Brazil, China have a lot to cooperate and benefit from, says Geraldo Berger, Head of Regulatory Science LatAm at Bayer

By Leonardo Gottems, reporter for AgroPages

AgroPages spoke exclusively with Geraldo Berger, Head of Regulatory Science LatAm at Bayer Crop Science. In this interview, he talks about the regulatory landscape in Brazil and in what aspects the country needs to evolve. Finally, he explains how the “regulatory synchrony” proposed by Bayer between Brazil and China would work, and how both can benefit from it. 

How do you analyze the current regulatory scenario in Brazil?

Brazil has evolved positively in the regulatory framework of biotechnology, always based on risk assessment which, in turn, based on science. The first Biosafety Law was enacted in 1995, which allowed the scientific advancement of biotechnology in Brazil beyond Universities and Research Institutes, creating a regulatory framework that opened the opportunity for the advancement of biotechnology in public and private institutions. With this milestone, it evolved to the point where the National Technical Biosafety Commission (CTNBio) approved the first commercial biotechnology product in Brazil in 1998, which was Roundup Ready soy.

In the following years, there was a need to evolve this framework and place more emphasis on scientific components and risk assessment as the basis for the biosafety assessments of biotechnology products in Brazil. Both, the scientific basis and the requirement for CTNBio members to have academic training (Ph.D.) in several biological areas of plants, environment, animals and humans were fundamental to consolidate technical standards with scientific rigor for the evaluation, review and approval of several biotechnology products. 

Today, there are hundreds of products linked to different areas, including plants generated by biotechnology that are essential for the sustainable development of our tropical agriculture. A relevant aspect is the transparency, openness and frequency of CTNBio meetings and decisions, which are public and also the technical opinions (extracts) that are published in the Federal Official Gazette to publicize these decisions.

What advances do you believe are important for the country in the coming years?

The CTNBio continues to evolve and review its regulations for the modernization of its biotechnology product evaluation system. This has allowed for the increasing participation of new actors in different segments, and from plants to vaccines developed by biotechnology. A pioneering evolution was the establishment of a standard to assess whether innovation by gene edition is considered a genetically modified organism (GMO) or not. If not, this product follows the process already established in the inspection and registration bodies (MAPA, Ibama, or Anvisa) and proceeds to its commercialization.

I believe that the fundamental aspect is precisely the risk assessments that CTNBio conducts based on science. Today, Brazilian agriculture has soybean, corn and cotton crops, mainly, but also sugar cane and eucalyptus. It has biotechnology as its main tool to help farmers grow in sustainable production. In this moment of the COVID-19 pandemic, the vast majority of vaccine research and development uses biotechnology as the basis for this evolution and CTNBio is evaluating and approving research in this area that is so relevant to humanity today.

How would the ‘regulatory synchrony’ proposed by Bayer between Brazil and China work?

For a biotechnology product to be evaluated and tested in China, it is necessary for a country that will grow this product to approve it commercially. In other words, the Chinese regulatory process only begins after prior commercial approval in another country, such as Brazil, for example. This is a requirement that only China has in the world and creates a very long delay in the development of new products and technologies that help farmers to have more productivity, sustainability and also greater stability of production and consistency of grain generation, which is one of the main products that China imports. 

In other words, what we propose is for China to withdraw this requirement and allow the beginning of scientific review and tests in parallel, at the same time as Brazil. This simple change can reduce the launch of new technologies by three to five years. Not only would Brazil benefit, but China itself would also benefit from increased availability and stability of Brazil's grain production.

There are good cooperation and technical collaborations between Brazil and China in their bilateral forums. Brazil and China should establish a pilot project to evaluate this opportunity, which can scientifically benefit both countries, Brazilian farmers and the availability of grains for China. This pilot project would be supported by the biosafety risk assessment of all approved genetically modified plants those in Brazil by CTNBio that were also approved by the National Biosafety Council (NBC/MARA) in China. In other words, the scientific criteria are the solid basis for these assessments and there are numerous opportunities for scientific collaboration between CTNBio and NBC.

After the approval of Intacta 2 Xtend in China, what stage is the release in Europe at?

Intacta 2 Xtend (I2X) is in the final approval phase in Europe. There is already a favorable opinion from the Food Safety Authority (EFSA) of Europe for I2X and only needs the ratification of the European Union, which we estimate for the end of 2020.

What innovations would you like to highlight for the coming years and months?

I2X will bring a new level of productivity to the Brazilian farmer. This will provide more efficient and sustainable soy production in Brazil. Biotechnology is a fundamental tool that must be expanded to develop new products for tropical agriculture. Brazil and China have a lot to cooperate and benefit from this technology.