Radiation Protection and Control Regulations 2022

The EPA seeks to promote the following principles in the development and implementation of the new regulatory framework:

Protecting people and the environment: the Radiation Protection Principle is the principle that people, and the environment should be protected from unnecessary exposure to radiation through the processes of justification, limitation, and optimisation. Justification requires that that the benefits of a practice involving ionising radiation outweigh the detriment. Limitation involves maximum dose limits are not exceeded. Optimisation means ensuring that protection measures are implemented to reduce radiation exposure or risk of exposure, without unduly compromising access to beneficial uses and in proportion to the level of risk.

Risk-based and proportionate: this requires robust risk analysis to determine the need for regulation and to design a proportionate regulatory response where it is needed. The achievement of zero radiation dose is neither an appropriate or feasible goal of regulatory intervention.

Graded approach: elements such as the level of analysis, the depth of documentation and the scope of actions necessary to comply with requirements are commensurate with the relative risks to health, safety, security, and the environment, and the characteristics of a facility or activity.

National and international best practice: ensure that South Australia meets best practice standards for radiation protection and regulation. This includes seeking nationally consistent regulatory outcomes as reflected in the National Strategy for Radiation Safety and the National Directory for Radiation Protection (the National Directory).

Outcome focused: avoid unnecessarily prescriptive requirements. Where possible, regulation should be principles-based and where it is prescriptive, there should be clear justification, eg high risk in the event of control failure.

Transparent and consistent: this applies to making and implementing regulation and is essential for ensuring confidence in the legislative process. It includes safeguarding opportunities to participate in the formulation of regulation.

Effective and efficient: avoiding unnecessary requirements, and duplication of requirements under different laws. Minimising the administrative burden, while enabling the EPA to step in when needed to prevent harm and sanction poor behaviour.

Simple and accessible: regulations should be easily understood and readily accessible. Good regulation should allow everybody to easily find and understand their obligations.

Accountable: responsibility for radiation safety rests with those undertaking activities that give rise to the exposure. The EPA does not through its regulatory role relieve holders of authorisations or their employers of their primary responsibility for radiation safety.

The objects of this Act are:

1. to protect people and the environment from the harmful effects of radiation by applying the radiation protection principle; and
2. to ensure that radiation sources are secured against misuse that may result in harm to people or the environment; and
3. to recognise the benefits of the safe and justified uses of radiation; and
4. to promote the principles of ecologically sustainable development.

Radiation protection principle

The radiation protection principle is that people and the environment should be protected from unnecessary exposure to radiation through the processes of justification, optimisation, and limitation.

The principle of justification requires that the introduction of a new source of radiation, or any actions that result in radiation exposure, have a net overall benefit. This concept is not unique to radiation protection, as many decisions in everyday life involve balancing benefits and risks. Once a decision has been made that a particular action is justified, then the next step is to apply the principle of optimisation.

Optimisation of protection, in relation to the conduct of a radiation practice, or the use of a radiation source, that may expose people or the environment to ionising radiation, means:

1. keeping the magnitude of individual doses of, or the number of people that may be exposed to, ionising radiation as low as is reasonably achievable, taking into account economic, social and environmental factors;
2. if the magnitude of individual doses, or the number of people that may be exposed, is uncertain – keeping the likelihood of incurring exposures of ionising radiation as low as is reasonably achievable, taking into account economic, social and environmental factors.

What does this mean

The role of the EPA is to ensure that only justified practices are authorised, and to establish and enforce requirements for the optimisation of protection and safety. Licensees must ensure that protection and safety is optimised [1].

Decisions on justification and optimisation go beyond radiation protection and need to take account of economic, societal and environmental considerations. In many instances, the benefits considered in justification or in optimisation accrue to society in general rather than to individuals.

The concepts of ‘good’ and ‘harm’, often expressed as ‘benefits’ and ‘risks’, are subjective and vary between individuals. Applying the principle of justification therefore involves judgement decisions that are seldom straightforward. Justification applies not only to the introduction of new sources of radiation, but also to actions designed to reduce radiation exposure.

All such actions have associated costs, as well as societal and environmental impacts, which must be considered as part of the decision-making process. Optimisation is directly linked to justification in that the extent to which radiation protection and safety can be optimised is one of the inputs into decisions on justification. Optimisation is about ensuring that, under the prevailing conditions, the best possible choices are made. As with justification, optimisation needs to take account of more than just the need to reduce radiation doses.

The application of the principles of justification and optimisation is reasonably well established when working with radiation sources. Where this is not the case, interested parties need by consulted and involved in the decision-making process.

The following diagram is a simplified depiction of the regulatory framework for the regulation of radiation safety in South Australia.

• The Act applies to everyone, including through the general duty provisions and provides the authority for the regulations, codes and standards.
• The regulations set out the requirements in more detail and identifies the codes and standards to be met to demonstrate radiation safety.
• Codes and standards generally apply to particular types of radiation sources and activities and further clarify the requirements for meeting obligations for radiation safety.
• Guidelines set out the approaches that will be regarded as compliant with the Act and Regulations.
• Authorisations are specific to a particular person or business and provides the legal authority to undertake specified activities that are subject to regulation.
• Radiation management plans are owned by the licence-holder and set out how they will comply with their authorisation.

Radiation Protection and Control Act 2021

The new RPC Act was assented to on 11 February 2021 and its implementation will be supported through new regulations and codes of compliance.

The new RPC Act provides a contemporary risk-based framework for radiation safety based on national and international standards of best practice. It reduces the number of licences needing to be held by an individual or a business, introduces offences for causing radiation harm when not acting in accordance with the Act, updates maximum penalties, order-making powers for gaining compliance, increases protection of security enhanced and high-risk radioactive sources, provides for a simplified process for adopting documents forming part of the National Directory, and financial assurances.

Draft Radiation Protection and Control Regulations 2022

The regulations aim to deliver three reforms enabled by the Act, while retaining the best aspects of the current regulations:

• A modern risk-based approach that focusses on important controls, simplifies requirements, and removes unnecessary administrative burdens.
• A responsive framework that provides flexibility, enables innovation and manages emerging technologies and risks. To replace one-size-fits all prescriptive requirements, and use the expertise of the leading practitioners to design more effective controls.
• Provide tools to enable the EPA to step in and take action where harm may be caused.

As subordinate legislation, the purpose of the new regulations is to support implementation of the Act, and to provide clarity and certainty on its application. The regulations set out the requirements to be followed when undertaking an activity involving radiation.

The regulations are specific to South Australia and its regulatory environment but reference internationally and nationally recognised standards where appropriate. This reflects the commitment to national uniformity in regulating radiation safety made by the Australian and state governments.

The responsibility for radiation safety first and foremost rests with those authorised to undertake activities involving radiation sources. The role of regulations is to formally state the obligations, roles, and responsibilities of the authorised party. It is the responsibility of the authorised party to demonstrate their knowledge, competence, and commitment to a strong safety culture.

Matters in the new Act requiring or allowing regulations to be made include (but are not limited to):

• Definitions of what constitutes a radiation facility, radioactive material, and security enhanced radioactive source for purposes of regulation.
• Exclusion of classes of operations, persons, material, circumstances, substances, apparatus, premises, and sources from the requirement to hold a licence
• Requirements for determining applications for authorisation
• Requirements for radiation management plans
• Standards, practices, and procedures to be complied with
• Requirements for medical examination of exposed persons
• Requirements for monitoring, record-keeping, and incident notification
• Requirements for identity checks and security background checks
• Responsibilities of employers and other responsible persons
• Fees and penalties

The new Radiation Protection and Control (RPC) Act introduces several changes to the way radiation safety is regulated, many of which are given more specific meaning through the draft regulations, codes of compliance and fees.

The changes are:

• greater national uniformity
• opportunity for consolidation of authorisations
• creating offences for causing harm
• setting new penalties
• introducing order-making powers.

Key changes can be found in the Explanatory Report and Public Consultation Report.

Specific changes in the draft regulations and codes include the following.

Exclusions

The RPC Act provides for the exclusion of matters from regulation through designation, definition, classification and prescription of materials, sources, and activities. These are given effect in the regulations through provisions for the exclusion of prescribed classes of operations, persons, circumstances, material, things, substances, apparatus, premises, and sources from regulation.

The exclusions are based on those agreed through the National Directory for Radiation Protection (NDRP), a comparison of exclusions/exemptions in other jurisdictions, and a review of exemptions approved by the EPA over the past 10 years. The regulations also provide for classes of exemptions based on prescribed factors (risk criteria) on which the Minister can further exempt persons, operations, circumstances, premises, sources, or apparatus from the requirement to hold an authorisation.

Exemptions

All existing individual exemptions will expire on the first anniversary of the commencement of the new RPC Act.

The general criteria for exemption are:

• radiation risks arising from the practice or from a source within the practice are sufficiently low as not to warrant regulatory control, with no appreciable likelihood of situations arising that could lead to a failure to meet the general criterion for exemption
  OR
• regulatory control of the practice or the source would yield no net benefit, in that no reasonable measures for regulatory control would achieve a worthwhile return in terms of reduction of individual doses or of health risks.

Paragraphs 35 and 36 of the NDRP describes the criteria for exemption, and Schedule 2 of the NDRP list specific radiation apparatus or radioactive sources to be exempted from notification, registration or licensing requirements.

NB: Exemption does not absolve a person from the general duty of care.

In addition to a new class of exemption where the Minister is satisfied that a licence or registration is not warranted, the following specific changes to exemptions are included in the draft regulations:

1. Testing for developmental purposes and mining or mineral processing – operations of a prescribed class
   1. Amend existing exemptions to include a broader range of treatment processes and removing the reference to ‘calendar’ year.
   2. Add a new class – operations where the Minister is satisfied that it will not under any reasonably foreseeable circumstances, including failure of control system, result in an annual dose above 1 mSv per year to any person.
2. Facilities – person of a prescribed class
   1. Kept existing and added a new class – persons where the facility can be registered as a source or apparatus and compliant with relevant regulations and codes associated with the source or apparatus.
3. Transport of radioactive material – prescribed circumstances
   1. Circumstances where a source is held under a licence to use or handle and is not required to have a management licence for possession.  
   2. Circumstances in which an individual transports radioactive material in the course of their employment by the holder of a radiation management licence that applies in respect of the radioactive material.
4. Transport of radioactive material – prescribed radioactive material
   1. Radioactive material contained in an excepted package as defined by the Transport Code. 
   2. Radioactive material within the body of a person or animal (living or dead).
5. Possession of a radiation source – prescribed circumstances
   1. Amended exemption while awaiting determination by allowing possession to be prohibited or restricted by notice.
   2. Amended by adding licence to transport to the other 3 management licences that do not also require a licence to possess.
6. Possession of a radiation source – prescribed things
   1. An article, device or other thing that only emits non-ionising radiation.
   2. A radiation source that is unsealed radioactive material listed in Schedule 6 Clause 2, in the specified circumstances
   3. Exempt radiation apparatus - see point 14 below.
   4. Exempt sealed radioactive source - see point 13 below.
7. Use or handle radioactive material – prescribed classes of person
   1. Kept existing.
8. Use or handle radioactive material – prescribed classes of substances
   1. The substances listed, or are contained in a device that is listed, in Schedule 6 Clause 2.
9. Operation of radiation apparatus – prescribed classes of persons
   1. Kept existing
10. Operation of radiation apparatus – prescribed classes of apparatus
    1. Kept existing and added apparatus listed in Schedule 6 Clause 1.
11. Registration of premises – prescribed classes of premises
    1. Kept existing and added transport licence to types of management licences that do not require separate registration of premises
    2. Premises in which unsealed radioactive ores are handled or kept that have not been subject to chemical processing or are less than 100 kg
    3. Premises at which unsealed radioactive sources are kept or handled while let out on hire if the period of hire is 3 months or less.
12. Registration of premises – prescribed classes of substances
    1. The unsealed radioactive materials listed in Schedule 6 Clause 2, in the specified circumstances.
13. Registration of sealed radioactive sources – prescribed classes of sources
    1. The sealed radioactive sources listed in Schedule 6 Clause 2, in the circumstances specified
    2. Sealed radioactive sources held within a facility the operations of which are authorised by a radiation management licence
    3. Sealed radioactive sources that are held only as stock for the purposes of sale and are not used
    4. Sealed radioactive sources that have been let out on hire for a period of 3 months or less and in respect of which the person receiving the source on hire holds a radiation management licence
14. Registration of apparatus – prescribed classes of apparatus
    1. Ionising radiation apparatus that produces ionising radiation incidental to its function (including electron microscopes and apparatus containing a cathode ray tube or an electronic valve) if the apparatus does not, in normal operating conditions, cause an equivalent dose rate exceeding 1 µSv/h at a distance of 0.1 m from any accessible surface of the apparatus
    2. Ionising radiation apparatus made incapable of operation
    3. Ionising radiation apparatus held as stock for sale by a person who has complied with regulation 36 (other than apparatus operated by another person and located at premises of a person who has not complied with that regulation)
    4. Ionising radiation apparatus being installed by a person who has complied with regulation 36
    5. Apparatus listed in Schedule 6 clause 1
15. Abandonment of radiation source – prescribed things
    1. Any radiation source not requiring a licence or registration.

A specific issue raised by stakeholders is the exemption of persons operating apparatus or handling radioactive material under supervision. The current regulations include 12 classes of persons exempt from the requirement to hold a licence when acting under supervision. It is important to ensure a robust system that accounts for direct and indirect supervision requirements via a graded approach.

A flexible approach for achieving this is to include a broad-based exemption of a prescribed class of persons working under supervision subject to supervision requirements approved as part of a radiation management plan. This could include specifying, based on the particular circumstances, the:

• nature of supervision, eg direct vs indirect based on competency progression supported by assessment
• qualification of supervisor, including requirement to hold a relevant licence
• operations and activities persons will undertake during the various stages of their training
• respective roles and responsibilities of the supervisor and supervised person in relation to the radiation operations and activities
• assessment process that will determine progression through the various supervision stages
• record-keeping arrangements that include documented assessments of supervised persons.    

What we heard so far

Following assent of the Radiation Protection and Control Act 2021 on 11 February 2021, the Australasian Radiation Protection Society (ARPS), South Australia Medical Imaging (SAMI), and the South Australia Chamber of Mines and Energy (SACOME) raised issues of interest to be considered in the development of new regulations with the EPA. Submissions received from ARPS and SAMI are available under the ‘documents’ Tab.

Key issues identified were:

1. National uniformity

The draft regulations adopt and align with the definitions, thresholds, exemptions, standards, and other provisions in the National Directory for Radiation Protection (NDRP). The new RPC Act allows for future changes or additions to the NDRP to be adopted more easily by Ministerial Notice.

Recent changes to the Mutual Recognition Act 1992 to introduce automatic deemed registration for some occupations across jurisdictions and work by ARPANSA’s Radiation Health Committee through the Radiation Health Expert Reference Panel on common competencies for radiation occupations promote common national standards for practitioners.

2. Flexibility

The draft regulations avoid the detailed technical requirements of the current regulations and instead reference activity-specific codes and standards that can be amended more easily to reflect changes in technology and practices. The draft Code of Compliance for Radiation Management Plans places the onus on employers and owners to put in place plans, systems and processes for radiation safety based on the nature, complexity and risks associated with the activities and sources at their facility.

3. Graded approach

The draft regulations support a graded approach through the exclusion of prescribed classes of persons, operations, circumstances, material, apparatus, and premises; and through the adoption of risk-based codes and standards. The draft Code of Compliance for Radiation Management Plans promotes alignment of protection and safety requirements at a facility with the complexity and radiation risks associated with the facility in a graded manner. There will also be opportunities for applying the graded approach outside of the regulations through risk-based licence fees, application requirements, conditions of licence, and compliance approach.

4. Adoption of standards

The draft regulations move away from many of the current prescriptive requirements and adopt the NDRP and the related ARPANSA standards, supplemented by EPA codes. The new RPC Act allows for any new standards, guidance, or codes of practice forming part of the NDRP to be adopted by notice in the Gazette. The EPA will also consider the adoption of standards, codes, guidelines, protocols, etc. developed by professional bodies.

5. Licensing requirements

The new RPC Act and draft regulations do not specify qualifications for a licence other than that the applicant must be a fit and proper person and have appropriate knowledge to carry out the activities proposed to be undertaken under the licence. New guidance will be published on how applications for a license or accreditation will be assessed, which will consider opportunities for national uniformity, including professional registration and other industry-based standards. The code for radiation management plans requires plans to include organisational and worker competencies to meet radiation safety obligations including competency assessment, qualifications, induction, training, and continuing development and reassessment

6. Exemptions

All existing exemptions will expire on the first anniversary of the commencement of the new RPC Act. Any not provided for in the new regulations will need to be re-applied for. The draft regulations adopt the nationally agreed exemptions in the NDRP and provide for further classes of exemptions to be determined by the Minister. This should minimise the need for individually determined exemptions.

7. Risk assessment

The new RPC Act adopts the Radiation Protection Principle that requires planned exposures to radiation to be justified, optimised and limited based on standards and limits of risk. The NDRP defines radiation risk and specifies dose limits, reference levels and dose coefficients with reference to national and international codes and standards. These codes and standards are also specified in the draft code for radiation management plans.

8. Quality assurance of apparatus

The EPA has existing guidelines for compliance testing of diagnostic X-ray apparatus, which have been included in new draft codes. The final versions of the codes will consider feedback from stakeholders, including the detailed submission by SA Medical Imaging (SAMI) – see under ‘Documents,’ and the outcome of the current consultation on draft Multijurisdictional Apparatus Testing Requirements by the Radiation Health Committee of ARPANSA.

9. Engagement

Issues with the current regulations identified by various sectors have helped to inform the draft regulations and codes of compliance. (See submissions by ARPS and SAMI under the documents Tab).

10. Miscellaneous

In addition to the above themes, stakeholders raised several other issues including definitions, authorisation of exposures, shielding requirements, incident reporting, and radioactive waste management that have been addressed in the draft regulations and codes. Any further feedback is welcome.