Agriculture Reference
In-Depth Information
(GMOs), with the purpose of protecting the life and health of humans,
animals, and plants, as well as the environment. It defined GMOs,
genetic engineering, DNA/RNA, and related expressions, regulated the
role of the National Biosafety Technical Commission (CNTBio), estab-
lished limits on genetic manipulation of living organisms and the release
and disposal of GMOs, and listed activities that would be illegal and sub-
ject to fines and penalties. It also set forth procedures for the review and
approval of GM crops.
Brazil had two paradigms to choose from when regulating these
issues, namely the approaches being taken in Europe and North Amer-
ica, which are markedly different. In the EU, regulations are focused on
the process of making GM crops; in the United States, on the character-
istics of GM products. Brazil, as many other countries, considered both
approaches in developing its 1995 law and established a system for regu-
latory oversight of GM crops that also incorporated controls for genetic
engineering research (Article 225). The Departments of Health, of the
Environment, and of Agriculture were made responsible for overseeing
production, harvest, and trading of GM organisms and GM crops. Most
observers view the Brazilian model, since its inception, as being closer
to the American paradigm, for it is based on the features of each GM
product.
This law also created the National Biosafety Technical Commission
(CTNBio),
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a multidisciplinary advisory group that is responsible for
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The Federal Biosafety Regulatory Agency, CTNBio, is formed by one representative
each of the Departments of Science and Technology; Health; the Environment; Edu-
cation and Sports; Foreign Affairs; two representatives of the Department of Agricul-
ture, Supply and Agrarian Reform; of one representative from a legally established
consumer defense agency; of one representative from legally established associations
representing the biotechnology business sector, nominated by the Minister of Science
and Technology, based out of a list of three names submitted by these associations;
and of one representative from a legally established agency for protection of work-
ers' health. These members of CTNBio serve for a term of three years and may be
reelected once. The agency is responsible for issuing standards and biosafety quality
certificates. Standards and provisions to be issued by CTNBio and pertaining to activi-
ties and projects related to GM crops and derivatives will include their making, culture,
handling, use, transportation, storage, marketing, consumption, release, and disposal,
