Gene-edited crops and food are regulated as conventional plants unless they contain foreign DNA, after a dossier is submitted to determine if they are exempt. Gene edited crops are assessed on a case-by-case basis by the Argentine Biosafety Commission (CONABIA). All gene-edited products must be submitted to CONABIA, or otherwise are considered a GMO.
In 2015, Argentina developed the first regulation in the world that specifically defines how crops developed using gene editing techniques are regulated. CONABIA considers gene edited crops on a case-by-case basis and must respond within 60 days whether the organism 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 undergo further monitoring by authorities. The previous regulation that defined and regulated GMOs is triggered by the genetic modification process used.
There is no legally mandated label for genetically engineered food.
Products/Research
- Non-browning potatoes: 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.
- Hypoallergenic milk: INTA used gene editing techniques to develop calves that produce milk that did not contain the genes of the proteins that cause allergic reactions.
- Higher quality alfalfa: National Institute of Agricultural Technology (INTA) is using CRISPR to develop more productive and higher quality alfalfa.
Regulatory Timeline
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
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of Argentina gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- USDA Agricultural Biotechnology Annual 2019: 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
