CTNBio

TECHNICAL CONCLUSIVE OPINION

The National Technical Biosafety Committee (CTNBio) concluded in its 5th extraordinary meeting in 24th September 1998, the evaluation of biosafety (environment and food/feed) regarding the use in commercial scale of the soybean cultivar genetically modified "Roundup Ready". The technical conclusive report refers to genotypes derived from the soybean line GTS 40-3-2 or its progenies tolerant to the herbicide glyphosate, according to the request sent to CTNBio by the Monsanto do Brasil Ltda. (process # 01200.002402/98-60).

A. Analysis of the Process

CTNBio concluded that there is no evidence of environmental risk or to the human or animal health from the use of the genetically modified soybean in question. This decision was based on the following elements:

A.1. Environmental Elements:

A.1.1. A. Soybean is a predominant self-pollinated plant species with an outcrossing rate of about 1.0%. Soybean is an exotic species without wild relatives that are sexually compatible in Brazil. Therefore, cross-pollination with wild species in the natural environment is not possible in the national territory.

A.1.2. Soybean is a domesticated species and highly dependent on the human intervention for survival. Thus, there is no scientific reason to predict that the soybean lines derived from GTS 40-3-2 will survive outside the agricultural environment. Furthermore, without the selective pressure (glyphosate use) the expression of the inserted gene does not provide any adaptive advantage (increased fitness).

A.1.3. The transgenic insertion is molecularly characterized. There was no observation of any pleiotropic effects from the transgenic insertion in studies conducted in many environments.

A.1.4. There are at least three weed species known to be naturally tolerant to the glyphosate herbicide (Richardia brasiliensis, Commelina virginica, Spermacoce latifolia). The use of the herbicide for over two decades in Brazil did not cause the development of any other weed species tolerant to glyphosate. The introduction of cultivars tolerant to glyphosate will not increase the selection pressure over weeds in terms of the glyphosate concentration (product/area).

A.1.5. There is no evidence that the routine utilization of the herbicide glyphosate in the soybean crop has any negative effect in the biological nitrogen fixation process. This observation is based on trials conducted by government and private Brazilian institutions, which indicated that the continued use of the herbicide did not affect nodulation of the soybean cultivars. The marker gene nptII that codes for kanamycin resistance was not transferred into the GTS 40-3-2 line.

A.1.6. There is no indication that the use of the cultivars derived from the GTS 40-3-2 will lead to significant alterations in the profile and population dynamics of insects associated to the conventional soybean crop.

A.2. Human and Animal Health Elements:

A.2.1. CTNBio concluded that the introduction of the transgene does not alter the chemical composition of the soybean, with the exception of the transgenic protein CP4 EPSPS. This conclusion in the equivalence of the chemical composition is based on evaluations conducted by scientific methodologies, published in international scientific referee journals. The safety of the protein CP4 EPSPS regarding the toxicological and allergenic aspects were also proved. It is important to mention that the utilization of the transgenic soybean and products thereof in South, Central and North America, Europe, and Asia there is not even one case of allergic reaction of any human person that is not allergic to the conventional soybean. Also, it is important to consider that individuals sensible to conventional soybean will continue to be sensible to the transgenic soybean; therefore, they should not use this product.

A.2.2. The analysis of the literature did not confirm any alleged increase in the allergenicity of the transgenic soybean in relation to the commercial cultivars. The scientific articles available and cited about the matter did not demonstrate an increase in the levels of the proteins reactive to the serum of a pool of individuals sensible to soybean (Burks and Fuchs, 1995; J. Aller. Clin. Immun. 96:1008-1010). The authors point out that: "our studies demonstrated that the introduction of the gene coding for the EPSPS protein to confer tolerance to glyphosate did not cause any noticed modification, qualitative or quantitative, in the composition of the endogenous allergenic soybean proteins in any of the cultivars resistance to glyphosate analyzed".

B. Technical Conclusive Opinion:

CTNBio approves the request submitted by the Monsanto do Brasil Ltda (Process 01200.002402/98-60), observing the determinations below:

B.1. CTNBio determines the monitoring of commercial production areas of soybean cultivars derived from the breeding line GTS 40-3-2 for a period of five years with the objective to develop "compared studies" about the plant species, insects and microorganisms present in the fields. The verification of potential significant alterations to biosafety may result in the immediate suspension of the commercial production.

B.2. The interested party (Monsanto) must make available areas for conducting and be responsible for the scientific monitoring to generate the complementary information, which will be supervised by technical experts nominated by the CTNBio. The information must be obtained in parallel to the commercial production of the crop. The areas, dimensions, location will be established in regions representative of the soybean growing areas in mutual agreement between CTNBio and Monsanto.

B.3. The monitoring must include the following:

B.3.1. Variation of the specific composition of the weed species community in the area, including the composition and magnitude of the seed reserve in the soil, as part of the evaluation;

B.3.2. Incidence of escapes of weed species determining if this was a consequence of the transfer of the transgene.

B.3.3. Periodic evaluation of the population dynamics of the organisms "indicadors": insects, pathogens, nitrogen fixing and phosphate solubilizing microorganisms

B.3.4. Provide an annual technical report to the executive secretary of the CTNBio by June 15th, following the crop season

B.4. The monitoring areas will be open to a scientific auditing by the organized society institutions interested, with a previous authorization of the CTNBio, in the presence of the Agricultural Ministry inspector.

B.5. The interested party (Monsanto) must inform in the package of the product that the users of the new technology may have technical visits of CTNBio, in the terms defined above.

C. The CTNBio declares its own rights to reevaluate this guidelines any time the committee considers needed under a justification, the lines of direction listed in item B.

D. CTNBio understands that due to reasons of legal nature related to labeling and planting authorization, the commercial use of the transgenic soybean is still pending.

E. Due to the item III of the article 7 of the 8974/95 - Biosafety Law - and its decree 1752/95, CTNBio issue a favorable conclusive technical report regarding biosafety and it does not provide an authorization for planting of the soybean under consideration. This is the responsibility of other legal Federal Competent Authorities.

Luiz Antonio Barreto de Castro

Chairman of CTNBio