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Risk Assessment generated by a regulatory process
(RA)
published: 21 Jul 2009
last updated: 22 Apr 2013
Approval of Herbicide Tolerant and Insect Resistant Cotton (Widestrike)
EN
19 Mar 2009
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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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Person:Dra Maria Sueli Felipe SoaresPresident,Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,Related OrganizationNational Technical Biosafety Comission (CTNBio)Government agency (National/Federal)Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,
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DAS-24236-5 × DAS-21Ø23-5 - WideStrike™ cotton| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths))
- National Thecnical Biosafety Commission [ English ]
There are no binding sites for the d-endotoxins of Bacillus
thuringiensis at the surface of the intestinal cells of mammals, therefore domestic
animals and humans are not susceptible to such proteins. A number of
experiments testing Bt proteins showed the lack of toxicity to man and
vertebrates, absence of adverse effects to non-target organisms and to the
environment.
EN
thuringiensis at the surface of the intestinal cells of mammals, therefore domestic
animals and humans are not susceptible to such proteins. A number of
experiments testing Bt proteins showed the lack of toxicity to man and
vertebrates, absence of adverse effects to non-target organisms and to the
environment.
All possible interactions among proteins Cry1F, Cr1Ac and PAT were
assessed in order to estimate any possible unforeseen interactions that
my cause adverse effects to man and animals, and all results supported
the initial evidences that stacked cotton is safe from the alimentary point
of view;
3. Event 281-24-236/3006-210-23 Cotton contributes to reduce the use of
insecticides and, consequently, reduces the impacts of such pesticides in
the environment, human and animal health;
4. The use of technology such as insect-resistant Bt cotton may have a
positive impact to population preservation of non-target organisms and
beneficial insects, making integrated management of crop pests easier;
5. Cultivation of event 281-24-236/3006-210-23 cotton will not cause
changes in the soil and its functional and ecologic relations different from
the changes caused by conventional corn varieties;
6. Proteins Cry1F and Cr1Ac have very specific action and act, through
ingestion only, in some species of the Lepidoptera order;
7. Protein PAT was extensively discussed by CTNBio during analysis
related to commercial release of Liberty Link corn, Bt corn and Liberty
Link cotton, where the conclusion was that such protein has no known
toxic and allergenic potential and that is rapidly digested by enzymes
(proteases) in the digestive system of animals, eliminating most of this
protein potential to be allergenic when consumed;
8. Assessment of proteins Cry1F and PAT expressed in event 281-24-236
and proteins Cr1Ac and PAT expressed in event 3006-210-23 failed to
identify any allergenicity potential in food products;
9. The event produces a protein that is toxic to some cotton pest insects
only, and does not have properties allergenic to mammals;
10. The source organism of proteins Cry1F and Cr1Ac, Bacillus thuringiensis,
and PAT, Streptomyces viridochromogenes are not recognized as
allergenic;
11. There are no ecologically relevant concerns with cultivation of 281-24-
236/3006-210-23 cotton expressing proteins Cry1F and Cr1Ac, since no
adverse environmental effect associated to this product was recorded;
12. Event 281-24-236/3006-210-23 Cotton is nutritionally equivalent to
conventional cotton;
13. Nutritional and productive equivalence of WideStrike Cotton was
evidenced in different research works conducted in the United States and
herein enclosed;
14. Nutritional quality of cotton remained unchanged related to ashes, total
fat, humidity, protein, carbohydrate, calorie, total fiber, fiber in acid
detergent, fiber in neutral detergent, amino acids in seeds and bran, fatty
acids in seed and seed oil, tocopherols in seed oil fraction, antinutrients in
leaf and floral bud and seed, oil and bran;
15. Crossing of WideStrike Cotton event 281-24-236/3006-210-23 with wild
kindred cotton and generation of hybrid offspring that may change into
pest plants harmful to agriculture or plants invaders of natural habitats is
unlikely;
16. Finally, given the detailed data submitted by applicant, the results
obtained in control and safety essays on this genetically modified
organism, the elements credited to authors of scientific works mentioned
and inexistence of facts contrary to nutritional, toxicological and allergenic
safety, no matter how much they have been scrutinized;
EN
assessed in order to estimate any possible unforeseen interactions that
my cause adverse effects to man and animals, and all results supported
the initial evidences that stacked cotton is safe from the alimentary point
of view;
3. Event 281-24-236/3006-210-23 Cotton contributes to reduce the use of
insecticides and, consequently, reduces the impacts of such pesticides in
the environment, human and animal health;
4. The use of technology such as insect-resistant Bt cotton may have a
positive impact to population preservation of non-target organisms and
beneficial insects, making integrated management of crop pests easier;
5. Cultivation of event 281-24-236/3006-210-23 cotton will not cause
changes in the soil and its functional and ecologic relations different from
the changes caused by conventional corn varieties;
6. Proteins Cry1F and Cr1Ac have very specific action and act, through
ingestion only, in some species of the Lepidoptera order;
7. Protein PAT was extensively discussed by CTNBio during analysis
related to commercial release of Liberty Link corn, Bt corn and Liberty
Link cotton, where the conclusion was that such protein has no known
toxic and allergenic potential and that is rapidly digested by enzymes
(proteases) in the digestive system of animals, eliminating most of this
protein potential to be allergenic when consumed;
8. Assessment of proteins Cry1F and PAT expressed in event 281-24-236
and proteins Cr1Ac and PAT expressed in event 3006-210-23 failed to
identify any allergenicity potential in food products;
9. The event produces a protein that is toxic to some cotton pest insects
only, and does not have properties allergenic to mammals;
10. The source organism of proteins Cry1F and Cr1Ac, Bacillus thuringiensis,
and PAT, Streptomyces viridochromogenes are not recognized as
allergenic;
11. There are no ecologically relevant concerns with cultivation of 281-24-
236/3006-210-23 cotton expressing proteins Cry1F and Cr1Ac, since no
adverse environmental effect associated to this product was recorded;
12. Event 281-24-236/3006-210-23 Cotton is nutritionally equivalent to
conventional cotton;
13. Nutritional and productive equivalence of WideStrike Cotton was
evidenced in different research works conducted in the United States and
herein enclosed;
14. Nutritional quality of cotton remained unchanged related to ashes, total
fat, humidity, protein, carbohydrate, calorie, total fiber, fiber in acid
detergent, fiber in neutral detergent, amino acids in seeds and bran, fatty
acids in seed and seed oil, tocopherols in seed oil fraction, antinutrients in
leaf and floral bud and seed, oil and bran;
15. Crossing of WideStrike Cotton event 281-24-236/3006-210-23 with wild
kindred cotton and generation of hybrid offspring that may change into
pest plants harmful to agriculture or plants invaders of natural habitats is
unlikely;
16. Finally, given the detailed data submitted by applicant, the results
obtained in control and safety essays on this genetically modified
organism, the elements credited to authors of scientific works mentioned
and inexistence of facts contrary to nutritional, toxicological and allergenic
safety, no matter how much they have been scrutinized;
not appllicable
EN
not appllicable
EN
According to Article 1 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
“research and cultivation of genetically modified organisms may not be conducted
in indigenous lands and areas of conservation units”.
not appllicable
EN
Modern agriculture is an activity responsible for significant negative
environmental impacts(9, 42, 79, 155, 193) and, therefore, the risk assessment of any
GM event shall be conducted in relation to that impact inherent to conventional
agriculture(13, 46, 138). Therefore, the analysis conducted by CTNBio intended to
assess whether the impact caused by WideStrike Cotton is significantly higher
than the one caused by conventional cotton varieties considering the practices
associated to each system.
All species of the Gossypium genus posses perfect flowers. Fecundation takes
place promptly after anthesis, and either self-fecundation, crossed pollination or
both are possible. The cotton plant pollen is relatively large, ranging from 81 to
143 micra, viscous (making the pollen grains to adhere to each other), spherical
in format, covered by a large amount of spicules and in practice is not transported
by wind(47). In the fields, its viability extends to late afternoon, but may last for up
to 24 hours if stored at temperatures from 2ºC to 3ºC(27). In order for crossed
fecundation to happen, presence of pollinating insects is necessary, mainly those
insects of the Hymenopterae family(29, 149, 150, 164). The crossing rate recorded
between cotton plant cultures is relatively low, displaying figures that enable
classifying cotton as a partially autogamous species or a species of a mixed
reproduction system.
Some authors suggest that gene flow from GM plants to wild genotypes may
result in biodiversity reduction. However, reduction of genetic variability results
from gene introgression, a process far more complex than simple hybridization(46,
49, 80, 175). In order for introgression to happen, hybridization is first necessary and
later a series of retro-crossings so that a gene be incorporated in a permanent
way into a new genome(80, 81).
EN
environmental impacts(9, 42, 79, 155, 193) and, therefore, the risk assessment of any
GM event shall be conducted in relation to that impact inherent to conventional
agriculture(13, 46, 138). Therefore, the analysis conducted by CTNBio intended to
assess whether the impact caused by WideStrike Cotton is significantly higher
than the one caused by conventional cotton varieties considering the practices
associated to each system.
All species of the Gossypium genus posses perfect flowers. Fecundation takes
place promptly after anthesis, and either self-fecundation, crossed pollination or
both are possible. The cotton plant pollen is relatively large, ranging from 81 to
143 micra, viscous (making the pollen grains to adhere to each other), spherical
in format, covered by a large amount of spicules and in practice is not transported
by wind(47). In the fields, its viability extends to late afternoon, but may last for up
to 24 hours if stored at temperatures from 2ºC to 3ºC(27). In order for crossed
fecundation to happen, presence of pollinating insects is necessary, mainly those
insects of the Hymenopterae family(29, 149, 150, 164). The crossing rate recorded
between cotton plant cultures is relatively low, displaying figures that enable
classifying cotton as a partially autogamous species or a species of a mixed
reproduction system.
Some authors suggest that gene flow from GM plants to wild genotypes may
result in biodiversity reduction. However, reduction of genetic variability results
from gene introgression, a process far more complex than simple hybridization(46,
49, 80, 175). In order for introgression to happen, hybridization is first necessary and
later a series of retro-crossings so that a gene be incorporated in a permanent
way into a new genome(80, 81).
Molecular Phenotypical Methods
EN
EN
- National Technical Biosafety Commission [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
