Radiation (Amendment) Regulations, 2022

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,857, 13 ta’ Mejju, 2022 B 763

L.N. 139 of 2022

NUCLEAR SAFETY AND RADIATION PROTECTION ACT

(CAP. 585)

Basic Safety Standards for Ionising

Radiation (Amendment) Regulations, 2022

IN EXERCISE of the powers conferred by article 62 of the

Nuclear Safety and Radiation Protection Act, the Minister for

Inclusion, Voluntary Organisations and Consumer Rights has made the

following regulations:-

The title of these regulations is the Basic Safety Standards Citation.

for Ionising Radiation (Amendment) Regulations, 2022 and these

regulations shall be read and construed as one with the Basic Safety S.L. 585.01.

Standards for Ionising Radiation Regulations, hereinafter referred to as

"the principal regulations".

Sub-regulation (2) of regulation 9 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

the principal

regulations.

"(2) The limit on effective dose for occupational exposure

shall be 20mSv in any single year. In special circumstances or

for certain exposure situations where the Secretariat is satisfied

that a dose in excess of the annual limit is appropriate, the

Secretariat may authorise a higher effective dose of up to 50mSv

in a single year, provided that the average annual dose over any

five (5) consecutive years, including the years for which the limit

has been exceeded, does not exceed 20mSv.".

Sub-regulation (2) of regulation 12 of the principal Amends

regulation 12 of

regulations shall be substituted by the following new sub-regulation

the principal

regulations.

"(2) The limit of the effective dose for public exposure is

1mSv per annum.".

Regulation 31 of the principal regulations shall be amended Amends

regulation 31 of

as follows

the principal

regulations.

(a) paragraph (a) of sub-regulation (1) thereof shall be

substituted by the following new paragraph

"(a) the practice is subject to licensing by the

Commission and shall impose specific requirements,

including criteria for individual implementation, that have

been established by the Commission, making reference to

guidance available from international bodies, in

cooperation with Maltese professional bodies of

practitioners, other governmental regulatory bodies and any

other such persons or bodies that the Commission sees fit

as appropriate;"; and

(b) sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(2) For procedures not using medical radiological

equipment, shall have dose constraints that shall be

established by the Commission and its value shall not

exceed an effective dose of 0.005mSv per procedure with a

limit of 0.1mSv per year for the individual exposed to that

procedure and;".

Sub-regulation (1) of regulation 34 of the principal

regulations shall be substituted by the following new sub-regulation

"(1) Notification is required for all justified practices,

including those identified according to regulation 33. The

notification shall be made at least thirty (30) days prior to a

practice commencing. Existing practices shall notify within

thirty (30) days of the publication of this regulation. The

Secretariat shall specify the information to be provided in

conjunction with the notification. Where an application for an

authorisation is submitted, no separate notification is needed. An

authorisation may lead to the Secretariat issuing the undertaking

with either a registration or license.".

Regulation 36 of the principal regulations shall be

substituted by the following new regulation

"36. (1) The Commission shall require either

registration or licensing of the following practices

(a) the operation of radiation generators or

accelerators or radioactive sources for medical

exposures or for non-medical imaging exposure

purposes; and

(b) the operation of radiation generators or

accelerators, except electron microscopes, or

radioactive sources for purposes not covered by

sub-paragraph (a).

(2) The Commission may require registration or

licensing of other types of practices.

(3) Subject to regulation 37, the Commission

shall, in accordance with sub-regulations (1) and (2),

determine which practices are subject to registration or

licensing. The Commission shall base its decision to

submit a type of practice to registration or licensing,

using a graded approach and based on regulatory

experience taking into account

(a) the magnitude of expected or potential

doses resulting from the practice;

(b) the impact that regulatory control may

have in reducing such doses or improving

radiological safety;

(c) the complexity of the practice; and

(d) safety and security having regard to the

circumstances in which the relevant practice is

proposed to be carried out.".

Sub-regulation (2) of regulation 44 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

the principal

regulations.

"(2) For workplaces specified in regulation 64(3) and

where the exposure of workers is liable to exceed an effective

dose of 6mSv per year or a corresponding time-integrated radon

exposure value to be determined by the Commission based on

international guidance, these shall be managed as a planned

exposure situation and the Commission shall determine which

requirements set out in this Part VI are appropriate. For

workplaces specified in regulation 64(3), and where the effective

dose to workers is less than or equal to 6mSv per year, or the

exposure less than the corresponding time integrated radon

exposure value for the workers, the Commission shall require

that exposures are kept under review.".

Regulation 45 of the principal regulations shall be Substitutes

regulation 45 of

substituted by the following new regulation

the principal

regulations.

"45. (1) Undertakings

shall

ensure

that

workplaces are designated as either controlled or

supervised, where appropriate, on the basis of the safety

assessment, made pursuant to regulation 101, of the

expected annual doses and the probability and magnitude

of potential exposures.

(2) Undertakings shall refer to the Commission

guidance on the classification of controlled and

supervised areas with regard to particular circumstances.

(3) Undertakings shall designate as a controlled

area any area under their control which

(a) it is necessary for any person who enters

or works in the area to follow special procedures

designed to restrict significant exposure to ionising

radiation in that area or prevent or limit the

probability and magnitude of radiation accidents or

their effects; or

(b) any person working in the area is likely

to receive an effective dose greater than 6mSv a

year or an equivalent dose greater than three-tenths

of any relevant dose limit referred to in these

regulations.

(4) Undertakings shall designate as a supervised

area any area under their control, not being an area

designated as a controlled area

(a) where it is necessary to keep the

conditions of the area under review to determine

whether the area should be designated as a

controlled area; or

(b) in which any person is likely to receive

an effective dose greater than 1mSv a year or an

equivalent dose greater than one-tenth of any

relevant dose limit referred to in these regulations.

(5) On the basis of the documentation supplied,

including the Safety Assessment, by the undertaking to

the Commission, the Secretariat shall confirm that the

appropriate area classification has been made.".

Sub-regulation (3) of regulation 66 of the principal

regulations shall be substituted by the following new sub-regulation

"(3)(a) The Commission shall establish and

regularly review national diagnostic reference levels for

radio-diagnostic examinations, having regard to the

current European diagnostic reference levels where

available, and where appropriate, for interventional

radiology procedures, and the availability of guidance for

this purpose.

(b) An undertaking shall ensure that diagnostic

reference levels for their radio-diagnostic examinations,

and where appropriate for interventional radiology

procedures, are established, regularly reviewed and used,

having regard to the national diagnostic reference levels

where available.".

Regulation 85 of the principal regulations shall be Substitutes

substituted by the following new regulation

85. (1) Undertakings shall take such measures

as are necessary to ensure the operational protection of

of members of

members of the public in normal circumstances having

regard to the relevant provisions of these regulations.

(2) For the purposes of these regulations,

"operational protection of members of the public" means,

in normal circumstances, all arrangements and surveys

for detecting and eliminating the factors which, in the

course of any operation, may result in actual or potential

exposure to members of the public exceeding the relevant

dose constraint such that the exposure from any one

practice is not liable to exceed 0.25mSv in a year.

(3) For relevant activities, the Commission shall

before granting a registration or a licence in respect of a

practice or amending any condition attached to a

registration or specified in a licence, or acceptance into

service of a facility, require the undertaking to submit to

it for examination and approval

(a) the proposed siting of the workplaces

from a radiation protection point of view, taking

into account relevant demographic, meteorological,

geological, hydrological and ecological conditions;

(b) a statement of planned arrangements to

ensure adequate protection against any exposure or

radioactive contamination liable to extend beyond

the perimeter of the workplaces or radioactive

contamination liable to extend to the ground

beneath the facility;

(c) pursuant to regulation 87, plans for the

discharge of radioactive effluents;

(d) the results of a screening assessment of

the doses liable to be received by the population as

a result of any practice carried out by it; and

(e) a statement of planned measures to

control the access of members of the public to the

facility.

(4) The Commission shall, pursuant to regulation

87, where appropriate, establish limits and conditions on

the quantities of radionuclides discharged to air or water

during a specified period, which shall take into account

(a) the results of the optimisation of

radiation protection;

(b) good practice in the operation of similar

facilities; and

(c) where appropriate, results of generic

screening assessment based on internationally

recognised scientific guidance, where such an

assessment has been required by the Commission.".

Sub-regulation (2) of regulation 96 of the principal

regulations shall be substituted by the following new sub-regulation

"(2) For areas with long-lasting residual

contamination the Commission shall consult entities that

have responsibilities for land use planning, land

ownership, environmental protection and public health

and shall advise the government on allowing habitation

and the resumption of social and economic activities, to

ensure that arrangements are in place, as necessary, for

the ongoing control of exposure with the aim of

establishing living conditions that can be considered as

normal, including

(a) establishment of appropriate reference

levels;

(b) establishment of an infrastructure to

support continuing self-help protective measures in

the affected areas, such as information provision,

advice and monitoring;

(c) if appropriate, remedial measures;

(d) if appropriate, delineated areas.".

Sub-regulations (2) and (3) of regulation 98 of the principal

regulations shall be substituted by the following new sub-regulations

"(2) For building materials which are identified by

the Commission as being of concern from a radiation

protection point of view, taking into account the

indicative list of materials set out in the Twelfth Schedule

with regard to their emitted gamma radiation, the

Commission shall consult with the entity responsible for

placing materials on the market in order that, before such

materials are placed on the market

(a) the activity concentrations of the

radionuclides specified in the Seventh Schedule are

determined, and that,

(b) information to the Commission on the

results of measurements and the corresponding

activity concentration index, as well as other

relevant factors, as defined in the Seventh Schedule

are provided if requested.

(3) For types of building materials identified in

accordance with sub-regulation (2) which are liable to

give doses exceeding the reference level, the

Commission consults the entity responsible for building

and construction on appropriate measures, which may

include specific requirements in relevant building codes

or restrictions on the envisaged use of such materials.".

Paragraph (a) of sub-regulation (1) of regulation 106 of the Amends

principal regulations shall be substituted by the following new regulation

"(a) have a degree in radiation protection, physics,

engineering, mathematics, radiography or a suitable combination

of other qualifications and experience; and".

Sub-regulation (1) of regulation 109 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

"(1) Medical physics experts shall meet the

following criteria for initial certification by the

Commission

(a) be registered by the Council for the

Professions complimentary to Medicine in Malta as

a medical physicist; and

(b) two (2) years documented full time

work experience, within the preceding twenty-eight

(28) months, in specialty (radiotherapy, nuclear

medicine, diagnostic and interventional radiology)

with

documented

Continuous

Professional

Development.".

Regulation 114 of the principal regulations shall be Amends

amended as follows

(a)

sub-regulation (3) thereof shall be amended as

(i) the words "Undertakings are required, that in

addition to the general licensing requirement set out in Part

V, shall have provided for, within its radiation protection

progamme for:" shall be substituted by the words "The

radiation protection progamme shall address the following

issues, which are in addition to the general licensing

requirements set out in Part V, shall be provided to the

Commission when applying for a license:";

(ii)

paragraph (m) thereof shall be substituted by

the following new paragraph

"(m) the confidentiality of information relating

to the security of sources;"; and

(iii) immediately after paragraph (m) thereof there

shall be added the following new paragraph

"(n) any other specific requirement that the

Commission may require."; and

(b) immediately after sub-regulation (5) thereof there

shall be added the following new sub-regulation

"(6) The Commission shall review the radiation

protection programme at the authorisation stage and may

impose specific conditions involving the use of high

activity sources in any licence that may be issued.".

Regulation 125 of the principal regulations shall be

substituted by the following new regulation

"125. (1) The Commission strategy to ensure the

appropriate management of existing exposure situations

commensurate with the risks and with the effectiveness

of protective measures shall consider

(a) delineation of the affected areas and

identification of the affected members of the

public;

(b) consideration of the need for and extent

of protective measures to be applied to the affected

areas and members of the public;

(c) consideration of the need to prevent or

control access to the affected areas, or to impose

restrictions on living conditions in these areas;

(d) assessment of the exposure of different

groups in the population and assessment of the

means available to individuals for controlling their

own exposure;

(e) controls on commodities incorporating

radionuclides from the contaminated area;

(f) consideration of the need to ensure that

the form, scale and duration of all protective

measures in the strategy are optimised; and

(g) provision for cooperation, where

appropriate, with entities responsibilities for land

use planning, land ownership, environmental

protection and public health.".

Sub-regulation (1) of regulation 126 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

of the principal

regulations.

"(1) Following consultations with entities responsible for

land use planning, land ownership, environmental protection and

public health, the Commission shall advise these entities and the

government on the implementation of strategies for the

management of existing exposure situations, and ensure

appropriate coordination between the entities involved in the

implementation of remedial and protective measures.

Stakeholders shall be involved as appropriate in decisions

regarding the development and implementation of strategies for

managing exposure situations.".

Sub-regulation (2) of regulation 127 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

of the principal

regulations.

"(2) The Commission shall make recommendations to the

entity responsible for building and construction on any

appropriate measures that may need to be included in the

national building codes to reduce radon ingress into new

buildings.".

Section B(1) of the Eleventh Schedule to the principal Amends the

Eleventh

regulations shall be substituted by the following new section

Schedule to the

principal

regulations.

"(1) On the basis of the emergency response plan

previously drawn up in the Commission, the members of

the public actually affected in the event of an emergency

shall rapidly and regularly receive

(a) information on the type of emergency

which has occurred and, where possible, its

characteristics (e.g. its origin, extent and probable

development);

(b) advice on protection, which, depending

on the type of emergency, may

(i) cover the following: restrictions on

the consumption of certain foodstuffs and

water likely to be contaminated, simple rules

on

hygiene

and

decontamination,

recommendations to stay indoors, distribution

and use of protective substances, evacuation

arrangements;

(ii) be accompanied, where necessary,

by special warnings for certain groups of the

members of the public;

(c) announcements

recommending

cooperation with instructions or requests.".

€0.45