The Model Project

Background

By its Statute, the IAEA is authorized to establish or adopt safety standards for protection of health and minimization of danger to life and property, and to provide for the application of these standards to its own operations as well as to operations making use of materials, services, equipment, facilities, and information made available by the IAEA. One of the main components through which these standards are applied is the Agency’s Technical Co-operation (TC) programme.

Since 1984, information specifically relevant to radiation safety infrastructure was obtained through more than 60 expert team missions undertaken by Radiation Protection Advisory Teams (RAPATs), follow-up technical visits and hundreds of individual expert missions undertaken within the framework of national, regional and/or interregional TC projects. Building on this xperience and subsequent policy reviews, the IAEA took steps to evaluate more systematically the needs for technical assistance in areas of nuclear and radiation safety. The outcome was the development of an integrated strategy designed to more closely assess needs and priorities and optimize resources for upgrading radiation and waste safety infrastructures in the IAEA’s Member States receiving its assistance. The main components of this strategy consist of collecting and evaluating information on the existing safety infrastructure, establishing and maintaining Country Radiation and Waste Safety Profiles and formulating and implementing Country Radiation and Waste Safety Action Plans. The latter are needed to rectify safety gaps and to sustain an effective radiation and waste safety infrastructure.

To implement the above strategy, the IAEA included in its TC programme a Model Project on Upgrading Radiation Protection Infrastructures in Member States receiving its assistance.

Project Objectives and Magnitude

The objectives of the Model Project are to assist those IAEA Member States which have an inadequate radiation protection infrastructure and are receiving IAEA assistance, so that they can comply with the International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources (BSS).

It was originally envisaged, in 1994, that some five to six Member States would benefit each year from the Model Project. However, material gathered indicated that more than 50 countries were in need of assistance (see participating countries). Hence programme and management adjustments had to be made. An integrated management approach was thus developed with the aim of achieving adequate national radiation and waste safety infrastructures in the participating countries. In support of this approach, the IAEA appointed four ‘Regional Managers’ for the regions of Africa, East and West Asia, Latin America, and Europe.

Country Radiation and Waste Safety Profiles

For all the participating countries, draft country radiation and waste safety profiles were prepared. The intention behind the establishment of the country radiation and waste safety profile is to keep updated all the data known to the IAEA on the radiation and waste safety infrastructure of the country. Files containing information such as laws and regulations, mission reports, papers describing the situation, and other material and relevant safety action plans are also maintained. The essential structure of the system relies on a questionnaire, the answers to which are the basic inputs for the computerized database.

The questionnaire and derived database cover the following main sections: organizational infrastructure; legal and regulatory status; training; extent of practices; individual monitoring; public exposure control; medical exposure control; radioactive waste safety; transport of radioactive material; planning for and response to radiation emergencies; and quality assurance.

Country Radiation and Waste Safety Action Plans

For all the participating Member States, Country Radiation and Waste Safety Action Plans were developed from an analysis of the country radiation and waste safety profiles against the requirements for an adequate safety infrastructure in accordance with the BSS. Action Plans cover 5 milestones: 1. Legislation and Regulations, Regulatory Authority, system of notification, authorization and control of radiation sources together with the inventory of radiation sources and installations; 2. Occupational Exposure Control; 3. Medical Exposure Control; 4. Public Exposure Control; 5. Emergency Response.

The action plans include tasks and actions which are the responsibility of the Member State and tasks which are the responsibility of the Agency with an agreed time table. The action plans cover 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 together with an inventory of radiation sources— whatever their use — within the country. 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.

Commitment by the Governments

The Model Project presumes that governments and national authorities are prepared to comply with their obligations as described in the Preamble of the BSS. For this reason, firm commitments were obtained from all participating countries, while all country safety action plans were discussed and finalized with, and then approved by relevant counterparts and authorities in each participating Member State. The implementation of the country radiation and waste safety action plans could not start before obtaining official approval from the Member State concerned. As a result of this approach, Member States firmly committed themselves to establishing a national infrastructure which includes inter alia:

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 authority empowered and authorized to inspect radiation users and to enforce the legislation and/or regulations
Sufficient resources
Adequate numbers of trained persons

Milestone Setting

After the preparation of the country radiation and waste safety profiles and during the preparation of the action plans, project milestones were defined in order to facilitate the setting of priorities, the timing and monitoring of progress and the optimization of resources. The first milestone and the most consuming activity covers legislation and regulations, the designation and empowerment of a national regulatory authority and the establishment of national system for notification, authorization and control of radiation sources together with the preparation of an inventory of radiation sources and installations. The second milestone deals with the establishment of occupational exposure control. The third and fourth milestones involve medical and public exposure control, respectively. The fifth milestone concerns the establishment of emergency preparedness and response capabilities.

Standardization and Harmonization of Activities

The efficient use of resources implies a balance between standardized measures and respect for the peculiarities of each specific Member State. As described herein, a number of activities and tasks have been harmonized thus improving the level of common understanding of all concerned. The main items standardized are:

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 Source; 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. A Model Legislation to establish a Regulatory Authority as presumed in the BSS and Model Regulations based upon the BSS are also provided in an Annex. Other Model regulations covering radioactive waste management safety and radioactive transport safety were also developed and annexed to the above document. All these Model Legislation and Regulations were translated into Arabic, French, Russian and Spanish.

Once the system of notification, authorization and control of radiation sources has been designed, there is a need for advice on how to implement it. A Technical Document was prepared describing 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 checklists for the main practices (such as industrial radiography, industrial irradiators, gauges, radiotherapy, nuclear medicine, diagnostic radiology, among others) in order to assist regulatory authorities in reviewing safety in the process of authorization and inspection.

The management of the regulatory programme needs prompt and updated information for planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and following up regulatory actions including monitoring deadlines. For this purpose, a software called the Regulatory Authority Information System (RAIS) has been developed and is currently being used by more than 80 % of participating Member States. The system is composed of five modules covering: inventory of radiation sources and installations; authorization process; inspection and enforcement; dosimetry of occupationally exposed personnel; and performance indicators for individual installations as well as for the overall regulatory programme.

Training of manpower for regulatory authorities and users have been provided in a synchronized and standardized manner, through regional and national training courses and workshops. Syllabi and prospectuses and training manuals were standardized and translated into Arabic, French, Russian and Spanish.

Peer Reviews

As the implementation of the country safety action plans progresses, both Member States and the IAEA need to appraise the effectiveness of the measures taken at the different stages of organization and implementation of the action plans in order to correct weaknesses and optimize resources. For this purpose, a draft Safety Report entitled Assessment by Peer Review of the Effectiveness of Regulatory Programmes for Protection against Ionizing Radiation and for the Safety of Radiation Sources was prepared. The document provides advice on the conduct of peer reviews using a methodology to obtain qualitative and quantitative information and on its analysis against performance criteria and indicators. Qualitative information (e.g., the quality of a safety assessment for licensing and inspection purposes) are being analysed by peer reviews through senior experts, but it will be greatly facilitated by prompt and reliable information on the regulatory programme, using information from the Regulatory Authority Information System.

The Peer Review missions were implemented during 1999 - 2001. Thirty- two Member States participating in the Model Project were visited during the period August 1999 - September 2001. The terms of reference of each Peer Review were:

To determine the status of radiation safety and assess the national regulatory infrastructure, in particular as it is established, organized and implemented
To determine how effective the Model Project has been improving the situation in the country
To submit findings, conclusions and recommendations, if any, for further strengthening of the national infrastructure for radiation protection and safety

Progress Achieved

During implementation, project activities were continuously monitored, inter alia, through regular co-ordination and planning meetings with participating Member States in each of the five regions. The meetings provided opportunities for direct contact with persons having political responsibilities (ministers, deputy ministers, members of parliament, etc.) and executive responsibilities (chairmen of atomic energy commissions, directors of regulatory authorities, project counterparts, etc.) in their countries with a view to facilitating the implementation of the project.

As a result of the above monitoring activities and the peer review missions, the status of project implementation as of September 2001 can be summarized as follows:

Activities relating to milestone 1 were implemented with varying degrees of success. The situation of the countries as of September 2001 was as follows:

About 77% of the participating countries had promulgated laws
Aabout 77% had established a regulatory authority
More than 42% had adopted regulations
About 80% had an inventory system in place and operational
About 50% had a system for the notification, authorization and control of radiation sources in place and operational

From the above figures, it may be concluded that about 50% had achieved the regulatory level of compliance presumed in the Preamble to the BSS by completing all activities foreseen under milestone 1. Considering the nearly six years of implementation, this specific level of achievement is much lower than originally expected; the time necessary to overcome some of the difficulties, already identified at the time of project design, was underestimated. Many countries did not attain milestone 1 for one or all of the the following reasons:

Time consuming legislative and regulatory procedures; institutional instability
Budgetary constraints, resulting among other things in high turnover of qualified staff
Unfocused regulatory structures (overlapping responsibilities)
Limited regulatory independence and empowerment
Inadequate supplementary documentation (implementing regulations
Authorization and inspection procedures, and regulatory guides)
Insufficient financial and technical resources, trained staff, and support services (e.g., individual monitoring)

Where possible, some activities relating to other milestones, particularly milestone 2, were initiated in parallel with the implementation of activities for attaining milestone 1.

The progress towards milestones 2-5 by the end of September 2001 can be summarized as follows:

Programmes for occupational exposure control (milestone 2) were being successfully implemented in most countries, with about 79% having individual monitoring and about 56% having workplace monitoring established and operational
Substantial parts of activities relating to milestones 3-5 had yet to be implemented by most of the participating countries

Conclusions

From the aforementioned continuous project monitoring and the peer reviews it may be concluded that substantial progress has been made in upgrading the radiation protection infrastructures in participating countries, especially the regulatory frameworks, including the systems for the notification, authorization and control of radiation sources and for occupational exposure control.

With respect to the results achieved, the participating countries may be divided into three categories:

Countries advanced in project implementation, which have attained milestones 1 and 2 and have succeeded in implementing several activities related to other milestones
Countries where there have been some implementation delays - these countries need to revise existing legislation and restructure existing radiation protection systems. There are indications that the national authorities concerned have become more committed, and that steps have been taken to expedite project implementation. If the observed trends continue, and there are no serious further delays, these countries should be able to report substantial progress in meeting the principal requirements of the BSS in the foreseeable future.
Countries where there have been major implementation delays as a result of difficulties due to institutional instability, severe general infrastructural weaknesses, inadequate support at the decision making level, changes in national programme priorities, inability to recognize the magnitude of certain problems, and failure to mobilize the necessary national human and financial resources. These countries had not attained even milestone 1. Further project monitoring and peer review missions in these countries are considered by the Secretariat to be necessary in order to assess progress, make recommendations and optimize the assistance effort for future improvements.

Current Activities

By the end of September 2001, the Secretariat had received requests from the following 29 countries (additional to the 52 Member States which participated in the first phase of the model project): in Africa - Angola, Burkina Faso, Egypt, Kenya, The Libyan Arab Jamahiriya, Morocco, Tunisia and the United Republic of Tanzania; in East Asia - China, Indonesia, Malaysia, Pakistan, the Philippines, Singapore and Thailand; In Europe - Bulgaria, Croatia, Hungary, Malta, Portugal, Romania, Slovenia and Turkey; in Latin America - Ecuador, Haiti, Uruguay and Venezuela; in West Asia - the Islamic Republic of Iran and Kuwait.

For further information please contact K. Mrabit