Regulatory Guide - Applying for a facility licence for a prescribed radiation facility (ARPANSA-GDE-1798)

Associated forms

Use the Regulatory Administration Database (RAD) Portal, which will populate the questions, or you can attach the following form:

Licence application form – prescribed radiation facility (PRF)

Completing the application form

This guide is to assist applicants filling out the licence application form.

• The information within the submission needs to help the CEO of ARPANSA to decide on whether the implications for safety of your proposed conduct will be satisfactorily managed
• The proposed conduct should be mature, and the submission should be an objective appraisal of the safety of the conduct 
• The amount of information in responses should be proportional to the complexity of the conduct you are proposing. If any of the headings included in the form are not relevant or do not need to be considered for this conduct, 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 applicants 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 been 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 application 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 applicant is referencing a specific part of a provided document, this reference should direct to a specific section/page/paragraph.

Section A: Applicant Information

Department or entity

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

Portfolio

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

Applicant/Responsible Person

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

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

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

Nominee

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

Radiation Safety Officer 

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

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

Declaration

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

Section B: Kind of prescribed radiation facility

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

Section C: Type of authorisation 

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

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

Section D: Facility Details

Provide a detailed description of the facility and its site including the site address (s46(1)(b) and s46(1)(c) of the Regulations). Include this information in the space provided or insert references to where this information can be found in supporting documents. The full title, version/edition, and approval date should be provided for all referenced documents. 

Section E: Safety Analysis Report

A safety analysis report (SAR) must be provided for each type of authorisation sought (s46(1)(e) of the Regulations). The SAR must be as complete as possible for each stage of licensing. If applying for siting and construction of a PRF in the same application, a single SAR may be provided which must be as complete as possible.

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

Section F: Plans & Arrangements

The applicant must have plans and arrangements for managing the facility to ensure the health and safety of people and protection of the environment (s46(1)(d) of the Regulations). These should be a comprehensive program of policies and procedures that demonstrate how safety and security will be ensured. The content of these plans and arrangements will vary depending on the hazard and complexity of the facility and the stage of licensing. In pre-operational licence applications, ARPANSA assessors are interested in these plans and arrangements where they impact the safety of the facility once any controlled material has been introduced. This includes quality control, organisational arrangements and project information that ensures design and safety objectives are met. 

There is no predetermined format for supplying this information. The applicant should describe them in the application form and refer to suitable organisational documents attached to the application. The applicant must clearly indicate on the application form where the relevant information can be found within accompanying documents, and provide the full title, version/edition, and/or approval date. ARPANSA expects licence holders to “say what they will do, do what they say, and show what they did”. This principle underpins ARPANSA’s regulatory oversight, and the plans and arrangements are central to demonstrating it.

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

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

ARPANSA also publishes international best practice (IBP) information with links to various international codes and standards that may be relevant to the proposed facility. Applicants should identify relevant IBP and describe how this will be implemented or taken into account (s32(3) of the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act)).

Effective Control Arrangements

Provide information to demonstrate how the applicant or nominee will establish and maintain effective control over the facility (s46(1)(d)(i) of the Regulations). This should cover issues such as organisational arrangements, management systems and resources.

Safety Management Plan

Describe the administrative arrangements for managing the safety of the facility and any associated sources (s46(1)(d)(ii) of the Regulations). This should cover issues such as safety culture, safety of premises and equipment, competency and training, incidents, auditing and record keeping. 

Radiation Protection Plan

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

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

Radioactive Waste Management Plan

A full description and anticipated amounts of any radioactive wastes, including discharges arising from the proposed conduct and the arrangements for the safe handling, treatment, storage and disposal of any such waste should be set out in a radioactive waste management plan (s46(1)(d)(iv) of the Regulations). 

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

Security Plan

Describe the arrangements for the security of the facility and any associated sources to prevent theft, damage or unauthorised access (s46(1)(d)(v) of the Regulations). These arrangements should demonstrate how the security of the facility will be maintained and how periodic inventory checks will be undertaken to confirm that all sources are secure in their assigned location.

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

Emergency Plan

Emergency arrangements should be developed for all foreseeable emergencies such as dispersion of materials, over-exposure of operators, or theft or loss of controlled material (s46(1)(d)(vi) of the Regulations). The arrangements should include the responsibilities of all parties in the event of an emergency, contact arrangements, emergency procedures, emergency equipment and reporting arrangements.  Where necessary, arrangements for involving external agencies such as police and other emergency services should be included. The level of detail should be commensurate with the hazard of the facility.

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

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

Environment Protection Plan

Arrangements should be developed for the protection of wildlife populations and ecosystems in parallel with radiation protection of people, consistent with international best practice (s46(1)(d)(vii) of the Regulations). The arrangements should include identification of all potential exposure scenarios and pathways to the environment and affected biota, with environmental radiological assessments of wildlife in their natural habitats based on the concept of reference organisms. Refer to RPS G-1 Guide for Radiation Protection of the Environment. 

Decommissioning Plan 

Arrangements should be developed that demonstrate adequate planning for decommissioning to protect workers, the public and the environment (s46(1)(d)(viii) of the Regulations). While most decommissioning activities take place in the final phase of a facility’s lifecycle, decommissioning should be considered as early as possible. An initial decommissioning plan should be developed at the design stage and periodically updated throughout subsequent life stages. The objective is to develop a final plan to be submitted when applying for authorisation to decommission the facility. 

Refer to Regulatory Guide: Decommissioning of controlled facilities.

Section G: Extra information

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

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

Prepare a site for a PRF

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

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

Construct a PRF

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

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

Possess or control a PRF

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

• The arrangements for safe storage of controlled material and maintaining the facility.

Operate a PRF

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

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

Decommission a prescribed radiation facility

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

• Schedule for decommissioning the facility

Dispose of or abandon a prescribed radiation facility

Provide the following information in support of an application to dispose of or abandon a PRF:

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

Section H: Associated sources

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

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

Section I: Source details

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

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

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

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

International best practice in radiation protection and nuclear safety 

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 applicant should demonstrate that international best practice has been considered in relation to the conduct (s32(3) of the Act). If there are aspects of the conduct 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.

Refer to the International Best Practice page for further information. 

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 (s53(c) of the Regulations).

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 the Optimisation of protection section 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 applicant’s management system (their plans and arrangements) to determine reasonable assurance that the conduct 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 conduct 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 facility
• 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 (it 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 conduct, taking account of the potential harm as well as the desired positive outcome. The benefits considered should be specific and a direct result of the conduct (s53(d) of the Regulations).

Net benefit arguments should weigh up the benefits and harm the planned work would entail. For example, if a worker is expected to receive a dose, this would need to be justified in terms of the benefit the conduct 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 the Undue Risk section.

Further information on the principle of justification 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 to see whether the benefits of the conduct 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 (s53(e) of the Regulations). 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 high hazard facilities than for low hazard facilities.

In determining measures that optimise radiation protection, an applicant 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 to 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 and security by providing evidence that technical, human and organisational factors have been considered and managed throughout all aspects of the conduct (s53(ea) of the Regulations). ARPANSA provides definitions of, and guidance on, technical, human and organisational factors in ARPANSA’s Holistic Safety Guide. 

Technical factors

Defence in depth: How is defence in depth achieved? 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 and competencies? Have staff received the necessary training? 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? Are there single points of accountability for each element important for safety? 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 the applicant has the resources, organisational support and willingness to comply with the Act, the Regulations and any licence conditions are of relevance.

Submissions will be assessed on capacity and willingness to comply by taking account of the following (s53(f) of the Regulations):

• The compliance history if the applicant is an existing licence holder, and any developments which may raise concerns regarding capacity or willingness to comply in the future. Any self-assessment applicants make of their own compliance history should be brief and objective.
• Availability and commitment of resources to safety, and the proposed conduct generally. Applicants should demonstrate that sufficient resources are dedicated to the facility to ensure the proposed conduct is carried out safely.
• The impact of competing goals and priorities on safety and organisational performance. Applicants 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 applicant. 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-applicant relationship and its impacts on capacity and willingness to comply.

The maturity of the applicant’s management system. This includes the requirements of s57 to s58 (inclusive) of the Regulations, and whether the applicant has the tools available to support critical safety functions and ongoing compliance requirements. In pre-operational phases this will include aspects such as the management of quality and non-conformance.

• 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. Applicants should show they are both capable and willing to follow procedure
• Where an applicant is an existing licence holder how it has learned from past incidents and accidents.   

Authorised signatory 

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

Checklist

A checklist is provided to confirm the application is complete.

Application fee

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

Submitting your application

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

How your application will be processed

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

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

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

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

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

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

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

Appealing a licence decision

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

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

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

Review by the Minister

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

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

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

Review by the Administrative Review Tribunal (ART)

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