S.L. 653.5 Art. 3Interpretation.

(1) In these regulations, unless the content otherwise requires:

"absorbed dose" (D) means the energy absorbed per unit mass

D = d/dm where d is the mean energy imparted by ionizing radiation to the matter in a volume element, dm is the mass of the matter in this volume element.

In these regulations, absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray;

"accelerator" means an apparatus or installation, in which particles are accelerated, emitting ionizing radiation with an energy higher than 1 mega-electron volt (MeV); "accident'' means any unintended event, including operating errors, equipment failures or other mishaps, the consequences or potential consequences of which are not negligible from the point of view of protection or safety;

"accidental exposure" means an exposure of individuals as a result of an accident. It does not include emergency exposure; "Act" means the National Interest (Enabling Powers) Act;

"activation" means the process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or high-energy gamma rays the material in which it is contained; "activities performed by an outside worker" means any service provided by an outside worker in a controlled area for which a radiation employer is responsible; "activity" (A) means the activity, A, of an amount of a radionuclide in a particular energy state at a given time and is the quotient of dN by dt, where dN is the expectation value of the number of spontaneous nuclear transitions from that energy state in the time interval dt: A = dN/dt The unit of activity is the becquerel; "ambient dose equivalent" means the quantity H*(d) at a point in a radiation field, defined as the dose equivalent that would be produced by the corresponding aligned and expanded field in the ICRU sphere at a depth d on the radius opposing the direction of the aligned field. A depth d = 10 mm is recommended for strongly penetrating radiation; "apprentice" means a person receiving training or instruction within an undertaking with a view to exercising a specific skill; "approved" means approved for the time being in writing for the purposes of these regulations by the Board, and published in such form as the Board or the considers appropriate;

"approved dosimetric service" means a body responsible for the calibration, reading or interpretation of individual monitoring devices, or for the measurement of radioactivity in the human body or in biological samples, or for assessment of doses, whose capacity to act in this respect is recognized by the Board;

"approved medical practitioner" means a medical practitioner responsible for the medical surveillance of category A workers, as defined in regulation 43(1), whose capacity to act in that respect is recognized by the Board; "approved occupational health service" means a body or bodies to which may be assigned responsibility for the radiation protection of exposed workers and/or medical surveillance of category A workers and whose capacity to act in that respect is recognized by the Board; "artificial sources" means radiation sources other than natural radiation sources; "authorization" means a permission granted in a document by the Board application, or granted by national legislation, to carry out a practice or any other action within the scope of these regulations. Authorisation can take the form of a registration or a licence; "avertable dose" means the dose to be saved by a protective action; that is, the difference between the dose to be expected with the protective action and that to be expected without it; "Becquerel" (Bq): the special name of the unit of activity. One becquerel is equivalent to one decay per second; "Board" means the Radiation Protection Board; "calendar year" means a period of twelve calendar months beginning with the 1st January; "clearance levels" means values, established by the Board, and expressed in terms of activity concentrations and/or total activity, at or below which radioactive substances or materials containing radioactive substances arising from any practice subject to the requirement of notification or authorization may be released from the requirements of these regulations;

"comforter and carer" means an individual who (other than as part of his occupation) knowingly and willingly incurs an exposure to ionizing radiation resulting from the support and comfort of another person who is undergoing or who has undergone any medical exposure; E() "committed effective dose" means the quantity defined as      E( ) = w .H ( ) = h(g) J + h(g) J T T j,ing j,ing j,inh j,inh T J J  where HT( ) is the committed equivalent dose to tissue T over the integration time , and w is the appropriate tissue weighting T factor. When  is not specified, it will be taken to be 50 years for adults and to age 70 years for intakes by children. The unit for committed effective dose is the sievert. Committed effective dose could also be assessed using the committed effective dose per unit-intake for ingested (h(g) ) or inhaled (h(g) ) radionuclide j j,ing j,inh [Sv/Bq] by an individual in group of age g; J and J j,ing j,inh respectively are the relevant intakes via ingestion and inhalation of the radionuclide j [Bq]; "committed equivalent dose" means the quantity H () defined T as: t + 0  H () = H (t)dt T T t 0 where t is the time of intake, H (t) is the equivalent dose rate at 0 T time t in an organ or tissue, T and  is the time elapsed after an intake of radioactive substances. When  is not specified it will be taken to be 50 years for adults and to age 70 years for intakes by children. The unit for committed equivalent dose is the sievert;

"controlled area" means any area in which specific protection measures and safety provisions are or could be required for controlling normal exposures or preventing the spread of contamination during normal working conditions and for preventing or limiting the extent of potential exposures, and to which access is controlled; "Convention" means the Convention on the Physical Protection of Nuclear Material; "critical group" means a group of members of the public which is reasonably homogeneous with respect to its exposure for a given radiation source and given exposure pathway and is typical of individuals receiving the highest effective dose or equivalent dose (as applicable) by the given exposure pathway from the given source; "deterministic effect" is a radiation effect for which generally exists a threshold of dose and above this threshold the severity of the effect increases with dose;

"disposal" means the emplacement of waste in a repository, or a given location, without the intention of retrieval. Disposal also covers the approved direct discharge of wastes into the environment, with subsequent dispersion; "dose" means, in relation to ionizing radiation, any dose quantity or sum of dose quantities mentioned in the Third Schedule; "dose constraint" means a restriction on the prospective doses to individuals, which may result from a defined source for use at the planning stage in radiation protection whenever optimization is involved; "dose limit" means, in relation to persons of a specified class, the limit on effective dose or equivalent dose that shall not be exceeded; "effective dose" means the quantity E. defined as a summation of the tissue equivalent doses, each multiplied by the appropriate tissue weighting factor:  E = w .H T T T

where H is the equivalent dose in tissue T and w is the tissue T T weighting factor for tissue T. From the definition of equivalent dose, it follows that:   E = w . w . D T R T.R T R

where w is the radiation weighting factor for radiation R and D R T.R is the average absorbed dose in the organ or tissue T. The unit of effective dose is the sievert (Sv). Taking into consideration various pathways of exposure, the effective dose may consist of external exposure and committed effective dose:

E = E + E() ext where E is the external dose; ext "emergency exposure" means an exposure of individuals implementing the necessary rapid action to bring help to endangered individuals, prevent exposure of a large number of people or save a valuable installation or goods, whereby one of the individual dose limits equal to that laid down for exposed workers could be exceeded. Emergency exposure shall apply only to volunteers;

"emergency plan" means the set of procedures to be implemented in the event of a radiological accident. Emergency plans may be either on-site, that is for the whole area under the control of the radiation employer where a source is present or intended to be present, or off-site, that is the area beyond that under the control of the radiation employer; "equivalent dose'' means the quantity H defined as: T.R H = D .w T.R T.R R where D is the absorbed dose delivered by radiation type R T.R averaged over a tissue or organ T and w is the radiation weighting R factor for radiation type R. When the radiation field is composed of different radiation types with different values of W the equivalent dose is: R  H = w . D T R T.R R

The unit of equivalent dose is J/kg, termed the sievert (Sv); "exclusion" means the process whereby the Board deems that the magnitude or likelihood of an exposure is essentially unamenable to control and is thus excluded from regulatory control; "exemption" (from regulatory control, including those of notification, registration and licensing) refers to practices or work activities and sources within justified practices, for which the Board is satisfied that the sources comply with the exemption criteria specified in regulation 18 or such sources satisfy other exemption levels determined by the Board;

"exposed workers" means persons, either self-employed or working for an employer, subject to an exposure incurred at work from practices and work activities covered by these regulations and liable to result in doses exceeding one or other of the dose levels equal to the dose limits for members of the public;

"exposure" means the act or condition of being exposed to ionizing radiation. Exposure can be either external exposure (irradiation by sources outside the body) or internal exposure (irradiation by sources inside the body). Exposure can be classified as either normal exposure or potential exposure; either occupational, medical or public exposure: and, in intervention situations, either emergency exposure or chronic exposure. The term exposure is also used in radiodosimetry to express the amount of ionization produced in air by ionizing radiation; "external employer" means any person, other than the radiation employer, and including members of the staff of the external employer, performing services of any sort in a controlled area; "Gray" (Gy) means the name of the unit of absorbed dose. One gray is equal to one joule per kilogram: -1 1 Gy = 1 J kg ; "health detriment" means an estimate of the risk at reduction in length and quality of life occurring in a population following exposure to ionizing radiation. This includes loss arising from somatic effects, cancer and severe genetic disorder;

"health record" means, in relation to a worker, the record of medical surveillance of that worker maintained by the employer in accordance with regulation 45; "intake" means the process of taking radionuclides into the body by inhalation or ingestion or through the skin; "international nuclear transport" means the carriage of a consignment of nuclear material by any means of transportation intended to go beyond the territory of the State where the shipment originates beginning with the departure from a facility of the shipper in that State and ending with the arrival at a facility of the receiver within the State of ultimate destination;

"intervention" means a human activity that prevents or decreases the exposure of individuals to radiation from sources which are not part of a practice and work activity or which are out of control, by acting on sources, transmission pathways and individuals themselves;

"intervention level" means a value of avertable equivalent dose, avertable effective dose or a derived value, at which intervention measures should be considered. The avertable dose or derived value is solely that associated with the exposure pathway to which the intervention measure is to be applied;

"ionizing radiation" means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 15 nanometers or less or a frequency of 3 X 10 Hertz or more capable of producing ion pairs in biological materials; "local rules" means rules made in accordance with regulation 36; "maintained", where the reference is to maintaining plant, apparatus, equipment or facilities, means maintained in an efficient state, in efficient working order and good repairs; "Maltese ship'' shall have the same meaning as is assigned to it by article 3 of the Merchant Shipping Act; "medical exposure" means exposure incurred by -

(a) patients as part of their own medical or dental diagnosis or treatment;

(b) persons knowingly and voluntarily helping (other than those occupationally exposed), in the support and comfort of patients undergoing medical diagnosis and treatment; and

(c) volunteers in a programme of biomedical research involving their exposure; "member of the public" means in a general sense, any individual in the population except, for the purposes of these regulations, when subject to occupational or medical exposure, and for the purpose of verifying compliance with the annual dose limit for public exposure, shall mean the representative individual in the relevant critical group;

"Minister" means the Ministers responsible for occupational health and safety, for the environment, for health or for internal affairs, acting together or separately as appropriate; "natural radiation sources" mean sources of ionizing radiation from natural terrestrial or cosmic origin; "normal exposure" means an exposure that is expected to be received under normal operating conditions of an installation or a source, including possible minor mishaps that can be maintained under control; "notification" means the requirement of submitting a document to the Board to notify the intention to carry out a practice or work activity or any other action within the scope of these regulations; "nuclear material" means plutonium except that with isotopic concentration exceeding 80% in plutonium-238; uranium-233; uranium enriched in the isotope 235 or 233; uranium containing the mixture of isotopes as occurring in nature other than in the form of ore or ore-residue; any material containing one or more of the foregoing;

"occupational exposure" consists of all exposures of workers incurred in the course of their work, with the exception of exposures excluded from these regulations and exposures from practices and work activities or sources exempted by these regulations;

"outside worker" means a category A person (including trainees, apprentices or students over 18 years) who carries out services in the controlled area of any employer (other than the controlled area of his own employer), whether employed temporarily, permanently, or as a self-employed person;

"person" includes a body of persons and any body corporate established by or under any law;

"potential exposure" means exposure, that is not expected to be delivered with certainty, with a probability of occurrence that can be estimated in advance, 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 action that can increase the exposure of individuals to radiation, or extend exposure or the likelihood of exposure to additional people from an artificial source, or from a natural radiation source where natural radionuclides are processed for their radioactive, fissile or fertile properties, except in the case of an emergency exposure; "public exposure" means an exposure incurred by members of the public from radiation sources, excluding any occupational or medical exposure as well as the radiation from the local undisturbed background, but including exposure from authorised sources, practices and from intervention situations; "qualified expert" means a person having the knowledge and training needed to carry out physical, technical or radiochemical tests enabling doses to be assessed, and to give advice in order to ensure effective protection of individuals and the correct operation of protective equipment, and whose capacity to act as a qualified expert is recognized by the Board. A qualified expert may be assigned the technical responsibility for the tasks of radiation protection of workers and members of the public; "radiation employer" shall have the same meaning as is assigned to the word "employer" by article 2 of the Health and Safety at Work Act and includes:

(a) any natural or legal person who carries out the practices or work activities referred to in regulation 4 and, for the purposes of regulations 17 and 19, includes a person who intends to carry out such work and who has the legal responsibility under national law for such practices or work activities; and

(b) any duty imposed by these regulations on an employer in respect of his worker shall extend to a self-employed person in respect of himself; "radiation passbook" means -

(a) in the case of a worker employed by an employer in Malta a passbook approved by the Board for the purpose of these regulations;

(b) in the case of an outside worker employed by an employer in an EU member State, a passbook authorised by the competent authority for that member State, as the case may be; "radiation weighting factor" (w ) is a dimensionless factor used R to weight the dose absorbed in tissue according to the type of radiation;

"radiation worker" is any person who works, whether full or part time or temporarily, for an employer who has recognised rights and duties in relation to occupational radiation protection; "radioactive contamination" means the presence of radioactive substances in or on any material, surface (including any surface of the body or clothing) or environment, including liquids or gases, or the human body where they are undesirable or could be harmful. In the specific case of the human body, this radioactive contamination includes both external skin contamination and internal contamination, irrespective of route of intake;

"radioactive substance" means any substance that contains one or more radionuclides the activity or concentration of which cannot be disregarded as far as radiation protection is concerned; "radiological emergency" means a situation that requires urgent action in order to protect workers, members of the public or the population either partially or as a whole; "radioactive waste" means a material of whatever physical form, remaining from practices and work activities or interventions, for which no further use is foreseen at present and which (i) contains or is contaminated with radioactive substances having activity or activity concentration higher than the relevant level of exemption from regulatory control, and (ii) exposure to which is not excluded from these regulations; "Registrar-General" shall have the same meaning as is assigned to it by article 2 of the Merchant Shipping Act; "regulatory authority" means the Radiation Protection Board, jointly set up by the below mentioned members, which exercise their respective regulatory functions in the area of nuclear safety and radiation protection through the Board:

(1) Occupational Health and Safety Authority set up in accordance with the Health and Safety at Work Act as regards the protection of workers from exposure to radiation sources at work;

(2) the Environment Protection Directorate or other competent authority as established by virtue of the Environment Protection Act, as regards protection of the environment from radiation sources;

(3) the Superintendent of Public Health in terms of the Department of Health (Constitution) Ordinance, in matters relating to the protection of the general population from radiation sources;

(4) the Civil Protection Department established by the Civil Protection Act in relation to preparation for and response to civil emergencies;

(5) any other authority which, in the opinion of the Prime Minister, after consultation with the Board, may have a regulatory function in the field of ionizing radiation;

(6) any other authority to which the Ministers responsible for occupational health and safety, civil protection, health or the environment may, from time to time, assign any of the responsibilities of the above-mentioned under these regulations: Provided that the Prime Minister shall issue a notice of any such assignment of responsibilities in the Gazette; "sealed source" means a source containing any radioactive substance that is permanently sealed in a capsule or closely bounded and in a solid form; and the capsule or material of which is strong enough to maintain leaktightness under the conditions of use and wear for which the source was designed as well as in cases of foreseeable mishaps; "Sievert" means the name of the unit of equivalent or effective dose. One sievert is equivalent to one joule per kilogram: -1 1 Sv = 1 J kg ; "stochastic effects" of radiation are radiation effects which generally occur without a threshold level of dose and whose probability of occurring is proportional to the dose magnitude, whereas the severity of effects is independent of dose;

"source" means an apparatus, a radioactive substance or an installation capable of emitting ionizing radiation or radioactive substances; "supervised area" means an area subject to appropriate supervision for the purpose of protection against ionizing radiation and which has been so designated by the employer in accordance with regulation 35;

"tissue weighting factor" (w ) is a dimensionless factor used to T weight the equivalent dose in a tissue T;

"trainee" means a person aged 16 years or over (including a student) who is undergoing instruction or training which involves operations which would, in the case of a worker, be work with ionising radiation;

"transport" means, in relation to a radioactive substance, carriage of that substance on a road or through another public place (whether on a conveyance or not), or by rail, inland waterway, sea or air and, in the case of transport on a conveyance, a substance shall be deemed as being transported from the time that it is loaded onto the conveyance for the purpose of transporting it until it is unloaded from that conveyance, but a substance shall not be considered as beings transported if -

(a) it is transported by means of a pipeline or similar means; or

(b) it forms an integral part of a conveyance and is used in connection with the operation of that conveyance; "Tribunal" shall have the same meaning as is assigned to it by article 2 of the Health and Safety at Work Act; "uranium enriched in the isotope 235 or 233" means uranium containing the isotope 235 or 233 or both in an amount such that the abundance ratio of the sum of these isotopes to the isotope 238 is greater than the ratio of the isotope 235 to the isotope 238 occurring in nature; "work'' shall have the same meaning as is assigned to it by article 2 of the Occupational Health and Safety Authority Act and shall include any instruction or training which a person undergoes as a trainee and the meaning of "at work" shall be considered accordingly; "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" shall have the same meaning as assigned to it by article 2 of the Health and Safety at Work Act.