Genetic experts raise questions on guidelines for genome-edited plants; amendments needed to take full advantage of technology

After a long time, the government has issued guidelines to develop plants and crops through genome-editing technology in order to keep genome-edited plants outside of the purview of biosafety guidelines. But no sooner were the guidelines issued by the Department of Biotechnology (DBT) of the Ministry of Science and Technology (MST) than controversies erupted.

Scientists who are experts in plant genetics say that the guidelines are not clear. If these are implemented in their current form, it won’t be possible to get the desired benefits of genome-editing technology in cutting short the process of developing new varieties of crops and plants, because the guidelines lack clarity about the process. The kind of monitoring and data requirements the guidelines talk about will put paid to gaining from the advantages of the technology.

Major scientists working in the field of genetics have written to the DBT and the Indian Council of Agricultural Research (ICAR) letters seeking changes in guidelines. The committee preparing the Standard Operating Procedure (SOP) on the basis of the guidelines has also been asked to resolve these issues. One of the members of the committee says that the issue would be resolved in SOP, but major scientists are not unanimous about it. Guidelines have also raised questions about decisions being made at the Institutional Biosafety Committee (IBSC) level.

The Union Cabinet had decided to exempt from the Biosafety Rules the plants under Site-Directed Nuclease (SDN)-1 and SDN-2 categories in which genes from the same plant family are edited. An Office Memorandum was issued in this regard by the Ministry of Environment, Forest and Climate Change (MoEF&CC) on 30 March 2022.

Subsequently, the guidelines were issued on 17 May 2022 and controversies have been raging ever since. There are three issues at stake — data regarding off-target mutations, backcross breeding and generational stability.

Scientists say that an off-target mutation is possible in any genome-edited process but it is of no use. Genetic scientists have their focus on targeted mutation and the aim is to develop new species or varieties on the basis of the same. The results of generational stability take a long time to come. If generational stability is made the basis for developing and approving a species, there will be no difference between genome-editing technology and the conventional breeding process, because it is developing a new species in a short time and attaining accurate results that make the genome-editing technology special. According to scientists, if we can’t save on time, we shall remain deprived of the real benefit of this technology. The issue of backcross breeding is also similar. The kind of regulation and data requirements that have been applied in the guidelines on all these three issues are totally unrealistic.

Deepak Paintal, former Vice-Chancellor of Delhi University and Professor (Genetics), wrote a detailed letter on 25 May 2022 on behalf of the South Campus-based Centre for Genetic Manipulation of Crop Plants (CGMCP) to DBT Secretary Dr Rajesh S Gokhale and ICAR Director-General Dr Trilochan Mahapatra and raised questions about the guidelines. The letter says that the guidelines are not in tune with the government’s earlier decision. They are not in the same spirit as that of the OM issued on March 30 that conveyed the decision to exempt gene-edited plants under the SDN-1 and SDN-2 categories from Rules, 1989. He has sought clarifications on four issues in his letter.

Prof. KC Bansal, former Director, National Bureau of Plant Genetic Resources, ICAR, said in an interview with Rural Voice that there was no major problem with the guidelines and that whatever questions had been raised would be settled in the SOP. He said that the new technology was going to prove crucial to the agricultural sector. A senior official of the ICAR also said to Rural Voice that a committee was studying these guidelines and hoped that the issues at stake would get resolved.

But several scientists do not agree with this. They say that amendments to the guidelines are necessary. The SOP will be prepared on the basis of these very guidelines. So, it would be better to issue revised guidelines and address the questions related to the three issues mentioned above.

The case had been pending for about a year. Officials of the Environment Ministry had written a letter to the states in September 2021 seeking their consent in this regard, but most of the scientists and departments concerned were not in favour of this. The memorandum issued in this regard on March 30 said that DBT, the Department of Agriculture Research and Education (DARE) and the Ministry of Agriculture and Farmers’ Welfare had recommended that the SDN1 and SDN2 genome-edited products free from exogenous introduced DNA be exempted from biosafety guidelines.

The genes from the same plant family are used in this technology and no foreign genes are involved. It is, therefore, different from Genetically Modified (GM) technology. It is on this basis that exemptions from biosafety guidelines had been sought for this technology. According to the memorandum, the said ministries and departments had sought exemption in pursuance of Rule 20 of the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells Rules, 1989. The Union Government had, therefore, decided to exempt the plants under SDN1 and SDN2 categories from the application of the provisions of Rule 7 to 11 of these Rules. For such genome-edited plants to be released as a new variety, further development and evaluation would be as per other applicable laws/acts/rules.

Rural Voice had carried a detailed story on this issue on 29 September 2021 which may be accessed at the following link:  https://eng.ruralvoice.in/national-23/seeking-consent-from-states-for-trials-of-genome-edited-plants-may-create-hurdles-in-benefiting-from-new-technology.html

In fact, the genes from one plant family are edited in this technique and it is possible to produce a new variety by selecting traits like better productivity, disease resistance and temperature resilience from plants of the same family. Besides, one may benefit from a better-targeted approach through this. The benefit of this technology is that it cuts short the process of developing new varieties. Scientists say the process gets accelerated. That is, any crop variety may be developed in a very short period. Biosafety regulations are not applicable to genome-edited technology in the US and UK either.

Exempting genome-edited technology from biosafety guidelines will lead to the faster development of new varieties. Another advantage is that the bio-resources available in the country can be utilized for public goods. The beauty of this technology lies in the fact that not only can higher-yield genes be introduced into the plants through it but it can also play a big role in food and nutrition security because the nutrients available in various varieties of a plant can be brought together in one plant. Besides, this technology can also make plants resistant to climate change and temperature variations. A banana species has been developed at the Mohali-based National Agri-Food Biotechnology Institute (NABI).

This technology has greatly shortened the process of developing new species. Besides, it is capable of producing accurate results. The new gene-editing technique is called Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas9. The 2020 Nobel Prize for Chemistry was awarded jointly to France’s Emmanuelle Charpentier and the US’s Jennifer Doudna for developing this gene-editing technique. The technique is being used to develop new species through gene editing. Several varieties have been released in the US and Japan using this technology.

In March 2021, institutes concerned with agriculture research had prepared a brief. These institutes included the Trust for Advancement in Agricultural Sciences (TAAS), National Academy of Agricultural Sciences (NAAS), ICAR, Biotech Consortium India Ltd (BCIL), Tata Institute for Genetics and Society (TIGS), National Agri-Food Biotechnology Institute (NABI) and Biotechnology Industry Research Assistance Council (BIRAC). These institutes had held a dialogue on this topic in March 2021 and found the technique necessary for the country’s agriculture.