SCHEDULE 2 AMENDMENT APPLICATION FORM – HIGH ACTIVITY SEALED RADIOACTIVE SOURCE (HASS)
This form, requesting approval for changes to the Inventory of High Activity Sealed Sources in Schedule 2 of an
existing licence, must be completed and forwarded to the EPA’s Office of Radiological Protection at least 28 days in
advance of the date of the proposed changes
Licence No:
Licensee Name:
Type of Amendment (please tick appropriate box and complete relevant sections)
If the amendment is a replacement of an existing source please tick both boxes 1 and 2 and complete amendment
type 1 and 2.
1.
Addition of a HASS Source to Licence
2.
Removal of an Existing HASS Source from Licence
3.
Change in Practice or Licensing Exception for Existing HASS Source
Please specify and justify the reason why this licence amendment is sought
[Please type here]
Office Use Only
Administration
Date P/W Rec: ________ Date P/W Checked: ___________ P/W Correct: Y/N Initials: _____
Inspectorate
P/W Approved: Y/N Initials: _____ Notes:
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AMENDMENT TYPE 1 (Addition of an HASS Source to Schedule 2)
The HASS radioactive source(s) shall not be acquired until this amendment has been approved. This amendment
request must be accompanied by:
1) Statement regarding Financial Provision for disposal/Return of HASS
2) Site security arrangements
3) Take-Back Agreement with supplier
4) Council Regulation (Euratom) No 1493/93* Form (where relevant)
5) A request for an Import Licence** (where relevant)
6) Revised Risk Assessment (where relevant)
7) Revised Radiation Safety Procedures (where relevant)
Where this is a replacement of an existing source the existing risk assessment must be reviewed to determine if
there are any revisions required to the radiation safety procedures. Where applicable, the revised risk assessment
and revised radiation safety procedures must accompany the amendment.
Note: The following documents may also be requested by the EPA:
8) Valid wipe test certificate for sealed sources
9) Certificate of Approval of Design for Special Form radioactive sources
* Purchasers of sealed radioactive sources from other Member States of the EU are required to complete a standard
declaration document pursuant to Council Regulation (Euratom) No. 1493/93. This document must be stamped by the EPA
before the source is shipped to the licensee.
** The importation of unsealed radioactive sources from a country outside of the EU requires an import licence. Such licences
are issued by the EPA separate to the general licence. These are required in advance of a shipment.
Name and address of Supplier:
Manufacturer:
__________________________________________________________________
_______________________________________________________________________________
Model (where relevant): _________________________________________________________________________
Serial Number: ________________________________________________________________________________
Radionuclide: __________________________________________________________________________________
Activity (Bq):
__________________________________________________________________________________
Physical Form (Solid, Liquid or Gas):
______________________________________________________________
Is the Source a Special Form Sealed Source? _______________________________________________________
Purpose or Use (e.g. calibration,density guage, ECD etc):
_____________________________________________
If the sealed source is located within an instrument provide instrument serial no: _________________________
Will the source be used in a Fixed Location or will it be Portable? _______________________________________
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State the name of the Area/Location/Room where HASS source will be held and stored (this will apear on schedule
Schedule 2):
____________________________________________________________________________________________
Is there a Take-Back Agreement:
Yes:
No:
Transport Arrangements from Supplier to your Premises (Please also specify the transport container serial number
for the Source)
_____________________________________________________________________________________________
Proposed Date of Receipt of Source (following EPA Approval):
_________________________________________
If the HASS source is to be mounted/housed within a source container please provide:
Container Model/Type:
Container ID/Distinguishing mark:
_______________________________________________________________
Arrangements for the Safe Management of HASS Source
Documented Take-Back Agreement with Manufacturer/Supplier:
Please attach documentary evidence of your Take-Back Agreement with this Amendment Form
Financial Provision to cover the cost of return or disposal of the HASS Source:
Please provide documentary evidence with this Amendment Form that adequate financial provision has
been made by the licensee to cover the cost of return or disposal of the HASS Source, even in the event of
insolvency of the licensee
Security Arrangements for the protection of HASS Source:
Please outline the site security arrangements that will be in place to safeguard the HASS Source
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AMENDMENT TYPE 2 (Removal of HASS Source from Schedule 2)
The HASS source(s) to be removed from Schedule 2 will initially have a licensing exception stating the method of
disposal/transfer. These source(s) will only be removed from Schedule 2 once the licensee has forwarded to the
EPA a copy of the confirmation of disposal/transfer.
In the case where the source(s) is not transferred to another licensee the EPA will require confirmation that the
source(s) have been received at the final destination prior to removing the source (s) from the Schedule 2.
This amendment request must be accompanied by copies of:
1) Council Regulation (Euratom) No 1493/93* Form (where relevant)
2) A request for an Export Licence** (where relevant)
* All shipments of sealed radioactive sources to other Member States of the EU must be supported by a completed standard
declaration document pursuant to Council Regulation (Euratom) No. 1493/93. This document must be stamped by the
Competent Authority in that member state before the source is shipped to its destination.
** The exportation of sealed radioactive sources to a country outside of the EU requires an export licence. Such licences are
issued by the EPA along with the general licence. These are required in advance of a shipment.
Manufacturer:
Model (where relevant): _________________________________________________________________________
Serial Number: ________________________________________________________________________________
Radionuclide:
Activity (Bq):
_____________________________________
State the Location of the sealed source as specified on Schedule 2 of Licence: ___________________________
Please State Method & Proposed Date of Disposal/Transfer of the Source:
______________________________
_____________________________________________________________________________________________
Transport arrangements for the source if being moved off site:
________________________________________
_____________________________________________________________________________________________
Description of packaging to be used for the transportation of HASS Source:
If the source is to be transferred to another licensee please provide their name and address:
_____________________________________________________________________________________________
Please forward a copy of the authorisation (e.g. stamped 1493 form) from the Competent Authority in the receiving
Country where the source is being returned
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AMENDMENT TYPE 3 (Change in Practice or licensing exception for an Existing Source)Please complete this section when there is a request to change the licensing exception listed on Schedule 2 of the
licence for the source or if there is a request to change the practice listed on the front cover of the licence.
Manufacturer: _________________________________________________________________________________
Model: _______________________________________________________________________________________
Serial Number: ________________________________________________________________________________
Radionuclide: ______________________________
Activity (Bq):
____________________________________
Location of Source as specified on Schedule 2 of the Licence: _________________________________________
Change in Practice (e.g. removal of use from licence cover): ___________________________________________
_ ___________________________________________________________________________________________
I hereby apply for a Schedule 2 amendment to the above licence. I declare that to the best of my knowledge, the
particulars given above are true.
Signed: _______________________________________________________________________________________
Name (print or type): ____________________________________________________________________________
Position:
Date _______________________________________
This Amendment Application Form must be signed by the Managing Director/Chief Executive, Hospital Manager (or
equivalent member of senior management), Radiation Protection Adviser (RPA) or Radiation Protection Officer (RPO)
nominated by the licensee submitting the Application. In the case of a licence issued in the name of an individual
person the form must be signed by that person.
On Completion, this Amendment Application Form should be sent to: Radiation Protection Regulation
Environmental Protection Agency
Office of Radiological Protection
3 Clonskeagh Square
Dublin 14
Telephone:
Fax:
Website:
(01) 2680100
(01) 2680199
www.epa.ie
Note: The form and any supporting documents may be scanned as a pdf and sent by email to radregulatory@epa.ie.
Version: August 2014
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