Regulators hiding trials data on GM mustard

Genetically modified (GM) mustard seeds could be a reality soon with advanced commercial trials already over and regulators expected to take a decision in the next fortnight itself. However, data related to the impact on health and environment is being kept under wraps with GM regulator Genetic Engineering Appraisal Committee (GEAC) citing "third party business interests".

An application for the approval for commercial cultivation of hybrid crop was moved in September. This is the first time in five years that a GM food crop is being considered for commercial cultivation in India -- an indefinite moratorium was placed on Bt brinjal in 2010.

Notwithstanding the many concerns over genetically modified foods, GEAC has refused to divulge information related to the commercially trial of GM mustard. In a RTI response accessed by dna, GEAC has referred to "commercial confidence trade secrets or intellectual property, the disclosure of which would harm the competitive position of third party". This is against the Supreme Court 2008 directive that people should know the details of agriculture product safety trials much before commercial approval.

The Central Information Commission (CIC) in 2009 had also said, "(the) toxicity and allergenicity of any product to be put on large scale field trial is a matter of overriding public interest" and that existing data had to be provided before any massive field trial.

But this is not being done. The GEAC has repeatedly turned down RTI requests for a copy of biosafety dossier of GM mustard. The battle has now reached CIC where the appellant is asking for an urgent hearing.
GEAC is not just in possession of a biosafety dossier, it has also backed advance commercial trials.

According to the minutes of the 121st meeting of the GEAC, the Centre for Genetic Manipulation of Crop Plants' (CGCMP) plea for large-scale trials, called BRL (Biosafety Research Level) II trials, was considered and approved on July 18 last year.

Field trials have two levels – BRL I and BRL II. While the former is done to take up a set of studies and to generate data, the second is an advanced commercial level trial. A team led by Delhi University's Deepak Pental has done both the trials. He heads the research on the transgenic mustard.

The agenda notes circulated to members at the meeting said, "The CGMCP has completed safety studies as per the prescribed guidelines". It also mentioned that the Committee appreciated the compilation of the biosafety dossier.

As an application moves from BRL I to BRL II, and from BRL II to commercial cultivation, regulators should be presumed to be making data-based decisions on whether permission should be accorded or not. Concerned scientists in the country should also be in a position to peruse such data and make effective representations if and where needed. Such data cannot be withheld on any grounds.

The quality of mustard trial is also a major concern as dna revealed on September 22, 2015 -- from 2008 to 2014, only 39 of the 133 GM crop field trials were properly monitored. In 2014, three GM mustard trials of Delhi University were taken up – at two sites in Punjab and one in Delhi – during the rabi season. There is enough evidence to suggest that there were no post-harvesting foolproof monitoring in these cases.

The issue of biosafety data of Bt brinjal being brought into public domain was a decisive turning point in its fate, given that subsequent analyses by international scientists pointed out to its lack of safety. Jairam Ramesh, the then environment minister who placed Bt brinjal under an indefinite moratorium, took note of allegations of conflict of interest in the regulatory body.

It is interesting to note that GEAC at this point of time has the presence of a member from CGCMP, the same Centre from where GM mustard has emerged.