Monday, July 26, 2010

The Kernel of Bad Ethics

The controversial Seeds Bill is lying in Parliament. It is anti-farmer, pro-industry and needs a drastic rewrite


IF DISRUPTIONS over phone tapping and the India Premier League controversy had not taken Parliament sessions hostage, the Rajya Sabha may have passed the controversial Seeds Bill in the week of April 26, when it was slated to come up for discussion.

The government was keen to give this Bill the force of law as soon as possible because the seed industry wants it. The Seeds Bill originally proposed in 2004 was met by resistance almost immediately. Just months after it was proposed, Gene Campaign organised a stakeholder consultation to critically analyse the Bill and suggest amendments. The pressure was kept up to have the Bill re-examined and it was referred to the Parliamentary Standing Committee on Agriculture in 2005. The Committee called for evidence and submissions from a number of agencies, including government departments, civil society groups and seed industries.

The Standing Committee accepted many of the amendments proposed by civil society groups and the amended draft Seeds Bill that was proposed to Parliament was vastly improved over the original. It made the playing field more level and while giving the seed industry a fair chance to profit from the seed trade, it incorporated safeguards for farmers. The Bill in that shape was however not accepted. Since then several other amendments have been proposed, some of which have been accepted in principle, others not.

So what is the Seeds Bill and is it needed? Many NGOs have been asking for the Bill to be scrapped. This is a dangerous proposition stemming from ignorance about what such a law is supposed to accomplish. The new Seeds Bill will replace the old Seed Act of 1966, which was meant to govern trading in seed. A law regulating the seed trade is necessary to ensure that farmers are protected against spurious seeds and that seed producers are obliged to put into the market only seeds of good and reliable quality. Such a seed law must encourage competitiveness to ensure good quality and low prices and not encourage monopolies.

Our seed law must ensure that the seeds produced by farming communities (Farmer Varieties) are treated at par with seeds produced by companies. The law must provide for a transparent system of seed testing and evaluation of performance so that the farmers get good quality seed and the nation’s goals of agricultural and food production are met in the most effective manner. So we do need a Seeds Act but we do not need this one.

The genesis of the current shape of the Seeds Bill is to be seen in the ire of the seed industry over the pro-farmer provisions of the Protection of Plant Variety and Farmers Rights Act (PPVFR), 2001. This IPR law that India enacted instead of accepting a patent law for seeds, gives intellectual property protection to the plant varieties of farmers as well as those of breeders. India is the only country in the world that has given legal rights to its farmers over seed, and the industry has been furious since. The seed industry wants monopolies over seed production and giving rights to farmers over their seeds spoils their plans. They retaliated by influencing the proposed Seeds Bill in a way that overrules the provisions of the PPVFR and Farmers Rights and had provisions written in that would allow seed sector monopolies with as little accountability as possible.

In the PPVFR, the breeder applies for registration for a Plant Breeders Right. This right is valid for a period of 15 years for crop varieties and 18 years for trees. The Seed Bill allows the period of protection to be doubled so that the seed varieties can be protected by the seed producer for 30 years and 36 years respectively. This extension of the seed owner’s right will allow monopolies to be established.

A KEY OBJECTION to the Seeds Bill is that despite several submissions for amendment, it still does not require the seed industry (plant breeders) to declare the parentage of the new seed that they have developed. This is bad science and bad ethics. Scientists always keep a record of the maternal and paternal parents of the new seed that they are developing. Resistance to submitting these records and keeping this provision out of the Bill means only one thing. The seed industry breeders will use the seed varieties developed by farmers and public sector scientists and pass this off as their own. This amounts to theft. The penalties for violation have been kept ridiculously low — Rs 5,000 — so that even if someone is caught stealing public sector material or that belonging to farmers, the punishment is a laughably small sum of money.

Of a piece with this is the refusal to accommodate a provision for pre-grant opposition. Law making in many parts of the world, including our own, particularly when rights are granted, as in IPR, allows an opportunity to the public to record its objections to the grant of such a right.

Many activists had wanted such a provision in the Seeds Bill as well so that if a seed company wanted to register a seed, which had used material from other, unauthorised sources, objections could be raised. But the government, anxious to please the seed industry refuses to include a provision for pre-grant opposition.

This Seeds Bill is distinctly anti-farmer and so against the interests of food security. It must be radically overhauled.

Dr Suman Sahai is a scientist trained in genetics. She heads Gene Campaign, a leading research and advocacy organisation

Are genetically modified foods safe?

Suman Sahai

GM crops are promoted as the answer to global hunger, to combat climate change, to produce renewable energy; it appears that if there is a problem anywhere, GM crops have the answer. Apart from this hyperbole, a fundamental question remains: does GM technology produce safe foods or should we be apprehensive about negative health impacts?

There is a substantial body of scientific data that demonstrates that the process of genetic engineering itself can cause changes in the cell that can lead to new and unpredictable changes in it.
Adverse health effects from GM food can result from the over-expression of an existing protein or activation of a dormant toxic substance, resulting in cell products that could be dangerous to human and animal health.
In addition to this, the genetic engineering of plants may result in the expression of totally new substances, which are not found in the natural plant species or, genes brought in from plants having known allergy provoking properties would bring the allergenic property along with them into the new transgenic plant.

The mere act of inserting alien genes into the chromosome of the host plant can create unintended effects and the formation of new and unknown toxic or allergy provoking compounds which are almost impossible to analyse and detect.
This can be a special problem in the case of plants like brinjal, which belong to the Solanacea family. This plant family to which nightshade, dhatura and tobacco (all highly poisonous) also belong has several natural toxins.

The chance of natural toxins being recreated through genetic engineering is high and therefore the genetic engineering of plants of this kind is more risky and more likely to produce foods that could be a threat to human health. Our regulatory system for GM crops have no provisions to conduct specific safety tests of this kind. Such tests, for instance, were not done for Bt brinjal.

It is known that allergenic proteins can be transferred by genetic engineering from one organism to another. The potential for development of toxic or allergic reactions to GM foods is likely to increase with advances in the scope and range of genetic modifications, increasingly radical transgenic combinations and the introduction of a greater variety of GM foods into the market, the last resulting in an increased exposure among people to foods carrying novel proteins.
With the widespread penetration of GM food in the market, food-allergic people will have to contend with new sources of allergens. The danger will be compounded by the difficulties of implementing labeling in India and making such labels intelligible to a large section of Indian people, particularly in rural areas. Allergic consumers will not even know what to avoid, resulting in a great risk to their health.

Children will be particularly vulnerable because their young immune systems will be less able to fight the allergen and also because their exposure to such novel proteins will be of longer duration, increasing their risk. The use of GM food products as food additives and processed foods, including baby foods, will lead to earlier exposure, especially for infants either directly or via breast milk. Maternal dietary food proteins are regularly detected in breast milk, and cow milk.

A particularly controversial area in the application of GM technology has been the use of marker genes which are introduced along with the gene for the desired trait as part of the gene construct that is inserted. The marker gene is just that, a marker to identify if the gene transfer has been successful.

Historically, the most common marker genes have been those that code for resistance to antibiotics. The concern is that these genes could find their way into pathogenic microbes, potentially compromising the clinical efficacy of antibiotics used in human medicine or livestock production. The indiscriminate use of antibiotics in human medicine is a large enough risk for giving rise to antibiotic resistant bacteria.

Testing can be done when the protein created by the foreign gene is known but problems arise when the toxicological hazard results from newly formed proteins which can not be predicted. It is not possible to test for what you do not know and the hazardous proteins can remain undetected. The problem is made worse by the fact that induction of food allergies by increasing dietary exposure may be difficult to detect because of low frequency in the population to start with and because years of ingestion may be required to provoke an allergic response. This has special implications in the case of proteins where allergies are likely to show up years later.
There is plenty of evidence about the health dangers of GM foods, from animal tests.

Studies done at the Russian Academy of sciences, on rats fed with GM soya showed high rates of mortality, severe stunting of pups and high levels of sterility in the surviving litter. The startling results showed that 36% of the litter born to emales fed GE soya were stunted at the age of two weeks, by the third week over 55% had died. The mortality was six to eight times higher than in the control group which had been fed non GE soya.

Data on the health damage caused by eating GM foods comes from Monsanto's own labs. Results from a secret study conducted on their GM maize Mon 863 which were accidentally leaked, showed that rats fed on Mon 863 developed organ abnormalities, changes in the blood profile and collapse of the immune system.

Earlier studies on rats have also shown that rodents appear to be averse to GM foods and reject them in laboratory tests. When the first genetically altered tomato "Flavr Savr" was fed to rodents in the labs in 1994, data revealed that many of the rats developed lesions in the stomach. Seven of the forty rats that were fed with GM tomatoes died within two weeks. There have been numerous other reports of stomach lesions in rats, false pregnancies in cows, excessive cell growth and damage to animal immune systems, following feeding studies conducted with GM foods.

Adequate testing procedures for allergenicity are not available in India. At present food toxicity is tested merely by the chemical analysis of nutrients and known toxins. This may fail to uncover several categories of toxins and allergens. This means that animals and humans could be exposed to allergens which are not being detected. Before any further commercialization is allowed, testing procedures of sufficiently stringent standards should be put in place.

Dr Suman Sahai, trained in genetics, is the chairperson of the Gene Campaign, She has served on the faculty of the Universities of Chicago and Heidelberg. She can be contacted at

Monday, July 12, 2010

Synthetic Life?

Suman Sahai

Synthia, the nickname given to the first synthetic bacterium created recently, has stirred up a global debate. Is it new life or just an efficient copy of life as it exists? As research prowess goes, the latter is nothing to scoff at. What Craig Venter’s group has done is a technological breakthrough. The researchers have created what they call ‘artificial life’ by creating a newly synthesized genome using off the shelf biological reagents. They then put this artificial genome into the shell of a bacterium from which most of the genetic material had been scraped out. The artificial genome revived the bacterial shell and made it functional. Venter announced his group had created ‘synthetic life’. This claim immediately became controversial.

While Venter says this is the first ever synthetic cell that's been made and the first ever life form on the planet “whose parent is a computer”, others in his team have been more modest and said that they had only taken "baby steps" toward custom-making an organism. Scientists too have had differing responses, some say that the new bacterium could not be called artificial life, that science does not as yet know enough about biology to really create new life. Others called this an epochal breakthrough in biology. As a biologist myself, I would say that the new research is dazzling but it’s not quite creating life. The newness is that the new DNA has not been created by replicating the DNA of an organism but by reading the code of the organism stored in a computer and creating the DNA spelt out by that code using store bought building blocks (nucleotides). That I would say is a brilliant mimicking of life , not creating it de novo.

Whatever the nature of the breakthrough, one thing is certain, the trigger for it is overwhelmingly commercial. Venter and his partners stand to make a huge amount of money on the patents that are already being taken out on all the processes and products associated with synthetic biology. The same thing had happened when Francis Collins and he had announced in 2000 that they had mapped the human genome, a full three years ahead of the international Human Genome Program being managed by a consortium of scientists from across several countries. A spate of patents on human gene sequences and even parts of genes followed. Many of these were not accepted as patentable subject matter because the function of the genetic material was unknown, but many were. For a patent to be granted, the invention must have demonstrable utility, if the function of the DNA sequences was unknown, it could not have utility. Despite these minor bottlenecks, Venter sits on a heap of patents which will spin gold when the time comes.

Speculation is rife about all that synthetic microorganisms could do for the benefit of mankind. Custom made bacteria and algae to produce whatever you want, creating drugs and vaccines, cleaning water and effluents, trapping carbon in cultures serving as carbon sinks, even novel foods, energy and fuels, industrial chemicals, paints and varnishes…almost anything. Venter has already mentioned a 600 million dollar deal with Exxon to create ‘synthetic ‘algae to produce biofuels; another deal for an undisclosed amount has been struck with the British petroleum giant BP. Despite this promising wish list that synthetic biology appears to offer, there are also immense ethical and security implications associated with this new technology.

The US system is gearing up to look at synthetic biology to identify ethical boundaries and minimize identified risks. President Obama has asked the Presidential Commission for the Study of Bioethical Issues to examine the new technology in this context. It will be interesting to see the outcome of this review, particularly in the back drop of how genetic engineering, another contested technology was reviewed. In that case, despite there being outstanding ethical and security issues associated with recombinant DNA technology, not dissimilar to the current situation with synthetic biology, it was commercial interests that ultimately prevailed. Transgenic technology was not considered violative of fundamental ethical principles and the security concerns were countered by the argument that there was sufficient vigilance and the benefits far outweighed the risks.

How should Indian science respond to the new developments? There is good potential for first class biological research in the country, even if some of it tends to be copycat. Indian labs will undoubtedly want to connect with this new technology domain. But before engaging with the field of synthetic biology , or any of the transformative technologies on the horizon, there should be a public debate involving Parliament on the desirability of this technology and more than that, the ability of our regulatory systems to cope with its more than considerable potential risks. The track record on regulating Agbiotech has been abysmal. Our regulatory bodies lack technical competence and are riddled with conflict of interest, lack of transparency and accountability.

In spite of sustained demands from a wide variety of people, to improve the regulatory system, vested interests are succeeding in maintaining a weak and ineffective regulation that does not get in the way of product release. The more radical the breakthroughs in biology, the more they upset the equilibrium achieved through evolution and the greater the danger of damage. By inference, therefore, the greater the need for caution and perhaps for abstinence. It does not stand that just because scientists can do something, society should endorse that it be done. We do after all have a self imposed ban on sexing a foetus, on human embryonal cloning and on germline therapy (doing genetic changes to the human germ cells which will allow the changes to be passed on to the next generation).

Proceeding with radical technologies that will alter, perhaps inalienably, many facets of our existence, needs the cautious and considered endorsement of society and its stewards.
If the decision is to move forward on synthetic biology, a new and effective regulatory system that has the confidence of the public must be put in place before the first test tube is picked up or the first culture plated.