School for Drafting Regulations on Radiation Safety Vienna, November 2012 General definitions of the terms in licensing process Jiří Veselý, SONS, Czech republic

Opening  What is the Nuclear Safety  General definitions  Sources for drafting  National approach

What is the Nuclear Safety Nuclear Safety is comprehensive attitude (approach) which included not only nuclear safety, but also radiation protection, emergency preparedness, physical protection, fire protection, industrial safety etc.

General definitions Where we can find general definitions – IAEA Glossary Glossary is very important book which covered all areas of nuclear activities and which afford clear explanation of terms which are using in legislative documentation Unified terms we need for correct understanding of legislative requirements

General definitions  At the first we can use IAEA Glossary  Second source are IAEA Documentation as a Safety policy, Safety standards and Safety guides  Other possibility is use definitions from foreign countries – e.g. US NRC or other national Regulatory authorities

General definitions Authorization  The granting by a regulatory body or other governmental body of written permission for an operator to perform specified activities.  Authorization could include, for example, licensing, certification or registration.  The term authorization is also sometimes used to describe the document granting such permission.  Authorization is normally a more formal process than approval.

General definitions Licence/Licensee  1. A legal document issued by the regulatory body granting authorization to perform specified activities related to a facility or activity.  The holder of a current licence is termed a licensee. Other derivative terms should not be needed; a licence is a product of the authorization process (although the term licensing process is sometimes used), and a practice with a current licence is an authorized practice.  Authorization may take other forms, such as registration.  The licensee is the person or organization having overall responsibility for a facility or activity (the responsible legal person).

General definitions applicant  A legal person who applies to a regulatory body for authorization to undertake specified activities.  Strictly, an applicant would be such from the time at which an application is submitted until the requested authorization is either granted or refused.  However, the term is often used a little more loosely than this, particularly incases where the authorization process is long and complex.

General definitions regulatory body  1. An authority or a system of authorities designated by the government of a State as having legal authority for conducting the regulatory process, including issuing authorizations, and thereby regulating nuclear, radiation, radioactive waste and transport safety.  The national competent authority for the regulation of radioactive material transport safety (see Ref. [2]) is included in this description, as is the Regulatory Authority for radiation protection and safety (see Ref. [1]).

Regulations/ Decrees ¨Regulatory guides, industry standards etc. Constitution Conventions Laws

Sources for drafting EU members:  EU Directives  IAEA Nuclear Safety documentation  National legislation  Legislation from other countries

Sources for drafting IAEA newcomers:  IAEA Nuclear Safety documentation  National legislation  Legislation from other countries

Sources for drafting GUIDELINES FOR DRAFTING IAEA SAFETY STANDARDS - Manual for the application of SPESS Version 1 – 18 November 2010

Sources for drafting 1. GENERAL INFORMATION SAFETY REQUIREMENTS SAFETY GUIDES 2. MANUSCRIPT PREPARATION FOR THE SAFETY STANDARDS SERIES Writing Structure Word processing Enumeration Tables Figures Numbers and units of measurement References List of contributors to drafting and review 3. DRAFTING CHECKLIST

National approach  Fulfillment of IAEA documentation  Fulfillment of EU Directive (for EU members only)  Implementation of national legislative  Respect of national specific conditions

Closing Thank you for your attention