Brazilian biosafety law and the new breeding technologies

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.