S.I. No. 875/2005 - Radiological Protection Act 1991 (Control of High-Activity Sealed Radioactive Sources) Order 2005
RADIOLOGICAL PROTECTION ACT 1991 (CONTROL OF HIGH-ACTIVITY SEALED RADIOACTIVE SOURCES) ORDER 2005 | |||||||||||
I, DICK ROCHE, Minister for the Environment, Heritage and Local Government, in exercise of the powers conferred on me by section 30(2) of the Radiological Protection Act 1991 (No. 9 of 1991) and the Meteorological Services, Radiological Protection and Nuclear Safety (Transfer of Departmental Administration and Ministerial Functions) Order 2002 ( S.I. No.303 of 2002 ) (as adapted by the Environment and Local Government (Alteration of Name of Department and Title of Minister) Order 2003 ( S.I. No. 233 of 2003 )), after consultation with the Ministers referred to in subsection (1) of that section and the Radiological Protection Institute of Ireland, for the purpose of giving effect to Council Directive 2003/122/EURATOM of 22 December 20031 , hereby order as follows: | |||||||||||
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Citation and commencement | 1. (1) This Order may be cited as the Radiological Protection Act 1991 (Control of High-Activity Sealed Radioactive Sources) Order 2005. | ||||||||||
(2) This Order comes into operation on 31 December 2005 | |||||||||||
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Interpretation | 2. (1) In this Order - | ||||||||||
“Council Directive” means Council Directive 2003/122/EURATOM of 22 December 20031 on the control of high-activity sealed radioactive sources and orphan sources; | |||||||||||
“high-activity source” means a sealed radioactive source containing a radionuclide whose activity at the time of manufacture or, if this is not known, of the first placing on the market is equal to or exceeds the relevant activity level specified in Annex I to the Council Directive. | |||||||||||
“holder” means a natural or legal person who is responsible for a source and includes a manufacturer, supplier or user of a source other than a recognised installation; | |||||||||||
“Institute” means Radiological Protection Institute of Ireland; | |||||||||||
“manufacturer” means a natural or legal person who manufactures a source; | |||||||||||
“recognised installation” means a facility located in the State for the long-term storage or disposal of sources or an installation for the interim storage of sources, authorised by the Institute; | |||||||||||
“source” means a high-activity source; | |||||||||||
“source container” means the containment of a sealed source not being an integral part of the source, but meant for transport or handling; | |||||||||||
“supplier” means a natural or legal person who supplies or makes available a source; | |||||||||||
“transfer” in relation to a source, means the transfer of the source from one holder to another. | |||||||||||
(2) A word or expression which is used in this Order and is also used in the Council Directive has, unless the context otherwise requires, the same meaning in this Order as it has in the Council Directive. | |||||||||||
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Scope | 3. (1) This Order applies to high-activity sources. | ||||||||||
(2) As regards sources placed on the market before 31 December 2005 Articles 5 6 and 7 of this Order do not apply until 31 December 2007, | |||||||||||
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Competent authority | 4. The Institute is the competent authority in the State to carry out tasks in accordance with this Order and the Council Directive. | ||||||||||
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Authorisations | 5. (1) A holder must obtain prior authorisation from the Institute under a licence for any practice involving a source including taking possession of a source. | ||||||||||
(2) The Institute before issuing any such authorisation shall ensure Article 3(2) of the Council Directive is adequately complied with and that any licence covers the matters referred to in paragraph (3) of that Article. | |||||||||||
(3) The Institute may attach to a licence (including a licence issued before the commencement of this Order) such terms or conditions as it considers necessary to comply with the requirements of paragraph 3(3) of the Council Directive. | |||||||||||
(4) In this Article “licence” means a licence issued by the Institute under and in accordance with the Radiological Protection Act 1991 (Ionising Radiation) Order 2000 ( S.I. No. 125 of 2000 ). | |||||||||||
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Records | 6. (1) A holder must keep records of all sources under his or her responsibility, their location and transfer. The records shall include the information set out in Annex II to the Council Directive. This information may be recorded on a standard sheet made available in electronic format by the Commission of the European Communities. | ||||||||||
(2) A holder shall provide the Institute with an electronic or written copy of all or part of the records referred to in paragraph (1), as required by the Institute - | |||||||||||
(a) without undue delay, at the time of the establishment of such record which should be as soon as possible after the source is acquired, | |||||||||||
(b) at intervals, determined by the Institute, of not more than 12 months thereafter, | |||||||||||
(c) if the situation indicated on the information sheet has changed, | |||||||||||
(d) without undue delay on the closure of the records for a specified source when the holder no longer holds this source, in this case the name of the holder or recognised installation to which the source is transferred shall be included, | |||||||||||
(e) without undue delay, on the closure of such records when the holder no longer holds any sources, or | |||||||||||
(f) whenever so requested by the Institute. | |||||||||||
(3) The Institute shall keep records of authorised holders in accordance with Article 5 (3) and (4) of the Council Directive. | |||||||||||
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Requirements for holders | 7. Each holder shall - | ||||||||||
(a) ensure that suitable tests, such as leak tests based on international standards, are undertaken regularly in order to check and maintain the integrity of each source, | |||||||||||
(b) regularly verify, at specific intervals which may be determined by the Institute, that each source and, where relevant, the equipment containing the source, is still present and in apparently good condition at its place of use or of storage, | |||||||||||
(c) ensure that each fixed and mobile source is subject to adequate documented measures, such as written protocols and procedures, aimed at preventing unauthorised access to or loss or theft of the source or its damage by fire, | |||||||||||
(d) promptly notify the Institute of any loss, theft or unauthorised use of a source, arrange for a check on the integrity of each source after any event, including fire, that may have damaged the source and, if appropriate, inform the Institute of this and of the measures taken, | |||||||||||
(e) return each disused source to the supplier or place it in a recognised installation or transfer it to another authorised holder unless otherwise agreed by the Institute, without undue delay after termination of the use, | |||||||||||
(f) ascertain that, before a transfer is made, the recipient holds appropriate authorisation, | |||||||||||
(g) promptly notify the Institute of any incident or accident resulting in unintentional exposure of a worker or member of the public. | |||||||||||
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Identification and marking | 8. (1) The manufacturer shall identify or, in the case of sources imported from outside the Community, the supplier shall ensure that each source is identified by a unique number. This number shall be engraved or stamped on the source and on the source container where practicable. If this is not feasible or in the case of reusable transport containers, the source container shall at least have information on the nature of the source. | ||||||||||
(2) The manufacturer or supplier shall ensure that the source container and, where practicable, the source are marked and labelled with an appropriate sign to warn people of the radiation hazard. | |||||||||||
(3) The manufacturer shall provide a photograph of each manufactured source design type and of the typical source container. | |||||||||||
(4) The holder shall ensure that each source is accompanied by written information indicating that the source is identified and marked in compliance with paragraph (1) and that the markings and labels referred to in that paragraph remain legible. This information shall include photographs of the source, source container, transport packaging device and equipment, as appropriate. | |||||||||||
(5) Notwithstanding the foregoing paragraphs, as regards sources placed on the market before 31 December 2005, this Article does not apply with the exception of the following requirements which apply by 31 December 2007, namely, that the holder shall ensure that, if practicable, each source and the source container are - | |||||||||||
(a) accompanied by written information to identify the source and its nature, and | |||||||||||
(b) labelled with an appropriate sign to warn people of the radiation hazard. | |||||||||||
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Training and information | 9. (1) When arranging information and training in the field of radiation protection the holder shall ensure that such training includes specific requirements for the safe management of sources. | ||||||||||
(2) The information and training shall - | |||||||||||
(a) place particular emphasis on the necessary safety requirements, | |||||||||||
(b) contain specific information on possible consequences of the loss of adequate control of sources, | |||||||||||
(c) be repeated at regular intervals and documented with a view to preparing the relevant workers adequately for such events, and | |||||||||||
(d) be addressed to exposed workers. | |||||||||||
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EXPLANATORY NOTE | |||||||||||
(This note is not part of the Instrument and does not purport to be a legal interpretation.) | |||||||||||
This Order is made by the power conferred on the Minister for the Environment, Heritage and Local Government under Section 30 (2) of the Radiological Protection Act of 1991 and provides for the implementation of Council Directive 2003/122/EURATOM of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources. The purpose of the Directive is to prevent exposure of workers and the public to ionising radiation arising from the inadequate control of high-activity sealed radioactive sources and orphan sources by defining specific requirements ensuring that each source is kept under control. | |||||||||||
