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according to the Gene Technology Regulations 2001 as amended*

Viral vector type Characteristics of donor nucleic acid or donor organism In vitro In vivo
Replication competent vectors
Non-pathogenic plant viral vector
or
Baculovirus (Autographa californica nuclear polyhedrosis virus), polyhedrin minus
not a pathogenic determinant and not a toxin and cultures used are 25 L Exempt, S2 p1 item 4 PC2 NLRD, S3, p2.1 (c)
not a pathogenic determinant and not a toxin and cultures used are > 25 L PC2 NLRD, S3 p2.1 (f) N/A
pathogenic determinant PC2 NLRD, S3 p2.1 (e) DNIR, S3 p3.1 (g)
toxin or uncharacterised gene from toxin producing organism DNIR, S3 p3.1 (a), (b) or (c)
genes whose expressed products are likely to increase the capacity of the virus/viral vector to induce an autoimmune response DNIR, S3 p3.1 (h)
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility DNIR, S3 p3.1 (i)
All other replication competent viruses
(including Avipox vectors)
not a pathogenic determinant and not a toxin and not an oncogenic modification and not immunomodulatory in humans PC2 NLRD, S3 p2.1 (c) or (d)
toxin or an uncharacterised gene from toxin producing organism DNIR, S3 p3.1 (a), (b) or (c)
oncogenic modification or immunomodulatory in humans DNIR, S3 p3.1 (e)
pathogenic determinant DNIR, S3 p3.1 (f) or (g)
virus satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 DNIR, S3 p3.1 (p)
genes whose expressed products are likely to increase the capacity of the virus/viral vector to induce an autoimmune response DNIR, S3 p3.1 (h)
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility DNIR, S3 p3.1 (i)
drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the virus/viral vector DNIR, S3 p3.1 (o)

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



Guidance on classification of contained dealings with viral vectors

according to the Gene Technology Regulations 2001 as amended*

Viral vector type Characteristics of donor nucleic acid or donor organism In vitro In vivo
Replication defective vectors - retroviral (includes lentiviruses)1
Any toxin or uncharacterised gene from toxin producing organism DNIR, S3 p3.1 (a), (b) or (c)
genes whose expressed products are likely to increase the capacity of the virus/viral vector to induce an autoimmune response DNIR, S3 p3.1 (h)
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility DNIR, S3 p3.1 (i)
drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the viral vector DNIR, S3 p3.1 (o)
Unable to transduce human cells not a pathogenic determinant and not a toxin and cultures used are 25 L Exempt, S2 p1 item 4 PC2 NLRD, S3 p2.1 (i)
not a pathogenic determinant and not a toxin and cultures used are > 25 L PC2 NLRD, S3 p2.1 (f) N/A
pathogenic determinant PC2 NLRD, 2.1 (e) PC2 NLRD, S3 p2.1 (i)
Able to transduce
human cells:
      Self inactivating
            and/or
      accessory genes
      are not present2
not a toxin and not an oncogenic modification and not immunomodulatory in humans PC2 NLRD, S3 p2.1 (l) PC2 NLRD, S3 p2.1 (m)
oncogenic modification or immunomodulatory in humans PC2 NLRD, S3 p2.1 (l) DNIR, S3 p3.1 (d) & (j)
Able to transduce
human cells:
      not self
      inactivating and
      accessory genes
      are present2
not a toxin and not an oncogenic modification and not immunomodulatory in humans DNIR, S3 p3.1 (j)
oncogenic modification or immunomodulatory in humans DNIR, S3 p3.1 (d) & (j)

1Replication defective retroviral vectors must include safety features to reduce the likelihood of recombination leading to replication competence being regained, including that all viral genes must be removed from the retroviral vector so that it cannot replicate or assemble into a virion without these functions being supplied in trans, and that viral genes needed for virion production must be expressed from independent, unlinked loci with minimal sequence overlap
2Only gagpol and env (and rev if a lentiviral vector) present in the packaging system



Guidance on classification of contained dealings with viral vectors

according to the Gene Technology Regulations 2001 as amended*

Viral vector type Characteristics of donor nucleic acid or donor organism In vitro In vivo
Replication defective vectors non-retroviral
Any toxin or uncharacterised gene from toxin producing organism DNIR, S3 p3.1 (a), (b) or (c)
genes whose expressed products are likely to increase the capacity of the viral vector to induce an autoimmune response DNIR, S3 p3.1 (h)
creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility DNIR, S3 p3.1 (i)
virus satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 DNIR, S3 p3.1 (p)
Unable to transduce human cells not a pathogenic determinant and not a toxin and cultures used are 25 L Exempt, S2 p1 item 4 PC2 NLRD, S3 p2.1 (i)
not a pathogenic determinant and not a toxin and cultures used are > 25 L PC2 NLRD, S3 p2.1 (f) N/A
pathogenic determinant PC2 NLRD, S3 p2.1 (e) PC2 NLRD, S3 p2.1 (i)
Able to transduce human cells:
Human adenovirus
        or
Adeno associated virus
not a toxin and not an oncogenic modification and not immunomodulatory in humans PC1 NLRD, S3 p1.1 (c) PC2 NLRD, S3 p2.1 (k)
oncogenic modification or immunomodulatory in humans PC2 NLRD, S3 p2.1 (j) DNIR, S3 p3.1 (d)
drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the viral vector DNIR, S3 p3.1 (o)
Able to transduce human cells:
all other viruses
not a toxin and not an oncogenic modification and not immunomodulatory in humans PC2 NLRD, S3 p2.1 (j) PC2 NLRD, S3 p2.1 (k)
oncogenic modification or immunomodulatory in humans PC2 NLRD, S3 p2.1 (j) DNIR, S3 p3.1 (d)
drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the viral vector DNIR, S3 p3.1 (o)

* Effective from 1 September 2011, incorporating amendments up to the Gene Techn ology Amendment Regulations 2011 (No. 1). This table provides guidance only and does not constitute legal advice. Users must refer to
   the complete applicable conditions and exclusions in the Gene Technology Regulations 2001, as amended.
   Telephone: 1800 181 030      Updated August 2011