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Risk Assessment generated by a regulatory process
(RA)
published: 21 Jul 2009
last updated: 28 Mar 2013
Risk Assessment for Insect Tolerant Cotton (Bollgard II)
EN
-
Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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MON-15985-7 - Bollgard II™ cotton| Monsanto | Resistance to antibiotics (Kanamycin, Neomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Selectable marker genes and reporter genes
- National Biosafety Committiee [ English ]
Agronomic characteristics of MON 15985
cotton are equally comparable to, or better than, those of conventional cotton.
The control of A. Argillacea, H. virescens and P. gossypiella was efficient,
especially under conditions of high infestation by the pests. In artificial infestations
of Spodoptera frugiperda there was a significant reduction in the number of
caterpillars and defoliation during Bollgard II treatment, yet efficacy in controlling
the pest was decreased when compared with other target pests. Apparently,
insertion of segment PV-GHBI11L was not harmful for the plant development.
Assessment of agronomic performance of MON 15985 lineages and cultivars
against conventional cultivars in Brazilian agricultural conditions revealed normal
variability between genetically modified and conventional plants regarding their
agronomic features (plant height, cycle up to flowering, precocity of maturation,
cycle up to harvest and boll weight) productivity and fiber quality. Though the
combination Cry1Ac and Cry2Ab2 has higher efficacy than Bollgard, Bollgard II is
currently susceptible to damages caused by Spodoptera ssp. and Helicoverpa
zea in conditions of high infestation, especially flowering times. Practices of pest
management associated to cotton Bt have caused a dramatic reduction in the use
of insecticides, which leads to a significant increase in the population of beneficial
insects and, consequently, contributes towards the natural control of some pests.
Studies were conducted with non-target organisms, such as birds, fish and
beneficial invertebrate species. The results evidenced that protein Cry2Ab2 in
MON 15985 cotton fails to impose premature risks for non-target organisms.
Adverse effects were not observed in concentrations significantly higher than the
ones foreseen by exposure to the environment. In all cases, the concentration of
the non-observed effect exceeds the top environmental concentration, indicating
minimum risk of protein Cry2Ab2 to non-target organisms. Results of several
studies indicated that protein Cry2Ab2 poses minimum risk for non-target
beneficial organisms. Studies with populations of predator species, such as
Geocoris spp., Orius Insidiosus, Nabis spp., Slenopsis invicta, spiders,
coccinellidae, chrysopidae and hemerobiidae, evidenced that the populations
were either equal or larger in treatments containing Bollgard and Bollgard II cotton
contrasted with treatments with conventional cotton. In a sample of over 40 field
experiments with cotton and maize expressing proteins Cry it became clear that,
in general, non-target invertebrates are more abundant in cotton and Bt corn
fields than in fields where conventional cultures were treated with insecticides.
However, in insect-resistant genetically modified cotton and corn fields, when
compared to fields with cultures that were not treated with pesticides, show a
statistically significant reduction in the number of some non-target organisms.
Other studies evidenced that, in general, there was no significant difference on
populations of natural enemies between Bollgard cotton and conventional cotton.
Whenever significant differences were apparent, natural enemies were more
abundant in Bollgard cotton fields, probably resulting from the decreased
EN
cotton are equally comparable to, or better than, those of conventional cotton.
The control of A. Argillacea, H. virescens and P. gossypiella was efficient,
especially under conditions of high infestation by the pests. In artificial infestations
of Spodoptera frugiperda there was a significant reduction in the number of
caterpillars and defoliation during Bollgard II treatment, yet efficacy in controlling
the pest was decreased when compared with other target pests. Apparently,
insertion of segment PV-GHBI11L was not harmful for the plant development.
Assessment of agronomic performance of MON 15985 lineages and cultivars
against conventional cultivars in Brazilian agricultural conditions revealed normal
variability between genetically modified and conventional plants regarding their
agronomic features (plant height, cycle up to flowering, precocity of maturation,
cycle up to harvest and boll weight) productivity and fiber quality. Though the
combination Cry1Ac and Cry2Ab2 has higher efficacy than Bollgard, Bollgard II is
currently susceptible to damages caused by Spodoptera ssp. and Helicoverpa
zea in conditions of high infestation, especially flowering times. Practices of pest
management associated to cotton Bt have caused a dramatic reduction in the use
of insecticides, which leads to a significant increase in the population of beneficial
insects and, consequently, contributes towards the natural control of some pests.
Studies were conducted with non-target organisms, such as birds, fish and
beneficial invertebrate species. The results evidenced that protein Cry2Ab2 in
MON 15985 cotton fails to impose premature risks for non-target organisms.
Adverse effects were not observed in concentrations significantly higher than the
ones foreseen by exposure to the environment. In all cases, the concentration of
the non-observed effect exceeds the top environmental concentration, indicating
minimum risk of protein Cry2Ab2 to non-target organisms. Results of several
studies indicated that protein Cry2Ab2 poses minimum risk for non-target
beneficial organisms. Studies with populations of predator species, such as
Geocoris spp., Orius Insidiosus, Nabis spp., Slenopsis invicta, spiders,
coccinellidae, chrysopidae and hemerobiidae, evidenced that the populations
were either equal or larger in treatments containing Bollgard and Bollgard II cotton
contrasted with treatments with conventional cotton. In a sample of over 40 field
experiments with cotton and maize expressing proteins Cry it became clear that,
in general, non-target invertebrates are more abundant in cotton and Bt corn
fields than in fields where conventional cultures were treated with insecticides.
However, in insect-resistant genetically modified cotton and corn fields, when
compared to fields with cultures that were not treated with pesticides, show a
statistically significant reduction in the number of some non-target organisms.
Other studies evidenced that, in general, there was no significant difference on
populations of natural enemies between Bollgard cotton and conventional cotton.
Whenever significant differences were apparent, natural enemies were more
abundant in Bollgard cotton fields, probably resulting from the decreased
Considering that Bollgard II cotton was developed from Bollgard cotton, which
was approved for commercial use by CTNBio in 2005 and, up to this moment,
there is no evidence of risk to human and animal health and to the environment;
Considering that Event MON 15895 is a single-copy event of stable insertion and
that Chi-square analysis evidenced that the insert segregates according to
Mendelian genetics, with a segregation pattern of a single gene regarding
detection of protein Cry2Ab2;
Considering that composition data failed to point significant differences between
the genetically modified and conventional varieties, suggesting an equivalence
between such varieties; and
Whereas:
1. Cotton plant is one of the most used plants among those cultivated by the
human being;
2. Proteins Cry1Ac and Cry2Ab2 are promptly digested after ingestion and
that effects of chronic exposure to such proteins are not expected;
3. Acute oral toxicity of proteins Cr1Ac and Cr1Ac is low, and they are
considered to be non toxic for mammals;
4. The DNA molecule is a natural component of food and there is no
evidence that it may have any adverse effect to humans when ingested in
food within acceptable amounts (no direct toxic effect);
5. There is no evidence that intact genes of plants may be transferred and
functionally integrated to the human or other mammals genome exposed
to the DNA or to food produced with such elements.
6. The likelihood that the herbaceous Bollgard II cotton plant becomes a
pest plant is negligible;
7. Exposure of living organisms and environment to B. thuringiensis or to
any element extracted from this bacterium is an event that occurs
abundantly in nature;
8. Insertion of segment PV-GHBK11L apparently failed to harm the
development of the plant regarding agronomic characteristics;
9. There are no reports in change of agronomic performance observed in
the commercial cultivation of this event in other countries;
10. Analysis of biochemical composition showed that event MON 15895
displays substantial equivalence with non-genetically modified varieties, a
robust suggestion that such event has no undesirable pleiotropic effects;
11. Literature and field experiment data suggest that event MON 15895 has
no impact against non-target organisms except those already inherent to
the culture of cotton;
12. Field data indicate that water and soil quality improved due to the less
use of pesticides in cultivars of GM cotton;
EN
was approved for commercial use by CTNBio in 2005 and, up to this moment,
there is no evidence of risk to human and animal health and to the environment;
Considering that Event MON 15895 is a single-copy event of stable insertion and
that Chi-square analysis evidenced that the insert segregates according to
Mendelian genetics, with a segregation pattern of a single gene regarding
detection of protein Cry2Ab2;
Considering that composition data failed to point significant differences between
the genetically modified and conventional varieties, suggesting an equivalence
between such varieties; and
Whereas:
1. Cotton plant is one of the most used plants among those cultivated by the
human being;
2. Proteins Cry1Ac and Cry2Ab2 are promptly digested after ingestion and
that effects of chronic exposure to such proteins are not expected;
3. Acute oral toxicity of proteins Cr1Ac and Cr1Ac is low, and they are
considered to be non toxic for mammals;
4. The DNA molecule is a natural component of food and there is no
evidence that it may have any adverse effect to humans when ingested in
food within acceptable amounts (no direct toxic effect);
5. There is no evidence that intact genes of plants may be transferred and
functionally integrated to the human or other mammals genome exposed
to the DNA or to food produced with such elements.
6. The likelihood that the herbaceous Bollgard II cotton plant becomes a
pest plant is negligible;
7. Exposure of living organisms and environment to B. thuringiensis or to
any element extracted from this bacterium is an event that occurs
abundantly in nature;
8. Insertion of segment PV-GHBK11L apparently failed to harm the
development of the plant regarding agronomic characteristics;
9. There are no reports in change of agronomic performance observed in
the commercial cultivation of this event in other countries;
10. Analysis of biochemical composition showed that event MON 15895
displays substantial equivalence with non-genetically modified varieties, a
robust suggestion that such event has no undesirable pleiotropic effects;
11. Literature and field experiment data suggest that event MON 15895 has
no impact against non-target organisms except those already inherent to
the culture of cotton;
12. Field data indicate that water and soil quality improved due to the less
use of pesticides in cultivars of GM cotton;
not applicable
EN
not applicable
EN
As established by Article 11 of Law no. 11,460, of March 21, 2007 “research and
cultivation of genetically modified organisms may not be conducted in indigenous
lands and areas of conservation units.”
EN
cultivation of genetically modified organisms may not be conducted in indigenous
lands and areas of conservation units.”
not applicable
EN
There are not in Brazil species sexually compatible with G. hirsutum displaying
characteristics of invading plants, and it is extremely unlikely that genes cry1Ac
and cry2Ab2 be transferred to pests making them more invasive. The cotton plant
has not any characteristic associated to potential invasiveness, such as seed
dormancy, persistence in soil, germination under adverse environmental
conditions, rapid vegetative growth, short life cycle, high production of seeds and
dispersion of seeds at long distance. Therefore, it is deemed unlikely that
herbaceous Bollgard II cotton may change into a pest plant.
It is worth noticing that genes cry were isolated from a soil bacterium B.
thuringiensis. Therefore, exposure of living organisms and environment to this
bacterium or to any element thereof is an event that occurs abundantly in nature.
EN
characteristics of invading plants, and it is extremely unlikely that genes cry1Ac
and cry2Ab2 be transferred to pests making them more invasive. The cotton plant
has not any characteristic associated to potential invasiveness, such as seed
dormancy, persistence in soil, germination under adverse environmental
conditions, rapid vegetative growth, short life cycle, high production of seeds and
dispersion of seeds at long distance. Therefore, it is deemed unlikely that
herbaceous Bollgard II cotton may change into a pest plant.
It is worth noticing that genes cry were isolated from a soil bacterium B.
thuringiensis. Therefore, exposure of living organisms and environment to this
bacterium or to any element thereof is an event that occurs abundantly in nature.
molecular traditional methods
EN
EN
- National Technical Biosafety Comission [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
