Policy for ARPANSA's regulatory activities

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.

The ARPANSA program of work entails six key objectives that guide our priorities and contribute to delivering radiation protection and nuclear safety outcomes to the Australian community:

  • Protect the public, workers and the environment from the harmful effects of 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 efficient regulation
  • Strengthen engagement with community and government
  • 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), supported by the staff of ARPANSA and aimed at management of radiation risks1. The regulatory functions form an important part of Australia’s and ARPANSA’s long term commitment to radiation protection and nuclear safety. ARPANSA regulates Commonwealth entities dealing with radiation as well as with radioactive and nuclear material including waste and spent fuel, and the transport of such material. ARPANSA is the national leader and principal driver for establishing a uniform regulatory framework across all Australian jurisdictions.

2. Purpose

This policy constitutes an over-arching framework for ARPANSA’s support of the CEO’s regulatory functions.

The policy outlines the commitment of the CEO to carry out their regulatory functions, and of ARPANSA to carry out activities that support the CEO’s regulatory functions, under the ARPANS Act and the Australian Radiation Protection and Nuclear Safety Regulations 1999 (the ARPANS Regulations; ref. 2), in the most efficient and effective manner possible for the purpose of protecting people and the environment from the harmful effects of radiation. It outlines the principles underpinning the supporting activities.

3. Scope

The Policy for ARPANSA’s Support of the CEO’s Regulatory Functions applies to the CEO and all ARPANSA staff and contractors undertaking work under the direction or commission of the CEO of ARPANSA. To the extent they support the CEO’s regulatory functions, the scope of this policy includes activities that relate to:

  • review and assessment
  • licensing decisions, taking international best practice into account
  • accreditation of services
  • monitoring of compliance, e.g. through inspections
  • enforcement actions
  • advice, education and information regarding compliance with regulation or supporting regulatory activities, including advice on international best practice
  • collation, analysis and dissemination of technical advice through the direct measurement or simulation of radiation exposures
  • development and promotion of a nationally uniform regulatory framework
  • national engagement and consultation with governments, other agencies with relevant regulatory responsibilities and stakeholders on regulatory matters
  • engagement with international bodies that develop and implement regulatory frameworks and risk assessments, and
  • organisation, staffing and management of ARPANSA.

4. Roles and responsibilities

The CEO of ARPANSA is the independent regulator of Commonwealth entities operating under the ARPANS Act, is responsible for ARPANSA’s regulatory activities and decisions, and is accountable to the Minister and Parliament. The CEO is also the promotor of uniformity of radiation protection and nuclear safety policy  and practices across jurisdictions of the Commonwealth, the states and the territories. The CEO’s functions and responsibilities are outlined in section 15 of the ARPANS Act.

The CEO establishes and maintains a high level framework for support of the regulatory functions as outlined in this policy.  Branch and Office Heads are accountable to the CEO for activities covered by this policy that fall within their areas of responsibility, including as directed under section 18 of the ARPANS Act.

All staff members have the responsibility to ensure the policy is followed, as applicable to their daily tasks.

5. Policy commitment

The CEO and ARPANSA are committed to providing the highest quality services to the Australian government and community. ARPANSA provides for:

  • sound and predictable regulatory arrangements, independent of promoting interests
  • a graded approach to the management of radiation risks, so that regulatory actions are commensurate with the level of hazard and risk, are appropriately managed and do not unduly impede on justified activities that involve radiation
  • intergenerational and transboundary protection
  • arrangements for stakeholder engagement, and
  • transparency and accountability in regulatory activities including decision making.

ARPANSA will, as applicable, implement and act in accordance with the Australian Government Guide to Regulation (ref. 3), the Australian Government’s Regulator Performance Framework, and the Australian Government publication International Standards and Risk Assessments (ref. 5); and with other guidance relevant to Commonwealth regulatory activities.ARPANSA promotes an approach to leadership and management (internally, among licence holders, and nationally) that ensures that all actions aimed at protection of health and the environment; protection of assets, property and infrastructure; and supporting safety, security, radiation protection and emergency management are carried out to the highest standards and in accordance with international best practice.

6. Principles

6.1 Regulatory activities and performance aligned with international best practice

International best practice shall guide ARPANSA’s regulatory activities and decision making.

In order to appropriately reflect international best practice, ARPANSA maintains a high level of engagement with international standard setting bodies as well as with international bodies that perform risk assessments2, and monitors adherence to international conventions as the designated Point of Contact or Competent Authority. ARPANSA takes into account international best practice and experience in countries with an advanced regulatory infrastructure in its regulatory actions and decision making, ensuring that information about international operating and regulatory experience is received and acted upon appropriately in the Australian context. To further support ARPANSA’s understanding of the international context, ARPANSA maintains cooperative arrangements with selected overseas regulators. ARPANSA supports activities aimed at promoting implementation of best practice regulation internationally, such as peer review missions, and will invite such missions to review its own activities at appropriate intervals.

ARPANSA provides regulatory and operational feedback to national and international stakeholders and counterparts in a timely way through its website and through its international engagement.

6.2 A nationally uniform approach

ARPANSA shall establish partnerships with state and territory regulators.

An effective collaboration with state and territory regulators that is characterised by mutual trust is necessary to promote and implement consistent regulatory arrangements and requirements across all jurisdictions. These arrangements promote national implementation of international standards and risk assessments as relevant in the Australian context, and contribute to the elimination of unnecessary obstacles to the nation-wide establishment of safe practices and businesses involving radiation. ARPANSA takes into account advice provided by the Radiation Health Committee (RHC), established under the ARPANS Act to assist the CEO of ARPANSA in promoting uniform national standards of radiation protection across jurisdictions. The RHC also forms a forum for exchange of regulatory experience. Agreed requirements and guidance are recorded in the Radiation Protection Series suite of publications, including the National Directory for Radiation Protection, or otherwise, and are available from the ARPANSA website. ARPANSA maintains currency of the requirements and guidance, and removes obsolete elements.

6.3 Engagement with government and national bodies

ARPANSA shall establish effective and efficient means of national regulatory collaboration.

The regulatory activities of ARPANSA interface with those carried out by other national bodies that have responsibilities for, among other things, measures directed towards safety (including work health and safety), security (including the control of nuclear material), protection of people and the environment, and emergency management. ARPANSA provides any necessary information, advice and feedback to government and national bodies. ARPANSA seeks to establish effective and efficient collaborative and coordination arrangements with national bodies, thus avoiding duplication of efforts and unnecessary regulatory burden. As appropriate, these arrangements are formalised in Memoranda of Understanding, or through arrangements to the same effect

6.4 Independence

ARPANSA shall act independently of any other interests in carrying out its regulatory activities.

The CEO of ARPANSA carries out their regulatory and other functions, free from political or economic pressures and is empowered and required to give independent advice. While ARPANSA engages with, and strives to understand the needs and views of licensees, applicants for an ARPANSA licence, and other stakeholders; the regulatory decisions are taken in the interest of safety and the protection of people and the environment, independent of such interests. This extends to ARPANSA’s licensed (under the ARPANS Act) dealings with controlled apparatus and controlled material, which as relevant and appropriate are independently observed by third parties to preserve independent decision-making. The CEO and ARPANSA staff are obliged to declare any interests in matters related to regulatory decision making to enable determination whether such interests may constitute a real, potential or perceived conflict of interest.

Potential conflicts of interest between the CEO’s regulatory and non-regulatory functions are identified and managed appropriately3.

6.5 Prime responsibility rests with the operator

ARPANSA shall establish and maintain clear demarcation of responsibilities between the regulator and the operator.

While ARPANSA directly regulates Commonwealth entities and actively engages with its licence holders and stakeholders more broadly in regulatory matters, the licence holder (operator) has the prime responsibility for protection, safety, security and on-site emergency management as well as for decommissioning and for management of radioactive waste and spent reactor fuel. ARPANSA will not through its activities relieve the licence holder from their responsibilities. Likewise, ARPANSA will not recommend specific technical, managerial, administrative or otherwise; arrangements pertaining to protection, safety, security and emergency management that could be perceived as relieving the licence holders of their responsibilities, or be perceived as pre-empting regulatory decisions.

6.6 Organisational structure and external advisors

ARPANSA shall optimise its structure and allocation of responsibilities and resources to promote best practicable regulatory performance.

ARPANSA supports the CEO’s regulatory functions. ARPANSA plans its human resources needs accordingly, including providing or obtaining training to develop any necessary skills, knowledge and abilities. ARPANSA recruits, develops and nurtures appropriately qualified staff with the expertise required to perform ARPANSA’s activities supporting the regulatory functions. ARPANSA maintains an organisational structure that ensures effective and efficient delivery of regulatory outputs of high standards, and that supports proper management of potentially conflicting interests. Branches and Offices work collaboratively in carrying out activities that support the CEO’s regulatory functions including promotion of national uniformity. Special care is taken with regard to licensing and enforcement decisions, which in terms of legality, potential conflicts and other aspects are properly vetted, e.g. by the ARPANSA General Counsel. Additionally, the CEO of ARPANSA is advised by three independent statutory external bodies4 and may seek independent advice via contractual arrangements from third parties 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.

6.7 Integrated Management System

ARPANSA shall capture the regulatory processes in its Integrated Management System.

ARPANSA develops and implements an Integrated Management System (IMS) that incorporates and connects existing systems for quality management, and provides for continual improvement across all processes and procedures. The IMS captures all regulatory processes as well as processes that support regulatory activities. The IMS allows for management of ARPANSA’s regulatory activities in a manner that is open and transparent, proportionate to hazards and risks, takes interdependencies into account, and mitigates risks for any conflict of interest. It also supports the development, retention, succession planning and recruitment of staff with the appropriate experience, qualifications and skillset. The IMS fosters and supports a culture of safety and security 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. As part of licensing or authorising regulated activities, ARPANSA verifies the competence of individuals having responsibility for those activities, and as necessary requires safety assessments for those activities. In managing and developing the IMS, ARPANSA emphasises the continuous enhancement of safety as a general objective, while at the same time recognising the risks associated with implementing changes. 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.

6.8 Multiple and graded approaches to management of radiation risks

ARPANSA’s regulatory approach shall be based on understanding hazards, risks and interdependencies, be predictable and strive to eliminate unnecessary regulatory burden.

ARPANSA’s regulatory approach is based on a firm understanding of hazards and risks associated with activities, facilities and sources, supported by a framework for risk management. The degree of regulatory control is commensurate with the hazards and risks, predictable and not unduly impeding on justified practices. ARPANSA is given statutory powers to require information to be provided by regulated bodies and the regulatory approach is further informed by compliance inspections. The inspection program will include planned and augmented inspections; inspections can if necessary be unannounced. Where risks are identified, ARPANSA can require corrective actions to be taken by regulated entities. There are interdependencies between protection, safety, security and emergency management that need consideration in regulatory decision making. ARPANSA establishes multi-disciplinary teams of experts to assess these interdependencies as appropriate. Different management options may need to be assessed by the license holder so that protection can be optimised. ARPANSA recognises that regulation is not the only means of managing radiation risks, and should be used only when necessary. Relevant weight is given to other measures to manage radiations risks such as operational and incident feedback, information, communication, education and engagement. To this end, ARPANSA also provides services and may accredit persons with technical expertise for the purpose of management of radiation risks. ARPANSA prepares appropriate emergency management guidance and provides expert advice to the government and to response organisations in relation to events that may lead to radiation risks. In reviewing and assessing activities or facilities, or modifications which might affect safety, ARPANSA develops appropriate understanding of the relevant designs and operating principles to inform its decisions.

6.9 Accountability

ARPANSA shall act transparently and engage with stakeholders.

ARPANSA promotes its accountability by reporting on its regulatory activities to government and by being transparent in regulatory actions, which includes publicising on its website its enforcement policy, inspection reports, statements of reasons for regulatory decisions, annual incident summaries and analyses, and guidance material in relation to its regulatory decision-making and actions.  ARPANSA promotes ways of informing and consulting with interested parties and the public as appropriate about possible radiation risks. 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 and effectiveness, including outputs and outcomes, 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 not only with licence holders and applicants as part of its regulatory oversight, but also with the broader community. 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 may be necessary long before an application has been received. ARPANSA regularly reviews and revises its guidance material to keep it up to date, and consistent with international standards and risk assessments.

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 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 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
    The Australian Government Guide to Regulation
www.cuttingredtape.gov.au
2014
    Regulator Performance Framework
www.cuttingredtape.gov.au/resources/rpf
2014
    International Standards and Risk Assessments
www.cuttingredtape.gov.au/resources/guidance/international-standards-and-risk-assessments
2014

 

1 Terms highlighted in bold are explained under Section 7 - Terms and Definitions

2 See international best practice 

3 See regulatory intersection with other functions

4 The Radiation Health and Safety Advisory Council; the Nuclear Safety Committee; the Radiation Health Committee. See ARPANSA’s website, www.arpansa.gov.au/about-us/advisory-council-and-committees