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Central America, Model Regulatory System for CRISPR Genome Editing in the Agricultural Sector

Agricultural seeds are essential, and with their genetic editing, a universe of opportunities has opened up for new seeds that contribute to the adaptation to climate change, to increase production and to improve food for a better quality of life. The challenge today is how to regulate genetically edited seeds.

The process of genetic improvement traditionally relies on identifying traits of interest and transferring them by pollination to commercial materials, or by inducing changes in the genome in a general way by means of tissue culture and the use of mutagenic agents such as ionizing radiation, UV light and chemical agents. These adjustments occur both in nature and by human intervention.

In 2012, the discovery of the CRISPR-Cas9 tool capable of locating and correcting hereditary material marked a milestone for humanity. In the agricultural sector even more so, because it is possible to eliminate, adjust or improve the traits of a crop in a precise way, and in much less time. The new techniques do not incorporate any additional genetic information, but rather adjust the genetics of the crop itself. It is for this reason that many of the legal norms that are emerging on this subject are based on the comparison with conventional breeding.

The legal status of an edited seed depends on the established norms at the country level based on a process that determines if the seed is a Living Modified Organism (LMO) or not. For Argentina, Australia, Colombia, Brazil and the United States, an edited seed is equivalent to a conventional one in the absence of foreign DNA.

Central America applies the same legal logic, with the particularity that it has exemplary regulations due to its international approach and specific procedures. The Central American countries are signatories to the Cartagena Protocol on Biosafety or Biological Diversity Agreement, which defines a Living Modified Organism (LMO) as “any living organism that has a new combination of genetic material obtained through the use of modern biotechnology. The keywords for clarifying what an LMO is “new combination of genetic material”. Since genetically edited seeds do not have combinations of genetic material, they are not considered LMOs. Furthermore, in Central America a new combination of genetic material is defined as meaning a stable insertion of DNA that could not be obtained through conventional breeding or is available in nature. This legal background provides a perspective for countries with regulations still under discussion and offers an international term for a science-based discussion.

An example of regulatory evolution is taking place in Europe, where a Supreme Court ruling had mandated that the Genetically Modified Organisms (GMO) rule apply to genome-edited plants. This led to an analysis and a proposal for a regulation in 2023 where the equivalence of conventional breeding with certain genome editing techniques is effectively recognized.

Breeding based on genetic editing techniques is a reality. In the U.S., you can find less-spicy mustard greens that look like lettuce and stay fresh longer, and healthy, temperature-stable, high-oleic oil produced with new soybean varieties. In Japan, fortified tomatoes that can lower blood pressure are available, and the Philippines has authorized a banana that doesn’t turn brown.

Products with better shelf life, better texture, cyanide-free cassava, rice with low arsenic content, low-cadmium cacao, gluten free wheat, lectin-free soybeans, and low-caffeine coffee are just some of the possibilities of gene editing. Fortunately, the countries are adopting regulations that favor technical and scientific analysis, so that the new edited seeds can reach the farmer and the consumer.

*CropLife Latin America is an international, non-profit trade organization, made up of six companies and a network of 26 associations in 18 Latin American countries. www.croplifela.org

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