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according to the Gene Technology Regulations 2001as amended *

Updated November 2007

Viral vector typeHostExempt system?Characteristics of donor nucleic acid or donor organismApplicable regulation*Class of dealing
Replication defective vectors
1) Not retroviral
  • unable to transduce human cells
tissue culture yes non -pathogenic / -toxic / -oncogenic
(if > 10 L cultures, then becomes)
S2 p1 item 4
(S3 p2 (f))
exempt
PC2 NLRD
oncogenicS3 p1 (b)PC1 NLRD
pathogenicS3 p2 (e)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p2 (h)DNIR
  • able to transduce human cells (eg Ad5)
tissue culture no non -oncogenic / -toxic S3 p1 (c)PC1 NLRD
oncogenicS3 p2 (i)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR
  • unable or able to transduce human cells
whole animal / plant no non -toxic / -oncogenic etc (see cells below) S3 p2 (c) or (d)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
oncogenic / immuno-modulatory / cytokine / leads to cell proliferationS3 p3 (d)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR

S = Schedule exempt = exempt dealing PC1 = Physical containment level 1 PC2 = Physical containment level 2
p = Part (of the Regulations) NLRD = notifiable low risk dealing DNIR = dealing not involving intentional release


Viral vector typeHostExempt system?Characteristics of donor nucleic acid or donor organismApplicable regulation *Class of dealing
Replication defective vectors
2) Retroviral
  • unable to transduce human cells

    (Note: same classification as for non-retroviral defective vectors unable to transduce human cells in tissue culture, above)
tissue cultureyesnon -pathogenic / -toxic / -oncogenic
(if > 10 L cultures, then becomes)
S2 p1 item 4
(S3 p2 (f))
exempt
(PC2 NLRD)
oncogenicS3 p1 (b)PC1 NLRD
pathogenicS3 p2 (e)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR
  • able to transduce human cells
tissue culturenonon-toxic (may be pathogenic, oncogenic)S3 p2 (i)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR
  • unable or able to transduce human cells

    (Note: same classification as non-retroviral defective vectors in animals, above)
whole animal / plantnonon -toxic / -oncogenic etc (see cells below)S3 p2 (c) or (d)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
oncogenic / immuno-modulatory / cytokine / leads to cell proliferationS3 p3 (d)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR
  • lentivirus able to transduce human cells unless all structural & accessory genes deleted and transcriptionally inactive
tissue culture
or
animal / plant
no any   (Note: if structural & accessory genes deleted and transcriptionally          inactive, classify as for other defective retroviral systems above) S3 p3 (i)DNIR

S = Schedule exempt = exempt dealing PC1 = Physical containment level 1 PC2 = Physical containment level 2
p = Part (of the Regulations) NLRD = notifiable low risk dealing DNIR = dealing not involving intentional release


Viral vector typeHostExempt system?Characteristics of donor nucleic acid or donor organismApplicable regulation*Class of dealing
Replication competent vectors
  • non-pathogenic plant viral vector
plant tissue culture yes non -pathogenic / -toxic / -oncogenic
(if > 10 L cultures, then becomes)
S2 p1 item 4
(S3 p2 (f))
exempt
(PC2 NLRD)
oncogenic (for vertebrate cell)S3 P1 (b)PC1 NLRD
pathogenicS3 p2 (e)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR
  • Baculovirus (polyhedron minus)

    or

  • Avipox
    (attenuated vaccine strains)
animal tissue culture yes non -pathogenic / -toxic / -oncogenic
(if > 10 L cultures, then becomes)
S2 p1 item 4
(S3 p2 (f))
exempt
(PC2 NLRD)
oncogenic (for vertebrate cell)S3 P1 (b)PC1 NLRD
pathogenicS3 p2 (e)PC2 NLRD
toxicS3 p3 (a), (b) or (c)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR
  • other plant or animal viruses:

    unable or able to transduce human cells
tissue culture
or
whole animal / plant
no non -pathogenic / -toxic / -oncogenic etc (see cells below) S3 p2 (c) or (d)PC2 NLRD
pathogenicS3 p3 (e) or (f)DNIR
toxicS3 p3 (a), (b) or (c)DNIR
oncogenic / immuno-modulatory / cytokine / leads to cell proliferationS3 p3 (d)DNIR
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibilityS3 p3 (h)DNIR

S = Schedule exempt = exempt dealing PC1 = Physical containment level 1 PC2 = Physical containment level 2
p = Part (of the Regulations) NLRD = notifiable low risk dealing DNIR = dealing not involving intentional release

*Effective from 1 July 2007, incorporating amendments up to the Gene Technology Amendment Regulations 2007 (No. 1). This table provides guidance only. Users must refer to the complete applicable conditions and exclusions in the Gene Technology Regulations 2001, as amended.