This document sets out the regulatory expectations that must be met for the CEO of ARPANSA to accept the surrender of a facility licence and release the site from regulatory control.
For a multi-facility site, the facility can be released from regulatory control or incorporated into another facility licence
Assessment criteria
Before the CEO will consent to the surrender of a facility licence the operating organisation must account for the full inventory of non-exempt radioactive material arising from the decommissioning process or previous authorised activities.
A licence holder seeking approval to surrender a facility licence should ensure the following expectations are fully addressed in their application:
1. The remaining structures, systems components and the environment at the location of the facility must no longer contain controlled material unless the activity concentrations of the material(s) are exempt from regulatory control.
Schedule 1 Part 1 of the Regulations sets out values for the total activity and activity concentration of radionuclides that require regulatory control. ARPANSA must be satisfied that the licence holder has adequately demonstrated, by analysis or measurement or both, that radionuclide total activity or activity concentration is below the stated values. Consideration should be given to commissioning independent assessment or measurement.
2. Radioactivity levels at the site which are associated with the facility (i.e. above natural background) should not pose an ongoing danger.
ARPANSA must be satisfied that any residual radioactivity resulting from the previously controlled activity is sufficiently low to not pose an ongoing hazard. An application to surrender a licence should demonstrate that the dose expected to be incurred by any member of the public is in the order of 10 µSv per year or less above natural background. This will be considered to demonstrate that there is no residual hazard from the controlled facility based on the following international standards, guidance and practices:
IAEA Safety Guide WS-G-5.12 (Item 6.1) sets a basic exposure limit of 1 mSv/yr above natural background for any critical group at a site released from regulatory control. However, the IAEA also states that a dose constraint in the order of 0.1 mSv/yr should be applied if any other practices are to be undertaken at the location.
IAEA Basic Safety Standards (Schedule I, Item I.2) states that, under all reasonably foreseeable circumstances the effective dose expected to be incurred by any individual owing to the exempt practice or the exempt source within the practice is of the order of 10 μSv or less in a year.
In regard to international best practice, some regulatory bodies use the 10 µSv/yr as equating to no ongoing danger. The IAEA Basic Safety Standards also considers low probability scenarios where a different criterion could be used, namely that the effective dose expected to be incurred by any individual for such low probability scenarios does not exceed 1 mSv in a year.
IAEA advice on the application of exemption principles is provided in IAEA Safety Standards Series No. GSG-17. This guide includes information on radionuclide concentrations which are consistent with this objective.
Justification should be provided by the licence holder to deviate from this objective.
3. All materials containing non-exempt radionuclide concentrations must be transferred to an appropriate licence or disposed of via an approved method.
The licence holder must account for the full inventory of non-exempt waste arising from the decommissioning process or prior operation of the facility. The licence holder must demonstrate that all non-exempt waste has been managed appropriately before a licence may be surrendered. Guidance on the disposal or transfer of controlled material is provided in Regulatory Guide: Disposal and transfer of sources.
Whenever a human activity causes an individual to be exposed to ionising radiation, the activity needs to be justified and optimised.
Radiation protection in Australia follows the principles of justification, optimisation and limitation as recommended by the International Commission on Radiological Protection (ICRP). The ICRP advises that when it is planned in advance to introduce a new activity requiring radiation protection and where actions can be taken on the source of the radiation to control exposure then the principle of justification applies.
The justification principle requires that no situation involving planned exposure should be introduced unless it can be demonstrated that sufficient net benefit is produced to the exposed individuals or to society to offset the radiation detriment it causes.
The overarching principles of justification and optimisation in relation to human imaging for security screening are contained in Annex I.
Scope
This guidance is applicable to the controlled use of ionising radiation in the security screening of humans for counter-terrorism and national security, by appropriate law enforcement, security or border protection authorities (applicants). It is intended for use by applicants seeking to justify the implementation of any proposed use of ionising radiation for human imaging for security screening and by Australian radiation regulators to determine whether the use of such imaging is justified for authorised use.
In addition to seeking advice from a radiation protection adviser, the applicant should seek advice from other professionals such as those involved in aviation security and matters of privacy.
The scope of this guide does not extend to the use of ionising radiation in screening humans for theft detection or anti-smuggling purposes.
Background
Screening technologies
Currently, there are two types of X-ray scanning systems available for security screening of humans, one type using radiation scattered back from an individual, the other type using radiation transmitted through an individual.
Backscatter X-ray systems use low energy X-rays that deposit most of their energy in the skin and underlying tissue, so they are useful for imaging objects hidden under clothing. These systems use a narrow beam of ionising radiation that scans the person at a high scanning speed where the source of ionising radiation and detectors are located in the same plane. The image is formed from the X-rays backscattered from within the body surface or other material present. The effective dose from such systems typically ranges from between 0.02 µSv and 0.1 µSv per scan.
Backscatter X-ray systems are sensitive to low atomic number elements, therefore they are particularly useful in the detection of light organic materials such as explosives and drugs. These systems cannot detect ingested objects, surgically concealed objects, or objects hidden in body cavities.
Transmission X-ray systems, similar to medical X-ray equipment, create an image by passing X-rays through the body to a detector on the other side of the body away from the X-ray source. This technique is used so that objects within the body may be visible. The effective dose from such systems is variable, and typically ranges from between 2 µSv and 5 µSv per scan.
Information about screening technologies which do not use ionising radiation can be found in Radiation and Health Fact Sheet Airport Passenger Screening Technologies, which is available from the ARPANSA website.
Policies and guidance
This guide reflects the current principles of radiation protection and recommendations in:
The 2007 Recommendations of the International Commission on Radiological Protection. ICRP Publication 103. Annals of the ICRP, 37 (2-4), 2007.
The following publications provide additional guidance on the specific considerations for the justification, optimisation and regulation of the use of ionising radiation for the screening of humans for security purposes:
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards. IAEA, GSR Part 3, 2014
ICRP Publication 125, Radiological Protection in Security Screening, 2014
IAEA Safety Guide, Justification of Practices, Including Non-Medical Human Imaging. IAEA, GSG-5, 2014
IAEA Safety Guide, Radiation Safety of X-Ray Generators and Other Radiation Sources Used for Inspection Purposes and Non-Medical Human Imaging. IAEA, SSG-55, 2020
NCRP Commentary No.16, Screening of Humans for Security Purposes Using Ionizing Radiation Scanning Systems, 2003
ISCORS Technical Report 2008-1, Guidance for Security Screening of Humans Utilizing Ionizing Radiation, Interagency Steering Committee on Radiation Standards, 2008.
Applicants and Australian radiation regulators may consider the guidance provided in the above publications during the justification, optimisation and authorisation process.
Until such time as an Australian standard or equivalent is published, the most relevant standard to be applied in the manufacture and operation of human security screening systems utilising ionising radiation is American National Standard ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Using X-ray or Gamma Radiation.
Justification of practices and optimisation process
This section is intended to assist applicants in identifying matters to be included in a justification submission and Australian radiation regulators involved in assessing such submissions.
It is a fundamental principle of radiation protection that any new practice involving ionising radiation has to be evaluated to determine if the expected benefit of the practice offsets the potential risk of the radiation. In addition, the balance between benefit and risk should be optimised so that individuals are subjected to the lowest dose necessary to ensure an effective outcome.
It is important that any decision on the justification of a new practice and the need for subsequent optimisation of the radiation dose be made at an early stage in the process. In the context of justification of a specific form of ionising radiation screening technology it is important to understand these concepts and their implications before committing to a technology.
A formal justification process should be undertaken when considering the use of specific screening systems based on any ionising radiation imaging technology. The decision to authorise the use of each type of ionising radiation technology to security screen humans should be made by an appropriate authority.
The depth of detail and resources devoted to answering the questions in the following sections should be commensurate with the risks from the proposed screening technology.
Define the need
The process of justifying the use of ionising radiation begins in the initial stages of considering screening methodologies, even before ionising radiation has been identified as the preferred technology. Careful consideration of the specific security need will facilitate the quantification of the desired benefit of a security screening practice for the risk-benefit analysis.
There should be an attempt to assign some numerical descriptors to the expected consequences of not screening. When a threat is not readily quantifiable, a relative scale for the probability and severity of an event or threat may be adequate and may be all that is practicable. In this case, categories like Certain, Very Likely, Possible, Not Likely, or Never might be the appropriate level of detail and analysis. Following are some key questions to be answered:
What are the threats?
Who is the population affected by the threat? How are they affected?
What is the probability that the threat will occur?
What can happen, how likely is it, and what are the probable consequences?
Data should be provided in support of any estimation although not all threats may be easily quantifiable.
After quantifying the probability and consequences of a threat, the desired effect of the proposed security screening practice(s) should be considered. Some key questions are:
What is driving the need for the screening?
What are you attempting to detect?
How can screening affect the probability of a threat?
How can screening affect the consequences of a threat?
How do false-positives affect the screening process? (For example, incorrectly identifying harmless items as threat objects may result in unwarranted delays or repeat screening)
What is the acceptable false-positive rate?
What is the acceptable success rate needed for each class of threat material or weapon in order for the screening to be worthwhile?
What are the expected benefits and who benefits?
Evaluate Options
There are usually several options, each with its own advantages and disadvantages, that may meet the security need(s). The following questions will assist in narrowing down and categorising available options:
Does the system do what you need it to do?
Are there non-radiation or non-ionising radiation options? (For example, physical searches.) Are they practicable? If a non-ionising technology option exists that achieves equivalent screening outcomes to the ionising radiation technology under consideration then this non-ionising radiation option should be preferred.
How well does the technology fulfil the defined need(s)?
Other than radiation safety issues, are there undesirable consequences of the technology?
Are there environmental factors?
Will the technology work in the intended environment? (For example, extreme heat, cold, humidity, etc.)
Will the technology impact the environment? (For example, hazardous materials, electromagnetic interference, noise, etc.)
Does the option increase some risks while reducing others? (Consider other hazards such as electrical shock, moving parts, sharp edges, etc.)
What guidelines, consensus standards, etc. exist to support this security screening technology? What are legal concerns/issues?
Liability
Perceived risks
Defence of justification
Impact of outsourcing on the Applicant’s regulatory responsibilities.
Are the available resources adequate for addressing associated legal, policy, statutory, and technology limitations?
What information technology system(s) will be used for this technology and how will they be integrated?
How will the technology be secured against unauthorised use?
Is any other applicant successfully utilising the technology? Is their use similar or different? How? Why?
Privacy Concerns
The justification should consider privacy concerns of employing the security screening technology. Advice should be sought from the Office of the Privacy Commissioner or equivalent authority.
Radiation risks from the technology and the net benefit of implementation
After arriving at a list of possible options, the next step is to consider the radiation risks associated with each proposed technology. It is not the purpose of this document to provide a universal formula for deciding whether the benefits outweigh the risks. Each applicant should decide the method used for such analysis based on the particular situation. What is important is that the analysis is performed. There should be a review of the analysis by a suitably qualified independent external radiation protection adviser.
Some key questions to be answered in assessing the radiation risks are:
What is the individual dose per scan to the person screened? To the operator?
How many scans is an individual likely to receive in a given time period (for example, in one year)?
What could be the total dose to an individual in one year?
What are the potential acute and chronic risks to individuals undergoing screening with the selected technology?
What are the risks to employees and bystanders?
Who is affected by the technology? How are they affected?
Do the benefits outweigh the risks?
How do you effectively communicate the benefits and risks to the scanned population?
What is the impact of communicating the benefits and risks to the scanned population? Exposure to radiation may cause fear and stress. Can adequate and easily understandable information be provided to alleviate concerns?
The applicant’s ability to implement the practice
The costs and consequences of implementation should be considered. The applicant should be prepared to provide the necessary safeguards to guarantee a safe and effective screening operation. The justification should consider the implementation of a radiation protection program. The extent of the program will depend on the nature of the equipment and the scope of the screening operation(s).
The following questions will assist in evaluating the Applicant’s ability to implement the practice.
Regulatory
What are the applicable laws and regulations for the practice? (Commonwealth, State or Territory)
Can the regulatory requirements be fulfilled on a continuing basis? (For example, licensing, registration, training requirements, maintenance, monitoring, routine tests, continuity of responsible individual, adequate and appropriate personnel resources.)
Operational
What engineering safeguards are in place? (For example, are there safety interlocks? Are the operating parameters subject to operator error?)
Are adequate resources available to implement the applicable provisions outlined in ANSI standard N43.17-2009?
If operations are outsourced, are adequate resources available for oversight of the contractor?
Is a procedure in place that assures an operating environment appropriate for safe use of the equipment?
Are detailed responsibilities clearly identified and assigned for all aspects of the security screening practice? (For example: operations, maintenance, training, budgeting, etc.).
Are there adequate resources available to provide controls over stored images for the purpose of privacy or evidence collection?
How will screened individuals be informed of the radiation dose and associated risks?
Is consent necessary? What kind of consent will be obtained? Will consent be sought or implied?
Are there adequate resources available to address any privacy issues? (For example: Who will see the images? How will the images be controlled?)
Training
What expertise is required to ensure all operational requirements are met? (For example: system operation, safety, image interpretation, etc.) What training is needed to attain and maintain that expertise? Note: This includes training of management and operational personnel.
Are there adequate resources available to ensure that the required training is provided?
If the security screening is to be outsourced, how will training be appropriately addressed? (For example: How will appropriate training and expertise be ensured?)
Does the training adequately address risk communication and image control for operators and management?
Concluding statement
The overall benefit must outweigh the risks associated with the proposed screening method. The following elements should be appropriately considered and documented:
The security need should be defined including the magnitude of the threat and the risk of not implementing the proposed security screening technology
The various options should be considered, including their effectiveness and their limitations
If a non-ionising technology option exists that achieves equivalent screening outcomes to the ionising radiation technology under consideration then this non-ionising radiation option should be preferred
The technologies should have been evaluated based on the expected reduction of the threat as weighed against the risks associated with the screening technology and social or legal implications. (Risks evaluated should include electrical shock, physical hazards, radiation exposures, environmental factors and any other associated risks)
The availability of sufficient resources and the ability to implement the proposed screening method, including an initial plan for instituting the necessary programs and allocating resources
There should be a documented commitment for periodic reassessment of the justification and optimization processes for the practice chosen and for ongoing conformity assessment of the systems adopted.
Annex 1
Justification and optimisation principles
Human imaging for security screening purposes using ionising radiation
Background
Screening to reveal objects concealed under clothing or in body cavities falls under the category ‘non-medical imaging’. The use of ionising radiation for this purpose by a Commonwealth entity or Commonwealth contractor is subject to the requirements of the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) and will be subject to mandatory licensing by ARPANSA. The use of ionising radiation for human imaging for security screening by any other entity is subject to the laws of the State or Territory in which the use is proposed.
Principles
Justification
Any use of ionising radiation for human imaging for the detection of concealed objects which can be used for terrorism or pose a national security threat requires that the use be justified. This would include use of ionising radiation in security screening of airline passengers for the purpose of revealing objects concealed under clothing.
Under these circumstances, the use of ionising radiation for the above purposes may be considered justified, provided the use of ionising radiation demonstrably does more good than harm. The justification process shall consider, inter alia
benefits and detriments of implementing the type of imaging procedure
benefits and detriments of not implementing the type of imaging procedure
any legal or ethical issues associated with the introduction of the type of imaging procedure
effectiveness and suitability of the proposed type of imaging procedure including the appropriateness of the radiation equipment for the proposed use
availability of sufficient resources to safely conduct the imaging procedure throughout the intended period of the practice
The use of ionising radiation for the purpose of imaging humans for the detection of concealed objects for theft detection purposes is not justified.
Optimisation
If use of ionising radiation for human imaging for security screening is deemed justified, exposures shall be maintained as low as reasonably achievable, according to the protocols applicable to planned exposure situations.
The optimisation shall consider, inter alia
measures to reduce exposure of those individuals subjected to screening, as well as to reduce the number of screened individuals,
measures to reduce and monitor exposure of staff,
analysis of the possibility or need to exclude certain individuals, e.g. pregnant women, children, or individuals with contraindications of any sort,
the training and competence of staff operating the screening technology,
the establishment of procedures and maintenance of relevant documentation, and
safety of the operations including analysis of the ways in which the operation of the screening technology may fail leading to potential exposures, and the consequence of such failures.
This regulatory guide applies to sealed sources in service. It does not apply to sources identified in the licence holder’s Source Inventory Workbook as G1-6 asealed source in storage awaiting disposal.
The term ‘sealed source’ refers to a radioactive source in which the radioactive material is permanently sealed in a capsule, or closely bonded and in a solid form1.
Sealed sources need to be tested at regular intervals to ensure that they have not developed a leak. Guidance on recurrent testing of sealed sources is provided in standards such as ISO9978:2020 Radiation protection – Sealed sources – Leakage test methods (ISO9978) and AS/NZS2243.4 or relevant codes of practice such as ARPANSA Radiation Protection Series No.13 Safe Use of Fixed Radiation Gauges (RPS13).
Different leakage test methods are specified in ISO9978 including wipe (or smear), immersion, bubble or helium leakage test methods. A wipe test is recommended in circumstances where a suitable laboratory or the source manufacturer is not available to perform a leakage test according to one of these methods.
AS/NZS2243.4 specifies that each sealed source or its housing must be examined for contamination and integrity on an annual basis. Wipe or smear testing is an example of how this can be achieved. AS/NZS2243.4 recommends that leak testing be performed at 10 yearly intervals and whenever leakage is suspected (citing ISO9978).
Wipe or smear testing of an in-scope sealed source must be done annually or at intervals specified in the relevant code of practice. All results of wipe tests must be recorded and retained with the source records. If a wipe test reveals contamination levels on a sealed source in excess of 200 Bq, the sealed source is not considered to be leak tight and must be withdrawn from use2.
If contamination is detected on a sealed source, but at a level that does not exceed 200 Bq, then action should be taken to establish whether this arises from source leakage. This could be achieved by repeating the tests more frequently (e.g. every six months) to determine whether the level of radioactivity is increasing.
Where access to the sealed source is neither possible nor desirable because of the unjustified exposure of personnel, a wipe or smear test may be carried out on the nearest accessible surface to the source. Under these circumstances, if contamination is detected in excess of 20 Bq3, the source is not considered to be leak tight and must be immediately withdrawn from use and the nature and extent of the contamination must be investigated.
ARPANSA notes that Australian laboratories capable of performing the immersion, bubble or helium test methods are not currently providing such services. Until further notice, if 10 yearly leak testing is required on a sealed source (as recommended by AS/NZS2243.4) then a wipe method may be used.
Use of sealed sources beyond recommended working life
The concept of ‘recommended working life’ was introduced by Amersham (Radiochemical Centre Ltd) in 1977 to draw the user’s attention to the fact that, like any manufactured article, a sealed source has a finite life4. The recommended working life was intended as a guide to create an awareness of the need for regular inspection and reasonable judgements to be made about the continued suitability of a sealed source for a particular application.
For sources that have exceeded their recommended working life, the frequency of testing needs to be increased to more closely monitor the integrity of the source capsule and its housing.
Where a recommended working life has not been assigned by the sealed source manufacturer, ARPANSA has determined that a recommended working life of:
15 years be assigned to the following sealed sources: Cs-137, Co-60, Ba-133, Am-241, Am-241/Be, Ra-226, Th-232, Sr-90 (industrial)
10 years be assigned to the following sealed sources: Ni-63, Sr-90 (medical and veterinary)
5 years be assigned to all other sealed sources, unless the user can demonstrate to the satisfaction of the CEO of ARPANSA that it should be longer.
ARPANSA will allow the continued use of a Group 1 sealed source (excluding source type G1-6) beyond its recommended working life – up to a period of one additional working life – without the need for prior approval, subject to the following conditions:
The sealed source, or nearest accessible part, must be wipe or smear tested at 12-month intervals
All results of wipe or smear tests must be recorded and retained with the source records.
In addition to Group 1 sources, ARPANSA will allow the continued use of the following types of Group 2 sealed sources beyond the recommended working life - up to a period of one additional working life without the need for prior approval:
This extension of recommended working life is subject to the following conditions:
For portable density/moisture gauges containing sealed sources - the source, or its housing at a point of closest approach to the source, must be wipe or smear tested at 6 monthly intervals in accordance with Annex F of RPS13. (Note that the relevant code of practice for portable density/moisture gauges, Radiation Protection Series No.56, does not provide specific guidance on this matter.)
For fixed radiation gauges - the sealed source, or its housing, at or immediately adjacent to the gauge shutter or source control mechanism, must be wipe or smear tested at 12 monthly intervals in accordance with Annex F of RPS13.
Results of wipe or smear tests must be recorded and retained with the source records.
Continued use of other higher hazard sealed sources in Group 2 or 3 beyond one recommended working life or any source beyond a second recommended working life (whether Group 1, 2 or 3) will be considered on a case-by-case basis, taking into account:
activity of the source
toxicity of the radionuclide and its half life
source construction
type of dealing
environment in which the source has been/will be used
details on source use
any other inspections or examinations that have been performed (e.g. 6 monthly or annual wipe tests)
A written submission should be made to ARPANSA for such cases.
Sealed sources that have exceeded their recommended working life must be clearly identified as such in the Source Inventory Workbook.
References
1 ARPANSA Radiation Protection Series C-1 Radiation Protection in Planned Exposure Situations
3 The specified level of contamination (20 Bq) has been derived on the assumption that there will likely be a loss during transfer of radioactivity from a leaking sealed source to the nearest accessible surface. ARPANSA is aware that this value is consistent with NSW Environment Protection Authority Radiation Guideline 3 – Recommendations for minimum standards and safety requirements for fixed radiation gauges (sealed source devices)
4 E A Lorch. The concept of recommended working life applied to radiation sources. Radiological Protection Bulletin No 34, May 1980
5 Australian Radiation Protection and Nuclear Safety Regulations 2018 Section 4
Paragraph 7(d)(i) of the Australian Radiation Protection and Nuclear Safety Regulations 2018 requires the CEO to make guidelines about how licence holders will report their compliance with the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act), the Regulations and licence conditions. This document fulfils that requirement and provides information on when, how and what licence holders must report.
ARPANSA applies a graded approach to compliance reporting. The frequency of reporting is aligned with the regulatory priority of the source or facility. The regulatory priority is risk-based.
When to report
Licence holders are required to report either quarterly, biannually or annually. The frequency of reporting is specified in Schedule 2 of the licence.
For licence holders who report quarterly, a report must be provided to the CEO of ARPANSA in an approved form within 28 days of the end of each quarter that is, by 28 January, April, July and October, or within such other period as determined by the CEO.
For licence holders who report annually, a report must be provided to the CEO in an approved form within 28 days of the end of the financial year, that is, by 28 July each year, or within such other period as determined by the CEO.
For licence holders who report 6 monthly, a report must be provided to the CEO by 28 January and 28 July each year, or within such other period as determined by the CEO.
An email reminder is sent to licence holders two weeks prior to the end of the reporting period.
How to report
Licence holders must use the appropriate template1 from the Regulatory Forms page unless there are other agreed arrangements in place.
Reports should be sent by the licence holder’s radiation safety officer or person authorised to provide such information on behalf of the licence holder. Reports should be sent to licenceadmin@arpansa.gov.au with a copy to the licence holder/nominee. Receipt of the report will be acknowledged by ARPANSA.
What to report
The licence holder should address all matters in the report template. Guidance on the information required is provided below.
1. Notifiable incidents (section 58 of the Regulations)
The licence holder should provide a summary of any notifiable incidents that occurred during the reporting period.
Under section 58 of the Regulations, the licence holder must tell the CEO about a notifiable incident within 24 hours of it happening and give the CEO a written report about the incident within 14 days of it happening.
Except as otherwise required by a special licence condition, the licence holder should report any other incident during the reporting period that had the potential to affect safety but which was not notifiable under section 58 of the Regulations.
This may include any unintended event, including operating error, equipment failure, initiating event, accident precursor, near miss or other mishap, or any unauthorised act whether or not it was malicious, the consequences or potential consequences of which are not negligible.
For example:
Loss of a Group 1 sealed source
Minor contamination of laboratory clothing or work area
Breach of operating limits and conditions
Deliberate exposure of a personal monitoring device
Incorrect settings on a safety system
Sticking shutter mechanism on a radiation gauge
Laser incident where there is the potential for injury
3. Personal monitoring
Part 6 Division 2 of the Regulations sets out the practices to be followed by licence holders with respect to dose limits (ionising radiation) or exposure limits (non-ionising radiation).
Any event where an individual is exposed to radiation exceeding a dose limit / exposure limit is regarded as a notifiable incident and must be reported under section 58.
Other unusual doses or exposures that required investigation or corrective action should be reported.
4. Acquisition of a source
The licence holder should provide a summary of sources acquired during the reporting period. Import permit numbers should be quoted where relevant.
When changes to the source inventory are reported, ARPANSA will provide the latest version of the SIW (exported from the Licence Administration Database) to be updated by the licence holder and returned.
Before acquiring a source the licence holder should consider which of the following regulatory actions is required:
New licence application
Prior approval under section 63 of the Regulations
Reporting a change to the source inventory under section 64 of the Regulations
For further guidance on the regulatory implications of making changes to the source inventory including acquiring, using, transferring or disposing of sources, see Appendix A.
5. Disposal of a source (section 65 of the Regulations)
The licence holder should provide a summary of sources acquired during the reporting period. Import permit numbers should be quoted where relevant.
When changes to the source inventory are reported, ARPANSA will provide the latest version of the source inventory workbook (SIW) to be updated by the licence holder and returned.
Before acquiring a source the licence holder should consider which of the following regulatory actions is required:
New licence application
Prior approval under section 63 of the Regulations
Reporting a change to the source inventory under section 64 of the Regulations
For further guidance on the regulatory implications of making changes to the source inventory including acquiring, using, transferring or disposing of sources, see Appendix A.
6. Transfer of a source (section 65 of the Regulations)
The licence holder should provide a summary of any source transfers made during the reporting period.
Transfer provisions also apply to infrequent sales, hires, loans, gifts, or donations within Commonwealth jurisdiction. Licence holders should notify the CEO about the transfer of a source using the Transfer Notice Form. Completed forms should be sent to licenceadmin@arpansa.gov.au.
Transfers under subsection 65(3) must generally be reported within 7 days unless the source is in security category 1, 2 or 32. In such cases, the CEO of ARPANSA must approve the transfer regardless of the jurisdiction to which it is being transferred.
Under subsection 65(5) of the Regulations the licence may make other arrangements with regard to source transfers such as where regular source transactions are part of routine operation and seeking prior approval for every transfer would be impractical. An example of such an arrangement is where there are regular sales of controlled material or controlled apparatus. Any alternative reporting arrangements will be specified in the licence.
Transfer of a controlled facility requires prior approval from the CEO under subsection 65(4) of the Regulations.
For further guidance on the regulatory implications of making changes to the source inventory including acquiring, using, transferring or disposing of sources, see Appendix A.
7. Corrective action arising from an inspection
The licence holder should report progress on any corrective actions arising from an inspection in accordance with the reporting requirements specified in the inspection report or covering letter.
8. Changes with significant implications for safety (section 63 of the Regulations)
The licence holder should provide a summary of any approvals sought and received under section 63 during the reporting period.
9. Changes unlikely to have significant implications for safety (section 64 of the Regulations)
Under section 64, licence holders must report any change that is unlikely to have significant implications for safety at least once every 3 months. Licence holders reporting quarterly will include this information in their quarterly report. However, licence holders reporting biannually or annually must inform ARPANSA of the change within 3 months.
10. Review of plans and arrangements (section 61 of the Regulations)
Licence holders are required to review their plans and arrangements at least once every 3 years and keep and maintain records of the review.
The licence holder should report progress against any special licence condition. Any such conditions will be removed when compliance has been adequately demonstrated.
12. Breaches of licence conditions (section 57 of the Regulations)
ARPANSA encourages licence holders to find and fix their own non-compliance. Such behaviour reflects a healthy and robust safety culture. Whenever a potential breach is encountered, the licence holder has a responsibility under section 57 to investigate and rectify the breach including any consequences of the breach as soon as reasonably practicable.
The licence holder must tell the CEO as soon as reasonably practicable if a breach of a licence condition is identified. The quarterly/biannual/annual report must also include a summary of any breach reported during the reporting period.
Common breaches relate to:
Section 57A: A licence holder not taking all reasonably practicable steps to prevent and minimise human errors and organisational failures.
Section 60: A licence holder not taking all reasonably practicable steps to comply with their plans and arrangements.
Section 61: A licence holder not reviewing and updating plans and arrangements at least once every 3 years/not keeping records of the review.
Section 63: A licence holder not seeking the CEO’s prior approval to make certain changes that have significant implications for safety.
Section 65: A licence holder not seeking prior approval from the CEO or telling the CEO about movement of a source or facility in particular failure to obtain prior approval before disposing of a source.
In many cases, the licence holder will be expected to perform a cause analysis to fully investigate the potential breach. An investigation that involves a root cause analysis (to prevent recurrence) may take considerable time.
Appendix A: Regulatory implications of changes to the source inventory
Under section 62 of the Regulations the licence holder must keep an accurate inventory of sources it deals with. The approved form for maintaining this information is the Source Inventory Workbook (SIW).
The licence holder must consider the regulatory implications of making any change to the source inventory after the licence is issued.
Licence holders intending to acquire, relocate, transfer, dispose of, or modify a source or facility should refer to sections 63-65 of the Regulations and licence conditions to identify what regulatory action is required. It is particularly important to identify whether a proposed change requires the prior approval of the CEO of ARPANSA or in some cases, whether a new application for licence is necessary.
If the licence holder intends to acquire a kind of source that is not authorised by the existing licence (or any other source licence that the licence holder might have3) then a new application must be submitted with the appropriate fee and the licence must be amended and re-issued by ARPANSA before taking possession of the source. Failure to do so may result in a breach of sub-section 31(1) of the Act.
Acquiring additional sources of a kind that is already authorised by the licence does not require prior approval but this is a change4 for the purpose of section 64 and should be reported within three months or in the next quarterly report.
Occasionally licence holders discover sources in their possession that are not listed in their SIW. These are often ‘legacy’ radioactive sources or sometimes non-ionising apparatus such as Class 3B lasers or UV sources.
If a kind of source not covered by the licence is identified it may be necessary for the licence holder to apply for an authorisation to continue to possess, have control of, or use it. Advice should be sought from ARPANSA if there is any doubt about the status of a newly identified source.
A2. Removing a source from the SIW
Under section 63 of the Regulations a licence holder must have prior approval from the CEO of ARPANSA to:
(i) dispose5 of a controlled apparatus or controlled material (source)
(ii) transfer a source to another jurisdiction (outside of the Commonwealth)
Transfers under subsection 65(3) must generally be reported within 7 days unless the source is in security category 1, 2 or 3 in which case the transfer must have the prior approval of the CEO of ARPANSA. This requirement comes from the Radiation Protection Series No. 11 - Code of Practice for the Security of Radioactive Sources which is a statutory licence condition under section 59 of the Regulations. Failure to comply with sections 59 or 65 of the Regulations may result in the licence holder being found in breach of sub-section 31(2) of the Act.
Following transfer or disposal of a source, its status should be changed in the SIW accordingly. The SIW is submitted to ARPANSA and uploaded into the LAD. The source will no longer appear in the next SIW generated by LAD.
When an item no longer meets the definition of a controlled apparatus or controlled material the licence holder should change its status in the SIW and provide further details where relevant, for example: the source has decayed below the exemption limit or changes to the apparatus mean that it no longer meets the definition of a controlled apparatus. The source will no longer appear in the next SIW generated by LAD.
A3. Licence holders with multiple divisions and/or multiple sites
Some licence holders have a number of divisions at one location or occupy premises spread over multiple sites. Each division may have a separate source licence and separate source inventory. The licence holder may also have one or more facility licences.
If a licence holder wants to undertake a new dealing in a particular division, the licence holder must determine whether section 63 applies or whether a new application is required. If the new dealing is not authorised by any existing source licence held by that organisation then a licence application is required. If the new dealing is authorised by an existing source licence, held elsewhere in the organisation, then section 63 applies.
If a licence holder wants to relocate a source from one division to another, from one site to another, or from one licence to another, the licence holder must determine whether a licence application is required or whether section 63 or 64 of the Regulations applies.
a) Relocation of a source within the same division at the same site
Section 64 applies; the licence holder must report the change to the source inventory within three months or in the next quarterly report.
b) Relocation of a source within the same division but at a different site
Section 64 applies if the source is to be used for the same purpose at the new site, otherwise section 63 applies.
c) Relocation of a source to a different division at the same site
Section 64 applies if the division receiving the source is authorised for the dealing, and provided there are no implications for safety, otherwise section 63 applies (see Scenario 3). Note that subsection 65(3) also applies as the transfer of a source from one licence to another must be reported to ARPANSA within 7 days, except for security-enhanced sources that require prior approval.
d) Relocation of a source to a different division at a different site
As for (c) above
e) Transfer of a source from a facility licence to a source licence
A licence application is required unless the dealing is authorised by an existing source licence. If authorised, then section 64 applies. Section 65(3) also applies - see (c) above.
f) Transfer of a source from a source licence to a facility licence
If the facility licence already authorises dealing with this kind of source then section 64 applies. If not, then section 63 applies and the CEO must approve the transfer. Note that dealing with the source must be included in the safety assessment report for the facility.
Further guidance is provided in the scenarios and examples below. If there is any uncertainty about the regulatory implications of a proposed change to the source inventory, please contact ARPANSA.
Scenario 1: A licence holder wants to acquire a source for a dealing that is already authorised by the licence
In this situation a licence application is not required and the existing licence does not need to be amended. This is because the licence holder’s plans and arrangements for managing that type of source have already been assessed as satisfactory for the particular dealing. The change is regarded as unlikely to have significant implications for safety and therefore subject to section 64 of the Regulations.
Example 1: A licence holder is authorised to deal with a fully enclosed x-ray analysis unit (Group 1 Item 13). The licence holder wants to acquire another fully enclosed x-ray analysis unit.
No amendment to the licence is necessary. Section 64 applies: acquisition of the source must be reported within three months. For most licence holders this will be in the next quarterly report. The licence holder will be requested to updated their SIW accordingly.
Scenario 2: A licence holder wants to acquire a source for a purpose not authorised by the licence
In most cases, a licence application will be required.
Example 2: A licence holder is authorised to deal with a fully enclosed X-ray analysis unit (Group 1 Item 13). The licence holder wants to acquire a partially enclosed X-ray analysis unit (Group 2 Item 11).
The licence holder must apply for a licence amendment to add Group 2 Item 11 before the apparatus is acquired.
Scenario 3: A licence holder wants to relocate source from the location specified in the source inventory
This is a proposed change to details provided in the licence application (or subsequently approved) and therefore a change relevant to either section 63 or 64. The licence holder must decide which applies, that is, whether the relocation is likely to have significant implications for safety.
Prior to moving a source, the licence holder must consider such things as shielding, storage, security, and transport. If there are significant implications for safety in the process of relocation or at the new location, then prior approval is required under section 63. If there are unlikely to be any significant implications for safety, prior approval is not required but relocation of the source must be reported under section 64 within three months or in the next quarterly report.
Example 3: A fixed industrial x-ray unit located in Building A is to be relocated to Building B
This may have a significant effect on safety in terms of protective shielding, interlocks, warning lights, etc. Such a change would require the prior approval of the CEO under section 63.
Example 4: The source inventory shows an unsealed source is being used in Laboratory C
If the licence holder relocates this source to Laboratory D with the same policies and procedures and with equivalent or better storage and handling, then the change is unlikely to have significant implications for safety. Such a change would fall under section 64 with no prior approval required. The change or location should be reported within three months or in the next quarterly report. The SIW will also need to be updated.
Scenario 4: A licence holder wishes to deal with a source that belongs to another organisation
There are certain situations where a licence holder may wish to use a source owned by another organisation. For example, a source may be leased, hired or borrowed or a controlled person may be required to use another organisation’s source at that organisation’s premises.
Under the Act, dealing includes possession or having control of. Therefore use of a source belonging to another organisation may only be undertaken if authorised by a source licence. In such circumstances the licence holder must consider whether the existing authorisation covers the proposed activity or whether an amendment to the licence or further licence application is required.
Example 5: Licence holder (Y) wants to lend a sealed source to another Commonwealth licence holder (Z) for a particular project
Licence holder Z must be authorised for the proposed dealing. The transfer of possession is covered by paragraph 65(2)(b) of the Regulations and must be reported to the CEO within seven days. In this case, the source inventory of licence holder Y should be amended to indicate that the source is temporarily on loan. The source inventory of licence holder Z should also be amended to include the source until it is returned. In any case the temporary transfer should also be reported in accordance with section 64. Similarly, the return of the source should also be reported and the SIW amended as appropriate.
Note: Changes to the SIW are only relevant if the loan is for an extended period, ie more than 3 months. Short-term loans should still be reported in the compliance report to ARPANSA.
Example 6: A source licence authorises the licence holder to deal with baggage x-ray unit. The licence holder leases an additional baggage x-ray unit from an equipment supplier
The licence holder must report the additional source within three months or in the next quarterly report. Eventual return of the sources to an organisation outside the Commonwealth’s jurisdiction requires prior approval.
Example 7: A source licence authorises dealings with a fully enclosed analytical x-ray unit. In a collaborative venture with a university, it is proposed that a controlled person covered under the source licence will use a fully enclosed analytical x-ray unit owned by the university at the university’s premises.
This dealing is authorised under the source licence. The CEO should be advised of this dealing under section 64. The conditions attached to the licence with respect to this kind of controlled apparatus are still applicable. Where direct compliance with these conditions is outside the control of the licence holder (as in the case of equipment maintenance) it is the responsibility of the licence holder to be satisfied that the conditions have been met and to provide supporting evidence to ARPANSA if required. For example, the licence holder may be required to provide ARPANSA with the licensing or registration information from the relevant State/Territory regulatory authority.
1 The report templates are designed for electronic use; the printed version may not display all data
4 The definition of a ‘change’ for the purposes of sections 63 & 64 is a change to (a) the details described in the application for the licence; or (b) a modification of the source or facility
5 Disposal of controlled apparatus for the purpose of subsection 65(1) includes destruction
Regulatory expectations for preserving the site following a radiation incident
1. Introduction
Legislative Framework
The objective of the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) is to protect the health and safety of people, and to protect the environment, from the harmful effects of radiation.
The Act and the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations) do not specify the requirements to preserve a site following an incident. However section 58 of the Regulations (Preventing, controlling and minimising accidents) and in particular section 60 (Managing Safety) require the licence holder to take all reasonably practicable steps to manage the safety of the facility or source; this includes the steps taken following a radiation incident (see ARPANSA Regulatory Guide: Plans and Arrangements for Managing Safety for further details and the ARPANSA Emergency Exposure Guide, RPSG3).
Further, under the Commonwealth Work Health and Safety Act 2011, Comcare must be notified of all notifiable incidents and the site must be preserved for investigation. Please refer to Comcare’s requirements.
2. Objective
The objective of this guide is to provide general information for licence holders, on-site and off-site first responders, local authorities and others who may have a role in the preservation of a site, including those providing assistance in the event of a radiation incident.
3. Scope
This guide provides high-level information regarding a radiation safety and/or security incident associated with a controlled facility, radiation source or site. It provides expectations for incident management to ensure safe, secure, effective and efficient operations where radiation exposure or contamination is known or suspected to be present.
This guide relates to site preservation only and does not attempt to inform on recovery or response procedures. These would be developed at the local level and be unique to the licence holder’s conduct or dealings.
4. Background
A radiation incident, as a result of work involving ionising radiation apparatus or radioactive material, may be defined as an unexpected deviation from normal conditions leading to an actual, or potential, unintended radiation exposure or contamination of persons or the environment (Section 7 Radiation Incidents AS/NZS 2243.4:2018 Safety in Laboratories – Ionizing Radiations).
ARPANSA’s National Directory for Radiation Protection defines a radiation incident as: any unintended or ill-advised event when using ionising radiation apparatus, specified types of non-ionising radiation apparatus or radioactive substances, which results in, or has the potential to result in, an exposure to radiation to any person or the environment, outside the range of that normally expected for a particular practice, including events resulting from operator error, equipment failure, or the failure of management systems that warranted investigation.
It is essential to ensure that all actions at the site of a radiation incident are carried out in a way that maintains the integrity of the site and that all relevant locally developed procedures are applied through effective radiological emergency (incident) management. While not covered in this document, as a reference point for development of response procedures, please see Section 7.2 Response Procedures of AS/NZS 2243.4:2018 Safety in Laboratories – Ionizing Radiations.
Management of the radiation incident includes the process of ensuring the orderly, accurate and effective collection and preservation of information so that it can be used for post incident investigation and site clean-up (see ARPANSA Regulatory Guide: Plans and Arrangements).
5. Preserving incident sites
While preservation of the incident site is of great importance, it is paramount that the safety of those involved with the incident is first priority and that any actions do not result in any undue risk to operators or persons present. As such, personnel safety, including decontamination activities, must be the first priority of those persons affected.
The person with management or control of a workplace at which a radiation incident has occurred must ensure as far as is reasonably practicable that the site where the incident occurred is not disturbed until the Radiation Safety Officer (or equivalent) or on-site response arrives and provides further instruction. When it is concluded that a radiation incident has occurred the following actions should be taken:
Establish perimeter control procedures in parallel with other immediate actions
Initiate pre-planned and coordinated actions
Report the radiation incident to the relevant competent authority
The primary goals of an incident investigation are to determine the cause of an incident, and/or to determine factors that contributed to the impact of the incident or the management of the incident (site reconstruction). This is done by identifying, collecting and analysing all relevant physical information and documenting the conditions at the incident site in a timely manner.
Special attention should be paid to the importance of securing the site/facility to prevent any destruction or cross-contamination of the physical information as well as for protection of responding personnel and other individuals. In addition, the site of the radiation incident should be managed in a way that takes into account the possible presence of multiple hazards.
Site Preservation Prerequisites
The following key prerequisites will ensure appropriate site preservation following a radiation incident:
Front line supervisors must be fully aware of the importance of site preservation and the role the supervisor can play
Quick decision-making on the level of investigation to be carried out and sending appropriate staff (this may include the Regulator) to the facility/site early to capture vital data and information
Licence holders should ensure that:
Persons are appropriately trained and competent in the procedures for dealing with foreseeable radiation incidents
Suitable personal protective equipment, radiation survey instrumentation and an emergency kit are available and maintained
The name and contact details of the person to contact in an emergency, and an alternate, are displayed at appropriate locations
Incidents are reported in accordance with locally developed incident management procedures
Adequate communications, including notifications to relevant personnel regarding the incident occur in a timely manner
Radiation incidents are investigated, recorded, and reported to ARPANSA as required by the Regulations as soon as practicable
Site Preservation Activities
Essential activities to consider when developing a radiation incident management plan or for input into existing plans and arrangement documents (see ARPANSA Regulatory Guide: Plans and Arrangements) are:
Contact relevant response personnel (or the RSO) so they arrive at the facility as soon as possible after the incident (ideally before physical evidence is disturbed)
Do not pre-judge the situation
Do not move or remove anything until evidence is recorded and measurements are taken; ask if anyone has moved or removed anything
Take necessary photographs with corresponding information/notes
Take videos as necessary
Take measurements
Identify staff (or contractors) who may have information that needs to be captured early; carry out preliminary interviews
Note the working conditions (including lighting and weather conditions)
Note the housekeeping
Record the chronological course of events, if possible
Record what tools, instrumentation and equipment were used at the incident site
Do a formal risk assessment as necessary
6. Conclusion
It is important that site preservation is well understood and actions to be taken if an incident occurs are clear. The following questions should be considered when developing a radiation incident management plan or for input into existing plans and arrangement documents (see ARPANSA Regulatory Guide: Plans and Arrangements):
Who is responsible and/or accountable for preservation of a radiation incident site?
Does your current training and awareness program provide the appropriate level of theoretical and practical sessions for a radiation incident?
Does your incident procedure or guideline outline what to do to preserve the site of an incident?
References
Australian & New Zealand Standard AS/NZS 2243.4: 2018 Safety in Laboratories – Ionizing Radiations
Long, Ian Simplicity in Safety Investigations, A Practitioner’s Guide to Applying Safety Science, Routledge, Great Britain, 2017 (pp 18–20 The Investigation Process - Scene Preservation)
Section 63 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations) requires the holder of a licence to seek the CEO’s approval to make certain changes that will have significant implications for safety.
If a change has significant implications for safety, the licence holder must seek approval to do either of the following: a) change anything described in the application for the licence b) modify the controlled source, apparatus or facility described in the licence
Examples of such changes can include: the alteration of processes; introduction or removal of equipment; modifications to structures, systems or components; changes in the way processes are undertaken or changes to the organisation; and changes to resourcing of a source or facility.
ARPANSA considers that an implication for safety is a suggested or inferred effect on safety which, even if it is not easily derivable, possesses some degree of probability. A significant implication is one which is important, notable, or of consequence, having regard to its context or intensity.
In relation to this definition, this guide provides advice on when ARPANSA will consider that a change has significant implications. Where there is any doubt remaining on whether a change needs to be managed under section 63, applicants are encouraged to seek further advice from ARPANSA.
2. Document structure
This guide consists of four main sections. The first discusses ‘General Principles’ which must be considered when assessing the safety implications of a change. The second section provides a table of consequence thresholds above which ARPANSA will expect to receive an application for approval. Sections 3 & 4 provide some practical examples of changes considered to fall under section 63 of the Regulations for both facilities and sources.
ARPANSA’s approach to determine whether or not a change has a significant implication for safety is to consider the potential consequences of the proposed change, including an assessment of any credible consequence that may result if the proposed change is improperly conceived or executed. In broad terms these consequences may include a radiological impact on people or the environment, a loss of control of a source or facility, or a reduction in defence in depth[1].
To obtain a licence, the applicant was required to provide ARPANSA with plans and arrangements to demonstrate acceptable levels of safety and security. The holder of a licence must comply with their plans and arrangements for managing safety. Those aspects of the plans and arrangements that formed the basis for ARPANSA’s decision to grant a licence are called the ‘licensing basis’. The licensing basis describes the controlled activity and establishes the boundary of activities within which safety is demonstrated.
Plans and arrangements describing how the licence holder maintains effective control, manages safety, provides radiation protection, deals with radioactive waste, manages security and prepares for and responds to emergencies will be part of the licensing basis. In the case of a facility, the safety analysis report (SAR), and the operating limits and conditions (OLCs) will also be key documents of the licensing basis.
In general, proposed changes to a facility that are within the bounds of its approved licensing basis have already been approved by ARPANSA and are therefore unlikely to have significant implications for safety. However, the significance of any changes that could impact on the boundary established by the licensing basis should be assessed against the criteria of this guide.
In addition, if any of the following apply to the proposed change, it is likely to have a significant implication for safety (and therefore requires prior approval):
Results in more than a minimal increase in the likelihood or consequences of an accident or malfunction previously evaluated in the SAR.
Creates the possibility of an accident or malfunction of a different type from what was evaluated in the SAR.
Results in one or more radiological consequence as described in the SAR being increased.
Involves departure from a method of evaluation described in the SAR used in establishing the design or in the safety analysis.
It should be noted that reviews by the licence holder to determine the applicability of section 63 or 64 of the Regulations do not necessarily aim to determine if the proposed change is good or bad. The licence holder is expected to have other processes for determining if the proposed change is justified or warranted. The review focuses merely on whether prior approval by ARPANSA is required.
A cumulative effect of two or more relevant changes which individually do not have significant implications for safety must also be considered. This principle addresses the scenario where successive minor changes can, over time, lead to a significant change in the safety of controlled sources or facilities (organisational drift). Licence holders should be able to show that cumulative effects have been considered when making relevant changes.
4. Consequence thresholds for section 63
The table below provides the thresholds above which ARPANSA considers a change to have significant implications for safety. In order to categorise changes, licence holders must have systems in place to evaluate the risk of certain changes. ARPANSA may ask licence holders to provide documentation to support their evaluation of a change considered unlikely to have significant implications for safety.
Note: Appropriate review allows licence holders to know and manage the risks associated with their operation
Implication for safety
Threshold for section 63
Radiological hazard outside of a controlled facility or building containing a source
Release activity at levels above discharge authorisations.
Release activity that may increase long term radiation levels off site to 20 µSv/yr or more (above background).
Release activity that may lead to a person being exposed to more than the annual dose limit to the public.
For further information on radiation limits refer to Regulations, Division 2 – Dose limits.
Exposure of people to radiation
Expose a member of the public to radiation in excess of the statutory annual limit (1 mSv).
Expose workers to radiation in excess of an annual dose limit.
Expose people to non-ionizing radiation at levels above appropriate exposure limits.
For further information on radiation limits refer to Regulations, Division 2 – Dose limits.
Impact on structures, systems or components important to safety
Cause failure or reduce the reliability or availability of any structure, system, or component that forms a primary means of ensuring radiation or nuclear safety, even where there is defence in depth remaining.
Impact on organisational controls or resourcing important to safety
Degrade safety management in a manner which removes organisational “checks and balances” for safety as described in the SAR or degrades defence in depth by failing to achieve adequate performance of staff in safety important roles.
To introduce or affect the likelihood or consequence of a dangerous occurrence
Increase the risk of operating outside of approved operating limits and conditions (where these are in place) or operational safety constraints.
Introduce a risk of an accident not previously considered, change consequences of an existing risk or affect the likelihood of a known risk.
Any change to an approved operating limit or condition (OLC) other than an editorial or typographical change. Note that the editorial or typographical change must NOT impact the safety case as presented in the Safety Analysis Report.
Any change that uses an alternative evaluation method from that relied on in the licence application or safety case.
Impact on the security of controlled facilities and apparatus
Potential to cause failure, or reduce the reliability or availability of a: system (including human systems); or structure or component that provides a primary protective security function (deterrence, detection, assessment, delay and response)—even where there are layers of defence remaining.
Potential to increase the threat level above that previously catered for by the protective security system and arrangements in place.
5. Examples of changes with significant implications for safety - facilities
The following examples of changes are provided for guidance only. It is important to relate any changes to the potential result of an unexpected outcome with a specific controlled facility.
Proposed change
Implications for safety
Replacement of Safety Interlock System
Following a fault, it is necessary to replace a safety interlock system. The original interlock is no longer manufactured. The new device is different in fit, form or function.
The replacement interlock component offers improved maintainability and introduces new technology without changing the overall safety function of the system.
The interlock is described in the SAR and is a primary means of ensuring radiation safety. Poor implementation of the change has the potential to affect reliability or performance of the system.
Safety System Logic
It is found that instrumentation and control logic in the first of two independent safety systems does not meet its full safety function requirements. A modification of the control logic is necessary to correct the deficiency.
The modification must, as described in the SAR, correct an error in the original system design or implementation. A modification of the control logic is planned. There is a potential for the change to fail to meet its required safety function or introduce a loss of function/reliability elsewhere if the change is poorly conceived or executed. Despite being one of two independent safety systems fulfilling essentially the same function, the potential risk of computer logic failure makes this a change with significant implications for safety based on the theoretical reduction in defence in depth level 3.
Increase Production of Radioisotopes
A licence holder wishes to increase the production rates by more frequent process runs in the existing facility. There is no need to change manufacturing methods.
An assessment of the change finds that the likelihood of an accident remains within the design basis authorised by the licence. However, increased processing may also increase the consequences of a design basis accident due to higher radionuclide inventory of the isotope and higher quantities of radioactive waste. The change therefore has significant implications for safety.
New radiation store
A licence holder plans to redesign and extend a radiation store to hold long-term radioactive waste and store radioactive materials. Existing controlled material will be centralised at the modified store.
The existing store is described in the SAR.
An assessment of the design and proposed management of the radiation store is necessary to ensure that it complies with relevant codes and standards.
A poorly designed and managed radiation store has the potential to expose workers to radiation in excess of the annual dose limit and to release activity to the environment.
Relocation of Radioactive Waste Store
For operational reasons it is decided to relocate a radioactive waste store.
During the course of relocation of radioactive materials to a new store, the potential exists for exposure and/or contamination of personnel and the environment. The SAR does not describe the movement of the store or its contents.
A risk assessment is undertaken which conservatively finds that damage to a container(s) during the movement may result in doses to workers at levels above the annual dose limits.
Changes to Working Hours
To improve customer service, it becomes necessary to alter worker shift rosters from an 8 hours working day (commencing at 9am) to a 12 hour working day (commencing at 6am). The average hours worked per week by staff will not be increased.
Assessment of the safety functions undertaken by workers shows that they are required to: operate controlled apparatus; maintain intended operational states; and detect and respond to process and equipment failures. Workers also have responsibility for emergency intervention and accident management.
Assessment of shift working indicates that disturbances to sleeping patterns can lead to fatigue. Fatigue is known to increase human error and accident rates by reducing alertness, slowing response time and impairing cogitative function. Failure mode and effects analysis identifies that human errors could cause loss of control, exposure to workers and releases of radioactivity above threshold values.
The change is categorised as significant to safety on the basis that, if not properly managed, it may degrade the safety function/performance of staff in roles that are important to safety.
Organisational Restructure
A review of operational priorities and resourcing has resulted in a number of recommended efficiencies.
The changes include: a change to management structures, as described in the SAR, to decentralise quality assurance activities and better align the associated resources with scientific research; a change to the terms of reference for a number of management committees including the safety review committee; and a change to various financing initiatives.
A review and risk assessment of each individual change is undertaken. This finds each to be a relevant change without significant implications for safety.
A review of the cumulative effect of the changes is also undertaken that compares the overall post change safety management practices with those in place at the time the licence was issued. The review finds that cumulatively checks and balances present when the licence was issued have been altered or removed and that safety and resource accountabilities have become blurred. Cumulatively it is assessed that the changes equate to being significant to safety as there is a possibility that staff performance may fail to meet required standards.
6. Examples of changes with significant implications for safety - sources
The following examples of changes are provided for guidance only. It is important to relate any changes to the potential result of an unexpected outcome with a specific source.
Proposed change
Implications for safety
New radiation source store
A licence holder plans to redesign and extend a radiation store to hold long-term radioactive waste and store radioactive materials. Existing controlled material will be centralised at the modified store.
An assessment of the design and proposed management of the radiation store is necessary to ensure that it complies with relevant codes and standards.
A poorly designed and managed radiation store has the potential to expose workers to radiation in excess of the annual dose limit and to release activity to the environment.
Relocation of Radioactive Waste Store
For operational reasons it is decided to relocate a radioactive waste store.
During the course of relocation of radioactive materials to a new store, a potential exists for exposure and/or contamination of personnel and the environment.
A risk assessment is undertaken which conservatively finds that damage to a container(s) during the movement may result in doses to workers at levels above the annual dose limit.
Class 4 laser used in the field
A licence holder plans to incorporate a Class 4 laser into an analyser which is to be used in the field in remote locations. The laser beam is not enclosed.
The licence holder is currently licensed to deal with Class 4 lasers, with the original licence application relating to lasers used in the laboratory.
The laser will be used in a situation not assessed in the original application.
Unless the change is implemented with appropriate safety measures there is the potential to expose a person to levels above the appropriate exposure limit.
Use of radioactive tracers
A licence holder is currently licensed to undertake tracer studies in the environment measuring C-14 uptake in plants.
The licence holder then wishes to undertake another environmental study which involved release of Tc‑99m tracer into a city harbour to study mixing current flows to establish how sewage outfall is being dispersed.
If inappropriately implemented, there is a potential for release of Tc-99m into the environment at concentrations such that the annual dose to a member of the public could exceed 1 mSv. The previously approved safety assessment did not address release to city harbour.
ARPANSA was also consulted by the licence holder on the regulatory implications of an environmental study that investigated critical pathways, and assessed the impact of uptake by flora and fauna. Advice was sought on the basis that the safety implications were notable (sensitive) even though under the threshold for environmental impact.
Organisational Restructure
A review of operational priorities and resourcing has resulted in a number of recommended efficiencies.
The changes include: a change to management structures, as described in the plans and arrangements, to decentralise quality assurance activities and better align the associated resources with scientific research; a change to the terms of reference for a number of management committees including the safety review committee; and a change to various financing initiatives.
A review and risk assessment of each individual change is undertaken. This finds each to be a relevant change without significant implications for safety.
A review of the cumulative effect of the changes is also undertaken that compares the overall post change safety management practices with those in place at the time the licence was issued. The review finds that cumulatively checks and balances present when the licence was issued have been altered or removed and that safety and resource accountabilities have become blurred. Cumulatively it is assessed that the changes equate to being significant to safety as there is a possibility that staff performance may fail to meet required standards.
[1] Defence in Depth is a commonly used practice of associating various safety barriers with different operational and accident states. The barriers can be physical or organisational and cover areas such as: design; maintaining intended operational states protection against accidents; and accident management and emergency off site response. Further information on defence in depth can be obtained from IAEA General Safety Requirements Part 3: Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards and IAEA General Safety Requirements Part 4: Safety Assessment for Facilities and Activities.
This Regulatory Guide informs licence holders on the actions to be taken if a radiation incident occurs, when ARPANSA must be notified, and how to make such a notification.
Incidents that must be reported to ARPANSA are defined as are the actions that must be taken by the licence holder if an incident occurs.
An incident is:
any unintended event, including an operating error, equipment failure, initiating event, accident precursor, near miss or other mishap; or
any unauthorised act, whether or not malicious, the consequences or potential consequences of which are not negligible.
Notifiable incidents
A notifiable incident requires immediate action and must be reported to ARPANSA within 24 hours.
A notifiable incident means any of the following:
an incident that exposes a person to a dose of ionising radiation that exceeds an effective dose limit mentioned in section 77 of the Regulations or an equivalent dose limit mentioned in section 79
an incident involving a diagnostic or interventional medical procedure resulting in an observable acute radiation effect
an incident involving exposure to non-ionising radiation from controlled apparatus that exceeds the non-ionising radiation exposure limits or results in noticeable eye or skin damage
theft or loss of controlled material or controlled apparatus, other than controlled material or controlled apparatus in Group 1
an incident involving the release of controlled material if the result of the activity value division steps* for the controlled material is greater than 104
an incident involving transport of a package of controlled material if the result of the activity value division steps for the controlled material is greater than 104 and the package is damaged in such a way that safety provisions are degraded
* activity value division steps for sources or controlled materials are the following:
Divide the activity of each nuclide in the sources or controlled materials by the activity value set out in Part 1 of Schedule 1 for the nuclide;
If there is more than one nuclide in the sources or controlled materials, total the result of paragraph (a) for each nuclide.
Note: Section 5 of the Regulations affects how the activity of a parent nuclide mentioned in Part 2 of Schedule 1 (or marked a in Part 1 of Schedule 1) is worked out, by providing for inclusion of the activity of certain progeny nuclides that are included in secular equilibrium with the parent nuclide.
Worked example
Suppose there are two vials in a laboratory cupboard, one containing 10 MBq of Co-60 and the other containing 100 MBq of Cs-137. Assume a fire destroys the cupboard and the vials and all activity is released. Is this a notifiable incident?
Schedule 1 Part 1 of the ARPANS Regulations gives activity values of 105 Bq and 104 Bq for Co-60 and Cs-137 respectively. If all activity is released, the result would be:
(107/105) + (108/104) =102 + 104 > 104
Hence this is a notifiable incident
What to do if a notifiable incident occurs
Preserve the site
It is essential that the integrity of the incident site is preserved to allow an analysis of the conditions at the site and a thorough investigation as to the cause(s) of the incident.
Special attention should be paid to the importance of securing the site or the facility to prevent any destruction or cross-contamination of the physical information as well as to protect responding personnel and others.
Investigate and provide a written report within 14 days
When investigating a radiation incident the following questions should be considered:
What happened?
How did it happen?
Why did it happen? Consider such things as environmental factors (e.g. distractions, shielding); human factors (e.g. experience, shielding, fatigue); controls (e.g. training, normal procedures, supervision); human and organisational factors (e.g. hazard identification, auditing, safety culture)
Was the severity of the incident and its likelihood of occurrence accurately reflected in the risk assessment?
These questions will help identify the root cause and contributing factors with the ultimate aim to improve controls and conditions to support individuals’ actions and reduce the risk of recurrence.
A written report must be provided to ARPANSA that contains an account of the incident and its consequences including where possible:
A root cause analysis
An estimate of the dose received by any person
An assessment of any impact on the environment
An assessment of human and organisational factors
Any corrective action taken as a result of the accident
Actions taken to prevent the recurrence of similar events
The impact on safety
Identified security implications
NOTE: If the report is not final it should still be submitted within 14 days and clearly marked as preliminary. The final version must be provided as soon as practicable and within a reasonable timeframe.
Review of plans and arrangements
Following a notifiable incident the licence holder must review and update plans and arrangements for managing safety. This review should include the design process for equipment or processes relevant to the incident and the performance of the risk assessment, review and safety approval system that authorised an activity that led to the incident.
The licence holder must complete the review within 6 months of the incident happening and must provide the CEO with a written summary of the outcome of actions resulting from the review within 7 months of the incident happening. The CEO may extend these periods on request.
Reporting other incidents
Any other incidents - such as operating errors, equipment failures, initiating events, accident precursors, near misses or other mishaps - that are not notifiable within 24 hours should be reported to ARPANSA as part of routine compliance reporting.
This allows ARPANSA to follow-up as necessary especially where there may be learnings for other licence holders or the industry more broadly.
Incidents of the type mentioned in the NDRP will be included in the Australian Radiation Incident Register (ARIR), Australia's national database of incidents and events resulting from activities involving radiation.
