Licensing

This document provides guidance to licence holders on the interaction of key technological, individual or human, and organisational factors necessary to create and maintain optimal safety.

Introduction

Citation

This publication may be cited as the Regulatory Guide: Holistic Safety (2025). This publication supersedes the Regulatory Guide - Holistic Safety (ARPANSA-GDE-1753).

Background

Charged with the function of protecting the health and safety of people and the environment from the harmful effects of radiation under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act), ARPANSA adopts a holistic safety approach to the regulation of radiation protection and nuclear safety.

A holistic safety approach considers the role of the whole system in managing safety. This includes technical (equipment, tools, technology, etc.), human (cognition, attention, perception, etc.) and organisational (culture, procedures, work environment, etc.) factors, as well as the interactions between them. 

Figure 1: Holistic safety is an interaction between technical, human, and organisational factors (THOF)

Holistic safety also takes a systems-thinking approach which recognises that work exists within a wide system, where safety responsibility and influence spans multiple system levels (Salmon et al., 2023). These levels include the work itself, the staff who perform the work, the leaders (both middle and senior management) who manage the work, the organisation commissioning the work, and external stakeholders (including regulators; Rasmussen, 1997).

ARPANSA encourages the adoption of holistic safety principles. This requires a comprehensive understanding of factors affecting the safety of day-to-day work, especially those that may otherwise be overlooked. This approach aims to prevent the decline of safety performance, in line with International Nuclear Safety Advisory Group (INSAG) Report 15. 

Figure 2: Information and influence should move across all levels of a system hierarchy, and in both directions.

Development of the Guide

This Guide has been developed in consultation with ARPANSA’s international nuclear regulator counterparts, Australian regulators in other high-risk industries, and ARPANSA licence holders. 

These guidelines are consistent with the aims of:

• international best practice on nuclear safety, including the International Atomic Energy Agency’s (IAEA’s) General Safety Requirements Part 2 – Leadership and Management for Safety and IAEA working document A Harmonized Safety Culture Model
• international standards established by the International Organization of Standardization (ISO) and Nuclear Energy Agency (NEA)
• academic publications on systems-thinking and safety science, including seminal papers on accident precursors and accident causation models (Dekker, 2011; Hollnagel, 2010; Salmon et al., 2023; Taylor et al., 2015).

Wherever possible, these references have been provided alongside their relevant factors within this guide.

Purpose

The purpose of this Guide is to provide ARPANSA applicants, licence holders, assessors, and inspectors an updated framework on holistic safety in line with modern best practice. When implemented, these guidelines should support applicants and licence holders in meeting their regulatory requirements, including sections 53(ea), 54(ea), 57A and 60 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations).

A secondary objective is to provide reference to high quality standards and research to assist in the practical application of this Guide. These resources can be used to assess systems and operations, develop internal assessment tools, and integrate holistic safety across organisations.

Scope

This Guide presents a high-level overview of what should be considered when taking a holistic approach. As a guide, the individual recommendations within this document are not regulatory requirements but instead establish ARPANSA’s regulatory expectations for best practice and inform ARPANSA’s approach to making licensing decisions (Act s32(3) and s33(3)).

ARPANSA is the Australian Government’s primary authority on radiation protection and nuclear safety. As such, all factors in this Guide are considered with respect to radiation protection and nuclear safety. Factors in this Guide may overlap with those considered by other regulators (e.g. Comcare). Licence holders should be aware that regulators may take different approaches to these factors due to differences in underlying legislation and jurisdiction.

A graded approach should be adopted by licence holders in the consideration and application of these factors, where the scale of actions taken is proportional to the significance of the associated risk. Licence holders should apply due consideration to the relevance of each factor and ensure alignment with international best practice and other applicable documents.

How to use this Guide

How licence holders should use this Guide

This Guide is designed to be a practical and enabling resource for the application of holistic safety throughout the work lifecycle (e.g. when designing systems, developing procedures, or conducting self-assessments).

The Guide is divided into 4 chapters: Technical Factors, Human Factors, Organisational Factors, and Systemic Factors. Each chapter includes a number of factor categories (e.g., Defence in Depth, Situation Awareness, Work Environment, etc.), which each contain factors. Each factor follows a set structure:

Licence holders are encouraged to reflect on the relevance and prevalence of each factor in their respective work/workplace. Once relevant factors are identified, licence holders should reflect on the individual considerations and interrogate how effectively those considerations are being addressed by their organisation. Licence holders should also determine where improvements are required and should develop specific action plans to achieve them. Reference tables should be used as additional support in developing actions. 

Where factors have been deemed less/not relevant, licence holders should justify reasons for exclusion. Where reference tables contain a limited number of resources, this should not be interpreted as an indication of the factor's limited relevance. Instead, it underscores the unique value of this document, which extends beyond the scope of factors addressed by other resources. Finally, reference tables are not exhaustive lists of related standards, codes, legislation, or best-practice.

The framework provided in this Guide should become part of a licence holder’s process for designing, implementing and assessing holistic safety in their systems, equipment, tools, tasks and general work environments. This Guide can also be used to inform investigations into incidents and other safety events.

Licence holders should adopt a systematic approach to the application of the factors within this framework and understand how the factors across the 4 chapters interact across the system. When implemented thoughtfully, selected controls and actions can be designed to support multiple factors at once. 

How ARPANSA will use this Guide

This Guide is ARPANSA’s principal document on holistic safety. It will serve as the main point of reference for ARPANSA’s regulatory approach, particularly sections 53(ea), 54(ea), 57A and 60 of the Regulations. This includes in the assessment of licence holder submissions and in conducting inspections.

ARPANSA adopts an evidence-based approach to regulation. Any decisions made by ARPANSA will reflect the data collected from/submitted by licence holders, in line with a graded approach. Where evidence points to issues regarding holistic safety, this may prompt further enquiry.

Chapter 1: Technical factors 

Technical factors are the set of technological and protective conditions that support operators in being safe. This chapter outlines the importance of distinct technical factors and their safety relevance.

Licence holders should demonstrate a concerted effort in addressing these factors when designing and implementing technology and related controls, including the unique interactions introduced by these technologies.

Technical factors are relevant wherever humans interact with technology. While these factors are particularly significant for human-operated technologies, all technology requires some degree of human involvement and organisational support in its design, development, monitoring, maintenance, and decommissioning. Consideration of technical factors, and their interactions with human and organisational factors, throughout each stage will support safety for all degrees of human involvement.

Technology factors

Technology integrations in the workplace can result in unique and unexpected interactions between systems and the people working with them. The factors in this category address the safety implications that may arise from the intersection of technology and the way work is fundamentally performed. 

Human-machine interfaces

Human-machine interfaces (HMIs) are the point of interaction between a human and a machine. This includes where the machine provides information on its status (output) and where an operator engages with the machine (input). These interfaces can include the user interface of a computer, analogue dials, control panels, etc. Good HMIs support users in making safe decisions by providing accurate and timely information in an intuitive, responsive and easy-to-understand format.

Licence holders should demonstrate:

a shared understanding across the workforce of the factors that support and limit the useability of HMIs that HMIs provide accurate and timely information and are intuitive, responsive and easy-to-understand application of proven and best-practice design principles that support the development of good HMIs consistency in the design principles of HMIs used across the organisation availability of training and resources for users on the use of HMIs regular review and revision of HMIs to ensure there are adequately maintained and support the changing needs of users

 

This factor is relevant to:	Reference:
Performance Objectives and Criteria for facilities (POCs(F))	C17.3, C21.10
General Safety Requirements (GSR) Part 2	2.2b
Australian or International Standards (AUS/INT STDs)	ISO 6385:2016, ISO 9241 (multiple parts)

Note: criteria listed from Performance Objectives and Criteria (facility) in reference tables may differ from matched criteria listed in Performance Objectives and Criteria (sources). Readers will need to compare documents to determine relevant criteria. 

Automation and artificial intelligence

Integration of automation (including semi-automation) and artificial intelligence (AI) into systems involves the transition from ‘humans as controllers’ to ‘humans as system managers’. As the complexity of automation and algorithms grows, so too does the challenge of deciphering the system's internal logic. This has implications for how individuals interact with systems, including how they assess risk, what decisions they make, and what actions they take. Outcomes can be either beneficial (e.g. system efficiency) or adverse (e.g. overconfidence in automated functions or impeded situation awareness) to safety. 

Licence holders should demonstrate:

rigorous processes for determining the appropriateness of automation/AI integration before implementation, including understanding the purpose, opportunities, risks and potential safety outcomes thorough piloting processes for verifying the use of selected automation/AI, including acceptance testing routine evaluations of the effectiveness of automation/AI integrations, with action taken to address outcomes clear chains-of-responsibility for automation/AI integrated systems, including operator responsibilities, that are well understood across the workforce processes for managing and responding to events when automation/AI integration fails

 

This factor is relevant to:	Reference:
GSR Part 2	4.30, 4.31, 4.32
AUS/INT STDs	ISO/IEC 42001:2023, ISO/IEC TR 24027:2021, Australian Government Voluntary AI Safety Standard

Control factors

Applying control measures, in a graded approach, is crucial for protecting safety and security. The following factor(s) address the way in which controls should be designed, selected and layered to provide maximum safety assurances.

Defence in Depth

Defence in depth (DiD) refers to the deployment of successive levels of protection, and is traditionally applied to nuclear safety. However, elements of DiD can be applied to safety generally. Specifically, DiD seeks to:

• compensate for potential failures (technical, human or organisational)
• provide, and maintain the effectiveness of, protective barriers
• protect the public and the environment when protective barriers are ineffective.

DiD, as presented in INSAG-10, is structured in five levels. If one level fails, subsequent levels should take effect. Importantly, conservative design, quality assurance and a mature safety culture are considered prerequisites to the effective implementation of DiD.

Level	Objective	Essential means
1	Prevent failures and ensure that anticipated operational occurrences/disturbances are infrequent	Conservative, high quality, proven design and high quality in construction
2	Maintain the intended operational states and detect failures	Process control and limiting systems, other surveillance features and procedures
3	Protect against design-basis accidents	Safety systems and accident procedures
4	Limit the progression and mitigate the consequences of beyond-design-basis accidents	Accident management and mitigation
5	Mitigate the radiological consequences of beyond-design-basis accidents	Off-site emergency response

 

Licence holders should demonstrate:

implementation of DiD across the facility that adequate action has been taken to implement the relevant levels of defence in depth regular evaluations of the effectiveness of protective barriers used in each successive level evaluation of the independence of defences to prevent cascading effects (e.g. due to tight coupling) the triggering of reviews and updates of controls if a layer of defence fails attention to internal or external events that have the potential to adversely affect more than one barrier at once, or to cause simultaneous failures of safety systems prerequisites of conservatism, quality assurance and safety culture are met that DiD is applied with a graded approach protection of safety barriers/controls themselves

 

This factor is relevant to:	Reference:
POCs(F)	C17.5, C21.9, C33.10, C34.2, C34.4, C37, C38
Other IBP	IAEA: INSAG-10; GSR Part 4 Safety Assessment for Facilities and Activities, Requirement 13; SRS No. 46

Chapter 2: Human factors

Human factors are the full array of complex mental, physical and psychosocial factors that contribute to an individual’s ability to work safely. This chapter outlines the importance of distinct human factors and their relevance to nuclear safety and radiation protection.

Licence holders should demonstrate consideration and integration of these factors when designing equipment, tools, tasks and the general work environment. This includes understanding how people think and feel, how they interact with each other, and the strengths and limitations of their capabilities (physical, psychological, or otherwise). Applicants and licence holders should further consider how human factors will interact with technical and organisational factors.

Cognitive factors

Cognitive factors relate to how individuals process information, specifically, how they think, perceive, understand and respond to their environment. Understanding human information processing is key as this can impact safety, both directly and indirectly.

The following factors explain the components of human information processing, their role in safety, and the considerations necessary for managing it. 

Situation awareness

Situation awareness refers to an individual’s ability to perceive a system’s current status, to anticipate its future status, and to respond appropriately (Endsley, 2015). Put more simply; ‘what is happening, what might happen next, and what can I do about it’. Good situation awareness allows individuals to respond appropriately and rapidly to changing circumstances, thereby supporting safety.

Licence holders should demonstrate:

a shared understanding across the workforce of the basic principles of situation awareness, including which factors can affect it, and which can be impacted by it that systems, equipment, tools, tasks and the general work environment are designed to support users in maintaining situation awareness training that develops competence in situation awareness, including how to build it, maintain it and recognise when it has been degraded

 

This factor is relevant to:	Reference:
POCs(F)	C5.3, C9.5, C17.3, C21.20, C21.23

Cognitive demands

Cognitive resources like memory and attention are limited and in demand. Individuals rely on these resources to diagnose risks and to guide decision-making. As the complexity of a task increases, so too do cognitive demands. On either extreme, cognitive demands have considerable implications for safety.

Licence holders should demonstrate:

a shared understanding across the workforce of the basic principles of situation awareness, including which factors can affect it, and which can be impacted by it that systems, equipment, tools, tasks and the general work environment are designed to support users in maintaining situation awareness training that develops competence in situation awareness, including how to build it, maintain it and recognise when it has been degraded

 

This factor is relevant to:	Reference:
POCs(F)	C5.3, C9.5, C17.3, C21.20, C21.23

Cognitive demands

Cognitive resources like memory and attention are limited and in demand. Individuals rely on these resources to diagnose risks and to guide decision-making. As the complexity of a task increases, so too do cognitive demands. On either extreme, cognitive demands have considerable implications for safety.

Figure 4: Balancing cognitive demands is key for optimal performance

Take for example, an operator who manages a control room with fully automated systems and where human intervention is rarely required. Over time, this operator may become inattentive, complacent or bored. Alternatively, operating a control room where systems are frequently and simultaneously in alarm and human intervention is frequently required may lead them to become overwhelmed, confused, or burnt out. Both cases can have cascading implications for situation awareness, decision-making, and safety overall.

When a task is novel, cognitive demands tend to be high as performance is based on the individual’s knowledge base (as there is no past experience to draw on). Over time, as individuals become more familiar and experienced, performance becomes more rule-based and skills-based, and cognitive demands decrease (Embrey, 2005; Rasmussen J. , 1983). If cognitive demands diminish too much, this can have negative safety implications. 

Optimising cognitive demands to align with the mental capacities of the person conducting the work, and accounting for changes in demands over time, is key to safety performance.

Licence holders should demonstrate:
an assessment of the type of cognitive resources in demand when designing systems, tasks, processes, and procedures an assessment of the cognitive demands of work, with consideration for how both high and low demands impact safety alignment of cognitive demands with the capabilities of those performing the work that procedural documents are prepared with consideration of cognitive demands

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C17.3, C33.7
AUS/INT STDs	ISO 10075-1:2017, ISO 10075-2:2024, ISO 10075-3:2004

Sensory perception

Sensory perception refers to the use of senses (vision, hearing, touch, smell and taste) to perceive and understand the physical environment. Accurate perception is necessary for making informed decisions and taking appropriate action. Perceptual deficiencies or overstimulation (e.g. a loud working environment) can interfere with this accuracy, thereby impacting safety.

Licence holders should demonstrate:
consideration of human sensory perception, and its limitations, in the design of the physical environment, systems, tasks and procedures assessments of the perceptual requirements of tasks and alignment of these requirements with the capabilities of those performing the work controls to identify and manage factors that may impact perceptual effectiveness

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C17.3, C33.7
AUS/INT STDs	AS/NZS 1269:2005, AS/NZS1680.2.4:2017

Decision-making

Decision-making is the process of reaching a judgement or choosing an option that meets the needs of a given situation. This can be done casually (intuitively) or analytically (through rational and logical evaluation) or even informed by technology (e.g. artificial intelligence). 

Figure 5: Roadmap illustrating the journey of a good decision-maker

Decision-making, at both an individual and organisational level, should be appropriately conservative, realistic, and proportionate to the potential risks. Taking a conservative approach, where actions are determined to be safe before proceeding, benefits safety. 

Licence holders should demonstrate:

a shared understanding across the workforce of how decision-making can contribute to positive and negative safety and security outcomes a conservative approach to decision-making active consideration of multiple options and justification for why one option was chosen over others various decision-making tools, models and processes, and an understanding of their strengths and weaknesses training programs that build competence in good decision-making clearly established roles, responsibilities and powers of individuals for decision-making. These should be well-known across the workforce consistent, transparent and systematic decision-making processes, which prioritise safety and security. This approach should be informed, rational, objective and prudent evaluations of the effectiveness of decision-making and integration of lessons learnt into the decision-making process

 

This factor is relevant to:	Reference:
POCs(F)	C14.2, C20.13, C34.3, C39.2
GSR Part 2	3.1d, 3.3c, 4.7d, 4.9d, 4.10, 4.14, 4.17, 5.2g
HSCM	DM.

Fitness for Duty factors

The factors within this category are those which may impact on both physical and psychological health and wellbeing. Organisations that adopt a holistic approach to the management of these factors protect safety outcomes by ensuring workers are fit for duty. 

Stress and burnout

Stress is the high emotional arousal an individual might feel in response to a physically or cognitively challenging event. Some stress can be beneficial and help motivate individuals to rise to the occasion. This can support safety by promoting vigilance and other positive safety behaviour. However, stress can also become overly taxing on an individual’s physical or mental resources or exceed their ability to cope. This can degrade health and subsequently safety. 

Figure 6: Relationship between arousal and performance

When individuals cope with stress by detaching from work, they are likely to be experiencing burnout. Burnout is a syndrome characterised by emotional exhaustion, increased mental distance from one’s job, and reduced feelings of personal accomplishment (World Health Organization, 2019). 

Stress and burnout impact personal safety as well as one’s ability to uphold one’s safety and security responsibilities at work.

Licence holders should demonstrate:

robust mechanisms to identify stressors and manage their implications (realised or potential) design jobs and work methods to consider and mitigate potential stressors adequate allocation of human and technical resources to support with tasks with inherently high demands methods for monitoring and managing employee stress increased opportunities for job control that can be availed by staff when dealing with high demands and other stressors supportive work groups and team resources to share occupational demands across staff training and resources which support individuals to manage stress

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C17.3, C33.7
GSR Part 2	6.3
HSCM	PI, WP.1
Other IBP	WHO/MNH/MND/94.21

Fatigue

Fatigue is a state of tiredness or diminished functioning. Fatigue can be both mental (e.g. complex decision-making), physical (e.g. physical exertion), or both (e.g. extended lack of sleep). Whilst individuals may be able to work through small amounts of fatigue, chronic fatigue can have increasingly dangerous effects on safety. The most insidious aspect of fatigue is that those who are fatigued often cannot recognise their own fatigue and thus, may continue to operate under these conditions. This can have considerable safety implications.

Licence holders should demonstrate:

a shared understanding across the workforce on the basics of fatigue, its implications on safety and security, and how to manage it contingency measures and staff planning arrangements to mitigate fatigue-related issues, particularly in the case of shiftwork consideration of external factors which may impact upon staff fatigue, and methods for management of them systems which measure, manage, monitor and report on staff fatigue. This includes peer evaluation and notification of fatigue work and systems that manage fatigue as part of their inherent design

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C17.3, C21.10, C33.7
GSR Part 2	6.3
HSCM	PI, WP.1

Psychosocial hazards

Psychosocial hazards are workplace factors which can cause psychological harm. These may arise from the design or management of work itself, the work environment, or workplace interactions. Psychosocial hazards can also interact to create new, changed, or more complex risks. For example, high workloads may become more hazardous when individuals also have insufficient breaks or poor peer support. Without intervention or controls, psychosocial hazards can impact safety (for example, by degrading decision-making or problem-solving abilities).

Licence holders should demonstrate:

a systematic approach to identifying reasonably foreseeable psychosocial hazards and eliminating or minimising them psychosocial hazards and risk management forms part of the design of training, systems, tasks, policies and processes and other key elements of work awareness and implementation of different psychosocial intervention methods, and their effectiveness routine evaluations of the effectiveness of implemented controls for psychosocial hazards, and adjustments made to ensure risks are reduced

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C17.3, C21.10
GSR Part 2	4.30, 5.2d
HSCM	PI, WP.1
AUS/INT STDs	ISO 45003:2021
Other IBP	Safe Work Australia Work-related psychological health and safety Safe Work Australia Managing psychosocial hazards at work

Alcohol and other drugs

The effects of alcohol and other drugs (AOD) can impair one’s fitness for duty by degrading the physical and mental functions that are critical to safety. These include:

Figure 7: The effects of AOD

Identifying and managing staffs’ use of AOD is critical for reducing the risk of injury, harm and other negative safety outcomes. 

Licence holders should demonstrate:

clear documentation and circulation of policies that deal constructively with AOD use and outline the standards and expectations of staff assessments of factors that may contribute to AOD use (including the physical environment, availability, stress, job characteristics and management style) mechanisms that address, limit, or eliminate factors that may contribute to AOD use established procedures for the detection, assessment and reporting of AOD use, including the use of legal substances that can impair function or magnify the effects of AOD

 

This factor is relevant to:	Reference:
POCs(F)	C1.2, C5.4, C8.1, C8.2, C9.1
HSCM	PI., RC.
Other IBP	Safe Work NSW Alcohol and other drugs in the workplace

Physical ergonomics 

The physical capabilities of an individual impact how they engage with equipment, tools, technology, tasks and the general work environment. The following sections outline the interplay between physical capabilities and safety and specifies the considerations necessary to ensure work environments are designed with consideration for those working within them.

Physical work environment

Physical work environment refers to the design of an individual’s and team’s workspace (e.g. desk, workbench) and the surrounding environmental conditions (e.g. lighting, noise, cleanliness). This can include the interactions between multiple workflows. Designing spaces to avoid unnecessary stresses and strains (e.g. postural risks and repetitive strain), whilst maintaining useability and accessibility, can help decrease the chance of error and enable safe practice. 

Licence holders should demonstrate:

that the design of the physical work environment eliminates or minimises hazards or risks to safety design and implementation of training, systems, tasks, policies and processes support a safe physical work environment routine assessment of the physical work environment and its impact on individuals, their work and overall outcomes a process to review and revise the physical work environment to ensure it remains optimised for the needs of people and the organisation

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C17
GSR Part 2	2.2a, 2.2b
AUS/INT STDs	ISO 6385:2016, AS(/NZS) 2243

Anthropometry

Anthropometry is the measurement of the proportions, size and form of the human body, and the application of this information to the design of workspaces and equipment. Anthropometric design helps ensure that an individual’s full functional capacity is maintained when doing a task. For example, hazmat suits should adequately conform to an individual’s physical dimensions, or equipment at workstations should be easily accessible for individuals of different heights and limb lengths. Importantly, this requires a thorough understanding obtained via assessment of the actual user group. 

Licence holders should demonstrate:

an assessment and understanding of the user group to guide anthropometric design activities use of anthropometric measurement and analysis in the design of equipment, tools, technology, tasks and the physical work environment (e.g. layout) use of anthropometric techniques to evaluate the appropriateness of equipment, tools, technology, tasks and the physical work environment, and action taken to address the outcomes of these evaluations

 

This factor is relevant to:	Reference:
POCs(F)	C9.5, C15.3, C17.2, C17.3, C19.1, C19.2
GSR Part 2	2.2a, 2.2b
AUS/INT STDs	ISO 6385:2016, ISO 7250-1:2017, AS 2243.1:2021

Chapter 3: Organisational factors 

Organisations are complex structures, with individuals, teams and leadership working together with equipment, systems, and technology, inside a dynamic working environment, to uphold safety. This chapter outlines the importance of distinct organisational factors and their relevance to nuclear and radiation safety.

Licence holders should demonstrate a concerted effort to address these factors when developing the policies, processes, procedures and practices for their broader organisational systems. This includes thinking and responsive planning for the long-term. Addressing organisational factors should involve the consideration of their impacts and interactions with technical and human factors.

Workforce factors

The factors in the following section address an organisation’s ability to develop and ensure their workforce possesses the fitness, readiness, capacity, and capability to perform their work safely, as both individuals and as a team.

Competence and training

Competence is the collection of knowledge, skills and experience necessary for an individual to perform their duties to a recognised standard, including those set for safety and security. Having a competent workforce is crucial for safe operations.

Training (and assessment) is a key mechanism for ensuring that competence is achieved and maintained. Training involves updating, developing, applying and practising knowledge and skills. Together, competency and training help mitigate safety issues that may arise from a lack of knowledge and/or skills.

Licence holders should demonstrate:

a competent workforce that ensures safety and security standards are upheld rigorous processes for determining the requisite competencies of safety related roles across all levels of the organisation, including leaders regular assessments of the competence of individuals to work safely across all levels of the organisation, including leaders that training builds competence to the required standard before any work is carried out that training is clearly linked to role requirements, includes learning objectives, and defines satisfactory performance, including for leaders that training is proactive, rather than reactive, and conducted regularly to maintain competence that training effectiveness is measured and used to improve systems of training succession planning arrangements that compensate for the departure of competent staff

 

This factor is relevant to:	Reference:
POCs(F)	C12
GSR Part 2	Requirement 9
HSCM	CL.
AUS/INT STDs	AS/NZS 45001:2018 7.2
IBP	IAEA GSR Part 1: Requirement 11

Recruitment and resourcing

Recruitment and resourcing refer to the selection and acquisition of staff, including contractors and consultants. This requires an appropriate number of suitably qualified and experienced persons (SQEPs) who are equipped with the resources (budget, time, training, etc.) necessary to perform their duties safely. This includes taking a long-term view of the organisation, anticipating future needs, and planning accordingly.

Licence holders should demonstrate:

sufficiency in resourcing (including personnel) needed for running a safe operation long-term planning of resources important for safety, including succession plans for safety functions or positions of expertise/leadership regular evaluation of current and future resource constraints, their potential impacts upon safety, and strategies to mitigate adverse effects. organisational structures which appropriately place SQEPs, in a manner that positively impacts safety and addresses resourcing constraints established and documented standards for the minimum level of education, experience, knowledge and skills required for all roles in the organisation rigorous and robust methods for the assessment and selection of SQEPs, and validation of these methods

 

This factor is relevant to:	Reference:
POCs(F)	C4.1, C4.2, C4.3, C12.2, C12.4
GSR Part 2	4.21, 4.22, 4.23, 4.24, 4.27
HSCM	LR.1
IBP	IAEA-TECDOC-1917 IAEA Competency Assessments for Nuclear Industry Personnel.

Communication

Communication is the interdependent exchange of information between parties, through speaking, writing, reading, listening, and remotely.

Figure 8: Good communication ensures a focus on safety, resulting in these outcomes

Effective communication can be a management aid for achieving shared meaning and driving safe performance. Ineffective communication can degrade safety by increasing the frequency and severity of errors. The effectiveness of communication depends on characteristics of the sender (e.g. clarity of message), characteristics of the receiver (e.g. receptiveness), and noise (e.g. distractions).

Figure 9: Effective communication is key to achieving shared meaning

Licence holders should demonstrate:

a shared understanding of the benefits of effective communication and the risks of inadequate communication on safety and security a shared understanding across the workforce of the barriers to effective communication, including types of communication errors and how to avoid them free flowing information across the organisation and with regulators, that builds transparency for internal and external stakeholders communication channels which facilitate flow of information upwards (from staff up to leaders), downwards (from leaders down to staff), and sideways (between those at the same level) mechanisms for verifying that the message communicated has been interpreted as intended dedicated communication channels for contractors, with regular communication to and from contractors availability of different communication methods, tools and modes of delivery, and an understanding of the strengths and limitations of each established systems, processes and policies that support effective internal and external communication training on the non-technical skill of communication

 

This factor is relevant to:	Reference:
POCs(F)	C5.1, C5.3, C10.4, C11.14, C12.3, C21.5
GSR Part 2	4.7a, 4.7b, 5.2c
HSCM	CO., CL.3
AUS/INT STDs	AS/NZS 45001:2018 7.4

Team Dynamics

Teams are groups of individuals, guided by a leader, working interdependently towards a common goal. The personal qualities, behaviours, styles and strategies adopted by both the individuals and the leader of a team influence safety. Leaders set the tone for safety by influencing norms, deciding on action, and allocating resources. This includes the leadership demonstrated by those outside of technical areas, as their example and decisions still impact upon safety. For example, a budgetary decision made by the CFO may apply a financial constraint that impacts the safety of work.

Groups that demonstrate good team dynamics can better adapt to adversity and solve more complex problems, thus supporting safety. 

Licence holders should demonstrate:

systems, policies, processes and procedures that support effective leadership and teamwork a shared understanding across the workforce of individual and group characteristics that influence team dynamics, including leadership a shared understanding across the workforce of the risks of inadequate leadership and teamwork and the benefits of effective leadership and teamwork on safety and security that staff are aware of their individual role/responsibility within teams, especially leaders that teams work effectively without diminishing the questioning attitude of individuals training on the non-technical skill of leadership and teamwork

 

This factor is relevant to:	Reference:
POCs(F)	C5.3, C6.2, C12.2, C12.3, C15.4
GSR Part 2	5.2a, 5.2c
HSCM	IR., CL.3, CL.4
AUS/INT STDs	AS/NZS 45001:2018 5.4

Safety culture

Safety culture is the assembly of values, attitudes, and behaviour of individuals that result in and from a collective commitment to safety. This commitment establishes safety as the overriding priority within an organisation [26, 47].

Leadership for safety

Leadership significantly influences the safety culture of an organisation. The more senior a leader, the greater their influence on culture. This influence is exerted through the policies they enact, the example they set, and the expectations they place on their staff. ‘Leadership for safety’ acknowledges the considerable role of leaders in shaping culture and outlines the approach that should be adopted to demonstrate that safety is the top priority.

Figure 11: A visual representation illustrating the greater influence of more senior leaders in an organisation

Leadership for safety comprises:

1. commitment to safety as a value
2. responsibility and accountability
3. communication, engagement and oversight.

Commitment to safety as a value

Leaders should hold, demonstrate, and institutionalise a strong commitment to safety as a core organisational value. 

Licence holders should demonstrate:
setting a good example for safety by role modelling safe behaviour and reinforcing safety as the overriding priority commitment to ensuring safety including both proactive and reactive involvement from all levels of leadership commitment to safety is reflected in all decisions, statements and actions, and not just on paper

Responsibility and accountability

It is important for leaders to understand, establish and adhere to their safety responsibilities and accountabilities.

Licence holders should demonstrate:

that authority, roles and responsibilities for safety are specific, well-defined and well-understood that ultimate responsibility and accountability for safety lies collectively with the CEO, or equivalent, of the licence holder and the senior management team of the licence holder the conditions necessary for safe operation, including that resources have been appropriately planned and dedicated, and that rewards and sanctions are appropriately distributed strategic, long-term alignment between organisational policies and safety goals, ensuring they are measurable and periodically reviewed single points of accountability within senior leadership for each activity, group and work area

Communication, engagement and oversight

Leaders shall engage and communicate across their organisation and ensure adequate safety oversight. 

Licence holders should demonstrate:

open, candid and free flowing communication, where information is shared both vertically and horizontally regular communication of decisions and actions that impact on safety, and the rationale behind them. Communication on change is particularly important active involvement and engagement with individuals across the organisation to improve safety. receptiveness to feedback and constructive criticism from across the organisation visible engagement with the workforce (e.g. field presence), which includes asking questions, reinforcing expectations and maintaining one’s own situation awareness an environment where lessons learnt are systematically shared and integrated across the organisation, preventing the formation of silos that trust is cultivated across the organisation, and everyone is treated with dignity, respect and openness informed questioning and strong oversight on safety matters recognition, encouragement and rewarding of behaviour that promotes safety, and coaching or sanctioning of behaviour that may hinder safety that an independent safety group is established, with real powers to investigate and intervene, reporting directly to the CEO

 

This factor is relevant to:	Reference:
POCs(F)	C1.1, C1.5, C1.6, C2.1, C2.2, C2.3, C2.5, C5.1, C5.4, C8.2, C10.6, C36
GSR Part 2	Requirements 1, 2, 3, and 4 4.7, 4.16, 4.25, 4.33, 5.2a, 5.2c, 6.4, 6.5, 6.10, 6.11
HSCM	LR, DM. 3, WE.3, RC.1

Individual responsibility

All individuals have a responsibility for safety, for both themselves and others. Individuals should feel a sense of ownership in knowing their safety responsibilities and striving to fulfil them.

Licence holders should demonstrate:

safety responsibilities and expectations for each role are specific, well-defined and well-understood by all individuals individuals have a strong sense of personal ownership for safety, and share learnings with others when necessary individuals adhere to set policies, procedures, processes and practices, particularly those relating to safety a culture that empowers staff to not report for duty if they believe themselves to be unfit individuals are responsible for collaboration and transparent communication across the organisation. This includes valuing diverse perspectives to safety and sharing safety lessons individuals understand their expectations for the reporting of safety events and the subsequent updating of procedures and practices

 

This factor is relevant to:	Reference:
POCs(F)	C1.1, C1.2, C1.6, C8.2, C21.2
GSR Part 2	3.1d, 3.2, 3.3, 4.25, 4.26, 5.2b
HSCM	IR. WE.2

Values and behaviour

A safe organisation will, at all levels, possess shared values and beliefs for safety. These values and beliefs produce and inform behavioural norms, which provide appropriate attention to safety and its prioritisation over competing goals.

Licence holders should demonstrate:
safety is the top priority for all individuals safety and production are seen to go hand in hand respect, trust and honesty are valued and cultivated an understanding (especially by leadership) of the impact of incentives/KPIs on the prioritisation of safety formal and informal reinforcement of safety values and behaviour

 

This factor is relevant to:	Reference:
POCs(F)	C2.2, C2.3, C8.1, C21.16
GSR Part 2	3.1, 3.2b, 5.1, 5.2
HSCM	LR.1, LR.6, WE.

Questioning attitude

A ‘questioning attitude’ is one where individuals are able and encouraged to question their work and working environment. This requires individuals to avoid complacency, remain vigilant, and voice concern even when the concern seems minor. This supports safety by identifying potential risks and taking action.

Licence holders should demonstrate:

that a questioning attitude is adopted, encouraged and enabled across the organisation that individuals are encouraged and enabled to offer different perspectives regarding safety, e.g. formal and informal systems for feedback and concerns that individuals understand the unique risks associated with their work, including potential safety implications that individuals are enabled to stop work when uncertain of the risks, and to seek advice before proceeding that individuals remain vigilant and avoid complacency

 

This factor is relevant to:	Reference:
POCs(F)	C10.8
GSR Part 2	3.2c, 5.2e
HSCM	QA., RC.

Just culture and fairness

A ‘just culture’ is one that acknowledges that errors are inevitable. Errors reflect a wider system of failures rather than a failure of the individual. A just culture balances safety and accountability (Dekker, 2007) by fairly distributing rewards and sanctions. Individuals are encouraged to continue reporting issues, even when linked to their own actions. This satisfies the need for accountability and provides an opportunity for learning and improvement. 

Fairness requires a consistent approach to be taken in the rewarding, sanctioning and general treatment of all staff. This is key to building a just culture.

Licence holders should demonstrate:

a shared understanding across the workforce of just culture and fairness, and how it impacts safety. an approach of ‘just culture’ across the organisation. policies upholding individuals’ rights for fair and confidential treatment, including intolerance of harassment, intimidation, retaliation or discrimination for raising safety concerns. fairness in rewarding and sanctioning actions that is consistent across all individuals. fairness in resolving conflicts, in a timely manner

 

This factor is relevant to:	Reference:
POCs(F)	C10.3
HSCM	LR.6, WE., RC.

Management systems

A comprehensive definition of management systems can be found in ARPANSA’s Regulatory Guide - Plans and arrangements for managing safety (ARPANSA-GDE-1735). Management systems are relevant to holistic safety due to their ability to influence an organisation’s safety culture, and for this safety culture to influence management systems in return. Management systems are the key location of the information required to conduct work safely. 

Procedure management

Procedure management refers to the foundational role of documented procedures in supporting safety. When properly implemented, these procedures offer a consistent, risk-assessed approach to work. Procedures that accurately reflect work-as-done, and are adhered to, contribute meaningfully to achieving safety objectives. Importantly, effective procedure management requires the support of underlying policies and processes, as well as good document management practices. Good oversight over, and periodic updates of, documents including creation, maintenance, management, and use of documents can safeguard against risks to safety.

Licence holders should demonstrate:

processes and procedures, particularly those impacting safety, are well-documented, precise, logical and readily available routine reviews and updates of documented processes and procedures, ensuring that they reflect work ‘as done’ and optimise safety a consultative approach to the design, development, documentation, and evaluation of processes and procedures clear ownership of procedures, policies and underlying documentation retention of records over time to support knowledge management and operational longevity that risk assessments are conducted and reviewed for all procedures that adherence expectations are established and systems for monitoring adherence are implemented that the design of processes and procedures considers the human operator undertaking each stage of that process/procedure, including human reliability quality assurance measures which verify that procedures are consistent, readable, current, and version controlled consideration of the interaction of a given process or procedure with another consideration of the information that needs to be communicated between different groups related to processes and procedures that where there is deviation from procedures, the deviations are reported, risks are assessed and procedures updated

 

This factor is relevant to:	Reference:
ARPANS Regulations	s76, s81
POCs(F)	C6.2, C7, C8.3, C12.20, C17.3, C18, C19.3, C20.5, C33.1, C33.10
GSR Part 2	4.28, 4.29, 4.32, 6.2, 6.3, Requirement 8 and 10
HSCM	WP.3
AUS/INT STDs	ISO 9001:2015
IBP	ARPANSA Regulatory Guide - Plans and arrangements for managing safety

Change management 

Change management is the process of undertaking change in a systematic and methodical way. Good change management maintains safety throughout all phases of the change. A typical change management process involves the following steps: 

Figure 10: The change management process

These steps should be followed diligently to ensure that changes have no detrimental effects on safety. 

Where a change has significant implications for safety, licence holders require prior approval from the CEO of ARPANSA under section 63 of the Regulations. Thresholds for when and how to seek approval can be found within ARPANSA’s Regulatory Guide - When to seek approval to make a change with significant implications for safety (ARPANSA-GDE-1751).

Licence holders should demonstrate:

that changes are adequately justified that the method chosen for conducting a change is selected as the best from a range of possible options a systematic, transparent and rigorous change management process, applied to all types of change, including assessment of the cumulative impact of multiple changes. The rigour of this process should be proportionate to the significance of the change a clear and well-communicated change management policy that prioritises safety adequate resourcing to support and manage change. This includes resourcing for retraining where necessary regular reviews of change as it progresses, and action taken to address any issues identified the presence and use of mechanisms for communicating and capturing the outcomes of changes. This includes communicating these outcomes with the regulator

 

This factor is relevant to:	Reference:
ARPANS Regulations	s61(2), 63
POCs(F)	C6.3, C11
GSR Part 2	4.13
HSCM	LR.4, LR.7, CL.3
IBP	IAEA-TECDOC-1226

Project management

Project management is the application of knowledge, skills, tools and techniques, to plan activities that meet the needs of a project. A project typically spans 5 phases: 

Figure 11: The typical timeline of a project

Managing safety is an integral part of project management and interacts with all phases of the project lifecycle. Making safety considerations early in the project planning phase may offer the greatest protection to safety outcomes. 

Licence holders should demonstrate:

projects are planned, communicated and implemented in a manner that promotes safety projects manage risks (both planned and unexpected), including identification, analysis, response planning, monitoring and control project documents are clear on the roles and responsibilities of project team members, including their safety responsibilities and accountabilities projects managed externally remain aligned with the organisation’s safety standards, and ultimate accountability for safety remains with CEO, or equivalent, of the licence holder and the senior management team of the licence holder

 

This factor is relevant to:	Reference:
POCs(F)	C1.1, C6.4, C8.3, C9.1

Contractor management

Calling upon the expertise of external service providers is often necessary. However, the use of contractors (incl. consultants) can introduce safety risks when improperly managed. Having a robust contractor management system can help mitigate these risks. This system should put in place arrangements that specify, monitor, and manage contractors in a way that aligns with the safety standards of the organisation.

Licence holders should demonstrate:

characteristics of an ‘intelligent customer’ in the use of contractors, ensuring the organisation is not adversely impacted in its ability to manage safety a contractor management system that specifies, monitors and manages contractors according to set safety standards policies, processes, procedures and practices (especially those regarding safety) extend to contractors clear documentation and communication of the safety responsibilities of contractors, whilst acknowledging that ultimate responsibility for safety is retained by the licence holder

 

This factor is relevant to:	Reference:
POCs(F)	C1.4, C1.5, C1.6, C5.1, C7.3, C21.6
GSR Part 2	Requirement 11

Chapter 4: Systemic factors

This category addresses broader factors which should be integrated into all systems across an organisation. The absence of these factors may signal an incomplete or potentially unsafe organisational system.

Resilience

Resilience refers to a set of abilities that enable a system to maintain or regain a safe and stable state. Systems achieve this by adjusting themselves before, during or after an event, and continuing to operate safely in both expected and unexpected conditions.

A resilient system is one which has the ability to respond, monitor, learn and anticipate (Hollnagel, 2010)

Figure 12: The abilities which enable strong resilience

The ability to respond

The ability to respond involves taking appropriate action to maintain or regain a safe and stable system state. This requires individuals to know what to do to adjust to both expected and unexpected conditions, including when to enact planned actions.

Licence holders should demonstrate:

regular appraisals of their systems to identify potential deviations that may lead to changes to the safety and stability of a system, including human factors that individuals are equipped with the capability to respond to any deviations (both expected and unexpected) and to return the system to safe and stable operations response capabilities and readiness are maintained for both emergency and non-emergency scenarios

The ability to monitor

The ability to monitor involves identifying and keeping track of indicators that help determine the safety and stability of a system. This includes indicators which both positively and negatively impact upon safety. Importantly, a long-term approach to monitoring is crucial, particularly in recognising slow, incremental changes that could have significant safety implications over time (i.e. drift; Dekker, 2011).

Licence holders should demonstrate:

a regularly updated and validated list of indicators relevant to monitoring the status of systems, including human factors routine monitoring of indicators, ensuring they are tracked, trended, evaluated and acted upon in a timely manner methods for identifying and managing factors that may impact the fitness for duty of the workforce active monitoring of long-term trends, including the incremental cutting back of safety margins and resources active monitoring and evaluation of remedial actions, including mechanisms for feeding back this information into a cycle for continuous improvement that quantitative assessments and analyses, including of human reliability, use values derived using verified, transparent methods that avoid subjective judgements that qualitative assessments, analysis and arguments establish clear criteria and apply consistent methods so as to avoid subjective judgements comparative assessments which benchmark the organisation against equivalent (national or international) organisations

The ability to learn

The ability to learn involves taking stock of past events, generating insights and lessons learnt, and understanding and leveraging these lessons to improve systems. The effectiveness of learning is impacted by which events are captured, how well they are analysed, and how meaningful the derived lessons are.

Licence holders should demonstrate:

clear and systematic principles to determine which events to investigate (including near-misses) sufficiency in resourcing to facilitate data collection, analysis and learning integration of lessons learnt (of both what did and did not go well) to drive improvements in safety learning that is effective, timely, continuous and shared across the organisation learning facilitated by both internal self-assessments and, where appropriate, external assessments

The ability to anticipate

The ability to anticipate involves forecasting for potential events, conditions, threats or opportunities that may either benefit or hinder the safety and stability of systems. Furthermore, it involves making plans and preparations to address them.

Licence holders should demonstrate:
systems and arrangements (including resources) dedicated to the role of anticipating future safety challenges regular reviews of potential future events that may impact upon safety, including human factors appropriate communication of anticipated future events and their safety impact to the wider organisation developed plans and arrangements that address anticipated future events

 

This factor is relevant to:	Reference:
ARPANS Regulations	s57B, s58, s61
POCs(F)	C6.1, C7.1, C7.2, C8.1, C9.4, C10, C11.1, C13, C14.5, C20, C22, C32.5, C32.21, C32.22, O7, O8
GSR Part 2	5.2(e), Requirement 13 and 14
HSCM	DM.4, WP.2, PI.
IBP	IAEA GSR Part 7 Emergency Preparedness and Response

Hierarchy of Controls

The Hierarchy of Controls (HoC) is a sequential approach to managing risk, arranged from most to least effective. Employing the highest level of control (elimination) is desirable and encouraged. However, this may not always be practicable. In this case, subsequent levels of control should be implemented. Effective protection will often involve the deployment of multiple controls across the hierarchy, with resources prioritised for controls higher in the hierarchy (e.g. engineering controls such as interlocks must be supported by maintenance and inspections procedures to effectively manage safety). 

Selecting which controls to deploy will require a thorough understanding of the people performing the work, the technologies they use, and the environment within which they operate. Importantly, controls must be visible and well understood by workers to be effective. Otherwise, they are routinely violated and often fail.

Figure 13: The hierarchy of controls demonstrates the various ways in which risk can be mitigated

Licence holders should demonstrate:

robust assessments that identify hazards across the organisation processes for determining controls including the consideration of multiple options justification for the controls selected, including combinations of controls across the hierarchy appreciation for human aspects when selecting, designing, implementing and maintaining controls implementation of controls and that they are being used effectively across the organisation that workers are aware of, and understand, the controls that are in place and what they protect against routine evaluations of the effectiveness of controls, and action taken to address outcomes

 

This factor is relevant to:	Reference:
POCs(F)	C6.3, C9.1, C9.5, C13.10, C17.1, C19, C37.1
AUS/INT STDs	ISO 45001:2018

User-centred design

User-centred design (UCD) places the end user at the centre of the design process. This helps designers understand (and design to) the needs of the end user, the work they do, and their work environment. Safety can degrade when design does not appropriately account for the real-life use cases of end users. For example, having touchscreen equipment in a lab where workers are wearing protective gloves, rendering the touchscreen unusable. UCD addresses this by encouraging users to participate in the design process upfront, thus helping protect systems from the threats of traditional design methods. 

Licence holders should demonstrate:
a shared understanding across the workforce of the principles of good and poor UCD, and their implications for safety application of UCD principles in the design of systems, equipment, tools, tasks and the physical work environment application of inclusive design practices within a UCD approach regular reviews of systems to ensure they remain user-centred and meet the current needs of end users

 

This factor is relevant to:	Reference:
POCs(F)	C6.2, C7.1, C17.2, C17.3, C21.10
GSR Part 2	2.2a, 2.2b, 5.2d
AUS/INT STDs	ISO 9241-220:2019

Security

Security is an essential part of safety, where any controlled source, apparatus or facility can only be considered safe if it is also secure.

Security Integration

Security concerns the implementation of systems and a culture which supports:

The common aim for these different forms of security is to mitigate the potential harm caused intentionally by bad actors, or inadvertently by good actors, to themselves or others.

Nuclear Security Culture

Nuclear security culture refers to the assembly of characteristics, attitudes and behaviours of individuals, organisations and institutions, which serve to support and enhance nuclear security. Whilst safety culture and security culture share common goals, security culture places additional emphasis on deliberate acts that are intended to cause harm. For this reason, a different set of attitudes and behaviour are required to establish a good security culture.

Safety-Security Intersection

At times, safety and security may be competing priorities. To ensure safety remains the overriding priority, without jeopardising security, it is important to understand and manage where safety and security intersect. 

Licence holders should demonstrate:

consideration and integration of security in policies, processes, procedures and practices, without negatively impacting safety effective security measures to meet the requirements of personnel security, including in recruitment effective security measures to meet the requirements of information security effective security measures to meet the requirements of physical security a strong security culture that is supported by all individuals and leadership, with appreciation for the different focuses of safety and security culture identification and management of the intersecting priorities of safety and security

 

This factor is relevant to:	Reference:
ARPANS Regulations	s57c
POCs(F)	C1.6, C2.2, C4.1, C10.2, C29, O6
GSR Part 2	4.10, 4.15b, 5.2h
HSCM	PI.1
IBP	ARPANSA RPS No. 11

For more information, see ARPANSA’s Radiation Protection Series No. 11 Code of Practice for the Security of Radioactive Sources (2019) and the Plans and Arrangements for Managing Safety Regulatory Guide.

 

Glossary

Note: Definitions for each factor included in this Guide are provided at the beginning of their respective sections.

 

Accountability

Being answerable for safety outcomes due to holding ownership over a system and its risks.

Contractor

A worker who is external to the licence holder’s organisation, but who performs work on behalf of the licence holder.

Constraint

Any system element that imposes limits on other parts of the system. These limits could be on resourcing, finances, time, radiation dose, etc.

Continuous improvement

The ongoing process of identifying, analysing, and making incremental improvements to systems, processes, procedures, and practices. 

Control

An element of, or change in, design which intends to eliminate or mitigate the risk of adverse events.

Coupling 

The degree of interdependence that exists between system elements. Tight coupling between system elements may allow for cascading failures through the system. Loose coupling may reduce control over the system.

Graded approach

An approach where the scale of actions taken is proportional to the significance of the risk

Holistic safety/holistic approach

A best-practice approach which considers technical, human and organisational factors, including how factors interact and the relationships between them.

Incidents, near misses and deviations 

Incident - the Regulations state that an “incident means:

(a) any unintended event, including an operating error, equipment failure, initiating event, accident precursor, near miss or other mishap; or

(b) any unauthorised act, whether or not malicious;

the consequences or potential consequences of which are not negligible.”

Near miss - an incident in which no harm was done to individuals or the environment, but where these consequences were narrowly avoided due to controls failing, or not being present.

Deviation - Any circumstance which results in a departure from normal conditions. A deviation may or may not result in an incident. For example, an authorised departure from procedure which results in no adverse consequences is still considered a deviation.

Heuristics

Mental short-cuts or rules of thumb which are less cognitively demanding but may oversimply a situation or event.

Intelligent Customer

The capability of the organization to have a clear understanding and knowledge of the product or service being supplied. The ‘intelligent customer’ concept relates mainly to a capability required of organizations when using contractors or external expert support.

Management system

The systems, tools and processes that allow for effective record-keeping, information availability and quality assurance, particularly during periods of development and change.

Performance

The extent to which a person is capable of carrying out a task or process safely and successfully.

Safety

Safety is the ability to perform work in varying, unpredictable environments without causing harm. This is demonstrated by the presence of defences, not the absence of accidents. 

System

A set of dynamically interacting elements. These elements include technologies, organisational structures and people.

This guide refers to multiple systems.

Systems-thinking

An approach which considers systems as a whole and emphasises the interactions and relationships between elements of the system. This often involves the consideration of a hierarchy which groups system elements in to work design, frontline staff, management, the organisation, and external elements (including government, regulators and the public).

Work-as-done

The way in which work is actually performed, rather than the way it is expected to be done when planning (work-as-planned).
 

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Safe Work Australia. (2019). Work-related psychological health and safety: A systematic approach to meeting your duties. Retrieved from https://www.safeworkaustralia.gov.au/system/files/documents/1911/work-r…

Safe Work Australia. (2022). Managing psychosocial hazards at work: Code of practice. Retrieved from https://www.safeworkaustralia.gov.au/sites/default/files/2022-08/model_…

Safe Work NSW. (2006). Alcohol and other drugs in the workplace: Guide to developing a workplace alcohol and other drugs policy. Retrieved from https://www.safework.nsw.gov.au/__data/assets/pdf_file/0003/49962/drugs…

Salmon, P., Hulme, A., Walker, G., Waterson, P., & Stanton, N. (2023). Towards a unified model of accident causation: refining and validating the systems thinking safety tenets. Ergonomics, 66(5), 644-657. doi:https://doi.org/10.1080/00140139.2022.2107709

Säteilyturvakeskus Radiation and Nuclear Safety Authority. (2019). Leadership and management for safety - Guide YVL A.3. Retrieved from https://finlex.fi/api/media/authority-regulation/545809/mainPdf/main.pd…

Taylor, R., van Wijk, L., May, J., & Carhart, N. J. (2015). A study of the precursors leading to ‘organisational’ accidents in complex industrial settings. Process Safety and Environmental Protection, 93(2015), 50-67. doi:https://doi.org/10.1016/j.psep.2014.06.010

Wiggins, M. (2022). Introduction to human factors for organisational psychologists. CRC Press.

World Association of Nuclear Operators. (2013). Traits of a Healthy Nuclear Safety Culture - PL 2013-1. Retrieved from https://www.wano.info/wp-content/uploads/2024/07/WANO-PL-2013-1-Pocketb…

World Health Organization. (1994). Guidelines for the primary prevention of meantal, neurological and psychosocial disorders - 5. Staff burnout. Retrieved from https://iris.who.int/bitstream/handle/10665/60992/WHO_MNH_MND_94.21.pdf…

World Health Organization. (2019). Burn-out an "occupational phenomenon: Interantional classificaiton of diseases. Retrieved from https://www.who.int/news/item/28-05-2019-burn-out-an-occupational-pheno…

 

1. Purpose

This document is provided to assist controlled persons to determine whether an ultraviolet (UV) source is classed as controlled apparatus under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act). In particular, it clarifies the conditions specified in section 9 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations). A number of case studies where typical UV emitting apparatus have been assessed in accordance with this guide have been published in the document UV emitting apparatus – case studies.

This document is valid for both pulsed and continuous sources of UV radiation where the exposure duration is not less than 0.1 ms. It does not apply to UV lasers. Exposure to lasers are covered by laser standard AS/NZS IEC 60825.1 Safety of laser products.

Reference documents

Radiation Protection Standard for Occupational Exposure to Ultraviolet Radiation (2006), ARPANSA Radiation Protection Series No. 12 (RPS 12). Extracts from this document can be found in Appendix 1.

To fulfil the requirements of section 2.1 of RPS 12 supplementary information and management plans for controlling exposure to UVR can be found on the ARPANSA website:

• Management Plan
• Supplementary information

Read this document in conjunction with Regulatory Guide: UV emitting apparatus case studies.

2. Definitions

Exposure limit: the exposure which it is believed that nearly all workers can be repeatedly exposed to without adverse effect (exposure limits for UV are given in Schedule 1 of RPS 12).

Note: The exposure limits apply to artificial sources of UVR. Due to highly variable ambient solar UVR levels the application of exposure limits is not practical and limiting solar UVR exposure to as low as possible is the most effective approach.

Permissible exposure time, t_PET: the time it takes to reach the exposure limit (calculated according to Schedule 1 of RPS 12).

3. Controlled apparatus

In section 4 Group 1 table of the Regulations defines an optical source, other than a laser product, emitting ultraviolet radiation, infrared or visible light as controlled apparatus.

4. Criteria to be satisfied

Section 9 of the Regulations consists of two separate criteria, both of which must be fulfilled for the apparatus to be classed as controlled apparatus.

The first criterion, paragraph 9(1)(b) concerns source emission. It is fulfilled if the apparatus produces non-ionising radiation that could lead to a person being exposed to radiation levels exceeding the non-ionizing radiation exposure limits. For UVR the relevant standard referred to in section 4 is Radiation Protection Standard for Occupational Exposure to Ultraviolet Radiation (2006), ARPANSA Radiation Protection Series No. 12 (RPS 12).

The second criterion, paragraph 9(1)(c) is based on the accessibility of the source. Factors determining whether radiation above the exposure limits is accessible to persons have to be evaluated. The condition is fulfilled if excess levels of radiation are readily accessible to persons in any of the following situations:

• in the course of intended operations or procedures of the apparatus; or
• as a result of a reasonably foreseeable abnormal event involving the apparatus; or
• as a result of a reasonably foreseeable single element failure of the apparatus; or
• without the use of tools or other specialised equipment required to remove protective barriers or access panels.

If the apparatus is not one of the exempt dealings in section 44(7) of the Regulations the procedure in the next section describes how to go through these two criteria to determine whether a UVR source is classed as controlled apparatus or not.

5. Procedure

This procedure (as show by the flow chart on page 4) will assist you to determine whether your apparatus is controlled or not. 

1. If the apparatus is a transilluminator or germicidal lamp where the emission is accessible, it is classed as controlled apparatus.
2. If the apparatus is a fluorescence microscope, a spectrophotometer or a high-performance liquid chromatography (HPLC) where the light source is completely enclosed, it is not controlled apparatus.
3. If there is a reasonably foreseeable abnormal event involving the apparatus that would lead to a person being exposed to levels above the exposure limits, the apparatus is classed as controlled apparatus. Examples of this are: forgetting or using the wrong PPE, possible exposure during normal maintenance, not using prescribed shielding to cover a sample, easy overriding of an interlock etc.
4. If there is a reasonably foreseeable single element failure of the apparatus that would lead to a person being exposed to levels above the exposure limits, the apparatus is classed as controlled apparatus. An example of this is a malfunctioning interlock. A failsafe interlock would not lead to a person being exposed as no UVR is emitted if the interlock fails.
5. If a person can receive excess levels of radiation when removing protective barriers or access panels that do not require the use of tools or other specialised equipment, then the apparatus is classed as controlled apparatus.
6. Determine if the source emits UV radiation that could lead to a person being exposed to radiation levels in excess of the exposure limits in the course of intended operations or procedures. Calculate the permissible exposure time, t_PET, according to the method described in Schedule 1 of RPS 12.

Notes:

The distance to the source when the unit is in operation should be taken into account. Using the inverse square law the radiation level is calculated at the position where the closest person is situated. If the unit is handheld and no distances are specified: assume that the skin and eyes are 20 cm and 50 cm, respectively, from the source.

Embedded devices can be designed in such a way that it can be considered safe for their intended use and during normal operation as the emission hazard only becomes accessible during service or maintenance. i.e. protective housing, interlocks and other organisational safety measures. The servicing of embedded UV sources can increase the risk of injury as the servicing may include various adjustments. To carry out servicing in a safe manner it may be necessary to implement temporary procedures and safeguards appropriate to the increased level of risk. Manufacturers may provide advice on safe procedures during servicing and maintenance.

Compare with the maximum exposure duration, t_exp.

If  t_exp> t _PET  the apparatus is classed as controlled apparatus.

If      the apparatus is not classed as controlled apparatus.

Flowchart for determining whether a UV source is a controlled apparatus

 

Appendix 1

Extracts from Schedule 1 Radiation Protection Standard for Occupational Exposure to Ultraviolet Radiation (2006)

Radiation Protection Series No. 12

Exposure Limits (EL) for UVR from Artificial Sources ¹

S1.1	The EL for occupational exposure to UVR incident upon the skin or eye where irradiance values are known and the exposure duration is controlled are as below. Note that S1.2 and S1.3 must both be satisfied independently.
S1.2	For the UV-A spectral region 315 to 400 nm, the total radiant exposure on the unprotected eye must not exceed 10 kJ.m–2 within an 8 hour period and the total 8 hour radiant exposure incident on the unprotected skin must not exceed the values given in Table 1. Values for the relative spectral effectiveness are given up to 400 nm to expand the action spectrum into the UV-A for determining the EL for skin exposure.
S1.3	In addition, the ultraviolet radiant exposure in the actinic UV spectral region (UV-B and UV-C from 180 to 315 nm) incident upon the unprotected skin and unprotected eye(s) within an 8 hour period must not exceed the values given in Table 1.
S1.4	For broadband sources emitting a range of wavelengths in the ultraviolet region (ie most UVR sources), determination of the effective irradiance of such a broadband source is done by weighting all wavelengths present in the emission with their corresponding spectral effectiveness by using the following weighting formula: Eeff       =       ∑Eλ. Sλ. ∆λ where Eeff       =       Effective irradiance in W.m–2 (J.s–1.m–2) normalised to a monochromatic source at 270 nm Eλ              =       Spectral irradiance in W.m–2.nm Sλ              =       Relative spectral effectiveness (unitless) ∆λ             =       Bandwidth in nanometres of the calculated or measurement intervals
S1.5	Permissible exposure time in seconds for exposure to actinic UVR incident upon the unprotected skin or eye may be computed by dividing 30 J.m–2 by Eeff in W.m–2. The maximum exposure duration may also be determined using Table 2 of this Schedule which provides representative exposure durations corresponding to effective irradiances in W.m–2 (and μW.cm-2).

¹ These exposure limits are intended to be used as guidelines only for Solar UVR exposure.

 

Table 1: Ultraviolet radiation exposure limits and Relative Spectral Effectiveness

Wavelengtha (nm)	Exposure limit (J.m-2)	Exposure limit (mJ.cm-2)	Relative Spectral Effectiveness Sλ
180	2 500	250	0.012
190	1 600	160	0.019
200	1 000	100	0.030
205	590	59	0.051
210	400	40	0.075
215	320	32	0.095
220	250	25	0.120
225	200	20	0.150
230	160	16	0.190
235	130	13	0.240
240	100	10	0.300
245	83	8.3	0.360
250	70	7.0	0.430
254b	60	6.0	0.500
255	58	5.8	0.520
260	46	4.6	0.650
265	37	3.7	0.810
270	30	3.0	1.000
275	31	3.1	0.960
280b	34	3.4	0.880
285	39	3.9	0.770
290	47	4.7	0.640
295	56	5.6	0.540
297b	65	6.5	0.460
300	100	10	0.300
303b	250	25	0.120
305	500	50	0.060
308	1 200	120	0.026
310	2 000	200	0.015
313b	5 000	500	0.006
315	1.0 × 104	1.0 × 103	0.003
316	1.3 × 104	1.3 × 103	0.0024
317	1.5 × 104	1.5 × 103	0.0020
318	1.9 × 104	1.9 × 103	0.0016
319	2.5 × 104	2.5 × 103	0.0012
320	2.9 × 104	2.9 × 103	0.0010
322	4.5 × 104	4.5 × 103	0.00067
323	5.6 × 104	5.6 × 103	0.00054
325	6.0 × 104	6.0 × 103	0.00050
328	6.8 × 104	6.8 × 103	0.00044
330	7.3 × 104	7.3 × 103	0.00041
333	8.1 × 104	8.1 × 103	0.00037
335	8.8 × 104	8.8 × 103	0.00034
340	1.1 × 105	1.1 × 104	0.00028
345	1.3 × 105	1.3 × 104	0.00024
350	1.5 × 105	1.5 × 104	0.00020
355	1.9 × 105	1.9 × 104	0.00016
360	2.3 × 105	2.3 × 104	0.00013
365b	2.7 × 105	2.7 × 104	0.00011
370	3.2 × 105	3.2 × 104	0.000093
375	3.9 × 105	3.9 × 104	0.000077
380	4.7 × 105	4.7 × 104	0.000064
385	5.7 × 105	5.7 × 104	0.000053
390	6.8 × 105	6.8 × 104	0.000044
395	8.3 × 105	8.3 × 104	0.000036
400	1.0 × 106	1.0 × 105	0.000030

^a Wavelengths chosen are representative; other values should be interpolated at intermediate wavelengths

^b Emission lines of a mercury discharge spectrum

Table 2: Limiting UV exposure durations based on EL 

Duration of exposure per day		Effective irradiance Eeff(W.m–2)  |  Eeff (µW.cm–2)
8	hr	0.001	0.1
4	hr	0.002	0.2
2	hr	0.004	0.4
1	hr	0.008	0.8
30	min	0.017	1.7
15	min	0.033	3.3
10	min	0.05	5
5	min	0.1	10
1	min	0.5	50
30	sec	1.0	100
10	sec	3.0	300
1	sec	30	3 000
0.5	sec	60	6 000
0.1	sec	300	30 000

 

On this page

• Purpose
• Background
• Class 1M lasers
• Class 2M lasers
• Summary

1. Purpose

This document is provided to assist controlled persons to determine whether a Class 1M and Class 2M laser product is classed as a controlled apparatus under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act). In particular, it clarifies the criteria used in section 9 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations).  

Reference documents

AS/NZS IEC 60825.1 Safety of laser products Part 1: Equipment classification and requirements
AS/NZS IEC 60825.2 Safety of laser products Part 2: Safety of optical fibre communication systems (OFCSs) 
AS/NZS IEC 60825.14 Safety of laser products Part 14: A user’s guide

2. Background

There are currently eight classifications for lasers based on the likelihood of injury. The classification of a laser is used to develop safety control measures. The Accessible Emission Limit (AEL) is the maximum accessible emission permitted within a particular class of laser.

In section 44 Item 7 of the Regulations the exempt dealings define a laser as an exempt laser product with an accessible emission that does not exceed the accessible emission limits of a Class 3R laser product, as set out in AS/NZS IEC 60825.1 and an optical fibre communication system that does not exceed the hazard level 3R, as set out in AS/NZS IEC 60825.2.

Therefore, a laser with an accessible emission greater than the AEL of a Class 3R laser product is deemed a controlled apparatus, and an optical fibre communication system that exceeds a Hazard Level 3R is deemed a controlled apparatus. 

Because the emission level of Class 1M and Class 2M laser products may exceed the AEL for Class 3R, Class 1M and Class 2M lasers are potentially classified as controlled apparatus. 

3. Class 1M lasers

A Class 1M laser is any laser product in the wavelength range from 302.5 nm to 4000 nm.

Since Class 1M is assigned to lasers where the exposure would not normally exceed the AEL of Class 1, most Class 1M lasers would not be considered to be a controlled apparatus.

The two notable exceptions to this would be where it is reasonably foreseeable that the beam may be viewed with magnifying optics like a telescope, binoculars or a microscope. Consequently the AEL may be greater than the AEL of a Class 3R laser: 

1. where the beam is collimated with a large diameter and optics are used to focus the beam, or
2. where the beam is highly divergent and optics are used near the laser aperture to collimate the beam.

Examples: Laser diodes, fibre communication systems.

4. Class 2M lasers

A Class 2M laser is any laser product in the wavelength range from 400 nm to 700 nm.

Class 2M applies only to visible lasers and assumes that a degree of protection is afforded by the aversion response (blinking and turning away). In most cases, due to the aversion response, it is not considered reasonably foreseeable that a person would deliberately view the beam for more than 0.25 s. The same conditions given for Class 1M lasers apply to Class 2M lasers: unless the beam is viewed with magnifying optics it is not considered to be a controlled apparatus. 

Warning for potential hazard to the skin or eye

If the accessible emission from a Class 1M or Class 2M laser is greater than the AEL of a Class 3R as determined with a 3.5 mm diameter aperture placed at the closest point of human access, then an additional warning regarding potential skin hazard and/or anterior parts of the eye hazard must be given. The following additional warning must be given on the device:

 

Hazard level 1M and 2M optical fibre communications systems (OFCSs)

Hazard level refers to the potential hazard from laser emissions at any location in an end-to-end fibre optic communication system that may be accessible during use or maintenance or in the event of a failure or fibre disconnection as described in AS/NZS IEC 60825.2. The assessment of the hazard level uses the class AEL described in AS/NZS IEC 60825.1.

Hazard level 1M and hazard level 2M OFCSs may be considered to be controlled apparatus if their emission level exceeds the AEL for a Class 3R laser and, in the course of intended operations or under a reasonably foreseeable abnormal event, may lead to persons being exposed to emission in excess of the maximum permissible exposure (MPE) mentioned in AS/NZS IEC 60825.1. Each accessible location in an extended enclosed optical transmission system will be designated by a hazard level as those for classifications in AS/NZS IEC 60825.1 and based on radiation that could become accessible and exceeds the AEL for a Class 3R laser under reasonably foreseeable circumstances such as a fibre cable break or disconnected fibre connector. Labelling and marking requirements can be found in AS/NZS IEC 60825.2.

5. Summary

Class 1M and Class 2M lasers may be considered to be controlled if their emission level exceeds the AEL for Class 3R and, in the course of intended operations or under a reasonably foreseeable abnormal event, may lead to persons being exposed to emission in excess of the MPE mentioned in AS/NZS IEC 60825.1. 

For the purposes of determining the hazard level of 1M and 2M optical fibre communications systems, the same rules apply as for Class 1M and 2M lasers.

1. Purpose

This document is provided to assist controlled persons to determine whether a radiofrequency (RF) source is classed as a controlled apparatus under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act). In particular, it clarifies conditions and defines terms used in Section 9 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations).

2. Controlled apparatus

The Group 1 table in section 4 of the Regulations defines some of the types of RF emitting devices which are classed as controlled apparatus. 

The following are examples of RF devices:

• a magnetic field non-destructive testing device
• an induction heater or induction furnace
• an industrial radiofrequency heater or welder 
• a radiofrequency plasma tube
• microwave or radiofrequency diathermy equipment
• an industrial microwave or radiofrequency processing system

More explanatory examples of the above listed RF emitting devices can be found in Appendix 1.

Note: In section 44 (7) of the Regulations exempt dealings for the following RF emitting devices:

• radar equipment used for detection and ranging
• radiofrequency equipment used for communications
• Klystron

3. Criteria to be satisfied

Section 9 of the Regulations consists of two separate criteria, both of which must be fulfilled for the apparatus to be classed as controlled apparatus. 

The first criterion paragraph 9(1)(b) concerns source emission. It is fulfilled if the apparatus produces non-ionising radiation that could lead to a person being exposed to radiation levels exceeding the non-ionizing radiation exposure limits. For RF the relevant standard referred to in section 4 is Radiation Protection Standard for Limiting Exposure to Radiofrequency Fields – 100 kHz to 300 GHz (RPS S-1). This document specifies reference levels which have been derived from the basic restriction levels. The reference levels have been chosen as they are based on quantities that are easy to measure and compliance with the reference levels will ensure compliance with the basic restrictions. See Appendix 2 for more details and extracts from RPS S-1.  

Some of the apparatus (for example induction heaters) also generate electric and magnetic fields at 50/60 Hz. In this case the exposure limits referred to in section 4 are in the ICNIRP Guidelines for Limiting Exposure to Time-Varying Electric and Magnetic Fields (1 Hz – 100 kHz). See Appendix 3 for more details and extracts from the ICNIRP Guidelines.  

The second criterion, paragraph 9(1)(c) is based on the accessibility of the source. Factors determining whether radiation above the exposure limits is accessible to persons have to be evaluated. The condition is fulfilled if excess levels of radiation are readily accessible to persons in any of the following situations: 

• in the course of intended operations or procedures of the apparatus; or
• as a result of a reasonably foreseeable abnormal event involving the apparatus; or 
• as a result of a reasonably foreseeable single element failure of the apparatus; or
• without the use of tools or other specialised equipment required to remove protective barriers or access panels.

The following procedure describes how to go through these two criteria to determine whether an RF emitting device is classed as controlled or not.

4. Radiofrequency (high frequency) and low frequency radiation

The part of the electromagnetic spectrum with high frequencies is in the range 3 kHz to 300 GHz and is referred to as radiofrequency (RF). The low frequency is in the range of 1 Hz to 100 kHz which include the 50/60 Hz electric and magnetic fields. The diagram below shows the divisions of the electromagnetic spectrum that are commonly accepted and will be used in this guide. Microwave (MW) frequency radiation is commonly used to denote a subset of RF radiation, typically at frequencies from 300 MHz to 300 GHz. 

RF and MW radiation are forms of non-ionising radiation where individual photons are not energetic enough to break chemical bonds or remove electrons (ionisation). Ultraviolet, visible and infrared light are other forms of non-ionising radiation.

 

Figure 1:  Electromagnetic spectrum with frequencies of some RF applications shown

Reference Documents

• Radiation Protection Standard for Limiting Exposure to Radiofrequency Fields – 100 kHz to 300 GHz (2021), ARPANSA Radiation Protection Series S-1 (RPS S-1). 
  
  The ARPANSA RF Standard sets limits for human exposure to RF EMR in the frequency range 100 kHz to 300 GHz. The Standard also includes requirements for management of risk in occupational exposure and measures for protection of the general public together with additional information on measurement and assessment of compliance. Extracts from this document can be found in Appendix 2.
   
• ICNIRP Guidelines for Limiting Exposure to Time-Varying Electric and Magnetic Fields 1Hz-100 kHz (2010), Health Physics 99(6):818-836. 
  
  The International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines are aimed at preventing the established health effects resulting from exposure to ELF EMF. The ICNIRP ELF guidelines are consistent with ARPANSA’s understanding of the scientific basis for the protection of the general public and workers from exposure to ELF EMF. Extracts from this document can be found in Appendix 3.

Definitions 

Exposure limits – E_limit: are defined in terms of basic restrictions for occupational and general public exposure as specified in RPS S-1 and the ICNIRP Guidelines. Different exposure limits apply for occupational exposure and exposure to the general public.

Controlled apparatus (non-ionising) as defined in the Act: an apparatus prescribed by the regulations that produces harmful non-ionising radiation when energised.

Procedure for determining controlled apparatus

This procedure (as illustrated by the flow chart below) will assist you to determine whether your apparatus is controlled or not.  

This procedure (as shown in the flow chart below) will assist you to determine whether your apparatus is controlled or not.  

1. A prescribed apparatus that produces non-ionizing radiation that could lead to a person being exposed to radiation levels exceeding the non-ionizing radiation exposure limits. For example, if the apparatus is one of the devices stated in Section 1 Controlled apparatus. 

2. If there is a reasonably foreseeable abnormal event that could lead to a person being exposed to radiation levels in excess of the maximum exposure level, as specified in RPS S-1 or the ICNIRP Guidelines and reproduced in Appendix 2 and Appendix 3, the apparatus is classed as controlled apparatus. Examples of reasonably foreseeable abnormal events are possible exposure during normal maintenance, easy overriding of an interlock, entry into exclusion zones etc.   

3. If there is a reasonably foreseeable single element failure of the apparatus that would lead to a person being exposed to levels above the maximum exposure level, then the apparatus is classed as controlled apparatus. An example of this is a malfunctioning interlock. 

4. If the apparatus is enclosed the possibility of removal of the access panels or protective barriers has to be assessed. If there is no enclosure, choose no, and go to the next step. If a person can be exposed to levels above the maximum exposure level when removing protective barriers or access panels that do not require the use of tools or other specialized equipment, the apparatus is classed as controlled apparatus. 

5. Estimate the exposure level that a person could receive in the course of intended operations and procedures, EL_op. The distance to the unit during intended operations should be estimated and the expected exposure level calculated or measured. The attenuation provided by any fixed shields should be taken into account. 

Compare with the exposure limits (Elimit) as specified in RPS S-1 or ICNIRP Guidelines.  

If     EL_op > E_limit    then the apparatus is classed as controlled apparatus

If     EL_op < E_limit     then the apparatus is not classed as controlled apparatus

 

Appendix 1: Examples of RF emitting apparatus 

1. Induction heater 

Definition: A heater that uses an induced electric current to produce heat.

Description: In an induction heater a conducting material is heated by induction of an electric current in the object to be heated. The resistance of the metal leads to heating. An induction heater consists of an electromagnet through which a high-frequency alternating current is passed. Heat can also be generated by magnetic hysteresis losses.  

Induction heating provides a controllable and localized method of heating without contact between the heater and the components. Typical uses for induction heaters are heat treatment of metals, hardening of steel, annealing, bonding, curing and forging. A typical induction heater is shown below in Figure 2 and induction heating of a metal bar is shown in Figure 3.

 

Figure 2: Induction heater

 

Figure 3: Induction heating of a metal bar

[Source: Remarkable Machines Affordable Price | Superior Induction Company]

Operating frequencies range from 50/60 Hz to over 1 MHz. Induction welders and induction solders are types of induction heaters and are included in the above category. 

2. Induction furnace

Definition: A furnace that uses an induced electric current to heat a metal to its melting point.

Description: An induction furnace uses induction to heat a metal to its melting point. The heating mechanism is the same as in the induction heater. Common metals that are melted are iron, steel, copper, aluminium and precious metals. Melting and mixing rates can be controlled by selecting and varying the frequency and power. A picture of an induction furnace is shown in Figure 4. 

 

Figure 4: Induction furnace

[Source: Induction Furnace by Amritsar Machine Tools from Faridabad Haryana | ID - 106212 (exportersindia.com)]

3. Industrial radiofrequency heater 

Definition: A heating device in which heat is generated through a radiofrequency field. Industrial signifies that the apparatus is not used for domestic applications. 

Description: The frequency of operation of RF heaters is in the range 10 MHz – 100 MHz, with output powers up to 100 kW. Common frequencies are 13.56 MHz, 27.12 MHz and 40.68 MHz. These frequencies have been designated to prevent interference with communications equipment.

RF heaters are used to heat, melt, dry or cure dielectric materials (insulators or poor conductors that can be polarized by an applied electric field). Plastic, glue and rubber are electrical and thermal insulators and consequently difficult to heat using conventional methods. These materials are well suited for heating with an RF heater. This is in contrast to induction heaters (defined in the previous section) which operate at lower frequencies and are used to heat materials which are good conductors of electricity. RF heaters can be used in industrial drying processes and are then often called RF dryers.

4. Industrial radiofrequency welder 

Definition: A heating device in which heat is generated through a radiofrequency field and the heat is used to weld the material. Industrial signifies that the apparatus is not used for domestic applications. 

Description: The heating mechanism is the same in an RF welder as in an RF heater. The material (often plastic) is heated to its melting point and the work pieces are joined together. RF welders are sometimes called RF sealers. An example of a RF welder is shown in Figure 5. 

 

Figure 5: Industrial RF welder 

[Source: RF Sealers with Bar Welders | Custom Automation | Cosmos and Kabar (cosmos-kabar.com)]

5. Radiofrequency plasma tube

Definition: A tube containing plasma which is created by a radiofrequency field.  

Description: An RF generator is attached to the RF tube and is used to generate the plasma. The tube typically contains a gas or a mixture of gases. As the gas is ionized, free electrons are accelerated in the field and collide with the atoms thereby exciting the atoms. As the atoms are de-excited photons are emitted resulting in visible or ultraviolet emission. A picture of an RF plasma tube is shown in Figure 6. Common frequencies are 13.56 MHz and 2.45 GHz.

 

Figure 6: A radiofrequency plasma tube 

[Source: Gas Plasma Tube For High Power RF (plasmasonics.com)]

6. Microwave or Radiofrequency (RF) diathermy equipment

Definition: Microwave diathermy equipment uses electromagnetic energy in the microwave frequency range (300 MHz to 300 GHz) for therapeutic purposes.

Whilst, RF diathermy equipment uses electromagnetic energy in the frequency range (3-30 MHz) for therapeutic purposes.

In Australia the only approved frequency for microwave diathermy treatment is 2450 MHz.  

RF diathermy is sometimes referred to as shortwave diathermy. In Australia the only approved frequency for RF diathermy is 27.12 MHz. A picture of a diathermy unit is shown in Figure 7.

 

Figure 7: Diathermy unit

[Source: China Microwave Diathermy, Microwave Diathermy Wholesale, Manufacturers, Price | Made-in-China.com]

Note: Microwave and RF diathermy are not used very much nowadays and very few licence holders have this apparatus. In both microwave diathermy and RF diathermy heating of muscular tissue is performed for therapeutic reasons. In surgical diathermy a high-frequency electric current is made to pass through the body between two contact electrodes. The frequency is lower than for RF diathermy, typically 0.5–3 MHz. Surgical diathermy is not included in the above definition for microwave and radiofrequency diathermy equipment.

7. Industrial microwave processing system

Definition: A system where energy in the form of microwaves is used for heating or drying. Industrial signifies that the apparatus is not used for domestic applications.  

Common microwave frequencies are 915 MHz, 2.45 GHz and 5.8 GHz. An industrial microwave is considered an industrial microwave processing system.

 

Figure 8: Industrial microwave processing system

[Source: Continuous Microwave Ovens | Cellencor]

8. Industrial radiofrequency processing system

Definition: A system where energy in the form of radiofrequency waves is used for heating or drying. Industrial signifies that the apparatus is not used for domestic applications.  

The most common RF frequencies are 13.56 MHz, 27.12 MHz and 40.68 MHz. Note that the definition for an industrial RF processing system is similar to the definition for an industrial RF heater. Typically an industrial RF processing system is a large enclosed unit used for large scale heating or drying (see Figure 9).

Radiofrequency and microwave processing systems are frequently used for heating and drying of materials such as paper, ceramics, food and plastics. Heating through RF and microwave is fast compared with conventional heating mechanisms which makes them a preferred option for pasteurization and sterilization. Microwave heating is a common choice in a laboratory environment. The heating mechanism is the same in RF heating, the only difference being the lower frequency. The selection of RF or microwave heating depends on the physical properties of the process. The penetration depth is greater for RF (longer wavelength) which can therefore be more suited for larger scale systems. RF systems also have a greater uniformity of heating.

 

Figure 9: Industrial RF processing system used for drying products

[Source: General Industry - Radio Frequency Co. - Industrial]

Appendix 2: Extracts from RPS S-1 Limiting Exposure to RF Fields – 100 kHz to 300 GHz (2021)

General information

The standard includes:

• mandatory basic restrictions for both occupational and general public exposure involving the whole body and also for exposure over localised areas of the body
• indicative reference levels for measurable quantities derived from the basic restrictions
• approaches for verification of compliance with the standard
• requirements for management of risk in occupational exposure and measures for protection of the general public 

Basic Restrictions:

Mandatory limits on exposure to RF fields are based on established health effects and are termed ‘basic restrictions’. Depending on the frequency the physical quantities used to specify the basic restrictions are induced electric field (Eind), specific absorption rate (SAR), specific energy absorption (SA) and absorbed energy density (Uab). These quantities are often impractical to measure. Therefore reference levels are measured as an alternative means of showing compliance with the mandatory basic restrictions.

Reference Levels:

Reference levels using quantities that are more practical to measure have been developed. The reference levels have been conservatively formulated such that compliance with the reference levels will ensure compliance with the basic restrictions. Provided that all basic restrictions are met and adverse effects can be excluded, the reference levels may be exceeded. Hence the reference levels have been conservatively formulated such that compliance with the reference levels will ensure compliance with the basic restrictions. The relevant reference level quantities are incident electric field strength (Einc), incident magnetic field strength (Hinc), incident power density (Sinc), plane-wave equivalent incident power density (Seq), incident energy density (Uinc), and plane-wave equivalent incident energy density (Ueq), all measured outside the body, and electric current (I) inside the body.

Reference levels are given for occupational exposure and exposure to the general public. These groups are distinguished by their potential level of exposure. 

In the extract from RPS S-1 below, reference levels are specified in Tables 4 - 7 and have been set to protect against effects associated with:

• Table 4 whole body exposure (averaged over 30 minutes) 
• Table 5 local exposure (averaged over 6 minutes)
• Table 6 brief local exposure (integrated over intervals between >0 and <6 minutes)
• Table 7 instantaneous local exposure (peak instantaneous field strength) 

For further information see Radiation Protection Series S-1.

Table 4: Reference levels for whole body exposure averaged over 30 minutes to RF electromagnetic fields from 100 kHz to 300 GHz (unperturbed rms fields)

Exposure Scenario	Frequency range	Incident E-field strength Einc (V/m)	Incident H-field strength Hinc (A/m)	Incident power density Sinc (W/m2)
Occupational	0.1-6.943MHz	ES	4.9/fM	NA
	>6.943-30 MHz	660/fM0.7	4.9/fM	NA
	>30-400 MHz	61	0.16	10
	400–2000MHz	3fM 0.5	0.008fM 0.5	fM /40
	2–300 GHz	NA	NA	50
General Public	0.1-6.27MHz	ES	2.2/fM	NA
	6.27-30 MHz	300/fM 0.7	2.2/fM	NA
	>30-400 MHz	27.7	0.073	2
	>400-2000 MHz	1.375fM 0.5	0.0037fM 0.5	fM/200
	>2–300 GHz	NA	NA	10

Notes:

1. ‘NA’ signifies ‘not applicable’ and does not need to be taken into account when determining compliance. 
2. ‘ES’ signifies that no reference level is available, as it would be greater than the reference level for spatial peak and temporal peak field strengths based on electrostimulation effects shown in Table 7. 
3. f_M is frequency in MHz. 
4. S_inc, E_inc and H_inc are to be averaged over 30 minutes, over the whole-body space. Temporal and spatial averaging of each of E_inc and H_inc must be conducted by averaging over the relevant square values (see ICNIRP guidelines for limiting exposure to electromagnetic fields (100 kHz to 300 GHz), Health Physics, 118(5):483–524 for details) see International best practice - non-ionising radiation safety | ARPANSA.
5. For frequencies of 100 kHz to 30 MHz, regardless of the far-field/near-field zone distinctions, compliance is demonstrated if neither E_inc nor H_inc exceeds the above reference level values. 
6. For frequencies of >30 MHz to 2 GHz: a) within the far-field and radiating near field zones: compliance is demonstrated if either S_inc, E_inc or H_inc, does not exceed the above reference level values (only one is required); S_eq derived from either E_inc or H_inc may be substituted for S_inc; b) within the reactive near-field zone: compliance is demonstrated if both E_inc and H_inc do not exceed the above reference level values; S_inc cannot be used to demonstrate compliance, and so basic restrictions must be assessed. 
7. For frequencies of >2 GHz to 300 GHz: a) within the far-field and radiating near field zones: compliance is demonstrated if S_inc does not exceed the above reference level values; S_eq derived from either E_inc or H_inc may be substituted for S_inc; b) within the reactive near-field zone, reference levels cannot be used to determine compliance, and so basic restrictions must be assessed. 

Table 5: Reference levels for local exposure averaged over 6 minutes, to electromagnetic fields from 100 kHz to 300 GHz (unperturbed rms fields)

Exposure Scenario	Frequency range	Incident E-field strength Einc (V/m)	Incident H-field strength Hinc (A/m)	Incident power density Sinc (W/m2)
Occupational	0.1-0.135 MHz	ES	ES	NA
	>0.135-10 MHz	ES	10.8/fM	NA
	>10-30 MHz	1504/fM0.7	10.8/fM	NA
	>30-400 MHz	139	0.36	50
	>400-2000 MHz	10.58fM0.43	0.0274fM0.43	0.29fM0.86
	>2-6 GHz	NA	NA	200
	>6-<300 GHz	NA	NA	275/fG0.177
	300 GHz	NA	NA	100
General Public	0.1-0.233 MHz	ES	ES	NA
	>0.233-10 MHz	ES	4.9/fM	NA
	>10-30 MHz	671/fM 0.7	4.9/fM	NA
	>30-400 MHz	62	0.163	10
	>400-2000 MHz	4.72fM 0.43	0.0123fM 0.43	0.058fM 0.86
	>2-6 GHz	NA	NA	40
	>6-<300 GHz	NA	NA	55/fG 0.177
	300 GHz	NA	NA	20

Notes:

1. ‘NA’ signifies ‘not applicable’ and does not need to be taken into account when determining compliance. 
2. ‘ES’ signifies that no reference level is available, as it would be greater than the reference level for spatial peak and temporal peak field strengths based on electrostimulation effects shown in Table 7. 
3. f_M is frequency in MHz; f_G is frequency in GHz. 
4. S_inc, E_inc and H_inc are to be averaged over 6 minutes, and where spatial averaging is specified in Notes 6-7, over the relevant projected body space. Temporal and spatial averaging of each of E_inc and H_inc must be conducted by averaging over the relevant square values (see ICNIRP guidelines for limiting exposure to electromagnetic fields (100 kHz to 300 GHz), Health Physics, 118(5):483–524 for details) see link International best practice - non-ionising radiation safety | ARPANSA to the ICNIRP website.
5. For frequencies of 100 kHz to 30 MHz, regardless of the far-field/near-field zone distinctions, compliance is demonstrated if neither peak spatial E_inc nor peak spatial H_inc, over the projected whole-body space, exceeds the above reference level values. 
6. For frequencies of >30 MHz to 6 GHz: a) within the far-field and radiating near field zones, compliance is demonstrated if one of peak spatial S_inc, E_inc or H_inc, over the projected whole-body space, does not exceed the above reference level values (only one is required); S_eq derived from either E_inc or H_inc may be substituted for S_inc; b) within the reactive near-field zone: compliance is demonstrated if both E_inc and H_inc do not exceed the above reference level values; S_inc cannot be used to demonstrate compliance; for frequencies >2 GHz, reference levels cannot be used to determine compliance, and so basic restrictions must be assessed.
7. For frequencies of >6 GHz to 300 GHz: a) within the far-field and radiating near field zones, compliance is demonstrated if S_inc, averaged over a square 4 cm² projected body surface space, does not exceed the above reference level values; S_eq derived from either Einc or H_inc may be substituted for S_inc; b) within the reactive near-field zone, reference levels cannot be used to determine compliance, and so basic restrictions must be assessed. 
8. For frequencies of >30 GHz to 300 GHz, exposure averaged over a square 1-cm² projected body surface space must not exceed twice that of the square 4 cm² S_inc restrictions.

Table 6: Reference levels for local exposure, integrated over intervals of between >0 and <6 minutes to RF electromagnetic fields from 100 kHz to 300 GHz (unperturbed rms fields)

Exposure Scenario	Frequency range	Incident energy density Uinc (kJ/m2)
Occupational	100 kHz – 400 MHz	NA
	>400 – 2000 MHz	0.29fM0.86 x 0.36(0.05+0.95[t/360]0.5)
	>2 – 6 GHz	200 x 0.36(0.05+0.95[t/360]0.5)
	>6 – <300 GHz	275/fG0.177 x 0.36(0.05+0.95[t/360]0.5)
	300 GHz	100 x 0.36(0.05+0.95[t/360]0.5)
General Public	100 kHz – 400 MHz	NA
	>400 – 2000 MHz	0.058fM0.86 x 0.36(0.05+0.95[t/360]0.5)
	>2 – 6 GHz	40 x 0.36(0.05+0.95[t/360]0.5)
	>6 – <300 GHz	55/fG0.177 x 0.36(0.05+0.95[t/360]0.5)
	300 GHz	20 x 0.36(0.05+0.95[t/360]0.5)

Notes:

1. ‘NA’ signifies ‘not applicable’ and does not need to be taken into account when determining compliance. 
2. f_M is frequency in MHz; f_G is frequency in GHz; t is the exposure time interval in seconds, such that exposure from any pulse, group of pulses, or subgroup of pulses in a train, as well as from the summation of exposures (including non-pulsed RF electromagnetic fields), delivered in t seconds, must not exceed these reference level values for any time 0 < t < 360 s. 
3. U_inc is to be calculated over time t, and where spatial averaging is specified in Notes 5-7, over the relevant projected body space. 
4. For frequencies of 100 kHz to 400 MHz, >0 to <6-minute restrictions are not required and so reference levels have not been set. 
5. For frequencies of >400 MHz to 6 GHz: a) within the far-field and radiating near field zones: compliance is demonstrated if peak spatial U_inc, over the projected whole-body space, does not exceed the above reference level values; U_eq derived from either E_inc or H_inc may be substituted for U_inc; b) within the reactive near-field zone, reference levels cannot be used to determine compliance, and so basic restrictions must be assessed. 
6. For frequencies of >6 GHz to 300 GHz: a) within the far-field or radiative near-field zone, compliance is demonstrated if U_inc, averaged over a square 4 cm² projected body surface space, does not exceed the above reference level values; U_eq derived from either E_inc or H_inc may be substituted for U_inc; b) within the reactive near-field zone, reference levels cannot be used to determine compliance, and so basic restrictions must be assessed. 
7. For frequencies of >30 GHz to 300 GHz: exposure averaged over a square 1cm² projected body surface space must not exceed 275/f_G^0.177 x 0.72(0.025+0.975[t/360]^0.5) kJ/m² for occupational and 55/f_G^0.177 x 0.72(0.025+0.975[t/360]^0.5) kJ/m² for general public exposure.

Table 7: Reference levels for spatial peak and temporal peak field strength to RF electromagnetic fields from 100 kHz to 300 GHz (unperturbed rms fields)

Exposure Scenario	Frequency range	Incident E-field strength Einc (V/m)	Incident H-field strength Hinc (A/m)
Occupational	100 kHz – 10 MHz	170	80
General Public	100 kHz – 10 MHz	83	21

Notes: 

1. Regardless of the far-field/near-field zone distinction, compliance is demonstrated if neither the temporal nor spatial peak E_inc or H_inc, over the space occupied by the body, exceeds the above reference level values. 

The figures for occupational and general public reference levels for whole body and local exposure to RF electromagnetic fields as specified in tables 4 and 5 can be found in RPS S-1 Schedule 1.

Reference levels for limb currents

Limb current reference levels have been set to account for effects of grounding near human body resonance frequencies that might otherwise lead to reference levels underestimating exposures within tissue at certain RF electromagnetic field frequencies (averaged over 6 minutes – see Table 8) Limb current reference levels are only relevant in exposure scenarios where a person is not electrically isolated from a ground plane.

Table 8: Reference levels for current induced in any limb averaged over 6 minutes at frequencies between 100 kHz and 110 MHz

Exposure Scenario	Frequency range	Current I (mA)
Occupational	10 MHz – 110 MHz	100
General Public	10 MHz – 110 MHz	45

Notes: 

1. Current intensity values must be determined by averaging over the relevant square values (see ICNIRP guidelines for limiting exposure to electromagnetic fields (100 kHz to 300 GHz), Health Physics, 118(5):483–524 for details), the document can be downloaded from the ARPANSA website link International best practice - non-ionising radiation safety | ARPANSA to the ICNIRP website.
2. Limb current intensity must be evaluated separately for each limb. 
3. Limb current reference levels are not provided for any other frequency range. 
4. Limb current reference levels are only required for cases where the human body is not electrically isolated from a ground plane. 

Tables 4 to 8 specify averaging and integrating times of the relevant exposure quantities to determine whether personal exposure level is compliant with the Standard. These averaging and integrating times are continuous periods.

Guidance for contact currents

Exposure due to contact currents is indirect, in that it requires an intermediate conducting object to transduce the field. This makes contact current exposure unpredictable, due to both behavioural factors (e.g., grasping versus touch contact) and environmental conditions (e.g., configuration of conductive objects), and reduces this Standard’s ability to protect against them. Accordingly, the ICNIRP guidelines and the Standard do not provide restrictions for contact currents, and instead provide ‘guidance’ to assist those responsible for transmitting high-power RF fields to understand contact currents, the potential hazards, and how to mitigate such hazards. 

In determining the likelihood and nature of the hazard due to potential contact current scenarios, ICNIRP views the following as important for the Responsible Person in managing risk associated with contact currents within the 100 kHz to 110 MHz region. 

(a) Contact current thresholds for reversible, mild pain, for adults and children, are likely to be approximately 20 mA and 10 mA respectively. 

(b) Contact current magnitude will increase as a function of field strength and is affected by conducting-object configuration such as the proximity to the original source and the angular alignment to the original source. 

(c) Risk of contact current hazards can be minimized by training workers to avoid contact with conducting objects, but where contact is required, the following factors are important: 

i.    Large conducting objects should be connected to ground (grounding). 

ii.    Workers should make contact via insulating materials or PPE (e.g., RF protective gloves). 

iii.    Reducing or removing the RF power at the original source can eliminate the risk. 

iv.    Workers should be made aware of the risks, including the possibility of ‘surprise’, which may impact on safety in ways other than the direct impact of the current on tissue (for example, by causing accidents when working at heights).

Appendix 3: Extracts from the ICNIRP Guidelines for Limiting Exposure to Time-Varying Electric and Magnetic Fields 1Hz-100 kHz (2010)

General information

This publication establishes guidelines for limiting exposure to electric and magnetic fields in the low frequency range of the electromagnetic spectrum. Separate guidance is given for occupational and general public exposures.

Reference Levels

A summary of the reference levels recommended for occupational and general public exposures to electric and a magnetic field is given in Tables 3 and 4.

Table 3: Reference levels for occupational exposure to time-varying electric and magnetic fields (unperturbed rms fields)

Frequency range	E-field strength E (kV/m-1)	Magnetic-field strength H (A m-1)	Magnetic flux density B (T)
1 Hz-8 Hz	20	1.63x105/f2	0.2/f2
8 Hz-25 Hz	20	2x104/f	2.5x10-2/f
25 Hz-300 Hz	5x102/f	8x102	1x10-3
300 Hz-3 kHz	5x102/f	2.4x105/f	0.3/f
3 kHz-10 MHz	1.7x10-1	80	1x10-4

Notes:

• f in Hz
• Refer ICNIRP Guidelines separate sections for advice on non-sinusoidal and multiple frequency exposure
• To prevent indirect effects especially in high electric fields, see section on “Protective measures” in the ICNIRP Guidelines
• In the frequency range above 100 kHz, RF specific reference levels need to be considered additionally.

Table 4: Reference levels for general public exposure to time-varying electric and magnetic fields (unperturbed rms values)

Frequency range	E-field strength E (kV/m-1)	Magnetic-field strength H (A m-1)	Magnetic flux density B (T)
1 Hz-8 Hz	5	3.2x104/f2	4x10-2/f2
8 Hz-25 Hz	5	4x103/f	5x10-3/f
25 Hz-50 Hz	5	1.6x102	2x10-4
50 Hz-400 Hz	2.5x102/f	1.6x102	2x10-4
400 Hz-3 kHz	2.5x102/f	6.4x104/f	8x10-2/f
3 kHz-10 MHz	8.3x10-2	21	2.7x10-5

Notes:

• f in Hz
• Refer ICNIRP Guidelines separate sections for advice on non-sinusoidal and multiple frequency exposure
• In the frequency range above 100 kHz, RF specific reference levels need to be considered additionally

For further information on the ICNIRP Guidelines for Limiting Exposure to Time-Varying Electric and Magnetic Fields 1Hz-100 kHz see International best practice - non-ionising radiation safety | ARPANSA.

Introduction

This document is provided to assist applicants and licence holders assess UV emitting apparatus. It may also be useful for non-licence holders to gain an understanding of the hazard of some typical UV emitting apparatus. It contains case studies of apparatus that have been assessed by ARPANSA. 

Read this guide in conjunction with Regulatory Guide: Determining whether a UV source is a controlled apparatus.

If you have any questions on how to evaluate your specific apparatus please contact your regulatory officer or send an email to: licenceadmin@arpansa.gov.au.

Note: Subsection 44(7) of the Regulations exempts dealings with the following UV emitting apparatus:

• an artificial optical source emitting ultraviolet A radiation (315 – 400 nm)
• a completely enclosed apparatus containing an ultraviolet radiation light source (e.g., a spectrophotometer)
• a biological safety cabinet (laminar flow or biohazard) with a failsafe interlocking system
   

Contents

Apparatus	Outcome
1. Biological safety cabinet – Example 1	Controlled apparatus
2. Biological safety cabinet – Example 2	Not controlled apparatus
3. High-performance liquid chromatography (HPLC)	Not controlled apparatus
4. Pen-ray Mercury lamp	Controlled apparatus
5. Spectrophotometer	Not controlled apparatus
6. Transilluminator	Controlled apparatus
7. UV light box	Controlled apparatus
8. Water steriliser – Example 1	Controlled apparatus
9. Water steriliser – Example 2	Not controlled apparatus

1. Biological safety cabinet – Example 1

 

Details of the apparatus 

• The biological safety cabinet emits at a wavelength of 254 nm, which is in the UVC region (180 – 280 nm). It is a germicidal lamp which means that the emission levels will be well above the exposure limits. 
• The lower access panel can be taken off while the UV lamp is energized.
• There is no interlock or the interlock can be overridden.

Assessment

During intended operations or procedures the exposure limits will not be exceeded, as the window and access panel will protect the user. The UV light is only used between procedures for disinfecting. It should not be used while samples are being handled.  

It is reasonably foreseeable that a person could remove the access panel while the UV light is on and receive an exposure. 

This biological safety cabinet is classed as controlled apparatus

2. Biological safety cabinet – Example 2

 

Details of the apparatus 

• The biological safety cabinet emits UV light at 254 nm (UVC). It is a germicidal lamp which means that the emission levels will be well above the exposure limits.
• The fluorescent lamps and UV light cannot work simultaneously as they are electronically interlocked.
• While the unit is in UV mode the sliding window cannot be opened.
• UV light cannot be turned on while the sliding door is open. 
• If a fault occurred and the window could be opened electronically or manually, an interlock will cut the UV emission. The interlock is failsafe (meaning that if it should fail the UV emission will terminate) and hard to override.

Assessment

During intended operations or procedures the exposure limits will not be exceeded. 

Due to the robust failsafe, interlock there is no reasonably foreseeable abnormal event that would expose a person to levels above the exposure limits. 

As the interlock is failsafe there is no reasonably foreseeable single element failure that would expose a person to levels above the exposure limits. 

This biological safety cabinet is not classed as controlled apparatus 

Comment 

This assessment is based on the above criteria for a biological safety cabinet. Most standard older biological safety (laminar flow/biohazard) cabinets containing a UV source are classed as controlled apparatus. Please contact an ARPANSA regulatory officer to discuss if you have a biological safety cabinet that you believe is not classed as controlled apparatus on the same grounds as in the example above.

3. High-performance liquid chromatography (HPLC)

 

Details of the apparatus 

• The UV light source is completely enclosed
• Low UV emission

Assessment

During intended operations or procedures the exposure limits will not be exceeded. 

It is not reasonably foreseeable that a person could access the UV source and receive exposures above the exposure limit. 

A person cannot remove access panels without use of tools or specialised equipment. 

The apparatus is not classed as controlled apparatus

Comment

If a unit is a standard HPLC with properties similar to the one above it is automatically classed as not controlled. There is no need to assess it against the regulatory guide.

4. Pen-Ray Mercury lamp

 

Source: http://uvp.com/mercury.html

Details of the apparatus

• UV lamp used in a number of applications in laboratories (sterilisation, fluorescent inspection, wavelength calibration etc.)  
• Lamp emits Mercury spectral lines with the primary emission at 254nm.
• Typical intensity:
  • 254 nm @ 20 mm distance = 4700 µW/cm² = 47 W/m² (UVC)
  • 365 nm @ 20 mm distance = 215 µW/cm² = 2.15 W/m² (UVA)

Assessment

Skin and Eye UVR exposure:

Calculate the effective irradiance according to RPS 12:

At 20 mm:

 

 

       
At 20 cm: 

 

It is reasonably foreseeable that someone would be exposed for more than 2 minutes at 20 cm distance or more than 1.3 seconds at 20 mm distance. This means that the UVR exposure limit could be exceeded.

Eye UVA (315 – 400 nm) exposure:

At 20 mm: E_365nm=  2.15 W/m²

 

 

At 50 cm:  

 

 

 

The exposure limit at 50 cm  

 

Maximum UVA exposure for the eyes will not be exceeded. The exposure to the skin will be the limiting factor.  

It is reasonably foreseeable that a person could be exposed to levels above the exposure limit.

The apparatus is classed as controlled apparatus

5. Spectrophotometer

 

Details of the apparatus 

• The UV light source is enclosed during operation
• Low UV emission

Assessment

During intended operations or procedures the exposure limits will not be exceeded. 

It is not reasonably foreseeable that a person could access the UV source and receive exposures above the exposure limit. 

The apparatus is not classed as controlled apparatus

Comment

If a unit is a standard spectrophotometer with properties similar to the one above it is automatically classed as not controlled. There is no need to assess it against the regulatory guide.

6. Transilluminator

 

 

Details of the apparatus 

• The emission of transilluminators is typically 254 nm, 312 nm or 366 nm.
• Transilluminators are powerful sources of UV radiation. Emission levels are above exposure limits. Transilluminators, used in research can be a significant source of occupational exposure to UVR. Hands, arms, face and eyes are likely sites of injury. Working unprotected for even a few minutes can cause injury.

Assessment

Reasonably foreseeable abnormal events where exposure limits could be exceeded are:

• shielding is removed or non-existent
• PPE is not worn or is not appropriate

Both transilluminators are classed as controlled apparatus

Comment 

There have been a number of incidents where the user of a transilluminator developed erythema because appropriate PPE was not used and a shield was not present.   

7. UV light box

 

 

Details of the apparatus 

• Homemade units 
• Manual switches turns UV source on and off
• Intensity levels unknown
• There is no interlock or fixed shielding

Assessment

It is reasonably foreseeable that someone might place their hand in the box while the UV source in on. If the levels are high enough the exposure levels could be exceeded. 

The apparatus is classed as controlled apparatus 

Comment 

If emission levels are measured and found to be low (no reasonably foreseeable abnormal event where a person would be exposed to levels above the exposure limit) the apparatus is not controlled.

8. Water steriliser – Example 1

 

Details of the apparatus 

• Water steriliser where UV lamp is used to kill bacteria as the water flows past. 
• Germicidal action which means that emission levels are high (primarily UVC – 254 nm). 
• UV light is leaking out from the back of the unit. The unit is completely enclosed apart from this opening. The emission levels of the escaping UV light have not been quantified. 
• The enclosure is interlocked. 

Assessment

We can assume that the intensity of the escaping light is low so that during intended operations or procedures the exposure limits will not be exceeded (a person will not normally be close to the unit). 
It is reasonably foreseeable that a person could hold their hand close to the unit and be exposed to the escaping light. As we do not know the intensity of the escaping light we make the conservative assumption that the exposure limit can be exceeded. 

The apparatus is classed as controlled apparatus

9. Water steriliser – Example 2

 

Details of the apparatus 

• Water steriliser where UV lamp is used to kill bacteria as the water flows past. 
• The emission of the UV light is at 254 nm (UVC). Germicidal action which means that emission levels are high. 
• The unit is fully enclosed and the housing is not interlocked.  
• A screwdriver is needed to open the housing. 

Assessment

During intended operations or procedures the exposure limits will not be exceeded as the source is completely enclosed.

A reasonably foreseeable abnormal event that would expose a person to levels above the exposure limit could be exposure during maintenance when the UV lamp is replaced. The standard operating procedure for changing the lamp illustrates that the lamp is completely enclosed in a special housing, and that the power has to be switched off before you can access the UV lamp. From this it is concluded that there is no risk of exposure during the process of changing the lamp. 

Excess levels of radiation are not accessible under a reasonable foreseeable single element failure of the apparatus and the source cannot be accessed without the use of tools or specialised equipment. 

The apparatus is not classed as controlled apparatus

Selecting the correct application form

Submissions should be competed via the Regulatory Administration Database RAD Portal (rad.arpansa.gov.au). The Portal will automatically populate the form with the relevant questions, depending on the selections made. 

Alternatively, there are 3 source licence application forms - the choice of form depends on the hazard of the source(s): Group 1 sources are considered low hazard, Group 2 sources are considered medium hazard and Group 3 sources are considered high hazard. Section 4 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations) describes the types of sources in each group and this will assist you to select the correct application form. 

Associated forms

• Licence application form – low hazard source
• Licence application form – medium hazard source
• Licence application form – high hazard source

Completing the application form

Section A: Applicant Information

Department or Commonwealth entity

This is the name of the Department or entity on behalf of which the application is being made. It may include further information for ease of identification, e.g. Division, Branch, Section. The licence holder should provide their ABN or name listed on the Commonwealth entities and companies Directory.

Portfolio

Name of the Commonwealth ministerial portfolio in which the Department or entity resides.

Applicant

The application must be made by the chief executive of the Department or entity, or by a person authorised by the chief executive.

The applicant must provide their full name and position. If it is made by an authorised person, the application must include a copy of the authorisation.

The Applicant may be the responsible person. The Responsible Person in relation to any radiation source, prescribed radiation facility or premises on which radiation sources are stored or used means the legal person: (a) having overall management responsibility including responsibility for the security and maintenance of the radiation source, facility or premises (b) having overall control over who may use the radiation source, facility or premises (c) in whose name the radiation source, facility or premises would be registered if this is required. RPS C-1 Code for Radiation Protection in Planned Exposure Situations.

Nominee

If the applicant is physically removed from the source dealing, such that they cannot demonstrate effective control, the name and contact details of a person more directly in control of the source dealing must be provided. This nominee must be in effective control of the sources. Generally, the nominee will be the manager of a division or agency’s operation at the site of the proposed activity or, in the case of mobile or portable devices, where the devices are usually stored. Another nominee may be acceptable where the hazards of the activity are low and only minimal control is required. If a nominee is appointed, an organisational chart should be provided showing the relationship of the nominee to the applicant and end users.

Radiation Safety Officer (RSO)

This is an individual appointed by the applicant to supervise radiation safety in relation to the sources for which the licence is sought. This person must be technically competent in radiation protection matters relevant to all sources, including non-ionising radiation sources if these are part of the application. Evidence of competency should be included. If there is more than one radiation safety officer, the details of other radiation safety officers should also be provided.

Note 2: An RSO may not always be required. Applicants should refer to the Regulatory Guide: Plans and Arrangements for Managing Safety, or contact ARPANSA. 

Declaration

The declaration must be signed by the applicant or authorised person.

Section B: Description of the source and proposed dealing  

Indicate the kind of controlled apparatus and/or controlled material in the table provided. If there is any doubt about the hazard category or description of a source the applicant should seek advice from Regulatory Services on (02) 9541 8333. 

Describe the source, the proposed dealing, and provide the full site address where the sources will be used or stored.

Section C: Source details

Section 47 of the Regulations sets out the information that must be provided about the sources to be dealt with under the licence. This must include the information shown in the table below. 

A dealing with a sealed source	(a) the nuclide, activity, chemical form, encapsulation material and physical form of the sealed source (b) the purpose and identification details of the sealed source (c) the place where the sealed source is to be located (d) a copy of any sealed source certificate for the sealed source
A dealing with an unsealed source	(a) the nuclide, chemical form and physical form of the unsealed source (b) the purpose and identification details of the unsealed source (c) the maximum activity of each nuclide to be held on particular premises at any one time (d) the place where the unsealed source is to be located
A dealing with a controlled apparatus that produces ionizing radiation	(a) the purpose and identification details of the controlled apparatus (b) the maximum kilovoltage (c) the place where the controlled apparatus is used
A dealing with a controlled apparatus that produces non‑ionizing radiation	(a) the purpose and identification details of the controlled apparatus (b) the likely exposure levels including the nature of the radiation (c) all output parameters relevant to the likely exposure conditions (d) the place where the controlled apparatus is used

The details of the sources (serial numbers, etc.) should be recorded in the RAD Portal or via a form approved by the CEO of ARPANSA. Once the licence application has been approved, the source inventory should be maintained via the RAD Portal.

Section D: Plans & arrangements for managing safety 

The applicant must have plans and arrangements for managing sources to ensure the health and safety of people and protection of the environment. These should be a comprehensive program of policies and procedures that demonstrate how radiation safety will be ensured. The content of these plans and arrangements will vary depending on the hazard and complexity of the sources to be dealt with. 

There is no pre-determined format for supplying this information. The applicant may either describe the plans and arrangements on the application form or may reference suitable organisational documents. If the latter option is taken, the applicant must clearly indicate on the application form where the relevant information can be found within accompanying documents.  

A brief description of what is expected in plans and arrangements is provided below. For more detailed information, refer to Regulatory Guide - Plans and Arrangements for Managing Safety. 

Applicants should identify the codes and standards relevant to the proposed dealing and describe how these will be implemented or taken into account in managing the safety of sources. This information may be incorporated into Section D of the licence application.  

Codes and standards applicable to each kind of source can be found here. These codes and standards will become conditions of licence should the application be approved. 

ARPANSA publishes information about international best practice (IBP) with links to international codes and standards that may be relevant to the proposed dealing. The applicant is advised to consider these where relevant. 

Depending on the type of source, the applicant may be required to address some or all of the following:

Effective Control Arrangements

Provide information to demonstrate how the applicant or nominee will maintain control over the particular dealings for which a licence is sought. The arrangements should cover such things as organisational arrangements, management systems and resources.

Safety Management 

Describe the administrative arrangements for managing safety. These arrangements may be minimal, where only low hazards are involved, but will be more extensive for dealings of higher hazard or complexity. The safety management plan should cover things such as safety culture, safety of premises and equipment, competency and training, incidents, auditing and record keeping. 

Radiation Protection Plan

Radiation protection policies and procedures should be set out in a radiation safety manual and in specific operating procedures. Guidance on the content of such a manual is provided in chapter 3 of RPS C-1 Code for Radiation Protection in Planned Exposure Situations. 

The radiation protection plan should cover issues such as principles of radiation protection, planning and design of the workplace, classification of work area, local procedures, radiation monitoring of individuals and the workplace and protection of the environment.  

Where sources are to be used for medical purposes, the plans and arrangements should address the requirements of RPS C-5 Code for Radiation Protection in Medical Exposure  and associated safety guides for diagnostic and interventional radiology, radiotherapy, and nuclear medicine; in particular, addressing optimisation of exposure and radiation protection of the patient. 

In addition, the applicant is responsible for ensuring that arrangements are implemented for the appointment of a suitably qualified radiation safety officer and/or radiation safety committee as appropriate. Information should be provided about the qualifications and experience of such persons and the arrangements in place for their continued competency. 

Radioactive Waste Management Plan

A full description and anticipated amounts of any radioactive wastes, including discharges arising from the proposed dealing and the arrangements for the safe handling, treatment, storage and disposal of any such waste should be set out in a radioactive waste management plan. 

Refer to RPS C-6 Code for the Disposal of Radioactive Waste by the User. 

Ultimate Disposal or Transfer Plan

Provide a plan for the ultimate transfer or disposal of sources. Copies of documented undertakings by other organisations to accept sources when no longer required should be provided where possible. Applicants should note that after a licence is issued, section 65 of the Regulations applies to the disposal and transfer of sources. 

Note 3: Stricter requirements apply to security enhanced sources - applicants should refer to RPS 11 Code of Practice for the Security of Radioactive Sources.

Security Plan

Describe the arrangements for the security of sources to prevent theft, damage or unauthorised access. These arrangements should ensure that control of sources is not relinquished without appropriate approvals required by the Regulations and conditions of licence.  The plan should provide for periodic inventory checks to confirm that all sources are secure and in their assigned location.

Refer to RPS 11 Code of Practice for the Security of Radioactive Sources. Compliance with this code is mandatory for security enhanced sources - in particular the need for an approved security plan.  

Note 4: A security enhanced source is a radioactive source or aggregation of sources assigned Security Category 1, 2 or 3 when using the methodology set out in Schedule B of RPS 11.   

Emergency Plan

Emergency arrangements must be developed for all foreseeable emergencies such as dispersion of materials, overexposure of operators, or theft or loss of controlled material. The arrangements should include: the responsibilities of all parties in the event of an emergency; contact arrangements; emergency procedures; emergency equipment; and reporting arrangements. Where necessary, arrangements for involving external agencies such as police and other emergency services should be included.

The plan should include arrangements for testing the emergency arrangements through regular reviews and exercises and rectifying any deficiencies found in the emergency plans. 

Refer to RPS G-3 Guide for Radiation Protection in Emergency Exposure Situations.

Section E: Matters to be taken into account by the CEO

Subsection 33(3) of the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) requires the CEO to take into account international best practice in relation to radiation protection and nuclear safety when making a decision whether to issue a source licence. The CEO must also take into account the matters prescribed in section 53 of the Regulations. Provide information on these matters in Section E for the CEO to consider.

International best practice in radiation protection and nuclear safety 

Describe how international best practice (IBP) has been considered in relation to the facility relevant to the type of authorisation sought. 

Each element of the proposed activity should be researched to determine what can be regarded as IBP. Undertaking research and benchmarking exercises are a useful way to establish IBP.

Implementation of relevant national and international codes and standards is considered a demonstration of best practice. 

Refer to the International Best Practice page for further information.     

Undue risk 

Provide information to demonstrate that sources can be dealt with without undue risk to the health and safety of people and the environment. This should include evidence that the radiation risks to people and the environment arising from the proposed dealing have been fully assessed, including the probability and magnitude of potential exposures arising from incident scenarios and abnormal occurrences.  

Net benefit 

Provide information to demonstrate that dealing with sources produces sufficient benefit to individuals or to society to offset the radiation harm that it might cause, taking into account societal, economic and other relevant factors; that is, the applicant must justify the dealing and demonstrate a net benefit from it.

Optimisation of protection

Provide information to demonstrate that protection has been optimised. The level of protection should be the best under prevailing circumstances and should provide for an adequate margin of benefit over harm. Information should show that the likelihood of incurring exposures, the number of people exposed, and the magnitude of exposures are as low as reasonably achievable, having regard to economic and societal factors. Information such as actual dose information, including dosimeter readings and surveys or sample dose calculations or both could be provided for this purpose.     

Technical, human and organisational factors

Provide information to demonstrate that interactions between technical, human and organisational factors have been considered in the management of safety.  

Human factors involve understanding human capability and limitations in operational and maintenance roles relating to sources. There are a variety of human factors assessments that can be used to both understand and demonstrate the management of safety critical risks. 

Organisational factors are aspects of the organisation that facilitate performance (in safety), e.g. culture, safety management systems, leadership, resilience, defence-in-depth. Organisational factors can be addressed through a variety of self-reflective practices and systemic design.

Technical factors include the design, operation and maintenance of equipment, machinery and tools. It is important the organisation thinks about the ways in which humans will respond, adapt, and learn from organisational and technical factors.

Guidance on what interactions to consider can be found in the Regulatory Guide - Holistic Safety.

Capacity to comply 

Provide information to demonstrate that the applicant has the capacity to comply with the Regulations and licence conditions that would be imposed under section 35 of the Act.  

Evidence of compliance with similar legislation such as that administered by Comcare or the Australian Safeguards and Non-Proliferation Office (ASNO) may be useful for this purpose.  A current ARPANSA licence holder may refer to their compliance history.   

Provide information to demonstrate that there are sufficient financial and human resources to safely deal with sources. 

Authorised signatory 

The application must be signed by an office holder of the applicant or a formally authorised person. An office holder is the Secretary, Chief Executive Officer or an equivalent person of the Department or entity that is named as the applicant. Where a person authorised by an office holder of the applicant signs the application, a copy of the instrument of authorisation must be provided.

Checklist

A checklist is provided to confirm the application is complete.

Application fee

Refer to section 49 of the Regulations to determine the appropriate fee. The fee must be received before the application can be assessed. Accepted payment methods are EFT, credit card or BPAY – please see Payment methods | ARPANSA.

Submitting your application

Application should be submitted via the RAD Portal (rad.arpansa.gov.au) together with all supporting documentation. Alternatively contact ARPANSA for advice on how to submit documentation, particularly any documentation that is of ‘protected’ or higher classification.

How your application will be processed

When your application is submitted it will be examined to see if all the necessary information is included, if it is properly signed, and if the correct application fee has been paid. If so, you will receive an acknowledgment email. If any of the basic information is missing, you will be contacted for further information or in some cases the application and fee may be returned.

Your application will then be forwarded to a regulatory officer. The regulatory officer will discuss and agree a time with you to complete the assessment. 

The regulatory officer will review all the information and consider the claims, arguments and evidence presented. Where matters require clarification, the regulatory officer will contact you or your nominee. The regulatory officer may also consider that an inspection or site visit is necessary and will contact you to arrange this. The officer will then prepare a regulatory assessment report to document the review. 

The assessment report will make a recommendation to the CEO about whether to issue a licence and may recommend licence conditions to be imposed under section 35 of the Act. The report undergoes a rigorous review and approval process prior to being sent to the decision maker with all relevant documentation. You will be advised in writing of the decision. 

Under section 37 of the Act, a licence may be issued indefinitely or for a period specified in the licence. When issued, a licence remains in force until it is cancelled or surrendered, or the specified period has elapsed.

Appealing a licence decision

Section 40 of the Act describes the rights of review available to eligible persons in respect of licence decisions made by the CEO. The following decisions are reviewable:

1. to refuse to grant a licence
2. to impose conditions on a licence
3. to suspend a licence
4. to cancel a licence
5. to amend a licence
6. not to approve the surrender of a licence
7. to issue a licence for a particular period, rather than for a longer period or indefinitely
8. not to extend the period for which a licence was issued

An eligible person in relation to a decision to refuse to grant a licence means the person who applied for the licence, and in relation to any other licence decision, it is the licence holder.

Review by the Minister

Should an applicant wish to have a licence decision reviewed, the applicant may request the Minister for Health to review the decision. The request must be in writing and be given to the Minister within 28 days of the making of the licence decision.  Once a request for review has been lodged, the Minister must reconsider the licence decision and confirm, vary or set aside the decision.

The Minister is taken to have confirmed the licence decision if the Minister does not give written notice of the Minister’s decision within 60 days of the request.

Review by the Administrative Review Tribunal (ART)

An application may be made to the ART for review of a decision of the Minister.
 

 

Associated forms

Licence application form – prescribed radiation facility (PRF)

Completing the application form

Section A: Applicant Information

Department or entity

Name of the Department or Commonwealth Body on behalf of which the application is being made. It may include further information for ease of identification e.g. Division, Branch, Section etc.

Portfolio

Name of the Commonwealth ministerial portfolio in which the Department or entity resides. 

Applicant/Responsible Person

The application must be made by the chief executive of the Department or entity or by a person authorised by the chief executive.

The applicant must provide their full name, position and business address. If it is made by an authorised person, the application must include a copy of the authorisation.

Note 1: Responsible person in relation to any radiation source, prescribed radiation facility or premises on which radiation sources are stored or used means the legal person: (a) having overall management responsibility including responsibility for the security and maintenance of the radiation source, facility or premises (b) having overall control over who may use the radiation source, facility or premises (c) in whose name the radiation source, facility or premises would be registered if this is required. RPS C-1 Code for Radiation Protection in Planned Exposure Situations

Nominee

If the applicant is sufficiently removed from the facility that they cannot demonstrate effective control, the name and contact details of a person more directly in control of the PRF must be provided. This nominee must be in effective control of the PRF. Generally the nominee will be the manager of a division or agency’s operation at the site of the proposed activity. If a nominee is appointed, an organisational chart should be provided, showing the relationship of the nominee to the applicant and the operators.

Radiation Safety Officer 

This is an individual appointed by the applicant to supervise radiation safety in relation to the controlled facility, controlled apparatus and/or controlled material for which the licence is sought. This person must be technically competent in radiation protection matters relevant to the facility and any associated sources. Evidence of competency should be included in the application. If there is more than one radiation safety officer, the details of other radiation safety officers should also be provided.  

Note 2: A RSO may not always be required. Applicants should refer to Regulatory Guide: Plans and Arrangements for Managing Safety or contact ARPANSA. 

Declaration

The declaration must be signed by the applicant or authorised person.

Section B: Kind of prescribed radiation facility

The applicant must indicate the kind of PRF for which a licence is sought.

Section C: Type of authorisation 

The applicant must indicate the type of authorisation sought relevant to the life cycle of the facility.  

Note 3: Under certain circumstances, the CEO of ARPANSA may exempt an applicant from the need to be authorised for certain conduct relating to a facility. For example, the CEO may exempt an applicant from the need for a siting licence where they intend to construct a similar facility on a previously authorised site. For more information on such exemptions, applicants should contact ARPANSA.  

Section D: Facility Details

Provide a detailed description of the facility and its site including the site address. Include this information in the space provided or insert references to where this information can be found in supporting documents. The full title, version/edition, and approval date should be provided for all referenced documents.

Section E: Safety Analysis Report

A safety analysis report (SAR) must be provided for each type of authorisation sought.  The SAR must be as complete as possible for each stage of licensing.  If applying to prepare a site for and construct a nuclear installation in the same application a SAR that is as complete as possible must be provided for each stage. 

Guidance on preparing a SAR can be found in Regulatory Guide: Preparation of the safety analysis report for non-reactor facilities.

Section F: Plans & Arrangements

The applicant must have plans and arrangements for managing the facility to ensure the health and safety of people and protection of the environment.These should be a comprehensive program of policies and procedures that demonstrate how safety and security will be ensured. The content of these plans and arrangements will vary depending on the hazard and complexity of the facility. 

There is no predetermined format for supplying this information. The applicant may either describe the plans and arrangements in the space provided or may reference suitable organisational documents. If the latter option is taken, the applicant must clearly indicate on the application form where the relevant information can be found within accompanying documents and provide the full title, version/edition, and/or approval date. 

A brief description of what is expected in the plans and arrangements is provided below. For more detailed information, refer to Regulatory Guide: Plans and Arrangements for Managing Safety.

If there are sources associated with the proposed facility, the applicant should identify the relevant codes and/or standards and describe how compliance with these documents will be achieved. This information may be included in Section F of the application. Codes and standards applicable to each kind of source can be found here.  Codes and standards applicable to PRFs can be found here. 

ARPANSA also publishes international best practice (IBP) information with links to various international codes and standards that may be relevant to the proposed facility. Applicants should identify relevant IBP and describe how this will be implemented or taken into account.

Effective Control Arrangements

Provide information to demonstrate how the applicant or nominee will establish and maintain effective control over the facility. This should cover issues such as organisational arrangements, management systems and resources.

Safety Management Plan

Describe the administrative arrangements for managing the safety of the facility and any associated sources. This should cover issues such as safety culture, safety of premises and equipment, competency and training, incidents, auditing and record keeping. 

Radiation Protection Plan

Radiation protection policies and procedures should be set out in a radiation safety manual and in specific operating procedures. Guidance on the content of such a manual is provided in RPS F-1 Fundamentals for Protection Against Ionising Radiation, RPS C-1 Code for Radiation Protection in Planned Exposure Situations and RPS G-2 Guide for Radiation Protection in Existing Exposure Situations. 

The radiation protection plan should cover issues such as principles of radiation protection, planning and design of the workplace, classification of work area, local procedures, radiation monitoring of individuals and the workplace.  

In addition, the applicant is responsible for ensuring that arrangements are implemented for the appointment of a suitably qualified radiation safety officer and/or radiation safety committee as appropriate. Provide information about the qualifications and experience of such persons and the arrangements in place for their continued competency. 

Radioactive Waste Management Plan

A full description and anticipated amounts of any radioactive wastes, including discharges arising from the proposed conduct and the arrangements for the safe handling, treatment, storage and disposal of any such waste should be set out in a radioactive waste management plan. 

Refer to RPS C-3 Code for Disposal Facilities for Solid Radioactive Waste, CRPS C-6 Code for Disposal of Radioactive Waste by the User, RPS G-4 Guide for Classification of Radioactive Waste, and relevant IBP.

Security Plan

Describe the arrangements for the security of the facility and any associated sources to prevent theft, damage or unauthorised access. These arrangements should demonstrate how the security of the facility will be maintained and how periodic inventory checks will be undertaken to confirm that all sources are in their assigned locations and are secure.

Refer to IAEA Nuclear Security Series NSS 14 Nuclear Security Recommendations on Radioactive Material and Associated Facilities and RPS 11 Code of Practice for Security of Radioactive Sources. Compliance with the latter code is mandatory for security enhanced sources. In particular, the need for an approved security plan should be noted.      

Emergency Plan

Emergency arrangements should be developed for all foreseeable emergencies such as dispersion of materials, over-exposure of operators, or theft or loss of controlled material. The level of detail should be commensurate with the hazard of the facility. The arrangements should include the responsibilities of all parties in the event of an emergency, contact arrangements, emergency procedures, emergency equipment and reporting arrangements.  Where necessary, arrangements for involving external agencies such as police and other emergency services should be included. 

The plan should include arrangements for testing the emergency arrangements through regular reviews and exercises, and rectifying any deficiencies found in the emergency plans.

Refer to RPS G-3 Guide for Radiation Protection in Emergency Exposure Situations and relevant IBP.  

Environment Protection Plan

Arrangements should be developed for the protection of wildlife populations and ecosystems in parallel with radiation protection of people, consistent with international best practice. The arrangements should include identification of all potential exposure scenarios and pathways to the environment and affected biota with environmental radiological assessments of wildlife in their natural habitats based on the concept of reference organisms. Refer to RPS G-1 Guide for Radiation Protection of the Environment. 

Decommissioning Plan 

Arrangements should be developed that demonstrate adequate planning for decommissioning to protect workers, the public and the environment. While most decommissioning activities take place in the final phase of a facility’s lifecycle, decommissioning should be considered as early as possible. An initial decommissioning plan should be developed at the design stage and periodically updated throughout subsequent life stages. The objective is to develop a final plan to be submitted when applying for authorisation to decommission the facility. 

Refer to Regulatory Guide: Decommissioning of controlled facilities.

Section G: Extra information

Provide the additional information as shown in the table in section 46 of the Regulations specific to the type of authorisation sought. Enter the information in the space provided or state clearly where this information can be found in the accompanying documentation. The full title, version/edition, and approval date should be provided for all referenced documents.

Prepare a site for a PRF

Provide the following information to support a facility application to prepare a site for a PRF:

• A detailed site evaluation establishing the suitability of the site
• A description of the characteristics of the site, including the extent to which the site may be affected by natural and human events
• Any environmental impact statement (however described) requested or required by a Commonwealth, state, territory or local government agency in relation to the site or facility, and the outcome of the environmental assessment. 

Construct a PRF

Provide the following information in support of a facility licence application to construct a PRF:

• The design of the facility, including ways in which the design deals with the physical and environmental characteristics of the site
• Any fundamental difficulties that will need to be resolved before any facility licence relating to the facility is issued
• The construction plan and schedule
• The arrangements for testing and commissioning safety related items. 

Possess or control a PRF

Provide the following information in support of a facility licence application to possess or control a PRF:

• The arrangements for maintaining criticality safety during loading, moving or storing nuclear fuel and other fissile materials at the controlled facility
• The arrangements for safe storage of controlled material and maintaining the facility.

Operate a PRF

Provide the following information in support of the application to operate a PRF:

• A description of the structures, components, systems and equipment of the facility as they have been constructed
• The operational limits and conditions of the facility
• The arrangements for commissioning the facility
• The arrangements for operating the facility
• Results of a field exercise to respond to a scenario that involves an emergency and has been agreed with the CEO

Decommission a prescribed radiation facility

Provide the following information in support of the application to decommission a PRF:

• Schedule for decommissioning the facility

Dispose of or abandon a prescribed radiation facility

Provide the following information in support of an application to decommission a PRF:

• Results of decommissioning activities at the facility
• Details of any environmental monitoring program proposed for the site of the facility

Section H: Associated sources

Sources that are part of, used in connection with, produced by, incorporated in, stored in, or disposed of in, a facility do not require a separate source licence, but must be authorised by the facility licence.  

Not all facilities have associated sources but where they do the applicant must indicate the kind of sources in Section H of the application. Common types of sources used in facilities are calibration sources. For sealed sources, a copy of any source certificate should be provided. 

Section I: Source details

The details of any sources associated with the facility must be recorded in a source inventory workbook (SIW). This is the form approved by the CEO for maintaining source records. The SIW template is available here. 

An explanation of terms and required information appears in the first worksheet of the SIW. If in doubt, contact ARPANSA for advice. The completed SIW is to be submitted with the application.

Section J: Matters to be taken into account by the CEO

Subsections 32(3) and 33(3) of the Act require the CEO to take into account international best practice in relation to radiation protection and nuclear safety when making a decision whether to issue a licence. The CEO is also required to take into account the matters prescribed in section 53 of the Regulations.  Provide information on these matters in Section J of the application form.

International best practice in radiation protection and nuclear safety 

Describe how international best practice (IBP) has been considered in relation to the facility relevant to the type of authorisation sought. 

Each element of the proposed activity should be researched to determine what can be regarded as IBP. Undertaking research and benchmarking exercises are useful ways to establish IBP. Implementation of relevant national and international codes and standards is considered a demonstration of best practice.  

Refer to the International Best Practice page for further information.     

Undue Risk 

Provide information to demonstrate that the proposed conduct can be undertaken without undue risk to the health and safety of people and the environment. This should include evidence that the radiation risks to people and the environment arising from the proposed conduct have been fully assessed, including the probability and magnitude of potential exposures arising from incident scenarios and abnormal occurrences.  

Net benefit 

Provide information to demonstrate that the proposed conduct produces sufficient benefit to individuals or to society to offset the radiation harm that it might cause, taking into account social, economic and other relevant factors; that is, the applicant must justify the conduct and demonstrate a net benefit from it.

Optimisation of protection 

Provide information to demonstrate that protection has been optimised. The level of protection should be the best under prevailing circumstances and should provide for an adequate margin of benefit over harm. Information should show that the likelihood of incurring exposures, the number of people exposed and the magnitude of exposures are as low as reasonably achievable, having regard to economic and societal factors. Information such as actual dose information, including dosimeter readings and surveys or sample dose calculations or both could be provided for this purpose.     

Technical, human and organisational factors 

Provide information to demonstrate that interactions between technical, human and organisational factors have been considered in the management of safety. 

Human factors involve understanding human capability and limitations in operational and maintenance roles relating to the PRF. There are a variety of human factors assessments that can be used to both understand and demonstrate the management of safety critical risks. 

Organisational factors are aspects of the organisation that facilitate performance (in safety), eg. culture, safety management systems, leadership, resilience, defence-in-depth. Organisational factors can be addressed through a variety of self-reflective practices and systemic design.

Technical factors include the design, operation and maintenance of equipment, machinery and tools. It is important the organisation thinks about the ways in which humans will respond, adapt, and learn from organisational and technical factors.

Guidance on what interactions to consider and questions to ask can be found in the Holistic Safety Guide and Holistic Safety Guide (sample questions).

Capacity to Comply 

Provide information to demonstrate that there is capacity to comply with the Regulations and licence conditions that would be imposed under section 35 of the Act.  

Evidence of compliance with similar legislation such as that administered by Comcare or the Australian Safeguards and Non-Proliferation Office (ASNO) may be useful for this purpose.  A current ARPANSA licence holder may refer to their compliance history.   

Provide information to demonstrate that there are sufficient financial and human resources to safely undertake the proposed conduct.      

Authorised signatory 

The application must be signed by an office holder of the applicant or a formally authorised person. An office holder is the Secretary, Chief Executive

Officer or an equivalent person of the Department or entity that is named as the applicant. Where a person authorised by an office holder of the applicant signs the application, a copy of the instrument of authorisation must be provided.

Checklist

A checklist is provided to confirm the application is complete.

Application fee

Refer to section 49 of the Regulations to determine the appropriate application fee. The fee must be received before the application can be assessed. Accepted payment methods are EFT, credit card or BPAY – please see payment methods.

Submitting your application

Send completed application form and all supporting documents to licenceadmin@arpansa.gov.au.  

How your application will be processed

When your application is submitted it will be examined to see if all the necessary information is included, if it is properly signed, and if the correct application fee has been paid. If so, you will receive an acknowledgment email. If any of the basic information is missing you will be contacted for further information or in some cases the application and fee may be returned.

As soon as practicable after receiving your application, and after confirming it is complete, the CEO is required by section 48 of the Regulations to publish a notice in a national daily newspaper and on ARPANSA’s website, stating the intention to make a decision on the application.   

Your application is then forwarded to a regulatory officer. The regulatory officer will discuss and agree a time with you to complete the assessment. 

The regulatory officer will review all the information and consider the claims, evidence and arguments presented. Where matters require clarification, the regulatory officer will contact you or your nominee. The regulatory officer may also consider that an inspection or site visit is necessary and will contact you to arrange. The officer will then prepare a regulatory assessment report to document the review. 

The assessment report will make a recommendation to the CEO about whether to issue a licence and may recommend licence conditions to be imposed under section 35 of the Act. The report undergoes a rigorous review and approval process prior to being sent to the decision maker with all relevant documentation.

You will be advised in writing of the decision. The CEO may also publish a ‘statement of reasons’ for the decision on this website.  

Detailed information about how ARPANSA undertakes assessments can be found in our Review and Assessment Manual on the 'how we regulate' page.   

Under section 37 of the Act, a licence may be issued indefinitely or for a specified period. When issued a licence remains in force until it is cancelled or surrendered, or the specified period has elapsed.  

Appealing a licence decision

Section 40 of the Act describes the rights of review available to eligible persons in respect of licence decisions made by the CEO. The following decisions are reviewable:

• to refuse to grant a licence
• to impose conditions on a licence
• to suspend a licence
• to cancel a licence
• to amend a licence
• not to approve the surrender of a licence
• to issue a licence for a particular period, rather than for a longer period or indefinitely
• not to extend the period for which a licence was issued

An eligible person in relation to a decision to refuse to grant a licence means the person who applied for the licence, and in relation to any other licence decision, it is the licence holder.

Review by the Minister

Should an applicant wish to have a licence decision reviewed, the applicant may request the Minister for Health to review the decision. The request must be in writing and be given to the Minister within 28 days of the making of the licence decision.

If a request for review is lodged, the Minister must reconsider the licence decision and confirm, vary or set aside the decision.

The Minister is taken to have confirmed the licence decision if the Minister does not give written notice within 60 days of the request.

Review by the Administrative Review Tribunal (ART)

An application may be made to the ART for review of a decision of the Minister.
 
 

 

 

Associated forms

• Licence application form – nuclear installation

Completing the application form

Section A: Applicant information

Department or Commonwealth entity 

Name of the Department or entity on behalf of which the application is being made. It may include further information for ease of identification, e.g. Division, Branch, Section.

Portfolio

Name of the Commonwealth ministerial portfolio in which the Department or entity resides. 

Applicant/Responsible Person

The application must be made by the chief executive of the Department or entity or by a person authorised by the chief executive.

The applicant must provide their full name, position and business address. If it is made by an authorised person, the application must include a copy of the authorisation.

Note 1: Responsible Person in relation to any radiation source, prescribed radiation facility or premises on which radiation sources are stored or used means the legal person: (a) having overall management responsibility including responsibility for the security and maintenance of the radiation source, facility or premises (b) having overall control over who may use the radiation source, facility or premises (c) in whose name the radiation source, facility or premises would be registered if this is required. RPS C-1 Code for Radiation Protection in Planned Exposure Situations

Nominee

If the applicant is physically removed from the facility such that they cannot demonstrate effective control, the name and contact details of a person more directly in control of the facility must be provided. This nominee must be in effective control of the nuclear installation. Generally the nominee will be the manager of a division or agency’s operation at the site of the proposed activity. If a nominee is appointed, an organisational chart should be provided showing the relationship of the nominee to the applicant and the operators. 

Radiation Safety Officer 

This is an individual appointed by the applicant to supervise radiation safety in relation to the facility, controlled apparatus and/or controlled material for which the licence is sought. This person must be technically competent in radiation protection matters relevant to the facility and any associated sources. Evidence of competency should be included with the application. If there is more than one radiation safety officer, the details of other radiation safety officers should also be provided.

Declaration

The declaration must be signed by the applicant or authorised person.

Section B: Kind of nuclear installation & type of authorisation

Indicate the kind of nuclear installation and type of authorisation that is sought. 

Section C: Facility details

Provide a detailed description of the facility and its site including the site address. Include this information in the space provided or insert references to where this information can be found in supporting documents. The full title, version/edition, and approval date should be provided for all referenced documents.

Section D: Safety Analysis Report

A safety analysis report (SAR) must be provided for each type of authorisation sought. The SAR must be as complete as possible for each stage of licensing. Guidance on preparation of a SAR can be found in Regulatory Guide: Preparation of the safety analysis report for non-reactor facilities

Section E: Plans & Arrangements

The applicant must have plans and arrangements for managing the facility to ensure the health and safety of people and protection of the environment. These should be a comprehensive program of policies and procedures that demonstrate how safety and security will be ensured. The content of these plans and arrangements will vary depending on the hazard and complexity of the facility. 

There is no predetermined format for supplying this information. The applicant may either describe the plans and arrangements in the space provided or may reference suitable organisational documents. If the latter option is taken, the applicant must clearly indicate on the application form where the relevant information can be found within accompanying documents, and provide the full title, version/edition, and approval date. 

A brief description of what is expected in the plans and arrangements is provided below. For more detailed information, refer to Regulatory Guide: Plans and Arrangements for Managing Safety.

If there are sources associated with the proposed facility, the applicant should identify the relevant codes and standards and describe how compliance with these documents will be achieved. This information may be included in Section E of the application. Codes and standards applicable to each kind of source can be found here.

ARPANSA publishes information about international best practice (IBP) with links to various international standards that may be relevant to the proposed facility. Applicants should identify relevant IBP and describe how this will be implemented or taken into account.

Effective Control Arrangements

The applicant must demonstrate how he/she or the nominee will establish and maintain effective control over the facility. This should cover issues such as organisational arrangements, management systems and resources.

Safety Management Plan

The applicant must describe the administrative arrangements for managing the safety of the facility and any associated sources. This should cover issues such as safety culture, safety of premises and equipment, competency and training, incidents, auditing and record keeping. 

Radiation Protection Plan

Radiation protection policies and procedures should be set out in a radiation safety manual and in specific operating procedures. Guidance on the content of such a manual is provided in RPS F-1 Fundamentals for Protection Against Ionising Radiation, RPS C-1 Code for Radiation Protection in Planned Exposure Situations and RPS G-2 Guide for Radiation Protection in Existing Exposure Situations. 

The radiation protection plan should cover issues such as principles of radiation protection, planning and design of the workplace, classification of work areas, local procedures, radiation monitoring of individuals and the workplace.

In addition, the applicant is responsible for ensuring that arrangements are implemented for the appointment of a suitably qualified radiation safety officer and/or radiation safety committee as appropriate. The applicant must provide information about the qualifications and experience of such persons and the arrangements in place for their continued competency. 

Radioactive Waste Management Plan

A full description and anticipated amounts of any radioactive wastes, including discharges arising from the proposed conduct and the arrangements for the safe handling, treatment, storage and disposal of any such waste should be set out in a radioactive waste management plan.

Refer to RPS C-3 Code for Disposal Facilities for Solid Radioactive Waste, RPS C‑6 Code for the Disposal of Radioactive Waste by the User, RPS G-4 Guide for Classification of Radioactive Waste, and relevant IBP.

Security Plan

Arrangements for the security of the facility and any associated sources to prevent theft, damage or unauthorised access must be provided. These arrangements should demonstrate how the security of the facility and any associated sources will be maintained and how periodic inventory checks will be undertaken to confirm that all sources are secure and in their assigned location.

Refer to IAEA Nuclear Security Series NSS-14 Nuclear Security Recommendations on Radioactive Material and Associated Facilities and RPS 11 Code of Practice for the Security of Radioactive Sources. Compliance with the latter code is mandatory for security enhanced sources. In particular, the need for an approved security plan should be noted.

Emergency Plan

Emergency arrangements should be developed for all foreseeable emergencies such as dispersion of materials, over-exposure of operators, or theft or loss of controlled material. The arrangements should include the responsibilities of all parties in the event of an emergency, contact arrangements, emergency procedures, emergency equipment and reporting arrangements. Where necessary, arrangements for involving external agencies such as police and other emergency services should be included. The level of detail should be commensurate with the hazard of the facility.

The plan should include arrangements for testing the emergency arrangements through regular reviews and exercises, and rectifying any deficiencies found in the plan.

Refer to RPS G-3 Guide for Radiation Protection in Emergency Exposure Situations and relevant IBP.

Environment Protection Plan

Arrangements should be developed for the protection of wildlife populations and ecosystems in parallel with radiation protection of people, consistent with international best practice. The arrangements should include identification of all potential exposure scenarios and pathways to the environment and affected biota, with environmental radiological assessments of wildlife in their natural habitats based on the concept of reference organisms. Refer to RPS G-1 Guide for Radiation Protection of the Environment.

Decommissioning Plan 

Arrangements should be developed that demonstrate adequate planning for decommissioning to protect workers, the public and the environment. While most decommissioning activities take place in the final phase of a facility’s lifecycle, decommissioning should be considered as early as possible. An initial decommissioning plan should be developed at the design stage and periodically updated throughout subsequent life stages. The objective is to develop a final plan to be submitted when applying for authorisation to decommission the facility. 

Refer to Regulatory Guide: Decommissioning of controlled facilities. 

Section F: Extra information

Applicants should provide additional information as shown in the table in section 46 of the Regulations specific to the type of authorisation sought. Applicants should enter the information in the space provided or state clearly where this information can be found in the accompanying documentation. The full title, version/edition, and approval date should be provided for all referenced documents.

Applicants should complete the section(s) corresponding to the type of authorisation sought.

Section G: Associated sources

Sources that are part of, used in connection with, produced by, incorporated in, stored in, or disposed of in, a facility do not need a separate source licence but must be authorised by the facility licence.

Not all facilities have associated sources but where they do, this should be indicated in Section G of the application. A common type of source used in facilities is a calibration source. For sealed sources, a copy of any source certificate should be provided.

Section H: Source details

The details of any sources associated with the facility must be recorded in a source inventory. These can be added using the RAD Portal or a format approved by the CEO. 

Once the licence application has been approved the source inventory should be maintained using the RAD Portal.

Section I: Matters to be taken into account by the CEO

Subsections 32(3) and 33(3) of the Act require the CEO to take into account international best practice in relation to radiation protection and nuclear safety when making a decision whether to issue a licence. The CEO must also take into account the matters prescribed in section 53 of the Regulations. Provide information on these matters in Section I of the application form.

International best practice in radiation protection and nuclear safety 

Describe how international best practice (IBP) has been considered in relation to the facility relevant to the type of authorisation sought. 

Each element of the proposed activity should be researched to determine what can be regarded as international best practice. Undertaking research and benchmarking exercises are useful ways to establish IBP. Implementation of relevant national and international codes and standards is considered a demonstration of best practice.

Agencies such as the International Atomic Energy Agency (IAEA) or the Nuclear Energy Agency are useful resources, particularly in relation to safety assessment and stakeholder involvement. The IAEA standards and recommendations have been developed by consensus of member countries and represent the distillation of best practice of their cumulative radiation and nuclear safety experience. 

Refer to the International Best Practice page for further information. 

Undue risk 

Provide information to demonstrate that the proposed conduct can be undertaken without undue risk to the health and safety of people and the environment. This should include evidence that the radiation risks to people and the environment arising from the proposed conduct have been fully assessed, including the probability and magnitude of potential exposures arising from incident scenarios and abnormal occurrences.

Net benefit 

Provide information to demonstrate that the proposed conduct produces sufficient benefit to individuals or to society to offset the radiation harm that it might cause, taking into account societal, economic and other relevant factors; that is, the applicant must justify the conduct and demonstrate a net benefit from it.

Optimisation of protection 

Provide information to demonstrate that protection has been optimised. The level of protection should be the best under prevailing circumstances and should provide for an adequate margin of benefit over harm. Information should show that the likelihood of incurring exposures, the number of people exposed and the magnitude of exposures are as low as reasonably achievable, having regard to economic and societal factors. Information such as actual dose information, including dosimeter readings and surveys or sample dose calculations or both could be provided for this purpose. 

Technical, human and organisational factors 

Provide information to demonstrate that interactions between technical, human and organisational factors have been considered in the management of safety.

Human factors involve understanding human capability and limitations in operational and maintenance roles relating to the nuclear installation. There are a variety of human factors assessments that can be used to both understand and demonstrate the management of safety-critical risks. 

Organisational factors are aspects of the organisation that facilitate performance (in safety), e.g. culture, safety management systems, leadership, resilience, defence-in-depth. Organisational factors can be addressed through a variety of self-reflective practices and systemic design.

Technical factors include the design, operation and maintenance of equipment, machinery and tools. It is important the organisation thinks about the ways in which humans will respond, adapt, and learn from organisational and technical factors.

Guidance on what interactions to consider and questions to ask can be found in the Regulatory Guide - Holistic Safety.

Capacity to comply 

Provide information to demonstrate that the applicant has the capacity to comply with the Act, the Regulations and licence conditions that would be imposed under section 35 of the Act.

Evidence of compliance with similar legislation such as that administered by Comcare or the Australian Safeguards and Non-Proliferation Office (ASNO) may be useful for this purpose. A current ARPANSA licence holder may refer to their compliance history.

Provide information to demonstrate that there are sufficient financial and human resources to safely undertake the proposed conduct. 

Authorised signatory 

The application must be signed by an office holder of the applicant or a formally authorised person. An office holder is the Secretary, Chief Executive Officer or an equivalent person of the Department or entity that is named as the applicant. Where a person authorised by an office holder of the applicant signs the application, a copy of the instrument of authorisation must be provided.

Checklist

A checklist is provided to confirm the application is complete.

Application fee

Refer to section 49 of the Regulations to determine the appropriate application fee. The fee must be received before the application can be assessed. Accepted payment methods are EFT, credit card or BPAY – please see Payment methods | ARPANSA.

Submitting your application

Send the completed application and all supporting documents to licenceadmin@arpansa.gov.au.

Note: A version of the application suitable for public review must also be provided. Documents for release must satisfy the Australian Government Web Accessibility guidelines.

How your application will be processed

When your application is submitted it will be examined to see if all the necessary information is included, if it is properly signed, if the correct application fee has been paid, and if a version of the application has been provided for public review. If so, you will receive an acknowledgment email. If any of the basic information is missing you will be contacted for further information or in some cases the application and fee may be returned.

As soon as practicable after receiving your application, and after confirming it is complete, the CEO is required by section 48 of the Regulations to publish a notice in a national daily newspaper and on ARPANSA’s website, stating the intention to make a decision on the application. The public version of the application will be published with the notice. The CEO will include in the notice:

• an invitation to people and bodies to make submissions about the application
• a period for making submissions
• procedures for making submissions.

Your application will then be assigned to a regulatory officer. The regulatory officer will discuss and agree a time with you to complete the assessment. 

The regulatory officer will review all the information and consider the claims, evidence and arguments presented. Where matters require clarification, the regulatory officer will contact you or your nominee. The regulatory officer may also consider that an inspection or site visit is necessary and will contact you to arrange. 

The officer will then prepare a regulatory assessment report to document the review. The content of any submissions made by members of the public about the application will be addressed in the report. 

The assessment report will make a recommendation to the CEO about whether to issue a licence and may recommend licence conditions to be imposed under section 35 of the Act. The assessment report undergoes a rigorous review and approval process prior to being sent to the decision maker with all relevant documentation.

You will be advised in writing of the decision. The CEO may also publish a ‘statement of reasons’ for the decision on this website.

Detailed information about how ARPANSA undertakes assessments can be found in our Review & Assessment Manual on the How we regulate page.

Under section 37 of the Act, a licence may be issued indefinitely or for a specified period. When issued a licence remains in force until it is cancelled or surrendered, or the specified period has elapsed.

Appealing a licence decision

Section 40 of the Act describes the rights of review available to eligible persons in respect of licence decisions made by the CEO. The following decisions are reviewable:

(a) to refuse to grant a licence
(b) to impose conditions on a licence
(c) to suspend a licence
(d) to cancel a licence
(e) to amend a licence 
(f) not to approve the surrender of a licence
(g) to issue a licence for a particular period, rather than for a longer period or indefinitely
(h) not to extend the period for which a licence was issued.

An eligible person in relation to a decision to refuse to grant a licence means the person who applied for the licence, and in relation to any other licence decision, it is the licence holder.

Review by the Minister

Should an applicant wish to have a licence decision reviewed, the applicant may request the Minister for Health to review the decision. The request must be in writing and be given to the Minister within 28 days of the making of the licence decision.

If a request for review is lodged, the Minister must reconsider the licence decision and confirm, vary or set aside the decision.

The Minister is taken to have confirmed the licence decision if the Minister does not give written notice of the Minister’s decision within 60 days of the request.

Review by the Administrative Review Tribunal (ART)

An application may be made to the ART for review of a decision of the Minister. 
 

 

A guide for applicants and licence holders on what ARPANSA expects to be considered in the preparation and maintenance of the safety analysis report for a non-reactor facility 

1. Introduction

1.1. Background

When a controlled person as defined in section 13 of Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) [1] intends to undertake any of the following activities:

• prepare a site for a controlled facility
• construct a controlled facility
• have possession or control of a controlled facility
• operate a controlled facility
• decommission, dispose of or abandon a controlled facility 
• remediate a prescribed legacy site

they must submit a facility licence application to ARPANSA. Section 46 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations) [2] details what the application must contain. In particular, section 46(1)(e) requires a safety analysis report (SAR) to be provided for each activity described above.

The SAR is a document produced by the operator which details the site and facility, describes any hazards and risks associated with the facility, how the facility will be used and managed, and the controls that must be in place to mitigate the risks.

The SAR must cover technical, organisational and human factors in a systemic/holistic approach to safety. The SAR is usually a detailed top-level document that references all supporting evidence, for example, the risk assessments and the operators’ management system (plans and arrangements).

The primary user of the SAR is the operator who should use it as a reference document to manage safety throughout the life of the facility. The SAR is a ‘living’ document which, as operations evolve and operational knowledge is gained, is continuously reviewed and updated so that operational safety margins are known and managed accordingly. All changes to the SAR must be assessed against the change requirements of s63 and s64 of the Regulations.

The SAR is also important to the regulator. Assessors must critically examine and test the SAR to ensure that it demonstrates that the facility is safe and can be operated safely into the future. The assessor must ensure that the SAR informs the licensing basis for the facility on which a program of safety oversight and compliance monitoring will be established. This is achieved through the clear identification of performance standards for any aspects important for safety including the arrangements to ensure that the SAR is maintained and accurate.

The SAR describes all activities with safety significance in appropriate detail including any restrictions on inputs to and outputs from the facility. It should include the application of the safety principles and criteria in the design for the protection of workers, the public and the environment. The SAR should contain an analysis of the hazards associated with the operation of the facility and should demonstrate compliance with the regulatory requirements. It should also contain analyses of accidents and of the safety features incorporated in the design for preventing accidents or minimising the likelihood of their occurrence and for mitigating their consequences in accordance with the concept of defence in depth.

1.2. Objective

This document provides guidance for an applicant, a licence holder and/or a responsible person¹[3], technical support organisations, and other interested parties on preparing safety analysis at each stage of the facility life. It aims to assist in ensuring that the safety analysis of non-reactor facilities is prepared in accordance with international best practice. This document is also used for the regulatory assessment of a licence application for each stage of a controlled facility.
The safety analysis confirms that the design of a facility:

• is capable of meeting the design and safety requirements and to derive or confirm operational limits and conditions that are consistent with the design and safety requirements
• assists in establishing and validating accident management procedures and guidelines
• assists in demonstrating that safety goals which may be established to limit the risks posed by the facility are met 
• helps to demonstrate that the design of the facility reflects effective defence in depth and that the plant design and operation are robust and provide acceptable levels of safety

1.3. Scope

This regulatory document provides guidance for undertaking the safety analysis of non-reactor nuclear facilities and other controlled facilities including radioisotope and radiopharmaceuticals production facilities, radioactive waste management facilities, particle accelerators and research and development facilities. The document covers radiation risks and associated consequences arising from facilities.

For guidance on the safety analysis of research reactors, ARPANSA uses guidance published by the IAEA in Specific Safety Guide SSG-20 [4]. 

For guidance on the safety analysis for remediating a prescribed legacy site, ARPANSA uses guidance published by the IAEA [5]. 

For the guidance on safety analysis for abandoning a prescribed legacy site, ARPANSA uses guidance published by the IAEA [6]. 

1.4. General Expectations

Submissions to ARPANSA should be accurate and complete and be built from claims, arguments and evidence. A claim is a statement by the applicant about a property of an object or process. The evidence is an artefact that establishes fact to support the claim.  Arguments describe the relationship that links the evidence with the claims to demonstrate that they have been met.  

The regulatory assessor must assess any claims and arguments that lack supporting evidence with caution. Such claims and statements should carry less weight in the overall assessment. A good quality SAR also helps to demonstrate the applicant’s understanding of a facility and its operation and is therefore an indirect indication of the applicant’s capacity to comply with any licence issued (as required under section 53(f) of the Regulations.  

An example of a claims-arguments-evidence approach is provided in Appendix A of this guide.

2. Content of the safety analysis report

This section of the guide provides general guidance on the topics for a typical SAR for a non-reactor facility. ARPANSA does not stipulate a format or structure for a SAR. This should be determined by the applicant or licence holder to meet its organisation’s requirements. The section headings shown below may be suitable for different chapters of the SAR. The content of the SAR should be applied as far as practicable and in a graded approach commensurate with the degree of hazard associated with the conduct or dealing. Graded approach is defined by the IAEA as a process or method in which the stringency of the control measures and conditions to be applied is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control.

2.1. Introduction and facility description

• An introduction of general information about the facility and any associated facilities.
• Facility overview should typically include the purpose of the facility, facility configuration, and the processes to be performed therein. The safety objectives and design requirements should also be included.      
• Facility description should include the facility and processes in support of hazard identification, hazard and accident analysis, and selection of hazard controls. The description of the facility will allow the reader to understand facility structures, operations and application. Graded information should be provided based on the hazard category and the complexity of the safety analyses.
• Facility structure should include facility buildings and structures including construction details such as floor plans, equipment layout, construction materials, and dimensions relevant to hazard and accident analyses.
• Process description should include details on basic process parameters including: (1) types and quantities of radioactive and other hazardous materials; (2) process equipment; (3) instrumentation and control systems and equipment; (4) basic flow diagrams; and (5) operations including major interfaces between structures, systems and components (SSC).

2.2. Site characteristics

The site description should describe the location of the site and of the facility on the overall site, identify facility boundaries, and locate nearby facilities that could affect the safety of operations or be affected by the facility. Information should be provided on external accident initiators both natural and man-made to support assumptions used in the hazard and accident analyses.

• Information on the geological, seismological, hydrological and meteorological characteristics of the site and the vicinity in conjunction with present and projected population distributions, land use, site activities, and planning controls should be included. For low hazard facilities it is not necessary to discuss meteorological conditions, hydrological, geological, seismological characteristics, and offsite accident effects.

2.3. Safety structures, systems and components

• Information should be provided on the structures, systems and components (SSCs) necessary to protect the public and workers and to provide major contributions to defence in depth. The section should also describe the attributes (functional requirements and performance criteria) required to support the safety functions identified in the hazard and accident analyses and to support subsequent derivation of safety requirements. In preparing information the Regulatory Guide: Construction of an item important for safety [7] should be consulted.
• The design codes, standards and guides used for establishing the safety basis of the facility should be listed. 
• The description of each such SSC should contain sufficient detail for describing its safety function and its relationship to the facility safety analysis taking into account the design basis and various modes of operation. 
• The SSCs should be categorised based on the importance of the safety function(s) they provide, the consequences of failure to perform the safety function, and related factors.
• Information on: component reliability, system interdependence, redundancy, diversity of fail-safe characteristics and physical separation of redundant system; evidence that the material used will withstand the postulated conditions; provisions for tests, inspections and surveillance, and effects of ageing on the operability of the SSC should be provided.

2.4. Hazard and accident analysis    

• Detailed information should be provided on the evaluation of normal, abnormal, and accident conditions. The process used to systematically identify hazards, categorise the facility, and evaluate the potential internal, man-made external, and natural phenomena events that could trigger accidents should be described in this chapter. 
• Postulated initiating events, including human induced events, which could affect safety should be identified and their effects, both individually and in credible combinations, should be evaluated. The list of internal and external hazards, including human induced hazards should be used to select initiating events for detailed analysis. Expert judgement, feedback from operating experience of similar facilities and deterministic assessment should be used for identifying postulated initiating events.
• Certain events might be consequences of other events, such as a flood following an earthquake. An external hazard causing multiple simultaneous events on a site and major releases of hazardous chemicals and radioactive material from various source locations should be considered in the hazard analysis. This should include the provision of external services to the facility that may be impacted. Credible consequential effects should form part of the initiating event. The impact of multiple correlated events on a single facility and the impact of a single event on all facilities on the same site should be considered in the safety analysis.
• For each hazard scenario, hazard evaluation should typically describe:
   
  • unmitigated hazard scenario and assumptions such as the initiating event, energy sources, qualitative or quantitative magnitude of radioactive or other hazardous material involved, release pathway(s), and initial conditions, if any
  • estimated likelihood of the unmitigated hazard scenario
  • estimated unmitigated consequences of the hazard scenario for the facility worker (qualitative or semi-quantitative), the workers of the co-located facilities (qualitative or semi-quantitative), and the public
  • available preventive and mitigating controls
     
• Where a large number of scenarios are involved simple summary groupings and summaries in terms of hazards, energy sources, causes, preventive and mitigating features, unmitigated consequence estimates, and unmitigated frequency estimates may be presented in this section.
• The accident analysis should include accident selection, design basis accident and design extension conditions. For each design basis accident or equivalent the consequences to personnel, the public and the environment should be evaluated.   
• In analysing the design basis accidents each event scenario (or group of event scenarios), the safety functions and corresponding items important to safety and administrative controls that are used to implement the defence in depth should be identified.     
• For multi-facility sites the potential interaction with or impact from accidents at other facilities on the same site should be considered in the analysis of the fourth and fifth levels of defence in depth.
• Where appropriate the analysis of design basis external events should demonstrate that the design is adequately conservative so that margins are available to withstand external events more severe than those selected for the design basis.
• The analysis of internal events should demonstrate whether the SSCs are able to perform their safety functions under the loads induced by normal operation and the anticipated operational occurrences and accident conditions that were taken into account explicitly in the design of the facility.

2.5. Operational limits and conditions

This chapter should provide and justify functional safety requirements derived from the functions of the SSCs and the accident analysis. This may include safety limits, safety systems settings, limiting conditions for operations, surveillance requirements and administrative requirements.

• The safety limits² of the process variables or parameters required for adequate control of the operation to protect the integrity of the physical system designed to guard against the uncontrolled release of radioactivity should be clearly described. These limits should reflect the capacity of the facility rather than its intended use or proposed production level. 
• Safety system settings³ should be provided for those process variables and parameters having significant safety functions such that if not controlled could result in a safety limit being exceeded.  The analysis should demonstrate that the safety limits will not be exceeded.
• Limiting conditions for safe operation should be clearly described demonstrating that there are acceptable margins between normal operating values and the safety system settings for items important to safety. 
• The settings for limiting conditions for safe operation should avoid the undesirably frequent actuation of safety systems. Limiting conditions for safe operation should include limits on operating parameters, requirements relating to minimum operable equipment and minimal staffing levels, and interventions to be taken by operating personnel to avoid the need for actuation of safety systems.
• Surveillance requirements describing the frequency and scope of periodic testing, calibration, or inspection activities to assure that necessary performance of systems and components is maintained and facility operations remain within safety limits, safety system settings and limiting conditions for safe operation.
• The administrative and organisational requirements for operational procedures, staffing, training and retraining of personnel, review and audit procedures, maintenance, modifications, records and reports, and required actions following a violation of operational limits and conditions should be clearly described. 
• The operational limits and conditions need to include administrative requirements concerning the organisational structure of the operating organisation and the responsibilities of key positions necessary for the safe operation of the facility.

2.6. Radiation protection

• A description of protection objectives, criteria and principles, including application of the principle of optimisation of protection and safety and the radiation sources in the facility. The information should include the radiation protection objectives of the design and a description of the dose limitation system for workers and the public including requirements for the optimisation of protection. All potential sources of radiation due to operation of the facility should also be described.
• Design features for radiation protection including radiation safety systems (e.g. shielding, ventilation) and appropriate equipment to ensure that radiation protection and contamination control are adequately provided for operational states of the facility should be described.
• The operational radiation protection program describing the administrative controls, equipment, instrumentation and facilities and procedures for radiation protection should be included noting that a ‘radiation protection plan’ is required by subsection 46(1)(iii) of the Regulations as part of the plans and arrangements for managing the facility. Detailed guidance on preparing a ‘radiation protection plan’ is presented in ARPANSA’s Regulatory Guide: Plans and arrangements for managing safety [8].

2.7. Radioactive waste management

• A description of the adequacy of measures for the safe management of all types of radioactive waste generated throughout the lifetime of the facility. These measures should be based on a waste management policy and strategy. This includes compliance with the applicable requirements for radioactive waste and effluent management. Descriptions of the facility design provisions, operating procedures and practices to minimise the generation of radioactive waste and effluents as well as the arrangements for managing the radioactive waste generated including segregation, monitoring, treatment, transport, storage and monitoring while in storage should also be included in this chapter. It is noted that a ‘radioactive waste management plan’ is required by subsection 46(1)(iv) of the Regulations as part of the plans and arrangements for managing the facility. Detailed guidance on preparing a ‘radioactive waste management plan’ is presented in ARPANSA’s Regulatory Guide: Plans and arrangements for managing safety.
• The radioactive waste management system covering gaseous, liquid, and solid waste should be described in accordance with the description of SSCs as applicable. The solid, liquid, and gaseous waste streams and sources including estimated inventories should be summarised in this chapter.
• Estimates of the quantity, volume, and characteristics of secondary radioactive waste resulting from radioactive waste pre-treatment or treatment in the facility. Possible disposal routes for the radioactive waste generated from the facility should be identified and presented in this section. Guidance for classifying radioactive waste with primary focus on long term safety after disposal is provided in the Guide for Classification of Radioactive Waste [9]. The classification scheme supports implementation of the safety requirements outlined in the Code for Disposal Facilities for Solid Radioactive Waste [10].

2.8. Decommissioning

• A comprehensive baseline radiological characterisation of a site should be undertaken prior to a facility becoming operational as this will greatly assist the decommissioning and site remediation processes.
• This chapter should describe the provisions and measures considered in the facility’s design, construction, commissioning and operation to facilitate decommissioning (e.g. modular construction to facilitate dismantling, operational practices to reduce generation of radioactive waste, operation and maintenance record keeping, control of modifications).
• Information on conceptual plans for decommissioning should be presented to demonstrate that adequate measures have been taken in the design and operation of the facility. This includes an evaluation of vulnerabilities to a spectrum of events to minimise site or environmental contamination that would complicate decommissioning or limit the effectiveness of environmental restoration.
• The provisions for managing the radioactive waste that will be generated during decommissioning of the facility should also be included in this chapter. Details of guidance on decommissioning are presented in the ARPANSA Regulatory Guide: Decommissioning of controlled facilities [11].
• Design aspects such as SSCs which will facilitate decommissioning, and potential points of contamination which will facilitate decommissioning should also be included in this chapter.
• The information on decommissioning should be adequate to demonstrate that an appropriate decommissioning plan has been prepared and will be maintained throughout the lifetime of the facility and that decommissioning can be accomplished safely and in such a way as to meet the defined end state.

2.9. Emergency planning and preparedness 

• A description of the emergency planning and preparedness arrangements of the facility describing policies and procedures including but not limited to the prompt declaration of an emergency, timely notification, activation of emergency response, assessment of the situation and implementation of necessary protective actions, and coordination of response actions and communication with relevant authorities. These arrangements should be based on the emergency preparedness category of the facility as required in GSR Part 7 [12].
• The emergency procedures should include the actions to be taken to mitigate the consequences of a nuclear or radiological emergency.
• Emergency procedures should be based on the accidents analysed in the safety analysis as well as those additionally postulated for the purposes of emergency planning in accordance with the requirements of GSR Part 7.
• Detailed guidance on preparing an ‘emergency plan’ is presented in ARPANSA’s Regulatory Guide: Plans and arrangements for managing safety [8].

2.10. Management System

• This chapter should describe the planning, implementation and control of essential activities relating to the management system procedures to ensure that the specific requirements at each stage of the facility — such as regulatory requirements, design and construction criteria, and acceptance criteria — are correctly applied and fulfilled. In particular, the responsibilities and authorities of the personnel concerned under the management system should be specified.
• The management system should consider four functional categories: management responsibility; resource management; process implementation; and measurement, assessment and improvement. The reporting hierarchy and lines of responsibility and authority should be such that they do not create conflicts between organisations and activities that could compromise safety during that conduct.    
• The management system should include provisions to ensure that relevant aspects of each stage of the facility such as the facility design, changes to the design, operating procedures, organisational structure and safety assessment are appropriately addressed.
• Activities including development, review, and approval of engineering calculations and documents, use of computer codes and their updates should be included in the management system.
• The management system should include the plans and arrangements for managing safety and in particular how effective control is maintained.

Detailed guidance on preparing the management system is presented in ARPANSA’s Regulatory Guide: Plans and arrangements for managing safety [8]. ARPANSA expects the management system to be reflective of IAEA GSR Part 2: Leadership and Management for Safety [13].

Appendix A: An example of a claims-arguments-evidence approach to demonstrating the safety case 

Claim: 

The facility presents an acceptably low risk of radiation exposure to personnel.

Arguments:

• The facility design has taken into account the potential for radiation exposure of personnel.
• Area radiation monitors are installed to provide indication of a radiation levels and to alarm if pre-set values are exceeded.
• Personnel receive training in radiation awareness, radiation protection, safety culture, task procedures and procedural use and adherence.
• Task procedures take radiation hazards and protection into account.
• A corrective action reporting system is in place to report radiation exposure risks, accidents and near misses.

Evidence:

• The facility and system design includes interlocks and shielding to protect personnel from radiation exposure.
• Commissioning and routine testing has confirmed the functionality of interlocks.
• Commissioning measurements and routine surveys show radiation levels around the facility to be acceptably low.
• Radiation levels in facility work areas are routinely monitored and logged.
• Personnel radiation monitoring show radiation exposures to be low and well below dose limits and constraints.
• Records indicate that the calibration of area radiation monitors and radiation survey instruments is maintained. 
• Work procedures provide pre-requisites, precautions and warnings in regard to radiation hazards and protection.
• Training records and assessments indicate attendance and proficiency in various topics including facility design, operation and safety.
• The corrective action database includes records demonstrating the actions to address radiation-related events.

References

[1] Australian Radiation Protection and Nuclear Safety Agency, Australian Radiation Protection and Nuclear Safety Act 1998.

[2] Australian Radiation Protection and Nuclear Safety Agency, Australian Radiation Protection and Nuclear Regulations 2018.

[3] Australian Radiation Protection and Nuclear Safety Agency, Code for Radiation Protection in Planned Exposure Situations, Radiation Protection Series C-1 (Rev 1) 2020.

[4] International Atomic Energy Agency, Safety Assessment for Research Reactors and Preparation of Safety Analysis Report, Specific Safety Guide No. SSG-20, IAEA, Vienna (2012).  

[5] International Atomic Energy Agency, Remediation Strategy and Process for Areas Affected by Past Activities or Accidents, Specific Safety Guide, WS-G-3.1

[6] International Atomic Energy Agency, Release of Sites from Regulatory Control on Termination of Practices, Safety Guide, WS-G-5.1 (2006)

[7] Australian Radiation Protection and Nuclear Safety Agency, Regulatory Guide: Construction of an item important for safety 

[8] Australian Radiation Protection and Nuclear Safety Agency, Regulatory Guide: Plans and arrangements for managing safety

[9] Australian Radiation Protection and Nuclear Safety Agency, Guide for Classification of Radioactive Waste, Radiation Protection Series G-4, 2020.

[10] Australian Radiation Protection and Nuclear Safety Agency, Code for Disposal Facilities for Solid Radioactive Waste, Radiation Protection Series C-3, 2018.

[11] Australian Radiation Protection and Nuclear Safety Agency, Regulatory Guide: Decommissioning of controlled facilities

[12] International Atomic Energy Agency, GSR Part 7 Preparedness and Response for a Nuclear or Radiological Emergency, 2015

[13] International Atomic Energy Agency, GSR Part 2 Leadership and Management for Safety, 2016

1 A Responsible Person has the same meaning as a Person Conducting a Business or Undertaking (PCBU), as defined in the Commonwealth Work Health and Safety Act 2011, who is conducting a business or undertaking that uses radiation and requires authorisation under appropriate legislation.

Responsible person is defined in the Code for Radiation Protection in Planned Exposure Situations Radiation Protection Series C-1 (Rev.1), 2020

2 Safety limits: Limits on operational parameters within which an authorised facility has been shown to be safe.

Safety limits are operational limits and conditions beyond those for normal operation. [IAEA Safety Glossary 2018]

3 Safety system settings: Settings for levels at which safety systems are automatically actuated in the event of anticipated operational occurrences or design basis accidents, to prevent safety limits from being exceeded. [IAEA Safety Glossary 2018]