38372 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Proposed Rules 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 31 

RIN 3150–AI33 

[NRC–2008–0272] 

Limiting the Quantity of Byproduct 

Material in a Generally Licensed 

Device 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is proposing to 

amend its regulations to limit the 

quantity of byproduct material 

contained in a generally licensed device 

to below one-tenth (1/10) of the 

International Atomic Energy Agency 

(IAEA) Category 3 thresholds. As a 

result of this amendment, individuals 

possessing devices with byproduct 

material meeting or exceeding these 

thresholds would be required to apply 

for and obtain a specific license. The 

NRC is also proposing to further clarify 

the requirements that apply when a 

device authorized to be used under the 

general license is instead held under a 

specific license. The proposed 

amendments would also modify the 

Compatibility Categories contained in 

the current regulations. 

DATES: Submit comments on the rule by 

October 19, 2009. Submit comments 

specific to the information collection 

aspects of this rule by September 2, 

2009. Comments received after the 

above date 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 this 

date. 

ADDRESSES: You may submit comments 

on the rule by any one of the following 

methods. Please include the Docket ID 

NRC–2008–0272 in the subject line of 

your comments. Comments submitted in 

writing or in electronic form will be 

posted on the NRC Web site and on the 

Federal rulemaking Web site 

Regulations.gov. Because your 

comments will not be edited to remove 

any identifying or contact information, 

the NRC cautions you against including 

any information in your submission that 

you do not want to be publicly 

disclosed. 

The NRC requests that any party 

soliciting or aggregating comments 

received from other persons for 

submission to the NRC inform those 

persons that the NRC will not edit their 

comments to remove any identifying or 

contact information, and therefore, they 

should not include any information in 

their comments that they do not want 

publicly disclosed. 

Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for documents filed under Docket ID 

NRC–2008–0272. Address questions 

about NRC dockets to Carol Gallagher at 

301–492–3668, e-mail: 

Carol.Gallagher@nrc.gov. 

Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

E-mail comments to: 

Rulemaking.Comments@nrc.gov. If you 

do not receive a reply e-mail confirming 

that we have received your comments, 

contact us directly at 301–415–1677. 

Hand-deliver comments to: 11555 

Rockville Pike, Rockville, Maryland 

20852, between 7:30 a.m. and 4:15 p.m. 

on Federal workdays. (Telephone 301– 

415–1677) 

Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at 301– 

415–1101. You may submit comments 

on the information collections by the 

methods indicated in the Paperwork 

Reduction Act Statement. 

You can access publicly available 

documents related to this proposed rule 

using the following methods: 

NRC’s Public Document Room (PDR): 

The public may examine and have 

copied for a fee publicly available 

documents at the NRC’s PDR, Public 

File Area O–1 F21, One White Flint 

North, 11555 Rockville Pike, Rockville, 

Maryland 20852. 

NRC’s Agencywide Document Access 

and Management System (ADAMS): 

Publicly available documents created or 

received at the NRC are available 

electronically at the NRC’s Electronic 

Reading Room at: http://www.nrc.gov/ 

reading-rm/adams.html. From this page, 

the public can gain entry into ADAMS, 

which provides text and image files of 

NRC’s public documents. If you do not 

have access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS, contact the NRC’s 

PDR Reference staff at 1–800–397–4209, 

301–415–4737, or by e-mail to 

PDR.Resource@nrc.gov. 

Federal Rulemaking Web site: Public 

comments and supporting materials 

related to this proposed rule can be 

found at http://www.regulations.gov by 

searching on Docket ID NRC–2008– 

0272. 

FOR FURTHER INFORMATION CONTACT: 

Solomon Sahle, Office of Federal and 

State Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone (301) 415– 

3781, e-mail: solomon.sahle@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Discussion 

A. Rationale for Limiting the Quantity of 

Byproduct Material in a Generally 

Licensed Device 

B. Decision on Proposed Amendment To 

Place a Limit on Quantity of Byproduct 

Material in Generally Licensed Devices 

C. Specific Licensees and Generally 

Licensed Devices 

D. Specific Questions for Comment 

E. Implementation of the Proposed Rule 

Amendments 

III. Discussion of Proposed Amendments by 

Section 

IV. Criminal Penalties 

V. Agreement State Compatibility 

VI. Plain Language 

VII. Voluntary Consensus Standards 

VIII. Environmental Impact: Categorical 

Exclusion 

IX. Paperwork Reduction Act Statement 

Public Protection Notification 

X. Regulatory Analysis 

XI. Regulatory Flexibility Certification 

XII. Backfit Analysis 

I. Background 

Prior to the terrorist attacks of 

September 11, 2001 (9/11), several 

national and international efforts were 

underway to address the potentially 

significant health and safety hazards 

posed by uncontrolled sources. These 

efforts recognized the need for increased 

control of high-risk radioactive 

materials to prevent inadvertent and 

intentional unauthorized access, 

primarily due to the potential health 

and safety hazards posed by the 

uncontrolled material. Following 9/11, 

these efforts were expanded to include 

a heightened awareness and increased 

focus on the need to prevent intentional 

unauthorized access due to potential 

malicious acts. These efforts, such as the 

IAEA Code of Conduct on the Safety 

and Security of Radioactive Sources 

(Code of Conduct) concerning Category 

1 and Category 2 sources, seek to 

increase the control over sources to 

prevent unintended radiation exposure 

and to prevent malicious acts. Proper 

security and control measures reduce 

the likelihood of intentional 

unauthorized access that could result in 

this radioactive material being used in 

radiological dispersal devices (RDD) or 

in radiological exposure devices (RED). 

In June 2002, the Secretary of Energy 

and the NRC Chairman met to discuss 

the adequate protection of nuclear 

materials that could be used in a RDD. 

At the June meeting, the Secretary of 

Energy and the NRC Chairman agreed to 

convene an Interagency Working Group 

on Radiological Dispersal Devices to 

address security concerns. In May 2003, 

the joint U.S. Department of Energy 

(DOE)/NRC working group issued its 


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report ‘‘Radiological Dispersal Devices: 

An Initial Study To Identify Radioactive 

Materials of Greatest Concern and 

Approaches to Their Tracking, Tagging, 

and Disposition.’’ 

The NRC also supported U.S. 

Government efforts to establish 

international guidance for the safety and 

security of radioactive materials of 

concern, which resulted in a major 

revision of the IAEA Code of Conduct. 

The IAEA Board of Governors approved 

the revised Code of Conduct in 

September 2003; it is available on the 

IAEA Web site at: http://wwwpub.iaea.org/MTCD/publications/PDF/ 

Code-2004_web.pdf. In particular, the 

Code of Conduct contains a 

recommendation that each IAEA 

Member State develop a national source 

registry of radioactive sources that 

includes as a minimum Category 1 and 

Category 2 radioactive sources as 

described in Annex 1 of the Code of 

Conduct. Annex 1 of the Code of 

Conduct source registry 

recommendation addressed 16 

radionuclides. 

The DOE/NRC joint report paralleled 

the work on the Code of Conduct and 

the development of IAEA TECDOC– 

1344, ‘‘Categorization of Radioactive 

Sources.’’ (Section A.4.1 of this 

document contains a description of the 

IAEA source categorization system.) The 

IAEA updated this categorization 

system for radioactive sources in August 

2005, in the IAEA Safety Standards 

Series No. RS–G–1.9 ‘‘Categorization of 

Radioactive Sources.’’ The Safety Guide 

is available on the IAEA’s Web site at 

http://www-pub.iaea.org/MTCD/ 

publications/PDF/Pub1227_web.pdf and 

provides the underlying methodology 

for the development of the Code of 

Conduct thresholds. The categorization 

system is based on the potential for 

sources to cause deterministic effects 

and uses radionuclide-specific activity 

levels (D values) as normalizing factors; 

the D values are used for emergency 

planning and response. The quantities 

of concern identified in the May 2003 

DOE/NRC report are similar to the IAEA 

Code of Conduct Category 2 threshold 

values, and therefore, to allow 

alignment between domestic and 

international efforts to increase the 

safety and security of radioactive 

sources, the NRC has adopted the 

Category 2 definitions contained in the 

IAEA’s Code of Conduct. The NRC 

considers IAEA Category 2 quantities 

(and higher) to be risk-significant 

radioactive material that has a potential 

to result in significant adverse impacts 

that could reasonably constitute a threat 

to the public health and safety, the 

environment, or the common defense 

and security of the United States (U.S.). 

While the various efforts and reviews 

previously noted in this notice have 

been ongoing, the NRC also 

implemented several measures to 

increase the safety and security of 

radioactive sources, with particular 

focus on radioactive sources of concern. 

These measures included the issuance 

of increased controls orders to specific 

licensees who possess IAEA Category 1 

and Category 2 radioactive sources (70 

FR 72128; December 1, 2005). The 

orders required these licensees to 

exercise added control over these 

sources. In addition, the NRC increased 

the frequency of inspections to further 

ensure that there is adequate control of 

these materials. The NRC also published 

a final rule in November 2006 that 

established a National Source Tracking 

System (NSTS) to provide better 

accountability and control over Category 

1 and Category 2 sources. The NRC 

proposed, in a separate rulemaking (73 

FR 19749; April 11, 2008), to expand the 

NSTS to include sources equal to, or 

greater than, 1/10 of the IAEA Category 

3 threshold values to address 

accountability of these sources and 

concerns over potential malevolent 

aggregation of these lower activity 

sources to IAEA Category 2 levels. 

(Note: Sources referred to as ‘‘1/10 of 

Category 3’’ were formerly referred to as 

‘‘Category 3.5’’ sources in these 

documents. To be consistent with IAEA 

terminology, the term ‘‘Category 3.5’’ 

has been changed to ‘‘1/10 of Category 

3.’’). The NRC staff evaluated the 

comments received on this proposed 

rule and, in SECY–09–0086 dated June 

10, 2009, requested approval from the 

Commission to publish the final rule in 

the Federal Register. Staff’s 

recommendation in SECY–09–0086 was 

to expand the NSTS to Category 3 

sources instead of 1/10 of Category 3. In 

a Staff Requirements Memorandum 

(SRM) dated June 30, 2009, the 

Commission stated that it was unable to 

reach a decision on the staff’s 

recommendation and therefore did not 

approve publication of the NSTS 

Expansion final rule. 

During this time, there has been 

increased concern regarding devices 

that are currently possessed under 

NRC’s general license (GL) regulatory 

program. The requirements for general 

licensees are described in 10 CFR Part 

31, ‘‘General Domestic Licenses for 

Byproduct Material.’’ The U.S. Congress 

and the U.S. Government 

Accountability Office (GAO) raised 

concerns regarding the safety and 

security of radioactive material covered 

by the GL regulatory system and the 

Organization of Agreement States (OAS) 

filed a petition for rulemaking on June 

27, 2005 (PRM–31–5), requesting that 

the NRC strengthen its GL regulatory 

system. The NRC staff has been 

considering similar issues, including 

that under the current GL regulatory 

system, the NRC and the Agreement 

States do not have an opportunity to 

review the purpose of use, adequacy of 

applicant facilities and equipment, 

training and experience, and the ability 

to meet any other applicable 

requirements for those that possess GL 

devices. Further, a licensee’s loss of 

control of radioactive sources, whether 

it be inadvertent or through a deliberate 

act, could result in significant adverse 

health impacts, which could constitute 

a threat to the public health and safety. 

Thus, the NRC has been considering 

whether it is appropriate to amend 10 

CFR Part 31 to require specific licensing 

for some materials currently regulated 

under the GL regulatory system. 

Limiting the source activity allowed 

under a GL would result in more 

specifically licensed devices, which 

would be regulated under 10 CFR Part 

30, ‘‘Rules of General Applicability to 

Domestic Licensing of Radioactive 

Material.’’ 

II. Discussion 

In this rulemaking, the NRC is 

proposing to amend its regulations to 

limit the quantity of byproduct material 

allowed in a generally licensed device. 

The proposed amendment to the NRC’s 

regulations would limit the quantity of 

certain byproduct material allowed in a 

generally licensed device to below 1/10 

of the IAEA’s Category 3 thresholds; 

licensees with devices containing 

byproduct material at or above this limit 

would be required to obtain a specific 

license (SL). This rulemaking is directed 

toward improving the safety and 

security of devices now held under GL 

containing radioactive sources falling 

within IAEA Categories 3 through 5 by 

causing a portion of them to be 

specifically licensed allowing the 

remaining portion to continue to be 

used under general license. 

In determining whether to place a 

limit on the quantity of byproduct 

material allowed in a generally licensed 

device, the NRC has considered the 

need to balance the secure handling and 

use of the materials without 

discouraging the beneficial use of GL 

devices in academic, medical, and 

industrial applications. Radioactive 

materials provide critical capabilities in 

the oil and gas, electrical power, 

construction, and food industries; are 

used to treat millions of patients each 

year in diagnostic and therapeutic 


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procedures; and are used in technology 

research and development involving 

academic, government, and private 

institutions. These materials are as 

diverse in geographical location as they 

are in functional use. 

Placing a limit on the quantity of 

byproduct material allowed in a 

generally licensed device is part of a 

comprehensive control program for 

radioactive materials of greatest 

concern, as discussed in SECY–07– 

0147, ‘‘Response to U.S. Government 

Accountability Office Recommendations 

and Other Recommendations to Address 

Security Issues in the U.S. Nuclear 

Regulatory Commission Materials 

Program,’’ dated August 25, 2007. 

Although this proposed amendment 

cannot by itself ensure the physical 

protection of sources, converting certain 

devices from use under a GL to use 

under an SL can provide greater device 

accountability and, as part of an overall 

effort in conjunction with other related 

activities (e.g., potential applicability of 

the NSTS, Web-based licensing, prelicensing site visits, and increased 

controls orders), can improve the 

control of radioactive sources and 

protect public health and safety, as well 

as common defense and security. 

This rulemaking also considers the 

issues raised by the OAS in its June 27, 

2005, petition for rulemaking, in which 

it requested that the NRC revise 10 CFR 

31.5 and change the Compatibility 

Category of 10 CFR 31.6 from ‘‘B’’ to 

‘‘C.’’ The rulemaking also considers the 

issues raised by the State of Florida in 

its June 3, 2005, request to change the 

Compatibility Category of 10 CFR 

31.5(c)(13)(i) from ‘‘B’’ to ‘‘C.’’ These 

issues were docketed by the NRC as 

PRM–31–5. 

The following sections of this 

statement of considerations discuss the 

rationale for placing a limit on the 

quantity of byproduct material in a 

generally licensed device (Section A) 

and the NRC’s decision on the approach 

in this proposed amendment (Section 

B). 

A. Rationale for Limiting the Quantity of 

Byproduct Material in a Generally 

Licensed Device 

A.1 Congressional Concerns/GAO 

Investigations 

The U.S. Senate and the GAO have 

expressed concerns regarding the safety 

and security of radioactive sources. In a 

report by the Permanent Subcommittee 

on Investigations (PSI), July 12, 2007, 

the subcommittee expressed concerns 

about certain U.S. Government practices 

and procedures for issuing licenses to 

possess radioactive materials and 

presented recommendations that would 

remedy their concerns. The GAO 

completed two investigations of the 

security aspects of NRC’s materials 

licensing process, including one in 2007 

(GAO–07–1038T, July 12, 2007) on the 

security of the NRC licensing process. In 

its report, the GAO raised concerns 

about the relative ease with which lower 

activity sources can be purchased and 

potentially aggregated to higher activity 

levels. 

A.2 Agreement State Issues 

Agreement States have also raised 

concerns about the security and 

accountability of byproduct materials in 

generally licensed devices. In its June 

27, 2005, petition for rulemaking, the 

OAS requested that NRC ‘‘strengthen 

the regulation of radioactive materials 

by requiring a specific license for 

higher-activity devices that are currently 

available under the general license in 10 

CFR 31.5.’’ Specifically, the petition 

requested that the NRC amend its 

regulations to require specific licensing 

for devices exceeding the registration 

quantity limits in 10 CFR 31.5(c) (13)(i). 

Additionally, the OAS requested that 

NRC revise the compatibility 

designation of 10 CFR 31.6 from ‘‘B’’ to 

‘‘C’’ which would allow States to better 

track service providers and distributors 

of generally licensed devices. In 

addition, the State of Florida also 

requested a compatibility category 

change for 10 CFR 31.5(c)(13)(i) from 

‘‘B’’ to ‘‘C’’ to allow the State to 

continue to require registration of other 

generally licensed devices in addition to 

those currently registered by the NRC. 

These petitions were docketed by NRC 

as PRM–31–5. The NRC requested 

public comment on PRM–31–5 on 

December 20, 2005 (70 FR 75423). Four 

comment letters were received on the 

petition; the commenters disagreed with 

using the registration levels to require 

general licensees to become specific 

licensees but had differing views on 

changing the compatibility categories. In 

considering the petition and the public 

comments, the NRC decided to consider 

the concerns and issues raised by OAS 

and the State of Florida in this 

rulemaking. By letter dated August 17, 

2007, the petitioners were informed of 

this decision. 

A.3 Recent NRC Actions 

On April 24, 2006, the NRC staff 

submitted SECY–06–0094, ‘‘Tracking or 

Providing Enhanced Controls for 

Category 3 Sources,’’ to the Commission 

for review. In that paper, the NRC staff 

proposed initiating a rulemaking that 

would set activity limits for general 

licensees at one-half (1⁄2) of the IAEA 

Category 2 threshold and reserve 

authorization to possess higher activity 

sources to specific licensees. The staff 

noted that a benefit of setting such a 

limit would be greater oversight of these 

licensees, allowing regulatory bodies the 

opportunity to perform an assessment of 

a licensee’s legitimacy or any other 

regulatory activities the Commission 

determined to be necessary. The NRC 

staff, in SECY–06–0094, recommended 

setting the GL limit at 1⁄2 of Category 2 

because the activity levels in such 

devices would be close to the Category 

2 levels and such a limit would not 

affect a significant number of licenses. 

In response to SECY–06–0094, the 

Commission, in a Staff Requirements 

Memorandum (SRM), dated June 9, 

2006, approved the staff’s plan to amend 

the GL requirements in 10 CFR 31.5, but 

disapproved the staff’s recommendation 

to set the limit at 1⁄2 of IAEA Category 

2. Instead, the Commission approved 

moving forward to evaluate requiring 

specific licensing of general licensees 

possessing devices greater than or equal 

to 1⁄10 of the IAEA’s Category 3 

threshold. 

A.4 Considerations Regarding the 

Need for Placing a Limit on the Quantity 

of Byproduct Material Allowed in a 

Generally Licensed Device, and 

Determining What the ‘‘Limit’’ Should 

Be 

This section briefly describes the 

IAEA source characterization system 

(Section A.4.1); the existing GL 

regulatory system (Section A.4.2); and 

the specific rationale for revising the 

existing GL regulatory system to place a 

limit on the quantity of byproduct 

material in a generally licensed device 

(Section A.4.3). 

A.4.1 The Five IAEA Categories and 

the Relative Health and Safety Risk 

Posed by Sources in Those Categories 

The IAEA source categorization 

scheme includes five categories. These 

categories are based on the potential for 

sources to cause health effects to 

persons exposed to them. Sources in 

Category 1 are considered to be the most 

dangerous because they can pose a very 

high risk to human health if not 

managed safely and securely. At the 

lower end of the categorization system, 

sources in Category 5 are the least 

dangerous, but even these sources could 

give rise to doses in excess of the dose 

limits if not properly controlled. Based 

on analysis of potential health effects, 

each of the IAEA Categories contain 

radioactive material in sealed sources in 

quantities that can be characterized as 

follows: 


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Category 1: Greater than or equal to 

the Category 1 threshold (e.g., for 

Cobalt-60 (Co-60): 810 Curies (Ci)); these 

sources are typically used in irradiators, 

radiation therapy, and radiothermal 

generators; 

Category 2: Less than the Category 1 

threshold but equal to or greater than 

the Category 2 threshold (which is 1⁄100

of Category 1; e.g., for Co-60: 8.1 Ci); 

these sources are typically used in 

industrial gamma radiography and high 

and medium dose rate brachytherapy; 

Category 3: Less than the Category 2 

threshold but equal to or greater than 

the Category 3 threshold (1⁄10 of 

Category 2; e.g., for Co-60: 0.81 Ci); 

these sources are typically used in fixed 

industrial gauges involving high activity 

sources; 

Category 4: Less than the Category 3 

threshold but equal to or greater than 

the Category 4 threshold (1⁄100 of 

Category 3; e.g., for Co-60: 0.0081 Ci); 

and 

Category 5: Less than the Category 4 

threshold down to IAEA exempt 

quantities. 

A.4.2 The Existing GL Regulatory 

System in 10 CFR Part 31 and Its 

Rationale 

The primary elements of the existing 

GL regulatory framework are contained 

in 10 CFR Part 31. A generally licensed 

device usually consists of byproduct 

material contained in a sealed source 

within a shielded housing. The device 

is designed with inherent radiation 

safety features so that it can be used by 

persons with no radiation training or 

experience. Thus, the GL regulatory 

program simplifies the licensing process 

because a case-by-case determination of 

the adequacy of the radiation training or 

experience of each user is not necessary. 

As part of the GL regulatory system, the 

NRC evaluates the adequacy of generally 

licensed products by ensuring that 

manufacturers and distributors of the 

products (all of whom hold specific 

licenses) meet the various specific 

requirements in Subpart B to 10 CFR 

Part 32. Although there is no limit 

specified in the existing GL regulatory 

system regarding the quantity of 

byproduct material that can be allowed 

in a device and still continue to be 

generally licensed, at this time all of the 

generally licensed devices are in IAEA 

Categories 3 through 5 (i.e., there are no 

Category 1 or Category 2 generally 

licensed devices currently in existence). 

As part of the current GL regulatory 

system, 10 CFR 31.5 contains 

requirements that certain generally 

licensed devices containing byproduct 

material in quantities above 

‘‘registration’’ levels listed in 10 CFR 

31.5(c)(13)(i) must be registered 

annually with the NRC. There are about 

1,200 general licensees possessing such 

devices who are currently registered 

with the NRC. The radionuclides listed 

in 10 CFR 31.5(c)(13)(i) are Co-60, 

Cesium-137, Strontium-90, Radium-226, 

Americium-241, and any other 

transuranics. As an example, the 

registration level for Co-60 is 0.001 Ci; 

which falls in the IAEA Category 5 

range and is approximately 1⁄1000 of the 

IAEA Category 3 threshold for Co-60 

(and approximately 1⁄10 of the Category 

4 threshold). 

The GL registration program was 

initiated in rule amendments finalized 

on August 4, 1999 (64 FR 42269), and 

December 18, 2000 (65 FR 79162). As 

noted in the Federal Register notice 

(FRN) for the August 4, 1999, 

rulemaking, the GL registration program 

is primarily intended to ensure that 

general licensees are aware of and 

understand the requirements for the 

possession of devices containing 

byproduct materials, and that such 

devices are maintained and transferred 

properly and not inadvertently 

discarded. In initiating the GL 

registration program, the NRC noted that 

it was most concerned about generally 

licensed devices that had not been 

handled or disposed of properly and 

believed that if general licensees were 

made aware of their responsibilities, 

they would be more likely to comply 

with the requirements for proper 

handling and disposal of generally 

licensed devices. Additional 

compliance with these requirements 

would help reduce the potential for 

incidents, including those related to 

sources not disposed of properly and 

accidently melted in steel mills, which 

can cause unnecessary radiation 

exposure and property contamination. 

A.4.3. Rationale for Revising the 

Existing GL Regulatory System and 

Placing a Limit on the Quantity of 

Radioactivity Allowed in a Generally 

Licensed Device 

In preparing this proposed rule, the 

NRC has determined that there is a need 

to enhance the security and 

accountability for devices with certain 

lower activity sources. The issues the 

NRC considered in this rulemaking 

include: 

(1) Whether to modify the existing GL 

regulatory system by placing a limit on 

the quantity of byproduct material 

allowed in generally licensed devices; 

and 

(2) The appropriate value for the 

limit, i.e., should the limit be set at 1⁄10

of the IAEA Category 3 threshold (as 

suggested in the June 9, 2006 SRM) or 

should it be set lower to include devices 

that are above the current registration 

levels which are at a level 

approximately 1⁄1000 of the IAEA 

Category 3 threshold (as suggested in 

the June 27, 2005 OAS petition for 

rulemaking). 

The rationale for modifying the 

existing GL regulatory system and a 

discussion of the selection of the 1⁄10 of 

Category 3 threshold are provided in 

Sections A.4.3.1 and A.4.3.2, 

respectively, of this document. 

A.4.3.1 Rationale for Revising the GL 

Regulatory System To Require Generally 

Licensed Devices Above a Certain Limit 

To Become Specific Licenses 

As part of its overall process, the NRC 

evaluated its current GL regulatory 

system, as described in Section A.4.2 of 

this document, and found that the 

relatively few administrative or 

operational regulatory constraints 

(mainly as a result of the safety features 

incorporated into their design), imposed 

on GL devices raise a number of 

concerns about security vulnerabilities. 

Under the current GL regulatory system, 

a general licensee would not be subject 

to the same regulatory controls (i.e., prelicensing reviews, inspection, safety and 

security requirements) as specific 

licensees possessing similar quantities 

of radioactive material. Placing certain 

generally licensed devices under the SL 

process would subject them to elements 

of oversight that are not part of the GL 

process, including the license 

application and review process, and 

more routine inspections and elements 

of security requirements. The SL 

regulatory controls would improve not 

only the ability to prevent any theft or 

diversion of these materials, but would 

also help prevent or detect any 

inadvertent loss of such devices that 

could potentially impact public health 

and safety. 

Further, requiring a specific license 

for some generally licensed devices 

would provide an opportunity for a 

detailed review of the radioactive 

materials program proposed by an 

applicant, an opportunity for oral and 

written dialogue with the applicant, and 

a regulatory decision as to whether to 

grant the license as requested, or if 

certain modifications are necessary. 

Specifically, this amendment would 

allow for a more rigorous screening of 

applicants through pre-licensing visits 

to the proposed location of licensed 

activities (currently under 

consideration); a more efficient 

licensing process to facilitate the rapid 

communication between regulators 

regarding the legitimacy of a given 

entity; and other potential 


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enhancements to the specific licensing 

process. 

The NRC does not routinely perform 

inspections of general licensees. 

Inspections of general licensees are only 

performed in certain circumstances, 

such as when there are indications of 

unsafe practices by the general 

licensees. By converting certain general 

licensees to specific licensees, the 

effectiveness of any applicable safety 

and security measures could be 

accurately determined in a more timely 

manner if needed. The SL inspection 

program is implemented by the NRC 

and Agreement States in a risk-informed 

manner (e.g., inspection frequency is 

commensurate with the scope and 

complexity of the licensed activity and 

the quantity and type/form of 

radioactive material authorized by the 

license) and by use of performancebased inspections, which focus on the 

program outcomes achieved by the 

licensee and then probe (through 

interview, observation, and reviews of 

selected records) where needed and 

appropriate to understand the basis for 

each outcome. 

A.4.3.2 Specific Rationale for 

Determining the Limit on the Quantity 

of Radioactivity Allowed in a Generally 

Licensed Device 

As noted in Section A.4.3 of this 

document, the NRC considered the 

appropriate value to limit the quantity 

of byproduct material allowed in a 

generally licensed device. The 

Commission’s June 9, 2006 SRM 

directed the staff to evaluate specific 

licensing at 1⁄10 of the IAEA Category 3 

thresholds, whereas the OAS, in its June 

27, 2005 petition, requested that the 

limit be set at a lower level to include 

devices that are at or above the current 

registration levels (approximately 1⁄1000

of the IAEA Category 3 threshold). 

Considerations as to what level to set 

the limit are based on the potential for 

aggregation to higher activity quantities 

of concern and also on the additional 

resource burden placed on licensees and 

on the regulatory bodies which would 

result from such an amendment. 

A.4.3.2.1 Potential for Aggregation to 

Higher IAEA Categories of Concern for 

Devices With Sources at or Above 1⁄10 of 

the IAEA Category 3 Thresholds 

Converting certain devices with 

sources that are equal to or greater than 

1⁄10 of Category 3 to specific licenses 

would involve sources in Category 3 

itself, as well as a subset of IAEA 

Category 4 sources (i.e., sources at the 

‘‘high end’’ of the Category 4 

radioactivity range that are equal to, or 

greater than, 1⁄10 of the Category 3 

threshold). These two groups are 

discussed below. 

Category 3 sources are defined by 

IAEA as ‘‘dangerous sources’’—i.e., 

sources that could, if not under control, 

give rise to exposure sufficient to cause 

severe deterministic effects, and thus 

even without any aggregation there is 

rationale for specifically licensing 

devices with Category 3 sources. 

Further, devices with Category 3 sources 

could be easily aggregated to Category 2 

levels because they contain sources with 

activity levels that range from just below 

the Category 2 threshold down to 1⁄10 of 

the Category 2 threshold. Thus, sources 

at the high end of the range of activities 

in Category 3 can be at levels just below 

the threshold of a Category 2 source, 

meaning that it would take only a few 

of these devices with such sources to 

aggregate to Category 2. The major 

category of licensees who possess 

devices with Category 3 sources include 

those with industrial gauges and, 

because these devices are relatively 

widespread in use and relatively 

broadly used in industry, there is 

potential for aggregation of sufficient 

numbers of them to Category 2 levels. 

With regard to devices with sources 

that are 1⁄10 of IAEA Category 3, these 

are actually a subset of IAEA Category 

4 sources that are in the high end of the 

Category 4 radioactivity range. A 

principal rationale for including sources 

at the high-end of the Category 4 range 

of activities (at 1⁄10 of Category 3) is the 

potential that a sufficient number of 

devices with these higher-activity 

Category 4 sources could be obtained 

and aggregated to create the equivalent 

of Category 2 sources. These ‘‘high-end’’ 

Category 4 sources can be at levels just 

below the threshold of a Category 3 

source, which is about 1⁄10 of the 

threshold of a Category 2 source, 

meaning that it would require about 10– 

12 of these devices with such sources to 

aggregate to Category 2 quantities. 

Devices with these high-end Category 4 

(1⁄10 Category 3) sources are possessed 

by similar licensees noted to have 

Category 3 sources, namely those with 

industrial gauges, and, as previously 

noted, are in relatively widespread use 

and broadly used in industry, thus 

allowing for the potential for 

aggregation of sufficient numbers of 

them to IAEA Category 2 levels. 

For Devices With Sources That Are at 

or Above Registration Levels: 

As noted above, the OAS in its June 

27, 2005, petition requested that the GL 

limit be set at a level that would include 

devices with sources that are at or above 

the current registration levels, which are 

approximately 1⁄1000 of the IAEA 

Category 3 threshold. The Commission 

has considered this level, which would 

include devices with sources in all of 

the IAEA Category 4 radioactivity range 

(i.e., including those in the ‘‘low-end’’ of 

the Category 4 radioactivity range) and 

also all devices with sources in IAEA 

Category 5. In general, these categories 

are so low that hundreds or thousands 

of devices with such sources would 

need to be aggregated to constitute a 

radioactive source in a quantity of 

concern. In view of the lower likelihood 

that devices with sources in the lower 

range of Category 4 or in Category 5 

would be aggregated to quantities of 

concern, the staff believes that the 

relatively low security risk does not 

justify the significant regulatory 

resources and impacts on licensees that 

would result from specifically licensing 

devices with sources in the lower 

Category 4 and Category 5 ranges. 

A.4.3.2.2 Consideration of the 

Additional Resource Burden on 

Licensees and Regulatory Bodies To 

Comply With These Proposed 

Amendments 

Requiring certain general licensees to 

obtain specific licenses would result in 

increased burden on licensees, and on 

the NRC and Agreement States, for 

preparation and review of specific 

license applications and amendments 

and for conducting inspections. In the 

Regulatory Analysis for this rulemaking 

(see Section X of this document), the 

Commission provides an analysis of the 

additional costs and benefits of placing 

a limit on the quantity of radioactivity 

allowed in a generally licensed device. 

A summary of the analysis follows. 

For Devices With Sources at or Above 1⁄10 of the IAEA Category 3 Thresholds: 

Limiting the quantity of byproduct 

material allowed in generally licensed 

devices to below 1⁄10 of the IAEA’s 

Category 3 thresholds would result in 

approximately 280 NRC general 

licensees being converted to specific 

licensees (approximately 1400 NRC and 

Agreement State general licensees). 

These licensees would now have to 

follow existing NRC requirements 

including 10 CFR Parts 19, 20, and 30. 

The added number of specific licensees 

would also result in an increase in the 

regulatory resources that would be 

devoted to reviewing the new SL 

applications and inspecting the 

licensees after the license is issued. 

However, the NRC and Agreement State 

resources incurred are not considered 

significant because the number of 

additional general licensees that would 

be converted to specific licensees 

represent only about 6 percent of the 

NRC and Agreement States existing 

population of specific licensees and, 


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hence, would not result in significant 

additional NRC and/or Agreement 

States resource commitment. 

For Devices With Sources at or Above 

Registration Levels: 

Limiting the quantity of byproduct 

material allowed in generally licensed 

devices to registration levels would 

result in approximately 1,200 NRC 

general licensees being converted to 

specific licensees (approximately 6,000 

NRC and Agreement State general 

licensees), these licensees, possessing 

Category 4 and upper-end Category 5 

sources, would now have to follow 

existing NRC requirements including 10 

CFR Parts 19, 20, and 30. The added 

number of specific licensees would 

result in an increase in the regulatory 

resources that would need to be devoted 

to reviewing the new SL applications 

and inspecting the licensees after the 

license is issued. It is estimated that the 

number of additional general licensees 

that would be converted into specific 

licensees represent about 25 percent of 

the NRC and Agreement States existing 

population of specific licensees and, 

hence, would represent a relatively 

significant additional NRC and/or 

Agreement States resource commitment. 

In view of the lower likelihood that 

devices with sources in the lower range 

of Category 4 or in Category 5 would be 

aggregated to quantities of concern, the 

staff believes that the relatively low 

security risk does not justify the 

significant regulatory resources and 

impacts on licensees that would result 

from specifically licensing devices with 

sources in the lower Category 4 and 

Category 5 ranges. 

B. Decision on Proposed Amendment To 

Place a Limit on the Quantity of 

Byproduct Material Allowed in 

Generally Licensed Devices 

Based on the considerations of 

Section II.A of this document, the NRC 

has decided to propose amending its 

regulations by limiting the quantity of 

byproduct material that can be in a 

generally licensed device to 1⁄10 of the 

IAEA Category 3 threshold. The 

regulatory text is based on the existing 

text of Appendix E to 10 CFR Part 20, 

i.e., with the limit ‘‘less than 1⁄100 of the 

thresholds listed in Appendix E to 10 

CFR Part 20 for Category 2.’’ 

The basis for this limit is discussed in 

Section A of this document. In sum, the 

NRC believes that the additional 

security and safety provided by the 

specific licensing process is necessary to 

limit the potential for aggregating 

Category 3 and high-end Category 4 

radioactive sources to IAEA Category 2 

quantities of concern. The NRC believes 

that the additional burden to licensees 

and regulatory bodies that would result 

from the proposed amendments is 

reasonable because of the enhanced 

public health and safety and security 

derived from placing these higher 

activity generally licensed devices 

under a greater range of regulatory 

controls. 

The need for this proposed 

amendment to the GL regulatory system 

was not foreseen in 1999 and 2000 

when NRC issued the rule amendments 

instituting the GL registration system. 

As noted in Section A.4.2 of this 

document, and in the Statements of 

Considerations for those rule 

amendments, the principal rationale for 

the GL registration program was to make 

general licensees more aware of 

applicable requirements, hence 

reducing the potential for improper 

handling or disposal of devices due to 

lack of knowledge or inadvertent 

misuse, and the belief that if general 

licenses are aware of their 

responsibilities they will comply with 

requirements for proper handling and 

disposal of generally licensed devices. 

The current rulemaking seeks to reflect 

the changed domestic and international 

threat environments, and related U.S. 

Government-supported international 

initiatives in the nuclear security area, 

by setting an upper limit for licensing of 

generally licensed devices at 1⁄10 of 

IAEA Category 3 for certain isotopes 

listed in Appendix E to 10 CFR Part 20. 

The NRC has chosen not to extend 

this new limit on generally licensed 

devices down to the 10 CFR 

31.5(c)(13)(i) registration levels, as 

requested by the OAS in its rulemaking 

petition because it is neither necessary 

nor appropriate from a source 

aggregation and cost-benefit basis. The 

NRC believes that the relatively low 

security risk posed by lower Category 4 

and Category 5 sources does not justify 

the significant regulatory resources and 

impacts on licensees that would result 

from specifically licensing devices with 

lower Category 4 and Category 5 

sources. Instead, the NRC has left the GL 

registration program as it currently 

exists for general licensees below the 

new GL limit because the rationale for 

instituting the GL registration program 

in the 1999 and 2000 rule amendments 

continues to remain valid today. The 

NRC successfully implemented the GL 

registration program with 80 to 98 

percent of general licensees responding 

annually with completed registration 

forms. This rate of registration can be 

attributed in part to general licensees’ 

enhanced awareness of regulatory 

reporting, transfer, disposal, and 

recordkeeping requirements. 

Nevertheless, the NRC recognizes the 

desire on the part of the States 

supporting the OAS petition to exercise 

greater control over the actions of their 

licensees. Therefore, the NRC is 

proposing to revise the Compatibility 

Category of 10 CFR 31.5(a) from ‘‘B’’ to 

‘‘C’’ and the Compatibility Category of 

10 CFR 31.6 from ‘‘B’’ to ‘‘C.’’ The OAS 

stated that these actions were needed to 

establish a higher national standard of 

regulation for higher risk generally 

licensed devices, and to allow retention 

of a tool used by Agreement States to 

track the location and movement of 

device manufacturers and service 

providers within the State limits. 

Revising these compatibility categories 

would provide the Agreement States the 

flexibility to adopt additional 

requirements, based on their 

circumstances and needs. The NRC is 

also revising the Compatibility Category 

of 10 CFR 31.5(c)(13)(i) from ‘‘B’’ to ‘‘C.’’ 

Florida stated that this action was 

necessary to avoid having to relax its 

existing health, safety, and security 

controls to be compatible with less 

stringent national standards in NRC’s 

regulations. Florida also noted that the 

registering of additional generally 

licensed devices in Florida does not 

have direct and significant effect on the 

transportation of the devices or on their 

movement into and out of Florida. 

C. Specific Licensees and Generally 

Licensed Devices 

The Commission is considering an 

additional revision to 10 CFR 31.5. This 

amendment would clarify the applicable 

requirements when a device that is 

authorized to be used under the general 

license in 10 CFR 31.5 is instead held 

by a licensee under an SL. Currently, a 

specific licensee may obtain a device 

approved for use under 10 CFR 31.5 as 

a specifically licensed device rather 

than use the authority of the GL. If a 

device is initially obtained as a 

generally licensed device, it can later be 

transferred for use under the SL in 

accordance with the procedures 

outlined in 10 CFR 31.5(c)(8)(iii). Some 

licensees have found it easier to comply 

with the regulations if all of their 

radioactive material is covered by the 

same requirements. Others have used 

these devices under their SL in order to 

minimize their fees. The proposed rule 

would add a new paragraph, 10 CFR 

31.5(b)(3), to further clarify that when a 

device is held under an SL, all terms 

and conditions of the SL apply, and the 

requirements in 10 CFR 31.5 do not 

apply. 

The Commission is also considering 

and may include in the final rule an 

additional change concerning generally 


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licensed devices held by specific 

licensees. The proposal would prohibit 

specific licensees from possessing 

generally licensed devices under 10 CFR 

31.5 at the same site. Any specific 

licensee possessing a device generally 

licensed under 10 CFR 31.5 at a site for 

which an SL is in place would be 

required to transfer the device to the 

authority of their SL. As noted, the 

possession and use of the device would 

then be subject to the terms and 

conditions of the user’s SL. Any such 

device obtained by specific licensees in 

the future would be required to be 

obtained as a specifically licensed 

device. Under these requirements, all 

licensed material at a site where 

specifically licensed material is used 

would be governed by the same set of 

regulations. 

This option to require all such devices 

to be held under the SL would make the 

requirements for these devices uniform 

with the other material held under the 

SL. All licensed material at a site (where 

specifically licensed material is used) 

would be governed by the same set of 

regulations and accounted for 

uniformly. The Commission believes 

that this proposal would reduce 

confusion and improve compliance with 

the regulations because a licensee 

would have to follow only one set of 

requirements at each site. This proposal 

would also reduce the number of 

generally licensed devices that the NRC 

would need to track. 

If this approach is included in the 

final rule, it is anticipated that the 

restriction would be limited to devices 

used at sites covered by the SL. There 

may be specifically licensed entities, 

such as large corporations, that hold 

generally licensed devices at other sites 

where specifically licensed material is 

not used. Such operations may be quite 

independent of the specifically licensed 

activities. It would be too burdensome 

to apply the requirements connected 

with an SL to generally licensed devices 

at separate sites owned by the same 

licensed entity. 

D. Specific Questions for Comment 

The NRC invites comment on its 

proposal to place a limit on the quantity 

of byproduct material allowed in 

generally licensed devices, specifically: 

(1) Whether the 1⁄10 of IAEA Category 

3 limit is the appropriate threshold level 

of byproduct material below which 

general licenses would still apply; 

(2) Whether there should be 

additional protection against 

aggregation of sources by either 

requiring that if the aggregated amount 

of byproduct material that a general 

licensee possesses in devices exceeds 

1⁄10 of IAEA Category 3, then the general 

licensee must obtain an SL, or more 

simply, by using the IAEA Category 4 

threshold level as the limit for the GL; 

(3) Whether an even lower threshold 

limit for requiring licensees to obtain a 

SL should be used, such as the 

registration levels in 10 CFR 

31.5(c)(13)(i). In providing support for 

this approach, the NRC is interested in 

whether there is specific information 

(i.e., lack of accountability due to 

generally licensed devices being lost 

and/or abandoned) that would indicate 

that the GL registration program as 

instituted in the 1999 and 2000 

rulemakings (see Section II.A.4.2 of this 

document) is no longer working 

satisfactorily from the standpoint of 

protecting the public health and safety 

from routine use of these devices by 

general licensees; or 

(4) Whether the approach regarding 

Compatibility Categories laid out in 

Section II.B of this document, i.e., in 

which States have flexibility to adopt 

more rigorous requirements for general 

licensees, based on their circumstances 

and needs, can work satisfactorily. In 

particular, will there be any significant 

transboundary issues related to this 

approach or, will such an approach not 

have direct and significant effect on the 

transportation of the devices or on their 

movement in and out of States? 

Concerning the proposal discussed in 

Section C of this document which 

would prohibit specific licensees from 

using GL devices under 10 CFR 31.5 and 

would require these devices to be 

possessed and used under an SL, the 

Commission requests comments to 

assist in its evaluation of the impacts of 

such a change on specific licensees and 

on how best to implement the change. 

Specific questions for comment: 

(A) How should this change be 

applied in the case of devices used by 

a specific licensee at different locations? 

Would there be difficulties in 

determining which devices used by a 

given entity must be under the specific 

license, if the applicability of 10 CFR 

31.5 were to be determined by the 

location of use, as suggested? 

(B) How much time should be 

allowed for the specific licensees to 

transfer their currently held generally 

licensed GL devices to their SLs? 

Should devices currently held under the 

GL only be added to the SL only at the 

time of license renewal or amendment? 

(C) Should the details of the voluntary 

transfer process in 10 CFR 31.5(c)(8)(iii) 

become mandatory and be maintained 

in the regulation to assist the process? 

(D) Would there be a significant 

impact from the applicability of 

reciprocity requirements in 10 CFR 

150.20 for portable gauges currently 

licensed under 10 CFR 31.5 and 

equivalent Agreement State regulations 

that are used in more than one 

jurisdiction? How would this proposal 

affect servicers of devices currently 

operating under the reciprocity 

provision of 10 CFR 31.6 and equivalent 

provisions of Agreement States? 

(E) Would it be preferable to maintain 

the applicability of 10 CFR 31.5, but to 

apply some or all of the terms and 

conditions of the SLs, e.g., by removing 

the exemptions in 10 CFR 31.5(c)(10) for 

those holding an SL? 

(F) How much impact would there be 

to 10 CFR 32.51 licensees and 

Agreement State equivalent licensees to 

ensure that they are transferring these 

devices to entities without an SL? 

(G) Should the sealed source and 

device registration certificates 

authorizing devices for use under 10 

CFR 31.5 and equivalent Agreement 

State regulations be required to address 

transfers to both general and specific 

licensees? 

E. Implementation of the Proposed Rule 

Amendments 

The amended regulations would 

require a specific license for each 

devices or source containing byproduct 

material meeting or exceeding 1⁄10 of the 

IAEA Category 3 thresholds as listed in 

Appendix E to 10 CFR Part 20. 

Additional information regarding 

implementation of these requirements 

will be provided as part of guidance for 

complying with these amended 

regulations. Examples of information 

that may be in included in guidance are 

the types of information needed in a 

license application; how general 

licensees would be notified that they 

need to obtain an SL (e.g., by the 

regulator or by the manufacturer); how 

general licensees and/or NRC would 

identify the quantity of byproduct 

material in devices; how decay of the 

source radioactivity levels within 

generally licensed devices would be 

identified and considered; and the 

relationship of the requirements to the 

sealed sources and device (SS&D) 

registry. 

The rule would become effective 60 

days after the final rule is published in 

the Federal Register. Any general 

licensee that currently possesses 

generally licensed devices meeting or 

exceeding 1⁄10 of the IAEA’s Category 3 

thresholds would be given an additional 

90 days beyond the effective date of the 

final rule to submit an application for a 

specific license (i.e., 150 days after the 

final rule is published in the Federal 

Register). 


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III. Discussion of Proposed 

Amendments by Section 

10 CFR 31.5(a) General Domestic 

Licenses for Byproduct Material 

The proposed rule would amend 10 

CFR 31.5(a) to limit the quantity of 

byproduct material in generally licensed 

devices to below 1⁄10 of the IAEA’s 

Category 3 threshold, for the isotopes 

listed in Appendix E to 10 CFR Part 20. 

Licensees who possess devices 

containing byproduct material meeting 

or exceeding these thresholds would be 

required to become specifically 

licensed, and would become subject to 

all applicable regulations. Devices 

containing byproduct material below 

these thresholds would continue to be 

generally licensed. 

The values corresponding to Category 

3 and 1⁄10 of Category 3 (or 1/100 of 

Category 2) in Appendix E to 10 CFR 

Part 20 for byproduct material 

radionuclides are provided here as 

information along with the notes to the 

table. 

Radioactive material Category 3 

(TBq) 

Category 3 

(Ci) 

1⁄10 Category 3 

(TBq) 

1⁄10 Category 3 

(Ci) 

Actinium-227 ............................................................................................ 0 .02 0 .54 0 .002 0 .054 

Americium-241 ......................................................................................... 0 .06 1 .6 0 .006 0 .16 

Americium-241/Be ................................................................................... 0 .06 1 .6 0 .006 0 .16 

Californium-252 ........................................................................................ 0 .02 0 .54 0 .002 0 .054 

Cobalt-60 ................................................................................................. 0 .03 0 .81 0 .003 0 .081 

Curium-244 .............................................................................................. 0 .05 1 .4 0 .005 0 .14 

Cesium-137 .............................................................................................. 0 .1 2 .7 0 .01 0 .27 

Gadolinium-153 ........................................................................................ 1 27 0 .1 2 .7 

Iridium-192 ............................................................................................... 0 .08 2 .2 0 .008 0 .22 

Plutonium-238 .......................................................................................... N/A N/A N/A N/A 

Plutonium-239/Be .................................................................................... N/A N/A N/A N/A 

Polonium-210 ........................................................................................... 0 .06 1 .6 0 .006 0 .16 

Promethium-147 ...................................................................................... 40 1100 4 110 

Radium-226 ............................................................................................. 0 .04 1 .1 0 .004 0 .11 

Selenium-75 ............................................................................................. 0 .2 5 .4 0 .02 0 .54 

Strontium-90 ............................................................................................ 1 .0 27 0 .1 2 .7 

Thorium-228 ............................................................................................. N/A N/A N/A N/A 

Thorium-229 ............................................................................................. N/A N/A N/A N/A 

Thulium-170 ............................................................................................. 20 540 2 54 

Ytterbium-169 .......................................................................................... 0 .3 8 .1 0 .03 0 .81 

Note: N/A means ‘‘not applicable’’ because Plutonium-238 and Plutonium-239/Be are not byproduct material but are special nuclear material. 

Thorium-228 and Thorium-229 are source material. 

10 CFR 31.5(b)(3) 

A clarification concerning the 

applicable requirements for devices 

authorized for use under 10 CFR 31.5 

but held under specific license would 

be added. 

IV. Criminal Penalties 

For the purpose of Section 223 of the 

Atomic Energy Act (AEA) of 1954, as 

amended, the Commission is proposing 

to amend 10 CFR Part 31 under one or 

more of Sections 161b, 161i, or 161o of 

the AEA. Willful violations of the rule 

would be subject to criminal 

enforcement. 

V. 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 on 

September 3, 1997 (62 FR 46517), the 

proposed rule would be a matter of 

compatibility between the NRC and the 

Agreement States, thereby providing 

consistency among the Agreement 

States and the NRC’s requirements. The 

NRC staff analyzed the proposed rule in 

accordance with the procedure 

established in Part III, ‘‘Categorization 

Process for NRC Program Elements,’’ of 

Handbook 5.9 to Management Directive 

5.9, ‘‘Adequacy and Compatibility of 

Agreement State Programs.’’ 

As a result of the amendments to 10 

CFR 31.5(a) and new section (b)(3), 

these sections would now be designated 

as Compatibility Category C. 

Compatibility Category C are those 

program elements that do not meet the 

criteria of Category A or B, but the 

essential objectives of which 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 national basis. 

An Agreement State should adopt these 

essential objectives. After considering 

the issues associated with the 

compatibility requirements for 10 CFR 

31.5(c)(13)(i), this section would now be 

designated as Compatibility Category C. 

After considering the issues associated 

with the compatibility requirements for 

10 CFR 31.6, this section would now be 

designated as Compatibility Category C. 

For the reasons provided in Section B 

of this document, the NRC is proposing 

to designate 10 CFR 31.5(a), (b)(3), 

(c)(13)(i), and 31.6 as Compatibility 

Category C and, by so doing, Agreement 

States would have flexibility to adopt 

additional requirements, based on their 

circumstances and needs, if necessary. 

This would also allow Agreement States 

the flexibility to adopt additional 

requirements for tracking the movement 

of service providers and the location of 

generally licensed devices. Designating 

10 CFR 31.5(a) and 31.6 as 

Compatibility Category C would address 

the issues and concerns raised by the 

OAS in their June 2005, petition for 

rulemaking. Designating 10 CFR 

31.5(c)(13)(i) as Compatibility Category 

C the NRC would address the issues and 

concerns raised by the State of Florida 

in their June 2005 request as part of the 

petition. Considering these issues in this 

rulemaking action closes the entire 

petition. 

VI. Plain Language 

The Presidential Memorandum ‘‘Plain 

Language in Government Writing’’ 

published June 10, 1998 (63 FR 31883), 

directed that the Government’s 

documents be in clear and accessible 

language. The NRC requests comments 

on this proposed rule specifically with 

respect to the clarity and effectiveness 

of the language used. Comments should 

be sent to the address listed under the 

ADDRESSES heading. 

VII. Voluntary Consensus Standards 

The National Technology Transfer Act 

of 1995 (Pub. L. 104–113) requires that 

Federal agencies use technical standards 


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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 would require licensees 

that possess generally licensed devices 

with any of the radioactive sources and 

thresholds specified in the proposed 

rule to submit an application for a 

specific license. This action does not 

constitute the establishment of a 

standard that contains generally 

applicable requirements. 

VIII. Environmental Impact: 

Categorical Exclusion 

The NRC has determined that this 

proposed rule is the type of action 

described as a categorical exclusion in 

10 CFR 51.22(c)(3)(iii). Therefore, 

neither an environmental impact 

statement nor an environmental 

assessment has been prepared for this 

proposed rule. 

IX. Paperwork Reduction Act 

Statement 

This proposed rule contains new or 

amended information collection 

requirements that are subject to the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). This rule has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval of the information collection 

requirements. 

Type of submission, new or revision: 

Revision. 

The title of the information collection: 

10 CFR Part 31, Limiting the Quantity 

of Byproduct Material in a Generally 

Licensed Device. 

How often the collection is required: 

Initially during license applications and 

at license renewals and amendments 

and other reporting for specific licenses. 

Who would be required or asked to 

report: Licensees in possession of 

devices containing quantities of 

byproduct material meeting or 

exceeding 1⁄10 of the IAEA Code of 

Conduct’s Category 3 thresholds. 

An estimate of the number of annual 

responses: 2,975 (1,575 responses; 1,400 

recordkeepers). 

The estimated number of annual 

respondents: 1,400 (280 NRC; 1,120 

Agreement State). 

An estimate of the total number of 

hours needed annually to complete the 

requirement or request: 31,114. 

Abstract: The NRC is proposing to 

amend its regulations to limit the 

amount of certain byproduct material in 

a generally licensed device to below 

1⁄10 of the IAEA Category 3 thresholds. 

The proposed amendment would 

require licensees possessing devices 

meeting or exceeding these thresholds 

to submit an application for a specific 

license. The NRC and/or the Agreement 

States would review such applications 

and issue licenses as appropriate. 

The NRC 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 

would have practical utility? 

2. Is the estimate of burden 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 

information collection be minimized, 

including the use of automated 

collection techniques? 

A copy of the OMB clearance package 

may be viewed free of charge at the NRC 

Public Document Room, One White 

Flint North, 11555 Rockville Pike, Room 

O–1 F21, Rockville, Maryland 20852. 

The OMB clearance package and rule 

are available at the NRC Worldwide 

Web site: http://www.nrc.gov/publicinvolve/doc-comment/omb/index.html 

for 60 days after the signature date of 

this notice. 

Send comments on any aspect of 

these proposed information collections, 

including suggestions for reducing the 

burden and on the above issues, by 

September 2, 2009 to the Records and 

FOIA/Privacy Services Branch (T–5 

F52), U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001, or by Internet electronic mail to 

INFOCOLLECTS.RESOURCE@NRC.GOV 

and to the Desk Officer, Christine Kymn, 

Office of Information and Regulatory 

Affairs, NEOB–10202 (3150–0016), 

Office of Management and Budget, 

Washington, DC 20503. Comments on 

the proposed information collections 

may also be submitted via Federal 

Rulemaking Web site http:// 

www.regulations.gov, Docket ID NRC– 

2008–0272. Comments received after 

this date will be considered if it is 

practical to do so, but assurance of 

consideration cannot be given to 

comments received after this date. You 

may also e-mail comments to 

Christine_J_Kymn@omb.eop.gov or 

comment by telephone at (202) 395– 

4638. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

X. Regulatory Analysis 

The Commission has prepared a draft 

regulatory analysis on this proposed 

regulation. The analysis examines the 

costs and benefits of the alternatives 

considered by the Commission. 

The Commission requests public 

comment on the draft regulatory 

analysis. Comments may be submitted 

to the NRC as indicated under the 

ADDRESSES heading. The analysis is 

available for inspection in the NRC 

Public Document Room, 11555 

Rockville Pike, Rockville, MD 20852, or 

online at http://www.regulations.gov. 

Single copies of the draft regulatory 

analysis are available from Solomon 

Sahle, telephone (301) 415–3781, 

e-mail: solomon.sahle@nrc.gov, of the 

Office of Federal and State Materials 

and Environmental Management 

Programs. 

XI. 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 promulgated, have a 

significant economic impact on a 

substantial number of small entities. 

The proposed rule would affect about 

280 NRC licensees and approximately 

an additional 1,120 Agreement State 

licensees possessing generally licensed 

devices with certain byproduct 

materials meeting or exceeding the 1⁄10

of IAEA’s Category 3 thresholds. 

Affected licensees include licensees 

using fixed gauges, x-ray fluorescence 

density/moisture/level interface gauges, 

fixed thickness gauges, and any other 

licensees possessing devices with 

sources meeting or exceeding these 

thresholds, some of which may qualify 

as small business entities as defined by 

10 CFR 2.810. However, the proposed 

rule is not expected to have a significant 

economic impact on these licensees. 

Because of the widely differing 

conditions under which impacted 

licensees operate, the NRC is 

specifically requesting public comment 

from licensees concerning the impact of 

the proposed regulation. The NRC 

particularly desires comment from 

licensees who qualify as small 

businesses, specifically as to how the 

proposed regulation would affect them 

and how the regulation may be tiered or 

otherwise modified to impose less 

stringent requirements on small entities 

while still adequately protecting the 

public health and safety. Comments on 

how the regulation could be modified to 

take into account the differing needs of 


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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Proposed Rules 38381 

small entities should specifically 

discuss: 

(1) The size of the business and how 

the proposed regulation would result in 

a significant economic burden upon it 

as compared to a larger organization in 

the same business community; 

(2) How the proposed regulation 

could be further modified to take into 

account the business’s differing needs or 

capabilities; 

(3) The benefits that would accrue, or 

the detriments that would be avoided, if 

the proposed regulation was modified as 

suggested by the commenter; 

(4) How the proposed regulation, as 

modified, would more closely equalize 

the impact of NRC regulations as 

opposed to providing special advantages 

to any individuals or groups; and 

(5) How the proposed regulation, as 

modified, would still adequately protect 

the public health and safety. 

Comments should be submitted as 

indicated under the ADDRESSES heading. 

XII. Backfit Analysis 

The NRC has determined that the 

backfit rule does not apply to this 

proposed rule because the amendments 

in this rule modify conditions of a 

general license for byproduct material, 

and do not involve any provisions that 

would impose backfits as defined in 10 

CFR 50.109, 70.76, 72.62, and 76.76. 

Therefore, a backfit analysis has not 

been prepared for this proposed rule. 

List of Subjects in 10 CFR Part 31 

Byproduct material, Criminal 

penalties, Labeling, Nuclear materials, 

Packaging and containers, Radiation 

protection, Reporting and recordkeeping 

requirements, Scientific equipment. 

For the reasons set out in the notice 

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. 553; the NRC is 

proposing to adopt the following 

amendments to 10 CFR Part 31. 

PART 31—GENERAL DOMESTIC 

LICENSES FOR BYPRODUCT 

MATERIAL 

1. The authority citation for part 31 

continues to read as follows: 

Authority: Secs. 81, 161, 183, 68 Stat. 935, 

948, 954, as amended (42 U.S.C. 2111, 2201, 

2233); secs. 201, as amended, 202, 88 Stat. 

1242, as amended, 1244 (42 U.S.C. 5841, 

5842); sec. 1704, 112 Stat. 2750 (44 U.S.C. 

3504 note); sec. 651(e), Public Law 109–58, 

119 Stat. 806–810 (42 U.S.C. 2014, 2021, 

2021b, 2111). 

2. In § 31.5, paragraph (a) is revised 

and paragraph (b)(3) is added to read as 

follows: 

§ 31.5 Certain detecting, measuring, 

gauging, or controlling devices and certain 

devices for producing light or an ionized 

atmosphere. 

(a) A general license is hereby issued 

to commercial and industrial firms and 

research, educational and medical 

institutions, individuals in the conduct 

of their business, and Federal, State or 

local government agencies to acquire, 

receive, possess, use or transfer, in 

accordance with the provisions of 

paragraphs (b), (c) and (d) of this 

section, byproduct material contained in 

devices designed and manufactured for 

the purpose of detecting, measuring, 

gauging or controlling thickness, 

density, level, interface location, 

radiation, leakage, or qualitative or 

quantitative chemical composition, or 

for producing light or an ionized 

atmosphere, provided that each device 

contains byproduct material in 

quantities less than 1/100th of the 

thresholds listed in Appendix E of 10 

CFR Part 20 for Category 2. 

(b) * * * 

(3) For devices meeting the criteria of 

this general license, but instead held 

under the authority of a specific license, 

all of the terms and conditions of the 

specific license apply in lieu of the 

provisions in this general license. 

* * * * * 

Dated at Rockville, Maryland, this 28th day 

of July 2009. 

For the Nuclear Regulatory Commission. 

Andrew L. Bates, 

Acting Secretary for the Commission. 

[FR Doc. E9–18438 Filed 7–31–09; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2009–0663; Directorate 

Identifier 2007–SW–25–AD] 

RIN 2120–AA64 

Airworthiness Directives; Eurocopter 

France Model AS 332 C, L, L1, and L2; 

AS 350 B3; AS 355 F, F1, F2, and N; 

SA 365 N and N1; AS 365 N2 and N3; 

SA 366 G1; EC 130 B4; and EC 155B 

and B1 Helicopters 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for the 

specified model helicopters. This 

proposed AD results from mandatory 

continuing airworthiness information 

(MCAI) originated by the European 

Aviation Safety Agency (EASA), which 

is the Technical Agent for the Member 

States of the European Community. The 

MCAI states that the AD is issued 

following a manufacturing 

nonconformity found on one batch of 

the servo-control caps. With a defective 

servo-control, rotation of the distributor 

might not be stopped mechanically 

since only friction of inner seals holds 

the distributor sleeve in its position. 

The proposed AD actions are intended 

to address the unsafe condition created 

by a manufacturing nonconformity 

found on one batch of servo-control 

caps. If not corrected this condition 

could cause untimely movements of 

servo-controls, which are used on main 

and anti-torque rotors, and lead to the 

loss of control of the helicopter. 

DATES: We must receive comments on 

this proposed AD by September 2, 2009. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

You may get the service information 

identified in this proposed AD from 

American Eurocopter Corporation, 2701 

Forum Drive, Grand Prairie, TX 75053– 

4005, telephone (972) 641–3460, fax 

(972) 641–3527, or at http:// 

www.eurocopter.com. 

Examining the Docket: You may 

examine the AD docket on the Internet 

at http://www.regulations.gov or in 

person at the Docket Operations office 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The AD docket contains this proposed 

AD, the economic evaluation, any 

comments received, and other 

information. The street address for the 

Docket Operations office (telephone 

(800) 647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Uday Garadi, Aviation Safety Engineer, 

Regulations and Policy Group, FAA, 

Rotorcraft Directorate, Fort Worth, 


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