SAFE TRANSPORT OFINFECTIOUS SUBSTANCES

ANDDIAGNOSTIC SPECIMENS

BY AIR

Alana Hansen

Flinders University

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.

REGULATORY FRAMEWORK

INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)

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

GENERAL PHILOSOPHYUnlike transport by road and sea, air transportation

has a unique set of circumstances:

Pressurized cabinEnclosed environmentOperating at altitude

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.

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!

KEY DEFINITIONS

Dangerous GoodsSubstances 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

COMPLIANCE PROCESS

STEP 1 Classify

STEP 2 Identify

STEP 3 Select packaging

STEP 4 Pack

STEP 5 Mark and label

STEP 6 Documentation

STEP 7 Advance arrangements

STEP 8 Emergency response

NINE (9) UN HAZARD CLASSESWith dangerous goods, the shipper must classify each item by determining which of the nine (9) Hazard Classes it falls within.

Class 1 – ExplosivesClass 2 – GasesClass 3 – Flammable LiquidsClass 4 – Flammable Solids; Substances Liable to Spontaneous Combustion; Substances Which in Contact With Water, Emit Flammable GasesClass 5 – Oxidising Substances and Organic PeroxideClass 6 – Toxic and Infectious SubstancesClass 7 – Radioactive MaterialClass 8 – CorrosivesClass 9 – Miscellaneous Dangerous Goods

STEP 1Classify

UN HAZARD CLASSES These may be further divided into Hazard Divisions

The order in which they appear does not imply relative degree of danger.

Non-flammable gasNon-flammable gasFlammable solidFlammable solid

OxidizerOxidizer

STEP 1Classify

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.

STEP 1Classify

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

STEP 1Classify

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.

STEP 1Classify

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 not permitted 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.

STEP 1Classify

BIOLOGICAL PRODUCTS Biological products are divided into three categories:

(1)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.

(2)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.

STEP 1Classify

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

Step 2Identify

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

Step 3 Select Packaging

MARKING AND LABELLING Infectious Substances

Infectious substance, affecting humans (Ebola virus) (liquid)UN 2814 Net Qty 50ml

UN 1845, DRY ICE, Net Weight 2kg

Shipper:Isolabs130 Fauntleroy AveRedcliffe WA 6104

Consignee:Northbank Hospital123 Langtree AveMildura VIC 3500

Emergency Contact: Sister Robins (08) 9475 4478

Ventilation Holes

4H / CLASS 6.2 / 02AUS / VB32

Step 5Mark & Label

MARKING AND LABELLING Diagnostic Specimens

UN3373 DIAGNOSTIC SPECIMENS

UN 1845, DRY ICE, Net Weight 2kg

Shipper:Isolabs130 Fauntleroy AveRedcliffe WA 6104

Consignee:Northbank Hospital123 Langtree AveMildura VIC 3500

Ventilation Holes

Step 5Mark & Label

MARKING AND LABELLINGOverpack

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:Isolabs130 Fauntleroy AveRedcliffe WA 6104

Consignee:Northbank Hospital123 Langtree AveMildura VIC 3500

Emergency Contact: Sister Robins (08) 9475 4478

INNER PACKAGES COMPLY WITH PRESCRIBED SPECIFICATIONS

Ventilation Holes

Step 5Mark & Label

DOCUMENTATION

Step 6Documentation

Step 6Documentation

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

Step 6Documentation

TRANSPORT PLANNING

Advance Arrangements need to be made between The SenderThe CarrierThe Receiver

Partner relationship required between the three parties

All have specific responsibilities to carry out

Step 7Advance Arrangements

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 ReductionRisk Management

Step 8 Emergency Response

CONCLUSIONThe 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.

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