Guidance Note on High Activity Sealed Sources

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Guidance note on High Activity Sealed Sources

Radiological Protection Institute of Ireland March 2009 3 Clonskeagh Square, Dublin 14

1. Introduction This guidance note is intended for holders of high activity sealed sources (HASS). Council Directive 2003/122/Euratom [1] on the control of high activity sealed sources and orphan sources, (the “HASS” Directive), was introduced in the light of experience worldwide which showed that, despite the existence of a regulatory framework, control of high activity sealed sources may nevertheless be lost, even in countries with rigorous regulatory systems. The HASS Directive aims to make HASS subject to strict control, from the time they are ready for sale or are imported into the Community to the time they are placed in a facility for long-term storage or disposal or are exported from the Community. The HASS Directive is transposed into Irish legislation as S.I. No. 875 of 2005 [2], which came into operation on 31st December 2005. Many of the controls required by the HASS Directive are already implemented in Irish legislation by S.I. No. 125 of 2000 [3] and the Radiological Protection Act 1991, as amended [4]. Under Article 5(1) of S.I. No. 875 of 2005 a licence must be obtained from the Radiological Protection Institute of Ireland (RPII) in advance for any practice involving HASS. All such licenses are issued under, and in accordance with Article 4 of S.I. No. 125 of 2000. All practices which involve a risk from ionising radiation are specified in Article 3 of S.I. No. 125 of 2000. HASS are defined in Annex 1 of the HASS Directive and the activity above which a source becomes a HASS is dependent on the radionuclide. Appendix 1 of this guidance note lists the thresholds for HASS for the majority of commonly used radionuclides. Under the HASS Directive a source can cease to be a HASS when its activity has fallen below the exemption levels specified in the Basic Safety Standards Directive (BSS) Directive [5]; these exemption levels are also given in Appendix 1 of this guidance note. This guidance note is for information purposes only and is without prejudice to any licence conditions imposed by the RPII. It sets out what is expected of holders of HASS in Ireland.

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2. Definitions What is a “High Activity Sealed SourceHigh Activity Sealed SourceHigh Activity Sealed SourceHigh Activity Sealed Source”? A High-Activity Sealed Source or HASS means a sealed 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 HASS threshold activity level specified in Annex 1 to the Council Directive (HASS Directive); or a sealed source containing a radionuclide which is listed in Annex 1, Table A, of Directive 96/29/Euratom (the BSS Directive) and whose activity at the time of manufacture is equal to or exceeds one hundredth of the corresponding A1 value given in the IAEA Regulations for the Safe Transport of Radioactive Material [6]. The HASS threshold activity levels for commonly used radionuclides are tabulated in Appendix 1 of this guidance note. If the source activity at the time of manufacture is not known, the threshold activity level applies to the activity at the time the source was first placed on the market. A “Sealed Source” is one whose structure is such as to prevent, under normal conditions of use, any dispersion of radioactive material into the environment, and includes, where applicable, the capsule enclosing the radioactive material as an integral part of the source. In the manufacture of sealed sources, a source becomes a HASS at the point when it is ready for sale, i.e. it is essentially assembled (although not necessarily packaged) and “on the shelf” ready for dispatch to a customer. What is an “EEEExisting HASSxisting HASSxisting HASSxisting HASS”? An existing HASS is a HASS first placed on the market on or before 31st December 2005. What is a “NNNNew HASSew HASSew HASSew HASS”? A new HASS is a HASS first placed on the market on or after 1st January 2006. What is a “DDDDisused isused isused isused SSSSourceourceourceource”? A disused source is a HASS that is no longer used or intended to be used by the licensed user for the practice for which it was licensed under S.I. No. 125 of 2000. What is a “PracticePracticePracticePractice”? A Practice is a human activity that can increase the exposure of individuals to radiation from an artificial source, or from a radioactive substance containing naturally occurring radionuclides which are processed for their radioactive, fissile or fertile properties. What is a “HHHHolderolderolderolder”? A 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. What is a “MMMManufactureranufactureranufactureranufacturer”? A Manufacturer means a natural or legal person who manufactures a source.

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What is a “RRRRecognised ecognised ecognised ecognised IIIInstallationnstallationnstallationnstallation”? A 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 RPII. There are no Recognised Installations in Ireland. Under the HASS Directive competent national authorities in Member States can authorise facilities located within their national territories as Recognised Installations, therefore Recognised Installations do exist in other Member States. What is a “SSSSource ource ource ource ContainerContainerContainerContainer”? A HASS “Source Container” means the containment of a sealed source not being an integral part of the source, but meant for transport or handling. What is a “SuSuSuSupplierpplierpplierpplier”? A Supplier means a natural or legal person who supplies or makes available a HASS. What is a “Source ource ource ource TTTTransferransferransferransfer”? A Source Transfer means the transfer of a source from one holder to another. 3. Licence Applications/Amendments From 1st January 2008 the HASS Directive requirements have applied to all HASS, both existing and new. Essentially there will be two types of applicant for a licence for HASS i.e. a) an existing licensee of the RPII applying for a licence amendment for HASS and b) a non-licensee (new applicant) applying for a licence for HASS. a) a) a) a) Existing Licensees:Existing Licensees:Existing Licensees:Existing Licensees: Existing licensees of the RPII who have HASS and/or are in the process of acquiring HASS should complete and forward to the Regulatory Services Division of the RPII a HASS HASS HASS HASS Schedule 2 Schedule 2 Schedule 2 Schedule 2 AmAmAmAmendment endment endment endment Application Application Application Application FormFormFormForm available from the RPII website (www.rpii.ie). All applications for HASS amendments must be accompanied by fully completed HASS Schedule 2 Amendment Application Forms, and if and when approved by the RPII, then by appropriate individually completed 1493 Forms pursuant to Council Regulation (EEC) No. 1493/93 [7] for each HASS originating in a Member State, in advance of any source procurement. If HASS are coming directly from outside the EU then application for appropriate Import Licences shall be made. b) b) b) b) New Licensees:New Licensees:New Licensees:New Licensees: Applications from new applicants for a licence for HASS should be made using the RPII’s SSSStandard Licence Application Formtandard Licence Application Formtandard Licence Application Formtandard Licence Application Form which is available by contacting the RPII. All applications for HASS licences from new applicants must be accompanied by fully completed Standard Licence Application Forms, and if and when approved by the RPII, then by appropriate individually completed 1493 Forms pursuant to Council Regulation (EEC) No. 1493/93 [7] for each HASS originating in a Member State, in advance of any source

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procurement. If HASS are coming directly from outside the EU then application for appropriate Import Licences shall be made. cccc) ) ) ) Safe Management, Financial and Security Requirements for all holders of HASSSafe Management, Financial and Security Requirements for all holders of HASSSafe Management, Financial and Security Requirements for all holders of HASSSafe Management, Financial and Security Requirements for all holders of HASS:::: The RPII will not issue a licence for HASS to a new applicant or issue a licence amendment for HASS to an existing licensee unless it is satisfied that:

1) Adequate arrangements are in place for the safe management of HASS, including when they become disused sources. The safe management of HASS shall be covered by appropriate risk assessments, radiation safety procedures and emergency/intervention plans. Applicants/Licensees must have in place a documented agreement with the Manufacturer/Supplier to take back the HASS, or a documented agreement with a Recognised Installation abroad to take the HASS, when they become disused sources. These documented agreements must be confirmed on an annual basis, and the letter of confirmation sent annually to the RPII.

2) Adequate provision has been made, by way of a financial security or any other equivalent means appropriate to the HASS in question, for the safe management of HASS when they become disused sources.

A documented financial costing for the safe management of HASS shall be submitted with all licence applications/amendments for HASS. This costing shall be signed by the General Manager or equivalent of the company concerned. In addition, a written guarantee from the General Manager or equivalent of the company concerned to cover the cost of management/disposal shall also accompany all licence applications/amendments. This guarantee shall cover the return or disposal of HASS, including all packaging, transport, return fees, etc., even in the event of the applicant/licensee becoming insolvent or going out of business. Any changes in the financial arrangements shall be confirmed in writing to the RPII on an annual basis.

3) Adequate measures are in place concerning site security as are appropriate to the

source(s) and premises in question.

All HASS shall be classified in accordance with the IAEA categorisation of radioactive sources [8], and the relevant security requirements as outlined in IAEA TECDOC-1355 [9] shall be deemed to apply. A security audit of the site(s) by the National Crime Prevention Unit shall be submitted to the RPII for consideration with any licence application/amendment.

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Any changes in the particulars of the security audit shall be confirmed in writing to the RPII on an annual basis.

3.1. Licence Requirements for HASS

All licensees shall ensure that the requirements to have suitable arrangements for dealing with HASS when they become disused sources and to have appropriate financial provision remain valid throughout the time that they hold the HASS. All licensees shall check annually that the Manufacturer/Supplier/Recognised Installation with which it has any agreement for dealing with HASS when they become disused sources is still in a position to honour that agreement; if it is not then the licensees will be required to make new arrangements. All licensees shall formally confirm these documented arrangements in writing with the RPII, on an annual basis, and to keep full, auditable records. All licensees must seek and obtain prior authorisation from the RPII in advance of any transfer of HASS or placement in a Recognised Installation abroad. The licensee shall inform the RPII in advance of any proposal to place in a Recognised Installation abroad, to lend or let on-hire, or sell-on HASS, and to forward copies of all relevant documentation. If authorisation is given by the RPII for any transfer then the new holder, in Ireland, must have a licence for HASS in advance of any transfer taking place. Please note that Recognised Installations abroad do not require a licence from the RPII. The licensee will be required to:

1) Verify at monthly intervals that all HASS, and, where relevant, the equipment containing the sources, are still present and in good condition at their place of use or storage. A log of all such checks shall be maintained and be available for inspection by RPII Inspectors.

2) Ensure that suitable tests, such as leak tests based on international standards, are

undertaken at two yearly intervals in order to check and maintain the integrity of all HASS.

3) Ensure that all fixed and mobile HASS are subject to adequate documented measures,

such as written protocols and procedures, aimed at preventing, insofar as is possible, unauthorised access to or loss or theft of HASS or damage by fire.

4) Notify the RPII, within 24 hours, of any loss, theft, exposure to fire or unauthorised use

of HASS. For HASS that have been involved in such incidents arrangements must be made for a check on the integrity of each source as soon as possible after any such events that may have damaged the source, and if appropriate, inform the RPII of this and of the measures taken.

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5) Return disused HASS to the Supplier/Manufacturer or place them in a Recognised Installation abroad or transfer them to another licensed holder in Ireland, unless otherwise agreed by the RPII, without undue delay after termination of use.

6) Ascertain in advance of any proposed transfer of HASS that the recipient, if in Ireland, is

licensed to hold HASS.

7) Notify the RPII, within 24 hours, of any incident or accident that may result in unintentional exposure of a worker or a member of the public.

3.2. New HASS

An existing licensee or a new applicant for a licence for HASS may not acquire HASS or any nuclear device incorporating or consisting of HASS that has been manufactured on/after 1st January 2006 unless:

a) It has been given a unique Identification Number by the Manufacturer/Supplier. b) Where practicable, it has been legibly engraved, stamped or otherwise suitably

marked with: ----Its Identification Number -The word “Radioactive” and -The Ionising Radiation symbol

c) It is accompanied by written Information indicating:

-Its Identification Number -How it is marked -Details of its radioactive content, and, where appropriate, the Identification Number of the source container -Photographs of the source and, as appropriate, the source container, transport packaging and any associated equipment

3.3. Existing HASS

An existing licensee or a new applicant for a licence for HASS who holds or acquires HASS or a nuclear device incorporating or consisting of HASS manufactured on/before 31st December 2005, which has not been given an Identification Number by the Manufacturer/Supplier, will need to allocate such a number and mark the source container with the information specified in Sections 3.2 and 3.4 and prepare written information as specified in Section 3.2. When deciding on marking the source container, account should be taken of its physical size and shape, and the magnitude of any dose that might be incurred by the person doing the marking.

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3.4. Source Containers

All licensees will be required to mark any container, in which HASS is kept or used, with:

-The Container Identification Number or distinguishing mark -The Source Identification Number -The date of receipt of the source -The name and activity of each radionuclide contained in the source on the day of receipt, and

-The word “Radioactive” and the Ionising Radiation symbol For dedicated source containers, the marking should be as permanent as possible i.e. engraved or stamped directly onto the container or onto a metal plate/tag which is securely mounted onto the container. For reusable source containers the Container Identification Number or distinguishing mark, the word Radioactive and the Ionising Radiation symbol should be as permanent as possible. However, the source-specific markings: Source Identification Number, Date of Receipt of the Source, and the Name and Activity of each Radionuclide contained in the source on the date of receipt should be engraved or stamped on a metal plate or tag, and the plate or tag securely mounted on the container. 3.5. Information

All information prepared by the licensee or provided by the Manufacturer/Supplier must be retained for the period that the HASS are held, and provided to any third parties to whom the HASS are transferred. The information may be held as hardcopy or in electronic form, provided it remains capable of being recovered at any time whilst the HASS are held under licence. When transferring HASS, a copy of all information pertaining to the HASS must be retained indefinitely by the licensee. 3.6. Information to be kept for HASS

For new HASS manufactured on/after 1st January 2006, the information provided by the Manufacturer/Supplier must include photographs of the source and, as appropriate, the source container, transport packaging and any associated equipment. The photographs should be of sufficient quality to be useful in searching for a lost source or in identifying a found source and, should preferably be in digital format. They should also include an indication of the dimensions of the licensed item. For licensees holding several HASS of the same design type, only one set of photographs is required. However the licensee must be able to provide copies of the photographs to each licensed holder to whom HASS may be transferred.

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For existing HASS first placed on the market on/before 31st December 2005, the licensee shall check whether photographs are available from the original Manufacturer/Supplier. If not then the licensee should take photographs of the source container, transport packaging and any associated equipment bearing in mind the magnitude of any radiation dose that might be incurred by the person doing the photography. 3.7. Requirements on Manufacturers

Licensees who manufacture/supply HASS or a nuclear device incorporating or consisting of HASS will be required to: -Give it a unique Identification Number

-Where practicable, mark it as specified in Sections 3.2 to 3.4 above -Produce information as specified in Sections 3.5 and 3.6 above, and provide that information to any person to whom the HASS is sold or otherwise transferred. The information must include photographs.

3.8. HASS Records

All licensed holders are required to keep individual records for each HASS, hereafter referred to as a HASS Record, and to forward this HASS Record to the RPII. The RPII has adapted the Commission’s Standard Record Sheet for HASS and this RPII Record Sheet for HASSRPII Record Sheet for HASSRPII Record Sheet for HASSRPII Record Sheet for HASS must be used by all licensed holders (See Appendix 2). All HASS Records must be accurate and kept up to date. It is important that the source information, and any subsequent changes made to it are promptly forwarded to the RPII. This will allow the RPII to maintain up-to-date records and will help ensure that RPII Inspectors have a clear understanding of the HASS that are held by licensees when they make compliance inspections. HASS Records shall include the information as set out in the RPIIRPIIRPIIRPII Record SheetRecord SheetRecord SheetRecord Sheet for HASS for HASS for HASS for HASS (see Appendix 2). This information shall be provided to the RPII

-In advance of any HASS licence amendments or transfers or placements in a Recognised Installation abroad. In these instances the name of the licensee or Manufacturer/Supplier to which the source is transferred or Recognised Installation shall be included on the Record Sheet -If the information on the Record Sheet changes -At intervals, determined by the RPII, of not more than twelve months -Within four weeks of the closure of the record for a specified source -Whenever requested by the RPII.

3.9. Training and Information

Licensees who hold HASS shall arrange training in the field of radiation protection and shall ensure that such training includes specific requirements for the safe management of sources.

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The information and training shall:-

-Place particular emphasis on the necessary safety requirements -Contain specific information on possible consequences of the loss of adequate

control of the sources -Be repeated at regular intervals and documented, with a view to preparing the

relevant workers adequately for such events, and -Be addressed to exposed workers

4. References 1. Council Directive 2003/122/Euratom of 22 December 2003 on the Control of High

Activity Sealed Sources and Orphan Sources. 2. Radiological Protection Act, 1991 (Control of High-Activity Sealed Radioactive Sources)

Order, 2005 (S.I. No. 875 of 2005). 3. Radiological Protection Act, 1991 (Ionising Radiation) Order, 2000 (S. I. No. 125 of

2000). 4. Radiological Protection (Amendment) Act, 2002 (No. 3 of 2002). 5. Council Directive 96/29/Euratom 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.

6. Regulations for the Safe Transport of Radioactive Material 2005 Edition. IAEA Safety

Standards Series, No. TS-R-1. 7. Council Regulation (Euratom) No. 1493/93 of 8 June 1993 on Shipments of

Radioactive Sources between Member States. 8. Categorization of radioactive sources – Revision of IAEA-TECDOC-1191, Categorization

of radiation sources IAEA-TECDOC-1344, July 2003.

9. Security of radioactive sources – Interim guidance for comment

IAEA- TECDOC-1355, June 2003.

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Appendix 1 HASS Threshold and Exemption LevelsHASS Threshold and Exemption LevelsHASS Threshold and Exemption LevelsHASS Threshold and Exemption Levels

RadionuclideRadionuclideRadionuclideRadionuclide HAHAHAHASS Threshold (Bq)SS Threshold (Bq)SS Threshold (Bq)SS Threshold (Bq) Exemption Level (Bq)Exemption Level (Bq)Exemption Level (Bq)Exemption Level (Bq)

Am-241 (b) 1E+11 1E+04

Cf-252 5E+08 1E+04

Co-60 4E+09 1E+05

Cs-137 (a) 2E+10 1E+04

Fe-55 4E+11 1E+06

Gd-153 1E+11 1E+07

I-125 2E+11 1E+06

Ir-192 1E+10 1E+04

Kr-85 1E+11 1E+04

Pd-103 (a) 4E+11 1E+08

Pm-147 4E+11 1E+07

Pu-238 (a) 1E+11 1E+04

Ra-226 (b) 2E+09 1E+04

Se-75 3E+10 1E+06

Sr-90 (a) 3E+09 1E+04

Tl-204 1E+11 1E+04

Tm-170 3E+10 1E+06

(a) Threshold refers to activity of parent nuclide but separate consideration of daughter

nuclides with half-lives less than 10 days is not required. (b) Includes neutron sources with beryllium.

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Appendix 2 RPII Record Sheet for HASSRPII Record Sheet for HASSRPII Record Sheet for HASSRPII Record Sheet for HASS

1. HASS Identification Number:1. HASS Identification Number:1. HASS Identification Number:1. HASS Identification Number: (Source Serial Number)

2. Manufacturer/Supplier2. Manufacturer/Supplier2. Manufacturer/Supplier2. Manufacturer/Supplier Name: Address: County: Manufacturer Supplier Date of Manufacturing:

3. HASS Characteristics3. HASS Characteristics3. HASS Characteristics3. HASS Characteristics Radionuclide: Activity at the Date of Manufacture: Or Activity when first placed on Market: Source type: Solid Liquid Gas ISO Classification ANSI Classification : Special Form Certificate :

4. Licensee4. Licensee4. Licensee4. Licensee Licence Number: Name: Address: County Licence Issue Date: Licence Expiry Date:

5. Receipt of HASS5. Receipt of HASS5. Receipt of HASS5. Receipt of HASS Date of Receipt: Receipt from Name: Address: Country: Manufacturer Supplier User Source Container/Housing/Equipment Identification Number:

6. Location of HASS 6. Location of HASS 6. Location of HASS 6. Location of HASS ( ( ( (If not the same as in 2) (Location where HASS usually kept, used or stored) Name: Address: Fixed use: Storage(Mobile):

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RPII Record Sheet for HASS RPII Record Sheet for HASS RPII Record Sheet for HASS RPII Record Sheet for HASS ((((conconconcontinued)tinued)tinued)tinued)

7. Operational Control of HASS7. Operational Control of HASS7. Operational Control of HASS7. Operational Control of HASS (Source Leak Test Dates Etc) Date: Date: Date: Date: Date: Date: Date: Date: Date: Date:

8. Transfer of HASS8. Transfer of HASS8. Transfer of HASS8. Transfer of HASS Date of Transfer: Transfer to Name: Address: Country: Manufacturer Supplier User

9. Further Information9. Further Information9. Further Information9. Further Information Loss Date of Loss: Theft Date of Theft: Placement in a Recognised Installation Date of Placement: Name of Recognised Installation: Address: Country:

10. Additional Information10. Additional Information10. Additional Information10. Additional Information Date this Record was Made: Replaces Record Made on: Or Amends Information about: Signed: Signed: Signed: Signed: Position: Position: Position: Position:

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Mission Statement “To protect people from the harmful effects of

ionising radiation, both natural and man-made,

through effective regulation, monitoring of the

environment and the provision of accurate and

timely advice to the public and to Government”

Contact us Radiological Protection Institute of Ireland (RPII) 3 Clonskeagh Square Dublin 14, Ireland Tel: +353 1 2697766 Fax: +353 1 2697437 Email: rpii@rpii.ie Web: www.rpii.ie