Transport of Biological Materials by Road in University and Private Vehicles Date of publication: 11 January 2012 Reviewed: January 2014 1 Scope This document covers: packaging, labelling and safety requirements for the transport of Category C and Exempt biological materials by road, in university (fleet) vehicles driven by staff or students packaging, labelling and safety requirements for the transport of non-human Category C and Exempt biological materials by road, in private vehicles driven by staff or students. Deakin’s Risk Management Unit has advised that the transportation of human samples must only be in suitable Deakin University owned vehicles and not private vehicles. This document does not cover: the transport of infectious substances in Categories A and B (pathogenic microorganisms) (refer to AS/NZS 2243.3: 2010 Section 13 or Dangerous Goods Division 6.2 Infectious microorganisms, if required) transport by courier companies transport of human body parts for medical purposes. A flow chart summarising the requirements is in Figure 1. Denise Elson Biosafety and Biosecurity Officer Page 1 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles Figure 1: Flow chart for transport of biological materials in university and private vehicles Do the biological materials contain, or have a high probability of containing, infectious substances (e.g. microbiological cultures)? Yes Categories A&B These pathogenic infectious substances are not covered by this document. Refer to Section 13 of AS/NZS 2243.3 & Dangerous Goods legislation Division 6.2 No Would the material cause community concern if leaked or spilled onto the road in the event of an accident? (e.g. human samples, animals or parts thereof) Yes Category C These are biological materials with a low probability of causing disease in humans (e.g. human and animal tissues or body parts). They would cause community concern if leaked or released Packaging requirements: Primary container = leak-proof e.g. specimen container Secondary container = leak-proof with absorbent material for liquids e.g. ziplock plastic bag or screwcap jar with cotton wool Outer packaging = solid, strong & durable e.g. sturdy box or plastic esky Wet ice must be held within its own container If using dry ice or liquid nitrogen allow for escape of gases. The package is to be transported separate to the passenger compartment (e.g. boot or back of ute) Secure packaging within vehicle * Note: Animal carcasses too large to comply with the above packaging guidelines should be secured within the vehicle No Exempt Examples are plants, aquatic organisms, water & soil samples, bird carcasses Packaging requirements: None - Transported in a secure manner If using dry ice or liquid nitrogen allow for escape of gases. The package is to be transported separate to the passenger compartment (e.g. boot or back of ute) Labelling requirements: ‘Dry Ice’, ‘Liquid Nitrogen’ or ‘Ethanol’ as appropriate Refer to Section 5 for more detail NOTE: For transport of materials that fall under OGTR, DA or SSBA legislation, the relevant documentation must be consulted Labelling requirements: Contents Contact name Organisation Emergency contact telephone number ‘Dry Ice’, ‘Liquid Nitrogen’ or ‘Ethanol’ as appropriate Refer to Section 3 for more detail Denise Elson Biosafety and Biosecurity Officer Page 2 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles 2 Categories of biological materials and examples Biological materials are categorised into four categories: A, B, C and Exempt. Categories A and B are pathogenic infectious substances and transport of these materials is covered in Section 13 of AS/NZS 2243.3 and Dangerous Goods legislation. The Biosafety and Biosecurity Officer can also be contacted for advice. For transport of GMOs and quarantine materials, see Section 7 below. Category C and Exempt Category biological materials are defined as follows: 2.1 Category C: materials with a low probability of causing disease in humans, such as human and animal tissues, that would cause community concerns if the samples were to leak or be released from their packaging (adapted from AS/NZS 2243.3:2010) Examples of biological materials that fall into this category are: all samples of human origin (except fixed slides etc); bat carcasses animal body parts, tissues and fluids, diagnostic samples Note: Animal carcasses may fall under this category if they would cause community concern if spilled onto the road (eg mammals). However it may not always be practicable to fulfil the packaging requirements as described in Section 3. See Section 4 for information. 2.2 Exempt Category: materials with a low probability of causing disease in humans that would not cause any cause community concerns if the samples were to leak from their packaging. Examples of biological materials that fall into this category are: plants or parts thereof eg leaves bird carcasses, aquatic organisms (eg starfish), fish or parts thereof or samples of their fluids or tissues water samples (which may contain living microbes, crustaceans etc) soil samples (which may contain living microbes etc). 3 Packaging and labelling of Category C biological materials (except animal carcasses) Category C biological materials must be transported in primary containers within secondary sealed containers and with outer packaging. They must be restrained in vehicles to minimise the likelihood of contamination of the environment or persons in the event of a road accident. Outer packaging must also be suitably labelled. The following requirements have been extracted from AS 4834: 2007. For full details please refer to this standard on-line. 3.1 The packaging shall be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport and closed to prevent any loss of contents that might be caused under normal conditions of transport by vibration or by changes in temperature or humidity. Denise Elson Biosafety and Biosecurity Officer Page 3 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles 3.2 The packaging shall consist of three components: (a) primary receptacle(s) eg screw top container or blood tube (b) secondary packaging eg plastic snap lock bag or screw capped jar (c) outer packaging eg sturdy box or plastic esky 3.3 The primary receptacle(s) shall be leak proof and packed in secondary packagings in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents. 3.4 Secondary packagings shall be leak proof and secured in outer packagings with suitable cushioning material. Any leakage of the contents shall not compromise the integrity of the cushioning material or of the outer packaging. For liquids, absorbent material should be present in case of leakage and for cushioning, if necessary. A liquid nitrogen dry shipper shall not be used as secondary packaging. 3.5 Outer packaging shall be a solid, strong and durable container fitted with a secure closure to prevent loss of contents under normal transport conditions. An unsupported expanded polystyrene container (commonly referred to as an esky) shall not be used as the outer packaging. 3.6 If wet ice is used, the outer packaging or overpack shall be leak proof. The ice shall be contained within its own container, for example a freezer brick or gel pack, or within the outer packaging or overpack. Interior supports shall be provided to secure the secondary packagings in the original position after the ice has melted. 3.7 If solid carbon dioxide (dry ice) is used the outer packaging shall permit the release of carbon dioxide gas to prevent a build-up of pressure that could rupture the packagings. The CO2 shall be placed between secondary and outer packagings or overpack. Interior supports shall be provided to secure the secondary packagings in the original position after the dry ice has dissipated. 3.8 If liquid nitrogen (LN2) is used, the outer packaging shall have provision for the escape of the expanding refrigerant when a dry shipper is not used. 3.9 Documentation shall be placed between secondary and outer packaging. 3.10 Masking tape can be used to seal outer container and attach address label. 3.11 The outer packaging shall be marked with the following information: (a) Contact name and organization (b) Emergency contact telephone number (c) If refrigerants are used, mark with ‘Dry ice’ or ‘Liquid nitrogen’ as appropriate. 3.12 Package shall be secured during transport eg by supplied webbing or netting in vehicle. Note: If using dry ice, liquid nitrogen, ethanol or other Dangerous Goods refer to Section 6. 4 Packaging of animal carcasses Animal carcasses that are too large to be packaged according to the requirements in Section 3 should be transported in a manner that secures them against accidental release from the vehicle. Note: If using dry ice, liquid nitrogen, ethanol or other Dangerous Goods refer to Section 6. 5 Packaging and labelling of Exempt Category biological materials Biological materials that are categorised as Exempt should be transported in a manner that preserves the integrity of the samples. There are no specific packaging or labelling requirements for this category, unless they are transported in dry ice or liquid nitrogen (LN2). Denise Elson Biosafety and Biosecurity Officer Page 4 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles The following requirements have been extracted from AS 4834: 2007. For full details please refer to this standard on-line. 5.1 If refrigerants are used to cool/freeze samples during transport, outer packaging should be labelled with ‘Dry ice’ or ‘Liquid nitrogen’ as appropriate and requirements in Section 6 followed. 5.2 If wet ice is used, the outer packaging or overpack should be leak proof. The ice should be contained within its own container, for example a freezer brick or gel pack, or within the outer packaging or overpack. 5.3 If dry ice is used the outer packaging shall permit the release of carbon dioxide gas to prevent a build-up of pressure that could rupture the packagings. 5.4 If liquid nitrogen is used, the outer packaging shall have provision for the escape of the expanding refrigerant when a dry shipper is not used. 6 Transport of specific Dangerous Goods: biological materials in dry ice, liquid nitrogen & ethanol Both solid carbon dioxide (‘dry ice’) and liquid nitrogen (LN2) can produce life-threatening levels of gases resulting in asphyxiation. They must therefore only be transported in wellventilated areas or if in small amounts, only by following careful management procedures. Solid carbon dioxide (CO2) or liquid nitrogen (LN2) may be transported by vehicle in approved closed insulated containers, closed dewars or closed vacuum flasks. When transported by vehicle, these containers must be positioned upright and properly secured (by belts, webbing, etc), so they will not lose their lids or closures in the event of an incident (e.g. should a vehicle be upside down). Ethanol (usually 80% v/v) is used for the storage of biological materials; these may be transported in ethanol at ambient temperatures, or in ethanol using dry ice or liquid nitrogen as a refrigerant. Transport of biological materials in small quantities of ethanol is covered by this document under Section 6.3. 6.1 Packaging, labelling and transport of Dangerous Goods All Dangerous Goods must be packaged correctly, be fully labelled and have the appropriate hazard division diamond affixed, and be loaded, secured, segregated and unloaded safely. For further information see Section 9.4 below or contact the University’s OHS Unit. 6.2 Transport of large quantities of refrigerants (>1kg dry ice and >1litre LN2) Large quantities of dry ice or liquid nitrogen (>1kg for dry ice and >1litre for LN2) must be able to vent to the environment and not into the passenger space within the vehicle e.g. the back of a utility vehicle with the cabin fully separate to the ventilated load space, or a purpose-built compartment with external venting. Note: This is required for large quantity dewars. 6.3 Occasional transport of small quantities of refrigerants (<1kg dry ice and <1litre LN2) or ethanol (<2.5L) in a vehicle boot If small quantities of dry ice or liquid nitrogen are required to be transported occasionally (and not routinely) without outside venting, or biological materials in small quantities of ethanol, Denise Elson Biosafety and Biosecurity Officer Page 5 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles action must be taken to minimise the possibility of the gases, or flammable ethanol vapours (in the event of an incident), entering the passenger space of the vehicle: (i) the boot has been checked and confirmed there are no air gaps into the passenger space, and that possible air gaps are not likely to open up into the passenger space in the event of an accident Reason: It is better to allow the build-up of vapours in the boot than to allow the solid CO2 or LN2 containers, or ethanol containers, to be in the passenger space (even if the space is kept ventilated), as in an emergency this means there is a clear segregation of the occupants from the asphyxiant gases or flammable vapours. (ii) the vehicle mechanical ventilation system is set to a moderate rate of fresh air (and tagged so as not able to be changed to recycle), (iii) rear vehicle windows are slightly open with at least a 0.5cm clear gap in case there is an accident and the mechanical ventilation ceases to operate. Reason: Should a car end up on its roof this allows the ethanol vapours or cold vapours of CO2 or nitrogen to escape from the vehicle or if the vehicle is right way up allows air to enter and exit from the car. (iv) at the end of the journey, the boot space shall be opened and allowed to ventilate prior to removal of containers. Reason: This will allow the release of any built-up of ethanol vapours, or cold gases vapours which will tend to accumulate in the bottom of the car boot. 6.4 Commercially available containers for LN2 that prevent any liquid from escaping Another option is to purchase commercially available containers for LN2 that prevent any liquid from escaping. MVE Vapor Shippers are dewars designed for the safe shipment of specimens in liquid nitrogen. By employing a hydrophobic compound, any spilled liquid nitrogen is absorbed. See Attachment 1. 7 Other legislation that may be applicable 7.1 Transport of Genetically Modified Organisms (GMOs) GMOs must be transported according to the Office of the Gene Technology Regulator (OGTR) Guidelines for the Transport, Storage and Disposal of GMOs at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/transport-guide-1 7.2 Transport of quarantine materials Biological materials that must be handled in Department of Agriculture (DA) Quarantine Approved Premises (QAPs) must follow Quarantine Approved Premises Criteria (a) 5.1 for Quarantine Containment Level 1 (QC1) Facilities and (b) 5.2 for Quarantine Containment Level 2 (QC2) Facilities. 7.3 Transport of Security Sensitive Biological Agents (SSBAs) The transport of microorganisms and toxins classified as Security Sensitive Biological Agents by the Department of Health and Ageing must be done according to Part 6 Transport of the Security Sensitive Biological Agent Standards, 14 July 2011. Denise Elson Biosafety and Biosecurity Officer Page 6 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles 8 Transport of live animals For transport of live animals, the following Minimum Standards are provided by the Department of Primary Industries: 1. 2. 3. 4. Food and water must be provided to the animals wherever possible during transport. Animals must not be transported for more than 24 hours without food and water. An assessment of the health and welfare of the animals must be made upon arrival. Containers for domestic, local and internal transportation of animals must be: a) adequately ventilated (with reduced stocking rates in containers with filters); vermin- and escape-proof; b) durable (including crush-proof); c) sufficiently spacious (higher stocking densities than normal housing may be required to prevent injury); d) provided with appropriate bedding (for thermoregulation and impact absorption); e) clearly labelled. For further guidance, please refer to the Department of Primary Industries website NOTE: The transport of all animals used for research and teaching by Deakin personnel must be conducted in accordance with the conditions outlined in the Animal Welfare Committee approval documentation. 9 Supporting information contained in references 9.1 AS/NZS 2243.3:2010 The flow diagram in Section 13 of this standard is useful for determining UN numbers and associated Packaging Instructions that must be followed for the transport of specific biological materials by air etc. 9.2 AS 4834:2007 See Section 5 Packaging Requirements and Section 6 Marking and Documentation; and Section 8 Refrigerants for packaging requirements in dry ice or liquid nitrogen. Appendices D and E in this standard give examples of packaging and labelling. 9.3 ADG Code, 7th edition – Category C Biological Materials not covered Interpretation of this Code was provided by John Borig, who was involved in its compilation. The ADG Code does not provide for the existence of Category C biological materials under ‘Division 6.2 Infectious Substances’. The materials to be transported under the requirements of this document fall into the Exempt category (2.6.3.2.3), under 2.6.3.2.3.1 and 2.6.3.2.3.6 in the ADG Code. Advice given by John Borig is that the biological materials do not need to be placarded as they are <10Kg of Category B substances (Category C not defined). If samples to be transported are < 25% of 10Kg, ie <2.5 Kg (actual sample weight, not including packaging), then these materials are exempt from the transport regulations and therefore the ADG Code. If any person needs to transport samples weighing >2.5 Kg, please consult the Biosafety and Biosecurity Officer for advice. Denise Elson Biosafety and Biosecurity Officer Page 7 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles 9.4 ADG Code 7th Edition: Transport in Dry Ice, Liquid Nitrogen (LN2) or Ethanol As the small volumes of dry ice, LN2 or ethanol used are covered by the Special Provisions of Tools of Trade (Vic DG Transport Reg 26), these samples are exempt from the full application of the ADG code, provided they are transported in accordance with Victorian Regulation 26. For this situation, the Vic Dangerous Goods Transport Regulation 26 requires that any sample (a) complies with the packaging requirements appropriate to the quantity of dangerous goods, as specified in Part 4 of these Regulations on pages 39-54, (which refers to the ADG Code); and (b) is appropriately marked as in Regulation 80 on page 55, (which refers to the ADG Code); and (c) is loaded, secured, segregated, unloaded and otherwise transported in such a way as to ensure that— (i) its packaging remains fit for its purpose; and (ii) the risk to any person, property or the environment is eliminated, or if it is not possible to eliminate the risk, is minimised to the maximum extent that is practicable. 10 References The following were consulted in preparation of this document: AS/NZS 2243.3: 2010 Australian Standard Safety in laboratories Part 3: Microbiological safety and containment, Section 13 Packaging for surface transport of biological material that may cause disease in humans, animals and plants (AS 4834:2007) Australian Code for the Transport of Dangerous Goods by Road and Rail (7th edn), Vol 1 Part 2 Victorian Dangerous Goods (Transport by Road or Rail) Regulations 2008: Regulation 24 (1) (b) and Regulation 26 for Tools of Trade (1), (2) & (3), which cover the requirements for Solid Carbon Dioxide & Liquid Nitrogen John Borig, consultant with Noel Arnold and Assoc, who provided the technical specialist knowledge for the compilation of the ADG Code Jeff Simpson, Deakin University Senior OH&S Consultant (Chemicals Management) contacted Worksafe Victoria Office of the Gene Technology Regulator (OGTR) Guidelines for the Transport, Storage and Disposal of GMOs Department of Agriculture (DA) Quarantine Approved Premises Criteria (a) 5.1 for Quarantine Containment Level 1 (QC1) Facilities and (b) 5.2 for Quarantine Containment Level 2 ( QC2) Facilities Department of Health and Ageing Security Sensitive Biological Agent Standards 14 July 2011, Part 6 Transport Department of Primary Industry Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits Sept 2011. Denise Elson Biosafety and Biosecurity Officer Page 8 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles Attachment 1 Denise Elson Biosafety and Biosecurity Officer Page 9 of 10 8 Jan 2014 Transport of Biological Materials by Road in University and Private Vehicles Denise Elson Biosafety and Biosecurity Officer Page 10 of 10 8 Jan 2014