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

Associated forms

Licence application form – prescribed radiation facility (PRF)

Completing the application form

Section A: Applicant Information

Department or entity

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

Portfolio

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

Applicant/Responsible Person

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

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

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

Nominee

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

Radiation Safety Officer 

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

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

Declaration

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

Section B: Kind of prescribed radiation facility

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

Section C: Type of authorisation 

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

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

Section D: Facility Details

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

Section E: Safety Analysis Report

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

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

Section F: Plans & Arrangements

The applicant must have plans and arrangements for managing the facility to ensure the health and safety of people and protection of the environment.

These should be a comprehensive program of policies and procedures that demonstrate how safety and security will be ensured. The content of these plans and arrangements will vary depending on the hazard and complexity of the facility. 

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

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

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

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

Effective Control Arrangements

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

Safety Management Plan

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

Radiation Protection Plan

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

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

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

Radioactive Waste Management Plan

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

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

Security Plan

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

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

Emergency Plan

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

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

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

Environment Protection Plan

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

Decommissioning Plan 

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

Refer to Regulatory Guide: Decommissioning of controlled facilities.

Section G: Extra information

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

Prepare a site for a PRF

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

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

Construct a PRF

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

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

Possess or control a PRF

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

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

Operate a PRF

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

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

Decommission a prescribed radiation facility

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

• Schedule for decommissioning the facility

Dispose of or abandon a prescribed radiation facility

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

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

Section H: Associated sources

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

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

Section I: Source details

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

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

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

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

International best practice in radiation protection and nuclear safety 

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

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

Refer to the International Best Practice page for further information.     

Undue Risk 

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

Net benefit 

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

Optimisation of protection 

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

Technical, human and organisational factors 

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

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

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

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

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

Capacity to Comply 

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

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

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

Authorised signatory 

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

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

Checklist

A checklist is provided to confirm the application is complete.

Application fee

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

Submitting your application

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

How your application will be processed

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

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

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

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

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

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

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

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

Appealing a licence decision

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

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

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

Review by the Minister

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

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

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

Review by the Administrative Review Tribunal (ART)

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