Biosafety Mechanism in India

An expert committee, appointed by Supreme Court, has recommended a 10-year moratorium on field trials of all genetically modified (GM) food crops and a complete ban on field trials of transgenics in crops which originate in India.

According to the committee’s interim report, field trials need to be put on hold till an independent committee of experts and stakeholders examined and assessed the potential hazard of herbicide tolerant crops and their suitability to India.

The CBD’s Cartagena Protocol — to which India is a signatory — aims to ensure the safe use of GMOs and cost-effective measures to prevent environmental degradation.

This is the first time that a high-level committee in India has found the regulatory system and the field trial protocol “unsatisfactory and inadequate, requiring major changes, restructuring and strengthening”.

The interim report holds great importance as it is being presented at a time when the Union government, especially the ministry of science and technology, is trying hard to introduce a new regulatory system for GM crops by the name Biotechnology Regulatory Authority of India (BRAI).

A bill proposes setting up BRAI under the ministry of science and technology which will act as a single window clearance system for products of modern biotechnology, including GM crops. At present GM crops are under the purview of the Union Ministry of Environment and Forests.

What are Bt Crops?

Bt crops are genetically modified (GM) plants that use a toxic protein from the naturally occurring soil bacterium, Bacillus thuringiensis (hence Bt), to kill insects.

The Bt technology, first developed by American biotech giant Monsanto Company in 1986, was introduced in India a decade ago in cotton seeds.

India and Bt Crops

Monsanto’s Indian partner, Maharashtra Hybrid Seed Company (Mahyco) sought to commercialise a GM brinjal or eggplant using the same Bt gene, but was stopped by then minister for environment and forests Jairam Ramesh, who imposed an indefinite moratorium on its release in the wake of widespread concerns over its safety in a food crop.

Recommendations of the committee

• There should be designated sites where stage I and stage II field trial can be carried.
• Trials should not be conducted in farmers fields.
• Ten-year moratorium on field trials of Bt transgenics in all food crops that are directly consumed by people
• Moratorium on field trials of herbicide tolerant (HT) crops
• Re-examination of all biosafety data for applications in process as well as those that have been approved for release. This should be done by scientists who are qualified in biosafety science and experienced in evaluation of biosafety dossiers for transgenic plants
• Long-term and inter-generational toxicity studies to the current requirement which stops at sub-chronic stage
• Scientists qualified in evaluation of the biosafety data of GM crops should be engaged to analyse safety data submitted by developers; preliminary biosafety tests prior to field trials, including sub-chronic toxicity in small animals, should be included in the protocol.

How Biosafety works in India?

RDAC—Recombinant DNA Advisory Committee; RCGM—Review Committee on Genetic Manipulation; IBSC—Institutional Biosafety Committee; GEAC—Genetic Engineering Approval Committee; SBCC—State Biotechnology Coordination Committee; DLC—District Level Committee; ICAR—Indian Council for Agricultural Research; MEC—Monitoring and Evaluation Committee.

Problem of Biosafety

The problem with India is that GM crop trials are being approved at dizzying speed—at one three-hour meeting, GEAC approved 144 applications—while little is done to monitor field trials, many of which are illegal because they do not comply with requirements.

As India becomes a vast testing ground for all kinds of GM crops, there are clear indications that regulations are being thrown overboard as private crop developers and the National Agriculture Research System (NARS) join hands on the testing of GM crops.