European Biological Resource Centres Network Information Resource

International Regulations for Packaging and Shipping of Microorganisms


This revised EBRCN information resource is based on the UN Model Regulations for the Transport of Dangerous Goods, 16th edition 2009, New York and Geneva, United Nations. A basic information document is also the WHO publication “Guidance on regulations for the Transport of Infectious Substances 2007-2008, WHO/CDS/EPR/2007.2

Introduction Definitions Checklist for shippers Example cases International organizations References


Introduction

Before a consignment containing microorganisms is offered for transport, the decision as to whether or not it includes an infectious substance is crucial, as is the destination of the consignment. In order to select the correct type of packaging and the correct mode of transport/carrier (postal mail or courier), shippers of biological material must have a sound knowledge of all relevant packaging and transport regulations. They must have recurrent training, according to the latest IATA Dangerous Goods Regulations (DGR, chapter 1.5), if infectious substances are transported by air. Air transport plays the dominant role in setting requirements when living biological materials are transported over long distances. The Dangerous Goods Regulations for air transport are user-friendly to ensure the responsible shipper is easily able to conform to international law. It is also important that the respective national or regional regulations for road transport are observed (e.g. ADR in Europe).


Infectious substances are by definition dangerous goods Class 6, Division 6.2, and the Dangerous Goods Regulations for transport fully apply so that they don’t present a hazard to those involved in the transportation chain, to animals or the environment. This does not usually apply to microorganisms classified in Risk Group 1. For the latter, other regulations for packaging and transport have to be observed. They can usually be transported by postal mail services when packed in accordance with the respective packaging regulations of the Universal Postal Union (UPU). Postal services differentiate between perishable (active) and non-perishable (dried, freeze-dried) biological substances. Shippers should be aware that any biological material is excluded from transport in postal parcels; UPU permits letter mail only (UPU Letter Post Manual Articles 16 and RL 129). Registered letter mail is generally recommended because of individual treatment and the potential for tracking. Note that postal mail systems exclude any dangerous goods, however, infectious substances classified in shipping Category B might be sent by national postal mail (on the road). The deregulated transport requirements for Category B cultures have become much less problematic. However, there are still strict requirements on shipper’s responsibility and packaging quality, on correct labelling and marking. For shippers of UN 3373 (see below) face-to-face training courses are not obligatory in all countries, this depends on the decision by the respective national aviation authority, but having knowledge is obligatory for all shippers. The relevant international bodies are currently discussing the future of harmonised training requirements.


Although the shipping Categories A and B have replaced the application of the Risk Group definitions, the existing Risk Group allocation of an organism still helps the sender classify the material for transport. The requirements for UN 3373 apply to the majority of Risk Group 2 microorganisms as the definition of this Risk Group conforms with the definition of Category B (see below): such cultures can be shipped under the same requirements as diagnostic specimens, using the same UN number 3373 and Packing Instruction PI 650 packaging. Neither a Shipper’s Declaration for dangerous goods form, a similar form for road transport nor a transport emergency card are required. UN packaging meeting the PI 602 requirements is permitted for UN 3373 and can be recommended as they withstand air vibrations, changes in temperature or high pressure during air transport. They have passed stricter tests compared to PI 650 packaging.


The transportation chain begins in the packaging department of an institute, ends in the recipients’ laboratory and may include transport by hand, postal or courier transport, this may be within countries or across borders and continents. Only a correctly labelled and documented shipment reaches its destination quickly and safely, therefore the courier services require their customers to fulfil the regulations. It is the responsibility of all laboratories supplying infectious substances to nominate a person who receives recurrent training and who takes responsibility for signing the shipping documents (in case of Category A shipments). The latter can ONLY be signed by a trained person (IATA DGR chapter 1.5, Training Requirements) who is thoroughly conversant with the regulations including the applicability, limitations (state or operator variations), classification, identification, packing, marking and labelling and documentation. If substances meeting the definition of Category A, UN 2814 or UN 2900 respectively are shipped, an experienced courier should be chosen, advance arrangements with courier and consignee are necessary. Category A meets the definition of “high consequence dangerous goods” and requires a transport security plan (IATA DGR 1.6.3).

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The most important definitions acc. to IATA DGR 50th ed. 2009

3.6.2.2.1 Infectious substances must be classified in Division 6.2 and assigned to UN 2814, UN 2900 or UN 3373, as appropriate.

3.6.2.2.2 Infectious substances are divided into the following categories:

3.6.2.2.2.1 Category A: An infectious substance which is transported 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. Indicative examples of substances that meet these criteria are given in Table 3.6.D (p. 112, IATA DGR 49th ed.). Note: this Table is not exhaustive. It contains microorganisms that, more or less, meet the definitions of the Risk Groups 3 and 4.

3.6.2.2.2.2 Category B: An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373.

Note: The Proper Shipping Name (PSN) of UN 3373 is “Biological substance, Category B”.


3.6.2.4 Genetically Modified Microorganisms and Organisms

3.6.2.2.4.1 Genetically Modified Microorganisms not meeting the definition of an infectious substance must be classified according to Subsection 3.9.


3.9.1.2 Genetically Modified Microorganisms (GMMOs) and Genetically Modified Organisms (GMOs) are organisms (microorganisms) in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally.


3.9.2.5.1 GMMOs and GMOs which do not meet the definition of infectious substances but which are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction. They must be assigned to UN 3245.


The Proper Shipping Name

The majority of the Risk Group 2 organisms can be sent under UN 3373 with the unique proper shipping name “Biological substance, Category B”. The use of the former shipping names “Diagnostic specimens” and “Clinical specimens” is no longer permitted. The PSN has to be printed in letters at least 6 mm high and must be marked on the outer package adjacent to the diamond-shaped label UN 3373.


Packing Instructions PI 650 and PI 602

All responsible shippers are asked to be conversant with both of these Packing Instructions. IATA PI 650 describes a UN-certified packaging system with less strength and usually smaller dimensions than IATA PI 602. See recommendations in this text. UN packaging fulfilling PI 602 requirements have to be used for Category A. They can also be used for Category B infectious substances, but there is no legal need to use this strong packaging for Category B.


Before dispatch of cultures

The sender of a microorganism must be sure that the receiver is authorised to work with it and has adequate facilities:

  1. Do NOT supply to private persons

  2. Do NOT supply to new customers/unknown recipients who have not specified their institution

  3. Only supply infectious substances to recipients who have the appropriate laboratory safety level (containment) which corresponds to the Risk Group of the organism

  4. Only supply animal or plant pathogens or genetically modified organisms to recipients having an appropriate laboratory and the relevant permits for work


When shipping outside the country, the sender must also be sure that the microorganism does not fall under export restrictions such as the Biological and Toxin Weapons Convention, Dual-use restrictions and other national legislation (relevant national Authorities are the national Export Office, Department of Commerce or the Foreign Office) and that, if applicable, quarantine requirements are fulfilled by the receiver and import permits (from Health Authorities) are ready to be shipped together with the organism. Please also see the respective EBRCN Information Resource documents for further information.


It is important for culture collections and all institutions shipping biological materials to

  1. establish a well-organised shipping department with trained staff

  2. have access to the latest IATA Dangerous Goods Regulations, to the latest regulations for road transport of dangerous goods and to all further relevant information sources

  3. develop a step-by-step checklist (see below) specific for the institution

  4. establish a computerised system for filling in the shipping documents in order to have a reliable system to avoid mistakes and to document any dispatch

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Step-by-step checklist for shippers

The following short instructions may be helpful in the proper packing and shipping of biological materials.

International shipments


  1. Is a permit or export licence needed to distribute the ordered material outside the sender's country?

Only written orders should be accepted and in cases of regulated/listed organisms an end user certificate is recommended, if not required by law. If unclear, contact your national authority (the Department of Commerce, Export Office or Foreign Office).

  1. Are there any import or quarantine restrictions for the customer’s country?

Some countries require an import permit for certain microorganisms (the recipient should provide a copy of this permit and it should accompany the consignment).

  1. Does the order include any infectious substances (Risk Group 2 - 4 organisms)?

If YES, these are dangerous goods and therefore all packaging and shipping requirements must be adhered to e.g. ADR (road) in Europe or IATA (air) internationally. Continue with 4 and 5. If NO, see under 6.

  1. Is the recipient qualified and authorised to handle the ordered cultures?

Recipients of cultures must confirm by written statement that they are entitled to receive and handle infectious biological materials, especially those of Risk Group 3 and 4 organisms (in some countries this is also a requirement for Risk Group 2 organisms). Is an export license required for the recipient culture (national biosecurity may restrict distribution of some organisms, their derivatives or products).

  1. Do the National Postal Authorities concerned (sender's, transit and customer's countries) accept infectious substances in the mail (observe IATA DGR 2.4 and UPU restrictions)?

If YES, the order can be sent by mail (rarely permitted!). If NO, the order may be sent by (air) freight only. Category A infectious substances (UN 2814 or UN 2900, respectively) are excluded from any postal mail transport. Category B infectious substances (UN 3373) may be sent by national postal systems on the road (observe packaging sizes PI 650 and PI 602).

  1. Are non-infectious perishable cultures (agar or liquid “active cultures”) included in the package?

If YES, continue with 7. If NO, see under 8.

  1. Do the National Postal Authorities concerned accept non-infectious perishable biological substances in the mail?

If YES, the order can be sent by registered airmail letter according to the relevant UPU packing requirements (see EXAMPLE cases below). If NO, the order might be sent by (air) freight only.

  1. Does the shipment contain only non-infectious and non-perishable (freeze-dried) biological substances?

If YES, the shipment can be sent by mail according to the relevant UPU packing requirements, preferably registered mail (see EXAMPLE cases below).


National shipments


  1. Does the order include any infectious substances (Risk Group 2 - 4 organisms)?

If YES, these are dangerous goods and all packaging and shipping requirements must be adhered to e.g. ADR in Europe (road) or specific national requirements.

  1. Is the recipient qualified to handle the ordered cultures?

Recipients must confirm by written statement that they are entitled to receive and handle infectious biological materials and/or they are obliged to send a copy of the respective working permit.

  1. Does the National Postal Authority accept infectious substances in the mail (observe IATA DGR 2.4 if applicable and UPU restrictions)?

If YES (rarely permitted!), the order can be sent by mail if the required packaging is in conformity with the respective national postal requirements. If NO, the order may be sent by courier only.

  1. Are non-infectious perishable cultures (agar or liquid “active cultures”) included in the package?

If YES, continue with 5. If NO, see under 6.

  1. Does the National Postal Authority accept non-infectious perishable biological substances in the mail?

If YES, the order can be sent by registered letter mail according to the relevant UPU packing requirements (see EXAMPLE cases below). If NO, the order might be sent by courier only.

  1. Does the shipment contain only non- infectious and non-perishable (dried or freeze dried) biological substances?

If YES, the shipment can be sent by (non-registered) mail according to the relevant UPU packing requirements (see EXAMPLE cases below).

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Example cases

Case A

The organism is non-infectious, not genetically engineered (does not fall under UN 3245, see Case D) and its distribution is not restricted under law >> May be sent nationally or internationally by postal letter mail, dependent on the regulations of the Postal Administrations of sender’s, transit and receiver’s countries. >> If permitted by Postal Administrations, the microorganism can be shipped by (registered) air mail letter according to UPU Articles 16 and RL129 requirements having a minimum strength of a triple packaging. There is no accepted packaging with less strength than PI 650. >> If not permitted by Postal Administrations, freight (courier service) must be used.


Case B

The organism is infectious but if exposure to it occurs it is not capable of causing permanent disability, life-threatening or fatal disease to humans or animals and does not meet the definition of Category A. It meets the definition of Category B, UN 3373 (the majority of Risk Group 2). >> Such organisms including laboratory cultures are dangerous goods of Class 6, Division 6.2 and can be sent according to PI 650, IATA DGR. A Shipper’s Declaration for Dangerous Goods is not required. The Proper Shipping Name is “Biological Substance, Category B”. Shipment by airmail is usually prohibited; some national postal services may permit intra-national transport on the road.


Case C

The organism is an infectious substance, affecting humans (UN 2814) classified in Risk Group 3 or 4 and/or the definition of Category A applies or it is affecting animals (UN 2900) meeting the Category A definition >> Such an organism is to be shipped as Class 6.2 dangerous good by freight, any postal mail is prohibited (IATA DGR 2.4). When shipping infectious substances of Category A, independently of the net weight, the UN Model Regulations apply for all modes of transport requiring a UN certified combination packaging system according to IATA Packing Instruction 602. The shipper is a trained person and is responsible for the consignment including all documents (IATA DGR 1.5).


Choose experienced courier services and clarify ALL steps before offering the consignment to the courier (destination manageable? Door-to-door? or door-to-airport delivery?). Make advance arrangements with the consignee (IATA DGR 8.1.6.11.4). Observe the IATA DGR Limitations chapter. Transport of these cultures is usually individual.


Case D

The organism is genetically engineered (GEM/GMO). The IATA DGR and other transport regulations distinguish between 2 kinds of GEMs: an infectious substance that is genetically engineered has to be shipped as >> UN 2814, UN 2900 (both Category A) or UN 3373 (Category B) respectively (for the latter see Case B). Animals containing or being contaminated with GEMs or infectious substances, must not be transported by air unless exempted under IATA DGR 2.6.1. GEMs that are not infectious substances but capable of altering animals, plants or microorganisms in a way which is not normally the result of natural reproduction must be classified in >> Class 9 (Miscellaneous Dangerous Goods) and assigned to UN 3245. >> Note: IATA Packing Instruction 913 applies requiring the strong quality of PI 602 packaging; Class 9 label required (black and white stripes). A Shipper’s Declaration for dangerous goods form is required.


Case E

Carbon dioxide, solid, dry ice, is used for shipping an organism. >> Dry ice is classified as dangerous goods (Class 9, UN 1845) and has to be packed according to IATA Packing Instruction 904. Packaging systems for shipping UN 2814/UN 2900 or UN 3373 infectious substances together with dry ice are commercially available. Such packaging systems fulfil both packing requirements, for infectious substances and for dry ice and carry both dangerous goods labels and specification markings.


Some general hints for safe packaging

Petri dishes as primary receptacles should not, if possible, be used for transport.

Screw caps, glass material and seals, used for the purpose of primary receptacle, should be of good quality so that leakage is avoided during transport.

For infectious substances, only industrially available certified UN packaging systems are permitted, no other self-made combinations.

When packaging is being re-used, it must not have any signs of damage or previous leakage.


Associated example materials as appropriate

Labels as required (if not directly printed on outer packaging surface)

Shipper’s Declaration for Dangerous Goods form (for UN 2814, UN 2900, UN 3245)

Documents such as quarantine import permits and working permits if applicable

Information on categorisation of hazard group

Information sources especially on handling and safety, and contact persons

List of contents in the consignment

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International Organizations

IATA: the International Air Transport Association annually updates the Dangerous Goods Regulations (DGR), the legally binding basis for shippers and carriers of dangerous goods for air transport.

ICAO: the International Civil Aviation Organization Council uses the UN Model Regulations as the basis for the Technical Instructions for the Safe Transport of Dangerous Goods by Air (updated every two years).

UN: the United Nations Committee of Experts on the Transport of Dangerous Goods publish the Recommendations on the Transport of Dangerous Goods (“Orange Book”), being the basis = “Model Regulations” for international transport regulations for dangerous goods for all carriers (air, road, rail, waterways).

UPU: the Universal Postal Union publishes the International Postal Convention through the Letter Post Compendium (constantly updated).

WHO: the World Health Organization defines the Risk Groups scheme for classification of biological substances and has published the “Laboratory Biosafety Manual (WHO/CDS/CSR/LYO/2004.11)”, the “Guidance on Regulations for the Transport of Infectious Substances” (WHO/CDS/EPR/2007.2) and the “Biorisk Management Laboratory Biosecurity Guidance” (WHO/CDS/EPR/2006.6).

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Useful References

* “Orange Book”: UN Model Regulations on the Transport of Dangerous Goods, UN, New York, 16th ed.

* Technical Instructions for the Safe Transport of Dangerous Goods by Air. Doc 9284-AN/905. Council of ICAO, International Civil Aviation Organization

* IATA-International Air Transport Association (2009) Dangerous Goods Regulations. 50th Ed.

Montreal, Geneva, ISBN 978-92-9229-035-1

* World Health Organization (2004) Laboratory Biosafety Manual, 3rd ed. World Health Organization, Geneva, ISBN 92- 4-154650 6

* World Health Organization (2007) Guidance on Regulations for the Transport of Infectious

Substances, WHO/CDS/EPR/2007.2, World Health Organization, Geneva

* European Parliament (2000) Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work. OJ No. L262, pp. 21-45 of 18.09.2000
* ADR Accord européen relatif au transport international des marchandises dangereuses par route. English version (2009). UN Economic Commission for Europe (UNECE)

* Best Practice Guidelines for Biological Resource Centres. Paris: OECD (published under BIO(2007)9FINAL)

* CEN Laboratory Biorisk Management Standard, Document CWA 15793:2008, European Committee for Standardization, Brussels (2008)

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Edited by:

Dr Christine Rohde, Plasmids, Phages, E. coli strains, DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Inhoffenstraße 7 B, 38124 Braunschweig, Germany. chr@dsmz.de

and

Dr David Smith, President World Federation for Culture Collections, CABI, Bakeham Lane, Egham, Surrey TW20 9TY, UK. d.smith@cabi.org


October 2009

 

European culture collections:
Biological diversity in safe hands