Submission Guide - Section 63 Request for Approval to Make a Change (ARPANSA-GDE-2321)

Last updated date:
25 March 2025

Background - section 63 submission guide

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 regulatory guide: When considering whether a section 63 request for approval is required, licence holders should read through ARPANSA’s: Regulatory Guide – When to seek approval to make a change with significant implications for safety (ARPANSA-GDE-1751). The regulatory guide provides information on when to seek approval, and includes thresholds beyond which approval is needed
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:

Effective control
Safety management plan
Radiation protection plan
Radioactive waste management plan
Plan for:
- Ultimate disposal or transfer (source licences)
- Decommissioning plan (facility licences)
Security plan
Emergency plan
Environmental protection plan
Safety analysis report (facility licences only)