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 

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 

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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 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 longterm 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 sitespecific 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 defensein-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. 

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 sitespecific 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 authorize 

closure of the LLRW disposal facility if 

there is reasonable assurance that the 

long-term 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 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. 

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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 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 nearsurface 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 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. 

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-bycase 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 sitespecific 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. 

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. 

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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 

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 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 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 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 

information in this paragraph has to be 

included in the application for closure. 

The NRC believes that the presence of 

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these provisions are necessary for the 

Commission to make a final decision on 

the amendment 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 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 

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 

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PROPOSED COMPATIBILITY TABLE FOR 10 CFR PART 61—Continued 

10 CFR Part 61 proposed 

rule section Change Subject 

Compatibility 

Existing New 

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: Office of Management and Budget approval.D .................. D 

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 

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 

61.42(b) ............................. New .................................. Protection of individuals from inadvertent intrusion .... ...................... B 

61.42(c) ............................. New .................................. Protection of individuals from inadvertent intrusion .... ...................... C 

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PROPOSED COMPATIBILITY TABLE FOR 10 CFR PART 61—Continued 

10 CFR Part 61 proposed 

rule section Change Subject 

Compatibility 

Existing New 

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 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. 

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 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 

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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 

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 

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. 

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 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 sitespecific 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 

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16116 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

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 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, 

email: 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. 

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 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 HighLevel Radioactive Waste, and ReactorRelated Greater Than Class C Waste,’’ 

and 10 CFR part 76, ‘‘Certification of 

Gaseous Diffusion Plants.’’ 

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. 

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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 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. 

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: 

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. * * * 

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.’’ 

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 low-level 

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 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 

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(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., shortlived 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. 

* * * * * 

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-indepth 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. 

* * * * * 

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 added in 

the future. Alternative methods of 

disposal may be approved on a case-bycase basis as needed under § 61.6. 

(2) Near-surface disposal of 

radioactive waste takes place at a nearsurface 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 sitespecific factors on the performance of 

the disposal facility 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 

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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 

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 longlived 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 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 nearsurface 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 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 longlived 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 longlived 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 

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16120 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 

limiting the quantities and 

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 siteand waste-specific. Enhanced controls 

or limitations could include additional 

limits on waste concentration or total 

activity, more robust intruder barriers, 

deeper burial depth, and 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 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: 

§ 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 

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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: 

§ 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: 

(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. 

(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. 

(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 longterm 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 

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term radiological impacts, consistent 

with available data and current 

scientific understanding. The analyses 

shall 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 sitespecific 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 

nuclides 2 ........................... 3 10 

Pu–241 ................................. 3 350 

Cm–242 ................................ 3 2,000 

1Values derived from § 61.55 Class A limits. 

2 Includes alpha-emitting transuranic 

nuclides as well as other long-lived alphaemitting 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). 

The revisions and addition 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 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 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: 

§ 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). 

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(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. 

(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. 

■ 17. Revise § 61.50 to read as follows: 

§ 61.50 Disposal site suitability 

requirements for land disposal. 

(a) Disposal site suitability for nearsurface 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 highhazard 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. 

(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. 

(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, longterm 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) * * * 

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(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. 

* * * * * 

(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. 

* * * * * 

■ 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. 

(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. 

(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. 

* * * * * 

(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; 

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Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Proposed Rules 16125 

(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. 

(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. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. 2015–06429 Filed 3–25–15; 8:45 am] 

BILLING CODE 7590–01–P 

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