Brazil needs to change Cultivar Protection Law to regulate gene editing, says head of Embrapa Soybean

The new genetic editing techniques ″require that concepts and the Brazilian regulatory framework be reviewed, such as the Cultivar Protection Law (LPC),″ said Alexandre Nepomuceno, General Manager of the National Soy Research Center (CNPS), of Embrapa Soja (Brazilian Agricultural Research Corporation).

Alexandre Nepomuceno, General Manager of the National Soy Research Center (CNPS), of Embrapa Soja (Brazilian Agricultural Research Corporation)

Law No. 9.456, known as the Cultivar Protection Law (LPC), completed 25 years of existence this year. Its implementation was one of the factors responsible for securing intellectual property rights in developing commercial plant varieties in Brazil.

However, over these 25 years, new technologies in Genetics have emerged and changed the Brazilian and world seed markets.

Since the development of genetically modified (GM) plants in the mid-1990s, insect resistance and herbicide tolerance events have emerged.

″The global adoption of GM crops has increased hundreds of times over the last two decades, bringing many benefits to all of agriculture, but with a special weight in the seed production sector,″ Nepomuceno said.

According to him, the regulatory frameworks prolonged the commercial release process excessively and established very complex and often unnecessary requirements for risk assessment.

″In practice, the use of GMOs has been limited to a few companies that can afford the costs of commercial release. Another effect caused by this excessively complex regulation was to limit the use of technology to a few crops with high economic returns, such as agricultural commodities,″ the expert argued.

With the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) genome editing technique, many countries have considered Edited Organisms (OEs) conventional.

″That is, they are organisms that have undergone mutations similar to those that already occur in nature or that were obtained by other techniques already established for the production of genetic variabilities, such as classical breeding and the induction of mutations by ionizing radiation or chemical agents,″ justified the head of research at Embrapa Soja.

Aligned with these nations, through the National Technical Biosafety Commission (CTNBio), Brazil established Normative Resolution No. 16 (RN16), which regulated the use of gene editing, here called Innovative Techniques for Improvement of Precision (TIMP).

RN16 provides that analysis requests are forwarded to CTNBio using a query letter and evaluated on a case-by-case basis. Depending on the type of gene editing performed, the organism in question may not be considered GM. That is, it will be categorized as a conventional organism.

″The opportunities for an organism that, even having its genome edited through the introduction of a certain characteristic of interest, is considered conventional are enormous,″ Nepomuceno pointed out.

According to him, there would be a reduction in costs because it is not necessary to go through a complex deregulation process, different from what happens with GMOs: ″Biosafety is preserved, as there is a pre-analysis by regulatory agencies.″

″But the main gain is from the technological point of view. There is added value and the possibility of solving previously difficult challenges, which took decades to be solved, or even problems that were once impossible to solve via classical breeding. Through the CRISPR technique, at more reasonable costs and with the speed that agribusiness needs, we can now overcome these obstacles,″ he added.

″The LPC, when implemented, did not foresee this technological evolution in genome editing. In this sense, one must modernize the LPC, so that the scientific and technological investment made in developing a new commercial variety based on these technologies is rewarded,″  the specialist recalled.

″Otherwise, the use of this essential tool to produce genetic variability, bringing new solutions to problems and adding value to agribusiness products, will not have its full potential exploited,″ he said in conclusion.

(Editing by Leonardo Gottems, reporter for AgroPages)