This submission guide was developed to align with the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act), and the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations).
Section 63 of the Regulations requires licence holders to obtain prior approval from the CEO of ARPANSA before making any changes with significant implications for safety. This requirement applies to anything described within the original licence application, including modification of any controlled apparatus, controlled material or controlled facility, and how they are operated or used.
ARPANSA has produced several documents which relate to section 63 requests for approval, and it is important that licence holders are aware of the role of each:
The submission guide: Refers to this document, which details what information should be provided by licence holders on the section 63 form
The form: Requests for approval to make a change with significant implications for safety are submitted to the CEO of ARPANSA via a form. The form includes headings under which licence holders are to provide written responses. Brief explanations are given in the form on what information is required from responses for each heading, but far more detailed explanations are provided within the submission guide (this document).
Structure of the submission guide
This submission guide initially provides information on the guide itself and how it is to be used. The submission guide then follows the structure of the s63 form, providing licence holders with information about what is best to include in each section and sub-section of their answers on the s63 form. This submission guide is structured in the following way:
How to use the submission guide – A brief description of how licence holders should use this guide when requesting approval for a change with significant implications for safety
How ARPANSA will use the submission guide – A brief description of how this guide will be used within ARPANSA assessments and when interacting with licence holders
Content of the s63 form – Here information is provided on what is best to include for each section of the s63 form
General Expectations
Part 1: Background Information
Part 2: How will the Proposed Change be Managed?
Part 3: Effect of the Change on Existing Licence Considerations
Part 4: Ongoing Safety and Security Maintenance
How to use the submission guide
After licence holders have read through the regulatory guide and identified that a section 63 submission is required, they should then read through this submission guide.
This submission guide is to assist licence holders with drafting answers to the form. This is done by detailing general expectations, what information is to be provided under each heading of the form, and what can be referred out to existing documentation to be provided as part of the submission. When this submission guide refers to ‘the submission’, this is to mean the completed s63 form and all accompanying documents to be sent to ARPANSA. Following the guidance provided here will help licence holders to only submit what is necessary. This should serve to make the submission process more efficient and less burdensome for licence holders.
How ARPANSA will use the submission guide
This submission guide includes criteria against which ARPANSA assessors will be assessing the answers that licence holders provide within the s63 form. This provides ARPANSA with a consistent approach to assessing submissions.
If there are issues with a licence holder’s submission (e.g. missing information, lack of supporting evidence) ARPANSA will raise this with the licence holder and direct them to the relevant section of this submission guide, where further information can be found.
Content of the Section 63 Form
Parts 1-4 of the s63 submission should include all the information ARPANSA requires to assess the submission and ensure the requirements of all relevant legislation are met. The length of guidance given does not necessarily reflect the length of answer expected from licence holders.
It is possible that the same information may be relevant to multiple sections of the form. For example, information provided in Part 2 on change management may also be relevant to Part 3c on optimisation. In this example referring back to specific information in Part 2 within the Part 3c response is appropriate so long as the relevance to optimisation is then explicitly outlined.
General expectations
The form outlines general expectations for responses. These expectations are replicated here with additional detail.
The information within the submission needs to help the CEO of ARPANSA to decide on whether the implications for safety of your proposed change will be satisfactorily managed.
The proposed change should be mature, and the submission should be an objective appraisal of the safety of the change.
The amount of information in responses should be proportional to the complexity of the change you are proposing to make, i.e. a change to a major facility will need more detail here than a change to a source licence. If any of the headings included in the form are not relevant or do not need to be considered for this change, explain why in the appropriate section.
The contents of the submission should follow a ‘claims, arguments, evidence’ structure. This refers to the way in which licence holders should demonstrate that the information provided is relevant and sufficient to meet ARPANSA’s requirements and for the CEO of ARPANSA to grant approval.
Claims should be a simple statement of actions or considerations that have or will be taken.
Arguments should explain why this action or consideration is relevant to both safety and the heading under which it is included.
Evidence should support the claim and argument being made and can include additional documents (e.g. risk assessments, work instructions, engineering diagrams) submitted alongside the completed s63 form. All additional documents provided should have a clear reason for being included in the submission.
All photographs, diagrams or graphs provided should be referred to within responses. Explanations should be provided of their content and relevance. These items should be properly formatted (e.g. graphs should have labelled axes). If particular aspects of these items are relevant, these aspects should be identified (e.g. highlighted, circled, identified using arrows).
If the licence holder is referencing a specific part of a provided document, this reference should direct to a specific section/page/paragraph.
Part 1: Background information
In Part 1 of the form licence holders should provide all details that ARPANSA assessors need to understand and fully appreciate the change being proposed. This includes context on what is being changed and its role within the existing licence.
This part contains two sections: Part 1a asks for the details on what the proposed change is and Part 1b asks why the change is being made. Information provided here should be proportional to the complexity of the change being proposed.
What change are you proposing to make?
Answers to this section should provide the details of the change being proposed. This includes all relevant background information, plans for how the change will be carried out, and intended outcomes of the change. Relevant information to provide includes:
Background information on the licence under which the change is being proposed, e.g. its function and role in the licence holder’s organisation.
Context on how this change will impact the function and role of the licensed controlled activity (e.g. if a facility is being modified, which aspect of the facility is being modified and how will this impact the safety of the facility).
A comparison of how things are before the change and how they are intended to be after the change.
Details on what work needs to be done in completing the change (e.g. replacing of components, changes of processes, changing of organisational structures).
Explanations of how the change is of relevance to nuclear safety or radiation protection.
Include discussion of risks this work could pose to workers, the public or the environment (e.g. risk of exposure). These discussions should be brief and objective
Licence holders can supplement their answers in the form by referring out to external documents (e.g. instructions, procedures, drawings) to evidence claims and arguments, or where greater detail is required.
Licence holders should clearly outline why the submission qualifies as a section 63. To assist in this, a drop-down box is provided in the form where licence holders are to select the primary implication for safety that the change entails. These implications for safety are taken directly from ARPANSA’s guide on when to seek a section 63 approval, which also contains the thresholds of each of these implications for safety. Beyond this selection, a brief sentence or two justifying this selection is sufficient.
Why are you making the change?
Answers in this section should explain why the proposed change is being made. This can include:
Explanation of why the change is being proposed now. For example, does equipment need to be replaced as it is nearing end-of-life?
Explanation of what would happen if no change were to occur.
Explanation of why making this change in this way was chosen over other possible alternatives.
Answers given in this section should demonstrate to ARPANSA assessors that the proposed change has been sufficiently considered.
Assessment of the change
The change should be assessed to understand the impact it will, or may, have on people and the environment. When working with radioactive sources, radiation-producing apparatus, and facilities, some level of exposure is reasonably expected to occur. The level of exposure expected from normal working conditions (normal exposures) to workers and the public should be understood and documented. There is also the potential for higher exposures to occur if there are failures of people, plant or equipment. The level of potential exposures should be understood in terms of the magnitude of impact and likelihood.
The assessment should clearly show the magnitude of the hazard present and the effect of any systems, structures, or components that modify the hazard. All input values should be specified and referenced so their source is visible and traceable. The assessment should be reviewed by others within the organisation and should be able to be readily understood by people independent of the project. A graded approach to the assessment should be performed. The greater the hazard associated with the change, the greater the effort expended on the assessment and the greater degree of documentation create
The assessment can be provided as a separate document but it is a key component that will be drawn upon and will underpin the below sections of the submission.
Part 2: How will the proposed change be managed?
Answers to this section should provide details on how the process of making the change will be managed and controlled to ensure safety, and that the safety objectives of the change are met. This part only concerns what is done during the change, with details on ongoing maintenance after the change to be provided in Part 4. Possible aspects to be considered include:
Control factors: How will the change be controlled while it is taking place? Will this include any temporary arrangements/measures? If so, what impacts could these arrangements have on safety?
Radiation protection: How will staff exposure be estimated, measured, and limited? How will exposure to staff not involved in the change be prevented?
Deviations: How will unintentional deviations from the plan be monitored, identified and managed?
Staff communication: How will the impacts of any changes made to organisation or team structures as part of the change be managed? For example, if you are changing your organisational structure, how will staff know who to report to?
Accountability: Who is accountable for leading the change and how will the organisation make sure this is communicated to those involved? Is there a single point of accountability for each part of the change?
Part 3: Effect of change on existing licence considerations
The subheadings within this part of the form are directly derived from legislation. Each is found in sections 53 or 54 of the Regulations, except for Part 3f International best practice which is derived from sections 32 and 33 of the Act. These sections of the legislation list matters that the CEO of ARPANSA must consider in granting a licence, and so ARPANSA assessors are to understand how each would be impacted by any changes made.
Undue risk
Scope: Undue risk is a risk that is unnecessary or excessive. Measures for controlling radiation risks must ensure that no individual bears an unacceptable risk of harm, and that the environment is protected.
The submission should demonstrate consideration of undue risk both during and after the proposed change.
The normal exposures to workers and the public should be as low as reasonably achievable (see optimisation below) and less than the relevant dose limits. Undue risk arguments should consider the risks that may be incurred in worst-case scenarios, emergencies or other instances where unexpected or unintended events may occur.
If potential exposures (i.e. impact) to workers and the public in worst-case scenarios are greater than the relevant dose limits, the likelihood of these exposures should be reduced to a level that is not expected to occur. The acceptable level of likelihood for these types of potential exposures should be commensurate with the magnitude of the exposure (i.e. the higher the magnitude, the lower the likelihood). However, where a consequence is high, a deterministic approach should be considered where the event leading to exposure is assumed to occur and controls or mitigations are put in place regardless of the likelihood of occurrence. Where mitigation action is planned to reduce the consequences of any anticipated abnormal occurrence, this action should adopt the principles of optimisation described in Part 3c below.
The radiation protection principle of limitation is relevant to this heading. Further information on this concept can be found in ARPANSA Radiation Protection Series F-1 under the heading ‘Limitation of risks’.
Submissions will be assessed on undue risk by taking account of the following:
The licence holder’s management system for their plans and arrangements to determine reasonable assurance that the change will be within the limits of the safety case. The assessor will use a holistic approach that considers the interaction of technical, human, and organisational factors.
The inherent risks and residual risks of the proposed change after the application of risk mitigating controls. The assessor needs to understand the likelihood that these controls will be properly applied during the operation of the proposed change.
The adequacy of the risk assessment and management process. This will include the reliability of data supporting the risk assessment.
Net benefit
Scope: The submission should show that the proposed activity is warranted by providing a net benefit to individuals or society (in the planned work, the change being made should do more good than harm). That is, the conduct should be justified, considering societal, economic and other relevant factors.
The radiation protection principle of justification is relevant to this heading. The submission should demonstrate the benefit of the change taking account of the harm of any work involved in the change as well as the desired outcome of the change. The benefits considered should be specific and a direct result of the change (e.g. detailing how an improved design will reduce exposure to workers).
Net benefit arguments should weigh up the benefits of making a change against the harm the planned work would entail. For example, if a worker is expected to receive a dose in making the change, this would need to be justified in terms of the benefit the change would bring about. It should be based on the expected safety risks rather than the worst-case scenarios. Consideration of worst-case scenarios outside of the planned work should be outlined in Part 3a Undue Risk.
The radiation protection principle of justification is relevant to this heading. Further information on this concept can be found in ARPANSA Radiation Protection Series F-1 under the heading ‘justification’.
Submissions will be assessed on net benefit by taking account of the following:
The information provided for the change to see whether the benefits of the change outweigh the potential harm to the community and the environment.
The level of net benefit to the community, research or other special populations.
The impact on future doses and potential exposures associated with waste management and decommissioning.
Optimisation of protection
Scope: Optimisation refers to the processes for managing the magnitude of individual doses, the number of people exposed, and the likelihood of exposure, being As Low As Reasonably Achievable (ALARA), taking into account economic and societal factors.
The submission should demonstrate consideration of optimisation of protection both during and after the proposed change. Optimisation should also be applied to mitigation actions associated with anticipated abnormal occurrences. There is no lower limit below which the process of optimisation should cease. However, the submission should take a graded approach to demonstrating an optimal solution has been achieved. For instance, far greater effort and detail of analysis would be expected for significant changes to hazardous facilities than for minor changes to low hazard activities with sources.
In determining measures that optimise radiation protection, a licence holder should consider any potential negative impact this may have on other areas of safety or security. This can be discussed and explained in the submission.
Submissions will be assessed on optimisation of protection by taking account of the following:
The number of people affected and the magnitude of normal exposures.
The number of people affected, the magnitude, and the likelihood of potential exposures.
The interface whereby the controls applied or the approach adopted for managing either normal or potential exposures affects other exposures.
The selection of suitable constraints for dose and risk for planned exposures. The dose and risk constraints should be set prior to considering the change and evaluating options/approaches and should drive good practice and continuous improvement in radiation protection.
The identification of protection options and the selection of the best option given the prevailing circumstances.
The effectiveness of implementation of the selected option.
Technical, human and organisational factors
Scope: The submission should acknowledge interactions between people, technology and the organisation in relation to safety.
The submission should demonstrate a holistic approach to safety by providing evidence that technical, human and organisational factors have been considered and managed throughout all aspects of the change. ARPANSA provides definitions of, and guidance on, technical, human and organisational factors in ARPANSA’s Holistic Safety Guide. A separate guidance document provides licence holders with sample questions regarding holistic safety.
Examples of specific factors which can be considered within a submission are given below. Not all of these factors, or the questions provided alongside them, may be relevant to all submissions.
ARPANSA assessors may assess consideration of technical, human, and organisational factors by taking account of some or all of the following:
Technical factors
Defence in depth: How is defence in depth impacted by the change during and after completion? Is defence in depth appropriate? Is there evidence of the effectiveness of these defences?
Human-technology interface: Is all required information provided to the operator by the machine interface (e.g. control panel, display screen) in an understandable and legible manner? Has the implementation of any technology impacted the way in which work is done, and has this been considered in safety and risk assessments?
Human factors
Expertise & training: Do staff possess the necessary expertise to perform the change? Have staff received the necessary training to perform the change? How are these aspects measured and verified?
Equipment design: Has the design of equipment been user-centred? Is equipment human-error tolerant/evident?
Human limitations: Have processes been designed to account for human factors/limitations? For example, fatigue, cognitive demand, physical limitations, the operational environment.
Non-technical skills: Have non-technical skills been considered? For example, leadership, communication, teamworking.
Organisational factors
Safety culture: Does the organisation have clearly recognised values, and is there evidence that they are upheld? Is there an open reporting culture within the organisation? Is there a clear history of safety and security forming part of decision-making?
Leadership and management structure: Are there clear reporting lines and points of accountability? Is this true of any temporary arrangements made to reporting lines or work teams for the purposes of the change? Are there single points of accountability for each aspect of the change? Do leaders model a commitment to safety and security? Do leaders seek out operational information, both good and bad?
Resilience: Has the organisation demonstrated the ability to respond, monitor, learn and anticipate?
Capacity to comply
Scope: Capacity to comply refers to the licence holder’s ability and willingness to comply with all legislative requirements under the Act, the Regulations, and licence conditions. Considerations of whether licence holders have the resources, organisational support and willingness to comply in making a change are of relevance.
The licence holder should demonstrate how the proposed change will affect their capacity and willingness to comply with the Act, the Regulations and licence conditions.
Submissions will be assessed on capacity and willingness to comply by taking account of the following:
The compliance history of the licence holder, and any developments which may raise concerns regarding capacity or willingness to comply in the future. Any self-assessment licence holders make of their own compliance history should be brief and objective.
Availability and commitment of resources to safety, and the proposed change generally. Licence holders should demonstrate that sufficient resources are dedicated to the change to ensure the proposed change is carried out safely.
The impact of competing goals and priorities on safety and organisational performance. Licence holders should demonstrate a capacity and willingness to manage competing goals and priorities to ensure the management of safety.
Leadership and the organisational structure of the licence holder. This includes the presence of clear lines of accountability and responsibility which serve to enhance capacity and willingness to comply.
Safety culture, including the regulator-licence holder relationship and its impacts on capacity and willingness to comply.
The maturity of the licence holder’s management system. This includes the requirements of s57 to s58 (inclusive) of the Regulations, and whether the licence holder has the tools available to support critical safety functions and ongoing compliance requirements.
The presence and effectiveness of organisational measures to control safety, e.g. independent safety assessment, review, and inspection/audit functions.
Staff being suitably qualified, experienced, and capable of covering both normal operations and emergency conditions. Licence holders should show they are both capable and willing to follow procedure.
How the licence holder has learned from past incidents and accidents.
International best practice
Scope: This submission should demonstrate that all aspects of the change are in line with current best practice as evidenced by international standards, collaboration, or precedent.
The licence holder should demonstrate that international best practice has been considered in relation to the proposed change. If there are aspects of the change which do not require the consideration of international best practice, explain why not.
Submissions will be assessed on international best practice by taking account of the following:
Conformance to international standards and guidance published by reputable international bodies. Whilst there are many such bodies, ARPANSA’s CEO has produced a list of organisations whose publications represent international consensus. Publications from other reputable organisations may also be considered relevant.
Identification of similar work having been conducted internationally.
Engagement and collaboration with international experts.
Collaboration with international industry partners.
Evidence of following the precedent set by international counterparts, or applying lessons learned from issues they have faced.
Part 4: Ongoing management of safety and security
Answers in this part should detail the ongoing impact of the proposed change on safety and security after the change has been made. This includes the impacts on effective control and plans which relate to safety and security. The sections within this part are derived from sections 46 and 47 of the Regulations and relate to aspects which must be included in an original licence submission. ARPANSA assessors must understand how these licence aspects will be impacted by any proposed change after the change is made. For further information on these aspects, refer to ARPANSA’s Plans and arrangement for managing safety guide.
Considerations to be made when answering this part include:
Full plans (e.g. safety management plans) need not be provided. Instead, only the aspects of these plans which are changed as a result of the proposed change need to be provided.
There may be no change to ongoing management of safety and security for some of the below headings. In this case, provide a brief justification to explain why this aspect will not be impacted by the proposed change.
Consideration should be made of all proposed changes to structures, systems and components, as well as the work environment. Systems can be organisational as well as physical. For example, if a new source has been installed, how will it be managed and controlled so that its ongoing safety is assured?
Submissions will be assessed on ongoing safety and security management by taking account of the following:
Whether provided details are sufficient to assess ongoing safety and security management.
Whether changes to aspects of the original licence are appropriately and sufficiently considered. This includes whether any aspects of the change negatively impact upon safety or security.
Whether the applicant’s management system will be adequate to support critical safety functions and adequately manage ongoing compliance requirements that may be impacted by the proposed change.
This guidance applies to all of the below headings within Part 4 of the s63 form:
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.
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.
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 precursorsand 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, Situational 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
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
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
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
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.
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
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
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).
Australian Radaition Protection and Nuclear Safety Agency. (2019). Radiation Protection Series No. 11: Code of practice for the security of radioactive sources. Retrieved from https://www.arpansa.gov.au/sites/default/files/rps11.pdf
Australian Radiation Protection and Nuclear Safety Act 1998 (Cth).
Australian Radiation Protection and Nuclear Safety Regulations 2018 (Cth).
Badri, A., Gbodossou, A., & Nadeau, S. (2012). Occupational health and safety risks: Towards the integration into project management. Safety Science, 50(2), 190-198. doi:https://doi.org/10.1016/j.ssci.2011.08.008
Endsley, M. (2015). Situation Awareness Misconceptions and Misunderstandings. Journal of Cognitive Engineering and Decision Making, 4-32. doi:10.1177/1555343415572631
Flin, R., O'Connor, P., & Crichton, M. (2008). Safety at the sharp end: A guide to non-technical skills. CRC Press. doi:https://doi.org/10.1201/9781315607467
Hollnagel, E. (2010). Resilience engineering in practice: a guidebook. Ashgate.
Internationa Organization for Standardization. (2016). Ergonomics principles in the design of work systems. (ISO 6385:2016). Retrieved from https://www.iso.org/standard/63785.html
International Atomic Energy Agency. (2023). The operating organization and the recruitment, training and qualification of personnel for research reactors - Specific safety fuide No. SSG-84. Retrieved from https://www-pub.iaea.org/MTCD/Publications/PDF/PUB2048_web.pdf
International Organanization for Standardization. (2015). Quality management systems - requirements. (ISO 9001:2015). Retrieved from https://www.iso.org/standard/62085.html
International Organization for Standardization. (2004). Ergonomic prinicples related to mental workload. Part 3: Principles and requirements concerning methods for measuring and assessing mental workload. (ISO 10075-3:2004). Retrieved from https://www.iso.org/standard/27571.html
International Organization for Standardization. (2017). Ergonomic principles related to mental workload. Part 1: General issues and concepts, terms and definitions. (ISO 10075-1:2017). Retrieved from https://www.iso.org/standard/66900.html
International Organization for Standardization. (2018). Occupational health and safety management systems - requirements with guidance for use. (ISO 45001:2018). Retrieved from https://www.iso.org/standard/63787.html
International Organization for Standardization. (2021). Occupational health and safety management - psychological health and safety at work - guidelines for managing psychosocial risks. (ISO 45003:2021). Retrieved from https://www.iso.org/standard/64283.html
International Organization for Standardization. (2022). Information and documentation - management systems for records - guidelines for implementation. (ISO 30302:2022). Retrieved from https://www.iso.org/standard/81595.html
International Organization for Standardization. (2024). Ergonomic principles related to mental workload. Part 2: Design principles. (ISO 10075-2:2024). Retrieved from https://www.iso.org/standard/76686.html
International Organization for Standardization. (n.d.). Ergonomics of human-system interaction ISO 9241 (multiple parts).
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
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.
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.
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:
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, tPET: 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.
If the apparatus is a transilluminator or germicidal lamp where the emission is accessible, it is classed as controlled apparatus.
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.
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.
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.
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.
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, tPET, 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, texp.
If texp>tPET 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
This document is provided to assist controlled persons to determine whether a Class 1M and Class 2M source is classed as a controlled apparatus under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act). In particular, it clarifies the conditions 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 (OFCS)
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(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 AEL greater than the accessible emission limit of a Class 3R laser product is deemed a controlled apparatus and an optical fibre communication system where it exceeds a Hazard Level 3R as 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:
where the beam is collimated with a large diameter and optics are used to focus the beam, or
where the beam is highly divergent and optics are used near the laser aperture to collimate the beam.
Example: Laser diodes, fibre communication systems.
4. Class 2M lasers
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 0.25s. 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, 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 (OFCS)
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 OFCS 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. 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 Class 3R 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.
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.
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
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.
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: E365nm= 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
This document provides guidance for licence holders to meet the requirements of the Code for the Safe Transport of Radioactive Material (2019) (Radiation Protection Series C-2, Rev. 1) (Transport Code).
Legislative Basis for Safe Transport of Radioactive Material
The CEO of ARPANSA is the Competent Authority for the transport of radioactive material by a Controlled Person as defined in section 13 of the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) by road, rail and inland water ways within Australia. One of the functions of the CEO according to subsection 7(c) of Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations) is to grant approvals under the Transport Code in the CEO’s capacity as competent authority for the Commonwealth for the purposes of the Transport Code.
Paragraph 59(1)(c) of the Regulations states that the holder of a facility or source licence must comply with the Transport Code (Code for the Safe Transport of Radioactive Material).
To address the requirements of the Transport Code, ARPANSA undertakes the following regulatory activities with respect to Controlled Persons:
a) Issuing approvals
b) Assessment of designs
c) Assessment of the management systems of licence holders
d) Inspection or observation of test arrangements
e) Inspection or observation of manufacturing
f) Inspection or observation of maintenance and service arrangements
g) Inspection or observation of transport operations
h) Inspection or observation of emergency arrangements
i) Communication with relevant stakeholders
j) Investigation of incidents and accidents
k) Enforcement actions
l) Distribution of information and liaison with relevant stakeholders
m) Interdepartmental liaison and cooperation
n) Review and updating the transport code reflecting national and international legislative requirements
Issuing approvals
The following approvals are subject to ARPANSA assessment and approval:
a) Design for: i. Special form radioactive material
ii. Low dispersible radioactive material
iii. Packages containing 0.1 kg or more of uranium hexafluoride
iv. Packages containing fissile material
v. Type B(U) packages and Type B(M) packages
vi. Type C packages
b) Special arrangements
c) Certain shipments
d) Radiation protection programs for special use vessels
e) The calculation of radionuclide values that are not listed in Table 2 of the Transport Code.
f) Validation of certificates
Note: Some of the items listed above may be subject to the approval of other competent authorities as listed in Schedule B of the Transport Code.
Applications for approval are assessed against all relevant regulatory requirements. Depending on the nature of approval sought, ARPANSA may request additional information. The results of assessment determine whether an approval certificate will be issued.
The approval process also takes into account whether the applicant and subsequent consignors and carriers have adequate provisions in place for preparedness and response to an emergency in the transport of radioactive material.
When considering applications for approval of shipments under special arrangement, ARPANSA takes into account the demonstration by the applicant that the overall level of safety provided by the design of the package and the supplementary operational controls during transport is at least equivalent to that which would be achieved if all applicable regulatory requirements were met.
During the assessment process for competent authority approvals, ARPANSA will take into account whether the applicant has appropriate arrangements in place for monitoring of radiation doses to persons due to the transport of radioactive material, to ensure that the system of protection and safety complies with Code for Radiation Protection in Planned Exposure Situations (Rev.1) (2020)1.
Applicants seeking an approval for any of the above should include the information as described in the Approval Checklists.
Design assessment
Paragraph 220 of the Transport Code defines ‘design’ as:
the description of fissile material excepted under para. 417(f), special form radioactive material, low dispersible radioactive material, package or packaging that enables such an item to be fully identified. The description may include specifications, engineering drawings, reports demonstrating compliance with regulatory requirements, and other relevant documentation.
Therefore, ‘design’ should be considered to include much more than the drawings and specifications that enable the packaging to be manufactured. The design assessment should include the supporting reports and documents that substantiate or verify statements or assumptions made by the designer. It should also include all relevant arrangements for package preparation, instructions or provisions for maintenance and servicing, and any approved procedures for repair or modification. Details of the requirements are described in section VI of the Transport Code, and Section VI of the Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material (2018 Edition) | IAEA describe how to address these requirements.
Management system
During the assessment process for competent authority approvals, ARPANSA will take into account whether the applicant has an appropriate management system based on international, national or other acceptable standards for the management of transport as required by the Transport Code (paragraph 3062).
Note: Depending on the type of the business the management system for transport can be integrated into the organizational management system.
The management system is subject to inspection to determine its compliance with a certified quality system. In general, inspection of a management system usually covers the items described in Appendix A1. However, this list is not exhaustive and additional items may be inspected to determine compliance with the Transport Code.
Test arrangements
It is imperative that packages and scale models or representative examples of package features and materials (including special form radioactive material) are tested to demonstrate compliance of the design with regulatory requirements. Testing may be carried out by the designer, the applicant, a third-party testing organisation, or the competent authority or its nominated independent agent. ARPANSA may witness the tests to verify that they are performed in accordance with established procedures.
Manufacture of packages
Packages should be manufactured in a controlled manner and in accordance with the design specifications and management system. In order to verify this, ARPANSA may inspect manufacturing of packages. Such inspections may use the checklist in Appendix A2.
Maintenance and servicing
The licence holder must demonstrate before each use of packaging that the requirements of paragraphs 502 and 503 of the Transport Code have been met. The inspection of maintenance and servicing operations may include the items in the checklist in Appendix A3. During the lifetime of the packaging, the user should maintain sufficient records to demonstrate that the requirements of paragraphs 502 and 503 of the Transport Code have been met. These records are subject to inspection by ARPANSA.
For approved packages, the user should record all safety related deviations from and modifications to the specifications as well as any significant damage noted during use of the packages. ARPANSA should be informed of these deviations before the packages are returned to service within an agreed time period. Corrective measures or modification proposals including any plans for repairs will be subject to agreement by ARPANSA. Any packages undergoing such repairs, modifications or changes should not be returned to use until ARPANSA has approved the change.
Transport operations
ARPANSA may undertake inspection of transport operations. Such inspections may be conducted during any phase of transport or during storage in transit and may be announced or unannounced. Typical transport inspection items appear in the checklist in Appendix A4.
The specific requirements for notification of the competent authority are established in paragraphs 557–563 of the Transport Code. The competent authority may request additional notification before a package is shipped or after it has been received to allow for certain inspections to be undertaken. The need for further notification should be determined in accordance with the package types and the number of shipments made and received.
Enforcement actions and investigations of incidents
ARPANSA’s Compliance Policy describes the graded approach to non-compliance. Investigation of incidents and accidents will be carried out in accordance with established procedures. If an incident involves more than one competent authority then the inspection may be jointly conducted.
Distribution of information
ARPANSA will prepare, distribute and update information and guidance such as this to facilitate compliance. Such information is intended to assist users in the application and interpretation of the Transport Code. ARPANSA may liaise with other relevant agencies to organise training, seminars and workshops.
Inter-jurisdictional liaison
ARPANSA liaises with other competent authorities to share information in relation to safe transport of radioactive material and to maintain national uniformity in regulating transport of radioactive material through the Radiation Regulators Network (RRN). ARPANSA leads a national competent authority working group, the ‘Transport Competent Authority Forum’ that discusses national and international issues related to transport of radioactive material to assure national uniformity and international harmonisation.
Review and update of requirements of the Transport Code
There is a process in place to review and update the Transport Code to maintain international harmonisation, reflecting the requirements of international standards and legislation such as IAEA Specific Safety Requirements for safe transport of radioactive material. Associated guidance documents are revised accordingly.
Appendix A – Inspection checklist
As part of compliance monitoring ARPANSA undertakes inspection and/or site visits of transport activities. The following appendices provide guidance on the elements considered in the inspection activities in the areas of Management System (Appendix A1), Manufacturing of Packages (Appendix A2), Maintenance and Servicing (Appendix A3) and Transport Operations (Appendix A4).
A1 Management System
a) Line of responsibility (organisational structure) and adequacy of resources to meet the requirements of the Transport Code
b) Training of personnel
c) Procedures for the design and fabrication or for the selection and procurement of packaging
d) Appropriateness of packaging for the specific contents of packages by the consignor
e) Records (e.g. certificates and any associated instructions for handling, loading, storage, use and maintenance of the packaging etc.)
f) Procedures are followed for the preparation and use of the package, in accordance with the approval certificate, the instruction manual and related documents
g) Procedures for marking and labelling of packages
h) Procedures for calibration instruments and monitoring of packages for both radiation and contamination.
i) Procedures are for preparation and control of all relevant shipping documents, for providing correct placarding of the carrier’s vehicles, for providing all the required documentation to carriers, and for providing any required notification to the competent authorities of each State into which or through which the consignment is transported.
j) During transport, carriers perform any required actions relating to placarding, stowage and segregation of packages, etc. particularly any administrative controls relating to exclusive use shipments, or supplementary operational controls as specified in the competent authority certificate.
k) Radiation protection program for its activities related to the transport of radioactive material
l) Procedures for non-conformance control, investigation, reporting and communication
m) Arrangements for emergency response
A2 Manufacturing of Packages
1. Management system
a) Availability of management system for manufacturing process
b) Quality assurance system verification
2. Equipment
a) Adequacy and suitability of equipment for production
b) Adequacy and suitability of inspection and test equipment
3. Personnel
a) Training and qualifications
b) Accreditation records
4. Documentation
a) Documented procedures/plans
b) Availability and currency of all drawings, specifications and records
c) Control procedures for documentation
d) Conformance with identification numbers and serial numbers
5. Materials
a) Control of material for manufacturing
b) Procurement of materials and conformance with standards
c) Storing and testing of materials for conformance with specifications
6. Manufacture
a) Conformance with design specifications
b) Any modifications to the approved design
c) Process controls, tests and inspections during manufacture
7. Records
a) Adequacy of records of operations
A3 Maintenance and servicing
1. Documentation
a) Availability of maintenance and service instructions and schedules
b) Specific reference to disassembly and assembly procedures and maintenance frequency in instructions and schedules
c) Package logbook
d) Verification of logbooks and records by authorised personnel
2. Specification of components or features
a) Identification and categorisation of package components or features
b) Verification of categories
3. Testing and inspection
a) Evidences of specific tests and inspections. For example, functions or operational tests of components; results of visual inspections; pressure test; dynamic testing; leak test; non-destructive testing
4. Packaging components
a) Procedures for repair, reconditioning, refurbishments and disposal of packaging components
5. Equipment and tools
a) Availability of specific test equipment
b) Calibration of equipment
c) Availability of special equipment
6. Training
a) Appropriate training of personnel (e.g. task specific)
b) Adequacy of training program
7. Records
a) Records management
A4 Transport operations
1. Phase of inspection
a) Prior to dispatch
b) During shipment
c) During trans-shipment
d) During storage in transit upon arrival at destination
2. Driver instructions/handbook
a) Availability of written instructions
b) Emergency procedures/instructions
c) Procedures/instructions for trans-shipment or en route storage requirements, in applicable
d) Training/competency certificate
3. Consignment of documentation (load manifest)
a) Availability of load manifest with shipment details
b) Details of load manifest such as source type and activity, package types, category labelling
c) CSI (criticality safety index)
d) Confirmation of TI (transport index) and/or SI
4. Particulars of consignment
a) Availability of competent authority certificates
b) Compliance with provisions and conditions of approvals
c) Completeness of documentation (e.g. authorisation, sign off, holding points)
5. Vehicles
a) Vehicle maintenance program and records
b) Suitability of the vehicle (e.g. weight limitations)
c) Tie-down and anchorage points (including test results)
d) Placarding of vehicles
e) Compliance with stowage conditions
6. Operators
a) Adequacy of training
b) Training records
c) Radiation protection program
7. Procedures
a) Approved written procedures
8. Emergency arrangements
a) Approved plans and procedures
b) Compatibility of consignor and carrier’s plans
Footnotes
1. RPS C-1 Code for Radiation Protection in Planned Exposure Situations (Rev. 1) (2020) sets out the requirements in Australia for the protection of occupationally exposed persons, the public and the environment in planned exposure situations. The primary means of controlling exposure in planned exposure situations is by good design of facilities, equipment, operating procedures and through training – all of which contribute to optimisation of protection. C-1 is based on the ‘requirements’ relating to planned exposure situations described in the Safety Requirements of the International Atomic Energy Agency (IAEA); Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards General Safety Requirements Part 3, GSR Part 3 (IAEA 2014).
2. Para 306: A management system based on international, national or other standards acceptable to the competent authority shall be established and implemented for all activities within the scope of the Regulations, as identified in para. 106, to ensure compliance with the relevant provisions of these Regulations. Certification that the design specification has been fully implemented shall be available to the competent authority. The manufacturer, consignor or user shall be prepared:
(a) To provide facilities for inspection during manufacture and use;
(b) To demonstrate compliance with these Regulations to the competent authority.
Where competent authority approval is required, such approval shall take into account and be contingent upon the adequacy of the management system.
This Regulatory Guide has been prepared to advise potential Commonwealth applicants, the public, and other stakeholders of the issues that will have to be addressed by an applicant when applying for a licence under the ARPANS Act to prepare a site for a controlled facility. It describes objectives for protection of human health and of the environment, drawing upon international best practice in relation to radiation protection and nuclear safety. I may decide to issue a licence authorising an applicant to prepare a site for a controlled facility only if the applicant demonstrates that the proposed facility will achieve the required level of radiation protection. The application should provide enough information to demonstrate that the facility can operate safely under all foreseeable circumstances. This Regulatory Guide is an update of the draft 1999 Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Regulatory Guidance. It has been finalised after consideration of comments received during stakeholder consultation that occurred in the production of this Guide.
Carl-Magnus Larsson
CEO of ARPANSA
August 2014.
1. Introduction
1.1 Purpose and Structure of this Regulatory Guide
This Regulatory Guide is directed to Commonwealth entities applying for a licence under the Australian Radiation Protection and Nuclear Safety (ARPANS) Act 1998 (Cwth 1998) to prepare a site for a controlled facility, and to other stakeholders including the public, to:
assist in understanding the overarching statutory considerations and how the application will be assessed by the regulatory body
assist in understanding the requirements for the content of an application and to address the question “what is required?” in the application process
provide guidance based on national and international best practice for meeting the requirements and attaining high levels of safety and security.
The relevant Australian regulatory and safety standards framework is summarised in this introductory chapter (Part 1).
Parts 2 and 3 of the Regulatory Guide, ‘Requirements for Siting a Controlled Facility’, present:
the requirements from Australian standards and codes of practice that are mandated in legislation
additional guiding principles based on international best practice that establish the expectations of the CEO of ARPANSA for the protection of people and the environment.
Parts 4 and 5, ‘Technical Aspects of Site Selection’, provide guidance from international best practice for consideration by the applicant in meeting the relevant requirements. Some guidance on the system for protection of human health and the environment is presented in Annex A1. This Regulatory Guide replaces the draft Regulatory Guide RG-4 Criteria for the Siting of Controlled Facilities (ARPANSA 1999).
1.2 Scope
This Regulatory Guide draws together the essentials (requirements) that are set out in the ARPANS Act, Regulations and relevant national codes, and presents advice (guidance) to inform potential applicants seeking regulatory approval to site a controlled facility. The Guide, in setting out international best practice and the requirements established in legislation, does not set any new requirements.
The guidance presented here is generally applicable to the siting of all controlled facilities in Australia. Controlled facilities are defined in Section 13 of the ARPANS Act as:
(a) a nuclear installation; or
(b) a prescribed radiation facility.
A nuclear installation defined in Section 13 means any of the following:
(a) a nuclear reactor for research or production of nuclear materials for industrial or medical use (including critical and subcritical assemblies)
(b) a plant for preparing or storing fuel for use in a nuclear reactor as described in paragraph (a)
(c) a nuclear waste storage or disposal facility with an activity that is greater than the activity level prescribed by regulations
(d) a facility for production of radioisotopes with an activity that is greater than then activity level prescribed by regulations made for the purposes of this section.
A prescribed radiation facility is defined in Regulation 6 of the Australian Radiation Protection and Nuclear Safety Regulations 1999 (ARPANS Regulations). The definition includes the following types of facilities:
(a) certain particle accelerators
(b) certain irradiators used to deliver very high doses of ionizing radiation to material
(c) facilities (other than nuclear installations) used for the production, processing, use, storage, management or disposal of certain sealed and unsealed sources.
The Regulatory Guide: Licensing of Radioactive Waste Storage and Disposal Facilities v2 (ARPANSA 2013a) should also be referred to for the siting of waste storage and disposal facilities, as this guide provides specific guidance on matters that may not be covered in detail here.
1.2.1 Requirements and Guidance
In this Regulatory Guide, a requirement is something that is established by the ARPANS Act or the ARPANS Regulations. Specific requirements are stated in relevant national codes referred to in this Guide. In this context, the word ‘must’ is used to indicate that the particular requirement is essential.
Under Section 32(3) of the ARPANS Act, the CEO of ARPANSA is required to take into account relevant international best practice in relation to radiation protection and nuclear safety in deciding whether to issue a facility licence. In International Atomic Energy Agency (IAEA) safety standards, the Safety Requirements, which flow from the Fundamental Safety Principles (IAEA 2006), provide international best practice requirements to be met to ensure the protection of people and the environment, both now and in the future. These requirements are expressed as ‘shall’ statements together with statements of associated conditions to be met. Experience and expertise from other countries and international organisations should also be considered when determining what constitutes international best practice. Guidance is practice-specific advice on best practice and on how to comply with the requirements. This advice is generally based on an international consensus on the measures recommended. In general, the guidance presented in this Regulatory Guide reflects national and international best practice to help users of this document to attain high levels of safety and security. The guidance is expressed as ‘should’ statements. The advice is not mandatory, and alternative means are acceptable so long as safety and security objectives are met.
1.3 Legislative and Regulatory Framework
The regulatory environment in the Commonwealth of Australia for radiation safety and security embraces the following principles:
the prime responsibility for safety must rest with the person or organisation responsible for facilities and activities that give rise to radiation risks. This is the first principle of the IAEA Fundamental Safety Principles (IAEA 2006), and of the new draft Australian Fundamentals: Protection Against Ionising Radiation (ARPANSA 2014a).
the regulator, ARPANSA, is entirely separate from the proponent and/or operator of a controlled facility
international best practice will inform regulatory decisions and guidance on how to achieve the required safety and security outcomes
consultation with stakeholders, including the public and relevant governments, will be an integral part of the regulatory and licensing processes. Stakeholders are regarded as an asset who will contribute knowledge to the process. The role of stakeholders and their interaction with the regulator will be to ensure the most informed decisions and best possible outcomes.
1.3.1 The ARPANS Act and Regulations
The Commonwealth legislation relevant to the regulation of radiation and nuclear activities undertaken by Commonwealth entities are:
Australian Radiation Protection and Nuclear Safety Act 1998 (Cwth 1998)
Australian Radiation Protection and Nuclear Safety Regulations 1999 (Cwth 1999a).
The object of the ARPANS Act is to protect the health and safety of people and to protect the environment from the harmful effects of radiation. An application to site a controlled facility must address all of the relevant matters specified in the ARPANS Act and Regulations as well as providing any additional relevant information requested by the CEO of ARPANSA.
1.3.2 Matters to be Considered by the CEO
Subsection 32(3) of the ARPANS Act states:
‘In deciding whether to issue a licence under subsection (1), the CEO must take into account the matters (if any) specified in the regulations, and must also take into account international best practice in relation to radiation protection and nuclear safety.’
Regulation 41 specifies the matters which the CEO must take into account when assessing a licence application. These include:
the content of any submissions made by members of the public about the application
whether the information establishes that the proposed conduct can be carried our without undue risk to the health and safety of people, and to the environment; • whether a net benefit from carrying out the conduct relating to the controlled facility has been demonstrated (which in the case of waste management facilities, may involve a progressive and systematic reduction of hazards)
whether the applicant has shown that the magnitude of individual doses, the number of people exposed, and the likelihood that exposure will happen, are as low as reasonably achievable, having regard to economic and social factors
whether the applicant has shown a capacity for complying with the ARPANS Regulations.
When taking this last point into account, the CEO may consider whether the applicant has sufficient resources (competence, funding, staff and other resources necessary to achieve the outcomes) available over the lifetime of the proposed facility.
Sub-regulation 40(2) of the ARPANS Regulations states that, as soon as practicable after receiving an application for a facility licence, the CEO must publish a notice in a daily newspaper circulating nationally, and in the Gazette, stating that the CEO intends to make a decision on the application. If the licence application relates to a nuclear installation, then the CEO must also 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.
1.3.3 CEO’s Guiding Principles
Regulation 39 and Part 1 of Schedule 3 to the ARPANS Regulations specify the information that the CEO of ARPANSA may require from applicants for a facility licence. ARPANSA’s application form for a facility licence requires the relevant information in Part 1 of Schedule 3 to the ARPANS Regulations to be provided. This may include information about other relevant matters. This additional information, based on international best practice, is presented in this Regulatory Guide as guiding principles. These guiding principles represent the expectations of the CEO in assessing the completeness of any licence applications submitted to ARPANSA. It is important to understand the distinction between a regulatory requirement and an expectation. Applicants cannot be made to ‘comply with’ international best practice until such time as it is legally applied to them through licence conditions imposed by the CEO. That does not happen until the licence is issued. Through this Regulatory Guide however, ARPANSA is indicating where more detail in an application will be expected by the CEO based on international best practice. Under the ARPANS Act, a licence that is issued by the CEO of ARPANSA is subject to conditions in Section 35 of the Act, conditions prescribed in the ARPANS Regulations (Part 4, Division 4), conditions imposed by the CEO at the time the licence is issued and any condition imposed by the CEO under subsection 36(2) after the licence is issued.
1.3.4 Relevant National Codes, Standards and Guides
Regulation 48 requires licence holders to comply with the following recommendations and codes of practice when dealing with controlled materials, apparatus and facilities, including disposal of controlled material and apparatus:
the Code of Practice for the Security of Radioactive Sources (ARPANSA 2007);
the Recommendations for Limiting Exposure to Ionizing Radiation and National Standard for Limiting Occupational Exposure to Ionizing Radiation (ARPANSA 2002);
the Code of Practice for the Safe Transport of Radioactive Material (ARPANSA 2008);
the Code of Practice for the Disposal of Radioactive Wastes by the User (NHMRC 1985)
the Code of Practice for the Near-Surface Disposal of Radioactive Waste in Australia (NHMRC 1992).
Other relevant Australian requirements and guidance are available in:
the National Directory for Radiation Protection (NDRP, ARPANSA 2011)
Holistic Safety Guidelines (ARPANSA 2012a).
1.3.5 Environmental Protection and Biodiversity Conservation Act (EPBC Act)
An application to prepare a site for a controlled facility could, under Sections 21 and 22 of the Environment Protection and Biodiversity Conservation(EPBC) Act 1999 (Cwth 1999b), constitute a ‘nuclear action’ and require approval from the Environment Minister, if the ‘nuclear action’ has, will have or is likely to have, a significant impact on the environment. Nuclear actions should be referred to the Environment Minister and may have to undergo an environmental assessment and approval process.
Applications for approval under the EPBC Act will generally precede a licence application under the ARPANS Act. The need for a referral under the EPBC Act and the timing for submitting a referral should be discussed with the Department of the Environment early in the planning process. More information on the approval process under the EPBC Act is provided on the Environment Department’s website: www.environment.gov.au/epbc/protect/nuclear.html.
1.4 Flow chart of siting process
Figure 1 provides an overview, albeit simplistic, of the siting process. It is important to note that the highest-ranked site may not be the most plausible site for various reasons. If a rigorous timeline is involved in the project delivery, then several well-ranked sites may be short-listed for simultaneous site characterisation to minimise potential delays, with the best being chosen through that process. More details are provided in the following sections.
Figure 1. Flow chart showing the decision process, proceeding from identification of multiple potential sites, the ranking of those sites, characterisation of preferred site leading to the licence application to site the controlled facility (adapted from IAEA 2013a).
Requirements for Siting a Controlled Facility
2. The Licensing Process
2.1 Staged Licensing Approach
The staged licensing process follows from Section 30 of the ARPANS Act. Part 1 of Schedule 3 of the ARPANS Regulations prescribes the information that the CEO may require from an applicant for each type of authorisation. The staged licensing approach is consistent with international best practice. The stages of the licensing process for a controlled facility may include:
licence application to prepare a site (including conceptual facility design)
licence application to construct
licence application to possess or control
licence application to operate
licence application to decommission, dispose of, or abandon (close) a facility.
It should be noted that whilst the overall process is staged, there is strong linkage between each individual licence application. The licence application for each stage needs to be forward looking and contain sufficient information on the safety and security aspects of subsequent stage(s), to allow for an informed decision to be made by the CEO. Under some circumstances, an applicant may choose to submit applications for more than one licence simultaneously. The application to prepare a site for a controlled facility is expected to include details of the conceptual design, as well as a preliminary safety case and other aspects as further detailed in this Regulatory Guide. The application should provide enough information to demonstrate that the facility can operate safely under all foreseeable circumstances. As the process proceeds through the various stages, the safety case and accompanying safety assessment will develop accordingly. The staged approach will allow for continuous improvement in design, operation and safety throughout the lifetime of the facility. ARPANSA recognises the importance of gaining community support during all phases of the licensing process. Experience has shown that sound technical assessments alone are generally insufficient to ensure successful implementation. As already stated above in Section 1.3, communication and consultation with stakeholders is crucially important in building trust and confidence in the regulatory process. Guidance on effective communication and consultation, and the role of the safety case in dialogue with the public and in building confidence in the safety of the facility, is presented below.
2.2 Content of the Application – Overview
Licence applicants need to complete an application form for either a prescribed radiation facility or nuclear installation, depending on the activity levels of the controlled material in the facility as calculated under the provisions in Regulations 7, 8 and 11 of the ARPANS Regulations. Application forms and general regulatory guidance for licence applications are available for download from the ARPANSA website: www.arpansa.gov.au/Regulation/guides.
Section 34 of the ARPANS Act requires an application for a licence to be in a form approved by the CEO and be accompanied by such fee as is prescribed by the regulations. Regulation 39 of the ARPANS Regulations specifies the information and documents that the CEO of ARPANSA may require to be provided by an applicant/proponent.
While the format of the application is a matter for the applicant, each of the elements needs to be addressed to meet the requirements of the ARPANS Act, the ARPANS Regulations and all relevant regulatory guidelines published by ARPANSA. A graded approach should be used when developing the application, such that the level of detail included is consistent with the magnitude of the possible radiation risks arising from the proposed facility. The application should be written so that the application and associated documents can be independently assessed. To this end, all sources of information need to be appropriately referenced.
In addition to the ARPANS Act and Regulations, the following guidance documents are available on the ARPANSA website for licence applicants:
Regulatory Assessment Principles for Controlled Facilities (ARPANSA 2001a);
Regulatory Assessment Criteria for the Design of New Controlled Facilities and Modifications to Existing Facilities (RB-STD-43-00 Rev 1, ARPANSA 2001b);
Regulatory Guide: Plans and Arrangements for Managing Safety (ARPANSA 2013b);
Regulatory Guide: Applying for a Facility Licence for a Nuclear Installation (ARPANSA 2012b); and
Regulatory Guide: Applying for a Facility Licence for a Prescribed Radiation Facility (ARPANSA 2012c).
The regulatory assessment principles detail how the issues of safety culture, safety analysis, and defence-in-depth should be addressed in a licence application. They are primarily written for ARPANSA assessors, but may also assist licence applicants or operators in the preparation of the safety analysis report (an element of the safety case) which accompanies the licence application for a controlled facility. The regulatory guide on plans and arrangements provides guidance on the information to provide for protection of human health and the environment when addressing Part 1 of Schedule 3 to the ARPANS Regulations.
These are:
effective control
safety management
radiation protection
radioactive waste management
security
emergency.
2.3 Licence to Prepare a Site for a Facility (Including Conceptual Design)
The application for a licence to prepare a site for a controlled facility must comprise, as a minimum, the general information referred to in items 1 to 4 of Part 1 of Schedule 3 to the ARPANS Regulations and the specific information referred to in items 5 to 7 of Part 1 of Schedule 3, which specify additional requirements to be met by an application seeking authorisation for preparing a site for a controlled facility. These additional requirements are:
a detailed site evaluation establishing the suitability of the site
information describing the characteristics of the site, including the extent to which the site may be affected by natural and man-made events
any environmental impact statement (EIS) requested or required by a government agency, and the outcome of the environmental assessment.
The wording of these additional requirements is taken from the current ARPANS Regulations. While applications for approval under the EPBC Act will generally precede a licence application under the ARPANS Act, it is acknowledged that the outcome of an EIS assessment may follow a siting licence application but would be expected prior to a decision being made on that licence. These requirements are in line with the IAEA Safety Requirements for site evaluation for nuclear installations.
The IAEA Safety Requirements document titled Site Evaluation for Nuclear Installations (IAEA 2003) states:
Proposed sites shall be adequately investigated with regard to all the site characteristics that could be significant to safety in external natural and human induced events.
The applicant is expected to supply, in addition to details on the site characteristics, information on:
the conceptual design for the facility, focusing on how the design impacts safety and security at and around the preferred site;
the transport system to and from the facility (modes of transport, transport routes, distances involved, current traffic/transport infrastructure conditions and usage and projected future traffic flows/usage for the life of the project and risk analysis thereof, and related safety and security considerations);
the beginnings of a decommissioning plan that will develop through the construction and operation phases of the facility. The IAEA Safety Requirements: Decommissioning of Facilities (IAEA 2014a) state that during siting, decommissioning is under ‘consideration’, and planning for decommissioning shall start during the design phase
the availability of resources over the lifetime of the proposed facility, including for decommissioning.
Some of these aspects (e.g. as regards facility design and decommissioning plan) are expected to develop as the project matures, and in their developed state must form part of the licence applications for future stages including the licence applications to construct or to operate the controlled facility.
3. Requirements and Guiding Principles
3.1 Demonstrating Radiation Protection
An application for a licence to site a controlled facility should contain enough information to demonstrate that there is a reasonable likelihood that the proposed facility:
can be sited, constructed, operated and closed safely
will meet all relevant legislative and regulatory requirements relating to radiation protection under all reasonably foreseeable circumstances.
It is recognised that some aspects related to this assessment may not be fully detailed at the siting stage; however, the assessment should consider reasonable values for materials that are likely to be handled at the site and any exposure scenarios that are likely to occur for this type of facility. Where site specific data are unavailable, data from similar sites and facilities could be used.
Additional information on the radiation protection principles and regulatory requirements that should be considered are provided in the national standard Recommendations for Limiting Exposure to Ionizing Radiation (1995) and National Standard for Limiting Occupational Exposure to Ionizing Radiation (2002) (ARPANSA 2002) and in Annex A1 of this guide.
3.2 Safety and the Safety Case
The requirements from international best practice to include a safety assessment and a developed safety case in an application for a licence to prepare a site for a controlled facility are implicit throughout the IAEA Safety Requirements.
The ARPANS Act and Regulations contain no specific requirement for the preparation of a safety case based around safety assessment principles for a controlled facility. However, based on international best practice requirements, a guiding principle of the CEO is that the applicant shall demonstrate that any proposed facility will meet the required level of protection by carrying out and presenting a safety case that draws upon the organisational and technical arrangements put in place, the characteristics of the site, the design of the facility, including any engineered safety barriers, and the arrangements for its construction and operation. Guidance for developing a safety case in compliance with this principle can be found in Section 4.2 of this Regulatory Guide.
3.3 Demographic Considerations
Based on international best practice, a guiding principle of the CEO is that an applicant for any licence covered by this Regulatory Guide shall, as part of the licence application, address the impact of the facility on the community in which the facility is, or is to be situated. All relevant current and future societal aspects shall be considered including transport routes within Australia and public concerns regarding local transport conditions.
3.4 Consultation
The expectation of the CEO is that the proponent shall include, in the application, an account of public consultation that has occurred, if any, including information on the format of the consultation, issues raised in submissions and responses to issues raised A guiding principle of the CEO is that the applicant for a facility licence for a nuclear installation will conduct appropriate stakeholder and public consultation, following a graded approach, in order to enable stakeholders to contribute knowledge to the siting and design processes. This is in addition to the requirement under Regulation 40 for public consultation by the CEO.
3.4.1 Summary of Application in Plain and Non-Technical Language
A guiding principle of the CEO is that the proponent shall provide a summary of the licence application and the supporting safety case, in plain and non-technical language, in order to facilitate stakeholder interaction in the review by the regulator of the licence application. The summary shall provide enough information and be presented in a format suitable for all stakeholders to understand the scope and content of the application, facilitate communication between all interested parties and promote understanding of the impact of the facility among all stakeholders. This plain-language summary may take the form of an executive summary of the safety case. Consideration shall be given to ensure that those who do not use English as their first language are included in the consultation process. Where Aboriginal people are involved as stakeholders, the expectation of the CEO is that such information shall be provided in a culturally appropriate manner.
3.5 Quality Assurance
In keeping with the IAEA Safety Requirements, a guiding principle of the CEO is that an application for a licence to prepare a site for a controlled facility shall include relevant aspects of a quality assurance programme, consistent with the stage of the project. A comprehensive quality assurance programme shall be applied to all safety-related activities, structures, systems and components of the controlled facility. This includes all related activities, from planning through siting, design, construction, operation, the various steps in the safety assessment process, long-term recordkeeping and decommissioning.
3.6 Provision of Adequate Funding
The IAEA states in the General Safety Requirements: Governmental, Legal and Regulatory Framework for Safety (GSR Part 1, IAEA 2010a) that:
The regulatory process shall provide a high degree of confidence… [that] authorized parties have the human, organizational, financial and technical capabilities to operate facilities safely or to conduct activities safely under all circumstances until their release from regulatory control.
A guiding principle of the CEO, based on international best practice, is that a licence application to prepare a site for a controlled facility shall include evidence of the provision of adequate financial resources over the lifetime of the controlled facility.
3.7 Security
An application for a licence to prepare a site for a controlled facility must address all relevant security issues as required under the Code of Practice for the Security of Radioactive Sources (RPS 11, ARPANSA 2007).
If nuclear material is involved in the facility, then progressively through the licencing process, beginning with concept design, the security systems and infrastructure protecting the nuclear material will need to comply with the requirements of the Convention on the Physical Protection of Nuclear Material (IAEA 1979) and the IAEA guidance document Nuclear Security Recommendations on Physical Protection of Nuclear Material and Nuclear Facilities (IAEA 2011a). This is managed through permits issued under s13 of the Nuclear Non-Proliferation (Safeguards) Act 1987 (Cwth 1987), administered by the Australian Safeguards and NonProliferation Office (ASNO). Nuclear security requirements vary considerably depending on the types and quantities of nuclear material and in many cases will be met by security measures put in place for compliance with RPS 11 without further modification.
3.8 Safety and Security Culture
Based on international best practice, a guiding principle of the CEO is that an applicant for a licence to site a controlled facility covered by this Regulatory Guide shall, as part of the licence application, provide information upon which an assessment can be made of the adequacy of the safety and security culture of the applicant organisation. The required information shall demonstrate the commitment of senior management within the operator to safety and security, and the establishment and maintenance of an appropriate culture within the facility to be licensed. ARPANSA’s expectations and advice are presented in the ARPANSA document Holistic Safety Guidelines (ARPANSA 2012a). Some details of how holistic safety will be implemented by ARPANSA are available on the ARPANSA website: http://www.arpansa.gov.au/Regulation/Holistic/index.
Any proposed change in the operator over the lifetime of the facility would be subject to similar scrutiny by the regulator.
The IAEA General Safety Requirements: Governmental, Legal and Regulatory Framework for Safety (GSR Part 1, IAEA 2010a) state the following:
Requirement 1 dealing with National Policy - “In the national policy and strategy, account shall be taken of the following: ... The promotion of leadership and management for safety, including safety culture.”
Requirement 29 dealing with Inspections - “In conducting inspections, the regulatory body shall consider a number of aspects, including: ... safety culture.”
3.9 Emergency and Remediation Preparedness
Principle 8 of the IAEA Fundamental Safety Principles (IAEA 2006) states that:
All practical efforts must be made to prevent and mitigate nuclear or radiation accidents.
The purpose of the information presented in this Regulatory Guide is to assist in selecting a site that will minimise the likelihood of any radiation accident associated with a controlled facility in Australia. However, history has clearly demonstrated that nuclear and radiation accidents that affect public and environmental health do occur.
Schedule 3 of the ARPANS Regulations states that an emergency plan for the controlled facility is required as part of the licence application to site a controlled facility. Information that may be useful in preparing this plan is available in Intervention in Emergency Situations Involving Radiation Exposure (ARPANSA 2004), and Regulatory Guide: Plans and Arrangements for Managing Safety (ARPANSA 2013b).
A guiding principle of the CEO based on international best practice (Larsson 2013) is that an application for a licence to site a controlled facility shall, as part of the licence application, provide information on how the chosen site meets criteria for remediation preparedness. The licence application to site a controlled facility shall include consideration of how the site characteristics may impact emergency and accident-recovery preparedness. Demonstration of adequate preparedness to remediate the effects of any environmental contamination arising from a radiation accident, including in the transport of radioactive materials, shall include information on the following:
division of responsibilities in accident recovery, including the role of stakeholders
approaches to defining targets and end states
potential methods and technology available for environmental remediation.
The purpose of such remediation preparedness, as well as helping to build trust and provide assurance for relevant stakeholders, is the recognition within the international radiation safety community, based on lessons learned from past major nuclear accidents, that it is too late to begin planning for accident recovery after an accident has occurred.
3.10 Identification of Representative Individuals of the Public
The International Commission on Radiological Protection (ICRP), in their Publication 101a Assessing Dose of the Representative Person for the Purpose of the Radiation Protection of the Public (ICRP 2006a) states that:
Dose to the public cannot be measured directly and, in some cases, it cannot be measured at all. Therefore, for the purpose of protection of the public, it is necessary to characterise an individual, either hypothetical or specific, whose dose can be used for determining compliance with the relevant dose constraint. This individual is defined as the ‘representative person’. The Commission’s goal of protection of the public is achieved if the relevant dose constraint for this individual for a single source is met and radiological protection is optimised. In accordance with the ICRP recommendations (ICRP 2006a), the CEO has determined as a guiding principle that the goal of protection of the public is achieved if the relevant dose constraint for the appropriately characterised representative individual is met and radiological protection is optimised.
3.11 Protection of the (Natural) Environment
In order to demonstrate that the proposed conduct can be carried out without undue risk to the health and safety of the environment, a guiding principle of the CEO is that the applicant shall undertake a screening assessment of doses to wildlife (i.e. animals and plants living within their natural environment) in the vicinity of the controlled facility by use of one of the internationally accepted screening tools. If a screening assessment indicates that exposures to relevant wildlife in the natural environment are likely to be higher than the screening dose rate (defined within the range 5 to 10 μGy per hour, depending on the conservatism demonstrated and species affected), more detailed assessments of potential environmental impact shall be undertaken.
Technical Aspects of Site Selection
4. General Guidance
General guidance applicable to the siting of controlled facilities is presented in this Section.
The ARPANS Act requires that, in deciding whether to issue a licence, the CEO must take into account international best practice in relation to radiation protection and nuclear safety. The CEO therefore expects an applicant for a licence to have regard to and apply international best practice. The previous sections describe the sources of international best practice for radiation protection and nuclear safety that predicate the CEO’s requirements and guiding principles. The sections below provide further guidance on the use of international best practice in framing an application for a licence to prepare a site for a controlled facility.
It is envisaged that an application will be based on:
international best practice in radiation protection and nuclear safety;
the results of available research; and
studies and data specific to the facility as appropriate.
Any and all unknown variables or assumptions made in the application should be clearly stated and discussed. The extent to which the limitations, if any, of available information may influence the conclusions of the application should be discussed.
ARPANSA recognises that there may be a need to make use of material that is considered to be of a confidential nature, for instance information of a commercial nature or on security grounds. The applicant may request that such information not be included in any publicly available document. ARPANSA would generally take the view that, subject to national security considerations, all relevant information would be available to the state/territory government where the facility is located.
4.1 Guidance on the use of the Graded Approach
The amount of detail provided in an application to site a controlled facility should be determined using a graded approach. This means that the level of detail and resources used should be proportional to the assessed level of risk (safety and security). When assessing the level of risk posed by the proposed facility, the applicant should consider:
the hazards and complexities of the work that will take place at the facility
the types of materials that will be used or stored at the facility
the particular characteristics of the planned facility and proposed site
potential impacts to workers, the public and the environment
any other relevant factors.
The application should provide enough information to demonstrate that the facility can operate safely under all reasonably foreseeable circumstances. If the possible risks to human and environmental health are low, the application may be less detailed than for a facility with higher risks.
If the EPBC Act is triggered, the siting licence application is likely to contain a similar level of detail to the Environmental Impact Statement required by the EPBC Act. The EPBC Act will have required a comparative assessment of the zero option (i.e. status quo – continue practices as now). This comparison process should be extended to the radiological safety and security aspects in the licence application.
Additional information on the graded approach can be found in the IAEA Safety Glossary (IAEA 2007).
4.2 Relevant International Standards
During the past decades, the IAEA has led the development of an international regime on nuclear and radiation safety. This involves three key elements: legally binding international treaties; globally agreed international safety standards; and provisions for facilitating the application of those standards.
A prime objective of the IAEA is to foster internationally harmonised approaches to radiation and nuclear safety, and to promote international best practice. A principal mechanism for achieving this harmonisation has been the establishment of internationally agreed safety standards and the promotion of their global application.
4.2.1 IAEA Safety Fundamentals
The hierarchy of IAEA Safety Standards involves three levels, with the IAEA Safety Fundamentals at the top. The document Fundamental Safety Principles (IAEA 2006) sets out the fundamental safety objective (to protect people and the environment from harmful effects of ionising radiation) and ten associated safety principles.
4.2.2 IAEA Safety Requirements
Beneath the Safety Fundamentals are the Safety Requirements, comprising seven General Safety Requirements (GSRs) and other Specific Safety Requirements. This integrated set of Safety Requirements establishes the international consensus of standards that is required to be met to ensure the protection of people and the environment, both now and in the future, governed by the objective and principles of the Safety Fundamentals.
An application for a licence to prepare a site for a controlled facility should address all relevant requirements from the GSRs and from the IAEA Nuclear Safety Requirements document Site Evaluation for Nuclear Installations (NS-R-3, IAEA 2003).
NS-R-3 establishes the requirements for site evaluation for a nuclear installation. Its purpose is to establish criteria to ensure that site related phenomena and characteristics are adequately taken into account, that emergency plans can be implemented over the lifetime of the facility, and that site-related hazards are defined.
The siting process for a nuclear installation generally consists of an investigation of a large region to select one or more candidate sites (site survey), followed by a detailed evaluation of those candidate sites. NS-R-3 is primarily concerned with the latter stage. It encompasses site related factors, and site-installation interaction factors, that relate to operating and accident conditions, including those that could lead to emergency measures. NS-R-3 is concerned with the evaluation of those site related factors important for ensuring that the site–installation combination does not constitute an unacceptable risk to individuals, the population or the environment over the lifetime of the installation.
The site evaluation for a nuclear installation covers the selection, assessment, pre-operational and operational stages. The requirements established in NS-R-3 do not apply to the site selection stage, for which a different series of criteria may be used, including criteria that have little direct relevance to safety.
4.2.3 IAEA Safety Guides
Beneath the Safety Requirements is a suite of Safety Guides which are based on an international consensus and provide assistance on how to comply with the Safety Requirements. Many of these guides have been developed primarily for the siting of nuclear power plants; however, they also contain information highly relevant to the siting of other facilities. Those that have particular relevance to siting are listed here:
Draft Specific Safety Guide DS433: Site Survey and Site Selection for Nuclear Installations (IAEA 2013a).
Safety Guide: External Human Induced Events in Site Evaluation for Nuclear Power Plants (IAEA 2002a).
Safety Guide: Dispersion of Radioactive Material in Air and Water and Consideration of Population Distribution in Site Evaluation for Nuclear Power Plants (IAEA 2002b).
Safety Guide: Geotechnical Aspects of Site Evaluation and Foundations for Nuclear Power Plants (IAEA 2004).
Safety Guide: Seismic Hazards in Site Evaluation for Nuclear Installations (IAEA 2010b).
Safety Guide: Meteorological and Hydrological Hazards in Site Evaluation for Nuclear Installations (IAEA 2011b).
Safety Guide: Volcanic Hazards in Site Evaluation for Nuclear Installations (IAEA 2012a).
The Nuclear Safety Requirements standard Site Evaluation for Nuclear Installations (IAEA 2003) does not cover the initial stage of the siting process, i.e. the site survey, when studies and investigations at regional scale are performed to identify potential sites from which candidate sites are chosen. This is covered in the new draft Safety Guide DS433: Site Survey and Site Selection for Nuclear Installations (IAEA 2013a)
The objective of DS433 is to provide guidance on the siting of a nuclear installation, for meeting the safety objectives of the IAEA Safety Fundamentals and complying with the Safety Requirements NS-R-3. Recommendations on criteria and approaches are provided in DS433 in order to identify suitable sites for nuclear installations complying with established safety requirements. The Safety Guide also has the objective of providing guidance on establishing a logical process for siting and establishing a suite of preferred candidate sites any of which could be selected for the construction and operation of a nuclear installation.
Safety Guide DS433 does not provide guidance on the final evaluation or characterisation of a site nor establish an assessment of the site hazard for use in the design evaluation for licensing purpose.
As the site survey and selection process does not require a licence from the regulatory body, the Safety Guide DS433 also has an informative role to the regulatory authority. If it is concluded during detailed assessment that no engineering solutions exist to design protective measures against those external hazards that challenge the safety of the nuclear installation, or there are no adequate measures to protect the peoples against unacceptable radiological risk, the site is not suitable and is not licensable. The siting process is intended to reduce such a late unfavourable conclusion from a safety point of view. The radiological safety of selected sites will be confirmed during the detailed site assessment stage.
DS433 explicitly addresses the safety aspects of the siting process of nuclear installations. It is recognized that there are other aspects that play an important role in the siting process, such as security, technology, economics, land use planning, cooling water availability, non-radiological environmental impact, and socio-economic aspects including public opinion.
As the siting process progresses, more and more sites will be screened out until only a few sites remain and the importance of safety aspects will become more pronounced.
The separation between the investigation processes of site survey and site evaluation may not be very distinct and will depend on the methodology used. There is a transition between these two stages of work and DS433 addresses the process that eventually terminates with the selection of site(s) for one or more nuclear installations.
As well as considering the siting of nuclear installations at new sites, DS433 provides recommendations regarding the collocation of new installations at existing sites.
4.3 The Safety Case
Systematic and internationally recognised approaches have been developed for assessing the safety of radiation and nuclear facilities. These involve developing a safety case for a specific facility. IAEA standards describe the safety case as an integration of arguments and evidence that describe, quantify and substantiate the safety, and the level of confidence in the safety, of the facility
A safety case submitted to ARPANSA as part of a siting licence application for a controlled facility should include the following elements as appropriate:
a safety assessment;
provision for periodic safety reviews and ongoing review and update as necessary of the safety assessment;
stakeholder involvement;
demonstration of the competence and adequate resources of the proponent;
a quality management system; and
methods for mitigating the consequences of an event or accident.
The safety case and supporting safety assessment provide the basis for demonstration of safety and for licensing, and should evolve with the development of the facility. The safety case should assist and guide decisions on siting as well as design and operations. The safety case will also be the main basis on which dialogue with interested parties will be conducted and on which confidence in the safety of the facility will be developed.
4.3.1 Safety Assessment
Safety assessment is the systematic assessment of all aspects of a practice that are relevant to protection and safety. The safety assessment should be started during the siting and conceptual design phase and be updated as necessary over the lifetime of the facility in order to account for possible changes in site characteristics, modifications to design or operation, new technical developments and regulatory standards.
The primary purpose of the safety assessment is to determine whether an adequate level of safety is being achieved for a facility or activity. Safety assessment provides reasonable assurance that the facility complies with all applicable regulatory requirements.
As stated in the IAEA General Safety Requirements: Safety Assessment for Facilities and Activities (IAEA 2009):
Safety assessments are to be undertaken as a means of evaluating compliance with safety requirements (and thereby the application of the fundamental safety principles) for all facilities and activities and to determine the measures that need to be taken to ensure safety. The safety assessments are to be carried out and documented by the organization responsible for operating the facility or conducting the activity, are to be independently verified and are to be submitted to the regulatory body as part of the licensing or authorization process.
IAEA (2009) lists 24 requirements for performing the safety assessment and all that are relevant will be considered in the assessment of any licence application. Particular attention is drawn to Requirement 1: Graded Approach to Safety Assessment;
A graded approach shall be used in determining the scope and level of detail of the safety assessment carried out in a particular State for any particular facility or activity, consistent with the magnitude of the possible radiation risks arising from the facility or activity.
It is expected that the safety assessment will become more detailed and based on the developed design and actual constructed facility as the project proceeds through the application stages.
The application should contain or make reference to sufficient information from any documentation or studies undertaken to enable the safety case to be understood by ARPANSA assessors and members of the public from the application alone.The application should provide the necessary information to enable interested stakeholders to understand the safety case and supporting safety assessment relating to the choice of the site and the proposed development of the controlled facility, having regard to international best practice in relation to radiation protection and nuclear safety.
4.4 The Representative Individual
For the purpose of radiation protection of the public, a representative person is an individual, either hypothetical or specific, who is characterised to be representative of the more highly exposed individuals in the population. It is considered that protection of the public is achieved when the dose to the representative person is less than the dose constraint, and when radiation protection is optimised.
When considering dose to the representative person, the ICRP (2006) recommend that the assessment should:
account for all relevant exposure pathways
consider the spatial distribution of radionuclides to ensure that the most exposed population is included
base habit data on the exposed population, and ensure that these data are reasonable, sustainable and homogenous
apply dose coefficients according to specific age categories.
Additional guidance on the use of the ‘representative individual’ in assessing doses to the public is available in the ICRP Publication 101a Assessing Dose of the Representative Person for the Purpose of the Radiation Protection of the Public (ICRP 2006a).
4.5 Public and Stakeholder Consultation
If the application is to site a nuclear installation, the public and relevant governments will be invited to comment and make submissions on the application (as per Regulation 40 of the ARPANS Regulations). The licence application will be the principal source of information on the facility from which interested individuals and groups may gain an understanding of what is proposed and the applicant’s arguments for its safety and security.
While ARPANSA is responsible for the conduct of the public submissions process under Regulation 40 of the ARPANS Regulations, the applicant should, separately, take appropriate steps to ensure that procedures are established and implemented to make information on safety aspects of the licence application available to members of the public.
The IAEA General Safety Requirements: Safety Assessment for Facilities and Activities (IAEA 2009), Requirement 22, requires that, “the processes by which the safety assessment is produced shall be planned, organized, applied, audited and reviewed.” This international bestpractice requirement includes the expectation that details of the safety case for the facility are communicated to the stakeholders:
Consideration is also to be given to ways in which results and insights from the safety assessment may best be communicated to a wide range of interested parties, including the designers, the operating organization, the regulatory body and other professionals. Communication of the results from the safety assessment to interested parties has to be commensurate with the possible radiation risks arising from the facility or activity and the complexity of the models and tools used.
In essence, in order to build confidence in the safety case, the applicant should demonstrate that there has been sufficient early and ongoing stakeholder involvement throughout the safety case development process.
4.6 Protection of the (Natural) Environment
The natural environment refers to all physical, chemical and biological conditions within which wild plants and animals normally live. Radiation protection of the environment is specifically concerned with wildlife living within its natural environment. Agricultural plants and domestic animals are considered under the protection of people.
The general intent of radiation protection of the natural environment is to protect ecosystems against radiation exposure that would have adverse consequences for populations of species (ICRP 2007).
The radiological environmental assessment for wildlife should be as simple as possible, but as complex as necessary. A graded approach should be used. The assessment should consider the likely exposure scenarios and pathways, including transfer of radionuclides to wildlife for internal dosimetry calculations. It should also include a discussion of scenarios and assumptions, limitations in the methodology or data used, and uncertainties in results. Protection should be subject to a screening dose rate for wildlife which depends on the conservatism demonstrated by the proponent in the screening assessment and species affected. The screening dose rate is defined in the range 5 to 10 µGy/h.
If the screening dose rate is exceeded, then a more complex assessment should be made. A more complex assessment could use, for example, less conservative assumptions or site specific data obtained from an environmental monitoring program. ARPANSA is currently preparing a safety guide titled Radiation Protection of the Environment (ARPANSA 2014b) to provide additional guidance on these types of assessment.
The IAEA is currently drafting the Safety Guide Radiation Protection of the Public and the Environment (IAEA 2014c) which will provide general guidance on the application of the IAEA Safety Fundamentals (IAEA 2006) and requirements of the revised International Basic Safety Standards (IAEA 2014b) in relation to protection of the public and the environment.
Another IAEA Safety Guide under development, A General Framework for Radiological Environmental Impact Assessment and Protection of the Public (IAEA 2014d), will assist the production of a Radiological Environmental Impact Analysis to assess the radiological impact on the environment of facilities and activities for which a radiation safety assessment is required for purposes of compliance with given acceptance criteria.
4.7 Security
Certain types of radioactive materials pose a security threat. Examples are radioactive sources of high activity, spent nuclear fuel and residues from reprocessing of nuclear fuel. A valid concern is that terrorist or criminal groups could gain access to such material and use it with harmful intent. Consequently, there has been a global trend towards increased control, accounting and security of such materials to prevent this happening.
To address these issues, the IAEA provides guidance and recommendations through the Nuclear Security Series and direct contacts with Member States on the security of radioactive sources. The recommendations from these documents and services are based on a set of Fundamental Security Principles and a methodology that considers the consequences of security-related events with respect to the State’s assessment of the threat. They enable the establishment of physical protection criteria that are balanced, provide security-in-depth, and whose implementation is graded by the severity of consequence.
The application of nuclear security principles to siting and the early stages of design of controlled facilities has the potential to increase security, decrease operational impact, lower operating costs and allow for greater integration with safety and safeguards systems. The types and quantities of radioactive material being held will largely influence the nature and extent of the consequences that may arise from security-related events.
It is often the case that the set of measures taken to establish a safety envelope or system for a facility or activity, as established and maintained through the implementation of relevant safety requirements, is affected by or “intersects” with the security envelope/system established through implementation of the security requirements. This intersection of measures taken to ensure facility or activity safety and security is commonly referred to as the safety-security interface. At this intersection, the measures taken to ensure safety or security can be mutually beneficial to maintaining the respective safety or security system. At the same time, some measures taken for maintaining the safety system may be detrimental to maintaining the security system, and vice versa. The importance for identifying these system interfaces is to ensure that the licence applicant recognises those that are not mutually supporting for safety and security, and the need for taking further measures to ensure that the respective safety and security system integrity is maintained. Less important, but worth identifying and taking advantage of, are those measures that are mutually beneficial.
The licence application should provide adequate information on security-related aspects of the site itself, including, but not limited to, site characteristics, proposed design of the facility and passive barriers, and proposed active security provisions such as alarms and on-site guards, etc. Where a proposed facility is to be collocated with new or existing facilities, any specific security issues arising from the collocation should be taken into account in the site evaluation for the proposed facility. For example, the siting of a new facility near an existing site which has security requirements that could be compromised may require special considerations during later phases.
5. Guidance on Site Selection and Characterisation
Selection and characterisation of potential sites for a controlled facility is a multi-step process as shown in Figure 2. The first step is to evaluate possible sites against a set of screening criteria. The sites that survive this process should then be evaluated and ranked against more rigorous selection criteria. The sites still under consideration will then undergo a detailed safety and impact assessment to determine whether the facility is likely to remain in compliance with legislative and regulatory requirements under all reasonably foreseeable circumstances. The conceptual design of the controlled facility should be taken into account during the site selection process in order to assess the potential radiological impact of the proposed facility.
Stakeholder involvement in the site selection process is extremely important, both in terms of general communication and also in terms of building confidence in the process.
While international best practice is to consider alternative sites, it is noted that in many cases for pragmatic reasons only one site is considered for full site evaluation
Figure 2: Flow chart showing the general steps involved in site selection and characterisation (adapted from IAEA 2013a).
5.1 Selection of potential sites
Initially, if there are multiple potential sites in the region of interest, these should be identified and assessed against the screening criteria.
5.1.1 Screening criteria
Screening criteria should be generic rather than site specific, and should be designed to eliminate sites that are obviously unsuitable from further consideration. The criteria should consider safety related aspects as well as any other aspects that would exclude a site from consideration.
Screening criteria should include:
site and regional characteristics that could obviously compromise safety
current and anticipated land use
cultural significance
economic significance
demographic considerations.
Screening criteria should be developed by the proponent, following international best practice and in consultation with stakeholders. Further information on the development of screening criteria can be found in the draft IAEA Safety Guide DS433 (IAEA 2013a).
5.2 Ranking of sites
Candidate sites should be compared and ranked in order of their attractiveness as the facility site. Selection criteria for ranking of sites should be more detailed than screening criteria and should be chosen to optimise the safety and efficiency of the proposed facility. Selection criteria may be site specific, particularly with respect to demography or environmental sensitivity issues, and will often include relevant social issues as well as technical/safety matters.
Criteria for ranking sites should be developed by the proponent in consultation with the regulator. Further guidance on the process of ranking potential sites is available in the draft IAEA Safety Guide DS433 (IAEA 2013a).
5.3 Evaluation of potential sites
The identification of the characteristics of the preferred site is an essential part of the site selection and evaluation process. There are several categories of site characteristics, including:
those that may affect the preparation of the site and the design of the proposed facility;
those that are needed to sustain the normal operation of the proposed facility;
those that provide input for the assessment of the radiological impact of a proposed controlled facility on the population and the environment; and
those that provide input for evaluating the feasibility of onsite and offsite emergency intervention and remediation preparedness following any accident.
Some characteristics (for example, availability of support services) may appear in more than one category.
The site characteristics (other than facility design) that could affect the assessment of the radiological impact of the proposed facility can be divided into three categories: features, events and processes. These are discussed in more detail in the following three sections.
Where relevant, the identified site characteristics should be assigned a frequency and severity, including uncertainties, from historical records. Where site specific frequency and severity data are unobtainable, data from other regions that are sufficiently relevant to the region of interest should be used. A graded approach should be used to determine the degree of detail required for the identification and description of site characteristics.
The information that should be considered for site characterisation is outlined in the following sections. This list is not exhaustive, and any additional information specific to the site under consideration should also be discussed.
5.3.1 Features
The features of a site that may affect the radiological impact of the proposed facility include geology, geomorphology, meteorology, and demography. Geology Geological information should include consideration of the following factors for both normal and extreme conditions (such as earthquakes and floods):
surface faulting
volcanic activity
landslides
permafrost
erosion processes
subsidence and collapse due to underground features
soil types and depths
rock types:
load bearing capacity
presence of fracturing
stability
liquefaction potential
groundwater levels and regimes.
Additional guidance can be found in the IAEA Safety Guide: Geotechnical Aspects of Site Evaluation and Foundations for Nuclear Power Plants (IAEA 2004).
Geomorphology
This includes geographical information about:
surface water features such as creeks and rivers
topography, such as mountains, valleys
any other features that could affect the diffusion or dispersion of airborne effluents or act as ultimate heat sinks.
Ecology
This includes information and details related to:
vegetation types and abundance
wildlife
threatened and endangered species.
Meteorology
Information on site-specific meteorological phenomena is essential for both site selection and facility design and for understanding the consequences of the releases of radioactive material at the site. Meteorological information should include data for both average and extreme conditions related to:
historical records of wind speed and direction, air temperature, precipitation (rain, snow, sleet), humidity, pressure, frontal systems
details of daily and seasonal and inter-annual variability
potential changes in climate and weather over the lifetime of the controlled facility.
Additional guidance can be found in the IAEA Safety Guide: Meteorological and Hydrological Hazards in Site Evaluation for Nuclear Installations (IAEA 2011b).
Demographics
This information should include:
present and projected population distributions in a form suitable for use in radiological assessments
details of transient, part-time or seasonal occupation, with best estimates of occupation time and numbers of occupants
details of present and projected land use (includes agriculture, livestock, dairy farming, wetlands, commercial, residential and recreation land and water use)
details of local diets, and locations and amounts of water used for drinking, industrial and recreational purposes
details of special needs groups (e.g. hospitals, aged care homes, prisons, child care facilities).
More detailed guidance can be found in the IAEA Safety Guide: Dispersion of Radioactive Material in Air and Water and Consideration of Population Distribution in Site Evaluation for Nuclear Power Plants (IAEA 2002b).
Services
The availability and vulnerability of services that are important to safety may influence the assessment of a site. Nearby services and transport routes may contribute to selecting the facility design and an understanding of the impact of a controlled facility on the population and the environment, and the feasibility of offsite emergency intervention.
Services of particular interest include:
electricity, gas, and water supplies, including back-up facilities;
provision of sewerage (which may be relevant to radioactive discharges);
communications;
transportation (road, rail, ship, air);
emergency services (fire, police, ambulance);
presence of facilities containing hazardous materials (e.g. chemical stores, munitions stores) or other hazardous facilities (e.g. chemical plant, fuel depot, power station) either on- or off-site; and
other nearby (collocated) on- or off-site facilities which may also require local services (interdependencies) and could contribute to or be impacted by emergency situations, particularly facilities and services which could potentially increase the risk to the public or the environment in emergency situations.
Radiological Baseline
Before any work commences on a proposed controlled facility, it is important to establish the radiological baseline of the site and surrounding areas, including information on the ambient radioactivity of the natural environment. This information should be used during operation of the facility to monitor performance of those site and facility features that help to isolate the facility from the surrounding environment. The information should also be used at the decommissioning and closure stages of the facility to assist in rehabilitation of the site to (approximately) its original state. Most of the (predictive) models used for assessment of post-closure impacts (including the effectiveness of decommissioning activities) on public health and the environment require a knowledge of the relevant source terms for possible releases of contaminated material to the environment and do not require information about the ambient background.
5.3.2 Events
The short-term events that may occur at a site that could affect the radiological impact of the proposed facility include:
severe weather phenomena such as thunderstorms, lightning, turbulence, cyclones, hail, storm surges, waterspouts, bushfires, drought and dust and sand storms;
floods on sites along streams, rivers and lakes caused by drainage, dam failure, ground water waves, or blockages and diversions in river systems ;
flooding resulting from extreme precipitation events, including those combined with snow and hail if appropriate;
tsunamis and related deposition, erosion and flooding;
seiches, storm surges and tidal variations for coastal regions;
earthquakes, fault displacement and other seismic events;
fires
inadvertent intrusion.
Information should be provided about historical occurrences, the likely future occurrences and potential impacts of these events.
Additional guidance can be found in the IAEA documents: Meteorological and Hydrological Hazards in Site Evaluation for Nuclear Installations (IAEA 2011b); Geotechnical Aspects of Site Evaluation and Foundations for Nuclear Power Plants (IAEA 2004); and Seismic Hazards in Site Evaluation for Nuclear Installations (IAEA 2010b).
5.3.3 Transfer Processes
In order to assess the impact of releases of radionuclides to the environment the on-going processes that can transfer radionuclides to (and through) the environment need to be understood. These processes can be both generic and site-specific.
In normal operating conditions, contaminated material from a facility can enter the environment as a result of processes such as erosion, or via discharge to the atmosphere, discharge to lakes and rivers, surface runoff following ingress of water, degradation of structures and containment barriers, leaching of contaminated material deposited on the ground, and via transport on vehicles and personnel leaving the site. These processes should also be considered when assessing the impact of unplanned releases of radioactive material to the environment.
Transport in the atmosphere
Detailed simulation of atmospheric transport processes requires information on wind direction, wind speed, atmospheric stability, diffusion, and wet and dry deposition. In addition, information considered should also include:
properties of the radioactive material released including total activity, chemical characteristics and physical properties
the type of release, including rate of release, time period of release, geometry and mechanics of discharge (and variation of these factors for different radionuclides).
In most situations the emphasis is on compliance, which means that the criteria against which an impact assessment is carried out are the annual dose limits set out in legislation, regulations or licence conditions. Information previously discussed on geomorphological and demographic features may also be required to complete these assessments.
Note that any airborne radioactive material that is deposited on the ground or on surface water could result in indirect contamination of surface water and/or groundwater.
More detailed guidance can be found in IAEA Safety Guide: Dispersion of Radioactive Material in Air and Water and Consideration of Population Distribution in Site Evaluation for Nuclear Power Plants (IAEA 2002b)).
Transport in the hydrosphere
The hydrosphere is a major pathway through which radioactive materials can be transported in both routine and emergency situations. This transport can occur via surface water (rivers, lakes, oceans and surface runoff), or in groundwater. Typically, radionuclides are transported rapidly in surface waters, and much more slowly in groundwater.
Surface water may become contaminated via direct contamination/discharge, or indirect contamination such as deposition of airborne contamination.
Radioactive materials may contaminate groundwater either directly or indirectly through either one of, or a combination of:
infiltration of contaminated surface water, resulting in leaching of radionuclides into groundwater
leakage of radioactive liquids to groundwater from a storage tank or reservoir
direct penetration into an aquifer.
The leaching process can be very slow and the time taken for contamination to reach measureable levels in groundwater depends strongly on the depth of the aquifer carrying the groundwater. This means that any impact assessment has to be carried out over an appropriate time period.
In all cases information about the source term for the discharge and the hydrological, physical, chemical and biological properties of the radioactive materials released should be considered in order to assess the impact of the discharge on people and the environment. The specific data necessary to assess these transport processes is different for surface water and for groundwater, and also varies depending on the water source (e.g. lakes, rivers, estuaries, seas and oceans, human made impoundments).
Any assessment of surface water and groundwater transport should also consider the features of the site detailed above, with specific consideration of:
agricultural, residential and recreational land use;
agricultural, residential, commercial and recreational water sources and water use;
land and water bodies supporting wildlife and livestock;
impacts on the food chain; and
detailed demographic information.
More detailed guidance can be found in the IAEA Safety Guide: Dispersion of Radioactive Material in Air and Water and Consideration of Population Distribution in Site Evaluation for Nuclear Power Plants (IAEA 2002b).
The aim of any assessment of the impact of a proposed facility for routine operating conditions is to determine whether the proposed facility will comply with all relevant legislative and regulatory requirements. Where an impact assessment is required in the later stages of the site selection process, information will be required on the conceptual facility design, potential source terms (inventory), environmental transfer pathways and exposure scenarios. These have already been discussed in earlier sections. At the siting stage, detailed site-specific information may not be available, so default data (IAEA, 2010) should be used where necessary.
Examples of impact assessments are given in the reports from the Environmental Modelling for Radiation Safety (EMRAS) programme conducted by the IAEA (IAEA 2008; IAEA 2013b).
5.3.5 Emergency Preparedness
Defence in Depth
Defence in depth is an important component of the internationally accepted approach to optimising safety in the siting and design of controlled facilities. It uses multiple layers of protection in such a way that a loss of safety at any level is compensated by the protection provided by additional layers. Further details can be found in ARPANSA’s Regulatory Assessment Principles (ARPANSA 2001a).
Usually only a conceptual design is available for the proposed controlled facility at the siting stage. Therefore it is not possible to address in detail the potential for ‘beyond design basis’ accidents during consideration of the siting licence application, except to the extent that some elements of siting, such as natural barriers, are of importance.
A new concept in international best practice for enhancing nuclear safety is the consideration of ‘design extension conditions’ in the siting and design of a controlled facility (IAEA 2012b, Requirement 20). Design extension conditions are intended to improve safety by enhancing the controlled facility’s capabilities to withstand, without unacceptable radiological consequences, accidents that are either more severe than design basis accidents or that involve additional failures. The main objective in considering design extension conditions at the siting stage is to provide assurance that the site will not compromise the provision of defence in depth.
While design extension conditions are primarily addressed in the design phase of the controlled facility, some considerations during the siting licence application phase could include:
combinations of events and failures, where the results of engineering judgement, deterministic safety assessments and probabilistic safety assessments indicate that combinations of events could lead to accident conditions
physical separation and operational independence of safety systems
optimising avoidance of long term off-site contamination
improvement of the layout, particularly with respect to collocated facilities, to facilitate operation in accidental conditions.
Reference Accident
In the context of this document, which covers a wide range of potential sites and facilities, the concept of a reference accident is used to assess the radiological consequences of a hypothetical, short-term release of a very large quantity of contaminated material to the environment around the site being considered, against criteria intended to protect people and the environment. The radiological consequences of the reference accident should be determined using conservative assumptions.
The use of a reference accident allows the radiological suitability of a site for a proposed controlled facility to be assessed at the conceptual planning stage before the detailed design of the facility is known. The purpose of examining a reference accident at the siting phase is to determine whether there are any gross characteristics of the site that would render it unsuitable from a health and safety perspective, whatever levels of defence in depth are likely to be incorporated in the future design of the facility.
Since the actual design of the proposed facility is unknown at the site selection stage, the reference accident should consider only site-dependent factors (where appropriate to the site under consideration) such as:
discharge to the atmosphere under prevailing meteorological conditions
discharge to rivers, lakes and oceans
deposition on the ground surface and subsequent surface run-off and leaching into groundwater
the effect of natural features of the site on the consequences of such a release
the availability of resources for mitigating the consequences of such a release
the demographics and impact on exposed populations
the consequences of the release with respect to current and future land use
the ease of remediating the site and its surroundings once the emergency stage of the accident is over.
As the project proceeds through the respective licensing phases and the design and operational details of the facility are developed the nature of the reference accident may change.
Where a new controlled facility is planned for a site that already has one or more controlled facilities, the existing facilities should be accounted for when determining the radiological consequences of the reference accident. Further guidance regarding the selection of a reference accident and the criteria by which it is assessed can be found in ARPANSA’s Regulatory Assessment Principles (ARPANSA 2001a).
5.3.6 Preparedness for accident recovery
Site-related criteria that are relevant when considering remediation preparedness following any accident, both in terms of the impact on these criteria of any accident at the chosen site and their potential utility in remediation, include:
demographics, particularly the proximity of towns and cities
value of land – cultural and societal importance of land for agriculture, recreational activities and natural resources
social amenities such as schools and hospitals
availability of, and ease of access, to relevant services including water and power supplies and transport infrastructure
availability of and ease of access to technology to monitor and perform environmental remediation
systems of local governance
communal knowledge and acceptance of the controlled facility; means of communication for dissemination of advice amongst stakeholders
availability of natural and man-made structures to store and dispose of accident waste, including landfill sites; and • geographic parameters.
Annexes
A1. Requirements for Protection of Human Health and the Environment
The requirements for ensuring the protection of people (workers and the public) and the environment, now and in the future, from harmful effects of ionizing radiation are found in the national standard Recommendations for Limiting Exposure to Ionizing Radiation (1995) and National Standard for Limiting Occupational Exposure to Ionizing Radiation (republished 2002, which is prescribed in Regulation 48 of the ARPANS Regulations as a condition of licence) (RPS 1, ARPANSA 2002).
Regulation 41 requires that in deciding to issue a facility licence, the CEO must take into account, amongst other things, whether:
the information establishes that the proposed conduct can be carried out without undue risk to the health and safety of people, and to the environment
the applicant has shown that the magnitude of individual doses, the number of people exposed, and the likelihood that exposure will happen, are as low as reasonably achievable, having regard to economic and social factors.
A1.1 Radiation Protection Principles
The international framework for radiation protection rests on 3 principles, which have been confirmed in the most recent Recommendations of the ICRP in Publication 103 (ICRP 2007). These are justification, optimisation and dose limitation. All of these principles, fundamental to the system for control of exposure to radiation, must be met in accordance with the national standard (ARPANSA 2002). The international framework is continuously evolving and the national framework is continuously revised on that basis, as necessary and appropriate. Note that RPS 1 (ARPANSA 2002) is currently being revised to take into account ICRP Publication 103 (ICRP 2007) and IAEA GSR Part 3 (IAEA 2014b).
A1.1.1 Justification
Justification involves a demonstration that there is a net benefit from a practice which leads to exposure to radiation. As the benefits and detriments to be considered encompass all aspects of the proposed practice, the decision-making process covers far more than radiation protection alone and shall involve all appropriate governmental and societal decision-making agencies. Further details of this principle and guidance in meeting it are found in RPS 1 (ARPANSA 2002).
A1.1.2 Optimisation
Optimisation is employed to make the best use of resources in reducing radiation risks, once a practice has been justified. The broad aim is to ensure that the magnitude of individual doses, the number of people exposed, and the likelihood that potential exposures will actually occur shall all be kept as low as reasonably achievable, economic and social factors being taken into account (ALARA). Further details of this principle and guidance in meeting it are found in ARPANSA 2002 (Recommendations for Limiting Exposure to Ionizing Radiation (1995) and National Standard for Limiting Occupational Exposure to Ionizing Radiation (2002)) and in the ICRP Publication 101b (ICRP 2006b).
A1.1.3 Dose Limitation
Dose Limitation involves applying dose limits and constraints to optimise the total dose to any individual in planned exposure situations. Further details of this principle and guidance in meeting it are found in the following section regarding dose limits and dose constraints and in RPS 1 (ARPANSA 2002).
A1.2 Radiation Protection Criteria
A1.2.1 Public and Occupational Dose Limits and Dose Constraints
In siting and designing a facility, it must be taken into account that during the operational phase, the applicant must show that the design and operation of the facility provides for the protection of workers and members of the public such that:
radiation doses to the public and workers do not exceed the dose limits in Regulations 59 and 60 of the ARPANS Regulations;
facilities are designed and operated in such a way that radiation protection of workers and members of the public is optimised according to the principles described in Regulation 58 of the ARPANS Regulations
the consequences of any reasonably foreseeable fault or accident condition are such that radiation protection of workers and the public is optimised according to the principles described in Regulation 58 of the ARPANS Regulations.
During the operational phase the applicant must also propose a dose constraint for workers, below which protection will be optimised, in accordance with RPS 1 (ARPANSA 2002) and which is agreed to by the CEO. The expectation of the CEO is that the constraint would not exceed 5 mSv per annum.
A2. Definitions
Terms defined in the ARPANS Act and the ARPANS Regulations have the same meaning when the terms are used in this Regulatory Guide. All other definitions in this Guide are intended to be consistent with the definitions in the IAEA Safety Glossary (IAEA 2007).
Community
In this Regulatory Guide the term ‘community’ is used to define the level of spatial and social organisation at which the issue of demographics should be addressed by the license applicant in terms of ‘the impact of the facility on the community in which the facility is, or is to be situated’.
Defence in depth
‘Defence in depth’ is the application of more than one protective measure for a given safety objective, such that the objective is achieved even if one of the protective measures fails. This is often achieved through a hierarchical deployment of different levels of equipment and procedures.
The International Nuclear Safety Group (INSAG) defines five levels of defence in depth:
Level 1: Prevention of abnormal operation and failures.
Level 2: Control of abnormal operation and detection of failures.
Level 3: Control of accidents within the design basis.
Level 4: Control of severe plant conditions, including prevention of accident progression and mitigation of the consequences of severe accidents.
Level 5: Mitigation of radiological consequences of significant releases of radioactive material.
Design basis
The ‘design basis’ is the range of conditions and events that are explicitly taken into account in the design of a facility, such that the facility can withstand them without exceeding authorised limits by the planned operation of safety systems.
Design basis accident
An accident involving conditions that the facility has been designed to withstand while keeping damage to nuclear fuel and the release of radioactive material within authorised limits.
Beyond design basis accident
An accident involving conditions more severe than a design basis accident.
Design extension conditions
A set of conditions derived on the basis of engineering judgement, deterministic assessments and probabilistic assessments for the purpose of further improving the safety of the controlled facility by enhancing the facility’s capabilities to withstand, without unacceptable radiological consequences, accidents that are either more severe than design basis accidents or that involve additional failures. These design extension conditions shall be used to identify the additional accident scenarios to be addressed in the siting and design and to plan practicable provisions for the prevention of such accidents or mitigation of their consequences if they do occur.
Ecosystem
A complex and dynamic community of living (e.g. plants, animals, micro-organisms) and nonliving (e.g. water, air) components that interact as a functional unit.
Graded Approach
An application of safety requirements that is commensurate with the characteristics of the practice or source and with the magnitude and likelihood of the exposures.
Natural Environment
A collective term for all of the physical, chemical, and biological conditions within which wild plants and animals normally live (based on the Environment Protection and Biodiversity Conservation (EPBC) Act).
Nuclear Material
Plutonium except that with isotopic concentration exceeding 80% in plutonium-238; uranium233; uranium enriched in the isotope 235 or 233; uranium containing the mixture of isotopes as occurring in nature other than in the form of ore or ore residue; depleted uranium; thorium; any material containing one or more of the foregoing (IAEA Safety Glossary, IAEA 2007).
For the purposes of safeguards, the Commonwealth Nuclear Non-Proliferation (Safeguards) Act 1987 (Cwth 1987) defines nuclear material in accordance with the Australia-IAEA Comprehensive Safeguards Agreement.
The IAEA places safeguards on nuclear material, which is defined via Article XX of the IAEA Statue and the IAEA document INFCIRC/153 (1972):
"Nuclear material" means any source material or any special fissionable material as defined in Article XX of the Statute. The term source material shall not be interpreted as applying to ore or ore residue.
There are some exceptions as to what nuclear material is covered by this definition, and is therefore controlled under the Nuclear Non-Proliferation (Safeguards) Act 1987, but essentially this means uranium, thorium and plutonium in any quantity or form.
(Nuclear) Security
Security involves the prevention and detection of, and response to, theft, sabotage, unauthorised access, illegal transfer or other malicious acts involving nuclear material, other radioactive substances or their associated facilities.
Radioactive Material
For the purposes of this regulatory guide, radioactive material is material designated in national law or by a regulatory body as being subject to regulatory control because of its radioactivity.
Safety Analysis Report
The safety analysis report is an ARPANSA regulatory requirement that documents the formal safety analysis. In the context of this Regulatory Guide, the safety analysis report, together with the safety assessment, are considered to be appropriate elements of the safety case that demonstrates the safety of the storage or disposal facility. The extent and rigour of the safety analysis report is commensurate with the hazard categorisation of the facility. It is a living document that is updated as appropriate throughout the life of the facility (including the decommissioning stage) to reflect its current state.
Safety Assessment
Assessment of all aspects of a practice that are relevant to protection and safety; for an authorised facility, this includes siting, design and operation of the facility. This will normally include formalised risk assessment.
Safety Case
The ‘safety case’ is a collection of arguments and evidence in support of the safety of a facility or activity. This will normally include the findings of a safety assessment and a statement of confidence in these findings together with the safety analysis report that is an ARPANSA regulatory requirement.
The safety case may relate to a given stage of development (e.g. siting). In such cases, the safety case should acknowledge the existence of any unresolved issues and should provide guidance for work to resolve these issues in future development stages.
Stakeholder
Stakeholder means an interested party — whether a person or a group, etc. — with an interest or concern in ensuring the success of a venture. To ‘have a stake in’ something, figuratively, means to have something to gain or lose by, or to have an interest in, the turn of events. In this Regulatory Guide, the term does not include the major players in the licensing process (proponent, operator, regulator) but does include other national and regional governments and agencies.
Wildlife
‘Wildlife’ is defined as an animal or plant living within its natural environment.
References
All websites accessed on 11 August 2014.
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ICRP 2006a. Assessing Dose of the Representative Person for the Purpose of the Radiation Protection of the Public (ICRP Publication 101a, Ann. ICRP 36 (3)).
ICRP 2006b. The Optimisation of Radiological Protection - Broadening the Process (ICRP Publication 101b, Ann. ICRP 36 (3)).
ICRP 2007. The 2007 Recommendations of the International Commission on Radiological Protection (ICRP Publication 103, Ann. ICRP 37 (2-4)). Larsson 2013. Chairperson’s Summary, International Experts Meeting on Decommissioning and Remediation after a Nuclear Accident (C-M. Larsson, IAEA IEM4, 28 Jan – 1 Feb 2013).
NHMRC 1985. Code of Practice for the Disposal of Radioactive Wastes by the User (Radiation Health Series No. 13).
NHMRC 1992. Code of Practice for the Near-Surface Disposal of Radioactive Waste in Australia (Radiation Health Series No. 35).
This guide is provided to assist licence holders who wish to merge two or more licences as a result of an organisational change.
A licence merger will usually require an amendment of an existing licence by the CEO of ARPANSA under section 36 of the Australian Radiation Protection and Nuclear Safety Act 1998.
Where the merger involves certain changes defined in section 63 of the Regulations, a request for approval by the CEO is required.
2. Process
The licence holder should write to the CEO, informing the CEO of the intended merger. The letter should indicate which licences will merge and provide the name in which the new licence should be issued. The letter should also indicate the timelines of the merger and request approval to surrender the superseded licence(s) when the new licence is issued.
If the licence holder wishes to retain a previous licence number, this should be indicated but is not guaranteed. In some cases, it may be more efficient and less confusing to issue a new licence rather than merge existing licences. ARPANSA will make this decision in consultation with the licence holder.
The licence holder should provide information about any movement of staff, laboratories, or controlled material and apparatus as a result of the merger. The licence holder should provide a new organisational chart indicating clear lines of responsibility for radiation protection and nuclear safety.
If, as a result of the merger, different people are undertaking dealings with radiation sources, the licence holder must ensure the new users have appropriate qualifications and training and provide evidence of this to ARPANSA.
The licence holder should send a new source inventory workbook (SIW) containing details of all sources from the merging licences. NOTE: It is critical that all ARPANSA source numbers are retained.
Revised and updated plans and arrangements and/or safe operating procedures should be submitted to ARPANSA, reflecting any changes resulting from the merger.
When ARPANSA is satisfied that the merger has been undertaken safely and any risks arising from the merger have been addressed, the CEO (or delegate) will consent to the surrender of the old licence(s) and issue a licence in the new organisational name.
ARPANSA’s expectations for how a licence holder or applicant will manage the safety and security of facilities and sources
Introduction
This guide sets out ARPANSA’s expectations for how a licence holder or applicant will manage the safety and security of facilities and sources.
Under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) and Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations), licence holders must develop and follow their own plans and arrangements to manage safety. This requirement is consistent with Principle 1 of the International Atomic Energy Agency’s Fundamental Safety Principles SF-1 which states that ‘the prime responsibility for safety is with the person or organisation responsible for facilities and activities that give rise to radiation risks.’
Sections 46 and 47 of the Regulations set out the information that is required in a licence application; this includes plans and arrangements that describe how the applicant proposes to manage the safety of the facility or source. Further information that the CEO may request will vary depending on the type of application but may also include siting, design or construction plans, operating limits and conditions, preliminary or final safety analysis report, source identification and location details, etc.
The CEO must be satisfied that the information provided demonstrates that the proposed conduct (for a facility) or proposed dealing (for a source) can be carried out without undue risk to
the health and safety of people and the environment. For facilities, this information will be collated in a safety case. The safety case is the collection of scientific, technical, administrative and managerial arguments and evidence in support of the safety of a facility, covering the suitability of the site and the design, construction and operation; the assessment of radiation risks and assurance of the adequacy and quality of all of the safety related work that is associated with the facility.
A major component of the safety case is the safety assessment, which includes the safety analysis. Important elements of the safety assessment are radiological impact on humans and the environment, site and engineering aspects, operational safety, non-radiological impacts and the management system. The safety analysis is the evaluation of the potential hazards associated with a facility or activity, documented in a safety analysis report (SAR). The safety case with its supporting safety assessment provides the basis for demonstrating safety for licensing purposes.
The arrangements in place to establish and manage a facility or activity, and the interdependencies between such arrangements, should be documented in a management system. A management system designed to support the object of the Act will integrate safety, health, environmental, security, quality, societal and economic elements.
The management system should foster and promote a culture for safety and security, which takes into account human factors such as attitudes and behaviour, as well as the general mindset by which all workers, including senior management, approach safety. These factors should interact with the technological and organisational factors in a way that promotes holistic safety (often referred to as systems safety), which is considered a best practice approach to safety management. A holistic approach to safety ensures the technology is safe to use; people perform tasks safely at work; and the organisation overall is managed safely.
Once a licence is issued and an applicant becomes a licence holder, section 60 of the Regulations requires the licence holder to comply with their plans and arrangements. Changes to plans and arrangements that will have significant implications for safety can only be made after the licence holder has sought and obtained approval from the CEO of ARPANSA under section 63 of the Regulations. Changes unlikely to have significant implications for safety do not need prior approval but must be reported to the CEO within three months under section 64 of the Regulations. Under section 61 of the Regulations, the licence holder must, at least every three years, review their plans and arrangements and keep and maintain records of the review and any changes.
Scope and Purpose
This Guide is applicable to both sources and facilities. Its purpose is to outline those key aspects that should comprise an organisation’s plans and arrangements for managing safety. It should be applied to the extent practicable and commensurate with the degree of hazard associated with the conduct or dealing. For example, the plans and arrangements for a complex facility will be different to those for a low hazard source. A graded approach is important to ensure that efforts and resources are directed to the matters that are most significant for protection of health and safety of people and the environment.
This Guide may be useful to applicants or licence holders to draft, modify or review some or all of their plans and arrangements.
ARPANSA will take this Guide into consideration when:
assessing an applicant’s plans and arrangements when submitted as part of a licence application.
assessing and monitoring licence holders’ compliance with the requirement to update any plans and arrangements for managing controlled facilities, controlled material or controlled apparatus under section 61 of the Regulations.
assessing requests for approval to make a change with significant implications for safety under section 63 of the Regulations.
overseeing general compliance through inspections, site visits, meetings, etc.
ARPANSA has drawn on international best practice to prepare this Guide. Where appropriate, links to trusted international standards and additional guidance are provided; applicants are expected to take these into account when developing and reviewing their plans and arrangements.
Structure
This Guide has eight chapters, based on sections 46 & 47 of the Regulations. Links to additional ARPANSA guidance and international standards are provided at the end of each chapter.
Statutory and regulatory compliance underpin all operations.
Plans and arrangements should demonstrate:
1.1 The processes or systems that will allow all relevant and applicable statutory and regulatory requirements to be identified.
1.2 How important statutory and regulatory compliance aspects will be shared and communicated to relevant personnel.
1.3 How all operations and functions will be in compliance with the identified requirements.
1.4 How the licence holder will ensure it stays up-to-date with applicable regulatory requirements.
Management commitment
Management is committed to maintaining safe and secure operations and work environment.
Plans and arrangements should demonstrate:
1.5 Management’s support, promotion and endorsement of the plans and arrangements and their use throughout the organisation1.
1.6 Management’s commitment to:
ensuring compliance with statutory and regulatory obligations
allocating adequate resources to safety and security
maintaining control over the source or facility
1.7 Management’s commitment to the principles of holistic safety:
human aspects and human performance
organisational aspects including safety culture and organisational learning
technological aspects
interactions between technical, human and organisational factors in the management of safety
1.8 How management’s commitment to the aforementioned will be clearly understood by all staff and promulgated across the organisation.
Accountabilities and responsibilities
Accountabilities and responsibilities are identified for all key functions and operations.
Plans and arrangements should demonstrate:
1.9 Accountabilities and responsibilities, including delegations, are clearly defined and described for:
the overall management of the plans and arrangements are clearly defined2
all conducts, dealings and operations and maintaining control over the source or facility
safety and security
statutory and regulatory compliance
resources
process implementation
1.10 Accountabilities and responsibilities are mapped out clearly for each section, branch and division.3
1.11 Systems are in place to ensure staff are fully aware of their own accountabilities and responsibilities and also those of other staff.
Resources
Resources are adequately allocated and controlled.
Plans and arrangements should demonstrate:
1.12 The systems in place to identify resource requirements.
1.13 How the organisation’s resources will be controlled.
1.14 How radiation protection and nuclear safety will be considered in allocation of resources.
1.15 The systems used to track and monitor resources.
1.16 The systems used to review resource allocations if circumstances change to ensure continued safety and security of operations.
Communication
Information is effectively communicated throughout the organisation.
Plans and arrangements should demonstrate:
1.17 Communication needs and requirements have been identified.
1.18 How communication processes and infrastructure will be maintained or put in place to address this need.
1.19 What modes of communication all staff, including contractors, are expected to use4.
1.20 How all staff, including contractors, is able to communicate information with radiation protection and nuclear safety implications efficiently and effectively.
Process implementation
Operations, processes, functions and activities are adequately controlled.
Plans and arrangements should demonstrate:
1.21 There is a consistent method or approach to develop, approve and roll-out new processes and operations, or review existing ones.
1.22 The systems that will be used to encourage all staff, including contractors, to follow and adopt this method or approach.
1.23 How staff and stakeholder consultation will be included or involved in process development and implementation.
1.24 How process implementation will be monitored and controlled.
Documentation and document control
Documentation is organised and effectively managed.
Plans and arrangements should demonstrate:
1.25 All processes, both administrative and practical, with implications for safety or security, is carried out in accordance with written procedures.
1.26 All conducts, dealings and operations with implications for radiation protection and nuclear safety are adequately documented and periodically reviewed.
1.27 There are criteria, methods or manuals outlining what specific processes and operations need to be documented5.
1.28 There are systems in place to ensure documents are integrated and consistent with one another6.
1.29 The systems used to ensure documents are quickly and easily accessible staff (including contractors) who need them.
1.30 Documents are managed in an appropriate quality system (preferably accredited).
Footnotes to Chapter 1
1 For example, this could be demonstrated by the CEO signing them.
2 For example, this should be someone who has ultimate responsibility for the plans and arrangements.
3 For example, this could be an organisational chart showing the organisational structure.
4 It should be noted that these modes may vary depending on safety and security needs.
5 For example, which operations require procedures, instructions, workflows, SOPs.
6 For example, methods clearly link to overarching organisational policies (vertically) and methods which describe operations integrate with one another (horizontally). Having a method, proforma or ‘document manual’ would help with this process, as is commonly applied by other organisations.
Overarching policies and objectives for safety are clearly defined.
Plans and arrangements should demonstrate:
2.1 An adequate overarching safety policy exists related to all functions, operations, conducts and dealings.
2.2 Safety objectives are clearly outlined7.
2.3 How all staff will be encouraged to fully adopt the safety policy and objectives and how the CEO (or management equivalent) will endorse their use.
2.4 The systems to ensure the safety policy and objectives will be communicated and understood by all staff8.
2.5 The systems to ensure the policy will be monitored, reviewed and kept up-to-date.
Monitoring and Measurement
Operations are tracked, monitored and measured.
Plans and arrangements should demonstrate:
2.6 Processes used to collect safety data, including from incidents, accidents, exceedances, events, tests, walk-downs, assessments, observations, reports, audits, comments and suggestions.
2.7 Processes in place to observe, assess and promote a good safety culture.
2.8 The systems, processes or infrastructure that is used to report and communicate safety data.
2.9 What type of safety data that will be collected i.e. reactive and predictive data.
2.10 Clear systems or processes used to encourage reporting and communication of data.
2.11 How this data and other safety related data will be securely collected, stored and analysed (see Risk Assessment and Mitigation below regarding analysis of data).
2.12 How differences between how things are done versus how they are described will be identified9.
2.13 How hazards throughout all operations, conducts and dealings will be identified.
Risk assessment and mitigation
Risks are reduced to acceptable levels by applying risk assessment and mitigation strategies.
Plans and arrangements should demonstrate:
2.14 The process by which safety and security data collected from monitoring and measurement is assessed.
2.15 This assessment process enables safety and security data to be filtered and assessed according to the risk.
2.16 The systems to ensure staff designated to conduct this risk assessment have appropriate experience, knowledge and competence.
2.17 There is a threshold or criteria that determine when deviations from an expected outcome are investigated.
2.18 How investigations will take place and how they will be conducted. This should include investigations of breaches required under section 57 of the Regulations.
2.19 Methods are clearly outlined for conducting investigations and how personnel with sufficient knowledge, experience and competence will be involved.
2.20 Processes are in place to develop control measures for risks that warrant mitigation.
2.21 Implementation of risk mitigation measures according to change control and process implementation guidelines and procedures (see 'Managing Change' below and also Process Implementation under Effective Control).
Managing change
Changes are safely managed.
Plans and arrangements should demonstrate:
2.22 A formal change management policy and process is in place.
2.23 How the need and objective for change will be identified or established.
2.24 The systems or processes used to develop options to meet this change objective.
2.25 How each option’s safety benefits, detriments and risks will be evaluated and compared.
2.26 How the preferred option(s) will be identified.
2.27 How plans to effectively implement the preferred option(s) are developed and how these plans are consistent with process implementation guidelines or instructions.
2.28 The systems or processes to ensure that the implemented change will be controlled and monitored so that safety is maintained and not degraded.
2.29 How the whole change process will be reviewed to ensure the change has been effective in meeting its radiation protection and nuclear safety objectives.
Learning and continuous improvement
Learning from experience and continuous improvement underpin all operations.
Plans and arrangements should demonstrate:
2.30 A policy or procedures are in place to ensure learning and continuous improvement occurs for all operations (including security and emergency preparedness and response).
2.31 The systems, processes or performance criteria used to determine when operations or functions are reviewed for the purpose of learning and continuous improvement.
2.32 How the review will take place and who will be involved.
2.33 The systems or processes that will allow the learning processes to be identified and shared across the organisation, where applicable10.
2.34 How improvements identified through the above processes will be implemented in a controlled manner.
2.35 How audit processes will be in place to ensure these improvement are actually being implemented on the shop floor, resulting in continuous improvement.
Training and education
Staff are provided with appropriate safety training and education programs.
Plans and arrangements should demonstrate:
2.36 The systems or processes used to identify and determine the competency requirements for operations with safety implications.
2.37 How safety training needs for staff (and their respective role and job functions) will be identified to maintain and meet these competency requirements. Training programs should be informed by performance assessment and should be periodically reviewed for effectiveness.
2.38 An adequate plan, program or method exists to ensure these training requirements continue to be met, such as succession-planning or refresher training.
2.39 There is a systematic process for developing, approving and reviewing training to ensure it is effective and continues to meet operational needs.
2.40 The systems or processes used ensure the content and delivery of the training involves stakeholder consultation, takes into account adult learning styles and other relevant factors so that the training is effective.
2.41 How training records for all staff will be controlled, monitored and kept up-to-date.
Footnotes to Chapter 2
7 These are the aims the organisation has with respect to safety.
8 An example could be that this is prominently displayed to staff.
9 This is equivalent to work as done versus work as imagined. It is important to evaluate this because it helps identify drift in operations i.e. both local and organisational operations and functions.
10 For example, this could include learning from deviations or any other functioning which the organisation can learn from for the purpose of improving operational safety and security.
The fundamental principles of optimisation, justification, limitation are taken into account.
Plans and arrangements should demonstrate:
3.1 Conducts and dealings are justified, that is, they must produce a net benefit to the exposed individual or the community, taking into account social, economic and other relevant factors.
3.2 The normal exposure of individuals must be limited so that neither the total effective dose nor the total equivalent dose to relevant organs or tissues, caused by the possible combination of exposures from conducts and dealings, exceeds any relevant dose limit specified in the Regulations.
3.3 For any conduct or dealing under the licence holder or applicant’s control, protection and safety must be optimised so that the magnitude of individual doses, the number of people exposed and the likelihood of incurring exposures are kept as low as reasonably achievable (ALARA), taking into account economic and social factors. For each radiation source, the level of radiation protection provided is optimised so that both individual and collective (normal and potential) exposures are kept ALARA.
3.4 The optimisation of the protection and safety measures associated with any particular conduct or dealing must be subject to dose constraints, the value of which is agreed by ARPANSA. Selection of dose constraints should be based on international best practice.
3.5 Provisions for appropriate reference levels11 above which some specific actions or decisions are taken. The reference levels may include recording levels, investigation levels, action levels, and intervention levels (see also Section 7: Emergency).
3.6 The consideration of wildlife (plants and animals) in their natural habitats. Protection should be subject to a screening dose rate for wildlife of 10 µGy/h for a conservative assessment. If this is exceeded, species-specific optimisation is required based on observed effects data in the form of Environmental Reference Levels (see Section 8: Environment Protection Plan).
3.7 Exposure to non-ionising radiation is kept below relevant exposure limits and to the lowest level that can be achieved, consistent with best practice.
Radiation safety officer
A suitably qualified radiation safety officer (RSO) is appointed as appropriate, to undertake specific duties in relation to radiation protection and nuclear safety.
Plans and arrangements should demonstrate:
3.8 A RSO has been appointed if:
The annual doses have the potential to exceed 10% of the limits prescribed in the Regulations
The conduct involves a controlled facility
The dealing involves Group 2, Group 3 or hazardous non-ionising radiation sources (eg Class 4 lasers)
3.9 The RSO has operational duties that are clearly specified in the radiation protection plan.
3.10 The RSO has sufficient knowledge of the Act and Regulations, relevant codes of practice, such as the ARPANSA Radiation Protection Series, Radiation Health Series, relevant Australian Standards and other guidance material and information relevant to the duties of the RSO, to facilitate the achievement of best practice for the conduct or dealing being undertaken.
Radiation safety committee
A suitably qualified radiation safety committee (RSC) is appointed as appropriate, to undertake specific duties in relation to radiation protection and nuclear safety.
Plans and arrangements should demonstrate:
3.11 A RSC has been established if any of the following are met:
The conduct or dealing has multiple activities involving controlled facilities, controlled apparatus and controlled material, or is spread over a number of premises.
The annual doses of ionising radiation from any conduct or dealing at any of the premises has the potential to exceed 10% of the limits specified in the Regulations.
There is potential exposure to non-ionising radiation above the limits specified in Schedule 1 of the Regulations.
3.12 The RSC has functions that are clearly specified in the radiation protection plan.
3.13 The RSC acts as an administrative and consultative body that reviews the radiation protection plans and policies for all conducts and dealings within the organisation and recommends to the licence holder or applicant the radiation protection policy that should be implemented.
3.14 The RSC is of size and membership determined by the type and size of the organisation using controlled facilities, controlled apparatus and controlled material.
3.15 The RSC meets at regular intervals (eg. quarterly) and hold special meetings to review important safety issues as required.
3.16 The RSC deputises persons for the Chair, the Secretary/Executive Officer and the RSO if any of them is unable to attend a meeting.
3.17 The RSC has standing orders relating to a quorum of members which would normally consist of at least one half of the committee membership including the Chair (or their deputy) and the RSO (or their deputy).
3.18 The RSC has a standard agenda item for the RSO to present a report on the state of radiation protection in the organisation.
3.19 The RSC keeps minutes of the RSC meetings that should be ratified at following meetings of the RSC.
3.20 The RSC forwards a copy of the RSC minutes to the senior management of the organisation.
3.21 The RSC establishes and maintains a channel of communication with the work health and safety committee of the organisation (if one exists).
3.22 The RSC undertakes consultation with controlled person and visitors who may be exposed to radiation in their work, and with controlled persons’ representatives, where appropriate.
Planning and design of the workplace
Design of the workplace is optimised for radiation protection consistent with international best practice12
Plans and arrangements should demonstrate:
3.23 The planning, design and construction of the workplace where conducts and dealings are undertaken is in compliance with trusted international standards.
3.24 The workplace has been planned and designed to ensure that:
Doses, including effective dose and equivalent dose, are in compliance with prescribed dose limits and are as low as reasonably achievable (ALARA), economic and social factors being taken into account, and that appropriate dose constraints have been used.
For each radiation source, the level of radiation protection provided is optimised so that both individual and collective (normal and potential) exposures are kept ALARA.
Exposure to ionising radiation is in compliance with a source related dose constraint of 10% of the effective dose limits specified in the Regulations (or another percentage agreed with the CEO).
Exposure to non-ionising radiation is kept below relevant exposure limits to the lowest level that can be achieved.
3.25 Priority is given to engineering controls (including ventilation, interlocks and shielding) to minimise reliance on administrative controls and personal protective equipment.
Classification of work areas
Work areas are classified in accordance with ARPANS legislation and trusted international standards.
Plans and arrangements should demonstrate:
3.26 Areas are classified as controlled areas wherever:
There exists a potential for significant internal or external exposure from radiation or contamination.
It is required to control normal exposures or prevent the spread of contamination during normal working conditions.
Measures are required to prevent or limit the extent of potential exposures.
3.27 Controlled areas are delineated by physical means or, where this is not reasonably practicable, by some other suitable means.
3.28 Suitable warning symbols and appropriate instructions are displayed at access points and other appropriate locations within controlled areas.
3.29 Appropriate occupational protection and safety measures are established for each controlled area, including the provision of local rules and procedures.
3.30 The following items are provided, as appropriate, at exits from controlled areas:
equipment for monitoring for contamination of skin and clothing
equipment for monitoring for contamination of any object or substance being removed from the area
washing or showering facilities
suitable storage for contaminated protective clothing and equipment
3.31 Supervised areas should be:
delineated by appropriate means
indicated by approved signs at appropriate access points
reviewed periodically to determine any need for protective measures and safety provisions, or changes to the boundaries
Local rules and procedures
Local rules and procedures are implemented for protection and safety of workers and other persons.
Plans and arrangements should demonstrate:
3.32 Implementation of local rules and procedures that describe:
Person responsible for radiation safety, and emergency arrangements in the event of an accident and/or incident
Accountability of sources
Managing criticality safety as applicable
Decontamination
Calibration and maintenance of equipment
Investigation level or authorised level, and measures to be followed in the event that any such level is exceeded
Personal protective equipment
Adequate and appropriate personal protective equipment is provided.
Plans and arrangements should demonstrate:
3.33 Controlled persons and visitors are provided with adequate and appropriate personal protective equipment which meets relevant standards or specifications, including:
protective clothing
protective respiratory equipment for which the protection characteristics are made known to the user
protective aprons, gloves and organ shields
3.34 Controlled persons and visitors receive adequate instruction in the proper use of respiratory protective equipment, where appropriate, including testing for good fit.
3.35 Tasks requiring the use of some specific personal protective equipment are assigned only to controlled persons who on the basis of medical advice are capable of safely sustaining the extra effort necessary.
3.36 All personal protective equipment is maintained in proper condition and tested at regular intervals.
3.37 Appropriate personal protective equipment is maintained for use in the event of intervention.
Monitoring of the workplace
Regular radiation and contamination monitoring of the workplace is conducted where appropriate.
Plans and arrangements should demonstrate:
3.38 A workplace monitoring program is established, maintained and regularly reviewed under the supervision of a RSO.
3.39 Workplace monitoring includes, as appropriate:
Leak and wipe tests
External ionising radiation levels
Surface contamination levels
Airborne contamination monitoring levels
Readily accessible exposure levels for non-ionising radiation.
3.40 Standard operating procedures are adhered to when workplace monitoring surveys are performed.
3.41 All monitoring instruments are calibrated periodically as required and the calibration of instruments checked prior to use.
3.42 Written reports are prepared following each workplace survey and made available to controlled persons.
3.43 Reports are referred to appropriate persons and any non-routine occurrences are investigated and appropriate action taken.
3.44 How survey results are analysed for risks and trends (See Risk Assessment and Mitigation).
Monitoring of individuals
Individuals monitoring and assessment of exposure to controlled persons and visitors.
Plans and arrangements should demonstrate:
3.45 That there is a clear, evidence-based rationale for the decision whether or not to implement a system of individual monitoring.
3.46 Individual monitoring is undertaken where appropriate and is adequate and feasible for any controlled person who is normally employed in a controlled area, or who occasionally works in a controlled area and may receive significant exposure.
3.47 Where individual monitoring is inappropriate, inadequate or not feasible, the exposure of the controlled person is assessed on the basis of the results of monitoring of the workplace and on information on the locations and duration of exposure of the controlled person. 3.48 The nature, frequency and precision of individual monitoring is determined with consideration of the magnitude and possible fluctuations of exposure levels and the likelihood and magnitude of potential exposures.
3.49 Controlled persons who enter and work in controlled and supervised areas are required to wear appropriate dosimetry devices (eg whole body exposure dosimeters, extremity exposure dosimeters, direct reading dosimeters, personal air samplers).
3.50 Visitors who enter controlled or supervised areas are required to wear a direct reading dosimeter and be accompanied by a controlled person.
3.51 Dosimetry devices are worn in the correct location and manner.
3.52 Controlled persons and visitors who may be exposed to radioactive contamination are identified and appropriately monitored (eg by bioassay and whole body monitoring) to demonstrate the effectiveness of the protection provided and to assess the intake of radioactive substances or the committed doses.
3.53 Equivalent, effective and collective doses received by controlled persons and visitors are assessed and collated.
3.54 Individual and collective doses are monitored and reviewed on a regular basis by the RSO and/or RSC.
3.55 Abnormal dose results are reported and investigated and actions are taken to avoid recurrence.
3.56 Exposures to non-ionising radiation received by controlled persons and visitors are assessed, including the determination of parameters which affect the exposure.
Monitoring of the environment
The licence holder or applicant is responsible for ensuring that plans and arrangements are in place and are implemented for the monitoring of the environment where appropriate.
Plans and arrangements should demonstrate:
3.57 All potential exposure pathways to the natural environment have been identified, including direct effects to wildlife in their natural habitats.
3.58 The level of potential exposure has been assessed for all potential exposure pathways.
3.59 Pathway analysis and relevant calculations are performed for each potential exposure pathway.
3.60 Where ongoing environmental monitoring is not considered necessary for a specific potential exposure pathway, this decision must be justified by appropriate analysis and calculations.
3.61 For those potential exposure pathways where exposure levels could be significant, an ongoing environmental monitoring regime is established, maintained and regularly reviewed.
3.62 The environmental monitoring regime complies with relevant standards and codes and is in accordance with international best practice.
Transport
The licence holder or applicant is responsible for ensuring that arrangements are implemented for the safe transport of controlled apparatus and controlled material, both on and off site, in compliance with the ARPANS legislation and international standards and codes.
Plans and arrangements for off-site transport should demonstrate compliance with the following where appropriate:
NOTE: ARPANSA does not administer the 1ADG Code or DGR however compliance is considered best practice and will be required by state and territory regulators for goods entering or passing through their jurisdictions.
Plans and arrangements for on-site transport should demonstrate:
3.63 The non-fixed contamination on the external surfaces of any package is kept as low as practicable and under the routine conditions of transport not exceeding the following limits averaged over any area of 300 cm2 of any part of the surface:
4 Bq/cm2 for beta and gamma emitters and low toxicity alpha emitters
0.4 Bq/cm2 for all alpha emitters
3.64 Use of a designated vehicle with appropriate labels and placards, as required.
3.65 A radiation safety officer is consulted if the surface dose of a package exceeds 2 mSv/hr to ensure appropriate arrangements are implemented including use of an over pack.
3.66 The integrity of shielding material used in the package design is maintained during on-site transport.
3.67 Any packages that are not certified by the Competent Authority13 use standard engineering design and proven technology.
3.68 Nuclear criticality safety is maintained and health physics coverage is provided for any package used for transport of fissile material.
3.69 Appropriate contamination clearance certification procedures.
3.70 Appropriate response to leakage, breakage, or abnormal occurrence.
3.71 In the case of spent fuel and fissile material, appropriate consideration and analysis of accident conditions.
3.72 Maintenance of all records of on-site transport including non-conformance and abnormal occurrences in an appropriate quality format.
Footnotes to Chapter 3
11 Diagnostic Reference Levels are used in medical imaging. The use of ionising radiation in medicine is covered by RPS C-5 Code for Radiation Protection in MedicalExposure (2019). See also the associated Safety Guides:
12 For controlled facilities applicants or licence holders should refer to other regulatory guides specifically for facilities on the ARPANSA website.
13 The CEO of ARPANSA is the Competent Authority for the transport of radioactive material by a Commonwealth entity and/or controlled person (as defined in section 13 of the Act) by road, rail and inland waterways within Australia.
Additional ARPANSA Fundamentals and Codes relevant to radiation protection:
The licence holder or applicant is responsible for ensuring that all radioactive waste (including gaseous and liquid discharges) arising from conducts and dealings, existing and anticipated, is appropriately managed.
Plans and arrangements should demonstrate:
4.1 A description of the arrangements for the safe handling, treatment, transport, storage and ultimate transfer or disposal of any waste arising from all past, current and proposed conducts and dealings.
4.2 A full description of the physical, chemical and radiological properties of the waste (including gaseous and liquid discharges) arising from all past, current and proposed conducts and dealings.
4.3 Arrangements for the minimisation of radioactive waste generation.
4.4 Processes for the collection, segregation, characterisation, classification, treatment, conditioning, storage and disposal of radioactive waste.
4.5 Provision for the safe handling of waste by having appropriate handling equipment and selecting short and uncomplicated routes.
4.6 An assessment is performed of the integrity of waste control measures to ensure that they are fault tolerant.
4.7 If fissile material is present, documentation (including calculations) to assess whether criticality is possible. If criticality is possible, documentation detailing the provisions for ensuring that criticality cannot occur. (See also Local Rules and Procedures 3.32)
4.8 Compliance with the requirements of appropriate statutory authorities and any local regulations (eg. Trade Waste Agreements).
Limiting exposure to radioactive waste
The licence holder or applicant is responsible for ensuring that exposure levels to radiation workers and members of the public are limited during the handling, treatment, transport, storage and transfer or ultimate disposal of radioactive waste.
Plans and arrangements should demonstrate:
4.9 Identification of all credible exposure pathways for all radioactive waste.
4.10 How exposure is limited during handling, treatment, transport, storage and transfer or ultimate disposal of all radioactive waste.
4.11 Processes for monitoring and assessing results to show that discharges are within specified limits. These procedures must clearly specify the following:
A reference to the method used for deriving the limits for the particular discharge pathway
The method of keeping records to show that these limits are not exceeded
Actions to be taken when radioactive waste discharges approach or exceed the discharge limit.
4.12 Documented system for demonstrating and reporting compliance with discharge limits based on the following:
The monitoring of discharges
Environmental monitoring results
Dose assessments, including independent checking of results and use of conservative methods and modelling.
Packaging and containment of radioactive waste
The licence holder or applicant is responsible for ensuring that radioactive waste arising from all conducts and dealings is packaged and contained to minimise the potential for migration or dispersion of radionuclide and to limit the external dose rate to within acceptable limits.
Plans and arrangements should demonstrate:
4.13 Provision of appropriate waste handling and packaging areas and facilities.
4.14 Documented procedures to ensure that containers are clearly labelled with the radiation warning sign, a description of the radioactive contents (ie. the radionuclide and form of the waste), the activity when packaged, the date of packaging and the name of the person who is to be contacted for further information or in the event of an abnormal occurrence.
4.15 Documented procedures for performing and recording dose rate measurements at the surface of each package and at one metre from the surface of each package to ensure compliance with the maximum allowable dose rates.
4.16 Provision of non-flammable spillage trays (with 2.5 times the volume of waste) for containers of liquid waste.
Storage of radioactive waste
The licence holder or applicant is responsible for ensuring that all radioactive waste arising from existing and anticipated conducts and dealings is stored safely. The licence holder or applicant is also responsible for ensuring that all such stores are adequately sited, designed, constructed, operated, secured and maintained to allow for the optimisation of provision of safe custody of the waste packages, and for the protection of persons, property and the environment from radiological hazards associated with radioactive waste.
Plans and arrangements should demonstrate:
4.17 Arrangements for storage of radioactive waste consider suitable provisions for safety and security including:
Location and adequate storage capacity
Suitability of the package for the type of storage and for the foreseeable time frame of storage
Use of adequate engineering controls (e.g. shielding, ventilation, monitoring equipment) and administrative controls (e.g. local rules and procedures)
Documented procedures for inspection, maintenance and monitoring
Documented procedures for managing criticality safety for waste containing fissile material
Documentation of radioactive waste
The licence holder or applicant is responsible for ensuring that documentation detailing the nature of any radioactive waste arising from conducts and dealings, its location, and all safety and security procedures is maintained.
Plans and arrangements should demonstrate:
4.18 Procedures for ensuring that an accurate inventory is kept of all waste packages and containers and their contents. An adequately maintained register or database should include:
The radionuclide type/content (physical, chemical and radiological characteristics)
The chain of custody (including details of acceptance, movement, storage, discharge and disposal)
The waste matrix used for immobilisation
The treatment or conditioning method
The ID number of the package (ie. a unique package designator).
4.19 Maintenance of documentation detailing any local government, State or Territory approvals and requirements which the licence holder or applicant is obliged to follow.
Routine discharge of radioactive waste to the sewer
The licence holder or applicant is responsible for ensuring that all radioactive waste arising from existing and anticipated conducts and dealings that is to be discharged to the sewer is disposed of safely.
Plans and arrangements should demonstrate:
4.20 Arrangements to ensure that the limits imposed by state or local water authorities are not exceeded. This may include a system for holding liquid waste in tanks to allow decay prior to disposal.
Routine discharge of radioactive waste to the atmosphere
The licence holder or applicant is responsible for ensuring that all radioactive waste arising from existing and anticipated conducts and dealings that is to be discharged to the atmosphere is disposed of safely.
Plans and arrangements should demonstrate:
4.21 A system to ensure that discharge of radioactive waste to the atmosphere does not exceed statutory limits.
The licence holder or applicant is responsible for ensuring that all radioactive waste arising from existing and anticipated conducts and dealings is ultimately disposed of or transferred in an appropriate manner.
Plans and arrangements should demonstrate:
5.1 Documented procedures to ensure that details of any radioactive waste to be ultimately disposed of or transferred are provided to ARPANSA.
5.2 Compliance with the following where appropriate:
Requirements of appropriate statutory authorities and any local regulations such as Trade Waste Agreements.
5.3 Documentation showing undertakings by other organisations to accept responsibility for controlled apparatus and controlled material when no longer required by the licence holder.
5.4 Provision for consultation with local government and other relevant authorities on all matters connected with ultimate disposal of controlled facilities, controlled apparatus and controlled material.
The licence holder or applicant is responsible for ensuring arrangements are made and implemented for the security of controlled facilities, controlled apparatus and controlled material, to prevent unauthorised access, damage, theft, loss or unauthorised use. The arrangements should include administrative and physical controls and barriers to ensure that the control of these items is not relinquished or improperly transferred, taking account of any relevant requirements imposed by the ARPANS legislation and, where applicable, the Australian Safeguards and Non-proliferation Office.
General security
Plans and arrangements should demonstrate:
6.1 International Standards14 that reflect international best practice for nuclear security are taken into account and the interfaces between security and safety have been considered.
6.2 Procedures ensure that all conduct and dealings with controlled materials, controlled apparatus and controlled facilities are in accordance with RPS 11 Code of Practice for the Security of Radioactive Sources.
6.3 Periodic reviews of inventories to confirm the category or aggregated category of sources in their designated locations.
6.4 Reasonable steps have been taken to ensure such security plans and arrangements are implemented.
6.5 Appropriate security for storage, use and transport (as applicable) of controlled apparatus and controlled material, including:
Details of the storage location
Description as to the authorised use of the source
Provision of a suitable temporary storage area in the event of off-site dealings
Provision of a secure storage area for any radioactive waste awaiting disposal.
6.6 Security plans are updated in a timely fashion in accordance with regulatory requirements; or as necessary to address issues or changes in threat environment identified in the threat assessment.
6.7 Records are kept of any changes made to the security plans and arrangements.
6.8 Clearly defined lines of responsibility for security and of authority for decision-making in matters of security of controlled facilities, controlled apparatus and controlled material.
6.9 A description of arrangements for the provision of security and response to security threats, including: scalable procedural and administrative security measures to meet increased levels of threat.
6.10 Appropriate back-up of security documentation and maintenance of computer security.
Security enhanced sources
Plans and arrangements for security category 1, 2 & 3 sources15 or facilities containing such sources should demonstrate:
A description of the source including details such as isotope, activity and the date of measurement, serial number and physical and chemical form.
A description of the radiation practice for which the source is used and the categorisation of the source calculated in accordance with the methodology set out in Schedule B.
A description of the specific location of the source in the building or facility where it is used or stored.
A plan of the building or facility in which the source is used or stored including the physical security measures used to protect the source and a definition of the secure area for the purposes of Schedule D.
Allocation of responsibilities for security to competent and qualified persons with appropriate authority to carry out their responsibilities.
A description of the specific security concerns to be addressed, for example theft or sabotage, or mechanical or electronic failure of a physical security measure.
A description of the physical security systems that will be used to address the security concerns and meet the requirements of the Code.
A description of the procedural security measures that will be used to address the security concerns and meet the requirements of the Code.
Arrangements for review and revision of the Source Security Plan, including maximum time between reviews in accordance with regulatory requirements.
Measures to effectively respond to a malicious act consistent with the threat.16
The threat assessment developed by the Australian government in consultation with the regulatory body should be used as a common basis for determining security requirements, and evaluating security measures implemented by the operator.17
To the extent possible, that security measures during a response to a nuclear security event do not adversely affect the safety of the personnel.
Plans and arrangements for controlled facilities including nuclear installations18 should include:
6.12 Arrangements for protection against unauthorised removal of nuclear material, noting that:
Nuclear material is radioactive material, which also requires protection against unauthorised removal where there are potentially significant consequences if dispersed or otherwise used for a malicious purpose. Protection requirements against unauthorised removal of nuclear material for potential subsequent offsite radiological exposure or dispersal are provided in IAEA Nuclear Security Series No. 14, Nuclear Security Recommendations on Radioactive Material and Associated Facilities.
Physical protection measures in IAEA Nuclear Security Series No. 13 should be additional to, and not a substitute for other measures established for nuclear safety, nuclear material accountancy and control or radiation protection purposes.19
6.13 When a facility contains nuclear material and other radioactive material, the physical protection requirements for both should be considered and implemented in a consistent and non-conflicting manner to achieve an adequate level of security.
In such cases, the more stringent requirements for physical protection should be applied.
NOTE: Levels of protection defined in IAEA Nuclear Security Series No. 13 are based on categorisation of nuclear material for use in the construction of a nuclear explosive device.20 The physical protection of nuclear material against unauthorised removal for use in a nuclear explosive device and the physical protection of nuclear facilities against sabotage are addressed in IAEA Nuclear Security Series No. 13, Nuclear Security Recommendations on Physical Protection of Nuclear Material and Nuclear Facilities (INFCIRC/225/Revision 5).
International Standards
6.14 International Standards may also be used by ARPANSA in assessing plans and arrangements for the security of radioactive material, associated facilities and activities for the prevention of malicious acts intended or likely to cause harmful radiological consequences. International standards provide additional guidance on elements of a security plan and emphasise a regulatory responsibility to verify compliance with the security plan.21 When a facility contains both nuclear material and other radioactive material, the protective requirements of an number of international standards should be considered and implemented in a manner such that the more stringent requirement for physical protection are applied.22
15 The security category is calculated according to methodology in Schedule B of RPS 11 Code of Practice Security of Sources
16 Nuclear Security Series No. 14 Paragraph 3.33
17 Nuclear Security Series No. 14 Paragraph 4.2
18‘Nuclear Installations’ as defined in Section 13 of the ARPANS Act (1998)
19 Nuclear Security Series 13 Paragraph 3.17
20 Nuclear Security Series No. 13 Paragraph 4.2
21Nuclear Security Series No. 14 paragraphs 4.20 and 4.21 and IAEA Nuclear Security Series No. 13 paragraph 3.27 provide further guidance on the elements of a security plan
22 Nuclear Security Series No. 13 Paragraph 1.15 and IAEA Nuclear Security Series No. 14 Paragraph 1.16
The licence holder or applicant is responsible for providing detailed emergency plans for any conduct or dealing that could give rise to a need for emergency intervention. This plan should be based on an assessment of the consequences of reasonably foreseeable accidents or incidents, and should aim to minimise the consequences and ensure the protection of on-site personnel, the public and the environment.
Plans and arrangements should demonstrate:
7.1 Emergency plans for any conduct or dealing which could give rise to a need for emergency intervention which are consummate with the Emergency Preparedness Category for the facility from RPS G-3 Guide for Radiation Protection in Emergency Exposure Situations.
7.2 Identification of the various operating and other conditions which could lead to the need for intervention.
7.3 Identification of potential incident and accident situations in terms of the hazard, the personnel at risk, and the consequences of potential accidents including environmental impact.
7.4 Classification of potential emergencies in terms of their consequences.
7.5 Suitable intervention and action levels are defined for the relevant protective actions taking into account the possible degrees of severity of accidents that could occur.
7.6 Consideration of a range of intervention measures.
7.7 Identify emergency zones for emergency planning purposes by defining responses to a localised dispersal of radioactive material; or radiological release from a facility.
7.8 The degree of emergency planning is commensurate with the nature and magnitude of the risk, and the feasibility of mitigating the consequences should an accident occur.
7.9 The emergency plan is coordinated with those plans and arrangements prepared by other relevant bodies that have radiological emergency response responsibilities in a nuclear or radiological emergency.
7.10 Responsibilities are specified for the management of interventions on-site, off-site and across state and national boundaries, as appropriate, in all separate but interconnecting plans.
7.11 Integration of emergency plans with other plans and arrangements such that safety and security measures do not contradict each other in emergency situations.
7.12 Intervening organisations have been involved in the preparation of emergency plans as appropriate.
7.13 Allocation of responsibilities for notifying the relevant authorities and for initiating intervention.
7.14 Identification of methods and instruments for assessing the accident and its consequences on and off the site.
7.15 The content, features and extent of emergency plans take into account:
The results of any accident analysis
Any lessons learned from operating experience
Any lesson learned from accidents that have occurred with conducts or dealings of a similar type.
7.16 Training and retraining arrangements for personnel involved in implementing the emergency plans.
7.17 Arrangements for public information releases in the event of an accident.
7.18 Provision for the early prediction or assessment of the extent and significance of any accidental discharge of radioactive substances to the environment.
7.19 Provision for rapid and continuous assessment of the accident, and determine the need for protective actions as the accident proceeds.
7.20 Provision for dissemination of information to members of the public who could reasonably be expected to be affected by the emergency both prior to and during the emergency.
7.21 Provision for protection and mitigation actions, and assigned responsibilities for initiating and discharging such actions.
7.22 Criteria for terminating each protective action are defined.
7.23 Defined actions to be taken during restoration.
7.24 Compliance with current legislation and national and international agreements including reporting to ARPANSA.
7.25 The emergency plan is reviewed and updated regularly taking into consideration the results of the emergency exercises.
Emergency procedures
The licence holder or applicant is responsible for ensuring that comprehensive emergency procedures are prepared in accordance with the objectives of the emergency plan for any conduct or dealing which could give rise to the need for emergency intervention.
Plans and arrangements should demonstrate:
7.26 A statement describing the potential emergency situation to which each procedure applies.
7.27 A statement of purpose for each procedure.
7.28 An organisational structure where the lines of authority and the functions of all individuals who will respond to an emergency are clearly defined.
7.29 The communication arrangements for contacting any relevant on-site personnel and intervening organisations, and for obtaining assistance from fire-fighting, medical, police and any other relevant organisations.
7.30 The actions needed both during emergency and during restoration after the emergency including:
A description of appropriate intervention and action levels
A description of the action sequence to achieve the purpose of the procedure
Specification of the precautions and limitations during the performance of the prescribed tasks
Specification of guidelines to be followed in the exercise of judgement on the part of an individual, either in interpretation of results, action levels, or recommendations of protective actions.
Take into account human performance in demanding circumstances.
7.31 The training requirements for all personnel involved in implementing the emergency plans.
7.32 Copies of examples of forms to be used in carrying out tasks relevant to the procedures.
7.33 Where appropriate, sign-off sheets, checklists and data sheets to document completion of the actions prescribed in the procedures.
7.34 A list of the emergency response facilities and equipment for use in the case of an accident (including radiation monitoring instruments, sampling and counting equipment, personnel dosimeters, personal protective equipment, decontamination supplies, emergency control rooms, communication facilities, maps, facility floor plans and reference material).
7.35 Provisions for all actions related to emergency preparedness (see 7.36 – 7.42).
Emergency preparedness
The licence holder or applicant is responsible for ensuring that all organisations identified in the emergency plan are prepared for such emergencies, and that adequate facilities and equipment are available and maintained.
Plans and arrangements should demonstrate:
7.36 An appropriate rostering system and back-up procedure is in place to ensure that emergency personnel are always available.
7.37 The emergency plan is exercised regularly to:
Test emergency equipment
Test the adequacy of on-site personnel resources
Ensure that personnel understand their responsibilities and relationships within their organisation; and procedures for interfacing with Intervening Organisations.
Test communications and communication equipment
Test evacuation procedures and evacuation routes
Confirm the viability of intervention measures to protect off-site personnel and the environment
Confirm the availability of suitable public information systems
Confirm the availability of external facilities, including those for the provision of medical aid to treat injured and/or radioactively contaminated persons
Test the emergency response interface with government, local authorities and off-site agencies.
7.38 Regular retraining of personnel is carried out in each organisational unit involved in the emergency plan.
7.39 Emergency contact lists and procedures are regularly reviewed and updated.
7.40 Emergency response facilities (including communications) are maintained.
7.41 Calibrated monitoring and sampling equipment for use in the case of an emergency is available.
7.42 A records management system has be established and maintained in relation to emergency arrangements to a radiological emergency in order to allow for their review and evaluation.
The licence holder or applicant is responsible for ensuring that arrangements are in place to demonstrate radiation protection of wildlife (plants and animals) in their natural habitats is consistent with international best practice.
Plans and arrangements should demonstrate:
8.1 Radiation protection of wildlife in their natural habitats has been considered in parallel with radiation protection of people.
8.2 Wildlife populations and ecosystems are shown to be protected using an environmental radiological assessment, consistent with the methodology outlined in RPS G-1 Guide for Radiation Protection of the Environment that:
Considers dose rates to wildlife above natural and normal background level.
Applies a graded approach that is as simple as possible, but as complex as necessary.
Demonstrates characterisation of the radiological source.
Identifies all potential exposure scenarios and pathways to the environment and affected biota.
Is based on the concept of reference organisms.
Documents assumptions made and limitations in methodologies and data, including uncertainties.
8.3 Environmental radiological assessments of wildlife in their natural habitats should be initially benchmarked to a screening dose rate of 10 µGy/h. The screening assessment should be conservative.
8.4 Where the screening dose rate is exceeded a more complex assessment is required that:
Uses less conservative consumptions or site-specific data.
Discusses population size and species likely to be affected, as well as potential impacts on biodiversity.
Is compared to an environmental reference level (ERL) for each affected species type which is based on knowledge of biological effects in wildlife related to dose rate.
8.5 Where a complex assessment still identifies incremental dose rates to wildlife above ERL(s) then further optimisation, including possible mitigation measures, may be required.
Decommissioning refers to administrative and technical actions taken to allow removal of some or all of the regulatory controls from a facility (except for a radioactive waste disposal facility, which is, by definition, subject to closure and not decommissioning). Such actions involve decontamination, dismantling and removal of radioactive materials, waste, components and structures. They are carried out to achieve a progressive and systematic reduction in radiological hazards and are taken on the basis of planning and assessment to ensure safety during decommissioning operations.
While much of the decommissioning activity takes place in the final phase in the lifecycle of the facility, planning for decommissioning nominally begins during facility design and continues through all phases of the facility lifecycle. Experience has shown the importance in considering decommissioning for new facilities at the design stage, developing an initial decommissioning plan, and periodically updating the initial decommissioning plan during and at the conclusion of the operational phase. The subsequent objective is to develop a final decommissioning plan prior to the start of decommissioning activities.
Plans and arrangements should demonstrate:
Consideration of relevant safety and regulatory aspects
Application of a graded approach
Selection of an appropriate decommissioning strategy
This regulatory guide sets out ARPANSA’s expectations for the disposal of:
Controlled apparatus and controlled material under section 65 of the Australia Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations)
In this guide the generic meaning of ‘disposal’ is used. It includes the transfer of controlled apparatus and controlled material (collectively referred to as sources) to another ARPANSA licence holder or to a person/organisation outside of ARPANSA’s jurisdiction.
The term ‘source’ is used to collectively mean controlled apparatus and controlled material.
A ’security enhanced source’ means a radioactive source or aggregation of sources assigned the Category 1, 2 or 3 when using the methodology set out in Schedule B of Code of Practice for the Security of Radioactive Sources (RPS 11).
Introduction
Section 65 of the Regulations provides 4 disposal options:
The licence holder may dispose of controlled material or controlled apparatus with prior approval from the CEO
The licence holder may without approval of the CEO transfer the controlled apparatus or controlled material to another licence holder under certain conditions
The licence holder may without approval of the CEO dispose of the controlled apparatus by returning certain controlled apparatus to the supplier of the controlled apparatus in certain circumstances
The licence holder may without approval of the CEO dispose of certain controlled apparatus by rendering the controlled apparatus permanently inoperable as a controlled apparatus in certain circumstances.
Under option 2, prior approval is not required to transfer a source to another ARPANSA licence holder provided:
both entities hold an appropriate licence issued by the CEO of ARPANSA,
the apparatus does not contain a security enhanced source, and
the licence holder disposing of the apparatus tells the CEO about the transfer within 7 days.
Where a licence holder routinely disposes of sources as part of routine operations the CEO of ARPANSA can make a special arrangement in the licence under subsection 65(5) of the Regulations so there is no need to seek prior approval to dispose of each source.
Note: Temporary transfer of sources to a service agent for repair or maintenance is not a disposal as ownership is retained by the licence holder. In such cases the licence holder must ensure that the service agent has appropriate training in radiation safety and training with respect to such activities (as required by all licences).
Disposal of controlled apparatus
As defined in section 13 of the Act, controlled apparatus means any of the following:
An apparatus that produces ionising radiation when energised or that would, if assembled or repaired, be capable of producing ionising radiation when energised
An apparatus that produces ionising radiation because it contains radioactive material
An apparatus prescribed by the regulations that produces harmful non-ionising radiation when energised.
Disposal of controlled apparatus often includes destruction or dismantling.
Disposal of controlled apparatus requires prior approval from the CEO of ARPANSA unless the licence makes other arrangements under subsection 65(5) of the Regulations OR the disposal meets the conditions described in paragraphs 65(1)(c) & (d) for certain controlled apparatus. This allows Group 1 controlled apparatus to be returned to the supplier or rendered permanently inoperable without prior approvalprovided it does not contain controlled material.
To satisfy the CEO of ARPANSA of the ‘destruction’ of a controlled apparatus it must be rendered inoperable in such a way that only expert knowledge and the use of specialised components could potentially restore its function.
In most cases, removal of a critical component(s) and severing the power cables will render the apparatus inoperable. For example:
In the case of x-ray apparatus, eliminating the vacuum inside the x-ray tube by breaking the glass envelope and severing the high-tension cables will effectively destroy the apparatus.
In the case of lasers removing the power supply, critical optical components or the amplifying medium will render the apparatus inoperable.
In all cases, the licence holder must take into account the presence of other hazardous materials, for example: beryllium, mercury, cadmium, etc. The licence holder should seek guidance from their local environmental agency on disposal requirements for such material or investigate possible recycling options.
Once destroyed, the apparatus ceases to meet the definition of a controlled apparatus and is therefore no longer subject to regulatory control. Individual dismantled parts are not deemed to be controlled apparatus.
If apparatus is to be disposed of because it has ceased to function, a critical component should still be removed so that repair is not possible.
In the case of apparatus containing radioactive material, removal of the material means the apparatus is no longer ‘controlled’. However, depending on the activity of the material removed, it may still be subject to regulatory control and need to be authorised by a licence.
Where disposal to landfill is proposed, the licence holder should ensure that the removed critical components are discarded separately to the rest of the apparatus unless they are to be retained as spare parts. This is to prevent any chance of them being recombined or repaired. Recycling should be considered where possible.
Transfer a source out of ARPANSA's jurisdiction
Sources are often sold, leased, hired, or given away to a person or organisation in another jurisdiction - such action is regarded as a ‘transfer’. This includes the return of controlled material to the original manufacturer or supplier in another jurisdiction or in some cases overseas.
In the majority of cases prior approval is required for a source to leave ARPANSA’s jurisdiction. However, paragraph 65(1)(c) of the Regulations provides for certain Group 1 controlled apparatus to be returned to the supplier without prior approval as noted above.
Particular attention is required when proposing to dispose of multiple low activity sources in a single shipment. The activity of all sources must be aggregated (using the method in Schedule B of RPS 11) to determine if additional security arrangements apply.
Additional requirements for security enhanced sources:
Licence holders must be aware of the additional security arrangements for security enhanced sources, in particular the requirement for an endorsed transport security plan – see RPS 11 (para 5.3).
It is important that receipt of the source is confirmed at its final destination particularly if overseas.
If the final destination is outside Australia the licence holder must ensure that the required documentation is completed noting that an ARPANSA Export Permit is required for the export of high activity sources. For the definition of a high activity source and information about how to apply for an export permit please see Export permits | ARPANSA.
Transfer a security enhanced source to another ARPANSA licence holder
Under RPS 11 (2.1.11) the transfer of a security enhanced source must have prior approval from the CEO even if the transfer is between ARPANSA licence holders.
Licence holders must comply with the additional security requirements, in particular the requirement for an endorsed transport security plan as per para 5.3 of RPS 11.
Following physical disposal, the status of the source in the source inventory workbook (SIW) should be changed to ‘Transferred’ or ‘Disposed’ and the date recorded.
Reporting compliance
Compliance reports submitted by licence holders must include summary information about disposals that have occurred during the reporting period. This includes disposals that did not require prior approval to ensure that databases are updated.
