Brazilian biosafety law and the new breeding technologies

Abstract

Globally, the area of land cultivated with genetically modified (GM) crops has increased a thousand-fold over the last two decades. Although this technology has become important for food production, the regulatory frameworks that underpin these outcomes are based on a list of requirements for a risk assessment that differ from country to country. In recent years, policymakers have had the opportunity to learn from the controversies over transgenics to create effective regulatory milestones for emerging technologies, allowing them to reach their potential for a more sustainable agriculture, ensuring food security. In Brazil, Law No. 11.105 of 24 March 2005 established a framework with four main organizations responsible for risk assessment and management. However, most of new breeding technologies did not exist at that time and were not considered in this law. In 2016, Normative Resolution No. 16 of the National Biosafety Technical Commission (CTNBio) was established to address this gap based on the evaluation of the products obtained through these techniques (termed Innovative Precision Improvement Techniques in the resolution), in a case-by-case consultation system. Briefly, if the product is designated to be a GM, the developer will have to go through the biosafety requirements and will be approved only after CTNBio risk assessment. If the product is designated not to be GM (for the purposes of the legislation), then it can be registered using the existing procedures. Currently, 152 GM products are commercially approved in Brazil. In 2018, CTNBio assessed the first consultation on commercial release of plants generated using the new breeding technologies and has subsequently approved six products. It is expected that many institutions would be able to participate in Brazilian and world markets, developing and introducing new biotechnological solutions and products through a more sustainable approach and without facing public disapproval, a common issue for GM crops.

Keywords

Brazilian legislation / CTNBio / genetically modified crops

References

[1] Global Status of Commercialized Biotech/GM Crops in 2017: Biotech Crop Adoption Surges as Economic Benefits Accumulate in 22 Years. ISAAA, 2019, 53 (in Portuguese). Available at ISAAA website on October 8, 2019

[2] Malingreau J P, Eva H D, de Miranda E E. Brazilian Amazon: a significant five year drop in deforestation rates but figures are on the rise again. Ambio, 2012, 41(3): 309–314

[3] Biotechnology Information Board, 2019(in Portuguese). Available at CIB website on October 8, 2019

Compliance with ethics guidelines

Alexandre Lima Nepomuceno, Renata Fuganti-Pagliarini, Maria Sueli Soares Felipe, Hugo Bruno Correa Molinari, Edivaldo Domingues Velini, Eduardo Romano de Campos Pinto, Maria Lucia Zaidan Dagli, Galdino Andrade Filho, and Patrícia Machado Bueno Fernandes declare that they have no conflicts of interest or financial conflicts to disclose.

This article does not contain any studies with human or animal subjects performed by any of the authors.

RIGHTS & PERMISSIONS

The Author(s) 2019. Published by Higher Education Press. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0)