Argentina has been a global leader in advancing genetic engineering in the agricultural sectors. The first GE crop was approved in 1996. With more than 26 million hectares planted with GE soybean, corn, and cotton crops, it is one of the three leading countries in the use of GE crops.
In 2015, Argentina became the first country in the world to develop regulatory criteria for gene editing and other new breeding techniques (NBTs). Now known globally as the “Argentina model,” the country only regulates genome-edited plants with permanent insertion of foreign DNA. A dossier needs to be submitted to determine if they are exempt. All gene-edited products must be submitted on a case-to-case basis to the Argentine Biosafety Commission (CONABIA) or are otherwise considered and regulated as a GMO. There is no legally mandated label for genetically engineered food, GMOs or gene-edited foods.
CONABIA must respond within 60 days whether a new product will be subject to GMO regulations. CONABIA considers: a) the techniques used in the process; b) the genetic change in the final product; and c) the absence of a transgene in the end product. Even if a crop is exempt from GMO regulations, if it possesses characteristics that present the probability of significant risk it can result in further monitoring by authorities.
In 2020 Argentina updated its regulation framework, linking it more closely to the Cartagena Protocol. It specifically updated the stacked GM crops assessment, which at present applies to transgenic crops. Previously, each stacked GM event in crops needs to be assessed independently. This is still the case, but the process is simplified and unimportant information of every independent event can be skipped in the final assessment. Stacked traits are treated on the same case-by-case basis for each new event.
With 80 “events” approved already, Argentina sets to approve more foods, with crops in various stages of greenhouse experimentation, field trial, and commercial availability.
Products/Research
- Approved Non-browning potatoes, 2018: The Institute of Agricultural Technology of Argentina (INTA) used CRISPR to develop potatoes that don’t turn brown. The genes of the sugars responsible for the browning process were turned off. Field trials began in 2020.
- Research Boll Weevil-resistant Cotton, 2019: Using gene silencing, INTA developed cotton that blocks an essential gene for weevil functionality.
- Research Higher quality alfalfa, 2019: INTA is using CRISPR to develop more productive and higher quality alfalfa.
Regulatory Timeline
2020: Multiple updates to the Regulatory framework done, based on the Cartagena Protocol.
2019: Ministry of Production and Work – Directorate of Biotechnology establishes the “Form for the presentation of Instances of Prior Consultation for plants, animals, and microorganisms obtained through New Improvement Techniques”, which streamlines CONABIA’s process to decide if new animals, microorganisms and crops obtained by gene editing will be considered a GMO or not.
2018: Argentina and 12 other nations, including Canada, Australia, Brazil and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”
2018: Ministries of Agriculture of the South Agricultural Council (Argentina, Brazil, Chile, Paraguay and Uruguay) publish declaration stating they would avoid arbitrary and unjustifiable distinctions between agricultural products obtained by gene editing and those obtained through other methods, share information about the development of products and regulatory frameworks, explore opportunities for regional and international harmonization, and work together including with other countries to avoid obstacles.
2015: Resolution 173/2015 establishes a case-by-case consultation process to determine if a gene edited product is within the scope of GMO legislation.
2011: Provisions No. 701 defines a Genetically Modified Organism as any living plant organism that possesses a combination of genetic material obtained through the use of modern biotechnology.
2004: Resolution 46/2004 requires GMO seeds to be registered in a specific National Registry of Operators of Genetically Modified Plant Organisms. Registration is a prerequisite to request authorization for the release of genetically modified organisms (GMOs) for testing and to obtain authorization for import or export of GM plants.
NGO Reaction
Environmental advocacy groups, including Argentina sin Tansgenicos (Argentina without transgenics), take the stance that gene editing is just the newest version of transgenic modification, arguing that gene editing has not been tested enough for safety and could lead to unintended side effects, so should be regulated as GMOs.
Additional Resources
- USDA Agricultural Biotechnology Annual 2022: Argentina
- Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina
- The regulatory current status of plant breeding technologies in some Latin American and the Caribbean countries
- Regulation of Genome Editing in Plant Biotechnology
- Gene Editing Regulation and Innovation Economics
- Biosafety Clearing-House: Argentina
- Biotec-LATAM: Argentina
Updated: 01/31/2023
