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December 28, 2004


Good for Goose and Gander; A Green Utopia; Fear for Profit; How to kill Biotech; Enlightened Environmentalism or Disguised Protectionism?


Today in AgBioView from www.agbioworld.org : December 28, 2004

* What is Good for the Goose Must be Good for the Gander
* Imagine A Green Utopia
* Fear for Profit
* Combining Multiple Viewpoints on Genetically Modified Foods
* Enlightened' Environmentalism or Disguised Protectionism? A
* India: How to kill the Biotech industry

What is Good for the Goose Must be Good for the Gander

- Kameswara Rao, and Shanthu Shantharam, AgBioView, December 28, 2004, www.agbioworld.org :

Apropos the Press Release by the Greenpeace, November 15, 2004, entitled "Bayer pulls out of Genetic Engineering Research in India". It seems that Bayer has admitted to Greenpeace that the future is in ''Conventional' Breeding". Greenpeace commented that the consumers 'don't want to eat genetically engineered food. We do not know which consumer they are talking about in India. It is good news to MNCs, who can continue producing conventional poisons, without spending time, money and energy on unrewarding ventures.

In 1977, the then Government of India governed by the Janata Party, under pressure from the socialist George Fernandez, sent IBM and Coca Cola packing out of the country. A new cola, the double seven (77), was launched to quench the thirst of the Indians to replace of Coca Cola. Both Janata Government and the new Cola went packing themselves later on. The Janata Government could not or did not do anything about computer technology development in the aftermath of IBM's exit. But this singular achievement of George Fernandez' cap was a drastic set back for the information technology development in India for more than two decades. India may be a software force o reckon with, but terribly lost out non hard ware technology prowess. Notwithstanding the fact that both IBM and Coca Cola are back in the country with a bang, the amazing gloating of Greenpeace in sending Bayer out of the country's field of genetic engineering, is as great an achievement as that of George Fernandez's.

Greenpeace must be ashamed of setting developing countries backward in science and technology development. The consolation is India has come a long way in biotechnology and there is a greater awareness amongst the Indian science community and other captains of Indian industry than Greenpeace activists in India have to let the opportunity slip by again. A Bayer may go temporarily, and another Bayer-like will takes its place (that is the beauty of market place), and biotechnology will move forward as it should and as it has.

According to an estimate in 1997, the annual increase in the human population is 2.5-3.0 per cent and the increase in food production is only about 1.0 per cent. The urgent measures are needed to bridge this huge gap. Crop protection to minimize yield losses is one of the definitive ways that biotechnology has to offer. This is exactly what is expected of Bt transgenic crops and this has been fulfilled to a great extent to the chagrin of the anti-biotech activists. They are moving heaven and earth to discredit the Bt-cotton technology and it does not seem to be working.

World wide crop losses without the use of pesticides and other non-chemical control strategies is estimated to be about 70 per cent of crop production, amounting to US $ 400 billion. The world wide pre-harvest losses due to insect pests, despite the use of insecticides are 15 per cent of the total production amounting to over US $ 100 billion. The annual cost of insect control itself amounts to US $ 8 billion; the global market for transgenic crops was US $ 148 million in 1996, and 3.94 billion in 2001. Very optimistically it is expected that transgenic crop business would reach US $ 5 billion in 2005 and US $ 10 billion by 2010. Transgenic pest resistant varieties constitute only part of this trade volume. This means that chemical pesticides are still as big a business as agricultural biotechnology, and thanks to Greenpeace, Bayer will quietly go back to selling its chemical insecticides and still thrive in its agribusiness. It will wait for another opportune moment to make a come back. All a part of good old savvy business strategy.

The production of a transgenic pest resistant variety involves anything between US $ 10 to 20 million, and a time period of about 10 years from the start to the time the crop becomes commercial, plus the perennial headache of facing criticisms, vehement opposition, and even violence and vandalism, leading to fear and suspicion in the public mind, not only about the product but even the company itself. Certainly, this situation does not go well with the share-holders. Under these uncertain circumstances, Bayer did the smart to derive the full benefits from its chemical pesticides. Unfortunately this means insects developing resistance to the chemical insecticides and pests becoming resistant to pesticides, cause damage to the environment due to excessive use of chemicals, damage to the health of the farm labor and the public who are affected by pesticide residues in the food. All thanks to Greenpeace's wrong headed activism against modern biotechnology.

Amidst the hullabaloo about GM crops, Kansas State University seems to have produced imidizalone resistant (Imi-resistant) maize, wheat and sorghum. Since this is by conventional breeding, no one will ask a single says a word about their safety to the consumer or damage to the environment or gene flow or damage to biodiversity or loss of farm labor income. No environmental activist will worry about those imi-resistant crops becoming super weeds or the prospect of their destroying the diversity. We will not hear about the unknown mutations that pose untold biosecurity risks. Apparently, all these are dangerous portends only with GM crops, but not with conventionally bred crops. How ignorant and ill informed are these activists? It is not the environment that these people are worried about, but they are against MNCs and their technologies. Science based concerns can go to hell!

If there is a science based logic, crops, whether produced by transgenic technology, or conventional techniques with unconventional origins or traits should follow good agricultural practices for a scientifically sound product stewardship which means go through the similar regulatory review to determine their environmental impacts. Lest someone mistake, by no means are we suggesting that conventional crops should be regulated.

If logic was ruling the current anti-biotech activism, we should apply such a protective monitoring even for Durum wheat, Triticale and crop varieties that had hundreds of parents in their lineage. Organic farming is projected as the new invention (several people regularly reinvent the wheel, anyway) and as such we do not know what deleterious effects the products of this kind of agricultural practice have on conventionally bred crops. Somehow, organic farming in India is self-regulated and self-certified by organic farmers without anyone concerned about its environmental impacts, because their methods of cultivation are supposed to be zero risk to the environment and human health. But, who has proved it? Let Greenpeace use its influence to insist on a refugea around every insect resistant crop and insecticide used in the field. What is good for the goose must be good for the gander.

If a Bt variety or an herbicide resistant variety is not suitable for the third world where land holdings are small, so is every other new crop variety. Amazing is the conviction of the anti-tech intelligentsia that a transgenic plant can become conscious of the fact that it is planted in a small area and/or in a poor country and become delinquent whereas any other local variety will thrive for the benefit of a poor farmer and make him rich.

GM Watch commented that 'Bayer's withdrawal from GE research in India and around the world is part of a larger pattern of retreat in the global biotechnology industry'. Certainly it is so. The companies are realizing that they can reap larger profits on conventional products, using existing expertise and facilities, without investing anything in developing new facilities and technologies, without the need to face the time and financial costs of burdensome regulatory oversight and more importantly without the need to face violence and vandalism.

If this is a retreat by Bayer, then it is a smart one. At least some MNCs may not want to fight hazy, ill-informed, misconceived and mischievous propaganda. They will bide their time which is not going to be that long, to come back at an opportune time. Bayer may be withdrawing from GM crops research in India, but they will continue with it elsewhere and come back when the time is ripe in India. Greenpeace's wrong headed activism against MNCs and their "evil" technologies betrays its woeful lack of understanding of the agricultural problems.

enpeace, if it is really concerned with protecting the environment, then it must learn to become a part of the solution and not be a part of the problem. It is unfathomable why those who want to protect the environment rail against GM crops that are proven cut down on nasty chemical inputs into crop cultivation. Greenpeace's misguided anti-GMO stance in developing countries seems more and more like war against humanity and the environment.

Prof. Kameswara Rao is at the Foundation for Biotechnology Awareness and Education, Bangalore, India (krao@vsnl.com) and Dr. Shanthu Shantharam is at the Biologistics International, Ellicott City, MD, USA (sshantharam@biologistics.us).


Imagine A Green Utopia

- Eileen Norcross Wall Street Journal, December 24, 2004

'Review Of The Frankenfood Myth By Henry I. Miller And Gregory Conko (Praeger, 290 Pages, $39.95)'

Imagine A Green Utopia: Overtilled land is returned to the forest. Waterways are unmenaced by the runoff of pesticides, now rarely used. Farmers are spared crop-killing frosts and insect plagues.

The Green Utopia is not a fiction. It arrived in 1973 when Stanley Cohen and Herbert Boyer spliced the DNA of one species of bacteria into another and cultivated a new organism. With refinements, recombinant DNA technology, or gene-splicing, has given us Genetically Modified Organisms (GMOs) such as the slow-ripening tomato, vitamin A-enriched rice and pest-resistant corn. And that is just a glimmer of its potential.

Yet gene-splicing is struggling to survive. The battle over its future is the subject of "The Frankenfood Myth," by Henry I. Miller and Gregory Conko. The authors show how foolish policies -- premised on junk science, media sensationalism and the mixed motives of bureaucrats and corporations -- are choking off a wonder-technology.

The word "frankenfood" owes a debt to Green activists, who warned early on that gene-splicing would create a world where superweeds would choke vegetation and monster tomatoes would sit in fields like ticking time-bombs. All baselessly, for the verdict of science is clear: Gene-splicing offers no new risks to man or his environment. Gene-swapping between unrelated organisms happens often in nature, and conventional plant breeding can move genes from one organism to another. Gene-splicing does essentially what hybridization doe s, but with more precision, predictability and possibility.

Still, the Environmental Protection Agency and the Agriculture Department require that biotech companies perform thousands of field experiments and thousands of hours of data-analysis before marketing their products. The companies have acceded meekly to such regulatory overkill, hoping that it will lessen public fear and thwart startup competition. Instead, it has increased research-and-development costs, diminished the interest of venture capital and stalled a revolution.

The U.S. biotech industry, once poised to transform agriculture, today merely putters along in staple crops such as soybeans, canola and corn. It has not spread to "small market" fruits and vegetables because costly regulatory requirements outweigh commercial gain.

The state of biotech in Europe is even worse, as Messrs. Miller and Conko remind us. The European Union lifted its ban on gene-splicing only earlier this year, replacing it with a "traceability" rule that requires companies to track all product-ingredients that have gene-spliced origins, however intricately combined they may be. The label on a bottle of ketchup alone could run to Gibbon-like lengths.

The trials of the new biotech are a travesty against reason, but not a human tragedy, at least in the West, where no one will starve if he is denied cheaper, vitamin-enriched foods. Elsewhere, though, the costs are high. In 2002, for instance, during the height of a famine, the Zambian and Zimbabwean governments rejected food aid in the form of gene-spliced corn, contending that, as the authors put it, "they would rather starve to death than get something toxic." But of course there was nothing toxic in what they were being offered.

Such irrational fear need not carry the day. Messrs. Miller and Conko urge those who know the truth about gene-splicing to tell it -- forcefully. As for business, it might take note, for once, that appeasement does not stop fanatics. It only encourages them.


Fear for Profit

- Sandy Szwarc, TCS, Dec 28, 2004 http://www.techcentralstation.com/122804C.html

"Government regulation is so pervasive, so intrusive upon our freedoms, that it should be carefully measured and based on rational considerations." -- John H. Moore, former deputy director, National Science Foundation

Virtually every aspect of our lives today is restricted in some way by the government and it's hard to imagine that such intrusions are based on anything but good science and good sense. But that's not the reality at all.

The more affluent we become, the less faith we place on scientific, reasoned approaches to our decisions. Those struggling every day to feed their children and stay alive, for example, must, of necessity, make decisions about what to eat based on evaluations balancing the benefits and risks. Only the well-to-do can afford the luxury of fretting over intangible concerns or moralizing about romantic ideals. Hence, Western developed nations are increasingly abandoning science-based assessments of risks. In their place is a growing "absolute safety at all costs" perspective that's been skillfully fueled by scares and misinformation from special interests. As a result, foods and technological developments that can and are bettering our lives and can save lives, are being maligned, feared and resisted far out of proportion to their potential risks.

The result of overly-cautious, inaccurate tenets is regulatory policies rife with blunders and inconsistencies that hurt consumers, most of all the poor and disadvantaged. We not only deny ourselves better choices, as well as perfectly safe foods, we deny them to others who may more desperately need them.

Virtually every food and health fear today fits this description: the "obesity crisis," pesticides in fruits and vegetables, mercury in fish, mad cow from beef, hormones in milk, "bad" fats in snacks, refined sugars in treats, arsenic in water, and the countless other unfounded scares bombarding us. But understanding how fears take hold, what's behind them, and what they're doing to us, is the first step towards helping ourselves.

Henry I. Miller and Greg Conko give us some of those insights in a chilling cautionary exposé that bravely counters today's emotionally-charged insanity over what we eat. In The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution (Praeger Publishers 2004), they reveal the story of genetically-engineered foods which have been targeted so vehemently, activists have ominously named them "Frankenfoods." While the authors touch on the misconceptions being spread about biotechnology, that's not their primary focus or this book's greatest value. It's a powerful wake-up call for scientists, policy makers and consumers on how all of today's food myths are invented and used, and the importance of returning to rational, science-based discussions and decisions.

Fears Versus Reality
The scientific community views the risks of genetically-modified crops to be no different, and even less, than those from conventional plant breeding. Their calm approach to the safety of biotechnology is due in part from the comfort that comes from understanding the research and scientific nuances of biotechnology; along with an excitement of its current and future possibilities to improve our foods and medicines and alleviate human suffering, enable farmers to grow more foods on less land using fewer chemicals and hence strengthen environmental stewardship, minimize food spoilage losses, and help -- especially subsistence farmers in developing countries -- produce food on inhospitable soils that are salty, acidic or drought-ridden, in harsh climates or in locales ravaged by pests and diseases which claim up to 40 percent of crops each year.

But the reality of food and health risks has nothing to do with how safe the public feels or how risks are regulated. The disparity between risk assessments by scientists and those by regulators and consumers is a source for considerable rancor and accusations of irrationality and ulterior motives. But while it may be easy for the scientific community to conclude that consumers who believe food scares or who view biotech as dangerous are being stupid, I think the public is actually responding in a very predictable way to the information they hear in the media and to their government's special attention in regulating apparent health concerns.

Consumers are being expertly played by those who usually do know exactly where the weight of scientific evidence lies concerning risks, and know exactly how to exploit people and the system for political, economic and social advantage, reveal Miller and Conko. They largely ascribe the unsound regulations surrounding biotechnology to those who are using fear to take advantage of the public -- namely special interest groups, regulators themselves, and the media.

Oh No! What If? How Can We Be Sure?
A key part of fear-based marketing is the promotion of the Precautionary Principle -- that's the belief that if something might go wrong, then we must do whatever possible to ensure that it doesn't. Of course, since everything in life entails risks, this makes it possible for fear mongers to object to and impose regulations on anything, especially new advancements in science, health and technology. Supporters of the Precautionary Principle believe that people are too dumb or ill-equipped to manage risky things safely and it's best to control access to them. This concurrently means rejecting the benefits such things might offer. Yet we safely use and benefit from potentially dangerous things every day, from chain saws, cars, hot water to aspirin.

Just like anything being sold to us, what's at the root of scares isn't altruism. While portraying themselves as moral defenders of the little people, say Miller and Conko, the environmental groups and nongovernment organizations behind today's food and health fears are actually a collection of well-financed professionals set out to shape public opinion and deceive people for their own benefit.

No one should mistake the anti-biotech [groups'] misdemeanors for naive exuberance or excessive zeal in a good cause," said Miller and Conko. "Their motives are self-serving and their tactics vicious." They not only don't hesitate to terrify consumers by twisting the truth and exaggerating risks, they intimidate policy makers with the threat of lawsuits, and threaten shakedowns on the food and biotech industries in what Dr. Alan McHughen calls "economic terrorism." Businesses acquiesce and buy their products, while policy makers grant them the regulations that shield them from national and global competitors, especially those in developing countries.

"The major beneficiaries from these unscientific policies are activist groups that have raked in hundreds of millions of dollars from gullible donors; the natural and organic food industry, which has exploited the surfeit of misinformation; and the regulators themselves," write Miller and Conko. Policy makers "use the blandishments and demands of activists as cover for their own overregulatory tendencies," according to the authors. Regulators' own desires are for more responsibilities, larger budgets, and grander bureaucratic empires. Claiming an obligation to regulate anything the public believes is a concern, regulators use fears to spawn the growth of government agencies, leaving the public to foot the bill. Worse, say the authors, government involvement endorses the activists' claims and raises consumers' fears because people view things that are regulated as being the most dangerous. "Pandering to near-superstitious hysteria only serves to enhance anti-biotech mythology," said Miller and Conko.

These groups aren't fueled by genuine health or environmental dangers, say the authors. They're actually anti-business, anti-technology and anti-establishment, merely trying to preserve their own commercial interests and sustain their ideological vision of a perfect world.

Desperate hunger is an alien affliction in the United States, so it's easy to romanticize about the backbreaking existence of hundreds of millions of people barely staying alive trying to live off the land. And it's impossible to overlook that the primary beneficiaries of biotechnology are brown- and yellow-skinned people from Third World countries. Technological progress and having enough to eat improves health, and has allowed industrialized nations to increase productivity and grow prosperous, write Miller and Conko. Yet while industrialized nations have enjoyed the benefits of science and development, denying them to developing countries is hardly an act of philanthropy.

Agriculture scientist Norman Borlaug, credited with saving the lives of one billion people and who wrote the Forward to this book, agrees. He told the Dallas Observer that opposition to biotechnology isn't a concern for human health, the millions of hungry people in the world threatened with starvation (852 million according to the latest UN Food and Agriculture Organization report), or the environment. This was demonstrated in what can only be called a crime against humanity when, during the worst food crisis in a decade, anti-biotech activists persuaded Zambian leaders to let over two million people starve rather than receive American food aid that contained genetically modified corn, they'd been told was "poisonous."

Regulations Impede Innovation
"What's happened more and more, from my point of view... is that the gene for common sense and judgment has been eroded all to hell and it doesn't function anymore." -- Norman Borlaug

The regulatory mess surrounding biotechnology began with the myth that it's somehow uniquely risky and therefore should be subject to special caution and regulatory oversight, say Conko and Miller. Genetic modification is nothing new, however, and virtually everything in our food supply has been changed by one method or another. But traditional plant breeding is slow, crude and imprecise as thousands of unwanted genes are introduced along with those offering the desired traits. Today's conventional breeding methods even employ violent blasts of radiation or chemicals to mutate genes, but these resultant food crops still aren't any more dangerous than those that mutated over hundreds of years.

Modern biotechnology simply offers a more precise, controlled means of improving plant characteristics that's less likely to cause unintentional, unwanted changes. Scientists can predict with a high degree of certainty whether a gene is likely to impose risks and take precautions depending on how much is known about the gene.

Currently, although two foods might be indistinguishable and virtually identical genes were modified, they're regulated differently according to the process in which they were created. The regulations are so onerous, "not a single conventional crop could meet the requirements being imposed by USDA on gene-spliced plants," say the authors. The result has been to add tens of millions of dollars to the testing and development costs of each new biotech crop variety, making them up to twenty times more expensive to develop. The added regulatory costs profoundly discourage innovation, hinder research and development, create market distortions as only a few of the largest companies can afford to comply and stay in business while smaller companies go out of business, raise prices for consumers, and mean that only a few of the most commercially profitable varieties that are able to be grown on vast scales reach the market.

What's the answer? Miller and Conko end Frankenfood Myth with carefully thought-out strategies for reforming today's run-amok regulatory system. All that's left for us to do is read their book.


Combining Multiple Viewpoints on Genetically Modified Foods

- Medical News Today, 27 Dec 2004 http://www.medicalnewstoday.com/medicalnews.php?newsid=18342

Worldwide, the production and consumption of foods derived from genetically modified crops (GM crops) is rising rapidly. However, in Europe only 58.000 hectares are planted with one GM crop (insect-protected maize in Spain).

The public debate in Europe demonstrates that rigorous safety assessment is necessary but not sufficient for gaining societal acceptance of agricultural biotechnology. Many natural scientists agree that currently available GM crops are as safe as conventional food crops. Some critics on the other hand point to possible adverse unintended effects; others hold more fundamental concerns about mankind messing with hereditary material. The challenge is to identify prerequisites for introducing products of agricultural biotechnology in a manner that is broadly accepted in societies with wide ranging viewpoints.

To address this challenge, the European Commission-sponsored research consortium ENTRANSFOOD brought together representatives from academia, regulatory agencies, food manufacturers, retailers and consumer groups from across Europe. The consortium's main conclusions are discussed below.

Safety assessment
The consortium developed a systematic approach to tailoring the safety assessment of foods derived from GM crops to the specific characteristics of the modified crop and the introduced trait. It also concluded that uncertainties relating to GM foods are similar to the questions which remain with regard to health impact of other plant-derived foods. New molecular tools will help scientists better understand potential health impacts of all foods we consume.

Gene transfer
ETRANSFOOD recommended that assessments of gene transfer should compare the risk of transfer of modified genes from GM crops to microbes or human cells to the risk of a similar event occurring in nature. Gene transfer between organisms is common in nature and has been a driving force in evolution. There is no inherent risk in the transfer of DNA between organisms, since DNA is not toxic. The risk assessment should therefore focus on two factors: first, on the function of the transferred DNA in the recipient cell; and secondly on whether the recipient cell may have acquired the same gene from a source other than the GM crop.

Regulatory and societal aspects
Consumer trust is key and social scientists in the consortium highlighted that process-based labelling of all foods containing GM crops is one prerequisite to allay the fears of EU citizens. However, the consortium also identified difficulties in the implementation of the EU's labelling requirements. For example, one challenge will be achieving international agreement on standards for the labelling and traceability of foods originating from or containing GM crops, as food is transferred between businesses and countries.

Summary: In conclusion, the balanced outcomes from ENTRANSFOOD reiterated the merit of platforms for deliberations, combining a range of diverse perspectives on new food technologies. The project also helped to prioritize a range of questions fundamental to comparing the merits and draw-backs of alternative food production methods.

SAFEFOODS, the successor project of ENTRANSFOOD, had its first meeting in May 2004 and aims to address these larger issues in order to facilitate the comparative evaluation of alternative ways of agro-food production. Placing the GM crop debate in the broader context of alternative ways for food production is required so that individuals and societies to make more informed choices.

Kuiper, H. A., Kleter, G. A., Konig, A., Hammes, W. P., Knudsen, I. (Eds.). 2004. Safety Assessment, Detection and Traceability, and Societal Aspects of Genetically Modified Foods. European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD). Food and Chemical Toxicology 42(7, special issue): 1043-1202.

More information


Enlightened' Environmentalism or Disguised Protectionism? Assessing the Impact of EU Precaution-Based Standards on Developing Countries

- Full document at http://www.nftc.org/default.asp?Mode=DirectoryDisplay&id=190

Conclusions: This study has revealed how certain health and safety and environmental standards and regulations implemented unilaterally by the EU impede economic growth, social welfare and public health maintenance in developing countries. All three NFTC studies in this series confirm that politically influential European-based ENGOs are often behind the EU's promulgation and adoption of precaution-based regulations and product standards, as well as its drafting of precaution-based provisions within multilateral environmental agreements ('MEAs') that bind developing countries to EU societal preferences. Furthermore, they find that ENGO campaigns launched in developing countries (e.g., concerning Biosafety (GMOs), REACH, Basel and POPs) seek to alter consumer perceptions and generate public fears about uncertain risks associated with potentially dangerous substances, industrial processes and novel technologies, without resort to objective and scientifically relevant fact-finding. These campaigns, moreover, ignore the social, economic and health benefits that would otherwise be realized by developing countries had they been granted access to such substances, processes, or technologies in the first place.

This third study, in particular, shows how the Precautionary Principle, an inherently nonscientific touchstone without foundation in WTO law, has been employed within the Stockholm Convention and the EU's more stringent POPs implementing regulation to ban the shipment of DDT to and among African countries for purposes of indoor spraying. It also identifies how U.N. and EU sponsored donor programs ban funding for DDT malaria vector control, and how U.S. donor programs fail to promote DDT as one of several viable alternatives for malaria prevention, thereby contributing to an ongoing African health crisis. These prohibitions have been imposed on African nations without presentation of conclusive scientific proof that the possible environmental risks accompanying DDT indoor residual spraying outweigh the risks posed to public health, social welfare and economic productivity by failure to use DDT at all. In other words, these measures are justified by neither a science-based risk assessment (i.e., sound science) nor an economic cost/benefit analysis (i.e., equitable balancing).

Furthermore, this third study discloses how the activities of economically and socially vital developing country industries, such as chemical manufacturing, ship-breaking, e-waste recycling and recovery and their many related downstream industries are threatened by overly stringent EU regulations and overly broad EU interpretations of MEA provisions. For example, the Precautionary Principle has been invoked unilaterally as justification for: 1) adopting a broad non-consensus-based interpretation of the Basel Convention's definition of 'hazardous waste'; 2) imposing the Convention's not yet effective Ban Amendment; 3) applying the revised EU Waste Shipment Regulation; and 4) proposing the EU's REACH Regulation. Each of these measures are global in scope and place onerous and often insurmountable financial and administrative burdens upon small and medium-sized enterprises (SMEs) which comprise local cottage or informal sector industries that serve as a major source of employment and social stability within developing countries.

Looking Towards the Future
Although the essays within this study focus exclusively on health and safety and environmental measures targeting industrial product exports, EU environmental protectionism extends also to the natural resource-intensive and agricultural commodity-driven exports of developing countries. In the case of agricultural products a number of EU measures have imposed very low tolerance levels for toxicity and residues of natural as well as proscribed substances (e.g., pesticides, herbicides, aflatoxins, hormones, antibiotics, GMOs, minerals, etc.). "Europe… wants to raise food safety standards. European countries import many foodstuffs and raw materials, which are thus required to meet safety standards. This can cause problems for developing countries in particular, as they have difficulty in meeting these stricter conditions." And, in the case of product inputs and exports derived from natural resource extraction (e.g., forest products, etc.), other EU measures besides stringent maximum residue limits apply. These include standards for product harvesting (certification), packaging, labeling and traceability.

Of course, the EU and its Member States are not the only WTO members to impose stringent health and environmental standards that may actually constitute disguised restrictions on international trade. The U.S. , Canada and Japan are also guilty, from time to time, of imposing such protectionist regulatory barriers. What is different about EU-based health and environmental restrictions, however, is that they reflect a systematic attempt to employ on a global basis a precaution-based rather than a risk-based regulatory approach that is WTO-inconsistent. The NFTC studies are intended to scrutinize these measures and to unmask their use as disguised barriers to trade in order to promote meaningful dialogue about how to eliminate them. Undoubtedly, the ability of all developed nations to reduce the use and impact of restrictive national measures and related MEA provisions on developing country exports will go a long way towards facilitating the full participation of such countries within the WTO rules-based trading system, consistent with the Doha mandate.


India: How to kill the Biotech industry

- P. Hari & Gina S Krishnan, Business World, January 1, 200

Full story at http://www.businessworldindia.com/Jan1204/indepth04.asp

'Create a committee called GEAC, catch the entrepreneur...'

This is the story of a bright young biotech entrepreneur. We don't know enough about the person yet but we'll learn as we go along. We will assume that the entrepreneur is male, although we will be sure only by the end. He has a Ph.D. in one of the biological sciences. He may have studied in the US and could even have come to the country with the sole purpose of setting up a company. He is full of beans.

The story starts a few weeks ago. The entrepreneur comes to India and starts talking to friends about ways of setting up a company. They tell him that the Department of Biotechnology (DBT) is the nodal agency for biotechnology in India. He goes to the DBT website and starts looking for guidelines on setting up companies. There are none, except an application form for single-window clearance. He asks his friends in the industry, and they tell him that the single-window clearance system does not work yet.

Our entrepreneur wants to start a company that makes genetically-engineered products for pharmaceutical uses. He learns that this area is tricky. There are three agencies purportedly involved: the Drug Controller General of India (DCGI), the DBT and a committee called the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests.

He has never heard of a committee called the GEAC, so he decides to investigate. He does a search on Google. One of the first few hits is a news story, "GEAC stalls new clot-busting drug". It turns out that the GEAC has taken the Hyderabad-based Shantha Biotechnics to task for conducting clinical trials without its permission. A Bangalore-based NGO had apparently told the GEAC that people died during the trials.........

Read on at http://www.businessworldindia.com/Jan1204/indepth04.asp