55864 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Parts 20, 30, 31, 32, 33, 35, 50, 

61, 62, 72, 110, 150, 170, and 171 

RIN 3150–AH84 

Requirements for Expanded Definition 

of Byproduct Material 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Final rule. 

SUMMARY: The Nuclear Regulatory 

Commission (NRC) is amending its 

regulations to include jurisdiction over 

discrete sources of radium-226, 

accelerator-produced radioactive 

materials, and discrete sources of 

naturally occurring radioactive material, 

as required by the Energy Policy Act of 

2005 (EPAct), which was signed into 

law on August 8, 2005. The EPAct 

expanded the Atomic Energy Act of 

1954 definition of Byproduct material to 

include any discrete source of radium226, any material made radioactive by 

use of a particle accelerator, and any 

discrete source of naturally occurring 

radioactive material, other than source 

material, that the Commission, in 

consultation with other Federal officials 

named in the EPAct, determines would 

pose a similar threat to the public health 

and safety or the common defense and 

security as a discrete source of radium226, that are extracted or converted after 

extraction for use for a commercial, 

medical, or research activity. In so 

doing, these materials were placed 

under the NRC’s regulatory authority. 

The EPAct also mandated that the 

Commission, after consultation with the 

States and other stakeholders, issue 

final regulations establishing 

requirements that the Commission 

determines necessary under the EPAct. 

This rulemaking effort has been 

undertaken in response to that mandate 

and includes significant contributions 

from many States that have regulated 

the naturally occurring and acceleratorproduced radioactive material, the 

Organization of Agreement States, Inc., 

the Conference of Radiation Control 

Program Directors, Inc. (CRCPD), and 

other stakeholders. In addition, this 

final rule was informed and guided by 

the CRCPD’s applicable Suggested State 

Regulations for the Control of Radiation. 

Licensees, individuals, and other 

entities who are engaged in activities 

involving the newly defined byproduct 

material in both Agreement States and 

non-Agreement States and United States 

Territories will be affected by this 

rulemaking. 

DATES: Effective Date: This final rule is 

effective on November 30, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Lydia Chang, Office of Federal and State 

Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone (301) 415– 

6319, e-mail lwc1@nrc.gov; or Catherine 

R. Mattsen, Office of Federal and State 

Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone (301) 415– 

6264, e-mail crm@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Discussion 

A. The New, Expanded Definition of 

Byproduct Material 

B. The NRC’s Regulatory Approach 

C. Changes to Existing NRC Regulations to 

Accommodate the New Byproduct 

Material 

D. License Application and Annual Fees 

E. Implementation Strategy 

III. Summary and Analysis of Public 

Comments on the Proposed Rule 

IV. Section-by-Section Analysis of Final 

Revisions 

V. Criminal Penalties 

VI. Agreement State Compatibility 

VII. Voluntary Consensus Standards 

VIII. Environmental Assessment and Finding 

of No Significant Environmental Impact: 

Availability 

IX. Paperwork Reduction Act Statement 

X. Regulatory Analysis 

XI. Regulatory Flexibility Certification 

XII. Backfit Analysis 

XIII. Congressional Review Act 

I. Background 

The Energy Policy Act of 2005 

On August 8, 2005, the President 

signed into law the EPAct. Among other 

provisions, Section 651(e) of the EPAct 

expanded the definition of Byproduct 

material as defined in Section 11e. of 

the Atomic Energy Act of 1954 (AEA), 

placing additional byproduct material 

under the NRC’s jurisdiction, and 

required the Commission to provide a 

regulatory framework for licensing and 

regulating this additional byproduct 

material. 

Specifically, Section 651(e) of the 

EPAct expanded the definition of 

Byproduct material by: (1) Adding any 

discrete source of radium-226 that is 

produced, extracted, or converted after 

extraction, before, on, or after the date 

of enactment of the EPAct for use for a 

commercial, medical, or research 

activity; or any material that has been 

made radioactive by use of a particle 

accelerator and is produced, extracted, 

or converted after extraction, before, on, 

or after the date of enactment of the 

EPAct for use for a commercial, 

medical, or research activity (Section 

11e.(3) of the AEA); and (2) adding any 

discrete source of naturally occurring 

radioactive material, other than source 

material, that the Commission, in 

consultation with the Administrator of 

the Environmental Protection Agency 

(EPA), the Secretary of the Department 

of Energy (DOE), the Secretary of the 

Department of Homeland Security 

(DHS), and the head of any other 

appropriate Federal agency, determines 

would pose a threat similar to the threat 

posed by a discrete source of radium226 to the public health and safety or 

the common defense and security; and 

is extracted or converted after extraction 

before, on, or after the date of enactment 

of the EPAct for use in a commercial, 

medical, or research activity (Section 

11e.(4) of the AEA). 

Although Section 651(e) of the EPAct 

became effective on August 8, 2005, the 

NRC did not have regulations in place 

that would specifically apply to this 

newly covered byproduct material 

(hereafter referred to as NARM). The 

EPAct also allowed the NRC to issue 

waivers to States and other entities 

while developing final regulations for 

NARM. A waiver was issued on August 

31, 2005 (70 FR 51581). 

Previous Regulatory Structures for 

NARM 

The AEA authorizes the States to 

assume regulatory control of certain 

radioactive materials provided the State 

has an adequate program to protect the 

public health and safety and is 

compatible with the NRC’s program for 

regulation of these materials and enters 

into an agreement with the NRC. As 

authorized by Section 274b of the AEA, 

34 States have assumed responsibility 

for regulating certain activities related to 

radioactive material by entering into 

agreements with the NRC. The activities 

regulated by these ‘‘Agreement States’’ 

include the use of byproduct material, 

source material, and special nuclear 

material. Each Agreement State issues 

licenses to persons who use these 

materials in that State except for DOE, 

other Government agencies, and 

Federally recognized Indian Tribes. The 

NRC issues licenses to persons using 

these materials in non-Agreement 

States. 

Before enactment of the EPAct, the 

NRC did not have authority over NARM 

or regulations for this type of material. 

Although the NRC has not regulated 

NARM in the past, all 34 Agreement 

States and certain non-Agreement States 

have regulatory programs for NARM. 

The NRC’s regulations did require 

licensees to account for dose 

contributed from NARM, as well as dose 


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contributed from other byproduct, 

source, or special nuclear material, 

because the definition of Occupational 

dose encompasses both licensed 

material and nonlicensed material such 

as NARM sources at a licensed facility. 

In addition, the NRC requires in its 

radiological criteria for license 

termination that licensees consider 

other nondiscrete sources, including 

radium, during decommissioning 

activities at sites contaminated with 

source material, such as rare-earth 

processing facilities. 

Currently, there are 16 nonAgreement States plus United States 

(U.S.) Territories. Although most nonAgreement States and U.S. Territories 

have some type of programs for NARM, 

the regulatory structures vary greatly. 

Certain non-Agreement States have 

established a licensing structure for 

regulating their NARM users. As such, 

the regulatory structure could parallel 

the NRC regulations issued in Title 10 

of the Code of Federal Regulations (10 

CFR) applicable to the current materials 

program, or it could parallel the 

Suggested State Regulations for the 

Control of Radiation (SSRs) developed 

by the CRCPD. Other non-Agreement 

States or U.S. Territories have elected to 

use registration as their regulatory 

structure for managing the NARM users. 

Some States register facilities; others 

register both facilities and devices. 

Some States use registration information 

to conduct inspections; others use 

registration to identify facility locations 

for security purposes. In general, there 

is limited regulatory oversight where 

registration is used in non-Agreement 

States. It was, in part, due to this lack 

of national consistency, that the EPAct 

placed these materials under the NRC’s 

jurisdiction. 

Agreement States have regulated 

NARM use for many decades in a fairly 

uniform and consistent manner. The 

Agreement States have accomplished 

this by using the same standards to 

regulate NARM as those used to regulate 

other byproduct, source, and special 

nuclear material under the NRC’s 

authority. In many respects, regulations 

applicable to NARM adopted by the 

Agreement States are compatible with 

the NRC’s regulations for the current 

materials program, or parallel the 

CRCPD’s SSRs. 

Although Agreement States do have 

some provisions specifically for NARM, 

in general, the regulatory structure used 

by Agreement States does not 

distinguish between NARM and other 

radioactive material. NARM users in the 

Agreement States are expected to 

implement all aspects of standards for 

their radiation protection programs with 

respect to NARM, including those 

aspects relating to receipt, possession, 

use, storage, transfer, transportation, 

and disposal of NARM. This regulatory 

structure also subjects NARM users in 

the Agreement States to the same 

licensing, inspection, and enforcement 

policies as those using other byproduct, 

source, or special nuclear materials. In 

addition, this regulatory structure 

allows for both specific and general 

licensing of various NARM products, 

the distribution of certain NARM items 

to persons exempt from regulation and, 

in most cases, includes provisions to 

review and approve proposals for sealed 

sources and devices containing NARM. 

The Agreement States have regulated 

a vast array of NARM produced for 

medical, industrial, research and 

development, commercial, and 

consumer purposes. In many Agreement 

States, this regulatory structure also 

captures some types of nondiscrete 

sources found in the oil and gas 

industry or mining industry; moreover, 

it captures inadvertently produced 

activation products from the use of 

proton beams for medical radiation 

therapy. However, the regulation of 

these nondiscrete sources and activation 

products varies from Agreement State to 

Agreement State. 

Other Federal Agencies’ Regulatory 

Authority Over NARM 

Although the States had the primary 

responsibility for regulating the use of 

NARM before the passage of the EPAct, 

certain Federal regulations continue to 

apply under some circumstances, such 

as environmental protection, workplace 

safety, drug safety, transportation, and 

disposal. With the passage of the EPAct, 

the NRC will have primary 

responsibility for radiation safety and in 

regulating the use of these materials in 

cooperation with the States, with the 

exception of those activities that are 

self-regulated by the DOE. 

Other Federal agencies have 

regulations or have established 

programs for self-regulating certain 

activities involving NARM. The 

Department of Transportation (DOT) 

regulates interstate transport of NARM. 

In cooperation with DOT, the NRC 

approves Type B packages through 

regulations in 10 CFR Part 71. The EPA 

has established controls for certain 

NARM through several authorities, 

including the Clean Air Act, the Safe 

Drinking Water Act, the Toxic 

Substances Control Act, the Resource 

Conservation and Recovery Act, and the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act. The Occupational Safety and 

Health Administration (OSHA) of the 

Department of Labor has the oversight 

for occupational health and safety for 

radiation protection. It has regulations 

governing radiation protection in the 

workplace, including provisions 

addressing the exposure of minors to 

radioactive material in the workplace, 

but defers to the NRC on AEA materials. 

The Department of Commerce (DOC) 

has controlled the export of radioactive 

material. Before the enactment of the 

EPAct, the DOC regulated the export of 

all radium-226. With the enactment of 

the EPAct, the NRC will regulate the 

export of discrete sources of radium226; DOC retains jurisdiction to regulate 

the export of nondiscrete sources of 

radium-226. The Consumer Product 

Safety Commission regulations have 

addressed hazardous substances other 

than byproduct, source, and special 

nuclear materials currently regulated by 

the NRC. The Food and Drug 

Administration (FDA) regulates all 

drugs (including drugs containing 

radioactive materials) by requiring good 

manufacturing practices to assure the 

purity, potency, and consistency of 

finished drugs with their labeling in 

establishing the safety and effectiveness 

of these drugs. 

Section 651(e)(3) of the EPAct 

provides that byproduct material, as 

defined by Section 11e.(3) or 11e.(4) of 

the AEA, may only be transferred to and 

disposed of in a disposal facility that is 

adequate to protect public health and 

safety, and is licensed by either the NRC 

or a State that has entered into an 

agreement with the Commission under 

Section 274b of the AEA or at a disposal 

facility in accordance with any Federal 

or State solid or hazardous waste law, 

including the Solid Waste Disposal Act, 

also known as the Resource 

Conservation and Recovery Act (RCRA). 

Development of the Suggested State 

Regulations (SSRs) 

Since enactment of the AEA in 1954, 

scientists continue to develop new 

technologies in producing 

radionuclides, such as the use of 

particle accelerators. At the beginning of 

the 20th century, naturally occurring 

radioactive material, including radium226, was routinely used in consumer 

products and in cancer treatment. 

Because there was no Federal mandate 

to regulate these materials, most States 

have since established regulatory 

structures for both accelerator-produced 

radioactive material and naturally 

occurring radioactive material, 

including radium-226. 

In 1968, CRCPD was chartered as a 

nonprofit organization to provide a 

forum for enhancing communication 

among States and Federal agencies 


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regarding radiation regulations and to 

promote a uniform radiation protection 

environment for all radioactive material. 

Throughout the years, CRCPD 

developed policies and guidance for its 

member States. In addition, CRCPD is 

responsible for the development of 

model regulations, known as the SSRs. 

Under the SSRs’ regulatory framework, 

NARM has been a regulated radioactive 

material comparable to byproduct 

material. Nearly all of the Agreement 

States have based their regulations on 

this model for NARM. 

For NARM regulation only, CRCPD 

also established ‘‘Licensing States’’

similar to the Agreement State Program 

under Section 274 of the AEA. 

Licensing States recognized by CRCPD 

under criteria found in Publication 94–

8, ‘‘CRCPD Recognition of Licensing 

States for the Regulation and Control of 

NARM,’’ are those States that have 

demonstrated an adequate and 

consistent regulatory control program 

for NARM. Licensing State designation 

assures comparable regulatory 

structures with respect to NARM, and 

other States may grant reciprocal 

recognition of their licenses or 

acceptance of their licensees’

manufactured products. 

Issuance of Waiver on August 31, 2005 

Section 651(e) of the EPAct became 

effective immediately upon signature by 

the President on August 8, 2005. Before 

enactment of the EPAct, the NRC did 

not have authority over NARM or 

regulations in place that would 

specifically apply to this material. 

Nonetheless, persons engaged in 

activities involving NARM could be, 

and States seeking to continue 

regulation of NARM would be, in 

technical violation of the AEA. 

Section 651(e)(5) of the EPAct 

authorized the Commission to issue a 

waiver of the requirements of Section 

651(e) to any entity with respect to 

NARM for specified periods of time if 

the Commission determined that the 

waiver was in accordance with the 

protection of the public health and 

safety and the promotion of the common 

defense and security. The Commission 

determined that there was no basis to 

conclude that these materials would not 

continue to be used in a manner that is 

protective of public health and safety 

while the waiver is in effect. The 

Commission also determined that it 

would be in the best interest of the 

public to allow continued use of NARM, 

especially for medical purposes, and to 

allow the States to continue to regulate 

NARM until the Commission could 

codify new regulations for these 

materials. 

The Commission believed that 

granting the waiver would allow the 

States to continue with their regulatory 

programs, allow persons engaged in 

activities involving NARM to continue 

their operations in a safe manner, and 

allow continued access to medical 

radiopharmaceuticals. In addition, it 

would enable the Commission to work 

with the States in developing 

appropriate regulations for NARM and 

in formulating a sound Transition Plan 

for implementation of these regulations. 

It would also provide an opportunity for 

non-Agreement States that currently do 

not have Agreement State regulatory 

programs under Section 274b. of the 

AEA to consider entering into an 

agreement with the NRC. The 

Commission determined that issuance 

of the waiver would be in accordance 

with the protection of public health and 

safety and the promotion of the common 

defense and security. 

The Commission granted a waiver (70 

FR 51581; August 31, 2005) from the 

requirements of Section 651(e) of the 

EPAct to: (1) All persons engaged in 

export from or import into the U.S. of 

byproduct material through August 7, 

2006, unless terminated sooner if the 

Commission determined that an earlier 

termination was warranted; and except 

with regard to the requirements of the 

DOC relating to export of byproduct 

material; (2) all persons acquiring, 

delivering, receiving, possessing, 

owning, using, or transferring byproduct 

material through August 7, 2009, unless 

terminated sooner if the Commission 

determined that an earlier termination 

was warranted; and (3) all States that 

had entered into an agreement with the 

Commission under Section 274b. of the 

AEA, and States that had not entered 

into such an Agreement, through August 

7, 2009, unless terminated sooner if the 

Commission determined an earlier 

termination was warranted, or for an 

Agreement State if the Commission 

made certain determinations required 

by Section 651(e)(5)(B)(ii) of the EPAct. 

Stakeholder Involvement in the 

Rulemaking Process 

The NRC took several initiatives in an 

effort to enhance stakeholder 

involvement and to improve efficiency 

during the rulemaking process. With 

assistance from the Organization of 

Agreement States (OAS) and CRCPD, 

the NRC was able to obtain participation 

of several State representatives in 

various working groups in the 

development of the proposed rule. 

Principals from OAS and CRCPD, 

representing interests for both 

Agreement States and non-Agreement 

States, also participated in the steering 

committee forming a partnership with 

the NRC in making rulemaking 

decisions. In an effort to keep 

stakeholders informed, the NRC held a 

public roundtable meeting in early 

November. In addition, the NRC has met 

with other Federal agencies to ensure 

coordination regarding this rulemaking. 

The NRC held a public meeting on 

November 9, 2005, to discuss 

rulemaking activities to incorporate 

NARM into its regulatory framework. 

The public meeting was in a 

‘‘roundtable’’ format to allow 

stakeholders an opportunity to discuss 

concerns and to enhance interaction 

among all interested parties on the 

subject of the NRC regulating NARM. 

Representatives from other Federal 

agencies, States, and a broad spectrum 

of interest groups were invited to 

participate in the ‘‘roundtable’’

discussion. A transcript of this meeting 

is available via the NRC’s and other 

related documents are available from 

(see FOR FURTHER INFORMATION CONTACT

section of this document.) 

Following the public meeting, the 

NRC received five written comments 

from interested parties related to the 

discussion at the meeting and the 

rulemaking activities. These comment 

letters were reviewed and considered by 

the NRC staff in the development of the 

proposed rule. 

In addition to the public meeting, the 

NRC interacted and met with FDA staff 

to exchange information regarding the 

NRC’s NARM rulemaking efforts and the 

FDA’s regulations for acceleratorproduced drugs. The primary objective 

of the FDA’s regulations is to ensure 

medical safety, purity, potency, and 

effectiveness of the drugs, and that of 

the NRC’s regulations is to ensure 

radiation safety. During the meeting, 

areas of potential dual regulation were 

discussed. Because the NRC and the 

FDA have different missions, the 

associated regulations are more 

complementary than duplicative. FDA 

has published a proposed rule (70 FR 

55038; September 20, 2005), ‘‘Current 

Good Manufacturing Practice for 

Positron Emission Tomography Drugs,’’

and expects to finalize the rule soon. 

The FDA’s final rule will establish 

criteria for the production and process/ 

quality controls for the Positron 

Emission Tomography (PET) drugs in 

PET centers registered with the FDA. 

The NRC hosted a meeting of Federal 

agency representatives on November 22, 

2005, to discuss the development of a 

definition of Discrete source to be added 

to the NRC’s regulations. Agencies 

represented at this meeting were DOT, 

DOE, including the National Nuclear 

Security Administration, Department of 


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Defense, DOC, EPA, and the U.S. 

Customs and Border Protection. A draft 

definition was formulated. This 

definition formed the basis for the 

definition in the proposed rule, with 

only minor changes and text 

rearrangement for clarity. 

The NRC published the proposed rule 

to establish the regulatory framework for 

the newly defined byproduct material 

on July 28, 2006 (71 FR 42952). Thirtynine comment letters were received. 

The commenters included a number of 

States, Federal agencies, professional 

organizations, universities, medical 

communities, industries, and 

individuals. 

II. Discussion 

A. The New, Expanded Definition of 

Byproduct Material 

Section 651(e) of the EPAct expanded 

the definition of Byproduct material to 

include: (1) Any discrete source of 

radium-226 that is produced, extracted, 

or converted after extraction, before, on, 

or after the date of enactment of the 

EPAct for use for a commercial, 

medical, or research activity; (2) any 

material that has been made radioactive 

by use of a particle accelerator and is 

produced, extracted, or converted after 

extraction, before, on, or after the date 

of enactment of the EPAct for use for a 

commercial, medical, or research 

activity; and (3) any discrete source of 

naturally occurring radioactive material, 

other than source material, that the 

Commission, in consultation with the 

Administrator of the EPA, the Secretary 

of DOE, the Secretary of DHS, and the 

head of any other appropriate Federal 

agency, determines would pose a threat 

similar to the threat posed by a discrete 

source of radium-226 to the public 

health and safety or the common 

defense and security, and that is 

extracted or converted after extraction, 

before, on, or after the date of enactment 

of the EPAct for use in a commercial, 

medical, or research activity. The NRC 

is revising the definition of Byproduct 

material in 10 CFR Parts 20, 30, 50, 72, 

150, 170, and 171 to be consistent with 

the EPAct. The same revision to the 

definition of Byproduct material was 

made in a separate rulemaking for 10 

CFR Part 110 (April 20, 2006; 71 FR 

20336). A different definition for the 

term Byproduct material is used in 10 

CFR Part 40, because 10 CFR Part 40 

regulations are limited to source 

material and the tailings or wastes 

associated with the extraction or 

concentration of source material. 

Therefore, 10 CFR Part 40 regulations 

are not impacted by the EPAct, and the 

definition of Byproduct material in that 

Part remains unchanged by this rule. 

Since the publication of the proposed 

rule, and after considering the 

comments on the new definition of 

byproduct material, the Commission has 

taken a closer look at the scope of the 

Commission’s jurisdiction over the 

newly added byproduct material. The 

EPAct covers discrete sources of 

radium-226 and accelerator-produced 

radioactive material that is ‘‘produced, 

extracted, or converted after extraction, 

before, on, or after August 8, 2005, for 

use for commercial, medical, or research 

activity’’ (emphasis added). 

Notwithstanding that a discrete source 

of radium-226 may have originated from 

a commercial supplier, the Commission 

has determined that discrete sources of 

radium-226 still in control of the 

military do not constitute ‘‘commercial 

use’’ under the EPAct, and are therefore, 

outside the Commission’s jurisdiction. 

Defining ‘‘commercial use’’ to include 

all material supplied to the military 

from a commercial supplier would 

result in virtually all military use of this 

material to be ‘‘commercial use.’’ This 

would vitiate any distinction that the 

EPAct intended to make for military 

use, as opposed to commercial use, by 

excluding military use from its 

coverage. 

However, this exclusion from the 

coverage of the EPAct only applies to a 

certain type of military use, i.e., NARM 

used for ‘‘military operations.’’ The term 

‘‘military operations’’ covers what is 

traditionally understood as the 

military’s primary mission for national 

defense, including warfare, combat, and 

battlefield missions, and, of course, 

training for battlefield missions. NARM 

used, or available for use, for these 

purposes would be excluded from the 

coverage of the EPAct and from the 

coverage of this rule. If the material is 

intended for use in military operations, 

it is excluded from the coverage of this 

rule notwithstanding the fact that it was 

originally produced by a commercial 

supplier. In addition, ‘‘military 

operational’’ material includes material 

still under the control of the military, 

i.e., in storage, or material that may be 

subject to decontamination and 

disposal. 

Other use of NARM by the military 

would be covered by this rule. Under 

the Commission’s interpretation of the 

EPAct, NARM, whether discrete sources 

or accelerator material, that is produced, 

extracted, or converted for use or has 

been used, in medical or research 

activities, or in a manner similar to a 

commercial activity, e.g., military 

museums, is covered by the EPAct and 

this rule. Furthermore, NARM that was 

used for military operations but is no 

longer under the control of the military, 

has been sold, or is in the possession of 

private individuals, is also within the 

coverage of this rule. 

The NRC intends to interact with the 

Department of Defense to obtain a 

common understanding of the uses of 

radium-226 and accelerator-produced 

radioactive material by the military to 

resolve any potential issues regarding 

the application of the Commission’s 

interpretation of the EPAct in regard to 

any specific case of military use. 

Radium-226 

Radium is a chemically reactive, 

silvery white, radioactive, metallic 

element with an atomic number of 88 

and symbol of Ra. Radium-226, the most 

abundant and most stable isotope of 

radium, is formed by the radioactive 

disintegration of thorium-230 in the 

decay series starting with uranium-238. 

Radium-226 can be found in all 

uranium ores. The half-life of radium226 is 1599 years. Radium-226 emits 

alpha particles and gamma radiation 

and decays to radon gas. 

Although radium was discovered in 

the ore pitchblende by the chemists 

Marie and Pierre Curie in 1898, no one 

understood the dangers of radium until 

later in the twentieth century. Based on 

radium’s properties, especially its 

ability to stimulate luminescence, 

industries started manufacturing 

hundreds of consumer products 

containing radium. Radium was added 

to products such as hair tonic, 

toothpaste, ointments, and elixirs. 

Radium paint was used in the mid1900s to paint the hands and numbers 

of some clocks, watches, doorknobs, and 

other objects to make them glow in the 

dark. Glow-in-the-dark watch and clock 

faces were particularly popular. Most of 

these uses were eventually discontinued 

for health and safety reasons, but its 

wide use in luminescent paints 

continued through World War II 

because radium’s luminescent glow 

made aircraft and vehicle dials, gauges, 

and other instruments visible at night. 

Many of these early products still 

remain in the possession of museums 

and individual collectors. Large 

inventories of radium-226 luminescent 

military and aircraft devices remain and 

periodically turn up in repair shops, 

and have resulted in contamination 

incidents. 

In more recent times, radium sources 

were used in industrial radiography and 

industrial smoke detectors. Currently, 

radium sources are still being used in 

some industrial products, such as 

industrial gauges, that measure certain 


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physical properties such as moisture 

and density. 

Accelerator-Produced Radioactive 

Material 

Particle Accelerators 

A particle accelerator is a device that 

imparts kinetic energy to subatomic 

particles by increasing their speed 

through electromagnetic interactions. 

Particle accelerators are used to produce 

radioactive material by directing a beam 

of high speed particles at a target 

composed of a specifically selected 

element, which is usually not 

radioactive. Nuclei in the target are 

struck by the high speed particles and 

undergo a nuclear transformation. A 

nuclide that is struck is transformed 

into a different nuclide. By careful 

selection of the target element, the 

particles accelerated, and the operating 

parameters of the accelerator (e.g., beam 

energy), a resultant proton-heavy 

nuclide can be produced. Usually the 

nuclide produced is radioactive and is 

created for the use of its radiological 

properties. The process of transforming 

nuclei from a stable element into a 

radionuclide is called activation. In 

some cases, the target is selected so that 

the accelerator produces a neutron beam 

that is, in turn, used to activate nuclides 

that are then used for their radioactive 

properties. Some particle accelerators 

are not used to produce radioactive 

material, but instead the high energy 

beam produced by the particle 

accelerator is used directly, for example, 

to treat cancer patients. 

The two basic designs of particle 

accelerators are linear and circular, also 

known as cyclotron. In either case, 

charged particles are injected into the 

accelerator to form a beam. The beam is 

accelerated and focused onto the target. 

In the circular designs, the beam must 

be directed to travel in a circular shaped 

path. For all accelerators, the process of 

accelerating, focusing, and directing the 

beam is accomplished by a combination 

of electrically charged structures and 

magnetic fields in the accelerator. 

During operation, these internal 

structures will be struck by particles 

from the beam and activated 

incidentally. 

Particle accelerators are often 

classified by the maximum energy of the 

accelerated particles, expressed in 

megaelectron-volts (MeV). An electronvolt is the amount of energy imparted to 

an electron by an accelerating potential 

of one volt. The small cyclotrons that 

produce radionuclides used in PET 

nuclear medicine usually operate at 

energies of up to about 30 MeV. By 

comparison, the accelerators used in 

basic physics research facilities reach 

energies in excess of 1000 MeV. 

For the purposes of this rulemaking, 

the NRC divided particle accelerators 

into three groupings: (1) Those that are 

always operated to intentionally 

produce radioactive materials in 

quantities useful for their radioactive 

properties for a commercial, medical, or 

research activity; (2) those that are 

operated to produce only particle beams 

and not radioactive materials; and (3) 

accelerators that are used to produce 

both radioactive materials and particle 

beams for other uses. Examples of 

accelerators that are operated to produce 

only particle beams and not radioactive 

materials include linear accelerators 

used for medical treatment of cancer 

and other health-related conditions. 

Other examples include the 

experimental particle physics research 

colliders used to probe the fundamental 

properties of nature (as long as that is 

their only use) and electron 

microscopes, i.e., particle accelerators 

that probe the structure of materials at 

a very small dimension (high 

magnification). Ion implanters are 

particle accelerators used to modify the 

electrical properties of materials in 

semiconductor fabrication. In these 

activities, no radioactive material is 

intentionally created; all activation is 

incidental to the intended use of the 

accelerator. 

The NRC will regulate the radioactive 

material both intentionally and 

incidentally produced by all 

accelerators that are intentionally 

operated to produce a radioactive 

material for its radioactive properties. 

The NRC will not regulate the incidental 

radioactive material produced by 

accelerators that are operated to produce 

only particle beams and not radioactive 

materials for use for a commercial, 

medical, or research activity. For those 

accelerators that are used to produce 

both radioactive material and particle 

beams, the NRC will regulate the 

intentionally produced radioactive 

material and all of the incidentally 

produced radioactive material, 

including incidental radioactive 

material produced when the accelerator 

is operated to produce radioactive 

material, as well as incidental 

radioactive material produced when it is 

operated to produce only a particle 

beam. The incidental radioactive 

materials produced in these accelerators 

are indistinguishable, so both will be 

considered byproduct material. The 

NRC believes very few, if any, 

accelerators are operated in this way. 

The EPAct does not give the NRC 

authority to regulate the possession or 

use of particle accelerators. The NRC 

has not adopted any rule regarding the 

operation of a particle accelerator or the 

qualification of any person maintaining 

or operating a particle accelerator. 

However, nothing in the EPAct directs 

the NRC to change the policy that 

radiation safety standards must consider 

unregulated as well as regulated sources 

of radiation. The NRC will continue to 

require any person subject to the dose 

limits in 10 CFR Part 20 to continue to 

include the radiation dose from the 

operation of a particle accelerator in 

meeting the dose limitations. The NRC 

is aware that the operation of a particle 

accelerator may activate materials in the 

structure of the building and facilities 

housing the accelerator. The NRC 

intends to assure the safe 

decommissioning of particle accelerator 

buildings and facilities, including the 

removal and disposal of activated 

building materials, to assure that the 

dose limits to members of the public are 

not exceeded. The decommissioning of 

these facilities will be required to meet 

the radiation dose limits in 10 CFR Part 

20 Subpart E—Radiological Criteria for 

License Termination. 

The majority of accelerator-produced 

radioactive material is now created for 

use in medicine. The NRC is aware of 

only two operations in the U.S. and a 

few importers, mostly from Europe and 

Canada, that are commercial producers 

of accelerator-produced radioactive 

material for use in industrial activities. 

The regulatory approach for 

manufacturing accelerator-produced 

radioactive material for industrial 

purposes is similar to the regulatory 

approach for manufacturing acceleratorproduced radioactive material for 

medical purposes. 

Accelerator-Produced Radioactive 

Material Used in Medical Activities 

Medical use of radioactive material 

began over 50 years ago. The medical 

use of sealed and unsealed radioactive 

materials continues to be an important 

component of medical specialties for 

both diagnosis and therapy purposes. 

The use of small quantities of unsealed 

radioactive materials 

(radiopharmaceuticals) in nuclear 

medicine is an integral part of patient 

care and is extremely valuable in the 

early diagnosis and treatment of medical 

conditions. Radiation oncology uses 

larger amounts of radioactivity in sealed 

sources to deliver therapeutic or 

palliative radiation doses. 

Almost all reactor-produced 

byproduct radionuclides for radioactive 

drugs are imported into the U.S., as well 

as most reactor-produced radionuclides 

used in sealed sources, although some 

used in radioactive drugs and sealed 


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sources are also produced in an NRCregulated nonpower reactor. 

Commercial manufacturers primarily 

use the imported radionuclides to 

produce specific sealed sources, 

radioactive drugs, and biologics. 

Commercial nuclear pharmacies may 

use radiochemicals to prepare 

radioactive drugs, as well as 

commercially produced radioactive 

drugs and drug sources, such as 

molybdenum-99/technetium-99m 

generators, to prepare unit dosages of 

other radioactive drugs. 

The U.S. has a limited number of 

commercial radionuclide production 

facilities that use accelerators to 

produce radionuclides, such as 

thallium-201, iodine-123, indium-111, 

and gallium-67 used in radioactive 

drugs. A larger number of radionuclide 

production facilities (often referred to as 

PET centers) use cyclotrons to produce 

the PET radionuclides fluorine-18, 

carbon-11, nitrogen-13, and oxygen-15 

for use in PET radioactive drugs. PET 

radionuclides decay by positron 

emission and, because of their relatively 

short half-life (minutes to hours), are 

produced at locations in close proximity 

to the patients (e.g., in hospitals or 

academic institutions) or at nearby 

locations. 

Palladium-103, the most common 

accelerator-produced medical use 

radionuclide contained in a sealed 

source, was originally produced at 

reactor facilities. Other radionuclides 

used in medical radiation therapy can 

also be produced with either reactors or 

accelerators. With the new definition of 

Byproduct material, sealed sources that 

can be produced from either pathway 

will be uniformly regulated. At this 

time, there are no teletherapy or remote 

afterloader or gamma stereotactic 

radiosurgery units with acceleratorproduced sources. 

Because production accelerators for 

medical radionuclides (e.g., PET 

production facilities) and industrial 

radionuclides are used to intentionally 

produce radioactive material for use of 

its radioactive properties for a 

commercial, medical, or research 

activity, the NRC will regulate both the 

radionuclides produced in these 

accelerators as well as the incidentally 

activated radioactive material. 

Other Naturally Occurring Radioactive 

Material With Similar Risk as Radium226 

The EPAct amended the definition of 

Byproduct material to include any 

discrete source of naturally occurring 

radioactive material, other than source 

material, that the Commission, in 

consultation with the Administrator of 

the EPA, the Secretary of Energy, the 

Secretary of Homeland Security, and the 

head of any other appropriate Federal 

agency, determines would pose a threat 

similar to the threat posed by a discrete 

source of radium-226 to the public 

health and safety or the common 

defense and security, and is extracted or 

converted after extraction, before, on, or 

after the date of enactment of the EPAct 

for use in a commercial, medical, or 

research activity. 

The inclusion of discrete sources of 

naturally occurring radioactive material 

into the definition of Byproduct 

material is contingent on the 

Commission’s determination, in 

consultation with other Federal 

agencies, that these discrete sources 

would pose a threat similar to the threat 

posed by a discrete source of radium226. The NRC has not currently 

identified any discrete sources of 

naturally occurring radioactive material 

under this provision, and the rule does 

not contain criteria for making such a 

determination. For comparison, the 

International Atomic Energy Agency 

(IAEA) has identified a list of sources 

that are considered to pose a high risk 

to human health and safety if not 

managed safely and securely. The IAEA 

Code of Conduct on the Safety and 

Security of Radioactive Sources (Code of 

Conduct) identified certain quantities of 

26 radionuclides that pose a significant 

risk to individuals, society, and the 

environment. The activity of these 

radionuclides at the IAEA Code of 

Conduct Category 1 or 2 level could be 

fatal or cause permanent injury to a 

person who handled them or was 

otherwise in contact with them for a 

short time, if not safely managed or 

securely protected. Of these 26 sources, 

only two naturally occurring 

radionuclides are listed: Radium-226 

and polonium-210. Because this rule 

addresses discrete sources of radium226, the only other naturally occurring 

radioactive material similar in hazard to 

radium-226 when using the IAEA 

criteria is polonium-210. However, 

naturally occurring polonium is scarce. 

One ton of uranium ore contains only 

about 100 micrograms (0.0001 grams) of 

polonium. Due to its scarcity in nature, 

polonium-210 used for commercial 

purposes is usually produced by 

bombarding bismuth-209 with neutrons 

in a nuclear reactor and had been 

regulated by the NRC before the EPAct. 

Additionally, polonium-210 is unlikely 

to be commercially used in individual 

radioactive sources with activity levels 

that would place them within the IAEA 

Code of Conduct Category 1 or 2. Hence, 

the NRC has determined that no other 

discrete sources of naturally occurring 

radioactive material pose a threat 

similar to the radium-226-level or IAEA 

Code of Conduct Category 1 or 2 

sources. 

Through interaction with other 

Federal agencies and States during 

development of the rule, the NRC 

concluded that, at this time, only 

polonium-210 has the potential to pose 

a threat similar to the threat posed by a 

discrete source of radium-226 to the 

public health and safety or the common 

defense and security. The NRC had 

already been regulating the use and 

possession of polonium-210 because it 

is produced in nuclear reactors and is 

rarely extracted as naturally occurring 

radioactive material. Therefore, 

although this rule adds this category of 

byproduct material to the definitions in 

the regulations, at this time, the NRC’s 

regulations will not apply to any 

discrete sources of naturally occurring 

radioactive material, other than radium226. The EPAct has provided a 

mechanism for the Commission to 

include additional discrete sources of 

naturally occurring radioactive material 

in the future following consultation 

with other Federal agencies, if the need 

arises to consider other naturally 

occurring radioactive material as 

byproduct material. No further revision 

to the regulations will be necessary to 

begin regulating a material identified 

through this mechanism. However, the 

NRC will provide an opportunity for 

public input before applying its 

regulations to other naturally occurring 

radionuclides that the NRC determines 

in consultation with other federal 

agencies, pose a threat similar to the 

threat posed by discrete source of 

radium-226. 

B. The NRC’s Regulatory Approach 

Consideration of Suggested State 

Regulations for the Control of Radiation 

(SSRs) 

All 34 Agreement States have 

regulations for NARM. Twelve nonAgreement States and certain U.S. 

Territories have some type of regulatory 

structure for NARM, while four nonAgreement States have no program for 

regulating NARM. The EPAct mandated 

that the NRC use model State standards 

to the maximum extent practicable in 

issuing regulations for the expanded 

definition of Byproduct material. The 

NRC considered the SSRs published by 

CRCPD (http://www.crcpd.org/ 

free_docs.asp) as the model State 

standard in developing this rule. Most 

Agreement States have regulated 

discrete sources of radium and 

accelerator-produced radioactive 


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material in a manner similar to and 

under the same requirements as reactorproduced radioactive material. Few 

provisions in the SSRs exist solely to 

address these materials. Where specific 

provisions do exist in the SSRs for these 

materials, they have been evaluated for 

possible inclusion in the NRC’s 

regulations. 

For radionuclide-specific values listed 

in 10 CFR part 20, Appendices B and C, 

the NRC found that there are no other 

radionuclides identified in the SSRs 

that are not already included in 10 CFR 

part 20. As discussed further in this 

document under Section C., ‘‘Changes to 

Existing NRC Regulations to 

Accommodate the New Byproduct 

Material,’’ most of the specific 

provisions related to NARM 

radionuclides in the SSRs have been 

adopted in this rule. These include 

exempt quantities in 10 CFR 30.18 and 

10 CFR 30.71, an exemption for 

timepieces in 10 CFR 30.15, a general 

license for calibration and reference 

sources in 10 CFR 31.8, a general license 

for use of radioactive material for 

certain in vitro clinical or laboratory 

testing in 10 CFR 31.11, contamination 

limits for strontium-82/rubidium-82 

generators, and requirements to measure 

the contamination limits in 10 CFR 

35.204 with corresponding 

recordkeeping requirements in 10 CFR 

35.2204. 

While SSRs do exist that address 

other types of naturally occurring 

radioactive material that are not covered 

by the EPAct or these new regulations, 

discrete sources of radium and 

accelerator-produced radioactive 

material are covered under the same 

provisions of the SSRs that apply to 

reactor-produced radioactive material. 

There is general agreement among the 

States, reflected in the SSRs, that the 

new categories of byproduct material 

should be regulated under the same 

requirements as reactor-produced 

radioactive material. This rule takes the 

same regulatory approach. Most of the 

requirements that will apply to users of 

the newly regulated material are 

preexisting NRC requirements. 

Other Related Rulemakings 

The NRC amended its regulations in 

10 CFR Part 110 revising the definition 

of Byproduct material to include 

discrete sources of radium-226, 

accelerator-produced radioactive 

material, and discrete sources of 

naturally occurring radioactive material 

(71 FR 20336; April 20, 2006). In 

addition, an earlier amendment (70 FR 

37985; July 1, 2005) added discrete 

sources of radium to 10 CFR Part 110, 

Appendix P. Together, the two 

amendments satisfy the requirements of 

Section 651(d) of the EPAct pertaining 

to the export or import of Category 1 or 

Category 2 radiation sources as defined 

by the IAEA Code of Conduct. By this 

final rule, the NRC is again amending is 

regulations in 10 CFR Part 110 to 

include a definition of Discrete source. 

Section 651(d) of the EPAct also 

requires the NRC to issue regulations 

establishing a mandatory tracking 

system for radiation sources, including 

radium-226, in the U.S. The NRC issued 

a final rule for national source tracking 

of sealed sources (71 FR 65686; 

November 8, 2006) that included 

radium-226 sources. 

Definition of Discrete Source 

The EPAct extended the definition of 

Byproduct material in the AEA to 

include any discrete source of radium226 and certain other naturally 

occurring radioactive material that is 

produced, extracted, or converted after 

extraction, before, on, or after the date 

of the enactment of the EPAct, for use 

for a commercial, medical, or research 

activity. The term Discrete source is not 

defined in the EPAct, and the EPAct 

specifically mandates that the final 

regulations, in establishing 

requirements necessary to carry out the 

amendment, shall include a definition 

of the term Discrete source. The 

definition of Discrete source is used for 

purposes of the new definition of 

Byproduct material in the case of 

radium-226 and other naturally 

occurring radioactive material other 

than source material. The term Discrete 

source is not used in conjunction with 

accelerator-produced radioactive 

material in the EPAct language. 

Thus, the EPAct gave the NRC 

authority over discrete sources of 

radium-226 but not over diffuse sources 

of radium-226. The EPAct did not 

extend the NRC’s authority over radium226 as it occurs in nature, or over other 

processes where radium-226 may be 

unintentionally concentrated. The focus 

was on those materials that presented a 

threat to public health and safety or to 

the common defense and security 

similar to the threat posed by discrete 

radium-226 sources. Scale from pipes 

used in the fossil fuel industry, fly ash 

from coal powerplants, phosphate 

fertilizers, or residuals from treatment of 

water to meet drinking water standards 

are not considered discrete sources. 

However, uranium and thorium within 

these materials may become licensable 

source material depending upon their 

concentration. 

The definition of Discrete source in 

the proposed rule was ‘‘a radioactive 

source with physical boundaries, which 

is separate and distinct from the 

radioactivity present in nature, and in 

which the radionuclide concentration 

has been increased by human processes 

with the intent that the concentrated 

radioactive material will be used for its 

radiological properties.’’ As a result of 

public comments on the proposed rule, 

the NRC changed the wording of the 

definition of Discrete source from that 

in the proposed rule. Discrete source is 

defined in this final rule as ‘‘a 

radionuclide that has been processed so 

that its concentration within a material 

has been purposely increased for use for 

commercial, medical, or research 

activities.’’ The changes are for 

clarification purposes only and do not 

change the original intent of the 

proposed definition of Discrete source 

or the scope of the NRC’s regulation of 

radium-226 or other naturally occurring 

radioactive materials identified in the 

future. The intent of the revised 

definition continues to be consistent 

with the proposed rule in that the NRC’s 

authority is not intended to extend to all 

naturally occurring radioactive material, 

specifically not to naturally occurring 

radioactive material that is found in 

nature in its original form and location, 

or that which is moved or concentrated 

inadvertently by some man-made 

process. A discrete source will have the 

same radiological characteristics (e.g., 

type of radiation, half-life) as the 

radionuclide found in nature but will 

have been purposefully concentrated for 

use for its specific properties after it has 

been removed from its original location 

in nature. This definition excludes the 

NRC’s jurisdiction over inadvertent 

movement or concentration of naturally 

occurring radioactive material such as 

scale from pipes used in the fossil fuel 

industry, fly ash from coal power plants, 

or phosphate fertilizers. It also excludes 

NRC jurisdiction over residuals from 

treatment of water. While radium, in 

particular, may be intentionally 

concentrated in this case, it is not for 

the purpose of using the radium, but to 

improve water quality. Only if, and 

when, this radium were further 

processed for use would it be 

considered a discrete source, and thus 

byproduct material. Neither the changes 

to the AEA as a result of the EPAct, nor 

anything in this rulemaking changes the 

NRC’s authority, in any manner, over 

source material. 

The words ‘‘a radionuclide that has 

been processed so that its concentration 

within a material has been purposely 

increased’’ are intended to further 

clarify that the extraction or processing 

relates to the intent to use the 

radionuclide itself, and not a material 


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that happens to contain the 

radionuclide, such as fertilizer. The 

addition of the phrase ‘‘for use for 

commercial, medical, or research 

activities’’ repeats a constraint that also 

appears in the definition of Byproduct 

material. The NRC has repeated this 

constraint in order to ensure that when 

the term ‘‘discrete source’’ is used 

separately from the term ‘‘byproduct 

material,’’ it will not be interpreted 

more broadly, but it will be clear that 

only material which is intended for use 

for commercial, medical, or research 

activities is being referenced. 

It should also be noted that in 

accordance with this definition of 

Discrete source, once a discrete source 

meets the definition of Byproduct 

material, any contamination resulting 

from the use of such discrete sources of 

this byproduct material will also be 

considered byproduct material. This 

issue is discussed further in this 

document under ‘‘Summary and 

Analysis of Public Comments on the 

Proposed Rule.’’

C. Changes to Existing NRC Regulations 

To Accommodate the New Byproduct 

Material 

The Commission has authority to 

issue both general and specific licenses 

for the use of byproduct material and to 

exempt byproduct material from 

regulatory control under Section 81 of 

the AEA. A general license, as provided 

by regulation, grants authority to a 

person for certain activities involving 

byproduct material and is effective 

without the filing of an application with 

the Commission or the issuance of a 

licensing document to a particular 

person. Requirements for general 

licensees appear in the regulations and 

are designed to be commensurate with 

the specific circumstances covered by 

each general license. 

In considering the expansion of the 

definition of Byproduct material to 

include discrete sources of radium-226 

and accelerator-produced radioactive 

material, the NRC has evaluated 

products and materials previously 

approved by the States for use under an 

exemption from licensing and under a 

general license. Generally, the NRC’s 

intent in this rule is to accommodate 

existing products and materials that 

were previously regulated by the States 

under similar provisions, if the potential 

doses are similar to those expected from 

other currently regulated products and 

materials. Many of these products have 

not been made for some time, so some 

of the provisions in this rule are limited 

to items manufactured in the past, 

which may still be in use or in storage. 

The bases of these exemptions and 

general licenses are primarily the SSRs 

and also information in NRC’s sealed 

source and device (SS&D) registry. The 

SS&D registry is the NRC’s national 

database of technical information on 

sealed sources and devices. 

Manufacturers or distributors may 

submit a request to the NRC for an 

evaluation of a product’s radiation 

safety information and for registration of 

the product. After satisfactory 

completion of the evaluation, the NRC 

issues a certificate of registration to the 

person making the request, and this 

certificate is added to the SS&D registry. 

Many Agreement States have similar 

registration procedures, and registration 

certificates for the sources and devices 

they review are added to the national 

SS&D registry. The NRC also has 

included SS&D certificates for NARM, 

which have been issued by the States. 

While this is not a complete database 

with respect to NARM, it includes 

detailed information about many 

products containing NARM previously 

evaluated by the States. In addition to 

SSRs and the information in the SS&D 

registry, the specific provisions of the 

various States also were considered in 

developing this rule. 

Regulating Items Containing Radium226 

Currently, items or products 

containing radium-226 are unique in 

that there are no new items in consumer 

commerce using radium-226 byproduct 

material. Although certain industrial 

devices such as moisture density gauges 

containing radium-226 are still in use, 

most radium-226 articles have not been 

produced for at least 20 years. 

Beginning in the early 1900s, radium226 was used to make self-luminescent 

paint and incorporated in watch and 

clock dials and hands and later used to 

illuminate airplane instrumentation 

dials and gauges as well as markers and 

signs. Beginning in the 1950s, other 

radionuclides began to replace radium226 as a self-luminescent material due 

to the recognition of the radiological 

hazard associated with radium-226. 

Currently, the radionuclides of choice 

for self-luminescent applications are 

promethium-147 and tritium due to the 

much reduced radiological hazard vis-avis radium-226. 

Based on the National Council on 

Radiation Protection and Measurements 

in Report 95, ‘‘Radiation Exposure of the 

U.S. Population from Consumer 

Products and Miscellaneous Sources,’’

radium-226 has not been used in 

radioluminescent watches since 1968 

and clocks since 1978. In fact, radium226 timepieces are currently kept 

largely as collectors’ items and only 

infrequently used by consumers as 

timepieces. When originally 

manufactured, the quantity of radium226 employed in watch and clock dials 

and hands varied by timepiece size, 

manufacturer, model, and from item to 

item. While the quantity of radium-226 

varied in the timepieces, there is a 

general agreement for typical average 

and upper bound quantities. Based 

upon the spectrum of timepiece sizes, 

wristwatches have the smallest quantity, 

with pocket watches and clocks having 

quantities several times higher than 

wristwatches. The radioactivity 

associated with wristwatches is 

generally on the order of several 

kilobecquerel (kBq) (tenths of a 

microcurie (μCi)) with an average of 5.6 

kBq (0.15 (μCi)). Pocket watches may 

have radioactivity of about 13 kBq (0.35 

μCi), and clocks are typically 18 kBq 

(0.5 μCi). However, collections of pocket 

watches and clocks are rare when 

compared to wristwatches. 

Before the discontinuation of the 

manufacturing of timepieces containing 

radium-226 in the 1970s, radium-226- 

illuminated timepieces were widely 

distributed throughout the country as a 

common consumer product. To date, a 

large number of radium-226 timepieces 

are still owned by individuals as valued 

heirlooms or collectors’ items or are on 

display in museums. Because museums 

and collectors normally collect a wide 

range of timepieces, a portion of their 

collection may contain radium-226 

timepieces. Some businesses and a few 

collectors are also engaged in repairing 

and refurbishing timepieces either as a 

hobby or professionally, and these 

activities may occasionally involve 

timepieces containing radium-226. 

Because these timepieces were 

manufactured before the NRC assumed 

regulatory authority over radium-226, 

and because these timepieces are 

already in public possession, the NRC 

intends to minimize regulatory impact 

to individuals, museums, or other 

entities in possession of these 

timepieces. In finalizing the rule, the 

NRC made its determination based on 

no significant risk to public health and 

safety and the environment. 

In the proposed rule, the NRC 

proposed to exempt intact timepieces 

containing no more than 37 kBq (1 μCi) 

of radium-226 per timepiece and repair 

of no more than 10 timepieces in any 

one year. In addition, the NRC proposed 

to generally license no more than 50 

timepiece hands and dials used or 

stored at the same location at any one 

time. Due to lack of sufficient health 

and safety information to make a final 

regulatory decision, the NRC conducted 


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a scoping study for estimating potential 

radiological doses to individuals 

associated with use, storage, and repair 

of radium-226 timepieces. The scoping 

approach taken by the NRC used widely 

accepted methods and employed 

conservative assumptions for various 

scenarios involving use, storage, and 

repair of radium-226 timepieces. 

Because the scoping study was designed 

to be conservative and meaningful and 

yet easy to perform, it is to be expected 

that the actual doses would be 

significantly lower than those predicted 

by the scoping study. 

To evaluate the potential doses 

associated with the proposed exemption 

of radium-226 timepieces, 37 kBq (1 

μCi) of radium-226 per timepiece was 

used in the scoping study instead of the 

typical average activities for timepieces, 

which provided for additional 

conservatism. Radon-222 is a decay 

product in the radium-226 decay series 

and may be emitted from the timepiece 

into the surrounding atmosphere and 

thus result in exposure to an individual 

in proximity to the timepiece. It is 

believed that the radon-222 emanating 

from the paint is almost totally trapped 

within the watch. Because of the age of 

radium-226 timepieces, and because 

there is no established method for 

quantifying the trapping behavior, the 

scoping study conducted by the NRC 

assumed that the entire inventory of 

decay products instantly escaped and 

became uniformly distributed into the 

surrounding building volume. This 

assumption is obviously very 

conservative. As a result, the estimated 

inhalation doses associated with radon222 are extremely conservative. The 

scoping study found that the estimated 

doses to a collector for repair, storage, 

and use of a radium-226 timepiece range 

from a fraction of 0.01 millisievert/yr 

(mSv/yr) [1 millirem/yr (mrem/yr)] to a 

few mSv/yr (mrem/yr) to over 1 mSv/yr 

(100 mrem/yr). 

At one time, there were repair 

facilities refurbishing radium timepieces 

on a regular basis by replacing radium226 paint with tritium paint. Scraping 

off the radium-226 paint may have 

resulted in significant contamination. 

The NRC is not aware of any current 

operations in which individuals are still 

routinely handling radium watches in 

such a way as to create a contamination 

problem. Based upon the estimated 

doses for repairs, the NRC believes that 

a specific limit on the annual number of 

repairs is not necessary. As long as these 

repairs are taking place under a general 

license, actions could always be taken if 

the Commission receives information 

that suggests that the public health and 

safety are not being adequately 

protected. 

The NRC’s intent is to minimize 

regulatory impact on those private 

collectors and museums as much as 

possible, and to be as consistent as 

possible with the regulatory approach 

taken by the Agreement States, many of 

whom have been regulating radium-226 

for several decades. Accordingly, in 

light of the public comments received, 

the Agreement States’ rulemaking 

involvement and the results of the 

scoping study in finalizing the rule, the 

NRC revised the proposed revisions 

related to radium-226 timepieces. 

Primarily, the change made in this final 

rule is to broaden the general license 

provision for the radium-226 

timepieces. Specifically, the NRC has 

concluded that a finite number of 

annual repairs as well as a limitation on 

the number of nonintact timepieces and 

timepiece hands and dials is 

unnecessary and not warranted based 

upon the NRC’s understanding of 

radium-226 timepieces either in 

collections or in use. As a result of the 

scoping study and in response to public 

comments, the NRC has concluded that 

it is appropriate to recategorize the 

repair of timepieces from an activity 

allowed under an exemption from 

licensing to one covered by a general 

license. This categorization is also more 

consistent with the Agreement States’

existing exemption provision. 

Although not mandated by 

regulations, the NRC advises that 

individual collectors or persons engaged 

in repair of these devices should use 

good practices such as wearing gloves 

when handling radium-226 timepieces, 

hands, and dials, and washing hands to 

minimize potential exposure to the 

radioactive material. In addition, 

individual collectors should ensure that 

storage areas are well ventilated to 

minimize potential exposure due to 

accumulation of radon-222 gas and 

should avoid unnecessary exposure to 

these types of timepieces. 

Exemptions From Licensing 

In 10 CFR Part 30, a number of 

exemptions from licensing requirements 

are included. These exemptions allow 

for certain products and materials 

containing byproduct material to be 

used without any regulatory 

requirements imposed on the user. The 

two exemptions in 10 CFR 30.19, Selfluminous products containing tritium, 

krypton-85, or promethium-147, and 10 

CFR 30.20, Gas and aerosol detectors 

containing byproduct material, are class 

exemptions which cover a broad class of 

products. Under these provisions, new 

products can be approved for use 

through the licensing process if the 

applicant demonstrates that the specific 

product is within the class and meets 

certain radiation dose criteria. This 

contrasts with other exemptions for 

which the level of safety is controlled 

through such limits as specification of 

radionuclides and quantities. Section 

30.14, Exempt concentrations, and 

Section 30.18, Exempt quantities, of 

NRC’s regulations, are broad materials 

exemptions, which allow the use of a 

large number of radionuclides. The 

specific radionuclide limits on these 

concentrations and quantities are 

contained in tables in 10 CFR 30.70 and 

10 CFR 30.71, respectively. The 

remaining exemptions from licensing 

are product specific, for which many 

assumptions can be and have been made 

concerning how the product is 

distributed, used, and disposed of. This 

final rule adds some products and 

materials containing NARM to some of 

the previously existing exemptions. The 

table of exempt concentrations in 10 

CFR 30.70 already included all of the 

radionuclides and associated limits 

contained in the equivalent section of 

the SSRs. Thus, the NRC is not revising 

the exempt concentration table in this 

final rule. 

Exempt Quantities 

Part C of the SSRs includes a list of 

exempt quantities which are identical to 

those in 10 CFR 30.71 but includes an 

additional 13 radionuclides, which are 

accelerator produced. This final rule 

adds these 13 radionuclides and their 

respective quantities, as already 

included in the SSRs, to the list of 

exempt quantities in 10 CFR 30.71. The 

technical bases of these values are 

similar to those used for the existing 

values in 10 CFR 30.71. 

The NRC considered whether there 

were additional radionuclides in use 

under comparable State exemptions that 

should be accommodated under 10 CFR 

30.71. It was noted that a few of the 

States’ regulations for exempt quantities 

include additional radionuclide-specific 

values, each appearing in only one or 

two States’ regulations. These 

radionuclides are specifically exempted 

in only one or two States; thus, they do 

not represent nationally recognized 

exemptions. It was also not clear as to 

what approach was used to calculate 

their exemption values. Therefore, the 

NRC is adding only the 13 radionuclides 

and values from the SSRs for which 

there are adequate technical bases, and 

no further additions to 10 CFR 30.71 are 

included in this final rule. It is noted, 

however, that for other byproduct 

material, excluding alpha emitters, 

which is the last item on the list in 10 


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CFR 30.71, Schedule B allows for 3.7 

kBq (0.1 μCi) to be used as an exempt 

quantity. This will apply to acceleratorproduced radionuclides as well. Minor 

changes are also being made to 10 CFR 

30.18 to accommodate any materials 

that may have been received before 

September 25, 1971, under a general 

license of a State similar to that then 

provided in 10 CFR 31.4. 

Timepieces Containing Radium-226 

The exemption in 10 CFR 30.15(a)(1) 

is being revised to include intact 

timepieces that were manufactured 

before the effective date of this final rule 

and containing no more than 37 kBq (1 

μCi) of radium-226. This provision is 

consistent with the SSRs, except that 

the rule is limited to ‘‘intact’’

timepieces. In the final rule, the repair 

of timepieces was moved from the 

exemption to the general license to be 

more consistent with the SSRs and to 

broaden the general license provision. 

As discussed earlier, the possession of 

nonintact timepieces, hands, and dials, 

and the repair of timepieces would be 

covered by a new general license. This 

general license provision should cover 

most current practices involving 

radium-226 and minimize impacts upon 

individual collectors and small 

businesses. A general license is 

automatically granted by NRC 

regulations to any person meeting the 

general license criteria. No action is 

required from these persons to obtain a 

general license, and no license or 

annual fees are applicable to persons 

operating under this general license. 

Self-Luminous Products 

Although the SSR section similar to 

10 CFR 30.19 includes an exemption for 

previously acquired self-luminous 

articles containing less than 3.7 kBq (0.1 

μCi) of radium-226, 10 CFR 30.19 is not 

being amended to include this 

exemption. The basis for not including 

this exemption is that, as currently 

written, 10 CFR 30.19 only applies to 

products manufactured and distributed 

under a specific license issued under 10 

CFR 32.22. The SSR exemption does not 

require that these products be 

previously manufactured and 

distributed under a specific license, nor 

do the SSRs provide for such a license 

with regard to radium-226. Instead, the 

possession, use, and transfer of these 

items will be subject to the general 

license for certain items and selfluminous products containing radium226 established in 10 CFR Part 31. 

Smoke Detectors 

Smoke detectors are included in the 

class exemption in 10 CFR 30.20 for gas 

and aerosol detectors. This exemption is 

being revised to include previously 

manufactured detectors containing 

radium-226. The provision for smoke 

detectors is different from the SSRs in 

that the SSRs contain a specific limit of 

3.7 kBq (0.1 μCi) for radium-226 that 

manufacturers may incorporate into the 

currently manufactured detectors. 

However, the SS&D registry includes 

certificates for smoke detectors 

categorized as exempt containing up to 

74 kBq (2 μCi) of radium-226. While 

some of these certificates are categorized 

as ‘‘Active,’’ meaning that continued 

distribution is permitted, a survey of the 

States with these certificates confirmed 

that the distribution of radium-226 in 

smoke detectors was, in fact, a past 

practice. The provision added to 10 CFR 

30.20 for detectors containing radium226 is limited to detectors previously 

manufactured and distributed under a 

specific license issued by a State under 

comparable provisions to 10 CFR 32.26. 

Thus, similar standards were used in 

approving distribution of these detectors 

for use under an exemption from 

licensing. This exemption does not 

cover smoke detectors manufactured 

earlier with larger quantities of radium226 and authorized for use under a 

general or specific license, or smoke 

detectors that may not have been 

distributed under a specific license. 

Distribution to Exempt Persons 

The NRC retains the authority for 

authorizing distribution of products and 

materials where the end user is exempt 

from licensing and regulatory 

requirements by regulation in 10 CFR 

150.15(a)(6), which states, in part, that 

persons in Agreement States are not 

exempt from the Commission’s 

licensing and regulatory requirements 

with respect to the transfer of 

possession or control of any equipment, 

device, commodity, or other products 

containing byproduct material to 

persons who are exempt from licensing 

and regulatory requirements of the 

Commission. The NRC does not transfer 

this authority when a State enters into 

an Agreement with the NRC. Therefore, 

persons who initially transfer products 

containing byproduct material to 

persons who are exempt from licensing 

must have a license from the NRC 

authorizing these activities. These 

distributors also need a specific license 

from either an Agreement State or from 

the NRC authorizing the possession and 

use of the byproduct material. As a 

result of the expansion of the definition 

of Byproduct material, the distribution 

of NARM to exempt persons, including 

distribution by licensees in Agreement 

States, will also be authorized only by 

the NRC. Currently, the States have only 

a few licensees authorized to distribute 

to persons exempt from licensing 

requirements. These are for exempt 

quantities of accelerator-produced 

radioactive material. In finalizing this 

rule, the NRC has determined that most, 

if not all, of these distribution licensees 

already have an NRC license under 10 

CFR 32.18 authorizing the distribution 

of exempt quantities of pre-EPAct 

byproduct material. For these 

distribution licensees, only a simple 

amendment of those NRC licenses will 

be required as a result of this aspect of 

this final rule. 

Existing General Licenses 

General License for Devices in 10 CFR 

31.5 

Section 31.5 is the primary general 

license provision in 10 CFR Part 31. It 

covers a broad range of 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.’’ These devices must be 

distributed under specific licenses 

issued under 10 CFR 32.51 or equivalent 

regulations of an Agreement State. 

There are numerous SS&D certificates 

for devices containing NARM that have 

been approved by the States for use 

under a general license. These are 

almost all for devices containing cobalt57, sodium-22, or radium-226. In many 

cases, models have been approved 

which are authorized to contain one of 

these radionuclides or one or more other 

radionuclides that were byproduct 

material before the EPAct. They have 

been evaluated under equivalent, in 

most cases, or at least comparable, 

standards by the States. The rule will 

accommodate generally licensed devices 

meeting the restrictions of the general 

license that were previously approved 

by the States under comparable 

provisions to 10 CFR 32.51. Active 

certificates would stand with 

amendments, if needed, being made to 

the distributors’ licenses to cover the 

new categories of byproduct material. 

Any new certificates would be issued by 

the NRC or the Agreement States under 

the AEA encompassing the new 

definition of Byproduct material. 

The criteria for registration of 

generally licensed devices under 10 CFR 

31.5(c)(13)(i) are revised to include a 

criterion for registration by general 

licensees of devices containing 3.7 

megabecquerels (MBq) (0.1 millicurie 

(mCi)) or more of radium-226. This 


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registration process is separate and quite 

different from the SS&D registry. It 

requires physical inventories and 

certification of device information by 

general licensees, allows the NRC and 

Agreement States with equivalent 

regulations to more fully track generally 

licensed devices meeting these criteria, 

and serves to remind general licensees 

of their responsibilities under the 

general license. SS&D certificates for 

generally licensed devices that will now 

come under 10 CFR 31.5 include 

devices with more than 3.7 MBq (0.1 

mCi) of radium-226. These devices will 

be subject to the registration 

requirement in 10 CFR 31.5(c)(13). 

Other certificates, which include 

devices with radium-226, allow only 

much smaller quantities. These devices 

will not be required to be registered. 

This criterion for registration of radium226 was chosen because of the low 

concentration levels which typically are 

required for decontamination and 

decommissioning involving radium-226, 

as well as the relative dispersibility of 

radium-226. A principal purpose of the 

registration process concerns reducing 

losses of devices that could significantly 

contaminate a smelter, if inadvertently 

melted. The NRC does not believe there 

are accelerator-produced materials used 

in significant quantities in these types of 

generally licensed devices to warrant 

registration. 

Distributors of NARM have typically 

also been distributors of pre-EPAct 

byproduct material. Many of them have 

not excluded information about 

transfers of devices containing NARM 

from reports of transfers made to the 

NRC on generally licensed devices 

transferred into the NRC jurisdiction. 

Therefore, the NRC already has 

information on some of these devices in 

its general license tracking system. The 

NRC will work with the States to 

examine methods to include State 

information. It is expected that the 

registration process will identify 

additional devices containing registrable 

quantities of radium-226, as users in 

many cases will already be registering 

other devices with the NRC containing 

other radionuclides and will need to 

add devices containing radium-226 

during the registration process. The 

requirements in 10 CFR 32.51, 32.51a, 

and 32.32 applicable to the manufacture 

or initial transfer of these devices did 

not need revision to accommodate 

NARM. 

Calibration and Reference Sources in 10 

CFR 31.8 

Section 31.8 provides a general 

license for the use of up to 185 kBq (5 

μCi) of americium-241 in calibration 

and reference sources. This final rule 

adds radium-226 to 10 CFR 31.8, 

consistent with the SSRs. This general 

license is only applicable to specific 

licensees that have calibration and 

reference sources as defined in 10 CFR 

31.8, and simply eliminates certain 

administrative requirements to address 

these sources under the specific license. 

The sources are covered by 

requirements applicable under the 

specific license, as well as additional 

requirements in 10 CFR 31.8. The 

requirements in 10 CFR 32.57, 32.58, 

32.59, and 32.102 applicable to licenses 

to manufacture or initially transfer these 

sources are also amended to include 

radium-226. 

General License for In Vitro Test Kits in 

10 CFR 31.11 

In keeping with the equivalent section 

of the SSRs, cobalt-57, in units not 

exceeding 370 kBq (10 μCi) each, is 

added to the general license in 10 CFR 

31.11 for use in certain in vitro clinical 

or laboratory testing. Also, the 

requirements in 10 CFR 32.71, which 

provide the licensing criteria for the 

manufacturer and distributor of the 

products used under this general 

license, are revised to apply to the 

cobalt-57 products included in the 

general license. 

New General License for Certain Items 

and Self-Luminous Products Containing 

Radium-226 

The Commission specifically 

requested information on the types and 

quantities of products containing 

radium-226 and any information that 

could assist the NRC in more fully 

evaluating the potential impact to 

public health and safety and the 

environment due to activities involving 

radium-226 sources. As discussed 

earlier, the general license provisions 

for radium-226 timepieces were 

changed to remove, from the proposed 

rule, a limitation on the number of 

timepieces that could be possessed. In 

response to public comment, the general 

license provision within this section for 

luminous gauges and other luminous 

products containing radium-226 was 

also changed with respect to the 

categories of products covered and the 

numbers of products allowed to be kept 

at any one location. This is discussed in 

this document under the section, 

‘‘Summary and Analysis of Public 

Comments on the Proposed Rule.’’

Because 10 CFR 31.2 delineates the 

applicability of specific provisions in 10 

CFR part 30 to the general licenses of 10 

CFR part 31, an exemption from the 

reporting and recordkeeping 

requirements of 10 CFR 30.50 and 30.51 

is added to further reduce the regulatory 

burden on stakeholders. Furthermore, 

because many of the circumstances that 

would require reporting under 10 CFR 

30.50 are unlikely to occur, the NRC 

believes that it is unnecessary to apply 

these requirements to this general 

license and that the reporting 

requirements in 10 CFR 31.12 are 

adequate. 

The new section added to 10 CFR part 

31 provides a general license to any 

person for other products and discrete 

sources containing radium-226 that are 

not exempted, and are apparently in the 

public domain, but were not otherwise 

covered under a license and are not 

specifically addressed in the SSRs. The 

general license includes: (1) Antiquities 

originally intended for use by the 

general public and distributed in the 

late 19th and early 20th centuries, such 

as radium emanator jars, revigators, 

radium water jars, radon generators, 

refrigerator cards, radium bath salts, and 

healing pads; (2) Nonintact luminous 

timepieces and timepiece hands and 

dials not contained in timepieces; (3) 

Luminous gauges and other items 

containing radium-226 installed in air, 

marine, or land vehicles (These include 

airplanes, helicopters, jeeps, trucks, 

tanks, ships, landing vessels, artillery 

pieces, and any other former military 

use vehicle no longer in control of the 

military.); (4) All other luminous 

products, provided that no more than 

100 are used or stored at the same 

location at any one time; and (5) Small 

radium sources containing no more than 

37 kBq (1 μCi) of radium-226 as discrete 

survey instrument calibration sources, 

sources contained in radiation 

measuring instruments, sources used in 

educational demonstrations (such as 

cloud chambers, and spinthariscopes), 

electron tubes, lightning rods, ionization 

sources, and static eliminators. As 

discussed earlier, this general license 

allows any person to acquire, receive, 

possess, use, or transfer radium-226 

contained in the previously mentioned 

products. Persons who receive, possess, 

use, or transfer the radium-226 items 

under the general license are exempt 

from the provisions of 10 CFR parts 19, 

20, 21, and 10 CFR 30.50 and 30.51 to 

the extent that the receipt, possession, 

use, or transfer is within the terms of the 

general license. 

The general license prohibits the 

manufacture, assembly, disassembly, 

repair, or import of products containing 

radium-226 except for the repair of 

timepieces; prohibits export under the 

general license; and requires that the 

product only be disposed of by transfer 

to a specific licensee authorized to 

receive it or to a disposal facility 


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authorized to dispose of the material in 

accordance with any Federal or State 

solid or hazardous waste law. The 

general license also prohibits 

abandonment of the product. The 

general license requires notifying the 

NRC if there is any indication of a 

possible failure of, or damage to, the 

product that could result in a loss of the 

byproduct material and requires persons 

possessing these devices under the 

general license to respond to written 

requests for information from the NRC. 

It should be noted that 10 CFR 31.2 

delineates the terms and conditions of 

10 CFR part 30 which apply to general 

licensees. These provisions generally 

will not require general licensees to 

initiate any actions. 

It is the NRC’s intent, through the 

general license provision, that the 

Agreement States, to a large extent, will 

be able to maintain the existing ‘‘status 

quo’’ in regulating these categories of 

discrete sources of radium-226. The 

Agreement States may continue with 

their programs, including requiring a 

specific Agreement State license or 

decommissioning plan when larger 

numbers of products may be involved or 

significant contamination of property 

has resulted. 

Specifically Licensed Sealed Sources 

and Devices 

Registration of Safety Information and 

Licensing of Sealed Sources and Devices 

The NRC is revising 10 CFR 30.32(g) 

to allow for the specific licensing of 

sealed sources and devices containing 

NARM that were previously regulated 

by the States. Sources and devices 

registered by the States may be licensed 

under 10 CFR 30.32(g)(1), and the user 

is only required to provide the 

manufacturer and model number as 

registered in the SS&D registry. 

A new paragraph (3) is also being 

added to 10 CFR 30.32(g) to allow for 

the licensing of sealed sources and 

devices containing NARM for which all 

of the information otherwise required is 

not available. This second provision has 

been added in this final rule as a result 

of public comment. Previously, if a 

source or device were not registered in 

the SS&D registry, the applicant who 

wanted to use the source or device 

would be required to submit all of the 

safety information identified in 10 CFR 

32.210(c), because this information had 

not been submitted previously by the 

manufacturer or distributor as part of 

registering the source or device. For 

older ‘‘legacy’’ devices for which the 

manufacturer is no longer in existence, 

it may be impossible to provide all of 

the categories of information identified 

in 10 CFR 32.210, as required by 10 CFR 

30.32(g)(2). The provision being added 

as 10 CFR 30.32(g)(3) delineates 

additional information that will be 

required to license a source or device for 

which all of the information previously 

required is not available. The 

information must include a description 

of the source or device, a description of 

radiation safety features, intended use 

and associated operating experience, 

and results of a recent leak test. The 

NRC licensing staff will review the 

submitted information to make a 

licensing decision regarding possession 

and use of the source and device. This 

new provision is only applicable to 

sources and devices containing NARM 

manufactured before the effective date 

of this final rule. 

The information to be provided must 

demonstrate that there is reasonable 

assurance that the radiation safety 

properties of the source or device are 

adequate to protect health and minimize 

danger to life and property. The amount 

of detail needed to make this finding 

will depend on such things as the 

nature of the source or device and the 

amount of information identified in 10 

CFR 32.210(c) that is available. 

However, generally, the source or device 

description might include the 

radionuclide(s), source activity, 

chemical and physical form, 

manufacturer’s name, distributor’s 

name, model number, construction 

details such as source or device 

dimensions, source encapsulation, any 

labeling, and a radiation profile. A 

description of device radiation safety 

features might include shielding, on-off 

mechanisms or indicators, methods for 

locking beam shutters, any safety 

warning labels, type of installation 

including method of attachment to its 

mounting if installed in a fixed location 

and means of relocation if portable, and 

any automatic safety features. The 

description of the intended use of the 

source or device could include how the 

source or device is used, the types of 

users, the locations of use, the occasions 

when persons will be near the device 

and the frequency of these occasions, 

and the likely environments to which 

the source or device will be subjected 

during normal use and likely accident 

conditions. A description of associated 

operating experience using the source or 

device should describe how the device 

has been used, particularly if the device 

will be used in this manner in the 

future, should include routine 

maintenance procedures and how 

frequently performed, should note any 

operating problems and their resolution, 

and should identify any parts that were 

repaired or replaced. A description of a 

recent leak test should identify when 

the swipe was taken and evaluated and 

describe how the leak test swipe was 

taken, the results, and who conducted 

the evaluation. 

Applicants are not authorized to 

remove sources from a device to obtain 

source details, unless qualified and 

specifically authorized to perform these 

activities under a license. For 

‘‘uncontained’’ sources, applicants will 

need to use caution and minimize 

exposure time when attempting to 

gather details or information directly 

from the source. 

Regulating the Accelerator-Produced 

Radioactive Material Used in Medical 

Activities 

When reviewing the public 

comments, it was clear that the 

discussion in the proposed rule of the 

NRC’s existing regulatory framework for 

medical products, the distinction 

between radionuclide production 

licensing and radioactive drug 

production licensing, and the 

commercial and noncommercial 

distribution provisions, as well as the 

introduction of the term ‘‘consortium,’’

were confusing to commenters. In 

addition to responding to individual 

comments on these subjects in the 

‘‘Summary and Analysis of Public 

Comments on the Proposed Rule’’

section of this document, the following 

discussion is provided to give a clearer 

overview of the NRC’s regulatory 

framework than was provided in the 

proposed rule discussion, particularly 

with respect to the delineation between 

production of radionuclides and 

radioactive drugs. 

Section 651(e) of the EPAct requires 

the NRC to consider the impact of its 

regulations on the availability of 

radioactive drugs to physicians and 

patients. After consideration, the NRC 

concluded that its well established 

regulatory framework for the 

production, distribution, and use of in 

vitro test kits, radioactive drugs (which 

include biologics), and SS&Ds for 

medical use activities involving 

byproduct material is also appropriate 

in large part to similar products 

containing accelerator-produced 

radioactive materials. Using the existing 

regulations could, with minor changes, 

minimize the impact on the availability 

of radioactive drugs containing 

accelerator-produced radionuclides. 

Therefore, this regulatory framework is 

applied to the producers, distributors, 

and medical users of in vitro test kits, 

radionuclides, radioactive drugs, and 

SS&Ds containing NARM that are 


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included in the EPAct’s expanded 

definition of Byproduct material. 

Radionuclide Production 

The preexisting regulatory framework 

is directly applicable to the commercial 

production and distribution of NARM 

radionuclides. Longer-lived acceleratorproduced radionuclides used in 

medicine may include: thallium-201, 

cobalt-57, and palladium-103. The 

shorter half-life PET radionuclides may 

include: fluorine-18, oxygen-15, and 

carbon-11. The production of 

radionuclides by accelerators (including 

PET radionuclides from cyclotrons), as 

well as the subsequent possession and 

use of these radionuclides, will be 

licensed under existing requirements in 

10 CFR part 30. The producer of the 

accelerator-produced radionuclides 

(including PET radionuclides) can 

transfer these radionuclides to 

manufacturers and other specific 

licensees under the provisions of 10 

CFR 30.41. This includes both 

commercial and noncommercial 

distribution of accelerator-produced 

radionuclides (including PET 

radionuclides) to specifically licensed 

universities and research laboratories 

for basic research but not for use on 

human beings, which is specifically 

excluded in the definition of Research 

and development in 10 CFR 30.4. 

These radionuclide production 

facilities include commercial nuclear 

pharmacies with PET centers, i.e., 

facilities with cyclotrons used to 

produce PET radionuclides. The NRC 

will review applications and the 

associated radiation safety programs of 

these radionuclide production facilities 

in accordance with the criteria in 10 

CFR 30.33 and other existing 

requirements such as 10 CFR parts 19 

and 20. In meeting the general training 

and experience requirement in 10 CFR 

30.33(a)(3), these applicants will need to 

have individuals with training and 

experience in the production of PET 

radionuclides, i.e., the processes from 

insertion of targets in the accelerator or 

cyclotron to radiochemical isolation, 

purification, and testing. Individuals, 

such as radiochemists, physicists, 

engineers, and others identified by the 

applicant with appropriate training and 

experience, will be recognized as 

authorized users (AUs) under the 

manufacturer’s, producer’s, or 

pharmacy’s 10 CFR part 30 license for 

the production of accelerator-produced 

radionuclides (including PET 

radionuclides) using cyclotrons or other 

types of accelerators. To ensure the 

continued availability of acceleratorproduced radionuclides used to 

manufacture or prepare radioactive 

drugs, it is expected that individuals, 

who can demonstrate that they 

performed the radionuclide production 

activities using an accelerator at a 

radionuclide production facility under 

the NRC’s waiver (70 FR 51581; August 

31, 2005), will be recognized as AUs as 

long as their duties and responsibilities 

do not significantly change. The 

applicant will be required to document 

that these individuals were responsible 

for the production of radionuclides 

using a cyclotron or accelerator when 

the waiver was in effect. 

The NRC is distinguishing between 

the ‘‘production of radionuclides’’ and 

‘‘preparation of radioactive drugs.’’

Production of radionuclides, which 

would include production of PET 

radionuclides using a cyclotron (or 

other accelerator), is regulated under 10 

CFR part 30. Preparation of radioactive 

drugs for medical use from 

radionuclides, including PET 

radionuclides, is regulated under 10 

CFR 32.72 and 10 CFR part 35. 

Preparation of radioactive drugs for 

medical use may occur at locations 

other than the production facility. In the 

proposed rule, 10 CFR 32.72 included a 

provision to authorize commercial 

nuclear pharmacies that were not 

registered with FDA or registered with 

a State as a PET drug production facility 

to produce PET radionuclides if their 

radiation safety programs meet the 

criteria in 10 CFR 30.33. However, the 

purpose of 10 CFR 32.72 is to address 

the criteria and requirements for the 

production and commercial distribution 

of radioactive drugs for medical use, 

and not the production of radionuclides. 

Therefore, the final rule does not 

include this provision. Based on a 

review of the requirements in 10 CFR 

part 30, no revisions to the regulations 

are needed to license PET radionuclide 

production under 10 CFR part 30. 

10 CFR Part 32 Specific Production and 

Distribution Requirements. 

Byproduct material may be 

transferred under 10 CFR 30.41 from 

one specific licensee to another person 

authorized to receive the material. 

However, not all transfers can be made 

under this provision, and certain 

transfers (or distributions) require that 

the manufacturer, preparer, or 

distributor meet specific provisions of 

10 CFR part 32. Specifically, a 

commercial radioactive drug 

manufacturer or a commercial nuclear 

pharmacy must obtain a distribution 

license issued under 10 CFR 32.71 to 

distribute certain in vitro test kits to 

generally licensed medical and 

veterinary clinical laboratories, and a 

medical distribution (MD) license 

issued under 10 CFR 32.72 to 

commercially distribute radioactive 

drugs to 10 CFR part 35 (and equivalent 

Agreement State) medical use licensees. 

The proposed rule included revisions to 

the qualifications for a licensee to obtain 

a 10 CFR 32.72 MD license to more 

accurately describe the FDA registration 

criteria and to include licensees 

registered with a State as a PET drug 

production facility. These provisions are 

unchanged in the final rule. No changes 

are necessary for MD licenses issued to 

medical SS&D manufacturers under 10 

CFR 32.74. The MD licenses issued 

under 10 CFR 32.72 and 10 CFR 32.74 

authorize distribution for medical use 

(10 CFR part 35 and equivalent State) 

licensees. Under the NRC’s licensing 

practice, most of the 10 CFR part 32 

distribution licenses do not authorize 

the possession and use of byproduct 

material; rather, separate 10 CFR part 30 

licenses are issued for this purpose. 

PET radioactive drugs are made with 

radionuclides that are usually very short 

lived. In addition to the commercial 

drug manufacturers and commercial 

nuclear pharmacies, individual 

hospitals, educational institutions, and 

Federal facilities may have cyclotrons 

used to produce PET radionuclides and 

may also prepare PET drugs from these 

PET radionuclides. Although most PET 

radionuclides are very short lived, 

certain PET radionuclides with longer 

half-lives may be transported from the 

production facility to the user’s site. The 

longer-lived PET radionuclides may also 

be combined with nonradioactive 

chemicals and biologics to produce new 

PET radioactive drugs. Hence, there are 

production and commercial 

distributions of some PET radioactive 

drugs (e.g., fluorine-18 deoxyglucose) to 

medical users (10 CFR part 35 

licensees). 

Consortiums and Noncommercial 

Distribution 

The extremely short-lived 

radionuclides used for medical use have 

to be made into drugs and administered 

immediately after production, 

essentially necessitating that the 

cyclotron be located in the medical 

facility or in very close proximity. Some 

educational institutions, medical use 

facilities, or Federal facilities may form 

‘‘consortiums’’ with adjacent or nearby 

hospitals to jointly own or share in the 

operation and maintenance costs of the 

PET radionuclide production facility. 

‘‘Consortium’’ in this context means an 

association of medical use licensees, 

and a PET radionuclide production 

facility, in the same geographical area, 

that jointly own or share in the 

operation and maintenance cost of the 


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PET radionuclide production facility 

that produces PET radionuclides, for 

use in producing radioactive drugs 

within the consortium, for 

noncommercial distributions among its 

associated members for medical use. 

The PET radionuclide production 

facility within the consortium must be 

located at an educational institution or 

a Federal facility or a medical facility. 

These facilities may produce PET 

radionuclides and radioactive drugs for 

members of their consortium and make 

these PET radionuclides and drugs 

available to these associated facilities 

through noncommercial distributions. 

Before this rulemaking, the NRC’s 

regulations did not allow for the 

noncommercial distribution of 

radioactive drugs to medical use 

licensees. The NRC’s regulations in 10 

CFR 32.72 for the manufacture, 

preparation, or transfer of radioactive 

drugs cover only commercial 

distribution. Medical uses of drugs 

under 10 CFR 35.100, 35.200, and 

35.300 were previously limited to drugs 

obtained from a 10 CFR 32.72 licensee, 

or Agreement State equivalent, or 

prepared by the medical use licensee 

under specific provisions in 10 CFR part 

35. Because the NRC did not allow 

noncommercial distribution of 

radioactive drugs, failure to address 

noncommercial distribution of PET 

radioactive drugs in the this final rule 

would impact the availability of these 

drugs to physicians and patients. 

Therefore, the NRC developed a new 

regulatory process based upon existing 

practices to minimize impact on the 

noncommercial distribution of PET 

radioactive drugs to medical use 

licensees within such a consortium. In 

accordance with this process, a part 35 

medical use facility that uses its own 

cyclotron to produce PET radionuclides 

for use under its own medical use 

license, would not need to be licensed 

for medical distribution under 10 CFR 

32.72, but it would have to be 

specifically authorized under 10 CFR 

part 30 for the production of PET 

radionuclides. 

The definition of Consortium 

incorporates the unique features 

associated with the noncommercial 

distribution of PET radioactive drugs. 

For example, the consortium members 

must be in the same geographical area 

because of the short half-lives of PET 

radionuclides, e.g., 1.8 hours for 

fluorine-18, 20 minutes for carbon-11, 

and 2 minutes for oxygen-15. The 

location of the PET radionuclide 

production facility is limited to an 

educational institution or a Federal 

facility or a medical facility because 

these are the noncommercial facilities 

that would have cyclotrons that could 

produce PET radionuclides. 

The NRC will review PET 

radionuclide production applications 

and their radiation safety programs in 

accordance with the criteria in 10 CFR 

30.32 and 30.33 and other applicable 

requirements. In the proposed rule, only 

the noncommercial transfer of PET 

radioactive drugs between 10 CFR part 

35 medical use licensees was 

considered. However, the NRC 

recognized that the entity within the 

consortium with the PET production 

operation may not be a medical 

licensee, but a university or Federal 

facility. In addition, the radionuclide 

production facility requires a specific 

license under 10 CFR part 30. For this 

reason, the labeling provisions in 10 

CFR 35.69, which would only have 

applied to medical licensees, were 

relocated from 10 CFR part 35 to 10 CFR 

part 30. 

The new definition of Consortium and 

the provisions for noncommercial 

distribution are added to 10 CFR 30.4, 

30.32, and 30.34 to allow for 

authorization of the production of PET 

radioactive drugs for noncommercial 

transfer to medical use licensees within 

a consortium. Thus, under these new 

provisions, a medical use facility, 

educational institution, or Federal 

facility with a licensed PET 

radionuclide production facility within 

its consortium does not need a medical 

distribution license under 10 CFR 32.72 

if it intends to transfer PET radioactive 

drugs to members of its consortium. If 

it intends to commercially distribute 

PET radioactive drugs or distribute to 

medical licensees outside of its 

consortium, then a medical distribution 

license under 10 CFR 32.72 would be 

required. In any event, a specific 

authorization would be required to 

produce the PET drugs for 

noncommercial transfer to medical use 

licensees within its consortium. The 

requirements for authorization to 

produce PET drugs for noncommercial 

transfer to consortium members and the 

definition of Consortium are being 

added to 10 CFR 30.4. Specific 

requirements applicable to this licensed 

activity are added to 10 CFR 30.34(j). 

These requirements parallel the 

requirements for the commercial 

distribution of PET radioactive drugs, 

e.g., the licensee is qualified to produce 

radioactive drugs, the labeling contains 

consistent information, transport 

containers are adequately shielded, and 

radioactivity is accurately determined. 

Noncommercial distribution of PET 

radioactive drugs within a consortium 

may occur among members that are 

located in the same geographical area 

even if in different jurisdictions (e.g., 

Federal facility or other NRC licensees 

and Agreement State licensees). Thus, 

these new provisions are being assigned 

a Compatibility Category B. 

Minor revisions were proposed to 10 

CFR part 35 to permit medical use 

facilities to receive PET radioactive 

drugs by noncommercial transfer and to 

permit the medical use licensee to use 

activity values or activity concentration 

values for these PET radioactive drugs 

based on the measurements made by a 

PET radioactive drug producer within 

its consortium. The final rule also 

includes these provisions (in 10 CFR 

35.65(b)(2) and (c)(3), 35.100(a), 

35.200(a), and 35.300(a)), but the 

provisions are revised to clarify that the 

PET radioactive drugs have been 

produced by, and the measurements 

made by, the licensee authorized under 

10 CFR 30.32(j) to produce PET 

radioactive drugs for noncommercial 

transfer to members of its consortium. 

Authorized Nuclear Pharmacists (ANPs) 

and Authorized Users (AUs). 

No regulatory changes were needed 

for ANPs to use all byproduct material 

(i.e., reactor-produced radionuclides, 

PET radionuclides, and other 

accelerator-produced radionuclides) to 

prepare PET radioactive drugs and other 

radioactive drugs under the practice of 

pharmacy. Medical use licensees that 

receive PET radionuclides that are 

added to ‘‘cold kits’’ may continue to 

prepare them under the same 

authorization in 10 CFR 35.100(b), 

35.200(b), and 35.300(b) as other 

unsealed byproduct materials for 

medical use. However, a minor revision 

was made to each of these sections to 

clarify that the ANP and the qualified 

AU were not authorized under these 

sections to produce radionuclides. 

Further, to ensure the availability of 

radioactive drugs made from 

accelerator-produced radionuclides, 

nuclear pharmacists responsible for the 

preparation of only PET or other NARM 

radioactive drugs under the NRC’s 

waiver (70 FR 51581; August 31, 2005) 

will be ‘‘grandfathered’’ and will not be 

required to meet the new training and 

experience requirements as long as their 

duties and responsibilities under the 

new license do not significantly change. 

The ‘‘grandfathering’’ provisions are 

included in the revised provisions of 10 

CFR 35.57 and 10 CFR 32.72(b)(4). The 

licensee is required by 10 CFR 

32.72(b)(5) or 10 CFR 35.14(a) to 

document that these individuals were 

responsible for the preparation of only 

PET or other NARM radioactive drugs 

when the waiver was in effect. 


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To ensure a smooth transition and 

availability of radioactive drugs and 

sealed sources made from acceleratorproduced radionuclides for medical use, 

those individuals, i.e., physicians, 

podiatrists, dentists, and radiation 

safety officers (RSOs), who used only 

NARM byproduct materials for medical 

uses under the NRC’s waiver (70 FR 

51581; August 31, 2005) will also be 

‘‘grandfathered’’ in 10 CFR 35.57 as long 

as their duties and responsibilities do 

not change significantly. These new 

grandfathering provisions are limited to 

those who used only NARM during the 

waiver, because any prior use of ‘‘old’’

byproduct material would have been 

subject to the existing requirements for 

being an AU or ANP or RSO. 

These grandfathering provisions were 

in the proposed rule. However, the final 

rule does not include revisions to the 

definition of an Authorized user or 

Authorized nuclear pharmacist in 10 

CFR 35.2. The NRC concluded that the 

definitions did not need to be revised 

because the grandfathering provisions 

for the RSOs, medical physicists, 

nuclear pharmacists, physicians, 

dentists, and podiatrists, who used only 

accelerator-produced radioactive 

material, were included in 10 CFR 

35.57. Language has been added to 10 

CFR 35.57 to clarify that these 

individuals qualify as AUs and ANPs 

for purposes of the regulations in part 

35. In addition, these individuals could 

continue to work as AUs, Authorized 

medical physicists (AMPs), or ANPs 

under the notification provisions of 10 

CFR 35.13 and 10 CFR 35.14. 

The radiation safety knowledge 

needed to safely use NARM for medical 

uses or for use in the practice of 

pharmacy is similar to that for other 

byproduct material. Therefore, 

individuals who only used NARM 

radioactive drugs or sealed sources in 

the practice of medicine or pharmacy 

will be authorized for use of all similar 

byproduct material for the same uses. 

The reverse is also true that individuals 

already authorized to use byproduct 

material in 10 CFR part 35 for medical 

use or for use in the practice of 

pharmacy are authorized to use NARM. 

Further, no changes were made to the 

training and experience criteria in 10 

CFR part 35 for any authorized 

individual. 

Actions Taken To Ensure Availability of 

Accelerator-Produced Radioactive Drugs 

In summary, to minimize the 

regulatory impact on the availability of 

accelerator-produced radioactive drugs, 

the NRC is taking the following actions: 

(1) Applying its established regulatory 

framework to the commercial 

distribution of these drugs; (2) 

expanding the regulations to permit 

production of PET drugs by medical use 

licensees, educational institution 

licensees, and Federal licensees for 

noncommercial distribution to members 

of their consortium; (3) permitting 

medical use licensees to use activity or 

activity concentration values measured 

by the PET radioactive drug producer in 

their consortium when determining 

dosages; (4) ‘‘grandfathering’’ current 

medical and pharmacy users of 

accelerator-produced radioactive drugs; 

and (5) retaining the existing training 

and experience criteria in 10 CFR part 

35 for authorized individuals. 

In addition, as discussed under 

‘‘Implementation Strategy’’ in this 

document, the NRC is revising Parts 30, 

32, and 35 to authorize persons that 

used accelerator-produced radioactive 

material under the NRC’s waiver (70 FR 

51581; August 31, 2005) to continue to 

use these materials after the waiver is 

terminated, provided that these persons 

apply for a license or request for a 

license amendment within the allotted 

time frames. This regulatory provision 

allows all persons, including those who 

manufacture, produce, transfer, receive, 

acquire, own, possess, or use these 

materials, to continue with their 

activities including medical activities 

until the NRC makes its final licensing 

decision. This provision also ensures 

the availability of accelerator-produced 

radionuclides, radioactive drugs, and 

sealed sources and devices used for 

medical uses. 

Amendments and Notifications for PET 

Radionuclide Production and Delivery 

Lines 

The NRC reviewed its regulations in 

10 CFR Part 35 to determine if there 

were radiation safety provisions in its 

existing regulations that needed revision 

to incorporate unique radiation safety 

issues associated with the use of 

accelerator-produced radionuclides for 

medical use. The medical use of 

extremely short-lived radionuclides, 

e.g., oxygen-15, requires that a PET 

radioactive drug containing this 

radionuclide be administered in the 

imaging and localization medical use 

area (10 CFR 35.200) immediately after 

the radionuclide is produced by the 

cyclotron and processed as a radioactive 

drug. This necessitates that the medical 

use area be co-located with the 

cyclotron or have a PET radioactive 

drug delivery line from the PET 

radionuclide production/PET 

radioactive drug processing area. This 

introduces the potential for a high 

radiation area in a medical use area that 

would otherwise be a low radiation 

area. This is a unique situation and was 

not envisioned when the NRC 

developed the requirements that 

permitted licensees to make changes in 

the areas where byproduct material is 

used only in accordance with 10 CFR 

35.100 or 10 CFR 35.200 without 

submitting a license amendment. As a 

result, changes have been made to the 

requirements in revised 10 CFR 35.13, 

‘‘License amendments,’’ 10 CFR 35.14, 

‘‘Notifications,’’ and 10 CFR 35.15, 

‘‘Exemptions regarding Type A specific 

licenses of broad scope.’’ The final rule 

provides that an amendment is required 

for a limited specific medical use 

licensee in the unique situation 

described previously if the changes 

involved movement of the cyclotron or 

a PET radioactive drug delivery line 

from the PET radionuclide production/ 

PET radioactive drug processing area. 

Changes to the typical 10 CFR 35.100 

and 10 CFR 35.200 medical use areas 

are not affected. Section 35.15 is revised 

to clarify that a licensee possessing a 

Type A specific license of broad scope 

would not need to meet the notification 

requirements in 10 CFR 35.14(b)(5) for 

any changes to the area of use identified 

in its application where byproduct 

material is used in accordance with 10 

CFR 35.100 or 10 CFR 35.200. This 

provision was revised from the 

proposed rule. 

Strontium/Rubidium Generators 

Contamination limits for strontium82/rubidium-82 generators and related 

requirements consistent with similar 

provisions of the SSRs are added to 10 

CFR part 35. The contamination limits 

are no more than 0.02 kBq of strontium82 per MBq of rubidium-82 chloride 

injection (0.02 μCi of strontium-82 per 

mCi of rubidium-82 chloride), or no 

more than 0.2 kBq of strontium-85 per 

MBq of rubidium-82 chloride injection 

(0.2 μCi of strontium-85 per mCi of 

rubidium-82). These limits and 

requirements to measure the 

contamination for compliance with 

these limits are added to 10 CFR 35.204, 

with corresponding recordkeeping 

requirements added to 10 CFR 35.2204. 

A corresponding provision for these 

tests and associated recordkeeping is 

also added to 10 CFR 30.34 for 

nonmedical use licensees, such as 

commercial nuclear pharmacies, using 

these generators. 


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Appendix B to Part 20—Annual Limits 

on Intake (ALIs) and Derived Air 

Concentrations (DACs) of Radionuclides 

for Occupational Exposure; Effluent 

Concentrations; Concentrations for 

Release to Sewerage 

The comparable provisions in Part D 

of the SSRs do not include any new 

accelerator-produced radionuclides 

other than the ones already in 10 CFR 

part 20, Appendix B. The NRC 

considered whether some other 

radionuclide-specific values should be 

added to 10 CFR part 20, Appendix B. 

Because nitrogen-13 and oxygen-15 are 

two of the accelerator-produced 

radionuclides that are produced for 

medical uses, the NRC performed a 

preliminary calculation of values based 

on dose factors published in National 

Council on Radiation Protection and 

Measurements (NCRP) Report No. 123 

on Screening Models for Releases of 

Radionuclides to Atmosphere, Surface 

Water, and Ground. Certain dose 

conversion factors were not readily 

available. Results from these 

preliminary calculations yielded a 

derived air concentration (DAC) based 

on the submersion scenario for both 

nitrogen-13 and oxygen-15 of about 1.48 

× 10¥2 becquerels per milliliter (Bq/ml) 

(4 × 10¥6 μCi/ml) for occupational 

exposure and a corresponding effluent 

concentration of 7.4 × 10¥4 Bq/ml (2 × 

10¥8 μCi/ml) for exposure of members 

of the public. These calculated values 

are larger than the default values for 

DAC and effluent concentration by a 

factor of 40 and 20, respectively, in 10 

CFR part 20, Appendix B. Because the 

approach used in calculating values for 

nitrogen-13 and oxygen-15 is different 

from that used for other radionuclides 

included in 10 CFR part 20, Appendix 

B, the NRC did not include adding 

specific values for these radionuclides 

in the proposed rule. Because certain 

medical communities had expressed the 

desire of having specific DACs for these 

two radionuclides, the Commission 

specifically requested public comment 

on the default values, and whether it 

should include larger specific values for 

oxygen-15 and nitrogen-13 in the final 

rule. As a result of comments, these 

values have been added to 10 CFR part 

20, Appendix B, in the final rule. This 

is discussed further in this document 

under ‘‘Summary and Analysis of Public 

Comments on the Proposed Rule.’’

Emergency Planning 

The regulations in 10 CFR 30.32(i)(1) 

require applications for specific licenses 

for byproduct material in unsealed form, 

on foils or plated sources, or sealed in 

glass in excess of the quantities in 10 

CFR 30.72, ‘‘Schedule C—Quantities of 

radioactive materials requiring 

consideration of the need for an 

emergency plan for responding to a 

release,’’ to contain either an evaluation 

showing that the maximum dose to a 

person offsite, due to a release of 

radioactive materials, would not exceed 

0.01 sievert (Sv) (1 rem) effective dose 

equivalent or 0.05 Sv (5 rems) to the 

thyroid, or an emergency plan for 

responding to a release of radioactive 

material. Schedule C also contains a 

release fraction for each radionuclide 

against which aspects of the evaluation 

submitted in place of an emergency plan 

must be compared in accordance with 

10 CFR 30.32(i)(2). 

Although Part P, ‘‘Contingency 

Planning for Response to Radioactive 

Material Emergencies,’’ of the SSRs 

addresses an emergency plan, a value 

for radium-226 is not specifically listed. 

The NRC staff therefore considered 

NUREG–1140, ‘‘A Regulatory Analysis 

on Emergency Preparedness for Fuel 

Cycle and Other Radioactive Material 

Licensees,’’ dated August 1991. 

NUREG–1140 was used as the technical 

basis in a past rulemaking effort related 

to quantities of radioactive materials 

requiring an emergency plan. NUREG–

1140 provided the basis for 10 CFR 

30.72 Schedule C values. Schedule C 

also contains a default value for alpha 

emitters of 74 gigabecquerels (GBq) (2 

curies (Ci)) (with release fraction 0.001), 

which would apply to discrete sources 

of radium-226 absent a specific value 

being added to the table. However, the 

quantity value for radium-226 in 

NUREG–1140 is 3.7 terabecquerels 

(TBq) (100 Ci) along with a release 

fraction value of 0.001. This final rule 

adds radium-226 with the quantity 3.7 

TBq (100 Ci) and release value 0.001 to 

10 CFR 30.72 Schedule C, which is 

consistent with the technical basis for 

the original emergency planning 

requirements. It is expected that few, if 

any, licensees, or applicants for a 

license, would have 3.7 TBq (100 Ci) of 

discrete sources of radium-226. Because 

the ‘‘rule of ratios’’ applies (See 

Footnote 1 to 10 CFR 30.72), licenses 

authorizing other byproduct material, in 

quantities approaching values that 

would require emergency planning, 

which are being amended to add 

significant quantities of discrete sources 

of radium-226, could potentially result 

in authorizing total quantities of 

byproduct material that would meet the 

criteria for emergency plan 

requirements. It is not expected that 

accelerator-produced radioactive 

materials are used in significant enough 

quantities to affect the applicability of 

emergency plan requirements. 

Low-Level Radioactive Waste and 

Decommissioning 

Low-Level Radioactive Waste 

Section 651(e)(3) of the EPAct 

mandates that the newly added 

byproduct material is not considered to 

be low-level radioactive waste for the 

purposes of the Low-Level Radioactive 

Waste Policy Amendments Act (42 

U.S.C. 2021b) (LLRWPAA). The intent 

of this provision is that the newly added 

byproduct material is not to be impacted 

by the compact process of the 

LLRWPAA. This provision does not 

have an impact on the NRC’s policy and 

requires only a minor change to the 

regulations to ensure that the term ‘‘lowlevel radioactive waste,’’ when used in 

the NRC’s requirements, does not 

include the newly added byproduct 

material. 

Although the newly added byproduct 

material is not considered low-level 

radioactive waste, it does pose a similar 

hazard, and it does need to be disposed 

of appropriately. Section 651(e)(3) of the 

EPAct requires that the newly added 

byproduct material must be disposed of 

in a facility that: (1) Is adequate to 

protect public health and safety; and (2) 

is licensed by the Commission or by an 

Agreement State. Even though it is not 

low-level radioactive waste, this 

provision clarifies that the newly added 

byproduct material is to be disposed of 

in a facility licensed by the NRC under 

10 CFR part 61 or the Agreement State 

requirements, which are compatible to 

10 CFR part 61. This provision also 

allows for the disposal of the newly 

added byproduct material in a facility 

licensed by the NRC under other parts 

of the NRC’s regulations, such as 

facilities licensed under 10 CFR part 40, 

Appendix A. 

To ensure that disposal facilities 

licensed under 10 CFR part 61 continue 

to be adequate to protect public health 

and safety, the NRC must consider the 

specific health and safety issues 

associated with disposal of discrete 

sources of radium. Rather than making 

any changes to 10 CFR part 61 at this 

time, the NRC will evaluate any specific 

disposals of discrete sources of radium 

at an NRC-licensed disposal facility 

under 10 CFR 61.58, ‘‘Alternative 

requirements for waste classification 

and characteristics.’’ The NRC has not 

identified any other radionuclides being 

added to the definition of Byproduct 

material that require any specific 

evaluations to ensure the proper 

disposal of waste in accordance with 10 

CFR part 61. 


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Notwithstanding the previously 

mentioned provisions for the NRC or 

Agreement State licensing of the 

disposal facility for the newly added 

byproduct material, Section 651(e)(3) of 

the EPAct does not affect the authority 

of any entity to dispose of the newly 

added byproduct material at a disposal 

facility in accordance with any Federal 

or State solid or hazardous waste law, 

including the Solid Waste Disposal Act. 

This means that Federal and State solid 

or hazardous waste laws can continue to 

be used as an authority to permit 

disposal of this newly added byproduct 

material. Disposal solutions already in 

place to allow disposal of the newly 

added byproduct material are unaffected 

by the EPAct. To implement this 

provision of the EPAct, the NRC is 

changing its regulations in 10 CFR Part 

20 to redefine Waste to allow disposal 

of the newly added byproduct material 

in the NRC-regulated disposal facilities 

or in a disposal facility permitted under 

Federal or State solid or hazardous 

waste laws. 

Appendix G of 10 CFR Part 20, the 

uniform manifesting requirements for 

low-level radioactive waste, includes 

numerous requirements containing the 

words ‘‘low-level radioactive waste’’

and ‘‘waste.’’ This is potentially 

confusing because the newly added 

byproduct material is not low-level 

radioactive waste in accordance with 

the provisions of the EPAct. However, 

no changes have been made to 

Appendix G to 10 CFR Part 20. The text 

changes made to the 10 CFR Part 20 

regulations to clarify that the newly 

added byproduct materials are not ‘‘lowlevel radioactive waste’’ make it clear 

that the Appendix G to 10 CFR Part 20 

requirements must be met if any of the 

newly added byproduct material waste 

is to be disposed of at a facility licensed 

under 10 CFR Part 61 or an equivalent 

Agreement State rule. 

Decommissioning Issues 

The inclusion of accelerator-produced 

radioactive material that is used for a 

commercial, medical, or research 

activity, in the definition of Byproduct 

material, requires the NRC to ensure 

that decommissioning funding is 

adequate at accelerator facilities to 

adequately decontaminate and 

decommission their facilities for license 

termination. Radioactive materials 

produced in accelerator facilities, that 

are produced, extracted or converted 

after extraction for use for commercial, 

medical, or research purposes and that 

are no longer residing in the accelerator, 

are not a concern for decommissioning. 

However, materials intentionally or 

incidentally made radioactive as a result 

of the production of the radioactive 

materials for use for commercial, 

medical, or research purposes must be 

managed safely. Any radioactive 

material residing in the accelerator or 

within the facility that houses the 

accelerator must be adequately 

considered for safe operation, and 

managed appropriately at the time of 

decommissioning of the acceleratorproduced radionuclide production 

facility, including the accelerator, and 

the NRC must ensure that adequate 

financial assurances are put in place to 

address the costs of decommissioning 

when the radionuclide production 

operation ceases, and the accelerator is 

shutdown, and the license is 

terminated. As with all decontamination 

and decommissioning situations, shortlived radionuclides are expected to 

decay to safe levels before license 

termination. Therefore, only 

radionuclides with a half-life of more 

than 120 days, that are present in 

sufficient quantities specified in 10 CFR 

30.35, need to be addressed for the 

purposes of establishing adequate 

financial assurances for 

decommissioning. 

Similarly, the addition of discrete 

sources of radium-226 in the definition 

of Byproduct material requires the NRC 

to ensure that decommissioning funding 

is adequate for holders of specific 

licenses for possession of discrete 

sources of radium-226. Radium-226 is 

already included in Appendix B of 10 

CFR Part 30 to determine the required 

level of financial assurance for holders 

of specific licenses in accordance with 

the requirements of 10 CFR 30.35. 

Therefore, applicants for specific 

licenses to possess discrete sources of 

radium-226 will need to assure that 

adequate financial assurances are 

provided for the types of sources and 

the total amount of radium-226 

contained in the sources they will 

possess. Holders of general licenses for 

possession of discrete sources of 

radium-226 do not need financial 

assurance for decommissioning. 

However, in accordance with the 

approach for general and specific 

licensing of discrete sources of radium226 being undertaken by the NRC in this 

final rule, a general licensee may 

become subject to specific licensing if 

the accumulated number of discrete 

sources of radium-226 exceeds the 

allowable quantities of a general license. 

If a general licensee becomes subject to 

specific licensing, the licensee would be 

required to acquire the financial 

assurances required under 10 CFR 

30.35. 

The NRC believes that the financial 

assurance requirements included in 10 

CFR 30.35 are adequate to ensure that 

any person who will receive a specific 

license authorizing possession and use 

of byproduct material will be required 

to have adequate financial assurance in 

place for decommissioning the facility. 

Therefore, the NRC is not changing the 

regulations governing financial 

assurance for decommissioning. 

The NRC is cognizant of the potential 

existence of facilities and sites which 

may be, or have the potential to become, 

contaminated with significant amounts 

of radium-226 from past practices or 

operations. Additionally, the potential 

exists for significant quantities of 

discrete sources of radium-226 to have 

been previously disposed of by both 

licensees and nonlicensees at their 

facilities. The existing requirements for 

licensing and decommissioning in 10 

CFR Part 30 are sufficient to address 

these situations for any facilities that 

will apply for a specific license or 

amendment to authorize possession of 

discrete sources of radium-226 for their 

current operations. The applications to 

the NRC, in these cases, would include 

a facility-specific decommissioning plan 

that addresses the current 

contamination and any previous onsite 

disposals. 

There are no similar assurances for 

any facility that is currently 

contaminated from discrete sources of 

radium-226 but is not licensed. With the 

inclusion of discrete sources of radium226 in the definition of Byproduct 

material, the NRC acquires the 

regulatory authority to address these 

situations where a specific license has 

not been issued (or where a potential 

licensee cannot be identified). At this 

time, there is not enough known about 

the breadth or depth of these potential 

radium-226 contamination situations to 

determine if any additional 

requirements may be needed to address 

them. Therefore, the NRC will address 

these situations on a case-by-case basis 

as they are identified following the 

effective date of this final rule. 

D. License Application and Annual Fees 

The NRC is required to recover 

approximately 90 percent of its budget 

authority each year under the Omnibus 

Budget Reconciliation Act of 1990 

(OBRA–90), as amended. Therefore, the 

NRC charges licensing, inspection, and 

annual fees to its applicants and 

licensees. Each type of fee includes 

agency and program overhead. The NRC 

revises these fees each year in light of 

its current fiscal year budget and other 

factors, including changes in the 

regulatory efforts associated with the 

different classes of licensees. 


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Persons applying for a license with 

the NRC, or requesting an amendment to 

their current licenses that may result in 

the addition of a new fee category, are 

required to pay a license application fee 

under 10 CFR Part 170, unless exempt 

under the fee exemption provisions of 

10 CFR 170.11. The application fees for 

materials users are ‘‘flat’’ fees that are 

calculated by multiplying the average 

professional staff hours needed to 

process the application by the 

professional staff-hour rate in 10 CFR 

170.20 ($258 in the FY 2007 final fee 

rule). An application fee must generally 

be paid for each applicable fee category. 

Additionally, all persons who hold 

licenses issued by the NRC are subject 

to annual fees under 10 CFR Part 171, 

unless exempt under the provisions of 

10 CFR 171.11. The 10 CFR Part 171 fee 

categories, and the associated fees for 

materials users, are provided in 10 CFR 

171.16, and must generally be paid for 

each applicable fee category. A licensee 

may request consideration as a small 

entity for the annual fees which may 

result in a reduced fee, as described in 

10 CFR 171.16. 

The annual fees for the materials 

users fee class are calculated based on 

the NRC’s budgeted resources allocated 

to regulating these types of licensees, 

less any receipts received from this fee 

class for 10 CFR Part 170 activities. The 

net dollar value of budgeted resources 

for this fee class is allocated to all 

materials user fee categories (subclasses) 

based on the average application and 

inspection costs associated with each 

category. This approach provides a 

proxy for allocating the generic and 

other regulatory resources to the diverse 

categories of licensees based on how 

much it costs the NRC to regulate each 

fee category. The fee calculation also 

considers the inspection frequency 

(priority based), which is indicative of 

the safety risk and resulting regulatory 

costs associated with these categories of 

licenses. 

The license application fees schedule 

is in 10 CFR 170.31. The annual fees 

schedule is in 10 CFR 171.16. The fee 

amounts included in the proposed rule 

were based on the FY 2005 fees. The fee 

amounts noted in the final rule are 

based on the final FY 2007 fees. The 

final 2007 fee rule was published June 

6, 2007 (72 FR 31402). 

The NRC believes that the majority of 

the NRC’s licensees affected by this final 

rulemaking will be using radioactive 

material in a manner similar to their 

existing authorizations, and their 

existing fee categories should not 

change as a result of this rule. However, 

some licensees may need to amend their 

licenses to add one or more new fee 

categories, if applicable, for new uses 

and radioactive material now 

considered byproduct material, i.e., 

accelerator-produced radioactive 

material or discrete sources of radium226. 

The NRC is establishing three new fee 

categories for activities that were not 

previously covered by its regulations. 

The new fee categories apply to certain 

items previously manufactured and selfluminous products containing radium226 and to the production of 

accelerator-produced radioactive 

material. In determining the fees for 

these new categories, the NRC evaluated 

existing fee categories that the NRC 

believes require a similar level of 

regulatory effort as these newly 

regulated activities for actions such as 

licensing, inspection, and event 

response. 

Most individuals and other entities 

collecting items containing radium-226 

are expected to be eligible to be exempt 

from license under 10 CFR 30.15 or for 

a general license under the new 10 CFR 

31.12, ‘‘General license for certain items 

and other self-luminous products 

containing radium-226.’’ Therefore, they 

would be subject to the requirements of 

10 CFR 30.15 or 10 CFR 31.12 (e.g. 

proper disposal of the radioactive 

material). However, if a person collects 

more than the number of items or limits 

specified in these sections, that person 

will be required to obtain a specific 

license and be subject to the regulations 

regarding license application and 

annual fees. The NRC is establishing a 

new fee category, 3.R., with a two-tiered 

fee level, for those persons requiring a 

specific license for items containing 

radium-226. The distinction between 

the two fee levels is based on the 

number of items or limits specified in 

10 CFR 31.12(a)(4) or (5) and the 

estimate of the level of regulatory effort 

between the two levels. Licensees who 

currently possess radium sources in 

amounts that exceed the general license 

provisions of 10 CFR 31.12 would be 

required to add the sources to their 

specific license. This would normally 

subject the licensee to the fees in this 

new fee category. However, if the 

radium-226 sources are used for 

operational purposes that are covered 

under another fee category, the licensee 

will not be subject to the fees in this 

new fee category. This exception will 

not apply if the radium sources are 

possessed for storage only. 

The first new fee Category 3.R.1. is for 

persons possessing quantities greater 

than the number of items or limits in 10 

CFR 31.12(a)(4) or (5), but less than or 

equal to 10 times these quantities. 

Because the estimated level of 

regulatory effort is comparable to the 

level of effort for Category 8, Civil 

defense, the license application and 

annual fees for 3.R.1. will be $590 and 

$2,100, respectively. The second new 

fee Category 3.R.2. is for persons 

possessing quantities greater than 10 

times the number of items or limits in 

10 CFR 31.12(a)(4) or (5). The license 

application and annual fees for this new 

category, 3.R.2., will be $1,400 and 

$2,700, respectively, comparable to the 

fees for Category 3.P., ‘‘All other specific 

byproduct material licenses, except 

those in Categories 4A through 9D.’’

Persons who wish to disassemble, 

repair, or assemble products containing 

radium-226 will be required to obtain a 

specific license and will be subject to 

the applicable license application and 

annual fees. The NRC is including this 

use in fee Category 3.B., ‘‘Other licenses 

for possession and use of byproduct 

material issued under 10 CFR Part 30 of 

this chapter for processing or 

manufacturing of items containing 

byproduct material for commercial 

distribution.’’ The license application 

fee for this category will be $4,600, and 

the annual fee will be $8,400. 

The NRC is adding a new fee Category 

3.S. for the production of acceleratorproduced radioactive materials. The 

NRC is adding this new fee category 

because these production activities need 

to be distinguished from those activities 

that only involve the use of alreadyprepared radionuclides. The regulatory 

effort for the new fee Category 3.S. is 

estimated to be similar to that for fee 

Category 3.C. The license application 

and annual fees for this new category 

will be $8,000 for the application fee 

and $10,900 for the annual fee. The 

annual fee for category 3.S. in this final 

rule is slightly less than that for category 

3.C. because the category 3.S. fee does 

not include a portion of the low-level 

waste (LLW) surcharge, while the 

category 3.C. fee does. This is because 

the licensees in fee category 3.C. 

directly benefit from the NRC’s LLW 

activities, but the licensees in fee 

category 3.S. do not. Fee amounts 

included in this final rule are different 

from those included in the proposed 

rule because they are based on the FY 

2007 Fee Schedules instead of the FY 

2005 Fee Schedules. 

E. Implementation Strategy 

Specific provisions are included in 

this rule, and several actions are 

planned in conjunction with, or 

following, the issuance of this final rule 

covering the newly added byproduct 

material, including: 

(1) Issuance and publication of a 

Transition Plan for the orderly 


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transition of regulatory authority for the 

newly added byproduct material; 

(2) Termination of the waiver issued 

by the NRC (70 FR 51581; August 31, 

2005) for the States and users of the 

newly added byproduct material; and 

(3) Inclusion of specific provisions 

allowing users of the newly added 

byproduct material to continue with 

their activities for a period of time while 

coming into compliance with the newly 

issued regulations. 

Transition Plan 

Section 651(e) of the EPAct requires 

the NRC, in issuing new regulations for 

the newly added byproduct material, to 

prepare and publish a Transition Plan 

for the orderly transition of regulatory 

authority over the newly added 

byproduct material for Agreement and 

non-Agreement States. The EPAct 

requires that the Transition Plan 

describe the conditions under which a 

State (including U.S. Territories and the 

District of Columbia) may exercise 

authority over the newly added 

byproduct material, and include a 

statement of the Commission, that any 

agreement between the Commission and 

a State under Section 274b. of the AEA, 

covering byproduct material, and 

entered into before the date of 

publication of the Transition Plan, be 

considered to include the newly added 

byproduct material. The statement of 

the Commission is subject to a 

certification provided by the Governor 

of the State to the Commission on the 

date of publication of the Transition 

Plan that: (1) the State has a program for 

licensing the newly covered byproduct 

material that is adequate to protect the 

public health and safety, as determined 

by the Commission; and (2) the State 

intends to continue to implement the 

regulatory responsibility of the State 

with respect to the byproduct material. 

The NRC also will include in the 

Transition Plan the process it will use 

to terminate the waiver issued by the 

NRC on August 31, 2005, and for the 

transition of regulatory authority 

following expiration or earlier 

termination of the waiver. 

Termination of Waiver 

The waiver issued by the NRC (70 FR 

51581; August 31, 2005) is effective 

through August 7, 2009 (except 

terminated August 7, 2006, for the 

import and export of materials covered 

by the waiver), unless terminated earlier 

by the Commission. The waiver applies 

to Agreement and non-Agreement State 

regulatory programs and users of the 

newly added byproduct material, and 

allows persons owning, using, and 

otherwise engaging in activities 

involving the material to continue with 

their activities and the States to 

continue to regulate this material during 

the applicable waiver period. All 

persons in States (including U.S. 

Territories and the District of Columbia) 

that do not have an agreement with the 

Commission under Section 274b. of the 

AEA that covers the newly added 

byproduct material on or before August 

7, 2009, will automatically be subject to 

the NRC regulatory authority for the 

material on August 8, 2009. The waiver 

also may be terminated earlier than 

August 7, 2009, if the Commission 

determines that an earlier termination is 

warranted. 

For a new or existing Agreement State 

that intends to implement the regulatory 

program of the State with respect to the 

newly added byproduct material, 

Section 651(e) of the EPAct requires that 

the waiver be terminated for the State 

when the Commission determines that 

the State has entered into an agreement 

with the Commission, under Section 

274b. of the AEA, that the State program 

covers the newly added byproduct 

material, and that the State program for 

licensing the newly added byproduct 

material is adequate to protect the 

public health and safety. The 

Commission determination and 

termination of the waiver will be 

noticed in the Federal Register 

(Notification of Waiver Termination). 

Users of the newly added byproduct 

material currently licensed, or 

registered, by an Agreement State that 

continues to implement its regulatory 

program, with respect to the newly 

added byproduct material, will continue 

to be subject to the Agreement State 

regulatory authority. 

With regard to the States that do not 

have an existing agreement with the 

Commission under Section 274b. of the 

AEA (non-Agreement States), the waiver 

period provides additional time for 

those States that desire to establish such 

an agreement for the newly added 

byproduct materials to develop a 

program. To establish this agreement 

with the Commission, the Governor of 

the current non-Agreement State will 

need to request an agreement with the 

Commission. The process of 

establishing these agreements can take 3 

or more years to complete. Options will 

be considered, on a case-by-case basis, 

to limit the impact of the transition of 

authority on affected users of the new 

byproduct material in the State. 

Additional details on the process that 

the NRC will use to terminate the 

waiver for Agreement and nonAgreement States and users in these 

States will be provided in the 

Commission’s Transition Plan, as 

required by Section 651(e) of the EPAct. 

The NRC plans to publish the Transition 

Plan following publication of this final 

rule and before the effective date of this 

final rule. 

Notification of Waiver Termination 

The Commission is terminating the 

waiver for Government agencies and 

Federally recognized Indian Tribes on 

the effective date of this final rule 

because there is currently limited 

regulatory oversight for the newly added 

byproduct material at these facilities. 

Waiver termination is necessary to 

require Government agencies and 

Federally recognized Indian Tribes to 

comply with the new requirements and 

for the NRC to ensure protection of 

public health and safety for the newly 

added byproduct material. 

The Commission has also determined 

that an earlier termination is warranted 

and is therefore terminating the waiver 

for persons owning, using, and 

otherwise engaging in activities 

involving the newly added byproduct 

material in the following States on the 

effective date of this final rule: 

Delaware, Indiana, Wyoming, and 

Montana, as well as the District of 

Columbia, Puerto Rico, and the U.S. 

Virgin Islands. The effective date of this 

final rule is 60 days after the date of 

publication in the Federal Register. 

Waiver termination is necessary to 

require persons owning, using, and 

otherwise engaging in activities 

involving the newly added byproduct 

material in these States, U.S. Territories, 

and the District of Columbia to comply 

with the new requirements and for the 

NRC to ensure protection of public 

health and safety for the newly added 

byproduct material. 

Implementation Period 

Although Government agencies, 

Federally recognized Indian Tribes, and 

certain persons owning, using, and 

otherwise engaging in activities 

involving the newly added byproduct 

material in the States of Delaware, 

Indiana, Wyoming, and Montana, and 

the District of Columbia, Puerto Rico, 

and the U.S. Virgin Islands are already 

being regulated by the NRC for the AEA 

11e.(1) and 11e.(2) byproduct material, 

the NRC is allowing a transitional 

period for them to submit a license 

amendment or a new license application 

for the newly added byproduct material. 

This final rule allows an additional 6- 

month period from the effective date of 

the final rule to apply for a license 

amendment; and an additional 12- 

month period from the effective date of 

the final rule to apply for a new license. 


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In addition, the rule contains specific 

provisions that gives Governmental 

agencies, Federally recognized Indian 

Tribes, and persons owning, using, and 

otherwise engaging in activities 

involving the newly added byproduct 

material, in the States of Delaware, 

Indiana, Wyoming, and Montana, and 

the District of Columbia, Puerto Rico, 

and the U.S. Virgin Islands, the 

authority to continue to use the newly 

added byproduct material during the 

period following the waiver termination 

until the date of the NRC’s final 

licensing determination, provided that 

either a license amendment or a license 

application is submitted within the 

specified time frame and while 

complying with all other aspects of the 

regulations (e.g., event reporting, 

personnel dosimetry) upon the effective 

date of this final rule. 

For persons owning, using, and 

otherwise engaging in activities 

involving the newly added byproduct 

material, compliance with the rule will 

be required depending on the date of 

waiver termination. For certain States 

and persons, the NRC plans to terminate 

the waiver earlier than the final date of 

the waiver, i.e., August 7, 2009. A 

decision for early termination will 

depend on a number of factors, 

including the status of an Agreement 

State Governor’s certification of 

adequate program for the newly added 

byproduct material, status of a nonAgreement State’s application to 

become an Agreement State, and 

activities or areas under exclusive NRC 

jurisdiction. Upon waiver termination, 

all persons that possess the new 

byproduct materials must be in 

compliance with NRC regulations. It is 

noted that being in compliance with the 

NRC regulations includes, for example, 

meeting the reporting and 

recordkeeping requirements for the new 

byproduct material once the waiver is 

terminated. In addition, such persons 

will either be required to: (1) apply for 

license amendments for the new 

byproduct material within 6 months 

from the date the waiver is terminated, 

if they hold an NRC specific byproduct 

materials license; or (2) submit a license 

application for the new byproduct 

material within 12 months from the date 

the waiver is terminated. It is noted that 

authorization statements for certain 

licenses are inclusive of byproduct 

materials and their uses so that an 

amendment may not be needed to 

specifically add NARM to the license. 

During the time between the 

termination of the waiver and the user’s 

application for an NRC license or 

license amendment, users in 

Government agencies, Federally 

recognized Indian Tribes, and nonAgreement States will be under the 

NRC’s jurisdiction for enforcement 

purposes. The NRC will handle 

enforcement cases involving the use of 

the newly regulated materials on a caseby-case basis. However, should the 

number of cases involving these 

materials be larger than anticipated, the 

staff will prepare additional 

enforcement guidance to ensure 

consistency in handling such issues. 

III. Summary and Analysis of Public 

Comments on the Proposed Rule 

The proposed rule on Requirements 

for Expanded Definition of Byproduct 

Material was published on July 28, 2006 

(71 FR 42952). The comment period 

ended on September 11, 2006. The NRC 

received 39 comment letters on the 

proposed rule. Comment letters were 

submitted from the States, other Federal 

agencies, professional organizations, 

universities, medical communities, 

industries, and individuals. On August 

22, 2006, the NRC held a public meeting 

in Las Vegas, Nevada, on the proposed 

rule during the comment period. Copies 

of the public comments and the public 

meeting transcripts are available for 

review in the NRC Public Document 

Room, 11555 Rockville Pike, Rockville, 

Maryland. 

In addition to requesting public 

comments on the proposed rule, the 

NRC specifically requested additional 

information or comments on 15 specific 

items outlined in Section II.G. of the 

proposed rule. A synopsis of the items 

and type of comments received are as 

follows: 

Item 1—Technical Information to 

Support Exemption of Old Radium-226 

Sources. One commenter provided 

information on potential pressure buildup within radium sources that could 

lead to the release of radium into the 

environment. Another commenter 

provided a reference to an FDA 

document. There were comments on the 

availability of information on radium226 items and on exemption of 

antiquities. The NRC appreciates the 

information. A discussion of the 

comments on exemption of antiquities 

and associated response is included 

later in this document under 

‘‘Comments Related to Radium-226.’’

Item 2—Extent of Use of Accelerators. 

No comments were received regarding 

the extent of accelerators that are used 

to intentionally produce radioactive 

material and also used to generate 

particle beams for basic science 

research. One commenter indicated that 

the commenter’s organization does not 

operate any particle accelerators for the 

purpose of producing radioactive 

materials and producing particle beams 

for other uses. Another commenter 

informed the NRC that it will be 

building a new accelerator facility 

where radionuclides will be produced. 

Item 3—Information on 

Decommissioning of Accelerator 

Facilities. Several comments were 

received regarding information on 

decommissioning of accelerator 

facilities, including accelerator 

components and facility building 

materials that may become activated. A 

detailed discussion of the comments 

and response is included later in this 

document under ‘‘Comments on Waste 

and Decommissioning.’’

Item 4—Inclusion of Specific ALI and 

DAC Values. In response to the NRC’s 

question on whether to develop specific 

ALI and DAC values for oxygen-15 and 

nitrogen-13 for inclusion in 10 CFR Part 

20, Appendix B, several commenters 

provided specific DAC values. A 

discussion of the values and the 

methodology used can be found later in 

this document under ‘‘Comments on 

Other General Requirements.’’

Item 5—Exemption of Radium-226 

Timepiece Repairs. In regard to the 

appropriateness of the proposed 

exemptions to allow repairs of 10 

radium-226 timepieces per year, one 

commenter suggested increasing the 

proposed limit of 10 per year to 18. The 

commenter did not provide specific data 

concerning how active the repair of 

radium-226 timepieces may be or the 

safety significance of the proposed 

exemption. However, there were several 

comments related to radium-226 

exemptions. Detailed discussion of 

these comments and the associated 

responses is included later in this 

document under ‘‘Comments Related to 

Radium-226.’’

Item 6—Health and Safety 

Information of Radium-226 Sources. 

The NRC requested information on the 

health and safety impact from activities 

involving radium-226 sources, in 

particular, information to support a 

technical basis for an exemption as an 

alternative to the proposed general 

licensing approach. Several commenters 

indicated that they believed that an 

exemption would be preferable to a 

general license for items containing 

radium-226, but no specific health and 

safety impact information was provided. 

Most commenters agreed that more 

information about risk is needed to 

make a final decision. Discussion of 

comments associated with this issue is 

included later in this document under 

‘‘Comments Related to Radium-226.’’

Item 7—Existing and Proposed Fee 

Categories. The NRC requested 

information on whether the majority of 


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licensees would remain in the existing 

fee categories and whether new NARM 

licensees would fall under the current 

fee categories or the new proposed fee 

categories. No specific information on 

this issue was received from the 

commenters. However, several 

commenters indicated that they 

believed that there is no need to 

establish a new fee category for the 

production of accelerator-produced 

radioactive material. All of the 

comments related to fees are discussed 

later in this document under 

‘‘Comments on Licensing Fees and Fee 

Categories’’. 

Item 8—Licensing Boundaries for 

Radium-226 Private Collectors. No 

information was received on whether 

private collectors of items or products 

containing radium-226 would remain 

within the boundaries of the proposed 

general license or be required to obtain 

a specific license and be charged with 

the associated licensing fees. One 

commenter recommended that an 

‘‘exception’’ be extended to certain 

organizations. A discussion of radium226 exemptions is included in 

subsection ‘‘Comments Related to 

Radium-226,’’ and a discussion of fees 

is included later in this document under 

‘‘Comments on Licensing Fees and Fee 

Categories’’. 

Item 9—Two-Tiered Fees for Radium226. No information was received 

regarding the two-tiered license fees 

proposed for possession of different 

quantities of radium-226 items. 

Comments received on the proposed fee 

categories and amounts are discussed 

later in this document under 

‘‘Comments on Licensing Fees and Fee 

Categories’’. 

Item 10—Effective Date and 

Implementation Periods. Several 

comments were received on the 

proposed effective date and 

implementation periods of the rule. A 

discussion is included later in this 

document under ‘‘Comments on Waiver 

Termination and Transitioning.’’

Item 11—Compatibility Category 

Designations. All comments related to 

the compatibility category designations 

are discussed later in this document 

under ‘‘Comments Related to Agreement 

States and Other Government 

Agencies’’. 

Item 12—Environmental Assessment. 

Comments received on the draft 

Environmental Assessment were 

considered in the final Environmental 

Assessment and Finding of No 

Significant Impact. 

Item 13—Information Collections. No 

comments were received on the 

information collections aspects of the 

rule. 

Item 14—Regulatory Analysis. No 

comments were received on the draft 

Regulatory Analysis. 

Item 15—Impact to Small Business. 

No comments were received on the 

impacts of the rule on small businesses. 

General information and editorial 

suggestions received on the proposed 

rule are appreciated but do not need to 

be discussed in this final rulemaking. 

Comments associated with nuclear 

reactors and the high-level waste 

repository are outside the scope of this 

rulemaking; therefore, they will not be 

addressed in this section. All other 

comments have been grouped into broad 

categories, and a detailed discussion of 

the comments and the NRC’s responses 

are as follows: 

Comments Related to Agreement States 

and Other Government Agencies 

Agreement State Compatibility 

Designations 

Comment: The comments received on 

‘‘compatibility’’ are primarily centered 

around one main concern: 

Implementation of the requirements for 

the Compatibility Category of Health 

and Safety (H&S) for several definitions. 

The basic concern expressed by these 

commenters was that the States should 

not be required to amend their 

definitions in their State statutes and 

regulations. In particular, some 

commenters were concerned about the 

designation of H&S for the definition of 

Byproduct material. These commenters 

indicated that they would support an 

H&S designation if the Statements of 

Consideration to the final rule provided 

that the NRC’s initial determination of 

the adequacy of definitions would rely 

on a Governor’s certification that the 

State’s program was ‘‘adequate,’’ and 

that if the Governor’s certification was 

accepted, no changes to the State’s 

definitions would be required. As an 

alternative, some commenters suggested 

that the Statements of Consideration 

recognize that the States could use 

alternative language in their definitions 

including the use of the more generic 

term of ‘‘radioactive material,’’ rather 

than revise the definitions to conform 

with the new definitions. In the absence 

of implementing those suggestions, 

these commenters recommended that 

the Compatibility Category designation 

for definitions be changed from H&S to 

D. 

These commenters generally 

indicated that if those suggestions could 

not be implemented, they would 

recommend that the NRC designate the 

definitions it was changing as 

Compatibility D. 

NRC Response: The NRC does not 

agree with the commenters’ assertion 

that the designation for the definition of 

Byproduct material should be changed 

from H&S. The NRC also does not agree 

that the Governor’s certification of the 

adequacy of an Agreement State’s 

program should relate to the need for 

the State to revise its regulations. 

However, the States may continue to use 

the existing definition including 

Radioactive material in State statutes 

and regulations, although there may be 

limited areas where a State may need to 

revise its regulations to include material 

now under the jurisdiction of the NRC 

(e.g., exempt distribution for certain 

materials). 

The NRC applied the criteria in 

Management Directive (MD) 5.9, 

‘‘Adequacy and Compatibility of 

Agreement State Programs,’’ in 

evaluating the compatibility category of 

the definitions, and determined that a 

category of H&S is appropriate for the 

definition of Byproduct material. MD 

5.9 provides that an H&S designation is 

appropriate for elements that are not 

required for compatibility but have been 

identified as having a particular health 

and safety role in the regulation of 

agreement material within the State. In 

accordance with this designation, the 

State should adopt program elements, 

based on those of the NRC, that embody 

the essential objectives of the NRC 

program elements because of particular 

health and safety considerations. A 

category of H&S is appropriate for the 

definition of Byproduct material 

because the absence of the essential 

objectives of the program element from 

an Agreement State program could 

create a situation that could directly 

result in exposure to an individual in 

excess of basic radiation protection 

standards. 

MD 5.9 provides that the NRC 

program elements in Compatibility 

Category D are those that do not meet 

the criteria of Compatibility Categories 

A, B, or C, and thus, do not need to be 

adopted by the Agreement States for 

purposes of compatibility. The NRC has 

determined that a Compatibility D 

designation is not appropriate for the 

definition of Byproduct material 

because if the definition of Byproduct 

material or another term which 

encompasses all of the byproduct 

material regulated by the State were not 

somewhere within the State program 

(i.e., in statute or in regulations), it is 

possible that some byproduct material 

could escape regulatory oversight with a 

result of exposure to an individual in 

excess of the 10 CFR Part 20 limits. The 

State regulatory program must include 

Sections 11e.(3) and 11e.(4) byproduct 


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material in its regulatory program if the 

Agreement includes this material, thus, 

an H&S designation (an assessment of 

adequacy) is appropriate. 

In implementing the Commission’s 

policy on Agreement States, a 

designation of H&S for the definition of 

Byproduct material will require NRC 

staff to continue to assure that the 

essential objectives (i.e. Sections 11e.(3) 

and (4) byproduct materials are 

addressed in the regulatory program) are 

met. The NRC staff notes that under a 

designation of D, this assurance would 

not be obtained because program 

elements designated D are not a 

required part of an Agreement State 

program (they could be dropped from or 

not included in the Agreement State 

program, and the program could still be 

found adequate and compatible). 

Comment: With regard to the 

definitions in 10 CFR 35.2 of Authorized 

nuclear pharmacist, Authorized user, 

and Positron Emission Tomography 

(PET), one commenter recommended 

that any Agreement State that has rule 

language essentially the same as the 

current CRCPD’s SSRs should be 

considered to have compatible rules and 

should not have to revise those rules 

regardless of the level of compatibility 

assigned by the NRC. The commenter 

further recommended that the NRC 

might include this recognition in the 

Statements of Consideration. 

NRC Response: The NRC has 

determined that it is not necessary to 

change the current definitions for an 

Authorized user or Authorized nuclear 

pharmacist. This rule does not change 

the existing definitions or impact the 

existing compatibility designation for 

these definitions. The definition of 

Positron Emission Tomography is not in 

the SSRs, and it is identified in the final 

rule as having a designation of ‘‘H&S,’’

which assures that the State’s regulatory 

programs adequately address the 

essential objectives of the NRC program 

elements when using the term Positron 

Emission Tomography. 

Comment: For each of the sections 

with a Compatibility B Category, it is 

not clear that the NRC accepts the 

language of the States that is essentially 

identical to the SSRs. 

NRC Response: For the definitions 

and sections assigned a Compatibility B 

designation, the NRC cannot 

automatically accept the States’

language; the States’ regulations must be 

reviewed. Agreement State regulations 

will be reviewed according to Office of 

Federal and State Materials and 

Environmental Management Programs 

(FSME) Procedure 201 (SA–201) and 

should be submitted within 3 years of 

publication, in accordance with the 

NRC’s 1997 Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs (62 FR 

46517; September 3, 1997). The NRC 

notes that portions of the SSRs may be 

outdated and do not reflect recent 

amendments (e.g., definitions of 

Authorized user and Authorized nuclear 

pharmacist) and so cannot be used. 

Comment: Referring to 10 CFR 32.72, 

a commenter recommends that the NRC 

specifically recognize that an Agreement 

State will not be required to amend its 

comparable regulation, as long as that 

comparable regulation provides for the 

same control of the manufacture and 

initial distribution of radium-226 

sources under a general license as was 

provided in the proposed regulation. 

NRC Response: The NRC does not 

agree with the comment. Section 32.72 

in 10 CFR Part 30 authorizes specific 

licensees to manufacture, prepare, and 

distribute radioactive drugs to medical 

use licensees. This provision does not 

include generally licensed material. 

Further, the NRC is unaware of any 

radioactive drugs containing radium226. Agreement States have 3 years to 

adopt regulatory requirements 

compatible with 10 CFR 32.72 revisions. 

For a specific license to allow the 

manufacture or initial transfer of 

calibration or reference sources 

containing radium-226, under 10 CFR 

32.57, for distribution to persons 

generally licensed, the NRC has 

included provisions in 10 CFR 31.8 to 

recognize specific licenses issued for 

these sources by a State with 

comparable regulations. 

Comment: A commenter stated that 

the NRC’s deliberate use of 

Compatibility B and H&S categories sets 

the tone that its considerations are 

preeminent. Another commenter stated 

that the language of the EPAct indicates 

that the burden should be on the NRC 

to bring its regulations into conformance 

with the Agreement State regulations. 

The commenter also stated that whether 

or not the NRC is making an effort to 

obey the EPAct language to cooperate 

with the States or use model State 

standards will depend on whether the 

NRC accepts the Agreement States’

regulations. The commenter believes 

that the Agreement State regulations do 

not need to be changed to be exactly like 

the NRC’s. 

NRC Response: In accordance with 

AEA Section 274b, for an agreement 

between the NRC and a State, a State 

program must be adequate to protect 

public health and safety and be 

compatible with the NRC. The EPAct 

gives the NRC jurisdiction over NARM 

byproduct material, and does not 

mandate that the NRC bring its 

regulations into conformance with the 

Agreement State regulations, but only 

requires that the Commission, to the 

maximum extent practicable, cooperate 

with the States and use model State 

standards. The Commission has fulfilled 

this mandate by working closely 

throughout the development of this final 

rule with OAS, the CRCPD, and other 

stakeholders, and by considering the 

model State standards. As discussed 

previously, the NRC applied criteria laid 

out in MD 5.9, ‘‘Adequacy and 

Compatibility of Agreement State 

Programs,’’ which includes criteria for 

the NRC to designate compatibility and 

adequacy categories to the NRC’s 

regulations and coordinating 

amendments for radioactive material 

included in the Agreement. In 

promulgating the final rule, these 

criteria were applied to the definitions 

and other requirements of the EPAct to 

determine the appropriate compatibility 

categories. 

Interaction With Other Federal Agencies 

Comment: A commenter asked if any 

Memorandum of Understanding (MOU) 

between the NRC and the DOT on 

byproduct materials would be affected 

by the changes in the proposed rule. 

NRC Response: The roles and 

responsibility between DOT and the 

NRC in the regulation of the 

transportation of radioactive material 

are clearly described in an MOU signed 

on June 8, 1979, and published in the 

Federal Register (44 FR 38690; July 2, 

1979). As delineated in the MOU, the 

DOT is generally responsible for 

regulating safety in transportation of all 

hazardous material, including 

radioactive material, and the NRC is 

responsible for regulating safety in 

receipt, possession, use, and transfer of 

byproduct, source, and special nuclear 

materials. The NRC is also responsible 

for approval of package designs for 

fissile materials and for other 

radioactive materials in quantities 

exceeding Type A limits. In reviewing 

the language of the existing MOU, the 

NRC has determined that no change is 

necessary as a result of this final rule. 

The MOU stated that the NRC is 

authorized to regulate, among other 

things, byproduct material under the 

AEA of 1954, as amended, and the 

Energy Reorganization Act of 1974, as 

amended. Because the EPAct amends 

the AEA, the expanded definition of 

Byproduct material will automatically 

be subject to the MOU. In addition, 

there are routine interactions between 

the NRC and the DOT, and the DOT is 

aware of the expanded definition of 

Byproduct material. 


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Comment: A commenter asked if the 

proposed changes in the regulations 

would have any impact on accelerators 

or accelerator radionuclides that are 

taken to sea or out of the U.S., and if 

those changes would also impact the 

EPA’s responsibilities, treaty 

requirements, or Status of Forces 

agreements. For example, the 

commenter noted that a research vessel, 

military hospital, or Centers for Disease 

Control vessel leaving the U.S. for 

foreign ports and returning to the U.S. 

may have an electron microscope or 

metabolic (Na, Cl, K) studies with 

accelerator-produced radionuclides on 

board. The commenter asked if 

activation from neutron radiography on 

board these ships would be an issue. 

The commenter also asked if the 

proposed changes would affect 

machines that the U.S. Customs uses to 

radiograph containers in foreign ports 

before they are placed on shipboard if 

the machine is greater than 1 MeV. The 

commenter also wanted to know how 

replaced parts of those machines will be 

handled, whether all parts would be 

controlled, and whether they could be 

disposed of in a foreign state. 

NRC Response: The commenter 

appears to be concerned, in part, about 

regulatory requirements pertaining to 

U.S. originated accelerator-produced 

radioactive material taken outside of the 

U.S., i.e., export of accelerator-produced 

radioactive material. Part 110 of the 

NRC’s regulations governs export and 

import of radioactive material within 

the NRC’s regulatory jurisdiction. On 

April 20, 2006 (71 FR 20336), the NRC 

issued a final rule amending 10 CFR 

Part 110 to reflect the EPAct’s 

augmentation of the NRC’s regulatory 

jurisdiction to include acceleratorproduced radioactive material. 

Specifically, the rule added 

‘‘accelerator-produced radioactive 

material’’ to the definition of Byproduct 

material in 10 CFR 110.2 and Appendix 

L to 10 CFR Part 110. Export and import 

of all byproduct material, including 

accelerator-produced radioactive 

material, are governed by 10 CFR Part 

110. There is no difference in regulatory 

treatment between byproduct material 

produced by an accelerator and 

byproduct material produced in a 

reactor. 

The commenter also asks whether this 

rule would affect U.S. Customs’ use of 

‘‘radiograph machines.’’ The NRC does 

not believe this final rule would have 

any impact on the Customs and Border 

Protection’s use of radiograph machines 

because these machines use byproduct 

material that is already regulated by the 

NRC because the material is produced 

in a reactor. With the revised definition 

of Byproduct material, there will be no 

difference in regulatory treatment 

between byproduct material produced 

by an accelerator and byproduct 

material produced in a reactor. If the 

radiograph machine uses the 

accelerator-produced radioactive 

material, it would now be subject to the 

same regulatory requirements as the 

machine-used byproduct material 

produced in a reactor. The NRC’s or any 

other requirements on the use of 

byproduct material in radiograph 

machines would be no different from 

the pre-EPAct condition for both the 

domestic and export context. 

Neutron radiograph machines do not 

use byproduct material; they are 

actually accelerators. Only neutron 

beams are generated in these types of 

radiograph machines for imaging 

purposes. Because these types of 

radiograph machines (or accelerators) 

do not produce radioactive material for 

use for commercial, medical, or research 

activities, the NRC has no regulatory 

authority over these machines or the 

activation material produced incidental 

to imaging operation. 

Comment: A commenter 

recommended that the NRC pursue an 

MOU with OSHA in order for the NRC 

to assume regulatory jurisdiction over 

the occupational exposure to ionizing 

radiation in non-Agreement States. The 

commenter noted that before the 

expansion of the NRC’s jurisdiction over 

NARM, OSHA had jurisdiction for 

occupational health and safety in nonAgreement States. The commenter noted 

that OSHA published a request for 

information to better understand what, 

if any, changes OSHA needed to 

consider in its regulation of the use of 

ionizing radiation in the workplace 

(See: Occupational Exposure to Ionizing 

Radiation—Request for Information; 70 

FR 22828; May 3, 2005). The commenter 

recommended that the NRC work 

actively with OSHA to streamline the 

regulatory requirements and eliminate 

duplication of authority over the use of 

NARM in non-Agreement States. 

NRC Response: The NRC has been 

working, and continues to work, with 

OSHA and other Federal agencies 

through the Interagency Steering 

Committee on Radiation Standards 

(ISCORS) to coordinate issues and 

activities, including the development of 

Federal Guidance for Occupational 

Exposure to Radiation and regulations 

related to radiation protection and 

safety. The NRC recognizes that the 

existing MOU is now out of date with 

respect to references of enabling 

legislation and the respective 

jurisdictions of the two agencies as a 

result of the EPAct. However, the 

procedures specifying the interactions 

between OSHA and the NRC and the 

authority and responsibilities of each 

agency remain appropriate and valid to 

cover interactions in the newly enacted 

jurisdictional framework. Thus, the NRC 

does not believe that there is an 

imminent need to reexamine and update 

the MOU. 

Comment: Several commenters 

requested clarification on the NRC’s 

jurisdiction and role regarding radium226 contaminated sites or old landfills, 

especially for sites currently under 

remediation by either the EPA or an 

authorized State under the RCRA or the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA, also known as 

Superfund) programs. One commenter 

asked if the NRC and EPA have 

executed an MOU for Superfund sites. 

Another commenter asked if the NRC/ 

EPA MOU on decommissioning (2002) 

will be impacted by this rule. Another 

commenter suggested that the NRC and 

EPA should have a dialogue to discuss 

a collaborative approach to address 

licensing of discrete sources covered by 

this rule that are already considered as 

part of the Superfund efforts. The 

commenter indicated that such dialogue 

would complement ongoing 

coordination between EPA and the NRC 

under the existing MOU, ‘‘Consultation 

and Finality on Decommissioning and 

Decontamination of Contaminated 

Sites’’. 

NRC Response: Under the EPAct, the 

NRC has the regulatory authority over 

any discrete source of radium-226 that 

is produced, extracted, or converted 

after extraction, before, on, or after the 

date of enactment of the act for use for 

a commercial, medical, or research 

activity. Hence, the NRC has the 

jurisdiction over old landfills or 

disposal sites contaminated with 

radium-226 due to past operations or 

disposal of discrete sources of radium226. 

The NRC typically has regulatory 

authority over sites undergoing 

radiological decommissioning, even 

those sites that also contain EPA 

hazardous materials (CERCLA and 

RCRA). The NRC and EPA have entered 

into site-specific agreements via formal 

letters in which the license for a site 

undergoing decommissioning was put 

in abeyance and regulatory authority for 

decommissioning the site deferred to 

the EPA. There is no MOU for these 

agreements because they are rare and 

very site specific. The NRC anticipates 

that this site-specific process will 

continue. 

The current MOU ‘‘Consultation and 

Finality on Decommissioning and 


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Decontamination of Contaminated 

Sites’’ between the NRC and EPA 

defines the policy for deferral of 

regulatory authority between the two 

agencies for radiological 

decommissioning and decontamination 

of the NRC-licensed sites. The MOU 

specifically provides that under certain 

clearly defined criteria, EPA agrees to a 

basic policy of EPA deferral to the NRC 

decisionmaking in the decommissioning 

of the NRC-licensed sites without the 

need for consultation. If the criteria are 

not met, the MOU directs the NRC to 

consult with the EPA regarding the site. 

The MOU does not provide for the 

deferral of regulatory authority from the 

NRC to the EPA. 

The NRC has routine interactions 

with EPA through ISCORS and through 

informal communications among staff 

on a multitude of subject areas. 

Currently, there are seven 

subcommittees in ISCORS, including 

Cleanup, Federal Guidance, Mixed 

Waste, Naturally Occurring Radioactive 

Material, Recycle, Risk Harmonization, 

and Sewage Sludge Subcommittees. The 

NRC will continue to work closely with 

EPA though ISCORS and other informal 

mechanisms regarding 

decommissioning and decontamination 

of sites. 

Because the NRC had been deferring 

regulatory authority to the EPA on a 

site-by-site basis in the past, the NRC 

believes, at this time, that there may not 

be a need to revise the existing MOU. 

Once the NRC has gained sufficient 

experience in dealing with old disposal 

sites contaminated with the newly 

added byproduct material and if 

significant issues arise regarding shared 

regulatory authority, the NRC will 

cooperate with EPA in evaluating the 

need to amend the existing MOU and in 

determining an approach in resolving 

issues in managing these old disposal 

sites. 

Comment: A commenter noted that 

the discussions on current regulatory 

structures for NARM, and on other 

Federal agencies’ regulatory authority 

over NARM, do not mention that some 

Federal licensees, such as licensees who 

hold a Master Materials License (MML), 

have established self-regulation 

requirements for NARM use. The 

commenter recommended that the NRC 

should describe the MML licensees’ role 

in the regulation of NARM. 

NRC Response: MML licensees are the 

NRC licensees and are required to 

comply with the NRC regulations. The 

fact that some MML licensees have 

established self-regulating requirements 

for accelerator-produced radioactive 

material and may have issued permits to 

their permittees for these materials is 

noted. 

Comment: A commenter stated that 

requirements under several sections 

related to a master materials license 

address ‘‘a permit issued by a 

Commission master material license 

broad scope permittee’’ with the 

implication that a broad-scope permittee 

is required to issue such a permit. The 

commenter stated that, in most cases, 

the permittee might issue an 

authorization or other type of document 

for an AU. The commenter requested 

that the regulatory requirement be 

revised as ‘‘a permit, or other 

authorization, issued by a Commission 

master material license broad-scope 

permittee’’. 

NRC Response: The NRC does not 

agree that this language is ambiguous. 

The use of the phrase ‘‘a permit issued 

by a Commission broad scope licensee’’

has been used by the NRC in 10 CFR 

Part 35 since the 1994 ‘‘Radiopharmacy 

Rule’’ (59 FR 61781; December 2, 1994) 

to designate the document that the 

broad-scope Radiation Safety Committee 

issues to individuals to permit or 

authorize them to use specific 

radionuclides for licensed activities. 

The same term was used in the major 

revision to 10 CFR Part 35 (67 FR 20370, 

April 24, 2002) for the same type of 

documentation issued by the MML 

broad-scope permittee to individuals at 

its facility. 

Comments on Defining the Byproduct 

Material 

Comment: A commenter, discussing 

the proposed Byproduct material 

definition in 10 CFR 20.1003 and 30.4, 

believes the wording ‘‘produced, 

extracted, or converted after extraction, 

before, on, or after August 8, 2005,’’ was 

confusing and ambiguous, stating that 

the phrase, ‘‘before, on, or after August 

8, 2005,’’ appears to be meaningless and 

that it was not clear whether the phrase 

referred only to material ‘‘converted 

after extraction,’’ or to material 

‘‘produced, extracted, or converted after 

extraction’’. 

NRC Response: The phrase, ‘‘before, 

on, or after August 8, 2005,’’ has been 

incorporated into the definition of 

Byproduct material in the AEA as a 

result of the language of the EPAct. It is 

included in the definition in the final 

rule because it is important to be clear 

that materials that have been produced, 

extracted, or converted after extraction 

at any time, even before promulgation of 

the EPAct, are included. This phrase is 

intended to apply to all of these 

activities, i.e., the production, 

extraction, and conversion after 

extraction. Not having such an explicit 

phrase in the definition may raise 

questions regarding applicability of the 

regulations for materials resulting from 

past activities. 

Definition of Discrete Source 

Comment: Commenters generally 

supported the stated result of the 

definition as to the limits of NRC’s 

authority and specifically the proposed 

limitation of the definition to exclude 

radium-bearing wastes generated by 

many facilities, including drinking 

water treatment plants and oil and gas 

production facilities. One commenter 

specifically agreed with the definition 

stating that it captured the important 

aspects of the discussions at the public 

and interagency meetings, as well as the 

original intent of earlier versions of 

legislation incorporated into the EPAct. 

However, other commenters expressed 

concerns about the clarity of the 

definition. Several commenters stated 

that some of the provisions in the 

proposed definition of discrete source, 

such as the requirements that the source 

have physical boundaries and that the 

materials have been concentrated for 

their radiological properties, were 

ambiguous and could lead to uneven 

regulation. The commenters 

recommended that the NRC revise the 

proposed definition, and two 

commenters suggested alternate 

definitions. 

One commenter stated that the 

phrases ‘‘with physical boundaries’’ and 

‘‘which is separate and distinct from the 

radioactivity present in nature’’ in the 

proposed definition of Discrete source 

could cause confusion. The commenter 

stated that the requirement for physical 

boundaries without further description 

or statement of the purpose of the 

physical boundaries is ambiguous and 

leaves room for uneven regulation. 

Commenters were also concerned with 

the words, ‘‘which is separate and 

distinct from the radioactivity present in 

nature,’’ particularly with the usage of 

‘‘radioactivity.’’ One commenter stated 

that a workable definition is crucial to 

keep unintended materials from being 

captured. 

Other commenters expressed concern 

about the phrase, ‘‘with the intent that 

the concentrated radioactive material 

will be used for its radiological 

properties,’’ with one commenter 

recommending that it be deleted. This 

commenter noted that it has 

encountered situations where discrete 

sources of radium-226 were deposited 

over a large area of land in which there 

were discrete nuggets and that there was 

no way of determining whether the 

discrete nuggets were produced for their 

radiological properties or not. 


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NRC Response: The proposed 

definition of Discrete source was ‘‘a 

radioactive source with physical 

boundaries, which is separate and 

distinct from the radioactivity present in 

nature, and in which the radionuclide 

concentration has been increased by 

human processes with the intent that 

the concentrated radioactive material 

will be used for its radiological 

properties.’’ It is clear from some of the 

comments that the proposed definition 

of Discrete source, particularly the 

phrase ‘‘with physical boundaries,’’

creates confusion that would, among 

other things, present problems with the 

regulation of material no longer in its 

original form, but which the NRC 

intends to regulate. 

The wording in the final rule has been 

revised to clarify the ambiguities that 

gave rise to these comments. The 

revised definition of Discrete source is 

‘‘a radionuclide that has been processed 

so that its concentration within a 

material has been purposely increased 

for use for commercial, medical, or 

research activities’’. 

With the modification of the 

definition of Discrete source to 

eliminate the word ‘‘separate’’ and the 

phrase ‘‘with physical boundaries,’’

radium contamination resulting from 

the use of purposely concentrated 

radium-226 falls within the definition of 

Discrete source. These changes should 

make it clearer that the NRC’s 

jurisdiction continues through 

decommissioning. The radiological 

criteria for unrestricted use in 10 CFR 

20.1402 refer to residual radioactivity 

that is distinguishable from background. 

Some commenters appeared concerned 

that for purposes of decommissioning, it 

would not be possible to distinguish 

between the atoms of material that had 

been purposely concentrated for use for 

its radiological properties from atoms of 

material present in nature. This concern 

is not warranted because, in practice, 

this is not the methodology used to 

determine the need for 

decontamination. 

The revised definition also removes 

the requirement that the purpose for 

concentrating radium-226 (or other 

identified naturally occurring 

radioactive material) be specifically for 

use of its radiological properties. 

However, this change is not expected to 

have any practical effect on the 

regulation of radium-226, as all known 

uses of radium-226 have been for its 

radiological properties and not 

primarily its chemical or physical 

properties. The only effect of revising 

the definition would be if a future use 

is made of a highly radioactive naturally 

occurring material involving chemical 

or physical, but not radiological, 

properties. To constitute byproduct 

material as it is now defined in Section 

11e.(4) of the revised AEA, this material 

would have to have been determined by 

the Commission to meet the standard of 

threat similar to that of radium-226. 

The comments on the definition of 

Discrete source relate mainly to 

questions concerning what naturally 

occurring radioactive material will be 

considered byproduct material, and thus 

be regulated by the NRC. In revising the 

definition of Discrete source, the 

Commission has also added the 

condition that to be a discrete source, 

the radionuclide has been processed so 

that its concentration within a material 

has been purposely increased ‘‘for use 

for commercial, medical, or research 

activities.’’ The addition of this limiting 

phrase may appear redundant, as the 

words ‘‘for use for a commercial, 

medical, or research activity’’ are 

already in the definition of Byproduct 

material, and a discrete source is a 

subcategory of byproduct material. 

However, the addition of these words to 

the definition of Discrete source ensures 

an understanding that the term ‘‘discrete 

source,’’ where used in the regulations 

other than in the definition section of 

the regulations, will be subject to this 

limitation. 

The Commission interprets the words 

in the definition of Byproduct material, 

‘‘produced, extracted, or converted after 

extraction for use for a commercial, 

medical, or research activity,’’ to mean 

a purposeful activity whereby the 

radium-226, or other specific 

radionuclide, if identified in accordance 

with Section 11e.(4) of the revised AEA, 

is processed for the use of the radium226 (or other specific radionuclide). 

This purposeful activity must relate to 

the radium-226 (or other radionuclide) 

and not to the overall material that 

inadvertently contains radium-226, for 

example, fertilizer. However, this 

activity need not involve an actual 

isotopic separation process specifically 

separating radium-226 from radium-228. 

In addition, the ‘‘new’’ byproduct 

material consists of the specific 

radionuclides only, and not the 

associated material. For example, in a 

radium salt, the atoms other than those 

of radium in the salt are not part of the 

byproduct material. The NRC notes that 

the original definition of Discrete 

source, as it had been proposed, was 

written to contain strict constraints to 

guard against any potential 

interpretation that the NRC was 

extending its jurisdiction in an 

unintended or unauthorized manner. 

However, the NRC has found that these 

constraints were, in a large part, 

unwarranted because, as already noted, 

a discrete source is a subset of the 

specifically delineated byproduct 

material that is being regulated and 

must, therefore, be constrained by the 

general definition of the new Byproduct 

material. In this connection, the NRC 

also removed the words ‘‘distinct from 

the radioactivity present in nature’’ as 

an unnecessary condition. 

Comment: Some commenters had 

questions concerning the regulatory 

authority over the manufacture of 

radiological sources and the associated 

waste management. One commenter 

noted that the EPAct does not assign 

responsibility to the NRC for regulating 

the manufacture of discrete sources, 

rather, the NRC’s responsibility applies 

after a discrete source is produced. The 

commenter asked whether the 

Agreement States would be required to 

regulate the manufacturing and waste 

management aspects of source 

production, and also who is responsible 

for radiological safety if the 

manufacturing occurs in a nonAgreement State. Another commenter 

asserted that the manufacture of radium 

sources should be specifically licensed, 

even though the radium may not yet 

meet the definition of a Discrete source. 

NRC Response: The EPAct gave the 

NRC authority to regulate radium-226 

that is produced, extracted, or converted 

after extraction, before, on, or after the 

date of enactment for use for a 

commercial, medical, or research 

activity. Therefore, the NRC does have 

authority for regulating the manufacture 

of sources, and the NRC’s responsibility 

applies before, on, or after a source is 

produced. This should be more evident 

with the revised wording of the 

definition of Discrete source. Radium226 is byproduct material and under the 

NRC’s jurisdiction if it is purposely 

concentrated and produced, extracted, 

or converted after extraction, for use for 

a commercial, medical, or research 

activity. 

Section 30.3, ‘‘Activities requiring 

license,’’ states ‘‘Except as provided in 

paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) 

of this section and for persons exempt 

as provided in this part and part 150 of 

this chapter, no person shall 

manufacture, produce, transfer, receive, 

acquire, own, possess, or use byproduct 

material except as authorized in a 

specific or general license issued in 

accordance with the regulations in this 

chapter.’’ Therefore, the NRC will 

regulate the manufacture of products 

involving the intentional use of discrete 

sources of radium-226, as well as 

resulting wastes. A specific license will 

be required for the manufacture of such 

radium sources. 


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Comment: A commenter asked if the 

proposed definition of Discrete source 

would include sources that are 

electroplated, i.e., where the 

radioactivity is on the surface of the 

source and is not encapsulated and 

therefore is not separate from nature 

(such as radium needles). 

NRC Response: Electroplated sources 

are included as the wording of the 

definition in the final rule clarifies. 

Comment: A commenter 

recommended that the NRC add the 

definition of Discrete source to 10 CFR 

Part 35 in addition to 10 CFR Parts 20 

and 30. 

NRC Response: The NRC Part 35 

licensees are required to comply with 10 

CFR Parts 20 and 30. The term Discrete 

source is being defined in those 

regulations. Therefore, it is not 

necessary to repeat the definition in Part 

35. 

Other Naturally Occurring Radioactive 

Material 

Comment: Two commenters asserted 

that they believe the NRC should 

consider other criteria in addition to the 

International Atomic Energy Agency 

Code of Conduct Categories 1 and 2 to 

determine if there are any other 

nuclides that would pose a threat to 

public health and safety and common 

defense and security similar to that 

posed by a discrete source of radium226. 

One commenter did not believe that 

using IAEA Categories 1 and 2 to 

measure the risk of other nuclides 

against the risk posed by discrete 

sources of radium-226 meets the EPAct 

requirement to consider comparative 

risk to public health and safety as well 

as common defense and security. The 

commenter stated that within the U.S., 

IAEA Categories 1 and 2 have been 

associated with ‘‘high-risk’’ sources and 

activities of concern to common defense 

and security, not to health and safety. 

The commenter argued that instead, 

because IAEA regards uncontrolled 

Categories 1, 2, and 3 sources as 

potentially dangerous to human health, 

Category 3 is also a threat, and the 

NRC’s analysis should at least include 

that Category in addition to Categories 

1 and 2. 

However, the commenter agreed with 

the NRC that polonium-210 does not 

need to be included in the definition of 

Byproduct material under the category 

of naturally occurring radioactive 

materials posing a similar risk as radium 

because the production of polonium-210 

discrete sources for commercial, 

medical, or research use is by activation 

in a reactor, and therefore it is already 

regulated as byproduct material. 

Another commenter asked if, by using 

IAEA Categories 1 and 2 to measure 

other nuclides’ comparative risk to 

radium-226, the NRC meant to only 

regulate materials that could be fatal or 

cause permanent injury if they are not 

safely managed or securely protected. 

The commenter asked whether discrete 

sources of radium-226 that do not meet 

the IAEA Category 1 or 2 definitions 

would not be regulated in the expanded 

definition of Byproduct material. The 

commenter asserted that regulations for 

radioactive materials should not be 

based solely on acute effects. 

NRC Response: The EPAct expanded 

the definition of Byproduct material to 

include any discrete source of naturally 

occurring radioactive material, other 

than source material, that the NRC, in 

consultation with the Administrator of 

the EPA, the Secretary of Energy, the 

Secretary of Homeland Security, and the 

head of any other appropriate Federal 

agency, determines would pose a threat 

similar to the threat posed by a discrete 

source of radium-226 to the public 

health and safety or the common 

defense and security. The legislation, 

and the proposed rule, do not contain 

criteria for making such a comparison or 

determination. The NRC, in its meeting 

with other Federal agencies, considered 

the IAEA list of sources in its Code of 

Conduct that are considered to pose a 

high risk to human health and safety if 

not managed safety and securely as a 

point of initiation for comparison. The 

NRC did not intend the Code of Conduct 

listing to be the sole criterion to 

measure comparative risk to public 

health and safety. Currently, the NRC, in 

consultation with other Federal 

agencies, has not found any other 

naturally occurring radioactive material 

that is extracted or converted after 

extraction that is used for a commercial, 

medical, or research activity that poses 

a threat to public health and safety, or 

to common defense and security, similar 

to radium-226. Discrete sources of 

radium-226 much lower in activity than 

discussed in the IAEA Code of Conduct 

are addressed in the regulations that 

will protect public health and safety. 

For instance, there are no exempt 

concentration or quantity levels for 

radium-226 in 10 CFR Part 30. There are 

Annual Limits on Intake and Derived 

Air Concentration limits in Appendix B 

to 10 CFR Part 20 for radium-226. The 

EPAct has provided a mechanism for 

the Commission to include additional 

discrete sources of naturally occurring 

radioactive material in the future 

following consultation with other 

Federal agencies, if the need arises to 

consider other naturally occurring 

radioactive material for byproduct 

material. The NRC, along with other 

Federal agencies, will use all of these 

criteria to determine if there are any 

other naturally occurring radioactive 

material posing a threat to public health 

and safety similar to radium-226. In 

addition, the NRC did not intend to 

imply that it was limiting its regulatory 

authority over radium-226 at quantities 

which could be fatal or cause permanent 

damage, or basing its regulations for 

radioactive material solely on acute 

effects. 

Comments Related to Radium-226 

Comment: A commenter, noting that 

radium-226 is a naturally occurring 

material present in most city water 

supplies, asked how the NRC proposes 

to differentiate regulated doses from 

background doses, and normal levels of 

radium-226 in building materials from 

regulated radium-226 contamination. 

The commenter also noted that because 

of radium’s high excretion rate, 

bioassays may need to include weekly 

to monthly fecal analyses to suppress 

the missed dose to a value less than a 

few Roentgen Equivalent Man (Rem) per 

year. The commenter asserted that it is 

highly unlikely that licensees will be 

able to determine if a nonoccupational 

individual received less than 1 mSv 

(100 mrem). 

NRC Response: The NRC’s regulations 

in 10 CFR 20.1502 specify the criteria 

that licensees must address to show 

compliance with monitoring 

requirements for occupational dose 

limits. The regulation requires licensees 

in monitoring occupational exposure to 

take into account radiation from both 

licensed and unlicensed radiation 

sources under the control of the 

licensee. Occupational exposure does 

not include doses from background 

radiation. It is true that radium is 

ubiquitous in nature. However, there are 

methods that can be used to determine 

and subtract background radiation from 

dose measurements of occupational 

dose, such as determining ambient 

exposure by surveys or monitoring in 

the absence of byproduct material, and 

using this information to subtract 

background component from readings 

that include a total of both background 

and occupational exposure. 

External exposure from radium-226 

sources comes from its daughter product 

and gamma radiation, and occupational 

exposure is usually determined by a 

radiation dosimeter (badge). For internal 

exposure, a licensee can measure the 

concentration of radioactive material in 

the air in the work area, the quantity of 

radionuclide in the body, the quantity of 

radionuclide excreted by the body, or a 


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combination of all these measurements. 

Excretion measurement is not the only 

method to determine dose from internal 

exposure. 

Comment: A commenter asked if, for 

source activity reporting and internal/ 

external dosimetry, owners would be 

required to report any information about 

the radionuclide products that come 

from radium (daughter products). The 

commenter asked whether the most 

current International Commission on 

Radiological Protection (ICRP)/National 

Council on Radiation Protection and 

Measurements (NCRP) internal/external 

dosimetry standards will be used by the 

NRC, and if the newer consensus 

standards regarding actinide uptakes 

would be acceptable. The commenter 

also asked whether the American 

National Standards Institute (ANSI)/ 

Health Physics Society (HPS) N43.4–

2000 Classification of Radioactive SelfLuminous Light Sources Standard is a 

reference document that will be used by 

the NRC. 

NRC Response: If the daughter 

products came from byproduct material 

(i.e., the radium-226 parent was 

byproduct material), the internal and 

external exposure would be required to 

be considered. Daughters from radium226, which are not byproduct material, 

would not fall under the NRC’s 

jurisdiction. However, 10 CFR 20.1502 

specifies that, for occupational 

exposure, licensees must take into 

account radiation from both licensed 

and unlicensed radiation sources under 

the control of the licensee. 

The current methodology used in 10 

CFR Part 20 is from Federal Guidance 

Report Number 11, ‘‘Limiting Values of 

Radionuclide Intake and Air 

Concentration and Dose Conversion 

Factors for Inhalation, Submersion, and 

Ingestion,’’ for internal dose 

coefficients, and ICRP 26, 

‘‘Recommendations of the International 

Commission on Radiological Protection, 

January 1977,’’ for external exposure. 

Radium-226 values in Appendix B to 10 

CFR Part 20 came from the Federal 

Guidance Report Number 11. The 

methodologies are not being changed at 

this time. 

The ANSI/HPS N43.4–2000 Standard, 

Classification of Radioactive SelfLuminous Light Sources, was not 

specifically referenced in the 

regulations or in the Statements of 

Consideration to the proposed rule. The 

N43.4–2000 Standard classifies certain 

radioactive self-luminous light sources 

but does not establish design or safety 

standards. It is more for the use of the 

supplier or user to establish design 

features by providing minimum 

prototype testing requirements for these 

types of sources, and promoting 

uniformity in the production of these 

types of light sources. 

Comment: A commenter stated that 

under the proposed rulemaking (10 CFR 

30.32(g)), any specific license 

applications authorizing prostate 

brachytherapy must identify source 

manufacturers and model numbers of 

Palladium-103 brachytherapy sources. 

The commenter suggested that this 

requirement could be avoided by 

amending 10 CFR 30.32(g) to remove the 

requirement for identifying 

manufacturers and model numbers for 

sources authorized for any medical uses 

(specifically those per 10 CFR 35.400). 

The commenter also believes that the 

proposed rule was unclear about how 

some legacy radium-226 sources that 

were not eligible for a general license 

could be specifically licensed per the 10 

CFR 30.32(g) requirements. 

NRC Response: Revision of 10 CFR 

30.32(g) to remove the requirement for 

identifying manufacturers and model 

numbers for sources authorized for any 

medical uses (specifically those per 10 

CFR 35.400) is outside the scope of this 

rulemaking effort. However, the NRC is 

revising 10 CFR 30.32(g) to address the 

issue of sealed sources to address the 

information required from licensees that 

have legacy sources containing the 

newly defined byproduct materials that 

are not in the SS&D registry. 

Comment: A commenter asserted that 

the radium-226 issues are likely to be 

much larger and broader than believed. 

The commenter also noted that there are 

few consultants available with radium 

experience and asked whether the NRC 

has considered that it may have to act 

as a resource to answer questions and 

resolve problems. 

NRC Response: The NRC recognizes 

that there may be broad issues regarding 

radium and that, although radium-226 

was widely used in the past, there does 

not appear to be a significant volume of 

information concerning its health and 

safety implications and past uses. The 

NRC plans to develop a link on its 

public website under Nuclear Materials 

for ‘‘Frequently Asked Questions’’ to try 

to help answer some of the questions 

about radium as they arise. 

Regulating Items Containing Radium226 

Comment: In response to Question 1 

in NRC’s request for additional 

information on issues in the proposed 

rule, technical information to support 

an exemption for old radium-226 

sources, several commenters discussed 

the availability of data on the possession 

and disposal of radium items. The 

commenters stated that they do not 

believe that a consolidated source of 

information on the items, their location, 

or owners exists that could provide 

enough safety information for the NRC 

to make an informed decision on the 

regulation of these items. 

One commenter recommended that 

the NRC conduct a systematic study to 

assess the potential individual and 

collective (population) radiation doses 

associated with the use, possession, 

transfer, and disposal of regulated 

radium items, especially antiquities, 

and suggested that the study could be 

similar to NUREG–1717, ‘‘Systematic 

Radiological Assessment of Exemptions 

for Source and Byproduct Materials.’’

The commenter further recommended 

that the NRC review NUREG/CP–0001, 

‘‘Radioactivity in Consumer Products,’’

dated August 1978, for more 

information on radium in watches, 

smoke detectors, lightning rods, and 

other consumer products. 

NRC Response: The NRC agrees that 

there does not appear to be a 

consolidated source of information 

concerning radium items, their location, 

or who may be in possession of these 

items. The NRC staff contacted several 

organizations, such as the National 

Association of Watch & Clock 

Collectors, to alert them of the 

publication of the proposed rule 

because they might have an interest in 

this rulemaking. In addition, these 

organizations might be able to provide 

further information to assist the NRC in 

making regulatory decisions regarding 

radium items. The NRC staff has also 

secured the services of a contractor to 

help it better characterize the likely 

activities and potential doses to users, 

initially, from the proposed exemption 

for radium timepieces, and, at a later 

date, other radium antiquities that will 

be subject to general licensing. The NRC 

staff has used NUREG/CP–0001 as part 

of its evaluation and has referred the 

NUREG to its contractor for use in its 

review. Evaluations of previously 

manufactured items would be somewhat 

different than those in NUREG–1717 as 

no new distribution is being allowed for 

many of these items. 

Comment: In response to the NRC’s 

Issue for Public Comment Q.1, a 

commenter noted that pre-WWII naval 

warships used radium luminescent 

buttons as deck edge markers. The 

commenter was concerned that these 

marker buttons may not meet the NRC’s 

descriptions of the various radium 

sources. The commenter suggested that 

the NRC expand the coverage of radium226 items beyond light sources in 

aircraft and medical uses. The 

commenter also asked if the NRC will 

bring enforcement actions against 


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persons who discover previously 

unknown radium-226 items, and who 

would be financially responsible for 

those items. 

NRC Response: The NRC has become 

aware that radium luminous items were 

also commonly used on military 

vehicles and naval ships in addition to 

aircraft. The NRC believes that vehicles 

with radium luminous items may be 

found in military museums and owned 

by private collectors. With regard to 

ships, it is the NRC’s understanding that 

the Navy made a concerted effort years 

ago to remove and dispose of radium 

luminous items. However, there may be 

some of these items remaining on 

‘‘mothballed’’ ships. The NRC agrees 

that the general license in 10 CFR 31.12 

should be expanded to include 

additional military vehicles. As 

restructured, the 10 CFR 31.12 general 

license would automatically apply to all 

possessors of antiquities originally 

intended for use by the general public, 

nonintact timepieces, and timepiece 

hands and dials no longer installed in 

timepieces; luminous items installed in 

air, marine, or land vessels or ships 

(This would include airplanes, 

helicopters, jeeps, trucks, tanks, ships, 

landing vessels, artillery pieces, and any 

other former military use vehicle no 

longer under the control of the military.) 

See discussion under New General 

License for Certain Items and SelfLuminous Products Containing Radium226, above; all other luminous products, 

provided that no more than 100 items 

are used or stored at the same location 

at any one time; and small radium 

sources containing no more than 0.037 

MBq (1 μCi) of radium-226. While the 

general license does not authorize the 

manufacture, assembly, disassembly, or 

repair of most of the listed items, the 

disassembly and repair of timepieces 

would be allowed. The general license 

is automatically granted by NRC 

regulations to persons meeting the 

general license criteria. No action is 

required from these persons to obtain a 

general license. The NRC foresees no 

issue regarding possession of these 

items provided that the restrictions on 

the general license are complied with. 

The NRC would hold persons who 

possess the items financially 

responsible for the items with regard to 

such things as disposal or meeting other 

requirements of the general license. 

The general license established in 10 

CFR 31.12 is revised from the proposed 

rule as follows: Paragraph (a)(2) is 

revised to read, ‘‘Nonintact timepieces 

and timepiece hands and dials no longer 

installed in timepieces’’; paragraph 

(a)(3) is revised to read, ‘‘Luminous 

items installed in air, marine, or land 

vehicles’’; paragraph (a)(4) is revised to 

read, ‘‘All other luminous items, 

provided that no more than 100 are used 

or stored at the same location at any one 

time’’; and paragraph (d) is revised to 

read, ‘‘The general license in paragraph 

(a) of this section does not authorize the 

manufacture, assembly, disassembly, 

repair, or import of products containing 

radium-226, except that timepieces may 

be disassembled and repaired’’. 

Comment: A commenter asked 

whether the NRC’s reporting 

requirements apply to owners of past 

accelerators or radium-226 items if they 

do not presently have control over the 

item. For example, the commenter noted 

that wrecked ships and airplanes could 

contain radium dials, and luminous dial 

instruments could be disposed of in a 

sanitary landfill, and the original 

owners of these items would not 

necessarily have any knowledge of their 

current location. 

NRC Response: The NRC’s regulations 

apply to persons who currently, or will 

in the future, possess byproduct 

material. The NRC would not hold 

persons responsible for reporting any 

previous possession, transfers, or 

disposals of materials that may have 

been disposed into locations such as 

municipal landfills over which they 

have no control. However, while the 

NRC will not hold anyone accountable 

for past disposals in a landfill, these 

persons might be accountable under 

EPA’s Superfund regulations. 

Comment: In response to the NRC’s 

Issue for Public Comment Q.1, a 

commenter stated that the trade of 

radium-dial watches has increased in 

the past 10 years with most of these sold 

through Internet auction sites or on 

personal web sites. The commenter does 

not believe that the majority of the 

people buying these watches are aware 

that the watches are radioactive or the 

degree of their radioactivity and is 

concerned about the effect of these 

watches on people who are 

inadvertently exposed to the watches by 

their incidental close proximity to 

someone wearing or carrying one. The 

commenter also noted that most owners 

of these watches are not aware that the 

radiation is still active because the 

luminous scintillating material in the 

paint mixture is no longer working. In 

the commenter’s opinion, the sale and 

use of vintage radium dial watches is 

not in keeping with the goal of ‘‘as low 

as is reasonably achievable’’ (ALARA). 

The commenter stated that many 

people open these watches to try to 

repair them, to clean their dials, and to 

replace hands, that many of these 

watches are bought and sold in poor 

condition (e.g., open, not sealed), and 

that often a watch is sold with the 

crystal (glass) missing and the radium 

paint on the dial exposed to the outside 

air. The commenter noted that radium 

powder/dust can and does flake off of 

exposed dials and broken watch cases. 

The commenter indicated that the 

NRC should require possessors of these 

kinds of watches to follow the same 

shipping requirements as businesses, 

because the watches exhibit the same 

types of hazards. The commenter 

recommended that the NRC consider 

these concerns in connection with 

defining byproduct material. The 

commenter does not think activity 

thresholds will be useful or practical, 

but that any rulemaking would have to 

consider ‘‘radium dial watch’’ as an 

entity. 

NRC Response: To further support the 

exemption and the related general 

license with regard to timepieces, the 

NRC conducted a scoping study to 

determine the typical and maximum 

radium activities used in various types 

of timepieces and the potential 

exposures that might result to users, 

collectors, and repair technicians. The 

results of this study indicate that the 

doses expected to an individual user, 

collector, or repair technician are 

acceptably low. 

As directed by the EPAct, the NRC’s 

development of the proposed rule 

considered the CRCPD’s applicable 

SSRs. As provided in the SSRs, the NRC 

has included an exemption from 

licensing for persons who possess intact 

timepieces that contain no more than 

0.037 megabecquerel (1.0 microcurie) of 

radium. The NRC regulation is more 

restrictive than the SSRs in that the 

exemption only applies to intact 

timepieces. In the proposed rule, the 

exemption would also have allowed 

antique collectors and watch repair 

facilities to repair up to 10 timepieces 

in any year. In the final rule, however, 

the allowance for repair is eliminated 

from the exemption and is now 

authorized under the general license 

provision. As noted, the exemption only 

applies to intact timepieces. Possession 

of nonintact timepieces, or radium 

luminous parts such as hands, dials, or 

faces, and timepiece disassembly and 

repair would be subject to the general 

license provided in 10 CFR 31.12. 

Shipment of radium timepieces are 

currently and will continue to be subject 

to regulations established by the DOT 

and the United States Postal Service. 

Such shipments will now also come 

under the NRC’s regulations in 10 CFR 

Part 71. 

The NRC has specifically included 

radium in the definition of Byproduct 

material. The NRC appreciates that most 


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consumers will probably not know how 

much activity there may be in a 

particular timepiece. However, the 

NRC’s evaluation indicates that most 

timepieces that were produced in the 

past contained less than the 1- 

microcurie (37 kBq) exempt limit. If a 

particular intact timepiece contains 

more than 1 microcurie (37 kBq), then 

possession would fall under the general 

license provided in 10 CFR 31.12. 

Comment: In response to the NRC’s 

Issue for Public Comment Q.1, a 

commenter stated that it has never 

found or been informed of a leak from 

any of the double-encapsulated and 

welded radium-226/beryllium sources 

in their gauges. The commenter noted 

that even in some worst-case accidents 

that occurred, such as compactors 

running over gauges, no source has 

leaked radioactive material, and no 

accident has caused the source to be 

separated from its shield. 

NRC Response: The NRC notes that 

the commenter appears to be describing 

sources used in portable moisturedensity measuring devices used in 

roadbed and other construction 

activities. Generally, these devices are 

possessed under a specific license, 

although there is a possibility some 

devices may have been authorized by a 

State under a specific license similar to 

10 CFR 32.51 for distribution to general 

licensees under requirements 

comparable to 10 CFR 31.5. As noted in 

response to another comment, if a 

device is generally licensed, a label on 

the product should indicate its generally 

licensed status. In either case, the 

licensing authorization would remain 

the same. Periodic source leak testing is 

generally required for such devices. 

Exemption of Certain Radium-226 Items 

Comment: One commenter 

recommended that the proposed limit 

for repairing timepieces containing 

radium-226 be increased from 10 to 18 

units per year. This commenter also 

suggested that the limitation should not 

be restricted by company, but by the 

number of qualified timepiece repair 

technicians employed. The commenter 

suggested that this change is needed to 

provide necessary consideration for 

industry consolidation, the emergence 

of specialized repair centers, and the 

expansion of geographic markets 

brought about by the Internet and 

globalization. 

NRC Response: The NRC conducted a 

scoping study regarding potential risk 

associated with handling timepieces 

containing radium. Based on the results 

of the scoping study on the potential 

health and safety impacts of repairing 

timepieces containing radium-226 

(including the storage of loose parts 

likely to be associated with repair 

facilities and not covered by the 

exemption), the Commission has 

decided not to limit the number of 

repairs. However, the repair will be 

subject to the general license in 10 CFR 

31.12. There may be limited 

circumstances where companies with a 

number of timepiece repair technicians 

specifically involved with handing 

radium-226 should be specifically 

licensed or may be required to conduct 

cleanup activities. See additional 

comment and response discussion on 

General License of Certain Radium-226 

Items and on Specific Licenses for 

Radium-226. 

Comment: A commenter disagreed 

with the NRC’s proposal under 10 CFR 

30.20 to exempt smoke detectors 

containing up to 74 kBq (2 μCi) of 

radium-226 from the licensing 

requirements in 10 CFR Parts 20, 30 

through 36, and 39. The commenter 

stated that radiation detection 

equipment at landfills and scrap 

facilities are very sensitive and are often 

set to thresholds less than twice the 

background radiation. The commenter 

noted that low activity sources, such as 

smoke detectors containing up to 74 kBq 

(2 μCi) of radium-226, will trigger these 

detectors and cause the arriving load to 

be rejected. The commenter stated that 

this would increase the number of 

incidents that the States would be 

required to respond to, which would 

result in an increased expenditure of 

time, human resources, and funds. The 

commenter recommended that these 

sources should not be allowed to be 

disposed of in the general waste stream, 

and that facilities with devices 

containing these levels of activity 

should be generally licensed and should 

be required to dispose of the sources 

properly. 

NRC Response: The exemption for 

smoke detectors is only being expanded 

to cover detectors previously distributed 

in accordance with a specific license 

issued by a State under comparable 

provisions to 10 CFR 32.26 authorizing 

distribution to persons exempt from 

licensing. Smoke detectors meeting this 

criteria are already exempted by most 

States. Documentation of the individual 

safety evaluations made to demonstrate 

that these detectors meet the applicable 

safety criteria is incomplete. However, 

the Bureau of Radiological Health (BRH) 

of the FDA, in consultation with the 

States and other Federal agencies 

including the NRC and its predecessor, 

the Atomic Energy Commission (AEC), 

developed NARM guides in the 1970’s, 

to assist the States to develop more 

uniform regulations for NARM. These 

guides included one for gas and aerosol 

detectors, which was essentially 

equivalent to the NRC’s regulations in 

10 CFR 32.26, 32.27 and 32.28. By the 

late 1970’s, the SSRs included 

comparable provisions. The guide and 

the SSRs also included a quantity limit 

of 3.7 kBq (0.1 μCi) for radium-226. 

Some information on potential 

impacts of disposal of these detectors is 

contained in the Nuclear Energy Agency 

document, ‘‘Recommendations for 

ionization chamber smoke detectors in 

implementation of radiation protection 

standards, 1977,’’ and NUREG/CR–1156, 

‘‘Environmental Assessment of 

Ionization Chamber Smoke Detectors 

Containing Am-241,’’ November 1979. 

According to these documents, 

americium-241 had almost completely 

replaced radium-226 in smoke detectors 

being sold by the late seventies, and the 

quantities of radium-226 used had 

generally been reduced to no more than 

3 kBq (1 μCi), typically 1.8 kBq (0.05 

μCi). It is not expected that there are 

large numbers of smoke detectors with 

radium-226 still in existence, with the 

smaller quantities being more common 

among those that are. Thus, it is not 

expected that large numbers of detectors 

containing radium-226 would be 

disposed of concurrently. The disposal 

of small numbers of such detectors in a 

landfill or municipal incinerator is not 

expected to result in a significant 

impact to public health and safety or the 

environment. 

The commenter was particularly 

concerned with the cost related to 

detectors containing radium being 

detected at landfills and scrap facilities. 

Exempting from the NRC’s regulations 

those detectors which have been 

previously exempted from regulation by 

the States will not add to the number of 

these incidents nor will not exempting 

them be able to prevent all such 

incidents. However, a significant part of 

the cost is incurred after identification 

of a source, if it requires a more 

expensive disposal route. In many cases, 

once a radioactive source has triggered 

a monitor, it can still be disposed of at 

the landfill if this is determined to be an 

acceptable disposal option. Because the 

EPAct allows for the disposal of the 

newly added byproduct material in 

disposal facilities permitted under 

Federal or State solid or hazardous 

waste laws, acceptability at landfills for 

disposal of an exempted product or 

material should be improved. What 

happens after identification will 

depend, in part, on the label, which 

would have been required by the State 

at the time of distribution. If intact and 

legible, it would indicate whether the 

product had been exempted from State 


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regulations or generally licensed. 

However, the NRC recognizes, as one 

commenter pointed out, that some 

landfill operators may not be obligated 

to accept such material at their facilities. 

The Commission continues to 

consider the exemption of these 

previously distributed detectors to be 

justified. The final rule includes this 

exemption in revised 10 CFR 30.20. 

Comment: Two of the State 

commenters stated that the NRC should 

add 3.7 kilobecquerel (kBq) [0.1 

microcurie (μCi)] of radium-226 to 10 

CFR 30.19 for self-luminous products or 

otherwise include exemption language 

from the SSRs for low activity radium226 sources rather than including those 

sources under a general license. One of 

these commenters specifically 

mentioned types of products other than 

self-luminous products listed in the 

proposed general license in 10 CFR 

31.12 and indicated that they should 

also be exempt if containing the same 

low quantity of radium-226. Both of 

these commenters asserted that there are 

no problems known to exist with these 

exempt sources so there is no sufficient 

reason for the NRC to not exempt them 

as the States have done for many 

decades, and stated that if the NRC is 

aware of some risk to public health and 

safety from these very low activity 

sources, then it should provide the 

information. 

NRC Response: There is only limited 

information on these items. However, 

there is some indication that the applied 

radium may be subject to such concerns 

as flaking off due to aging. The NARM 

guides developed by BRH/FDA in the 

1970’s included a guide for 

radioluminous products which 

contained safety criteria for approval of 

a product for use under a general 

license, but not for use under an 

exemption. The SSRs do not include 

provisions similar to those in 10 CFR 

32.22, 32.23, and 32.24, for the 

manufacture or initial distribution of 

self-luminous products for use under an 

exemption. The SSR provision similar 

to 10 CFR 30.19 covers only previously 

acquired products in the case of items 

containing radium-226. It appears that 

these products were generally not 

evaluated under provisions comparable 

to those in 10 CFR 32.22, 32.23, and 

32.24 for self-luminous products. This 

SSR provision exempts ‘‘articles’’

containing radium under the heading 

‘‘Self-luminous products.’’ While the 

quantity limit is less than that for 

watches, the category of product is very 

open-ended and could include items 

where the radium is not contained. 

For these reasons, the Commission 

considers it prudent not to exempt this 

category of products that is covered by 

an exemption in the SSRs, or other 

unspecified products with no more than 

3.7 kBq (0.1 μCi) of radium-226. In 

addition, there are many self-luminous 

products containing more than 3.7 kBq 

(0.1 μCi) of radium-226 and most would 

not be labeled with the quantity or 

activity of the radium-226. It would be 

difficult to determine which products 

would fall under the exemption and 

which would fall under the general 

license in 10 CFR 31.12. 

Comment: One commenter noted the 

proposed graded approach for different 

levels of radium-226 sources and also 

mentioned the discussion in the 

Statements of Consideration of various 

approaches used by the non-Agreement 

States. This commenter responded to 

the NRC’s request for input on whether 

a general license approach or exemption 

approach would be better for some of 

the devices containing radium-226, by 

saying that an exemption would gather 

no data, and therefore not be the desired 

path except for the smallest amounts 

(e.g., 1 μCi). This commenter also stated 

that an exemption concentration level of 

1 μCi (and an appropriate corresponding 

exempt quantity limit) could be 

considered with the specific/general 

license approach for materials above 

that de minis amount. 

NRC Response: The SSRs do not 

include an exempt quantity or exempt 

concentration for radium-226. With the 

exception of an exempt quantity of 

polonium-210, these exemptions do not 

include alpha emitters. Given that there 

are no materials in use that have been 

previously universally exempt from 

licensing under State regulations, there 

is no justification for adding such 

exemptions now. Without a 

demonstrated need, the NRC does not 

consider it prudent to allow 

introduction of radium-226 into 

materials and products to be used by 

persons exempt from licensing or to 

allow the distribution of radium-226 as 

exempt quantities. 

The requirements for registration of 

generally licensed devices only apply to 

those generally licensed under 10 CFR 

31.5 and then only if the device 

contains a radium source of 3.7 MBq 

(0.1 mCi) or greater. The new general 

license in 10 CFR 31.12 will not require 

registration by possessors of the items 

identified in the regulation nor does the 

NRC believe there is a need to impose 

such a regulatory burden on the general 

licensee. 

Comment: A commenter 

recommended that the NRC include an 

exemption in the final rule for Internal 

Revenue Service (IRS)-designated 

501(c)(3) organizations that existed 

before the effective date of the final rule 

that operate, in whole or in part, as an 

accredited school of watch and/or clock 

repair and/or specialty museum with a 

primary focus on housing and 

exhibiting timepieces and related 

objects. The commenter noted that it is 

important for students to have access to 

examples of radium parts and watches 

as part of their training, and museums 

must be able to preserve and present 

practices and objects through exhibits to 

fulfill their educational mission. The 

commenter stated that without this 

exemption, the proposed inventory 

process and licensing fees would create 

an undue burden on these 

organizations. 

NRC Response: The status of an 

organization as a nonprofit institution 

and whether its mission is educational 

are not appropriate bases for exemption 

from licensing requirements. 

Exemptions from licensing are based 

primarily on findings with respect to 

health, safety, and environmental 

impacts. It should be noted, however, 

that organizations categorized as small 

entities in accordance with 10 CFR 

2.810 are eligible for reduced annual 

licensing fees in accordance with 10 

CFR 171.16. Also, a licensee, such as a 

nonprofit educational institution, may 

be exempt from application fees under 

10 CFR 170.11 and annual licensing fees 

under 10 CFR 171.11, depending on the 

licensed activities. Also, a museum or 

school may possess watches under the 

exemption in 10 CFR 30.15(a)(1) 

irrespective of whether other products 

or activities require these entities to be 

a general or specific licensee. 

General License of Certain Radium-226 

Items 

Comment: Several commenters 

responded to the NRC’s Issue for Public 

Comment Q.6 request for information on 

health and safety impact from activities 

involving radium-226 sources that 

would support a regulatory framework 

other than general licensing, such as an 

exemption. In general, the commenters 

agreed that an exemption would be 

preferable to a general license for items 

containing radium-226; however, most 

of the commenters also agreed that more 

information on the risks of these items 

is needed before a final decision is 

made. 

Several of the commenters, citing a 

number of reasons, recommended that 

the NRC create a time-limited 

exemption for antiquities containing 

radium-226 until such time as sufficient 

data are gathered and analyzed to 

determine whether these items exhibit 

high enough risk to require a license 

rather than a permanent exemption. 


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Two commenters noted that their 

States have had to respond to scrap 

metal yards, steel mills, and municipal 

waste sites where radium-226 items had 

caused loads to be rejected and noted 

that this happens because possessors of 

these items do not usually know how to 

safely dispose of them. 

Other commenters suggested that an 

exemption for items containing radium226 is better as long as enough safety 

data exist proving a low risk level for 

these items to justify the exemption and 

recommended that more investigation, 

which might include working groups 

and a public outreach effort, is needed 

into the safety risks of these items. One 

commenter noted that such an outreach 

effort would place a burden on State 

financial and human resources, and 

recommended that the NRC conduct a 

cost-benefit analysis to analyze these 

impacts on the States. 

While the commenters were in 

general agreement with the NRC’s 

proposed approach regarding the 

specific constraints in the proposed 

exemption in 10 CFR 30.15(a)(1)(viii), 

one commenter asked how the NRC 

proposes to regulate radiological 

antiquities that are bought and sold on 

the Internet. 

NRC Response: The NRC notes that, 

for the most part, there appears to be no 

existing regulatory approach for many of 

the radium items identified in the 10 

CFR 31.12 general license, and that very 

little information exists. Therefore, the 

NRC believes it is more appropriate to 

regulate the products under a general 

license until the NRC has had the 

opportunity to further document and 

evaluate these items and practices, and 

determine whether or not additional 

exemptions may be appropriate. The 

NRC also recognizes that many 

individuals may not be aware that they 

possess radium items and that 

‘‘incidents’’ where these items are 

identified at waste sites may continue 

into the future. 

Based on its initial evaluations, the 

NRC has been able to find only limited 

information regarding existing safety 

data which show a low risk level for 

these items which is necessary to justify 

an exemption. The NRC currently has 

plans to conduct further evaluations, 

including gathering information 

concerning the products, to help it 

better characterize the likely activities 

and potential doses to users from 

radium antiquities that will be subject to 

general licensing. The NRC will 

consider the commenter’s suggestion 

regarding a public outreach program 

and the program’s impact on State and 

Federal resources. 

The general license in 10 CFR 31.12 

allows general licensees to transfer 

possession of antiquities and other 

products between general licensees, and 

this includes antiquities bought and 

sold over the Internet. The NRC believes 

this is acceptable while the NRC 

conducts evaluations and because the 

limited information available does 

indicate a low risk associated with these 

items. 

Comment: Several commenters 

discussed the appropriate regulation of 

the repair and disassembly of items 

containing radium-226. One commenter 

stated that it believes a ‘‘prohibition of 

these activities under general licensure’’

is appropriate. The commenter 

recommended that disassembly, repair, 

and assembly work on an antique item 

should be authorized by a specific 

license, not a general license. Another 

commenter recommended that facilities 

disassembling or repairing timepieces 

containing radium be generally licensed 

until a study is conducted and 

completed to assess the potential 

individual and collective (population) 

radiation doses associated with this 

industry. 

NRC Response: The NRC agrees that 

the repair and dissassembly of certain 

items containing radium-226 should 

only be conducted under a specific 

license and notes that 10 CFR 31.12(d) 

prohibits these activities under the 

general license. The NRC conducted a 

scoping study on potential exposures 

regarding activities involving timepieces 

containing radium-226. Based on the 

results of the scoping study, the NRC 

will allow timepiece disassembly and 

repair under the general license 

provision. 

Comment: Several commenters were 

in support of a general license for items 

containing radium. One commenter 

requested clarification of the general 

license requirements for radium dials, 

gauges, and buttons installed in aircraft 

used as static displays, in aircraft used 

in museums, in aircraft that are in 

storage for potential re-use as 

refurbished piloted aircraft, as 

unmanned drone aircraft (potentially 

used as targets), or as a source for spare 

parts, and in dials, gauges, buttons, and/ 

or painted lettering or numbering that 

do not have a glass or crystal face 

covering, or for which the covering is 

damaged or broken. The commenter also 

expressed concern that the transfer 

requirements of proposed 10 CFR 

31.12(c)(2) may place an undue burden 

on the licensees and recommended that 

the NRC should allow for easier transfer 

under the general license from one 

entity to another. 

One commenter stated that some 

museums possess devices containing 

radium-226 in gauges and other safety 

devices installed in ground vehicles 

(e.g., trucks, armored tanks, artillery 

pieces), portable radios, and submarine 

instrument panels on display and that 

public access to these devices is 

controlled in the same manner as 

aircraft at these museums. The 

commenter recommended that the NRC 

expand the 10 CFR 30.12 general license 

to include radium containing devices 

installed on other types of vehicles and 

equipment besides just aircraft. 

Another commenter stated that a 

common practice on World War II 

aircraft was to apply radium paint over 

the words and numbers engraved on 

cockpit instrument panels so that they 

were visible in the dark. The commenter 

noted that in these cases, the painted 

surfaces are not contained behind glass 

as in gauges. 

NRC Response: The rule allowing 

possession under the general license 

rule applies to all luminous items 

installed in aircraft regardless of 

whether the material is in an intact 

gauge, a gauge missing a face plate, or 

as luminous paint applied on the 

outside of a gauge. The general license 

also applies to all aircraft regardless if 

the aircraft is routinely used or in 

storage. 

Paragraph (a) of 10 CFR 31.12 allows 

any general licensee to transfer any 

generally licensed item identified in this 

section to another general licensee for 

possession and use without restriction. 

The provisions in 10 CFR 31.12(c)(2) 

only restrict transfers to specific 

licensees or as otherwise authorized by 

the NRC under 10 CFR 20.2008 when 

the general licensee is intending to 

dispose of the item. 

The NRC agrees that the general 

license should be extended to include 

luminous items installed in additional 

large military transport vehicles no 

longer under the control of the military 

and has modified 10 CFR 31.12 to 

include marine ships and land vehicles 

in addition to aircraft. The general 

license also allows for the possession of 

up to 100 other luminous items, 

including uninstalled aircraft safety 

devices. 

Specific License for Radium-226 

Comment: A commenter stated that 

there should be a threshold level for 

possession of radium-226 luminous 

items that are not contained in an intact 

product beyond which a specific license 

is preferable, whether or not the items 

are intact. The commenter 

recommended that the NRC consider 

requiring a specific license for a number 


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of items that is at least the exempt 

quantity value times 10 to 100. The 

commenter also stated that commercial 

transfers of items containing radium-226 

should not be treated the same as 

possession and use and recommended 

that the NRC require a specific license 

for commercial transfers. 

NRC Response: The NRC does not 

agree, based on other comments and the 

information currently available, that it 

should impose more restrictive 

requirements beyond those provided in 

10 CFR 31.12. However, the NRC may 

consider the commenter’s suggestions in 

a future rulemaking should the results 

from further evaluations, and 

characterization of the likely activities 

and potential doses to users from 

radium antiquities, indicate a need for 

additional restrictions in these areas. 

Comment: With regard to proposed 10 

CFR 31.8(b), which relates to the general 

license for radium-226 in calibration or 

reference sources, one commenter 

recommended that the NRC provide a 

‘‘grandfather clause for [radium-226] 

items’’ that were approved for 

manufacture before 10 CFR 32.57 was 

adopted in its current form. The 

commenter stated that the States should 

be able to simply attest that the 

calibration or reference sources were 

manufactured to standards or criteria 

that have been demonstrated through 

years of use to be adequate to protect the 

public health and safety and the users 

of the sources. The commenter asserted 

that, unless the NRC has knowledge of 

problems of leaking sources of this type, 

the NRC should provide clarification 

that these sources are acceptable as 

manufactured. 

NRC Response: ‘‘The general license 

in 10 CFR 31.8 contains a footnote to 

include any sources labeled in 

accordance with the provisions 

applicable before January 19, 1975, i.e., 

with labels referring to the AEC before 

the creation of the NRC. In addition to 

the revision of paragraph (b) of 10 CFR 

31.8, this footnote is being revised to 

include a requirement that sources 

containing radium-226 be labeled as 

required by the authorizing State at the 

time of manufacture. Therefore, the NRC 

believes that there is no need for any 

further grandfathering. Any calibration 

and reference source (or its container) 

containing radium-226, that was 

manufactured or initially transferred 

under requirements comparable to 10 

CFR 32.57, would be labeled 

accordingly. As suggested by the 

commenter, the NRC expects that these 

sources are acceptable as manufactured. 

Comment: A commenter noted that 

the proposed 10 CFR 32.59 required 

testing for leakage ‘‘with a filter paper’’

and ‘‘application of moderate finger 

pressure.’’ The commenter believes this 

is overly prescriptive, prohibiting the 

use of other materials and requiring the 

use of ‘‘the fingers.’’

NRC Response: The requirements 

referred to by the commenter are the 

existing requirements for distributors of 

calibration and reference sources 

containing americium-241 for use under 

the general license in 10 CFR 31.8 and 

equivalent general licenses of the 

Agreement States, to which radium-226 

is being added. It is consistent with the 

SSRs. The commenter’s request for this 

general revision is outside of the scope 

of this rulemaking. 

Comments Related to Accelerator and 

Accelerator-Produced Radioactive 

Material 

Comment: One commenter believes 

that the definition of Cyclotron was 

unclear, noting the statement that 

particles are ‘‘bent’’. 

NRC Response: To address the 

commenter’s concern, the NRC is 

revising the definition of Cyclotron to 

indicate that the charged particles travel 

in an outward spiral or circular path. 

Comment: A commenter stated that 

the definition of Particle accelerator 

should be revised. The commenter 

noted that the definition currently states 

that a particle accelerator is a machine 

capable of ‘‘discharging the resultant 

particles or other radiation into a 

medium at energies in excess of 1 

megaelectron volt (MeV).’’ The 

commenter noted that cathode ray tube 

television sets were developed from 

early particle accelerators, and that 

while commercial television sets 

operate at 0.035 MeV, overzealous 

application of the rule might include 

these and other smaller particle 

accelerators. The commenter also stated 

that it is possible that any beta-emitting 

source with energies greater than 1 MeV 

in a vacuum might also be considered 

an accelerator. The commenter noted 

that the ‘‘NRC is now regulating exotic 

particles such as muons, but that [the 

commenter’s] search of 10 CFR part 20 

did not find any reference to muons.’’

The commenter noted that the NRC 

should also ‘‘expect to see extremity 

doses approaching 50 REM per year for 

the preparers of the acceleratorproduced medical isotope unit doses’’

and apparently that the NRC should 

consider those health effects in its 

regulation of NARM. 

NRC Response: The definition of 

Particle accelerator has been used by 

State radiation control programs for 

many years. The lower limit of 1 MeV 

was chosen to avoid regulation of lower 

energy accelerators. Consistent with the 

intent of the EPAct, the NRC will 

regulate byproduct material as defined 

in the EPAct as radioactive material 

produced by use of a particle 

accelerator. The NRC will not regulate 

the possession or operation of any 

particle accelerators that will not 

produce the byproduct material that the 

NRC will regulate. Also, note that the 

NRC will not regulate particles such as 

protons or electrons, or exotic particles 

such as muons generated in these 

particle accelerators that will not 

produce byproduct material. 

The NRC is aware that high radiation 

doses are possible from handling 

accelerator-produced radioactive 

materials. Because licensees are 

required to comply with the radiation 

safety program requirements in 10 CFR 

Part 20, the NRC expects that licensees 

will use handling methods and 

equipment as part of their radiation 

safety program to prevent high radiation 

doses. No change is made to the 

definition. 

Comment: A commenter noted that 

for hadronic beams, measurements of 

energy per nucleon (MeV/nucleon) may 

provide more useful information 

(apparently rather than the maximum 

energy of the accelerated particles). The 

commenter gave as an example that a 1- 

MeV proton will have different 

activation potential than a uranium-238 

nucleus with (collectively) 1 MeV. 

NRC Response: The commenter’s 

view on energy level is noted. Because 

the NRC only regulates the radioactive 

material produced by using a particle 

accelerator and not the radiation beam 

itself, the activation potential of the 

beam or particle has no direct impact in 

the NRC’s determination of the 

regulated material. Radioactive material 

is defined as byproduct material if it is 

produced for use for commercial, 

medical, or research activities and is 

produced by irradiation or activation in 

a particle accelerator regardless of the 

type or energy level of the particle. 

Comment: A commenter asked if the 

NRC’s jurisdiction over accelerators 

includes particle beam weapons in 

space, the ion drive technologies being 

developed for interplanetary use, or 

laser wake field accelerators; or if the 

NRC’s jurisdiction would extend to such 

items and materials as beam energy, 

interlock requirements, minimization of 

activated/spallated materials, ion 

species accelerated/charge state, or 

minimization of beryllium components 

(neutron spallation targets). The 

commenter also asked what parts of an 

accelerator (e.g., magnets, power 

supplies, RF cavities, beam pipe, nuts, 

bolts, wire, shielding, tools) the NRC 

will regulate. The commenter noted that 


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these parts are transferred between the 

DOE-owned/NRC-regulated accelerators 

and worldwide researchers. 

NRC Response: The NRC’s authority 

does not include regulating accelerators 

or parts of an accelerator, nor does it 

include particles or particle beams. The 

NRC does not regulate accelerator or 

accelerator operating parameters. 

However, certain Agreement and nonAgreement States may regulate 

accelerators, accelerator operations, and 

accelerator safety requirements within 

their State’s radiation control programs. 

Under the EPAct, the NRC will regulate 

radioactive materials produced in an 

accelerator used to intentionally 

produce radioactive material for use for 

commercial, medical, or research 

activities. This will also include any 

activated radioactive material that may 

still reside within the accelerator as a 

result of using the accelerator to 

intentionally produce radioactive 

material. The determination of the 

regulated material is based on whether 

a radioactive material is produced in a 

particle accelerator for use for 

commercial, medical, or research 

activities. In addition to regulating the 

accelerator-produced radioactive 

material, the production facility will 

also be regulated through the NRC or 

Agreement State licensing process to 

ensure safe handling of the material and 

to ensure protection of public health 

and safety and the environment. 

Comment: A commenter stated that 

most activation/spallation in 

accelerators occurs in high loss areas. 

The commenter noted that beam dumps 

can become very radioactive in higher 

energy machines. The commenter stated 

that caution should be exercised 

because the efficiency of Geiger-Mueller 

(GM) photon counters for photon-only 

emitting radionuclides that are common 

in accelerator environments is 0.17 

percent as opposed to a GM photoncounting efficiency of 30 percent for 

medium energy beta emitters. 

NRC Response: The NRC appreciates 

the commenter’s insight. The NRC 

expects licensees to be knowledgeable, 

based on their qualification through 

training and experience, of the response 

characteristics of survey and 

measurement instrumentation relative 

to the radioactive material being 

produced or used. Licensee RSOs are 

required to show evidence of such 

training and experience as part of the 

licensing process. 

Comment: Two commenters asked if 

entities other than particle accelerator 

users would be regulated by the NRC. 

One commenter asked if the NRC will 

license accelerator producers and 

distributors. Another commenter asked 

who the NRC anticipates will regulate 

the safety of accelerator facilities and 

their operation in both Agreement and 

non-Agreement States. The commenter 

noted that many States have 

implemented the SSR accelerator 

regulations. However, the commenter 

stated that ‘‘the regulatory responsibility 

for the radiation safety of the accelerator 

facility, the production of the 

radionuclides (licensing of accelerator 

targets), and the radioactive waste 

management (specifically, accelerator 

targets) is unclear in Non-Agreement 

States, particularly in Federal 

institutions.’’

NRC Response: The NRC has no 

jurisdiction over accelerators; therefore, 

the NRC will not license or regulate 

producers, distributors, or users of 

particle accelerators. The NRC will, 

however, regulate persons that handle 

radioactive material from an accelerator 

that is used to intentionally produce 

radioactive material for use for 

commercial, medical, or research 

activities. Although the NRC will not 

license or otherwise regulate the sales or 

distribution of particle accelerators, 

certain Agreement States and nonAgreement States may have regulatory 

programs for registration, licensing, 

and/or safe operation of accelerators. 

As provided by the EPAct, the NRC or 

the Agreement States have the 

regulatory authority for regulating the 

accelerator-produced radioactive 

material, the production of acceleratorproduced radioactive material, and the 

associated waste. Once the Agreement 

State certifies, and the NRC determines 

that the State’s program is adequate to 

protect the public health and safety for 

the newly added byproduct material, 

the State will have regulatory authority 

over the newly added byproduct 

material. If an Agreement State did not 

certify or the NRC determined that the 

State’s program is inadequate, the NRC 

will retain its regulatory authority over 

the newly added byproduct material. In 

a non-Agreement State, the NRC has the 

regulatory authority for all AEA 

materials including the newly added 

byproduct material. As for Federal 

facilities, the NRC has the regulatory 

authority regardless if the Federal 

facility is located in an Agreement State 

or in a non-Agreement State. 

Comment: Two commenters agreed 

with the NRC’s proposed delineation of 

particle accelerators into three varieties, 

especially with the one category specific 

to accelerators that are operated to 

produce only particle beams and not 

radioactive materials. The commenters 

agreed that these types of accelerators, 

which include linear accelerators used 

in radiation therapy, should not be 

regulated. One commenter supported 

the NRC’s proposal to not include 

incidental radioactive material 

produced by medical linear accelerators 

in the regulation. 

One commenter recommended that 

the NRC should, in the final rule, 

include a specific exemption for 

commercially available linear 

accelerators used only for medical 

purposes to treat patients. The 

commenter recommended modifying 

the definition of Particle accelerator for 

such exemption and provided specific 

language for the modification. 

NRC Response: Under the EPAct, the 

NRC only has regulatory authority over 

accelerator-produced radioactive 

material and not over the accelerator. 

Because the NRC can only exempt 

material or activity under its 

jurisdiction, it would not be appropriate 

for the NRC to exempt accelerators in its 

regulation. 

Comment: A commenter asked if the 

NRC would regulate neutron generators 

as accelerators. The commenter noted 

that these neutron generators operate by 

D,T [deuterium, tritium] reactions that 

use a 4-MeV (2 MeV per nucleon) 

deuteron to produce up to a 12-MeV 

evaporation neutron. The commenter 

stated that confusion will occur if the 

NRC regulates accelerators based on 

their acceleration potential. As an 

example, the commenter stated that a 4- 

MeV electron will accelerate a nucleon 

to 4 MeV if only one electron is 

removed from the electron shell (charge 

state), but if two electrons are stripped, 

then the acceleration energy will be 8 

MeV (4 MeV × 2). 

NRC Response: The NRC will not 

regulate accelerators nor the operation 

of an accelerator. The NRC will only 

regulate the radioactive material 

produced in an accelerator intentionally 

operated to produce radioactive material 

for use for commercial, medical, or 

research activities. Therefore, the 

acceleration potential is irrelevant to the 

NRC’s regulatory program. A minimum 

accelerator potential of 1 MeV is 

specified in the definition of Particle 

accelerator to be consistent with the 

SSRs. 

If a neutron generated by the 

accelerator is used to produce 

radioactive material via neutron 

activation, and the resulting radioactive 

material is used for a commercial, 

medical, or research activity, the 

radioactive material (and any 

incidentally produced radioactive 

material) would be regulated as 

byproduct material under Section 

11e.(3) of the AEA as amended by the 

EPAct. 


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Comment: A commenter 

recommended that the NRC add the 

definition of Particle accelerator to 10 

CFR Part 35 in addition to 10 CFR Parts 

20 and 30. 

NRC Response: The NRC Part 35 

licensees are required to comply with 10 

CFR Parts 20 and 30, in which the term 

Particle accelerator is defined. 

Therefore, it is not necessary to repeat 

this definition. In addition, including 

the definition of Particle accelerator in 

10 CFR Part 35 may inaccurately reflect 

that Part 35 includes regulations for 

particle accelerators. 

Accelerator-Produced Radioactive 

Material 

Comment: A commenter stated that 

certain materials have low nuclear 

binding energy. As with neutron sources 

using a ‘‘(gamma, N) reaction,’’ particle 

beams can produce substantial neutron 

fluxes if they strike a beryllium target. 

The commenter asked whether the NRC 

would consider the materials activated 

by these neutrons as byproduct material 

or accelerator-produced material. 

NRC Response: Before the EPAct, the 

NRC regulated americium/beryllium 

neutron generators but not radium/ 

beryllium neutron generators because 

americium-241 was included in the 

definition of Byproduct material, and 

radium-226 was not. Both generators 

will now be regulated by the NRC 

because they both contain byproduct 

material. The NRC also considers 

activation products produced by 

neutron emissions from byproduct 

material (e.g., californium-252) to be 

byproduct material. The NRC also 

regulates the tritium targets in well 

logging tools and other accelerators that 

produced neutron beams because 

tritium is a byproduct material. The 

EPAct gives the NRC regulatory 

authority over discrete sources of 

radium-226 and accelerator produced 

radioactive materials. Therefore, the 

NRC now regulates, as byproduct 

material, the activation products 

produced by a neutron beam 

accelerator, when the activation 

products are used for commercial, 

medical or research and development 

uses. 

Comment: A commenter noted that 

DOE may begin production of 

radionuclides and radioactive material 

accelerators [Reference: See http:// 

www.eh.doe.gov/nepa/eis/eis0310/ 

eis0310.html Volume l, Chapter 2a (see 

page 7 of the first enclosure)]. The 

commenter asked if this would cause 

any problems. 

NRC Response: As an initial matter, 

the EPAct did not give the NRC 

jurisdiction over the production of 

accelerators. Therefore, the production 

of radioactive material accelerators 

would not impact the NRC’s regulatory 

authority. In addition, DOE activities are 

not subject to licensing unless they fall 

within the purview of certain activities 

specified in Section 202 of the Energy 

Reorganization Act. The production of 

radionuclides would not fall within the 

scope of these activities. Therefore, DOE 

would not need a license to produce 

radionuclides. With the exception of 

restrictions in 10 CFR Part 35 for 

medical use licensees and in 10 CFR 

Part 30 for general licensees, there are 

no restrictions on who may transfer the 

radioactive materials to the NRC 

licensees. If DOE were to begin to 

produce radioactive material, it could 

transfer radionuclides to the NRC 

licensees provided the NRC licensee 

was specifically authorized to receive 

the radioactive material. However, if 

DOE pursued production of radioactive 

drugs or sealed sources for direct 

distribution to medical use licensees, 

the NRC may have to change its 

regulations because the existing 

regulations only allow medical use 

licensees to obtain these products from 

a 10 CFR Part 32 licensee. Similar 

changes may be needed to distribute 

material to general licensees or to 

persons exempt from licensing. 

Comment: A commenter asked if the 

NRC will allow the use of the most 

current ANSI/IRCP/NCRP neutron flux 

to dose conversion factors because the 

accelerator neutron spectrum may 

exceed the maximum energy of only 400 

MeV listed in 10 CFR Part 20. 

NRC Response: For those cases in 

which greater than 400-MeV neutrons 

are encountered during a licensed 

activity, the licensee can request prior 

approval to use a specific ANSI/ICRP/ 

NCRP neutron flux to dose equivalent 

conversion. 

Comment: Three commenters 

provided their views on the NRC’s 

proposal not to regulate incidental 

radioactive material produced by 

accelerators that are operated only to 

produce particle beams. 

Two commenters agreed with the 

NRC’s suggested regulatory approach of 

not regulating incidental radioactive 

material produced by accelerators that 

are operated only to produce particle 

beams. One commenter indicated 

agreement with this approach because 

only small amounts of the incidental 

radioactive materials are produced in 

the particle beam-generating process, 

and those typically have a short halflife. The other commenter agreed 

because it believed that the incidental 

radioactive materials are 

indistinguishable from the particles 

produced intentionally in particle 

beams and would not be an undue 

burden on licensees. A third commenter 

disagreed with the NRC’s proposed 

regulatory approach and recommended 

that all incidentally produced 

radioactive material be regulated by the 

NRC regardless of the use of the 

accelerator. The commenter questioned 

treating incidental material that was 

made radioactive from an accelerator 

used only to produce particle beams 

differently than incidental material 

made radioactive from an accelerator 

used to produce both radioactive 

material and particle beams. The 

commenter stated that the incidental 

accelerator-produced material is 

radioactive material regardless of the 

purpose for which the accelerator is 

being used, and that in certain 

situations during disposal of the 

accelerator, the activated internal 

components of all accelerators will enter 

the waste stream. Furthermore, the 

commenter noted that in its experience, 

some activation products in the 

accelerator components were still 

radioactive a month after removal. 

NRC Response: The NRC agrees that 

there is essentially no radiological 

difference between incidental 

radioactive material made from an 

accelerator used only to produce 

particle beams and an accelerator used 

to produce both radioactive material 

and particle beams. However, the NRC’s 

authority under the EPAct does not 

extend to incidentally produced 

radioactive material unless the 

incidentally produced radioactive 

material was made during the process of 

making radioactive materials for 

commercial, medical, or research uses. 

Comment: One commenter agreed 

with the NRC’s proposed approach to 

regulate intentionally and incidentally 

produced radioactive materials without 

regulating the actual possession or 

operation of the accelerator. However, 

the commenter requested clarification of 

the NRC regulatory oversight of the 

radioactive material produced by an 

accelerator and the decommissioning of 

accelerator facilities in a non-Agreement 

State if the NRC does not have the 

authority under the EPAct to regulate 

the possession and operation of the 

accelerators that produce these 

materials. The commenter noted that 

some States do not have licensing 

requirements for operating an 

accelerator or for the material an 

accelerator produces. 

NRC Response: Although the NRC 

does not regulate the operation of the 

accelerator, it will regulate the 

production of byproduct material and 

the byproduct material once it is 


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produced. The NRC will also regulate 

the use of the radioactive materials 

produced by the accelerator including 

operational steps that expose 

individuals to radioactive materials 

being produced, or the radiation from 

these materials and maintenance 

processes that involve handling 

components of the accelerator that have 

become radioactive. The NRC will issue 

a specific license to any person, as 

defined in 10 CFR 30.4, ‘‘Definitions,’’

that produces byproduct material with 

an accelerator, provided the person 

meets the requirements in 10 CFR 30.33, 

‘‘General requirements for issuance of a 

specific license.’’ This license will 

authorize the production of radioactive 

materials by the accelerator and the 

incidental radioactive materials 

produced during the production 

process. 

Under the provisions of the waiver 

that the NRC issued on August 31, 2005, 

a person producing byproduct material 

with an accelerator may continue that 

activity until the waiver is terminated. 

Under the waiver, the person was not 

required to have a license. When the 

NRC terminates the waiver under which 

the person is producing byproduct 

material with an accelerator, the person 

is subject to all the NRC regulations 

pertaining to the production, 

possession, use, transfer, and disposal of 

the radionuclides produced by the 

accelerator, and must apply for a license 

or an amendment to continue these 

activities. The person is permitted to 

continue producing radionuclides with 

the accelerator until the NRC takes final 

licensing action provided the person 

applies for an NRC license (or an 

amendment to an NRC license) within 

the time specified in the regulations. 

Therefore, the NRC’s authority applies 

to the owner and operator of the 

accelerator facility in a non-Agreement 

State, and a license does not have to be 

in place for the transition of authority 

from a non-Agreement State to the NRC. 

The NRC will regulate all radioactive 

materials and the disposal of 

components and decommissioning of 

facilities made radioactive during the 

use of the accelerator if the accelerator 

is used to produce byproduct material 

for a commercial, medical, or research 

activity. If the accelerator is never used 

to produce byproduct material for such 

a purpose, then the NRC will not 

regulate the incidental radioactive 

material produced during the operation 

of the accelerator. 

Regulating Accelerator-Produced 

Radioactive Material 

Comment: One commenter noted that 

the NRC has set up a regulatory 

framework that would issue one license 

for production and distribution and 

another for possession and use. The 

commenter recommended that the NRC 

continue to allow flexibility for the 

States to either follow the NRC’s 

licensing approach or to streamline the 

licensing process by combining both 

license authorizations into a single 

license. Some States use the single 

license approach so facilities are not 

being required to pay multiple fees for 

multiple licenses or so a single facility 

with a single operator has only one 

radiation safety program for the State to 

evaluate. The commenter concluded 

that the additional authorizations 

require only a few extra lines of text in 

a license document, so the licensee 

should not have to pay separate 

licensing fees. 

Another commenter requested that 

the NRC clarify whether a single license 

might include authorizations under both 

10 CFR Part 30 and 10 CFR 32.72 or 

whether separate licenses are required 

by the NRC. 

NRC Response: Licensing procedures 

are considered as a matter of adequacy 

for the Agreement States, not 

compatibility. As long as the license or 

licenses written by an Agreement State 

are adequate to assure that the licensed 

program will protect public health and 

safety, the licensing procedures need 

not be the same as those used by the 

NRC. The NRC will continue to consider 

the adequacy of Agreement State 

licensing procedures for all byproduct 

licenses, including those for the newly 

added byproduct material, as part of the 

Integrated Materials Performance 

Evaluation Program (IMPEP) reviews. 

The NRC fees are based on the 

number of the NRC-regulated activities 

conducted by the licensee. The NRC 

regulations list fee categories for the 

various activities. A license may include 

more than one fee category, and each fee 

category has a separate fee to recover the 

budgeted resources associated with that 

regulated activity. 

The NRC intends to license the 

production of radionuclides by 

accelerators as a separate Part 30 license 

and has developed a separate licensing 

guide for this activity (i.e., NUREG–

1556, Volume 21, ‘‘Program Specific 

Guidance About Possession Licenses for 

Production of Radioactive Materials 

Using an Accelerator’’). Commercial 

distribution will continue to be licensed 

under 10 CFR 32.72 for radioactive 

drugs and under 10 CFR 32.74 for 

medical sealed sources. This licensing 

process provides a clear delineation 

between radionuclide production or 

radioactive drug manufacture and 

commercial distribution of radioactive 

drugs or medical sealed sources to 

medical use licensees. 

Historically, a radioactive drug 

manufacturer has to obtain a Part 30 

license for possession of the licensed 

material. A Part 30 license also 

authorizes the transfer of byproduct 

material under 10 CFR 30.41 to other 

licensees, but it does not authorize 

distribution of radioactive drugs to 

medical use licensees. Distribution of 

radioactive drugs containing byproduct 

material to medical use licensees for 

medical use must be authorized by a 

‘‘Medical Distribution’’ (MD) license 

under 10 CFR 32.72 or 10 CFR 32.74. 

The NRC issues MD licenses to 

commercial nuclear pharmacies for 

distribution of radioactive drugs to 

medical use licensees with a Part 30 

authorization for possession and use. 

However, the NRC does not consider 

commercial nuclear pharmacies to be 

drug manufacturers, i.e., registered with 

FDA or a State as a drug manufacturer. 

Comment: A commenter stated that 

medical radionuclides can initially 

produce very high doses of radiation 

from the exterior of a patient after 

treatment. The commenter asked 

whether, because of this, there are any 

patient releasability issues such as those 

for the release of iodine-131 therapy 

patients. The commenter also asked 

whether there would be any 

releasability issues for activated or 

spallated patients. 

NRC Response: The requirements in 

10 CFR 35.75, ‘‘Release of individuals 

containing unsealed byproduct material 

or implants containing byproduct 

material,’’ apply to all medical uses and 

all medical use licensees. It is the 

licensee’s responsibility for a release 

determination of a patient or human 

research subject to determine whether 

he or she: (1) cannot be released under 

10 CFR 35.75; (2) can be released with 

written instructions; or (3) can be 

released without written instructions. 

These decisions are based on whether 

the total effective dose equivalent to any 

other individual is likely to exceed 

certain values. These values apply to the 

evaluation of all patients including 

activated patients. 

Comment: Several commenters 

supported the ‘‘grandfathering’’ of 

individuals (i.e., not requiring 

individuals to meet new training and 

experience requirements in order to 

continue their previous 

responsibilities), discussed in the 

Statements of Consideration for 

individuals producing acceleratorproduced radionuclides and in the 

proposed rule text for ANPs, medical 

use AUs, and RSOs. These commenters 

wanted a grandfathering provision for 


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AUs responsible for the production and 

use of PET radionuclides included in 10 

CFR Part 30. Some of these commenters 

requested that the NRC strengthen the 

language to clarify the extent of the 

grandfathering authorizations. Several 

commenters requested that the NRC 

consider using this rulemaking to 

resolve other general issues related to 

grandfathering of AMPs and RSOs. The 

commenters agreed that individuals 

already authorized to use byproduct 

materials in 10 CFR Part 35 should also 

be authorized to use the newly covered 

accelerator-produced materials. One 

commenter wanted the NRC to clarify 

that the reverse was also true, i.e., 

individuals who previously only used 

NARM were now qualified to use all 

byproduct material. 

NRC Response: Unlike 10 CFR Part 35 

medical use licensees that are required 

to meet specific training and experience 

requirements, 10 CFR Part 30 licensees 

that use accelerators to produce 

byproduct material are required to meet 

general performance criteria in 10 CFR 

30.33(a)(3). The training and experience 

of individuals involved in the licensing 

activities to produce the newly added 

byproduct material are reviewed during 

the licensing process to ensure that they 

are qualified to perform those activities. 

Because the NRC does not have specific 

requirements for these individuals, 

there is no need to provide a 

‘‘grandfather provision’’ for them. 

Applicants with accelerators used to 

produce byproduct material will be 

required to describe the radiation safety 

training and work experience of those 

individuals using materials that they are 

seeking authorization to use. It is 

expected that these individuals that 

used the newly added byproduct 

materials will be able to document that 

their radiation safety training and work 

experience from using these materials 

are sufficient to meet the general 

performance criteria and that they be 

recognized as authorized individuals. 

Section 35.57 was amended in the 

proposed rule to provide that certain 

authorized individuals who used only 

the newly defined byproduct material 

may be grandfathered (i.e., need not 

comply with the relevant training 

requirements in Part 35) for performing 

the same uses. The NRC does not 

believe that the language in the 

provisions should be revised. 

The NRC has determined that revising 

the regulations to address general issues 

related to the grandfathering of AMPs 

and RSOs would be outside of the scope 

of this rulemaking. These issues will be 

addressed separately in response to a 

petition for rulemaking (PRM–35–20) 

filed by the American Association of 

Physicists in Medicine on September 

10, 2006. 

Comment: There were several 

comments on the NRC’s proposal for the 

noncommercial transfer of PET 

radionuclides, drugs, and biologics to 

other medical facilities in its consortium 

by a medical use facility that uses its 

own cyclotron to produce PET 

radionuclides. One commenter stated 

that it agreed that facilities authorized 

by a State to produce PET radionuclides 

for noncommercial distribution should 

be allowed to do so without a medical 

distribution license. 

Generally, the commenters agreed that 

distribution licenses should not be 

required for distribution of 

radionuclides from PET facilities to 

medical facilities under contract to 

them, but thought it was unclear which 

facilities would be included in the 

definition of ‘‘medical facilities in its 

consortium.’’ As an example, one 

commenter was not sure whether a 

cyclotron producing PET radionuclides, 

that is located at a facility owned by 

Company A but operated under a 

separate license by a different Company 

B, would need a commercial 

distribution license. The commenter 

also asked for clarification on whether 

Company B would need a medical 

distribution license if it also supplied 

PET radionuclides to other facilities in 

its geographical area under contract. 

Another commenter noted that only 

noncommercial distribution to a 

medical consortium was addressed, and 

not the noncommercial distribution 

within the consortium in support of 

research and development. The 

commenter asked that the NRC expand 

its proposed regulatory framework to 

include authorization for licensees 

producing PET radionuclides, drugs, 

and biologics to allow noncommercial 

transfer to any licensee approved for 

research and development uses of these 

materials. This commenter also asked 

the NRC to provide specific guidance on 

what is considered commercial transfer 

and noncommercial transfer in advance 

of requiring license application and 

amendment submissions for the 

production of accelerator-produced 

radionuclides. The commenter’s interest 

was based on its being funded to do 

research involving nonstandard 

radionuclides and to make the results 

available to the research community and 

others. The commenter asserted that the 

NRC, in the past, approved similar 

efforts by universities to produce and 

supply nonstandard radionuclides not 

otherwise available. 

NRC Response: The NRC recognizes 

that the PET radionuclide production 

facility may be located in a medical 

facility, educational institution, or 

Federal facility that has formed a 

consortium to produce PET radioactive 

drugs for its members. The NRC is 

adding a definition of Consortium in 10 

CFR 30.4 to clarify the purpose and 

members of a consortium. In general, 

the members of the consortium jointly 

own or share in the operation and 

maintenance cost of the PET 

radionuclide production facility, and 

the production facility or another 

member of the consortium produces 

PET radioactive drugs (including 

radioactive biologics) only for its 

consortium member’s medical uses. The 

NRC’s authorization for the 

noncommercial distribution of PET 

radioactive drugs within a medical use 

consortium is not dependent on an 

authorization by a State to produce PET 

radionuclides for noncommercial 

distribution. A person or a licensee that 

has or receives PET radionuclides from 

a PET radionuclide production facility 

may request authorization for 

noncommercial distribution of PET 

radioactive drugs within its consortium. 

The NRC will review the request along 

with the description of the consortium 

during the licensing review process to 

ensure eligibility for noncommercial 

distribution and issuance of the 

authorization. 

For clarification purposes, the NRC, 

in the final rule, has moved the 

noncommercial distribution provisions 

for PET radioactive drugs to 10 CFR Part 

30. For noncommercial distribution of 

PET radioactive drugs, the NRC is 

applying the same requirements as those 

included in 10 CFR 32.72 for 

commercial distribution of these drugs. 

Regarding different licensing 

situations, a university that has both a 

10 CFR Part 30 license and a 10 CFR 

Part 35 license could transfer PET 

radioactive drugs to its medical facility 

without a commercial distribution 

license. If the PET radionuclide 

production facility produces PET 

radioactive drugs and is located at a 

medical facility, but owned, operated, 

and licensed by another entity under a 

10 CFR Part 30 license, then the PET 

radionuclide production facility 

licensee would need a 10 CFR 32.72 

license to distribute PET radioactive 

drugs to the medical facility for medical 

use. If a PET radionuclide production 

facility produces PET radioactive drugs 

and wants to distribute excess PET 

radioactive drugs to other licensees 

outside its consortium, a 10 CFR 32.72 

commercial medical distribution license 

would be required. In general, a PET 

radionuclide production facility may 

transfer excess PET radionuclides to 

other licensees that are authorized to 


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receive such PET radionuclide transfer 

under 10 CFR 30.41. However, if a PET 

radionuclide production facility 

produces radionuclides for commercial 

distribution, then a distribution 

authorization would be required as well. 

An applicant’s intent regarding 

noncommercial distribution, transfer, or 

commercial distribution will be 

evaluated as part of the licensing review 

process to ensure that the proper license 

or authorization is issued. 

A PET radionuclide production 

facility is required to obtain a 10 CFR 

Part 30 license for production, 

possession, and use of byproduct 

material. Under 10 CFR 30.41, a licensee 

is allowed to transfer byproduct 

material (including PET radionuclide) to 

any person authorized to receive such 

byproduct material. However, as 

required in 10 CFR Part 35 regulations, 

medical use licensees can only obtain 

PET radioactive drugs for medical use 

from persons meeting specific 

requirements for commercial 

distribution of radioactive drugs in 10 

CFR 32.72. There are no such 

limitations for nonmedical use. 

Therefore, a specific provision would be 

needed to allow medical use licensees 

to obtain PET radioactive drugs through 

noncommercial distribution or from 

persons not covered under 10 CFR 

32.72. A new provision is added in 10 

CFR 30.32(j) to allow a PET 

radionuclide production facility to 

noncommercially distribute PET 

radioactive drugs to members of its 

consortium. Such a provision is not 

needed for a PET radionuclide 

production facility to transfer PET 

radionuclides because transfer is 

already allowed under 10 CFR 30.41. 

Comment: A commenter requested 

that the NRC clarify whether facilities 

that prepare PET drugs for use in 

research under Investigational New 

Drug exemptions (INDs) filed with the 

FDA, or used in research conducted 

under approvals granted by Radioactive 

Drug Research Committees (RDRCs) 

operating as branches of the FDA under 

21 CFR 361.1, would be considered 

‘‘registered’’ by the FDA. 

NRC Response: As specified in 10 

CFR 30.32(j) and 10 CFR 32.72, being 

registered with the FDA is only one of 

the five ways that an applicant can 

demonstrate that it is qualified to 

produce PET radioactive drugs for 

noncommercial or commercial 

distribution to medical use licensees. 

Because the NRC neither interprets nor 

enforces FDA requirements, it is the 

applicant’s responsibility to provide 

documentation of the proper FDA 

registration. If there is a question as to 

whether a specific facility that prepares 

PET drugs under INDs or RDRCs is 

‘‘registered’’ by the FDA, the applicant 

should contact FDA for a determination. 

It is important to note that a 10 CFR 

Part 35 medical use licensee may obtain 

unsealed byproduct material for uptake, 

dilution, excretion, imaging, or 

localization from an NRC or Agreement 

State licensee that prepared the material 

for research in accordance with an 

RDRC-approved protocol or an IND 

protocol accepted by FDA as permitted 

in current provisions of 10 CFR 35.100 

and 35.200. This provision is separate 

from the provision that the byproduct 

material must be obtained from a 

commercial manufacturer or preparer 

licensed under 10 CFR 32.72 or by 

noncommercial distribution from a 

member of its consortium under 10 CFR 

30.32(j). 

Comment: A commenter expressed 

concern that language in the proposed 

rule could place undue burden on 

health care providers who use 

cyclotrons for the production of 

radiotracers by requiring them to meet 

FDA’s Good Manufacturing Practices 

(GMPs) standard that is applied to 

commercial entities producing products 

for sale to the public. The commenter 

stated that it was inappropriate to apply 

GMPs to noncommercial production of 

radiotracers. The commenter stated that: 

(1) the EPAct does not give the NRC the 

authority to require health care 

providers to follow GMPs in their 

clinical practices; (2) enforcing drug 

production quality standards falls under 

FDA’s jurisdiction, and the NRC should 

not enforce FDA requirements; (3) such 

a requirement would have a detrimental 

effect on exploration of new treatment 

pathways; and (4) health care providers 

have not been required to apply 

commercial GMP standards previously. 

The commenter asserted that regulation 

of cyclotron byproduct material should 

not include processes involving drug 

production and patient care. The 

commenter further indicated that the 

production of radiopharmaceuticals 

using a cyclotron is no different than 

using a molybdenum or rubidium 

generator. 

NRC Response: The NRC disagrees 

that its regulations would require health 

care providers to follow GMPs in their 

clinical practice. The NRC requires 

licensees that distribute radioactive 

drugs (including radioactive biologics) 

to medical use licensees to be qualified 

to produce radioactive drugs for medical 

use. To demonstrate this qualification, 

the NRC requires in 10 CFR 30.32(j) and 

10 CFR 32.72 that the applicant or 

licensee submit evidence that it meets at 

least one of the following criteria: (1) be 

registered with the FDA, (2) be 

registered or licensed with a State 

agency as a drug manufacturer, (3) be 

licensed as a pharmacy by a State Board 

of Pharmacy, (4) be operating as a 

nuclear pharmacy within a Federal 

medical institution, or (5) be a PET drug 

production facility registered with a 

State agency. The FDA’s rule on Good 

Manufacturing Practice for PET drugs 

establishes criteria for the production 

and process/quality controls of PET 

drugs in PET centers registered with the 

FDA. While the NRC recognizes the 

FDA registration in the NRC’s 

regulations, registration with the FDA is 

only one of five different criteria that 

licensees may meet to demonstrate they 

are qualified to distribute radioactive 

drugs to medical use licensees. 

The NRC agrees that the production of 

radiopharmaceuticals using 

radionuclides from a cyclotron is no 

different than using molybdenum or 

rubidium generators. The producer of 

the molybdenum generator is registered 

with the FDA as a drug manufacturer 

and is licensed by the NRC under both 

10 CFR Part 30 and 10 CFR 32.72. The 

use of the generator to prepare other 

radioactive drugs is required in 10 CFR 

32.72 to be done by a commercial 

nuclear pharmacy or in 10 CFR 35.200 

to be done at the medical use facility by 

an AU meeting specific training and 

experience criteria or an ANP. The NRC 

has applied the same flexibility in 

recognizing that certain drugs are 

produced by facilities registered with 

the FDA or States and that other drugs 

are prepared by or under the 

supervision of AUs or ANPs. 

Comment: A commenter 

recommended that the NRC should 

include an exemption for changes that 

involve the addition or relocation of 

either a PET radionuclide production 

area or a radionuclide delivery line from 

the PET production area from license 

amendment or the NRC notification 

requirements for broad scope Type A 

licenses under 10 CFR 35.15. The 

commenter stated that this allowance is 

consistent with the level of authority the 

NRC has historically granted under this 

list of exemptions. 

NRC Response: The NRC agrees with 

the commenter and revised proposed 10 

CFR 35.15(f) to make it clear that a Type 

A specific license of broad scope is 

exempt from the notification provisions 

in 10 CFR 35.14(b)(5). In this final rule, 

the NRC’s licensing practice for Type A 

specific licenses of broad scope is to 

have the licensee describe significant 

facilities, such as the PET radionuclide 

production area or radionuclide 

delivery tube, and provide the NRC its 

criteria for reviewing and approving the 

addition or relocation of these facilities. 


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The broad scope licensee with a PET 

radionuclide production facility will 

need to submit an application to license 

the production facility and, if 

applicable, increase its radionuclide 

possession levels. 

Comments on Waste and 

Decommissioning 

Decommissioning and Decontamination 

Comment: A commenter noted that 

under the proposed rule, activities 

under the new definition of Byproduct 

material would need to be licensed 

within 6 to 12 months after the final 

rule takes effect. The commenter 

requested clarification as to whether 

this new requirement would result in 

MML licensees having to permit/license 

all sites containing radium or radium 

contamination due to radium paint 

operations or gauge maintenance. The 

commenter noted that current U.S. Air 

Force (USAF) policy is to forgo 

permitting sites, until intrusive 

characterization of the site has been 

performed. The commenter requested 

that the NRC state whether this rule 

would affect the current USAF policy. 

NRC Response: As previously 

discussed, since the publication of the 

proposed rule, and after considering the 

comments on the new definition of 

Byproduct material, the Commission 

has taken a closer look at the scope of 

the Commission’s jurisdiction over the 

newly added byproduct material 

including discrete sources of radium226. The EPAct covers material that is 

‘‘produced, extracted, or converted after 

extraction, before, on, or after August 8, 

2005, for use for commercial, medical, 

or research activity.’’ Notwithstanding 

that a discrete source of radium-226 

may have originated from a commercial 

supplier, the Commission has 

determined that discrete sources of 

radium-226 still under the control of the 

military do not constitute ‘‘commercial 

use’’ under the EPAct and are, therefore, 

outside the Commission’s jurisdiction. 

Defining ‘‘commercial use’’ to include 

all material supplied to the military 

from a commercial supplier would 

result in virtually all military use of this 

material to be ‘‘commercial use.’’ This 

would vitiate any distinction that the 

EPAct intended to make for military 

use, as opposed to commercial use, by 

excluding military use from its 

coverage. 

However, this exclusion from the 

coverage of the EPAct only applies to a 

certain type of military use, i.e., NARM 

used for ‘‘military operations.’’ The term 

‘‘military operations’’ covers what is 

traditionally understood as the 

military’s primary mission for national 

defense, including warfare, combat, and 

battlefield missions, and, of course, 

training for battlefield missions. NARM 

used, or available for use, for these 

purposes would be excluded from the 

coverage of the EPAct and from the 

coverage of this rule. If the material is 

intended for use in military operations, 

it is excluded from the coverage of this 

rule notwithstanding the fact that it was 

originally produced by a commercial 

supplier. In addition, ‘‘military 

operational’’ material includes material 

still under the control of the military, 

i.e., in storage, or material that may be 

subject to decontamination and 

disposal. Other use of NARM by the 

military would be covered by this rule. 

The NRC no longer authorizes specific 

byproduct material use licensees to bury 

licensed materials at their facility. 

Although the MML licensee cannot 

issue permits for new burial sites, 

licensees are required under 10 CFR 

30.35 to maintain documentation of 

information that is necessary for 

decommissioning. 

Comment: A commenter stated that 

Actinide/radium-226 surface 

contamination levels less than 1000–

1500 dpm/100cm2 are typically not 

detectable at 1–2 sigma counting 

statistics. The commenter stated that 

radium-226 captured in clothing/porous 

materials could have much higher 

counting errors and asked if the NRC 

has accepted the technological shortfall 

for detection of radium-226 and 

proposed an alternative. 

NRC Response: Licensees are required 

to ‘‘demonstrate’’ to the NRC that post 

remediation contamination levels meet 

the release criteria for their sites. 

‘‘Demonstration’’ includes specifically 

addressing instrumentation used for 

detecting and measuring the 

contamination. If instruments can’t 

detect the contamination, other means 

to identify contamination levels must be 

addressed in the licensee’s 

Decommissioning Plan. The NRC 

guidance documents NUREG–1757, 

‘‘Consolidated NMSS Decommissioning 

Guidance,’’ and NUREG–1575, ‘‘MultiAgency Radiological Survey and Site 

Investigation Manual,’’ both address 

instrumentation. 

Comment: Two commenters requested 

that the NRC modify its regulations in 

10 CFR 30.36 to allow a longer time 

frame of at least 10 years for completion 

of decommissioning for accelerator 

production facilities. One commenter 

stated that decommissioning of a 

particle accelerator and its associated 

facility can range from a return of a selfshielded cyclotron unit to the 

manufacturer to a major cleanup of an 

older accelerator unit and its facility. 

The commenter stated that cost for 

decommissioning will be significantly 

impacted by the time frame allowed to 

complete this action. Under the current 

10 CFR 30.36 regulations, completion of 

decommissioning for an accelerator 

production facility could be required in 

as little as 48 months following 

cessation of operation. On the other 

hand, under 10 CFR 50.82, 

decommissioning of a power reactor is 

required to be completed within 60 

years following cessation of operation. 

Hence, the commenter requested that 

the NRC modify its regulations in 10 

CFR 30.36 to allow a longer time frame 

of at least 10 years for completion of 

decommissioning for accelerator 

production facilities. 

NRC Response: The NRC’s regulations 

in 10 CFR 30.36 require that the site or 

any separate building or outdoor area 

that has not been used for 2 years must 

be promptly remediated if the 

remediation activities are allowed by 

the existing license. If remediation 

activities are not allowed under an 

existing license, the licensee must 

develop a decommissioning plan and 

submit a request for a license 

amendment within 1 year. The 

decommissioning process must be 

completed within 2 years, unless an 

alternative schedule for completion of 

decommissioning is approved by the 

Commission. 

The level of effort for 

decommissioning a radioactive material 

production facility depends on many 

factors such as the design, age, operating 

condition, and usage of the accelerator 

and the type of facility where the 

accelerator is located. Decommissioning 

activity can range from simply a return 

of a self-shielded cyclotron unit to the 

original manufacturer to a more 

complicated cleanup of an older 

accelerator unit and its facility. Because 

alternative schedules for 

decommissioning are allowed within 

the existing regulations, there is no need 

to modify 10 CFR 30.36. 

Comment: In response to the NRC’s 

request for comments on the 

decommissioning of accelerator 

facilities and accelerator components, 

one commenter requested clarification 

in Part 35 that the term 

decommissioning does not apply to the 

removal or replacement of a linear 

accelerator used for medical treatment. 

Another commenter recommended that 

the NRC include a specific exemption 

that states that ‘‘decommissioning’’ does 

not include: (a) replacement of one 

medical accelerator for another; (b) 

upgrading of a medical accelerator; (c) 

replacement of one cyclotron for 


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another within the same facility; or (d) 

upgrading of an existing cyclotron. 

NRC Response: The EPAct gave the 

NRC the authority to regulate any 

material that has been made radioactive 

by use of a particle accelerator and is 

produced, extracted, or converted for 

use for a commercial, medical, or 

research activity. Under the EPAct, the 

NRC only has authority over the 

radioactive material and not over 

accelerators including linear 

accelerators used for medical treatment. 

Because linear accelerators used for 

medical treatment do not produce 

radioactive material that is used for 

commercial, medical, or research 

activities, the NRC will not be regulating 

the activated material that may be 

produced during medical treatment. 

Because medical linear accelerators 

and activated material associated with 

these types of accelerators are not 

regulated by the NRC, no specific 

exemption is needed for non-NRC 

regulated material, including 

replacement or upgrade of a medical 

linear accelerator. Decommissioning 

regulations are not applicable to 

nonregulated material such as a medical 

linear accelerator. 

Replacement or upgrade of a 

cyclotron is not typically considered a 

decommissioning activity; therefore, an 

exemption for such activity would not 

be required. However, if the cyclotron is 

used to produce radioactive material for 

commercial, medical, or research 

activities, and accelerator components 

become activated incidental to the 

production of radioactive material, both 

the radioactive material and the 

components would be regulated as 

licensed material. The activated 

components would require 

decommissioning upon cessation of 

licensed activity. If licensed activity 

continues, the replacement or upgrade 

of a cyclotron or its activated 

components would be addressed in the 

license. The removed cyclotron and its 

activated components are considered 

licensed material and would be treated 

as radioactive waste. 

Comment: A commenter stated that 

the NRC should address volumetric 

contamination of materials by 

activation/spallation and recommended 

that the NRC develop release criteria for 

the various accelerator-produced 

radionuclides. 

NRC Response: For decommissioned 

sites, the release criterion for 

unrestricted use is 25 mrem per year 

(0.25 mSv per year) as listed under 10 

CFR Part 20, Subpart E, and 10 CFR 

30.36, including all radionuclides and 

all pathways. If an accelerator is used to 

produce regulated material, and 

accelerator components become 

activated incidental to the production of 

the regulated material, the activated 

components would be licensed and 

subject to 10 CFR Part 20, Subpart E, 

and 10 CFR 30.36 requirements. 

Even though the NRC has, in the past, 

considered exposure criteria for release 

of waste and contaminated scrap, no 

rule has been adopted regarding 

exposure criteria. Currently, the NRC 

does not plan to develop release criteria 

for various accelerator-produced 

radionuclides. Activated waste 

produced in an accelerator will be 

treated like any other radioactive waste. 

Guidance regarding decommissioning 

and waste disposal can be found in 

NUREG–1757, ‘‘Consolidated NMSS 

Decommissioning Guidance.’’

Comment: Two commenters asked 

whether the NRC will be proposing 

acceptable de minimus values, release 

criteria, or remediation criterion for 

surficial and volumetric radium 

contamination on building structures 

and soil that can be generally applied to 

decommissioning operations. One 

commenter asked if the NRC accepts 5 

pCi/gram of soil as volumetric de 

minimus values that EPA or States have 

approved for radium-226 contamination 

release value at certain remediation 

sites. 

NRC Response: Currently, there are no 

de minimus values or release criteria for 

decommissioning sites. As provided in 

10 CFR 20.1402, the release criterion for 

unrestricted use is 25 mrem per year 

(0.25 mSv per year) for all sources and 

all pathways. The NRC will only accept 

a release value of 5 pCi/gram (0.185 Bq) 

for radium-226 contamination in soil if 

the site will also meet the NRC’s release 

criterion of 25 mrem per year (0.25 mSv 

per year). 

The NRC does have screening values 

for building surfaces and surface soil 

concentrations. Screening values are 

based on the 25-mrem per year (0.25- 

mSv per year) release criterion and can 

be used to simplify decommissioning 

efforts where low levels of 

contamination exist. Screening values 

are listed in tables included in 

Appendix B of NUREG–1757, 

‘‘Consolidated Decommissioning 

Guidance-Decommissioning Process for 

Materials Licensees,’’ for each 

radionuclide for building surfaces and 

soil surfaces. These screening values are 

not de minimus values. Unlike de 

minimus values, the screening values 

were developed under certain site 

conditions (e.g., type of facility, depth of 

soil contamination, type of surface 

contamination); therefore, screening 

values may only be used if a site meets 

these specific conditions. For a site with 

mixed radionuclides, the ‘‘unity rule’’

(or sum of the fractions rule) applies, 

and screening values would change 

depending on the site’s isotopic 

mixture. There are only a few sites that 

can use the screening method for 

decommissioning because sites are very 

different from each other, and most sites 

do not meet the conditions for using 

screening values. 

Comment: One commenter provided 

some insight on a radium-226 dosimeter 

calibration source breach at a facility in 

the 1950s and indicated that current 

survey equipment has difficulty 

detecting actinide contamination under 

1000–1500 dpm/100cm2. The 

commenter stated that if the radium-226 

breach occurred before the 1970s, it is 

likely that the contamination still exists. 

Because the NRC has taken authority 

over all past, present, and future 

radium-226 sources, the commenter 

asked whether the NRC’s authority 

includes authority over the 

contamination resulting from a radium226 source breach. 

NRC Response: Under the EPAct, the 

NRC has the regulatory authority over 

all past, present, and future discrete 

sources of radium-226 and any 

contamination associated with the 

discrete sources. However, the NRC 

does not intend to require nonlicensed 

owners of properties that may be 

contaminated with radium-226 to obtain 

licenses. If contamination is discovered 

at a nonlicensed person’s facility, such 

as contaminated buildings or grounds, 

the NRC will work with the facility 

owner to perform decommissioning of 

the site. If the site presents a significant 

threat to the public health and safety, 

the NRC may order the owner to obtain 

a license and to perform 

decommissioning of the site. In 

addition, the NRC may seek assistance 

from EPA to consider listing the site on 

EPA’s National Priority List and clean 

up the site under the CERCLA or 

Superfund Program. Any arrangement 

between the NRC and EPA regarding 

regulatory authority over 

decommissioning would be agreed upon 

on a site-specific basis. 

Comment: One commenter indicated 

that a number of gaslight and luminous 

production sites are abandoned, and 

some are Superfund sites. The 

commenter asked whether the NRC has 

the financial ability to clean up these 

sites. 

NRC Response: The NRC does not 

perform or provide funds for cleanup of 

contaminated sites because the NRC 

does not have authority in spending 

Federal funds for conducting cleanup 

activities. The NRC relies solely on 

licensees or property owners to perform 


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the necessary cleanup work. Unlike the 

NRC, EPA has the funds under the 

CERCLA or Superfund Program to 

evaluate the extent of the contamination 

and to conduct the cleanup efforts. EPA 

also has the statutory authority to 

recover the cost associated with the 

cleanup activities from the potentially 

responsible parties. 

Comment: One commenter asked 

whether there will be any requirements 

for the NRC’s review of radiumcontaminated sites that have been 

remediated before the effective date of 

this rule. 

NRC Response: The NRC does not 

intend to revisit sites that have already 

been remediated. If sites are discovered 

to be contaminated with sufficient 

quantities of radionuclides to 

potentially warrant additional 

decommissioning, the NRC will contact 

and work with the owner of the 

property to re-commence the 

decommissioning process. 

Comment: One commenter asked how 

the NRC will review decommissioning 

plans and final status surveys for sites 

where AEA Section 91(b) materials may 

be the predominant contaminant with 

respect to AEA materials regulated by 

the NRC and whether there is a limit of 

the NRC’s interests in these sites. 

NRC Response: Decommissioning of a 

licensed facility falls under the 

requirements of 10 CFR part 20, Subpart 

E, and 10 CFR 30.36. The NRC will 

review decommissioning plans and the 

final status survey to ensure that the 

licensed facility meets the release 

criterion of 25 mrem per year (0.25 mSv 

per year) for unrestricted use for all 

radionuclides and all pathways. The 

NRC will use this approach for all sites 

that are contaminated by any licensed 

material including sites where 

unlicensed radionuclides such as 

Section 91(b) material contribute to the 

dose estimates in the all-pathway 

analysis. The NRC has no regulatory 

authority over a site that is 

contaminated with only Section 91(b) 

material and not licensed material. 

Comment: One commenter raised a 

question on whether the NRC will 

subsume the predominant regulatory 

role for remediation of sites that predate 

the USAF MML and were established 

under AEC purview. 

NRC Response: The NRC has the 

predominate regulatory role in the 

decommissioning of sites under the 

MML. Sites containing licensed material 

must be decommissioned under 10 CFR 

part 20, subpart E, and 10 CFR 30.36 

requirements regardless of whether such 

sites predate the MML or were under 

the purview of AEC. 

Comment: Two commenters 

expressed their concern regarding the 

statement in the Statements of 

Consideration for the proposed rule that 

only radionuclides with a half-life of 

more than 120 days, that are present in 

sufficient quantities to cause a public 

health and safety concern, need to be 

addressed for the purpose of 

establishing adequate financial 

assurances for decommissioning leading 

to license termination. One commenter 

requested that the final rule include 

specifications of which radionuclides 

and the threshold amounts would be 

sufficient to lead to license termination. 

Another commenter recommended that 

the term ‘‘sufficient quantities’’ be 

defined in terms of 10 CFR part 20 dose 

limits. 

NRC Response: In the proposed rule, 

the term ‘‘sufficient quantities’’ is 

referring to quantities of radionuclides 

with a half-life of more than 120 days 

for the purpose of establishing adequate 

financial assurance for 

decommissioning leading to license 

termination. The specific quantities are 

established in 10 CFR 30.35. For 

unsealed byproduct material in 

quantities exceeding 105 times, or for 

sealed sources or plated foils in 

quantities exceeding 1012 times the 

applicable quantities in Appendix B to 

10 CFR part 30, the licensee is required 

to submit a decommissioning funding 

plan. For unsealed byproduct material 

in quantities exceeding 103 but less than 

or equal to 105 times, or for sealed 

sources or plated foils in quantities 

exceeding 1010 but less than or equal to 

1012 times the applicable quantities in 

Appendix B to 10 CFR part 30, the 

licensee is required to submit either a 

decommissioning funding plan or a 

certification that financial assurance for 

decommissioning had been provided in 

the amount prescribed in 10 CFR 

30.35(d). Revising the quantities 

requiring financial assurance is beyond 

the scope of this rule. 

For license termination, the release 

criterion for unrestricted use is 25 mrem 

per year (0.25 mSv per year) as listed 

under 10 CFR part 20, subpart E, and 10 

CFR 30.36. All radionuclides, regardless 

of the quantities present, must be 

considered in the all-pathway analysis 

in demonstrating compliance with the 

release criteria. 

Waste Disposal 

Comment: One commenter asked 

whether radioactive waste site licenses 

will need to be changed to reflect the 

newly regulated radioactive materials 

and whether it is the waste site 

licensee’s responsibility to incur the 

cost of changing the license. 

NRC Response: Waste site licenses 

may or may not need to be amended to 

include newly regulated radionuclides. 

The need for amending a license will 

depend on how the existing license 

identifies the licensed material (listed as 

a group of radionuclides or listed by 

each individual radionuclide). The cost 

for a license amendment would be the 

responsibility of the licensee. 

Comment: One commenter asked 

whether there are disposal sites that can 

inexpensively dispose of consumer 

products and luminous light sources. If 

not, the commenter stated that 

abandonment may become the only 

method of disposal. 

NRC Response: There are radioactive 

waste disposal sites, licensed by the 

Agreement States, and hazardous or 

solid waste disposal sites, permitted by 

the EPA or its authorized States, 

available for disposal of the newly 

added byproduct material. Disposal 

charges are set by each of the disposal 

facilities based on the type of material 

and the contamination level. It is the 

licensee’s responsibility to locate a 

disposal facility that could accept the 

waste and to negotiate disposal cost. 

There are also certain manufacturers 

that accept returned or spent sources 

from their customers. In the past, DOE 

has, in certain unique situations, 

cooperated with the NRC and the 

CRCPD in collecting certain orphaned 

sources for storage and/or disposal at 

DOE facilities due to lack of disposal 

options. However, these programs are 

typically limited in scope and designed 

for urgent needs. 

In general, consumer products are 

manufactured by a specific license and 

distributed to consumers as an exempt 

product. These consumer products 

contain very small amounts of 

radioactive material in order to meet the 

stringent criteria for an exempt product. 

There are no disposal requirements for 

exempted products based on the amount 

of the radioactive material present and 

the negligible impact to public health 

and safety. Hence, exempt products are 

allowed to be disposed of in municipal 

landfills. 

Comment: One commenter was 

concerned regarding the disposal of 

exempted smoke detectors containing 

radium-226. 

NRC Response: This issue is 

discussed earlier in this document 

under ‘‘Exemption of Certain Radium226 Items.’’

Comment: One commenter asked if 

the NRC will accept decay-in-storage as 

a method of disposal for acceleratorproduced medical radionuclides. The 

commenter also asked whether decayin-storage could also be applied to 


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accelerator components that are 

volumetrically activated or spallated, 

and whether the time period under 

which the accelerator is turned off or in 

a low energy mode could be counted as 

the decay-in-storage time. 

NRC Response: Decay-in-storage has 

been, and will continue to be, an 

accepted means for disposal of 

radionuclides with short half lives, 

including medical radionuclides. 

Activated components either within or 

removed from the accelerator will be 

treated as any other radioactive source. 

Therefore, activated components 

contaminated with short-lived 

radionuclides with half lives less than 

120 days will be allowed to use decayin-storage as a disposal method. 

Activated components contaminated 

with radionuclides with half lives 

greater than 120 days would either have 

to be disposed of as radioactive waste or 

have to be addressed later during 

decommissioning as part of the license 

termination process. 

Comment: For decay-in-storage or 

disposal, a commenter asked whether 

accelerator-produced medical 

radionuclide users will be able to ignore 

short-lived radionuclides. As an 

example, the commenter noted that 

many ‘‘hundreds of thousands’’ of 

fluorine-18 disintegrations on the skin 

surface will produce only microrem 

doses to the skin or deep tissue. 

NRC Response: All acceleratorproduced radionuclides, including 

short-lived radionuclides, will be 

regulated. Licensees may not ignore 

short-lived radionuclides in meeting the 

NRC’s regulatory requirements. 

However, licensees may use decay-instorage as a means for disposal in 

accordance with the NRC criteria. 

Comment: One commenter stated that 

decommissioning of accelerator 

facilities can result in the removal of 

building materials and accelerator parts 

that are activated. Recycling and 

disposal of material that meet the NRC’s 

materials contamination limits may still 

trigger detectors at landfill and scrap 

facility checkpoints. The commenter 

recommended that the NRC consider 

exposure criteria for release of these 

materials. 

NRC Response: In the past, the NRC 

has considered development of 

exposure criteria for release of waste 

and scrap through the rulemaking 

process. Due to public comments on the 

rulemaking effort, the NRC decided to 

defer the rulemaking to a later date, and 

no rulemaking on this issue was 

promulgated. 

Sites released for unrestricted use 

based on the 25-mrem per year (0.25- 

mSv per year) criterion specified in 10 

CFR Part 20, Subpart E, have no 

restrictions placed on the use of the site 

or disposition of material located on the 

site or disposal of waste or materials 

from the site. If a detector is triggered at 

a landfill, the operator of the landfill 

should notify the State or another 

regulatory authority. Typically, the NRC 

would be notified of the event, but, in 

most cases, no action would be taken 

because the material met the NRC’s 

release criteria. 

If the site is discovered to be 

recontaminated to levels above the 

release criteria, the NRC may contact the 

site owner or former licensee to begin 

the decommissioning process. 

Comment: A commenter concurred 

with the NRC’s proposed approach 

towards waste disposal to change Part 

20 to redefine the definition of Waste to 

allow disposal of the newly added 

byproduct material in the NRCregulated disposal facilities or in a 

disposal facility permitted under 

Federal or State solid or hazardous 

waste laws. However, the commenter 

questioned whether such an approach 

may be arbitrary or capricious, since 

other similar low-level wastes may still 

fall under the Compact jurisdiction (i.e., 

Section 11e.(1) byproduct material). The 

commenter suggested that this situation 

could be avoided by managing the 

radium as radioactive material instead 

of byproduct material. 

NRC Response: The commenter 

appears to be concerned that it may be 

arbitrary to treat some byproduct 

materials as low-level waste and some 

as non-low-level waste and suggested to 

manage the newly added byproduct 

material as radioactive material instead 

of as byproduct material. However, the 

EPAct defines the newly added 

byproduct material, i.e., discrete sources 

of radium-226 and accelerator-produced 

radioactive material, as a byproduct 

material. Defining the newly added 

byproduct material as radioactive 

material would be inconsistent with the 

statutory requirement. In addition, the 

NRC only has authority to regulate AEA 

material and not all radioactive 

material. Because the discrete source of 

radium-226 is a byproduct material, and 

byproduct material is only a subset of 

radioactive material, treating radium226 as radioactive material instead of 

byproduct material would have the 

appearance that the NRC has regulatory 

authority over all radioactive material. 

The EPAct provides an additional 

disposal approach for the newly added 

byproduct material to include disposal 

at a disposal facility permitted under 

Federal or State solid or hazardous 

waste laws. This approach is consistent 

with many existing State programs that 

regulate naturally occurring and 

accelerator-produced radioactive 

material as radioactive material and not 

as byproduct material. In addition, this 

approach would enhance proper and 

timely disposal of the newly added 

byproduct material. Similar to low-level 

waste disposal facilities, disposal 

facilities permitted under Federal or 

State solid or hazardous waste laws also 

need to consider all radionuclides as 

source terms in conducting the 

performance assessment and in 

formulating the waste acceptance 

criteria to ensure protection to public 

health and safety and the environment. 

Comment: One commenter concurred 

with providing multiple options for 

disposal of the newly added byproduct 

material but was not sure if this is 

consistent with some compacts’

definitions. The EPAct and the NRC 

state that the new byproduct material is 

not low-level radioactive waste (LLW) 

such that it is not to be impacted by the 

compact process of the Low-Level 

Radioactive Waste Policy Amendments 

Act (LLRWPAA). The commenter stated 

that this seems ‘‘backward,’’ as the 

Rocky Mountain Compact specifically 

captures radium in its definitions and 

traditionally has treated discrete radium 

as LLW. 

NRC Response: Although the newly 

added byproduct material would not be 

considered LLW with respect to the 

compact process of the LLRWPAA, the 

newly added byproduct material may 

still be disposed of at an LLW disposal 

site. The EPAct provides additional 

options for disposal of the newly added 

byproduct material and does not 

prohibit the existing option of LLW 

disposal. 

Comment: Because the newly added 

byproduct material would be allowed to 

be disposed of in either the NRCregulated disposal facilities or in a 

disposal facility permitted under 

Federal or State solid or hazardous 

waste laws, a commenter asked if waste 

disposed of in a CERCLA site would 

incur ‘‘potential responsible parties’’

(PRP) status should the solid or 

hazardous waste facility fail. 

NRC Response: Currently, disposal 

sites already dispose of radium-226 and 

other accelerator-produced and 

naturally occurring radioactive material 

as daughter products or as radioactive 

waste. The EPAct allows these disposal 

sites to continue with their current 

practice. Therefore, nothing would 

change for these disposal sites under the 

new regulations. The EPA has 

jurisdiction over any site that becomes 

a CERCLA or a Superfund site, and the 

EPA has the statutory authority to 

recover cleanup cost from PRPs. Under 


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the Superfund, any party who is 

associated with the site, used the site, 

disposed of material at the site, or 

contributed to the contamination at the 

site could all be considered as a PRP 

and liable for the cleanup. 

Comment: A commenter indicated 

that any disposals in solid or hazardous 

waste facilities must take into account 

potential release of radium from the 

discrete source and therefore radon. The 

commenter suggested that discrete 

sources can be further encapsulated 

before burial as a treatment to reduce 

the potential for radium leakage and 

mitigate the potential for radon. 

NRC Response: Disposal facilities 

need to consider all radionuclides and 

their daughter products when 

conducting the performance assessment 

and when developing the waste 

acceptance criteria regarding the type of 

radioactive waste that may be safely 

disposed of at the site. Depending on 

the performance assessment and the 

waste acceptance criteria, certain 

disposal facilities may require 

additional treatment of certain wastes to 

control the daughter products or 

migration of certain radionuclides. 

However, the NRC sees no reason to 

require further encapsulation of discrete 

sources before disposal because waste 

forms would depend on site-specific 

waste acceptance criteria for each 

disposal site. 

Financial Assurance 

Comment: Two commenters strongly 

support an exemption for facilities with 

18-MeV or less cyclotrons from the 

requirements of 10 CFR 30.35 for 

financial assurance for 

decommissioning because they do not 

believe these cyclotrons are capable of 

producing activation products in the 

quantity sufficient to trigger the 

financial assurance requirements. One 

commenter stated that this approach 

should be the standard in all nonAgreement States. In addition, these 

commenters stated that many 

burdensome expenditures are associated 

with calculating and securing financial 

assurance for decommissioning, 

including expensive concrete bunker 

boring and analysis. These costs would 

inevitably put some existing medical 

and scientific accelerator facilities out of 

business and would also deter 

prospective hospitals and educational 

institutions from obtaining onsite 

cyclotrons, potentially impacting 

patient access to services. In support of 

an exemption, one commenter stated 

that it could provide data to the NRC on 

incidental activation resulting from a 

16.5-MeV cyclotron running at 

maximum beam current at maximum 

duty cycle. 

NRC Response: Although the 

commenters do not believe cyclotrons 

operating at 18-MeV or less are capable 

of producing activation products in the 

quantity sufficient to trigger the 

financial assurance requirements, 

supporting data have not been provided 

to the NRC. Financial assurance is 

required for the cost associated with 

decommissioning. Cost for 

decommissioning a cyclotron depends 

heavily on the complexity of 

decommissioning activities, which 

would be impacted by multiple factors 

such as design of the cyclotron, 

operating conditions, maintenance 

practices, and usage period. A 

standardized approach would not be 

suitable for all cyclotrons with various 

designs. The NRC’s financial assurance 

regulations require financial assurance 

for decommissioning costs based on the 

type, quantity, half-life, and physical 

form of the radionuclides authorized in 

the license. The regulations implement 

a graded approach that requires 

increased financial assurance as the 

authorized quantity of licensed material 

increases. If the license authorizes a 

quantity above a threshold amount, 

financial assurance is required. 

Financial assurance is required because 

the cost of decommissioning should be 

borne by the organization that obtains 

the benefits of using the licensed 

material. The need for financial 

assurance increases where the 

decommissioning activities are complex 

or costly. 

The cost of preparing a cost estimate 

for decommissioning cannot be avoided 

because the licensee must perform its 

obligation to decommission the facility 

at the end of licensed operations. 

Likewise, the cost of characterizing the 

extent of contamination cannot be 

avoided because characterization is 

necessary to prepare a decommissioning 

plan. 

A licensee can reduce its financial 

assurance costs in several ways allowed 

by the regulations. The licensee can 

reduce its licensed possession limits to 

a level below the threshold that requires 

financial assurance, or to a level that 

allows lower amounts of financial 

assurance. The financial assurance 

regulations permit a licensee to submit 

a site-specific decommissioning funding 

plan. If the prescribed amounts of 

financial assurance exceed a reasonable 

estimate of decommissioning costs, the 

licensee may submit a site-specific 

decommissioning funding plan to justify 

a lower amount of financial assurance. 

Information relevant to the amount of 

radioactive material that must be 

removed to permit license termination, 

and the cost of doing so, can be 

presented in the license application. 

The financial assurance regulations 

allow for a number of different financial 

instruments to provide financial 

assurance, which allows the licensee to 

select the lowest cost alternative. 

Consequently, the NRC does not 

anticipate creating an exception from 

financial assurance requirements for 

cyclotron licensees. 

Comment: One commenter stated that 

the NRC should urge the Agreement 

States to adopt their current 

requirements for decommissioning 

through IMPEP for Agreement States. 

NRC Response: Agreement States are 

required under AEA Section 274 b. to 

adopt the NRC’s regulations according 

to the compatibility designations within 

3 years. Agreement State programs are 

regularly evaluated through IMPEP 

reviews. The NRC has worked, and will 

continue to work, closely with the 

Agreement States to ensure that State 

programs are compatible with the NRC. 

Comment: One commenter indicated 

that there should also be surety 

requirements for decommissioning of 

facilities used to manufacture sealed 

sources. 

NRC Response: If the manufacturer of 

sealed sources has possession limits that 

exceed the threshold amount, it will be 

required under existing NRC regulations 

to provide financial assurance. 

Threshold quantities are included in 10 

CFR 30.35. 

Comment: One commenter stated that 

decommissioning funding should 

account for activation products because 

some activation products, such as rebar 

and steel structural components from 

accelerator facilities, have half lives 

longer than 120 days and could pose a 

disposal issue. Gamma exposure due to 

activated products could be an issue in 

certain scenarios. If a licensee were to 

abandon its facility, the potential 

certainly exists for new legacy sites that 

the NRC is trying to avoid. 

NRC Response: If an accelerator is 

used to produce regulated material, and 

accelerator components become 

activated incidental to the production of 

the regulated material, the activated 

components would be licensed and 

subject to 10 CFR Part 20, Subpart E, 

and 10 CFR 30.36 requirements. In 

accordance with 10 CFR 30.35, financial 

assurance for decommissioning of 

licensed material is required based on 

the radionuclides and threshold 

quantities authorized in the license. 

Financial assurance provides funds for 

the licensee to conduct 

decommissioning activities or to hire a 

third-party contractor to decommission 


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a facility. These funds could be used in 

the event a licensee abandoned its 

facility. 

Comments on Other General 

Requirements 

10 CFR Part 20, Appendix B, Derived 

Air Concentration (DAC) 

Comment: Several commenters 

recommended that the NRC should use 

specific values for nitrogen-13 and 

oxygen-15 in 10 CFR part 20, appendix 

B. One commenter stated that the use of 

default values does not allow the 

licensee to use a risk-based approach for 

compliance. 

Most of the commenters endorsed the 

DAC values for nitrogen-13 and oxygen15 calculated by Dr. Michael Stabin at 

Vanderbilt University. The commenters 

noted that Dr. Stabin based his 

calculations on EPA Federal Guidance 

Report No. 12 (FGR–12) in conjunction 

with exposure limits and times used by 

the NRC in other calculated values in 10 

CFR part 20, Appendix B. The 

commenters also noted that the dose 

conversion values from FGR–12 are 

used by the NRC in other applications 

and for other radionuclides currently in 

10 CFR part 20, appendix B. 

The commenters recommended that 

the DAC values for nitrogen-13 and 

oxygen-15 calculated by Dr. Stabin 

should be rounded to one significant 

number and added to part 20, appendix 

B. 

NRC Response: In Section G of the 

proposed rulemaking, the NRC 

requested comments on a number of 

specific issues, including the adequacy 

of the applicable default ALIs and DACs 

in 10 CFR part 20, appendix B, for 

oxygen-15 and nitrogen-13, and whether 

staff should develop larger specific 

values for these radionuclides. All six 

commenters addressing this issue 

believed that specific values for DAC 

should be used rather than the current 

default DAC value of 10¥7 and 10¥9

microcuries per milliliter of air for 

occupational and member of the public, 

respectively. Reasons given that the 

default values in 10 CFR part 20, 

appendix B, were not appropriate 

included: (1) They are unnecessarily 

restrictive default values that can result 

in unjustified cost for unnecessary 

radiological monitoring and controls; (2) 

the use of default values in general does 

not allow the licensee to use a riskbased approach to compliance; (3) 

values in the proposed rule would be 

unreasonably low; and (4) FGR–12 dose 

conversion values are endorsed and 

used by the NRC in other applications, 

such as dose modeling in support of the 

License Termination Rule. 

One commenter submitted an analysis 

and DAC values for nitrogen-13 and 

oxygen-15 to be incorporated in 10 CFR 

part 20, appendix B, Table 1, Column 3, 

and Table 2, Column 1, for the DAC 

occupational value and air effluent 

concentration value. This was endorsed 

by several commenters. The analysis 

used dose equivalent conversion factors 

for submersion in a semi-infinite cloud 

from FGR–12, ‘‘External Exposure To 

Radionuclides in Air, Water, and Soil,’’

along with exposure parameters used by 

the NRC in other calculations in 10 CFR 

part 20, appendix B. 

Models describing deposition and 

retention in the respiratory tract, levels 

and times of absorption to blood, and 

the biokinetics involved were not 

available. The ICRP publications for 

workers or members of the public do not 

have dose coefficients for radionuclides 

with half-lives less than 10 minutes. 

ICRP Publication 53, Radiation Dose to 

Patients from Radiopharmaceuticals 

(1987), does have dose coefficients for 

inhalation of these radionuclides, but 

the biokinetic models generally are not 

directly applicable to worker intakes or 

environmental emissions. Because 

information was not available for dose 

conversion factors for intakes of oxygen15 and nitrogen-13 to compare with the 

dose conversion factors for submersion, 

the NRC arranged for a study during the 

comment period. The purpose of the 

study was to develop scientifically 

sound inhalation dose coefficients for 

occupational and public exposures to 

forms of nitrogen-13 and oxygen-15, in 

order to compare DAC values from 

inhalation with DAC derived from 

submersion in contaminated air. The 

study developed biokinetic models 

describing deposition and respiratory 

tract retention, levels and time for 

absorption into blood, and systemic 

biokinetics of absorbed activity. Dose 

coefficients and derived air 

concentrations were developed for 

inhalation of nitrogen-13 as a gas and as 

ammonia, and oxygen-15 as molecular 

oxygen and as water vapor. The dose 

coefficients for submersion in air 

contaminated with nitrogen-13 and 

oxygen-15 were taken from FGR–12. 

These coefficients for air submersion are 

virtually identical because of their 

similar photon emissions. 

The study verified that the limiting 

dose is from submersion in a cloud of 

the radionuclide and also arrived at 

limiting values for submersion that were 

submitted by the commenter, above, and 

that were endorsed by three other 

commenters. In light of the supporting 

documentation and technical basis for 

providing a specific value for the DACs 

for oxygen-15 and nitrogen-13 from 

submersion in a semi-infinite cloud, the 

NRC is incorporating values of 4E–6 

microcuries per milliliter for the 

occupational value in Table 1, Column 

3, and 2E–8 microcuries per milliliter 

for the effluent concentration in Table 2, 

Column 1, of Appendix B to 10 CFR part 

20, for submersion values of both 

radionuclides. 

Other Comments on Exemptions and 

General License 

Comment: Some commenters agreed 

with the NRC’s proposed delineation of 

particle accelerators into three varieties. 

The commenters agreed that the 

category of accelerators operated to 

produce only particle beams and not 

radioactive material, which include 

linear accelerators used in radiation 

therapy, should not be regulated. One 

commenter supported the NRC’s 

proposal not to regulate incidental 

radioactive material produced by 

medical linear accelerators. 

The commenters recommended that 

the NRC expand the exclusion in the 

final rule to include a specific 

exemption for commercially available 

linear accelerators used only for medical 

purposes to treat patients. One of the 

commenters recommended that the 

following or similar language may be 

appropriate: ‘‘Particle accelerator means 

any machine capable of accelerating 

electrons, protons, deuterons, or other 

charged particles in a vacuum and of 

discharging the resultant particulate or 

other radiation into a medium at 

energies usually in excess of 1 

megaelectron volt and does not include 

machines that only produce particle 

beams and not radioactive materials. For 

purposes of this definition, accelerator 

is an equivalent term.’’

NRC Response: The NRC regulates 

radioactive material produced by using 

particle accelerators but does not 

regulate particle accelerators, including 

linear accelerators. Therefore, the NRC 

cannot include in its regulations the 

exemption suggested by the 

commenters. The definition for particle 

accelerator incorporated in the NRC 

regulation is the same as the definition 

found in the SSRs. The commenter 

suggested adding a statement to the 

definition indicating that it does not 

include machines that produce particle 

beams and not radioactive material. The 

NRC does not believe this statement 

needs to be added because the NRC does 

not regulate accelerators and revising 

the definition of Particle accelerator as 

suggested by the commenter would 

introduce unnecessary confusion and 

inconsistency with State regulations. 

Comment: A commenter noted a 

potential case in which the use of 


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byproduct material may not be covered 

by the proposed regulations. The 

commenter asked if a person, in an 

Agreement State who received 

byproduct material before September 

25, 1971, for use under an Agreement 

State’s general license similar to the 

general license then provided in 10 CFR 

31.4, could still possess the radioactive 

material under 10 CFR 30.18(b). The 

commenter asserted that the new 10 

CFR 30.18(b) should cover the old 

byproduct material as well as newly 

regulated accelerator-produced 

radioactive material. 

NRC Response: The Commission 

agrees that the proposed wording of 10 

CFR 30.18 did not cover materials 

distributed for use under the previous 

equivalent general license of Agreement 

States that may now be used within the 

NRC’s jurisdiction. The wording has 

been corrected in the final rule to 

address this comment. 

Comment: A commenter noted that in 

the Section-by-Section Analysis under 

Section 30.18 exempt quantities, it was 

stated that Paragraph (b) would be 

revised to include accelerator-produced 

radioactive material that had been 

received or acquired under the general 

license in 10 CFR 31.4. The commenter 

did not believe that 10 CFR 31.4 

provided coverage of acceleratorproduced radioactive material. 

NRC Response: The Commission 

agrees that the Section-by-Section 

Analysis on this provision did not 

appropriately describe the proposed 

change, and this is corrected in this 

notice. 

Comment: A commenter stated that 

the discussion for general licenses in 10 

CFR 31.5 does not address consistency 

with 10 CFR 35.65, which authorizes 

sealed source possession. The 

commenter requested clarification of 

regulatory requirements for sealed 

sources under 10 CFR part 35 that are 

also generally licensed under 10 CFR 

31.5. A similar clarification was also 

suggested with respect to the general 

license in 10 CFR 31.8. 

In addition, the commenter noted that 

the proposed rule does not address 

possible alternative licensing methods 

for a generally licensed sealed source 

that is subject to registration 

requirements and fees but that might 

also be listed as a sealed source on a 

specific license and achieve the same 

level of regulatory oversight and 

tracking. Further, the commenter stated 

that the discussion does not clearly 

indicate whether the requirements in 10 

CFR 31.5 are for all sealed sources or 

only registered sealed sources. 

NRC Response: The possession and 

use of a source or device is not 

authorized by both a general and a 

specific license concurrently, or by 

more than one general license. The 

general license in 10 CFR 31.5 only 

covers sealed sources incorporated into 

a device, although in some cases, a 

specialized source housing may also be 

considered a device. The general license 

in 10 CFR 31.8 only covers americium241, and now radium-226, calibration 

and reference sources with a maximum 

possession limit of 5 μCi (185 kBq) at 

any one time in any one place. All 

devices under 10 CFR 31.5 and sources 

under 10 CFR 31.8 must have a label 

that identifies them as generally 

licensed devices or sources. 

The regulations in 10 CFR 35.65 

provide specific authority for medical 

use licensees to receive, possess, and 

use certain specifically licensed sealed 

sources and other byproduct material. 

This section does not authorize the 

possession of generally licensed sources 

or devices. Although a 10 CFR part 35 

licensee may also possess sealed sources 

and devices as authorized by these 

general licenses, it does so under the 

general license provisions of 10 CFR 

31.5 and 10 CFR 31.8. 

A specific licensee may use a source 

or device authorized under a general 

license under the authority of its 

specific license if the licensee requests 

transferring the authority from the 

general license to the specific license 

and provides assurance that 

requirements of both licenses are met. 

This practice normally arises because of 

the registration and fees associated with 

certain devices covered by the 10 CFR 

31.5 general license. 

Devices being authorized for use 

under 10 CFR 31.5 and equivalent 

Agreement State regulations are 

evaluated for registration in the SS&D 

registry. In large part, SS&D certificates 

for devices containing radium-226 and 

accelerator-produced radioactive 

material have been added to the SS&D 

registry, as a means of sharing this 

information amongst the States, even 

though NRC did not regulate these 

materials in the past. If these devices 

have been authorized under State 

regulations that are similar to NRC 

requirements, the NRC would accept 

these devices containing radium-226 or 

accelerator-produced radioactive 

material as generally licensed under 10 

CFR 31.5, and would also expect users 

to follow the requirements of 10 CFR 

31.5 without regard to whether or not 

the State registered the device in the 

SS&D registry before the effective date 

of this final rule. 

Comments on Licensing Fees and Fee 

Categories 

Comment: One commenter felt that 

the discussion in the Statements of 

Consideration for the proposed rule 

related to license application and 

annual fees was not clear in providing 

the average professional staff hours for 

the licensing categories, and suggested 

that to assist stakeholders in reviewing 

this proposed rulemaking, the average 

and total professional staff hours be 

listed by categories. The commenter 

suggested that the breakdown for these 

categories, and any possible changes in 

the annual fee for existing licenses that 

might require an amendment based on 

the proposed rule, be in 0.25 full time 

equivalent (FTE) units. The commenter 

also felt that the discussion related to 

accelerator-produced radioactive 

material was unclear as to whether the 

discussion applied only to commercial 

distribution or also applied to 

noncommercial distribution. 

NRC Response: The FTE breakdown 

for the proposed new fee categories 

could be calculated based on the hourly 

rate and the time spent in reviewing 

license applications or in conducting 

inspections. The average license 

application hours used to calculate the 

license application fees (as presented in 

the proposed rule), for the proposed 

new fee categories 3.R.1, 3.R.2, 3.S., and 

the proposed revised 3.B. fee category, 

are 2.3, 5.4, 24, and 17.7, respectively. 

These values could be calculated by 

dividing the FY 2005 application fees by 

the hourly rate of $197, as described in 

the proposed rule. 

As explained in the proposed rule, the 

annual fees for the materials users fee 

class are calculated based on the NRC’s 

budgeted resources allocated to 

regulating these types of licensees, less 

any receipts received from this fee class 

for 10 CFR part 170 activities. The net 

dollar value of budgeted resources for 

this fee class is allocated to all materials 

users fee categories (subclasses), based 

on the average application and 

inspection hours associated with each 

fee category. The average inspection 

hours (associated with the annual fees 

presented in the proposed rule) for the 

proposed new fee categories 3.R.1, 

3.R.2, 3.S., and revised 3.B. fee category, 

are 11.2, 12.2, 21.8, and 18.6, 

respectively. 

The NRC’s fee calculations are 

described in further detail each year in 

its fee rulemakings and supporting 

documentation. These rulemakings 

include details on the FTE and contract 

dollars allocated to the materials users 

fee class, for each agency-planned 

activity level. On February 2, 2007 (72 


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FR 5108), the NRC published in the 

Federal Register its FY 2007 proposed 

fee rule. The proposed fee rule, and its 

supporting documentation, presents and 

explains the fee calculations for all fee 

categories, including the new fee 

categories included in this rule. The 

final 2007 fee rule was published June 

6, 2007 (72 FR 31402). Note that the 

NRC does not plan to assess fees for the 

new fee categories of 3.R.1, 3.R.2, and 

3.S. until the effective date of this final 

rule. 

The new fee category 3.S. applies to 

production of accelerator-produced 

byproduct material, i.e., a radionuclide 

production facility. Because specific 

provisions for noncommercial 

distribution of PET radioactive drugs 

within a consortium, which includes a 

PET radionuclide production facility, 

have been added to 10 CFR 30.32(j), 

there is no additional fee for 

noncommercial distribution of PET 

radioactive drugs. If an acceleratorproduced radionuclide production 

facility wants to commercially distribute 

radioactive drugs, then the existing fee 

categories 3.C. and 3.D. would apply for 

the commercial distribution portion as 

well as the new fee category 3.S. for the 

radionuclide production portion of the 

activities. 

Comment: A number of commenters 

did not agree that there was a need to 

establish the new fee category for the 

production of accelerator-produced 

radioactive materials, 3.S., in Section 

II.G.(7). These commenters felt that the 

existing fee categories covered 

byproduct materials whose possession, 

use, processing, manufacturing, 

distribution, and redistribution were 

similar to accelerator-produced 

byproduct material. One commenter 

stated further that using these existing 

fee categories was consistent with the 

NRC’s conclusion regarding the 

‘‘grandfathering’’ of medical uses, and 

that the choice of existing fee categories 

should be based on the type of particle 

accelerators used and the types and 

quantities of radioactive materials being 

produced. This commenter stated that 

the establishment of a new fee category 

was inconsistent with the NRC’s attempt 

to minimize impact on the 

noncommercial distribution of PET 

radionuclides, drugs, and biologics. 

While not supporting the 3.S. fee 

category, another commenter requested 

that, if retained, the language of the final 

rule explicitly state that fee category 3.S. 

would be applied per facility, not per 

accelerator, and that the NRC should be 

mindful that additional costs would 

inevitably be passed on to the health 

care system and patients. 

NRC Response: The NRC is retaining 

the new fee category 3.S. because the 

NRC incurs budgeted resources in 

regulating the production of acceleratorproduced radioactive material, which 

are in addition to the budgeted 

resources the NRC incurs in regulating 

the activities covered by existing fee 

categories. Therefore, the NRC believes 

a separate fee for this activity is 

appropriate. The fee is applicable for 

each licensed facility regardless of how 

many accelerators reside in the facility. 

Comment: One commenter 

recommended that exceptions be 

extended to IRS-designated 501(c)(3) 

organizations operating in whole or in 

part as an accredited school of watch 

and/or clock repair and/or specialty 

museum with a primary focus on 

housing and exhibiting timepieces and 

related objects. 

NRC Response: Exemptions of 

persons from the NRC’s regulations for 

timepieces and repairs of timepieces are 

discussed earlier in subsection 

‘‘Comments Related to Radium-226.’’ In 

10 CFR 170.11 and 171.11, the NRC lists 

fee exemptions for license fees and 

annual fees for certain licensees, 

including those for nonprofit 

educational institutions. In 10 CFR 

170.3 and 171.5, a nonprofit educational 

institution is defined as ‘‘a public or 

nonprofit educational institution whose 

primary function is education, whose 

programs are accredited by a nationally 

recognized accrediting agency or 

association, who is legally authorized to 

provide a program of organized 

instruction or study, who provides an 

educational program for which it 

awards academic degrees, and whose 

educational programs are available to 

the public.’’ Historically, the NRC has 

not included any fee exemptions for 

museums. Because the final rule 

contains exemption for intact 

timepieces containing less than 37 kBq 

(1 μCi) of radium-226 and general 

license provisions for various items 

containing radium-226, the NRC does 

not expect this rule to have major 

impacts on museums that would 

necessitate the NRC to establish a fee 

exemption in its regulations. Under 10 

CFR parts 170 and 171, an applicant or 

a licensee may file a fee exemption 

request with the NRC, and the NRC will 

evaluate each request on a case-by-case 

basis. Requests for a fee exemption must 

be filed with the NRC within 90 days 

from the effective date of this final rule 

establishing the annual fees for which 

the exemption is sought. However, filing 

of an exemption request does not extend 

the date on which the bill is payable. 

Comments on Waiver Termination and 

Transitioning 

Comment: A commenter noted that 

some non-Agreement States may 

continue to require licenses or 

registration for the production of 

accelerator-produced radioactive 

materials, along with their associated 

fees. The commenter stated that some 

States have already indicated that they 

will require a NARM license regardless 

of whether an NRC license is required. 

The commenter stated that this situation 

would expand, rather than streamline, 

regulation of radioactive materials. 

The commenter noted that it 

understood that the States will continue 

to regulate radiation-producing 

accelerators because the NRC will not 

have jurisdiction over the possession 

and operation of these machines. The 

commenter stated that the NRC should 

be aware of its concern that some States 

will not discontinue their current 

license requirements for the resulting 

accelerator-produced materials and 

recommended that the NRC address this 

in its Transition Plan. 

NRC Response: Upon expiration of 

the waiver, non-Agreement States will 

no longer have authority to license the 

radioactive material produced in an 

accelerator for use for commercial, 

medical, or research activities. The 

production of the radioactive material, 

however, is only one facet of the 

operation of the accelerator. Because the 

NRC only has regulatory authority over 

the radioactive material and not the 

accelerator, some non-Agreement States 

may continue to license the accelerator 

and its operation. It is possible that 

certain producers of radioactive material 

may be required to hold two licenses: 

One from the State for possession and 

operating the accelerator, and one from 

the NRC for the possession and use of 

the byproduct material produced by the 

accelerator. This would not be an issue 

for the Agreement States because the 

Agreement State will be the only 

regulatory authority for radiation 

control within its State. 

The NRC has worked very closely 

with both Agreement States and nonAgreement States in developing the 

Transition Plan. The Transition Plan 

includes various scenarios and 

implementation guidance to ensure a 

smooth regulatory transition. On 

October 25, 2006, the NRC transmitted 

the proposed Transition Plan to the 

States for comments. The NRC will 

consider State comments in finalizing 

the Transition Plan and plans to publish 

the final Transition Plan subsequent to 

the publication of the final rule but 


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before the effective date of this final 

rule. 

Comment: A commenter requested 

that to protect the supply chain with 

regard to radiopharmaceuticals, the NRC 

should work closely with OAS and the 

CRCPD, as well as the States 

themselves, to address any licensing or 

transactional issues that may arise as a 

result of the transition of authority. 

NRC Response: The NRC has worked 

closely with OAS and CRCPD and 

involved the Agreement States and nonAgreement States throughout the 

rulemaking process and the 

development of the Transition Plan. The 

NRC is committed to continued 

cooperation with the States during the 

transition process. 

Comments: A number of respondents 

emphasized the importance of 

stakeholder education and guidance to 

assure a smooth transition to the NRC’s 

regulatory control. Two commenters 

expressed interest in the development of 

a comprehensive guidance document to 

be released upon implementation of the 

rule, and another commenter mentioned 

assistance to stakeholders through an 

outline of proposed revisions to the 

existing regulatory guidelines. One 

commenter also offered its 

organization’s publications, websites, 

and meetings to assist the NRC with 

outreach to the medical user 

community. 

NRC Response: The NRC is 

developing guidance in a separate 

action parallel to this rulemaking. A 

writing team was established in July 

2006 to amend existing guidance and, if 

necessary, to develop new guidance 

within the NUREG–1556, ‘‘Consolidated 

Guidance About Materials Licenses,’’

series of volumes to reflect the new 

authority over discrete sources of 

radium-226 and the acceleratorproduced radioactive material. The NRC 

is in the process of revising Volume 9, 

‘‘Consolidated Guidance About 

Materials Licenses Program-Specific 

Guidance About Medical Use Licenses’’

and Volume 13, ‘‘Consolidated 

Guidance About Materials Licenses 

Program-Specific Guidance About 

Commercial Radiopharmacy Licenses.’’

The NRC is developing new guidance, 

Volume 21, ‘‘Consolidated Guidance 

About Materials Licenses ProgramSpecific Guidance About Possession 

Licenses for Production of Radioactive 

Materials Using An Accelerator.’’ The 

NUREG–1556 series provides guidance 

in areas of the NRC’s jurisdiction and 

may be helpful to Agreement States. The 

NRC made the draft final guidance 

publicly available for comment after the 

draft final rule was made publicly 

available. The draft guidance documents 

were provided for comment to the States 

and the Advisory Committee on Medical 

Uses of Radioisotopes at that time. The 

NRC expects to finalize the guidance 

documents near the effective date of this 

rule (60 days after publication). The 

guidance documents are being 

published for use by current or potential 

NRC licensees. It is important to note 

that some Agreement States may already 

have similar guidance documents. 

Comment: A commenter requested the 

NRC to confirm that on the effective 

date of the proposed rule, holders of 

licenses that authorize the use of 

licensed material at temporary job sites, 

where the NRC maintains jurisdiction, 

would be able to amend them to include 

accelerator-produced radionuclides. The 

commenter also requested the NRC to 

confirm that once such licenses were 

amended, the licensees would be able to 

perform activities using acceleratorproduced materials authorized in the 

licenses, at temporary locations within 

non-Agreement States, upon 

termination of the waiver period on 

August 8, 2009. 

NRC Response: On the effective date 

of this final rule or on the date of waiver 

termination, if that date is later, persons 

who use accelerator-produced 

radionuclides at temporary job sites may 

continue those activities regardless of 

whether they have an NRC license, 

provided that: (1) The person, with an 

NRC license that does not authorize use 

of byproduct material at temporary job 

sites where the NRC has jurisdiction, 

applies for an amendment to its license 

to authorize uses at these temporary job 

sites on or before 6 months from the 

effective date of this final rule or on the 

date of waiver termination, if that date 

is later; or (2) The person without an 

NRC specific license applies for a 

license on or before 1 year from the 

effective date of this final rule or on the 

date of waiver termination, whichever is 

later. 

If the person already has an NRC 

license authorizing the use of byproduct 

material at temporary job sites where 

the NRC has jurisdiction, the person 

may continue those activities. With the 

amended definition of Byproduct 

material in the NRC’s regulations, the 

term ‘‘Byproduct material’’ in the 

existing license will be interpreted as 

including accelerator-produced 

radioactive material. It is possible that 

an amendment may be needed to 

increase the maximum activity limits or 

add specific sealed sources or devices to 

the license. 

If the person did not use acceleratorproduced materials at temporary job 

sites before the date of waiver 

termination, and its existing license 

does not authorize the use of byproduct 

material at temporary job sites, the 

person must apply for and receive a 

license or amendment before using 

these materials. 

Comment: Two commenters stated 

that if the NRC required the States to 

change their statutes, then the effective 

date for the final rule should be 

extended by 5 years in order for 

Agreement States to amend their State 

statutes and regulations. One 

commenter stated that it agreed with the 

proposed effective date for the final rule 

and other implementation periods only 

if the NRC did not require such a change 

from the States. 

NRC Response: The NRC does not 

believe that changes to the State statutes 

would be required by this rulemaking. 

The NRC will apply existing policies 

and procedures to work with the 

Agreement States in implementing this 

rule. These existing policies and 

procedures allow considerable 

flexibility by the States in meeting the 

compatibility requirements. The 

Agreement States will have up to 3 

years to adopt the compatible 

requirements of this rule. The NRC will 

continue to work with the States to 

resolve any issues that may arise. 

Comment: A commenter called 

attention to the discussion in the 

Statements of Consideration for the 

proposed rule concerning the 

termination of the waiver issued by the 

NRC on August 31, 2005. The 

commenter noted that the discussion 

included a reference to a ‘‘special 

arrangement’’ that would need to be 

made between a State and the NRC if 

the State had not become an Agreement 

State by August 7, 2009, when the 

waiver will terminate. The commenter 

requested additional information on 

what would constitute a ‘‘special 

arrangement’’ between a State and the 

NRC, and how one could be obtained. 

NRC Response: The NRC has 

considered this comment and has 

determined that the wording referred to 

by the commenter did not accurately 

describe the Commission’s intent in this 

regard. What the Commission intended 

to convey was that it understands that 

situations may arise which may delay 

the completion and effective date of an 

Agreement. If an Agreement cannot be 

completed for a State before the waiver 

expires on August 8, 2009, the staff will 

determine, on a case-by-case basis, 

options to limit the impact of the 

transition of authority on affected users 

of the new byproduct material in the 

State. 

The NRC has been communicating 

with the non-Agreement States that the 

Commission believes might be seeking 


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an Agreement in order to avoid this type 

of situation. The Commission will 

continue to closely coordinate with 

these States and monitor the process of 

completing any Agreements with these 

States in order to decrease the 

likelihood that this type of situation will 

arise. 

Comment: A commenter 

recommended that the NRC clarify 

whether any additional actions are 

needed on the part of licensees that are 

currently covered by the waivers issued 

to the States. 

NRC Response: The waiver was 

issued to all persons, including 

individuals and licensees as well as 

States, that acquire, deliver, receive, 

possess, own, use, or transfer the newly 

regulated byproduct material. No 

actions are needed on the part of these 

entities. Once the waiver is terminated, 

these persons or licensees are required 

to comply with the requirements of this 

rule or the corresponding requirements 

of the Agreement States. 

Comment: A commenter felt that the 

discussion in the Statements of 

Consideration for the proposed rule 

under termination of the waiver for 

government agencies was not consistent 

with an earlier discussion in the 

Supplementary Information that 

concluded that radioactive materials 

would continue to be used in a manner 

protective of public health and safety. 

The commenter believed that the later 

discussion appeared to equate 

regulatory oversight with outcomes 

more protective of public health and 

safety. The commenter felt that the basis 

for concluding the waivers to be 

acceptable for a period of time, and then 

requiring termination of those waivers, 

should be explained. 

NRC Response: The NRC does not 

agree that there are inconsistencies, as 

stated by the commenter, in the 

discussion in the Statements of 

Consideration for the proposed rule. As 

explained in the discussion concerning 

issuance of the waiver on August 31, 

2005, the NRC was given regulatory 

authority over the new byproduct 

material when the EPAct became 

effective. Therefore, although the NRC 

did not have regulations in place that 

would specifically apply to this 

material, persons continuing to engage 

in activities involving the newly 

regulated byproduct material, and States 

seeking to continue to regulate this 

byproduct material would be in 

technical violation of the AEA. The NRC 

determined that it would be prudent to 

establish a mechanism to allow these 

activities to continue while the NRC 

established a regulatory framework for 

the new byproduct material. Section 

651e(5) of the EPAct provides that the 

Commission could achieve this goal 

through issuing a waiver of the 

requirements of Section 651(e) if the 

Commission determined that the waiver 

was in accordance with the protection 

of public health and safety and the 

promotion of the common defense and 

security. The Commission determined 

that the waiver that it issued on August 

31, 2005, met this requirement. 

However, the EPAct also mandated that 

any such waiver issued would have to 

expire no more than 4 years after the 

date of the enactment of the EPAct. 

Therefore, the waivers must expire no 

later than August 8, 2009, although 

under the EPAct, the Commission may 

terminate waivers at an earlier time if it 

finds such termination is warranted. 

As explained in the discussion 

concerning the termination of the 

waiver, the NRC established a 

Transition Plan, as required by Section 

651(e) of the EPAct, to facilitate an 

orderly transition of regulatory authority 

once the Commission had established a 

regulatory framework for regulating the 

new byproduct material. This regulatory 

framework has now been established 

through promulgation of this final rule. 

In accordance with the provisions of the 

Transition Plan, and to facilitate the 

transition of regulatory authority in an 

orderly manner, the waivers will be 

terminated in stages for users of the new 

byproduct material. As explained in the 

discussion for termination of the waiver 

for Government agencies and Federally 

recognized Indian Tribes, the 

Commission determined to terminate 

the waiver for these entities on the 

effective date of the final rule because 

there is currently limited regulatory 

oversight for the newly added 

byproduct material at these facilities. 

Options will be considered, on a caseby-case basis, to limit the impact of the 

transition of the authority on affected 

users of the new byproduct material in 

the State. Terminating the waiver for 

these entities at that time will provide 

for regulatory oversight of the newly 

added byproduct material. 

Comment: A commenter stated that it 

holds Agreement State licenses and 

licenses from the NRC that authorize 

‘‘radioactive material’’ for a broad range 

of radionuclides, i.e., any byproduct 

material with atomic numbers 1 through 

83 or any byproduct material with 

atomic numbers 84 through 102. It also 

holds NRC licenses that authorize 

‘‘byproduct material’’ for the same broad 

range of radionuclides. The commenter 

requested that the newly regulated 

byproduct materials be authorized 

under the current license authorizations 

until the licenses are renewed or 

amended. The commenter 

recommended that one way to 

accomplish this would be to provide a 

general license for specific licensees 

containing broad scope authorizations. 

As an alternate approach, the 

commenter suggested that the rule could 

provide that licensees authorized for 

such activities as using, receiving, or 

possessing radionuclides with a range of 

atomic numbers are similarly authorized 

with respect to the newly regulated 

radionuclides. The commenter stated 

that these licensees already have the 

controls in place to allow for safe 

handling of the new radionuclides and 

that the blanket authorization will save 

the licensees and the NRC paperwork 

and expenses. The commenter suggested 

that the NRC could request information 

by letter on which licensees are 

handling the newly regulated 

radionuclides. 

NRC Response: From the commenter’s 

description of its NRC specific license 

authorization, it should already be 

authorized to use the newly regulated 

byproduct material. With the amended 

definition of Byproduct material in the 

NRC regulations via this rule, the use of 

Byproduct material in an existing 

license will be interpreted as 

authorizing all radioactive materials that 

fall under the newly expanded 

definition of Byproduct material. With 

the broad authorization in the specific 

license, a license amendment would 

only be needed if the quantity possessed 

for one or more particular radionuclides 

exceeds the individual limits specified 

in the existing license authorization. If 

an amendment is needed, the 

regulations provide that all licensees 

have 6 months from the effective date of 

this final rule or from the waiver 

termination date to submit an 

amendment request. In addition, the 

amended regulation would allow 

licensees to continue to use the newly 

regulated materials until the NRC takes 

final licensing action provided that the 

amendment request was submitted 

within the allotted time. The NRC 

believes that it has already provided 

adequate relief in its regulations to 

assure a smooth transition once the 

licensee’s waiver is terminated, and that 

neither a general license nor a rule 

change is necessary for this purpose. 

Comment: Two commenters requested 

that the NRC allow sufficient time for 

users to prepare for the regulatory 

change by simultaneously terminating 

all waivers August 7, 2009, and not 

chance the supply disruption of PET 

radionuclides, drugs, and biologics. The 

commenter stated that there were many 

differing State regulations for NARM, 

and that a step-by-step approach to 


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terminating State waivers could leave 

unintended voids in the regulations, 

thus disrupting supplies of PET 

radionuclides. Another commenter 

requested that the NRC terminate all 

waivers at the same time on August 7, 

2009, to avoid disruption. The 

commenter stated that acceleratorproduction facilities, which were 

designed and built to meet less 

restrictive State regulations, may require 

significant time to be modified to meet 

the NRC’s regulations, and older 

facilities may require special approvals 

from the NRC. 

NRC Response: The EPAct requires 

that all waivers must be terminated no 

later than 4 years after the date of 

enactment of the EPAct. As explained in 

the discussion concerning the 

termination of the waiver, the NRC 

established a Transition Plan, as 

required by Section 651(e) of the EPAct, 

to facilitate an orderly transition of 

regulatory authority once the 

Commission had established a 

regulatory framework for regulating the 

newly added byproduct material. This 

regulatory framework has now been 

established through promulgation of 

this final rule. 

The NRC recognizes the importance of 

minimizing disruption of PET 

radionuclides, drugs, and biologics and 

that many States have regulatory 

programs for NARM. While all of the 

waivers cannot be terminated in 

conjunction with the August 7, 2009, 

statutory deadline, the NRC is revising 

the proposed rule [10 CFR 30.3(c)(2) and 

(c)(3), 10 CFR 32.1(c)(2), 10 CFR 

35.11(c)(2), and 10 CFR 35.13(a)(2)] to 

provide for some waivers to be 

terminated in conjunction with the 

expiration of the waiver on August 7, 

2009. One aspect of the implementation 

approach in the proposed rule provided 

that requests for licensing actions (e.g., 

amendments or new applications) 

would need to be received by the NRC 

on or before August 7, 2009, or earlier, 

depending upon the date of the waiver 

termination. This would essentially 

mean waivers would need to be 

terminated in August 2008, in order to 

provide all affected persons the same 

amount of time, as discussed in the draft 

Transition Plan, to submit licensing 

actions to the NRC. In response to the 

comment, the NRC is revising the 

proposed rule to provide for some 

waivers to be terminated in conjunction 

with the expiration of the waiver on 

August 7, 2009. The NRC plans to 

terminate waivers in stages starting from 

the effective date of this final rule and 

ending on August 7, 2009. When the 

waiver is terminated for persons in a 

State, all persons in that State have to 

comply with the NRC regulations for the 

newly defined byproduct material, 

regardless of whether a license has been 

issued by the NRC. If the waiver has not 

been terminated for the State, all 

persons in the State are still permitted 

under the waiver to continue to use the 

newly defined byproduct material. 

The NRC does not agree that supplies 

of PET radionuclides will be disrupted. 

Under the waiver, PET radionuclide 

production facilities can continue to 

produce PET radionuclides. Once the 

waiver is terminated, a PET 

radionuclide production facility may 

continue to produce PET radionuclides 

while its license application or 

amendment request is under review, 

provided that a license application is 

submitted within 1 year or an 

amendment request within 6 months 

from the date of waiver termination. 

Medical use licensees can continue to 

receive PET radionuclides from these 

production facilities or PET radioactive 

drugs from drug manufacturers or 

commercial nuclear pharmacies either 

under the waiver or under the NRC’s 

regulations allowing continued 

operation provided that the license 

application or amendment request was 

submitted within the allotted time. 

Comments: Two commenters stated 

that the transition time created by the 

waiver was critical for the nonAgreement States so that patient care 

and research activities could continue 

without interruption. These commenters 

requested that the NRC maintain the 

waiver until the local medical and 

scientific communities become fully 

prepared for the new licensing costs and 

requirements. 

NRC Response: The EPAct authorized 

the NRC to grant waivers for 4 years 

from the date of enactment of the Act; 

it did not include any provisions that 

would allow the NRC to extend the 

waiver beyond the statutory deadline of 

August 8, 2009. The NRC recognizes the 

importance of continuing patient care 

and research activities without 

interruption and the need for local 

medical and scientific communities to 

have adequate time to become fully 

prepared for the new licensing costs and 

requirements. 

The NRC has taken several steps to 

ensure a smooth transition of the NRC’s 

regulatory authority over the newly 

defined byproduct material. In addition 

to preparing a Transition Plan, the NRC 

has, in this rulemaking, included 

regulatory provisions for persons or 

licensees in a non-Agreement State to 

continue using the newly defined 

byproduct material after the waiver is 

terminated for that State provided a 

license application or an amendment 

request is submitted within the allotted 

time frame. The NRC believes that its 

transitioning approach and the 

regulatory provisions will provide 

adequate time for licensees to transition 

to the new regulations without 

interrupting patient care or research for 

the following reasons: First, most 

medical and scientific communities in 

the non-Agreement States are already 

using both the traditional byproduct 

materials and the newly defined 

byproduct materials in similar uses; 

therefore, regulatory impact, including 

licensing fees and radiation safety 

programs, to these people should be 

minimal to none. Second, the NRC has 

made rulemaking-related documents 

and draft rules publicly available to 

keep stakeholders informed. Third, the 

NRC has allowed time for applicants to 

prepare new license applications or 

amendment requests in the regulations, 

during which they may continue to use 

the newly regulated byproduct material 

to provide for a smoother transition. 

Comment: Two commenters were 

concerned that a ‘‘phased-in’’ approach 

for terminating the waivers issued in 

August 2005 had not been structured to 

allow for the transfer of PET 

radionuclides, drugs, and biologics to an 

NRC licensee from a radionuclide or 

drug production facility using 

accelerators that has not yet had the 

waiver terminated. One commenter 

asked for clarification of potential 

impacts to the medical community due 

to early termination of the waiver to 

Federal facilities such as Veterans 

Hospitals (i.e., could Federal facilities 

still accept radioactive drugs from 

companies that are still covered under 

the waiver). 

NRC Response: The NRC’s phased 

waiver termination plan will not affect 

the transfer of PET radionuclides, drugs, 

and biologics to an NRC licensee from 

a PET radionuclide production facility 

that has not yet had the NRC waiver 

terminated. For example, a Government 

agency that is currently receiving PET 

radionuclides or drugs under the waiver 

may continue to be able to receive PET 

radionuclides or drugs from a PET 

radionuclide and drug producer or 

distributor when its waiver is 

terminated. Upon waiver termination, 

the Government agency’s existing 

license or MML permit may already be 

authorized to receive PET drugs if the 

license or MML permit is for all 

Byproduct material. If the Government 

agency has used PET radionuclides and 

drugs under the waiver and the license 

(or MML permit) needs to be amended, 

the Government agency may continue to 

use the PET radionuclides and drugs 

while preparing the amendment and 


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until the NRC (or the MML licensee) 

makes its final licensing decision, 

provided that an amendment request is 

submitted within 6 months from the 

date of waiver termination. If the 

Government agency used PET 

radionuclides and drugs under the 

waiver and did not have an NRC license 

(or MML permit), the Government 

agency may still continue to use the PET 

radionuclides and drugs while 

preparing a new license application and 

until the NRC (or the MML licensee) 

makes its final licensing decision, 

provided that a license application is 

submitted within 1 year from the date 

of waiver termination. 

While all of the waivers cannot be 

terminated in conjunction with the 

August 7, 2009, statutory deadline, the 

NRC is revising the proposed rule [10 

CFR 30.3(c)(2) and (c)(3), 10 CFR 

32.1(c)(2), 10 CFR 35.11(c)(2), and 10 

CFR 35.13(a)(2)] to provide for some 

waivers to be terminated in conjunction 

with the expiration of the waiver on 

August 7, 2009. The NRC plans to 

terminate waivers in stages starting from 

the effective date of this final rule and 

ending on August 7, 2009. 

These same principles would apply to 

the PET radionuclide and drug 

producers or distributors. After this rule 

becomes effective, the PET radionuclide 

and drug producers or distributors may 

continue to operate until the waiver is 

terminated for them. Once the waiver is 

terminated, they may continue to 

operate if the existing license authorizes 

all ‘‘byproduct material’’ or as 

authorized by this rule while preparing 

a new license application or an 

amendment request or while waiting for 

the NRC’s final licensing decision, 

provided that the license application or 

amendment request is submitted within 

the allotted time as stated in this rule. 

IV. Section-by-Section Analysis of Final 

Revisions 

Part 20—Standards for Protection 

Against Radiation 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 20.1003—Definitions 

The definition of Byproduct material 

is revised to reflect the new definition 

as mandated in Section 651(e) of the 

EPAct. 

Definitions for Accelerator-produced 

radioactive material, Discrete source, 

and Particle accelerator are added. 

A definition of Waste is added to 

clarify that, as mandated by the EPAct, 

byproduct material as defined in 

Sections 11e.(3) and 11e.(4) of the AEA 

is not low-level radioactive waste as 

defined in the LLRWPAA. 

Section 20.1009—Information 

Collection Requirements: OMB 

Approval 

Reference to § 20.2008 is added. 

Section 20.2001—General Requirements 

Paragraph (a)(4) is revised to include 

the new § 20.2008 which addresses 

disposal of waste. 

Section 20.2006—Transfer for Disposal 

and Manifests 

Paragraph (e) is added to require the 

use of uniform manifests for disposal of 

byproduct material as defined in 

Sections 11e.(3) and 11e.(4) of the AEA 

if intended for ultimate disposal at a 

land disposal facility licensed under 10 

CFR Part 61. 

Section 20.2008—Disposal of Certain 

Byproduct Material 

This section is added to part 20 to 

address disposal requirements for 

byproduct material as defined in 

Sections 11e.(3) and 11e.(4) of the AEA. 

Appendix B to Part 20—Annual Limits 

on Intake (ALIs) and Derived Air 

Concentrations (DACs) of Radionuclides 

for Occupational Exposure; Effluent 

Concentrations; Concentrations for 

Release to Sewerage 

The List of Elements table is revised 

to include the elements nitrogen and 

oxygen that are now considered 

byproduct material. Tables 1, 2, and 3 

are revised to specifically include 

nitrogen-13 and oxygen-15 and their 

associated values. 

Part 30—Rules of General Applicability 

to Domestic Licensing of Byproduct 

Material 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 30.3—Activities Requiring 

License 

This section is revised to inform 

Government agencies, Federally 

recognized Indian Tribes, other 

licensees, and other persons who 

possessed and used byproduct material 

as defined in Section 11e.(3) of the AEA 

under the provisions of NRC’s waiver 

(70 FR 51581; August 31, 2005) which 

sections of the regulations will apply to 

them when their waiver is terminated 

before issuance of an amendment or 

new license for byproduct material. For 

the Government agencies and Federally 

recognized Indian Tribes, requirements 

for the newly added byproduct material 

will apply to them on the effective date 

of the final rule. 

This section is also revised to allow 

for transition for Government agencies, 

Federally recognized Indian Tribes, 

other persons, and other licensees, who 

possessed and used byproduct material 

as defined in Section 11e.(3) of the AEA 

under the waiver, to continue to use 

these materials while applying for and 

receiving licenses or amendments to 

existing licenses. This section revises 

the authority and responsibilities of 

persons or licensees that do not file for 

the license or amendment within the 

required time with respect to receipt, 

use, possession, and disposal of 

byproduct material and the 

decommissioning of facilities. 

Section 30.4—Definitions 

The definition of Byproduct material 

is revised to be consistent with the new 

definition in the AEA, with the 

exception that it does not include 

byproduct material as defined in 

Section 11e.(2) of the AEA. 

The following definitions are added to 

this section: Accelerator-produced 

radioactive material, Consortium, 

Cyclotron, Discrete source, and Particle 

accelerator. 

Section 30.15—Certain Items 

Containing Byproduct Material 

This section is revised to add 

paragraph (a)(1)(viii) to authorize 0.037 

MBq (1 μCi) of radium-226 per 

timepiece in intact timepieces 

manufactured before the effective date 

of the final rule. 

Section 30.18—Exempt Quantities 

Paragraph (b) is revised to include 

byproduct material received or acquired 

before September 25, 1971, under a 

general license provided in 10 CFR 31.4 

or by a State provision similar to 10 CFR 

31.4. 

Section 30.20—Gas and Aerosol 

Detectors Containing Byproduct 

Material 

Paragraph (a) is revised to apply to gas 

and aerosol detectors manufactured or 

distributed before the effective date of 

the final rule in accordance with a 

specific license issued by a State with 

comparable provisions to 10 CFR 32.26. 

Section 30.32—Application for Specific 

Licenses 

Paragraph (g) is revised to accept 

information from sealed source or 

device registrations with regard to 

NARM issued by the States under 

provisions comparable to 10 CFR 32.210 

as a basis for licensing the use of 

sources and devices. The paragraph is 

also revised to allow a basis for 

licensing sources or devices containing 

NARM, that were manufactured before 

the effective date of the final rule, are 

not registered with the Commission 


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under 10 CFR 32.210 or with an 

Agreement State, and for which all the 

information identified in 10 CFR 32.210 

is unavailable. 

Paragraph (j) is added to this section 

to inform an educational institution, a 

medical facility, or a Government 

facility applicant of the information 

required by the NRC to authorize the 

production of PET radioactive drugs 

used for medical uses under 10 CFR part 

35 for the noncommercial transfer to 

medical facilities in its consortium. 

Section 30.34—Terms and Conditions of 

Licenses 

Paragraph (g) is revised to require 

licensees to measure strontium-82 and 

strontium-85 contamination before use 

of the first eluate when eluding 

strontium-82/rubidium-82 generators. 

Paragraph (j) is added to clarify that 

nothing in the authorization under 10 

CFR 30.32(j) relieves the licensee from 

complying with FDA, other Federal, or 

State requirements for radioactive drugs, 

and to include requirements associated 

with the labeling and production of PET 

radioactive drugs by licensees 

authorized under the provisions of 10 

CFR 30.32(j) to produce PET radioactive 

drugs for the noncommercial transfer to 

medical use licensees in their 

consortium. This section also requires 

licensees to use the notification process 

in 10 CFR 32.72 when permitting 

qualified authorized nuclear 

pharmacists to work as ANPs. 

Section 30.71—Schedule B 

Schedule B is revised to include 13 

radionuclides that are now considered 

byproduct material and their associated 

exempt quantities. 

Section 30.72—Schedule C—Quantities 

of Radioactive Materials Requiring 

Consideration of the Need for an 

Emergency Plan for Responding to a 

Release 

The table in Schedule C is revised to 

specifically include radium-226 and its 

associated values. 

Part 31—General Domestic Licenses 

For Byproduct Material 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 31.4—Information Collection 

Requirements: OMB Approval 

Reference to §31.12 is added. 

Section 31.5—Certain Detecting, 

Measuring, Gauging, or Controlling 

Devices and Certain Devices for 

Producing Light or an Ionized 

Atmosphere 

Paragraph (b)(1) is revised to add 

authority under the general license for 

byproduct material contained in devices 

which have been manufactured or 

initially transferred and labeled in 

accordance with the specifications 

contained in an equivalent specific 

license issued by a State with 

comparable provisions to 10 CFR 32.51. 

Paragraph (c)(13)(i) is revised to add 

radium-226, with an activity of at least 

3.7 MBq (0.1 μCi) to the criteria for 

devices requiring registration. 

Section 31.8—Americium-241 and 

Radium-226 in the Form of Calibration 

or Reference Sources 

The section heading and paragraph (a) 

are revised to include radium-226 in a 

general license for calibration and 

reference sources. 

Paragraph (b) is revised to recognize 

sources manufactured or initially 

transferred in accordance with the 

specifications contained in a specific 

license issued by a State with 

comparable provisions to 10 CFR 32.57. 

Paragraph (c)(1) is revised to include 

an activity limit of 0.185 MBq (5 μCi) of 

radium-226. 

Paragraph (c)(2) is revised to include 

radium-226 in the labeling requirement, 

with the provision added to footnote 1 

that, for those sources manufactured 

before the effective date of the final rule, 

sources containing radium-226 shall be 

labeled in accordance with the 

applicable State regulations at the time 

of manufacture or import. 

Paragraphs (c)(4), (d), and (e) are 

revised to include radium-226. 

Section 31.11—General License for Use 

of Byproduct Material for Certain In 

Vitro Clinical or Laboratory Testing 

Paragraphs (a) and (c) are revised to 

include cobalt-57 in the list of 

authorized byproduct material for use in 

in vitro clinical or laboratory testing. 

Paragraph (d) is revised to allow 

receipt of prepackaged units that are 

labeled in accordance with a specific 

license issued by a State with 

comparable provisions to 10 CFR 32.71. 

Sections 31.12, 31.13, and 31.14 Are 

Redesignated as §§ 31.21, 31.22, and 

31.23, Respectively 

Section 31.12—General License for 

Certain Items and Self-luminous 

Products Containing Radium-226 

This section is added to the 

regulations to add a general license for 

certain items and self-luminous 

products containing radium-226 that 

were manufactured before the effective 

date of the final rule. The general 

license addresses radium-226 contained 

in products such as antiquities; 

timepieces; luminous items installed in 

air, marine, or land vehicles; all other 

luminous products; and small radium 

sources containing no more than 0.037 

MBq (1 μCi) of radium-226. 

The general license exempts persons 

from the provisions of 10 CFR parts 19, 

20, and 21, and 10 CFR 30.50 and 10 

CFR 30.51. 

The general license includes 

requirements for notification, reporting, 

disposal, and certain prohibitions. 

However, the general license allows 

timepieces containing radium-226 to be 

disassembled and repaired. 

Part 32—Specific Domestic Licenses To 

Manufacture or Transfer Certain Items 

Containing Byproduct Material 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 32.1—Purpose and Scope 

A new paragraph (c) is added to 

inform Government agencies, Federally 

recognized Indian Tribes, other 

licensees, and other persons who 

manufacture or initially transfer items 

containing accelerator-produced 

radioactive material or discrete sources 

of radium-226 for sale or distribution to 

persons exempted from the licensing 

requirements of part 30 of this chapter, 

and persons generally licensed under 

part 31 or part 35 of this chapter, and 

radioactive drugs and sources and 

devices to medical use licensees, that 

the requirements in part 32 will apply 

to them when their waiver is terminated 

before issuance of an amendment or 

new license for such activities. The 

requirements will apply to Government 

agencies and Federally recognized 

Indian Tribes on the effective date of the 

final rule. 

This paragraph allows Government 

agencies, Federally recognized Indian 

Tribes, other persons, and other 

licensees who manufacture or initially 

transfer items containing acceleratorproduced radioactive material or 

discrete sources of radium-226 for sale 

or distribution to persons exempted 

from the licensing requirements of part 

30 of this chapter, persons generally 

licensed under part 31 or part 35 of this 

chapter, and radioactive drugs and 

sources and devices to medical use 

licensees to continue to manufacture or 

initially transfer these items to such 

persons when their waiver is terminated 

before issuance of an amendment or 

new license for such activities. 

Section 32.57—Calibration or Reference 

Sources Containing Americium-241 or 

Radium-226: Requirements for License 

to Manufacture or Initially Transfer 

The heading and the section are 

revised to add radium-226. 


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55914 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 

Section 32.58—Same: Labeling of 

Devices 

This section is revised to include 

radium-226 in the example label. 

Section 32.59—Same: Leak Testing of 

Each Source 

This section is revised to include 

radium-226. 

Section 32.71—Manufacture and 

Distribution of Byproduct Material for 

Certain In Vitro Clinical or Laboratory 

Testing Under General License 

Paragraph (b)(8) is added to include 

cobalt-57, in units not exceeding 0.37 

MBq (10 μCi) each, to the list of 

authorized byproduct material approved 

for distribution. 

Paragraph (c)(1) is revised to include 

cobalt-57. 

Section 32.72—Manufacture, 

Preparation, or Transfer for Commercial 

Distribution of Radioactive Drugs 

Containing Byproduct Material for 

Medical Use Under Part 35 

Paragraph (a) is revised to ensure that 

the NRC’s regulation encompasses all 

drug manufacturers that are registered 

with the FDA or a State agency. The 

description of who is registered with the 

FDA was updated to conform with FDA 

regulations. 

Paragraph (b) is revised to recognize 

nuclear pharmacists, who prepared only 

accelerator-produced radioactive drugs, 

before the effective date of the final rule 

and authorized nuclear pharmacists 

identified on permits issued by master 

material licensees or by a master 

material permittee of broad scope, to 

work as authorized nuclear pharmacists 

at a commercial nuclear pharmacy 

under the notification process in 10 CFR 

32.72. 

Section 32.102—Schedule C—Prototype 

Tests for Calibration or Reference 

Sources Containing Americium-241 or 

Radium-226 

The heading and section are revised 

to include radium-226. 

Part 33—Specific Domestic Licenses of 

Broad Scope for Byproduct Material 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 33.100—Schedule A 

This table is revised to add four 

additional radionuclides and their 

associated values. 

Part 35—Medical Use of Byproduct 

Material 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 35.2—Definitions 

The definitions of Cyclotron and 

Positron Emission Tomography (PET) 

radionuclide production facility are 

added. 

Section 35.10—Implementation 

Paragraph (a) is added to clarify that 

Government agencies and Federally 

recognized Indian Tribes possessing and 

using accelerator-produced radioactive 

material and discrete sources of radium226 for medical use must comply with 

the requirements in this part on the 

effective date of the final rule. The 

paragraph also informs other persons 

using this material for medical use 

when they must comply with the 

requirements of this part. 

Section 35.11—License Required 

Paragraph (a) is revised, and 

paragraph (c) is added to allow 

Government agencies, Federally 

recognized Indian Tribes, and other 

persons who possessed and used 

accelerator-produced radioactive 

materials or discrete sources of radium226, under the provisions of the NRC’s 

waiver (70 FR 51581; August 31, 2005), 

to have time to apply for and receive a 

new medical use license and allow them 

to continue to use these materials, 

provided the new license was applied 

for in the time required. This section 

also provides the time period for 

applying for a new license. 

Section 35.13—License Amendments 

Paragraph (a) is modified to allow 

Government agencies, Federally 

recognized Indian Tribes, and other 

licensees that possessed and used 

accelerator-produced radioactive 

materials or discrete sources of radium226, under the provisions of the NRC’s 

waiver (70 FR 51581; August 31, 2005), 

to continue to use this material 

provided that they submit an 

application to amend their licenses in 

the specified time required. This section 

also provides the time period for 

amending licenses. 

A new paragraph (b)(5) is added to 

permit physicians and pharmacists who 

only used accelerator-produced 

radioactive materials or discrete sources 

of radium-226 during the NRC’s waiver 

(70 FR 51581; August 31, 2005) to use 

the notification process. 

Paragraph (e) is modified to require an 

amendment before a licensee adds to, or 

changes, areas of use identified in the 

application or on the license, including 

areas used in accordance with either 10 

CFR 35.100 or 35.200 if the change 

includes the addition or relocation of 

either an area where PET radionuclides 

are produced or a PET radioactive drug 

delivery line from the PET 

radionuclide/PET radioactive drug 

production area. Other areas of use 

where byproduct material is used only 

in accordance with either 10 CFR 35.100 

or 10 CFR 35.200 continue to be 

excluded from this requirement. 

Section 35.14—Notifications 

Paragraph (a) is revised to address 

information needed for NRC notification 

of nuclear pharmacists and physicians 

who used only accelerator-produced 

radioactive materials and discrete 

sources of radium-226 who have not 

been identified on a license or permit 

during the NRC’s waiver (70 FR 51581; 

August 31, 2005). 

Paragraph (b) is revised to retain, in 

the notification requirements, any 

additions or changes in 10 CFR 35.100 

or 10 CFR 35.200 areas of use, if the 

changes do not involve additions or 

relocations of either an area where PET 

radionuclides are produced or a PET 

radioactive drug delivery line from the 

PET radionuclide/PET radioactive drug 

production area. 

Section 35.15—Exemptions Regarding 

Type A Specific Licenses of Broad 

Scope 

Paragraph (f) is revised to clarify that 

the broad scope licensee is exempted 

from making the notification of addition 

or changes in 10 CFR 35.100 or 10 CFR 

35.200 areas of use. 

Section 35.57—Training for 

Experienced Radiation Safety Officer, 

Teletherapy or Medical Physicist, 

Authorized Medical Physicist, 

Authorized User, Nuclear Pharmacist, 

and Authorized Nuclear Pharmacist 

A new paragraph (a)(3) is added to 

grandfather RSOs, medical physicists, or 

nuclear pharmacists who used only 

accelerator-produced radioactive 

materials or discrete sources of radium226, or both, during the NRC’s waiver 

(70 FR 51581; August 31, 2005) from 

training requirements and to recognize 

them as RSOs, AMPs, or ANPs for those 

same materials and uses. 

A new paragraph (b)(3) is added to 

grandfather physicians, dentists, or 

podiatrists who used only acceleratorproduced radioactive materials or 

discrete sources of radium-226, or both, 

under the NRC’s waiver (70 FR 51581; 

August 31, 2005) from training 

requirements and to recognize them as 

AUs for those same materials and uses. 

Section 35.63—Determination of 

Dosages of Unsealed Byproduct Material 

for Medical Use 

This section is revised to add a new 

provision in paragraphs (b)(2) and (c)(3) 


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Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 55915 

to include PET radioactive drug 

producers licensed under 10 CFR 

30.32(j) for the production of PET 

radioactive drugs transferred 

noncommercially to members of their 

consortium. 

Section 35.100—Use of Unsealed 

Byproduct Material for Uptake, Dilution, 

and Excretion Studies for Which a 

Written Directive is Not Required 

Paragraph (a) is revised to permit 

medical use licensees to obtain PET 

drugs from PET radioactive drug 

producers licensed under 10 CFR 

30.32(j) for the production of PET 

radioactive drugs transferred 

noncommercially to members of their 

consortium. 

Paragraph (b) is revised to continue to 

clarify that 10 CFR 35.100 licensees are 

not allowed to produce PET 

radionuclides. 

Section 35.200—Use of Unsealed 

Byproduct Material for Imaging and 

Localization Studies for Which a 

Written Directive is Not Required 

Paragraph (a) is revised to permit 

medical use licensees to obtain PET 

drugs from PET radioactive drug 

producers licensed under 10 CFR 

30.32(j) for the production of PET 

radioactive drugs transferred 

noncommercially to members of their 

consortium. 

Paragraph (b) is revised to clarify that 

10 CFR 35.200 licensees are not allowed 

to produce PET radionuclides. 

Section 35.204—Permissible 

Molybdenum-99, Strontium-82, and 

Strontium-85 Concentrations 

The section heading is revised to add 

strontium-82 and strontium-85. 

Paragraph (a) is revised to address 

acceptable strontium-82 and strontium85 concentrations when eluting 

strontium-82/rubidium-82 generators. 

Paragraph (c) is revised and 

redesignated, and a new paragraph (c) is 

added to address measuring 

requirements for strontium-82 and 

strontium-85. 

Section 35.300—Use of Unsealed 

Byproduct Material for Which a Written 

Directive is Required 

Paragraph (a) is revised to permit 

medical use licensees to obtain PET 

drugs from PET radioactive drug 

producers licensed under 10 CFR 

30.32(j) for the production of PET 

radioactive drugs transferred 

noncommercially to members of their 

consortium. 

Paragraph (b) is revised to clarify that 

10 CFR 35.300 licensees are not allowed 

to produce PET radionuclides. 

Section 35.2204—Records of 

Molybdenum-99, Strontium-82, and 

Strontium-85 Concentrations 

The section heading is revised to add 

strontium-82 and strontium-85, and this 

section is revised to include a 

recordkeeping requirement of the 

strontium-82 and strontium-85 

concentration tests required by 10 CFR 

35.204(b) and (c). 

Part 50—Domestic Licensing of 

Production and Utilization Facilities 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 50.2—Definitions 

The definition of Byproduct material 

is revised to be consistent with the new 

definition as mandated by the EPAct, 

with the exception that it will not 

include byproduct material as defined 

in Section 11e.(2) of the AEA. 

Part 61—Licensing Requirements for 

Land Disposal of Radioactive Waste 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 61.2—Definitions 

The definition of Waste is revised to 

clarify that, as mandated by the EPAct, 

byproduct material, as defined in 

Sections 11e.(3) and 11e.(4) of the AEA, 

is not low-level radioactive waste as 

defined in the LLRWPAA. 

Part 62—Criteria and Procedures for 

Emergency Access to Non-Federal and 

Regional Low-Level Waste Disposal 

Facilities 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 62.2—Definitions 

The definition of Low-level 

radioactive waste (LLW) is revised to 

clarify that byproduct material, as 

defined in Sections 11e.(3) and 11e.(4) 

of the AEA, is not considered low-level 

radioactive waste. 

Part 72—Licensing Requirements for 

the Independent Storage of Spent 

Nuclear Fuel, High-Level Radioactive 

Waste, and Reactor-Related Greater 

Than Class C Waste 

Section 72.3—Definitions 

The definition of Byproduct material 

is revised to be consistent with the 

definition in 10 CFR 30.4. This 

definition is consistent with the 

definition of Byproduct material in the 

EPAct, with the exception that it will 

not include byproduct material as 

defined in Section 11e.(2) of the AEA. 

Part 110—Export and Import of 

Nuclear Equipment and Material 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 110.2—Definitions 

Definitions of Accelerator-produced 

radioactive material, Discrete source, 

and Particle accelerator are added. 

Part 150—Exemptions and Continued 

Regulatory Authority in Agreement 

States and in Offshore Waters Under 

Section 274 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 150.3—Definitions 

The definition of Byproduct material 

is revised to be consistent with the 

definition in the EPAct. 

A definition of Discrete source is 

added. 

Part 170—Fees for Facilities, Materials, 

Import and Export Licenses, and Other 

Regulatory Services Under the Atomic 

Energy Act of 1954, as Amended 

The authority citation for this part is 

revised to reflect the EPAct. 

Section 170.3—Definitions 

The definition of Byproduct material 

is revised to be consistent with the new 

definition in the AEA, with the 

exception that it does not include 

byproduct material as defined in 

Section 11e.(2) of the AEA. 

Section 170.31—Schedule of Fees for 

Materials Licenses and Other Regulatory 

Services, Including Inspections, and 

Import and Export Licenses 

This section is revised to include 

licenses that are not included in existing 

fee categories. Fee Category 3.B. is 

revised to include licenses for repair, 

assembly, and disassembly of products 

containing radium-226. Two new fee 

categories, 3.R. with additional 

subcategories and 3.S., are added to 

include fees for possession of items or 

products containing radium-226, which 

exceed the number of items or limits 

specified in 10 CFR 31.12, and for 

production of accelerator-produced 

radioactive material. 

Part 171—Annual Fees for Reactor 

Licenses and Fuel Cycle Licenses and 

Materials Licenses, Including Holders 

of Certificates of Compliance, 

Registrations, and Quality Assurance 

Program Approvals and Government 

Agencies Licensed by the NRC 

The authority citation for this part is 

revised to reflect the EPAct. 


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Section 171.5—Definitions 

The definition of Byproduct material 

is revised to be consistent with the new 

definition in the AEA, with the 

exception that it does not include 

byproduct material as defined in 

Section 11e.(2) of the AEA. 

Section 171.16—Annual fees: Materials 

Licenses, Holders of Certificates of 

Compliance, Holders of Sealed Source 

and Device Registrations, Holders of 

Quality Assurance Program Approvals, 

and Government Agencies Licensed by 

the NRC 

This section is revised to include 

licenses that are not included in existing 

fee categories. Fee Category 3.B. is 

revised to include licenses for repair, 

assembly, and disassembly of products 

containing radium-226. Two new fee 

categories, 3.R. with additional 

subcategories and 3.S., are added to 

include fees for possession of items or 

products containing radium-226, which 

exceed the number of items or limits 

specified in 10 CFR 31.12, and for 

production of accelerator-produced 

radioactive material. 

V. Criminal Penalties 

For the purpose of Section 223 of the 

Atomic Energy Act (AEA), the 

Commission is amending 10 CFR Parts 

20, 30, 31, 32, 33, 35, 50, 61, 62, 72, 110, 

150, 170, and 171 under one or more of 

Sections 161b, 161i, or 161o of the AEA. 

Willful violations of the rule would be 

subject to criminal enforcement. 

VI. Agreement State Compatibility 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997, and 

published in the Federal Register (62 

FR 46517; September 3, 1997), this 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 rule in accordance with 

the procedure established within Part 

III, ‘‘Categorization Process for NRC 

Program Elements,’’ of Handbook 5.9 to 

Management Directive 5.9, ‘‘Adequacy 

and Compatibility of Agreement State 

Programs’’ (a copy of which may be 

viewed at http://www.nrc.gov/readingrm/doc-collections/managementdirectives/). 

The NRC program elements 

(including regulations) are placed into 

four compatibility categories (See the 

Compatibility Table in this section). In 

addition, the NRC program elements can 

also be identified as having particular 

health and safety significance or as 

being reserved solely to the NRC. 

Compatibility Category A are 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 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 are those program elements 

that apply to activities that have direct 

and significant effects in multiple 

jurisdictions. An Agreement State 

should adopt Category B program 

elements in an essentially identical 

manner. 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 nationwide 

basis. An Agreement State should adopt 

the essential objectives of the Category 

C program elements. Compatibility 

Category D are those program elements 

that do not meet any of the criteria of 

Category A, B, or C, above, and, thus, do 

not need to be adopted by Agreement 

States for purposes of compatibility. 

Health and Safety (H&S) are program 

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 of the NRC that embody the 

essential objectives of the NRC program 

elements because of particular health 

and safety considerations. Compatibility 

Category NRC are those program 

elements that address areas of regulation 

that cannot be relinquished to 

Agreement States under the AEA, as 

amended, or provisions of Title 10 of 

the Code of Federal Regulations. These 

program elements are not adopted by 

the Agreement States. 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.’’ A bracket around a category 

means that the section may have been 

adopted elsewhere, and it is not 

necessary to adopt it again. 

The definition of Byproduct material 

in the AEA was expanded by Section 

651(e) of the EPAct to incorporate 

certain discrete sources of radium-226 

and certain accelerator-produced 

radioactive materials. The definition of 

Byproduct material in 10 CFR parts 20, 

30, 50, 72, 150, 170, and 171 is amended 

to reflect the changes to the AEA. The 

definition of Byproduct material in parts 

50, 72, 170, and 171 is reserved to the 

NRC. The definition of Byproduct 

material in 10 CFR parts 20, 30, and 150 

are categorized as H&S. This designation 

is for regulatory program elements that 

have particular health and safety 

significance. The H&S designation 

indicates that the definition is needed 

for purposes of ‘‘adequacy.’’ If NARM is 

included in the Agreement between the 

NRC and the Agreement State, then 

NARM would be a necessary program 

element of the Agreement State program 

to adequately ensure public health and 

safety. The definition of Discrete source 

has also been identified in this rule as 

H&S because it is part of the definition 

of Byproduct material. 

COMPATIBILITY TABLE

Section Change Subject 

Compatibility 

Existing New 

20.1003 .............................. Amend ............................... Definition: Byproduct Material (add 11e.(3) & 11e.(4) 

material).

[A] ................ [H&S] 

20.1003 .............................. Add .................................... Definition: Discrete Source ........................................... ..................... H&S 

20.1003 .............................. Add .................................... Definition: Particle Accelerator ..................................... ..................... H&S 

20.1003 .............................. Add .................................... Definition: Waste .......................................................... ..................... B 

20.1009 .............................. Amend ............................... List of OMB approved information collections ............. D ................. D 

20.2001(a)(4) ..................... Amend ............................... General requirements (add reference to new 

§ 20.2008).

C ................. C 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

20.2006(e) .......................... Add .................................... Transfer for disposal and manifests (add 11e.(3) and

11e.(4) byproduct material).

..................... B 

20.2008 .............................. Add .................................... Disposal of 11e.(3) and 11e.(4) byproduct material 

(new section).

..................... B 

Appendix B to Part 20 ....... Amend ............................... Add limits for N–13 and O–15 ...................................... A .................. A 

30.3(a) ................................ Amend ............................... Activities requiring license (add reference to paragraph (c)).C ................. C 

30.3(b)(1) ........................... Add .................................... Activities requiring license (requirements that apply to 

Government agencies and Federally recognized Indian Tribes at waiver termination).

..................... NRC 

30.3(b)(2) ........................... Add .................................... Activities requiring license (authorization for Government agencies and Federally recognized Indian 

Tribes to possess and use 11e.(3) materials while 

applying for a license amendment).

..................... NRC 

30.3(b)(3) ........................... Add .................................... Activities requiring license (authorization for Government agencies and Federally recognized Indian 

Tribes to possess and use 11e.(3) materials while 

applying for a new license).

..................... NRC 

30.3(c)(1) ........................... Add .................................... Activities requiring license (requirements that apply to 

all other persons at waiver termination).

..................... D 

30.3(c)(2) ........................... Add .................................... Activities requiring license (authorization for all other 

persons to possess and use 11e.(3) materials while 

applying for a license amendment).

..................... D 

30.3(c)(3) ........................... Add .................................... Activities requiring license (authorization for all other 

persons to possess and use 11e.(3) materials while 

applying for a new license).

..................... D 

30.3(d) ................................ Add .................................... Activities requiring license (continuation of authority 

for failure to submit amendment or license).

..................... D 

30.4 .................................... Add .................................... Definition: Accelerator-produced radioactive material .. ..................... H&S 

30.4 .................................... Amend ............................... Definition: Byproduct material (add 11e.(3) & 11e.(4) 

material).

[A] ................ [H&S] 

30.4 .................................... Add .................................... Definition: Consortium .................................................. ..................... C 

30.4 .................................... Add .................................... Definition: Cyclotron ..................................................... ..................... D 

30.4 .................................... Add .................................... Definition: Discrete source ........................................... ..................... H&S 

30.4 .................................... Add .................................... Definition: Particle accelerator ...................................... ..................... H&S 

30.15(a)(1)(viii) ................... Add .................................... Certain items containing byproduct material (add radium-226 intact timepieces and limited repairs).B ..................

(all § 30.15)

B 

30.18(b) .............................. Amend ............................... Exempt quantities (add 11e.(3) material) ..................... B ..................

(all § 30.18)

B 

30.20(a) .............................. Amend ............................... Gas and aerosol detectors containing byproduct material (grandfather 11e.(3) detectors).B ..................

(all § 30.20)

B 

30.32(g) .............................. Amend ............................... Application for specific licenses ................................... C .................. C 

30.32(j) ............................... Add .................................... Application for specific licenses (add noncommercial 

transfer of PET drugs).

..................... B 

30.34(g) .............................. Amend ............................... Terms and conditions of licenses (add strontium-82/ 

rubidium-82 generators).

D ................. H&S 

30.34(j) ............................... Add .................................... Terms and conditions of licenses (add noncommercial 

transfer of PET drugs).

..................... B 

30.71 .................................. Amend ............................... Schedule B (add 11e.(3) material) ............................... B .................. B 

30.72 .................................. Amend ............................... Schedule C—Quantities of radioactive materials requiring consideration of the need for an emergency 

plan for responding to a release (add radium-226).

H&S ............. H&S 

31.4 .................................... Amend ............................... List of OMB approved information collections ............. D .................. D 

31.5(b)(1) & (c)(13) ............ Amend ............................... Certain detecting, measuring, gauging, or controlling 

devices and/or an ionizing atmosphere (add devices with NARM approved by States).

B ..................

(all § 31.5) ...

B 

31.8 .................................... Amend ............................... Americium-241 in the form of calibration or reference 

sources (add radium-226).

D ................. D 

31.11 .................................. Amend ............................... General license for use of byproduct material for certain in vitro clinical or laboratory testing (add cobalt57).D ................. D 

31.12 .................................. Add .................................... General license for certain items and self-luminous 

products containing radium-226 (new section).

..................... C 

32.1(c)(1) ........................... Add .................................... Purpose and scope (requirements that apply to Government agencies and Federally recognized Indian 

Tribes at waiver termination and authorization to 

manufacture and distribute items with 11e.(3) material while applying for amendment or license).

..................... NRC 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

32.1(c)(2) ........................... Add .................................... Purpose and scope (requirements that apply to all 

other persons at waiver termination and authorization to manufacture and distribute items with 

11e.(3) material while applying for amendment or license).

..................... D 

32.57 .................................. Amend ............................... Calibration or reference sources containing americium-241: Requirements for license to manufacture 

or initially transfer (add radium-226).

B .................. B 

32.58 .................................. Amend ............................... Same: Labeling of devices (add radium-226) .............. B .................. B 

32.59 .................................. Amend ............................... Same: Leak testing of each source (add radium-226) B .................. B 

32.71(b)(8) & (c)(1) ............ Add .................................... Manufacture and distribution of byproduct material for 

certain in vitro clinical or laboratory testing under 

general license (add cobalt-57).

B .................. B 

32.72(a)(2)(i), (iii), (iv), (v), 

& (b).

Amend ............................... Manufacture, preparation, or transfer for commercial 

distribution of radioactive drugs containing byproduct material for medical use under part 35 (recognize FDA and State registrations of PET facilities 

and pharmacist using 11e.(3) material).

B .................. B 

32.102 ................................ Amend ............................... Schedule C—prototype tests for calibration or reference sources containing americium-241 (add radium-226).B .................. B 

33.100 ................................ Amend ............................... Schedule A (add beryllium-7, cobalt-57, radium-226, 

& sodium-22).

D ................. D 

35.2 .................................... Add .................................... Definition: Cyclotron ..................................................... ..................... D 

35.2 .................................... Add .................................... Definition: Positron Emission Tomography (PET) 

radionuclide production facility.

..................... H&S 

35.10(a) .............................. Add .................................... Implementation (requirements that apply at waiver termination)...................... D 

35.10(g) .............................. Redesignated .................... Implementation ............................................................. ..................... D 

35.11(a) .............................. Amend ............................... License required (reference to § 35.11(c)) ................... C ................. C 

35.11(c)(1) ......................... Add .................................... License required (authorize medical use of 11e.(3) 

materials by Government agencies and Federally 

recognized Indian Tribes while applying for license).

..................... NRC 

35.11(c)(2) ......................... Add .................................... License required (authorize medical use of 11e.(3) 

materials by all other persons while applying for license).

..................... D 

35.13(a)(1) ......................... Amend ............................... License amendments (authorize medical use of 

11e.(3) materials by Government agencies and 

Federally recognized Indian Tribes while applying 

for amendment).

..................... NRC 

35.13(a)(2) ......................... Amend ............................... License amendments (authorize medical use of 

11e.(3) materials by all other licensees while applying for amendment).

..................... D 

35.13(b)(5) ......................... Add .................................... License amendments (grandfather physicians and 

pharmacists that used 11e.(3) material).

D ................. D 

35.13(e) .............................. Amend ............................... License amendments (clarify amendment need) ......... D ................. D 

35.14(a) and (b)(5) ............ Amend ............................... Notifications (using notification to allow continued operation for certain 11e.(3) material).D ................. D 

35.15(f) ............................... Amend ............................... Exemptions regarding Type A specific licenses of 

broad scope (clarify the exemption).

D ................. D 

35.57(a)(3) & (b)(3) ............ Add .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and 

nuclear pharmacist (grandfather RSO, AMP, ANP, 

and AU who used only 11e.(3) material).

..................... D 

35.63(b)(2)(ii) & (c)(3) ........ Amend ............................... Determination of dosages of unsealed byproduct material for medical use (recognize State licenses and 

State requirements).

H&S ............. H&S 

35.63(b)(2)(iii) .................... Add .................................... Determination of dosages of unsealed byproduct material for medical use (recognize State licenses of 

PET facilities).

..................... H&S 

35.100(a) & (b) .................. Amend ............................... Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required (allow use of PET radionuclides).H&S ............. H&S 

35.200(a) & (b) .................. Amend ............................... Use of unsealed byproduct material for imaging and 

localization studies for which a written directive is 

not required (allow use of PET radionuclides).

H&S ............. H&S 

35.204(a) ............................ Amend ............................... Permissible molybdenum-99 concentrations (add 

strontium-82 & strontium-85).

H&S ............. H&S 

35.204(c) ............................ Add .................................... Permissible molybdenum-99 concentrations (add 

strontium-82 & strontium-85.

..................... D 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

35.204(d) ............................ Redesignated .................... Permissible molybdenum-99 concentrations ................ D .................. D 

35.300(a) and (b) ............... Amend ............................... Use of unsealed byproduct material for which a written directive is required (allow use of PET radionuclides).H&S ............. H&S 

35.2204 .............................. Amend ............................... Records of molybdenum-99 concentrations (add 

strontium-82 & strontium-85).

D ................. D 

50.2 .................................... Amend ............................... Definition: Byproduct material (add 11e.(3) & 11e.(4) 

material).

NRC ............ NRC 

61.2 .................................... Amend ............................... Definition: Waste (clarify 11e.(3) & 11e.(4) material) ... B .................. B 

62.2 .................................... Amend ............................... Definition: Low-level radioactive waste (clarify 11e.(3) 

& 11e.(4) material).

NRC ............ NRC 

72.3 .................................... Amend ............................... Definition: Byproduct material (add 11e.(3) & 11e.(4) 

material).

NRC ............ NRC 

110.2 .................................. Add .................................... Definition: Accelerator-produced radioactive material .. ..................... NRC 

110.2 .................................. Add .................................... Definition: Discrete source ........................................... ..................... NRC 

110.2 .................................. Add .................................... Definition: Particle accelerator ...................................... ..................... NRC 

150.3 .................................. Amend ............................... Definition: Byproduct material (add 11e.(3) & 11e.(4) 

material).

A .................. H&S 

150.3 .................................. Add .................................... Definition: Discrete source ........................................... ..................... H&S 

10 CFR Parts 170 and 171 address areas that generally are applicable only to the NRC’s regulatory program; therefore, no compatibility designation is assigned. 

VII. 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 final rule, the NRC 

is assuming regulation of certain 

discrete sources of naturally occurring 

radioactive material and acceleratorproduced radioactive material in 

addition to those byproduct materials 

already under the NRC’s jurisdiction. 

This action does not constitute the 

establishment of a standard that 

establishes generally applicable 

requirements. 

The EPAct requires that the NRC use 

model State standards to the maximum 

extent practicable in developing and 

issuing regulations for the newly 

expanded definition of Byproduct 

material. In developing this final rule, 

the NRC has consulted with Agreement 

and non-Agreement States about their 

regulations. To the maximum extent 

practicable, the NRC has incorporated 

the CRCPD’s SSRs into this final rule. 

VIII. Environmental Assessment and 

Finding of No Significant 

Environmental Impact: Availability 

The Commission has determined 

under the National Environmental 

Policy Act of 1969, as amended, and the 

Commission’s regulations in Subpart A 

of 10 CFR part 51, that this rule is not 

a major Federal action significantly 

affecting the quality of the human 

environment and therefore an 

environmental impact statement is not 

required. The Commission has prepared 

an environmental assessment for this 

final rule. 

Amendments to the NRC’s regulations 

incorporate new materials into the 

NRC’s byproduct material regulatory 

program and establish new program 

elements where needed. Before the 

EPAct, the regulation of NARM, other 

than source material, was left primarily 

to the individual States. Although 

efforts were made by several States to 

provide a uniform regulatory 

environment, particularly for 

accelerator-produced radioactive 

material, there is currently no 

nationwide consistency to the 

regulation of NARM. The amendments 

to the NRC’s regulations will provide a 

uniform regulatory environment for the 

acquisition, possession, use, transfer, 

and disposal of NARM. This uniform 

regulatory environment has been 

developed in cooperation with the 

States, using model State standards in 

existence to the maximum extent 

practicable. Because the approach for 

developing the generic NRC 

requirements started with the existing 

generic requirements for acceleratorproduced radioactive material that had 

already been developed by the States for 

the SSRs, little change is expected to the 

byproduct material regulatory programs 

already in place for the Agreement 

States. Consequently, for Agreement 

States, the primary foreseeable impact of 

the regulatory changes applicable to 

accelerator-produced radioactive 

material is that the regulations will be 

uniformly applied by all Agreement 

States. Therefore, for the regulation of 

accelerator-produced radioactive 

material by the Agreement States, these 

amendments to the NRC’s regulations 

are not expected to have any adverse 

environmental impacts. 

In non-Agreement States, these 

amendments to the NRC’s regulations 

generally impose more restrictive 

requirements on the acquisition, 

possession, use, transfer, and disposal of 

accelerator-produced radioactive 

materials. In situations where the new 

NRC requirements are more restrictive 

than those already imposed by 

individual States’ existing regulations, 

the result will likely be a positive 

impact on the environment. In 

situations where the NRC’s 

requirements are less restrictive than the 

individual State’s regulations, it is likely 

that the licensee will, in large part, 

continue with its current practices, and 

no substantial impact on the 

environment is anticipated. Therefore, it 

is expected that the overall 

environmental impacts of the regulation 

of accelerator-produced radioactive 

material in non-Agreement States will 

be positive. 

The effects of the amendments to the 

NRC’s regulations applicable to discrete 

sources of radium-226 and discrete 

sources of other naturally occurring 

radioactive material will be greater for 

the non-Agreement States than for the 

Agreement States because certain nonAgreement States do not have a 

regulatory program addressing this 

material. The imposition of regulations 


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on the acquisition, possession, use, 

transfer, and disposal of these discrete 

sources of naturally occurring 

radioactive material will provide greater 

assurance that these activities are 

performed in a manner that is expected 

to be less harmful to the environment 

than would be assured without these 

regulations. Therefore, the effect of the 

NRC’s regulations applicable to discrete 

sources of naturally occurring 

radioactive material is anticipated to be 

beneficial to the environment, and it is 

expected that the overall environmental 

impacts will be positive. 

Therefore, the determination of the 

environmental assessment is that there 

will be no significant impact to the 

human environment from this action. 

The NRC sent a copy of the 

environmental assessment and the 

proposed rule to every State Liaison 

Officer and requested their comments 

on the environmental assessment. No 

significant comments were received that 

changed this conclusion. 

IX. Paperwork Reduction Act 

Statement 

This final rule amends information 

collection requirements contained in 10 

CFR Parts 19, 20, 30, 31, 32, and 35 that 

are subject to the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

These requirements were approved by 

the Office of Management and Budget, 

approval numbers 3150–0044, –0014, 

–0017, –0016, –0001, –0010, and –0120. 

The changes to 10 CFR Parts 33, 50, 61, 

62, 72, 110, 150, 170, and 171 do not 

contain new or amended information 

collection requirements. 

The burden to the public for these 

information collections is estimated to 

average 24 hours per response, 

including the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the information collection. 

Send comments on any aspect of these 

information collections, including 

suggestions for reducing the burden, 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@NRC.GOV; and to the 

Desk Officer, Office of Information and 

Regulatory Affairs, NEOB–10202 (3150–

0044, –0014, –0017, –0016, –0001, 

–0010, and –0120, Office of 

Management and Budget, Washington, 

DC 20503. 

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 

regulatory analysis on this regulation. 

The regulatory analysis examines the 

costs and benefits of the alternatives 

considered by the Commission. 

The regulatory analysis is available 

for inspection in the NRC Public 

Document Room, 11555 Rockville Pike, 

Rockville, MD, and may be downloaded 

from the rule forum Web site at http:// 

ruleforum.llnl.gov. Single copies of the 

regulatory analysis are available from 

Catherine R. Mattsen, Office of Federal 

and State Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone (301) 415–

6264, e-mail crm@nrc.gov. 

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 

will not have a significant economic 

impact on a substantial number of small 

entities. The majority of companies that 

own these businesses do not fall within 

the scope of the definition of ‘‘small 

entities’’ set forth in the Regulatory 

Flexibility Act or the Small Business 

Size Standards set out in regulations 

issued by the Small Business 

Administration at 13 CFR part 121. 

Section 651(e) of the EPAct expanded 

the definition of Byproduct material in 

Section 11e. of the AEA to include any 

discrete source of radium-226, any 

material made radioactive by use of a 

particle accelerator, and any discrete 

source of naturally occurring radioactive 

material that would pose a similar threat 

to the public health and safety or the 

common defense and security as a 

discrete source of radium-226 that is 

extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. This rulemaking 

amends the NRC’s regulations to 

include this newly defined byproduct 

material. This amendment will 

potentially affect large numbers of 

individuals, businesses, or licensees 

engaged in activities involving discrete 

radium-226 sources or acceleratorproduced radioactive material used for 

commercial, medical, or research 

activities. Many individuals, businesses, 

or licensees qualify as small business 

entities as defined by 10 CFR 2.810. 

However, the rule is not expected to 

have a significant economic impact on 

these individuals, businesses, or 

licensees because the NRC is using the 

existing regulatory framework to 

regulate these materials and is allowing 

sufficient time for individuals, 

businesses, and licensees to implement 

the requirements for this radioactive 

material. Based on the regulatory 

analysis, the NRC believes that the 

selected alternative reflected in the 

amendment is protective of public 

health and safety and is not overly 

burdensome to accomplish the NRC’s 

regulatory objective. The NRC also notes 

that several Agreement States have 

imposed similar requirements on their 

licensees either by rule, order, or license 

condition. 

XII. Backfit Analysis 

The NRC has determined that the 

backfit rule (10 CFR 50.109, 70.76, 

72.62, or 76.76) does not apply to this 

rule because this amendment does not 

involve any provisions that would 

impose backfits as defined in 10 CFR 

Chapter 1. Therefore, a backfit analysis 

is not required. 

XIII. Congressional Review Act 

In accordance with the Congressional 

Review Act of 1996, the NRC has 

determined that this action is not a 

major rule and has verified this 

determination with the Office of 

Information and Regulatory Affairs of 

OMB. 

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 30 

Byproduct material, Criminal 

penalties, Government contracts, 

Intergovernmental relations, Isotopes, 

Nuclear materials, Radiation protection, 

Reporting and recordkeeping 

requirements. 

10 CFR Part 31 

Byproduct material, Criminal 

penalties, Labeling, Nuclear materials, 

Packaging and containers, Radiation 

protection, Reporting and recordkeeping 

requirements, Scientific equipment. 

10 CFR Part 32 

Byproduct material, Criminal 

penalties, Labeling, Nuclear materials, 

Radiation protection, Reporting and 

recordkeeping requirements. 


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10 CFR Part 33 

Byproduct material, Criminal 

penalties, Nuclear materials, Radiation 

protection, Reporting and recordkeeping 

requirements. 

10 CFR Part 35 

Byproduct material, Criminal 

penalties, Drugs, Health facilities, 

Health professions, Medical devices, 

Nuclear materials, Occupational safety 

and health, Radiation protection, 

Reporting and recordkeeping 

requirements. 

10 CFR Part 50 

Antitrust, Classified information, 

Criminal penalties, Fire protection, 

Intergovernmental relations, Nuclear 

power plants and reactors, Radiation 

protection, Reactor siting criteria, 

Reporting and recordkeeping 

requirements. 

10 CFR Part 61 

Criminal penalties, Low-level waste, 

Nuclear materials, Reporting and 

recordkeeping requirements, Waste 

treatment and disposal. 

10 CFR Part 62 

Administrative practice and 

procedure, Denial of access, Emergency 

access to low-level waste disposal, Lowlevel radioactive waste, Low-level 

radioactive waste treatment and 

disposal, Low-level waste policy 

amendments act of 1985, Nuclear 

materials, Reporting and recordkeeping 

requirements. 

10 CFR Part 72 

Administrative practice and 

procedure, Criminal penalties, 

Manpower training programs, Nuclear 

materials, Occupational safety and 

health, Penalties, Radiation protection, 

Reporting and recordkeeping 

requirements, Security measures, Spent 

fuel, Whistleblowing. 

10 CFR Part 110 

Administrative practice and 

procedure, Classified information, 

Criminal penalties, Export, Import, 

Intergovernmental relations, Nuclear 

materials, Nuclear power plants and 

reactors, Reporting and recordkeeping 

requirements, Scientific equipment. 

10 CFR Part 150 

Criminal penalties, Hazardous 

materials transportation, 

Intergovernmental relations, Nuclear 

materials, Reporting and recordkeeping 

requirements, Security measures, 

Source material, Special nuclear 

material. 

10 CFR Part 170 

Byproduct material, Import and 

export licenses, Intergovernmental 

relations, Nonpayment penalties, 

Nuclear materials, Nuclear power plants 

and reactors, Source material, Special 

nuclear material. 

10 CFR Part 171 

Annual charges, Byproduct material, 

Holders of certificates, registrations, 

approvals, Intergovernmental relations, 

Nonpayment penalties, Nuclear 

materials, Nuclear power plants and 

reactors, Source material, Special 

nuclear material. 

■ 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 adopting the following 

amendments to 10 CFR parts 20, 30, 31, 

32, 33, 35, 50, 61, 62, 72, 110, 150, 170, 

and 171. 

PART 20—STANDARDS FOR 

PROTECTION AGAINST RADIATION 

■ 1. The authority citation for part 20 is 

revised to read as follows: 

Authority: Secs. 53, 63, 65, 81, 103, 104, 

161, 182, 186, 68 Stat. 930, 933, 935, 936, 

937, 948, 953, 955, as amended, sec. 1701, 

106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 

2093, 2095, 2111, 2133, 2134, 2201, 2232, 

2236, 2297f), secs. 201, as amended, 202, 

206, 88 Stat. 1242, as amended, 1244, 1246 

(42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 

Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), 

Pub. L. 109–58, 119 Stat. 806–810 (42 U.S.C. 

2014, 2021, 2021b, 2111). 

■ 2. In § 20.1003, the definition of 

Byproduct material is revised, and 

definitions of Accelerator-produced 

radioactive material, Discrete source, 

Particle accelerator, and Waste are 

added alphabetically to read as follows: 

§ 20.1003 Definitions. 

* * * * * 

Accelerator-produced radioactive 

material means any material made 

radioactive by a particle accelerator. 

* * * * * 

Byproduct material means—

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2) The tailings or wastes produced by 

the extraction or concentration of 

uranium or thorium from ore processed 

primarily for its source material content, 

including discrete surface wastes 

resulting from uranium solution 

extraction processes. Underground ore 

bodies depleted by these solution 

extraction operations do not constitute 

‘‘byproduct material’’ within this 

definition; 

(3)(i) Any discrete source of radium226 that is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—

(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(4) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium-226 to the public health and 

safety or the common defense and 

security; and 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

Discrete source means a radionuclide 

that has been processed so that its 

concentration within a material has 

been purposely increased for use for 

commercial, medical, or research 

activities. 

* * * * * 

Particle accelerator means any 

machine capable of accelerating 

electrons, protons, deuterons, or other 

charged particles in a vacuum and of 

discharging the resultant particulate or 

other radiation into a medium at 

energies usually in excess of 1 

megaelectron volt. For purposes of this 

definition, ‘‘accelerator’’ is an 

equivalent term. 

* * * * * 

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 


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definition of Byproduct material set 

forth in this section. 

* * * * * 

■ 3. In § 20.1009, paragraph (b) is 

revised to read as follows: 

§ 20.1009 Information collection 

requirements: OMB approval. 

(b) The approved information 

collection requirements contained in 

this part appear in §§20.1003, 20.1101, 

20.1202, 20.1203, 20.1204, 20.1206, 

20.1208, 20.1301, 20.1302, 20.1403, 

20.1404, 20.1406, 20.1501, 20.1601, 

20.1703, 20.1901, 20.1904, 20.1905, 

20.1906, 20.2002, 20.2004, 20.2005, 

20.2006, 20.2008, 20.2102, 20.2103, 

20.2104, 20.2105, 20.2106, 20.2107, 

20.2108, 20.2110, 20.2201, 20.2202, 

20.2203, 20.2204, 20.2205, 20.2206, 

20.2207, 20.2301, and appendix G to 

this part. 

* * * * * 

■ 4. In § 20.2001, paragraph (a)(4) is 

revised to read as follows: 

§ 20.2001 General requirements. 

(a) * * * 

(4) As authorized under §§20.2002, 

20.2003, 20.2004, 20.2005, or 20.2008. 

* * * * * 

■ 5. In § 20.2006, paragraph (e) is added 

to read as follows: 

§ 20.2006 Transfer for disposal and 

manifests. 

* * * * * 

(e) Any licensee shipping byproduct 

material as defined in paragraphs (3) 

and (4) of the definition of Byproduct 

material set forth in § 20.1003 intended 

for ultimate disposal at a land disposal 

facility licensed under part 61 of this 

chapter must document the information 

required on the NRC’s Uniform LowLevel Radioactive Waste Manifest and 

transfer this recorded manifest 

information to the intended consignee 

in accordance with appendix G to this 

part. 

■ 6. Section 20.2008 is added to Subpart 

K—Waste Disposal—to read as follows: 

§ 20.2008 Disposal of certain byproduct 

material. 

(a) Licensed material as defined in 

paragraphs (3) and (4) of the definition 

of Byproduct material set forth in 

§20.1003 may be disposed of in 

accordance with part 61 of this chapter, 

even though it is not defined as lowlevel radioactive waste. Therefore, any 

licensed byproduct material being 

disposed of at a facility, or transferred 

for ultimate disposal at a facility 

licensed under part 61 of this chapter, 

must meet the requirements of 

§20.2006. 

(b) A licensee may dispose of 

byproduct material, as defined in 

paragraphs (3) and (4) of the definition 

of Byproduct material set forth in §

20.1003, at a disposal facility authorized 

to dispose of such material in 

accordance with any Federal or State 

solid or hazardous waste law, including 

the Solid Waste Disposal Act, as 

authorized under the Energy Policy Act 

of 2005. 

■ 7. In Appendix B to part 20, the List 

of Elements table is amended by adding 

Nitrogen and Oxygen in alphabetical 

order, and page 1 of Tables 1, 2, and 3 

following the List of Elements is revised 

to read as follows: 

Appendix B to Part 20—Annual Limits 

on Intake (ALIs) and Derived Air 

Concentrations (DACs) of 

Radionuclides for Occupational 

Exposure; Effluent Concentrations; 

Concentrations for Release to Sewerage 

* * * * * 

LIST OF ELEMENTS

Name 

Atomic 

Symbol No. 

* * * * * * * 

Nitrogen ....................................................................................... N ................................................................................................ 7 

* * * * * * * 

Oxygen ........................................................................................ O ................................................................................................ 8 

* * * * * * * 

* * * * * 

BILLING CODE 7590–01–P 


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BILLING CODE 7590–01–C 


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* * * * * 

Footnotes 

1 ‘‘Submersion’’ means that values given 

are for submersion in a hemispherical semiinfinite cloud of airborne material. 2These radionuclides have radiological 

half-lives of less than 2 hours. The total 

effective dose equivalent received during 

operations with these radionuclides might 

include a significant contribution from 

external exposure. The DAC values for all 

radionuclides, other than those designated 

Class ‘‘Submersion,’’ are based upon the 

committed effective dose equivalent due to 

the intake of the radionuclide into the body 

and do not include potentially significant 

contributions to dose equivalent from 

external exposures. The licensee may 

substitute 1E–7 μCi/ml for the listed DAC to 

account for the submersion dose 

prospectively, but should use individual 

monitoring devices or other radiation 

measuring instruments that measure external 

exposure to demonstrate compliance with the 

limits. (See § 20.1203.) 

* * * * * 

PART 30—RULES OF GENERAL 

APPLICABILITY TO DOMESTIC 

LICENSING OF BYPRODUCT 

MATERIAL 

■ 8. The authority citation for part 30 is 

revised to read as follows: 

Authority: Secs. 81, 82, 161, 182, 183, 186, 

68 Stat. 935, 948, 953, 954, 955, as amended, 

sec. 234, 83 Stat. 444, as amended (42 U.S.C. 

2111, 2112, 2201, 2232, 2233, 2236, 2282); 

secs. 201, as amended, 202, 206, 88 Stat. 

1242, as amended, 1244, 1246 (42 U.S.C. 

5841, 5842, 5846); sec. 1704, 112 Stat. 2750 

(44 U.S.C. 3504 note); sec. 651(e), Pub. L. 

109–58, 119 Stat. 806–810 (42 U.S.C. 2014, 

2021, 2021b, 2111). 

Section 30.7 also issued under Pub. L. 95–

601, sec. 10, 92 Stat. 2951 as amended by 

Pub. L. 102–486, sec. 2902, 106 Stat. 3123 (42 

U.S.C. 5851). Section 30.34(b) also issued 

under sec. 184, 68 Stat. 954, as amended (42 

U.S.C. 2234). Section 30.61 also issued under 

sec. 187, 68 Stat. 955 (42 U.S.C. 2237). 

■ 9. Section 30.3 is revised to read as 

follows: 

§ 30.3 Activities requiring license. 

(a) Except as provided in paragraphs 

(b)(2), (b)(3), (c)(2), and (c)(3) of this 

section and for persons exempt as 

provided in this part and part 150 of 

this chapter, no person shall 

manufacture, produce, transfer, receive, 

acquire, own, possess, or use byproduct 

material except as authorized in a 

specific or general license issued in 

accordance with the regulations in this 

chapter. 

(b)(1) The requirements, including 

provisions that are specific to licensees, 

in this part and parts 19, 20, 21, and 71 

of this chapter, as well as the additional 

requirements for specific broad scope, 

industrial radiography, irradiator, or 

well logging uses in 10 CFR parts 33, 34, 

36, or 39, respectively, shall apply to 

Government agencies or Federally 

recognized Indian Tribes on November 

30, 2007, when conducting activities 

under the authority provided by 

paragraphs (b)(2) and (b)(3) of this 

section. 

(2) A specifically licensed 

Government agency or Federally 

recognized Indian Tribe that possesses 

and uses accelerator-produced 

radioactive material or discrete sources 

of radium-226 for which a license 

amendment is required to authorize the 

activities in paragraph (a) of this 

section, may continue to use these 

materials for uses permitted under this 

part until the date of the NRC’s final 

licensing determination, provided that 

the licensee submits an amendment 

application on or before June 2, 2008. 

(3) A Government agency or Federally 

recognized Indian Tribe that possesses 

and uses accelerator-produced 

radioactive material or discrete sources 

of radium-226 for which a specific 

license is required in paragraph (a) of 

this section, may continue to use such 

material for uses permitted under this 

part until the date of the NRC’s final 

licensing determination provided that 

the agency or Indian Tribe submits an 

application for a license authorizing 

activities involving these materials on or 

before December 1, 2008. 

(c)(1) The requirements, including 

provisions that are specific to licensees 

in this part and parts 19, 20, 21, and 71 

of this chapter, as well as the additional 

requirements for specific broad scope, 

industrial radiography, irradiator, or 

well logging uses in 10 CFR parts 33, 34, 

36, or 39, respectively, shall apply to all 

persons, other than those included in 

paragraph (b)(1) of this section, on 

August 8, 2009, or earlier as noticed by 

the NRC, when conducting activities 

under the authority provided by 

paragraphs (c)(2) and (c)(3) of this 

section. 

(2) Except as provided in paragraph 

(b)(2) of this section, all other licensees, 

who possess and use acceleratorproduced radioactive material or 

discrete sources of radium-226 for 

which a license amendment is required 

to authorize the activities in paragraph 

(a) of this section, may continue to use 

these materials for uses permitted under 

this part until the date of the NRC’s final 

licensing determination, provided that 

the person submits an amendment 

application within 6 months from the 

waiver expiration date of August 7, 2009 

or within 6 months from the date of an 

earlier termination of the waiver as 

noticed by the NRC, whichever date is 

earlier. 

(3) Except as provided in paragraph 

(b)(3) of this section, all other persons, 

who possess and use acceleratorproduced radioactive material or 

discrete sources of radium-226 for 

which a specific license is required in 

paragraph (a) of this section, may 

continue to use such material for uses 

permitted under this part until the date 

of the NRC’s final licensing 

determination, provided that the person 

submits a license application within 12 

months from the waiver expiration date 

of August 7, 2009 or within 12 months 

from the date of an earlier termination 

of the waiver as noticed by the NRC, 

whichever date is earlier. 

(d) If a person or licensee is required 

to file an application for a license or 

amendment in accordance with 

paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) 

of this section, but does not file for the 

license or amendment within the 

required time, the authority provided by 

paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) 

of this section to receive or use the 

accelerator-produced radioactive 

material or discrete sources of radium226 shall expire with respect to the 

person’s or licensee’s authority to 

receive and use such byproduct 

material. This authority shall not expire 

with respect to the responsibility of the 

person or licensee regarding the 

possession of such byproduct material, 

the decommissioning (including 

financial assurance) of facilities, or the 

disposal of such byproduct material. 

■ 10. In § 30.4, the definition of 

Byproduct material is revised, and the 

definitions of Accelerator-produced 

radioactive material, Consortium, 

Cyclotron, Discrete source, and Particle 

accelerator are added alphabetically to 

read as follows: 

§ 30.4 Definitions. 

* * * * * 

Accelerator-produced radioactive 

material means any material made 

radioactive by a particle accelerator. 

* * * * * 

Byproduct material means—

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2)(i) Any discrete source of radium226 that is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—


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(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(3) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium-226 to the public health and 

safety or the common defense and 

security; and 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

Consortium means an association of 

medical use licensees and a PET 

radionuclide production facility in the 

same geographical area that jointly own 

or share in the operation and 

maintenance cost of the PET 

radionuclide production facility that 

produces PET radionuclides for use in 

producing radioactive drugs within the 

consortium for noncommercial 

distributions among its associated 

members for medical use. The PET 

radionuclide production facility within 

the consortium must be located at an 

educational institution or a Federal 

facility or a medical facility. 

* * * * * 

Cyclotron means a particle accelerator 

in which the charged particles travel in 

an outward spiral or circular path. A 

cyclotron accelerates charged particles 

at energies usually in excess of 10 

megaelectron volts and is commonly 

used for production of short half-life 

radionuclides for medical use. 

* * * * * 

Discrete source means a radionuclide 

that has been processed so that its 

concentration within a material has 

been purposely increased for use for 

commercial, medical, or research 

activities. 

* * * * * 

Particle accelerator means any 

machine capable of accelerating 

electrons, protons, deuterons, or other 

charged particles in a vacuum and of 

discharging the resultant particulate or 

other radiation into a medium at 

energies usually in excess of 1 

megaelectron volt. For purposes of this 

definition, accelerator is an equivalent 

term. 

* * * * * 

■ 11. In § 30.15, paragraph (a)(1)(viii) is 

added to read as follows: 

§ 30.15 Certain items containing 

byproduct material. 

(a) * * * 

(1) * * * 

(viii) 0.037 megabecquerel (1 

microcurie) of radium-226 per timepiece 

in intact timepieces manufactured prior 

to November 30, 2007. 

* * * * * 

■ 12. In § 30.18, paragraph (b) is revised 

to read as follows: 

§ 30.18 Exempt quantities. 

* * * * * 

(b) Any person, who possesses 

byproduct material received or acquired 

before September 25, 1971, under the 

general license then provided in § 31.4 

of this chapter or similar general license 

of a State, is exempt from the 

requirements for a license set forth in 

section 81 of the Act and from the 

regulations in parts 30 through 34, 36 

and 39 of this chapter to the extent that 

this person possesses, uses, transfers, or 

owns byproduct material. 

* * * * * 

■ 13. In § 30.20, paragraph (a) is revised 

to read as follows: 

§ 30.20 Gas and aerosol detectors 

containing byproduct material. 

(a) Except for persons who 

manufacture, process, produce, or 

initially transfer for sale or distribution 

gas and aerosol detectors containing 

byproduct material, any person is 

exempt from the requirements for a 

license set forth in section 81 of the Act 

and from the regulations in parts 19, 20, 

and 30 through 36, and 39 of this 

chapter to the extent that the person 

receives, possesses, uses, transfers, 

owns, or acquires byproduct material in 

gas and aerosol detectors designed to 

protect life or property from fires and 

airborne hazards, and manufactured, 

processed, produced, or initially 

transferred in accordance with a specific 

license issued under § 32.26 of this 

chapter, which license authorizes the 

initial transfer of the product for use 

under this section. This exemption also 

covers gas and aerosol detectors 

manufactured or distributed before 

November 30, 2007 in accordance with 

a specific license issued by a State 

under comparable provisions to § 32.26 

of this chapter authorizing distribution 

to persons exempt from regulatory 

requirements. 

* * * * * 

■ 14. In § 30.32, paragraphs (g)(1) and 

(g)(2) are revised and paragraphs (g)(3) 

and (j) are added to read as follows: 

§ 30.32 Application for specific licenses. 

* * * * * 

(g) * * * 

(1) Identify the source or device by 

manufacturer and model number as 

registered with the Commission under 

§ 32.210 of this chapter, with an 

Agreement State, or for a source or a 

device containing radium-226 or 

accelerator-produced radioactive 

material with a State under provisions 

comparable to § 32.210 of this chapter; 

or 

(2) Contain the information identified 

in § 32.210(c) of this chapter; or 

(3) For sources or devices containing 

naturally occurring or acceleratorproduced radioactive material 

manufactured prior to November 30, 

2007 that are not registered with the 

Commission under § 32.210 of this 

chapter or with an Agreement State, and 

for which the applicant is unable to 

provide all categories of information 

specified in § 32.210(c) of this chapter, 

the applicant must provide: 

(i) All available information identified 

in § 32.210(c) of this chapter concerning 

the source, and, if applicable, the 

device; and 

(ii) Sufficient additional information 

to demonstrate that there is reasonable 

assurance that the radiation safety 

properties of the source or device are 

adequate to protect health and minimize 

danger to life and property. Such 

information must include a description 

of the source or device, a description of 

radiation safety features, the intended 

use and associated operating 

experience, and the results of a recent 

leak test. 

* * * * * 

(j) An application from a medical 

facility, educational institution, or 

Federal facility to produce Positron 

Emission Tomography (PET) radioactive 

drugs for noncommercial transfer to 

licensees in its consortium authorized 

for medical use under part 35 of this 

chapter or equivalent Agreement State 

requirements shall include: 

(1) A request for authorization for the 

production of PET radionuclides or 

evidence of an existing license issued 

under part 30 of this chapter or 

Agreement State requirements for a PET 

radionuclide production facility within 

its consortium from which it receives 

PET radionuclides. 

(2) Evidence that the applicant is 

qualified to produce radioactive drugs 

for medical use by meeting one of the 

criteria in § 32.72(a)(2) of this chapter. 


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2Persons possessing byproduct material in 

devices under a general license in § 31.5 before 

January 15, 1975, may continue to possess, use, or 

transfer that material in accordance with the 

labeling requirements of § 31.5 in effect on January 

14, 1975. 

(3) Identification of individual(s) 

authorized to prepare the PET 

radioactive drugs if the applicant is a 

pharmacy, and documentation that each 

individual meets the requirements of an 

authorized nuclear pharmacist as 

specified in § 32.72(b)(2) of this chapter. 

(4) Information identified in 

§ 32.72(a)(3) of this chapter on the PET 

drugs to be noncommercially transferred 

to members of its consortium. 

■ 15. In § 30.34, paragraph (g) is revised 

and paragraph (j) is added to read as 

follows: 

§ 30.34 Terms and conditions of licenses. 

* * * * * 

(g) Each licensee preparing 

technetium-99m radiopharmaceuticals 

from molybdenum-99/technetium-99m 

generators or rubidium-82 from 

strontium-82/rubidium-82 generators 

shall test the generator eluates for 

molybdenum-99 breakthrough or 

strontium-82 and strontium-85 

contamination, respectively, in 

accordance with § 35.204 of this 

chapter. The licensee shall record the 

results of each test and retain each 

record for 3 years after the record is 

made. 

* * * * * 

(j)(1) Authorization under § 30.32(j) to 

produce Positron Emission Tomography 

(PET) radioactive drugs for 

noncommercial transfer to medical use 

licensees in its consortium does not 

relieve the licensee from complying 

with applicable FDA, other Federal, and 

State requirements governing 

radioactive drugs. 

(2) Each licensee authorized under 

§ 30.32(j) to produce PET radioactive 

drugs for noncommercial transfer to 

medical use licensees in its consortium 

shall: 

(i) Satisfy the labeling requirements in 

§ 32.72(a)(4) of this chapter for each PET 

radioactive drug transport radiation 

shield and each syringe, vial, or other 

container used to hold a PET radioactive 

drug intended for noncommercial 

distribution to members of its 

consortium. 

(ii) Possess and use instrumentation 

to measure the radioactivity of the PET 

radioactive drugs intended for 

noncommercial distribution to members 

of its consortium and meet the 

procedural, radioactivity measurement, 

instrument test, instrument check, and 

instrument adjustment requirements in 

§ 32.72(c) of this chapter. 

(3) A licensee that is a pharmacy 

authorized under § 30.32(j) to produce 

PET radioactive drugs for 

noncommercial transfer to medical use 

licensees in its consortium shall require 

that any individual that prepares PET 

radioactive drugs shall be: 

(i) an authorized nuclear pharmacist 

that meets the requirements in 

§ 32.72(b)(2) of this chapter, or 

(ii) an individual under the 

supervision of an authorized nuclear 

pharmacist as specified in § 35.27 of this 

chapter. 

(4) A pharmacy, authorized under 

§ 30.32(j) to produce PET radioactive 

drugs for noncommercial transfer to 

medical use licensees in its consortium 

that allows an individual to work as an 

authorized nuclear pharmacist, shall 

meet the requirements of § 32.72(b)(5) of 

this chapter. 

■ 16. Section 30.71 is amended by 

adding Cesium 129 (Cs 129), Cobalt 57 

(Co 57), Gallium 67 (Ga 67), Germanium 

68 (Ge 68), Gold 195 (Au 195), Indium 

111 (In 111), Iodine 123 (I 123), Iron 52 

(Fe 52), Potassium 43 (K 43), Rubidium 

81 (Rb 81), Sodium 22 (Na 22), Yttrium 

87 (Y 87), and Yttrium 88 (Y 88) in 

alphabetical order by element as 

follows: 

§ 30.71 Schedule B. 

Byproduct material Microcuries 

* * * * * 

Cesium 129 (Cs 129) ........... 100 

* * * * * 

Cobalt 57 (Co 57) ................. 100 

* * * * * 

Gallium 67 (Ga 67) ............... 100 

* * * * * 

Germanium 68 (Ge 68) ........ 10 

* * * * * 

Gold 195 (Au 195) ................ 10 

* * * * * 

Indium 111 (In 111) .............. 100 

* * * * * 

Iodine 123 (I 123) ................. 100 

* * * * * 

Iron 52 (Fe 52) ..................... 10 

* * * * * 

Potassium 43 (K 43) ............. 10 

* * * * * 

Rubidium 81 (Rb 81) ............ 10 

* * * * * 

Sodium 22 (Na 22) ............... 10 

* * * * * 

Yttrium 87 (Y 87) .................. 10 

Yttrium 88 (Y 88) .................. 10 

* * * * * 

■ 17. Section 30.72 is amended by 

adding radium-226 in alphabetical order 

to read as follows: 

§ 30.72 Schedule C—Quantities of 

radioactive materials requiring 

consideration of the need for an emergency 

plan for responding to a release. 

Radioactive 

material 1

Release 

fraction 

Quantity 

(curies) 

* * * * * 

Radium-226 ...... 0.001 100 

* * * * * 

1For combinations of radioactive materials, 

consideration of the need for an emergency 

plan is required if the sum of the ratios of the 

quantity of each radioactive material authorized to the quantity listed for that material in 

Schedule C exceeds one. 

* * * * * 

PART 31—GENERAL DOMESTIC 

LICENSES FOR BYPRODUCT 

MATERIAL 

■ 18. The authority citation for part 31 

is revised 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), P. Law 109–58, 119 

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

2111). 

■ 19. In § 31.4, paragraph (b) is revised 

to read as follows: 

§ 31.4 Information collection 

requirements: OMB approval. 

* * * * * 

(b) The approved information 

collection requirements contained in 

this part appear in § § 31.5, 31.8, 31.11, 

and 31.12. 

* * * * * 

■ 20. In § 31.5, paragraphs (b)(1)(i), 

(b)(1)(ii), and (c)(13)(i) are revised and 

paragraph (b)(1)(iii) 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.2

* * * * * 

(b)(1) * * * 

(i) A specific license issued under 

§ 32.51 of this chapter; or 

(ii) An equivalent specific license 

issued by an Agreement State; or 


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1Sources generally licensed under this section 

before January 19, 1975, may bear labels authorized 

by the regulations in effect on January 1, 1975. 

Sources containing radium-226 generally licensed 

under this section and manufactured before 

November 30, 2007 shall be labeled in accordance 

with the applicable State regulations at the time of 

manufacture or import. 

(iii) An equivalent specific license 

issued by a State with provisions 

comparable to § 32.51 of this chapter. 

* * * * * 

(c) * * * 

(13)(i) Shall register, in accordance 

with paragraphs (c)(13)(ii) and (iii) of 

this section, devices containing at least 

370 megabecquerels (10 millicuries) of 

cesium-137, 3.7 megabecquerels (0.1 

millicurie) of strontium-90, 37 

megabecquerels (1 millicurie) of cobalt60, 3.7 megabecquerels (0.1 millicurie) 

of radium-226, or 37 megabecquerels (1 

millicurie) of americium-241 or any 

other transuranic (i.e., element with 

atomic number greater than uranium 

(92)), based on the activity indicated on 

the label. Each address for a location of 

use, as described under paragraph 

(c)(13)(iii)(D) of this section, represents 

a separate general licensee and requires 

a separate registration and fee. 

* * * * * 

■ 21. Section 31.8 is revised to read as 

follows: 

§ 31.8 Americium-241 and radium-226 in 

the form of calibration or reference sources. 

(a) A general license is issued to those 

persons listed in this section to own, 

receive, acquire, possess, use, and 

transfer, in accordance with the 

provisions of paragraphs (b) and (c) of 

this section, americium-241 or radium226 in the form of calibration or 

reference sources: 

(1) Any person in a non-Agreement 

State who holds a specific license 

issued under this chapter which 

authorizes receipt, possession, use, and 

transfer of byproduct material, source 

material, or special nuclear material; 

and 

(2) Any Government agency, as 

defined in § 30.4 of this chapter, which 

holds a specific license issued under 

this chapter which authorizes it to 

receive, possess, use, and transfer 

byproduct material, source material, or 

special nuclear material. 

(b) The general license in paragraph 

(a) of this section applies only to 

calibration or reference sources which 

have been manufactured or initially 

transferred in accordance with the 

specifications contained in a specific 

license issued under § 32.57 of this 

chapter or in accordance with the 

specifications contained in a specific 

license issued to the manufacturer by an 

Agreement State which authorizes 

manufacture of the sources for 

distribution to persons generally 

licensed by the Agreement State, or in 

accordance with a specific license 

issued by a State with comparable 

provisions to § 32.57. 

(c) The general license in paragraph 

(a) of this section is subject to the 

provisions of § § 30.14(d), 30.34 (a) to 

(e), and 30.50 to 30.63 of this chapter, 

and to the provisions of parts 19, 20, 

and 21, of this chapter. In addition, 

persons who own, receive, acquire, 

possess, use, and transfer one or more 

calibration or reference sources under 

this general license: 

(1) Shall not possess at any one time, 

at any one location of storage or use, 

more than 0.185 megabecquerel (5 

microcuries) of americium-241 or 0.185 

megabecquerel (5 microcuries) of 

radium-226 in such sources; 

(2) Shall not receive, possess, use, or 

transfer a source unless the source, or 

the storage container, bears a label 

which includes the following statement 

or a substantially similar statement 

which contains the information called 

for in the following statement: 1

The receipt, possession, use, and 

transfer of this source, Model XX, Serial 

No. XX, are subject to a general license 

and the regulations of the United States 

Nuclear Regulatory Commission or of a 

State with which the Commission has 

entered into an agreement for the 

exercise of regulatory authority. Do not 

remove this label. 

CAUTION—RADIOACTIVE 

MATERIAL—THIS SOURCE 

CONTAINS AMERICIUM–241 [or 

RADIUM–226, as appropriate]. DO NOT 

TOUCH RADIOACTIVE PORTION OF 

THIS SOURCE. 

lllllllllllllllllll

(Name of manufacturer or initial 

transferor) 

(3) Shall not transfer, abandon, or 

dispose of a source except by transfer to 

a person authorized by a license issued 

under this chapter or by an Agreement 

State to receive the source. 

(4) Shall store a source, except when 

the source is being used, in a closed 

container adequately designed and 

constructed to contain americium-241 

or radium-226 which might otherwise 

escape during storage. 

(5) Shall not use a source for any 

purpose other than the calibration of 

radiation detectors or the 

standardization of other sources. 

(d) This general license does not 

authorize the manufacture or import of 

calibration or reference sources 

containing americium-241 or radium226. 

(e) This general license does not 

authorize the export of calibration or 

reference sources containing americium241 or radium-226. 

■ 22. In § 31.11, paragraph (a)(8) is 

added, and paragraphs (c)(1) and (d)(1) 

are revised to read as follows: 

§ 31.11 General license for use of 

byproduct material for certain in vitro 

clinical or laboratory testing. 

(a) * * * 

(8) Cobalt-57, in units not exceeding 

0.37 megabecquerel (10 microcuries) 

each for use in in vitro clinical or 

laboratory tests not involving internal or 

external administration of byproduct 

material, or the radiation therefrom, to 

human beings or animals. 

* * * * * 

(c) * * * 

(1) The general licensee shall not 

possess at any one time, under the 

general license in paragraph (a) of this 

section, at any one location of storage or 

use, a total amount of iodine-125, 

iodine-131, selenium-75, cobalt-57 and/ 

or iron-59 in excess of 7.4 

megabecquerels (200 microcuries). 

* * * * * 

(d) * * * 

(1) Except as prepackaged units which 

are labeled in accordance with the 

provisions of a specific license issued 

under the provisions of § 32.71 of this 

chapter or in accordance with the 

provisions of a specific license issued 

by an Agreement State, or before 

November 30, 2007, and the provisions 

of a specific license issued by a State 

with comparable provisions to § 32.71 

that authorize manufacture and 

distribution of iodine-125, iodine-131, 

carbon-14, hydrogen-3 (tritium), 

selenium-75, iron-59, cobalt-57, or Mock 

Iodine-125 for distribution to persons 

generally licensed by the Agreement 

State or the State with comparable 

provisions to § 32.71. 

* * * * * 

§ § 31.12, 31.13, and 31.14 [Redesignated] 

■ 23. Sections 31.12, 31.13, and 31.14 

are redesignated as § 31.21, § 31.22, and 

§ 31.23, respectively, § § 31.13 through 

31.20 are reserved, and a new § 31.12 is 

added to read as follows: 

§ 31.12 General license for certain items 

and self-luminous products containing 

radium-226. 

(a) A general license is hereby issued 

to any person to acquire, receive, 

possess, use, or transfer, in accordance 

with the provisions of paragraphs (b), 

(c), and (d) of this section, radium-226 

contained in the following products 


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55928 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 

manufactured prior to November 30, 

2007. 

(1) Antiquities originally intended for 

use by the general public. For the 

purposes of this paragraph, antiquities 

mean products originally intended for 

use by the general public and 

distributed in the late 19th and early 

20th centuries, such as radium emanator 

jars, revigators, radium water jars, radon 

generators, refrigerator cards, radium 

bath salts, and healing pads. 

(2) Intact timepieces containing 

greater than 0.037 megabecquerel (1 

microcurie), nonintact timepieces, and 

timepiece hands and dials no longer 

installed in timepieces. 

(3) Luminous items installed in air, 

marine, or land vehicles. 

(4) All other luminous products, 

provided that no more than 100 items 

are used or stored at the same location 

at any one time. 

(5) Small radium sources containing 

no more than 0.037 megabecquerel (1 

microcurie) of radium-226. For the 

purposes of this paragraph, ‘‘small 

radium sources’’ means discrete survey 

instrument check sources, sources 

contained in radiation measuring 

instruments, sources used in 

educational demonstrations (such as 

cloud chambers and spinthariscopes), 

electron tubes, lightning rods, ionization 

sources, static eliminators, or as 

designated by the NRC. 

(b) Persons who acquire, receive, 

possess, use, or transfer byproduct 

material under the general license 

issued in paragraph (a) of this section 

are exempt from the provisions of 10 

CFR parts 19, 20, and 21, and § 30.50 

and 30.51 of this chapter, to the extent 

that the receipt, possession, use, or 

transfer of byproduct material is within 

the terms of the general license; 

provided, however, that this exemption 

shall not be deemed to apply to any 

such person specifically licensed under 

this chapter. 

(c) Any person who acquires, 

receives, possesses, uses, or transfers 

byproduct material in accordance with 

the general license in paragraph (a) of 

this section: 

(1) Shall notify the NRC should there 

be any indication of possible damage to 

the product so that it appears it could 

result in a loss of the radioactive 

material. A report containing a brief 

description of the event, and the 

remedial action taken, must be 

furnished to the Director of the Office of 

Federal and State Materials and 

Environmental Management Programs, 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555–0001 within 30 

days. 

(2) Shall not abandon products 

containing radium-226. The product, 

and any radioactive material from the 

product, may only be disposed of 

according to § 20.2008 of this chapter or 

by transfer to a person authorized by a 

specific license to receive the radium226 in the product or as otherwise 

approved by the NRC. 

(3) Shall not export products 

containing radium-226 except in 

accordance with part 110 of this 

chapter. 

(4) Shall dispose of products 

containing radium-226 at a disposal 

facility authorized to dispose of 

radioactive material in accordance with 

any Federal or State solid or hazardous 

waste law, including the Solid Waste 

Disposal Act, as authorized under the 

Energy Policy Act of 2005, by transfer to 

a person authorized to receive radium226 by a specific license issued under 

part 30 of this chapter, or equivalent 

regulations of an Agreement State, or as 

otherwise approved by the NRC. 

(5) Shall respond to written requests 

from the NRC to provide information 

relating to the general license within 30 

calendar days of the date of the request, 

or other time specified in the request. If 

the general licensee cannot provide the 

requested information within the 

allotted time, it shall, within that same 

time period, request a longer period to 

supply the information by providing the 

Director of the Office of Federal and 

State Materials and Environmental 

Management Programs, by an 

appropriate method listed in § 30.6(a) of 

this chapter, a written justification for 

the request. 

(d) The general license in paragraph 

(a) of this section does not authorize the 

manufacture, assembly, disassembly, 

repair, or import of products containing 

radium-226, except that timepieces may 

be disassembled and repaired. 

PART 32—SPECIFIC DOMESTIC 

LICENSES TO MANUFACTURE OR 

TRANSFER CERTAIN ITEMS 

CONTAINING BYPRODUCT MATERIAL 

■ 24. The authority citation for part 32 

is revised to read as follows: 

Authority: Secs. 81, 161, 182, 183, 68 Stat. 

935, 948, 953, 954, as amended (42 U.S.C. 

2111, 2201, 2232, 2233); sec. 201, 88 Stat. 

1242, as amended (42 U.S.C. 5841); sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec. 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021b, 2111). 

■ 25. In § 32.1, paragraph (c) is added to 

read as follows: 

§ 32.1 Purpose and scope. 

* * * * * 

(c)(1) The requirements in this part, 

including provisions that are specific to 

licensees, shall apply to Government 

agencies and Federally recognized 

Indian Tribes with respect to 

accelerator-produced radioactive 

material or discrete sources of radium226 on November 30, 2007 except that 

the agency or tribe may continue to 

manufacture or initially transfer items 

containing accelerator-produced 

radioactive material or discrete sources 

of radium-226 for sale or distribution to 

persons exempted from the licensing 

requirements of part 30 of this chapter, 

and to persons generally licensed under 

part 31 of this chapter, and radioactive 

drugs and sources and devices to 

medical use licensees, until the date of 

the NRC’s final licensing determination, 

provided that the agency or tribe 

submits a new license application for 

these activities on or before December 1, 

2008 or an amendment application for 

these activities on or before June 2, 

2008. 

(2) The requirements in this part, 

including provisions that are specific to 

licensees, shall apply to all persons 

other than those included in paragraph 

(c)(1) of this section with respect to 

accelerator-produced radioactive 

material or discrete sources of radium226 on August 8, 2009, or earlier as 

noticed by the NRC, except that these 

persons may continue to manufacture or 

initially transfer items containing 

accelerator-produced radioactive 

material or discrete sources of radium226 for sale or distribution to persons 

exempted from the licensing 

requirements of part 30 of this chapter, 

and to persons generally licensed under 

part 31 of this chapter, and to sell or 

manufacture radioactive drugs and 

sources and devices to medical use 

licensees until the date of the NRC’s 

final licensing determination, provided 

that the person submits a license 

application within 12 months from the 

waiver expiration date of August 7, 2009 

or within 12 months from the date of an 

earlier termination of the waiver as 

noticed by the NRC, whichever is 

earlier; or that the person submits an 

amendment request within 6 months 

from the waiver expiration date of 

August 7, 2009 or within 6 months from 

the date of an earlier termination of the 

waiver as noticed by the NRC, 

whichever date is earlier. 

■ 26. In § 32.57, the heading and the 

introductory text are revised to read as 

follows: 


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1Sources licensed under § 32.57 before January 

19, 1975, may bear labels authorized by the 

regulations in effect on January 1, 1975. 

§ 32.57 Calibration or reference sources 

containing americium-241 or radium-226: 

Requirements for license to manufacture or 

initially transfer. 

An application for a specific license 

to manufacture or initially transfer 

calibration or reference sources 

containing americium-241 or radium226, for distribution to persons 

generally licensed under § 31.8 of this 

chapter, will be approved if: 

* * * * * 

■ 27. Section 32.58 is revised to read as 

follows: 

§ 32.58 Same: Labeling of devices. 

Each person licensed under § 32.57 

shall affix to each source, or storage 

container for the source, a label which 

shall contain sufficient information 

relative to safe use and storage of the 

source and shall include the following 

statement or a substantially similar 

statement which contains the 

information called for in the following 

statement: 1

The receipt, possession, use, and 

transfer of this source, Model , Serial 

No., are subject to a general license and 

the regulations of the United States 

Nuclear Regulatory Commission or of a 

State with which the Commission has 

entered into an agreement for the 

exercise of regulatory authority. Do not 

remove this label. 

CAUTION-RADIOACTIVE MATERIAL–THIS 

SOURCE CONTAINS AMERICIUM-241 (or 

RADIUM-226). DO NOT TOUCH 

RADIOACTIVE PORTION OF THIS SOURCE 

lllllllllllllllllllll

(Name of manufacturer or initial transferor) 

■ 28. Section 32.59 is revised to read as 

follows: 

§ 32.59 Same: Leak testing of each source. 

Each person licensed under § 32.57 

shall perform a dry wipe test upon each 

source containing more than 3.7 

kilobecquerels (0.1 microcurie) of 

americium-241 or radium-226 before 

transferring the source to a general 

licensee under § 31.8 of this chapter. 

This test shall be performed by wiping 

the entire radioactive surface of the 

source with a filter paper with the 

application of moderate finger pressure. 

The radioactivity on the paper shall be 

measured by using radiation detection 

instrumentation capable of detecting 

0.185 kilobecquerel (0.005 microcurie) 

of americium-241 or radium-226. If this 

test discloses more than 0.185 

kilobecquerel (0.005 microcurie) of 

radioactive material, the source shall be 

deemed to be leaking or losing 

americium-241 or radium-226 and shall 

not be transferred to a general licensee 

under § 31.8 of this chapter or 

equivalent regulations of an Agreement 

State. 

■ 29. In § 32.71, paragraph (b)(8) is 

added, and paragraph (c)(1) is revised to 

read as follows: 

§ 32.71 Manufacture and distribution of 

byproduct material for certain in vitro 

clinical or laboratory testing under general 

license. 

* * * * * 

(b) * * * 

(8) Cobalt-57 in units not exceeding 

0.37 megabecquerel (10 microcuries) 

each. 

(c) * * * 

(1) Identifying the radioactive 

contents as to chemical form and 

radionuclide, and indicating that the 

amount of radioactivity does not exceed 

0.37 megabecquerel (10 microcuries) of 

iodine-131, iodine-125, selenium-75, or 

carbon-14; 1.85 megabecquerels (50 

microcuries) of hydrogen-3 (tritium); or 

0.74 megabecquerel (20 microcuries) of 

iron-59; or Mock Iodine-125 in units not 

exceeding 1.85 kilobecquerels (0.05 

microcurie) of iodine-129 and 0.185 

kilobecquerel (0.005 microcurie) of 

americium-241 each; or cobalt-57 in 

units not exceeding 0.37 megabecquerel 

(10 microcuries); and 

* * * * * 

■ 30. In § 32.72, paragraphs (a)(2)(i), 

(a)(2)(iii), (a)(2)(iv), (b)(2)(ii), (b)(4), and 

(b)(5) are revised, and a new paragraph 

(a)(2)(v) is added to read as follows: 

§ 32.72 Manufacture, preparation, or 

transfer for commercial distribution of 

radioactive drugs containing byproduct 

material for medical use under part 35. 

(a) * * * 

(2) * * * 

(i) Registered with the U.S. Food and 

Drug Administration (FDA) as the 

owner or operator of a drug 

establishment that engages in the 

manufacture, preparation, propagation, 

compounding, or processing of a drug 

under 21 CFR 207.20(a); 

* * * * * 

(iii) Licensed as a pharmacy by a State 

Board of Pharmacy; 

(iv) Operating as a nuclear pharmacy 

within a Federal medical institution; or 

(v) A Positron Emission Tomography 

(PET) drug production facility registered 

with a State agency. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) This individual meets the 

requirements specified in § 35.55(b) and 

35.59 of this chapter, and the licensee 

has received an approved license 

amendment identifying this individual 

as an authorized nuclear pharmacist; or 

* * * * * 

(4) May designate a pharmacist (as 

defined in § 35.2 of this chapter) as an 

authorized nuclear pharmacist if: 

(i) The individual was a nuclear 

pharmacist preparing only radioactive 

drugs containing accelerator-produced 

radioactive material, and 

(ii) The individual practiced at a 

pharmacy at a Government agency or 

Federally recognized Indian Tribe 

before November 30, 2007 or at all other 

pharmacies before August 8, 2009, or an 

earlier date as noticed by the NRC. 

(5) Shall provide to the Commission: 

(i) A copy of each individual’s 

certification by a specialty board whose 

certification process has been 

recognized by the Commission or an 

Agreement State as specified in 

§ 35.55(a) of this chapter with the 

written attestation signed by a preceptor 

as required by § 35.55(b)(2) of this 

chapter; or 

(ii) The Commission or Agreement 

State license, or 

(iii) Commission master materials 

licensee permit, or 

(iv) The permit issued by a licensee or 

Commission master materials permittee 

of broad scope or the authorization from 

a commercial nuclear pharmacy 

authorized to list its own authorized 

nuclear pharmacist, or 

(v) Documentation that only 

accelerator-produced radioactive 

materials were used in the practice of 

nuclear pharmacy at a Government 

agency or Federally recognized Indian 

Tribe before November 30, 2007 or at all 

other locations of use before August 8, 

2009, or an earlier date as noticed by the 

NRC; and 

(vi) A copy of the State pharmacy 

licensure or registration, no later than 

30 days after the date that the licensee 

allows, under paragraphs (b)(2)(i) and 

(b)(2)(iii) of this section, the individual 

to work as an authorized nuclear 

pharmacist. 

* * * * * 

■ 31. In § 32.102, the heading and the 

introductory paragraph are revised to 

read as follows: 

§ 32.102 Schedule C—prototype tests for 

calibration or reference sources containing 

americium-241 or radium-226. 

An applicant for a license under 

§ 32.57 shall, for any type of source 

which is designed to contain more than 

0.185 kilobecquerel (0.005 microcurie) 

of americium-241 or radium-226, 

conduct prototype tests, in the order 

listed, on each of five prototypes of the 

source, which contains more than 0.185 


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kilobecquerel (0.005 microcurie) of 

americium-241 or radium-226, as 

follows: 

* * * * * 

PART 33—SPECIFIC DOMESTIC 

LICENSES OF BROAD SCOPE FOR 

BYPRODUCT MATERIAL 

■ 32. The authority citation for part 33 

is revised to read as follows: 

Authority: Secs. 81, 161, 182, 183, 68 Stat. 

935, 948, 953, 954, as amended (42 U.S.C. 

2111, 2201, 2232, 2233); sec. 201, 88 Stat. 

1242, as amended (42 U.S.C. 5841); sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec. 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021b, 2111). 

■ 33. Section 33.100 is amended by 

adding Beryllium-7, Cobalt-57, Radium226, and Sodium-22 in alphabetical 

order to read as follows: 

§ 33.100 Schedule A. 

Byproduct material Col. I curies Col. II curies 

* * * * * * * 

Beryllium-7 ........................................................................................................................................................... 10 0 .1 

* * * * * * * 

Cobalt-57 .............................................................................................................................................................. 10 0 .1 

* * * * * * * 

Radium-226 .......................................................................................................................................................... 0 .01 0 .0001 

* * * * * * * 

Sodium-22 ............................................................................................................................................................ 0 .1 0 .001 

* * * * * 

PART 35—MEDICAL USE OF 

BYPRODUCT MATERIAL 

■ 34. The authority citation for part 35 

is revised to read as follows: 

Authority: Secs. 81, 161, 182, 183, 68 Stat. 

935, 948, 953, 954, as amended (42 U.S.C. 

2111, 2201, 2232, 2233); sec. 201, 88 Stat. 

1242, as amended (42 U.S.C. 5841); sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec. 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021b, 2111). 

■ 35. In § 35.2, new definitions for 

Cyclotron and Positron Emission 

Tomography (PET) radionuclide 

production facility are added 

alphabetically to read as follows: 

§ 35.2 Definitions. 

* * * * * 

Cyclotron means a particle accelerator 

in which the charged particles travel in 

an outward spiral or circular path. A 

cyclotron accelerates charged particles 

at energies usually in excess of 10 

megaelectron volts and is commonly 

used for production of short half-life 

radionuclides for medical use. 

* * * * * 

Positron Emission Tomography (PET) 

radionuclide production facility is 

defined as a facility operating a 

cyclotron or accelerator for the purpose 

of producing PET radionuclides. 

* * * * * 

■ 36. In § 35.10, paragraph (a) is added 

to read as follows: 

§ 35.10 Implementation. 

(a) A Government agency or a 

Federally recognized Indian Tribe that 

possesses and uses accelerator-produced 

radioactive material or discrete sources 

of radium-226 for which a specific 

medical use license is required by the 

Atomic Energy Act of 1954, as amended, 

must comply with the requirements of 

this part, including provisions that are 

specific to licensees, on November 30, 

2007. All other persons who possess 

and use accelerator-produced 

radioactive material or discrete sources 

of radium-226 for which a specific 

medical use license is required, must 

comply with the requirements of this 

part, including provisions that are 

specific to licensees, on August 8, 2009, 

or earlier as noticed by the NRC. 

* * * * * 

■ 37. In § 35.11, paragraph (a) is revised, 

and paragraph (c) is added to read as 

follows: 

§ 35.11 License required. 

(a) A person may manufacture, 

produce, acquire, receive, possess, 

prepare, use, or transfer byproduct 

material for medical use only in 

accordance with a specific license 

issued by the Commission or an 

Agreement State, or as allowed in 

paragraph (b) or (c) of this section. 

* * * * * 

(c)(1) A Government agency or a 

Federally recognized Indian Tribe, that 

possesses and uses accelerator-produced 

radioactive material or discrete sources 

of radium-226 for which a specific 

medical use license is required in 

paragraph (a) of this section, may 

continue to use such materials for 

medical uses until the date of the NRC’s 

final licensing determination, provided 

that the person submits a medical use 

license application on or before 

December 1, 2008. 

(2) Except as provided in paragraph 

(c)(1) of this section, all other persons, 

who possess and use acceleratorproduced radioactive material or 

discrete sources of radium-226 for 

which a specific medical use license is 

required in paragraph (a) of this section, 

may continue to use this type of 

material for medical uses permitted 

under this part until the date of the 

NRC’s final licensing determination, 

provided that the person submits a 

medical use license application within 

12 months from the waiver expiration 

date of August 7, 2009 or within 12 

months from the date of an earlier 

termination of the waiver as noticed by 

the NRC, whichever date is earlier. 

■ 38. In § 35.13, paragraphs (a) and (e) 

are revised, and paragraph (b)(5) is 

added to read as follows: 

§ 35.13 License amendments. 

* * * * * 

(a) Before it receives, prepares, or uses 

byproduct material for a type of use that 

is permitted under this part, but is not 

authorized on the licensee’s current 

license issued under this part; except 

that—

(1) A Government agency or a 

Federally recognized Indian Tribe 

licensee who possesses and uses 

accelerator-produced radioactive 

material or discrete sources of radium226 may continue to use such material 

for medical uses permitted under this 

part until the date of the NRC’s final 

licensing determination, provided that 


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Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 55931 

the licensee submits an amendment 

application on or before June 2, 2008. 

(2) Except as provided in paragraph 

(a)(1) of this section, all other licensees 

who possess and use acceleratorproduced radioactive material or 

discrete sources of radium-226 may 

continue to use those materials for 

medical uses permitted under this part 

until the date of the NRC’s final 

licensing determination, provided that 

the person submits a medical use 

license amendment request within 6 

months from the waiver expiration date 

of August 7, 2009 or within 6 months 

from the date of an earlier termination 

of the waiver as noticed by the NRC, 

whichever date is earlier. 

(b) * * * 

(5) A physician, podiatrist, or dentist 

who used only accelerator-produced 

radioactive materials, discrete sources of 

radium-226, or both, for medical uses or 

a nuclear pharmacist who used only 

accelerator-produced radioactive 

materials in the practice of nuclear 

pharmacy at a Government agency or 

Federally recognized Indian Tribe 

before November 30, 2007 or at all other 

locations of use before August 8, 2009, 

or an earlier date as noticed by the NRC, 

and for only those materials and uses 

performed before these dates. 

* * * * * 

(e) Before it adds to or changes the 

areas of use identified in the application 

or on the license, including areas used 

in accordance with either § 35.100 or 

§ 35.200 if the change includes addition 

or relocation of either an area where 

PET radionuclides are produced or a 

PET radioactive drug delivery line from 

the PET radionuclide/PET radioactive 

drug production area. Other areas of use 

where byproduct material is used only 

in accordance with either § 35.100 or 

§ 35.200 are exempt; 

* * * * * 

■ 39. In § 35.14, the introductory text of 

paragraph (a) and paragraph (b)(5) are 

revised to read as follows: 

§ 35.14 Notifications. 

(a) A licensee shall provide the 

Commission a copy of the board 

certification and the written 

attestation(s), signed by a preceptor, the 

Commission or Agreement State license, 

the permit issued by a Commission 

master material licensee, the permit 

issued by a Commission or Agreement 

State licensee of broad scope, the permit 

issued by a Commission master material 

license broad scope permittee, or 

documentation that only acceleratorproduced radioactive materials, discrete 

sources of radium-226, or both, were 

used for medical use or in the practice 

of nuclear pharmacy at a Government 

agency or Federally recognized Indian 

Tribe before November 30, 2007 or at all 

other locations of use before August 8, 

2009, or an earlier date as noticed by the 

NRC, and for each individual no later 

than 30 days after the date that the 

licensee permits the individual to work 

as an authorized user, an authorized 

nuclear pharmacist, or an authorized 

medical physicist, under § 35.13(b). For 

individuals permitted to work under 

§ 35.13(b)(4), within the same 30-day 

time frame, the licensee shall also 

provide, as appropriate, verification of 

completion of; 

* * * * * 

(b) * * * 

(5) The licensee has added to or 

changed the areas of use identified in 

the application or on the license where 

byproduct material is used in 

accordance with either § 35.100 or 

§ 35.200 if the change does not include 

addition or relocation of either an area 

where PET radionuclides are produced 

or a PET radioactive drug delivery line 

from the PET radionuclide/PET 

radioactive drug production area. 

* * * * * 

■ 40. In § 35.15, paragraph (f) is revised 

to read as follows: 

§ 35.15 Exemptions regarding Type A 

specific licenses of broad scope. 

* * * * * 

(f) The provisions of § 35.14(b)(5). 

* * * * * 

■ 41. In § 35.57, paragraphs (a)(3) and 

(b)(3) are added to read as follows: 

§ 35.57 Training for experienced Radiation 

Safety Officer, teletherapy or medical 

physicist, authorized medical physicist, 

authorized user, nuclear pharmacist, and 

authorized nuclear pharmacist. 

(a) * * * 

(3) A Radiation Safety Officer, a 

medical physicist, or a nuclear 

pharmacist, who used only acceleratorproduced radioactive materials, discrete 

sources of radium-226, or both, for 

medical uses or in the practice of 

nuclear pharmacy at a Government 

agency or Federally recognized Indian 

Tribe before November 30, 2007 or at all 

other locations of use before August 8, 

2009, or an earlier date as noticed by the 

NRC, need not comply with the training 

requirements of § 35.50, § 35.51 or 

§ 35.55, respectively, when performing 

the same uses. A nuclear pharmacist, 

who prepared only radioactive drugs 

containing accelerator-produced 

radioactive materials, or a medical 

physicist, who used only acceleratorproduced radioactive materials, at the 

locations and time period identified in 

this paragraph, qualifies as an 

authorized nuclear pharmacist or an 

authorized medical physicist, 

respectively, for those materials and 

uses performed before these dates, for 

purposes of this chapter. 

(b) * * * 

(3) Physicians, dentists, or podiatrists 

who used only accelerator-produced 

radioactive materials, discrete sources of 

radium-226, or both, for medical uses 

performed at a Government agency or 

Federally recognized Indian Tribe 

before November 30, 2007 or at all other 

locations of use before August 8, 2009, 

or an earlier date as noticed by the NRC, 

need not comply with the training 

requirements of subparts D through H of 

this part when performing the same 

medical uses. A physician, dentist, or 

podiatrist, who used only acceleratorproduced radioactive materials, discrete 

sources of radium-226, or both, for 

medical uses at the locations and time 

period identified in this paragraph, 

qualifies as an authorized user for those 

materials and uses performed before 

these dates, for purposes of this chapter. 

■ 42. In § 35.63, paragraphs (b)(2)(ii) 

and (c)(3) are revised, and paragraph 

(b)(2)(iii) is added to read as follows: 

§ 35.63 Determination of dosages of 

unsealed byproduct material for medical 

use. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) An NRC or Agreement State 

licensee for use in research in 

accordance with a Radioactive Drug 

Research Committee-approved protocol 

or an Investigational New Drug (IND) 

protocol accepted by FDA; or 

(iii) A PET radioactive drug producer 

licensed under § 30.32(j) of this chapter 

or equivalent Agreement State 

requirements. 

(c) * * * 

(3) Combination of volumetric 

measurements and mathematical 

calculations, based on the measurement 

made by: 

(i) A manufacturer or preparer 

licensed under § 32.72 of this chapter or 

equivalent Agreement State 

requirements; or 

(ii) A PET radioactive drug producer 

licensed under § 30.32(j) of this chapter 

or equivalent Agreement State 

requirements. 

* * * * * 

■ 43. In § 35.100, paragraph (a) and the 

introductory text of paragraph (b) are 

revised to read as follows: 

§ 35.100 Use of unsealed byproduct 

material for uptake, dilution, and excretion 

studies for which a written directive is not 

required. 

* * * * * 


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55932 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 

(a) Obtained from: 

(1) A manufacturer or preparer 

licensed under § 32.72 of this chapter or 

equivalent Agreement State 

requirements; or 

(2) A PET radioactive drug producer 

licensed under § 30.32(j) of this chapter 

or equivalent Agreement State 

requirements; or 

(b) Excluding production of PET 

radionuclides, prepared by: 

* * * * * 

■ 44. In § 35.200, paragraph (a) and the 

introductory text of paragraph (b) are 

revised to read as follows: 

§ 35.200 Use of unsealed byproduct 

material for imaging and localization 

studies for which a written directive is not 

required. 

* * * * * 

(a) Obtained from: 

(1) A manufacturer or preparer 

licensed under § 32.72 of this chapter or 

equivalent Agreement State 

requirements; or 

(2) A PET radioactive drug producer 

licensed under § 30.32(j) of this chapter 

or equivalent Agreement State 

requirements; or 

(b) Excluding production of PET 

radionuclides, prepared by: 

* * * * * 

■ 45. In § 35.204, the heading and 

paragraph (a) are revised, paragraph (c) 

is redesignated as (d) and revised, and 

a new paragraph (c) is added to read as 

follows: 

§ 35.204 Permissible molybdenum-99, 

strontium-82, and strontium-85 

concentrations. 

(a) A licensee may not administer to 

humans a radiopharmaceutical that 

contains: 

(1) More than 0.15 kilobecquerel of 

molybdenum-99 per megabecquerel of 

technetium-99m (0.15 microcurie of 

molybdenum-99 per millicurie of 

technetium-99m); or 

(2) More than 0.02 kilobecquerel of 

strontium-82 per megabecquerel of 

rubidium-82 chloride injection (0.02 

microcurie of strontium-82 per 

millicurie of rubidium-82 chloride); or 

more than 0.2 kilobecquerel of 

strontium-85 per megabecquerel of 

rubidium-82 chloride injection (0.2 

microcurie of strontium-85 per 

millicurie of rubidium-82). 

* * * * * 

(c) A licensee that uses a strontium82/rubidium-82 generator for preparing 

a rubidium-82 radiopharmaceutical 

shall, before the first patient use of the 

day, measure the concentration of 

radionuclides strontium-82 and 

strontium-85 to demonstrate compliance 

with paragraph (a) of this section. 

(d) If a licensee is required to measure 

the molybdenum-99 concentration or 

strontium-82 and strontium-85 

concentrations, the licensee shall retain 

a record of each measurement in 

accordance with § 35.2204. 

■ 46. In § 35.300, paragraph (a) and the 

introductory text of paragraph (b) are 

revised to read as follows: 

§ 35.300 Use of unsealed byproduct 

material for which a written directive is 

required. 

* * * * * 

(a) Obtained from: 

(1) A manufacturer or preparer 

licensed under § 32.72 of this chapter or 

equivalent Agreement State 

requirements; or 

(2) A PET radioactive drug producer 

licensed under § 30.32(j) of this chapter 

or equivalent Agreement State 

requirements; or 

(b) Excluding production of PET 

radionuclides, prepared by: 

■ 47. Section 35.2204 is revised to read 

as follows: 

§ 35.2204 Records of molybdenum-99, 

strontium-82, and strontium-85 

concentrations. 

A licensee shall maintain a record of 

the molybdenum-99 concentration or 

strontium-82 and strontium-85 

concentration tests required by 

§ 35.204(b) and (c) for 3 years. The 

record must include: 

(a) For each measured elution of 

technetium-99m, the ratio of the 

measures expressed as kilobecquerel of 

molybdenum-99 per megabecquerel of 

technetium-99m (or microcuries of 

molybdenum per millicurie of 

technetium), the time and date of the 

measurement, and the name of the 

individual who made the measurement; 

or 

(b) For each measured elution of 

rubidium-82, the ratio of the measures 

expressed as kilobecquerel of strontium82 per megabecquerel of rubidium-82 

(or microcuries of strontium-82 per 

millicurie of rubidium), kilobecquerel of 

strontium-85 per megabecquerel of 

rubidium-82 (or microcuries of 

strontium-85 per millicurie of 

rubidium), the time and date of the 

measurement, and the name of the 

individual who made the measurement. 

PART 50—DOMESTIC LICENSING OF 

PRODUCTION AND UTILIZATION 

FACILITIES 

■ 48. The authority citation for part 50 

is revised to read as follows: 

Authority: Secs. 102, 103, 104, 161, 182, 

183, 186, 189, 68 Stat. 936, 937, 938, 948, 

953, 954, 955, 956, as amended, sec. 234, 83 

Stat. 444, as amended (42 U.S.C. 2132, 2133, 

2134, 2135, 2201, 2232, 2233, 2236, 2239, 

2282); secs. 201, as amended, 202, 206, 88 

Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 

5841, 5842, 5846); sec. 1704, 112 Stat. 2750 

(44 U.S.C. 3504 note); sec. 651(e), Pub. L. 

109–58, 119 Stat. 806–810 (42 U.S.C. 2014, 

2021, 2021b, 2111). Section 50.7 also issued 

under Pub. L. 95–601, sec. 10, 92 Stat. 2951 

(42 U.S.C. 5841). Section 50.10 also issued 

under secs. 101, 185, 68 Stat. 955, as 

amended (42 U.S.C. 2131, 2235); sec. 102, 

Pub. L. 91–190, 83 Stat. 853 (42 U.S.C. 4332). 

Sections 50.13, 50.54(dd), and 50.103 also 

issued under sec. 108, 68 Stat. 939, as 

amended (42 U.S.C. 2138). 

Sections 50.23, 50.35, 50.55, and 50.56 also 

issued under sec. 185, 68 Stat. 955 (42 U.S.C. 

2235). Sections 50.33a, 50.55a and Appendix 

Q also issued under sec. 102, Pub. L. 91–190, 

83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 

and 50.54 also issued under sec. 204, 88 Stat. 

1245 (42 U.S.C. 5844). Sections 50.58, 50.91, 

and 50.92 also issued under Pub. L. 97–415, 

96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 

also issued under sec. 122, 68 Stat. 939 (42 

U.S.C. 2152). Sections 50.80–50.81 also 

issued under sec. 184, 68 Stat. 954, as 

amended (42 U.S.C. 2234). Appendix F also 

issued under sec. 187, 68 Stat. 955 (42 U.S.C. 

2237). 

■ 49. In § 50.2, the definition of 

Byproduct material is revised to read as 

follows: 

§ 50.2 Definitions. 

* * * * * 

Byproduct material means—

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2)(i) Any discrete source of radium226 that is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—

(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(3) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium-226 to the public health and 

safety or the common defense and 

security; and 


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Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 55933 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

PART 61—LICENSING 

REQUIREMENTS FOR LAND 

DISPOSAL OF RADIOACTIVE WASTE 

■ 50. The authority citation for part 61 

is revised to read as follows: 

Authority: Secs. 53, 57, 62, 63, 65, 81, 161, 

182, 183, 68 Stat. 930, 932, 933, 935, 948, 

953, 954, as amended (42 U.S.C. 2073, 2077, 

2092, st2093, 2095, 2111, 2201, 2232, 2233); 

secs. 202, 206, 88 Stat. 1244, 1246 (42 U.S.C. 

5842, 5846); secs. 10 and 14, Pub. L. 95–601, 

92 Stat. 2951 (42 U.S.C. 2021a and 5851) and 

Pub. L. 102–486, sec. 2902, 106 Stat. 3123, 

(42 U.S.C. 5851); sec. 1704, 112 Stat. 2750 (44 

U.S.C. 3504 note); sec. 651(e), Pub. L. 109–

58, 119 Stat. 806–810 (42 U.S.C. 2014, 2021, 

2021b, 2111). 

■ 51. In § 61.2, the definition for Waste 

is revised to read as follows: 

§ 61.2 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 § 20.1003 of this chapter. 

PART 62—CRITERIA AND 

PROCEDURES FOR EMERGENCY 

ACCESS TO NON-FEDERAL AND 

REGIONAL LOW-LEVEL WASTE 

DISPOSAL FACILITIES 

■ 52. The authority citation for part 62 

is revised to read as follows: 

Authority: Secs. 81, 161, as amended, 68 

Stat. 935, 948, 950, 951, as amended (42 

U.S.C. 211, 2201; secs. 201, 209, as amended, 

88 Stat. 1242, 1248, as amended (42 U.S.C. 

5841, 5849); secs. 3, 4, 5, 6, 99 Stat. 1843, 

1844, 1845, 1846, 1847, 1848, 1849, 1850, 

1851, 1852, 1853, 1854, 1855, 1856, 1857 (42 

U.S.C. 2021c, 2021d, 2021e, 2021f; sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec. 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021b, 2111). 

■ 53. In § 62.2, the definition for Lowlevel radioactive waste (LLW) is revised 

to read as follows: 

§ 62.2 Definitions. 

* * * * * 

Low-level radioactive waste (LLW) 

means radioactive material that—

(1) Is not high-level radioactive 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); and 

(2) The NRC, consistent with existing 

law and in accordance with paragraph 

(1) of this definition, classifies as lowlevel radioactive waste. 

* * * * * 

PART 72—LICENSING 

REQUIREMENTS FOR THE 

INDEPENDENT STORAGE OF SPENT 

NUCLEAR FUEL, HIGH–LEVEL 

RADIOACTIVE WASTE AND 

REACTOR-RELATED GREATER THAN 

CLASS C WASTE 

■ 54. The authority citation for part 72 

continues to read as follows: 

Authority: Secs. 51, 53, 57, 62, 63, 65, 69, 

81, 161, 182, 183, 184, 186, 187, 189, 68 Stat. 

929, 930, 932, 933, 934, 935, 948, 953, 954, 

955, as amended, sec. 234, 83 Stat. 444, as 

amended (42 U.S.C. 2071, 2073, 2077, 2092, 

2093, 2095, 2099, 2111, 2201, 2232, 2233, 

2234, 2236, 2237, 2238, 2282); sec. 274, Pub. 

L. 86–373, 73 Stat. 688, as amended (42 

U.S.C. 2021); sec. 201, as amended, 202, 206, 

88 Stat. 1242, as amended, 1244, 1246 (42 

U.S.C. 5841, 5842, 5846); Pub. L. 95–601, sec. 

10, 92 Stat. 2951 as amended by Pub. L. 102–

486, sec. 7902, 106 Stat. 3123 (42 U.S.C. 

5851); sec. 102, Pub. L. 91–190, 83 Stat. 853 

(42 U.S.C. 4332); secs. 131, 132, 133, 135, 

137, 141, Pub. L. 97–425, 96 Stat. 2229, 2230, 

2232, 2241, sec. 148, Pub. L. 100–203, 101 

Stat. 1330–235 (42 U.S.C. 10151, 10152, 

10153, 10155, 10157, 10161, 10168); sec. 

1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 

sec. 651(e), Pub. L. 109–58, 119 Stat. 806–810 

(42 U.S.C. 2014, 2021, 2021b, 2111). 

Section 72.44(g) also issued under secs. 

142(b) and 148(c), (d), Pub. L. 100–203, 101 

Stat. 1330–232, 1330–236 (42 U.S.C. 

10162(b), 10168(c), (d)). Section 72.46 also 

issued under sec. 189, 68 Stat. 955 (42 U.S.C. 

2239); sec. 134, Pub. L. 97–425, 96 Stat. 2230 

(42 U.S.C. 10154). Section 72.96(d) also 

issued under sec. 145(g), Pub. L. 100–203, 

101 Stat. 1330–235 (42 U.S.C. 10165(g)). 

Subpart J also issued under secs. 2(2), 2(15), 

2(19), 117(a), 141(h), Pub. L. 97–425, 96 Stat. 

2202, 2203, 2204, 2222, 2224 (42 U.S.C. 

10101, 10137(a), 10161(h)). Subparts K and L 

are also issued under sec. 133, 98 Stat. 2230 

(42 U.S.C. 10153) and sec. 218(a), 96 Stat. 

2252 (42 U.S.C. 10198). 

■ 55. In § 72.3, the definition for 

Byproduct material is revised to read as 

follows: 

§ 72.3 Definitions. 

* * * * * 

Byproduct material means—

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2)(i) Any discrete source of radium226 that is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—

(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(3) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium-226 to the public health and 

safety or the common defense and 

security; and 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

PART 110—EXPORT AND IMPORT OF 

NUCLEAR EQUIPMENT AND 

MATERIAL 

■ 56. The authority citation for part 110 

is revised to read as follows: 

Authority: Secs. 51, 53, 54, 57, 63, 64, 65, 

81, 82, 103, 104, 109, 111, 126, 127, 128, 129, 

161, 181, 182, 183, 187, 189, 68 Stat. 929, 

930, 931, 932, 933, 936, 937, 948, 953, 954, 

955, 956, as amended (42 U.S.C. 2071, 2073, 

2074, 2077, 2092–2095, 2111, 2112, 2133, 

2134, 2139, 2139a, 2141, 2154–2158, 2201, 

2231–2233, 2237, 2239); sec. 201, 88 Stat. 

1242, as amended (42 U.S.C. 5841; sec 5, 

Pub. L. 101–575, 104 Stat 2835 (42 

U.S.C.2243); sec. 1704, 112 Stat. 2750 (44 

U.S.C. 3504 note); Energy Policy Act of 2005; 

Pub. L. 109–58, 119 Stat. 594 (2005). 

Sections 110.1(b)(2) and 110.1(b)(3) also 

issued under Pub. L. 96–92, 93 Stat. 710 (22 

U.S.C. 2403). Section 110.11 also issued 

under sec. 122, 68 Stat. 939 (42 U.S.C. 2152) 

and secs. 54c and 57d., 88 Stat. 473, 475 (42 

U.S.C. 2074). Section 110.27 also issued 

under sec. 309(a), Pub. L. 99–440. Section 

110.50(b)(3) also issued under sec. 123, 92 

Stat. 142 (42 U.S.C. 2153). Section 110.51 

also issued under sec. 184, 68 Stat. 954, as 

amended (42 U.S.C. 2234). Section 110.52 

also issued under sec. 186, 68 Stat. 955 (42 

U.S.C. 2236). Sections 110.80–110.113 also 

issued under 5 U.S.C. 552, 554. Sections 

110.130–110.135 also issued under 5 U.S.C. 

553. Sections 110.2 and 110.42 (a)(9) also 


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issued under sec. 903, Pub. L. 102–496 (42 

U.S.C. 2151 et seq.). 

■ 57. In § 110.2, definitions of 

Accelerator-produced radioactive 

material, Discrete source, and Particle 

accelerator are added alphabetically to 

read as follows: 

§ 110.2 Definitions. 

* * * * * 

Accelerator-produced radioactive 

material means any material made 

radioactive by a particle accelerator. 

* * * * * 

Discrete source means a radionuclide 

that has been processed so that its 

concentration within a material has 

been purposely increased for use for 

commercial, medical, or research 

activities. 

* * * * * 

Particle accelerator means any 

machine capable of accelerating 

electrons, protons, deuterons, or other 

charged particles in a vacuum and of 

discharging the resultant particulate or 

other radiation into a medium at 

energies usually in excess of 1 

megaelectron volt. For purposes of this 

definition, ‘‘accelerator’’ is an 

equivalent term. 

* * * * * 

PART 150—EXEMPTIONS AND 

CONTINUED REGULATORY 

AUTHORITY IN AGREEMENT STATES 

AND IN OFFSHORE WATERS UNDER 

SECTION 274 

■ 58. The authority citation for part 150 

is revised to read as follows: 

Authority: Sec. 161, 68 Stat. 948, as 

amended, sec. 274, 73 Stat. 688 (42 U.S.C. 

2201, 2021); sec. 201, 88 Stat. 1242, as 

amended (42 U.S.C. 5841); sec. 1704, 112 

Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), 

Pub. L. 109–58, 119 Stat. 806–810 (42 U.S.C. 

2014, 2021, 2021b, 2111). 

Sections 150.3, 150.15, 150.15a, 150.31, 

150.32 also issued under secs. 11e(2), 81, 68 

Stat. 923, 935, as amended, secs. 83, 84, 92 

Stat. 3033, 3039 (42 U.S.C. 2014e(2), 2111, 

2113, 2114). Section 150.14 also issued under 

sec. 53, 68 Stat. 930, as amended (42 U.S.C. 

2073). Section 150.15 also issued under secs. 

135, 141, Pub. L. 97–425, 96 Stat. 2232, 2241 

(42 U.S.C. 10155, 10161). Section 150.17a 

also issued under sec. 122, 68 Stat. 939 (42 

U.S.C. 2152). Section 150.30 also issued 

under sec. 234, 83 Stat. 444 (42 U.S.C. 2282). 

■ 59. In § 150.3, the definition of 

Byproduct material is revised, and a 

definition of Discrete source is added 

alphabetically to read as follows: 

§ 150.3 Definitions. 

* * * * * 

Byproduct material means—

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2) The tailings or wastes produced by 

the extraction or concentration of 

uranium or thorium from ore processed 

primarily for its source material content, 

including discrete surface wastes 

resulting from uranium solution 

extraction processes. Underground ore 

bodies depleted by these solution 

extraction operations do not constitute 

‘‘byproduct material’’ within this 

definition; (3)(i) Any discrete source of 

radium-226 that is produced, extracted, 

or converted after extraction, before, on, 

or after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—

(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(4) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium-226 to the public health and 

safety or the common defense and 

security; and 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

Discrete source means a radionuclide 

that has been processed so that its 

concentration within a material has 

been purposely increased for use for 

commercial, medical, or research 

activities. 

* * * * * 

PART 170—FEES FOR FACILITIES, 

MATERIALS, IMPORT AND EXPORT 

LICENSES, AND OTHER 

REGULATORY SERVICES UNDER THE 

ATOMIC ENERGY ACT OF 1954, AS 

AMENDED 

■ 60. The authority citation for part 170 

is revised to read as follows: 

Authority: Sec. 9701, Pub. L. 97–258, 96 

Stat. 1051 (31 U.S.C. 9701); sec. 301, Pub. L. 

92–314, 86 Stat. 227 (42 U.S.C. 2201w); sec. 

201, Pub. L. 93–438, 88 Stat. 1242, as 

amended (42 U.S.C. 5841); sec. 205a, Pub. L. 

101–576, 104 Stat. 2842, as amended (31 U.S. 

C. 901, 902); sec. 1704, 112 Stat. 2750 (44 

U.S.C. 3504 note); sec. 623, Pub. L. 109–58, 

119 Stat. 783 (42 U.S.C. 2201(w)); sec. 651(e), 

Pub. L. 109–58, 119 Stat. 806–810 (42 U.S.C. 

2014, 2021, 2021(b), 2111). 

■ 61. In § 170.3, the definition of 

Byproduct material is revised to read as 

follows: 

§ 170.3 Definitions. 

* * * * * 

Byproduct material means—

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2)(i) Any discrete source of radium226 that is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—

(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(3) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium-226 to the public health and 

safety or the common defense and 

security; and 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

■ 62. In § 170.31, in the table, 

‘‘Schedule of Materials Fees,’’ paragraph 

3.B. is revised, and new categories 3.R. 

and 3.S. and corresponding fees are 

added to read as follows: 

§ 170.31 Schedule of fees for materials 

licenses and other regulatory services, 

including inspections, and import and 

export licenses. 

* * * * * 


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SCHEDULE OF MATERIALS FEES

Category of materials licenses and type of fees 1 Fee 2 3

* * * * * * * 

3. Byproduct material: 

* * * * * * * 

B. Other licenses for possession and use of byproduct material issued under part 30 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution. This category also includes licenses for repair, assembly, and disassembly of products containing radium-226. 

Application ............................................................................................................................................................................. $4,600 

* * * * * * * 

R. Possession of items or products containing radium-226 identified in 10 CFR 31.12 which exceed the number of items or 

limits specified in that section.6

1. Possession of quantities exceeding the number of items or limits in 10 CFR 31.12(a)(4), or (5) but less than or equal to 

10 times the number of items or limits specified. 

Application ...................................................................................................................................................................... 590 

2. Possession of quantities exceeding 10 times the number of items or limits specified in 10 CFR 31.12(a) (4), or (5). 

Application ...................................................................................................................................................................... 1,400 

S. Licenses for production of accelerator-produced radionuclides. 

Application ............................................................................................................................................................................. 8,000 

* * * * * * * 

1Types of fees—Separate charges, as shown in the schedule, will be assessed for pre-application consultations and reviews; applications for 

new licenses, approvals, or license terminations; possession only licenses; issuance of new licenses and approvals; certain amendments and renewals to existing licenses and approvals; safety evaluations of sealed sources and devices; generally licensed device registrations; and certain 

inspections. The following guidelines apply to these charges: 

(a) Application and registration fees. Applications for new materials licenses and export and import licenses; applications to reinstate expired, 

terminated, or inactive licenses except those subject to fees assessed at full costs; applications filed by Agreement State licensees to register 

under the general license provisions of 10 CFR 150.20; and applications for amendments to materials licenses that would place the license in a 

higher fee category or add a new fee category must be accompanied by the prescribed application fee for each category. 

(1) Applications for licenses covering more than one fee category of special nuclear material or source material must be accompanied by the 

prescribed application fee for the highest fee category. 

(2) Applications for new licenses that cover both byproduct material and special nuclear material in sealed sources for use in gauging devices 

will pay the appropriate application fee for fee Category 1.C. only. 

(b) Licensing fees. Fees for reviews of applications for new licenses and for renewals and amendments to existing licenses, for preapplication 

consultations and for reviews of other documents submitted to the NRC for review, and project manager time for fee categories subject to full 

cost fees are due upon notification by the Commission in accordance with § 170.12(b). 

(c) Amendment fees. Applications for amendments to export and import licenses must be accompanied by the prescribed amendment fee for 

each license affected. An application for an amendment to an export or import license or approval classified in more than one fee category must 

be accompanied by the prescribed amendment fee for the category affected by the amendment unless the amendment is applicable to two or 

more fee categories, in which case the amendment fee for the highest fee category will apply. 

(d) Inspection fees. Inspections resulting from investigations conducted by the Office of Investigations and nonroutine inspections that result 

from third-party allegations are not subject to fees. Inspection fees are due upon notification by the Commission in accordance with § 170.12(c). 

(e) Generally licensed device registrations under 10 CFR 31.5. Submittals of registration information must be accompanied by the prescribed 

fee. 2Fees will not be charged for orders related to civil penalties or other civil sanctions issued by the Commission under 10 CFR 2.202 or for 

amendments resulting specifically from the requirements of these orders. For orders unrelated to civil penalties or other civil sanctions, fees will 

be charged for any resulting licensee-specific activities not otherwise exempted from fees under this chapter. Fees will be charged for approvals 

issued under a specific exemption provision of the Commission’s regulations under Title 10 of the Code of Federal Regulations (e.g., 10 CFR 

30.11, 40.14, 70.14, 73.5, and any other sections in effect now or in the future), regardless of whether the approval is in the form of a license 

amendment, letter of approval, safety evaluation report, or other form. In addition to the fee shown, an applicant may be assessed an additional 

fee for sealed source and device evaluations as shown in Categories 9A through 9D. 3Full cost fees will be determined based on the professional staff time multiplied by the appropriate professional hourly rate established in 

§ 170.20 in effect at the time the service is provided, and the appropriate contractual support services expended. For applications currently on file 

for which review costs have reached an applicable fee ceiling established by the June 20, 1984, and July 2, 1990, rules, but are still pending 

completion of the review, the cost incurred after any applicable ceiling was reached through January 29, 1989, will not be billed to the applicant. 

Any professional staff-hours expended above those ceilings on or after January 30, 1989, will be assessed at the applicable rates established by 

§ 170.20, as appropriate, except for topical reports whose costs exceed $50,000. Costs which exceed $50,000 for each topical report, amendment, revision, or supplement to a topical report completed or under review from January 30, 1989, through August 8, 1991, will not be billed to 

the applicant. Any professional hours expended on or after August 9, 1991, will be assessed at the applicable rate established in § 70.20. 

* * * * * * * 

6Persons who possess radium sources that are used for operational purposes in another fee category are not also subject to the fees in this 

category. (This exception does not apply if the radium sources are possessed for storage only.) 


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* * * * * 

PART 171—ANNUAL FEES FOR 

REACTOR LICENSES AND FUEL 

CYCLE LICENSES AND MATERIALS 

LICENSES, INCLUDING HOLDERS OF 

CERTIFICATES OF COMPLIANCE, 

REGISTRATIONS, AND QUALITY 

ASSURANCE PROGRAM APPROVALS 

AND GOVERNMENT AGENCIES 

LICENSED BY THE NRC 

■ 63. The authority citation for part 171 

is revised to read as follows: 

Authority: Sec. 7601, Pub. L. 99-272, 100 

Stat. 146, as amended by sec. 5601, Pub. L. 

100–203, 101 Stat. 1330 as amended by sec. 

3201, Pub. L. 101–239, 103 Stat. 2132, as 

amended by sec. 6101, Pub. L. 101–508, 104 

Stat. 1388, as amended by sec. 2903a, Pub. 

L. 102–486, 106 Stat. 3125 (42 U.S.C. 2213, 

2214); and as amended by Title IV, Pub. L. 

109–103, 119 Stat. 2283 (42 U.S.C. 2214; sec. 

301, Pub. L. 92–314, 86 Stat. 227 (42 U.S.C. 

2201w); sec. 201, Pub. L. 93–438, 88 Stat. 

1242, as amended (42 U.S.C. 5841); sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021(b), 2111). 

■ 64. In § 171.5, the definition of 

Byproduct material is revised to read as 

follows: 

§ 171.5 Definitions. 

* * * * * 

Byproduct material means–

(1) Any radioactive material (except 

special nuclear material) yielded in, or 

made radioactive by, exposure to the 

radiation incident to the process of 

producing or using special nuclear 

material; 

(2)(i) Any discrete source of radium–

226 that is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; or 

(ii) Any material that—

(A) Has been made radioactive by use 

of a particle accelerator; and 

(B) Is produced, extracted, or 

converted after extraction, before, on, or 

after August 8, 2005, for use for a 

commercial, medical, or research 

activity; and 

(3) Any discrete source of naturally 

occurring radioactive material, other 

than source material, that—

(i) The Commission, in consultation 

with the Administrator of the 

Environmental Protection Agency, the 

Secretary of Energy, the Secretary of 

Homeland Security, and the head of any 

other appropriate Federal agency, 

determines would pose a threat similar 

to the threat posed by a discrete source 

of radium–226 to the public health and 

safety or the common defense and 

security; and 

(ii) Before, on, or after August 8, 2005, 

is extracted or converted after extraction 

for use in a commercial, medical, or 

research activity. 

* * * * * 

■ 65. In § 171.16, paragraph (d), in the 

table, Schedule of Materials Annual 

Fees and Fees for Government Agencies 

Licensed by the NRC, paragraph 3.B. is 

revised, and new categories 3.R. and 

3.S. and corresponding fees are added to 

read as follows: 

§ 171.16 Annual Fees: Materials licensees, 

holders of certificates of compliance, 

holders of sealed source and device 

registrations, holders of quality assurance 

program approvals, and government 

agencies licensed by the NRC. 

SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICENSED BY THE NRC 

Category of materials licenses Annual 

fees123

* * * * * * * 

3. Byproduct material: 

* * * * * * * 

B. Other licenses for possession and use of byproduct material issued under part 30 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution. This category also includes licenses for repair, assembly, and disassembly of products containing radium–226 ..................................................................................... $8,400 

* * * * * * * 

R. Possession of items or products containing radium–226 identified in 10 CFR 31.12 which exceed the number of items or 

limits specified in that section:14

1. Possession of quantities exceeding the number of items or limits in 10 CFR 31.12(a)(4), or (5) but less than or equal 

to 10 times the number of items or limits specified .......................................................................................................... 2,100 

2. Possession of quantities exceeding 10 times the number of items or limits specified in 10 CFR 31.12(a)(4), or (5) .... 2,700 

S. Licenses for production of accelerator-produced radionuclides .............................................................................................. 10,800 

* * * * * * * 

1Annual fees will be assessed based on whether a licensee held a valid license with the NRC authorizing possession and use of radioactive 

material during the current fiscal year. However, the annual fee is waived for those materials licensees and holders of certificates, registrations, 

and approvals who either filed for termination of their licenses or approvals or filed for possession only/storage licenses before October 1, 2004, 

and permanently ceased licensed activities entirely by September 30, 2004. Annual fees for licensees who filed for termination of a license, 

downgrade of a license, or for a possession only license during the fiscal year and for new licenses issued during the fiscal year will be prorated 

in accordance with the provisions of § 171.17. If a person holds more than one license, certificate, registration, or approval, the annual fee(s) will 

be assessed for each license, certificate, registration, or approval held by that person. For licenses that authorize more than one activity on a 

single license (e.g., human use and irradiator activities), annual fees will be assessed for each category applicable to the license. Licensees paying annual fees under Category 1A(1) are not subject to the annual fees for Category 1.C. and 1.D. for sealed sources authorized in the license. 2Payment of the prescribed annual fee does not automatically renew the license, certificate, registration, or approval for which the fee is paid. 

Renewal applications must be filed in accordance with the requirements of parts 30, 40, 70, 71, 72, or 76 of this chapter. 3Each fiscal year, fees for these materials licenses will be calculated and assessed in accordance with § 171.13 and will be published in the 

Federal Register for notice and comment. 

* * * * * * * 

14Persons who possess radium sources that are used for operational purposes in another fee category are not also subject to the fees in this 

category. (This exception does not apply if the radium sources are possessed for storage only.) 


jlentini on PROD1PC65 with RULES2
Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules and Regulations 55937 

* * * * * Dated at Rockville, Maryland, this 13th day 

of September 2007. 

For the Nuclear Regulatory Commission. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. 07–4735 Filed 9–28–07; 8:45 am] 

BILLING CODE 7590–01–P 


jlentini on PROD1PC65 with RULES2