Regulatory Guide - Applying for a source licence (or amendment) (ARPANSA-GDE-1740)

Associated forms

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

Selecting the correct application form

There are three application forms - the choice of form depends on the hazard of the source

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

Completing the application form

Section A: Applicant Information

Department or Commonwealth entity

This is the name of the Department or entity on behalf of which the application is being made. It may include further information for ease of identification e.g. Division, Branch, Section 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 physically removed from the source dealing such that they cannot demonstrate effective control, the name and contact details of a person more directly in control of the source dealing must be provided. This nominee must be in effective control of the sources. Generally the nominee will be the manager of a division or agency’s operation at the site of the proposed activity or, in the case of mobile devices, where the devices are usually stored. Other nominees may also be acceptable where the hazards of the activity are low and only minimal control is required. If a nominee is appointed, an organisational chart should be provided showing the relationship of the nominee to the applicant and end users.

Radiation Safety Officer

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

Note 2: 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: Description of the source and proposed dealing  

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

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

Section C: Source details

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

The details of all sources should be recorded in a source inventory workbook (SIW) which is an Excel spreadsheet available here. This is the form approved by the CEO for maintaining source records. 

An explanation of terms and required information appears in the first worksheet. The completed SIW must be submitted with the application.

Section D: Plans & arrangements for managing safety 

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

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

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

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

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

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

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

Effective Control Arrangements

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

Safety Management Plan

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

Radiation Protection Plan

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

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

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

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

Radioactive Waste Management Plan

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

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

Ultimate Disposal or Transfer Plan

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

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

Security Plan

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

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

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

Emergency Plan

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

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

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

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

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

International best practice in radiation protection and nuclear safety 

Describe how international best practice (IBP) has been considered in relation to the facility relevant to the type of authorisation sought. 
Each element of the proposed activity should be researched to determine what can be regarded as IBP. Undertaking research and benchmarking exercises are a useful way to establish IBP.   
Implementation of relevant national and international codes and standards is considered a demonstration of best practice.  

Refer to the International Best Practice page for further information.     

Undue risk 

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

Net benefit 

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

Optimisation of protection

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

Technical, human and organisational factors

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

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

Organisational factors are aspects of the organisation that facilitate performance (in safety), 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 the applicant has the capacity to comply with the Regulations and licence conditions that would be imposed under section 35 of the Act.  

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

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

Authorised signatory 

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

Checklist

A checklist is provided to confirm the application is complete.

Application fee

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

Submitting your application

Send completed application form and all supporting documentation 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.

Your application will then be forwarded to a regulatory officer. The regulatory officer will discuss and agree a time with you to complete the assessment. 
The regulatory officer will review all the information and consider the claims, 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. 

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

Appealing a licence decision

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

• 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.  Once a request for review has been lodged, the Minister must reconsider the licence decision and confirm, vary or set aside the decision.

The Minister is taken to have confirmed the licence decision if the Minister does not give written notice 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.