Restrictions For Risk Group 2 and 3 - (Dual Use)
Some species or strains, classified in risk group 2 or 3, are so-called dual-use microorganisms, liable to be attractive for terrorist actions. Most of these are marked, in our site, with an '!' after the CCUG accession number. On this page, we will explain, case-by-case how we deal with requests for these strains.
Vibrio cholerae is suggested to be classified in risk group 2 according to Swedish law, AFS 2005:1 pages 23-26, assuming presence of toxin as the normal state of the bacterium.
'Bilaga 2A' explains the basis of the classification, but does not stipulate who is authorized to classify. In our opinion, non-toxinogenic strains can not be put in 'risk group 1' and there is no reason to question the classification in risk group 2.
Apart the classification in risk groups, which regulates the use in laboratories and the transport proceedures and documents, there are separate regulations for 'dual-use' organisms: COUNCIL REGULATION (EC) No 394/2006 of 27 February 2006 amending and updating Regulation (EC) No 1334/2000 setting up a Community regime for the control of exports of dual-use items and technology We are presently trying to understand how to apply these regulations.
The Swedish Inspectorate of Strategic Products, ISP informed the CCUG Curator (February 2007) that no permit was needed for the export of dual-use microorganisms to countries belonging to EU. However, a closer study of the regulations reveals that it does apply to the EU. Furthermore, more items are involved:
- Bartonella quintana - (risk group 2)
- Vibrio cholerae (even nontoxigenic ?) - (risk group 2)
- Clostridium perfringens - with epsilon toxin - (risk group 2)
- Sweden considers all Vibrio cholerae as belonging to risk group 2
- We may make new batches of toxinogenic V. cholerae strains when needed.
- We are happy to sell toxinogenic strains within the EU to competent laboratories, but we need an official export permit from the ISP.
- Because of the classification on the dual-use list, we keep toxinogenic strain locked up as if they were true risk group 3 organisms.
- A substancial charge will apply for the establishment of the official export permits.
- A carrier with a trackable service will be used for the toxinogenic strains.
- The CCUG shipper will use FedEx under UN2814 for the toxinogenic strains. This service is more expensive than the UN3373 and restricted to destinations were FedEx have set up transport of dangerous goods.