A recent study published in Plants (Basel) by Dr. Miguel Ángel Sánchez, Executive Director of ChileBio, highlights Chile’s role in agricultural biotechnology. In 2017, Chile adopted a science-based regulatory framework for new breeding techniques (NBTs), including CRISPR and TALEN, solidifying its role as a regional innovation hub.
Genomic Editing in Agriculture
Genomic editing has revolutionized modern agriculture, enabling precise genetic modifications to enhance pest resistance, climate tolerance, productivity, and nutritional value. Techniques like CRISPR-Cas9 and TALENs offer faster, more precise improvements than traditional breeding, but their adoption depends on national regulatory policies.
Chile’s Regulatory Framework
The Agricultural and Livestock Service (SAG), under the Ministry of Agriculture, oversees biotechnology regulations. While Chile has not ratified the Cartagena Protocol, it aligns with its GMO definition but makes a key distinction: plants modified via NBTs without exogenous DNA are not classified as GMOs. This progressive regulatory approach treats such products as conventional, fostering agricultural innovation while maintaining biosafety standards.
Sánchez points out that “the regulatory process in Chile is not an authorization, but a case-by-case determination to establish whether a vegetable product is a GMO or not.” The application form consists of two sections: information of the applicant and technical information on the taxonomy, cultivars or lines, phenotype, biotechnological technique used, determination of the absence of foreign DNA and indication of whether the propagation material has been authorized by an official agency in another country. “The response time is 20 business days, and the process has been praised for its simplicity, speed and predictability,” describes the researcher.
Genetically Edited Products in Chile
Since the adoption of Chile’s regulatory framework in 2017, the Agricultural and Livestock Service (SAG) has reviewed 57 applications as of November 2024. Of these, 52 were classified as non-GMOs due to the absence of foreign genetic material, while 5 were designated as GMOs — either due to the use of a promoter from a non-sexually compatible species or the presence of the CRISPR/Cas system in the plant genome.
Applications have covered nine different crop species, with corn and soybeans being the most common. The most sought-after phenotypic characteristics include improvements in performance, resistance to fungal diseases and resistance to shelling of pods. The CRISPR-Cas9 technique is the most used, reflecting global trends in genomic editing preferences, according to a press release.
Chile has attracted requests from both local and foreign developers, with 7 of the 57 applications coming from local institutions and 50 from foreign entities, which reflects an international interest in using the Chilean regulatory route.
Sanchez points out that “of the 57 applications already submitted to the Chilean regulatory system, these included not 57 but 1,103 lines. Only 21 applications (37%) include only one line/cultivar to be evaluated by the SAG. Interestingly, 16 requests contain more than 10 lines, six have more than 50 and four have more than 100.” He adds that “the request that included the largest number of lines was one with 270”.
The researcher notes a growing trend towards multiplexing in the submitted applications, where multiple genes are edited simultaneously, or a single gene is modified in different regions. This approach is essential for developing complex traits like climate resistance and improved performance. In Chile’s NBT regulatory framework, 51% of the 57 applications have utilized multiplexing strategies.
The framework allows multiple lines derived from a single genomic editing process to be submitted under one request, simplifying the evaluation process and reducing administrative load.
You can access the full study: https://www.mdpi.com/2223-7747/13/24/3597
