Radiation Act 2005 Annual report for the financial year ending 30 June 2017 i To receive this publication in an accessible format phone 1300 767 469, using the National Relay Service 13 36 77 if required, or email <[email protected]>. Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne. © State of Victoria, Department of Health and Human Services, October 2017. Except where otherwise indicated, the images in this publication show models and illustrative settings only, and do not necessarily depict actual services, facilities or recipients of services. Available at <https://www2.health.vic.gov.au/public-health/radiation/radiation-regulatory-framework/ radiation-act-annual-reports>. Radiation Act 2005 Annual report for the financial year ending 30 June 2017 Contents Radiation regulation in Victoria in 2016–17 – a snapshot 3 1. Introduction 6 2. Legislation 8 2.1 The Radiation Act 2005 8 2.2 Radiation Regulations 2007 8 2.3 Development of the Radiation Regulations 2017 9 3. Regulatory framework 10 3.1 The regulatory objective 10 3.2 Regulatory outcomes for the department 10 3.3 Regulatory work overview 10 3.3.1 Development of a stakeholder engagement and communication strategy 11 3.3.2 Performance measurement 11 3.3.3 Development of a risk management framework 11 3.3.4 Risk assessment of radiation practices 12 3.3.5 Radiation practices to be targeted for more intensive regulatory efforts 12 3.4 International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service 13 4. Summary of authorities issued by the department 14 5. Compliance monitoring program 16 6. Enforcement action 17 6.1 Prosecutions 18 6.2 Training of authorised officers to carry out investigations 18 7. Focused activities 19 7.1 Regulation of medical and industrial radiography practices 19 7.1.1 CT practices 19 7.1.2 Linear accelerators in radiation oncology 19 7.1.3 Interventional fluoroscopic apparatus 20 7.1.4 Radiation sources in industrial radiography 20 7.2 Portable density/moisture gauges (PDMGs) 20 7.3 Dual-energy X-ray absorptiometry (DEXA) units 20 7.4 Commercial tanning practices 21 7.5 Mandatory testing of medical diagnostic X-ray units 21 7.6 Mineral sands mining and processing 22 7.6.1 Iluka Resources Limited 23 7.6.2 Donald Mineral Sands 24 7.7 Review of the licensing requirements for dental intraoral X-ray units 24 7.7.1 The current regulatory approach 24 7.7.2 The proposed regulatory approach 25 7.7.3 The rationale for the proposed regulatory approach 25 7.7.4 What the proposed regulatory approach would mean for practices 25 7.7.5 Consultation 26 7.8 Metro Tunnel Project and radiation practices at a Melbourne hospital 26 7.9 Naturally occurring radioactive material at Hazelwood power station 26 7.10 Werribee Employment Precinct 26 7.11 Emergency response service 26 7.12 Representation on national committees 27 7.13 Development of national standards 27 7.13.1 Code for radiation protection in planned exposure situations (2016) 28 7.14 Education sessions 29 8. Radiation incidents 30 8.1 Mandatory reporting 30 Appendix 1: Radiation incident details 32 Appendix 2: Overview of reported incidents for the past five years, per financial year 66 Appendix 3: Diagnostic imaging services over the past five years in Victoria 67 2 Radiation Act 2005 Annual report 2016–17 Radiation regulation in Victoria in 2016–17 – a snapshot The purpose of the Radiation Act 2005, which commenced in September 2007, is to protect the health and safety of Victorians and the environment from the harmful effects of radiation. The Act requires that the Secretary to the Department of Health and Human Services publish an annual report that describes the activities of the Secretary under the Act. The report must summarise all authorities issued, renewed, suspended, cancelled, varied, transferred or surrendered during that year, as well as reporting on all radiation incidents investigated and listing all prosecutions for offences in that year. Under the Act, it is an offence to conduct a radiation practice or to use a radiation source without a licence. Currently there are 13,641 ‘use licences’ and 2,664 ‘management licences’ issued in Victoria, the majority of which are held in the medical and dental sectors. The department conducted 483 inspections in the 2016–17 financial year as part of its compliance monitoring program. One improvement notice and three prohibition notices were issued. Radiation Regulations 2017 The Radiation Regulations 2007 sunset on 28 August 2017. The Radiation Regulations 2017 replace them but create a similar regulatory environment to that in which Victoria currently operates, which is already closely aligned with international and national best practice. In addition to continuing to prescribe the elements in the Radiation Regulations 2007, the main focus of the changes in the Radiation Regulations 2017 is to strengthen the security of high-consequence radioactive material and to implement changes to the occupational dose limit to the lens of the eye to reflect recent international, national and state developments. The Radiation Regulations 2017 came into operation on 27 August 2017. Regulatory framework The department has been working towards improving the regulatory framework regarding radiation in Victoria. This includes documenting both the regulatory objectives and the outcomes it aims to achieve. The framework has also included developing a stakeholder communication strategy, assessing the costs of the regulatory activities, drafting performance indicators, continuing to implement a risk management framework and assessing the risks posed by different radiation practices. Regulation of medical practices (computed tomography, linear accelerators in radiation oncology and interventional fluoroscopic apparatus) During the 2016–17 financial year the department has continued its computed tomography (CT) practice inspection program, with a view to implementing a process requiring applicants seeking authority to own CT equipment to provide, with their application for licence, evidence of compliance with certain requirements pertaining to justification before a licence is granted. 3 The department also focused on regulating linear accelerators used in radiation oncology and identified a lack of consistent external auditing of dose delivery as an area of high risk. In order to address this risk the department has developed new dosimetric auditing requirements that have been specified in a document titled Requirements for independent dosimetric auditing of linear accelerators, available on the department website at <https://www2.health.vic.gov.au/about/publications/policiesandguidelines/ requirements-independent-dosimetric-auditing-linear-accelerators>. This document was developed to become a condition of licence for management licences authorising the possession of a linear accelerator for the purpose of radiation therapy. In the 2016–17 financial year, the department undertook inspections of practices involving fluoroscopic apparatus used in image-guided interventional procedures. These practices can deliver doses large enough to cause skin burns at the area of entry of the X-ray beam. The information collected through these inspections will be used to inform regulatory actions in respect of fluoroscopic apparatus in the 2017–18 financial year. Portable density/moisture gauges Inspections of radiation practices using these types of highly portable radiation sources (commonly used to measure moisture in soils, sands and so on) were completed and have resulted in a new condition of licence developed to improve the physical security of the devices. Dual-energy X-ray absorptiometry (DEXA) units These units are used to measure bone density, body fat levels and muscle mass. The department has identified an increase in the use of these units in the sports and fitness industry to determine body composition. The question for the department remains whether there is adequate medical justification for the procedure. The department continued a series of inspections of practices using these units to review the strength of justification for the use of radiation in the sports and fitness industry. Commercial tanning practices Commercial tanning practices were banned at the end of 2014. The department has taken a strong approach to enforcing the ban on commercial tanning practices through investigations of all allegations of illegal practices. During the financial year, the department continued to investigate the illegal use of commercial tanning units in Victoria with a view to prosecuting serious offenders. During the financial year, the department initiated 19 investigations, successfully completed two prosecutions, brought one case before the courts and executed 11 search warrants. Nine tanning units were seized by or forfeited to the department during search warrant actions. Mandatory testing of medical diagnostic X-ray units A prescribed radiation source may only be used for human diagnostic purposes if there is a current certificate of compliance in place. The department continued to monitor licensees for compliance with the testing requirements in 2016–17 and to monitor approved testers for compliance both with the conditions of their approval and with the provisions of the Act. A high level of compliance was observed during 2016–17. 4 Radiation Act 2005 Annual report 2016–17 Mineral sand mining and processing Mining mineral-rich sands generally requires the radiation safety aspects of the operation to be regulated