THE MODEL PROJECT 1. Project objectives

The objectives of the Model Project are to assist those IAEA Member States which have an inadequate radiation and waste safety infrastructure and are already receiving IAEA assistance, so that they can comply with the BSS by the year 2000.

The project draws upon the findings of RAPAT missions to 64 countries, which had served to increase awareness of radiation safety issues, and upon numerous expert missions on radiation protection undertaken in the past ten years.

One of the first actions in implementing the project was to define more clearly what constituted an adequate radiation and waste safety infrastructure. This had to be done for different types of radiation application, ranging from common industrial and medical uses found in every country to the full nuclear fuel cycle, which exists in relatively few developing countries.

IAEA-CN-70/B2.2 63

Decisions were taken about what was needed to bring each country up to an adequate level, about how to implement the provision of technical assistance and about how to verify results.

The main components of this process consist of collecting and evaluating infor-mation on the existing safety infrastructure, establishing and maintaining Country Safety Profiles and formulating and implementing Country Safety Action Plans. The latter are needed to rectify weak or non-existent infrastructure elements, to monitor the development of improvements in safety infrastructure, and to sustain an effective infrastructure and develop it for additional uses of radiation.

In 1994 it was originally envisaged that five or six countries would benefit each year from the Model Project. However, data gathered subsequently indicated that more than 50 countries were in need of assistance (Table I). Hence, programme and management adjustments had to be made, since achieving the objectives under an approach concentrating only on five or six countries per year would require more than a decade. An integrated management approach was thus developed, with the aim of achieving adequate national radiation and waste safety infrastructures in most partic-ipating countries by the year 2000. In support of the new approach, the Department of Technical Co-operation appointed Regional Managers for Africa, West and East Asia, Latin America, and Europe.

For all participating countries, assessments were made to identify their infra-structure weaknesses. These included, for example, legislative and regulatory weak-nesses, inadequate information — or even a complete lack of information — on the radiation sources in the country, and deficiencies in radiation and waste safety regu-lations, personnel dosimetry services, and the calibration and state of repair of equipment. Shortcomings were discussed by the Regional Managers with national authorities as part of the preparation of detailed Country Safety Action Plans. In all of the participating countries, these plans have already been approved, and their implementation is now well under way.

2.2. Country Safety Profiles

The intention behind the establishment of a Country Safety Profile information system is to maintain and keep updated all the data known to the IAEA on the radiation and waste safety infrastructure of a given country. Although the system includes a computerized database which will be made available to all concerned, it is not limited to the database alone. It also includes the assembly of 'hard' information including laws and regulations, mission reports, papers describing the situation, and other material and relevant Safety Action Plans. The essential structure of the system relies on a questionnaire, the answers to which are the basic inputs for the database.

The questionnaire and the database comprise nine main sections: organizational infrastructure; legal and regulatory status, including training; extent of practices

TABLE I. COUNTRIES PARTICIPATING IN THE MODEL PROJECT TO UPGRADE RADIATION AND WASTE SAFETY INFRASTRUCTURE

Africa East Asia and the Pacific Cameroon Bangladesh

involving ionizing radiation; provisions for individual dosimetry; public exposure control; radiation protection and safety of patients in medical diagnosis and therapy;

transport of radioactive material; planning and preparedness for radiation emergen-cies; and quality assurance.

3. METHODOLOGY

3.1. Commitment by the governments

It should be noted that the Model Project presumes that governments and national authorities are prepared to comply with their obligations as described in the

IAEA-CN-70/B2.2 65

Preamble of the BSS. For this reason, firm commitments were obtained from all participating countries, and all Country Safety Action Plans were discussed and final-ized with and approved by relevant counterparts and authorities in each participating Member State. The implementation of the Country Safety Action Plans could not start before official approval from the Member State concerned was obtained. As a result of this approach, Member States firmly committed themselves to establishing a national infrastructure which includes: an appropriate national legislation and/or regulations (the type of regulatory system will depend on the size, complexity and safety implications of the regulated practices and sources as well as on the regulatory traditions in the country); a regulatory body empowered and authorized to inspect radiation users and to enforce the legislation and/or regulations; sufficient resources;

and adequate numbers of trained persons.

3.2. Country Safety Action Plans

Country Safety Action Plans were developed from an analysis of the Country Safety Profiles against the requirements for an adequate infrastructure. Missing or deficient items were identified and documented for the preparation of a Safety Action Plan specific to each country. The Action Plan includes actions that are needed for the country to achieve a full and adequate infrastructure commensurate with its existing and planned applications of ionizing radiation.

Once the Department of Technical Co-operation received the agreement by the government on the Action Plan, it would start implementing the scheduled activities.

The Plans include both generic and specific activities. Generic activities apply to all countries and as a first priority cover notification, authorization, and control of all radiation sources — whatever their use — within the country. Later steps will cover protection of workers, patients receiving medical treatment and the public from envi-ronmental releases; emergency plans; transport arrangements; and other areas. Specific activities are tailored to each country's particular needs, such as personnel training or the provision of necessary equipment.

The development of human resources through training is an important component of the Model Project. It involves not only training in nuclear technologies but covers administrators, regulators, radiation protection specialists and medical personnel. The establishment and sustainability of a sound infrastructure for assuring radiation and waste safety depends heavily upon national capabilities in these areas.

3.3. Milestone setting

The first milestone to be achieved under the Model Project is the establishment of a system of notification and authorization as required by the BSS. The regional managers are expected to monitor and report on each country's compliance, and in

December 1998 the IAEA is scheduled to submit a comprehensive report on the progress achieved to its Board of Governors.

The approach used for the implementation of the Model Project represents a system that is being generalized to all Member States receiving IAEA assistance. It will provide the IAEA with a fully documented system for assessing the current status of any country with respect to its radiation and waste safety infrastructure and a prioritized and agreed set of needs that should form the basis of future technical assistance activities. There will also be enough data to assess the capacity of the country to assure the safety of other developments of technology or requested items of equipment that could pose radiation hazards.

Over time, the system should provide a firmer basis for the IAEA's co-operative work with its Member States and for the provision of technical assistance in areas of radiation and waste safety. Efforts can be better directed towards achieving a situation in which no Member State which actively co-operates with the IAEA can have an inadequate radiation and waste safety infrastructure. Under an agreed Action Plan, this work will encompass measures for improving the identifi-cation of needs and requirements and for enhancing the use of resources to further strengthen national capabilities to ensure safety in the peaceful applications of nuclear and radiation technologies.

3.4. Relevant IAEA standards and guidance

Regardless of its own stage of nuclear technological development, every country has a primary responsibility and a role to play in ensuring the safe use of radiation applications and the disposal of radioactive waste. To control the radiation exposure of workers, medical patients and the public, countries need laws and regulations supported by administrative measures and enforced by inspectors. Just as important are internationally agreed standards for radiation safety. The IAEA developed the BSS [1] in co-operation with the Food and Agriculture Organization of the United Nations, the International Labour Organisation, the OECD Nuclear Energy Agency, the Pan American Health Organization and the World Health Organization.

The BSS place requirements on registrants and licensees, who therefore have the primary responsibility for applying them; governments, however, have the respon-sibility to enforce the application of the requirements, generally through a system that includes a regulatory authority. Moreover, governments generally provide for certain services that exceed or complement the capabilities of the legal 'persons' authorized to conduct practices involving radiation sources. The BSS are therefore based on the presumption, outlined in their preamble, that a national infrastructure is in place enabling the Government to discharge its responsibilities for radiation protection and safety. The elements of the Country Safety Action Plans for the Model Projects are derived from the elements of the infrastructure as described in the preamble.

IAEA-CN-70/B2.2 67

A document that is instrumental in the implementation of the first milestone of the Model Project is the Technical Document entitled Organization and Implementation of a National Infrastructure Governing Protection against Ionizing Radiation and the Safety of Radiation Sources; this document provides guidance on how to optimize and integrate each element of a regulatory infrastructure with its other elements. The elements covered include regulations, authorization, exemption, inspection, enforcement, accident investigation and dissemination of information.

More specifically, the system of notification and authorization and the options for combining registration and licensing are discussed in terms of the number and size of radiation practices within the country, the number of staff involved and their level of training, and the availability of expert consultant assistance. Model legislation to establish a regulatory authority as contemplated in the BSS and model regulations based upon the BSS are also provided in an annex.

Once the system has been designed, there is a need for advice on how to imple-ment it. A draft IAEA publication describes methods and review plans to facilitate authorization and inspection of radiation sources, including how to prepare and conduct an inspection and follow-up actions. The document includes specific check-lists for the main practices (such as industrial radiography, industrial irradiators, gauges, radiotherapy, nuclear medicine and diagnostic radiology) to assist regulatory authorities in reviewing safety in the process of authorization and inspection.

3.5. Standardization of activities

The efficient use of resources implies a balance between standardized measures and respect for the peculiarities of each Member State. As described herein, a number of activities have been standardized:

(a) The Country Safety Action Plans contain the same elements for all Member States, although individual actions may differ depending on the country profiles used for tailoring the Action Plans.

(b) Model legislation and model regulations ensure a consistent and coherent inter-national approach, and yet inter-national legal traditions are respected by allowing for local adaptation.

(c) Checklists for the safety review of the main practices using radiation have been provided to more than 50 Member States.

(d) Training of personnel for the regulatory programme is being done in a synchro-nized and standardized manner, through regional training events, and information exchange is being fostered through regional workshops.

(e) The setting of milestones facilitates a common methodology and timing to monitor progress (see Section 4).

(f) An information system for regulatory authorities is being implemented simulta-neously in more than 50 Member States (see Section 4).

4. MONITORING PROGRESS