IAEA SAFETY STANDARDS

Transcription

1 DS379 Draft 0.3 Clean Date: 22 June 2007 IAEA SAFETY STANDARDS for protecting people and the environment Status: Working draft for the Technical Meeting of July being a compilation of materials developed by the first-round drafting meetings, following partial editing by IAEA Secretariat. International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (Title is subject to discussion) Draft Safety Requirements DS379

2 (Front inside cover) IAEA SAFETY RELATED PUBLICATIONS IAEA SAFETY STANDARDS Under the terms of Article III of its Statute, the IAEA is authorized to establish or adopt standards of safety for protection of health and minimization of danger to life and property, and to provide for the application of these standards. The publications by means of which the IAEA establishes standards are issued in the IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, transport safety and waste safety, and also general safety (i.e. all these areas of safety). The publication categories in the series are Safety Fundamentals, Safety Requirements and Safety Guides. Safety standards are coded according to their coverage: nuclear safety (NS), radiation safety (RS), transport safety (TS), waste safety (WS) and general safety (GS). Information on the IAEA s safety standards programme is available at the IAEA Internet site The site provides the texts in English of published and draft safety standards. The texts of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety Glossary and a status report for safety standards under development are also available. For further information, please contact the IAEA at P.O. Box 100, A-1400 Vienna, Austria. All users of IAEA safety standards are invited to inform the IAEA of experience in their use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the purpose of ensuring that they continue to meet users needs. Information may be provided via the IAEA Internet site or by post, as above, or by to Official.Mail@iaea.org. OTHER SAFETY RELATED PUBLICATIONS The IAEA provides for the application of the standards and, under the terms of Articles III and VIII.C of its Statute, makes available and fosters the exchange of information relating to peaceful nuclear activities and serves as an intermediary among its Member States for this purpose. Reports on safety and protection in nuclear activities are issued in other publications series, in particular the Safety Reports Series. Safety Reports provide practical examples and detailed methods that can be used in support of the safety standards. Other IAEA series of safety related publications are the Provision for the Application of Safety Standards Series, the

3 Radiological Assessment Reports Series and the International Nuclear Safety Group s INSAG Series. The IAEA also issues reports on radiological accidents and other special publications. Safety related publications are also issued in the Technical Reports Series, the IAEA- TECDOC Series, the Training Course Series, and the IAEA Services Series, and as Practical Radiation Safety Manuals and Practical Radiation Technical Manuals. Security related publications are issued in the IAEA Nuclear Security Series.

4 The following States are Members of the International Atomic Energy Agency: AFGHANISTAN ALBANIA ALGERIA ARGENTINA ARMENIA AUSTRALIA AUSTRIA BANGLADESH BELARUS BELGIUM BENIN BOLIVIA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA BURKINA FASO CAMBODIA CAMEROON CANADA CHILE CHINA COLOMBIA COSTA RICA COTE D IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DEMOCRATIC REPUBLIC OF THE CONGO DENMARK DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GABON GEORGIA GERMANY GHANA GREECE GUATEMALA HAITI HOLY SEE HUNGARY ICELAND INDIA INDONESIA IRAN, ISLAMIC REPUBLIC OF IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRIYA LIECHTENSTEIN LITHUANIA LUXEMBOURG MADAGASCAR MALAYSIA MALI MALTA MARSHALL ISLANDS MAURITIUS MEXICO MONACO MONGOLIA MOROCCO MYANMAR NAMIBIA NETHERLANDS NEW ZEALAND NICARAGUA NIGER NIGERIA NORWAY PAKISTAN PANAMA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL QATAR REPUBLIC OF MOLDOVA ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SENEGAL SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SUDAN SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC THAILAND THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND UNITED REPUBLIC OF TANZANIA UNITED STATES OF AMERICA URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN YUGOSLAVIA ZAMBIA ZIMBABWE The Agency s Statute was approved on 23 October 1956 by the Conference on the Statute of the IAEA held at United Nations Headquarters, New York; it entered into force on 29 July The Headquarters of the Agency are situated in Vienna. Its principal objective is to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world. IAEA,???? Permission to reproduce or translate the information contained in this publication may be obtained by writing to the International Atomic Energy Agency, Wagramer Strasse 5, P.O. Box 100, A-1400 Vienna, Austria. Printed by the IAEA in Austria??????? STI/PUB/????

5 IAEA SAFETY STANDARDS SERIES No.?? INTERNATIONAL BASIC SAFETY STANDARDS FOR PROTECTION AGAINST IONIZING RADIATION AND FOR THE SAFETY OF RADIATION SOURCES SAFETY REQUIREMENTS [Jointly sponsored by: Food and Agriculture Organization of the United Nations International Atomic Energy Agency International Labour Organisation Nuclear Energy Agency of the Organisation for Economic Co-operation and Development Pan American Health Organization World Health Organization - current cosponsors of SS115: future cosponsorship to be determined] INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 200x

6 To appear on the same page as the VIC Library CIP data, as for all publications: COPYRIGHT NOTICE All IAEA scientific and technical sales publications are protected by the terms of the Universal Copyright Convention as adopted in 1952 (Berne) and as revised in 1972 (Paris). The copyright has since been extended by the World Intellectual Property Organization (Geneva) to include electronic and virtual intellectual property. Permission to use whole or parts of texts contained in IAEA publications in printed or electronic form must be obtained and is usually subject to royalty agreements. Proposals for noncommercial reproductions and translations are welcomed and will be considered on a case-by-case basis. Enquiries should be addressed by to the Publishing Section, IAEA, at sales.publications@iaea.org or by post to: Sales and Promotion Unit, Publishing Section International Atomic Energy Agency Wagramer Strasse 5 P.O. Box 100 A-1400 Vienna Austria fax: tel.: VIC Library Cataloguing in Publication Data The Management System for Facilities and Activities International Atomic Energy Agency,????. p. ; 24 cm. (Safety standards series, ISSN?????????? ; no. RS-G-1.10[tbc]) STI/PUB/????? ISBN??????????? Includes bibliographical references. 1.????????????????? I. International Atomic Energy Agency. II. Series. VICL?????????

7 FOREWORD by Mohamed ElBaradei Director General DS379 Draft 0.3 Clean 22 June 2007 The IAEA s Statute authorizes the Agency to establish safety standards to protect health and minimize danger to life and property standards which the IAEA must use in its own operations, and which a State can apply by means of its regulatory provisions for nuclear and radiation safety. A comprehensive body of safety standards under regular review, together with the IAEA s assistance in their application, has become a key element in a global safety regime. In the mid-1990s, a major overhaul of the IAEA s safety standards programme was initiated, with a revised oversight committee structure and a systematic approach to updating the entire corpus of standards. The new standards that have resulted are of a high calibre and reflect best practices in Member States. With the assistance of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its safety standards. Safety standards are only effective, however, if they are properly applied in practice. The IAEA s safety services which range in scope from engineering safety, operational safety, and radiation, transport and waste safety to regulatory matters and safety culture in organizations assist Member States in applying the standards and appraise their effectiveness. These safety services enable valuable insights to be shared and I continue to urge all Member States to make use of them. Regulating nuclear and radiation safety is a national responsibility, and many Member States have decided to adopt the IAEA s safety standards for use in their national regulations. For the Contracting Parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions. The standards are also applied by designers, manufacturers and operators around the world to enhance nuclear and radiation safety in power generation, medicine, industry, agriculture, research and education. The IAEA takes seriously the enduring challenge for users and regulators everywhere: that of ensuring a high level of safety in the use of nuclear materials and radiation sources around the world. Their continuing utilization for the benefit of humankind must be managed in a safe manner, and the IAEA safety standards are designed to facilitate the achievement of that goal.

8 PROMOTIONAL TEXT FOR THE BACK COVER: Safety through international standards The IAEA s standards have become a key element of the global safety regime for the beneficial uses of nuclear and radiation related technologies. IAEA safety standards are being applied in nuclear power generation as well as in medicine, industry, agriculture, research and education to ensure the proper protection of people and the environment. Mohamed ElBaradei IAEA Director General

9 IAEA SAFETY STANDARDS SAFETY THROUGH INTERNATIONAL STANDARDS While safety is a national responsibility, international standards and approaches to safety promote consistency, help to provide assurance that nuclear and radiation related technologies are used safely, and facilitate international technical co-operation and trade. The standards also provide support for States in meeting their international obligations. One general international obligation is that a State must not pursue activities that cause damage in another State. More specific obligations on Contracting States are set out in international safety related conventions. The internationally agreed IAEA safety standards provide the basis for States to demonstrate that they are meeting these obligations. THE IAEA STANDARDS The IAEA safety standards have a status derived from the IAEA s Statute, which authorizes the Agency to establish standards of safety for nuclear and radiation related facilities and activities and to provide for their application. The safety standards reflect an international consensus on what constitutes a high level of safety for protecting people and the environment. They are issued in the IAEA Safety Standards Series, which has three categories: Safety Fundamentals Presenting the objectives, concepts and principles of protection and safety and providing the basis for the safety requirements. Safety Requirements Establishing the requirements that must be met to ensure the protection of people and the environment, both now and in the future. The requirements, which are expressed as shall statements, are governed by the objectives, concepts and principles of the Safety Fundamentals. If they are not met, measures must be taken to reach or restore the required level of safety. The Safety Requirements use regulatory language to enable them to be incorporated into national laws and regulations. Safety Guides Providing recommendations and guidance on how to comply with the Safety Requirements. Recommendations in the Safety Guides are expressed as should statements. It is recommended to take the measures stated or equivalent alternative measures. The Safety

10 Guides present international good practices and increasingly they reflect best practices to help users striving to achieve high levels of safety. Each Safety Requirements publication is supplemented by a number of Safety Guides, which can be used in developing national regulatory guides. The IAEA safety standards need to be complemented by industry standards and must be implemented within appropriate national regulatory infrastructures to be fully effective. The IAEA produces a wide range of technical publications to help States in developing these national standards and infrastructures. MAIN USERS OF THE STANDARDS As well as by regulatory bodies and governmental departments, authorities and agencies, the standards are used by authorities and operating organizations in the nuclear industry; by organizations that design, manufacture for and apply nuclear and radiation related technologies, including operating organizations of facilities of various types; by users and others involved with radiation and radioactive material in medicine, industry, agriculture, research and education; and by engineers, scientists, technicians and other specialists. The standards are used by the IAEA itself in its safety reviews and for developing education and training courses. DEVELOPMENT PROCESS FOR THE STANDARDS The preparation and review of safety standards involves the IAEA Secretariat and four safety standards committees for safety in the areas of nuclear safety (NUSSC), radiation safety (RASSC), the safety of radioactive waste (WASSC) and the safe transport of radioactive material (TRANSSC), and a Commission on Safety Standards (CSS), which oversees the entire safety standards programme. All IAEA Member States may nominate experts for the safety standards committees and may provide comments on draft standards. The membership of the CSS is appointed by the Director General and includes senior government officials having responsibility for establishing national standards. For Safety Fundamentals and Safety Requirements, the drafts endorsed by the Commission are submitted to the IAEA Board of Governors for approval for publication. Safety Guides are published on the approval of the Director General. Through this process the standards come to represent a consensus view of the IAEA s Member States. The findings of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) and the recommendations of international expert bodies, notably the International Commission on Radiological Protection (ICRP), are taken into

11 account in developing the standards. Some standards are developed in co-operation with other bodies in the United Nations system or other specialized agencies; including the Food and Agriculture Organization of the United Nations, the International Labour Organization, the OECD Nuclear Energy Agency, the Pan American Health Organization and the World Health Organization. The safety standards are kept up to date: five years after publication they are reviewed to determine whether revision is necessary. Outline and work plan prepared by the Secretariat; review by the safety standards committees and the CSS Secretariat and consultants: drafting of new or revision of existing safety standard Draft Review by safety standards committee(s) Draft Comments Member States Final draft Endorsement by the CSS The process for developing a new safety standard or revising an existing one. APPLICATION AND SCOPE OF THE STANDARDS The IAEA Statute makes the safety standards binding on the IAEA in relation to its own operations and on States in relation to operations assisted by the IAEA. Any State wishing to enter into an agreement with the IAEA concerning any form of Agency assistance is required to comply with the requirements of the safety standards that pertain to the activities covered by the agreement. International conventions also contain similar requirements to those in the safety standards, and make them binding on contracting parties. The Safety Fundamentals were used as the basis for the development of the Convention on Nuclear Safety and the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management.

12 The Safety Requirements on Preparedness and Response for a Nuclear or Radiological Emergency reflect the obligations on States under the Convention on Early Notification of a Nuclear Accident and the Convention on Assistance in the Case of a Nuclear Accident or Radiological Emergency. The safety standards, incorporated into national legislation and regulations and supplemented by international conventions and detailed national requirements, establish a basis for protecting people and the environment. However, there will also be special aspects of safety that need to be assessed case by case at the national level. For example, many of the safety standards, particularly those addressing planning or design aspects of safety, are intended to apply primarily to new facilities and activities. The requirements and recommendations specified in the IAEA safety standards might not be fully met at some facilities built to earlier standards. The way in which the safety standards are to be applied to such facilities is a decision for individual States. INTERPRETATION OF THE TEXT The safety standards use the form shall in establishing international consensus requirements, responsibilities and obligations. Many requirements are not addressed to a specific party, the implication being that the appropriate party or parties should be responsible for fulfilling them. Recommendations are expressed as should statements, indicating an international consensus that it is necessary to take the measures recommended (or equivalent alternative measures) for complying with the requirements. Safety related terms are to be interpreted as defined in the IAEA Safety Glossary ( Otherwise, words are used with the spellings and meanings assigned to them in the latest edition of The Concise Oxford Dictionary. For Safety Guides, the English version of the text is the authoritative version. The background and context of each standard within the Safety Standards Series and its objective, scope and structure are explained in Section 1, Introduction, of each publication. Material for which there is no appropriate place in the body text (e.g. material that is subsidiary to or separate from the body text, is included in support of statements in the main text, or describes methods of calculation, experimental procedures or limits and conditions) may be presented in appendices or annexes. An appendix, if included, is considered to form an integral part of the standard. Material in an appendix has the same status as the main text and the IAEA assumes authorship of it. Annexes and footnotes to the main text, if included, are used to provide practical examples or

13 additional information or explanation. An annex is not an integral part of the main text. Annex material published by the IAEA is not necessarily issued under its authorship; material published in standards that is under other authorship may be presented in annexes. Extraneous material presented in annexes is excerpted and adapted as necessary to be generally useful.

14 PREFACE (to be written) 14

15 CONTENTS (to be prepared) DS379 Draft 0.3 Clean 22 June 2007

16 1. INTRODUCTION BACKGROUND 1.1. It is well known that ionizing radiation can cause harm to human tissues. Very high doses may cause damage to organs and tissues to such an extent that clinical injury or organ malfunction results. High doses also lead to an increased risk of developing cancer. It is therefore essential that people are properly protected from high levels of exposure to ionizing radiation. Very low doses may or may not carry a risk of developing cancer: scientific studies are not yet able to provide definitive answers. Nevertheless, for the purpose of being confident that people are protected from harm, protection principles are based on the assumption that exposure to ionizing radiation can increase the risk of cancer down to the lowest doses. Radiation protection standards are therefore designed to take into account all exposures Consistent with its statutory function to establish standards of safety for the protection of health and the minimization of danger to life, the IAEA, not long after its inception in 1957, developed radiation protection and safety standards. The Board of Governors of the IAEA first approved radiation protection and safety measures in March , when it was stated that "The Agency's basic safety standards... will be based, to the extent possible, on the recommendations of the International Commission on Radiological Protection (ICRP)". The Board first approved basic safety standards in June 1962, and they were published by the IAEA as Safety Series No A revised version was published in A third revision was published as the 1982 Edition of Safety Series No. 9 4 ; this Edition was jointly sponsored by IAEA, ILO, OECD/NEA and WHO. 1 INTERNATIONAL ATOMIC ENERGY AGENCY, The Agency's Health and Safety Measures, INFCIRC/18, IAEA, Vienna (1960); The Agency's Safety Standards and Measures, INFCIRC/18/Rev.1, IAEA, Vienna (1976). 2 INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for Radiation Protection, Safety Series No. 9, IAEA, Vienna (1962). 3 INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for Radiation Protection (1967 Edition), Safety Series No. 9, IAEA, Vienna (1967). 4 INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for Radiation Protection (1982 Edition), Safety Series No. 9, IAEA, Vienna (1982). 16

17 1.3. The IAEA s Statute specifically authorizes the IAEA to establish safety standards in consultation with the United Nations and the specialized agencies concerned. Cosponsorship of its basic safety standards by other UN organizations and other relevant bodies has therefore been encouraged and, in 1996, the IAEA published the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (SS115), which was cosponsored by IAEA, FAO, ILO, OECD/NEA, PAHO and WHO 5, and which superseded Safety Series No The associated Safety Fundamentals publication on Radiation Protection and the Safety of Radiation Sources 6, established in cooperation with the same cosponsoring organizations and published in 1996, presents the principles of protection and safety on which the International Basic Safety Standards were founded The United National Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), which compiles, assesses and disseminates information on the health effects of radiation and on levels of radiation exposure due to different sources, provided the scientific information on which the Safety Fundamentals and International Basic Safety Standards were based. The principles and approach to protection and safety were based primarily on the recommendations of the International Commission on Radiological Protection (ICRP). At the time, the most recent recommendations of the ICRP were issued in In 2003, the Board of Governors approved the text of the Code of Conduct on the Safety and Security of Radioactive Sources. The September 2003 IAEA General Conference adopted 5 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, Safety Series No. 115, IAEA, Vienna (1996). 6 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, Radiation Protection and the Safety of Radiation Sources, Safety Series No. 120, IAEA, Vienna (1996). 7 INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection, Publication No. 60, Pergamon Press, Oxford and New York (1991). 17

18 resolution GC(47)/RES/7 endorsing the objectives and principles set out in the Code, while recognizing that the Code is not a legally binding instrument. Further, the General Conference recognized that a high priority should be given to developing and following the guidance in support of the Code of Conduct. The resolution also urged Member States to report to the IAEA s Director General that it fully supports and endorses the IAEA s efforts to enhance the safety and security of radioactive sources and that it is working toward following the guidance contained in the Code of Conduct. The Code relies on existing international standards relating to nuclear, radiation, radioactive waste and transport safety and to the control of radioactive sources, including the International Basic Safety Standards, and is intended to complement these standards. However, it contains some more specific expectations in respect of the control of the import and export of radioactive sources In 2006, the IAEA published new Fundamental Safety Principles 8, which brought into one document the principles covering radiation protection and safety, transport safety, radioactive waste safety and the safety of nuclear installations. In another development, ICRP have produced revised Recommendations 9. These events combined with the experience gained in the implementation of the International Basic Safety Standards and the Code of Conduct led to the decision to develop a revised set of safety standards covering radiation protection and safety. The work was undertaken in cooperation with the cosponsors of the International Basic Safety Standards, the Commission of the European Community (EC), the United Nations Environment Program (UNEP), ICRP, and the International Radiation Protection Association (IRPA). OBJECTIVE 1.8. The purpose of the Standards is to specify the basic requirements for protection against the risks associated with exposure to ionizing radiation and for the safety of radiation sources that may deliver such exposure. The Standards are based on the Fundamental Safety 8 COMMISSION OF THE EUROPEAN COMMUNITY (EURATOM), FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL MARITIME ORGANIZATION, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGNSATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards, SF-1, IAEA, Vienna (2006). 9 Ref to new ICRP. 18

19 Principles and take account of the latest information on biological effects of exposure to radiation provided by UNSCEAR and the recommendation of ICRP. They also take account of experience gained in implementing the International Basic Safety Standards (SS115) and the Code of Conduct on the Safety and Security of Radiation Sources The Standards are intended to apply to all situations involving exposure to radiation that can reasonably be subject to control. However, it is recognized that additional requirements will be necessary for large and complex radiation sources, such as nuclear reactors and radioactive waste management facilities, and for the transport of radioactive material, in order to achieve acceptable levels of safety. The Standards are therefore complemented by other Safety Requirements dealing in more detail with these matters These Standards are aimed to serve as a practical guide for governments, regulatory bodies and other public authorities, employers and workers, specialized radiation protection bodies, and health and safety committees. The requirements indicate those matters that are considered essential in order for a radiation protection programme to be effective. SCOPE The Standards comprise the basic requirements to be fulfilled in all activities involving radiation exposure. A sister Safety Requirements document on Legal and Governmental Infrastructure 10 provides details of the administrative and organizational framework that is necessary in order to implement the requirements given in these Standards. The infrastructure requirements that are essential for radiation protection and safety are summarized in this document The Standards cover all circumstances of exposure to radiation. In the International Basic Safety Standards (SS115), the exposure situations were broadly divided into two groups. The first related to human activities that result in a consequential increase in radiation exposure over that which people normally incur due to natural background radiation, or in the likelihood of incurring exposure: they were termed practices. The second related to human activities that seek to reduce unwanted existing radiation exposure, or the existing likelihood 10 INTERNATIONAL ATOMIC ENERGY AGENCY, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, IAEA Safety Standards Series, GS-R-1, IAEA, Vienna (2000). 19

20 of incurring exposure which is not part of a controlled practice: they were termed interventions. The term practice is retained in these Standards, but intervention is now covered by the separate terms existing situation of exposure and emergency situation of exposure. The actions taken to reduce exposure in these situations are interventions, but use of the term has largely been discontinued to avoid confusion with the new ICRP Recommendations The Fundamental Safety Principles (SF-1) refer to facilities and activities existing and new utilized for peaceful purposes, and to protective actions to reduce existing radiation risks. The first part of this phrase is taken to encompass any human activity that may cause people to be exposed to radiation risks arising from naturally occurring or artificial sources and can be taken as being broadly equivalent to the use of the word practice. Facilities includes: nuclear facilities; irradiation installations; some mining and raw material processing facilities such as uranium and other mines in which exposure to natural sources of radiation requires attention; radioactive waste management facilities; and any other places where radioactive materials are produced, processed, used, handled, stored or disposed of or where radiation generators are installed on such a scale that consideration of protection and safety is required. Activities includes: the production, use, import and export of radiation sources for industrial, research and medical purposes; the transport of radioactive material; the decommissioning of facilities; radioactive waste management activities such as the discharge of effluents; and some aspects of the remediation of sites affected by residues from past practices. The second part of the phrase in the Fundamental Safety Principles protective actions to reduce existing radiation risks is taken to be equivalent to the use of existing situations of exposure for example, from natural sources of radiation such as radon in dwellings or radioactive residues from past practices that were not controlled according to present-day standards and emergency situations of exposure, such as those following an accident It is virtually certain that some radiation exposures will result from the carrying out of practices and that their magnitudes will be predictable, albeit with some degree of uncertainty: such expected exposures are referred to as normal exposures. Exposure scenarios can also be envisaged for which there is a potential for exposure, but no certainty that an exposure will in fact occur: such unexpected but feasible exposures are termed potential exposures. Potential exposures can become actual exposures if the unexpected situation does occur; for example as a consequence of equipment failure, design or operating errors, or unforeseen 20

21 changes in environmental conditions, e.g. at a disposal site for radioactive waste. If the occurrence of such events can be foreseen, the probability of their occurrence and the resulting radiation exposure can be estimated The primary means for controlling normal and potential exposures is by good design of installations, equipment and operating procedures. This is intended to restrict normal exposures to levels that are as low as reasonably achievable and the probability of occurrence of events that could lead to unplanned exposures and to restrict the magnitudes of the exposures that could result if such events were to occur. Thus, for a practice, provisions for radiation protection and safety can be made before its commencement, and the associated radiation exposures and their likelihood can be restricted from the outset. In the case of intervention, however, the circumstances giving rise to exposures or the likelihood of exposures already exist, and their reduction can only be achieved by means of remedial or protective actions, with a balance being made between the costs of the actions and the reduction in exposure The relevant radiation exposures covered by these Standards encompass the exposures, both normal and potential, of workers pursuing their occupations, of patients in diagnosis or treatment, and of members of the public who may be affected by a practice or by an intervention. Thus exposures are divided into: occupational exposures which are incurred at work and principally as a result of work; medical exposures which are principally exposures of patients in diagnosis or treatment; and public exposures which comprise all other exposures The Standards are intended to cover all people who may be exposed to radiation, including those in future generations who could be affected by present practices or activities The scope of the Standards is primarily concerned with the protection of human beings since, in general, it is considered that standards of protection that are adequate for this purpose will also ensure that no other species is threatened as a population, even if individuals of the species may be harmed. However, there is currently a concern to ensure that the environment is adequately protected in its own right, and a number of scientific initiatives have been undertaken to consider this problem 11. The general intent of measures taken for the purpose of the radiation protection of the environment is to protect ecosystems against 11 Ref to ICRP Committee 5 and IAEA project. Comment [GM1]: The DPP raised the possibility of a separate section and chapter on protection of the environment. At this time, it is not clear what such a chapter could contain. A general requirement to pay due heed to protection of the environment is at para.3.12 in Chapter 3. For discussion. 21

22 radiation exposure that would have adverse consequences for populations of a living species. When there is a need to demonstrate protection of the environment in the absence of humans, approaches explicitly considering effects on the environment might be used, but there is not yet an international consensus on how to do this. Consequently, these Standards do not contain separate prescriptive requirements for protection of the environment. It is anticipated that an evolving consensus on this issue may lead to such requirements being included in a future edition of the Standards The Standards apply only to ionizing radiation, namely gamma and X-rays and alpha, beta and other particles that can induce ionization. They do not apply to non-ionizing radiation; and they do not apply to the control of non-radiological aspects of health and safety The Standards apply to practices, including any sources within the practices, and interventions which are: (a) carried out in a State that chooses to adopt the Standards or requests any of the Sponsoring Organizations to provide for the application of the Standards; (b) (c) undertaken by States with the assistance of FAO, IAEA, ILO, PAHO, or WHO, in the light of relevant national rules and regulations; carried out by the IAEA or involve the use of materials, services, equipment, facilities and non-published information made available by the IAEA or at its request or under its control or supervision; or (d) carried out under any bilateral or multilateral arrangement whereby the parties request the IAEA to provide for the application of the Standards. STRUCTURE The Standards comprise four main sections. Section I deals with the regulatory and governmental framework required for the control of exposure. This includes the responsibilities of government and governmental bodies, including the regulatory body. Section II deals with the requirements for practices and covers the control of occupational, public and medical exposures. Section III provides the requirements for emergency actions and Section IV deals with existing exposure situations. Three Schedules provide numerical 22

23 values needed to support the requirements. A Glossary, derived from the IAEA s Nuclear Safety Glossary, defines the terms that are used in these Standards. 23

24 SECTION I LEGAL AND GOVERNMENTAL FRAMEWORK 24

25 2. LEGAL AND GOVERNMENTAL FRAMEWORK FOR RADIATION PROTECTION AND SAFETY [Comment (not part of the proposed text): This draft chapter is based on the output from a drafting meeting held in May 2007, updated and edited by IAEA. It is mostly new material, since in the current BSS the topic is covered only in the Preamble. It is consistent with the much more detailed requirements for governments and regulatory bodies set out in GS-R-1. It focuses on the general requirements the framework for governments and regulatory bodies, leaving specific requirements to be covered in subsequent chapters. To allow traceability back to SS115, the original BSS paragraph numbering, where applicable, has been included in braces { }.] Comment [GM2]: Legal and governmental is used in the chapter title for consistency with Principle 2 of the Safety Fundamentals and with GS-R-1. The framework covers not only regulation but also arrangements for other governmental responsibilities, e.g. paras.2.8 to THE GOVERNMENT 2.1. The government shall establish an appropriate, effective and sustainable legal and governmental framework for radiation protection and safety 12 in order to implement the requirements of these Standards. The framework shall provide the basis for ensuring adequate protection of people and the environment, both now and in the future, against the harmful effects of radiation without unduly limiting the operation of facilities or the conduct of activities that give rise to radiation risks. The framework shall cover both the implementation of governmental responsibilities and regulatory control of facilities and activities that give rise to radiation risks. For national governments 13, the framework shall allow for fulfilment of international obligations The government shall establish legislation that provides the statutory basis for regulatory requirements for protection and safety. The legislation shall ensure that the prime responsibility for protection and safety rests with the person or organization responsible for facilities and activities that give rise to radiation risks. Comment [GM3]: The phrase these Standards, used here and elsewhere throughout the document, is based on the title of the BSS remaining unchanged or very similar to the current title. If a new title is adopted, the phrase these Requirements may need to be substituted. Comment [GM4]: Sentence on justification moved to later (2.6) it is too specific for this opening paragraph. Comment [GM5]: Text on graded approach moved to later it is too specific for this opening paragraph. Replaced instead by a sentence saying what is covered The government shall, through legislation, establish and maintain a regulatory body 14 with clearly defined functions and responsibilities for regulating radiation protection and safety The government shall ensure that the regulatory body is effectively independent of persons and organizations using or otherwise promoting the use of radiation, so that it is free 12 Protection and safety : glossary definition. 13 In some countries, radiation protection is regulated at state or provincial level. 14 Regulatory body can mean more than one body, each having different responsibilities. 25

26 from any undue pressure from interested parties and any conflict of interest. The government shall ensure that the regulatory body has the legal authority, competence, and resources necessary to fulfill its statutory obligations The government shall establish a mechanism to ensure that, where appropriate, the activities of the regulatory body are coordinated with those of other national or international organizations with related responsibilities The government shall ensure that appropriate arrangements are in place for making decisions regarding the justification of practices and of protective or remedial actions in emergency or existing exposure situations. The government shall adopt a graded approach to control of radiation exposure, so that the scale of regulatory requirements applied to an exposure situation is commensurate with the associated radiation risks The government shall establish an effective system for the control of exposure in situations that are subject to regulation as practices. The government or regulatory body shall define the practices and sources to which regulatory requirements apply and shall ensure that practices are regulated in accordance with these Standards and, as appropriate, with other Safety Requirements publications in the Safety Standards Series The government shall establish an effective system of emergency preparedness and response at the local, national and transboundary levels, as relevant, to deal with nuclear and radiation emergencies The government shall establish an effective system for protective or remedial actions to reduce exposure in existing situations that are not subject to regulation as practices. In particular, it shall appoint intervening organizations to be responsible, as necessary, for making arrangements for protective or remedial actions. The government or regulatory body shall determine the degree to which existing exposure situations are to be regulated. Whatever the degree of regulation, the government shall establish the criteria for protective or remedial action The government shall ensure that arrangements are in place for regaining control of orphan sources The government shall ensure that arrangements are in place for building the technical competence of persons having responsibilities related to radiation protection and safety. 26

27 2.12. The government shall ensure that arrangements are in place for the provision of necessary technical services related to radiation protection and safety such as personal dosimetry, environmental monitoring and calibration of equipment relevant for protection and safety. THE REGULATORY BODY In order to fulfil its statutory obligations, the regulatory body shall define policies, safety principles and associated criteria that provide the basis for its regulatory actions The regulatory body shall make provisions for the exemption of practices and sources from any or all requirements in accordance with Schedule I. Exemption shall not be granted for practices deemed not to be justified The regulatory body shall implement regulations for the control of exposure to radiation. It shall establish a system for notification and authorization of practices, for inspection of facilities and activities, for assessment of protection and safety, for enforcement of regulatory requirements and, as necessary, for dealing with emergency situations and existing exposure situations.. Comment [GM6]: Note: this leaves all substantive text concerning exemption in a Schedule. Is this satisfactory? Comment [GM7]: Text edited to make the paragraph more precise and avoid duplication with The regulatory body shall establish, implement, assess and strive to continually improve an effective management system that is aligned with its goals and contributes to the achievement of those goals The regulatory body shall set up appropriate means of informing and consulting parties affected by its decisions and, as appropriate, the public and other interested parties. 27

28 SECTION II REQUIREMENTS FOR PRACTICES 28

29 3. CONTROL OF EXPOSURE IN PRACTICES [Comment (not part of the proposed text): This draft chapter is based on the output from a drafting meeting held in May 2007, updated and edited by IAEA. To allow traceability back to SS115, the original BSS paragraph numbering, where applicable, has been included in braces { }. Notes: 1. The following Principal Requirements of SS115 are covered (but not verbatim) in Chapter 2: { } and { }. 2. Para 3.xx {2.9} on transport is yet to be fully developed but there is a place-holder under Technical Requirements. 3. The DPP called for a merging of the Principal Requirements and Appendix IV, plus additional material from Code of Conduct etc, and this has been attempted. Specific comments are most welcome on the logic flow, further reduction of duplication, the proposed new additions, etc. 4. The subjunctive mood is used frequently in the current BSS, often in the context of ensuring that something be done (e.g. {I.28 (d)} ensure that personal protective equipment be maintained ). This is commonplace in legal instruments but is archaic in ordinary English. In order to use ordinary English as far as possible, subjunctive forms using be have been changed to is (singular) or are (plural). The above example then becomes: ensure that personal protective equipment is maintained.... This ought not to cause difficulty when translating into languages that retain a common use of the subjunctive, as translators would be well aware of the distinction. This proposed change is, of course, subject to discussion.] JUSTIFICATION OF PRACTICES 3.1. {2.20.} No practice or source within a practice shall be authorized unless the practice produces sufficient benefit to the exposed individuals or to society to offset the radiation harm that it might cause; that is: unless the practice is justified, taking into account social, economic and other relevant factors {2.21.} Detailed requirements for the justification of practices involving medical exposures are given in Chapter 6. Comment [GM8]: This is current BSS text, but it is in general a bad practice to use requirements statements as a vehicle for defining terms {2.22.} Except for justified practices involving medical exposures, the following practices are deemed to be not justified whenever they would result in an increase, by deliberate addition of radioactive substances or by activation, in the activity of the associated commodities or products: 29

30 (a) practices involving food, beverages, cosmetics or any other commodity or product intended for ingestion, inhalation or percutaneous intake by, or application to, a human being; and (b) practices involving the frivolous use of radiation or radioactive substances in commodities or products such as toys and personal jewellery or adornments. SCOPE OF APPLICATION OF THE STANDARDS Practices 3.4. {2.1.} The practices to which the Standards shall apply include: (a) the production and transport of sources, and the use of radiation or radioactive material for medical, industrial, veterinary or agricultural purposes, or for education, training or research, including any activities related to such use which involve or could involve exposure to radiation or radioactive material; and (b) the generation of nuclear power and any other activities within the nuclear fuel cycle which involve or could involve exposure to radiation or radioactive material. Sources Comment [JW9]: Should there be something in Chapter 3 about exposing people for theft/detection purposes? Comment [GM10]: Yes, the old {II.9} does not belong in the medical exposure chapter. But the text needs to be written very carefully in order not to prohibit things that are considered acceptable. Comment [GM11]: Why has transport been singled out? Comment [GM12]: substances has been changed (everywhere) to material for consistency with other publications, e.g. the Transport Regulations. Comment [GM13]: Proposed 3.4(c) deleted and replaced with alternative proposal of {2.2.} The sources within any practice to which the requirements for practices of the Standards shall apply include: (a) radioactive material and devices that contain radioactive material or produce radiation, including sealed sources and unsealed sources; radiation generators, including mobile radiography equipment; consumer products that contain radioactive material; and (b) facilities which contain radioactive material or devices which produce radiation, including irradiation facilities,, some mines and other facilities for the extraction and processing of minerals, nuclear installations, and radioactive waste management facilities {2.3.} The requirements shall apply to individual sources of radiation within an installation or facility and to the complete installation or facility regarded as a source, as appropriate, according to the requirements of the regulatory body. Comment [N14]: Need to broaden from just mines to include also mineral processing facilities. Mill now redundant so deleted Comment [GM15]: Proposed 3.5(c) deleted and replaced with alternative proposal of 3.8. Comment [GM16]: Catch-all clause provisionally deleted. 30