Background
The Australian Nuclear Medicine Molydenum-99 Facility (ANM Mo99) will be a purpose built radiopharmaceuticals production facility at the ANSTO Lucas Heights site in Sydney. This facility will ensure supplies of Mo-99 for the Australian market and will also have the capacity to export Mo-99 to help secure the future global supply. The CEO of ARPANSA issued a construction licence for the ANM Mo99 facility on 27 June 2014.
Licence application
In October 2012, the Australian Nuclear Science and Technology Organisation (ANSTO) announced its intention to expand its Molybdenum-99 (Mo-99) production with the construction of a new Mo-99 facility at Lucas Heights. Molybdenum-99 is an important radioisotope used in nuclear medicine for the diagnosis of a wide variety of medical disorders and ANSTO is a major national and international supplier.
On 4 October 2013, the CEO of ARPANSA decided to issue a licence to the Australian Nuclear Science and Technology Organisation (ANSTO) to prepare a site for a controlled facility (the ANSTO Nuclear Medicine Molybdenum-99 Facility) at the ANSTO Lucas Heights Science and Technology Centre.
ARPANSA received a licence application, dated 22 November 2013, to construct the ANSTO Nuclear Medicine Facility at the Lucas Heights Science and Technology Centre.
Under the Act, ARPANSA’s CEO is required to assess the applications and decide whether or not a licence should be granted.
Public consultation
In line with the Act, the CEO of ARPANSA placed a notice of intention to make a decision on the ANSTO Nuclear Medicine Molybdenum-99 facility construction licence application on the ARPANSA website and advertised this via national and local daily newspapers, and the Public Service Gazette.
In this notice ARPANSA also provided an invitation to the public to make submissions on the licence application. Submissions closed on 31 January 2014.
ARPANSA received no submissions during the public consultation period for the construction licence. More information on the public consultation process is available on our Public consultation webpage
Decision on licence application
On 27 June 2014, the CEO of ARPANSA decided to issue a licence to the Australian Nuclear Science and Technology Organisation (ANSTO) to construct a controlled facility (the ANSTO Nuclear Medicine Molybdenum-99 Facility) at the ANSTO Lucas Heights Science and Technology Centre. The CEO's Statement of Reasons and the Regulatory Assessment Report are available via the following link:
CEO decision - ANSTO nuclear medicine molybdenum-99 facility
Application and review process
ARPANSA assesses applications based on the process shown in the following diagram:
Statements of reasons
Full article: ARPANSA issues ‘licence to operate’ for ANSTO’s Mo-99 facility (12 April 2018)
Full article: ARPANSA authorises limited production of molybdenum-99 in the ANM facility (8 April 2019)
Full article: ARPANSA authorises ANSTO to commence routine production of molybdenum-99 in the ANM facility (27 April 2019)
Full article: ARPANSA authorises ANSTO Nuclear Medicine facility to return to routine operation (31 March 2020)
Notes:
1Application
The licence application may be for an individual phase or may cover more than one phase. Licences are required for each of the phases:
(a) Siting
(b) Construction
(c) Possession or control of a prescribed radiation facility
(d) Operation of a prescribed radiation facility
(e) Decommission of a prescribed radiation facility
(f) Abandon a prescribed radiation facility
ARPANSA has issued application guides for a prescribed radiation facility and a nuclear installation which can be found at Regulatory guides.
2Technical review
The issues to be considered during the technical review include, but are not limited to, the following:
(a) Health and Safety of people and the environment, including whether doses are as low as reasonably achievable
(b) Net benefit
(c) Public submissions
(d) Requirements under the Australian Radiation Protection and Nuclear Safety Act and Regulations
(e) International Best Practice
(f) Contingency arrangements
(g) Plans and arrangements for operation of the facility which detail:
- effective control
- safety management plan
- radiation protection plan
- radioactive waste management plan (for waste that might arise during operations)
- ultimate disposal or transfer
- security plan
- emergency plan
(h) Design of the facility
(i) Fundamental difficulties needing resolution
(j) Construction plan and schedule
(k) Preliminary safety analysis report
(l) Testing and commissioning arrangements.
3Consultation
The Regulations require ARPANSA to undertake a community consultation process for nuclear installation licence applications. The consultation process involves the following steps:
(a) Once an application is received, and considered complete for the purpose of commencing its review (including public consultation), the CEO of ARPANSA must publish a notice advising of the intention to make a decision on the application in:
- the nationally circulated daily newspapers The Financial Review or The Australian
- the Government Gazette
The CEO may also publish notices advising of his intention to make a decision on the application in:
- a Sydney metropolitan daily newspaper
- a local newspaper.
(b) The CEO will also use this notice to invite members of the public and other bodies to make submissions about the application (within a fixed timeframe and provide procedures for making submissions).
(c) When seeking public submissions about the application, the CEO will also make the application public on the ARPANSA website and be open to requests for further consultation processes (such as public hearings).
(d) Public hearings, panels or other forms of community engagement may be organised after the submission time and be based on some of the concerns raised in the submissions. ARPANSA may invite additional experts to provide information as required.
(e) ARPANSA will accept submissions in any form. While electronic submission (via website or email) is preferable, ARPANSA will accept other forms including written and verbal.
(f) The proposed public submission period is one month.
4Determination
The decision to grant a licence, to grant a licence with conditions, or to decline the application will take a minimum of three months. The exact time is dependent on the quality of the application and issues raised during the review.
Appeals of ARPANSA licensing decisions:
(a) Any decision by the CEO to refuse to grant a licence is reviewable under section 40 the Australian Radiation Protection and Nuclear Safety Act 1998.
(b) Stakeholders may also have rights under administrative law to seek review. See for example the Administrative Decisions (Judicial Review Act) 1977.
More information
To contact ARPANSA directly, see Contact us.
