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| Quarantine and postal regulations/restrictions | ||
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The issues of shipping, packaging and quarantine are covered in a paper submitted to SGM Microbiology Today and also available on the SGM web site. This paper is available to provide relevant information on how the law affects culture collection work. Further information on:
Quarantine regulationsNationalClients in the UK who wish to obtain cultures of non-indigenous plant pathogens must first obtain a Ministry of Agriculture Fisheries and Food (MAFF) license. Under the terms of such a licence the shipper is required to see a copy of the Ministry permit before such strains can be supplied. Such licences are available in England and Wales from Ministry of Agriculture, Fisheries and Food, Room 340, Foss House, Kings Pool, 1-2 Peace Holme Green, York YO1 2PX and in Scotland from Plant Health Section, Agricultural Science Agency, East Craigs, Edinburgh EH12 8NJ. Non-indigenous tree pathogens can only be supplied if the customer holds a current permit issued by The Forestry Commission: Forestry Commission Headquarters, 231 Corsthorphine Road, Edinburgh EH12 7AP. All shipments to Canada and the USA for plant pathogens must be accompanied by import mailing labels, without which entry of cultures to these countries is refused. Applications for these labels, stating the names of the organisms and the purpose for which they are required, should be made for Canada to the Chief of the Plant Protection Division, Agriculture Canada Science Division, Science Service Building, Ottawa, Ontario, Canada K1AS 0C5 and for the USA to USDA Agricultural Research Service, Plant Protection & Quarantine, Room 764, 6505 Belcrest Road, Hyattsville, Maryland 20782, USA. The specified Animal pathogens order 1998 makes it an offence to possess or spread a listed animal pathogen (e.g. Brucella) within Great Britain without a licence. It is supplemented by the importation of Animal Pathogens Order 1980 which makes it an offence to import any animal pathogen, or potential or actual carrier, of an animal pathogen from an non-EC country, except under license. Both the supplier and recipient must hold the appropriate licences and undergo regular inspections from MAFF. Requests for strains must be refused where the requestor is unable to produce a copy of the appropriate licence. Such licences can be obtained in the UK from MAFF, AHDC Branch C, Tolworth (Toby Jug), Hook Rise, South Tolworth, Surbiton, Surrey KT6 7NF. RegionalInformation on the transport of plant pathogens throughout Europe can be obtained from the European and Mediterranean Plant Protection Organisation (EPPO), 1 rue le Nôtre, 75016 Paris, France. Postal Regulations and SafetyCountries have their own regulations governing the packaging and transport of biological material in their domestic mail. International Postal Regulations regarding the postage of human and animal pathogens are very strict on account of the safety hazard they present. There are several organisations that set regulations controlling the international transfer of such material. These include the International Air Transport Association (IATA), International Civil Aviation Organisation (ICAO), United Nations Committee of Experts on the Transport of Dangerous Goods, the Universal Postal Union (UPU) and the World Health Organisation (WHO). It is common place to send microorganisms by post, as this is more convenient and less expensive than airfreight. However, many countries prohibit the movement of biological substances through their postal services. The International Bureau of the UPU in Berne publishes all import and export restrictions for biological materials by national postal services. This information can also be found in the countries table published in the DSMZ Shipping of infectious, non-infectious and genetically modified biological materials. International Regulations brochure (Anon, 1998). The UK Post Office leaflet on "Infectious and non-infectious perishable biological substances in the overseas post" is available from The Post Office, Corporate Headquarters, 30 St James Square, London SW1 4PY. Tel: +44 171 490 2888; Fax: +44 181 681 9387 and provides the relevant information. Some countries will not accept human pathogens through the post for carriage overseas and this now includes the UK. A list, which changes from time to time, of these countries can also be obtained from the Post Office (also see Anon, 1998; Smith, 1996). It is probably not uncommon for cultures to be transported on the person. This is a practice that should be resisted. Such an act contravenes public transport regulations and where aircraft are concerned cultures are considered dangerous goods under the IATA regulations with the possibility of heavy penalties imposed on those caught. Carriage on the person also circumvents all the controls described herein, which are designed to promote safety. PackagingIATA Dangerous Goods Regulations (DGR) require that packaging used for the transport of hazard group 2, 3 or 4 must meet defined standards, IATA packing instruction 602 (class 6.2) (IATA, 1998). The DSMZ has collected all relevant guidelines for the shipping of microorganisms and updated it on a regular basis (Anon, 1998) this will also be available shortly on the DSMZ web-site . Packaging must meet EN 829 triple containment requirements for hazard group 1 organisms (Anon, 1996b). However, microorganisms that qualify as dangerous goods (class 6.2), must be sent in UN certified combination packages. These packages must be sent by airfreight or courier if the postal services of the countries through which it passes do not allow the organisms in their postal systems. IATA (1998) Sections 2.4.1, 2.4.2 and 2.4.2.1, the carriage of dangerous goods in the mail is forbidden by UPU except as permitted in sections 2.4.2.1 which states: Infectious substances, provided a "Shipper�s Declaration" accompanies the consignment, and Carbon dioxide, solid (dry ice) when used as a refrigerant for infectious substances. There are additional costs above the freight charges and package costs, if the carrier does not have its own fleet the package and documentation will require checking at the airport DGR Centre for which a fee is charged. There are currently very few private carriers that transport dangerous goods internationally. These private carriers do provide assistance in completing the Shipper�s Declaration forms. The shipper is exclusively responsible for the shipment, its correct packaging, documentation, marking and labelling. Ready to use, re-usable packaging can be obtained from Air Sea Containers Ltd. at www.air-sea.co.uk and SAF-T-Pak Inc. at www.saftpak.com and both can provide useful information for the shipper of dangerous goods. Regulations governing distribution of culturesThe IATA Dangerous Goods Regulations require that shippers of microorganisms of hazard groups 2, 3 or 4 must be trained by IATA certified and approved instructors. They also require shippers declaration forms, which should accompany the package in duplicate, and specified labels are used for organisms in transit by air (IATA, 1998). There are several other regulations that impose export restrictions on the distribution of microorganisms. These include control of distribution of agents that could be used in biological warfare, EU Council Regulation 3381/94/EEC on the control of export of dual-use goods (Official J. L 367, p1) and more generally countries are currently implementing Access Regulations to Genetic Resources under the Convention on Biological Diversity. It is critical that microbiologists are aware of and follow such legislation. Some cultures represent a health hazard, and for post and packaging purposes these are placed into four classes by the UPU as follows:
For further details see Packaging and Shipping of Biological Materials at ATCC (Alexander & Brandon, 1986) and Shipping of infectious, non-infectious and genetically modified biological materials, International Regulations DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Braunschweig, Germany (1998), IATA Dangerous Goods Regulations (IATA, 1998). In Europe non-pathogenic biological materials of risk group 1are transported by road packed according to EN 829 requirements. Transport by road is regulated by the Accord Européen relatif au transport international des merchandises dangereuses par routes (ADR). This clearly separates class 6.2 into two subclasses, A: highly infectious material (hazard groups 3 and 4) and B: other infectious material. These two groups A and B, have different packaging requirements. Therefore the UN specification containers for class 6.2 materials must be used for both subclasses. The EU have made an attempt to co-ordinate Member State laws on transport of dangerous goods by road with the �ADR-Directive� EC Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member states on the transport of dangerous goods by road (EC, 1994, 1996). The basis for all regulations governing the safe transport of goods for all carriers are laid down in the Orange Book, Recommendations on the Transport of Dangerous Goods (Anon, 1997d). Safety information provided to the recipient of microorganismsA safety data sheet must be despatched with an organism indicating which hazard group it belongs to and what containment and disposal procedures are necessary. In the UK, microorganisms are covered by the Control of Substances Hazardous to Health (COSHH) regulations (1988), HSW Act s.6(4)(c) and subject to the Approved Code of Practice for Biological Agents 1994 (Anon, 1994). Article 10 of the EU Directive 90/379/EEC regulates that manufacturers, importers, distributors and suppliers must provide safety data sheets in a prescribed format. A safety data sheet accompanying a microorganism must include:
Useful ReferencesAlexander, M.T. & Brandon, B.A. (eds.) (1986) Packaging and shipping of biological materials at ATCC. Rockville, Maryland: American Type Culture Collection. Anon (1993d) Royal Mail International (RMI) Service Guide. pp. 501-502. London: Royal Mail International. Anon (1994). Approved Code of Practice for Biological Agents 1994. Health and Safety Executive. Sudbury: HSE Books. Anon (1995) Categorisation of pathogens according to hazard and categories of containment. Fourth edition. Advisory Committee on Dangerous Pathogens (ACDP). London: HMSO. Anon (1996a). COSHH (General ACOP), Control of Carcinogenic substances, Biological Agents: Approved Codes of Practice (1996). London: HSE. Anon (1996b). European Standard EN 829:1996 E: Transport packages for medical and biological specimens, Requirements, tests. Brussels: CEN, European Committee for Standardisation. Anon (1997a). Safe Biotechnology, Classification of Biological Agents, Bacteria. Berufsgenossenschaft der chemischen Industrie. Merkblatt B 006e, 2/97, ZH 1/346. 69021 Heidelberg: Jedermann-Verlag. Anon (1997b). Safe Biotechnology, Classification of Biological Agents, Fungi. Berufsgenossenschaft der chemischen Industrie. Merkblatt B 007e, 2/97, ZH 1/346. 69021 Heidelberg: Jedermann-Verlag. Anon (1997d). Orange Book, Recommendations on the Transport of Dangerous Goods, Tests and Criteria. 10th edition. New York: UNO. Anon (1998) Shipping of infectious, non-infectious and genetically modified biological materials, International Regulations DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Braunschweig, Germany. Anon (1998b) Sichere Biotechnologie, Eingruppierung biologischer Agenzien: Bakterien. Merkblatt B006, 1998, Germany: BG Chemie. Davison, A. Brabandere, J. de., & Smith, D. (1998) Microbes, collections and the MOSAICC approach. Microbiology Australia 19(1), 36-37. de Hoog, G.S. (1996) Risk assessment of fungi reported from humans and animals. Mycoses 39, 407-417. EC Council Directive 77/93/EEC on protective measures against the introduction into the Member States of harmful organisms of plant or plant products. Official Journal of the European Communities 20, 20-54 (1977) EC Council Directive 94/55/EC on the approximation of the laws of Member States on the transport of dangerous goods by road. Official Journal of the European Communities L319, 7. EC (1996). Annexes of EC Council Directive 94/55/EC on the approximation of the laws of Member States on the transport of dangerous goods by road. Official Journal of the European Communities L275. L374 Volume 33, 31 December 1990. EEC Directives 90/679/EEC. Protection of workers from risks related to biological agents IATA - International Air Transport Association(1998) Dangerous Goods Regulations. 39th edition. Montreal; Geneva: IATA. L117 Volume 33, 8 May 1990. EEC Directives 90/219/EEC. Contained use of genetically modified microorganisms (GMO's) EEC Directives 90/220/EEC. Release of GMO's Smith, D. (ed.) (1996). Committee on postal, quarantine and safety regulations report 1996, Postal, quarantine and safety regulations: status and concerns. Braunschweig, Germany: World Federation for Culture Collections. pp39. Smith, D. & Onions A.H.S. (1994). The Preservation and Maintenance of Living Fungi. Second edition. IMI Technical Handbooks No. 2, pp 122. Wallingford, UK: CAB INTERNATIONAL. Substances for use at work: the provision of information (1985). HSE booklet HS(G)27. London: HMSO. UPU (1998). Universal Postal Convention, Compendium of Information. Edition of 1 January 1996 - last update 15.06.98. Berne: Universal Postal Union, Berne (International Bureau)
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