Management of Radioactive Waste Regulations, 2019

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,214, 18 ta’ Ġunju, 2019 B 879

Taqsima B

L.N. 123 of 2019

NUCLEAR SAFETY AND RADIATION PROTECTION ACT

(CAP. 585)

Management of Radioactive Waste Regulations, 2019

IN EXERCISE of the powers conferred by article 62 of the

Nuclear Safety and Radiation Protection Act, the Minister for

European Affairs and Equality has made the following regulations:-

The title of these regulations is the Management of Title.

Radioactive Waste Regulations, 2019.

(1) The objective of these regulations is to ensure that Scope.

radioactive waste is managed in a manner that protects human health

and the environment now and in the future, without imposing undue

burdens on future generations.

(2)

These regulations

(a) provide the arrangements for safety in radioactive

waste management to protect workers and the general public

against the dangers arising from ionising radiation;

(b) apply to all stages of: radioactive waste management,

from generation to disposal, when the radioactive waste results

from civilian activities;

(c) provide for the necessary public information and

participation in relation to radioactive waste management while

having due regard to security and proprietary information;

(d) bring into effect the provisions of Council Directive

2011/70/Euratom of 19 July 2011 establishing a Community

framework for the responsible and safe management of spent

fuel and radioactive waste and the International Atomic Energy

Agency’s Joint Convention on the Safety of Spent Fuel

Management and on the Safety of Radioactive Waste

Management; and

(e) provide additional measures, procedures and

guidance to those mentioned in Basic Safety Standards for

Ionising Radiation Regulations.

(1) These regulations shall apply to all radioactive waste Application.

with the exception of

(a) releases authorised by virtue of regulation 87 of the

Basic Safety Standards for Ionising Radiation Regulations; and

(b) waste that may be radioactive which falls within the

scope of the Waste Management (Management of Waste from

Extractive Industries and Backfilling) Regulations.

(2) Regulation 15 shall not apply to repatriation of disused

sealed sources to a supplier or manufacturer.

(3) These regulations allow for the return of radioactive waste

after processing in Malta to its country of origin where

(a) the radioactive waste is to be shipped to that Member

State or undertaking for processing; or

(b) other material is to be shipped to that Member State

or undertaking with the purpose of recovering the radioactive

waste

Provided that relevant provisions of the Waste

Management (Supervision and Control of Shipments of

Radioactive Waste and Spent Fuel) Regulations are complied

with.

For the purpose of these regulations, unless the context

otherwise

"Act" means the Nuclear Safety and Radiation Protection

Act ;

"closure" means the completion of all operations at some

time after the emplacement of radioactive waste in a disposal

facility, including the final engineering or other work required to

bring the facility to a condition that will be safe in the long term;

"Commission" means the Commission for the Protection

from Ionising and Non-Ionising Radiation, as established by

article 10 of the Act which acts as the regulatory authority in the

field of nuclear safety and radiation protection and has the legal

authority for the purpose of these regulations;

"disposal" means the emplacement of radioactive waste in a

facility without the intention of retrieval;

"disposal facility" means any facility or installation the

primary purpose of which is radioactive waste disposal;

"licence" means a legal document issued by the

Commission related to the management of radioactive waste, or

to confer responsibility for siting, design, construction,

commissioning, operation, decommissioning or closure of a

radioactive waste management facility;

"licence holder" means a legal or natural person having

overall responsibility for any activity or facility related to the

management of radioactive waste as specified in a licence;

"Minister" means the minister responsible for the Act;

"radioactive waste" means radioactive material in gaseous,

liquid or solid form for which no further use is foreseen or

considered by the Commission;

"radioactive waste management" means all activities that

relate to handling, pre-treatment, treatment, conditioning,

storage, or disposal of radioactive waste, excluding off-site

transportation;

"radioactive waste management facility" means any

facility or installation the primary purpose of which is

radioactive waste management;

"Secretariat" means the Secretariat to the Commission, as

established by article 12 of the Nuclear Safety and Radiation

Protection Act.

"storage" means the holding of radioactive waste in a

facility with the intention of retrieval.

(1) There shall be a national programme for the Radioactive

management of radioactive waste in Malta entitled the ‘Radioactive Waste

Management

Waste Management Programme’.

Programme.

(2)

The radioactive waste management programme shall

(a) enable radioactive waste to be treated in a sustainable

manner that protects human health and the environment now and

in the future without imposing undue burdens on future

generations;

(b) include policies and strategies for the management of

radioactive waste. The policies shall reflect priorities,

circumstances, structures, and available human and financial

resources whilst the strategies shall implement the policies and

shall consider

(i) all stages of radioactive waste management,

from generation to disposal;

(ii) the concepts or plans for the post-closure period

of a disposal facility’s lifetime, including the period during

which appropriate controls are retained and the means to be

employed to preserve knowledge of that facility in the

longer term; and

(iii) research, development and demonstration

activities that are needed in order to implement solutions

for the management of spent fuel and radioactive waste.

(3) In the event that radioactive waste is sent overseas for

processing, the ultimate responsibility for the safe and responsible

disposal of those materials, will remain in Malta or the other country

from which the radioactive material was shipped.

(1) Radioactive policies referred to in regulation 5(2)(b)

shall take into due account

(a) the requirement for the minimisation of activity and

volume of radioactive waste and shall include the options to

recycle and reuse of materials;

(b) the use of passive safety features for the long term

management of radioactive waste;

(c)

the need

(i) to consider the interdependencies between all

steps in radioactive waste generation and management,

including the need for the appropriate conditioning of

waste;

(ii) for the implementation of measures to follow a

graded approach;

(iii) that the radioactive waste management can be

financed in the long term; and

(d) the need for evidence-based and documented

decision-making process to be applied with regard to all stages

of the management of radioactive waste.

(2)

Radioactive waste shall be

(a) disposed of in the Member State in which it was

generated, unless at the time of shipment an agreement, taking

into account the Waste Management (Supervision and Control of S.L. 549.51.

Shipments of Radioactive Waste and Spent Fuel) Regulations,

has entered into force between Malta and another country to use

a disposal facility in one of them; and

(b) managed in the long term by an entity independent

from the Commission and licensed by the Commission.

(3) The public and workers shall be involved in the decision

making process and shall be given, in particular

(a) necessary information on the management of

radioactive waste; and

(b) the necessary opportunities to participate effectively

in the decision- making process regarding radioactive waste.

(4)

The Commission shall set up procedures for

(a) gaining control over sources that are out of regulatory

control; and

(b) setting discharge limits from nuclear medicine

departments.

(1) The Commission shall provide the Minister with Financing the

estimates of the costing of the radioactive waste management radioactive

waste

programme.

management

programme.

(2) The estimates shall include an assessment of the national

programme costs and the underlying basis and hypotheses for that

assessment, which must include a profile over time.

All licence holders

(a) shall be responsible for financing of the management

of their radioactive waste; and

(b) may be charged for the storage and disposal of

radioactive waste.

If there is no licence holder for a source or other Responsibility

responsible party, the responsibility for the source rests with the for

case there is no

government of Malta.

license holder.

In order to license a waste management facility, the

Commission shall consider the following with regard to waste

facilities

(a)

siting, design and construction;

(b)

safety and environmental assessments;

(c)

operational aspects;

(d)

post closure aspects; and

(e)

any other relevant factors.

(1) Radioactive Waste management activities

and

facilities shall require a license to be issued by the Commission.

The Commission shall

(a) have overall responsibility for the implementation of

these regulations;

(b) develop and maintain national Radioactive Waste

Management Programme;

(c) in particular have the following functions with

respect to these regulations

(i) advise the Minister on financial issues relating

to the radioactive waste management programme;

(ii) advise the Minister on

assignment

of

responsibilities to various stakeholders;

(d) have the responsibility for the monitoring of the

radioactive waste management programme key performance

indicators. The key performance indicators shall include the

significant milestones to achieve the permanent solution

(including central storage and disposal) and time-frames for the

achievement of those milestones;

(e) maintain an inventory of all radioactive waste and

estimates for future quantities, indicating the location and

amount of the radioactive waste in accordance with appropriate

classification of the radioactive waste as required;

(f)

provide licensing of radioactive waste management

activities, including appropriate measures for the post-closure

periods of disposal facilities;

(g) perform enforcement actions, including the

suspension of activities and the modification, expiration or

revocation of a licence together with requirements, if

appropriate, for alternative solutions that lead to improved

safety;

(h) seek to improve the national framework, taking into

account operating experience, insights gained from the decision-

making process referred to in regulation 6(2), and the

development of relevant technology and research;

(i) review and update as required the national

programme, taking into account technical and scientific progress

as appropriate as well as recommendations, lessons learned and

good practices from peer reviews;

(j) notify to the European Commission of the national

programmes and any subsequent significant changes;

(k) report to the European Commission on the

implementation of these regulations for the first time by 23

August 2015, and every 3 years thereafter, taking advantage of

the review and reporting under the Joint Convention;

(l) respond to any request from the European

Commission for any clarification made in connection with the

national programme;

(m) at least every 10 years, arrange for self-assessments

of their national framework, competent regulatory authority,

national programme and its implementation, and invite

international peer review of their national framework, competent

regulatory authority and, or national programme with the aim of

ensuring that high safety standards are achieved in the safe

management of radioactive waste. The outcomes of any peer

review shall be reported to the European Commission and the

other Member States, and may be made available to the public

where there is no conflict with security and proprietary

information; and

(n) comply with the local reporting requirements and full

attendance of meetings under the Joint Convention on the Safety

of Spent Fuel Management and on the Safety of Radioactive

Waste Management.

(1) The Commission shall ensure that the members of its

Secretariat have sufficient understanding of the safety and security

aspects related to management of radioactive waste. In particular the

Commission shall ensure that members of the Secretariat participate in

on-going training.

(2) During the licensing process by the Commission, the

Secretariat shall require that arrangements for education and training

have been undertaken by potential license holders.

(1) The prime responsibility for the safety of radioactive

waste management facilities and, or activities rests with the licence

holder.

(2)

Licence holders shall

(a) regularly assess, verify and continuously improve, as

far as is reasonably achievable, the safety of the radioactive

waste management facility or activity in a systematic and

verifiable manner. This shall be achieved through an appropriate

safety assessment, other arguments and evidence;

(b) as part of the licensing of a facility or activity the

safety demonstration shall cover the development and operation

of an activity and the development, operation and

decommissioning of a facility or closure of a disposal facility as

well as the post-closure phase of a disposal facility. The extent of

the safety demonstration shall be commensurate with the

complexity of the operation and the magnitude of the hazards

associated with the radioactive waste, and the facility or activity.

The licensing process shall contribute to safety in the facility or

activity during normal operating conditions, anticipated

operational occurrences and design basis accidents. It shall

provide the required assurance of safety in the facility or activity.

Measures shall be in place to prevent accidents and mitigate the

consequences of accidents, including verification of physical

barriers and the licence holder’s administrative protection

procedures that would have to fail before workers and the

general public would be significantly affected by ionising

radiation. That approach shall identify and reduce uncertainties;

(c) establish and implement integrated management

systems, including quality assurance, which give due priority for

overall management of radioactive waste to safety and are

regularly verified by the Commission; and

(d) provide for and maintain adequate financial and

human resources to fulfil their obligations with respect to the

safety of radioactive waste management.

Prior to a shipment to a third country, the Commission shall Waste

inform the European Commission of the content of any such shipments

third countries.

agreement and take reasonable measures to be assured that

(a) the country of destination has concluded an

agreement with the Community covering radioactive waste

management or is a party to the Joint Convention on the Safety

of Spent Fuel Management and on the Safety of Radioactive

Waste Management;

(b) the country of destination has radioactive waste

management and disposal programmes with objectives

representing a high level of safety equivalent to those established

by these regulations; and

(c) the disposal facility in the country of destination is

authorised for the radioactive waste to be shipped, is operating

prior to the shipment, and is managed in accordance with the

requirements set down in the radioactive waste management and

disposal programme of that country of destination.

(1)

The Commission shall enforce these regulations.

Enforcement.

(2)

Any breach of any of these regulations shall be deemed an

offence.

(3) In any proceedings for an offence under these regulations

consisting of a failure to comply with a duty or requirement to do

something, it shall be for the accused to prove, as the case may be, that

it was not practicable to do more than was in fact done to satisfy the

requirement or duty, or that there was no better practicable means than

was in fact used to satisfy the duty or requirement.

The Convention on Nuclear Safety Regulations are hereby Repeal.

repealed.

B

€0.45