Nformation on the donor organism




Дата канвертавання21.04.2016
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Form_B1
NFORMATION ON THE DONOR ORGANISM1

1. The donor organism is (please, tick):

viroid




RNA virus




DNA virus2




bacteria




fungus (mould, yeast)




higher plant




animal




other (please specify)













  1. Name ( unless a higher plant is involved/ Gymnospermae and Angiospermae/)

order or higher taxon




genus




Species




Subspecies




Strain (for microorganisms)




Latin name




Common name







  1. Name ( where a higher plant is involved/ Gymnospermae and Angiospermae/)

Family name




Genus




Species




Subspecies




Variety/ breeding line




Latin name




Common name







  1. Origin

collection




Collection number




supplier




other







  1. Risk class (please fill in q. 5 only in case of notification for contained use of GMOs)

5.1. Is there existing previous classification of the donor, including classification according to Regulation Nr.4 on the protection of employees against risks related to the exposure to biological agents at work?


Yes No


If yes, please specify the risk class and the source of the information.




5.2. If the donor organism does not have a previous risk classification, please give reasons for its risk group classification in accordance with Chapter Three, Part I of the GMO Act.







6. Does knowledge exist about pathogenic, mutagenic or allergenic effects of the donor on humans or about pathogenic effects on animals and/or plants?

Yes No


If yes, please tick all the relevant fields and specify details:

Infectivity










Toxigenicity










Virulence










Allergenicity










Pathogenicity










Possible vectors










Possible hosts










Possible activation of latent viruses (proviruses)










Ability to colonise other organisms











7. Degree of relatedness between the donor and recipient organism, or between the parental organisms





8. Techniques for identification and detection of the donor organism (please, fill in separately for each technique)


description




sensitivity and reliability in quantitative terms




specificity





9. Geographical distribution of the organism

Natural habitat in Bulgaria




Natural habitat in Europe







Natural habitat of the organism (please tick)

If microorganism:




  • water




  • soil, free




  • soil, connected to the plant roots







  • connected to animals




  • other




If plant:




  • natural habitat (agro-ecosystem)










If animal:




  • natural habitat (agro-ecosystem)







10. Use or cultivation of the organism

In Bulgaria




In Europe





11. Possible interactions with other organisms in the environment (including natural prey, predators, parasites, competitors, symbionts and hosts)

Yes No

If yes, please specify:





12. Involvement in environmental processes (primary production, nutrient turnover, decomposition of organic matter, respiration, etc.)

Yes No

If yes, please, specify:







13. A


ntibiotic resistance

Yes No

If yes, please specify the type as well as the potential use of these antibiotics in the prophylaxis and/or the therapy of humans and animals.







14. Genetic stability of the donor and factors affecting it





15. Does knowledge exist about the existence of transfer of genetic material between the donor and other organisms under natural conditions?

Yes No


If yes, please, specify:





16. Information on survival, including seasonability and the ability to form survival structures (seeds, spores, sclerotia:





17. Information on the reproduction of the donor organisms under natural conditions
17.1. Generation time in natural ecosystems



17.2. Generation time in the ecosystem of the site of release (please, fill in 16.2 only in case of notification for release into the environment)





17.3. Reproductive cycle


Sexual Asexual

Please, specify:




17.4. Factors, affecting the reproduction ability of the donor organism

Yes No

If yes, please, specify:







18. Nature of indigenous vectors:


nucleotid sequence




frequency of mobilisation




specificity




presence of genes which confer resistance





19. Are there any previous genetic modification of the donor organism?





Yes No
If yes, please specify:







20. Will a parental organism3 other than the actual donor organism, be used to obtain the nucleic acid to be transferred?


Yes No
If yes, please, fill in and enclose a separate Form_B1 for the parental organism.


21.




Name, surname

Date, place

Signature

Notifier










Project leader










Biosafety officer












1 If the nucleic acid to be transferred stem from different donor organisms, use a separate Form B1 for each one.

2 Please, enclose a genetic map if available.


3 A parental organism is a GMO that serves as a source for the isolation of genetic material for gene transfer purposes, but which is not the original host of this material and hence not a the donor organism (e.g., as in the case of intermediate cloning of a gene).


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