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Regulatory Activities Policy

 

1 . Introduction

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is the Australian Government’s primary authority on radiation protection and nuclear safety. Our purpose is to protect the Australian people and the environment from the harmful effects of radiation, through understanding risks, best practice regulation, research, policy, services, partnerships and engaging with the community.

Under the vision of “a safe radiation environment for the Australian community”, the ARPANSA work program entails six key objectives that guide our priorities and contribute to delivering radiation protection and nuclear safety outcomes to the Australian community: 

  • identify, assess and communicate health, safety and environmental risks from radiation 
  • promote radiological and nuclear safety and security, and emergency preparedness 
  • promote the safe and effective use of ionising radiation in medicine 
  • ensure risk informed and effective regulation
  • enhance engagement with stakeholders
  • enhance organisational innovation, capability and resilience.

The CEO of ARPANSA has regulatory functions under the Australian Radiation Protection and Nuclear Safety Act 1998 (the ARPANS Act; ref. 1) and the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the ARPANS Regulations; ref. 2). In carrying out their regulatory functions, the CEO is assisted by the staff of ARPANSA.

The Australian Government Guide to Regulation (ref. 3) states that ‘regulation’ may be defined as “any rule endorsed by government where there is an expectation of compliance”. The Productivity Commission (ref. 4) identified four primary activities of a regulator:

  • licensing and or approval processes, including registration/accreditation, that control entry to or participation in a market
  • monitoring and compliance activities, including imposing and collecting fees
  • enforcement actions for non-compliance and complaints resolution
  • providing guidance regarding compliance with regulation, including education around compliance.

ARPANSA carries out all these activities. The activities are enabled and supported by an integrated management system (IMS), by scientific evidence and technical advice, and by corporate functions, policies and practices applied across ARPANSA. 

Section 6 of this document outlines ten principles ARPANSA shall adhere to in its regulatory activities. The explanatory text to the principles outlines ARPANSA’s current regulatory approach and intent.

2 . Purpose

The Regulatory Activities Policy (the Policy; this document) provides an over-arching framework for efficient and effective regulatory management of radiation risks1 for the purpose of achieving the object of the ARPANS Act; “to protect the health and safety of people, and to protect the environment, from the harmful effects of radiation.

By making the Policy public on ARPANSA’s website, and by reviewing it regularly and revising it as required, stakeholders and interested parties can stay informed of ARPANSA’s regulatory approach and how the principles underpinning that approach are implemented, in practice.

3 . Scope

The Policy applies to all ARPANSA staff and contractors or consultants engaged by, or undertaking work at the direction of, ARPANSA officials. To the extent it supports the achievement of regulatory objectives, the scope of the Policy includes, but is not limited to, matters listed below:

  • review and assessment of safety2
  • licensing decisions
  • accreditation of services
  • compliance with the ARPANS Act, ARPANS Regulations and licence conditions
  • inspections, environmental monitoring and risk assessments
  • enforcement
  • advice, education and information regarding compliance with the ARPANS Act and Regulations, and with licence conditions, including advice on international best practice 
  • collation, analysis and dissemination of technical advice through the direct measurement or simulation of radiation exposures 
  • promotion of a national regulatory framework that provides for consistent safety outcomes across Australian jurisdictions
  • national engagement and consultation with governments, other agencies, licensees, and stakeholders; on regulatory matters 
  • national arrangements for emergency preparedness and response
  • engagement with international bodies that develop and implement regulatory frameworks and risk assessments
  • organisation, staffing and management of ARPANSA 
  • the integrated management system.

ARPANSA will, as appropriate, implement and act in accordance with the Australian Government Guide to Regulation (ref. 3), the Australian Government’s Regulator Performance Framework (ref. 4), the Australian Government publication International Standards and Risk Assessments (ref. 5), the Australian Government Cost Recovery Guidelines (ref. 7), and with other guidance relevant to Commonwealth regulatory activities. 

Under the ARPANS Act, international best practice must be taken into consideration in licensing decisions. ARPANSA strives to align its regulatory activities with international standards. This Policy takes into account the safety standards of the International Atomic Energy Agency (IAEA), specifically the Safety Fundamentals No. SF-1 Fundamental Safety Principles (ref. 8), and General Safety Requirements No. GSR Part 1 (Rev. 1) Governmental, Legal and Regulatory Framework for Safety (ref. 9). 

Other relevant IAEA guidance for regulatory bodies include General Safety Guide No. GSG-12 Organization, Management and Staffing of the Regulatory Body for Safety (ref. 10) and General Safety Guide No. GSG-13 Functions and Processes of the Regulatory Body for Safety (ref. 11).

4 . Roles and responsibilities

The functions of the CEO are outlined in section 15 of the ARPANS Act and section 7 of the ARPANS Regulations. 
The CEO is responsible for ARPANSA’s regulatory activities and is accountable to the Minister and Parliament. Branch and Office Heads are accountable to the CEO for activities covered by the Policy that fall within their remit.

The CEO and ARPANSA staff shall ensure the Policy is followed, as applicable to their daily tasks.

5 . Policy commitment

ARPANSA strives to implement best practice in the regulation of nuclear installations, radiation facilities and radiation sources to achieve our vision of a safe radiation environment for the Australian community.

ARPANSA is committed to providing the highest quality services to the Australian government and community. ARPANSA will ensure:

  • stability and consistency of regulatory decisions, independent of promoting interests
  • authorisation of only justified actions to introduce or alter a source, or alter the pathways of exposure
  • establishment of appropriate controls of sources that already exist when a decision on such controls has to be taken, and for exposures during an emergency 
  • a graded approach to regulatory actions so that they are commensurate with the level of hazard and risk, are optimised, effective, and do not unduly impede on justified activities that involve radiation
  • a holistic approach to safety that takes into account technical, managerial, human and organisational aspects. 
  • intergenerational equity of safety, including in the area of radioactive waste and spent fuel management
  • spatial equity of safety, including across national borders
  • arrangements for stakeholder engagement
  • transparency and accountability.

6 . Principles

6.1 Integrity

ARPANSA will carry out its regulatory activities with utmost integrity

ARPANSA carries out the regulatory activities free from political or economic pressures and is empowered to provide independent advice on regulatory matters. Regulatory decisions are based on the object of the ARPANS Act, to protect the health and safety of people, and to protect the environment, from the harmful effects of radiation, independent of promoting interests. 

Direct regulatory oversight of ARPANSA’s own source and facility licences is functionally separated from the activities carried out under those licences. The integrity of the regulatory oversight of such licences is regularly monitored by third parties, normally a health or environmental regulator from a State or Territory jurisdiction. Potential conflicts of interest between the CEO’s regulatory and non-regulatory functions are identified and managed.3

ARPANSA staff are obliged to declare any interests or any circumstance that may lead to bias in matters related to regulatory decision making, to enable determination of whether such interests may constitute a real, potential or perceived conflict of interest. Measures are taken to avoid regulatory capture, including staff rotation and special arrangements for on-boarding staff recruited from licenced entities.

6.2 Prime responsibility rests with the operator

ARPANSA will maintain clear separation of responsibilities between the regulator and the operator

Although ARPANSA actively engages with licence holders in regulatory matters, the licence holder (operator) has the primary responsibility for safety. ARPANSA will assess the plans and arrangements of the licence holder, and whether the licence holder has the necessary capacity and capability, including competence and resources, to effectively implement those plans and arrangements. 

ARPANSA will not, through its regulatory actions, relieve the licence holder from their responsibilities. ARPANSA will not recommend specific technical, managerial, administrative or otherwise; arrangements that could be perceived as pre-empting regulatory decisions. Although prime responsibility for safety rests with the operator, this will not in any way affect the exercise of the CEO’s power to issue directions, or ARPANSA staff’s power to issue improvement notices, to licence holders when the statutory requirements for those regulatory actions are triggered.

ARPANSA will critically assess whether incidents and accidents among licence holders can be related to deficiencies in the regulatory framework and/or its application in the assessment and verification of safety among regulated entities, and make changes as necessary.

6.3 Alignment with international best practice

International best practice will guide ARPANSA’s regulatory activities

In order to appropriately apply international best practice, ARPANSA maintains a high level of engagement with international standard setting bodies as well as with international bodies that perform risk assessments4, and also maintains co-operative arrangements with selected overseas organisations. ARPANSA provides feedback on regulatory experience in international fora and reports to international databases, for example on events in Australia that warrant rating on the International Nuclear and Radiological Event Scale5 (INES). 

ARPANSA supports activities aimed at promoting the implementation of best practice regulation internationally and nationally. This includes participation in international peer review missions, and ARPANSA will from time-to-time invite such missions to review its own activities as appropriate6. ARPANSA monitors Australia’s adherence to international instruments and submits reports on behalf of Australia as required under those instruments. In its activities, ARPANSA takes into account international best practice and experience in countries with advanced regulatory infrastructures, ensuring that information about international regulatory developments and experience is received and appropriately acted upon within the Australian regulatory context. 

6.4 National arrangements for consistent regulatory actions and outcomes

ARPANSA will establish partnerships with Commonwealth, State and Territory regulators

The regulatory activities of ARPANSA interface with those carried out by other Commonwealth bodies with responsibilities for, among other things, safety (including work health and safety), security (including the control of nuclear material), protection of the environment, and emergency management. ARPANSA seeks to establish effective and efficient collaborative and coordination arrangements with such bodies, thus avoiding duplication of efforts and unnecessary regulatory burden. As appropriate, these arrangements are formalised in Memoranda of Understanding or other agreements to the same effect.

Effective collaboration with Commonwealth, State and Territory radiation regulators ensures a consistent level of protection of people and the environment across all Australian jurisdictions, in principle and in practice, and minimises or eliminates obstacles to the nation-wide establishment of justified and safe practices and businesses involving radiation. It also promotes national adoption of international standards and risk assessments, as relevant in the Australian context. ARPANSA works collaboratively with State and Territory regulators through the Radiation Health Committee (RHC), established under the ARPANS Act, and with the Environmental Health Standing Committee7 (enHealth) and its Radiation Health Expert Reference Panel to achieve nationally consistent health and environmental protection outcomes, including codifying nationally agreed principles and requirements in the National Directory for Radiation Protection (NDRP). 

The RHC is also a forum for exchange of national and international regulatory experience and information on incidents and accidents between regulatory peers. ARPANSA supports the Radiation Regulators Network, which is a forum open to regulators for collegiate resolution of matters relating to, for example, licensing, entry into market, and competence requirements. 

6.5 Engagement with the Australian Government and Commonwealth licence holders

ARPANSA will establish effective and efficient means of national regulatory engagement

ARPANSA regularly provides advice to the Australian Government on management of radiation risks, prepares guidance for emergency management, and provides expert advice to the government and to response organisations in relation to events that may lead to radiation risks. ARPANSA’s advice to government also cover safety of decommissioning of facilities, management of radioactive waste and spent reactor fuel, and siting and establishment of storage and disposal facilities for radioactive waste.

To the extent advice is regulatory in nature and directed to government departments and agencies that are licence holders under the ARPANS Act, care is taken to maintain separation of responsibilities in line with section 6.2 of this Policy. Day-to-day interactions with licence holders will be as informal as possible and as formal as necessary. For major licence holders, liaison fora have been established for regular exchange of information and discussions. The terms of reference for these fora, and summary notes from meetings, are posted on ARPANSA’s website. It may, for certain facilities, also be appropriate to establish procedures governing interaction in the pre-licensing phase, and disclose these arrangements publically.

6.6 Skills, structure and allocation of resources

ARPANSA will optimise its workforce planning, allocation of tasks and resources, and utilisation of external advice

ARPANSA recruits, develops and nurtures appropriately qualified staff with the expertise required to support and carry out its regulatory activities. ARPANSA plans its human resources accordingly, including recruitment, retention, and succession planning of staff with the appropriate experience, qualifications and skillsets. ARPANSA provides learning opportunities to develop necessary skills, knowledge and abilities, including on-the-job training and training in emergency response, and promotes interaction with regulatory colleagues nationally and internationally.  

ARPANSA maintains an organisational structure that supports effective and efficient collaboration and delivery of regulatory outputs of high standards, while identifying and managing potentially conflicting interests. Special care is taken with regard to licensing and enforcement decisions, which go through a peer review process before being vetted by the Office of the General Counsel. 

The CEO of ARPANSA is advised by three statutory advisory bodies8 and may seek independent advice via contractual arrangements from third parties with relevant expertise as necessary, ensuring that any conflicts of interest are identified and addressed during those processes. ARPANSA maintains the core expertise to obtain, assess and implement advice from external bodies or third parties, and assumes full responsibility for all decisions informed by such advice.

6.7 Integrated Management System

ARPANSA will capture the regulatory processes in its Integrated Management System

ARPANSA has implemented and maintains an Integrated Management System (IMS) that provides for continual improvement across all processes and procedures. The IMS guides the management of ARPANSA’s regulatory activities, including provisions for maintaining an appropriate skills basis, and fosters a culture of safety within ARPANSA. 

The IMS specifies the planned and systematic actions necessary to provide confidence that the statutory obligations placed on ARPANSA are being fulfilled and regularly assessed and improved as appropriate. It captures the processes by which ARPANSA carries out its regulatory activities to ensure licence holders assume responsibility for safety and carries out justified activities under their licences safely and with due regard to optimisation of protection. It ensures stability and consistency in regulatory decisions, and guides leadership and management for safety among ARPANSA’s staff as well as among licenced entities.  

ARPANSA emphasises the continuous enhancement of safety as a general objective, while at the same time recognising the risks associated with implementing changes of significance for safety. ARPANSA makes provision for establishing, maintaining and retrieving records relating to the safety of facilities, sources and activities, or for requiring regulated entities to establish, maintain or retrieve such records. Those records include inventories of radioactive waste and spent fuel, registers of sources, and records relating to the safety of facilities and activities.

The IMS supports the development of regulatory guides for ARPANSA’s licence holders, and of regulatory codes and standards for national adoption, and their periodic revision. ARPANSA maintains the currency of regulatory documents on its website, and removes obsolete material.

6.8 Graded approach to control of radiation risks

ARPANSA’s regulatory approach is risk-informed, provides for optimisation, is effective, and will seek to eliminate unnecessary regulatory action

ARPANSA’s regulatory approach is based on a firm understanding of radiation risks and provides for optimisation of protection in dealings that are deemed justified. The review, assessment and verification of safety is supported by ARPANSA’s framework for risk management and by appropriate understanding of the specific circumstances under which licence holders operate. Safety assessments will be requested in a format appropriate to the nature and magnitude of the radiation risk to be managed. The nature and frequency of monitoring of licence holder performance, including inspections, is informed by the licence holders’ risk profiles including performance history and safety culture. The inspection program includes planned and augmented inspections; inspections can also be unannounced. 

In reviewing and assessing licence applications, activities or facilities, or modifications which might affect safety, ARPANSA develops the required understanding of the relevant designs and operating principles to inform its decisions. ARPANSA has been given statutory powers to require information to be provided by licence holders, if necessary. Interdependencies between different aspects of safety as well as societal impact is addressed by multi-disciplinary teams of experts across ARPANSA, and different management options will be explored to optimise protection.  

ARPANSA recognises that regulatory control is only one means of managing radiation risks and may be on occasions inappropriately burdensome to regulated entities if the radiation risk of justified practices are of minor regulatory concern. In such circumstances, using a risk-informed approach, relevant weight is given to other measures to manage radiations risks, such as information, communication, education and engagement.  

6.9 Graded approach to enforcement

ARPANSA will take a proportionate and effective approach to enforcement

ARPANSA maintains a tiered enforcement approach with a range of tools available to intervene where necessary. These include, but are not limited to; reporting back to the licence holder on areas for improvement after an inspection, the issuance of improvement notices by inspectors, imposing additional licence conditions on licence holders, the issuance of directions by the CEO of ARPANSA, the suspension or cancellation of licences, and, in extreme cases, prosecution of specified offences under the ARPANS Act, which may result in Court imposed fines. 

Decisions on enforcement actions are taken based on the severity of non-compliance and impact on health and safety of workers, the public and the environment. Enforcement decisions also take into account licence holders’ awareness of the nature and severity of non-compliance (demonstrated for example by self-reporting and initiation of corrective actions), repeated or systemic nature of safety events, status of leadership and management for safety, and any mitigating circumstances. Enforcement actions shall be effective in achieving the desired change in arrangements for safety among licence holders.

While regulatory interventions may be required to ensure that people and the environment are protected from the harmful effects of radiation, they do not remove the licence holder’s primary responsibility for safety. The consequences for third parties of enforcement actions is taken into account.

6.10 Accountability

ARPANSA will act with openness and transparency

ARPANSA periodically reports on its licensing decisions and on major events to Parliament via ARPANSA’s Minister, and will under special circumstances table reports in parliament related to events with safety significance, and accidents.

A broad range of regulatory documents, including inspection reports, statements of reasons for regulatory decisions, annual incident summaries and analyses, and guidance material are published on ARPANSA’s website. As a matter of course, regulatory guides are consulted on and feedback taken into account. ARPANSA is accountable to licence holders in terms of the annual charges being reflective of actual regulatory work including its overheads. ARPANSA periodically reviews the efficiency of its regulatory activities against the key performance indicators of the Australian Government’s Regulator Performance Framework (ref. 4) and publishes the result of the reviews. 

ARPANSA engages with the broader community and will request licence holders to communicate with stakeholders and the broader community in relation to events of community interest or consequences for third parties including the public. Stakeholders are considered an asset whose knowledge and views will provide for informed regulatory decisions. ARPANSA develops mechanisms to be a visible and recognised partner in relation to the potential establishment of contentious facilities, where the lead time is long and considerable interaction with the community may be necessary before an application has been received.

7 . Terms and definitions

Term Definition
Radiation risk

Detrimental health effects of exposure to ionising radiation including the likelihood of such effects occurring, and other risks including environmental risks, that might arise from exposure to ionising radiation; the presence of radioactive material (including radioactive waste) or its release to the environment; or a loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or any other source of radiation; alone or in combination.

Health effects (including the environment) and health risks associated with acute or prolonged exposure to non-ionising radiation such as ultraviolet radiation, radiofrequency radiation, optical radiation and other types of non-ionising radiation; either in occupational settings or as members of the public.

International Standard A collective term for international requirements, recommendations, guidance and other instruments; with which compliance can be considered mandatory or, at least, good practice. These include but are not limited to: the International Atomic Energy Agency (IAEA) safety standards and security guidance, recommendations of the International Commission on Radiological Protection (ICRP) and the International Commission on Non-Ionising radiation Protection (ICNIRP); the World Health Regulations issued by the World Health Organization (WHO); Conventions to which Australia is a Contracting Party; Codes with which Australia has declared its intention to comply; and IAEA General Conference Resolutions.

8 . References

Ref Abbreviation Title Issue date
1 ARPANS Act Australian Radiation Protection and Nuclear Safety Act 1998 1998
2 ARPANS Regulations Australian Radiation Protection and Nuclear Safety Regulations 1999 1999
3   The Australian Government Guide to Regulation 2014
4   Regulator Performance Framework 2014
5   Regulator Audit Framework. Commonwealth of Australia. 2014
6   International Standards and Risk Assessments 2014
7 SF-1 Fundamental Safety Principles, International Atomic Energy Agency, Vienna, Austria 2006
8   Australian Government Cost Recovery Guidelines 2014
9 GSR Part 1 (Rev. 1) Governmental, Legal and Regulatory Framework for Safety, International Atomic Energy Agency, Vienna, Austria 2016
10 GSG-12 Organization, Management and Staffing of the Regulatory Body for Safety, International Atomic Energy Agency, Vienna, Austria 2018
11 GSG-13 Functions and Processes for the Regulatory Body for Safety 2018

1 Terms highlighted in bold are explained in Section 7 – Terms and Definitions

2 For the purpose of this Policy, safety encompasses radiation safety (here synonymous to radiation protection and radiological protection), nuclear safety, waste safety, transport safety, security, and emergency management

3 See regulatory intersection with other functions on ARPANSA’s website

4 See international best practice on ARPANSA’s website

5 https://www.iaea.org/sites/default/files/ines.pdf 

6 Integrated Regulatory Review Service (IRRS) missions were invited in 2007 (followed up in 2011) and in 2018

7 https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-environ-enhealth-committee.htm

8 The Radiation Health and Safety Advisory Council (members and chair appointed by the Minister); the Nuclear Safety Committee and the Radiation Health Committee (members and chair appointed by the CEO of ARPANSA).