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Home >Companies >Regulation of biotech in India is not predictable: Michael Frank

Michael J. Frank, vice-president, global commercial at Monsanto, the world’s largest seed company, says India’s regulatory environment on genetically-modified (GM) technology is stuck and not predictable enough for investments. During a recent visit to India, he spoke on new technologies, labelling and enlisting academics in the US to quell safety concerns about such crops. Edited excerpts from an interview:

Where does India figure in Monsanto’s global business? Are you expanding into newer fields?

This is an exciting year in India because this is our 40th year of operation. India continues to be a very important market for us, not so much the size of the business that it is today, but the potential of making an impact by working with farmers. Back in 2002, the launch of Bollgard cotton (Bt cotton) transformed the industry. Then again in 2006, with Bollgard II, we brought another tool for cotton farmers.

We are also spending a lot of resources on using digital tools on making farming efficient. Farmers buy a range of inputs like fertilizers, seeds and chemicals, and we believe that using data tools or big data can help them make better decisions to maximize productivity.

Can you give an example?

In the US we have launched a product—a nitrogen utilization advisor. So, on a field by field basis, by understanding what kind of soil is in the field, what has happened with the weather over the last few years, what the crop patterns have been, you can understand, through the growing season, how much nitrogen has been used by the plant or how much nitrogen has evaporated. So, a farmer can go online to see how much nitrogen is still there.

In terms of scientific innovation, what next-generation GM technologies are you working on?

We are going to launch our first biotech product that uses RNA Interference in 2017 in the US. One of the common insects that impacts yields is corn rootworm and we have been able to design the corn to create an RNA I molecule in the roots so that when the corn rootworm eats that, it dies and the plant stays healthier.

India is going through a deficit monsoon year—consecutive crop failures for the second year. How do you think technology like GM can help?

We launched our first drought-resistant technology in the US about three years ago. Corn farmers in the US have access to it and we are taking it to Africa. Like other technologies, there will be further iterations. This is a first generation of our drought trait that is very good, so these are tools that could benefit Indian farmers.

So far, India has approved only Bt cotton and no other GM food crops. What is your opinion on the present regulatory regime in India? Many expected that biotech would get a boost after Narendra Modi became prime minister.

We respect that every country has its own sovereign right on what kinds of tools and technologies it wants to provide farmers. We sit on the sidelines and watch the regulatory system either evolve or stay stuck, and today it does appear that it is stuck. And companies that invest in innovation don’t invest in a region where the regulatory system is stuck and is not science based, or predictable.

When we think about which countries to invest in, we think, do they respect intellectual property? Is the regulatory system science based? Is it predictable? India has so much potential and we have been here so long; we stay committed to India, even though, logically, you could say it has been stuck since 2006, may be even before that. We are optimistic with this new government that things will move forward, but it does appear that in other regions, things are moving forward (faster).

In China, Vietnam, the Philippines, Indonesia, Australia, South Africa, Bangladesh, now even in sub-Saharan Africa, from Kenya to other countries, governments are moving forward…with a regulatory system that moves with certain amount of pace which gives companies the confidence to invest. To spur innovation, there needs to be some amount of predictability; in India, that has been challenging in the last few years.

There is a case being made in India that Monsanto was collecting royalty payments on Bt cotton without having a patent for it. We are aware farmers are now using Bollgard II and that is patented. What is your response?

With technologies, there are various elements of intellectual property; with Bollgard I—on patents you are correct; but there are other intellectual property that went into the technology. Today, the reality is that farmers have moved to Bollgard II because it provides a wider spectrum of control.

We were the ones to bring in the technology (Bollgard I) to India…and we went through for the regulatory process for eight years, before the technology got the green signal. It was known from the beginning that there was no product patent as far as Mon 531 is concerned, but intellectual property resides in the data and several other elements that goes into the product. We chose to make the technology available—today we have 49 companies who have access to this…the contracts entered with these willing companies was mutually discussed and decided upon.

This year, some states like Maharashtra reduced Bt cotton seed prices by 100 per packet. How does Monsanto see such interventions?

Farmers are very smart—if you give them the choice they will know which seed to purchase. If the government gets involved and decides how to price every input that a farmer uses it creates a very challenging environment for companies that are investing in innovation.

The reality is that cost of cotton seeds are less than 5% of a farmers’ cost of cultivation. The last time prices were increased was in 2011 when a packet of seed cost 930. The seed sector is research intensive…; a system which does not recognize this and takes unpredictable decisions is not very encouraging for the industry.

Debates on GM safety in India and around the world continues to be shrill with polarized opinions. How can consumers make a choice in such a situation?

At the end of the day, one can only trust science—what it says about the environment, food safety and health impacts. A regulatory system that is science based that runs it through those filters..., then its up for the market to work. Our perspective is that there needs to be good regulatory oversight on safety.

Scientific opinion on GM safety is like climate change. While some scientists say its real some say it’s not. But the consensus is that climate change is real. The consensus on biotech and GMOs (genetically modified organisms) is that they are safe.

Recently, an investigation by The New York Times showed how Monsanto and other companies enlisted US academics to make a case for safety of GMOs and offered them research and travel grants. In such a situation, how can a consumer trust any of the research?

When I read the article and the emails that were leaked, I am very proud of Monsanto’s position. We know that society has a desire to understand this issue that is complex with a lot of voices. The scientific community has a real opportunity to help bring knowledge and make science more simple. We have worked with scientists—independent scientists—and we have encouraged them to get involved in the discussion. If you look at all the peer reviewed journals— over 1,700—have all said the technology is safe.

There is nothing wrong in a scientist speaking out for GM. What appears unethical is to have research grants tied to this.

We work with a lot of scientists who are with universities and public institutions—that’s a good way to get third-party information. Typically, I think a scientist will disclose they have got a grant from Monsanto. Personally, I find it offensive that someone would then indicate that they are no longer credible or independent. My experience with scientists and university personnel is that they are fiercely independent and they have strong views. It’s complicated. But we do work with multiple scientists—some of it is extension of our own work while some of it is independent.

Why is the industry opposed to labelling of GMOs?

Every country can make its independent decision about its rules. Our position is that labels that offer health information to consumers are important. We believe voluntary labelling makes more sense. If a food company wants to claim that it’s non-GMO, it has the right. But for the government to mandate a labelling, we think that’s unnecessary. Ultimately it increases the cost for the consumer. If you have to label something non-GMO you have to track the supply chain, which is why organic food costs more because you’re running the expense of monitoring the whole supply chain. Now, why would you force a premium on folks who aren’t interested?

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