Management of Radioactive Waste Regulations, 2013

L.N. 186 of 2013

NATIONAL INTEREST (ENABLING POWERS) ACT

(CAP. 365)

Management of Radioactive Waste Regulations, 2013

IN exercise of the powers conferred by article 3 of the National

Interest (Enabling Powers) Act, the Prime Minister has made the

following regulations:-

(1)

The title of these regulations is the Management of

Radioactive Waste Regulations, 2013.

(2) These regulations shall come into force on the 23rd August

2013.

The aim 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.

(1)

These regulations provide the arrangements for

safety in radioactive waste management to protect workers and the

general public against the dangers arising from ionising radiation.

(2) These regulations shall apply to all stages of radioactive

waste management, from generation to disposal, when the radioactive

waste results from civilian activities.

(3) These regulations provide for the necessary public

information and participation in relation to radioactive waste

management while having due regard to security and proprietary

information issues.

(4) These regulations 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.

(5) These regulations provide additional measures, procedures

and guidance to those mentioned in the Nuclear Safety and Radiation

Protection Regulations.

(1)

These regulations shall apply to all radioactive Applicability.

waste with the exception of

(a)

releases authorised by virtue of regulation 19(4) of

the Nuclear Safety and Radiation Protection Regulations; and

(b)

waste which may be radioactive which falls within

the scope of the Waste Management (Management of Waste S.L. 504.87

from Extractive Industries and Backfilling) Regulations.

(2) Regulation 10 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.

For the purpose of these regulations, the following Interpretation.

definitions shall apply

"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;

"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 Radiation

Protection Board 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;

"Radiation Protection Board" means the Radiation Protection

Board established by virtue of regulation 9 of the Nuclear Safety and S.L. 365.15

Radiation Protection Regulations;

"radioactive waste" means radioactive material in gaseous,

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

by the Radiation Protection Board;

"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;

"storage" means the holding of radioactive waste in a facility

with the intention of retrieval.

(1)

The objective of the radioactive waste management

programme is to enable radioactive waste to be treated in a manner

that protects human health and the environment now and in the future

without imposing undue burdens on future generations.

(2) The Radiation Protection Board has the responsibility for

the management of radioactive waste through the actions of its

member entities and through the radioactive waste national

programme. This programme includes a national policy and strategy

for the management of radioactive waste. The policy reflects the

Maltese priorities, circumstances, structures, and available human

and financial resources whilst the strategy shall implement the policy.

(3) The national programme shall consider all stages of

radioactive waste management, from generation to disposal.

(4) The responsibility of the coordination of the

implementation of the national programme rests with the Radiation

Protection Board (RPB).

(5) In connection with radioactive waste management

facilities due consideration will be given, but will not be limited to

(a)

the siting of the facility;

(b)

design and construction aspects of the facility;

(c)

safety and environmental assessments;

(d)

operational aspects; and

(e)

post-closure aspects.

(6) 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.

(7) The policy and strategy shall specify

(a)

the requirement for the minimisation of radioactive

waste; generation of radioactive waste shall be kept to the

minimum which is reasonably practicable, both in terms of

activity and volume, by means of appropriate design measures

and of operating and decommissioning practices, including the

recycling and reuse of materials;

(b)

the interdependencies between all steps in

radioactive waste generation and management shall be taken

into account;

(c)

the use of passive safety features for the long term

management of radioactive waste;

(d)

the need for the implementation of measures to

follow a graded approach;

(e)

the requirements for on-site and off-site emergency

plans;

(f)

financing systems for the management of waste

including the polluter pays principle;

(g)

the need for evidence-based and documented

decision-making process shall be applied with regard to all

stages of the management of radioactive waste;

(h)

that radioactive waste shall be disposed of in the

Member State in which it was generated, unless at the time of

shipment an agreement, taking into account the Waste S.L. 504.38

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;

(i)

that radioactive waste (stipulated in regulation 4)

shall be centrally managed waste in the long term;

(j)

the significant milestones to achieve the permanent

solution (including central storage and disposal) and timeframes

for the achievement of those milestones. These milestones will

include

(i)

the setting up of a central storage facility;

(ii)

disposal of radioactive waste;

(k)

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;

(l)

the assignment of responsibilities to the various

stakeholders;

(m)

research, development and demonstration activities

that are needed in order to implement solutions for the

management of radioactive waste;

(n)

an assessment of the national programme costs and

the underlying basis and hypotheses for that assessment, which

must include a profile over time;

(o)

financing schemes;

(p)

public information, involvement and transparency

policy or process

(i) necessary information on the management of

radioactive waste be made available to workers and the

general public. Information shall be made available to the

public in accordance with national legislation and

international obligations, provided that this does not

jeopardise other interests such as, inter alia, security,

recognised in national legislation or international

obligations;

(ii) to ensure that the public be given the

necessary opportunities to participate effectively in the

decision-making process regarding radioactive waste

management in accordance with national legislation and

international obligations;

(q)

gaining control over sources that are out of

regulatory control;

(r)

source recovery plan;

(s)

if there is no licence holder for a source or other

responsible party, the responsibility for the source rests with the

Government of Malta;

(t)

requirements for waste conditioning;

(u)

return of new sealed sources;

(v)

discharges from nuclear medicine departments;

(w)

require all parties to make arrangements for

education and training for their staff, as well as research and

development activities to cover the needs of the national

programme for radioactive waste management in order to

obtain, maintain and to further develop necessary expertise and

skills.

(1)

The competent authority that shall have overall Competent

responsibility for the implementation of these regulations is the authority.

Radiation Protection Board, established under regulation 9 of the S.L. 365.15

Nuclear Safety and Radiation Protection Regulations.

(2) It shall be the joint duty of the member agencies

constituting the Board to ensure matters pertaining to these

regulations are carried out in close collaboration and as efficiently as

possible, and the Occupational Health and Safety Authority shall take

the lead in co-ordinating the administrative actions.

The functions of the Board with respect to these Functions of the

Board.

regulations shall be to

(a)

be responsible for the establishment and

implementation of the national programme and the key

performance indicators to monitor progress towards

implementation;

(b)

to assess the national programme costs and the

underlying basis and hypotheses for that assessment, which

must include a profile over time;

(c)

advise the Prime Minister pursuant to regulation

9(3)(b) of the Nuclear Safety and Radiation Protection S.L. 365.15

Regulations, on the allocation of responsibility to the bodies

involved in the different steps of radioactive waste

management; in particular, the national framework shall give

primary responsibility for radioactive waste to their generators

or, under specific circumstances, to a licence holder to whom

this responsibility has been entrusted by competent bodies;

(d)

advise the Prime Minister pursuant to regulation

9(3)(b) of the Nuclear Safety and Radiation Protection

Regulations on the finance required for the national programme;

(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;

(f)

licence of radioactive waste management activities,

facilities or both, including the prohibition of radioactive waste

management activities, of the operation of a radioactive waste

management facility without a licence or both and, if

appropriate, prescribing conditions for further management of

the activity, facility or both;

(g)

provide a system of appropriate control, a

management system, regulatory inspections, documentation and

reporting obligations for radioactive waste management

activities, facilities or both, including appropriate measures for

the post-closure periods of disposal facilities;

(h)

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;

(i)

seek to improve the national framework, taking

into account operating experience, insights gained from the

decision-making process referred to in regulation 6(7)(g), and

the development of relevant technology and research;

(j)

perform reviews and update as required its national

programme, taking into account technical and scientific

progress as appropriate as well as recommendations, lessons

learned and good practices from peer reviews;

(k)

notify the national programme and any subsequent

significant changes to the Commission;

(l)

report to the Commission on the implementation 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, for the

first time by 23 August 2015, and every three years thereafter,

taking advantage of the review and reporting under the Joint

Convention;

(m)

respond to any request from the Commission for

any clarification made in connection with the national

programme;

(n)

at least every ten years, arrange for self-

assessments of the national framework, Radiation Protection

Board, national programme and its implementation, and invite

international peer review of the national framework, Radiation

Protection Board 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 Commission and the other

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

there is no conflict with security and proprietary information;

(o)

meet the Maltese reporting requirements and attend

meetings under the Joint Convention on the Safety of Spent

Fuel Management and on the Safety of Radioactive Waste

Management;

(p)

require that licence holders 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

Radiation Protection Board.

(1)

The prime responsibility for the safety of Licence holders.

radioactive waste management facilities and, or activities rest with

the licence holder.

(2) Licence holders shall 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.

(3) (a)

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.

(b)

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.

(4) Licence holders shall establish and implement integrated

management systems, including quality assurance, which give due

priority for overall management of radioactive waste to safety.

(5) Licence holders shall provide for and maintain adequate

financial and human resources to fulfil their obligations with respect

to the safety of radioactive waste management as laid down in sub-

regulations (1) to (4).

Prior to a shipment to a third country, the Radiation

Protection Board shall inform the 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 ("the Joint Convention");

(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;

(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.

Licence holders are responsible for their Radioactive waste

and through the polluter pays principle and are responsible for all

financing of the management of their waste.

(1)

The member agencies of the Radiation Protection

Board shall enforce their respective regulatory functions within their

remit of matters pertaining to these regulations through their

respective powers.

(2) 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.

Any person who commits an offence against these Offences and

regulations shall, on conviction, be liable to imprisonment for a penalties.

period of not more than five years or to a fine (multa) not exceeding

one hundred and sixteen thousand four hundred and sixty-eight euro

(€116,468), or to both such imprisonment and fine.

The Court of Magistrates (Malta) and the Court of Procedures

Magistrates (Gozo) as courts of criminal judicature, shall, before

and Gozo

notwithstanding the provisions of article 370 of the Criminal Code, be Courts.

competent to try all offences against these regulations.

Where the facts constituting a breach of any of the above Proceedings in

provisions also constitute a breach of any other law prohibited by the respect

other law.

particular regulations, proceedings shall not be taken in respect of the

breach of these regulations, but only in respect of the breach of the

other law.

€0.99