Cap. 585 Art. 3Interpretation.

In this Act, unless the context otherwise requires:

"accident" shall mean any unintended event, including operating errors, equipment failures and other mishaps, the consequences or potential consequences of which are not negligible from the point of view of radiation protection or safety;

"activities" means the production, use, import and export of radiation sources for industrial, research and medical purposes; the transport of radioactive material; the setting, construction, commissioning, operation and decommissioning of facilities; radioactive waste management activities and site rehabilitation;

"Additional Protocol" means the Additional Protocol to the Safeguards Agreement, which came into force for Malta on 1 July 2007;

"applicant" means a natural or legal person who applies to the Secretariat by filing an application for the purpose of obtaining the authorization for undertaking specific activities in relation to this Act;

"authorization" means the granting by the Secretariat of a written permission for an undertaking to perform a specified activity and may include a registration or licence;

"carers and comforters" means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone medical exposure;

"Chairperson" means the Non-Executive Chairperson responsible for the Commission and includes the Deputy Chairperson when acting as Chairperson in instances where the Chairperson is unable to perform the functions of his office;

"clearance" means the removal of regulatory control by the Secretariat after consultation with the Commission from radioactive material or radioactive objects within notified or authorized practices;

"clearance level" means a value, established by the Commission and expressed in terms of activity concentration, at or below which regulatory control may be removed from a source of radiation within a notified or authorized practice;

"Commission" means Commission for the Protection from Ionising and Non-Ionising Radiation as defined in article 10; "compliance" means conformity with the requirements of this Act or regulations made thereunder;

"decommissioning" means all steps leading to the release of a facility, other than a disposal facility, from regulatory control other than confirming the decommissioned status of a facility. These steps include the processes of decontamination and dismantling;

"disposal" means the emplacement of radioactive waste in an appropriate facility without the intention of retrieval;

"effective dose" means the sum of the weighted equivalent doses from ionising radiation in all the tissues and organs of the body from internal and external exposure;

"equipment" means a manufactured product that produces ionising or non-ionising radiation;

"exclusion" means the deliberate exclusion of a particular category of exposure from the scope of this Act on the grounds that it is not considered amenable to regulatory control;

"Executive Secretary" means the secretary responsible for the proper and efficient organization of the Secretariat;

"exemption" means the determination by the Commission that a source or practice need not be subject to some or all aspects of regulatory control on the basis that the exposure and the potential exposure due to the source or practice is too small to warrant the application of those aspects or that this is the optimum option for protection irrespective of the actual level of the doses or risks as specified in this Act;

"exemption level" means a value, established by the Commission and expressed in terms of activity concentration, total activity at or below which a source of ionising radiation need not be subject to notification or authorization;

"exposure" means the act of exposing or condition of being exposed to ionising or non-ionising radiation;

"facilities" means any installation which has a source of ionising or non-ionising radiation;

"graded approach" means a structured method by which the stringency of control to be applied to a product or process is commensurate with the risk;

"inspection" means the examination, observation, measurement, or test undertaken to assess structures, components, and materials, as well as operational activities, technical processes, organisational processes, procedures, and personnel competence; "intervention" means any action intended to reduce or avert exposure or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as a consequence of an accident;

"ionising radiation" means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less capable of producing ions directly or indirectly;

"licence" means a legal document issued by the Secretariat granting authorization to perform specified activities related to a facility or activity;

"licensee" means the holder of a current licence granted for an activity or practice who has recognized rights and duties for the activity or practice, particularly in relation to safety and security;

"medical exposure" means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, with ionising radiation and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research;

"Minister" means the Minister responsible for matters related to and incidental to this Act and such Minister shall not have under his responsibility any form of ionising or non-ionising radiation facility or source;

"non-ionising radiation" means energy transferred in the form of electromagnetic waves of a wavelength greater than 100 nanometres and is not capable of producing ions directly or indirectly;

"notification" means a document submitted to the Secretariat by an undertaking to notify an intention to carry out a practice or other use of a source;

"nuclear damage" means:

(a) damage due to death, physical injury, or other infringement to human health, loss or damage to property, occurring or being a consequence of radioactive characteristics or a combination of such characteristics with poisonous, explosive or other hazardous characteristics of nuclear fuel or radioactive products or waste located in a nuclear facility, or nuclear material sent to a nuclear facility or produced in the facility or being sent out of it;

(b) damage due to death, physical injury, or other infringement to human health, loss or damage to property, occurring or being a consequence of other ionising radiation originating from any other radiation source in a nuclear facility;

"nuclear facility" means any facility where activities or practices utilizing nuclear material are conducted, including a nuclear power plant, research reactor, fuel fabrication plant, spent fuel storage facility, enrichment plant, reprocessing facility or any other facility determined by the Commission. For purposes of the application of International Atomic Energy Agency safeguards, it means a facility as defined in the relevant Safeguards Agreement between Malta and the International Atomic Energy Agency;

"nuclear material" means uranium and thorium of natural isotopic structure, uranium with reduced (depleted uranium), or increased contents of isotope 235, uranium of isotopic structure 233, plutonium 239 and its heavier isotopes, industrial products or products made of such substances, as well as other substances designated by the Commission. For purposes of the application of International Atomic Energy Agency safeguards, it means any special fissionable material or source material as defined in the relevant Safeguards Agreement between Malta and the International Atomic Energy Agency; it shall not be interpreted as applying to ore or ore residue;

"nuclear or radiological emergency" means an emergency in which there is, or is perceived to be, a hazard due to:

(a) the energy resulting from a nuclear chain reaction or from the decay of the products of a chain reaction; or

(b) radiation exposure;

"occupational exposure" means exposure of workers, apprentices and students, incurred in the course of their work with ionising or non-ionising radiation;

"owner" means the person or company who owns, or is responsible for, the operation of an installation emitting non-ionising and ionising radiation into the environment or workplace;

"potential exposure" means an exposure that is not expected to occur with certainty but that may result from an accident at a source or owing to an event or sequence of events of a probabilistic nature, including equipment failures and operating errors;

"practice" means any human activity that introduces additional sources of exposure or exposure pathways or extends exposure to additional people or modifies the network of exposure pathways from existing sources in a way that increases the exposure or the likelihood of exposure of people or the number of people exposed; "public" means everyone who is not a worker or a patient under medical care;

"public officer" has the same meaning as assigned to it by article 124 of the Constitution, but does not include a Judge of the Superior Courts or a Magistrate of the Inferior Courts;

"public exposure" means exposure of individuals, excluding any occupational or medical exposure;

"radiation" refers to either ionising or non-ionising radiation;

"radiation protection" means protection of people from the harmful effects of exposure to ionising or non-ionising radiation, and the means for achieving this protection;

"radiation protection programme" means the systemic arrangements that are aimed at providing adequate consideration of radiation protection;

"radioactive material" means material (solid, liquid, or gas), which spontaneously emits radiation, including accelerator-produced material, by-product material, natural material, source and special nuclear material;

"registration" means a form of authorization for practices of low risk, through a simplified procedure to carry out a practice;

"radiation source" means an ionising radiation generator, or a radioactive source or other radioactive material outside the nuclear fuel cycles of research and power reactors;

"radioactive waste" means material, in whatever physical form, remaining from practices or interventions and for which no further use is foreseen -

(a) that contains or is contaminated with radioactive substances and has an activity or activity concentration higher than the level set for clearance from regulatory requirements, and

(b) exposure to which is not excluded under applicable regulations;

"radioactive waste management" means all administrative and operational activities which involve handling, pre-treatment, treatment, conditioning, transport, storage, and disposal of radioactive waste;

"reference level" means an exposure level to ionising or non-ionising radiation provided for practical exposure assessment purposes to determine whether the basic restrictions are likely to be exceeded;

"regulatory control" means any form of control or of regulation applied by the Secretariat to facilities or activities, for the reasons relating to radiation protection or to safety of radiation sources, or security of radioactive sources;

"Safeguards Agreement" means the Agreement between the European Union Non-nuclear-weapon Member States, the European Atomic Energy Community and the International Atomic Energy Agency in implementation of Article III(1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (Agreement 78/164/ Euratom) which came into force for Malta on 1 July 2007;

"safety" means the protection of people and the environment against radiation risks, and the safety of facilities and activities that give rise to radiation risks;

"safety culture" means the assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, protection and safety issues receive the attention warranted by their significance. Safety culture includes:

(a) individual and collective commitment to safety on the part of the leadership, the management and personnel at all levels;

(b) accountability of organizations and of individuals at all levels for safety; and

(c) measures to encourage a questioning and learning attitude and to discourage complacency with regard to safety;

"Secretariat" means the Secretatiat of the Commission as established by article 12;

"security" means the prevention and detection of, and response to, theft, sabotage, unauthorized access, illegal transfer or other malicious acts involving nuclear or other radioactive material, or their associated facilities;

"security culture" means characteristics and attitudes in organisations and of individuals which establish that security issues receive the attention warranted by their significance;

"source" means anything that may cause radiation exposure -such as by emitting ionising or non-ionising radiation or by releasing radioactive substances or material and can be treated as a single entity for protection and safety purposes;

"source material" includes:

(a) uranium containing an isotopic mixture appearing in nature,

(b) depleted uranium in 235 isotope,

(c) thorium,

(d) any of the stated materials in the form of metal, alloy, chemical compound, or concentrate, and

(e) any material other substance containing one or more of the above stated elements with concentration level designated by the Commission;

"spent fuel" means nuclear fuel that has been irradiated in and permanently removed from a reactor core;

"technical service provider" means service providers in safety, providing either consultancy and maintenance services or calibration and testing services;

"transport" means all operations and conditions associated with and involved in the movement of nuclear or other radioactive material. This includes the design, manufacture, maintenance and repair of packaging, and the preparation, consigning, loading, carriage including in-transit storage, unloading and receipt at the final destination of loads of such material and packages;

"Tribunal" means the Appeals Tribunal as referred to in article 14;

"undertaking" means a natural or legal person who has legal responsibility under national law for carrying out a practice, or for a radiation, whether ionising, or non-ionising source (including cases where the owner or holder of a radiation source does not conduct related human activities);

"work activity" means a sequence of man-made actions, involving naturally occurring radionuclides, which are not aimed at processing and, or extracting these radionuclides for their radioactive, fissile or fertile properties;

"worker" means an employee or self-employed individual who is subjected to ionising or non-ionising exposure at work.