Regulatory Guide - Applying for a licence for a nuclear installation (ARPANSA-GDE-1795WEB)
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Section A: Applicant information
Department or Commonwealth body
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
Name of the Commonwealth ministerial portfolio in which the Department or Commonwealth Body resides.
The application must be made by:
(a) the Chief Executive Officer of the Department or Commonwealth entity (the applicant); or
(b) a person authorised by the applicant to lodge an application1.
In the case of (b), the application must include a copy of the authorisation.
The applicant must provide their full name, position and business address.
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 facility (the nominee) must be provided. The nominee must be in effective control of the nuclear installation. 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 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 with the application. If there is more than one radiation safety officer, the details of other radiation safety officers should also be provided.
The declaration must be signed by the applicant or authorised person.
Section B: Kind of nuclear installation & type of authorisation
The applicant must indicate the kind of nuclear installation and type of authorisation for which a licence is sought.
Section C: Facility details
The applicant must provide a detailed description of the facility and its site including the site address.
A description of the purpose of the facility and specific information relevant to the type of authorisation sought must be provided. Applicants should 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/or approval date should be provided for all referenced documents.
Section D: 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 preparation of a SAR can be found in:
- Regulatory Guide: Preparation of the safety analysis report for non-reactor facilities (ARPANSA, 2020)
- Specific Safety Guide SSG-20 Safety assessment for research reactors and preparation of the safety analysis report (IAEA, 2010)
Section E: 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. The plans and arrangements 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, applicants should refer to the 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 may be incorporated into Section H. Codes and/or standards applicable to each kind of source can be found here.
ARPANSA also publishes international best practice (IBP) information with links to various International Standards that may be relevant to the proposed facility. Applicants should identify relevant IBP and describe how this will be applied or taken into account.
1. Effective Control Arrangements
The applicant must demonstrate how he/she or the nominee will establish and maintain effective control over the facility. This should cover issues such as organisational arrangements, management systems and resources.
2. Safety Management Plan
The applicant must 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 and accidents, auditing and record keeping.
3. 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 Fundamentals for Protection Against Ionising Radiation (2014) (RPS F-1), Code for Radiation Protection in Planned Exposure Situations (2016) (RPS C-1) and Guide for Radiation Protection in Existing Exposure Situations (2017) (RPS G-2).
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. The applicant must provide information about the qualifications and experience of such persons and the arrangements in place for their continued competency.
4. 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. Applicants should refer to relevant IBP.
5. Security Plan
Arrangements for the security of the facility and any associated sources to prevent theft, damage or unauthorised use must be provided. These arrangements should demonstrate how the security of the facility and any associated sources will be maintained and how periodic inventory checks will be undertaken to confirm that all sources are in their assigned locations and are secure.
Applicants should refer to the IAEA Nuclear Security Series NSS 14 Nuclear Security Recommendations on Radioactive Material and Associated Facilities and Code of Practice for Security of Radioactive Sources (RPS 11). Compliance with the latter code is mandatory for security enhanced sources. In particular, the need for an approved security plan should be noted.
6. 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 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.
The level of detail should be commensurate with the hazard of the facility as per Part 7 Preparedness and response for a nuclear or radiological emergency (IAEA, 2015).
7. 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. Applicants should refer to the Guide for Radiation Protection of the Environment (RPS G-1).
8. 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.
Applicants should refer to Regulatory Guide: Decommissioning of controlled facilities (ARPANSA, 2020)
Section F: Extra information
Applicants should provide additional information as shown in the table in section 46 of the Regulations specific to the type of authorisation sought. Applicants should 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/or approval date should be provided for all referenced documents.
Applicants should complete the section(s) corresponding to the type of authorisation sought.
Section G: 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 need a separate source licence but must be authorised by the facility licence.
Not all facilities have associated sources but where they do, this should be indicated in Section G. Common types of sources in facilities are calibration sources.
Section H: 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.
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 should be submitted with the application.
Section G: Matters to be taken into account by the CEO
In deciding whether to issue a facility licence, the CEO must take into account certain matters prescribed in the Regulations as well as international best practice in relation to radiation protection and nuclear safety.
Section 53 of the Regulations sets out the matters that the CEO must take into account and these are reflected in Section I of the application form.
The applicant should provide information under the following headings for the CEO to consider:
1. International Best Practice in Radiation Protection and Nuclear Safety
Under subsection 32(3) of the Act the CEO must take into account international best practice in radiation protection and nuclear safety. The applicant should provide information about how international best practice 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 find what can be regarded as international best practice. Agencies such as the International Atomic Energy Agency (IAEA) or the Nuclear Energy Agency are useful resources, particularly in relation to safety assessment and stakeholder involvement.
The IAEA standards and recommendations have been developed by consensus of member countries and represent the distillation of best practice of their cumulative radiation and nuclear safety experience. Undertaking research and benchmarking exercises will give an indication of international best practice.
Applicants should refer to the International Best Practice webpage for further information.
2. Information asked for by the CEO
Section 46 of the Regulations sets out what must be included in a facility application. The applicant should confirm that all information has been provided.
Information provided under the following headings will assist the CEO in making a decision on the application:
Under subsection 53(c) the CEO must consider whether the information provided by the applicant establishes that the proposed conduct can be carried out without undue risk to the health and safety of people and to the environment. For this purpose, the applicant must demonstrate 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 accident scenarios or abnormal occurrences.
The CEO must consider whether the applicant has shown that there is a net benefit from carrying out the conduct relating to the facility. For this purpose the applicant must 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 the conduct.
Optimisation of protection
The CEO must consider whether the applicant has shown that protection has been optimised so that radiation risks are as low as reasonably achievable. The level of protection should be the best under prevailing circumstances and should provide for an adequate margin of benefit over harm. The applicant must 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. For this purpose, the applicant could provide actual dose information, including dosimeter readings and surveys or sample dose calculations or both.
Capacity to Comply
The CEO must consider whether the applicant has shown a capacity for complying with the Regulations and the licence conditions that would be imposed under section 35 of the Act. For this purpose, the applicant should provide a statement that demonstrates its capacity to comply with the Regulations and any conditions that may be imposed if a licence is issued.
An applicant may provide evidence of compliance with similar legislation such as that administered by Comcare or the Australian Safeguards and Non-Proliferation Office (ASNO) in order to demonstrate its capacity to comply. A current ARPANSA licence holder may provide details of its compliance history.
An applicant should also demonstrate that it has or will have sufficient financial and human resources to safely undertake the proposed dealing.
The CEO must be satisfied that the application has been signed by an office holder of the applicant or a person authorised by an office holder of the applicant. An office holder is the Secretary, Chief Executive Officer or an equivalent person of the Department or Commonwealth Body 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 with the application.
A checklist is provided as final confirmation that the application is complete and in a form acceptable to the CEO of ARPANSA.
Submitting the application
The completed application and all supporting documents should be sent to //licenceadminarpansa.gov.au">licenceadminarpansa.gov.au.
Applicants should refer to section 49 of the Regulations to determine the appropriate application fee. The fee must be received before the application can be assessed.
How an application is decided
Once an application has been submitted it will be examined to see if all the necessary information has been included, if it is properly signed, and if the application fees have been paid. If so, the applicant will receive an email of acknowledgment. If any of the basic information is not included the applicant may be contacted for further information or the application and application fee may be returned with an explanation of the omission.
As soon as practicable after receiving an application for a facility licence, and once it has been determined to be complete, section 48 requires the CEO to publish a notice in a national daily newspaper and on ARPANSA's website, stating the CEO's intention to make a decision on the application. The CEO will include in the notice:
- an invitation to people and bodies to make submissions about the application
- a period for making submissions
- procedures for making submissions
Applications are then forwarded to a regulatory officer for assessment. Where matters require clarification, the regulatory officer will contact the applicant or nominee. The regulatory officer may also consider that an inspection or site visit is necessary and may contact the applicant to make arrangements.
Once the Regulatory Officer has reviewed and assessed all the information provided, a regulatory assessment report (RAR) is produced. This report will address the matters to be taken into account by the CEO of ARPANSA in accordance with subsection 32(3) of the Act, namely international best practice in relation to radiation protection and nuclear safety and the matters specified in Section 53 of the regulations.
In the case of a nuclear installation, the content of any submissions made by members of the public about the application will be addressed in the report.
The regulatory assessment report will make a recommendation to the CEO (or delegate) about whether to issue a licence and may recommend licence conditions to be imposed under section 35 of the Act. The regulatory assessment report undergoes a rigorous review and approval process prior to being sent to the decision make with all relevant documentation.
The applicant will be advised in writing of the decision. The CEO (or delegate) may also publish a ‘statement of reasons’ for the decision on the ARPANSA website.
Detailed information about we undertake 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 for an indefinite period or for a specified period. Once 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:
(a) to refuse to grant a licence
(b) to impose conditions on a licence
(c) to suspend a licence
(d) to cancel a licence
(e) to amend a licence
(f) not to approve the surrender of a licence
(g) to issue a licence for a particular period, rather than for a longer period or indefinitely
(h) 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 Appeals Tribunal (AAT)
An application may be made to the AAT for review of a decision of the Minister.