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Risk Assessment generated by a regulatory process
(RA)
last updated: 24 Apr 2012
Scientific field research using maize that has altered growth characteristics
EN
16 Mar 2012
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Competent National Authority:Federal Public Service (FPS) Health, Food Chain Safety and Environment - DG Animals, Plants and Foodstuffs ()Avenue Galilée 5/2Brussels,
B-1210, BelgiumPhone: +32 2 524 97 97,Fax:Website: http://www.ogm-ggo.be,
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Person:Prof. Corinne Vander WauvenPresident,c/o Secretariat of the Biosafety Advisory Council Sciensano Service Biosafety and Biotechnology Rue J. Wytsmanstraat 14Brussels,
B-1050, BelgiumPhone: +32 2 642 52 93,Fax: +32 2 642 52 92,Email: bac@sciensano.be,Website: http://www.bio-council.be,Related OrganizationBelgian Biosafety Advisory Council (BAC)Other (Advisory Body)c/o Secretariat of the Biosafety Advisory Council Sciensano Service Biosafety and Biotechnology Rue J. Wytsmanstraat 14Brussels,
B-1050, BelgiumPhone: +32 2 642 52 93,Fax: +32 2 642 52 92,Email: bac@sciensano.be,Website: http://www.bio-council.be,
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Maize with altered growth and tolerance to herbicides| VIB-UGent | Changes in physiology and/or production (Growth rate), Changes in quality and/or metabolite content (Cellulose, Lignin), Resistance to herbicides (Glufosinate)
- Belgian Biosafety Advisory Council [ English ]
- Advice Belgian Biosafety Advisory Council [ English ]
According to the dossier, laboratory observations with the GA20OXI line indicate no alteration in the inflorescence, formation of pollen, seed formation or seed dispersal. The increased amount of plant bio-active gibberellin (i.e. 3-fold increase of GA1 in leaves) is not expected to present harmful effects such as toxic effects for organisms or allergic effects for human health. According to the notifier, potential unintended effects due to the insertion of the gene of interest in the plant genome cannot be ruled out. However, due to i) the prevention of pollen dispersal by removal of the tassels ii) the unlikely natural dispersal of seeds iii) the low winter tolerance of rare spilled seed, iv) the low probability of appearance of volunteers; gene flow (if any occurs) is not expected to cause harm to the environment. Based on these elements, the notifier mentions that no particular measures will be taken for post trial monitoring.
Current scientific evidence indicates that the transfer of genes from GM plants into bacteria and their stable integration, either does not occur or, if it occurred, has been below the limit of detection in the studies performed. The possibility of horizontal gene transfer between the GA20OX1 maize plants and bacteria has been given particular attention due to the presence of the recombination sites attB4, attB1 and attB2. However, the occurrence of an active integrase-excisionase complex in an environment where attP4, attP1 and attP2 are present is estimated low. In addition, if any horizontal gene transfer of Ga20Oxidase-1 gene and its expression would occur (in GA20OX1, the GA20oxidase-1 gene is under the control of a ubiquinine promoter which is a promoter that is not functional in bacteria), no apparent selective advantage would be conferred to bacteria. The same holds for the presence of the bar-gene. As regards to the aadh gene, adverse effects on human health and the environment resulting from a transfer from the GM plants to bacteria is judged unlikely, mainly due to the distribution of genes conferring streptomycine resistance in bacteria from a range of European environmental habitats (EFSA,2009).
EN
Current scientific evidence indicates that the transfer of genes from GM plants into bacteria and their stable integration, either does not occur or, if it occurred, has been below the limit of detection in the studies performed. The possibility of horizontal gene transfer between the GA20OX1 maize plants and bacteria has been given particular attention due to the presence of the recombination sites attB4, attB1 and attB2. However, the occurrence of an active integrase-excisionase complex in an environment where attP4, attP1 and attP2 are present is estimated low. In addition, if any horizontal gene transfer of Ga20Oxidase-1 gene and its expression would occur (in GA20OX1, the GA20oxidase-1 gene is under the control of a ubiquinine promoter which is a promoter that is not functional in bacteria), no apparent selective advantage would be conferred to bacteria. The same holds for the presence of the bar-gene. As regards to the aadh gene, adverse effects on human health and the environment resulting from a transfer from the GM plants to bacteria is judged unlikely, mainly due to the distribution of genes conferring streptomycine resistance in bacteria from a range of European environmental habitats (EFSA,2009).
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With the dossier, a permission is asked for a field trial to be conducted during three consecutive years (from May 2012 until October 2014). The field, harbouring the trial is well indicated. According to the dossier, the surface of the area for cultivation of the parental line and the GM maize GA20OXI will not exceed 500 m2. Weeds will be destroyed by conventional herbicides. No glufosinate treatment will be applied. Harvesting will occur in October of each year. Seeds will be sown approximately at 20 April and at a depth of 4 cm; bird nets will be used to prevent birds from removing seeds or seedlings. Early sowing is scheduled for two reasons i) to take into account the late maturity of B104 and ii) to test the cold tolerance during early growth (the latter aspect mentioned in the ATQ and not in the dossier).
Prior complete formation, tassels will be removed by hand in order to prevent the dispersal of pollen. Monitoring of upcoming tassels will start on July, 1st and will take place three times a week. Monitoring will be enforced and occur on a daily basis from the moment the formation of a tassel has been observed. This extended monitoring will be maintained until the last tassel has been removed by hand. The collected tassels will be transported in closed bags and will be inactivated by incineration.
During harvesting, kernels are said to be collected by hand and transported in closed and labelled bags to the lab. Seeds will be stored for research or will be inactivated as GMO (incineration). Stems and leaves will be collected in closed bags. Roots and the lowest part of the stem will be left in the ground.
According to the dossier, the year following the trial, the field plot will be used again for the cultivation of maize. No measures will a priori be taken for post field trial monitoring of volunteers based on the low probability that volunteers will arise: pollen dispersal will be prevented by removal of the tassels, natural dispersal of seeds will be prevented and cobs with seeds will be carefully removed upon manual harvest in October. The notifier writes that he is willing to install a non maize crop the year of the trial, should the BAC ask for this. Such a crop would make it easier to spot and destroy potential volunteers.
The dossier mentions that the trial will be performed with the GA20OX1 line. It mentions a homozygous and an azygous version of this line.
The dossier provides two field designs, one for the year 2012 and a larger one which will be used both in 2013 and in 2014. The smaller size in 2012 is due to the restricted seed availability. Planned plant densities are 9, 10 and 11 plants per m2.
In all designs transformed maize plants will be detasselled, the field trial is surrounded by a border of 3 m of the non-transformed isoline, and the whole area is situated within a maize field.
The area of the trial exceeds 500 m2 in 2013 and 2014.
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Prior complete formation, tassels will be removed by hand in order to prevent the dispersal of pollen. Monitoring of upcoming tassels will start on July, 1st and will take place three times a week. Monitoring will be enforced and occur on a daily basis from the moment the formation of a tassel has been observed. This extended monitoring will be maintained until the last tassel has been removed by hand. The collected tassels will be transported in closed bags and will be inactivated by incineration.
During harvesting, kernels are said to be collected by hand and transported in closed and labelled bags to the lab. Seeds will be stored for research or will be inactivated as GMO (incineration). Stems and leaves will be collected in closed bags. Roots and the lowest part of the stem will be left in the ground.
According to the dossier, the year following the trial, the field plot will be used again for the cultivation of maize. No measures will a priori be taken for post field trial monitoring of volunteers based on the low probability that volunteers will arise: pollen dispersal will be prevented by removal of the tassels, natural dispersal of seeds will be prevented and cobs with seeds will be carefully removed upon manual harvest in October. The notifier writes that he is willing to install a non maize crop the year of the trial, should the BAC ask for this. Such a crop would make it easier to spot and destroy potential volunteers.
The dossier mentions that the trial will be performed with the GA20OX1 line. It mentions a homozygous and an azygous version of this line.
The dossier provides two field designs, one for the year 2012 and a larger one which will be used both in 2013 and in 2014. The smaller size in 2012 is due to the restricted seed availability. Planned plant densities are 9, 10 and 11 plants per m2.
In all designs transformed maize plants will be detasselled, the field trial is surrounded by a border of 3 m of the non-transformed isoline, and the whole area is situated within a maize field.
The area of the trial exceeds 500 m2 in 2013 and 2014.
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- Final Decision of the Ministers (in Dutch) [ English ]
- Summary Notification Information Format (SNIF) [ English ]
