Thematic Safety Areas: Legislation and Regulation

Law and Order for Nuclear Technology

Regardless of what it is, where it comes from, what purpose it serves and what risks it presents, every radiation source shares one common attribute: the need to be “track-able” throughout its entire life cycle—i.e., from “manufacture to disposal”. During that period a source might travel many places and be handled by many people. These variables are the impetus for all aspects of radiation protection and are particularly relevant to the fundamental questions of who should track and control the source and how to best accomplish such a complex task.

Not surprising then, the first step in building a radiation protection infrastructure is largely a matter of establishing law and order—i.e., drafting a solid legislative framework and relevant regulations and setting up a fully independent regulatory body with enough authority, people power and financial resources to put the law into practice.

The act of creating legislation to support radiation protection is no different from other law-making exercises. However, some developing countries had limited expertise in the legislative process and little or no previous experience in radiation science. Similarly, while the concept of a regulatory authority was not new, defining the role of a regulatory authority for radiation protection was. One of its primary roles is to establish the rules by which users of radiation-based technology must abide. The IAEA helped such countries advance quickly through this phase by producing Model Legislation and Regulations—sample laws and related procedures to support the overarching goal of protecting people and the environment from unnecessary radiation exposure.

In order to fulfil its mandate to “…regulate the introduction and conduct of any practice involving sources of radiation”, the regulatory authority must oversee four key processes: notification, authorization, inspection and enforcement. The first two areas deal primarily with putting radiation sources to work. Organizations wishing to acquire radiation sources or radiation-based technologies must notify the regulatory authority, which makes the decision to grant a license or registration (in some cases, an authorization process must be carried out to verify that the organization has the capacity to ensure the safety and security of the radiation source and other related concerns). Inspection and enforcement address the need to ‘give regulations teeth’ by reminding users that compliance is mandatory, that the regulatory authority has the right to carry out inspections and that penalties are a part of reality.

Because radiation sources are used by both private and public organizations, the regulatory authority must be effectively independent and, thus, able to act impartially. Because radiation sources are now used in so many fields—particularly medicine and industry—the regulatory authority must be staffed by well-educated and trained individuals who have a high level of understanding of radiation protection issues, including the handling of radiation sources and radioactive waste.

Standardization and harmonization of legislation and regulations make it possible to hand many of the activities that support radiation protection down the chain of command. In fact, once a license or authorization has been granted, the licensee becomes responsible for the source—including ensuring that all employees are adequately trained to handle it appropriately so as to protect their own safety and that of patients or the public at large. In reality, the safety and security of radiation-based technologies depends on the thousands of people around the world who follow strict procedures day after day.

Each regulatory authority carries an enormous responsibility that requires careful execution of a multitude of tasks and ready access to mountains of data and information. The IAEA recognized the need to help developing nations, in particular, improve management of these areas—in a very practical way.

The Regulatory Authority Information System (RAIS) is a database created by the IAEA to help regulators track every parameter associated with their activities. RAIS combines the strengths of an extensive inventory and a detailed record of national expertise. It stores information on every radiation source and the facility in which it is used, including records of licenses and registration. On the expertise side, RAIS has a complete record of the qualifications of personnel and users, as well as the radiation doses received by individuals in occupational or medical settings. For developing nations, a ready-made database represents significant savings—and means limited resources can be devoted to other areas of radiation protection.

Establishing and maintaining an inventory of radiation sources can be challenging and time consuming. The regulatory authority may have to actively seek out sources already in use (which may or may not be registered) or conduct a thorough search for sources not in use as well as “orphan” sources (sources that have been improperly disposed of or for which it is impossible to identify an owner). Orphan sources represent particular safety and security risks in terms of potential accidents that could result in radiation emission, contamination or other public exposure. Their high value on the black market further opens the possibility that the radiation source could be re-used for malicious purposes.

For every Member State, the ultimate goal is effective and sustainable regulatory control. The IAEA supports this goal through education and training for young professionals and through expert assistance, procurement of radiation monitoring equipment, and technical implementation. But increasingly, Member States are working together on a regional basis through the Radiation Safety Regulators Network (RaSaRen) and through the technical cooperation programme. Peer-to-peer interaction facilitates sharing knowledge and experience while also improving cooperation, fostering an integrated and harmonized safety approach, and promoting continuous improvement.

One important benefit that arises from international harmonization and cooperation between Member States is reducing the vulnerability of radioactive sources during transfer between States and prevention of illicit trafficking. With the information tools in place at the national level and at the IAEA, it is much easier for the regulatory authority in the exporting country to exercise due care in ensuring that the recipient country has an adequate regulatory system in place. The IAEA further enhances cross-border safety by working with the World Customs Organization to developing training programmes for customs officers that focus on how to identify and deal with radiation sources.