Agriculture Reference
In-Depth Information
the regulation of products of agricultural biotechnology, among others. It
evaluates the scientific and technical issues of environmental, health, and
agricultural aspects of releasing GM crops and it reviews applications for
testing and commercializing GM crops in the country. Different from the
American model, it concentrated the screening of GM crops in one single
institution.
In accordance with Articles 2 and 3 of Statute n. 8974, combined with
Chapter V of Decree n. 1752, dated December 20, 1995, national, for-
eign, or international entities that develop, or intend to develop, activi-
ties and projects related to GMOs and derived substances, must request
a CTNBio a Certificate of Quality in Biosafety (CQB). Furthermore, to
conduct a GMO field trial, the proponent must follow the steps required
by CTNBio's norms. For example, the first step is a proposal by the
chief researcher to conduct the field trial. This proposition is analyzed
by a Biosafety Committee of the proponent organization, followed by
an analysis conducted by CTNBio. The final decision is that of CTNBio,
allowing or forbidding the field trial.
After at least one release into the environment has been approved
and the safety of the GM crop has been demonstrated, the applicant
can apply for a “flexibilization” permit, which allows future releases and
the commercialization of the GM crop. A GM crop that was previously
approved by the CTNBio for planned release may be exempted from
these norms providing that, according to the judgment of the CTNBio,
the experience has shown acceptable risk levels. An exemption may be
unconditional or subject to conditions. The guidelines of CTNBio are
similar to those in the United States, because they are based on the char-
acteristics and risks of end products, not the process.
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with special emphasis on safety of the material and protection of living beings and
the environment. The Biosafety Quality Certificate is required by domestic or interna-
tional entities or companies as a prerequisite to the development of activities related
to GM crops and derivatives. Among these entities are those dedicated to teaching,
scientific research, technological development, and provision of services involving GM
crops and derivatives on Brazilian territory.
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Article 7, item VII of Statute n. 8974/1995.
