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Biosafety in the laboratory - VIB

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3. Activities with animal cells <strong>in</strong> comb<strong>in</strong>ation with viruses or viral vectors<br />

Second direction<br />

Activities <strong>in</strong> which genetic material is or has been added that has not been<br />

characterised<br />

Activities <strong>in</strong> which characterised genetic material<br />

is or has been added<br />

First direction<br />

7. The viral vector is a complete or<br />

defective ecotropic mouse<br />

retrovirus<br />

8. The viral vector is a human or<br />

animal pathogenic autonomously<br />

replicat<strong>in</strong>g <strong>in</strong>fectious<br />

virus of respectively risk group<br />

4, 3 or 2 or a defective virus<br />

that has been developed from it<br />

and <strong>the</strong> possibility that automously<br />

replicat<strong>in</strong>g virusparticles<br />

emerge does exist<br />

9. The viral vector is, or has been<br />

developed from a satelite virus<br />

or is a defective virus developed<br />

from a human or animal pathogen<br />

of respectively risk group 4,<br />

3 or 2; <strong>the</strong> possibility that automously<br />

replicat<strong>in</strong>g virusparticles<br />

emerge does not exist<br />

a. The donor produces a tox<strong>in</strong> of T3 L2 Resp. L4, L4, L4 Resp. L3, L3, L3<br />

respectively class T2 L2 Resp. L4, L4, L3 Resp. L3, L2, L2<br />

T1 L2 Resp. L4, L4, L3 Resp. L3, L2, L2<br />

b. The donor is, or has been developed from, Risk group 4 L4 Resp. L4, L4, L4 Resp. L4, L4, L4<br />

a for eucaryotic cells <strong>in</strong>fectious virus of Risk group 3 L3 Resp. L4, L3, L3 Resp. L3, L3, L3<br />

respectively risk group 4, 3 or 2, and <strong>the</strong> Risk group 2 L2 Resp. L4, L3, L2 Resp. L3, L2, L2<br />

viral sequences that have been brought<br />

<strong>in</strong>to <strong>the</strong> host can give rise to <strong>the</strong><br />

formation of autonomously replicat<strong>in</strong>g<br />

virusparticles*<br />

c. The donor is, or has been developed from, Risk group 4 L3 Resp. L4, L3, L3 Resp. L3, L3, L3<br />

a defect for eucaryotic cells <strong>in</strong>fectious Risk group 3 L2 Resp. L4, L3, L2 Resp. L3, L2, L2<br />

virus of respectively risk group 4, 3 or 2, Risk group 2 L1 Resp. L4, L3, L2 Resp. L3, L2, L1<br />

and <strong>the</strong> viral sequences that have been<br />

brought <strong>in</strong>to <strong>the</strong> host cannot give rise to<br />

<strong>the</strong> formation of autonomously<br />

replicat<strong>in</strong>g virusparticles*<br />

d. The donor is a non-viral pathogen of Risk group 4 L3 Resp. L4, L3, L3 Resp. L3, L3, L3<br />

respectively Risk group 3 L2 Resp. L4, L3, L2 Resp. L3, L2, L2<br />

Risk group 2 L1 Resp. L4, L3, L2 Resp. L3, L2, L1<br />

e. The donor is an organism of biological risk L1 Resp. L4, L3, L2 Resp. L3, L2, L1<br />

risk group 1, or a plant or an animal<br />

f. The sequence conta<strong>in</strong>s genetic T3 L2 Resp. L4, L4, L4 Resp. L3, L3, L3<br />

<strong>in</strong>formation that codes for <strong>the</strong> production T2 L2 Resp. L4, L4, L3 Resp. L3, L2, L2<br />

of a tox<strong>in</strong> of respectively class T1 L2 Resp. L4, L4, L3 Resp. L3, L2, L2<br />

g. The sequence conta<strong>in</strong>s genetic Risk group 4 L4 Resp. L4, L4, L4 Resp. L4, L4, L4<br />

<strong>in</strong>formation for <strong>the</strong> formation of a for Risk group 3 L3 Resp. L4, L3, L3 Resp. L3, L3, L3<br />

eucaryotic cells <strong>in</strong>fectious virus, of Risk group 2 L2 Resp. L4, L3, L2 Resp. L3, L2, L2<br />

respectively risk group 4, 3 or 2 and <strong>the</strong><br />

viral sequences that have been brought<br />

<strong>in</strong>to <strong>the</strong> host can give rise to <strong>the</strong><br />

formation of autonomously<br />

replicat<strong>in</strong>g virusparticles*<br />

h. The sequence conta<strong>in</strong>s genetic Risk group 4 L3 Resp. L4, L3, L3 Resp. L3, L3, L3<br />

<strong>in</strong>formation for <strong>the</strong> formation of a defect Risk group 3 L2 Resp. L4, L3, L2 Resp. L3, L2, L2<br />

for eucaryotic cells <strong>in</strong>fectious virus, of Risk group 2 L1 Resp. L4, L3, L2 Resp. L3, L2, L1<br />

respectively risk group 4, 3 or 2 and <strong>the</strong><br />

viral sequences that have been brought<br />

<strong>in</strong>to <strong>the</strong> host cannot give rise to <strong>the</strong><br />

formation of autonomously<br />

replicat<strong>in</strong>g virusparticles*<br />

i. The sequence conta<strong>in</strong>s genetic L2 Resp. L4, L3, L2 Resp. L3, L2, L2<br />

<strong>in</strong>formation that codes for a hazardous<br />

gene product, o<strong>the</strong>r than <strong>in</strong> f.**<br />

j. The sequence does not conta<strong>in</strong> genetic L1 Resp. L4, L3, L2 Resp. L3, L2, L1<br />

<strong>in</strong>formation that codes for a hazardous<br />

gene product<br />

* The risk classification may <strong>in</strong> some cases have to be higher than given above <strong>in</strong> <strong>the</strong> case of <strong>the</strong> formation of an <strong>in</strong>fectious virusparticle with an<br />

<strong>in</strong>creased host(cell)range or an <strong>in</strong>creased virulence or pathogenicity.<br />

** What constitutes a hazardous gene product is <strong>the</strong> most difficult risk classification question. Virulence gene products might be an example of a<br />

hazardous gene product. F<strong>in</strong>al risk classification depends on <strong>the</strong> suspected effect of <strong>the</strong> gene product <strong>in</strong> <strong>the</strong> used hostorganism.<br />

60<br />

<strong>Biosafety</strong> <strong>in</strong> <strong>the</strong> <strong>laboratory</strong>

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