S.I. No. 654 of 2007

RADIOLOGICAL PROTECTION ACT, 1991 (LICENSING APPLICATION AND FEES) REGULATIONS, 2007

Notice of the making of this Statutory Instrument was published in

�Iris Oifigi�il� of 2nd October, 2007.

I, JOHN GORMLEY, Minister for the Environment, Heritage and Local Government, in exercise of the powers conferred on me by subsection 7 of section 30 of the Radiological Protection Act. 1991 (No. 9 of 1991) (as amended by Section 2 of the Radiological Protection (Amendment) Act 2002 ) and the Meteorological Services, Radiological Protection and Nuclear Safety (Transfer of Departmental Administration and Ministerial Functions) Order 2002, and with the consent of the Minister for Finance hereby make the following regulations:

1. Citation and Commencement

(1) These regulations may be cited as the Radiological Protection Act, 1991 (Licence Application and Fees) Regulations, 2007.

(2) These regulations shall come into operation on 1 October 2007.

2. Interpretation

(1) �Institute� means the Radiological Protection Institute of Ireland;

�ionising radiation� means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or less, or a frequency of 3 x 1015 Hertz or more, capable of producing ions directly or indirectly;

�Ionising Radiation Order� means the Radiological Protection Act, 1991 (Ionising Radiation) Order, 2000 ( S.I. No. 125 of 2000 ),

�irradiating apparatus� means an apparatus capable of producing ionising radiation and containing components operating at a potential difference of more than 5 kV;

�licence� means a licence referred to in section 30 of the Principal Act and required pursuant to Article 4 of the Ionising Radiation Order;

�Minister� means the Minister for the Environment, Heritage and Local Government;

�nuclear device� means any machine or apparatus the operation of which involves the use of a radioactive substance, an irradiating apparatus or a nuclear reactor;

�practice� means a human activity that can increase the exposure of individuals to radiation from an artificial source, or from a natural radiation source where natural radionuclides are processed for their radioactive, fissile or fertile properties, other than an activity that results in an emergency exposure;

�Principal Act� means the Radiological Protection Act, 1991 (No. 9 of 1991);

�quarter� means a period of three calendar months;

�radioactive substance� means any substance capable of emitting ionising radiation and includes any radionuclide, whether natural or artificial;

�source� means an apparatus, a radioactive substance or an installation capable of emitting ionising radiation or radioactive substances;

�undertaking� means any natural or legal person who, as a self employed person or employer as the case may be, carries on or intends to carry on any practice to which these regulations apply, and references to �the undertaking� are to the particular undertaking carrying on the practice concerned.

(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 an Article or Schedule is a reference to an Article 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.

3. Application Provisions

(1) An application for a licence shall be made to the Institute before the proposed commencement of the practice concerned. The practice shall not be commenced by the applicant unless and until the licence has been granted by the Institute.

(2) An application for the renewal of a licence shall be made to the Institute before the expiration of the licence previously in force in respect of the practice concerned. The 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 by the Institute.

(3) An application for an amendment of a licence shall be made to the Institute before the proposed implementation of the change in respect of the practice concerned. The change in practice shall not be implemented by the applicant unless and until the licence has been amended by the Institute.

(4) An application for a licence, or for the renewal of a licence, shall be in such form and include such information as the Institute determines and, without prejudice to the generality of the foregoing, shall include-

(a) the particulars specified in Schedule 1, and in the case of an application for a licence,

(b) the current radiation safety procedures referred to in Article 17(1) of the Ionising Radiation Order, and

(c) the risk assessment for the proposed practice referred to in Article 9(2) of the Ionising Radiation Order.

(5) In the case of a practice for which justification in accordance with Article 8 of the Ionising Radiation Order is required, an application for a licence in respect of the practice shall also include a statement setting out grounds for the justification of the practice.

(6) An application for an amendment of a licence shall be in such form and contain such particulars as the Institute specifies and, without prejudice to the generality of the foregoing, shall

(a) specify the reasons for the proposed amendment, and

(b) as appropriate, furnish a revised risk assessment and revised radiation safety procedures.

(7) Where in the opinion of the Institute the information supplied by an applicant in an application is insufficient or inadequate for the purpose of enabling the Institute to decide whether or not to grant, renew or amend a licence, it may by notice in writing (sent to the applicant at the address specified in the application) require the applicant to furnish the Institute with such additional information as it specifies in the notice.

(8) Unless revoked by the Institute under Section 30(5) of the Principal Act, a licence shall, subject to any condition relating to expiry specified in the licence, expire on the date specified in that behalf in the licence.

(9) When a licence has been granted, no modifications to practices, equipment or facilities, the subject of that licence, shall be carried out without the prior consent of the Institute.

(10) The provisions of this Article are without prejudice to Article 8 of the Ionising Radiation Order.

4. Licence fee charging

(1) The Institute shall determine the category of licence required for the practice concerned, in accordance with the criteria referred to in Part 2 of Schedule 2.

(2) A fee shall be paid to the Institute by an applicant in respect of an application for a licence, or for the renewal of a licence.

(3) The fee payable under sub-article (2) on an application for a licence shall be the aggregate of the amounts indicated in Columns 2 and 3 of Part I of Schedule 2 opposite the relevant licence category specified in column 1 of Part I of Schedule 2 as has been determined by the Institute in accordance with those criteria set out in Part 2 of Schedule 2 and as referred to in sub-article (1) of these regulations. Where an amount so indicated in Column 3 is stated to be an annual amount, the fee payable shall be the amount so specified multiplied by the number of years for which the licence will be granted and for this purpose where the licence is to be granted for a period that is not an exact number of years the fee payable shall be one quarter of the amount so specified multiplied by the number of quarters for which the licence will be issued and where the licence is to be issued for a period that is not an exact number of quarters a portion of a quarter shall be counted as a full quarter.

(4) The fee payable under sub-article (1) on a renewal of a licence shall be the amount indicated in Column 3 of Part I of Schedule 2 opposite the relevant licence category specified in column 1 of Part I of Schedule 2. Where an amount so indicated in Column 3 is stated to be an annual amount, the fee payable shall be the amount so specified multiplied by the number of years for which the licence will be renewed and for this purpose where the licence is to be renewed for a period that is not an exact number of years the fee payable shall be one quarter of the amount so specified multiplied by the number of quarters for which the licence will be renewed and where the licence is to be renewed for a period that is not an exact number of quarters a portion of a quarter shall be counted as a full quarter.

(5) Where the Institute determines, by reference to the criteria referred to in Part 2 of Schedule 2, that the category of licence required for the practice concerned has changed during the duration of a licence from Category L to Category M or Category H, or from Category M to Category H, then on being so notified by the Institute the licensee shall pay to the Institute an additional fee calculated by reference to the differential between the annual amount indicated in Column 3 of Part 1 of Schedule 2 opposite the relevant new higher licence category and the amount actually paid by the licensee in question from the date of such change as determined by the Institute to the date of expiry of the licence. Where the Institute determines, by reference to the criteria referred to in Part 2 of Schedule 2, that the category of licence required for the practice concerned has changed during the duration of a licence from Category H to Category M or Category L, or from Category M to Category L, then the Institute shall refund to the licensee the differential between the annual amount indicated in Column 3 of Part 1 of Schedule 2 opposite the relevant new lower category and the amount actually paid by the licensee in question from the date of such change as determined by the Institute to the date of expiry of the licence.

(6) That portion of the fee payable on an application for a licence as is specified in Column 2 of Part 1 of Schedule 2 shall be paid to the Institute at the same time as the application in question is made to the Institute. A fee paid hereunder shall not be refundable by the Institute to the applicant in whole or in part if the application is unsuccessful for any reason. The fee payable hereunder for an application for a licence shall be paid by the method, or by one of the methods, for the time being specified by the Institute.

(7) That portion of the fee payable on an application for a licence, or for the renewal of a licence as is specified in Column 3 of Part 1 of Schedule 2 shall be paid by the method, or by one of the methods, and at the time or times, for the time being specified by the Institute. The Institute shall be entitled to specify different times of payment for different permitted methods of payment. Without prejudice to the generality of the foregoing, the method of payment which the Institute may specify from time to time may include direct debit payment on an annual basis of the amount specified in the Third Column of the First Part of the Second Schedule to these regulations. The applicant shall not be entitled to require that the licence in question be so granted or renewed unless and until the Institute has notified the applicant in writing of its decision to grant or renew the licence and the said fee has been paid to the Institute. A fee paid hereunder shall not be refundable by the Institute to the licensee in whole or in part if the licence granted or renewed is revoked by the Institute or the practice concerned is terminated by the licensee prior to the expiry of the licence.

5. Transitional Provisions

The provisions of these regulations shall not apply to a licence granted pursuant to the Ionising Radiation Order which is in force immediately before the commencement of these regulations until application is made for its renewal.

SCHEDULE 1 INFORMATION TO BE PROVIDED IN A LICENCE APPLICATION FOR A PRACTICE

(1) The name and address of the undertaking and a telephone number, fax number or electronic mail address at which it can be contacted at that address.

(2) The address of the premises where or from where the practice is to be carried on and a telephone number, fax number or electronic mail address at which the undertaking can be contacted at that address.

(3) The nature and business of the undertaking.

(4) Into which of the following categories the source or sources of ionising radiation concerned fall-

(a) nuclear device/sealed source,

(b) unsealed radioactive substance,

(c) irradiating apparatus.

(5) The addresses of any premises, other than the address stated under paragraph 2, at which the source or each source of ionising radiation is to be used.

(6) The proposed date of commencement of the practice.

(7) The following additional information if the Institute requires it:

(a) a description of the work with ionising radiation,

(b) particulars of the sources of ionising radiation,

(c) the quantities of any radioactive substances involved,

(d) the identity of any person engaged in the practice, and

(e) the name of the radiation protection adviser.

SCHEDULE 2

PART 1 LICENCE CATEGORIES AND FEES

PART 2 CRITERIA TO BE APPLIED BY INSTITUTE TO DETERMINE CATEGORY OF LICENCE REQUIRED

a. the number of practices to be licensed and the level of complexity of the practice(s);

b. the type, size, number and complexity of the radioactive source or irradiating apparatus;

c. the security and safety measures required;

d. the complexity of radiation protective measures required;

e. potential for doses arising to workers or members of the public; and

f. consequences of an accident.

GIVEN under my hand,

26 September 2007

JOHN GORMLEY,

Minister for the Environment, Heritage and Local Government.