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Argentina: Animals

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Determined: No Unique Regulations*

Gene-edited animals that do not contain DNA from another species are regulated as conventional animals, so they don’t face the tighter restrictions of GMOs.

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).

Products/Research

  • 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.

Regulatory Timeline

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).

NGO Reaction

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.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

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Argentina

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Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
 
 
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
 
 
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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