Radiation Act 2005 - Frequently asked questions

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1. What is the purpose of the Radiation Act 2005?
2. What are the main features of the Radiation Act 2005?

MRP specific questions

3. Do medical radiation practitioners need licences as well as professional registration?
4. Why should a medical radiation practitioner or other practitioners have to have a ‘use’ licence and professional registration?
5. When will medical radiation practitioners need a use licence?

Licencing and fees

6. Why does the Act introduce management licences?
7. Will there be increased charges and fees under the Act?
8. Why does the Act have emergency powers?
9. How will the Act impact on security of radiation sources in Victoria?
10. Does the Act change the Nuclear Activities (Prohibition) Act 1983?
11. How does the Act regulate radioactive waste in Victoria?
12. What is the National Directory for Radiation Protection?
13. What avenues for review are available under the Act?
14. Why does the Act provide for the secretary to declare certain materials and apparatus not to be radiation sources?
15. Why does the Act provide for the secretary to exempt people from needing a management or use licence?
16. What is the compliance program and how will it be managed?

Definitions

17. What is the difference between ionising and non-ionising radiation?
18. What are “radiation sources”?
19. What are “radiation apparatus”?
20. What are “ionising radiation apparatus”?
21. What are “non-ionising radiation apparatus”?
22. What are “radiation practices”?
23. What is “radioactive material”?
24. What are “sealed sources”?
25. What does “use” mean in the context of the Act?
26. What is a “radiation facility”?

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1: What is the purpose of the Radiation Act 2005?

The purpose of the Radiation Act 2005 is to protect the health and safety of people and the environment from the harmful effects of radiation. The Act is designed to regulate all radiation elements of practices that involve radiation sources including medical, industrial, research, and mining sectors. The Act addresses public, occupational, and environmental aspects of radiation practices and provides a cohesive framework of controls consistent with national and international requirements for optimised health and environmental protection. The Act regulates all uses of radiation whether or not they occur in or outside a workplace.

2: What are the main features of the Radiation Act 2005?

• It defines a regulatory framework and licensing regime that is consistent with the National Directory for Radiation Protection and facilitates greater national consistency in the regulation of radiation practices. This means that persons or companies wishing to conduct an activity involving radiation must hold a management licence.
• All users of radiation sources also need to be licensed unless specifically exempted from that requirement.
• It has emergency powers that enable the government to respond to emergencies relating to radiation.
• It has enforcement powers and penalties that ensure the government can achieve it’s goal of protection of persons and the environment from the harmful effects of radiation. Enforcement powers are balanced by strict statutory procedures to ensure that the rights of regulated parties are protected.
• It ensures that regulatory process are conducted with accountability and transparency. For instance:
  • All Secretarial declarations that an apparatus or material is not a radiation source must be tabled in Parliament and may be disallowed by either House of Parliament;
• All exemptions granted by the Secretary under the Act will need to be published in the Government Gazette; and
• Licensing decisions are subject to internal review within the Department of Health. Licensing decisions, except for those relating to radiation facilities, are reviewable by VCAT.

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MRP specific questions

3: Do medical radiation practitioners need licences as well as professional registration?

In addition to their registration with the Medical Radiation Practitioners Board, medical radiation practitioners are required to be licensed under the Radiation Act.

4: Why should a medical radiation practitioner or other health practitioners have to have a ‘use’ licence and professional registration?

Requiring a use licence for medical radiation practitioners brings these professionals in to line with all other health professionals who use radiation sources. This group includes cardiologists, radiologists, orthopaedic surgeons, dentists, and other professionals who are required to be licensed to use radiation sources in addition to their need to maintain registration with their relevant health practitioner board. This approach is designed to ensure that all radiation users are subject to common radiation controls.

A use licence and professional registration serve two different purposes. Professional registration aims to protect the public by registration of health professionals, by regulation of the standards of practice of health professionals through issuing guidelines and policies, accreditation of courses leading to professional registration and as investigating instances of professional misconduct.  The Radiation Act does not seek to regulate health practice, but does seek to regulate radiation practices conducted by health practitioners.

5: When will medical radiation practitioners need a use licence?

From 1 September 2009 the exemption from the requirement to hold a use licence terminated and from that date all medical radiation practitioners who use radiation sources now require a use licence.

Licensing and Fees

6: Why does the Act introduce management licences?

The Act requires that a management licence be held prior to a radiation practice being conducted. A radiation practice could be as simple as possession of a radiation source e.g. an x-ray machine. A management licence will define the radiation practice that is permitted to be conducted and in practice this will include the types of radiation sources that are permitted to be possessed. This will ensure that the regulator and the licence holder have a clear understanding of the practice that has been authorised and of the conditions which apply to that licence. These conditions could relate to matters such as the safety and security of the radiation sources through to the manner in which the practice may be conducted.

7: Will there be increased charges and fees under the Act?

The fees for management licences are based on the numbers of sources authorised and therefore represent the scale of the operation.

Licence holders have some flexibility for in the term of their licence, with the opportunity for a periods of one, two, or three years.

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8: Why does the Act have emergency powers?

The Act contains emergency powers to ensure that the government has the ability to respond to radiation incidents involving the release or potential release of radiation from a radiation source that poses a serious risk to the health or safety of persons or the environment.

Incidents could arise in a number of ways including the spill of radioactive material inside a building or during transport.
Emergency powers that may need to be exercised include the need to detain a person for the purposes of decontaminating that person where they have been contaminated with radioactive material to ensure that they do not pose a danger to other persons.

The Act provides for safeguards to the abuse of this power including that the use of the power must be authorised by the Secretary to the Department of Health. In practice, this power has been delegated to a senior officer of the Department to ensure that immediate response is available to deal quickly with incidents.

The Department of Health provides a 24 by 7 emergency response service involving two radiation scientists with specialist equipment available to respond when required, supported by additional staff of the Department as needed. The Department is also able to liaise with other emergency services.

9: How will the Act impact on security of radiation sources in Victoria?

The Act will require that any person conducting a radiation practice (including the possession of a radiation source) must hold a management licence authorising, amongst other things, the possession of those sources.

A condition has been imposed on all management licences requiring the management licence holder to notify the Secretary to the Department of Health of the acquisition or disposal of a radiation source within 14 days. A register of radiation sources is maintained that enables the department to monitor where and what radiation sources are kept, and by whom, throughout Victoria.

A condition will also be imposed on some management licences that authorise the possession of the largest types of sealed sources that relates to the physical security of the radiation sources. This condition will make reference to the Code of Practice for the Security of Radioactive Sources, making compliance with this code mandatory.

The Act also requires the holder of the management licence to notify the Secretary immediately following the theft or loss of a radiation source.

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10: Does the Act change the Nuclear Activities (Prohibition) Act 1983?

The Act makes consequential amendments to the Nuclear Activities (Prohibition) Act 1983 so that the Act refers to the Radiation Act 2005 rather than Health Act 1958.

The Act does not change any aspect of nuclear activities currently prohibited by the Nuclear Activities (Prohibition) Act.

The Nuclear Activities (Prohibition) Act 1983 is administered by the Minister for Energy.
The Act prohibits certain nuclear activities, such as:

• The exploration, mining or milling of uranium or thorium;
• The construction or operation of a facility for conversion or enrichment of any nuclear material or the reprocessing spent fuel;
• The construction or operation of a nuclear reactor or a nuclear power reactor;
• The construction or operation of a facility for the storage or disposal of certain nuclear materials; and
• Possessing, using, selling, transporting, storing or disposing of nuclear material unless, in respect of the nuclear material concerned—
  • the person is licensed to do so under the Radiation Act 2005 or exempted by the Secretary to the Department of Health under the Radiation Act; or
  • has complied with section 113 of the Mineral Resources Development Act 1990.

11: How does the Act regulate radioactive waste in Victoria?

As a minimum, any person seeking to store or dispose of radioactive material will need to hold a management licence permitting that activity. This will mean that a business which generates radioactive waste and wishes to store that material until it is no longer radioactive or dispose of the material will need to hold an appropriate licence which permits that activity. The management licence could also include conditions requiring specific steps be undertaken to ensure safety and security of the radioactive sources involved.

It is likely that a future amendment of the National Directory for Radiation Protection will specify as a radiation facility a place which stores specific types of radioactive materials. Victorian regulations made under this Act would then be expected to define such a facility as a radiation facility within the meaning of the Act. These new regulations would allow for increased controls over the establishment of such a facility than currently exist in a manner consistent with the National Directory for Radiation Protection e.g. it would require that a facility construction licence must be issued before the construction commenced on a site.

It is also noted that the Nuclear Activities (Prohibition) Act 1983 prohibits the construction or operation of certain facilities to store or dispose of nuclear materials. This includes a facility for the disposal of waste nuclear materials from a nuclear reactor.

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12: What is the National Directory for Radiation Protection?

In August 1999, the Australian Health Ministers Council (“AHMC”) agreed that the National Directory for Radiation Protection (“NDRP”) would be developed as the means to achieve uniformity in radiation protection. The purpose of the NDRP is to provide an agreed framework for radiation safety together with clear regulatory statements to be adopted by the Commonwealth, States and Territories.

In 2001, AHMC agreed that all States and Territories of Australia would implement the provisions of the National Directory for Radiation Protection.

On 29 July 2004, AHMC endorsed the adoption of the Edition 1.0 of NDRP.

The Directory, which is amended from time to time, describes general principles and uniform regulatory elements rather than being a legislation template or a model Act.

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13: What avenues for review of decisions are available under the Act?

Certain decisions made by the Secretary are described in the Act as reviewable decisions. These include:

• suspension or cancellation of a licence
• refusal to issue a licence
• the imposition of conditions on a licence

The licence holder or the applicant, as the case may be, is eligible for an internal review by the Secretary and if the licence holder or applicant is still aggrieved following that review, they are also eligible to apply to the Victorian Civil and Administrative Tribunal for review of the decision.

In the case of radiation facilities, the applicant or licence holder will be eligible for an internal review by the Secretary.

All licence holders and applicants for licences (including those relating to radiation facilities) will be able to apply to the Supreme Court for judicial review of any decision.

14: Why does the Act provide for the secretary to declare certain materials and apparatus not to be radiation sources?

There may be material or apparatus that would otherwise meet the definitions of radiation sources in the Act even though it is not of regulatory concern because it did not pose a significant risk to the health or safety of any person or the safety of the environment. It is therefore important that there is a mechanism to declare a material or an apparatus not to be a radiation source to ensure that regulatory effort is spent on other materials or apparatus that are of regulatory concern.

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15: Why does the Act provide for the secretary to exempt people from needing a management or use licence?

It is technically possible that there may be practices that meet the definition of “radiation practice” as defined in the Act even though the nature or circumstances of that practice mean that it did not pose a significant risk to the health or safety of any person or the safety of the environment. It is therefore important that a power exists for exemption of a person or class of person from the requirement to hold a management licence or a use licence.

16: What is the compliance program and how will it be managed?

Certain equipment “prescribed radiation sources” are prescribed in Regulations and therefore are required to have a “certificate of compliance” for it to be operated.

Currently medical and dental X-ray equipment (e.g. radiography and fluoroscopy units, mammography, and CT scanners ) require periodic testing against the Standards declared by the Secretary. These types of x-ray machines cannot be used for human diagnostic purposes without having been issued a certificate of compliance by an approved tester.

Persons issued with a testers approval are available to perform compliance testing . The Standards required for compliance are those critical for an item to perform correctly and safely in order to make testing as efficient and cost effective as possible. Prospective testers are assessed based on their qualifications and experience. An individual’s t esters approval specifies what range of sources they may issue certificates for. Only approved testers can issue a compliance certificate for the purposes of the Act.

There are “conflict of interest” provisions meaning that approves testers are allowed to test equipment in which they or their employer possesses or has an interest. A proportion of testers work is audited and the audit program is designed to ensure that all testing is up to Standard regardless of who the client is or the cost of the service.

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Definitions

17(a): What is the difference between ionising and non-ionising radiation?

The electromagnetic spectrum includes radiowaves, microwaves, infrared waves, light, ultraviolet rays, x-rays and gamma rays. The different forms of electromagnetic radiation are distinguished from each other by their wavelength and the amount of energy they transfer.

These properties also determine their ability to travel through objects, their heating effect and their effect on living tissue.

What is non-ionising radiation?

Non-ionising radiation is found at the long wavelength end of the electromagnetic spectrum and may have enough energy to excite molecules and atoms causing then to vibrate faster. This is very obvious in a microwave oven where the radiation causes water molecules to vibrate faster creating heat.

Non-ionizing radiation ranges from extremely low frequency radiation, and includes the radio frequency, microwave, and visible portions of the spectrum into the ultraviolet range.

Extremely low-frequency radiation has very long wavelengths (in the order of a thousand kilometres or more) and frequencies in the range of 100 hertz or less. Radio frequencies have wavelengths of between 1 and 100 metres and frequencies in the range of 1 million to 100 million hertz. Microwaves that we use to heat food have wavelengths that are a few centimetres long and have frequencies of about 10 thousand million hertz.

What is ionising radiation?

Ionising radiation has more energy than non-ionizing radiation; enough to cause chemical changes by breaking chemical bonds. This effect can cause damage to living tissue.

Shorter wavelength ultraviolet radiation begins to have enough energy to break chemical bonds. X-ray and gamma ray radiation, which are at the upper end of electromagnetic spectrum, have very high frequencies (in the range of 10 million million million hertz) and very short wavelengths (1 million millionth of a metre). Radiation in this range has extremely high energy. It has enough energy to strip electrons from an atom or, in the case of very high-energy radiation, break up the nucleus of the atom.

The process in which an electron is given enough energy to break away from an atom is called ionisation. This process results in the formation of two charged particles or ions: the molecule with a net positive charge, and the free electron with a negative charge.

Each ionization releases energy which is absorbed by material surrounding the ionized atom. Compared to other types of radiation that may be absorbed, ionizing radiation deposits a large amount of energy into a small area. In fact, the energy from one ionization is more than enough energy to disrupt the chemical bond between two carbon atoms. All ionizing radiation is capable, directly or indirectly, of removing electrons from most molecules.

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18: What are “radiation sources”?

A radiation source is defined as:

• radioactive material (which includes a sealed source);
• a radiation apparatus (which is defined as both ionising radiation apparatus and non-ionising radiation apparatus); and
• a sealed source apparatus.

If something is exempted (by regulation or declaration) from being a radioactive material, radiation apparatus or a sealed source apparatus, then it is not a radiation source.

There are over 5,500 radiation sources in Victoria. Sealed sources are used in industrial gauges that measure thickness and density in the manufacture of many products.

Industrial uses of radiation provide safer construction and are used to monitor quality in many manufactured goods. For example:

• Iridium is used to x-ray steel in the construction, mining, petroleum and gas sectors.
• Americium is used to determine the thickness of everything from paper to plastics.
• Some moisture gauges used by farmers contain radioactive materials.
• The level of soft drink in bottles is commonly determined by fluid level gauges using radiation technologies.
• Cobalt is used to sterilise surgical instruments and feminine hygiene products.

Medical uses of radioactive material are an essential part of the diagnosis and treatment of many health conditions. Radio-phosphorous is an essential tool in pathology laboratories for the correct diagnosis of disease. Radio-iodine treats thyroid cancer whilst radio-strontium provides palliative pain relief for bone cancer patients.

19: What are “radiation apparatus”?

Radiation apparatus are defined in the Act as including both ionising radiation apparatus and non-ionising radiation apparatus.

The term “ionising radiation apparatus” means an apparatus that produces ionising radiation when energised, unless the apparatus is a sealed source apparatus or there is a regulation or Secretarial declaration that the apparatus is not an ionising radiation apparatus.

Non-ionising radiation apparatus are defined in the Act as an apparatus that produces non-ionising radiation when energised and is prescribed in the Regulations to be made under the Act as a non-ionising radiation apparatus.

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20: What are “ionising radiation apparatus”?

Ionising radiation apparatus are mostly x-ray machines, examples include:

• a diagnostic x-ray machine;
• a CT scanner;
• a baggage x-ray machine; and
• an industrial radiography x-ray machine used to take x-rays of pipes and welds for quality assurance purposes.

In determining which apparatus should be prescribed or declared to not be an ionising radiation apparatus, it would be necessary to consider the risk posed by the emissions for the apparatus. The National Directory for Radiation Protection proposes that the following apparatus should be exempted:

• television receivers;
• visual display units;
• cold cathode gas discharge tubes; and
• electron microscopes.

The definitions of “ionising radiation apparatus” and non ionising has been drawn from the National Directory for Radiation Protection.

21: What are “non-ionising radiation apparatus”?

Examples of apparatus that produce non-ionising radiation when energised are:

• commercial tanning units (as used in solaria) used to enhance cosmetic tanning;
• magnetic Resonance Imaging (MRI) medical scanners
• high powered lasers (such as class 3B and 4 lasers) typically used in surgical procedures and industrial applications ;
• induction heaters used to melt metals in industry;
• industrial microwaves used for drying timber.

Currently only commercial tanning units are prescribed by regulations to be non-ionising radiation apparatus.

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22: What are “radiation practices”?

“Radiation practice” is defined as meaning various specified activities such as:

• possession of a radiation source;
• the selling of a radiation source; or
• the transport of radioactive material.
  

The Act provides that a person who carries out one of the specified activities (other than possession of a radiation source) during the course of his or her employment is not to be taken to be conducting a radiation practice. For instance, a person who drives the truck with radioactive material as an employee is not conducting a radiation practice. The employer, however, will be conducting a radiation practice and, subject to any exemptions, will need to hold a management licence.

The definition of radiation practice is central term of the Act. Subject to limited exceptions, a person who conducts a radiation practice must have a management licence. Further, there are a number of offences that are limited to situations when a person is conducting a radiation practice.

23: What is “radioactive material”?

It is defined in the Act in the definitions section in 4 parts. In simple terms, it is what is in paragraph (a) or (b) of that definition unless those things are excluded by paragraphs (c) or (d).

Paragraph (a) relates to material that spontaneously emits ionising radiation with an activity concentration equal to, or greater than, the amount prescribed by the regulations and consists of, or contains, an activity equal to, or greater than, the amount prescribed by the regulations.

In order to comply with the national agreement to implement the National Directory for Radiation Protection, the prescribed activity and activity concentration would need to reflect the levels in Schedule 4 of the Directory.

Most material of interest to regulators because of its potential risk to heath or the environment falls into this category. Examples of this include radioactive materials used in nuclear medicine for the treatment of disease, and radiotracers used in research for industrial processes.

Paragraph (b) relates to any material that spontaneously emits ionising radiation that has an activity concentration, or consists of, or contains, an activity, less than the amount prescribed by the regulations and occurs in prescribed circumstances. This provision is intended to deal with the cases where the activity concentration is relatively low but the practice involved means that people’s exposure to radiation is sufficiently high to justify regulatory control. An example of where this power could be used is the inclusion of large scale practices involving concentrations of naturally occurring radioactive materials such as the mineral sand mining sector.

Paragraph (c) relates to raw material with unmodified concentrations of radionuclides. Some raw materials, such as granite, have naturally occurring radioactive material. Raw material with unmodified concentrations of radionuclides is not radioactive material for the purpose of this Act, unless regulations are made pursuant to paragraph (c) that prescribes the material to be radioactive material. If raw material is modified in ways that the modified product contains increased concentrations of radionuclides, then the product ceases to be a raw material as described in this paragraph and whether it would be radioactive material would be determined by the other provisions in the definition.

Paragraph (d) relates to material that is prescribed by the regulations not to be radioactive material or declared not to be radioactive material under clause 4. An example of where this power could be used is the exemption of small consumer items such as household smoke alarms containing small traces of radioactive material.

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24: What are “sealed sources”?

Sealed sources are defined in the Act as radioactive material that is permanently sealed in a capsule or closely bound and in solid form. The radioactive material within certain forms of smoke detectors is an example of a sealed source.

25: What does “use” mean in the context of the Act?

The term “use” is defined in the Act in relation to a radiation source as meaning actual use by a natural person of a radiation source and includes the use by a natural person of radiation emitted from a radiation source and the injection, or implanting, of radioactive material into a person or animal.

Examples of use are:

• the actual use of a dental x-ray unit by a dentist whilst performing an x-ray of their patients’ teeth;
• the use of radiation in the form of radioactive material implanted in the body to treat a cancer in a patient;
• the testing of soil moisture by farmers to get optimum crop yield
• the testing of road compaction by construction companies
• the taking of industrial radiographs to verify major structural components.

26: What is a “radiation facility”?

Radiation facility is defined as a facility that is prescribed to be a radiation facility.

A Radiation Facility cannot be constructed without a facility construction licence. The National Directory for Radiation Protection, which has been endorsed by the Australian Health Ministers Council as the regulatory framework for radiation safety across Australia, outlines the types of facilities that are likely to be included in a subsequent Edition of the Directory as a radiation facility.

These are typically the radiation sources with the highest activity and which warrant the most stringent controls. These include:

• Certain types of particle accelerators typically found only in cancer treatment facilities
• Certain types of high activity irradiators typically found only in industrial irradiation plants.
• Facilities used for the production, processing, use, storage, management or disposal of certain types of radiation sources
• Facilities where certain types of mixtures of radioactive materials are produced.

Currently there are no prescribed facilities. If the Australian Health Ministers Council approved an amendment to the Directory that contained a list of radiation facilities, the regulations would need to prescribe those facilities in order for Victoria to comply with the agreement to implement the Directory.

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