PACKING AND SHIPPING OF BIOLOGICAL MATERIALS : SOME INSTRUCTIONS, LEGAL REQUIREMENTS AND INTERNATIONAL REGULATIONS

Christine Rohde, Dieter Claus and Khursheed A. Malik

DSM-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH
Mascheroder Weg 1B, 38124 Braunschweig. Germany
Fax : + 49 531 2616418

INTRODUCTION

International organizations such as the United Nations Committee of Experts on the Transport of Dangerous Goods, the Universal Postal Union (UPU), the International Air Transport Association (IATA), the International Civil Aviation Organization (ICAO) and the World Health Organization (WHO) have arranged regulations on the safe transportation of biological substances. Such internationally agreed regulations apply everywhere for shipping biological material overseas by mail, by air freight or other common carriers. However, various countries may have their own regulations governing the packaging and transport of biological material in domestic mail. Usually, biological materials like microbial cultures are shipped by mail which is cheaper and more convenient than air freight. Many countries prohibit the movement of biological substances through postal services. Such import and export restrictions for non-infectious perishable (NPBS) or infectious perishable biological substances (IPBS) by national postal services are published by the International Bureau of the UPU in Berne. A list of countries responding to such restrictions (admitting or not admitting) is given in Table 1.

The purpose of this publication is to describe the procedures of packaging and transport of biological materials according to the legal regulations and requirements of international and governmental (national) agencies involved in the shipment of biological specimens. For more details the readers are recommended to see Ref.6 and Ref.7.

DEFINITIONS

Non-infectious Perishable Biological Substances (NPBS) : According to UPU these are substances containing viable microorganisms which are known not causing any disease in animals or humans (all organisms of Risk Group I).

Infectious Substances (according to IATA) or Infectious Perishable Biological Substances (IPBS, according to UPU) or Etiological Agents : These are substances containing viable microorganisms of all kinds or their toxins suspected to cause disease in animals or humans (all organisms of Risk Groups 2-4).

Genetically modified organisms : An organisms the genetic material of which being altered in a way that does not occur naturally. According to IATA regulations there are two groups of genetically modified organisms : ‡T) meeting the definition of an infectious substance given above (these are classified as infectious substance), ‡U) not meeting the definition of an infectious substance (these are classified in Class 9 and assigned UN 3245), see Ref.1.

CLASSIFICATION OF MICROORGANISMS ON THE BASIS OF HAZARD

The Risk Groups :

Risk Group 1 (L1) : Biological agents unlikely to cause disease in humans or animals.

Risk Group 2 (L2) : Biological agents that may cause disease in humans or animals.

Risk Group 3 (L3) : Biological agents that may cause severe disease in humans or animals. Hazardous if spread into the environment. Prophylaxis and treatment mostly available.

Risk Group 4 (L4) : Biological agents that may cause severe disease in humans or animals. Contact and spread mmust be strictly avoided. No effective prophylaxis and treatment available. So far, only viruses belong to this group.

Human pathogens : Whereas the definitions of the Risk Groups 1-4 are internationally agreed, the classification of a species to a Risk Group may vary in different countries. The European Union has published a list of species classified in Risk Groups 2,3,4 (see Ref. 2). A permit from health authorities may be required for the export or import of organisms of Risk Groups 2,3,4.

Animal pathogens : An internationally agreed classification scheme does not exist. Import licences are required by various countries for some organisms.

Plant pathogens : Many countries require import permits for certain species, no international classification scheme exists. Data sheets on "Quarantine Pests for Europe" have been published by the Commonwealth Agricultural Bureau (CAB International) in association with the European and Mediterranean Plant Protection Organization (EPPO) in 1992 (see Ref. 3). The European Union has published a Commission Directive (see Ref.4).

Toxinogenic microorganisms : Import / export restrictions for different countries have to be observed in case of certain toxin producing bacteria or fungi.

INTERNATIONAL SHIPPING REGULATIONS

1. Postal Services

National post offices are internationally linked together through the UPU. UPU has published the UNIVERSAL POSTAL CONVENTION (updated in 1984) regulating the transport of NPBS & IPBS by mail. According to Article 21 all kinds of perishable biological substances should be sent as registered letter by air mail. Therefore airlines not only act as freight carriers but also as postal carriers. Rules relating to the packing of biological specimens are given in Articles 118 (Packing), 119 (IPBS) and 120 (NPBS).

For shipping of refrigerated biological materials air freight is to be preferred. (Freeze-) dried non-infectious substances may not be considered to be perishable and may be shipped to any country by mail (observe possible restrictions). Handle all infectious non-perishable substances like IPBS.

Requirements for packing of NPBS and IPBS : (Fig.1)

-An itemized list of contents between the secondary packaging and the outer packaging.

-The address label marked as "LETTRE" .

-The green cmustoms declaration slip (Fig.1A) for cmustoms clearance (available form post office). Enter type and number of material and their value. Declare "No commercial value" only in case of free exchange.

-Airlines request postal offices to hand over IPBS in conformity with the IATA regulations. Therefore air mail containing IPBS mmust be accompanied by a Shipper's Declaration for Dangerous Goods in duplicate (available from IATA Tape Service and Dangerous Goods Services, 2000 Peel Street, Montreal, Canada H3A 2R4 or from national companies) in a plastic envelope on outer packaging. For NPBS a violet label (Fig.1B) "Perishable Biological Substances" and for IPBS a standardized diamond-shaped label (Fig.1C) "Infectious Substances" (10cm x10cm or 5cm x 5cm, black on white), both are available from national companies or from IATA Tape Service.

Fig.1. Packing system for NPBS and IPBS with the required labels and declaration documents

2. Air Freight

Airlines are linked together through IATA. The IATA Dangerous Goods Regulations specify the transport of infectious substances. Infectious substances as well as other dangerous goods are not allowed to be carried in or as passengers checked or carry-on baggage. Infectious substances, provided a Shipper's Declaration is accompanying the shipment, may be accepted in mail for air carriage subject to the provisions of the national Postal Authorities. Sippers of infectious substances mmust comply with any applicable regulations of the States of origin, transit and destination. The shipper of infectious material mmust ensure the material is properly classified, packed, marked and labelled and mmust have made advance arrangements with the consignee and received confirmation that the material may be legally imported without delay in delivery. In case a country does not accept non-infectious, perishable biological substances in the (air) mail (see countries listed above), shipment can be made by air freight. Shipment of NPBS is not regulated by IATA. Instead of the "Shipper's Declaration for Dangerous Goods" the IATA Form "Shipper's Declaration for Articles not regulated as Dangerous Goods" should be used (available from IATA Tape Services, see above). It is recommended to use packages as used for air freight of infectious substances. Genetically modified infectious substances mmust be treated like other infectious substances (see Definitions). Genetically modified, non-infectious substances have to be sent according to IATA Packing Instruction 913 using the respective label.

Articles and substances which are considered by IATA as dangerous goods have been included in the List of Dangerous Goods the information of which is given below :

1. For transport of infectious substances affecting humans the following documents are required (see Ref. 1) : UN or ID no.: 2814, Class or Division : 6.2, Hazard Label : "Infectious Substance", Packing Instruction : 602, max. per package : 50ml or 50g.

2. For transport of infectious substances affecting animals the following documents are required (see Ref. 1) : UN or ID no.: 2900, Class or Division : 6.2, Hazard Label : "Infectious Substance", Packing Instruction : 602, max. per package : 50ml or 50g.

3. For transport of genetically modified microorganisms the following documents are required (see Ref. 1) : UN or ID no.: 3245, Class or Division : 9, Hazard Label (Fig. 1D) : Miscellaneous, Packing Instruction: 913, max. net quantity : 100ml or 100g.

In the Dangerous Goods List the following information is included :

1. UN or ID : Serial or identification number assigned to specific substances or articles under the UN classification system.

2. Name and Description : Proper shipping names of dangerous goods, scientific name required in brackets

3. Class or Division : Class or Division number assigned to the substance

4. Hazard Label (s) : Description of the hazard label (s) to be applied to the outside of each package

5. Packing Group : Packing group numbers have been assigned to certain dangerous goods

6. Packing Instructions : Refers to the relevant packing instructions for Passenger or Cargo Aircraft

7. Maximum Net Quantity : Maximum weight or volume of the substance per package

8. Special Provisions: A 47 (Ref.1) : Infectious genetically modified substances mmust be transported as UN 2814 or UN 2900. Other genetically modified microorganisms, not meeting the definition of infectious substances but capable of altering animals, plants or microorganisms in a way not normally the result of natural reproduction must be assigned to this entry.

STEP BY STEP INSTRUCTIONS FOR PACKING AND SHIPPING OF BIOLOGICAL MATERIALS (Addresses of suppliers of suitable packaging systems are given at the end of this publication).

1. Supply cultures only in conformity with the applicable regulations. Obtain a permit or export license (such as from national health or agricultural authorities or from the department of commerce) if needed to distribute the ordered material outside the sender's country.

2. For the import of all kinds of biological materials an import permit mmust be submitted for certain countries (see Tab.1). Comply to the import or quarantine restrictions of the cmustomer's country, if any. For genetically modified organisms see the "Definitions".

3. If the order includes any infectious substances (Risk Group 2,3,4), continue with step 4. If not, go to step 6.

4. Confirm if the cmustomer is qualified to handle the ordered cultures. Cmustomers may have to prove by a written statement that they are entitled to receive and to handle infectious biological materials, especially for Risk Group 3,4 organisms (in some countries also for Risk Group 2). It may be the shipper's obligation to ensure compliance with national law or regulations.

5. Confirm if the postal administration of the cmustomer's country accepts infectious substances in the mail. If yes, the order can be sent by registered air mail letter. If not, the order might be sent by air freight only.

6. If non-infectious perishable cultures (agar, liquid) are to be included in the package, continue with step 7. If not, go to step 8.

7. If the postal administration of the cmustomer's country accepts non-infectious perishable materials (NPBS) in the mail, the order can be sent by registered air mail letter. If not, the order should be sent by air freight only.

8. If the shipment contains only non-infectious and non-perishable (dried or freeze-dried) biological substances, the shipment can be sent by (non-registered) air mail.

9. Consider carefully the "Notes".

NOTES :

1. For shipping of biological materials use only watertight "primary containers" such as glass ampoules, heat sealed, glass tubes or bottles, screw capped, plastic tubes or bottles, screw capped. Caps should be reinforced with waterproof tape. Loosely capped tubes or petri dish cultures should not be sent in the post. If improperly sealed, liquid cultures media may disappear during air transport because of reduced pressure.

2. Wrap all primary containers individually. Use absorbent material in case cultures are on agar on in liquid medium. The material mmust be able to take the entire liquid.

3. Transfer one or more primary containers into a watertight secondary container. The secondary container should be a screw-capped metal can or plastic container. Primary culture containers are surrounded by further absorbent wadding. Any movement within the secondary container should be avoided. It mmust be ensured that primary containers do not rub and thus break.

4. Screw the cap of the secondary container tightly and seal cap with waterproof tape.

5. Transfer secondary container(s) into an outer container. Enclose itemized list of contents. One or more secondary containers are packed firmly together in a larger metal can or a (round or rectangular) strong card board container. The outer package mmust be at least 100 mm in the smallest overall external dimension. The packing note and any handling instructions mmust be enclosed between the secondary packaging and the outer container. Seal the outer container with adhesive tape.

6. Add the address and all necessary information to the outer container. For all air mail shipments of infectious substances two copies of the IATA SHIPPER'S DECLARATION FOR DANGEROUS GOODS mmust be attached in a plastic envelope to the outside of the outer container for inspection by the flight carrier.

Suppliers of Commercially available certified packaging systems for infectious substances :

1. Environmental Packaging Systems Ltd., One Research Drive, Dartmouth, NS B2Y 4M9, Canada. Fax: ++1 902 466 6889

2. Air Sea Containers, 318 New Chester Road, Bikenhead, Merseyside L42 1LE, UK. Fax : ++44 51 644 9268

3. Air Sea Containers Inc., 2749 N.W. 82nd Avenue, Miami, FL 33122, USA. Fax : ++1 305 599 1668

4. HAZPAK Pty. Ltd., P.O. Box 4000, Dandenong South, Victoria 3164, Amustralia. Fax : ++61 3 706 7593

Table 1 : List of countries with Import and Export Restrictions for NPBS or IPBS by National Postal Services (see Ref.5) (Countries admitting receipt and despatch of NPBS and IPBS are not listed here).

1. Admitting receipt and despatch of NPBS only : Argentina, Belgium, Benin, Birma, Chad, China People's Rep., El Salvador, Futuna Islands, Hong Kong, Indonesia, Isle of Man Israel, Kuwait, Libyan Jamahiriya, Lithuania, Luxembourg, Macao, Mongolian People's Rep., New Caledonia, Pakistan, Panama, Peru, Rwanda, Saudi Arabia, Spain, Tanzania, Tobago, Trinidad, Vanuata, Wallis Islands, Zimbabwe.

2. Admitting receipt and despatch of IPBS (unknown for NPBS) : Cayman Islands, Dominica, Dominican Rep., Jamaica, Kampuchea, Democratic, Lebanon, Liberia, Namibia, Saint Vincent and the Grenadines, Togo, Uganda, Ukraine.

3. Not admitting receipt and despatch of IPBS (unknown for NPBS) : Djibouti, Guinea-Bissau, Korea Dem. People's Rep., Montserrat, Nepal, Tonga, Viet Nam.

4. Not admitting receipt and despatch of NPBS (unknown for IPBS) : Comoros.

5. Not admitting receipt and despatch of NPBS, but admitting receipt and despatch of IPBS : Botswana, Christmas Islands, Zaire.

6. Admitting receipt of NPBS and IPBS, but not admitting despatch of NPBS and IPBS : Ascension, Belize, Seychelles, Sierra Leone, St. Helena.

7. Admitting receipt and despatch of NPBS and receipt of IPBS only : Croatia, Malaysia, Saint Lucia, Tuvalu.

8. Admitting receipt of NPBS only : Bhutan, Cape Verde, Latvia.

9. Unknown status of admitment : Albania, Equatorial Guinea, Myanmar, Nicaragua, Paraguay, San Marino, Sao Tomé, Princiope.

10. With unknown admitment of receipt and despatch of NPBS, admitting receipt of IPBS : Gambia, Mauritania, Virgin Islands.

11. Admitting despatch of IPBS (other admitments unknown) : Guatemala.

12. Not admitting receipt and desatch of NPBS or IPBS : Afghanistan, Algeria, Angola, Anguilla, Aruba, Bahamas, Bahrain, Bangladesh, Bermuda, Bolivia, Brazil, Burkina Faso, Burundi, Canada, Caicos Islands, Central African Rep., Chile, Colombia, Cook Islands, Costa Rica, Côte d'Ivoire, Cuba, Ecuador, Egypt, Fiji, French Polynesia, French Southern & Antarctic Territories, Gabon, Ghana, Gibraltar, Greece, Guinea, Guyana, Haiti, Honduras, Iran, Iraq, Jordan, Lao People's Dem. Rep., Lesotho, Maldives, Mauritius, Mexico, Moldavia, Mozambique, Nauru, Netherlands Antilles, Niger, Nigeria, Oman, Papua New Guinea, Philippines, Pitcairn Islands, Poland, Qatar, Romania, Somalia, Sudan, Swaziland, Syrian Arab. Rep., Tristan da Cunha, Tunisia, Turkey, Turks Islands, United Arab Emirates, Uruguay, Vatican, Venezuela, Western Samoa, Yemen.

13. Countries with various other restrictions: Amustralia : Subject to certain conditions and prior approval; Czech. Rep. & Slovakia: EMS (Express Mail Service) items only; Finland: By special agreement (regarding IPBS); Germany : Perishable biological substances which contain neither living pathogenic microorganisms or living pathogenic viruses are admitted only as "letter". Perishable biological substances consisting of living pathogenic viruses are admitted only as "air parcel" and those consisting of AIDS viruses mmust in addition be sent a insured parcels; Grenada: For admittance unknown status, despatch of IPBS allowed; Mali: Only despatch to CAPTEAO countries (Conference of the Postal and Telecommunications Administrations of the States of West Africa) Benin, Burkina Faso, Ivory Coast, Mali, Mauritania, Niger, Senegal; Netherlands: Only after bilateral agreement; Thailand : By reciprocal agreement.

REFERENCES:

1. Dangerous Goods Regulations. IATA, International Air Transport Association. 36th edition 1995, Montreal-Geneva.

2. Council Directive 93/88/EEC of 12 October 1993, amending Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work

3. CABI and EPPO: Quarantine Pests for Europe : Data sheets on quarantine pests for the European Communities and for the European and Mediterranean Plant Protection Organization. 1992. ISBN 0 85198 825 3.

4. Commission Directive 92/103/EEC of 1 December 1992, amending Annexes I to IV to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread.

5. Compendium of Information (Convension). Intern. Bureau of the Universal Postal Union, Berne, 1 March 1994.

6. Claus, D., Rohde, C. (eds.) 1995. Shipping of Infectious, non-infectious and genetically modified microorganisms: International Regulations. ECCO Publication. Available at the DSM, 38124 Braunschweig, Germany.

7. Brown, E.M., Simione, F.P. (eds.) 1994. ATCC guide to packaging and shipping of biological materials. Available at the ATCC, Rockville, Maryland 20852-1776, USA. Telefax: + 1 301 770-2587

---

Published by : UNESCO / WFCC-Education Committee 1995