Compatibility Issues Compatibility Issues Regarding Agreement State Regarding Agreement State

Regulations for Portable Regulations for Portable Devices Containing RAM Devices Containing RAM

SourcesSources

Sean Chapel, PresidentSean Chapel, President

Presented at the 2006 Presented at the 2006 Annual Meeting of the Annual Meeting of the Health Physics SocietyHealth Physics Society

Providence, RI Providence, RI

Chapel ConsultingChapel Consulting

Chapel Consulting assists Chapel Consulting assists distributors of instruments distributors of instruments containing radioactive sources containing radioactive sources with regulatory compliance issues with regulatory compliance issues

In order to provide this assistance In order to provide this assistance we must be constantly aware of we must be constantly aware of regulatory trends and issuesregulatory trends and issues

Portable Hand Held Portable Hand Held DevicesDevices

Portable, hand held devices Portable, hand held devices containing radioactive sources containing radioactive sources are used throughout our society are used throughout our society for such purposes as detection of for such purposes as detection of explosives, narcotics, explosives, narcotics, bioweapons, etc.bioweapons, etc.

NRC Has Three NRC Has Three Categories of Device Categories of Device

ApprovalApprovalSpecificSpecific

GeneralGeneral

ExemptExempt

Specifically Licensed Specifically Licensed DevicesDevices

May only be used by persons May only be used by persons possessing a written authorization in possessing a written authorization in the form of a license issued by the NRC the form of a license issued by the NRC or an Agreement State. or an Agreement State.

Among the requirements, the RSO Among the requirements, the RSO must complete comprehensive must complete comprehensive radiation safety training radiation safety training

An example is a moisture/density An example is a moisture/density detector used in road construction. detector used in road construction.

Generally Licensed Generally Licensed DevicesDevices

Do not require possession of a written Do not require possession of a written license to be purchasedlicense to be purchased

End user must agree to certain End user must agree to certain conditions regarding the use of the conditions regarding the use of the device, leak testing, maintaining device, leak testing, maintaining records, and lawful disposal. records, and lawful disposal.

Some types of Generally Licensed Some types of Generally Licensed Devices require registration with the Devices require registration with the NRC or the Agreement State NRC or the Agreement State

An example of this type of device is a An example of this type of device is a static eliminator.static eliminator.

Exempt DevicesExempt Devices

Do not have any requirements for Do not have any requirements for use by the end user. use by the end user.

An example of this type of device An example of this type of device is a typical 10 microcurie Am-241 is a typical 10 microcurie Am-241 smoke detector.smoke detector.

Tracking of Portable Tracking of Portable GL DevicesGL Devices

The tracking of generally licensed The tracking of generally licensed devices in the United States has devices in the United States has always been a daunting task. There always been a daunting task. There are thousands of these devices in are thousands of these devices in existence and are often moved existence and are often moved about from company to company about from company to company and individual to individual, not and individual to individual, not always in accordance with always in accordance with regulations.regulations.

Registration of GL Registration of GL DevicesDevices

As of May 2006 39 States have a As of May 2006 39 States have a

program in place for the registration of program in place for the registration of

generally licensed devices. The NRC is generally licensed devices. The NRC is

also registering GL devices with certain also registering GL devices with certain

radionuclides in quantities specified in radionuclides in quantities specified in

10 CFR 31.5.10 CFR 31.5.

Registration ProcessRegistration Process

Registration of devices involves the Registration of devices involves the end end

user submitting an application to the user submitting an application to the

NRC, Agreement State, or Non-NRC, Agreement State, or Non-

Agreement State with information Agreement State with information

about the device, contact person, and about the device, contact person, and a a

fee.fee.

Lack of Consensus on Lack of Consensus on Portable GL DevicesPortable GL Devices

Some Agreement States have Some Agreement States have policies which require specific policies which require specific licenses for portable GL Deviceslicenses for portable GL Devices

This is an attempt to have greater This is an attempt to have greater tracking and accountability for tracking and accountability for devices, as well as radiation devices, as well as radiation safety training for end users.safety training for end users.

Exemption Exemption Complicates IssueComplicates Issue

In 2004 the NRC approved a In 2004 the NRC approved a portable GL device already in portable GL device already in wide usage to be re-distributed as wide usage to be re-distributed as exempt. Some Agreement States exempt. Some Agreement States were not pleased with this were not pleased with this decision, as they are trying todecision, as they are trying to

maintain greater control over maintain greater control over these types of devices.these types of devices.

Need for ReformNeed for Reform

The possibility of registration, a specific The possibility of registration, a specific

license, or GL status only license, or GL status only for the same for the same

devicedevice with different policies in each with different policies in each

state creates a cumbersome, state creates a cumbersome,

inconsistent regulatory environment for inconsistent regulatory environment for

all stakeholders.all stakeholders.

What does “portable” What does “portable” meanmean

No clear definition exists of the term No clear definition exists of the term “portable”.“portable”.

Some Agreement States regard Some Agreement States regard “portable” to mean the device may “portable” to mean the device may be moved offsite to be used at be moved offsite to be used at temporary job sites.temporary job sites.

If the device is not moved offsite, it If the device is not moved offsite, it may not be regarded as being may not be regarded as being “portable”“portable”

Proposed Definitions Proposed Definitions for Portability of for Portability of

DevicesDevices Portable:Portable: A device which is hand held, is not A device which is hand held, is not

connected to an external power source, and connected to an external power source, and can be easily moved from place to place to can be easily moved from place to place to temporary job sites.temporary job sites.

Semi-Portable:Semi-Portable: A device which is not hand A device which is not hand held, is not connected to an external power held, is not connected to an external power source, and can be moved from place to source, and can be moved from place to place to temporary job sites.place to temporary job sites.

Non-Portable:Non-Portable: A device which is not hand A device which is not hand held, but designed to be permanently fixed held, but designed to be permanently fixed or mounted for use at a facility. It may or or mounted for use at a facility. It may or may not have an external power source, and may not have an external power source, and can not be used at temporary job sites.can not be used at temporary job sites.

Importance of Nationally Importance of Nationally Recognized Standards Recognized Standards for Portable GL Devicesfor Portable GL Devices

The adoption of nationally The adoption of nationally recognized recognized

manufacturing standards referenced manufacturing standards referenced

during the approval process of during the approval process of

portable GL devices is vital to the portable GL devices is vital to the

regulatory community, device regulatory community, device

manufacturers, and end users.manufacturers, and end users.

Criteria for Portable GL Criteria for Portable GL Device ApprovalsDevice Approvals

Degree of Portability of the InstrumentDegree of Portability of the Instrument Radiotoxicity of the SourceRadiotoxicity of the Source Conditions of UseConditions of Use If the end user has direct access to the If the end user has direct access to the

sourcesource Greater control for devices with shuttersGreater control for devices with shutters Tamper resistant screws to prevent Tamper resistant screws to prevent

unauthorized removal of the sourceunauthorized removal of the source If Radiation safety training required to If Radiation safety training required to

operate the device safelyoperate the device safely Record of safe use as a GL device before Record of safe use as a GL device before

being declared exemptbeing declared exempt

Who will issue Who will issue standards?standards?

A joint ANSI/HPS committee which A joint ANSI/HPS committee which amends ANSI N538-1979, amends ANSI N538-1979, Classification of Industrial Classification of Industrial Radiation Gauging DevicesRadiation Gauging Devices, to , to include a section on portable include a section on portable devices.devices.

Revised Policy Revised Policy DecisionsDecisions

Revised policy could come from:Revised policy could come from: NRC, in the form of an updated version NRC, in the form of an updated version

of NUREG 1556, Vol.3 to include a of NUREG 1556, Vol.3 to include a section on requirements for portable section on requirements for portable devicesdevices

CRCPD, in the form of amendments to CRCPD, in the form of amendments to the Suggested State Regulationsthe Suggested State Regulations

OAS, providing guidance on Agreement OAS, providing guidance on Agreement State adoption and implementationState adoption and implementation

Inclusion of All Inclusion of All StakeholdersStakeholders

It is important for regulators to It is important for regulators to balance radiation safety criteria balance radiation safety criteria with the requirements of the with the requirements of the manufacturer as well as the needs manufacturer as well as the needs end users of the device. Portable end users of the device. Portable devices which are approved as devices which are approved as safe for use as a GL should meet safe for use as a GL should meet the same, consistent standards the same, consistent standards and be recognized for non-and be recognized for non-specifically licensed use specifically licensed use throughout the U.S.throughout the U.S.

ReferencesReferences

““10 CRF 31.5, Certain detecting, measuring, 10 CRF 31.5, Certain detecting, measuring, gauging, or controlling devices and certain gauging, or controlling devices and certain Devices for producing light or an ionized Devices for producing light or an ionized atmosphere”, U.S.N.R.C., October 1999.atmosphere”, U.S.N.R.C., October 1999.

““Dredging Up the Problems of Portable GL Dredging Up the Problems of Portable GL Devices.”, the Organization of Agreement Devices.”, the Organization of Agreement States (OAS) 2005 Annual Meeting, David K. States (OAS) 2005 Annual Meeting, David K. Walter, Director, Radioactive Materials Walter, Director, Radioactive Materials Licensing, Alabama Office of Radiation Licensing, Alabama Office of Radiation Control, State Health Department, October Control, State Health Department, October 4, 2005.4, 2005.

G.E. Ion Track Device Registration Sheet G.E. Ion Track Device Registration Sheet NR-0339-D-101-E, US NRC.,August 19, 2004.NR-0339-D-101-E, US NRC.,August 19, 2004.