Details of any licensee breaches in the financial year

The CEO was made aware of an event which resulted in two breaches with significant implications for safety:

• The Australian Nuclear Science and Technology Organisation (ANSTO) was found in breach of sections 58 and 79 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (Regulations) in September 2019 by failing to take all reasonably practicable steps to prevent accidents, and ensuring that doses to workers are below relevant limits, respectively, with regards to an accident which occurred at the ANSTO Nuclear Medicine facility on 21 June 2019.

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

The CEO was made aware of 11 breaches with no, or minor, safety implications:

• The CEO was made aware of 11 breaches with no, or minor, safety implications:
• Three breaches for failing to review the plans and arrangements for managing radiation safety, which are required to be reviewed at least every three years under section 61 of the Regulations.
• One breach related to not complying with a relevant code or standard, including requirements of the Radiation Health Series publication Code of Practice for the Design and Safe Operation of Non-medical Irradiation Facilities (1988) (RHS 24).
• One breach for failing to seek approval to dispose of a radiation source as required under section 65(1) of the Regulations. During a refurbishment six apparatus were disposed of, which was subsequently self-reported to ARPANSA.
• One breach for failing to maintain a current source inventory. Specifically, a legacy X-ray apparatus was discovered that was not recorded on the inventory, which was promptly self-reported to ARPANSA. The apparatus had not been intended to be used again.
• Two breaches for failing to seek prior approval for the transfer of a radiation source as required under section 65(2) of the Regulations. One source was transferred to a state jurisdiction licence holder without the required prior approval. The other was a low-risk source that was transferred without prior approval to a recipient that was found not to be licensed for this type of equipment. Both breaches were self-reported and involved low-hazard apparatus.
• One breach for failing to seek approval to dispose of a source as required under section 65(1) of the Regulations. The CEO was not notified within seven days of disposal of the X-ray equipment. This breach was self-reported.
• One breach for failing to take reasonably practicable steps to ensure plans and arrangements for managing safety were implemented under section 60 of the regulations. Instances where they were not fully implemented included routine checks and calibrations.
• One breach for failing to ensure that the requirements of the Code of Practice for the Security of Radioactive Sources (2019) (Radiation Protection Series 11) were implemented, including having appropriate physical detection measures in place and having an endorsed security plan, which is required under section 59 (1) of the regulations.

Whilst these breaches were assessed as having no or minor implications for safety, their identification and rectification is important to setting high standards of radiation protection and to avoid more significant safety incidents and accidents.

In all cases the licence holder undertook appropriate corrective actions.

Details of any improvement notices or directions issued during the year

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

There were no directions issued under section 41 of the ARPANS Act.

Areas for improvement

During regulatory inspections of licence holders, ARPANSA may identify an area for improvement (AFI) which represents an opportunity for licence holders to enhance their safety performance. An AFI identifies where a licence holder’s safety performance may be improved, as opposed to a breach where there is a non- compliance with a legal requirement and which may involve enforcement action. An AFI can help enhance safety performance by highlighting examples of international best practice, practices adopted elsewhere, or practices that may avoid potential future non-compliances. An AFI can also highlight a local non-conformance with a licence holders own management system and internal processes.

ARPANSA typically finds over 100 AFIs each financial year from across all licence holders and follows up on their implementation as part of the inspection process. During the 2019–2020 reporting period, ARPANSA found 137 areas for improvement from across 91 facility and source licences. As with previous reporting periods, issues related to documentation remain the most common AFI. Documentation is an important safety area as it captures an organisation’s requirements, work practices and conditions, which are assessed by ARPANSA as part of any licence application process and ongoing compliance monitoring. Figure 2 shows the breakdown of the most common areas for improvement by category type for the 2019–2020 reporting period with further explanation about each category provided in Table A1.1.

Figure 2: Areas for improvement by category 2019–2020

ANSTO licence conditions

On 5 July 2019 ARPANSA imposed a condition on the ANSTO Nuclear Medicine (ANM)
facility licence as a response to a radiation contamination event that occurred on
21 June 2019 that was determined to be an accident under section 58 of the regulations. The licence condition restricted production at the ANM facility to a level that satisfied the domestic demand for nuclear medicine only. The condition ensured that ANSTO resources could be directed to improve process safety.

Following imposition of the licence condition, ARPANSA undertook a number of inspections and undertook regulatory oversight activities to track the progress of safety improvements by ANSTO. ARPANSA eventually removed the condition from the licence on 27 March 2020 after it had achieved its objective of ensuring that measures were in place to improve safety in a number of areas. A new licence condition was then imposed that required ANSTO to notify ARPANSA at key points prior to implementation of the planned staged increase in production including evidence that safety factors and risk mitigation measures had been appropriately considered. This license condition will give additional assurance that key controls are in place and will allow for effective monitoring by ARPANSA.

Further details of the regulatory response to this accident are published on the ARPANSA website at arpansa.gov.au/ansto-return.

ANSTO mechanical failure

A further disruption to ANM production occurred in September 2019 due to the mechanical failure of a gate valve used in the transfer of uranium target plates to the facility. Whilst the gate valve failure had no direct safety consequence it resulted in a loss of production for an extended period of time. ARPANSA provided a fast-tracked response for required regulatory approvals of necessary modifications so that the disruption to the supply of nuclear medicine to the Australian community was minimised.

ANSTO Health Safety Review Implementation Plan

ARPANSA continues to monitor the progress of the ANSTO Health Safety Review Implementation Plan. An inspection of the nuclear medicine facility known as Health Products was completed in May 2020 which covered some of the improvements ANSTO indicated had been completed but, due to COVID-19 restrictions, the majority of the inspection was conducted remotely with a limited scope. As a result, not all actions could be verified. Based on information ANSTO provided to ARPANSA in January 2020, 27% of all actions have been validated as being complete; 2% of actions have been reported as being behind schedule, 16% of actions have not been started, with the remaining actions (45%) in progress and on schedule. With a six-month reporting requirement, the next progress report is expected by end of July 2020.

National Radioactive Waste Management Facility Project

On 30 June 2020, ARPANSA attended a public hearing by Senate Standing Committees on Economics on the National Radioactive Waste Management Amendment (Site Specification, Community Fund and Other Measures) Bill 2020. This work was part of ARPANSA’s National Radioactive Waste Management Facility (NRWMF) Project, which prepares ARPANSA for the review and assessment work that will be required once a licence application is received, and which also provides advice to relevant stakeholders across Government on matters related to the regulatory requirements for a NRWMF.

Facility licences as at 30 June 2020

Source licences as at 30 June 2020