2017–18 Annual Report - Part 6 - Appendix 1: ARPANSA licensing activities

ARPANSA licensing activities

Details of any breaches by a licensee during the financial year of which the CEO is aware

Breaches with significant safety implications during the year

The CEO was made aware of three breaches with significant safety implications:

  • The Australian Nuclear Science and Technology Organisation (ANSTO) was found in breach of subsection 30(2) of the ARPANS Act on two counts under:
    • regulation 48 for not complying with a code or standard
    • regulation 46(1) for failing to prevent accidents involving controlled materials, apparatus or facilities.

This was related to a reported accident, categorised at International Nuclear Event Scale (INES) Level 3, which involved the contamination of the hands of a Quality Control Analyst conducting routine operations. The analyst received a radiation dose to the hands in excess of the annual statutory dose limit.

The CEO of ARPANSA consequently tabled a report in Parliament on 26 February 2018 under Section 61(1) of the Act detailing this accident.

  • The Department of Defence and Australian Defence Force was found in breach of licence conditions under subsection 31(2) of the ARPANS Act by failing to comply with regulations 53(1A) and 48(3)(d) by disposing of controlled (radioactive) material without prior approval and by not following the transport code for radioactive sources.

Breaches with no, or minor, safety implications during the year

The CEO was made aware of twelve breaches with no, or minor, safety implications:

  • A licence holder disposed of a UV sterilisation source without the required prior approval — this breach was self-identified.
  • A licence holder did not follow their plans and arrangements on change management.
  • A licence holder did not have a security plan that was endorsed or approved in accordance with RPS 11.
  • A licence holder did not comply with a requirement in a code or standard which was a condition of licence.
  • A licence holder was found in breach of a licence condition requiring review against the requirements of a code of practice; the licence holder was also found in breach of regulation 49 by failing to comply with their plans and arrangements. These breaches were found as part of an inspection based on a licence holder reported event.
  • A licence holder did not comply with plans and arrangements in accordance with regulation 49, and failed to adequately notify the CEO of the breach in accordance with regulation 45(3).
  • A licence holder did not maintain an accurate source inventory in accordance with licence conditions.
  • A licence holder did not comply with a requirement to maintain calibrated equipment in accordance with a code or standard that was a condition of licence.
  • A licence holder did not perform routine environmental monitoring in accordance with the timelines set out in a licence condition. However, the monitoring has now taken place.
  • A licence holder disposed of a medical X-ray apparatus without prior approval under regulation 53(1).

In all cases appropriate corrective actions were undertaken by the licence holder.

Other non-safety-related breaches of the Act during the year

The CEO was made aware of one breach of the Act with no safety implications where the Department of Home Affairs took possession of a UV apparatus which was not covered by their licence. This was self‑reported and the UV functionality had not been utilised.

Details of any improvement notices or directions issued during the year

There were no improvement notices issued under section 80A of the ARPANS Act.

One direction was issued under section 41 of the ARPANS Act.

On 29 June 2018, a direction was given to ANSTO by the CEO of ARPANSA under section 41(1A) of the Act with regards to activities carried out by ANSTO Health under licence F0262 in Building 23, Lucas Heights Science and Technology Centre, NSW.

The Direction was issued following four separate events with implications for safety, including the event described in the report tabled in Parliament under section 61(1) of the Act on 26 February 2018.

The direction required ANSTO to:

  • take immediate steps to initiate an independent review of the approach to occupational radiation safety of processes and operational procedures in Building 23, in particular those associated with quality control of molybdenum-99 (Mo-99) samples
  • appoint an external reviewer and, as necessary, external experts to support the reviewer in carrying out their task including providing recommendations to ANSTO with regard to relevant practices at ANSTO​​​​​​
    • the external reviewer and supporting experts must be considered suitable for the task by ARPANSA before being appointed by ANSTO
    • the terms of reference for the review must be approved by ARPANSA
  • support the review in any way necessary, including but not limited to providing access to facilities and documentation, as well as access to staff under arrangements that enable staff to interact openly with the reviewer
  • provide ARPANSA with a progress report 30 days after commencement of the review
  • within 60 days after commencement of the review, provide ARPANSA with the final report, including the recommendations by the reviewer and ANSTO’s response to those recommendations
  • at the same time, provide a plan and associated timelines for the implementation of actions responding to the report’s recommendations for ARPANSA’s approval.

Information regarding the direction is also available on the ARPANSA website at arpansa.gov.au/significant-regulatoryactivities.

Other significant activities

On 12 April 2018, the CEO of ARPANSA issued a licence to operate the ANSTO Nuclear Medicine Molybdenum-99 (Mo-99) facility (see case study 2). This followed an assessment period of over one year by ARPANSA. The CEO invited public submissions on the application and sought advice from the ARPANSA Nuclear Safety Committee before issuing the licence. A detailed Statement of Reasons by the CEO on the issue of the licence can be found on the ARPANSA website at arpansa.gov.au/SOR-ANM-operations.

Facility licences as at 30 June 2018

Commonwealth entity Licences held
Australian National University 3
Australian Nuclear Science and Technology Organisation 21
Australian Radiation Protection and Nuclear Safety Agency 2
Department of Defence/Australian Defence Forces 4
Department of Home Affairs 4
Department of the Environment and Energy 1
Total 35

Source licences as at 30 June 2018

Commonwealth entity Licences held
ASC Pty Ltd and ASC AWD Shipbuilder Pty Ltd 1
Attorney-General's Department 2
Australian Transaction Reports and Analysis Centre 1
Australian Trade and Investment Commission 1
Australian Criminal Intelligence Commission 1
Australian Federal Police 1
Australian Institute of Marine Science 1
Australian National University 2
Australian National Maritime Museum  1
Australian Nuclear Science and Technology Organisation  3
Australian Postal Corporation  1
Australian Radiation Protection and Nuclear Safety Agency  2
Australian Securities and Investments Commission  1
Australian Sports Commission  1
Australian War Memorial  1
Commonwealth Bureau of Meteorology  1
Commonwealth Scientific and Industrial Research Organisation  9
Decipha Pty Ltd  1
Department of Agriculture and Water Resources  1
Department of Defence/Australian Defence Forces  1
Department of Foreign Affairs and Trade  1
Department of Home Affairs  3
Department of Industry, Innovation and Science  3
Department of Infrastructure, Regional Development and Cities  1
Department of Parliamentary Services  1
Department of the Environment and Energy  4
Department of the Prime Minister and Cabinet  1
Federal Court of Australia  1
High Court of Australia  1
Indian Ocean Territories Health Service  1
Law Courts Limited  1
National Archives of Australia  1
National Gallery of Australia  1
National Museum of Australia  1
Note Printing Australia 1
Reserve Bank of Australia  1
Royal Australian Mint  1
Silex Systems Limited  1
Total 58