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Central America: Crops / Food

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Proposed: No Unique Regulations

Agreements and resolutions support regulating gene-edited crops as conventional unless they are transgenic (contain "foreign" DNA).

Honduras, Guatemala and El Salvador have signed agreements and resolutions stating that gene-edited crops that do not fulfill the definition of GMOs should be regulated as conventional crops. All three countries are actively discussing, harmonizing and deciding on a case-by-case basis how products of gene editing will be regulated.

In 2018, Honduras, Guatemala and 11 other nations, including Argentina, Australia, Brazil and the US, issued a joint statement to the World Trade Organization supporting more relaxed regulations for plant gene editing, stating that governments should “avoid arbitrary and unjustifiable distinctions” between crops developed through gene editing and crops developed through conventional breeding. The ministries agreed to avoid obstacles without a scientific basis for the commercialization of products improved by genome editing, exchange information about products’ developments and applicable regulations and explore opportunities for regional harmonization.

In 2019, the three countries signed an inter-ministerial agreement to streamline the research and commercialization of crops developed through biotechnology. The agreement requires that each country create a national advisory committee for the risk assessment evaluation of living modified organisms for agricultural use. The agreement also defines “novel combination of new genetic material”, setting the legal basis to define gene-edited products as conventional.

In 2019, Honduras published a resolution to establish a streamlined authorization procedure for crops developed using new breeding techniques (NBTs). El Salvador is expected to follow Honduras’ lead. Guatemala published an agreement in 2019 to create a simplified process for evaluation and registration of seeds that have been approved by other countries with commercial ties with Guatemala, outline procedures for evaluation and registration of novel seeds/plants, and exempt plants that do not have added DNA or a new combination of DNA from regulation. Although a legal appeal was submitted in 2019 requesting the Ministry of Economy to resolve an opposition, the Guatemala norms have not been suspended.

Products/Research

  • Gene editing research in rice: University of Costa Rica researchers, in collaboration with other countries, are studying drought resistance in rice as a way to mitigate climate change effects and contribute to food security.

Regulatory Timeline

2019: Honduras publishes agreement to treat gene editing techniques as equivalent to conventional breeding.

2019: Guatemala publishes Acuerdo Ministerial No. 271, which creates a simplified process for evaluation and registration of seeds that have been approved by other countries with commercial ties with Guatemala, outlines procedures for evaluation and registration of novel seeds/plants, and exempts plants that do not have added DNA or a new combination of DNA from regulation, after the government verifies that they meet those conditions.

2019: Inter-ministerial agreement RT 65:06.01:18 between Honduras, Guatemala, and El Salvador proposes a streamlined system for the commercialization of crops developed through biotechnology, including a requirement that each country creates a national advisory committee, for the risk assessment evaluation of living modified organisms for agricultural use.

2018: Honduras, Guatemala and 11 other nations 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: Draft genetic engineering regulation submitted to the World Trade Organization (WTO) by Guatemala and Honduras seeks to harmonize the testing and commercialization of genetically engineered plants and animals, but the regulation is not intended for innovative biotechnologies like gene editing. It is restrictive of all living modified organisms (LMOs) and requires a confined trial, field experimental trial, and a pre-commercial trial, before attempting a commercial release. 

2018: Honduras publishes Guide of Processes and Procedures of the Regulatory System for “Genetically Modified Organisms,” which provides users with procedures to follow in field test, pre-commercial, and commercialization stages of production.

 2018: El Salvador concludes GEF program to implement a regulatory framework for agricultural biotechnology, which includes guidelines for technical rulings regarding consumption of genetically engineered organisms (for direct use as human food, animal feed, or for processing).

2017: Honduras’ National Biotechnology and Agricultural Biosafety Committee is created (CNBBA) as part of the National Service of Agrifood Health and Safety (SENASA).

2014: Presidential Decree 207-2014, overseen by the Council of Protected Areas (CONAP), establishes the national policy on genetically engineered organisms, which acts as a disincentive to use biotechnology in agriculture and food production.

2008: Cartagena Protocol (an international agreement) ratified by Honduras, which protects the transport and use of organisms modified by biotechnology.

2008: El Salvador abolishes Article 30 of Planting Seed Law that requires imported seeds to have a certificate with an additional declaration stating that the seeds did not contain genetically engineered organisms.

2006: Guatemala publishes Ministerial Decree 386-2006, which allows for field trials and commercial seed exports of genetically engineered crops, but does not allow commercial production.

2004: Cartagena Protocol (an international agreement) ratified by Guatemala, which protects the transport and use of organisms modified by biotechnology.

2003: Cartagena Protocol (an international agreement) ratified by El Salvador, which protects the transport and use of organisms modified by biotechnology.

2001: El Salvador’s Planting Seed Law goes into effect, which prohibits the import, investigation, production and commercialization of genetically engineered seeds.

1998: Honduras passes Biosafety Regulation with Emphasis on Transgenic Plants, which requires the evaluation of possible health and environmental risks.

1998: El Salvador passes Environment Law, which provides regulations for environmental impact studies determining if genetically engineered organisms are harmful to the environment.

NGO Reaction

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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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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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