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NBRA and the Supreme Court Appointed Non-Biosafety Expert
An eminent agricultural scientist once jokingly remarked a decade ago that India’s three tiered biotech regulatory oversight committees, the Institutional Biosafety Committee (IBC), the Review Committee on Genetic manipulation (RCGM), and the Genetic Engineering Approval Committee (GEAC) function in an increasing order of ignorance and incompetence.  eriously, that is not true.  India’s biotech regulatory system has been under relentless attack, mostly by the anti-GM groups just because it has not banned or stopped any any field trial of GM crop.The anti-GM crowd will not be satisfied until the GM crops technology is completely banned from the country.  Now, we have a court appointed scientific biosafety ““expert” going around the country criticizing GEAC on his pseudo scientific pretences.   Can anyone take these Luddites seriously?  For the anti-GM crowd, regulatory system must employ the “precautionary principle” sensu stricto just like their leading light,  the European Union (EU) has done, and order all sorts of tests for the next fifty years so that no product will ever come to the market.  After all the anti-GM crowd in India gets its inspiration from their comrades in Europe.

A sound regulatory system is one that facilitates safe products to the market place, and is vigilant to catch unsafe products to take corrective action.  But, the Luddites want to use the regulatory system to stifle technology growth  just  to  their own leftist/socialist  political ideology.   Criticize India’s agbiotech regulations for all you want, but it has functioned  albeit like any other Indian government program.  Is it really that bad?  The answer is NO!  Is there room for improvement? Definitely, YES!  All regulatory systems need constant updating and revising as technologies make progress and advancements.  ,  Every regulatory system in the world is under attack by the anti-GM lobby just because none of them have banned any of the GM crops.  No surprises there!  What is lacking in India’s regulatory system is their ways of functioning that lacks a defined process, documentation and sufficient transparency.  Even here, GEAC has made some progress and still has ways to go.   If GEAC allows for a public comment of their DRAFT decisions  and address all  comments, then they would have done an eminent job.  This they can do right away.  To their credit, RCGM and GEAC have been courageous in facilitating so many field trials, but save for Bt cotton, their score card on commercialization leaves a lot to be desired.  India has sufficient expertise (certainly more than the two scientific experts appointed by the Supreme Court) to scientifically judge the safety of GM crops except that they should stop reacting to the cries of the anti-GM lobby.  RCGM and GEAC members swear that they don’t needlessly care for the anti-GM lobby, but they certainly do as demonstrated by some of the needless, pointless and useless tests and data they keep asking for from the applicants that has nothing to do with safety or environmental impacts of GM crops.  If they think that the  anti’s will go away just because you throw some sops at them, they are wrong.  These anti’s have a nasty habit of keep coming back for more.  GEAC must realize that the goal of the ant-GM lobby is to shut down GM crops in the country and they will not stop until they get their wish.

Now the GEAC has to put up with the Supreme Court imposed  “experts”  on the committee to oversee how GEAC makes their decisions.  One of them, Dr. MS Swaminathan has stayed away from the committee as he has better things to do, but    Dr. Pushpa Bhargava, who has nothing better to do has started needling GEAC, and has released a letter to the media that he has written to  GEAC about the alleged laxities of the Bt brinjal biosafety review.  I bet that Dr. Bhargava will be doing the biddings of the anti-GM lobby with whom he has gone to bed, and it will do everything to use him to throw stumbling blocks for GEAC from taking any decision.  Dr. Bhargava will argue he is using science to ask questions.  He does not kidn me on that score.  Anyone who understands basics of brinjal  reproductive biology and toxicology of Bt proteins would  laugh at the suggestions and claims he has made in that letter.  His letter betrays his complete ignorance of biosafety and modern biotechnology.  Now the Ministry of Environment and Forests (MoEF) has a great opportunity to go back to the court with this letter, and prove that Dr. Bhargava is no biosafety expert, and certainly has no clue to regulatory affairs, and get this monkey off its back.  Mark my word, the anti-GM lobby will now go to town waving this ” eminent”  scientist's letter, and say how GEAC is not doing its job properly.  The fact of the matter is Dr. Bhargava is eminent because he is notorious.  He is a toady of the anti-GM lobby.  He is no expert on biosafety, and wish that DBT or MoEF would have protested at his nomination, and gotten rid of him right at the beginning.   It is not too late even now.  He clearly has a conflict of interest by being on the management committee  of at least one anti-GM NGO., and the other “biosafety expert” Dr. Swaminathan is the Chariman of the same NGO.  In fact, all objections raised by Dr. Bhargava  are taken straight out of the books of the anti-GM lobby as he is their poster boy.  His “claim to fame” in the past thirty years is that he established the Center for Cellular and Molecular Biology (CCMB) in Hyderabad more than two decades ago with copious funding from the  government.  India had not seen a lab of such opulence until then. That is where his claim to fame ends.

Dr. Bhargava was an accomplished biochemist at one time, and has dubious claim to have coined the term “genetic engineering”.  The fact is that phrase had been used by an yeast microbiologist Dr. Jost in 1940s when Dr. Bhargava had not even heard of “genetics”, and he is still clueless about it.  Only scientific ignoramuses in the anti-GM lobby recognize him as a great biotechnologist because he insists on it, and he serves   their purpose for now.  None of the current practitioners of the art accept him as an expert in modern biotechnology, and   for sure no one should accept him as an expert on biosafety of GM crops or environmental risk assessment.  No doubt, he is smart and intelligent, and knows how to get attention. He certainly has learnt (from these anti-GM NGOs) how to draw attention to himself by making loud noises.  He seems to have read something called genomics and proteomics lately, and now he wants all GM crop events submit a genomic and proteomic profiling to discover only he knows what.  He might impress  his ignoramus friends in the anti-GM lobby by throwing around  fancy scientific jargons.  But,  he cannot fool those who know what those terms really mean, and what their worth is. 

Does Dr. Bhargava have any idea how much it costs to get all these fancy but useless tests? If he has his way (hope he does not), only multi-national companies with deep pockets will get their products through, and no indigenous company or a public sector lab will be able to release a GM crop variety in the country.  The anti-GM lobby has long complained that safety data developed by the companies should not be accepted as they are suspect.  Dr. Bhargava repeats the same nonsense in his letter to GEAC. This is what the anti-GM NGOs have been crying about forever.  Who else is going to spend money and time to develop safety data ofr products developed by someone else,  if not the company that developed  Them.  By the way, pharmaceutical companies have been developing their own safety and efficacy data of their products for eons,  which is perfectly acceptable, and why not if the safety data of GM crops comes from an agbiotech company that developed it?  This is nothing but skullduggery.  What is important is for the scientific experts to judge the quality of the data and the rigor of the methods used by whoever develops the data. There is no guarantee that a public sector agency can develop any better or high quality data.  Indian public sector labs can hardly afford sophisticated technologies and techniques. This will be perfect recipe to ensure dominance of private companies over agricultural biotechnology as no public sector lab can afford the costs of such useless tests.  By the way, this is one of the complaints of anti-GM lobby that multi-nationals dominate this technology, and public sector institutions are nowhere I the picture, and that is why modern GM crops cost more.  The sad truth of the matter is, all over the wold because of the anti-GM lobbying, regulatory systems either do nto exist ot if they exist don’t  function effectively and public sector developed agbiotech products are nowhere in sight.  The anti-GM lobby has done and effective job of killing the technogly with connivance of the UN systems that are there to ostensibly to help developing country governments acquire modern biotech capabilities. Instead, they have played into the hands of the anti-GM lobby to kill technology development where it is needed the most.

India’s biotech regulatory system has suffered considerable growing pains for almost fifteen years of its existence.  Finally, the Department of Biotechnology (DBT) is moving ahead to establish a National Biotechnology Regulatory Authority (NBRA), and they are holding countrywide stakeholder consultations by rounding up the usual suspects.  It remains to be seen how MoEF will let loose its grip on biotech regulations.  As can be expected, the anti-GM activists will be demanding that NBRA shut the door on GM crops for good, and they will do so by asking authorities to raise the biosafety bar high.  The tactic is simple.  Make regulations so tough that no one will be able to pass the muster, and that will ensure the death of agricultural biotechnology in the country.  This has been the tactic of all anti-GM forces around the world, and their Indian brethren are just borrowing this idea from the European International Non-Governmental Organizations (INGOs).  The tactic has worked in Europe, and is taking roots in many other developing countries of the world. 

Well good times are ahead, only if NBRA gets it right. It should resist temptations to overreach on regulations and do not   act like an imperious authority.  Instead, use the best possible science and common sense to review biosafety data, and make quick decisions.  They should carry out proper environmental risk assessment, and give opportunities for public comment.  The anti-GM lobby wants a seat at  the decision making table just to obstruct, delay, and stop testing. They should not be allowed a role in decision-making or governance.  They can have their input and comments on a DRAFT risk assessment just like any other member of the public, but the final decision must be taken by the statutorily competent authority.  The reviewers must address all objections and comments from the public before making their decision and document them just so that no one may complain that their comments have been ignored.  NBRA can have a policy advisory board that should not have any decision-making powers on any application.  Individual regulatory decisions must be taken by scientific and technical personnel who are properly trained and skilled in the art of regulatory review and risk assessment.   If anyone has a problem with the final decision, they can always appeal to the NBRA or go to the court. 

Dr. Shanthu Shantharam,
June 5, 2008