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Regulatory Guide - How to seek an exemption from a licence

Last updated date: 
1 September 2020
Reason for update: 
Updated to reflect 2018 Regulations

Introduction

Section 30 of the Australian Radiation Protection and Nuclear Safety Act 1998 prohibits certain activities in relation to controlled facilities. Section 31 of the Act prohibits any dealing with controlled material or controlled apparatus unless the activity or dealing is authorised by a facility or source licence as appropriate, or is prescribed in Part 5 Division 2 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations) as exempt. 

Section 43 of the Regulations describes exemption of controlled persons from requirements for a facility licence for conduct relating to a controlled facility. This refers to Section 30(1)(g) of the Act.

Section 44 of the Regulations describes certain dealings with controlled apparatus and controlled material that are exempt. Schedule 1 Part 1 of the Regulations sets out exempt activity and activity concentration values for specific radionuclides. The Regulations do not prescribe any controlled facility as exempt.

In addition to the exemptions prescribed in the Regulations the CEO may also exempt from the need to be licensed those activities in relation to controlled facilities that require a licence under section 30 and those dealings with controlled material or controlled apparatus that require a licence under section 31.The CEO’s powers to exempt are derived from the following parts of the Regulations: 

  • Subsection 9(2) for apparatus that produces harmful non ionising radiation when energised prescribed under subsection 9(1) 
  • Subsection 13(2) for radiation facilities prescribed under subsection 13(1) 
  • Subsection 43(2) for one or more conducts specified in paragraph 30(1)(a), (b), (c), (d), (e) or (ea) of the Act in respect of a specified controlled person and in relation to a particular controlled facility
  • Subsection 44(3) for controlled material or controlled apparatus that produce ionising radiation 

The criteria that the CEO will use to determine if an exemption is to be granted and the matters that will be taken into account are explained below.  

1. Apparatus that produces harmful non ionising radiation when energised  

Subsection 9(1) of the Regulations prescribes those apparatus that produce harmful non-ionising radiation and which require a licence from ARPANSA under section 31 of the Act. However, under subsection 9(2) the CEO may declare in writing that a particular non-ionising radiation apparatus is not a controlled apparatus thereby removing the requirement for a licence.

Under subsection 9(3) the CEO must not make a declaration under subsection 9(2) unless the CEO is satisfied that:

(a) the apparatus does not pose an unacceptable hazard to the health and safety of people or to the environment; or

(b) it would be inappropriate for the apparatus to be a controlled apparatus.

A controlled person seeking a declaration under subsection 9(2) must provide sufficient evidence for the CEO to make a declaration that the apparatus meets the respective criteria under paragraphs (a) and (b) above in normal or routine conditions as well as under all reasonably foreseeable abnormal events or conditions.  

Note: Dealings with controlled apparatus that can produce non-ionising radiation that are prescribed in the table in subsection 44(1) are exempt. 

2. Prescribed radiation facilities 

Subsection 13(1) of the Regulations prescribes those facilities that are for the purposes of the Act ‘prescribed radiation facilities’ (PRFs). These controlled facilities require a licence for any of the conducts specified in paragraphs 30(1)(a), (b), (c), (d), (e) or (ea).  However under subsection 13(2) the CEO may declare in writing that a particular facility is not a PRF thereby removing the requirement for a licence.

Under subsection 13(3) the CEO must not make a declaration under subsection 13(2) unless the CEO is satisfied that:

a) the facility does not pose an unacceptable hazard to the health and safety of people or to the environment; and

b) it would be inappropriate for the facility to be a prescribed radiation facility.

A controlled person seeking a declaration under subsection 13(2) must provide sufficient evidence for the CEO to make a declaration that the facility meets the respective criteria under paragraphs (a) and (b) above in normal or routine conditions as well as under all reasonably foreseeable abnormal events or conditions.  

3. Conduct by a particular controlled person in relation to a particular controlled facility 

Subsection 43(2) of the Regulations provides the CEO the power to exempt any of the conducts mentioned in paragraph 30(1)(a), (b), (c), (d) (e) or (ea) of the Act by a particular controlled person in relation to a particular controlled facility (including any future conduct by the controlled person in relation to the controlled facility) provided the conduct does not or will not pose an unacceptable potential hazard to the health and safety of people or to the environment.

A controlled person seeking a declaration under subsection 43(2) must provide sufficient evidence for the CEO make a declaration that the conduct for which the exemption is sought will not pose an unacceptable potential hazard to the health and safety of people and the environment in normal or routine conditions as well as under all reasonably foreseeable abnormal events or conditions.

Note that unlike subsection 13(2), which gives the CEO the power to declare that a particular controlled facility is not a PRF (e.g. a portable neutron generator), subsection 43(2) gives the CEO the power to exempt a controlled person from the need to be licensed to undertake a particular conduct in relation to a particular controlled facility (e.g. decommission a linear accelerator).

4. Controlled material or controlled apparatus that produces ionising radiation

Dealing with a controlled apparatus or controlled material that can produce ionising radiation that is prescribed in section 44(1) is exempt. However, even if a controlled apparatus or controlled material is not listed in section 44(1), subsection 44(3) provides for the CEO to make a declaration under subsection 44(4) or 44(5) for certain low-dose or low-risk dealings, thereby exempting those controlled apparatus or controlled material. The CEO will only make such a declaration if satisfied of certain matters prescribed in the respective subsection. 

1. To seek an exemption under subsection 44(4) for a low-dose dealing, an applicant must make a written submission to the CEO and demonstrate that for the particular dealing for which an exemption is sought:

a) the annual effective dose to an individual during normal operations is not likely to exceed 10 μSv; or

b) an accident, misuse or exceptional circumstance affecting the dealing is not likely to produce an annual effective dose greater than 1 mSv.

Any submission for an exemption under paragraph 44(4)(a) should consider annual effective doses for:

  • normal use
  • accident scenarios
  • ultimate disposal scenarios
  • routine maintenance scenarios
  • source repair scenarios

To seek an exemption under subsection 44(5) in relation to one of the following:

a)    a radiological emergency or its after-effects

b)    the after-effects of a previous dealing

c)    naturally occurring material or bulk material with a mass more than 1000 kg

the applicant must make a written submission to the CEO and include an assessment of the magnitude of individual doses, the number of people exposed and the likelihood that potential exposure will actually occur justifies the dealing being exempt.

5. Regulatory assessment of a request 

ARPANSA will consider each application on its merits to determine whether the required statutory tests have been met. Decisions will be based on international best practice taking into account studies published by scientific and technology based organisations or other regulatory bodies. The implications of unregulated disposal will also be considered. 

6. Notice of intention to declare an exemption

If the CEO proposes to make a declaration of exemption under subsection 43(2) with respect to a controlled facility the CEO must publish the intention to do so in a daily national newspaper and on the ARPANSA website as soon as practicable. The notice must include either:  

a) a copy of the proposed declaration or

b) a description of the controlled person, the kind of conduct and the controlled facility that are to be the subject of the declaration and any conditions relevant to subsection 43(3). 

If the proposed declaration relates to a nuclear installation the CEO must issue an invitation for public submissions and provide information about the timing and procedures for making submissions.    

7. Publish a declaration of exemption

The CEO must publish a declaration under subsection 9(2), 13(2), 43(2), 44(2), 44(4) or 44(5) on ARPANSA’s website as soon as practicable after making it. 

8. Revoke a declaration of exemption

The CEO may revoke a declaration made under subsection 43(2) if the circumstances under which the controlled facility is owned, possessed or used has changed such that the controlled person can no longer satisfy the statutory tests on which the CEO’s earlier decision was made. 

9. Exception to exemption

Under subsection 44(2) the CEO may declare in writing that a particular dealing described in the table in subsection 44(1) has a risk of excessive dose and is therefore not exempted under subsection 44(1). This decision may be taken when:

(a) the annual effective dose to an individual during normal operations is likely to be greater than 10 μSv; or

(b) an accident, misuse or exceptional circumstance affecting the dealing is likely to produce an annual effective dose greater than 1 mSv.

10. Reviewable decision

A decision by the CEO to refuse to make a declaration under subsection 9(2), 13(2), 43(2) or 44(4) or 44(5) or to make a declaration under subsection 44(2) is reviewable under section 86 of the Regulations.