Shivaramiah Shantharam of Biologistics, a Washington-based biotech consultancy, is an expert on genetically modified (GM) products. In his earlier avatar as director, US department of agriculture (USDA), he formulated environment and people-sensitive regulatory frameworks for promoting the new technology. “A blanket rejection of all GM products is unjustified,” he tells Narayani Ganesh on the sidelines of a national symposium on “Relevance of GM technology to Indian agriculture and food security” organised by Gene Campaign:

Question: What kind of regulatory framework for GM products would you suggest for India?

Answer: I would suggest an independent statutory regulatory body independent of ministerial interference. It should be autonomous with enforcement powers, staffed with good quality risk-assessment experts working full-time: Scientists, ecologists, environmental scientists and other experts who can do comprehensive risk assessment.

Q: Should all countries follow an international framework?

A: Absolutely not. environmental risk assessment is the process by which you estimate or assess the interaction of the organism you introduce into the environment. That is why it is so important to conduct field trials before GM seeds are made available for commercial cultivation. Peculiarities of weather and soil conditions need to be taken into account, so every country has to work out its own risk- management and regulation.

Q: But isn’t it the case that most field trial data lacks credibility because it is obtained from the same MNCs who are supplying the GM seeds in the first place?

A: It is the job of the regulatory authorities to do a competent job of verifying whether the data is reliable or not. When fellow scientists submit their research work for peer review, that’s what they do. Hard-nosed questions are asked; statistics are checked thoroughly. That’s why regulatory bodies should have experts as members. Take the case of pharma companies conducting clinical trials for new drugs. Is that data not taken at face value? It is not feasible to conduct parallel research to test out every R&D pro-duct — but certainly, the results can be veri-fied with thorough analysis and scrutiny.

Q: Why do you say that labelling GM products is unnecessary? What about consumers’ right to choice?

A: I didn’t say that; I said labelling is not an issue. It has been politicised. There are all those products out there that are not labelled. So why single out GM products?
But slackness in labelling other products cannot justify leaving GM products unlabelled.
True, that’s why you should have a good critical evaluation system that will go into questions of viability, toxicity and so on.

Q: Is it worthwhile for developing countries to incur the high costs of making and marketing GM products?

A: Yes, provided you have put in place safety structures that will examine all aspects of it. Then it will eventually become cost- effective. But don’t build a regulatory regime that is so demanding that it is not commensurate with the nature and quantum of risk. Proper risk-assessment should tell you what is risky; then you create the required regulation to minimise that risk.

Q: What advice would you give to the Indian government on this?

A: Make sure you do proper risk assessment; put together a risk-management plan; and then communicate that risk effectively.
I took a look at the department of biotechnology’s vision document and found that it was too general — full of motherhood and apple pie statements, spread too thin, a mere wish list. There was neither a roadmap nor clear policy on addressing social, ethical or economic needs of society. There is much confusion about whether to have or not have a biotech policy. Eminent scientists like Prof M S Swaminathan and biotech entrepreneurs have said that it’s high time India had a national biotech policy. But the DBT spokes- person has said that there is no requirement for a separate biotech policy. This is not surprising because, tradition-ally, official India is so secretive; it is averse to public consultation and accountability.

Q: Why promote GM products when it is distribution, not production, that is creating food insecurity in most places?

A: Even in the US, 14 million poor lack access to food because of distribution problems. In fact, the Bill and Melinda Gates Foundation has made available a software called Second Harvest to track where the hungry are, where the surplus food is available, so that distribution logistics can be worked out. But to attribute all food security problems to faulty distribution is an over-simplification.
We have to be mindful of the huge opportunity costs caused by delays in the diffusion of modern biotechnology. The problem is, there is too much discourse, which has in itself become an industry. Biotech and GM crops have entered India through a tortuous route, which is largely private sector-driven. But, in the interest of Indian farmers, private-public sector partnership is important. The absence of regulation is bad, but regulations that are too stringent and limiting only add to the cost. For a GM crop to get approval, it costs $8 million in the US and $12 million in the EU. You have to strike a balance.