SAFE TRANSPORT OF INFECTIOUS SUBSTANCES AND DIAGNOSTIC SPECIMENS BY AIR

1. SAFE TRANSPORT OFINFECTIOUS SUBSTANCES ANDDIAGNOSTIC SPECIMENS BY AIR Alana Hansen Flinders University

2. REGULATIONS as of 1 JULY 2004 • If either you or your staff packs or supervises an individual who packs dangerous goods for transport by air (including enclosing the goods in packaging, or marking or labelling the consignment or preparing a shipper’s declaration) then you are required by the Civil Aviation Safety Regulation Part 92 (CASR 92) to ensure that both you and your staff receive dangerous goods training on a Civil Aviation Safety Authority (CASA) approved course from 1st July 2004 and every two years thereafter.

3. REGULATORY FRAMEWORK United Nations Committee of Experts (CoE) International Atomic Energy Agency (IAEA) International Civil Aviation Organisation (ICAO) International Air Transport Association (IATA) Civil Aviation Safety Authority (CASA) Australia

4. GENERAL PHILOSOPHY Unlike transport by road and sea, air transportation has a unique set of circumstances: • Pressurized cabin • Enclosed environment • Operating at altitude

5. WHY AWARENESS TRAINING? • In the interest of global public health infectious substances and diagnostic specimens need to be transported by air safely and efficiently. • More than 90% of all aviation accidents and incidents worldwide involving dangerous goods were caused by UNDECLARED dangerous goods. • Less than 1% of dangerous goods incidents worldwide were caused by correctly packaged, declared and documented dangerous goods.

6. THE CASE FOR AWARENESS TRAINING • A heavy duty plastic cylinder exploded as it was being transported by a courier. • Dry ice was packed into a cylinder (secondary packaging) contrary to both the IATA Regulations and the manufacturers instructions. • Just imagine if this had happened onboard an aircraft in flight!

7. KEY DEFINITIONS • Dangerous Goods • Substances capable of posing a risk to health, safety, property or the environment when transported by air • Carbon Dioxide, Solid (Dry Ice) • Diagnostic Specimens • Biological products

8. COMPLIANCE PROCESS

9. STEP 1 Classify NINE (9) UN HAZARD CLASSES With dangerous goods, the shipper must classify each item by determining which of the nine (9) Hazard Classes it falls within. Class 1 – Explosives Class 2 – Gases Class 3 – Flammable Liquids Class 4 – Flammable Solids; Substances Liable to Spontaneous Combustion; Substances Which in Contact With Water, Emit Flammable Gases Class 5 – Oxidising Substances and Organic Peroxide Class 6– Toxic and Infectious Substances Class 7 – Radioactive Material Class 8 – Corrosives Class 9 – Miscellaneous Dangerous Goods

10. STEP 1 Classify UN HAZARD CLASSES • These may be further divided into Hazard Divisions • The order in which they appear does not imply relative degree of danger.

11. STEP 1 Classify CLASS 6.2 - INFECTIOUS SUBSTANCES • Division 6.2 materials are substances which are known to contain or reasonably expected to contain pathogens. • Pathogens are micro-organisms (such as bacteria, viruses, rickettsia parasites and fungi) and recombinant micro- organisms (hybrid or mutant) that may cause infectious diseases in humans or animals. • Division 6.2 includes biological products; diagnostic specimens such as blood, body fluids and tissue samples; clinical and medical waste; and genetically modified micro- organisms and organisms.

12. STEP 1 Classify RISK GROUPS • Classification into the appropriate Risk Group is based upon: • The pathogenicity of the organism. • The mode and relative ease of transmission. • The degree of risk to both an individual and a community. • Reversibility of the disease through the availability of known • and effective preventative agents • and treatment. • Risk groups 1,2,3,4

13. STEP 1 Classify GENETICALLY MODIFIED MICRO-ORGANISMS AND ORGANISMS • Genetically modified micro-organisms which meet the definition of an infectious substance must be classified in Division 6.2 and assigned UN 2814 or UN 2900. • Animals which contain, or are contaminated with, genetically modified micro-organisms that meet the definition of an infectious substance must not be transported by air unless exempted by the State concerned. • Genetically modified micro-organisms which do not meet the definition of an infectious substance, but are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction must be classified in Class 9 and assigned to UN 3245.

14. STEP 1 Classify DIAGNOSTIC SPECIMENS • Diagnostic specimens, including those taken from apparently healthy individuals, may contain pathogens that meet the criteria for Risk Groups 1, 2, 3 or 4. Diagnostic Specimens that contain pathogens which meet the criteria for Risk Group 1, 2 and 3 must be assigned to UN 3373. • Specimens containing Risk Group 4 pathogens are notpermitted for transport as ‘diagnostic specimens’ and must be assigned to UN 2814 or UN 2900 and transported according to the requirements for infectious substances. Shippers must exercise their professional judgment when assessing the possible presence of pathogens from Risk Group 4. • Blood which has been collected for the purpose of blood transfusion or for the preparation of blood products, and blood products or any tissues or organs intended for use in transplants are not subject to the IATA Dangerous Goods Regulations.

15. STEP 1 Classify BIOLOGICAL PRODUCTS • Biological products are divided into three categories: • Biological products containing pathogens in Risk Group 1 • are not considered to be infectious substances and are not subject to the provisions of the IATA DGRs. • Biological products manufactured and packaged in accordance with the requirements of national governmental health authorities and transported for the purposes of final packaging or distribution, and for use for personal health care by medical professional or individuals are not subject to the requirements for Division 6.2 substances. • (3) Biological products known or reasonably known to contain pathogens in Risk Groups 2. 3 or 4 and which do not meet the criteria of (2) above must be classified in Division 6.2 under UN 2814 or UN 2900 as appropriate.

16. Step 2 Identify SHIPPER’S RESPONSIBILITIES • Assign, where relevant, each item to one of three Packing Groups (I, II or III) • Identify the Proper Shipping Name, UN Identification Number, cargo and passenger aircraft limitations and any special provisions. • Comply with IATA Regulations

17. Step 3 Select Packaging GENERAL PACKING REQUIREMENTS • Use only packaging permitted by applicable Packaging Instructions • Follow manufacturers instructions • Use only certified package configurations • Restrict the overpack quantity to design specifications • Restrict quantity per package to the specified limits • Packaging must be: • Good quality • Strong enough • Constructed to prevent loss of content • Closed so as to prevent loss of content

19. Step 5 Mark & Label Ventilation Holes Infectious substance, affecting humans (Ebola virus) (liquid) UN 2814 Net Qty 50ml UN 1845, DRY ICE, Net Weight 2kg Shipper: Isolabs 130 Fauntleroy Ave Redcliffe WA 6104 Consignee: Northbank Hospital 123 Langtree Ave Mildura VIC 3500 Emergency Contact: Sister Robins (08) 9475 4478 4H / CLASS 6.2 / 02 AUS / VB32 MARKING AND LABELLING Infectious Substances

20. Step 5 Mark & Label Ventilation Holes UN3373 DIAGNOSTIC SPECIMENS UN 1845, DRY ICE, Net Weight 2kg Shipper: Isolabs 130 Fauntleroy Ave Redcliffe WA 6104 Consignee: Northbank Hospital 123 Langtree Ave Mildura VIC 3500 MARKING AND LABELLING Diagnostic Specimens

21. Step 5 Mark & Label Ventilation Holes Infectious substance, affecting animals (Bluetongue virus) only (liquid) UN 2900, Net. Qty 200mL Infectious substance, affecting animals (Goatpox virus) only (liquid) UN 2900, Net. Qty 50 mL UN 1845, DRY ICE, Net Weight 2kg Shipper: Isolabs 130 Fauntleroy Ave Redcliffe WA 6104 Consignee: Northbank Hospital 123 Langtree Ave Mildura VIC 3500 Emergency Contact: Sister Robins (08) 9475 4478 INNER PACKAGES COMPLY WITH PRESCRIBED SPECIFICATIONS MARKING AND LABELLINGOverpack

22. Step 6 Documentation DOCUMENTATION

23. Step 6 Documentation

24. Step 6 Documentation GENERAL REQUIREMENTS • Two colour formats • Legible (computerised or handwritten) • Two copies required by all Operators • Full signature required when any type of amendment made except: • Air waybill or con-note number • Airport of Departure • Airport of Destination

25. Step 7 Advance Arrangements TRANSPORT PLANNING Advance Arrangements need to be made between • The Sender • The Carrier • The Receiver • Partner relationship required between the three parties • All have specific responsibilities to carry out

26. Step 8Emergency Response EMERGENCY RESPONSE • Emergency Response information must accompany all shipments of dangerous goods and must be available at all facilities involved in the transport process. • Risk Reduction • Risk Management

27. CONCLUSION • The Civil Aviation Academy Australasia’s ‘Safe Transport of Infectious Substances and Diagnostic Specimens’ Course is CASA approved. • One-day tutorial course ($140 per person) • Via correspondence ($99 per person + $6 postage and handling). • For further information www.caaa.com.au or ph. 1800 754 774.

28. ACKNOWLEDGEMENT Many thanks to Sue-anne Roberts and Robyn McMenamin from the Civil Aviation Academy Australasia Pty Ltd for their assistance in putting this presentation together. THANK YOU