The Radioactive Substances Act 1993: The Hass (Scotland) Directions 2005

Description	HASS (Scotland) Directions 2005, made by the Scottish Ministers under the terms of the Radioactive Substances Act 1993 (RSA 93), requiring SEPA to comply with the provisions of Council Directive 2003/122/EURATOM on the control of high-activity sealed radioactive sources and orphan sources (“the HASS Directive”)in the exercise of existing regulatory powers. These Directions supplement the High-activity Sealed Radioactive Sources and Orphan Sources Regulations 2005, which were laid before the UK
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Website Publication Date	September 30, 2005

The Scottish Ministers, in exercise of the powers conferred by section 23 of the Radioactive Substances Act 1993( [1]) and of all other powers enabling them in that behalf, and having consulted with the Scottish Environment Protection Agency ("SEPA"), hereby give SEPA the following Directions:

1.-(1) These directions may be referred to as the HASS (Scotland) Directions 2005 and shall come into force on 20 October 2005.

(2) These directions are made to SEPA and require it to exercise its powers in or as regards Scotland only.

"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( [2]) of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation;

"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( [3]) of 22 December 2003 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 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 directions as they do in the that Act or, as the case may be, that Directive.

concerning the keeping or use of a high-activity source (other than an existing high-activity source) on or after 1st January 2006, it is directed when exercising its powers to comply with subparagraph (2).

(2) Where subparagraph (1) applies and in relation to the source in question, SEPA shall ensure that-

(a) the application or the registration complies with Articles 3(2) and (3) of the HASS Directive and that appropriate limitations and conditions are attached to a registration; and

(b) any registration is made subject to limitations and conditions to comply with Articles 5(1), 5(2), 6 and, as appropriate, 7(1) and 7(2) of that Directive.

concerning the keeping or use of an existing high-activity source on or after 1st January 2008, it is directed when exercising its powers to comply with subparagraph (4).

(4) Where subparagraph (3) applies and in relation to the source in question, SEPA shall ensure that-

(a) the application or the registration complies with Articles 3(2) and (3) of the HASS Directive and that appropriate limitations and conditions are attached to a registration; and

(b) any registration is made subject to limitations and conditions to comply with Articles 5(1) and 5(2), 6 and 16(1)(b) of that Directive.

concerning the disposal or accumulation of a high-activity source (other than an existing high-activity source) on or after 1st January 2006, it is directed when exercising its powers to comply with subparagraph (2).

(2) Where subparagraph (1) applies and in relation to the source in question, SEPA shall ensure that-

(a) the application or authorisation complies with Articles 3(2) and (3) of the HASS Directive and that appropriate limitations and conditions are attached to an authorisation; and

(b) any authorisation is made subject to limitations and conditions to comply with Articles 5(1), 5(2), 6 and, as appropriate, 7(1) and (2) of that Directive.

concerning the disposal or accumulation of an existing high-activity source on or after 1st January 2008, it is directed when exercising its powers to comply with subparagraph (4).

(4) Where subparagraph (3) applies and in relation to the source in question, SEPA shall ensure that-

(a) the application or authorisation complies with Articles 3(2) and (3) of the HASS Directive and that appropriate limitations and conditions are attached to an authorisation; and

(b) any authorisation is made subject to limitations and conditions to comply with Articles 5(1), 5(2), 6 and 16(1)(b) of that Directive.

(b) a variation of a registration under section 12 of the 1993 Act or a variation of an authorisation under section 17 of that Act;

concerning high-activity sources or any other sealed sources which, in SEPA's opinion, are of a similar level of potential hazard to high-activity sources;

(a) that it must be satisfied that there are in place adequate measures concerning site security, including the security measures in subparagraph (3), as are appropriate to the source and premises in question; and

(b) that it must have regard to any advice published by the police, security services or other appropriate persons on site security;

and to attach to a registration or authorisation appropriate limitations and conditions.

(a) ensuring the physical security of the premises, including alarm and detection systems and retaining documentary evidence of those measures,

(i) to prevent unauthorised access to, or loss or theft of, the sources referred to in subparagraph (1),

(iii) to review and enhance the physical security of the premises in response to any increased risk of unauthorised access, loss or theft taking place,

(c) following written procedures to ensure that before a person is authorised to have access to the sources referred to in subparagraph (1)-

(i) that person has been subjected to, and has passed, checks to verify their identity, and

(ii) satisfactory written references have been obtained which confirm, as far as reasonably practicable, that there is no information to indicate that the person presents any security risk to the sources,

(b) a variation of a registration under section 12 of the 1993 Act or a variation of an authorisation under section 17 of that Act;

(2) SEPA is directed in exercising its powers to attach appropriate limitations and conditions to a registration or authorisation which allow it to set up a system to enable it to be adequately informed of individual transfers of sources as required by Article 4 of the HASS Directive.

7. The provisions of the HASS Directive referred to in these directions are set out for reference in the Schedule.

Article 3

Authorisation

1. Member States shall require the holder to obtain prior authorisation for any practice involving a source, including taking possession of a source.

2. Member States shall ensure that, before issuing authorisation:

(a) adequate arrangements, including those arising from this Directive, have been made for the safe management of sources, including when they become disused sources. These latter arrangements may provide for the transfer of these sources to the supplier or their placement in a recognised installation or an obligation for the manufacturer or the supplier to receive these sources;

(b) adequate provision, by way of a financial security or any other equivalent means appropriate to the source in question, have been made for the safe management of sources when they become disused sources, including the case where the holder becomes insolvent or goes out of business.

3. Member States shall ensure that the authorisation covers:

(a) responsibilities;

(b) minimum staff competencies, including information and training;

(d) requirements for emergency procedures and communication links;

(e) work procedures to be followed;

(f) maintenance of equipment, sources and containers;

(g) adequate management of disused sources, including agreements regarding the transfer, if appropriate, of disused sources to a supplier, another authorised holder or a recognised installation.

Article 4

Transfers

Member States shall set up a system to enable them to be adequately informed of individual transfers of sources.

Article 5

Records

1. The holder shall keep records of all sources under his responsibility, their location and their transfer. The records shall include the information set out in Annex II. This information may be recorded on a standard record sheet pursuant to paragraph 5.

2. The holder shall provide the competent authority with an electronic or written copy of all or part of the records referred to in paragraph 1, as required by the Member State concerned,

- without undue delay, at the time of the establishment of such records, which should be as soon as possible after the source is acquired,

- at intervals, to be determined by Member States/competent authorities, of not more than 12 months thereafter,

- if the situation indicated on the information sheet has changed,

- without undue delay on the closure of the records for a specific 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,

- without undue delay on the closure of such records when the holder no longer holds any sources, and

- whenever so requested by the competent authority.

The holder's records shall be available for inspection by the competent authority.

3. The competent authorities shall keep records of authorised holders and of the sources they hold. These records shall include the radionuclide involved, the activity at the time of manufacture, or if this activity is not known, the activity at the time of the first placing on the market or at the time the holder acquired the source, and the type of source.

4. The competent authorities shall keep the records up to date, taking transfers into account, among other factors.

5. The Commission shall make available in electronic format the standard record sheet for the records set out in Annex II.

6. The Commission may, in accordance with the procedure referred to in Article 17, update the required information set out in Annex II and the standard record sheet for the records set out in Annex II.

Article 6

Requirements for holders

Each holder of sources 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 Member States, 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 competent authority 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 competent authority thereof 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 competent authority, 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 competent authority of any incident or accident resulting in unintentional exposure of a worker or a member of the public.

Article 7

Identification and marking

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, where practicable.

This number shall also be engraved or stamped on the source container. 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.

The manufacturer or the 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.

The manufacturer shall provide a photograph of each manufactured source design type and of the typical source container.

2. 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 paragraph 1 remain legible. The information shall include photographs of the source, source container, transport packaging, device and equipment as appropriate.

Article 16

Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 December 2005.

Member States may provide, as regards sources placed on the market before the date referred to in the first subparagraph, that:

(a) Articles 3 to 6 shall not apply until 31 December 2007;

(b) Article 7 shall not apply, with the exception of the following requirements which shall apply by 31 December 2007 at the latest:

- the holder shall ensure that, if practicable, each such source and the source container are accompanied by written information to identify the source and its nature,

- the holder shall ensure that, if practicable, each such source, if practicable, and the source container are labelled with an appropriate sign to warn people of the radiation hazard.

Where these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

NOTE to the directions

(This note is not part of the Directions)

These directions are addressed to the Scottish Environment Protection Agency ("SEPA") and make provisions required by Council Directive 2003/122/EURATOM of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources ("the HASS Directive") (OJ L 346, 31.12.2003, p.57). Paragraph 5 provides for matters concerning site security that supplement requirements of the HASS Directive.

Paragraph 3 provides that in relation to the keeping or use of high-activity sources, SEPA must ensure that any application for registration, or any existing registration, of such sources under the Radioactive Substances Act 1993 ("the 1993 Act") complies with Articles 3(2), 3(3), 5(1), 5(2), 6 and, as appropriate, 7(1) and 7(2) or 16(1)(b) of the HASS Directive.

Paragraph 4 provides for similar matters as paragraph 3 in relation to authorisations for the disposal of or accumulation of high-activity sources under the 1993 Act.

Paragraph 5 provides that in relation to applications under the 1993 Act for the registration or authorisation of high-activity sources (and other sealed sources which, in SEPA's opinion, are of a similar level of potential hazard to high-activity sources) or for variations of such matters, SEPA must ensure that there are adequate measures concerning site security. SEPA must also have regard to advice of the police, security services and other appropriate persons concerning site security.

Paragraph 6 provides that SEPA must attach appropriate limitations and conditions to a registration or authorisation that allow it to set up a system that enables it to be adequately informed of individual transfers of sources as required by Article 4 of the HASS Directive.

( [1]) c.12. The functions of the Secretary of State, in relation to Scotland, were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998 (c.46).

( [2]) OJ L 159, 29.6.1996, p.1.

( [3]) OJ L 346, 31.12.2003, p.57.

The Scottish Government

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The Radioactive Substances Act 1993: The Hass (Scotland) Directions 2005