|Licence holder||CSIRO Digital, National Facilities and Collections (DNFC)|
|Location inspected||Australian Centre for Disease Preparedness (ACDP) East Geelong, Victoria|
|Date of inspection||22 March 2023|
An inspection was conducted as part of ARPANSA’s source inspection program to assess compliance with the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act), the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations), and conditions of source licence S0216.
The scope of the inspection included an assessment of performance at ACDP against the Source Performance Objectives and Criteria (SPOC).The inspection consisted of a review of records, interviews, and physical inspection of sources.
The ACDP is a national biocontainment research facility to protect Australia from emerging infectious disease threats. ACDP sources are regulated under the CSIRO DNFC source licence S0216 authorised under section 33 of the Act to deal with unsealed sources; optical sources and laser products.
The main codes and standards applicable to ACDP under this licence are:
- RPS C-1 Code for Radiation Protection in Planned Exposure Situations (Rev 1) (2020)
- RPS 11 Code of Practice for the Security of Radioactive Sources (2019)
- RPS C-2 Code for the Safety Transport of Radioactive Material (2019)
- RPS C-6 Code for Disposal of Radioactive Waste by the User (2018)
- Australian/New Zealand Standard: Safety in laboratories Part 4: Ionizing radiations (AS/NZS 2243.4:2018)
- AS/NZS IEC 60825-1:2014 Australian/New Zealand Standard: Safety of laser products Part 1: Equipment classification and requirements
- AS/NZS IEC 60825-14:2022 Australian/New Zealand Standard: Safety of laser products Part 14: A user’s guide
- Radiation Protection Series No. 12 Radiation Protection Standard for Occupational Exposure to Ultraviolet Radiation (2006) (RPS12)
- Australian/New Zealand Standard Safety in Laboratories – Non-ionizing radiations-Electromagnetic, sound and ultrasound (2004) (AS/NZS 2243.5:2004)
In general, the management of safety and security was found to be satisfactory. In some cases, however, there appeared to be room for improvement with respect to:
- inaccurate signage on laboratory entry doors, and
- inappropriate laboratory flooring for dealings with unsealed sources.
Accountabilities and responsibilities
The ACDP Radiation Protection Plan (RPP) Version 2.2 as revised in March 2023 Chapter 2 Effective Control Section 2.3 (page 11) indicates ACDP resides within CSIRO’s Future Industries Sector (FIS). CSIRO advised that ACDP was moved out of the DNFC sector into the FIS approximately one year ago. CSIRO further advised that although three BUs within the FIS hold three individual BUs source licences, the FIS itself does not hold a single source licence that covers all source dealings within its Sector. However, interim arrangements are in place to manage control over ACDP sources during a period of organisational change. For example, ACDP RPP Section 1 ARPANSA Licence Coverage states that S0216 covers multiple businesses in the DNFC Sector including ACDP, and the CSIRO DNFC Sector Licence Organizational Structure Flowchart (RPP page 7) indicates ACDP remains licensed with DNFC Sector ‘for radiation management purposes.’
CSIRO demonstrates continued control over ACDP sources by maintaining a current S0216 SIW and Quarterly reports which include ACDP. The radiation safety risks associated with this misalignment between the current corporate responsibility for ACDP and S0216 licence responsibilities is managed at the executive level by the DNFC Sector Executive LH Nominee. Inspectors noted that CSIRO has taken steps in the RPP to clarify management responsibility for radiation safety at the operational level. For example, RPP Chapter 2 Effective Control section 2.4 Accountability – Roles and Responsibilities indicates the ACDP BU Director has management responsibility for radiation safety in ACDP, including the effective implementation of the RPP and training of Site RSO roles.
Documentation and document control
The ACDP RPP uses tables to identify specific information such as locations in ACDP where radioisotope work is conducted; and tasks requiring personal dosimetry (For example: Tables 11, 14 and 18).
CSIRO RPPs have a standardised format and appear to have adopted similar text across documents with the aim of delivering consistent safety messaging; however, copied text between unrelated RPPs may contain examples that are not applicable to a site. For example:
- The recently revised RPP for ACDP (Version 2.2 March 2023) section 4-12 ‘Individual Monitoring’ refers to work on unsealed volatile radioactive material such as iodine-125. However, CSIRO confirmed ACDP does not deal with I-125. The I-125 example is replicated across other RPPs and appears to have been incorporated as generic text in the ACDP RPP.
In addition, subject matter text that is not applicable to the ACDP should not be included in the ACDP RPP V.2.2. For example:
- Section 7.1.2 ‘Security Enhanced Sources’ is not relevant because ACDP does not deal with any security enhanced sources. The text discussing the development and endorsement of a security plan is not applicable to ACDP.
BU specific RPPs should contain safety and security information relevant to the source dealings.
CSIRO RPPs, including ACDP RPP at section 4.18, acknowledge ‘managing change is an important part of maintaining safety and compliance’, and identify six circumstances in which a change management process will be implemented. However, inspectors observed that changes in management structure affecting the source licence, LH responsibilities or regulatory compliance is not listed. CSIRO could consider listing the realignment of its business units and management structure which may affect licensing arrangements, and LH nominee responsibilities over sources as an additional circumstance requiring the implementation of a formal change management process.
Training and education
CSIRO management commitment to radiation safety at ACDP is evidenced by the appointment of two Site Radiation Safety Officers (RSO) to manage radiation safety on either side of the biosecurity partitioned research facility. However, an experienced Site RSO is due to retire in 2023. Inspectors noted CSIRO’s process for managing staff transition in this key radiation safety role includes retaining the services of the current Site RSO to support the induction and training of a new Site RSO responsible for controlled apparatus in the secure containment laboratories.
Planning and design of the workplace
The previous ARPANSA inspection in 2018 identified human factor risks in the laboratory layout which had the potential to adversely impact safety when dealing with unsealed sources of uranyl acetate in powder and liquid reagent forms. CSIRO has undertaken a review of the end-to-end workflow and tasks associated with the make-up of staining reagent. The inspectors noted that CSIRO has placed an emphasis on optimising safety in the redesign of a new laboratory outside the secure containment area which effectively eliminates the human factor risks inherent in the process layout of the original laboratory. The new laboratory had not been commissioned at the time of the inspection due to the delay in the installation of a transmission electron microscope.
As an interim measure, CSIRO set up a temporary laboratory inside secure containment to consolidate the performance of tasks associated with its dealing with unsealed sources of uranyl acetate including storage, weighing and reagent preparation. The staining reagent was due to expire within a month of this inspection requiring the weighing and handling of uranyl acetate powder (LAD 704) on a monthly basis. Separate disposable gowns are used when handling unsealed radioactive material.
Uranyl acetate powder contained in nine appropriately labelled bottles was securely stored in a combination-lock safe. An electronic inventory is used to record the remaining weight of uranyl acetate in each bottle when powder is removed to make a reagent. Individual subsample numbers identify each bottle. All samples are subject to safeguards inspection.
The aqueous staining reagent containing uranium is used three times a week. The preparation of a staining reagent using uranyl acetate is carried out inside an ‘AHH2’ Cabinet with a dedicated disposal bin and balance displaying radiation hazard warning signage. A calibrated contamination monitor was present in the laboratory (next due for recalibration in 2026). An ACDP Housekeeping Checklist was also sighted during the inspection.
A radiation spill kit is available when making the liquid uranium reagent. However, the spill kit was observed to be in the corridor outside the lockable temporary laboratory. In addition, it was observed that this interim laboratory had porous concrete grout between the ceramic floor tiles. This flooring is unlike the impervious lino flooring in other laboratories at ACDP which has impervious characteristics and is installed as a continuous barrier which aids in the clean-up of a spill.
Inspectors note that the use of this secure room to deal with unsealed uranium chemicals and reagents is an interim measure to mitigate human risk factors identified in a previous inspection prior to the commissioning of a new purpose-built laboratory later in 2023. However, CSIRO should take steps to make the flooring resistant to the absorption of aqueous reagent spills and reduce the risk of adsorption of radioactive power onto concrete grout.
Local rules and procedures
CSIRO has a specific RPP for the local ACDP plans and arrangements which was revised in March 2023.
The ACDP work environment requires the adherence to strict biosecurity protocols which places constraints on the use of items in the secure area including unnecessary generation of paper waste. This biosecurity constraint needs to be managed against competing radiation laboratory safety best practice, including having safe work instructions (SWI) procedures for controlled apparatus available for referral by the operator.
CSIRO has not introduced the QR Code system used by other Business Units for electronically associating the current SWI for operating controlled apparatus or undertaking a hazardous source handling task at ACDP. The main reason CSIRO identified for not introducing this electronic document access system for use by an operator at ACDP is the unavailability of a device with a QR Code reader due to constraints moving devices within high biosecurity containment facility. Mobile devices are not permitted in some areas and a reliable mobile internet connection is not guaranteed in all areas. Inspectors observed a tablet with an embedded camera in use within the secure area on which a QR Code reader app could potentially be installed; however, this tablet was used to take photos for documenting hazards. In addition, inspectors also noted that ACDP preferentially use an electronic log when weighing and recording the use of unsealed sources to reduce the use of paper-based records. The use of a QR Code to provide the operator access to SWI negates the need to replace paper versions of SWI with a new revision when procedures are updated and reduces unnecessary generation of paper waste in the high biosecurity containment area.
Compliant non-ionising radiation (NIR) sources and controlled apparatus
The hazard warning signage on apparatus and at the entry to laboratories is generally compliant with the laboratory standard and consistent with CSIRO’s plans and arrangements. The inspectors noted however, that radiation hazard signage was displayed on the access door to a laboratory where radioactive material is no longer in use. It is important that hazard signage reflects actual hazards present to ensure that staff and emergency responders can rely on the safety information, including hazards, applicable to the laboratory. CSIRO therefore needs to review the hazard warning signage on access doors to all laboratories to ensure hazard warnings are current.
A demonstration of the operation of the LSM 800 laser microscope (LAD 6936) by a trained ACDP operator revealed the potential for operator exposure to a laser light. Inspectors requested further information from the operator manual or advice from the supplier. CSIRO provided the results of the annual LSM Laser Safety Test on this controlled apparatus undertaken on 4 May 2022 by a service engineer which concluded the instrument is safe to operate when used as intended by following the manufacturer’s instructions. Additional information provided to inspectors in support of the safe and compliant operation of this LSM 800 laser microscope includes:
- All commission, repair and maintenance work is performed by Zeiss technician or authorised persons
- There is extensive labelling on the exterior of the instrument about potential laser exposure if covers are removed
- Laser module has a keyed interlock
- Laser module can only be activated by ZEN software package even if turned on manually
- Zeiss provide warning regarding not using reflective objects in the beam path, not opening panels or covers, not leaving microscope nose piece uncovered
- Safety eyewear clearly specified as >1.5 OD for the wavelength in use (405/488/561/640 nm)
- The user interface can emit Class 2 laser radiation however laser safety shields remain in place while in use
- Statement from Zeiss that under normal operating conditions LSM800 will not pose a laser hazard for operating personnel
- Users have Opticum Level 3 Laser Safety Operator training as current.
Monitoring of the workplace and individuals
Personal dosimetry is required when using unsealed radioactive sources. Personal dose data is recorded quarterly; and personal occupational radiation exposure records are provided to ARPANSA for inclusion in the Australian National Radiation Dose Register (ANRDR) in accordance with S0216 licence condition 7.
Radioactive waste - ultimate disposal and transfer
Management of ultimate disposal and transfer
ACDP has completed the transfer of legacy radioactive sources to consolidated waste stores at other locations where CSIRO will manage their ultimate disposal or transfer as part of the wider CSIRO legacy waste management program.
Site security observed during the inspection and as outlined in RPP Section provide adequate defence in depth protection to deny unauthorised site access and prevent theft by an external adversary. The safety/security procures 7.1 (a),(b),(d),(g),(h) and the staff reporting requirements in relation to the discovery of a breach of source security or loss of control over a source serve as a general deterrent to insider threats.
Unsealed nuclear material is securely stored in a dedicated safe with combination lock. The safeguards accounting practices including the electronic record keeping for the residual weight in each labelled container also acts as a means of monitoring and assessment that security of the unsealed source has not been compromised.
RPP Section 7.1.2 specifically addresses security enhanced sources; however, there are no Category 1,2, or 3 sources at ACDP which would require an endorsed source security plan. Inspectors considered that the security procedures outlined in Section 7.1 of the RPP are appropriate for maintaining effective control over ACDP sources and controlled apparatus.
ACDP deals with unsealed nuclear material and the ACDP RPP radiation incident emergency response procedure contains instructions on responding to spills of ionising sources and dealing with contamination. CSIRO has a formal incident and hazard reporting system. The RPP includes a protocol for recording an incident in the CSIRO’s ‘Donesafe’ system and for notifying ARPANSA of the event. An up-to-date list of key contacts is included in the RPP March 2023 version 2.2. However, this contact list will need to be revised upon the retirement of one of the site radiation safety officers on the contact list.
The licence holder was found in compliance with the requirements of the Act, the Regulations, and licence conditions.
The inspection revealed the following areas for improvement:
- Unsealed sources were being used in a laboratory with a floor comprised of porous material such as unsealed concrete
- Hazard warning signage information on access doors to some laboratories did not accurately reflect the hazards therein.
It is expected that improvement actions will be taken in a timely manner.