Download PROPOSAL FOR GENETIC MODIFICATION PROJECT

GMA201
RISK ASSESSMENT OF ACTIVITIES INVOLVING GENETICALLY MODIFIED ANIMALS.
Department of Veterinary Medicine. University of Cambridge.
This form should be completed for all work involving genetically modified animals, i.e. Animals with
recombinant nucleic acid incorporated into them in a relatively stable form even if not all cells of the
animal contain the modification (e.g. mosaics and non-germ-line modifications). It does not include
DNA vaccination. “Self-cloned” animals where the GMO is unlikely to cause harm to humans or the
environment are exempt (this will include the vast majority of knock-out mice). Detailed on-line
help for some questions is available using the help key. Prompts are available at the bottom of the
screen.
Proposer:
Date:
Project Title:
Staff involved:
Home Office License Number:
Section A:Description of the Genetically Modified Animal.
Q1. What species is the genetically modified animal?
Q2. Is it an indigenous species?
If “No” also complete Section B.
Q3. What is the nature of the genetic modification?
Q4. Describe the nature of the modification(s):
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Q5. Can this modification be considered to be “self-cloning”?
If “No” also complete Section B.
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Q6. Does the genetically modified animal pose any significant risk to humans?
If “yes” also complete Section C.
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Q7. Do you intend to keep the animals anywhere other than the Innes Building?
If “Yes”, where do you intend to keep them, and what are the containment measures?
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Q8. Do you intend to infect this GM animal with a pathogen or GM organism?
If “yes” attach an approved GM or pathogens risk assessment.
No
Reference #
If you have not been directed to fill in another section, the form is now complete. Please sign a
hard copy and send it with an electronic version to Chris Brown ([email protected])
and c.c to [email protected]
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Section B. Environmental Risk Assessment of Genetically Modified Animals.
Assuming a breach of containment were to occur (E.g. escape to the outside world):
Q9. Could the animal survive, establish, disseminate and/or displace other animals?
If yes, specify:
Q10. Would recapture of the animal be feasible?
Q11. Could the animal have any direct adverse effects on animals or plants?
If yes, specify:
Q12. Could the modified genes be transferred to other species?
If yes, specify:
Q13. If the gene products are biologically active, are they likely to be harmful?
Q14. Is the organism phenotypically and genetically stable?
Q15. Could the animal act as a novel disease vector or host?
Q16. Does the project include any plans for deliberate release of the GMO?
If yes, give details:
Q17. Are any additional measures required to prevent accidental release?
Q18. What is the likelihood of risk?
Q19. How serious would the consequences of a breach of containment be?
Justification:
Q20. What is the level of environmental risk?
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Section C. Risk Assessment for Human Health and Safety:
Q21. Are there any hazards intrinsic to the species concerned?
If “yes” specify.
Q22. Does the genetic modification significantly increase these risks?
If “Yes” specify:
Q23. Are any additional measures required to control these risks?
If “Yes” specify:
Q24. What is the likelihood of risk to human health?
Q25. How serious would the consequences be?
Q26. What is the level of risk?
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If the answer to Q25 is “medium” or “severe”, it will be necessary to notify the
H.S.E.
Signature of proposer:
Local ACGM use Proposal no:
Decision:
Category:
Comments:
LST 5/11
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Date: