Abstract
The emergence of new technologies for genetic modification has broadened the range of possible new products. The regulations of many countries that could benefit from these new products may not be prepared to assess risks and enable science-based decision-making. This is especially acute in the case of genetically modified insects with potential use in public health and agriculture. Modifications of the regulatory framework, sometimes necessary to allow a proper risk assessment of products from new technologies, are strongly influenced by political decisions derived from the balance of power and interest among stakeholders. This article discusses the genesis of the Brazilian regulatory framework, its applicability for the risk assessment of genetically modified insects and the scenarios that have shaped the two biosafety laws that established the basis for the use of modern biotechnology in the country. It is concluded that, for the adoption of the new technologies, it is important to carefully navigate the political tensions by seeking the engagement and empowerment of stakeholders supporting science-based decision-making in order to gather the necessary support for adoption of risk assessment as the basis for final decisions, allowing the use of new technologies.
Highlights
The emergence of new technologies for genetic modification has broadened the range of possible new products
In 1995, the first Biosafety Law created a centralized agency – the National Biosafety Technical Committee (CTNBio) - to assess Genetically modified organism (GMO) risks and to decide on a scientific basis if a GMO can be used in field experiments or commercially released
If new hazards or damages are identified by any third party, they can be reported to National biosafety technical committee (CTNBio), which must reassess the product and, if non-negligible risks are identified, act
Summary
The emergence of new technologies for genetic modification has broadened the range of possible new products. The structure and function of the Brazilian National Biosafety System Like many other countries, Brazil has adopted a technology-based approach to regulate GMOs [1].
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