ACT No. XVIII of 2018 An ACT to make provision for the protection of individuals in current and future generations against the harmful effects of ionising and non-ionising radiation and for the safety of radiation sources and to introduce preventive and protective measures of control for human

I assent.

(L.S.)

MARIE-LOUISE

COLEIRO PRECA

President

25th May, 2018

ACT No. XVIII of 2018

An ACT to make provision for the protection of individuals in

current and future generations against the harmful effects of ionising

and non-ionising radiation and for the safety of radiation sources and

to introduce preventive and protective measures of control for human

exposure to ionising and non-ionising radiation and matters connected

therewith or ancillary thereto.

BE IT enacted by the President, by and with the advice and

consent of the House of Representatives in this Present Parliament

assembled, and by the authority of the same as follows: -

The short title of this Act is the Nuclear Safety and Short title .

Radiation Protection Act, 2018.

(1)

The scope of this Act is to

Scope.

(a)

allow the beneficial and justified uses of ionising

and non-ionising radiation;

(b) provide for adequate protection of people in current

and future generations against the harmful effects of ionising

radiation and for the safety of radiation sources;

(c)

provide for the physical protection of nuclear

material;

(d) provide a mechanism whereby these objectives are

achieved through the establishment of a Radiation Protection

Commission and its Secretariat hereinafter referred to as the

"Commission" and "Secretariat", to act as the competent

national authority in the field of nuclear safety and radiation

protection.

(2) Notwithstanding the provisions of sub-article (1), this Act

shall apply to

(a)

the programmed safe management of radioactive

waste;

(b)

conditions for the security of the ionising radiation

sources;

(c)

the implementation of the requirements, including

but not only, the enactments of any act or regulation, required to

give effect to any treaty, convention or protocol related to the

ionising radiation, nuclear safety and security related

international legal instruments which the Government accedes

and ratifies;

(d) equipment, articles and non-nuclear material

specified for the reporting of exports and imports according to

Article 2(a)(ix) of the Additional Protocol

Provided that this Act shall not apply to activities or

practices involving exposures that have been excluded from

regulatory control.

(3) Without prejudice to the generality of this article the aim of

this Act is also to introduce preventive and protective measures of

control of detrimental human exposure to non-ionising radiations

against known or otherwise anticipated biological effects that have a

detrimental effect on mental, physical and, or general well-being of

exposed people, either in the short term or long term from any facility

or equipment emitting such fields.

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.

(1)

This Act shall apply to all practices and work Applicability.

activities which involve a risk from ionising radiation emanating

from an artificial source or from a natural radiation source in cases

where natural radionuclides are or have been processed in view of

their radioactive, fissile or fertile properties, namely

(a) the manufacture, production, processing, handling,

disposal, use, holding, storage, transport, supply import to and

export from Malta, transit through Maltese territory and

disposal of radioactive substances;

(b) the manufacture and the operation of any electrical

equipment emitting ionising radiation and containing

components operating at a potential difference of more than

5kV;

(c) human activities which involve the presence of

natural radiation sources that lead to significant increase in the

exposure of workers or members of the public;

(d) discontinuance or cessation of a practice or work

activity involving radioactive substances and devices that

produce radiation and are used for industrial, medical,

agricultural, research, and education purposes;

(e) any other practice or work activity specified from

time to time by the Commission.

(2) This Act shall apply to nuclear material used for peaceful

purposes while in international transport, and as applicable to

domestic use, storage and transport.

(3) This Act shall also apply to work activities which are not

covered by sub-article (1) but which involve the presence of natural

radiation sources and may lead to a significant increase in the

exposure of workers or members of the public which cannot be

disregarded from the radiation protection point of view.

(4) Without prejudice to the other provisions of this article,

this Act shall also apply to any intervention in cases of radiological

emergencies or in cases of lasting exposure resulting from the after-

effects of a radiological emergency or a past or old practice or work

activity.

(5) Without prejudice to the generality of this article and the

provisions of this Act and any regulations made thereunder, this Act

shall apply for any facility or equipment that emits non-ionising

radiation that the Commission specifies

Provided that, without prejudice to the generality of the

provisions of this article, sub-articles (2), (3), (4), and (5) shall apply

mutatis mutandis to the activities carried out by any member of the

disciplined forces, and the crew of vessels or aircraft registered in

Malta.

(6) This Act shall also apply to the exposure of workers or

members of the public to indoor radon, the external exposure from

building materials and cases of lasting exposure resulting from the

after-effects of an emergency or past human activity.

(7) This Act shall not apply to exposures associated with

situations excluded or exempted by the Commission.

(8) This Act shall not apply to radio communications apparatus,

electronic communications networks and services which are subject to

the requirements of any law administered by the Malta

Communications Authority.

Part II - General Principles of Protection against Ionising

and Non-ionising Radiation

(1) The prime responsibility for the safety and security Prime

of ionising and non-ionising radiation sources rests with the responsibility.

undertaking

Provided that the prime responsibility for safety and

security rests with the licence holder. That responsibility cannot be

delegated and includes responsibility for the activities of contractors

and sub-contractors whose activities might effect safety and security.

(2) Undertakings shall promote both a safety culture and a

security culture within their organisation.

No practice involving exposures to ionising or non- Justification.

ionising radiation shall be adopted unless it produces sufficient

benefit to the exposed individual or to society to offset the detriment

it causes.

Exposure to ionising and non-ionising radiation must be Optimization.

kept as low as reasonably achievable, taking economic and social

factors into account.

(1) For the purposes of this Act the recommendations Limits of

by the International Commission on Non-Ionising Radiation exposure.

Protection with respect to Basic Restrictions and Reference Levels in

the electromagnetic field shall be adopted as the relevant exposure

limits for electromagnetic fields.

(2) The effective ionising radiation dose to individuals shall

not exceed the dose limits specified by the Commission as defined in

article 10.

A graded approach shall be applied by the Commission

and the Secretariat in performing their functions.

Part III – The Regulatory Framework

(1) There shall be set up a Commission for the

Protection from Ionising and Non-Ionising Radiation, hereinafter

referred to as "the Commission", which shall act as the regulatory

authority in the field of nuclear safety and radiation protection. The

Commission shall have such functions in respect of its structures as

are set out in this Act and such other functions as may devolve upon it

under any other law, or as may be assigned to it by the Minister.

(2) It shall be the function of the Commission to

(a) draw up and establish policies and strategies in

consultation with the Minister to be followed by the Secretariat,

relating to the protection against ionising and non-ionising

radiation and other concerns addressed by the Act;

(b) co-ordinate the preparation of regulations governing

any issues made in connection with this Act;

(c)

act as a body of general review of the Secretariat;

(d) provide advice to the Secretariat when required as to

the interpretation of the relevant provision in this Act;

(e)

be the national body which gives effect to any

decision of the UN Security Council or International Atomic

Energy Agency, European Commission or internationally

recognised entity or competent authority in the field of nuclear

safety and radiation protection whenever so directed by the

Minister;

(f)

implement the regulatory requirements of

Conventions and other EU legislation within the scope of this

Act

Provided that the Commission shall regulate its own

procedures upon consultation with the Secretariat and the

Minister on all matters related to its functions on matters

regulated by this Act;

(g) prescribe the fees to be paid in respect of the issue,

validation, renewal, extension or variation of any certificate,

licence or other document or the undergoing of any examination

or test required by this Act or any regulations, directive or order

made thereunder and in respect of any other matters in respect

of which it appears to the Commission to be expedient for the

purpose of the Act, regulations, directive or order to charge

fees

Provided that the Commission may appoint for this

purpose, committees or sub-committees and it may co-opt on such

committees or sub-committees competent persons from outside its

membership, who in the opinion of the Commission, have

professional or expert knowledge on any matter dealt with under this

Act; so however that the co-opted members shall not have a vote on

any matter before a committee or sub-committee.

(3) Without prejudice to the generality of this article, the

Commission may undertake such other activity it may deem

necessary or expedient for the purposes of its functions and objectives

under this Act.

(4) The Commission shall consist of a Non-Executive

Chairperson, a Deputy Chairperson, and not more than nine members.

(5) The Minister shall appoint members, as expert members in

the Commission, for a period of three years and such period may be

extended for further periods of three years each. The Commission

shall be composed as follows

(a) one member with regard to occupational health and

safety issues;

(b)

one member with regard to environment issues;

(c)

one member with regard to the public health issues;

(d)

one member with regard to the civil protection

issues;

(e)

one member with regard to transportation issues;

(f)

one member with regard to the electromagnetic field

issues;

(g)

one member with regard to customs issues;

(h)

one member representing civil society; and

(i)

one

member

representing

the

field

of

communications

Provided that the Minister may change the composition of

the Commission so as to reflect the regulatory exigencies developing

from time to time, provided that no members shall be responsible for

the use of any form of ionising or non-ionising radiation.

Members of the Commission shall be allowed to be

represented by a replacement at meetings of the Commission and any

such replacements shall have voting rights.

The Executive Secretary shall attend all meetings of the

Commission but shall not have voting rights.

(6) The Chairperson and the Deputy Chairperson shall be

appointed by the Minister for a period of three years and such period

may be extended for further periods of three years each

Provided that where the Chairperson is absent from Malta

or is otherwise temporarily unable to perform the functions of that

office, all duties and functions of the Chairperson shall be assumed by

the Deputy Chairperson.

(1) Subject to the other provisions of this Act, the

affairs and business of the Commission shall be the responsibility of

the Commission itself but, save as aforesaid, the conduct of the

Commission, its administration and organisation shall be the

responsibility of the Chairperson of the Commission, who shall have

such other powers as may from time to time be delegated by the

Commission.

(2) The Chairperson shall attend all the meetings of the

Commission and shall have the casting vote at such meetings.

(3) The Chairperson shall be responsible for the

implementation of the objectives and functions of the Commission.

Without prejudice to the generality of the foregoing, the Chairperson

shall be responsible for evaluating the implementation and fulfillment

of the Commission’s established goals and shall report directly to the

Commission.

(4) The quorum for the meetings of the Commission shall be

constituted by the presence of any four members and the Chairperson.

(5) The Commission shall be obliged to convene at least once

every three months.

(6) The Commission shall provide a report on its activities and

the activities of the Secretariat for each calendar year not later than

the 15 th April of the following year to the Minister.

(1) There shall be set up the Secretariat for the The Secretariat.

Commission, hereinafter referred to as "the Secretariat", which shall

act as the executive of the regulatory authority in the field of nuclear

safety and radiation protection.

(2) The Secretariat shall have such functions as may devolve

on it under any other law or as may be assigned to in writing by the

Minister. In the case that other regulations are in force governing

occupational, public and medical exposures, or environmental

protection and safety of sources, which in some way address the uses

of ionising radiation or non-ionising radiation, or any other substance

the use or exposure of which is regulated by this Act, the Secretariat

shall recommend to the Commission, if it considers it necessary, to

make recommendations to the Minister for the reallocation of the

regulatory responsibility to the Secretariat itself or to some other

authority as the Secretariat after consultation with the Commission

deems fit.

(3) It shall be the function of the Secretariat to

(a)

issue authorizations and grant exemptions

concerning the possession and use of radiation sources;

(b) inspect, monitor and assess activities and practices

for the purpose of verifying compliance with this Act,

applicable regulations and the terms and conditions of

authorizations and, or licences;

(c)

maintain a national register of radiation sources and

a national register of undertakings;

(d) gather the required data to enable an assessment of

total exposure from all practices and work activities in Malta

and including the distribution of the individual occupational and

public exposures for each type of practice, and to enable the

setting up of a national register for occupational exposure to

ionising radiation;

(e)

establish and maintain a national system of

accounting for and control of nuclear material and a national

system for the registration of licences for nuclear material, and

to establish the necessary reporting and record keeping and

requirements pursuant to the Safeguards Agreement, and

Additional Protocol;

(f)

develop the necessary strategies for

the

implementation of the objectives of the Commission;

(g) advise the Commission on any matter it may refer or

on any matter which is considered necessary or expedient; and

any such duties as the Commission may assign from time to

time;

(h) provide technical advise to the Minister or other

governmental entities; and

(i)

conduct any other functions that are deemed

necessary by the Commission, to protect people and the

environment of Malta.

(4) Without prejudice to the other provisions of this Act and to

any regulations made thereunder, the Secretariat shall, following

consultation with the Commission, adopt rules of procedure which

shall regulate every stage of its operations.

(5) The Secretariat shall be responsible for keeping the

proceedings referred to in article 12(3) and also a register wherein the

findings and rulings of the Secretariat shall be entered.

(1) The Minister shall appoint a person to act as the

Executive Secretary of the Secretariat, who shall be responsible for

the proper and efficient organization of the Secretariat.

(2) The Executive Secretary of the Secretariat shall hold office

for a period of three years and may be re-appointed on the expiry of

the term

Provided that the Executive Secretary shall remain in

office on completion of the term until the Minister formally informs

the Executive Secretary of the appointment of a substitute.

(3) The Executive Secretary shall appoint public officers and

other employees as officers of the Secretariat on such terms and

conditions as approved by the Commission.

(4) For the purposes of the Criminal Code and of any

provision of a penal nature in any other law, the members of the

Commission, officers and employees of the Secretariat, shall be

deemed to be public officers.

(5) An officer of the Secretariat shall be issued with means of

proper identification signed by the Executive Secretary, and such

document shall be produced at the time of any examination,

investigation or inspection

Provided that the Executive Secretary shall be deemed to

be an officer, and the document of identification as an officer shall be

signed by the Chairperson.

(6) Officers of the Secretariat shall have the following powers

(a) to enter freely and without previous notice in any

activity, facility, practice or any other place that is deemed to be

carrying out the use of unlawful activities;

(b) to request the assistance of a member of the Police

Force in the execution of the officer’s duties;

(c)

to question, alone or in the presence of witnesses,

including the person, if such is the case, putting forward the

complaint, any employer or worker, including any person acting

on behalf of any employer or carrying out work for such

employer, on any of the matters falling under this Act or under

any regulations made thereunder;

(d) to inspect any document the keeping of which is

prescribed by this Act or by any regulation made thereunder, or

any book, document, design, plan, or list of technical

specifications which may throw light with regard to ionising

safety at any particular practice or activity;

(e)

to take possession, upon giving receipt therefor, of

any object required for tests or as evidence of any ionising

radiation accident, injury or disease, or of any alleged violation

of this Act or of any regulations made thereunder;

(f)

to examine or see to the examination of any practice

or activity and of any object therein, and to take samples for

examination of any article, substance or material found in any

workplace or within its curtilage for the purpose of radiation

protection, and to ensure that such samples are preserved for use

as evidence in any proceedings taken in accordance with this

Act;

(g) to order that nothing be disturbed at a practice or

activity for any period which may be reasonably required for the

purpose of any examination, investigation or inspection referred

to in the foregoing paragraphs;

(h) to require the operation or the setting in motion of

any equipment, machine, device, thing or process, as well as the

operation of any system or procedure which, in the opinion of

the officer, may be relevant to any examination, investigation or

inspection referred to in paragraphs (a) to (e);

to require any undertaking to provide at the

(i)

undertaking’s expense

(i) a certificate signed by suitably qualified

persons with regard to the radiation safety of any building

or structure, including any temporary structures;

(ii) a certificate signed by suitably qualified

persons with regard to the radiation safety of any radiation

producing equipment, as the case may be;

(iii) a certificate signed by a medical practitioner

relating to the medical surveillance of any worker or any

class of workers, which shall be presented to the

Commission;

(iv) any information relative to radiation

protection, including information which refers to

protective measures;

(j)

to require any undertaking, agent, manufacturer,

importer, supplier, user or other person to provide at their

expense any document, certificate or list of technical

specifications in relation to any matter concerning radiation

protection, the method of handling or use of any radiation

producing equipment, machinery, article, substance or chemical

which is used or intended to be used; and

(k) for the purposes of a prosecution for any offence

under this Act, or for the purposes of any appeal to the Appeals

Tribunal against an order by an officer, to disclose to the Court

or to the Appeals Tribunal such results or information received

or collected during the course of the investigations.

(7) No action, disciplinary or otherwise, or other proceeding

for damages, shall lie or be instituted against the Executive Secretary,

or against an officer for an act done or omitted to be done by them in

good faith in the execution or intended execution of any power, right

or duty under this Act or any regulation made thereunder.

(1) There is hereby established a tribunal to be known

as the Radiation Protection Appeals Tribunal, hereinafter referred to

as "the Appeals Tribunal" to hear and decide upon appeals from any

decision taken by the Secretariat.

(2) Save as otherwise provided in this article, the Appeals

Tribunal shall consist of a President of the Appeals Tribunal and two

members who shall be appointed as follows

(a) the President of the Appeals Tribunal shall be one of

a panel of persons appointed by the Minister, being persons who

are advocates of at least seven (7) years experience and such

persons shall serve as President either in turn or in accordance

with such distribution of duties, and subject to such provisions

as to inability to serve and other circumstances, as the persons

on the said panel may with the approval of the Prime Minister,

establish;

(b) the other members of the Appeals Tribunal shall be

selected by the President of the Appeals Tribunal from a list of

persons who are neither advocates nor legal procurators,

appointed by the Minister to serve as Members of the Appeals

Tribunal as occasion may require.

(3) No member or officer of any Commission may be

appointed on the Appeal’s Tribunal.

(4) The names of persons appointed to serve as Presidents or

as members of the Appeals Tribunal shall be notified in the Gazette.

(5) The Appeals Tribunal shall consist of the President and

two members whenever the appeal concerns

(a) an order relating to the barring in full of a

workplace; or

(b) orders relating to the prohibition of use of any

equipment, plant, or facility which, where the order to be

implemented, would result in the cessation of all work

activities; or

(c)

appeals by third parties that would involve the

barring in full of a workplace or the cessation of all work

activities.

(6) Saving the provisions of sub-article (5), the Appeals

Tribunal shall consist of the President alone provided that each one of

the parties may request that the appeal be heard by an Appeals

Tribunal made up of the President and two members, and such

requests shall be decided by the President alone during the

preliminary stages of the appeal as may be prescribed by regulations

which the Minister may make by virtue of sub-article (11).

(7) The President shall have the right to administer the oath

and examine witnesses.

(8) The Appeals Tribunal shall have the right to seek expert

advice as it may deem fit.

(9) The Minister may from time to time vary the composition

of the lists as provided in this article, but a person actually serving as

a member of the Appeals Tribunal shall, notwithstanding the removal

of one’s name from the panel, continue to serve in the proceedings as

a member until the conclusion of those proceedings and for the

purpose of the interpretation of any decision given therein

Provided that in the case of the death or other impossibility

of such member to continue hearing such a case, another person shall

be subrogated from the existing panel to hear the case.

(10) The Minister shall also appoint a person to act as secretary

of the Appeals Tribunal.

(11) The Minister may make regulations prescribing the

procedure to be used for an appeal to be made to the Secretary of the

Appeals Tribunal and to regulate the procedure to be used by the

Appeals Tribunal.

Part IV - Notification, authorization, inspection, enforcement

and penalties

(1) Any person who intends to adopt or introduce,

conduct, discontinue or cease to operate a practice or work activity

involving the use of ionising radiation, as well as design,

manufacture, construct or assemble, acquire, import or export,

distribute, sell, loan or hire, possess, locate, commission, use and

operate, maintain or repair, transfer or decommission, disassemble,

transport, store or dispose of radioactive material, as applicable,

within a practice or work activity, shall submit to the Secretariat a

formal written notification of the intention to do so giving all

information required within the time limits required by the

Secretariat.

(2) Any person who intends to adopt or introduce, conduct,

discontinue or cease to operate a practice or work activity involving

the use of non-ionising radiation that requires notification as specified

by the Commission by virtue of article 4(5) shall submit to the

Secretariat a formal written notification of the intention to do so

giving all information required within the time limits required by the

Secretariat.

(3) On submission of a formal written notification or a formal

request of authorization, where appropriate the Secretariat may

request a security bond

Provided that the Secretariat must state in writing the

reasons why it considered the necessity to impose such bond and the

process of quantification of such bond.

(1) No activity shall be introduced, implemented, Authorization.

ceased or stopped, and no source shall be designed, produced, built or

assembled, purchased, imported or exported, distributed, sold,

borrowed or leased, possessed, located, put in operation, used or

operated, maintained or repaired, transferred, transported or

decommissioned, disassembled, stored or finally disposed, if not in

line with relevant provisions on safety of radiation sources and, or

other requirements established by this Act.

(2) Without prejudice to the provisions of sub-article (1), the

prohibition of action shall be in effect until radiation exposure, or

non-ionising emittance from such an operation or source, is excluded

from the contents of the relevant regulation, or until the Secretariat

excludes such an operation or source from the regulatory control,

including notification and authorization requests.

(3) Without prejudice to the provisions of sub-articles (1) and

(2), it shall be unlawful to possess a radiation source or perform a

practice involving an ionising radiation source without an

authorization from the Secretariat.

(4) Without prejudice to the provisions of sub-article (2) it

shall be unlawful to possess a non-ionising radiation source as

specified by the Commission by virtue of article 4(5) or perform a

practice involving such sources without an authorization from the

Secretariat

Provided that the Secretariat may issue staged

authorizations. In such cases, before the issuance of a staged

authorization, each preceding and completed stage shall be subject to

full review and assessment.

Any licence or authorization issued pursuant to this Act Suspension,

may be suspended, modified or revoked by the Secretariat in the modification,

revocation of

event of a violation of its conditions, when the conditions under licence

authorization.

which it was issued are no longer met, or in any circumstance where

the Secretariat determines that continued activity under the licence or

authorization would pose an unacceptable risk to people or the

environment.

(1) Any person or entity licenced or authorized to

conduct an activity or practice shall have the primary responsibility

for the safe and secure conduct of that activity or practice and for

ensuring compliance with this Act and all applicable regulatory

requirements and conditions of the licence or authorization related to

that activity or practice.

(2) A license holder shall be liable for safe management of

radioactive waste resulting from the practice involving the

radioactive source.

(1) The Secretariat shall have the authority to conduct

announced and unannounced inspections and to carry out any other

such examination as may be necessary to verify compliance with the

provisions of this Act, applicable regulations and any applicable

conditions of licences or authorizations.

(2) For cases representing an immediate safety or security

hazard to people or the environment, the Secretariat may require the

person or entity subject to enforcement action to suspend its

activities, or parts thereof until the situation has been corrected. In

such cases, the Secretariat may also suspend, revoke or modify the

terms and conditions of the licence or authorization.

(3) In cases of persistent or extremely serious non-compliance

with or violation of the terms and conditions of an authorization or a

licence or in cases of significant release of radioactive material into

the environment, the Secretariat may revoke the authorization or

licence and require the licensee to remedy any unsafe condition.

(4) No person may threaten, insult, molest or disturb

inspectors in the performance of their duties, or knowingly give an

officer false information, or break or tamper with any seal made, or

with any monitoring equipment installed, put up or left by an officer

in a work place or, in the case of personal monitoring equipment, on a

worker.

(1) Any officer of the Secretariat may give an order,

verbally or in writing, and every person shall obey such order

forthwith until such time as it is revoked by the Secretariat or the

Appeals Tribunal

Provided that the person who receives the order, whether

such person is a worker or an undertaking, may defend himself from

the charge of having disobeyed the order if he proves that compliance

with the order would have constituted a violation under this Act

Provided further that any order given verbally shall be

confirmed in writing and served upon the person to whom it was

given within three working days.

(2) Any officer of the Secretariat may affix seals or use other

means in order to ensure that any equipment cannot be operated, if

ordered as such, until such a time that the order is revoked.

(3) Any officer of the Secretariat may order that a workplace

or part of a workplace be condemned, and ordered to cease its

operations therefrom, and may revoke any such order. When a

workplace or part thereof is condemned according to the provisions of

this sub-article, no person shall enter the condemned area without the

Secretariat’s written authorization.

(4) Any officer of the Secretariat when making an order in

writing under this article, may affix in the workplace, or on any

equipment, machine, apparatus, article or thing, a copy thereof, and

no person except an officer authorized by the Secretariat shall remove

such copy.

(5) Where any officer of the Secretariat makes an order in

writing under this article, or issues a report of inspection to an

undertaking or to a person in charge of work, the undertaking or

person in charge of work shall forthwith cause a copy or copies

thereof to be posted in a conspicuous place or places at the practice or

activity where it is most likely to come to the attention of workers

Provided that it shall also be at the discretion of the

Secretariat, with the concurrence of the Commission, to publish such

order in the Gazette, if it is such to safeguard the public interest.

(6) No pleas of breach of the right to a fair hearing shall be

raised by the investigated party before the issuance of an order.

(1) Any person who fails to comply with the provisions Penalties.

of this Act, or any regulations made thereunder shall be guilty of an

offence and shall be subject to the penalties established by this Act

and any applicable regulations.

(2) Any person who acts in contravention of the provisions of

articles 5, 6, 7, 8, 15, 16, 18, 19, 20, 25, 28, 34, 35, 37, 38, 39, 40, 45,

47, 49, 53, 54 or 55 or in contravention of any of the provisions of

any regulations made under this Act, and any person who conspires or

attempts, or aids, abets, counsels or procures any other person, to

contravene the provisions aforementioned, shall be guilty of an

offence against this Act.

(3) Any person who, in connection with any matter under this

Act, or under any regulations made by virtue of this Act -

(a) furnishes any information which that person knows

to be false in a particular detail, or recklessly furnishes any

information which is false in a particular detail; or

(b) with intent to deceive, produce, furnish, send or

otherwise make use of any document which is false in a

particular detail; or

(c)

wilfully refuses or without lawful excuse, the proof

whereof shall lie on that person, withholds any material

information; or

(d) knowingly or recklessly makes any incorrect

statement or entry in any record or return or on any document

kept or furnished under this Act or under any regulations made

thereunder; or

(e)

unlawfully refuses or fails to answer to the best of

that person’s knowledge any question made to him by an officer

in the exercise of that officer’s functions; or fails to co-operate

fully with an officer in the pursuance of that officer’s duties; or

(f)

unlawfully refuses or fails to comply with any

requirement duly provided under this Act or under any

regulations made by virtue of this Act; or

(g) hinders an officer in the performance of that

officer’s duty under this Act or under any regulations made by

virtue of this Act,

shall be guilty of an offence against this Act or regulations made by

virtue of this Act.

(4) Except in the case of article 39, any person who commits

an offence against this Act, or regulations made by virtue of this Act,

shall, on conviction, be liable to imprisonment for a period of not

more than two years or to a fine (multa) of not less than five hundred

euro (€500) but not exceeding twelve thousand euro (€12,000), or to

both such fine and imprisonment; and moreover the court may, at the

request of the prosecution, cancel all or any licences, warrants or

permits issued to or in the name of the person found guilty in

connection with the workplace where the offence was committed

Provided that no proceedings shall be taken against any

person who, after receiving an intimation by the Commission for the

payment of a penalty not exceeding five hundred euro (€500) for

having contravened the provisions of this Act or of any regulations

made by virtue of this Act, pays such penalty to the Commission in

either case within fifteen days from the date of receipt of such

intimation.

(5) Any person who commits an offence against article 39 or

acts listed in articles 57 and 59 shall be punishable with imprisonment

for a period of two (2) years but not exceeding five (5) years, and, or

a fine (multa) not exceeding five hundred thousand euro (€500,000).

(6) Notwithstanding the provisions of article 370 of the

Criminal Code, proceedings for an offence against this Act shall be Cap. 9.

taken before the Court of Magistrates (Malta) or the Court of

Magistrates (Gozo), as the case may be, sitting as courts of criminal

judicature.

(7) In criminal proceedings instituted by the Police before the

Court of Magistrates for an offence against the provisions of this Act,

the Executive Secretary may assist the Police in the conduct of the

prosecution and in the production of the evidence.

(8) The Executive Secretary or any officer deputed by him for

the purposes of sub-article (5) may nevertheless be produced as a

witness but should his evidence be required as part of the case for the

prosecution, his evidence shall be heard before that of any other

witness for the prosecution unless the necessity of his evidence arises

subsequently.

(9) Notwithstanding the provisions of the Criminal Code, the Cap. 9.

Attorney General shall always have a right of appeal from any

judgement given by the Courts of Magistrates (Malta) or by the Court

of Magistrates (Gozo) in respect of proceedings for any offence

against this Act or any regulations made by virtue of this Act.

(10) The punishments provided in this Act shall apply unless

the fact constitutes a more serious offence under the Criminal Code or Cap. 9.

any other law, in which case the provision of the Criminal Code or of

such other law shall apply.

(11) Notwithstanding the provisions of the Criminal Code Cap. 9.

proceedings for an offence under this Act may be commenced at any

time within six years from the commission of the offence.

Administrative remedial measures carried out by the Administrative

Secretariat may include suspension, modification or revocation of a remedial

measures.

licence or authorization.

Any decision issued by the Secretariat, in terms of article Appeals.

12, shall be subject to appeal on points of law and fact before the

Appeals Tribunal

Provided that any appeal on points of law shall be heard by

the Court of Appeal (Civil Jurisdiction)

Provided further that any appeal from any decision

referred to in article 12(5), which carries a criminal fine upon

conviction, shall be subject to prosecution before the Criminal Court

and subject to appeal before the Court of Appeal (Criminal

Jurisdiction).

Part V - Radiation Protection

(1) Without prejudice to the generality of articles 10 and

12, the Commission shall establish legal requirements and an

appropriate regime of regulatory control for all exposure situations,

reflecting a system of radiation protection based on the principles of

justification, optimisation and limitation of exposure.

(2) The Commission shall set criteria to be met for different

categories of persons involved in radiation protection activities

covered by this Act or any regulations made under this Act.

(1) All undertakings shall implement an appropriate

radiation protection programme.

(2) Undertakings shall ensure that only workers who have

undergone adequate radiation protection training, including the use of

related equipment used in the course of their employment, shall carry

out work with radiation sources or in radiation environments.

Part VI - Regulatory Control of Sources

(1) The Secretariat shall establish a system of control

over sources and equipment in which such sources are incorporated to

ensure that they are safely managed and securely protected during

their useful lives and at the end of their useful lives.

(2) Based on internationally recognized guidance, the

Commission shall adopt a categorization of radioactive sources based

on the potential injury to people and the environment that could result

if such sources are not safely managed or securely protected.

Part VII - Environmental Monitoring

(1) The Commission shall ensure that a system for the

routine monitoring of the environment, food, water, milk and animal

feeds is in place.

(2) The Secretariat shall collate results and distribute and, or

publish the said results as required.

(3) Other governmental agencies or other technical support

organisations shall provide all support necessary for the collection

and testing of samples and for monitoring the environment.

Part VIII - Discharges of Radionuclides to the Environment

(1) The Commission shall establish requirements for Function of

discharges to the environment including exemption levels and Commission

and Secretariat

clearance levels.

on discharges of

radionuclides to

the

(2) Prior approval must be obtained from the Secretariat for environment.

discharges of radioactivity to the environment above clearance and,

or exemption levels.

The Secretariat shall issue discharge licences for any Issuance of

discharge activities it approves. Discharge licences shall specify discharge

licenses.

activity limits and shall specify conditions.

Part IX - Emergency Response

No licence to conduct an activity or practice, operate a Authorized

facility, or possess or use a source may be granted unless and until an party’s

emergency

appropriate emergency preparedness and response plan has been plans.

developed by the applicant and reviewed by the Secretariat.

A national emergency plan for responding to potential Establishment

nuclear or radiological emergencies shall be developed and and

maintenance of

maintained by the Secretariat in conjunction with the Commission a emergency

and approved by the Minister, after consultation with the Commission

and other Ministers, if the Minister believes that their consultation is

necessary to fulfill his functions under this Act.

In the event of a nuclear or radiological emergency that Trans-frontier

poses a risk that radioactive contamination could spread beyond the emergencies.

territorial waters of Malta, the Commission shall immediately notify

the International Atomic Energy Agency and the European

Commission.

The Commission may also decide to notify to the

International Atomic Energy Agency and the European Commission

of other incidents it deems relevant

Provided that the Secretariat shall serve as the point of

contact for providing any information or assistance regarding nuclear

or radiological emergencies under the terms of relevant international

instruments, including the Convention on Early Notification of a

Nuclear Accident and the Convention on Assistance in the Case of a

Nuclear Accident or Radiological Emergency

Provided further that, subject to the international

conventions, including the Vienna Convention on Civil Liability for

Nuclear Damage, the Commission in conjunction with the Secretariat

shall be obliged to develop the state nuclear safety plan in the event of

accidents in nuclear facilities in other countries, which can affect

nuclear safety status in Malta.

Part X - Transport, Import and Export of Radioactive Material

The Commission shall establish requirements for the

transport of radioactive material to, from and within the jurisdiction

of Malta after consultation with government entities responsible for

transport and the import and export of goods.

(1) No person or entity shall engage in the transport of

radioactive material without appropriate authorization from the

Secretariat.

(2) Any transport of radioactive material shall be carried out in

compliance with the applicable national transport regulations and

with the technical requirements of the Regulations for the Safe

Transport of Radioactive Material of the International Atomic Energy

Agency, and applicable requirements of the European Agreement

concerning the International Carriage of Dangerous Goods by Road

(ADR), the International Maritime Organisation (IMO) and the

International Civil Aviation Organisation (ICAO), as amended from

time to time.

(1) No import or export of radioactive material is

permitted prior to notification to the Secretariat.

(2) Upon notification the Secretariat will then approve or

otherwise the import or export of radioactive material.

Part XI - Waste

To ensure the safe and secure management of radioactive

waste in Malta, the Commission in conjunction with the Secretariat

shall maintain

(a) a national policy and strategy for radioactive waste

management;

(b) applicable safety and security requirements and

regulations for the protection of people and the environment

from adverse impacts of radioactive waste management

activities.

The prime responsibility for ensuring the safety and Prime

security of radioactive waste inside or outside a radioactive waste responsibility

upon

facility throughout its life rests with the holder of the relevant authorization.

authorization or licence

Provided that the responsibility for ensuring the safety and

security of radioactive waste for which no undertaking or entity can

be determined shall rest with the relevant body governing matters

related to the disposal of radioactive waste.

The licensee who is in possession of the radioactive waste Responsibility

for the financing

shall be responsible for financing the disposal of the waste.

of the disposal

of waste.

The importation of radioactive waste is an offence under Illicit

this Act and is punishable with imprisonment for a period of two (2) importation

radioactive

years but not exceeding five (5) years, and, or a fine (multa) not waste.

exceeding five hundred thousand euro (€500,000).

Radioactive waste generated within Malta may be exported Export of

only upon the issuance of an authorisation or a licence by the radioactive

waste is

Secretariat and provided the obligations set in the Supervision and permitted

authorization.

Control of Shipments of Radioactive Waste Regulations have been S.L. 549.51

met.

Part XII - Reduction of Existing or Unregulated Risks

The Commission shall ensure that existing exposure Evaluation of

situations that have been identified are evaluated to determine which exposures.

occupational exposures and public exposures are of concern from the

point of view of radiation protection.

The Commission shall recommend to the Minister the Remedial

justified remedial actions that need to be taken for the protection of actions.

the public and which ensure that protection and safety is optimized.

The Commission shall collate information on levels of Levels of radon.

radon indoors and the associated health risks and, if appropriate, shall

establish and implement an action plan for controlling public

exposure due to radon indoors.

The Commission shall establish reference levels for Exposure of

exposure due to radionuclides in commodities, and enforce radionuclides.

requirements for the protection of workers in existing exposure

situations.

Part XIII - Safeguards

Nuclear material in Malta shall be used exclusively for

peaceful purposes and in accordance with relevant international

obligations undertaken by Malta.

To ensure compliance with the relevant commitments of

Malta to the Safeguards Agreement and the Additional Protocol the

Secretariat shall

(a) verify the implementation of the obligations of

Malta arising from Safeguards Agreement and the Additional

Protocol;

(b) collect and provide to the European Atomic Energy

Community and the International Atomic Energy Agency the

information required to fully implement the Safeguards

Agreement and the Additional Protocol; and

(c)

facilitate access by European Atomic Energy

Community and the International Atomic Energy Agency

inspectors within the territory of Malta.

All agencies of the Government of Malta and authorized or

licensed persons and entities shall cooperate fully with the European

Atomic Energy Community and the International Atomic Energy

Agency in the application of safeguards measures, including by

(a) promptly providing all necessary information under

the Safeguards Agreement and the Additional Protocol;

(b) providing access to locations as required by the

Safeguards Agreement and the Additional Protocol;

(c)

providing support to the Commission, the

Secretariat, the European Atomic Energy Community and the

International Atomic Energy Agency inspectors in the

performance of their tasks; and

(d) rendering to the Secretariat, the European Atomic

Energy Community and the International Atomic Energy

Agency inspectors all necessary services in connection with

their inspections.

Duly authorized representatives of the Secretariat and Right of access

designated inspectors of the European Atomic Energy Community of

the European

and the International Atomic Energy Agency shall have access to any Atomic

Community and

location or facility as provided for under the Safeguards Agreement the International

and any protocols thereto, with a view to conducting the verification Atomic

Agency and the

activities authorized by these instruments.

Secretariat.

Any person performing activities subject to the Safeguards Obligation of

Agreement and any protocols thereto shall allow the Secretariat and access.

duly designated inspectors of the European Atomic Energy

Community and the International Atomic Energy Agency to carry out

any measures the Secretariat or the European Atomic Energy

Community and the International Atomic Energy Agency,

respectively, consider necessary or appropriate for achieving

compliance with the undertakings of Malta arising from the

Safeguards Agreement and additional protocol.

The Commission shall be responsible for approving the Approval of

designation to Malta of inspectors proposed by the European Atomic inspectors

proposed by the

Energy Community and the International Atomic Energy Agency.

European

Atomic Energy

Community and

the International

Energy Agency.

The Secretariat shall arrange with other governmental Arrangements

entities, as required, to ensure that any necessary permission(s), for

functions in

including visas, where required, are issued, in an expedited manner, Malta.

to enable designated inspectors of the International Atomic Energy

Agency to Malta to enter and remain in the territory of Malta for the

purpose of carrying out their safeguards functions in accordance with

the Safeguards Agreement and any protocols thereto.

The Commission shall ensure the effective implementation Implementation

of safeguards in

of safeguards in Malta by establishing and implementing

Malta.

(a)

a system for the measurement of nuclear material;

(b)

procedures for carrying out physical inventories;

(c)

a system of records and reports for tracking nuclear

material inventories;

(d) procedures for ensuring that accounting procedures

and arrangements are being operated correctly; and

(e)

procedures for reporting to the International Atomic

Energy Agency.

Undertakings authorized to possess, use, handle or process

nuclear material subject to the Safeguards Agreement and any

protocol thereto shall

(a)

maintain records as prescribed by the Secretariat;

(b)

submit the prescribed reports to the Secretariat;

(c)

give notice to the Secretariat of the import or export

of nuclear material, as specified by the Secretariat;

(d) maintain physical protection and other security

measures with respect to nuclear material, as specified by the

Secretariat;

(e)

without delay, report to the Secretariat any loss of

nuclear material in excess of limits prescribed by the

Commission;

(f)

provide reports on planned future activities, as

specified by the Commission;

(g) allow authorized representatives of the Secretariat

and designated officials of the European Atomic Energy

Community and the International Atomic Energy Agency to

carry out, without hindrance, inspections at any facility or other

location as provided for under this Act, the Safeguards

Agreement or any protocol thereto.

Any person intending to carry out research and

development activities related to the nuclear fuel cycle, as defined in

the Safeguards Agreement and any protocols thereto, shall provide to

the Secretariat information on these activities prior to their

commencement.

Any undertaking performing activities subject to the

Safeguards Agreement or any protocol thereto shall submit to the

Secretariat the information and data necessary for compliance by

Malta with the undertakings by Malta arising from this Act.

Part XIV - Nuclear Security, Physical Protection

and Illicit Trafficking

The Commission shall establish requirements for the Functions of the

physical protection of nuclear (and other radioactive) material, Secretariat

the protection of

including

nuclear and

other

radioactive

(a)

a categorization of nuclear (and other radioactive) material.

material based on an assessment of the damage that could result

from theft or diversion of a certain type and quantity of material

from authorized uses, or from sabotage of a facility in which

nuclear and other radioactive material is produced, processed,

used, handled, stored or disposed of;

(b) protection measures

necessary

for

different

categories of material; and

(c)

accounting and control measures for nuclear (and

other radioactive) material.

In the event of theft, robbery or unlawful taking, or Theft, robbery

credible threat of unlawful taking, of nuclear (or other radioactive) or

possession of

material, the Secretariat shall take appropriate steps as soon as radioactive

material.

possible to inform other States or international organizations that may

be affected of the circumstances of the incident.

The Secretariat shall be the central authority responsible Physical

for physical protection of nuclear material and for coordinating protection

nuclear

recovery and response in the event of any theft or unlawful taking of materials.

nuclear (or other radioactive) material.

In the event of theft or any other unlawful taking of nuclear Cooperation and

(or other radioactive) material, the Secretariat shall be responsible for assistance

arrangements in

determining the necessary cooperation and assistance arrangements in the

illicit possession

the recovery and protection of such material to be agreed with any of nuclear

materials.

State or international organization that so requests.

The Secretariat shall provide information on incidents Provision of

involving the theft, robbery or any other unlawful taking of nuclear information

incidents

(or other radioactive) material, equipment and technology to the involving

illicit possession

International Atomic Energy Agency under arrangements established of nuclear

materials.

by that Agency.

Part XV - Financial Provisions

(1) The Commission and the Secretariat shall be Financial

provided with adequate financial and human resources, through the provisions.

national budget, to fulfil their responsibilities under this Act and

applicable regulations.

(2) The Commission may charge fees pursuant to article

10(2)(g)

Provided that any fees or fines collected by the Secretariat

shall be paid to the Ministry for Finance.

(3) The Minister responsible for Finance may, after

consultation with the Minister, make advances to the Commission of

such sums as the Minister responsible for Finance may agree to be

required by the Commission for carrying out any of its functions

under this Act, and may make such advances on such terms and

conditions as the Minister responsible for Finance may, after

consultation as aforesaid, deem appropriate. Any such advance may

be made by the Minister responsible for Finance out of the

Consolidated Fund, and without further appropriation other than this

Act, by warrant, authorising the Accountant General to make such

advance.

(4) The Commission shall be responsible for developing its

own budget and for presenting it to the Minister for approval.

(5) The Commission shall cause to be prepared, at the end of

every financial year, a financial report recording the income and

expenditure of the Commission and the Secretariat and the projected

estimates of the income and expenditure of Commission and the

Secretariat for the next following financial year

Provided that the estimates of the Commission for the first

financial year of the Commission shall be prepared and adopted

within such time as Minister may, by notice in writing to the

Commission, specify.

Part XVI - Final Provisions

The Minister may make regulations generally so as to give

effect to the provisions of this Act, and for the better carrying out of

any of the provisions of this Act including regulations implementing

all international legal instruments relating to ionising and non-

ionising radiation, nuclear safety and security.

(1) Regulations made under any provision of this Act

may be made in the English language only.

(2) In the event of conflict or incompatibility between the

Maltese and English texts of any regulations made under this Act, the

English language version shall prevail.

(1) Authorisations issued by virtue of the Nuclear Transitory

Safety and Radiation Protection Regulations shall remain valid until provisions.

their expiry date.

(2) All other existing regulations relating to the use of ionising

radiation shall remain in force until they are expressly revoked.

Passed by the House of Representatives at Sitting No. 114 of the

21st May, 2018.

ANĠLU FARRUGIA

Speaker

RAYMOND SCICLUNA

Clerk of the House of Representatives

€3.42