Guide To Shipping Biological Materials

Introduction

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This manual is to aid in the shipment of biological materials from NC State University in compliance with the US Department of Transportation (DOT) and the International Air

Transporters Association (IATA). This manual does not include agricultural and foreign customs restrictions.

Carrying biological materials on one’s person onto an aircraft is prohibited. All biological materials must be properly packaged and checked as luggage or transported via a courier.

The steps to properly ship biological materials include:

*             Classification

*             Packaging

*             Labeling

*             Documentation

Anyone participating in any one of the previous steps must be trained and certified according to DOT and IATA regulations. Training can be scheduled at the Environmental Health and Safety Center by calling 515-2895.

Biological materials fall into the following categories:

*             Infectious substances

–              Category A infectious substances

–              Category B infectious substances

*             Diagnostic specimens

*             Biological products

8 Genetically modified organisms and micro- organisms

*             Unregulated biological   materials

Infectious substance shipping regulations do not apply if the biological material to be shipped cannot cause disease. Substances that have a low probability of containing infectious substances such as water samples or food are not subject to these requirements.

 

Infectious Substances

Infectious substances are those substances known to contain, or reasonably expected to contain pathogens. Pathogens are defined as microorganisms or recombinant microorganisms that are known or reasonably expected to cause infectious disease in humans or animals. However, they are not subject to the provisions of shipping if they are unlikely to cause human or animal disease. Infectious substances are subject to the regulations only if they are capable of spreading disease when exposure to them occurs.

Category A Infectious Substances

Category A infectious substances are capable of causing permanent disability, life threatening or fatal disease to humans or animals when exposure to them occurs. Category A infectious substances have two shipping names: “Infectious substances, affecting humans” (UN 2814) or “Infectious substances, affecting animals” (UN 2900).

Packaging

Category A infectious substances must be tripled packaged and compliant with IATA Packing Instruction 602 detailed in Figure 1. The maximum quantity of Category A infectious substance that can be shipped by air in one package is 4 L or 4 kg. The maximum allowable quantity on passenger aircraft is 50 ml or 50 g.

Labeling

The outer container of all Category A infectious substance packages must display the following on two opposite sides:

*             Sender’s name and address

*             Recipient’s name and address

*             Infectious substance label

*             Proper shipping name, UN number, and net quantity of infectious substance

*             Name and telephone number of person responsible for shipment

*             Cargo Aircraft Only label when shipping over 50 ml or 50 g

*             Class 9 label, including UN 1845, and net weight if packaged with dry ice

 

Category B Infectious Substances

Category B infectious substances are infectious but do not meet the criteria for Category

1. Category B infectious substances have the proper shipping name “Biological Substance, Category B” and the identification number UN 3373.

 Packaging

Category B infectious substances must be tripled packaged and compliant with IATA Packing Instruction 650. The maximum quantity for a primary receptacle is 500 ml or 500g and outer packaging must not contain more than 4 L or 4 kg.

Labeling

The outer container of all Category B infectious substance packages must display the following on two opposite sides:

*             Sender’s name and address

*             Recipient’s name and address

*             The words “Biological Substance, Category B”

*             UN 3373 label

*             Class 9 label, including UN 1845, and net weight if packaged with dry ice

Diagnostic Specimens

Any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposed, but excluding live infected animals.

Diagnostic specimens must be assigned to UN3373 unless the source patient or animal has or may have a serious human or animal disease which can be readily transmitted form one individual to another, directly or indirectly and for which effective treatment and preventable measures are not usually available in which case they must be assigned to UN2814 or UN 2900.

Packaging

Diagnostic and clinical specimens must be tripled packaged and compliant with IATA Packing Instruction 650 detailed in Figure 2. The maximum quantity for a primary receptacle is 500 ml or 500g and outer packaging must not contain more than 4 L or 4 kg.

Labeling

The outer container of all diagnostic/clinical specimen packages must display the following on two opposite sides:

*             Sender’s name and address

*             Recipient’s name and     address

*             The words “Biological Substance, Category B”

*            UN 3373 label

*             Class 9 label, including UN 1845, and net weight if packaged with dry ice

Biological Products

These are products derived from living organisms, that are manufactured and distributed

in accordance with the requirements of national governmental authorities which may have special licensing requirements, and are used either for prevention, treatment or diagnosis of disease in human or animals, or for development, experimental or investigational purposed related thereto. They include, but are not limited to, finished or unfinished products such as vaccines and diagnostic products.

Biological products transported for final packaging, distribution, or uses by medical professionals are not subject to shipping regulations. Biological products that do not meet these requirements must be assigned to UN 2814, UN 2900, or UN 3373 as appropriate.

Genetically Modified Organisms and Micro-organisms

These are microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. They are divided into the following categories:

1. Genetically modified microorganisms, which meet the definition of an infectious agent. they must be classified in division 6.2 and assigned un2814 or UN 2900.
2. Animals, which contain or are contaminated with genetically, modified microorganisms or organisms that meet the definition of an infectious substance. They must not be transported by air unless exempted by the States concerned.
3. Genetically modified organisms, which are known or suspected to be dangerous to humans, animals or the environment. They must not be transported by air unless exempted by the States concerned.
4. Except when authorized for unconditional use by the states of origin, transit and destination, genetically modified microorganisms which do not meet the definition of infectious substances but which are capable of altering animals, plants or microbiological substances in a way which isnot normally the result of natural reproduction must be classified in Class 9 and assigned to UN 3245.

Genetically modified organism and organisms which do not meet the definition of an infectious substance and which are not otherwise included under (a) to (d)

above are not subject to these regulations.

 Packaging

These materials must be packaged in the same manner as category A infectious substances except there are no testing requirements for the packaging. The packing instructions are IATA Packing Instruction 913. If this packaging cannot be purchased, use packages compliant with Packing Instruction 602.

The maximum allowable quantity per primary receptacle is 100 ml or 100 g. There is no maximum net quantity per package.

Labeling

The outer container of a genetically modified organism assigned to UN 3245 must have the following labels:

*             Sender’s name and address

*             Recipient’s name and address

*             Class 9 label

*             Genetically Modified micro-organisms, UN 3245

Packaging Biological Materials

Potentially hazardous biological materials must be packaged to withstand content

leakage, shocks, temperature changes, pressure changes, and other conditions that can occur during transport. When ordering, specify what category of materials you will be shipping: infectious substances, diagnostic specimens, dry ice, ice packs, etc. All biological materials must be tripled packaged.