MANAGEMENT OF RADIOACTIVE WASTE REGULATIONS

SUBSIDIARY LEGISLATION 585.03

MANAGEMENT OF RADIOACTIVE

WASTE REGULATIONS

18 th June, 2019

LEGAL NOTICE 123 of 2019.

The title of these regulations is the Management of

Radioactive Waste Regulations.

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

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 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

management of radioactive waste in Malta entitled the ‘Radioactive

Waste Management 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 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

estimates of the costing of the radioactive waste 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

responsible party, the responsibility for the source rests with the

government of Malta.

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 inform the European Commission of the content of any such

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.

(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

MANAGEMENT OF RADIOACTIVE WASTE

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

was in fact used to satisfy the duty or requirement.