Notification of Standard Operating Procedures(SOPs) for regulatory review of Genome Edited Plants under SDN-1 and SDN-2 categories, 2022

Source: The post is based on the article “Notification of Standard Operating Procedures(SOPs) for regulatory review of Genome Edited Plants under SDN-1 and SDN-2 categories, 2022” published in PIB on 26th October 2022

What is the News?

The Department of Biotechnology has released guidelines for safety assessment for a regulatory review of genome-edited plants that aims to speed up the development of plant varieties and reduce the time taken for approval by authorities.

These guidelines shall be applicable to all organizations involved in research, development and handling of the Genome Edited Plants under SDN-1 and SDN-2 categories.

Note: Recently, the Ministry of Environment Forests and Climate Change has ​​exempted SDN1 and SDN2 genome-edited plants which are free of exogenous introduced DNA from the stringent regulations applicable on genetically modified or GM crops.

What is Genome Editing?

Genome editing is a group of technologies that give scientists the ability to change an organism’s DNA. 

These technologies allow genetic material to be added, removed or altered at particular locations in the genome. 

Approaches to Genome Editing

Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, which is short for clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9.

This tool has opened up various possibilities in plant breeding. Using this tool, agricultural scientists can now edit the genome to insert specific traits in the gene sequence.

What are the various types of Site-Directed Nuclease processes?

Depending on the nature of the edit that is carried out, the process is divided into three categories — Site-Directed Nuclease(SDN 1), SDN 2 and SDN 3:

SDN 1 introduces changes in the host genome’s DNA through small insertions/deletions without the introduction of foreign genetic material.

In SDN 2, the edit involves using a small DNA template to generate specific changes. Both these processes do not involve alien genetic material and the end result is indistinguishable from conventionally bred crop varieties.

The SDN3 process involves larger DNA elements or full-length genes of foreign origin which makes it similar to Genetically Modified Organisms (GMO) development.