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Brazil: Crops / Food

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Determined: No Unique Regulations*

Regulated on a case-by-case basis based on the product produced, not the process used.

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. Changes introduced in January 2018 determined that NBTs should not be regulated as transgenic GMOs when no genes are retained from other (e.g. foreign) species. Each product is evaluated on a case-by-case-basis. Regulations focus on the characteristics of the final product, as does the US, rather than the process used to create the product, as is the case in the EU. The government assesses the risk level of each newly developed plant or food, whether new genetic material was introduced and whether the product has already been approved for commercialization in other countries, and responds to the applicant within 20-90 business days.

Genetically modified organisms (GMOs) are governed by the National Technical Commission for Biosafety (CTNBio), which sets safety standards for GMOs. In 2018, CTNBio declared that new breeding techniques that do not possess foreign genes would not be considered GMOs. The resolution establishes the requirements for whether a product can be exempt from the GMO regulatory framework.

Products/Research

  • Spicy tomato: The Federal University of Viçosa developed a tomato with capsaicinoids, the compounds that give spicy peppers their heat.
  • Nematode-resistant soybean: The Brazilian company Tropical Melhoramento & Genética and the Israeli company Evogene collaborated to develop a soybean resistant to a plant parasite that destroys crops and decreases crop yields.
  • Yeast for biofuel production: An application was submitted to CTNBio for gene-edited yeast that can be used for ethanol and bioethanol production.
  • “Waxy” maize: An application was submitted to CTNBio for gene-edited corn with extra starch.
  • Antioxidant-rich tomato: The University of Viçosa, University of São Paulo and the University of Minnesota developed a tomato with high levels of lycopene, an important antioxidant. For research purposes only.
  • Yeast for bioethanol: Four gene-edited varieties of yeast for production of bioethanol and other purposes were approved by CTNBio in 2018.

Regulatory Timeline

2018: Brazil and 12 other nations, including Argentina, Australia, Canada 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: National Technical Biosafety Commission (CTNBio) releases Normative Resolution No. 16, focusing on NBTs. It clarifies that many products derived from genetic engineering do not meet the definition of a GMO as defined by the 2005 regulation and determines that NBTs should be regulated on a case-by-case basis.

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.

2005: Brazil establishes CTNBio under Law No. 11.105 to set rules for laboratories and establish authorization procedures for GMO research, the production and marketing of GMOs, restrictions on their release into the environment, regimes for their cultivation, requirements for reporting their release, inspections and monitoring of GMO research activities and their commercial release, implementing authorities and authorizing procedures for their release and restrictions on GMOs in foods. It provides for the punishment of administrative violations and criminal offenses. CTNBio has approved the commercial use of approximately fifty GMOs.

2003: Decree is issued to regulate the labelling of food and food ingredients intended for human consumption and animal feed when they contain or are produced from GMOs.

1995: Brazil passes Law No. 8.974, which establishes safety and inspection requirements for genetic engineering in agriculture and humans. The aim is to protect human, animal and plant health as well as the environment. It establishes which manipulation methods are prohibited.

NGO Reaction

Farmers and anti-biotechnology advocacy organizations protested the 2018 CTNBio resolution that determined that NBTs would not be regulated as GMOs. They published an open letter claiming that the resolution would only benefit large agricultural businesses and that it could lead to new transgenic organisms being released, even though it does not include transgenic organisms in the changes.

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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United States

United States

Australia

Australia

Canada

China

United Kingdom

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Israel

Argentina

Argentina

Japan

Mexico

Russia

Chile

Uruguay

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India

Africa

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Southeast Asia

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Central America

Colombia

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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.