There are no transgenic or gene-edited animals yet approved for sale in Argentina. Gene edited animals, when developed, will not be subject to regulation as genetically engineered organisms unless they contain foreign DNA. All gene-edited products must be submitted to CONABIA, or otherwise are considered a GMO. Gene-edited animals will be assessed on a case-by-case basis by the National Advisory Commission on Agricultural Biotechnology (CONABIA) and will require authorization from the Secretary of Agriculture, Livestock and Fisheries.
In 2015, Argentina became the first country in the world to develop specific regulations defining gene editing products and techniques. Although the regulations have so far been applied only to gene edited crops, Argentina will apply the same evaluation process to gene edited animals. Gene editing is not considered genetic modification unless foreign DNA is added. Therefore, most gene editing techniques will not be subject to additional regulation.
In January, 2019, CONBIA determined that gene-edited tilapia, developed by Intrexon’s AquaBounty subsidiary, will not be classified as a GMO and was granted a regulatory exemption. According to its developers, the tilapia demonstrates a 70% improvement in fillet yield, 16% increase in growth rate and 14% improvement in feed conversion ratio.
AquaBounty’s AquAdvantage Atlantic salmon that grows to maturity twice as fast as conventional salmon is often referred to as gene edited. However, it contains genes added from two other fish species and was developed using classic genetic modification techniques. Although Argentina has ruled that it is exempt from GM regulations, it is not yet for sale in Argentina (It is sold in Canada and approved, but not sold in the US).
Argentina is currently developing genetically engineered animals for production of pharmaceutical products (details are still in the confidential stage).
- Yield-enhanced and fast-growing tilapia: Developed by Intrexon’s AquaBounty division, which also developed the GMO fast-growing salmon. The tilapia is expected to be the first gene edited animal consumed anywhere in the world. AquaBounty says, “standard food and environmental safety considerations will still apply to this product prior to introduction”.
- Hornless cows: The US firm Recombinetics is looking to market the “polled” cattle in Argentina. However, as of 2019, this project is on hold as researchers develop a new line of hornless cows using CRISPR.
- Heat tolerant cows: Using TALENS, Minnesota Red Angus cows are being modified to handle heat more easily. Known as Genzel, the cloned cow awaits approval. Recombinetics is looking to market the cattle in Argentina.
- Cloned horses: Kheiron and FLENI medical center researchers developed cloned equine embryos with improved muscle development, endurance and speed using CRISPR. For research purposes only, but could possibly be used in the future for improved polo horses.
- Milk for infants: National Agricultural Research Institute (INTA) and the University of San Martin developed the first genetically engineered calf in 2011 that produces two proteins contained in human milk. The proteins offer infants better antibacterial and antiviral protection than normal cow’s milk. For research purposes only.
- Hypoallergenic milk: INTA used gene editing techniques to develop calves that produce milk without the genes of the proteins that cause allergic reactions in milk.
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.
2017: Resolution 79-E/2017 published, which updated animal biotechnology regulations to include gene edited animals.
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.
2003: Resolution 57/03 Argentina establishes regulations for the confined release of genetically modified animals of agricultural interest (for experimental purposes).
The Argentine Polo Horse Association has expressed concern about polo horses being genetically edited for sport and breeding. It is concerned that the misuse of genetic therapies to improve performance could result in a new phase of doping, threatening equestrian sports.
- 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
- The regulatory current status of plant breeding technologies in some Latin American and the Caribbean countries
- Gene Editing Regulation and Innovation Economics