Transport of gmo’s and biological material

Transport of gmo’s and biological material

There are strict rules concerning the packaging and the transportation of Biological material. Road transportation of infectious material and genetically modified organisms (gmo) must be done by packaging the material according to legal rules included in the ADR, the European agreement concerning international transport of goods by road. Transport by air must be in accordance with the rules of the International Air Transport Association (IATA).

This procedure describes the rules in relation to the internal / external transport of biological agents and GMO material. The order / receipt of GMO material is always after consultation with the principal investigator (VM) of the project. The VM checks whether the material is granted under the license. In case of deliveries, the VM ensured that the recipient has an appropriate license for contained use.

Transportation of waste which might be contaminated with gmo’s or pathogenenic micro-organisms is, described in the waste management regulation University of Twente.

1

Internal transportation

Non-infectious genetically modified organisms (gmo) (ML-I) are packed in a closed, unbreakable leak proof package with inscription GMO. The packaging can be done in a closable box which can be disinfected.

Infectious material (gmo’s from ML-II and empathogenes and microorganisms from risk class 2 or higher) must be transported in a closed, leak proof package, supplied with a Biohazard symbol. This can be a box which can be closed and disinfected.

2

External transportation

For external transportation and sending of biological material a triple containment is always necessary, it must consist of:

1 Hermetically sealed, leak proof, unbreakable first container (Eppendorf tube, bottle etc.) in which the contents and the obligatory containment level is mentioned.

2 Hermetically sealed, leak proof, unbreakable second container, in which the first container is surrounded by sufficient absorbing material for the whole contents

3 The outside of the packaging of the triple containment must be a sturdy, f.i. a firm box.

In case the package contains (dry) ice or another cooling medium, then a suitable package must be used.

For transport of the various samples by road specific packing and labeling are a must. These are stated in the table. Next to that the following regulations must be applied:

1 When transporting liquids the outside needs to have the following orientation sticker on oppposite sides of the package. Color black or red on white background.

2 If the material is sent on dry ice addional specifications are required:

Maximum total weight of 25 kg per submission

Minimum size of box: 25x25x25

When transporting by road the package must be labelled with an extra label: UN 1845 on which the amoutn of dry ice is reported. When transporting by air the label for class 9 needs to be administered.

UN1845

The amount of dry ice must be sufficient for at least 3 days (10KG). In all cases the box with dry ice needs to be padded with styrofoam or another dry filling material.

Packaging must be such that pressure build up is not possible inside the package. The primary and secondary package must be able to withstand low temperatures.

General

Every transport by road or air must be equipped with a freight letter in which is stated:

·

Place and date of drawn up;

·

Name and adress of sender;

·

Name and adress of carrier;

·

Name and adress of adressee;

·

Place and date of receipt of goods and the palce ment for deliverance of goods;

·

Correct transportname of amterial: see colum 4 of the table;

·

Gross weight or the amount of goods.

For shipment of GMOs / biological material, the compony Biologistic Services (http://biologistic.nl/) can be used. Compliance with the requirements regarding appropriate packaging, labels and shipping documents are secured in this way.

Table: Overview of the packaging and labelling demands for sending biological material

Biological material

Packaging material

Labeling:

Documents besides the freight letter and naming

Humane diagnostic and research material, not contaminated with pathogens class 3 or 4

(Cat B)*)

Triple containment of which the outside is sturdy

UN3373

Biological Substance B

Animal diagnostic and research material, not contaminated with pathogens of risk class 3 or 4

(Cat B)*)

Triple containment of which the outside is sturdy

UN3373

For Research and diagnostics only black and white letters

Trade document if the submission is within the EU (see work instruction and safe working with animal material) For outside EU: country specific demands.

Non infectious GMO’s

Triple containment of which the outside is sturdy

UN3245_label

ADR 9

On the freight letter the indication:

”Genetically modified organisms”

Infectious material, pathogenic for man and animal of risk class 2 or higher and classified as Cat. A*)

UN approved sturdy packaging that also go for 2814

Biological Substance 6

+

UN 2814

On the freight letter the indication: infectious substance affecting humans

Infectious material, pathogenic for animals

(Cat A)*)

UN approved sturdy packaging that also go for 2814

Biological Substance 6

+ UN 2900 label

Freight letter with indication:

Infectious substance affecting animals

Remark: in case of combined air- and road transport follow the demands of airtravel.

*) Definition category A or B:

Category A is an infectious substance which is carried in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. Indicatieve examples of substances that meet these criteria are given in a table in the ADR-document (ADR 2.2.62.1.4.1).

Infectious substances meeting these criteria which cause disease in humans or both in humans and animals shall be assigned tot UN No. 2814. Infectious substances meeting these criteria which cause disease only in animals shall be assigned to UN No. 2900.

There is an exception for three microorganism on the Category A list. When the cultures of Mycobacterium tuberculosis, Shigella dysenteria type 1 en Escherichia coli verotoxigen are intended for diagnostic or clinical purpose, they may be classified as infectious substances of Category B.

If there is doubt as tot whether or not a substance meets the criteria it shall be included in Category A.

Category B substance is an infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B shall be assigned tot UN No. 3373. An example is human materials (patient specimens) used for purposes such as research and diagnosis activities (not containing category A organisms).