Argentina and Brazil merge law and science to regulate new breeding techniques

A Brazilian farmer in the São Francisco River Valley in Pernambuco. Photo: Depositphotos

Author: Pablo Orozco, attorney in Guatemala and an Alliance for Science Legal Affairs Fellow.

New breeding techniques, or “NBTs” as they have come to be known, are a set of innovative tools that can have remarkable impacts in the fields of animal and plant science. They equip scientists with more precision and thus can allow more efficient and effective impacts when tackling emerging environmental and food security problems.

In the field of agriculture, they are different from methods that have been employed in the past. NBTs may utilize molecular biology techniques similar to the ones used by “modern agricultural biotechnology,” but can create end-products that do not have a transgene, and thus are more similar to crops produced by “conventional” breeding methods than to GMOs. Due to these defining characteristics they may not fit into the biotech oversight provisions established around the world. This means that policymakers are faced with the task of deciding how to regulate them.

To up the stakes, national legislation on the matter will also have consequences on world trade and on the way international sharing of technological advancements is conducted.

The world’s governments have different opinions on how to approach the issue and their legislative bodies are starting to come forward with possible solutions. South America now has two initial approaches to look at: Argentina, through its resolution number 173/2015; and Brazil’s normative resolution number 16, published this past week. The concepts, principles and scope of national biosafety laws in Argentina and Brazil served as the starting point for their approach, but both countries leveraged their experience in regulating new technologies in order to balance risk assessment and the allowance of innovation.

Argentina continues its pioneering approach

Argentina’s previous provisions (No. 701 of 2011) defined a Genetically Modified Organism as “any living plant organism that possesses a combination of genetic material obtained through the use of modern biotechnology.” This means its regulation can be triggered by a) the presence of novel traits in the end product; and b) the genetic modification process used. Thus its NBT resolution is regulated in a way that distinguishes them on both levels.

Moreover, as one of the first countries in the world to establish a regulatory framework for GMOs, Argentina is well aware of both the added value and the complex and evolving issues that each new technology can represent and rightfully highlights the heterogeneity that characterizes crops derived of NBT techniques in resolution 173/2015.

Consequently, Argentina establishes a case by case assessment, through a simplified procedure in which applicants can request the corresponding administrative authority to determine if a product falls under the category of a GMO or not.

The analysis considers a) the techniques used in the process; b) if there was a permanent genetic change; and c) the absence of a transgene in the end product. Moreover, the process prioritizes risk analysis by stating that even if a crop is exempt from GMO regulations, if it possesses characteristics that may present the probability of a noteworthy risk it can be susceptible to further monitoring by the corresponding authorities. At the same time, in line with its biosafety bill considerations and in order to help developers with time efficiency, the norm allows preliminary inquiries to be filed for products in the pipeline, thus allowing developers to anticipate if their expected products will fall within the scope of GMO regulations.

Argentina’s approach integrates regulatory, commercial and technological concepts in order to keep a conscious balance of safety considerations while not disregarding product development.

Brazil takes a major step

Brazil has also taken a major step in this direction with the new Normative Resolution 16 (NR 16). It establishes the requirements for a consultation on whether a product can be exempt from the GMO regulatory framework. Thus in some cases the full risk assessment and management for GMOs must be applied, while in other cases products deriving from NBTs and innovative precision improvements can be exempt.

It is a hybrid system, focusing mainly on the characteristics and safety of the final product. It considers whether an introduced genetic material is absent, as well as the risk level classification of the modified organism. When applicable, it also takes into account information on the manipulated genes or genetic elements function and whether the product has already been approved for commercialization in other countries.

According to this new NR 16, the National Technical Commission on Biosafety (CTNBio) can exempt new products from the same GMO regulatory assessment. However, since Brazil’s previous provisions consisted of GMO regulation heavily triggered by the genetic modification procedures used, NR 16 contains an annex with a list of NBT procedures that may create a product not considered a GMO. It includes the caveat that the resolution is not limited to these examples, and may ultimately apply to other forthcoming technologies. The inclusion of a list differs from the Argentinian resolution, but the overall case-by-case approach is the same.

Moving forward

NBT regulations must respond to each country’s national biosafety definitions and its triggering characteristics. Moreover, in Latin America most countries’ established governances on biotechnology rely heavily on principles and concepts enshrined in the Cartagena Protocol on Biosafety, with many applying it in a supplementary manner or utilizing it as the basis for their national legislation.

The recent actions taken by Argentina and Brazil set an example for how to use detailed concepts, scientific peer review data and sound technical advice to regulate NBTs and ensure that policy makers are not shackled by rules that were developed for different procedures.