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India: Crops / Food

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Ongoing Research, Regulations In Development

Draft guidelines suggest one type of crop gene editing will be lightly regulated while the rest will require additional tests and approvals.

In 2020, the Department of Biotechnology published draft guidelines for gene editing regulation that require additional safety and efficacy testing for gene-edited crops. The guidelines continue to be extensively discussed and debated. The guidelines regulate the process used to create gene-edited plants rather than focusing on the characteristics of the final products, as is typically the case in the US and many other countries. A tiered regulatory approval process is proposed, with each tier requiring testing and oversight.

Group I includes plants edited “with one or a few base pair edits or deletions” (sometimes called SDN-1 techniques) and requires confirmation that the gene editing was successful, though the data requirements for confirmation are extensive. Oversight would be done by the research institution’s internal bio-safety committee. Group II includes plants “whose cells harbour a few or several base pair edits” (sometimes called SDN-2 techniques) and require more intensive field trials and data to ensure the edits were successful. It is unclear exactly how distinctions between Group I and Group II plants would be determined or who would make that decision. Group III are plants with large DNA changes, including insertion of foreign DNA (sometimes called SDN-3 techniques) and require the same extensive testing as GMOs, including field trials to test safety to human health, animals, and the environment, with approvals to be obtained from the Institutional Biosafety Committee (IBSC), the Review Committee on Genetic Manipulation (RCGM), and the Genetic Engineering Appraisal Committee (GEAC).

The Genetic Engineering Appraisal Committee (GEAC) is responsible for the approval of genetically engineered crops and products for research, development and cultivation and for processed non-food products. There are currently no defined timelines for regulatory approval of gene-edited products. Prior to commercial approval or importation, current Indian regulations do stipulate that the GEAC must conduct an appraisal of all biotech food and agricultural products, and of products derived from biotech plants and animals.

Food Safety and Standard Authority of India (FSSAI) is responsible for regulating food, but there is an absence of regulations and operational infrastructure for biotechnology products.

Products/Research

  • Salt-tolerant rice: National Institute for Plant Biotechnology researchers in New Delhi used CRISPR in 2019 to develop rice able to withstand high concentrations of salt in soil, which reduces rice growth.
  • Vitamin A-fortified banana: National Agri-Food Biotechnology Institute researchers used CRISPR in 2018 to biofortify bananas to help address vitamin A deficiency in developing countries.

Regulatory Timeline

2020: Draft guidelines published by the Department of Biotechnology propose tiered regulation where two types of gene editing are highly regulated.

2017: Supreme Court of India issues directives to the Food Safety and Standard Authority of India (FSSAI) to frame regulations that would enable approval of genetically engineered food products.

2016: Genetic Engineering Appraisal Committee (GEAC) accepts new guidelines on environmental risk assessment of genetically engineered plants, which provide a more systematic and structured process, including public consultation for the first time in the approval process.

2013: Department of Consumer Affairs (DCA) stipulates all genetically modified food shall be labeled “GM,” but there has been no enforcement of the labeling requirement.

2008: GEAC adopts Guidelines and Standard Operating Procedures for the Conduct of Confined Field Trials and Guidelines for Safety Assessment of Foods derived from Genetically Engineered Plants. 

2006: Food Safety and Standards Act of 2006 enacted, which regulates genetically engineered food products and processed foods.

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

1990: Recombinant DNA Guidelines developed.

1989: Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989, known as the Rules, 1989, finalized, which regulate research, development, large-scale use and import of genetically engineered organisms and products.

NGO Reaction

Environmental and consumer groups, often supported by Greenpeace, campaign against genetically engineered organisms and products, and have been influential in blocking the introduction of biotechnology, arguing that “GE crops harm the environment” and pose risks to human health. The most aggressive critic is Vandana Shiva, an India-born global anti-biotechnology activist, who maintains that the Green Revolution caused more problems than it solved and that biotechnology is a form of corporate colonialism. She opposes even the testing of biotechnology crops and actively promotes direct action campaigns, including eco-terrorism to destroy field trials and research. Seed and agricultural technology companies formed an association in 2018, Alliance for Agri-Innovation (AAI), to promote agricultural biotechnologies and other plant breeding innovations.

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.

World single states political map

European Union

European Union

Brazil

New Zealand

New Zealand

United States

United States

Australia

Australia

Canada

China

United Kingdom

United Kingdom

Israel

Argentina

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Southeast Asia

Central America

Central America

Colombia

Norway

Ecuador

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.