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J.K. PEREIRA

Canadian Nuclear Safety Commission, Ottawa, Ontario, Canada

There is now wide agreement that safe and secure use of radioactive sources can only be ensured by commitment to continuous control measures.

So, what is meant by continuous control? It is the implementation of regulatory oversight of radioactive sources at every stage of their life cycle, i.e. from cradle to grave. An effective and comprehensive cradle to grave regime has to extend beyond national borders. It requires participation by the international community in ensuring safe and secure use of radioactive sources.

We cannot ignore the wide extent of the distribution and use of radioactive sources. Each entity involved in any stage of the life cycle of radioactive sources has roles and responsibilities for the assurance of safety and security. Hence there has to be engagement by regulators, manufacturers, distributors, users and transporters. A life cycle approach to radioactive source management is a cornerstone for successful and effective regulatory control over high risk radioactive sources. Each entity should play its role and discharge its responsibilities with a commitment to assurance of safety and security in the use of these substances.

Competent national authorities should implement their regulatory requirements in accordance with the risk posed by the radioactive sources that fall within their jurisdictions. Their regulatory systems should be risk-informed in order to optimize resource allocation and so enhance the regulatory oversight of radioactive sources. Continuous regulatory oversight introduces challenges that need to be addressed. A primary one is the challenge of achieving effective international regulatory control without unduly restricting the medical, industrial, academic or research benefits received from the use of radioactive sources. Nuclear regulators have differing mandates when it comes to regulating radioactive sources, and these differences should not be ignored when addressing the issues of life cycle control of sources. In Canada, the nuclear regulator, the Canadian Nuclear Safety Commission, has as part of its mandate the requirement to regulate the production, possession, use and transport of nuclear substances to protect health, safety and security. It carries out these functions via a comprehensive regulatory licensing regime. Licensees

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are required to conduct their activities within their authorizations and with due diligence.

There are unique control and security challenges that need to be addressed in each phase of the life cycle of a radioactive source. The first phase is the manufacture of the radioactive source and the design of the device in which it is installed. The concerns involve the risk of theft of the source, and the degree of dispersability of radioactive material if the sealed source is breached.

Regulatory initiatives should be undertaken to reduce the production of easily dispersable radioactive material. Competent national authorities and manufac-turers should collaborate in investigating how devices can be designed to make them less attractive for malicious use purposes. Radioactive source production is centralized in a relatively few countries which supply users throughout the world. Hence it may be possible to achieve relatively large benefits through focused efforts on the part of this small industry group.

The second phase of the life cycle of a radioactive source commences when distributors or manufacturers transfer or sell sources to users nationally or internationally. The nuclear regulator should require that anyone wishing to use a radioactive source be authorized to possess and use the source for a specific application. It also must ensure that the person is qualified to carry out this licensed activity and that the nuclear regulator with the jurisdiction in the location of use has in place a comprehensive compliance programme to verify that the licensed activity is carried out in accordance with the national regula-tions. Prior to authorizing the possession and use of a radioactive source, the nuclear regulator must verify that the prospective user is a legitimate entity with valid reasons for wanting to possess the source and that the prospective user will make adequate provisions to ensure health, safety and security.

During this stage, the responsibility of the manufacturers and distributors is to verify that they transfer radioactive sources only to holders of valid authoriza-tions. In some situations, the manufacturer or distributor will also install sources into devices and provide management oversight training regarding safety culture, worker training, and security measures and procedures.

In order to ensure continuous control and verify security during the transfer and use of sources, regulators must ensure that adequate source tracking is being carried out. This is accomplished by requiring the manufac-turers and distributors to:

(a) Manufacture sources with unique identifiers;

(b) Obtain authorization information for the possession and use of the sources;

(c) Provide transaction records to the regulatory body;

(d) Maintain records of the disposition of returned sources.

SUSTAINABLE CONTINUOUS CONTROL OF THE USE OF RADIOACTIVE SOURCES

51 Nuclear regulators must establish national sealed source registries for high risk radioactive sources. The sealed source registry will provide the nuclear regulator with a means to manage the risk posed by these radioactive sources. The existence of this registry will facilitate the tracking of high risk sources as they are being transferred, used, imported or exported. Periodic regulatory self-assessment must be carried out by the competent national authority to ensure that existing regulatory programmes are effective in ensuring regulatory oversight of radioactive sources. When needed, the competent authority should enhance its regulatory programmes so as to exercise control that is appropriate for the risk posed by the radioactive sources within national boundaries.

Consideration should also be given to requirements for manufacturers or suppliers to inform the regulator of unusual requests for the supply of radioactive sources. Examples are requests for sources with increased activity levels, requests for more sources than normal and changes in the frequency of orders.

These steps would improve the overall control over sources within national boundaries. However, countries that manufacture and supply radioactive sources are not able to exert the same level of regulatory control over buyers in other countries. In most cases, there is very little regulatory oversight in controlling the export of sources. Currently, exporting countries are only able to carry out a limited verification that buyers are authorized to possess the sources being sought. Clearly the verification of the legitimacy of end users and their possession of proper authorizations, and that adequate provisions for the safety and security of high risk radioactive sources are in place, can only be carried out by national regulatory bodies.

Acceptance of the principles for controlling the export of radioactive sources, by providing political commitment to the IAEA Code of Conduct on the Safety and Security of Radioactive Sources and its import/export guidance, will ensure international harmonization for continuous regulatory control over high risk radioactive sources. The implementation of this guidance through international agreements would enhance the overall control and security in both the short and the long term.

The final phase of the life cycle of a radioactive source is its disposal or recycling when it has reached the end of its useful life. The cost of properly disposing of an unwanted source is a financial burden users would rather not have. Manufacturers and exporting countries should be urged to facilitate the return of unwanted sources to entities that can provide the necessary controls.

It will always be better to do so than to leave the sources in the possession of individuals with no desire or resources to implement adequate control over

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them. One issue that is an obstacle for manufacturers in readily accepting the return of unwanted sources is the uncertainty of future disposal costs.

In summary, efforts to enhance the control and security over radioactive sources cannot be carried out in isolation by the regulatory authorities. Collab-oration with manufacturers and suppliers of sources is needed when developing and implementing an overall regulatory regime.

In addition, bilateral, multilateral and, where needed, regional arrange-ments will also enhance the control and security of radioactive sources. On the North American continent, there has already been some collaboration between Canada, Mexico and the United States of America for trilateral enhancement of the safety and security of radioactive sources used in the three States.

Member States are encouraged to initiate regional discussions for successful implementation of the Code of Conduct and its guidance on the import and export of radioactive sources. They should capitalize on the experience of other Member States who have mature regulatory systems.

The IAEA offers several guidance documents that will aid competent authorities in facing regulatory challenges. Adoption of these principles will ensure international harmonization and promote international cooperation.

The IAEA has in place several regulatory enhancement programmes. Member States are encouraged to embark on these programmes either to enhance their existing regulatory programmes or to establish new ones.

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