Responsibilities

A fundamental concept in the legislation is that prime responsibility for radiation safety resides with those authorized to possess and to use, manufacture, supply or install radiation sources. “The prime responsibility for safety shall be assigned to the operator” (Ref. [31], para. 2.3).

Authorization by licensing is required by the regulatory body for all practices, other than those to which an exemption applies, that are not otherwise designated as suitable for notification alone or registration [11]. In all cases the operators using a sealed source are, as a minimum, required to submit in support of notification and for application for authorization the information described in requirements 3.32 and 3.33 of GS-R-1 [29]. Most Member States have systems in place that date back to the time prior to the purchase of the sources, currently in use. This means that all sources in current use are likely to be covered by a license.

Sealed sources have a life cycle, beginning with manufacture and ending in disposal. Each source life cycle comprises a number of sequential steps, which are illustrated in Fig. 43. A source life cycle can involve a series of individuals in various organizations, such as regulatory body, source manufacturer, device manufacturer, distributor, user(s) (one or subsequent users), waste processing organization, and operator of a storage and/or disposal facility.

The potential involvement of a large number of organizations and their interactions mean that source life cycles are indeed complex and often difficult to establish.

FIG. 43. The life cycle of a radioactive source.

The key issue during the entire life cycle of a SRS is the protection of individuals or groups from inadvertent radiation exposure and minimization of risk from malevolent use of sources.

5.2.1. source manufacturer

A source manufacturer usually accepts ownership of the radioactive material at the time of delivery from the radioisotope production facility. The source manufacturer is then legally responsible for the safe handling of the radioactive material in his possession and for the subsequent transfer of ownership.

The source manufacturer is required to supply to the user and regulatory body a source certificate that contains comprehensive information about the source, such as model and serial number, radionuclide, activity, date of calibration, capsule type, special form certificate number and manufacturer information. This information is critical in demonstrating source specific information for compliance with the requirements for the management of sources when they become disused.

5.2.2. Device/equipment manufacturer

A device/equipment manufacturer provides the equipment into which a source is loaded, either before shipment to the user’s site or after installation.

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The device manufacturer is required to meet national and international standards for the safety of the equipment, including the design approval from the relevant regulatory authority. In addition, the equipment manufacturer is required by regulations to provide to the user all information needed to safely and properly operate and maintain the equipment. This includes all relevant information about the source and source transportation procedures, including the means of securing the source in a safe condition, interlocks, and emergency preparedness.

For high activity radioactive sources, such as teletherapy machines, the equipment manufacturer is required to provide technical services related to the periodic reloading of radioactive sources.

5.2.3. Distributor

A distributor authorized by the regulatory body is responsible for carrying out some transport and supply operations in accordance with international laws that pertain to transportation of radioactive materials. These responsibilities could include verifying that the consignee is an authorized person or entity to possess radioactive material in accordance with national regulations and applicable notification requirements.

The source manufacturer/equipment manufacturer (who may, depending on the terms of delivery, continue ownership of the source during transportation) and the distributor have shared responsibilities during transportation and supply operations.

5.2.4. User

A user usually accepts ownership of the source material at the time of delivery from the distributor. Users (registrants and licensees) are responsible for setting up and implementing the technical and organizational measures that are needed to ensure the security and safety of the sources. The user is legally responsible for the safe handling of the radioactive material under all applicable laws and licenses, and for its subsequent transfer of ownership. License conditions typically require the user to securely retain a copy of the source certificate information provided by the source manufacturer. Although not usually required by a license, the user needs to retain all technical information about the equipment provided by the equipment manufacturer.

When the source becomes disused, after short on-site storage, the source will be transferred to another place where its long term storage or disposal can be ensured. Then ownership is transferred to another party, such as a source manufacturer or a central radioactive waste management organization (CRWMO). In the event that the user stores the source prior to a formal transfer of ownership (temporary storage), the responsibility for the safety and security issues during interim storage of the source lies with the user.

5.2.5. Central radioactive waste management organization

A CRWMO provides handling, conditioning and storage of disused sources from various applications in the country. It is legally responsible for the safe and secure conditioning and storage of the sources under its ownership, and typically operates under license conditions established by a regulatory body. This responsibility ends when the source has decayed sufficiently to be disposed of as non-hazardous material, or until the source is legally transferred to another organization, such as a disposal facility. As a requirement of its license, a CRWMO maintains an up to date inventory of all sources in its possession, including all specific details provided by the source manufacturer.

In the event that a licensee is incapable of managing disused sources, or the license is revoked, or the licensee no longer exists, the CRWMO may become responsible for the overall management of the disused sources, if requested by the regulatory body.

In large countries, instead of one CRWMO, there could be several regional operating organizations with the same functions.

5.2.6. Disposal facility

A waste disposal facility is legally responsible for all radioactive waste including DSRSs accepted for disposal. In most countries this is a centralized facility providing services for the disposition of DSRSs received from all users in the country. The disposal facility may carry out some conditioning and associated operations on the site, in this case its operating license should cover also these activities and facilities if any.