Compatibility Issues Regarding Agreement State Regulations for Portable Devices Containing RAM Sources Sean Chapel, President Presented at the 2006 Annual Meeting of the Health Physics Society Providence, RI

Chapel Consulting Chapel Consulting assists distributors of instruments containing radioactive sources with regulatory compliance issues Chapel Consulting assists distributors of instruments containing radioactive sources with regulatory compliance issues In order to provide this assistance we must be constantly aware of regulatory trends and issues In order to provide this assistance we must be constantly aware of regulatory trends and issues

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

NRC Has Three Categories of Device Approval Specific Specific General General Exempt Exempt

Specifically Licensed Devices May only be used by persons possessing a written authorization in the form of a license issued by the NRC or an Agreement State. May only be used by persons possessing a written authorization in the form of a license issued by the NRC or an Agreement State. Among the requirements, the RSO must complete comprehensive radiation safety training Among the requirements, the RSO must complete comprehensive radiation safety training An example is a moisture/density detector used in road construction. An example is a moisture/density detector used in road construction.

Generally Licensed Devices Do not require possession of a written license to be purchased Do not require possession of a written license to be purchased End user must agree to certain conditions regarding the use of the device, leak testing, maintaining records, and lawful disposal. End user must agree to certain conditions regarding the use of the device, leak testing, maintaining records, and lawful disposal. Some types of Generally Licensed Devices require registration with the NRC or the Agreement State Some types of Generally Licensed Devices require registration with the NRC or the Agreement State An example of this type of device is a static eliminator. An example of this type of device is a static eliminator.

Exempt Devices Do not have any requirements for use by the end user. Do not have any requirements for use by the end user. An example of this type of device is a typical 10 microcurie Am-241 smoke detector. An example of this type of device is a typical 10 microcurie Am-241 smoke detector.

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

Registration of GL Devices As of May States have a program in place for the registration of generally licensed devices. The NRC is also registering GL devices with certain radionuclides in quantities specified in 10 CFR 31.5.

Registration Process Registration of devices involves the end user submitting an application to the NRC, Agreement State, or Non- Agreement State with information about the device, contact person, and a fee.

Lack of Consensus on Portable GL Devices Some Agreement States have policies which require specific licenses for portable GL Devices Some Agreement States have policies which require specific licenses for portable GL Devices This is an attempt to have greater tracking and accountability for devices, as well as radiation safety training for end users. This is an attempt to have greater tracking and accountability for devices, as well as radiation safety training for end users.

Exemption Complicates Issue In 2004 the NRC approved a portable GL device already in wide usage to be re-distributed as exempt. Some Agreement States were not pleased with this decision, as they are trying to In 2004 the NRC approved a portable GL device already in wide usage to be re-distributed as exempt. Some Agreement States were not pleased with this decision, as they are trying to maintain greater control over these types of devices. maintain greater control over these types of devices.

Need for Reform The possibility of registration, a specific license, or GL status only for the same device with different policies in each state creates a cumbersome, inconsistent regulatory environment for all stakeholders.

What does portable mean No clear definition exists of the term portable. No clear definition exists of the term portable. Some Agreement States regard portable to mean the device may be moved offsite to be used at temporary job sites. Some Agreement States regard portable to mean the device may be moved offsite to be used at temporary job sites. If the device is not moved offsite, it may not be regarded as being portable If the device is not moved offsite, it may not be regarded as being portable

Proposed Definitions for Portability of Devices Portable: A device which is hand held, is not connected to an external power source, and can be easily moved from place to place to temporary job sites. Portable: A device which is hand held, is not connected to an external power source, and can be easily moved from place to place to temporary job sites. Semi-Portable: A device which is not hand held, is not connected to an external power source, and can be moved from place to place to temporary job sites. Semi-Portable: A device which is not hand held, is not connected to an external power source, and can be moved from place to place to temporary job sites. Non-Portable: A device which is not hand held, but designed to be permanently fixed or mounted for use at a facility. It may or may not have an external power source, and can not be used at temporary job sites. Non-Portable: A device which is not hand held, but designed to be permanently fixed or mounted for use at a facility. It may or may not have an external power source, and can not be used at temporary job sites.

Importance of Nationally Recognized Standards for Portable GL Devices The adoption of nationally recognized The adoption of nationally 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 Device Approvals Degree of Portability of the Instrument Degree of Portability of the Instrument Radiotoxicity of the Source Radiotoxicity of the Source Conditions of Use Conditions of Use If the end user has direct access to the source If the end user has direct access to the source Greater control for devices with shutters Greater control for devices with shutters Tamper resistant screws to prevent unauthorized removal of the source Tamper resistant screws to prevent unauthorized removal of the source If Radiation safety training required to operate the device safely If Radiation safety training required to operate the device safely Record of safe use as a GL device before being declared exempt Record of safe use as a GL device before being declared exempt

Who will issue standards? A joint ANSI/HPS committee which amends ANSI N , Classification of Industrial Radiation Gauging Devices, to include a section on portable devices. A joint ANSI/HPS committee which amends ANSI N , Classification of Industrial Radiation Gauging Devices, to include a section on portable devices.

Revised Policy Decisions Revised policy could come from: NRC, in the form of an updated version of NUREG 1556, Vol.3 to include a section on requirements for portable devices NRC, in the form of an updated version of NUREG 1556, Vol.3 to include a section on requirements for portable devices CRCPD, in the form of amendments to the Suggested State Regulations CRCPD, in the form of amendments to the Suggested State Regulations OAS, providing guidance on Agreement State adoption and implementation OAS, providing guidance on Agreement State adoption and implementation

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

References 10 CRF 31.5, Certain detecting, measuring, gauging, or controlling devices and certain Devices for producing light or an ionized atmosphere, U.S.N.R.C., October CRF 31.5, Certain detecting, measuring, gauging, or controlling devices and certain Devices for producing light or an ionized atmosphere, U.S.N.R.C., October Dredging Up the Problems of Portable GL Devices., the Organization of Agreement States (OAS) 2005 Annual Meeting, David K. Walter, Director, Radioactive Materials Licensing, Alabama Office of Radiation Control, State Health Department, October 4, Dredging Up the Problems of Portable GL Devices., the Organization of Agreement States (OAS) 2005 Annual Meeting, David K. Walter, Director, Radioactive Materials Licensing, Alabama Office of Radiation Control, State Health Department, October 4, G.E. Ion Track Device Registration Sheet NR D-101-E, US NRC.,August 19, G.E. Ion Track Device Registration Sheet NR D-101-E, US NRC.,August 19, 2004.