Part I: Risk Assessment for Human Health and Safety See ACGM/HSE/Doe Note 5 (Nov 1992), Pp 2-4

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University of Manchester

Genetic Modification and Biohazards Safety Sub-Committee

COMPLETE THIS FORM IF YOUR WORK INVOLVES GM VIRUSES AND/OR VIRAL VECTORS. ATTACH IT TO YOUR MAIN GM APPLICATION FORM

You will need to consult the “Compendium of Guidance from the Health and Safety Commission’s Advisory Committee on Genetic Modification, 1997”, Part 2B and its Annexes.

Part I:Risk assessment for human health and safety

1. Is the viral vector disabled? / Yes/No
2. Describe the origin of the virus, the mechanism of attenuation, and its stability in both the
parent viral vector and the recombinant vector
3. Indicate the probability of reversion to the wild-type
4. Is the viral vector replication competent? / Yes/No
5. Does the viral vector infect humans or human cells in vitro? / Yes/No

Describe the nature of the inserted gene and the properties of the final genetically

modified viral vector

Does the insert code for a protein with known or suspected physiological, pathological

and/or pharmacological effect? / Yes/No

Is there reason to suspect that the tissue tropism or host range of the recombinant

virus will be any different from that of the parent vector or virus? / Yes/No

Is there reason to suspect that the modified virus may have altered interactions with

host defence mechanisms? / Yes/No
10. If yes to Q9, will normal immune status be compromised by the modified virus? / Yes/No
11. Is vaccination available to protect against the modified virus? / Yes/No

Is the recombinant likely to have an enhanced effect upon an immunocompromised

host beyond those normally expected with the parent host? / Yes/No

Will viral susceptibility to anti-viral drugs (if available) be affected by the genetic

modification? / Yes/No

Are all potential routes of transmission of the virus known, eg: those that may occur

during a laboratory accident? / Yes/No

If yes to Q14, will the routes of transmission deliver the virus or its products to

tissues where it may be biologically active? / Yes/No

Will the viral vector contain any natural or inserted oncogene and/or oncogenic

sequences? / Yes/No
17. Based on the responses given above, what level of containment is required for human safety?
Give reasons.

Part II:Risk assessment for environmental protection

Are all potential routes of transmission or escape of the virus to the environment

known (e.g. following a laboratory accident)? / Yes/No

Does the insert code for a protein with known or suspected inhibitory, detrimental,

or other physiologically active effect on any living organism? / Yes/No

Is there reason to suspect that the tissue tropism of the recombinant virus in host

organisms will be different from that of the unmodified virus? / Yes/No

Will the modified virus alter infectivity or interactions with host defence

mechanisms? / Yes/No
22. Will viral susceptibility to control agents be affected by genetic modification? / Yes/No
23. Will the insert cause changes in the host range of the virus? / Yes/No

Is there reason to suspect that the modified virus may have enhanced environmental

survival factors; e.g. enhanced tolerance to UV, temperature, desiccation etc.? / Yes/No

Now complete the environmental Risk Assessment on page 3 of the main form. If you answered "yes" to any of Questions 19 to 24, give details on a separate sheet.

Inform your local Biological Safety Officer of any new developments with viral vectors you may have used. These will be reported to the Local GM Safety Committee and the University Biological Safety Officer.