Licensing – what you need to know

Every business or organisation which is involved, or may become involved, in storing, using, transporting, or disposing of radioactive materials, irradiation apparatus or other sources of ionising radiation, must apply to the EPA Office of Radiological Protection (EPA-ORP) for a licence.

Types of licence

There are various categories of licence including

  • Industrial Radiography
  • Industrial Users
  • Hospitals/Medical
  • Government Departments & State Agencies
  • Distributors
  • Third Level Colleges
  • Veterinary Surgeons
  • Dental Surgeons

The duration of these licences varies depending on the licensed activities.

New applicants

  • Before you acquire radioactive materials or irradiating apparatus, you need a licence from the EPA
  • A licence is a legal requirement under Statutory Instrument 125 (2000)
  • If you acquire a source of ionising radiation without a licence you could be prosecuted
  • As a licensee you must appoint an approved Radiation Protection Adviser (RPA) to advise your practice on all aspects of radiation protection.

How to apply for a radiological licence - signing up to EDEN

Obligations of licensees

It is a condition of a licence that you

  • Keep records of all radioactive materials and irradiating apparatus
  • Inform the EPA-ORP of any change in the inventory of licensed items
  • Keep records of dose monitoring, disposals, incidents, faults, and other relevant information involving the licensed items
  • Ensure that any proposed changes to licensed facilities (e.g. new X-ray equipment, relocation of materials or equipment) are approved by the Radiation Protection Adviser (RPA) or Radiation Protection Officer (RPO)
  • Develop and maintain a Radiation Safety Manual/Radiation Safety Procedures. The document shall be updated at least once during the licence period. For more information on drafting these documents see Guide for the Compilation of a Radiation Safety Manual
  • Notify the local Fire Officer of the location and nature of all radioactive materials
  • Inform the EPA-ORP of the loss or theft of any licensed items, or of any incident or accident involving a licensed item
  • Display a copy of the licence in a public place
  • Ensure proper labelling of all radioactive materials and irradiating apparatus
  • Make sure that all licensed items are subject to routine maintenance in accordance with the manufacturers’ instructions, and undergoes appropriate quality assurance testing, as recommended by the RPA/RPO
  • Display a sign warning female patients to declare their known or suspected pregnancy (in the case of medical and dental practitioners)
  • Obtain authorisation from the EPA-ORP prior to the disposal of any licensed item
  • Ensure that, when licensed equipment or material is sold, the purchaser is aware of their obligation to acquire a licence from the EPA-ORP
  • Ensure that, when X-ray equipment is disposed of, it is rendered incapable of producing ionising radiation
  • Have an agreement in place with the supplier of any sealed radioactive sources to take back the source when no longer of use.

This list is not exhaustive. Specific categories of licences are governed by additional legal obligations. Further information can be obtained by contacting the EPA’s Office of Radiological Protection.

Renewing your licence

  • You must apply to renew your licence at least 30 days before its expiry date
  • When renewing your licence, you must ensure that all details are correct.

Renewing your Dental Radiological Licence

Renewing Other Radiological Licence

Inspections

The EPA routinely carries out inspections to ensure that licensees are in compliance with safety procedures and licensing conditions.  Its inspection activities are accredited by the Irish National Accreditation Board to ISO 17020.

Inspections are divided into two parts

  1. Administrative details – this will include a review of all documentation relating to the licence, personal dosimetry, disposals, acquisitions, quality assurance testing, training, servicing etc.
  2. Audit of Equipment/Facilities – this will include a visual examination of the licensed items and protective equipment; and an assessment of the radiation protection shielding, storage arrangements etc. The inspector may also make measurements as appropriate.

In addition to routine inspections, the EPA may carry out inspections where:

  • A complaint has been made against a licensee
  • A radiation incident has been reported
  • There is reasonable suspicion that a source of ionising radiation is being held or used without a licence
  • There are concerns over documentation submitted to support a licensing application or amendment.

Enforcement

The EPA-ORP has a number of options for dealing with failure to comply with the regulations and licensing conditions. They include:

  • Direction: ordering persons to vacate buildings, premises and land and to refrain from performing any acts which could escalate the danger
  • Licence suspension or withdrawal
  • Prosecution

The chosen option decided upon will depend upon the seriousness of the breach of the regulations or licensing conditions.

Approved Dosimetry Services

From 2013 dosimetry services operating in Ireland must be approved by the EPA in accordance with S.I. 125 of 2000 as amended by S.I. 152 of 2012. The new approval mechanism is intended to provide confidence that dosimetry services operating in Ireland are technically competent and provide an appropriate service.