Which laws and regulations apply to the safe transport and export of high-risk biological agents? And to what extent is the corresponding knowledge and technology subject to European export control regulations?
In the transport or external transport of high-risk material, there is almost always a period during which neither the sender nor the receiver have physical control over the material. Therefore additional measures and procedures for the security and monitoring of transport may be necessary, in addition to the laws and regulations already in force. Furthermore some materials, knowledge, and technologies are subject to licensing if they appear on the export control list of the European dual-use regulation. This page contains national and international guidelines and rules for the transport and export of biological material, useful documents and best practices regarding transport security and export control.
Transport legislation
In the Netherlands, the rules that apply to the transport of hazardous substances are stipulated in two laws: Carriage of Dangerous Goods Act (Wet vervoer gevaarlijke stoffen – WVGS)) and the Aviation Act (Wet luchtvaart). The implementation of these laws is specified in the Carriage of Dangerous Goods Decree (Besluit vervoer gevaarlijke stoffen – BVGS) and the decree on transport of dangerous goods by air. Technical requirements are described in additional regulations, such as the Provisions concerning the Carriage of Hazardous Substances by Land (VLG), the Provisions concerning the Carriage of Hazardous Substances by Railway (VSG), and the Provisions concerning the Carriage of Hazardous Substances on inland waterways (VBG).
The following international regulations have been transposed into Dutch legislation on the transport of hazardous materials, and are consequently in force within the Netherlands:
- For road transport this is the ADR (Accord européen relatif au transport international des marchandises Dangereuses par Route)
- For rail transport, this is the RID (Règlement concernant le transport international ferroviaire des marchandises dangereuses)
- For inland waterway transport, this is the ADN (Accord European and international transport of the marchandises Dangereuses par voies de Navigation intérieures)
- Various international codes apply to maritime transport, including the International Maritime Dangerous Goods Code (IMDG code).
- For aviation, documents from the International Air Transport Associations (IATA) and the International Civil Aviation Organisation (ICAO) apply.
Transport laws and regulations apply to high-risk material that is covered in the ADR as ‘infectious material hazard classes 6.1, 6.2 and 9’ (ADR). Please note that additional rules apply to the transport or import of quarantine organisms, or to the import of animals or animal products, and an exemption or import license from the Netherlands Food and Consumer Product Authority (NVWA) is required.
European Export Control regarding biological material
In addition to transport legislation, an export licence may be required for the export of biological material to countries outside the European Union. This is the case if the material is included on the list of strategic goods of the European dual-use regulation. The list of strategic goods contains agents that have potential for malicious use and thus have a dual-use nature. In contrast to transport legislation, RNA/DNA that encodes for pathogenicity is also subject to export controls, and export of knowledge and technologies related to strategic goods can be subject to licensing.
Export control with regard to knowledge and technologies
The European dual-use regulation can also apply to the export of knowledge and technologies on high-risk pathogens that are designated as strategic goods. This can have consequences for research, publishing research and other communication about research. If you are unsure whether research, knowledge or technologies require an export license, you can contact the Dutch Ministry of Foreign Affairs.
To ensure that the process runs as smoothly as possible when applying for the definitive license, you can request a trial application (sondage) for a license to export knowledge or technologies from the Central Import and Export Office (CDIU).
Gap between sender and receiver
During the transport or export of high-risk biological material, there is almost always a period in which neither the sender nor the receiver have physical control over the material. Clear procedures for documentation, packaging and categorisation during transport and export contribute to a safe internal transport process, and help to ensure compliance with laws and regulations. Allocating responsibilities for the entire transport process within the organisation helps employees to identify abnormal situations and prevent biological or security incidents that have consequences both inside and outside the organisation.
Only certified carriers who comply with the ADR are permitted to transport hazardous materials by road. The carrier has a security plan that can be reviewed by the organisation. Agreements can be made with the carrier regarding the safety and security of transport.