Gene Editing Techniques and other new gene technologies have to be regulated as per EPA 1989 Rules

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From: GM Free India <>
Date: Fri, 17 Aug 2018 at 12:26
Subject: Gene Editing Techniques and other new gene technologies have to be regulated as per EPA 1989 Rules
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Cc: <>, <>, Madhumita Biswas <>, <>,  <>, sesikeran B <>, <>, <>, <>, <>, <>, <>, <>, <>, <>, <>, <>, <>, O P GOVILA <>, <>, <>, <>, <>, Vijendra Mishra <>, <>, <>, Raman Kant Mishra <>, WARRIER <>, <>, <>, <>

To:                                                                                                                                          August 17th, 2018

The Chairperson,

Genetic Engineering Appraisal Committee,

Ministry of Environment, Forest & Climate Change,

Indira Paryavaran Bhawan, Jor Bagh,

New Delhi 110 003


Dear Sir,

Sub: New gene editing techniques to be brought under the purview of regulation by GEAC – reg.

Greetings! This is with regard to new genome editing techniques (also called as Gene Editing) that India should explicitly bring under the purview of regulations by the Genetic Engineering Appraisal Committee, as required under the EPA 1986’s 1989 Rules.


In a recent RTI response, the GEAC had clarified, based on the 1989 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms / Genetically Engineered Organisms or Cells of the Environment Protection Act 1986, that Genetic Engineering means “3. (iv) Genetic Engineering means the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self-cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material”. The Rules also define “Gene Technology” to mean the application of gene technique called genetic engineering, including self-cloning and deletion as well as cell hybridisation. As you are aware, the 1989 Rules also specify under Rule 2 (3) “Application”, that “these rules shall also apply to new gene technologies apart from those referred to in clauses (ii) and (iv) of Rule 3 and these Rules shall apply to organisms/mico-organisms and cells generated by the utilisation of such other gene technologies and to substances and products of which such organism and cells form part of”.

Meanwhile, newly emerging Gene Editing technologies allow genetic material to be added, removed or altered at particular locations in the genome. In CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats and CRISPR-associated protein 9 respectively), for instance, scientists create a small piece of RNA (a modified RNA that has a short guide sequence) that attaches to a specific target sequence of DNA in a genome and the Cas9 enzyme cuts the DNA at the targeted location. Once the DNA is cut, researchers use the cell’s own DNA repair machinery to add or delete pieces of genetic material or to make changes to the DNA by replacing an existing segment with a customised DNA sequence. This therefore, constitutes Genetic Engineering as defined in the 1989 Rules. In this context, the GEAC RTI response that says, “till date, GEAC has not received any applications seeking permission for trials/release with CRISPR Cas9 technology”, is of concern to us. It is obvious that scientists and crop developers experimenting with these technologies will apply to GEAC only when there is an explicit requirement imposed on them, citing EPA 1989 Rules.


It is worth noting that there is a growing body of scientific evidence on the unpredictable effects of different kinds of genome editing techniques using enzymes/nucleases. There is much debate on the ethical aspects to the technology, especially in the context of human genomic modification (in gene and cell therapy). The potential of the technology to cause hundreds of unintended mutations into the genome has been documented — on-target mutagenesis other than off-target mutations, single nucleotide mutations, mutations in non-coding regions of the genome etc have been documented through whole genome sequencing. Studies are also pointing to such mutations being more widespread than previously thought (Ref. Kellie A Schaefer et al (2017): Unexpected mutations after CRISPR-Cas9 editing in vivo, Nature Methods 14, 547-548Michael Kosicki et al (16th July 2018): ‘Repair of CRISPR–Cas9-induced double-stranded breaks leads to large deletions and complex rearrangements’, Nature Biotechnology. It is clear that Gene Editing techniques do pose issues of biosafety, and that the mandate of EPA 1989 Rules, that of protecting the environment, nature and health in connection with the application of these technologies, should be upheld in this context.  This also means that a precautionary approach has to be adopted for these technologies.

As you would be aware, the European Court of Justice has recently (on July 25th 2018) ruled that genome editing also counts as genetic engineering. The ECJ stated that organisms obtained by mutagenesis are GMOs and this covers any alteration to a genome. It follows that those organisms obtained by gene editing techniques come within the scope of regulation related to GM.


While this is so, in India, there are reports of research being initiated on genome editing. There is not enough preparation in terms of procedures at the regulatory level, as we see. On the other hand, alarmingly, Department of Biotechnology has developed new guidelines titled “Regulations and Guidelines for Recombinant DNA Research and Biocontainment 2017”, on 1st April 2018, to encourage and speed up research on this front. This is a clear case of flouting the EPA 1989 Rules.

In the Office Memorandum of the DBT, there is an explicit mention of gene editing as offering enormous opportunities for understanding of science and enabling of new discoveries while proper containment guidelines are absolutely essential if this has to be done in a responsible manner. The new guidelines were notified by the DBT, using the EPA 1989 Rules and include research, contained/laboratory use, import and export, storage and handling, manufacturing, disposal and emergency procedure and facility certification. These hastily-drawn-up guidelines have now superseded all other existing guidelines from the past.

We find that Plant Biosafety Level 1 (PBSL-1) now consists of Category I genetic engineering on plants, which are classified as those experiments which generally do not pose significant risks to laboratory workers or community or the environment! Here, experiments involving genome editing leading to Site Directed Nucleases (SDN) 1 type mutations that are genetically indistinguishable from organisms which have occurred naturally have been included. Based on this understanding of risk, the regulatory requirement is that of only an intimation to the IBSC, by the scientist. An additional condition laid down is only that “it is desirable to designate a separate area in the facility with proper labelling for category I GE experiments to avoid any chances of contamination” (our emphasis).

Under PBSL-2, which is described as “experiments that may pose low level risks to laboratory workers, community or the environment”, experiments involving genome editing leading to SDN2 and 3 type modifications have been included. Here the requirement for this Category II GE experiments is prior authorisation from IBSC before the commencement of experiments, and once again, it is desirable to designate a separate area in the facility with proper labelling for Category II GE experiments to avoid any chances of contamination.

Approval of RCGM is only required for experiments involving Risk Group 3 and 4 organisms now, corresponding to which the PBSL levels have been created.  


With this, India seems to have excluded Genome Editing technology from regulation by RCGM and GEAC and this is why we are writing to you now. The EPA 1989 Rules were created with a view to protecting the environment, nature and health in connection with the application of gene technology and micro-organisms, and the emerging evidence on gene editing techniques is nothing that can be termed as risk-free.

Therefore, we write to you to demand that gene editing experiments be brought under the radar of GEAC as well as regulators like RCGM and ensure that such experimentation does not take place in open environment and certainly not without authorisation. All research has to be stopped, until full satisfactory regulatory procedures are developed that ensure the main mandate of regulation in India of these technologies. These procedures have to be developed through a widespread public consultation process. Thank you.




Kavitha Kuruganti


Mob: +91-8880067772






Coalition for a GM-free India 

Website:, email :,  Facebook page – GM Watch India


Coalition for a GM-free India 

Website:, email :,  Facebook page – GM Watch India

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