The review committee on genetic manipulation (RCGM) is the apex technical body under the department of biotechnology in the ministry of science and technology. It prescribes protocols for research and safety trials of genetically-engineered crops.
B Sesikaran has been its chairman for the past three years, and a member for an equal stretch before that. A medical pathologist by training, Sesikaran was director of the National institute of Nutrition for six years till 2012. In an interview with Vivian Fernandes, Sesikaran says that the release of GE Mustard and BT Brinjal has already been delayed quite a bit. Edited excepts.
The world has grown GE crops for the past two decades. Area under the crops has expanded more than a hundred times to two-billion hectares in 28 countries since the crops were first grown in 1996, according to ISAAA, an advocacy, of which Normal Borlaug was the first founding patron. Yet, there is much political opposition to GE crops in India and their safety is still doubted.
It is only when the usefulness and sustainability of the technology are established that it comes to RCGM, which is the first step in regulation, concerned with safety. When we receive the dossiers, we go through them thoroughly and help the applicant develop a protocol for proving environmental and bio-safety. We have enough expertise in RCGM for this. Once the studies are done, we review the data to see whether all aspects of environmental safety are addressed. Genetic engineering technology is two decades old. The history of safe human use is evidence of safety. Till date, we have had no human safety issues. This is a wonderful technology.
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Products like PCPs were considered safe at one time but are banned now. Why cannot the same happen with GE crops?
Those products were chemical entities. They were not part of our diet or environment. They were introduced for a particular purpose, run through a variety of safety tests, and approved. Over a period of time misuse of the chemicals occurred. These are largely responsible for long-term side effects. If used as originally intended, there would have been no issue. Science itself does advance. One can never be categorical. Over time you find there are certain effects. Certain modifications and adaptabilities take place, and therefore you have to relook them. Genetic modification is part of the natural genomic process in a particular crop. We are accelerating or manipulating it using modern technology.
But these genes may not have jumped species in the normal course.
That is right. We are pumping protein from outside in the form of bio-pesticides, and putting it inside the plant.
You are talking about the Bt protein which is derived from a soil bacterium, whose insecticidal properties were discovered in 1901. It was used as a bio-pesticide since 1938.
If you look at the biological cycle it is already there. Many people say how come there are anti-bodies in blood? That is because you already have Bt protein in the environment. It was used as a bio-pesticide in large quantities. Now, it has been put in plant tissues. It kills worms (bollworms in cotton and fruit borers in brinjal) right at the beginning. So, you are saving a lot of crop that would have been lost to pests.
Activists opposing GE technology say that the data which RCGM relies on before it orders their testing for safety is provided by the applicants themselves and is therefore not independent.
How are drugs developed? Initially, the entire development process is done by industry itself. This is true of other products too. The regulator comes in when things have taken shape. It then orders tests for safety and usefulness. This is a standard process.
They also say there is a revolving door between regulators and industry. The regulators may come from academia but there is a likelihood of them joining private industry. That colours their decision.
We want people with competence and knowledge. There are government regulations which say until three years after you have retired from the government you should not take up any assignment in private industry. Most people observe this. If someone misuses the system it does not make everybody a rotten guy.
In his letter to the PM opposing approval of the GM mustard hybrid, DMH-11, Bihar’s CM Nitish Kumar says “conflicts of interest plague the decision-making system.” He does not name you, but activists have alleged a conflict of interest because some of the safety tests which were conducted at the National Institute of Nutrition, when you were director.
My (former) institute is a government institute. It is under ICMR. It has a testing facility. It works independently. Anybody can see the data which shows there is no hanky-panky. I was director of 20 other departments. Our primary aim was to look at nutrition and not do toxicology testing. ICMR’s then DG, Nirmal Kumar Ganguly, felt since we have the infrastructure we should do the testing. We began with pharmaceuticals and after that biotechnology. The same activists also object to testing done in private facilities. Once you become suspicious of anybody and everybody there are always ways of finding conflicts of interest.
Another such conflict attributed to me is that I am a member of the International Life Sciences Institute. It is a world body with presence in 40 countries, set up by industry as an autonomous institute to promote science. I became a public trustee two years ago. The only conflict of interest there is that in the consortium of funders has companies like Coca-Cola and Monsanto. If you look at it this way we will ultimately land up with activists as regulators.
Scientists will always be involved with industry. In the US, academic research always goes hand-in-hand with industrial development. It is only in our country we draw a line saying government guys are holy cows. This is why science does not get rapidity transferred into action. The translation part will never happen unless you break the wall. Otherwise, it will be papers published versus technology brought in from outside.
If this were to happen, how do you create public confidence?
Abroad, when they make a decision, they develop detailed dossiers, which provide scientific basis. You develop a risk assessment report clearly stating the reasons.
Have we done that?
Yes, in the case of the GE mustard we have a risk assessment document. It clearly states why something is valid and why it is not, why something is beneficial and something cannot actually happen.
There is also the allegation that entire 3,000+ page report was not published.
The documents were made available for public scrutiny. They were not entirely uploaded because some of them may have IPR issues. But anyone can access them at the environment ministry. We only put a gist in the public domain.
Do you think DMHybrid-11 developed by Deepak Pental and his team at Delhi University must be released?
I think it has been delayed quite a bit. I feel even Bt brinjal should be released. (A moratorium was imposed in 2010) You have seen for the past two-and-a-half years what has happened in Bangladesh (which approved its release based on India’s bio-safety data in October 2013). Has anybody died? Farmers are happy there and right across the border our West Bengal farmers are crying because their crops are getting eaten up by pests.
Should DMH-11 be released for its yield potential or because it is an efficient technology to create mustard hybrids?
The benefit will be better yields. This is required as we have a shortfall of oil.
Let us for the sake of argument say that the yield potential is not as much as is claimed. Would you still like it to be released for cultivation?
How will we know unless we approve the technology? We now have data from controlled field conditions, confined field studies, which shows it works. Take a drug. It goes through phase-I, phase-II and phase-III trials. But after it is released, for the next two years we do a post-market study. Because we need to study how it behaves in actual field conditions. If by chance what the activists say is right and there is not enough yield advantage we need to find out the reason and improve the technology. Is there a strong negative effect that you cannot release it? There is no such thing.
It is absolutely safe?
Yes, safety is not an issue at all.
Fernandes is editor of http://www.smartindianagricuture.in