The High-activity Sealed Radioactive Sources and Orphan Sources Regulations 2005

Made: 24th September 2005

Laid before Parliament: 28th September 2005

Coming into force: 20th October 2005

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to the making of measures relating to basic safety standards for health protection of the general public and workers against the dangers of ionising radiation, in exercise of the powers conferred upon her by that section , makes the following Regulations:

Citation, commencement and extent

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• (1) These Regulations may be cited as the High-activity Sealed Radioactive Sources and Orphan Sources Regulations 2005.

• (2) These Regulations shall come into force on 20th October 2005.

• (3) These Regulations extend to the United Kingdom except regulation 5 which extends to England, Wales and Scotland.

Interpretation

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• (1) In these Regulations—

• “the 1993 Act” means the Radioactive Substances Act 1993 ;

• “authorisation” means an authorisation granted under section 13 or 14 of the 1993 Act;

• “the Basic Safety Standards Directive” means Council Directive 96/29/EURATOM laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation;

• “the Basic Safety Standards Directive” means Council Directive 2013/59/EURATOM laying down basic safety standards for protection against the dangers arising from the exposure to ionising radiation and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom;

• “existing high-activity source” means a high-activity source first placed on the market on or before 31st December 2005;

• “the HASS Directive” means Council Directive 2003/122/EURATOM on the control of high-activity sealed radioactive sources and orphan sources;

• “high-activity source” has the same meaning as it has in the HASS Directive but excluding any such source once its activity level has fallen below the exemption levels specified in column 2 of Table A to Annex I to the Basic Safety Standards Directive;

• “high-activity source” means a sealed source for which the activity of the contained radionuclide is equal to or exceeds the relevant activity value laid down in Annex III of the Basic Safety Standards Directive;

• “orphan source” has the same meaning as in the Basic Safety Standards Directive;

• “registration” means a registration made under section 7 or 10 of the 1993 Act.

• “sealed source” has the same meaning as in the Basic Safety Standards Directive;

• (1A) Any reference to the “HASS Directive” in these regulations shall be deemed to be a reference to the Basic Safety Standards Directive.

• (2) Unless otherwise stated, expressions used that appear in the 1993 Act or the HASS Directive have the same meaning in these Regulations as they do in that Act or, as the case may be, that Directive.

Variation of registrations

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• (1) Subject to paragraph (2), where a person holds a registration in respect of any high-activity source and either—

• (a) intends to keep or use a high-activity source (other than an existing high-activity source) on or after 1st January 2006; or

• (b) intends to keep or use an existing high-activity source on or after 1st January 2008;

that person shall apply to the appropriate Agency or the chief inspector under section 12 of the 1993 Act to vary his registration to enable the appropriate Agency or the chief inspector to ensure that the registration complies with the relevant provisions of the HASS Directive and that person shall make that application in accordance with paragraph (3).

• (2) The appropriate Agency or the chief inspector may notify a person to whom paragraph (1) applies—

• (a) that such person is not required to make an application under paragraph (1); or

• (b) if it, or he, is satisfied that in its, or his, opinion exceptional circumstances apply to that person, that such person may make an application within a period shorter than that provided for under paragraph (3).

• (3) Except where notification is given under subparagraph (2)(b), the application under paragraph (1) shall be made—

• (a) at least four months before the date the source is intended to be kept or used; or

• (b) in the case of a high-activity source (other than an existing high-activity source) which is intended to be kept or used within four months of these Regulations coming into force, as soon as practicable and in any event at least two months before the date of intended keeping or use of the source.

• (4) If a person fails to make an application in accordance with paragraph (3), his registration shall be cancelled by the appropriate Agency or the chief inspector, so far as it relates to the high-activity source in question.

Variation of authorisations

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• (1) Subject to paragraph (2), where a person holds an authorisation in respect of any high-activity source and either—

• (a) intends to dispose of or accumulate a high-activity source (other than an existing high-activity source) on or after 1st January 2006; or

• (b) intends to dispose of or accumulate an existing high-activity source on or after 1st January 2008;

that person shall apply to the appropriate Agency or the chief inspector under section 17 of the 1993 Act to vary his authorisation to enable the appropriate Agency or the chief inspector to ensure that the authorisation complies with the relevant provisions of the HASS Directive and that person shall make that application in accordance with paragraph (3).

• (2) The appropriate Agency or the chief inspector may notify a person to whom paragraph (1) applies—

• (a) that such person is not required to make an application under paragraph (1); or

• (b) if it, or he, is satisfied that in its, or his, opinion exceptional circumstances apply to that person, that such person may make an application within a period shorter than that provided for under paragraph (3).

• (3) Except where notification is given under subparagraph (2)(b), the application under paragraph (1) shall be made—

• (a) at least four months before the date the source is intended to be disposed of or accumulated; or

• (b) in the case of a high-activity source (other than an existing high-activity source) which is intended to be disposed of or accumulated within four months of these Regulations coming into force, as soon as practicable and in any event at least two months before the date of intended disposal or accumulation of the source.

• (4) If a person fails to make an application in accordance with paragraph (3), his authorisation shall be revoked by the appropriate Agency or the chief inspector, so far as it relates to the high-activity source in question.

Exercise of powers of the appropriate Agency

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• (1) Paragraph (2) applies with regard to the exercise of the powers of the appropriate Agency concerning the prevention of unauthorised access to, or loss or theft of—

• (a) high-activity sources; or

• (b) other sealed sources which, in the opinion of the appropriate Agency, are of a similar level of potential hazard to high-activity sources;

including matters relating to the security of sites where such material is held.

• (2) The appropriate Agency may exercise its powers under any enactment in relation to the matters referred to in paragraph (1) notwithstanding that the control of pollution is not the primary or only purpose for which the powers are exercised.

• (3) For the purposes of paragraph (2), “any enactment” includes any Act of the Scottish Parliament or any subordinate legislation made under such an Act.

Site security

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• (1) Subject to paragraph (2), in performing its, or his, functions under sections 7, 10, 12, 13, 14 or 17 of the 1993 Act, the appropriate Agency or chief inspector shall comply with paragraphs (3) and (4) where the following material is, or will be, kept, used, disposed of or accumulated on any premises—

• (a) high-activity sources; or

• (b) other sealed sources which, in the opinion of the appropriate Agency or the chief inspector, are of a similar level of potential hazard to high-activity sources.

• (2) Paragraph (1) shall not apply where the premises are, or are part of, a nuclear site.

• (3) Where paragraph (1) applies, the appropriate Agency or chief inspector, in considering if the measures taken, or to be taken, by the applicant or person granted the registration or authorisation ensure the adequate security of any premises, shall where it, or he, considers it appropriate—

• (a) inspect those premises; and

• (b) consult with the police and such other persons as it, or he, considers appropriate concerning the measures.

• (4) Where paragraph (1) applies, the appropriate Agency or chief inspector shall have regard to any advice it, or he, receives from the police or other persons within such time as the appropriate Agency or chief inspector believes is reasonable before—

• (a) determining the registration or authorisation or effecting any variation or cancellation of the registration or authorisation; or

• (b) imposing any limitations and conditions on the registration or authorisation.

• (5) Where the appropriate Agency or chief inspector inspect any premises under paragraph (3), it, or he, may be accompanied by such other persons as are appropriate to assist it, or him, in assessing the measures.

• (6) An applicant or person holding a registration or authorisation shall permit the appropriate Agency or chief inspector (and any person accompanying them) reasonable access to any premises it, or he, wishes to inspect under paragraph (3).

• (7) If an applicant or person holding a registration or authorisation fails to comply with paragraph (6), the appropriate Agency or chief inspector may refuse the application or cancel the registration or revoke the authorisation insofar as it relates to the sources referred to in paragraph (1).

Records and inspections

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The appropriate Agency and the chief inspector shall—

• (a) keep records of those matters—

• (i) required by Articles 5(3) and (4) of the HASS Directive; and

• (ii) notified to it, him or them under Article 6 of that Directive;

and

• (b) establish or maintain a system of inspections to enforce the provisions of Articles 3, 4, 5 and 6, and 7 (subject to 16(1)(b)) of the HASS Directive which must be complied with by persons holding registrations or authorisations.

Advice and assistance in respect of orphan sources

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• (1) The relevant person referred to in paragraph (2) shall ensure that—

• (a) in relation to the public and workers, specialised technical advice and assistance is promptly made available to such persons who are not normally involved in operations subject to radiation protection requirements and who suspect the presence of an orphan source; and

• (b) the primary aim of such advice and assistance is—

• (i) the safety of the source; and

• (ii) the protection of the public and workers from radiation.

• (2) For the purposes of paragraph (1)—

• (a) in relation to England and Wales and Scotland and the protection of workers and in relation to England and the protection of the public (except workers), the relevant person means the Secretary of State;

• (b) in relation to Wales and the protection of the public (except workers), the relevant person means the National Assembly for Wales,

• (c) in relation to Scotland and the protection of the public (except workers), the relevant person means the Scottish Ministers, and

• (d) in relation to Northern Ireland and the protection of the public (except workers), the relevant person means the Department of the Environment and in relation to the protection of workers the relevant person means the Department of Enterprise, Trade and Investment.

Amendment of section 7 of the 1993 Act

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Section 7 of the 1993 Act (registration of users of radioactive material) shall be amended as follows—

• (a) in subsection (7), omit from “,except in” to “subsection (6),”;

• (b) after subsection (7) insert—

(7A) Subsection (7) does not apply— (a) in relation to high-activity sources and to other sealed sources which, in the opinion of the appropriate Agency or the chief inspector, are of a similar level of potential hazard to high-activity sources, or (b) in determining whether to impose any conditions falling within paragraph (b) or (c) of subsection (6).

;and

• (c) in subsection (8), for paragraph (a) substitute—

(a) shall furnish him with a certificate which contains all material particulars of the registration or gives sufficient information as to the particulars to enable them to be ascertained, and

Amendment of section 10 of the 1993 Act

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In subsection (5) of section 10 of the 1993 Act (registration of mobile radioactive apparatus), for paragraph (a) substitute—

(a) shall furnish him with a certificate which contains all material particulars of the registration or gives sufficient information as to the particulars to enable them to be ascertained, and

Amendment of section 12 of the 1993 Act

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After subsection (1) of section 12 of the 1993 Act (cancellation or variation of registration) insert—

(1A) The powers of the appropriate Agency and of the chief inspector under this section are exercisable with or without the making of an application by the person holding the registration.

Amendment of section 16 of the 1993 Act

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In subsection (9) of section 16 of the 1993 Act (grant of authorisations), for paragraph (a) substitute—

(a) shall furnish the person to whom the authorisation is granted with a certificate which contains all material particulars of the authorisation or gives sufficient information as to the particulars to enable them to be ascertained, and

Amendment of section 16A of the 1993 Act

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In subsection (8) of section 16A of the 1993 Act (transfer of authorisations), for paragraph (b) substitute—

(b) furnish the transferee with a certificate which contains all material particulars of the authorisation he holds as a result of the transfer or gives sufficient information as to the particulars to enable them to be ascertained;

Amendment of section 20 of the 1993 Act

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Section 20 of the 1993 Act (retention and production of site or disposal records) shall be amended as follows—

• (a) in subsection (1) after the word “site” add “, source transfer”; and

• (b) in subsection (4), in the definition of “records” after the words “of any place where the apparatus is kept” insert—

“,source transfer records” means records relating to the transfer of control of high-activity sources

Amendment of section 23 of the 1993 Act

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After subsection (5) of section 23 of the 1993 Act (power of Secretary of State to give directions to the appropriate agency and chief inspector) insert—

(6) In Northern Ireland, where the Department of the Environment gives directions to the chief inspector under this section for the purpose of implementing provisions of the HASS Directive the following requirements apply— (a) any direction shall be published in such manner as the Department considers appropriate for the purpose of bringing the matters to which it relates to the attention of persons likely to be affected by it; (b) copies of a direction shall be made available to the public; (c) notice of a direction and of where a copy may be obtained shall be given in the Belfast Gazette; (d) a direction shall be given only after consultation with the chief inspector; and (e) no direction shall be varied or revoked unless, notwithstanding the variation or revocation, the provisions of the HASS Directive as they have effect for the time being which were implemented by that direction, continue to be implemented, whether by directions or any other instrument or by any enactment.

Section 30A of the 1993 Act

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After section 30 of the 1993 Act (power of the appropriate Agency to dispose of radioactive waste) insert the following—

(30A) (1) The appropriate Agency shall be prepared or have made provision, including assignment of responsibilities, to recover any orphan source and shall have drawn up appropriate response plans and measures. (2) The appropriate Agency shall have the power to recover any expenses reasonably incurred by it (or by a person on its behalf) in the recovery and disposal of an orphan source from the holder of that source or from the occupier or owner of the premises where the source is located. (3) For the purposes of paragraph (2), “holder” means the person who is or is required to be registered or authorised under this Act in relation to that orphan source. (4) If the relevant person thinks fit, the relevant person may make available to the appropriate Agency a sum or sums of money in respect of costs and expenses incurred or to be incurred by the appropriate Agency (or by a person on its behalf) in relation to the recovery and disposal of orphan sources where— (a) the amount of such costs and expenses exceeds or is expected to exceed any reasonable provision for such costs and expenses made by the appropriate Agency, and (b) the making available of such sum or sums is necessary to enable the recovery and disposal of any orphan source. (5) In subsection (4), “relevant person” means— (a) in relation to England, the Secretary of State, (b) in relation to Wales, the National Assembly for Wales, (c) in relation to Scotland, the Scottish Ministers, and (d) in relation to Northern Ireland, the Department of the Environment. (6) In the application of this section to Northern Ireland a reference to the appropriate Agency must be taken to be a reference to the chief inspector.