AUDIT REPORT

Audit of NRC‟s 10 CFR Part 31 General Licensing Program

OIG-12-A-21 September 26, 2012

All publicly available OIG reports (including this report) are accessible through

NRC‟s Web site at: 

http:/www.nrc.gov/reading-rm/doc-collections/insp-gen/
UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, D.C. 20555-0001

OFFICE OF THE

INSPECTOR GENERAL

September 26, 2012

MEMORANDUM TO: R. William Borchardt

Executive Director for Operations

FROM: Stephen D. Dingbaum /RA/

Assistant Inspector General for Audits

SUBJECT: AUDIT OF NRC’S 10 CFR PART 31 GENERAL LICENSING 

PROGRAM (OIG-12-A-21)

Attached is the Office of the Inspector General’s (OIG) audit report titled, Audit of NRC’s

10 CFR Part 31 General Licensing Program.

The report presents the results of the subject audit. Agency comments provided at the 

September 4, 2012, exit conference have been incorporated, as appropriate, into this 

report. On September 21, 2012, the agency provided a formal response to this report. 

No changes were made to the report, based on the agency’s formal response. 

Please provide information on actions taken or planned on each of the 

recommendations within 30 days of the date of this memorandum. Actions taken or 

planned are subject to OIG followup as stated in Management Directive 6.1.

We appreciate the cooperation extended to us by members of your staff during the 

audit. If you have any questions or comments about our report, please contact me at 

415-5915 or Sherri Miotla, Team Leader, Nuclear Materials and Waste Safety Audit 

Team, at 415-5914.

Attachment: As stated 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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EXECUTIVE SUMMARY

BACKGROUND

The Nuclear Regulatory Commission (NRC) issues two types of domestic 

licenses to users of nuclear materials. Specific licenses are issued to named 

individuals who have filed an acceptable application to use certain types or 

quantities of radioactive materials. In contrast, general licenses are provided 

by regulations found in Title 10, Code of Federal Regulations, Part 31, General 

Domestic Licenses for Byproduct Material. These regulations allow persons to 

receive and use a general licensed device containing byproduct or source 

material if the device has been manufactured and distributed in accordance 

with a specific license issued by NRC or an Agreement State.

General Licensed Devices

A general licensed device (GLD) consists of radioactive material encased in a 

capsule within a shielded device. NRC asserts that the GLDs are designed 

with inherent radiation safety features so that they can be used by persons with 

no radiation safety training or experience. A few of the more commonly used 

GLDs include fixed gauges, static elimination devices, x-ray fluorescence 

analyzers, and luminous (tritium) exit signs. 

How NRC Regulates GLDs

NRC‟s Office of Federal and State Materials and Environmental Management 

Programs is primarily responsible for the regulation of GLDs. Specifically, the 

Licensing Branch within the office provides program oversight for the general 

license program. In addition to developing and implementing technical and 

policy guidance, the branch is responsible for the following:

Safety evaluation reviews of sealed sources and devices–The design 

and use of a device must undergo a technical and safety review prior to 

distribution as a GLD. Satisfying the review ensures that the device 

meets NRC‟s safety requirements. 

General License Tracking System (GLTS)–GLTS facilitates the tracking 

and accountability of GLDs and general licensees. This database is 

populated primarily with information provided to NRC

from device manufacturers. 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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Registration–General licensees in possession of GLDs containing 

certain isotopes and activity are required to register their devices with 

NRC annually. 

OBJECTIVE

The audit objective was to determine if NRC‟s general licensing program 

provides for the necessary accountability and tracking of general licensed 

devices to protect public health and safety. 

RESULTS IN BRIEF

Many General Licensees Are Unaware of NRC Regulatory Requirements

Over the past decade, NRC has made some improvements to its oversight of 

general licensees and GLDs to facilitate adequate protection of public health 

and safety and the environment; however, opportunities exist for NRC to further 

strengthen its oversight of this type of licensee. In order to improve program 

oversight, NRC has developed and maintains GLTS and the registration 

program. NRC can further improve oversight of general licensees and GLDs by 

informing each new general licensee of regulatory requirements, and 

periodically re-informing general licensees of regulatory requirements.

The Atomic Energy Act, through the Code of Federal Regulations, establishes 

regulatory requirements for GLDs. However, NRC relies on manufacturers to 

make general licensees aware of these requirements, thereby delegating some 

of its responsibilities. When licensees are unaware of their regulatory 

requirements, there is an increased probability that accountability of GLDs will 

decrease, placing public health and safety and the environment at risk. 

RECOMMENDATIONS

This report makes two recommendations to improve the agency‟s accountability 

and tracking of general licensed devices. 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

iii

AGENCY COMMENTS 

An exit conference was held with the agency on September 4, 2012. At this 

meeting, agency management provided supplemental information that has 

been incorporated into this report as appropriate. 

On September 21, 2012, NRC‟s Executive Director for Operations provided a 

formal response to this report (Appendix C). No changes were made to the 

report, based on the agency‟s formal response. OIG‟s response to the 

agency‟s formal comments is presented in Appendix D.
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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ABBREVIATIONS AND ACRONYMS

CFR Code of Federal Regulations 

GLD general licensed device

GLTS General License Tracking System 

NMED Nuclear Materials Events Database 

NRC Nuclear Regulatory Commission

OIG Office of the Inspector General
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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TABLE OF CONTENTS

EXECUTIVE SUMMARY ............................................................................ i

ABBREVIATIONS AND ACRONYMS........................................................iv

I. BACKGROUND................................................................................. 1

II. OBJECTIVE....................................................................................... 4

III. FINDING............................................................................................ 4

RECOMMENDATIONS................................................................... 17

IV. AGENCY COMMENTS.................................................................... 18

APPENDIXES

A. OBJECTIVE, SCOPE, AND METHODOLOGY........................ 19

B. Appendixes B-1 through B-6 provide General License 

Regulatory Requirements for various categories of devices 

and materials covered in 10 CFR Part 31................................ 21

C. FORMAL AGENCY COMMENTS............................................ 28

D. OIG RESPONSE TO FORMAL AGENCY COMMENTS ......... 29
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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I. BACKGROUND

The Nuclear Regulatory Commission‟s (NRC) mission is to regulate the 

Nation's civilian use of byproduct, source, and special nuclear materials1to 

ensure adequate protection of public health and safety, to promote the common 

defense and security, and to protect the environment. NRC issues two types of 

domestic licenses to users of nuclear materials. Specific licenses2are issued 

to named individuals who have filed an acceptable application to use certain 

types or quantities of radioactive materials. In contrast, general licenses are 

provided by regulations found in Title 10, Code of Federal Regulations (10 

CFR) Part 31, General Domestic Licenses for Byproduct Material. These 

regulations allow persons to receive and use a general licensed device 

containing byproduct or source material if the device has been manufactured 

and distributed in accordance with a specific license issued by NRC or an 

Agreement State.3

General Licensed Devices 

A general licensed device (GLD) consists of radioactive material encased in a 

capsule within a shielded device. The design of a GLD is subject to a 

regulatory review and safety evaluation to ensure that the device is in 

compliance with NRC requirements prior to approval for distribution. NRC 

asserts that the GLDs are designed with inherent radiation safety features so 

that they can be used by persons with no radiation safety training or 

experience. A few of the more commonly used GLDs include fixed gauges, 

static elimination devices, x-ray fluorescence analyzers, and luminous (tritium)

exit signs. 

 

1

Byproduct material includes, but is not limited to, nuclear material (other than special nuclear material) that is 

produced or made radioactive in a nuclear reactor, discrete sources of radium-226, and accelerator produced 

radioactive material that is produced, extracted, or converted after extraction for a commercial, medical, or 

research activity. Source material is either the element thorium or the element uranium, provided that the 

uranium has not been enriched in the isotope uranium-235. Depleted uranium (left over from uranium 

enrichment) is also considered source material. Special nuclear material consists of uranium-233 or 

uranium-235, enriched uranium, or plutonium. 

2

A specific license is a document issued by NRC to a named person who has filed an application. NRC 

conducts a detailed review of the radioactive materials program proposed by the applicant. A specific licensee 

is subject to routine inspections and other requirements. 

3

An Agreement State is a U.S. State that has signed an agreement with NRC authorizing the State to regulate 

certain uses of radioactive materials within the State. NRC relinquishes to such States portions of its regulatory 

authority to license and regulate byproduct materials, source materials, and certain quantities of special nuclear 

materials.
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How NRC Regulates General Licenses and GLDs

NRC‟s Office of Federal and State Materials and Environmental Management 

Programs is primarily responsible for the regulation of GLDs. Specifically, the 

Licensing Branch within the office provides program oversight for the general 

licensing program. In addition to developing and implementing technical and 

policy guidance, the branch is responsible for the following:

Safety evaluation reviews of sealed sources and devices–The design and 

use of a device must undergo a technical and safety review prior to 

distribution as a GLD. This review ensures that the device is designed and 

built to be used safely by someone without training in radiological protection. 

Satisfying the review ensures that the device meets NRC‟s safety 

requirements. NRC staff monitor reports of events involving nuclear 

materials in the Nuclear Material Events Database (NMED)4to ensure that 

devices approved for distribution as GLDs continue to meet safety 

requirements in practice.

General License Tracking System (GLTS)–GLTS facilitates the tracking and 

accountability of GLDs and general licensees. This database is populated 

primarily with information provided to NRC from device manufacturers. 

GLTS is also updated when a general licensee or a vendor reports a device 

transfer. The database stores information about NRC‟s current general 

licensees, with device and vendor information.

Registration–General licensees in possession of GLDs containing certain 

isotopes and activity5are required to register their devices with NRC 

annually. The registration requires licensees to verify and provide NRC the 

location of the devices and specific information about the licensee and 

submit an annual fee (currently $400) to NRC. 

When needed, inspection support for general license oversight is provided by 

three NRC regional offices (Region I, King of Prussia, PA; Region III, Lisle, IL; 

and Region IV, Arlington, TX).

6

 

 

4 NMED contains records of events involving nuclear material reported to the NRC by NRC licensees, 

Agreement States, and non-licensees. 

5

Activity is the rate of disintegration or decay of radioactive material per unit of time. 

6 General licensees are not inspected routinely. Failure of a licensee to return NRC‟s annual registration 

paperwork or a significant reported event are often causes for an inspection. 
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Universe of NRC GLDs and General Licensees

The universe of GLDs and general licensees tracked in GLTS is shown below 

in Table 1:

Table 1: The Universe of NRC GLDs and General Licensees

 Tracked in GLTS7

Number of Active 

Devices

Number of

General Licensees

All General Licensees 147,734 17,115

General Licensees 

Possessing Only Tritium 

Exit Signs

96,980 9,667

General Licensees 

Required to Register 3,055 633

Source: GLTS as of June 2012

In NRC jurisdiction, 147,734 active devices are tracked in GLTS. Tritium exit 

signs represent the vast majority of the devices tracked in GLTS. Tritium exit 

signs are considered very low risk to public health and safety and are exempt 

from regulation in some other industrialized countries. Approximately 3.7 

percent of the 17,115 general licensees in NRC jurisdiction are required to 

register their devices. 

Resources Allocated

In fiscal year 2012, NRC dedicated approximately $890,000 in total resources 

to administering the general licensing program. This includes 2.3 full-time 

equivalent staff located at NRC headquarters and regional offices.

 

7 GLTS tracks only items distributed pursuant to §31.5 and §31.7, which are required to be reported to NRC, 

therefore, Table 1 represents only these GLDs and general licensees possessing these items in NRC 

jurisdiction. The majority of general licensees are in Agreement States who oversee approximately 85 percent 

of materials licensees. 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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II. OBJECTIVE

The audit objective was to determine if NRC‟s general licensing program 

provides for the necessary accountability and tracking of general licensed 

devices to protect public health and safety. Appendix A provides information on 

the audit scope and methodology.

III. FINDING

Over the past decade, NRC has made some improvements to its oversight of 

general licensees and GLDs to facilitate adequate protection of public health 

and safety and the environment; however, opportunities exist for NRC to further 

strengthen its oversight of this type of licensee. In order to improve program 

oversight, NRC has developed and maintains GLTS and the registration 

program. NRC can further improve oversight of general licensees and GLDs by

informing each new general licensee of regulatory requirements, and

periodically re-informing general licensees of regulatory requirements.

Many general licensees are unaware of NRC regulatory requirements. The 

Atomic Energy Act, through the Code of Federal Regulations, establishes 

regulatory requirements for GLDs. However, NRC relies on manufacturers to 

make general licensees aware of these requirements, thereby delegating some 

of its responsibilities. When licensees are unaware of their regulatory 

requirements, there is an increased probability that accountability of GLDs will

decrease, placing public health and safety and the environment at risk. 

The Atomic Energy Act and the Code of Federal Regulations

The Atomic Energy Act, as interpreted by NRC in the Code of Federal 

Regulations, establishes standards which the licensees must meet.

Atomic Energy Act

The Atomic Energy Act of 1954, as amended, establishes the licensing of 

byproduct material for research or development purposes; for medical therapy, 

industrial, and agricultural uses; or other applications. General licenses, as well 

as specific licenses, are authorized in the act. The act also obligates NRC to 

ensure the capabilities of any licensee, including a general licensee, to use the 

byproduct material according to regulatory standards, stating NRC: 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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shall not permit the distribution of any byproduct material

[such as in a GLD] . . . to any licensee, who is not equipped

to observe or who fails to observe such safety standards

. . . to protect health or who uses such material in violation

of law. . . .

8

To fulfill its mission of ensuring protection of public health and safety when 

nuclear materials are used, NRC must obtain assurance that its licensees have 

the necessary resources to perform licensed activities in a manner that protects 

public health and safety. 

Figure 1: Continuous Gamma Level Gauge

Source: Thermo Scientific Web site

Code of Federal Regulations

10 CFR defines how NRC will oversee general licenses by providing 

requirements for the general licensees and for the specific licensees who 

manufacture and distribute GLDs.

NRC issues and regulates a variety of general licenses under 10 CFR Part 31.

The specific requirements vary with the type of device and radioactive material 

covered in each section of the regulations. Typical general licenses are listed 

in Table 2. The NRC regulatory requirements for these types of general 

licenses are enumerated in Appendixes B-1 through B-6 of this report.

 

8

Atomic Energy Act of 1954, as amended, §81.a.
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 Table 2: Types of Part 31 General Licenses9

10 CFR 

Section

Type of General License Regulatory Requirements

§31.5

Certain detecting, measuring, and 

controlling devices, and certain devices 

for producing light or an ionized 

atmosphere (e.g., density gauges, gas 

chromatographs, and luminous tritium

exit signs).

Subject to numerous regulatory 

requirements for reporting, 

recordkeeping, transfers, and 

disposal, among other 

responsibilities. Requirements 

presented in greater detail in 

§31.7 Appendixes B-1 and B-2.

Luminous safety devices for use in 

aircraft (with not more than 10 curies of 

tritium or 300 millicuries of promethium147 per device).

§31.8 Americium-241 and radium-226 in the 

form of calibration or reference sources.

Sources not tracked; used in 

conjunction with specific license.

§31.10

Strontium-90 in ice detection devices

(containing not more than 50 

microcuries).

No reporting requirements; not 

tracked.

§31.11 Use of byproduct material for certain 

 in vitro clinical or laboratory testing.

Materials not tracked; used with 

a specific license or registered 

as practicing in vitro testing.

§31.12 Certain items and self-luminous devices 

containing radium-226.

Not tracked; specific license 

required above a threshold 

quantity of items.

 Source: Office of the Inspector General (OIG) analysis of NRC regulations 

NRC made a risk-informed decision not to track §31.10 and §31.12 items. 

There are no reporting requirements for devices covered by the general 

license in §31.10. However, devices containing greater amounts of 

strontium-90 are subject to the requirements in §31.5 and are tracked, and 

certain devices with higher levels of activity must be registered.

Items subject to the general license in §31.12 are, for the most part, small 

timepieces and self-luminous devices in aircraft and marine vehicles. Many 

are part of museum collections or may be possessed by individual 

collectors. The general license contains a limit for the number of items that 

 

9 Regulatory requirements for certain static eliminators and ion generating tubes general licensed under 10 CFR 

§31.3 are not included in this table. Rulemaking (Federal Register 77:143, pages 43666-43696) effective 

October 23, 2012, will exempt these devices from licensing.

 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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can be used or stored under a general license; when that number is 

exceeded, a specific license must be obtained.

NRC‟s general licensing program focuses on §31.5 and §31.7 devices. These 

licensees are expected to comply with a range of requirements for the general 

license. These requirements fall into several broad categories, such as 

submitting reports to NRC within prescribed time limits, adhering to restrictions 

on the transfer and disposal of GLDs, and implementing a program to manage 

the possession and routine use of GLDs. The full requirements for general 

licensees under 10 CFR §31.5 and §31.7 are listed in Appendixes B-1 and B-2.

NRC‟s ability to oversee general licensees, and to track GLDs and the 

radiological material they contain, depends on proper fulfillment of restrictions 

on servicing and transfers of GLDs and meeting requirements for general 

licensee recordkeeping and reporting to NRC. General licensees must remain

aware of and comply with all of the requirements so that NRC can ensure 

public health and safety.

NRC regulations assign an important role for GLD manufacturers10 in ensuring 

general licensee awareness of regulatory requirements. Manufacturers must 

hold specific licenses. In addition to ensuring that their devices meet NRC 

guidelines for safety, manufacturers also have regulatory requirements under 

10 CFR Part 32 related to distribution of GLDs. One important requirement for 

manufacturers is that they must provide specific information to general 

licensees about regulatory requirements. The regulations state that 

manufacturers of devices for possession and use under 10 CFR Part 31.5 must 

provide the following: 

A copy of the general license and safety requirements from NRC regulations 

or equivalent Agreement State regulations.

A list of services that can be performed only by a specific licensee, such as 

transportation or repair of the GLD.

Information on acceptable disposal options and estimated costs of disposal.

An explanation of possible penalties for improper disposal.

 

10 Although the regulations for providing information to general licensees apply to both manufacturers and 

distributors of GLDs, to simplify, this report will refer only to manufacturers hereafter.
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Manufacturers also must report to NRC, on a quarterly or annual basis, all 

transfers of devices to general licensees. The reports must include information 

about the device and about the general licensee receiving the device, such as 

address and name of responsible person. Accurate and timely reports enable 

NRC to track individual GLDs. 

General Licensees Lack Awareness of NRC Regulatory Requirements

Many general licensees are unaware of NRC regulatory requirements despite 

provisions requiring manufacturers to provide this information to general 

licensees at the time of device distribution. Through NMED and NRC 

inspection reports, staff have identified many cases in which general licensees 

are unaware of NRC regulatory requirements. These cases show that

throughout the last decade, general licensees have failed to fulfill every 

applicable requirement in 10 CFR Part 31. Several recent examples of 

licensees failing to fulfill NRC‟s regulatory requirements follow. 

Device Transfer Reporting Requirement

A Federal agency laboratory possessing specifically licensed devices and 

GLDs did not leak test its GLDs as required by regulations and also transferred 

GLDs to another licensee without proper reporting to NRC. The laboratory 

program management was not aware that there were different requirements for 

the GLDs than for the materials and devices under the specific license.

Appointment of Responsible Person Requirement

One large general licensee lost numerous GLDs. NRC inspectors found that 

the corporate office centrally purchased the devices and received all technical 

information about regulatory requirements for the GLDs. Local managers 

should have been appointed as the “responsible persons,” but they did not 

receive the information, were not aware of the requirements for the devices 

installed in their facilities, and did not maintain accountability for the devices. 

Recordkeeping Requirement

An NRC inspector visited a facility and found a GLD in use at the location on 

record but could not verify that the required tests had been conducted on the 

GLD. A personnel change at the facility led to a loss of records related to the

required leak tests and shutter tests for the GLD. 
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Bankruptcy Notification Requirement

A company possessing GLDs had been acquired by another firm, which then 

became the general licensee. The new general licensee did not notify NRC, as 

required by regulations, when it later went bankrupt. NRC discovered the 

bankruptcy when it attempted to verify the location of the device for registration.

NRC headquarters and regional office staff described lack of awareness as a 

significant challenge with general licensees. Some observed it is a common 

occurrence, especially among smaller firms, that the person initially responsible 

for the devices will leave, as in the bankruptcy example where the business 

changed hands. Although some NRC staff asserted that larger firms are aware 

of the regulatory requirements, this is not always the case. Other examples 

show that Federal agencies and large corporations also can lack awareness of 

the regulatory requirements for GLDs.

Manufacturers Provide NRC‟s Regulatory Requirements to General Licensees

Manufacturers meet the regulatory requirement11 of providing information prior 

to distribution of devices to general licensees. In some cases, however, the 

information provided to general licensees regarding regulatory requirements for 

GLDs is unclear and potentially confusing. The following examples of guidance

supplied by manufacturers illustrate the challenges:

One manufacturer‟s safety manual places important information regarding 

general licenses and GLD safety in the specific license section, where it 

could be overlooked by a general licensee.

Another manufacturer‟s manual conveys the required regulations to the 

general licensee but adds the incorrect and confusing statement that

because the device has been distributed under the manufacturer‟s specific 

license, the user is “a „General Licensee‟ under the [manufacturer‟s]

license.”

A third manufacturer provides the essential requirements to the general 

licensee in two separate booklets. The operating manual has the 

regulations reprinted in full, and the safety manual contains specific 

descriptions of what the general licensee is required to do and how to do it. 

The separation of material in this way could make it more likely that 

 

11 10 CFR 32.51a(a)
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

10

important information will be overlooked or lost, preventing a 

general licensee‟s complete understanding of the regulatory requirements.

Such diverse styles of presenting regulatory requirements may not provide a 

clear and consistent understanding of the requirements among all general 

licensees. NRC staff questioned whether manufacturers supply all the 

information general licensees need and stated that NRC should ensure GLD 

manufacturers provide the proper information to device recipients. 

NRC Approach to Problems with NRC‟s General Licensing Program

The challenges facing the general licensing program are not new, and NRC has 

been working to address them since the 1980s. An NRC study in 1987 first 

summarized general licensee incognizance of regulatory requirements, stating 

that:

General licensees did not know the location of their devices.

General licensees frequently misplaced or did not read material supplied by 

the device manufacturer and did not realize they had any responsibility to 

comply with NRC requirements.

Many general licensees were unaware of particular NRC requirements for 

disposal, transfer, reporting, leak tests, or shutter testing.

While considering how to address such lack of awareness, NRC conducted 

another study, published in 1996. This study found that awareness of general 

license requirements declines over time while a device is in a general 

licensee‟s possession. A GLD may be in use for many years, during which 

personnel who have knowledge of the device or applicable regulations leave, or 

labels with general license information become lost or illegible. 

NRC developed the annual registration program and GLTS in 2000-2001 to 

address some issues identified by the agency studies. 
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Figure 2: Static Eliminator

Source: Amstat Web site

Registration Program

NRC‟s general licensee annual registration program was intended to obtain an 

annual inventory report from those general licensees possessing risk-significant 

devices. Registration is currently functioning as designed in that NRC has a 

99-percent response rate from the subset of general licensees required to 

register their devices annually. However, the information provided annually by 

NRC to general licensees (the registration package) does not include any 

safety- or program management-related reminders to licensees. Instead, 

NRC‟s registration package explains the requirement to register and how to file 

the form confirming their inventory of GLDs. In addition, registration focuses on 

only about 4 percent of general licensees; therefore, NRC tracks the remaining 

96 percent only through GLTS.

General License Tracking System

GLTS was designed to be an information system to track GLDs. Currently, the 

system supports the registration program, but contains errors that may hamper 

broad oversight of general licensees. NRC staff report problems when they 

attempt to use information from GLTS to locate missing general licensees and 

GLDs. A general licensee‟s failure to return the registration form triggers NRC 

staff attempts to verify the location of the devices required to be registered. 

Examples of errors in GLTS information that surface during verification include

the following:

A company had changed hands and the GLD was in use in the same 

location but the information had not been reported to NRC as required.
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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Devices had been placed on a company's specific license but the NRC 

general licensing program did not receive a report from the general licensee 

or from the NRC regional office.

Although GLTS contained correct contact information for one registered 

device, the information supplied to the inspector was from a different, 

incorrect field of the GLTS record, and the inspector was unable to locate 

the general licensee or the device.

A facility was closed for 15 years and the devices returned to the 

manufacturer, but the general licensee had failed to report this to NRC.

Failure of the general licensee to report as required was a problem in three of 

these examples. General licensees that are unaware of NRC‟s regulatory 

requirements frequently have lapses in compliance. 

NRC Relies on Manufacturers and Does Not Routinely Communicate With 

General Licensees 

General licensees lack awareness of NRC‟s regulatory requirements because 

NRC relies on manufacturers to communicate with general licensees. NRC

does not routinely communicate with all of its general licensees.

NRC Relies on Manufacturers 

NRC relies on manufacturers to make general licensees aware of NRC‟s 

regulatory requirements, delegating some of its oversight responsibilities. 

Manufacturers provide NRC regulatory information to the general licensee and 

report general licensee information to NRC, thus acting as the intermediary 

between NRC and the general licensees at the time of device distribution. 
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Table 3: Communication From Manufacturers

Manufacturer/ Distributor

Provides regulations to licensee Provides reports to NRC NRC has no contact with licensees unless the device requires registration

Licensee NRC

Source: OIG

However, NRC requires general licensees to be familiar with and abide by more 

regulations than manufacturers are required to deliver with the device. NRC 

requires general licensees to comply with numerous regulations. (See

Appendix B for a complete listing of the regulations.) However, manufacturers 

are not required to include all of these regulations in the information they 

provide with devices. Upon distribution of GLDs, manufacturers are required to 

provide general licensees with copies of certain NRC regulations. The specific 

regulations that 10 CFR Part 31.5 device manufacturers are required to 

distribute are: 

10 CFR 31.5, the general license.

10 CFR 31.2, general terms and conditions for general licenses.

10 CFR 30.51, recordkeeping for transfers and disposal.

10 CFR 20.2201 and 10 CFR 20.2202, reporting loss or theft and radiation 

overexposure incidents. 

A challenge to general licensees arises from 10 CFR 31.2, which incorporates 

by reference several sections of other regulations, “unless indicated otherwise 

in the specific provision of the general license.” Specific provisions of the 

general license in 10 CFR 31.5 preempt several of the general terms and 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

14

conditions in 10 CFR 31.2. Other referenced regulations relate to what it 

means to be an NRC licensee, such as limits to licensed activities, submitting to 

inspections, and the possibility of civil penalties for violations. These significant 

requirements still apply to general licenses under 10 CFR 31.5, but 

manufacturers are not required by NRC regulations to provide the full text of all 

the applicable regulations. Although general licensees do not submit an 

application and most do not pay an annual fee, they remain NRC licensees and 

need to be fully informed of all requirements. 

Some manufacturers may provide NRC‟s Internet address for general licensees 

to look up the regulations. However, it may be difficult for general licensees 

unfamiliar with Federal regulations to locate and understand the numerous 

regulatory requirements from NRC‟s home page.

NRC Does Not Routinely Communicate With the Vast Majority of General 

Licensees

NRC does not routinely communicate with most general licensees. Unless 

devices require registration, NRC has no contact with general licensees and 

takes a hands-off approach for GLDs. An NRC working group12 report stated

the following: 

. . . a major contributing factor to licensees losing control 

and accountability is the lack of adequate oversight by 

regulatory authorities. Specifically, many users do not 

have routine contact with the regulatory authorities. . . .

For almost all general licensees, the only connection

between the licensee and the regulatory authority is 

through the vendor of the device.

Because most general licensees are not required to register their devices, 

those possessing about 98 percent of GLDs do not receive any regular contact 

with or followup from NRC. According to NRC staff, lack of contact with the 

agency contributes to general licensees‟ lack of awareness and 

misunderstanding of regulatory requirements.

 

12 Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed 

Devices, October 1996 (NUREG-1551).
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

15

NRC has made some non-routine efforts to provide general licensees with 

important information, but the effectiveness of the efforts may be limited. For 

example:

NRC has a Web page that contains a toolkit for general licensees. This is a 

passive approach to communication and assumes general licensees will 

know there is a need to look for information and have access to the Web 

site.

Although NRC staff lack confidence that Information Notices13 change 

behavior of materials licensees, NRC issued Information Notices to general 

licensees because not all regulatory requirements were being met. 

However, the Information Notices required no specific licensee action or 

response. 

NRC took a more direct approach when it published a Regulatory Issue 

Summary14 in 2006 about disposal of tritium exit signs. This mailing, to both 

general licensees possessing tritium exit signs and to the specific licensees that 

manufacture and distribute them, reiterated NRC‟s regulatory requirements with 

the intent of minimizing chances that the devices would be disposed of 

incorrectly. The use of the Regulatory Issue Summary was a reaction to 

concerns about general licensees‟ lack of awareness regarding their 

responsibilities. However, NRC‟s approach remains based on a regulatory 

structure that tightly controls manufacturers. By contrast, unless a general 

licensee is required to register a device, NRC‟s monitoring of GLDs is limited. 

Decreased Accountability of General Licensed Devices Poses a Potential 

Risk to Public Health and Safety and the Environment

When licensees are unaware of their regulatory requirements, there is an 

increased probability that accountability for GLDs will decrease. Decreased 

accountability for GLDs can place public health and safety and the environment 

at risk. 

 

13 NRC uses Information Notices to provide significant recently identified operational information about safety, 

safeguards, or environmental issues. Addressees are expected to review the information for applicability to their 

facilities and consider actions, as appropriate, to avoid similar problems.

14 NRC uses Regulatory Issue Summaries to announce technical or policy positions not previously 

communicated to industry or not broadly understood.
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

16

Figure 3: Continuous Level Detector

Source: Ohmart/Vega Web site

Lost, Abandoned, and Improperly Disposed Devices

General licensees continue to lose, abandon, and improperly dispose of GLDs 

containing radioactive material, just as they did when NRC first studied the 

problem in the 1980s. NRC tracks events and monitors nuclear material trends 

across the country through NMED. A search of NMED identified that over a 5-

year period,

15 there were 341 reports16 of lost, abandoned, and improperly 

disposed GLDs reported across the United States. As would be expected, 

approximately 80 percent of the event reports came from Agreement States. 

However, such events also commonly occurred in NRC jurisdiction throughout 

the 5-year period. 

Members of the public who encounter GLDs after they have been lost, 

abandoned, or improperly disposed can be exposed to low doses of radiation. 

There is also ongoing concern with the environmental impact resulting from 

inadequate control of products containing radioactive materials. In the past, 

improper disposal has led to the contamination of metal scrap process recycling 

streams, resulting in significant environmental cleanup costs and potential 

worker exposure. Many metal recycling facilities have installed detectors to 

screen incoming loads for radioactive materials and, as a result, lost GLDs are 

sometimes discovered in scrap metal. However, not all lost radioactive devices 

 

15 July 1, 2007, through June 30, 2012.

16 Of the 341 reports, 253 were related to lost or improperly disposed luminous (tritium) exit signs. 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

17

are recovered; some improperly disposed devices are exported in scrap metal 

shipments.

NRC Staff Concerns

NRC staff note the continued problems from loss of accountability and control 

of GLDs. One staff member stated that the “lack of awareness by general 

licensees is the reason NRC finds general licensed devices on the auction 

block or in the scrapyard.” Another staff member agreed with the statement, 

adding that GLDs “are not recognized as radioactive and are sold or sent to 

scrapyards.” A stakeholder pointed out that NRC cannot know what is not 

reported.

Reporting Reliability

When general licensees are unaware of regulations and fail to report as 

required by NRC, the agency lacks the best information to support effective 

long-term oversight of the program. For NRC to ensure that general licensees 

are conducting their activities in a manner that protects public health and safety 

and the environment, NRC must have reliable information to track general 

licensees and GLDs. 

Recommendations

OIG recommends that the Executive Director for Operations:

1. Develop and implement procedures for NRC to provide information 

clearly describing all applicable regulatory requirements each time an 

NRC general licensed device is distributed to an NRC general licensee. 

2. Develop and implement procedures for NRC to periodically reinform 

existing general licensees of applicable regulatory requirements.
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

18

IV. AGENCY COMMENTS

An exit conference was held with the agency on September 4, 2012. At this 

meeting, agency management provided supplemental information that has 

been incorporated into this report as appropriate. 

On September 21, 2012, NRC‟s Executive Director for Operations provided a 

formal response to this report (Appendix C). No changes were made to the 

report, based on the agency‟s formal response. OIG‟s response to the 

agency‟s formal comments is presented as Appendix D.
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

19

APPENDIX A

OBJECTIVE, SCOPE, AND METHODOLOGY 

OBJECTIVE

The audit objective was to determine if NRC‟s general licensing program 

provides for the necessary accountability and tracking of general licensed 

devices to protect public health and safety.

SCOPE

We conducted this performance audit at NRC headquarters (Rockville, MD)

and three NRC regional offices (Region I, King of Prussia, PA; Region III, Lisle, 

IL; and Region IV, Arlington, TX) from November 2011 through June 2012. 

OIG also interviewed staff in the Agreement States of Maryland (Baltimore) and 

Pennsylvania (Harrisburg), during this timeframe. Internal controls related to 

the audit objectives were reviewed and analyzed. Throughout the audit, 

auditors were aware of the possibility or existence of fraud, waste, or misuse in 

the program.

METHODOLOGY

The audit team reviewed relevant criteria, including the Atomic Energy Act of 

1954, as amended; 10 CFR Part 31, General Domestic Licenses for Byproduct 

Material, and Part 32, Specific Domestic Licenses to Manufacture or Transfer 

Certain Items Containing Byproduct Material; and NRC's Principles of Good 

Regulation. The team also reviewed NRC Information Notices, Commission 

Papers, and Staff Requirements Memoranda.

The audit team reviewed NMED and inspection reports to determine whether 

general licensees comply with NRC requirements. The team also reviewed the

reporting and tracking of general licensed devices in GLTS.

At NRC headquarters, auditors interviewed Office of Federal and State 

Materials and Environmental Management Programs staff and management to 

gain an understanding of their roles and responsibilities related to the oversight 

of general licenses. Auditors interviewed staff and management from NRC 

Regions I, III, and IV to gain an understanding of how each region oversees 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

20

general licenses. Auditors also interviewed staff in the Agreement States to 

gain an understanding of the State general licensing programs.

We conducted this performance audit in accordance with generally accepted 

Government auditing standards. Those standards require that we plan and 

perform the audit to obtain sufficient, appropriate evidence to provide a 

reasonable basis for our findings and conclusions based on our audit 

objectives. We believe that the evidence obtained provides a reasonable basis 

for our findings and conclusions based on our audit objectives.

The audit work was conducted by Sherri Miotla, Team Leader; Robert 

Woodward, Audit Manager; Kevin Nietmann, Senior Technical Advisor;

Maxinne Lorette, Senior Auditor; and Amy Hardin, Auditor.
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

21

APPENDIX B-1

Regulatory requirements for certain detecting, measuring, and controlling devices,

and certain devices for producing light or an ionized atmosphere

generally licensed under 10 CFR Part 31.5

Requirement 

Name Description of Requirement Regulation 

1

Report theft or 

loss of licensed 

radioactive 

material

Describes when licensee must report by telephone or in writing a 

theft or loss; certain reports must be made within 24 hours, others 

within 30 days; specifies content of reports.

10 CFR 20.2201 

2

Report exposure 

incidents

Describes exposure thresholds where licensee must report 

radiation incidents to NRC.

10 CFR 20.2202 

3

Exempt 

quantities and 

products

Transfer to an exempt person must be under a specific license. 10 CFR 30.14(d)

4

License terms 

and conditions 

Licensee shall confine his possession and use to the locations and 

purposes authorized in the license; Commission can change terms 

by rule or order.

10 CFR 30.34(a)-(e)

5

Transfers of 

licensed 

radioactive 

material

Transfer permitted to a specific licensee or a general licensee; 

transferring licensee must verify that recipient is authorized to 

possess the material. 

10 CFR 30.41 

6

Reporting 

requirements

Describes when licensee must report incidents by telephone or in 

writing; certain reports must be made immediately, within 24 

hours, others within 30 days; specifies content of reports. 

10 CFR 30.50 

7

Records Receipt/transfer/disposal of material; transfer records to NRC 

when license terminated; retention periods specified elsewhere in 

regulations or as license condition.

10 CFR 30.51 

8

Inspections General licensees not normally inspected but if NRC wishes to 

inspect a general licensee, material, facility, and records must be 

available for inspection.

10 CFR 30.52 

9

Tests as required Licensee shall perform such tests of byproduct material, facilities, 

radiation detection devices as the Commission deems necessary 

to administer the regulations.

10 CFR 30.53 

10

Modify license 

conditions by rule 

change

License conditions can be modified by amendment of laws or 

regulations; license can be revoked for false statements or for 

violations.

10 CFR 30.61 

11

Withholding 

materials 

Commission may withhold byproduct material from a licensee not 

equipped to observe or who fails to observe safety standards or 

protect health.

10 CFR 30.62 

12

Violations and 

civil penalties

Commission may obtain a court order to prevent violation of the 

Commission‟s regulations; Commission may impose a civil penalty 

for violations.

10 CFR 30.63 

13

General license 

terms and 

conditions

Licensee shall confine his possession and use of the byproduct 

material to the locations and purposes authorized in the license; in 

addition, general licensees subject to 30.14(d), 30.34(a)-(e),

30.41, 30.50 to 30.53, 30.61 to 30.63, and Parts 19, 20, and 21,

unless otherwise specified.

10 CFR 31.2 

14

Types of devices General licensee is permitted to acquire, receive, possess, use or 

transfer byproduct material contained in devices designed and 

manufactured by a specific licensee under §32.51 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. 

10 CFR 31.5 

15 Labels Labels must remain attached and general licensee must comply 

with instructions of label.

10 CFR 31.5(c)(1) 

16 Leak testing Leak test at least every 6 months (tritium exit signs exempt). 10 CFR 31.5(c)(2) 

17

Testing and 

service by a 

specific licensee

Must have a specific licensee perform these tasks. 10 CFR 31.5(c)(3) 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

22

APPENDIX B-1 continued

 18 Records of leak 

testing

Maintain records showing compliance with leak testing 

requirement.

10 CFR 31.5(c)(4) 

19 Stop use if device 

fails

Suspend operation if failure of shielding or on/off 

mechanism, report to NRC, repair by specific licensee.

10 CFR 31.5(c)(5) 

20 Do not abandon 

device

Shall not abandon the device containing byproduct material. 10 CFR 31.5(c)(6) 

21 Do not export the 

device 

Shall not export the device containing byproduct material. 10 CFR 31.5(c)(7) 

22

Report Transfers Shall transfer only to a specific licensee, and within 30 days 

after the transfer of a device to a specific licensee or export, 

furnish a report to NRC.

10 CFR 31.5(c)(8) 

23 Transfer device 

to general 

licensee

Shall transfer the device to another general licensee only if 

the device remains in use at a particular location.

10 CFR 31.5(c)(9) 

24 Reporting 

radiation 

incidents, theft or 

loss

Shall comply with the provisions of §§ 20.2201 and 20.2202 

of this chapter for reporting radiation incidents, theft or loss 

of licensed material, otherwise exempt from Part 19, 20, 21.

10 CFR 31.5(c)(10)

25 Respond to 

written requests 

from NRC

Shall respond to written requests from the Nuclear 

Regulatory Commission 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. 

10 CFR 31.5(c)(11) 

26 Appoint a 

responsible 

person

Shall appoint an individual responsible for having knowledge 

of the appropriate regulations and requirements and the 

authority for taking required actions to comply with 

appropriate regulations and requirements. 

10 CFR 31.5(c)(12) 

27 Register 

appropriate 

devices

Shall register, 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 cobalt-60, 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. 

10 CFR 31.5(c)(13) 

28 Report changes 

in mailing 

address

Shall report changes to the mailing address for the location 

of use to NRC within 30 days of the effective date of the 

change.

10 CFR 31.5(c)(14) 

29 Do not hold 

devices not in 

use more than 2 

years

May not hold devices that are not in use for longer than 2 

years. If devices with shutters are not being used, the shutter 

must be locked in the closed position. The testing required 

by paragraph (c)(2) of this section need not be performed 

during the period of storage only. 

10 CFR 31.5(c)(15) 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

23

APPENDIX B-2

Regulatory requirements for luminous safety devices for use in aircraft

(with not more than 10 curies of tritium or 300 millicuries of promethium-147 per device)

licensed under 10 CFR Part 31.7

Requirement 

Name Description of Requirement Regulation 

1

Report theft or 

loss of licensed 

radioactive 

material

Describes when licensee must report by telephone or in 

writing a theft or loss; certain reports must be made within 24 

hours, others within 30 days; specifies content of reports.

10 CFR 20.2201 

2

Report exposure 

incidents

Describes exposure thresholds where licensee must report 

radiation incidents to NRC.

10 CFR 20.2202 

3

Exempt 

quantities and 

products

Transfer to an exempt person must be under a specific 

license.

10 CFR 30.14(d)

4

License terms 

and conditions 

Licensee shall confine his possession and use to the 

locations and purposes authorized in the license; 

Commission can change terms by rule or order.

10 CFR 30.34(a)-(e)

5

Transfers of 

licensed 

radioactive 

material

Transfer permitted to a specific licensee or a general 

licensee; transferring licensee must verify that recipient is 

authorized to possess the material. 

10 CFR 30.41 

6

Reporting 

requirements

Describes when licensee must report incidents by telephone 

or in writing; certain reports must be made immediately, 

within 24 hours, others within 30 days; specifies content of 

reports. 

10 CFR 30.50 

7

Records Receipt/transfer/disposal of material; transfer records to NRC 

when license terminated; retention periods specified 

elsewhere in regulations or as license condition.

10 CFR 30.51 

8

Inspections General licensees not normally inspected but if NRC wishes 

to inspect a general licensee, material, facility, and records 

must be available for inspection.

10 CFR 30.52 

9

Tests as required Licensee shall perform such tests of byproduct material, 

facilities, radiation detection devices as the Commission 

deems necessary to administer the regulations.

10 CFR 30.53 

10

Modify license 

conditions by rule 

change

License conditions can be modified by amendment of laws or 

regulations; license can be revoked for false statements or 

for violations.

10 CFR 30.61 

11

Withholding 

materials 

Commission may withhold byproduct material from a 

licensee not equipped to observe or who fails to observe 

safety standards or protect health.

10 CFR 30.62 

12

Violations and 

civil penalties

Commission may obtain a court order to prevent violation of 

the Commission‟s regulations; Commission may impose a 

civil penalty for violations.

10 CFR 30.63 

13

General license 

terms and 

conditions

Licensee shall confine his possession and use of the 

byproduct material to the locations and purposes authorized 

in the license; in addition, general licensees subject to 

30.14(d), 30.34(a)-(e), 30.41, 30.50 to 30.53, 30.61 to 30.63, 

and Parts 19, 20, and 21, unless otherwise specified.

10 CFR 31.2 

14

Type of device 

and material 

threshold

Permits the ownership, receipt, acquisition, possession, and 

use of tritium or promethium-147 contained in luminous 

safety devices for use in aircraft provided that each device 

contains not more than 10 curies of tritium or 300 millicuries 

of promethium-147; devices must be manufactured by a 

specific licensee under §32.53; General licensees exempt for 

requirements of parts 19, 20, and 21 except for except for 

the provisions in §20.2201 and 20.2202.

10 CFR 31.7 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

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APPENDIX B-3

Regulatory requirements for americium-241 and radium-226 in the form of calibration or 

reference sources generally licensed under 10 CFR Part 31.8

Requirement 

Name Description of Requirement Regulation 

1

Training for 

workers in 

radiation safety

Describes the notices (including postings of regulations) and 

instructions to workers. Information that must be given to individuals 

who in the course of employment are likely to receive a one year 

occupational dose in excess of 100 millirem.

10 CFR 19 

2

Radiation 

protection 

standards and 

programs

Dose limits for workers and for members of the public; the features of 

radiation safety programs to protect workers and the public; 

recordkeeping; reporting (e.g., theft or loss and incidents); and 

enforcement of the requirements.

10 CFR 20 

3

Device defect 

reporting

Specific requirements for identifying and reporting defects with 

substantial safety hazards to NRC within specific time limits.

10 CFR 21 

4

Exempt 

quantities and 

products

Transfer to an exempt person must be under a specific license. 10 CFR 30.14(d)

5

License terms 

and conditions 

Licensee shall confine his possession and use to the locations and 

purposes authorized in the license; Commission can change terms 

by rule or order.

10 CFR 30.34(a)-(e)

6

Reporting 

requirements

Describes when licensee must report incidents by telephone or in 

writing; certain reports must be made immediately, within 24 hours, 

others within 30 days; specifies content of reports. 

10 CFR 30.50

7

Records Receipt/transfer/disposal of material; transfer records to NRC when 

license terminated; retention periods specified elsewhere in 

regulations or as license condition.

10 CFR 30.51

8

Inspections General licensees not normally inspected but if NRC wishes to 

inspect a general licensee, material, facility, and records must be 

available for inspection.

10 CFR 30.52

9

Tests as required Licensee shall perform such tests of byproduct material, facilities, 

radiation detection devices as the Commission deems necessary to 

administer the regulations. 

10 CFR 30.53 

10

Modify license 

conditions by rule 

change

License conditions can be modified by amendment of laws or 

regulations; license can be revoked for false statements or for 

violations.

10 CFR 30.61 

11

Withholding 

materials 

Commission may withhold byproduct material from a licensee not 

equipped to observe or who fails to observe safety standards or 

protect health.

10 CFR 30.62 

12

Violations and 

civil penalties

Commission may obtain a court order to prevent violation of the 

Commission‟s regulations; Commission may impose a civil penalty 

for violations.

10 CFR 30.63 

13

General license 

terms and 

conditions

Licensee shall confine his possession and use of the byproduct 

material to the locations and purposes authorized in the license; in 

addition, general licensees subject to 30.14(d), 30.34(a)-(e), 30.41, 

30.50 to 30.53, 30.61 to 30.63, and Parts 19, 20, and 21, unless 

otherwise specified.

10 CFR 31.2

14

Must have 

specific license to 

use this general 

license. 

General license to possess calibration and reference sources 

containing Am-241 and Ra-226 is granted to persons or government 

agencies that hold specific licenses to possess, use, or transfer other 

byproduct material; source must have been manufactured under a 

specific license under §32.57.

10 CFR 31.8(a)-(b) 

15

Requirements for 

these sources

General licensee is subject to §§30.14, 30.34(a)-(e), and 30.50 to 

30.63; also subject to 10 CFR Parts 19, 20, 21; limits for use, 

storage, transfer and disposal, prohibits abandonment, export, or 

import.

10 CFR 31.8(c)-(e)
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

25

APPENDIX B-4

Regulatory requirements for a general license for strontium-90

in ice detection devices under 10 CFR Part 31.10

Requirement 

Name Description of Requirement Regulation 

1

Disposal 

requirements

A licensee shall dispose of licensed material only by transfer 

to an authorized recipient, by decay in storage, by release in 

effluents, or as otherwise authorized.

10 CFR 20.2001

2

Report theft or 

loss of licensed 

radioactive 

material

Describes when licensee must report by telephone or in 

writing a theft or loss; certain reports must be made within 24 

hours, others within 30 days; specifies content of reports.

10 CFR 20.2201 

3

Report exposure 

incidents

Describes exposure thresholds where licensee must report 

radiation incidents to NRC.

10 CFR 20.2202 

4

Exempt 

quantities and 

products

Transfer to an exempt person must be under a specific license.10 CFR 30.14(d)

5

License terms 

and conditions 

Licensee shall confine his possession and use to the 

locations and purposes authorized in the license; 

Commission can change terms by rule or order.

10 CFR 30.34(a)-(e)

6

Transfers of 

licensed 

radioactive 

material

Transfer permitted to a specific licensee or a general 

licensee; transferring licensee must verify that recipient is 

authorized to possess the material.

10 CFR 30.41 

7

Reporting 

requirements

Describes when licensee must report incidents by telephone 

or in writing; certain reports must be made immediately, 

within 24 hours, others within 30 days; specifies content of 

reports. 

10 CFR 30.50 

8

Records Receipt/transfer/disposal of material; transfer records to NRC 

when license terminated; retention periods specified 

elsewhere in regulations or as license condition.

10 CFR 30.51 

9

Inspections General licensees not normally inspected but if NRC wishes 

to inspect a general licensee, material, facility, and records 

must be available for inspection.

10 CFR 30.52

10

Tests as required Licensee shall perform such tests of byproduct material, 

facilities, radiation detection devices as the Commission 

deems necessary to administer the regulations.

10 CFR 30.53 

11

Modify license 

conditions by rule 

change

License conditions can be modified by amendment of laws or 

regulations; license can be revoked for false statements or 

for violations.

10 CFR 30.61 

12

Withholding 

materials 

Commission may withhold byproduct material from a 

licensee not equipped to observe or who fails to observe 

safety standards or protect health.

10 CFR 30.62 

13

Violations and 

civil penalties

Commission may obtain a court order to prevent violation of 

the Commission‟s regulations; Commission may impose a 

civil penalty for violations.

10 CFR 30.63

14

General license 

terms and 

conditions

Licensee shall confine his possession and use of the 

byproduct material to the locations and purposes authorized 

in the license; in addition, general licensees subject to 

30.14(d), 30.34(a)-(e), 30.41, 30.50 to 30.53, 30.61 to 30.63, 

and Parts 19, 20, and 21, unless otherwise specified.

10 CFR 31.2

15

Ice detection 

devices 

containing 

strontium-90

General license to own, use, transfer Sr-90 in ice detection 

devices as long as activity not greater than 50 microcuries 

and device is manufactured by a specific licensee under 

§32.61; discontinue use in case of observable damage, 

service should be provided by a specific licensee; label must 

be maintained. Exempt from 19,20,21 except for 20.2001, 

20.2201, 20.2202.

10 CFR 31.10 
Audit of NRC‟s 10 CFR Part 31 General Licensing Program

26

APPENDIX B-5

Regulatory requirements for byproduct material for certain in vitro clinical 

or laboratory testing generally licensed under 10 CFR Part 31.11

Requirement 

Name Description of Requirement Regulation 

1

Disposal of waste 

containing licensed 

material

Licensee shall dispose of licensed material only by transfer to 

an authorized recipient under §20.2006 or as authorized in 

§§20.2002, 20.2003, 20.2004, 20.2005, 20.2008 (applicable 

only to users of Mock-Iodine-125).

10 CFR 20.2001 

2

Report theft or loss of 

licensed radioactive 

material

Describes when licensee must report by telephone or in writing 

a theft or loss; certain reports must be made within 24 hours, 

others within 30 days; specifies content of reports (applicable 

only to users of Mock-Iodine-125)..

10 CFR 20.2201 

3

Report exposure 

incidents

Describes exposure thresholds where licensee must report 

radiation incidents to NRC (applicable only to users of MockIodine-125).

10 CFR 20.2202 

4

Exempt quantities and 

products

Transfer to an exempt person must be under a specific license. 10 CFR 30.14(d)

5

License terms and 

conditions 

Licensee shall confine his possession and use to the locations 

and purposes authorized in the license; Commission can 

change terms by rule or order.

10 CFR 30.34(a)-(e)

6

Reporting 

requirements

Describes when licensee must report incidents by telephone or 

in writing; certain reports must be made immediately, within 24 

hours, others within 30 days; specifies content of reports. 

10 CFR 30.50

7

Records Receipt/transfer/disposal of material; transfer records to NRC 

when license terminated; retention periods specified elsewhere 

in regulations or as license condition.

10 CFR 30.51

8

Inspections General licensees not normally inspected but if NRC wishes to 

inspect a general licensee, material, facility, and records must 

be available for inspection.

10 CFR 30.52

9

Tests as required Licensee shall perform such tests of byproduct material, 

facilities, radiation detection devices as the Commission deems 

necessary to administer the regulations.

10 CFR 30.53 

10

Modify license 

conditions by rule 

change

License conditions can be modified by amendment of laws or 

regulations; license can be revoked for false statements or for 

violations.

10 CFR 30.61 

11

Withholding materials Commission may withhold byproduct material from a licensee 

not equipped to observe or who fails to observe safety 

standards or protect health.

10 CFR 30.62 

12

Violations and civil 

penalties

Commission may obtain a court order to prevent violation of the 

Commission‟s regulations; Commission may impose a civil 

penalty for violations.

10 CFR 30.63 

13

General license terms 

and conditions

Licensee shall confine his possession and use of the byproduct 

material to the locations and purposes authorized in the license; 

in addition, general licensees subject to 30.14(d), 30.34(a)-(e),

30.41, 30.50 to 30.53, 30.61 to 30.63, and Parts 19, 20, and 21,

unless otherwise specified.

10 CFR 31.2

14

General license for 

limited quantities

General license to possess limited quantities of specified 

isotopes is granted to physicians, veterinarians, clinical 

laboratories, or hospitals; material must be in the form of a prepackaged units manufactured under a specific license under 

§32.71 and affixed with a required label.

10 CFR 31.11(a)(1)-(8), (d)(1)-(2)

15

Must register or have 

a specific license to 

use this general 

license. 

Persons possessing and using byproduct material under this 

general license must: register with NRC as practicing in vitro

testing; or hold specific licenses under 10 CFR Part 35, Medical 

Use of Byproduct Material. 

10 CFR 31.11(b)(1)-(2)

 16

Requirements for 

receiving, acquiring, 

possessing, and use 

under this general 

license.

General licensee is subject to §§30.14, 30.34(a)-(e), and 30.50 

to 30.63; with respect to the byproduct material under general 

license, exempt from 10 CFR Parts 19, 20, 21, except for users 

of Mock-Iodine-125, who are subject to §§20.2001, 20.2201, 

20.2202; limits for use, storage, and transfer.

10 CFR 31.11(c)(1)-(5), (e), (f) 
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APPENDIX B-6

Regulatory requirements for a general license for certain items and

self-luminous devices containing radium-226 under 10 CFR Part 31.12

Requirement 

Name Description of Requirement Regulation 

1

Disposal of 

certain byproduct 

material

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 [discrete sources of Ra-226], at a 

disposal facility authorized to dispose of such material in 

accordance with any Federal or State solid or hazardous 

waste law.

10 CFR 20.2008 

2

Exempt 

quantities and 

products

Transfer to an exempt person must be under a specific 

license.

10 CFR 30.14(d) 

3

License terms 

and conditions 

Licensee shall confine his possession and use to the 

locations and purposes authorized in the license; 

Commission can change terms by rule or order.

10 CFR 30.34(a)-(e)

4

Transfers of 

licensed 

radioactive 

material

Transfer permitted to a specific licensee or a general 

licensee; transferring licensee must verify that recipient is 

authorized to possess the material.

10 CFR 30.41 

5

Inspections General licensees not normally inspected but if NRC wishes 

to inspect a general licensee, material, facility, and records 

must be available for inspection.

10 CFR 30.52 

6

Tests as required Licensee shall perform such tests of byproduct material, 

facilities, radiation detection devices as the Commission 

deems necessary to administer the regulations.

10 CFR 30.53 

7

Modify license 

conditions by rule 

change

License conditions can be modified by amendment of laws or 

regulations; license can be revoked for false statements or 

for violations.

10 CFR 30.61 

8

Withholding 

materials 

Commission may withhold byproduct material from a 

licensee not equipped to observe or who fails to observe 

safety standards or protect health.

10 CFR 30.62 

9

Violations and 

civil penalties

Commission may obtain a court order to prevent violation of 

the Commission‟s regulations; Commission may impose a 

civil penalty for violations.

10 CFR 30.63 

10

General license 

terms and 

conditions

Licensee shall confine his possession and use of the 

byproduct material to the locations and purposes authorized 

in the license; in addition, general licensees subject to 

30.14(d), 30.34(a)-(e), 30.41, 30.50 to 30.53, 30.61 to 30.63, 

and Parts 19, 20, and 21, unless otherwise specified. 

10 CFR 31.2 

11

General license

issued for 

particular items 

(including 

antiques) in 

limited uses

Antique items originally intended for use by the public, intact 

timepieces, luminous items installed in land, air, or marine 

vehicles, all other luminous products so long as no more 

than 100 items are used or stored at the same location at 

any one time, small radium sources such as are used in 

educational demonstration items; report damage to NRC, do 

not abandon or export, shall dispose only as specified in 

§20.2008, shall respond to NRC request for information, only 

timepieces may be disassembled; general licensees exempt 

from Parts 19,20, and 21 except for §20.2008, and from 

§30.50 and 30.51.

10 CFR 31.12
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APPENDIX C

FORMAL AGENCY COMMENTS 
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APPENDIX D

OIG RESPONSE TO FORMAL AGENCY COMMENTS 

On September 21, 2012, NRC‟s Executive Director for Operations provided a 

formal response to this report which expressed agreement that the report‟s 

recommendations may aid in improving general licensees‟ awareness of 

regulatory requirements and, subsequently, enhance the control of generally 

licensed devices over time.

OIG will review the adequacy of agency corrective actions taken to address the 

report‟s recommendations during the audit followup process.