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November 3, 2005


Excessive Obsession with Safety; EU Greenlights Maize; Africans Embrace Biotech; Gambler's Principle; Poison Paradox


Today in AgBioView from www.agbioworld.org : Nov. 3, 2005

* U.N.'s Excessive, Absurd 'Biosafety Protocol'
* EU Authorizes Imports of GMO Maize for Use in Feed
* EU's Go Ahead for Biotech Maize
* Follow Up on Julie Newman's Response
* Africans Embrace Biotech Future
* Introducing Issues with Opposing Viewpoints - Genetic Engineering
* Decade of Plant Biotech: Past Lessons and Future Challenges
* Ag Biotech in the Public Sector: Challenges to Developing Country Markets
* GM Crops: Global Economic and Environmental Impact
* Rejecting the Gambler's Principle
* Mixed Reactions: The Poison Paradox- Chemicals as Friends and Foes

from Prakash: Sorry about the resending of the newsletter. Due to a server problem, the previous email contained a clipped version

U.N.'s Excessive, Absurd 'Biosafety Protocol'

- Wall Street Journal, Letters to the Editor, Nov. 2, 2005

The inability of U.N. Secretary-General Kofi Annan to understand the relationship between public policy and innovation ("Hot Topic: Political Virus," Review & Outlook, Oct. 22, and Letters to the Editor, Oct. 31) is only the tip of the iceberg. Last month in Tokyo I participated in a bizarre meeting of the U.N.-sponsored task force on biotechnology-derived foods. The scope of the work, which has gone on for five years, is unscientific, the projects are pointless and gratuitous, the attendees (from scores of countries) are inexpert, and political correctness prevails. Focused on regulatory requirements only for foods made with the newest, most precise and predictable techniques of biotechnology, the project exempts other products made with far more crude and less predictable technologies, including irradiation mutagenesis and hybridization. As a result, there is an inverse relationship between risk and the degree of regulation.

This task force, operating under the auspices of the U.N.'s Food and Agriculture Organization and World Health Organization, makes a mockery of the U.N.'s own Millennium Development Goals -- especially the first and most ambitious: "to eradicate extreme poverty and hunger" by 2015. That can't be accomplished without innovative technology, and there won't be innovative technology if it is regulated excessively and stupidly as mandated by this project and the "biosafety protocol" of the U.N.-based Convention on Biological Diversity.

Other Millennium Goals inevitably will be compromised, directly or indirectly, by these initiatives. For example, an important and cost-effective way to "reduce child mortality," the fourth goal, would be to produce childhood vaccines cheaply in edible fruits and vegetables, but there is near hysteria at U.N. conferences over conjectural problems with this approach.

The U.N. deliberations on biotech foods are also disastrous politically. Unscientific, unduly burdensome U.N. standards for biotech foods compromise hopes of World Trade Organization relief from protectionist policies in Europe and elsewhere. U.N. standards provide cover for unfair trade practices, because with them in place, a country that wishes to block trade in gene-spliced foods for any reason can defend against charges of unfair trade practices simply by remonstrating that it's deferring to the U.N.

U.N. agencies should be expending every available resource -- every dollar and every bureaucrat-hour -- on coping with the epidemic of avian influenza that is sweeping much of the planet and threatening a human pandemic, and on the care and feeding of the victims of the earthquake in Pakistan. Instead, they persist in perseverating about foods made with superior genetic techniques.

But that is what we have come to expect from the United Nations: incompetence, self-interest and utter cluelessness.

- Henry I. Miller, M.D., The Hoover Institution, Stanford, Calif.


EU Authorizes Imports of GMO Maize for Use in Feed

- Reuters, Brussels Nov 3, 2005

The European Union has authorized imports of a genetically modified (GMO) maize, the fifth new GMO approval since the EU ended its informal biotech ban last year, the bloc's executive Commission said on Thursday.

The maize, known by its code number 1507, is jointly made by Pioneer Hi-Bred International, a subsidiary of DuPont Co., and Dow AgroSciences unit Mycogen Seeds. The maize, modified to resist certain insects and herbicides, will be used in animal feed. The authorization is valid across the EU-25 for 10 years.

"Robust post-marketing rules will ensure that the product can be traced and monitored when put on the market," the Commission said in a statement. "When put on the market, it will need to be clearly labeled as containing genetically modified maize. Its post-market monitoring will be assured through a unique identifier assigned to the maize to enable its traceability."

The EU decision is a rubberstamp procedure applied by the Commission. It is permitted under a legal default process that kicks in when ministers are unable to agree among themselves after a period of three months. Despite last year's lifting of an effective biotech moratorium using default procedures, EU countries have not managed to agree by themselves on a GMO approval since 1998. Luxembourg, Greece and Austria consistently vote against GMO approvals. They are offset by countries like Britain, Finland and the Netherlands that almost always vote in favor. Others sit on the fence or vary their vote according to the product concerned.

Europe's consumers have been far more reluctant than those in the United States to accept GMO products, which manufacturers insist are safe. In late August the Commission rubberstamped a similar approval for a GMO rapeseed made by U.S. biotech giant Monsanto, again for use in animal feed.


EU's Go Ahead for Biotech Maize

- EuropaBio, Brussels, November 3, 2005

The European biotechnology industry welcomes the EU Commission's decision to approve biotech maize 1507 for import and processing, including for use in animal feed throughout the European Union. This decision follows after the EU Council in September was unable to reach the required qualified majority to approve 1507 maize.

The product is already approved in 12 other countries around the world and meets all the EU's regulatory requirements, including a positive safety opinion from the European Food Safety Authority (EFSA).

"Acting in accordance with EU regulations and the positive safety opinion of 1507 maize given by EFSA, the Commission has today given its decision to approve 1507 maize," says Simon Barber, Director of the Plant Biotechnology Unit at EuropaBio, the EU Association for bioindustries (2). "While we welcome today's decision, it is unacceptable that a minority of Member States continue to delay the process for approving safe new biotech products which have been given the all-clear by EFSA. We urge Member States to play by the rules that they themselves established and vote on new biotech products according to their safety evaluation given by the EU's own institutions."

Before imports derived from 1507 maize can enter the EU, the 1507 maize must also undergo another separate approval process to authorise its use in food. The approval of 1507 maize for food use is expected in early 2006.

1507 maize is genetically modified with a Bt gene, making it resistant to certain insect pests and was jointly developed by Pioneer Hi-Bred International, Inc., a subsidiary of DuPont, and by Dow AgroSciences.

Updated fact sheet - EuropaBio Background Briefing on 1507 maize


Follow Up on Julie Newman's Response

- Christopher Preston, University of Adelaide, Australia

Events have moved and I have new information on the attitude of the Network of Concerned Farmers to GM canola trials. The Network of Concerned Farmers put out a Press Release yesterday demanding that all GM trials grown by Bayer Cropsciences be banned (Ban trials until Bayer Cropscience pays for damages).

They are asking for Bayer to pay damages for the inadvertent growing of Grace canola containing a trace amount of GM material. The trouble is that a recent decision by the State Agriculture Ministers means that canola containing up to 0.9% adventitious presence will be accepted this year. This means that farmers do not have to suffer damages.

Meanwhile Graincorp, one of the grain handling companies, has announced growers will not have to make declarations about the GM status of their canola and will not be held to account is unintended GM material is found (http://www.abc.net.au/rural/content/2005/s1496131.htm). The Graincorp managing director, Tom Keene, suggested in the same news report that this attitude will likely go across the industry.


Africans Embrace Biotech Future

'Homegrown initiatives empowering farmers, improving yields'

Full article at http://www.whybiotech.com/index.asp?id=5266

As individual African farmers plant, nurture and harvest crops successfully, they build a better quality of life for their often-struggling families, communities and nations. But when those farmers face ongoing battles against drought, disease and infestations, their countries grow dependent on international subsidies and agricultural imports, and they clamber to maintain a hopeful vision of self-sufficiency. That's why the recent explosion of local biotechnology initiatives, which farmers themselves often lead, may be critically important to the long-term sustainability of African agriculture.

Grassroots development of agricultural biotechnology across the continent has the support of senior scientists and policymakers through the African Panel on Biotechnology. The panel is advising the African Union, an organization of African states, on how to adopt biotechnology in appropriate ways that involve local growers and integrate with community customs. The panel's mission is "a clear sign the African Union is finally pushing Africa toward science-led development," said Norah Olembo, executive director of the African Biotechnology Stakeholders Forum, which promotes public awareness of biotechnology solutions to Africa's problems.

Calestous Juma, former executive secretary of the United Nations Convention on Biodiversity, co-chairs the panel and agreed that the issues facing African agriculture require an aggressive approach.
"Africa must take charge of its future and assess the usefulness of all existing technological options for meeting its needs," Calestous said. "The challenge is how to make biotechnology relevant to local needs and how to ensure that existing institutions meet this challenge."

Local farmers and institutions already are vested in Africa's biotechnology future. For example, seven African countries are holding trials on genetically modified crops that resist destructive pests. Following are examples of trailblazing biotechnology initiatives from Kenya, Tanzania, South Africa and Uganda.

Read on at http://www.whybiotech.com/index.asp?id=5266


Genetic Engineering (Introducing Issues with Opposing Viewpoints)

- Scott Barbour; $32.45, 125 pages, Greenhaven Press (October 5, 2005), ISBN: 0737732237


A Decade of Plant Biotechnology: Past Lessons and Future Challenges

- AAAS Annual Meeting Symposium, St. Louis, MO; February 17, 2006; http://www.aaas.org/meetings/Annual_Meeting/

Biotech crops have prompted intense discussion among diverse stakeholders. This year marks the tenth year of planting biotech crops and the global acreage of biotech crops has increased more than 47-fold since 1996. The rapid, global adoption of biotech crops is due to the significant economic and environmental benefits these crops provide for growers and society.

In this symposium, global experts will address these topics with a focus on the global social, economic, and environmental impacts of biotech crops. The speakers will address a range of issues from the past decade of biotechnology. Has biotechnology been successful for industrial farmers in North America? What has been the experience of resource-poor, small-holder farmers in developing countries with biotech crops? Has biotechnology met the needs of the developing world's farmers? What has been the impact of biotech crops on agricultural production systems in countries ranging from Canada to Argentina, and from Spain to South Africa?

The symposium will conclude with a look toward the future and the next generation of biotech crops for the coming decade. This symposium is well-timed to explore the impacts from the first decade of biotech crops and the challenges for the next decade of biotechnology.

Speakers: Clive James, Sujatha Sankula, Graham Brookes, Stephen Padgette

*********** *

Agricultural Biotechnology in the Public Sector: Overcoming Challenges to Reach Developing Country Markets

- AAAS Annual Meeting Symposium, St. Louis, MO; February 19, 2006; http://www.aaas.org/meetings/Annual_Meeting/

Discussions of the benefits of biotechnology often focus on potential applications to enhance agricultural production and quality in developing countries. Scientists in both public and private sector laboratories are producing genetically engineered plants with improved nutritional traits and increased resistance to diseases, pests, and drought.

Yet very few of these biotech crop plants are finding their way from laboratories to markets in developing countries. This is especially true for public sector research. What is slowing down delivery of useful biotech products to farmers in developing countries? What are the biggest challenges in moving from a scientific concept to an improved seed that a farmer can plant?

This symposium brings together important actors on the forefront of development assistance from the research, regulatory, donor, and technology transfer communities to reflect on their experiences. Discussion will focus on the best approaches to moving public sector research beyond the laboratory and into the hands of poor farmers who stand to gain the most. Twenty years after the first field trials of transgenic crops, applying biotechnology to solve problems in developing countries remains both a grand challenge and a great opportunity.

Speakers: Katherine Kahn, Dennis Gonsalves, Robert Horsch, Hector Quemada, Mpoko Bokanga, Nigel Taylor, Walter Hill, Lawrence Kent


GM Crops: The Global Economic and Environmental Impact - The First Nine Years 1996-2004

- Graham Brookes and Peter Barfoot, AgBioForum, 8(2&3), 187-196. Full paper at http://www.agbioforum.org/v8n23/v8n23a15-brookes.htm

2005 represents the tenth planting season since genetically modified (GM) crops were first grown in 1996. This milestone provides the opportunity to critically assess the impact this technology is having on global agriculture. This study examines specific global economic impacts on farm income and environmental impacts of the technology with respect to pesticide usage and greenhouse gas emissions for each of the countries where GM crops have been grown since 1996. The analysis shows that there have been substantial net economic benefits at the farm level amounting to a cumulative total of $27 billion. The technology has reduced pesticide spraying by 172 million kg and has reduced the environmental footprint associated with pesticide use by 14%. The technology has also significantly reduced the release of greenhouse gas emissions from agriculture, which is equivalent to removing five million cars from the roads.

This study presents the findings of research into the global economic and environmental impact of genetically modified (GM) crops since their commercial introduction in 1996. Several studies have investigated the economic and environmental perspectives of GM crops, but these have usually been limited by trait, country, and/or year. This study therefore aims to quantify these impacts cumulatively for the period 1996-2004 through a combination of collating and extrapolating economic analysis findings from past studies and undertaking new environmental impact analysis. This global cumulative analysis over a nine-year period will better identify consistent trends in the technology impact over time as well as identify salient differences in impact between crops, traits, and countries.

The economic impact analysis concentrates on farm income effects, because this is a primary driver of adoption amongst farmers and is an area for which much analysis has been undertaken. The environmental impact analysis focuses on changes in the use of insecticides and herbicides with GM crops and the resulting impact on the environmental load from crop production. Previous investigations have been limited to an examination of changes in pesticide volumes with GM crops, whereas this study expands the analysis and includes a more robust assessment of the specific pesticide products used in different production systems and their environmental load impact. Lastly, we investigate for the first time the contribution of GM crops towards reducing global greenhouse gas (GHG) emissions because of the importance of this issue to the global environment. Methodology

The report has been compiled based largely on extensive analysis of existing farm-level impact data from GM crops. Primary data for impacts of commercial cultivation were, of course, not available for every crop, in every year, and for each country, but all identified representative previous research has been utilized. The findings of this research have been used as the basis for the analysis presented, although where relevant, primary analysis has been undertaken from base data, most notably in relation to the environmental impacts.

The analysis presented is largely based on the average performance and impact recorded in different crops. The economic performance and environmental footprint of the technology at the farm level does vary widely, both between and within regions and countries. As a result, the impact of this technology, and any new technology, GM or otherwise, is subject to variation at the local level. Therefore, the performance and impact should be considered on a case-by-case basis in terms of crop and trait combinations.

Agricultural production systems are dynamic and vary with time. This analysis seeks to address this issue, wherever possible, by comparing GM production systems with the most likely conventional alternative that could provide competitive levels of efficacy if GM technology had not been available. This approach has been used by other researchers.

Concluding Comments

This study quantified the cumulative global impact of GM technology between 1996 and 2004 on farm income, pesticide usage, and greenhouse gas emissions. The analysis shows that there have been substantial economic benefits at the farm level, amounting to a cumulative total of $27 billion. GM technology has also resulted in 172 million kg less pesticide use by growers and a 14% reduction in the environmental footprint associated with pesticide use. GM crops have also made a significant contribution to reducing greenhouse gas emissions by over 10 billion kg, equivalent to removing five million cars from the roads for a year. The impacts identified are, however, probably conservative, reflecting the limitations of the methodologies used to estimate each of the three main categories of impact and the limited availability of relevant data. As such, subsequent research might usefully extend the analysis to incorporate more sophisticated consideration of dynamic economic impacts and some of the less-tangible economic impacts (e.g., on labor savings). Further analysis of the environmental impact might also usefully include additional environmental indicators such as impact on soil erosion.


Rejecting the Gambler's Principle

- Reviewed by: Daniel Callahan, Nature Biotechnology v.23, p.1220; October 2005. www.nature.com/nbt . Reproduced in AgBioView with the permission of the editor.

"Rights and Liberties in theBiotech Age: Why We Need a Genetic Bill of Rights - edited by Sheldon Krimsky and Peter Shorett; Rowman & Littlefield Publishers, 2005; 256 pp., cloth, $70; paperback, $27, ISBN 0-7425-4340-4"

Through one of those tricks that history likes to play on us, the 1960s and 1970s saw both the emergence of a visionary genetics enterprise and the last gasps of a postwar critique of technology. That critique had been heavily fed by a widespread anxiety about nuclear weapons proliferation and it carried over, for a short time, into biology. In those days it was said, with a mixture of excitement and foreboding, that the emerging 'biological revolution' was supplanting the earlier revolution in physics as the science of the future.

Ironically, the voluntary 1974 moratorium on recombinant DNA research--often celebrated as a mark of scientific responsibility in the face of uncertainty--actually marked the high point of caution and wariness about the genetic developments. Though he had been an earlier supporter of the moratorium, James D. Watson used his reputation to publicly condemn it later as a great mistake, a triumph of worried hand-wringing over boldness, serving only to inflame an uneducated public. There have been no moratoriums since then. As Watson would later say, "You should never put off doing something useful for fear of evil that may never arrive."

Although there was talk in the 1970s and 1980s about the need for a precautionary principle, particularly in agricultural genetics, the more dominant rule has been what might be called the gambler's principle: stop worrying and go for it. That most American combination of driving forces, profit and progress, fueled the charge. The prospect of saving lives, relieving suffering and making lots of money in the process proved irresistible. Skeptics of that development are variously labeled as the religious right, as ignorant and superstitious, as indifferent to human suffering, or just as old-fashioned Luddites.

The Council for Responsible Genetics belies every one of those stereotypes, and Rights and Liberties in the Biotech Age makes clear that there is an alternative set of wary perspectives. The book grew out of the Council's efforts to develop a set of principles, framed in the language of rights, "to protect the civil liberties, communitarian values, and minority rights of people against a technology that is out of control." The Council--one of the few voices of liberal fears about the direction of genetic research for the past 21 years--noted that "there is an assumption among many people that there is some inexorable power vested in science that obligates societies to adopt its discoveries." This view, they argue, "is patently false," as is the notion that there is "an inalienable right for science and technology to move forward." Those are strong and challenging statements, and all the more so in coming from a group that counts a number of distinguished geneticists and molecular biologists among its members.

There are ten rights articulated in the Council's genetic bill of rights, and the book has commentaries on each of them, written by a diverse group of scientists and others. Some of the rights bear on environmental and ecological issues, for example, "the right to preservation of the earth's biological and genetic diversity". Others seek to preserve the right of indigenous people "to manage their own biological resources, [and] to preserve their traditional knowledge." Still others focus on the protection of individuals, including a right to genetic privacy, freedom from genetic discrimination, and "the right to have been conceived, gestated, and born without genetic manipulation." The language of rights is defended on the grounds that it establishes a burden of proof such that "those who wish to violate the right must demonstrate a compelling government interest" to do so.

It is obvious that this approach to the pursuit and use of genetic knowledge flatly rejects the gambler's principle. But it no less goes beyond many of the softer versions of the precautionary principle as well, erecting some powerful barriers to any headlong dash in the name of progress and scientific freedom. In an afterword to the book, Paul Billings, a member of the Council's board, argues that, far from harming scientific research, the bill of rights will encourage innovation, creativity, and ingenuity. It will provide "a context that could produce a newly responsible science that meets--rather than defines--human needs."

There is little doubt that many people in mainline science and their enthusiastic corporate and lay supporters see science as the key to the human future: the Enlightenment project is still alive and well, even flourishing. But that project in its contemporary incarnation has never caught on to a basic point: science is utterly unable to tell us, as people and citizens, what it is that science should seek, and how it should be used to fashion a good life for individuals and societies. Scientific knowledge does not tell us how to use scientific knowledge. We have to look elsewhere for that wisdom.

I cannot help but note that the President's Council on Bioethics has taken up many of the issues of concern to the Council for Responsible Genetics, showing that the two groups share many of the same worries, even if often using vastly different concepts (the language of 'dignity' rather than 'rights,' for instance). Yet the work of the President's Council has been labeled conservative and hostile to science. No doubt this bill of rights will meet some resistance as well, though it is a voice from the left rather than the right. But it is encouraging that the work of the two very different councils converges in many important ways, suggesting the possibility of some future coalitions. Both reject the gambler's principle, both understand that the appropriate pursuit of scientific knowledge must be determined outside of science and both root their views in a notion of the human good. That convergence is not a bad starting point for some serious dialogue, just as this book is a wonderful contribution to a much needed assessment of the potential dangers awaiting us if we proceed in a reckless way.

Daniel Callahan is at The Hastings Center, 21 Malcolm Gordon Road, Garrison, New York 10524, USA. He is the author, most recently, of What Price Better Health: Hazards of the Research Imperative (University of California Press). callahan@thehastingscenter.org


Mixed Reactions

- Pierluigi Nicotera, Nature 437, 1093; October 20, 2005. www.nature.com/nature

"BOOK REVIEWED -The Poison Paradox: Chemicals as Friends and Foes by John Timbrell; Oxford University Press: 2005. 360 pp. 19.99, $29.95"

It is remarkable that historical periods characterized by a surge of intellectual growth have also been remembered for violence and mischief. As Harry Lime (played by Orson Welles) famously remarked in the film The Third Man: "In Italy for 30 years under the Borgias they had warfare, terror, murder and bloodshed, but they produced Michelangelo, Leonardo da Vinci and the Renaissance. In Switzerland they had brotherly love -- they had 500 years of democracy and peace, and what did that produce? The cuckoo clock."

Although we may not entirely sympathize with this quote, it is clear that cultural development and scientific and economic progress almost inevitably have side effects. During the Renaissance in France and Italy, the first systematic studies of anatomy and physiology, and the empirical experimentation of the dose-effect relationship (often in humans who did not volunteer), led to a better understanding, and more accurate use, of poisons.

Unwanted side effects of scientific and technological progress are evident throughout human history. The industrial age has produced one of the most obvious: the contamination of the environment by potentially harmful, synthetic products. More recently, with the mass production of foods, widespread dietary contamination has become a problem. Finally, while a better understanding of disease processes has fostered the development of effective and powerful drugs, these can also cause unexpected, adverse reactions.

Better education and information have also increased the general awareness of the risks posed by chemicals and drugs, raising concern among the public, media and governments. In the past three decades, there has been pressure to reduce environmental contamination, and the safety requirements for foods and drugs have become more stringent. Nevertheless, the public perception of risk from chemicals has since grown disproportionately. It may be possible in many cases to provide safe products without adverse effects, but it is not universally achievable. Hence, the margins for developing safe yet effective medicines have been consistently reduced by the increasing pressure to develop drugs that are devoid of side effects. For example, aspirin would probably not pass the regulatory process today because of its many side effects, despite its therapeutic value. Chemicals are intrinsically hazardous and all pose some degree of risk, which is perhaps not entirely appreciated by the public. Virtually all human endeavours are potentially harmful, and all agents are potentially toxic. However, the dose or level of exposure and an individual's susceptibility will play a major role in determining the risk posed by a compound.

In The Poison Paradox, John Timbrell addresses the problem of the risks posed by chemicals, and considers how, when and why they can be toxic. The book is pervaded by the reminder that it is the dose that makes a chemical toxic. Using easily understandable examples, Timbrell guides the reader through the basic principles of toxicology (such as the interaction between chemicals and biological organisms). Often using an anecdotal style, he clearly explains the dangers and risks linked to natural and synthetic products, including medicines, food and environmental contaminants. Finally, he summarizes the criteria required to assess chemical hazard and risk.

This is not a book for the specialist, but rather is aimed at a general reader who wants to understand the principles that have guided toxicology and the difference between hazards, risks and their assessment. The conclusions are well balanced and illustrate the difficulty of predicting and determining the risk of exposure to agents that we perceive as toxic. One revealing example is given in the chapter on endocrine disruptors -- chemicals that cause adverse health effects as a result of changes in hormone function, such as dioxins and oestrogens. Timbrell describes the experimental evidence for their toxicity, the problem with different species' susceptibility to these chemicals, and the lack of convincing evidence for their toxicity in man. He concludes that further evidence is needed to assess their potential adverse health effects in humans.

The chapters on risk assessment and the perception of risk by the public further highlight the need for a better understanding of risk, and show how some risk is unavoidable. Through the analysis of known and yet unresolved problems linked to chemical toxicity, the book also suggests that we need more and diverse research in toxicology. Science, rather than precaution or concern, should drive the assessment of risk and decisions on public health, as Timbrell states: "When the public perception of risk is greater than it really is, politicians need to take steps (which are really unnecessary) to reduce the risk, with the result that huge sums of money may be spent for no real benefit."

The Poison Paradox provides the reader with the information to form an educated perception of risk and its implications in toxicology.