Radiological Protection Act 1991 (Authorisation Application And Fees) Regulations 2019

 
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Notice of the making of this Statutory Instrument was published in

Iris Oifigiúil” of 12th February, 2019

I, RICHARD BRUTON, Minister for Communications, Climate Action and Environment in exercise of the powers conferred on me by subsection (7) of section 30 of the Radiological Protection Act 1991 (No. 9 of 1991) and with the consent of the Minister for Public Expenditure and Reform, hereby make the following Regulations: —

Citation and Commencement

1. (1) These Regulations may be cited as the Radiological Protection Act 1991 (Authorisation Application and Fees) Regulations 2019.

(2) These Regulations shall come into operation on the 8th day of February 2019.

Interpretation

2. (1) “Agency” means the Environmental Protection Agency established under Section 19 of the Environmental Protection Agency Act 1992 (No. 7 of 1992);

“an inspector” means a person appointed under section 28 of the Principal Act to be an inspector for the purposes of the Principal Act and any orders or Regulations made under the Principal Act;

“application portal” means the online Environmental Data Exchange Network maintained by the Environmental Protection Agency at www.epa.ie

“authorisation” means a registration or a licence;

“exposure” means the act of exposing or condition of being exposed to ionising radiation emitted outside the body (external exposure) or within the body (internal exposure);

“Ionising Radiation Regulations” means the Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019 ( S.I. No. 30 of 2019 );

“licence” means a licence granted by the Agency to permit a person to carry, subject to conditions (if any) specified in the licence, the relevant activity in respect of which the licence is granted, pursuant to the Ionising Radiation Regulations;

“licensee” means a person to whom a licence is for the time being granted;

“medical exposure” means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research;

“non-medical imaging exposure” means any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed;

“practice” means a relevant activity that is managed as a planned exposure situation;

“Principal Act” means the Radiological Protection Act 1991 (No. 9 of 1991);

“quality assurance” means all those planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily in compliance with agreed standards. Quality control is a part of quality assurance;

“quality control” means the set of operations (programming, coordinating, implementing) intended to maintain or to improve quality. It includes monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled;

“radiation source” means an entity that may cause exposure such as by emitting ionising radiation or by releasing radioactive material and encompasses a radiation generator, radioactive material, radioactive source and radioactive substance;

“radioactive source” means a radiation source incorporating radioactive material for the purpose of utilising its radioactivity;

“radioactive waste management” means all activities that relate to handling, pre-treatment, treatment, conditioning, storage, or disposal of radioactive waste, excluding off-site transportation;

“registered person” means a person to whom a registration is for the time being granted;

“registration” means a registration granted by the Agency to permit a person to carry out, subject to the conditions (if any) attached to the registration, the activity pursuant to the Ionising Radiation Regulations;

“relevant activity” means a human activity which can increase the exposure of individuals to radiation from a radiation source and includes the custody, production, processing, handling, holding, storage, use, recycling, manufacture, import, distribution, transport, export or other disposal of the radiation source;

“undertaking” means a person who has legal responsibility for the carrying out of a practice, or for a radiation source (including cases where the owner or holder of a radiation source does not conduct related human activities);

“workplace” includes any place, land or other location at, in, upon or near which, work is carried out whether occasionally or otherwise and, in particular, includes: –

(a) a premises, including a cave or mine;

(b) an installation on land and any offshore installation;

(c) a tent, a temporary structure or movable structure; and

(d) a vehicle, vessel, aircraft or spacecraft.

(2) A word or expression that is used in these Regulations and is also used in the Principal Act shall, unless the contrary intention appears, have the same meaning that it has in the Principal Act.

(3) In these Regulations: —

(a) a reference to a Regulation or schedule is a reference to a Regulation of or schedule to these Regulations unless it is indicated that a reference to some other enactment is intended;

(b) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the reference occurs unless it is indicated that reference to some other provision is intended.

Authorisation procedure

3. (1) An application for the grant or the amendment of an authorisation or renewal of a licence, shall be made by electronic means through the application portal.

(2) An application for an authorisation shall be made to the Agency not later than one month before the proposed commencement of the practice.

(3) (a) An application for the renewal of a licence shall be made to the Agency not later than one month before the expiration of the licence;

(b) A practice shall not be continued by the applicant beyond the expiration of the licence previously in force in respect of the practice concerned unless and until the licence has been renewed or a registration in respect of the practice has been granted.

(4) An application for an amendment of a registration or a licence shall be made to the Agency before the proposed implementation of the change in respect of the practice concerned. The change in practice shall not be implemented by the applicant until such time as the registration or licence has been amended by the Agency in accordance with Regulation 12(2) of the Ionising Radiation Regulations.

Information to be provided

4. (1) The application for the grant or the amendment of an authorisation or renewal of a licence shall include the particulars specified in Schedule 1, Part 1, and may include at the discretion of the Agency: —

(a) the particulars specified in Schedule 1, Part 2;

(b) radiation safety procedures referred to in Regulation 32 (1) of the Ionising Radiation Regulations; and

(c) the risk assessment for the proposed practice referred to in Regulation 31 (2) of the Ionising Radiation Regulations;

(d) for relevant workplaces, the information referred to in Regulation 51(3) of the Ionising Radiation Regulations;

(e) for practices involving non-medical imaging exposure using medical radiological...

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