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The Indian Ministry of Environment, Forest and Climate Change
has decided to exempt products derived through two gene editing
techniques, site directed nuclease (SDN)-1 and SDN-2, from the
purview of the country's regulations governing genetically modified
organisms, national media report. The move allows such products to
circumvent biosafety assessments undertaken by the country's apex
biotechnology regulatory body, the Genetic Engineering Appraisal
Committee (GEAC), besides reassigning the jurisdiction of these
products to India's Seeds Act, in lieu of the Environment
Protection Act.
SDN creates site-specific double-stranded breaks at defined
sequences, typically by recognising a specific DNA sequence and
cleaving DNA within such a sequence or nearby. SDN-1 produces a
double-stranded break in the genome of a plant without the addition
of foreign DNA. SDN-2 produces a double-stranded break, and while
the break is repaired by the cell, a small nucleotide template is
supplied that is complementary to the area of the break, which in
turn, is used by the cell to repair the break. SDN-3 also induces a
double-stranded break in the DNA but is accompanied by a template
containing a gene or other sequence of genetic material. While
SDN-1 and SDN-2 result either in a random (SDN-1) or intended
(SDN-2) modification of a targeted genomic locus without the
insertion of foreign DNA, the aim of the SDN-3 approach is to
modify the targeted locus by inserting an exogenous DNA template of
various lengths.
Following the new rule development in India, requests for
approval of SDN1 and SDN2 gene-edited products are to be treated
differently from their transgenic counterparts, as both techniques
involve "knocking off" or "overexpressing" certain traits within a
gene without introducing new genetic material. However, products
derived through SDN-3 will still be considered as GMOs as the
process involves the introduction of foreign genes.
India is reportedly leveraging SDN-1 and SDN-2 gene editing to
breed new crop varieties and develop traits such as disease
resistance and drought tolerance. The government's directive paves
the way for plants derived using these processes to be treated at
par with their conventionally bred counterparts. Furthermore, it is
likely to result in wider adoption of new breeding techniques
(NBTs) and gene editing technologies such as CRISPR in plant
biotechnology and research.
Notably, India does not allow the commercial cultivation of GM
crops for food use. Bt cotton is the only GM crop allowed for
cultivation in the country, with the government clearing Bayer
legacy business Monsanto's Bollgard I cotton for cultivation in
2005. The GM cotton line contains the Bt Cry1Ac toxin to
combat bollworms (Helicoverpa armigera).
Posted 28 April 2022 by Sanjiv Rana, Editor-in-Chief (Crop Science Market Reporting), S&P Global Commodity Insights
This article was published by S&P Global Commodity Insights and not by S&P Global Ratings, which is a separately managed division of S&P Global.