Today's Topics in AgBioView.
* The Future of Food Biotechnology
* Wealth of Nations Depends on Jack Frost, Research Finds
* ISEES Safety First Workshop Report
* FOE: Plant 5000 Trees In Tribute To Terrorist Attack Victims
* Foods From Genetically Improved Crops In Africa
* Educational Web Sites for Genetics
* Science and Ethics
* Owning Agbiotech
The Future of Food Biotechnology
October 29-30, 2001; Washington, DC
Examination and Analysis of Biotech Developments in Domestic and EU Regulation and Policy of Food, Commodity Crops and Other Agricultural Products
This conference will cover the fundamental elements of food biotechnology regulation with an emphasis on what the future holds for genetically engineered agricultural products and other foods. Speakers from industry, government and consumer groups will examine the commercial implications of this technology for the food industry, and explore the global controversy of biotech labeling standards. The reaction of consumers and U.S. trading partners will be presented. The conference will also feature a lively discussion on FDA's policy on biotech labeling, an exploration of issues associated with testing and detection for biotechnology traits and events and concurrent mini-workshops on very focused and timely topics such as transgenic animals and "pharming."
Attendees will learn the workings of the U.S. Coordinated Framework for Regulation of Biotechnology, with particular emphasis on the evolving risk assessment process at FDA and EPA for new crop varieties. The program will analyze FDA's food labeling policy and provide the consumer perspective on food derived from biotechnology processes. You will hear the reaction from the U.S. and its global trading partners to biotechnology foods, and updates on labeling, traceability, and bioengineering of food producing animals and plant biologics.
This conference is designed to provide critical educational information for all professionals in the food industry who must work together and manage biotechnology issues for their companies: attorneys, regulatory specialists, public affairs and public relations professionals, scientists who wish to possess a regulatory background, consumers, technology companies developing biotechnology crops, and anyone involved in the production, distribution or sale of food products.
Stanley H. Abramson, Partner, Arent Fox Kintner Plotkin & Kahn, PLLC
Please visit the website http://www.fdli.org/ for list of speakers and registration information.
Wealth of Nations Depends on Jack Frost, Research Finds
September 18, 2001; Purdue University Press Release (via Agnet)
WEST LAFAYETTE, Ind. - Why do the rich get richer and the poor stay poor? When it comes to nations, the answers may include frost, according to a study that for the first time links economic and new global climate data. Economists and co-authors William Masters of Purdue University and Margaret McMillan of Tufts University, say frost plays two important roles: It helps farmers increase agricultural productivity, and it helps people control disease, particularly malaria. Their paper, "Climate and Scale in Economic Growth," is published this month in the Journal of Economic Growth.
Since antiquity, observers have noted differences between people living in the tropics and those living in temperate zones. In 350 B.C., the Greek philosopher Aristotle wrote, "Those who live in a cold climate are full of spirit." And from at least the time of Adam Smith's 1776 "Wealth of Nations" to 1998's Pulitzer Prize-winning book by Jared Diamond, "Guns, Germs, and Steel," people have speculated why some areas of the globe are wealthy while others seem destined for poverty.
"The broad puzzle is why are poor countries in geographic tropics, and most of the wealthy countries are not in the tropics," Masters says. There are exceptions to this general rule, of course. "In the temperate regions you have North Korea and Mongolia, which are both poor. But these are countries that have totalitarian governments and exist in isolation," Masters says. "On the other hand, city-state countries such as Hong Kong and Singapore are tropical nations that are wealthy, but they are trade centers that haven't depended on local resources to accumulate their wealth."
Masters and McMillan took advantage of recent advances in global information systems data about the earth's climate to take another look at the ancient question. "For the first time, we can put detailed biophysical data into economic models to try to understand how climate and geography have influenced economic performance without indulging in economic determinism," Masters says. "Learning about the causes of persistent poverty helps us see what can be done about it." They discovered that the factors differentiating wealthy countries from poor included annual hard frosts. McMillan says this finding was unexpected. "A generation of economists have focused on institutions as the key differences between societies," she says. "Many of them - including me - are now quite surprised to find that biophysical factors like climate matter, too."
Cold weather has two major effects, the researchers say: The temperate areas have historically had less disease and better agriculture, at least from the point where the citizens of those countries learned how to take advantage of the seasonal frost cycle. "Having frost and winter forces insects into a dormant state, which makes it much easier to control insect-borne diseases. In the United States we had malaria, and we had other diseases, but we were able to more easily eradicate these than in other countries, partly because the insects were knocked back each year," Masters says. The connection between frost and agricultural success isn't always as obvious.
"People think of the frost-free tropics as a lush paradise with abundant biodiversity, and there are abundant species in the tropics," Masters says. "But too much biodiversity can be a big problem. We get annual crops out of the tropics and plant them in the temperate regions and they do better. Corn, potatoes, wheat, and virtually all of our crop species, first evolved in the warmer areas of the world but are now grown for export by countries in temperate regions." Part of the reason for this is that frost allows a build-up of organic matter that leads to rich, fertile topsoil. "In the tropics, that matter is broken down by insects and microbes very quickly, and the nitrogen and carbon in the dead plant material evaporates into the air or is leached into the ground by rainwater," Masters says. "In a temperate zone, that nitrogen and carbon builds up and remains in the soil in the form of organic matter." Another benefit of frost is that it ensures moist soil for spring planting. Snow and ice accumulates in
"Looking forward," the researchers write in the paper, "tropical countries could be helped to grow not only through trade, but also through technical change from accelerated investment in public health and agricultural research." Helping tropical nations catch up will require more than scientific advances, though, Masters says. "The kinds of technologies involved, such as vaccines for tropical diseases and crop varieties adapted to tropical conditions, could be developed if we were willing to pursue them. But most tropical regions are too poor to attract enough R&D from private pharmaceutical and agribusiness firms," he says. "So public-sector investments are needed, and that depends not on science, but on the calculus of politics."
ISEES Safety First Workshop Report
Dear Colleagues, We are pleased to inform you that the Final Report from the Safety First Workshop, held in March this year, is completed. The Workshop captured and then forcefully propelled an exciting and potentially quite important convergence of diverse but previously antagonistic groups concerned about biotechnology. The Institute is continuing to work energetically with a wide range of groups and funders.
In addition to documenting the Workshop’s outcomes, the report presents the next steps proposed by and for the Institute in developing an industry-wide and industry-run Safety Program that defines pre-market safety design and verification, as well as post-market safety follow-up, in order to adequately govern genetically modified organisms (GMOs) and other products of biotechnology.
The report can be downloaded from the Internet as a MS Word Document, at our website: <http://www.fw.umn.edu/isees>http://www.fw.umn.edu/isees
- Anne R. Kapuscinski and Larry R. Jacobs; Institute for Social, Economic, and Ecological Sustainability (ISEES); University of Minnesota
Plant 5000 Trees In Tribute To Terrorist Attack Victims
- Says Friends of The Earth (From: Kathleen Kelso )
(Ottawa, September 18, 2001) - As a lasting tribute to the victims of last weekís terrorist attacks in the United States, Friends of the Earth Canada (FOE) is calling on concerned citizens and community leaders in towns, cities and villages across Canada to plant memorial trees in places like parks, cenotaphs and municipal squares. FOE hopes that between today and October 11 over 5,000 memorial trees will be planted across Canada to represent the number of victims.
"These Memorial Trees will be a living symbol of our grief but also the resolve with which all Canadians strive to ensure a safer, healthier earth for today and future generations," says Beatrice Olivastri, CEO, Friends of the Earth Canada.
Friends of the Earth asks all community leaders and concerned citizens from across Canada to contact FOE to register their memorial planting (1-888-385-4444 or firstname.lastname@example.org). FOE is preparing a national map and registry to present to President Bush on behalf of all participants.
Today, Friends of the Earth launched the map on its website (www.foecanada.org) to record the location of all memorial trees to be planted. FOE has also prepared suggested text for an inscription for each memorial planting. FOE asks that every Memorial Tree be given an inscription plaque so that every Canadian or visitor from around the world will be able to pay their respects in any community they are visiting in Canada. The Memorial Treesí registry on the FOE website will be updated daily to record all new memorial plantings.
MEMORIAL TREE INSCRIPTION: In memory of the victims of the September 11, 2001 tragedy in the USA - with resolve for a safer, healthier earth for today and future generations -
Ms. Olivastri concludes: 'I hope every civic leader in Canada will immediately embrace this idea despite the advancing fall season. It will be a wonderful tribute now, next spring and each one thereafter as we will never forget this tragedy."
Friends of the Earth Canada is dedicated to renewing communities and the earth as part of the worldís most extensive environmental network with almost one million supporters across five continents. To register your Memorial Tree, call 1-888-385-4444 or e-mail: email@example.com
- Kathleen Kelso, Program Manager, Friends of the Earth Canada http://www.foecanada.org
Foods From Genetically Improved Crops In Africa
September 19, 2001; The San Diego Center for Molecular Agriculture/AfricaBio
The agricultural scientists and farmers all over the world who improve our crops are the true heroes of our time. They have kept food production ahead of massive population increases. These advances were made possible by the continued genetic improvement of our crops. In addition, our food is safer now than it has been in human history.
Most of us know very little about the way our food plants are grown and are far removed from the factories where they are processed. All we care about is that our food be wholesome, nutritious, and tasty. Critics of crop biotechnology are of the opinion that potential ecological and food safety disasters are looming on the horizon because genetically improved (GI) or genetically modified (GM) crops have entered the food chain. Alarmists have introduced emotionally charged terms into the debate and speak of "frankenfoods" and "genetic pollution." The debate that rages in Europe has now reached Africa. This debate has important consequences for us in Africa where many countries have limited arable soil and extreme climates.
We believe that the issues of food safety and food sufficiency are extremely important. The debate cannot be left to the well-funded efforts of the big multinational agricultural biotechnology companies or to the opponents of GI foods funded by the organic food industry, "green" organisations, and radical "consumer" groups. We take our responsibilities seriously and this brochure is our own small contribution to this debate. As scientists, we demand facts or evidence. It has been claimed that the risks of genetically improved crops will be "super weeds" and "super bacteria", the appearance of unknown toxins and allergens in our food, paralysing crop losses, and extensive ecological damage. We have not seen any evidence of these scenarios even though we have been testing these GI crops for 20 years and they have been eaten by millions of people on a daily basis since 1996.
We believe that agriculture can be less ecologically damag-ing and more sustainable, and that GI crops can play a positive role in this development. We also believe that GI crops will make food cheaper to produce and more nutritious. We hope that you will read this brochure and think through the issues raised by the GI food debate. Many scientists and professional scientific societies support the introduc-tion of GI crops in the human food chain but as consumers you have the last word. If the food is good, whether GI or not, you will buy it; if it is not, you won’t. Maarten J. Chrispeels Jocelyn Webster Director Executive Director San Diego Center for Molecular Agriculture AfricaBio firstname.lastname@example.org email@example.com
The complete brochure is available in pdf format at this url:
Educational Web Sites for Genetics
A Primer on Molecular Genetics
Cold Spring Harbor Laboratory
Science and Ethics
Maurizio Iaccarino, EMBO Reports vol. 2 no. 9 pp 747-750 ; 2001
Maurizio Iaccarino is the Secretary General of the UNESCO–ICSU World Conference on Science and presently works at the International Institute of Genetics and Biophysics of the CNR in Naples, Italy. The author wishes to thank L. Pica and G. Ventrella for useful discussions. E-mail: firstname.lastname@example.org
'As research and technology are changing society and the way we live, scientists can no longer claim that science is neutral but must consider the ethical and social aspects of their work'
Less than 500 years ago, science was a dangerous business. In 1600, the Italian monk Giordano Bruno was sentenced to death and burned at the stake because he believed in free thinking in philosophy and science. Galileo Galilei narrowly avoided the same fate but only by publicly renouncing his support of Copernicus’ heliocentric view. Of course, the days of autodafés are over and modern science has an important influence on the development of society as a whole, compared with the days of the ill-fated Bruno. But while scientific progress has been rapid and astonishing, it is still disturbing for those people who feel excluded from the debate surrounding the application of science in new technologies and products. Furthermore, as scientific progress becomes increasingly fundamental to society, it is constantly challenging if not completely clashing with long-held beliefs concerning our ethical values. It is, therefore, necessary to conduct ethical discussions in order to adapt the use of scientific knowledge—
The word ‘ethics’ comes from the Greek word ‘ethos’, meaning custom or behaviour. The concept of ethics was originally proposed by the Greek philosopher Aristotle for the discussion of philosophical questions relating to daily life: the ‘ethike theoria’ deals with the study of, and gives criteria for the evaluation of human behaviour. Since then, ethics has become one of the major topics in Western philosophy when debating social and individual values, their relationship and their hierarchy in society. Today, the meaning of ‘ethics’ is more or less equivalent to that of ‘morals’, which comes from the Latin word ‘mos, moris’ and also means custom or behaviour, but at a more personal level. Moralists, such as Nietzsche, Santayana and Russell, claim that ethical values are rather personal interpretations, deliberations or preferences and not general principles that can be proven true or false. John Ziman, the former Chairman of the Council for Science and Society, interprets ethics not as an abstract disciplin
Indeed, discussions about the ethical foundations of a society and their re-interpretation usually take place when traditional customs or behaviours are challenged by new developments. In a static society, values are well codified, usually by religion or by tradition. This is true for numerous ancient societies, which remained unchanged for centuries. But wars, invasions or a new culture or religion usually prompt the evaluation of the traditional values. For instance, the French and Russian revolutions in Europe as well as colonialism on other continents effectively upset and irrevocably changed society’s traditional values to varying degrees. Later in the 20th century, the creation of new technologies through scientific progress had a profound effect on society, public opinion and our way of life and has thus sparked discussion on how to use this knowledge (http://www.pugwash.org/). In the 1950s and 1960s, ethical discussions dealt mainly with the use of physics and engineering for the construction of new
Scientific progress, the driving force for the majority of the changes witnessed in the 20th century, requires a critical mind, free of prejudice and open to new ways of thinking. The rapid development of modern science since the Renaissance is due mainly to the postulate that scientific theories should be independent of theological or religious beliefs. In the 17th and 18th century, knowledge was mainly exchanged through scientific academies which disseminated new theories and thus accelerated scientific progress. At the beginning of the 19th century, there was a remarkable rise in academic research at universities, also labelled ‘pure’ research. Scientists were not interested in practicalities and were not concerned with the technological applications of the results of their endeavours. They proclaimed the neutrality of science, stating that the advancement of knowledge could not be considered good or bad. In this context, science was not responsible for its applications, and even less for their subsequen
Industrial research, on the other hand, was radically different. Although based on the same knowledge, it had completely different aims and rules. Results were not owned by scientists, but were the property of the industries financing the research. The aim was not to acquire new knowledge, but to invent new products in order to increase profits. Ethical problems were considered to be the responsibility of the company and not of the scientists.
As a result, discussions concerning ethical problems were more or less absent from both realms. In academia, scientists were indifferent to the possible consequences of their work and in industry, employers did not consider it appropriate for scientists to worry about ethical problems. Of course, this description of academic and industrial research is schematic and does not truly represent the real world. Nevertheless, it still exists and sways the minds of those who have the greatest influence on our contemporary scientific culture.
Since the 1950s, large changes in the interactions between academic and industrial research have taken place, even in their definition, and ample literature exists on this subject. Scientists in academia receive more financing than in the past. Furthermore, science administrators usually make decisions on the basis of social considerations, namely on the expected contribution to problems such as health, food, energy, etc. Such research policies have an ethical component as they aim to solve social problems. As a consequence, it has become pertinent and necessary to evaluate, from an ethical point of view, not only the use of scientific knowledge, but also its production. Industrial research, on the other hand, has become more sophisticated and its results are often published in peer-reviewed journals. Furthermore, scientists in academia and industry are increasingly collaborating, and this is even encouraged in most countries.
The relationship between public and private research is the source of further ethical issues, which are important not only for the research community, but for all sectors of society. Universities and public research institutes encourage their scientists to request funds from industry and to patent their results. Scientists working in the public sector increasingly own patents or shares, or act as consultants for companies (http://www.cspinet.org/integrity/database.html). These activities are an important source of income as well as expertise and proprietary technology for the universities. Moreover, they are encouraged by politicians since they generate start-up companies and stimulate local economies. Although this phenomenon is considered to be very useful, it can and already has caused conflicts of interest (Cech, 2001; sidebar). There are worries that, especially in clinical research, the conflicts of interest have become so pervasive (Smaglik, 2000) and so difficult to disclose (Holden, 2001; Knight, 2
As an example of the necessity of conducting discussions on ethics, I wish to refer to the debate on embryonic stem cells (Lachmann, 2001; http://bioethics.gov/stemcell_exec_intro.htm). Knowledge concerning human stem cells could be used to devise new therapies that may benefit millions of patients (Vogel, 2001). These totipotent cells could be grown and differentiated in vitro to produce specific cell lines, which could be used as cell transplants, for example to replace ‘dopaminergic’ neurons for the treatment of Parkinson’s disease, or pancreatic cells for the treatment of diabetes. This is a research strategy and not a working technology; it is not clear yet whether this goal will be achieved easily, since the implantation of new cells in an organism may alter mechanisms of cell interaction and metabolic circuits. However, the public debate asks if it is ethical to destroy human embryos in order to gain knowledge for the purpose of curing diseases (Science, 2000). The arguments against the use of embryo
I am convinced that this topic is so sensitive because society does not have an informed opinion and therefore still has to find a consensus. Again, this is a question of hierarchy of values: is the life of a frozen embryo more important than a cure for a disease? A moratorium to suspend research using human embryonic cells must include both the public and private domains since to allow the latter to continue would be true hypocrisy. Of course, no restriction should be imposed on research using adult stem cells or embryonic stem cells isolated from animals. But I think it would be difficult to establish such a moratorium for several reasons. First, it should be respected all over the world and not only in some nations. Secondly, it would be difficult to reach a consensus on a moratorium since patient associations and the industrial sector would certainly lobby for the continuation of this research. Thirdly, we should recognise that scientists have an intellectual, but also a practical interest, since result
The debate surrounding embryonic stem cells is not the only example of an ethical controversy born out of scientific research. Genetically modified (GM) plants have also stirred a growing public controversy. While stem cell research challenges views on the very nature of humanity itself, the ethical implications of GM plants rather raises questions on how to deal with the environment. Proponents point out the benefits of this research, namely in feeding an ever-increasing human population—particularly in the Third World—while dealing with the environmental problems (Leaver and Trewavas, 2001) created by this very population. The critics want to see GM plants banned forever because they fear irrevocable damage to the environment (Flothmann and van Aken, 2001).
GM crops and the use of embryonic cells are only two examples among the numerous ethical problems and questions arising from the rate of scientific progress and the ensuing new technologies that we must face today (Lenoir, 1996). In the case of stem cells, scientific progress is generating new technologies that are causing ethical problems. But scientific knowledge alone can create ethical problems of its own. In the case of abortion, new insights into embryo development have given fresh arguments to those who want to see abortion banned. In fact, in the past, the embryo and the fertilised egg were considered to be without life or without soul, while today we know much more about their potential. Indeed, it is becoming increasingly necessary for scientists to devote more attention to ethical problems concerning their research and resulting new technologies (Rotblat, 1999a,b). Everybody should be involved, because the solutions to ethical problems that come from scientific progress cannot be imposed by dogma
Unfortunately, such a commitment to debate ethical challenges is insufficient at all levels of society and within the scientific community. Furthermore, the conflicts of interest I mentioned above complicate the issue. It is therefore important that governments, public and private funding organisations, scientific societies and the researchers themselves become more sensitive to ethical questions. In the present climate, upholding the neutrality of science would not be amoral, but immoral. Scientists are the first to receive crucial information, sometimes years in advance, about the potential dangers of certain scientific knowledge. I refer, for example, to Niels Bohr and the atomic bomb, to Paul Berg and genetic engineering or to Ian Wilmut and cloning. Thus, the onus is on the scientists to inform the public about the potential dangers of new technologies and to engage the public in debates on how to use their knowledge wisely and in the best public interest (Iaccarino, 2001).
What are the most important ethical implications of scientific research and the development of new technologies? In 1999, UNESCO and ICSU organised a World Conference on Science, for governments to discuss problems regarding science and society. They eventually approved a document, the ‘Science Agenda—Framework for Action’, that contains a chapter on ethical issues. As this document was approved following thorough consultation with all UNESCO member states and informed discussion with their respective scientific communities, it can be considered a useful reference to identify and deal with ethical problems that stem from scientific research in a general context. Here, I report a summary, in my words, of each paragraph (see sidebar). Obviously, it is necessary to consult the original text for the simple reason that each word was approved after long discussion (http://www.unesco.org/science/wcs/eng/framework.htm).
And how can we make the scientists more sensitive to the ethical implications of their work? I think it is necessary to start from the bottom, namely at the level of individual scientists. The most appropriate context to discuss ethical questions is the annual meetings of scientific societies (Smaglik and Macilwain, 2001). I suggest that participants are asked to propose and discuss ethical commitments, and to decide whether it is necessary to make them obligatory for all members of that particular scientific society. Of course, it is also necessary to invite members of the public, or even critics, in order to appreciate their perceptions and expectations of scientific research. Only in this way can we understand what are the most sensitive issues for researchers and make them more aware of the ethical implications of their work. Researchers, who are often university professors, would then be more prepared to inform their students about ethical problems. Subsequently, it will be possible to come to a more g
We live in a world in which scientific knowledge and new technologies continuously challenge our values. We all have to live our daily lives and make decisions based on the fundamental values of human dignity embedded in our civilisation. Scientists are no exception. Rather, I am convinced that they have an obligation to make a special effort to contribute to this discussion, because they often have more information and more basic knowledge about the very issues that generate these ethical dilemmas.
For REFERENCES Please see the original website http://embo-reports.oupjournals.org/cgi/content/full/2/9/747
- Ann M. Thayer, Chemical & Engineering News, Sept17, 2001 Vol 79, no 38 pp. 25-32
Consolidation, significant investments in R&D, and savvy market development have created just a few major forces in agbiotech
A handful of companies have spent billions of dollars over the past decade to buy most of the first generation of small agricultural biotechnology companies, major seed producers, and others' agrochemical operations. Driven by the need to consolidate in a dismal agrochemical market, these developers of agbiotech products also were trying to build technology bases and market access. They've succeeded.
For example, during a spate of activity from 1995 to 1998, what are now the five leading companies acquired or allied with nearly 70 different seed companies. They gained significant market channels through which they could introduce products. While antitrust authorities watched these combinations closely, the result is that Monsanto, Syngenta, DuPont, Dow Chemical, and Aventis CropScience dominate agbiotech today.
Consolidation can combine complementary resources, result in lower cost production, and create needed economies of scale. Nevertheless, opponents of agribusiness consolidation, if not of agbiotech itself--such as the advocacy groups Action Group on Erosion, Technology & Concentration (ETC, formerly the Rural Advancement Foundation International), Institute for Agriculture & Trade Policy, and Greenpeace are alarmed by what they see as unprecedented control over markets, technology, and, some say, the very processes of life.
"Fewer and fewer companies are making critical decisions about the agricultural research agenda, and the future of agriculture," ETC's research director, Hope Shand, told the World Agricultural Forum in St. Louis in May. "The Gene Giants' control of patented genes, traits, and fundamental research tools has already created legal barriers which make it difficult or impossible for small companies or public-sector researchers to compete, or to gain access to new agricultural technologies."
Industry and supporters of intellectual property ownership view IP as a needed incentive to advance technology and product development. "In developing and sharing technology with the world, it is essential that our intellectual property rights are protected," A. Charles Fischer, Dow AgroSciences' president and chief executive officer, said at the May forum. "Without that protection, companies will not be motivated to invest in new products."
"There are so many things still to be patented--no large company has cornered all the creativity." THE PATENT SYSTEM was created to help inventors recoup the cost and reduce the risk of investing in R&D by granting the right to exclude others. Within just the past two decades, the system has been extended to include plants, other living organisms, gene sequences, and biotechnology inventions. Many groups now questioning the scope and use of agbiotech IP fundamentally oppose genetic transformations and the patenting of living things.
Others are concerned that genetic resources are being removed from the public domain and claimed as private property. In particular, there is worry about crops traditionally planted by subsistence farmers in developing countries. Such farmers also may be accustomed to saving seed from previous crops to replant--something that IP protection might preclude. Thus, ownership of genetic resources, access to food versus commercial or profit interests, and gaps between rich and poor are among the issues activists are raising.
Greenpeace and Misereor, the German Catholic Church development agency, recently filed an objection with the European Patent Office regarding a patent on corn (maize) with high oil and oleic acid content awarded to DuPont. They claim that European patent law doesn't cover plants and that such varieties are unpatentable anyway since they "may exist naturally and have been developed by [Latin American] maize breeders for a long time."
"If the patent is upheld in this form, it will be a clear case of biopiracy," says Martin Bröckelmann-Simon, Misereor's executive director. "Farmers across the world could suffer in the form of trade restrictions, license fees, and the loss of marketing rights." DuPont did not respond to C&EN inquiries about this challenge or its licensing policies.
SIMILARLY, ETC takes issue with patents held by Monsanto and Syngenta, alleging that the two companies could "stifle innovation, shackle public-sector research, and foster ever-increasing industry consolidation." The two companies, ETC contends, have a potential monopoly over gene marker systems that are used to identify successful gene transfer.
Even worse, Shand believes, a U.S. patent awarded in January to Monsanto has "blindsided biotech scientists," who already widely use the covered gene marker technology and could, she believes, now be denied access. ETC calls Syngenta's patented Positech technology "the only practical alternative."
Syngenta's position on the gene marker has been that it will "make the technology widely available to both the biotechnology industry and the academic scientific community through simple licensing procedures." As of May 2000, more than 100 labs had been licensed to use Positech. The company also provides it "royalty-free for subsistence farmers in developing countries through local institutes or companies." ETC criticizes Syngenta, however, for agreements that the advocacy group says give the company rights to any results.
For Monsanto, "it can be very strongly documented that we have very actively helped the broad scientific community around the world get access to, and be able to use for research, the enabling technologies that we've helped to pioneer," says Robert Horsch, Monsanto vice president for product and technology cooperation.
Along with enabling patent disclosures, publishing scientific papers, and making materials available, the company has "a long history of making research licenses available free of charge to people who felt they needed one," Horsch says. "And that will continue because it's our practice to actually facilitate the advancement of science."
Monsanto, DuPont, and others have rights to several technologies fundamental to the genetic transformation of cells in agbiotech research. Common approaches include using Agrobacterium tumefaciens or microprojectile systems, often called "biolistics" or the "gene gun." Cornell University developed the gun and sold it to DuPont in 1990.The companies' openness toward the sharing of these technologies has been mixed. DuPont has been accused of holding tightly to the gene gun technology. Yet, DuPont and Monsanto are on separate collaborative teams that recently publicly released the Agrobacterium genetic sequence so that scientists could better understand and improve on its use as a tool. The Federal Trade Commission required Monsanto to transfer Agrobacterium rights to the University of California, Berkeley, as a condition for buying seed producer DeKalb Genetics in late 1998.
However, Students for Responsible Research at UC Berkeley have opposed the technology transfer and "question the benefits of such strong ties between a public university and a private company," whose products the group does not support. The group also believes that a $25 million alliance that the university formed in 1998 with the agbiotech R&D institute of Novartis, now Syngenta, conflicts with a land-grant university's mission and hurts its scientific integrity.
Despite these public-private ties, there has been a "privatization" of agricultural research and IP in the U.S. "Expanded intellectual property rights for biological inventions, the development of hybrid seeds, and biotechnology applications have stimulated private-sector efforts in the past 25 years," the U.S. Department of Agriculture's Economic Research Service (ERS) concludes in its on-line briefing room.
Prior to 1980, public agricultural research resources exceeded private industry's, ERS reports. Private investment overtook the public side in the mid-1980s and continues to grow in real terms, whereas public spending has declined slightly. In 1996, the most recent year for which ERS gives figures, industry was spending about $4 billion per year compared with $3.1 billion on the public side.
Patents Companies dominate among top 10 holders in agbiotech ASSIGNEEa U.S. PATENTSb Monsanto 287 DuPont 279 Syngenta 173 Dow Chemical 157 U.S. Department of Agriculture 102 Aventis 77 University of California 48 Savia 38 Cornell University 33 Iowa State University 29 a Includes other companies gained through acquisitions. b Through 1998. For enabling technologies, genes, germplasm, plant varieties, and hybrid lines. SOURCE: University of California, Berkeley Coupled with this substantial R&D investment, consolidation and acquisitions have created significant IP estates for just a few companies. According to figures from UC Berkeley researchers, the U.S. Patent & Trademark Office awarded 1,386 agbiotech-related patents through 1998. Private companies hold 79% of these, with 71% at the five leading firms. USDA has more than a third of the 21% in public-sector hands.
"Industry patenting of IP hasn't affected university research, if that research does not have commercial impact," says the director of a leading Midwest agricultural research institute. "If the research does, then it becomes quite important to make sure that one is not using technologies that represent the holdings of a company and for which there would be substantial licensing issues to move that work ahead."
Patent law includes a research exclusion that allows anyone to practice on an invention for improving it, Horsch points out. On top of that, he adds, "Monsanto would never want to try to get judgments against universities for patent infringement" on research uses of technology. It has, however, sued farmers for failing to abide by licensing agreements that cover use of its seeds, defending its IP successfully at least once.
"One of the things that's nice about intellectual property is that you can segment its uses between research and commercial applications," Horsch says, "and we do that where it's appropriate." In some crops, such as the sweet potato, the company may not be interested in retaining commercial rights, he explains. "But in something like sharing access to the genome of rice," the company wants the ability to license back inventions that are relevant to other crops, such as corn.
Public- and private-sector researchers agree that the present system drives many to creatively "invent around" patents and to develop alternatives. "There is still great opportunity for people to develop their own set of tools," the institute's director says. "It may sound like going back to ground zero, but there needs to be more scientific discovery because additional tools are really required to address the problems we've seen, improve capabilities, and drive research."
THE IP SYSTEM also motivates choices about which areas of research or business to pursue. "The public sector has conducted research with limited private incentives," ERS reports, such as in minor crops, or where the work is too long term, too risky, or serves social needs, rather than being focused on marketable products.
"Public-sector research institutions, such as USDA's Agricultural Research Service, have increasingly shifted their plant-breeding research toward conservation and characterization of plant genetics resources relatively neglected by the private sector," USDA notes. Industry, on the other hand, has focused largely on input traits, such as herbicide tolerance and insect resistance, and major crops where large markets offer opportunities for a return on investment.
Many involved in agricultural research say that this division between public and private efforts--and the diversity it brings to research--is both positive and needed. Others, however, believe industry's alignment of R&D and profit incentives has led to a neglect of large segments of agriculture. Because many key technologies are in private hands, ERS believes that further agbiotech developments will require partnerships between firms, along with public-private collaborations.
This past February, UC Berkeley's Center for Sustainable Resource Development and UC's Office of Technology Transfer held a meeting to address "the continuing concern of researchers at universities and public-sector research institutions--in both the U.S. and developing countries--with their lack of access and limited capacity to commercialize new technologies because of IP considerations." Among the participants' recommendations were increasing technology access and transfer, leveraging their licensing power, and improving IP management.
"Technologies clearly need to be made more readily available to universities and essentially royalty free in minor crops," says Ralph W. F. Hardy, president of the National Agricultural Biotechnology Council, a group of largely land-grant universities that promotes discussion on agbiotech issues. "If a university develops something new in a minor crop, a reasonable thing would be right of first refusal to the company that provided the technology. But the university should have the right to file a patent, too."
THE PUBLIC SECTOR--namely, USDA--was the one to license the most vilified of patented agbiotech inventions, that for producing sterile seeds, to its seed industry partner while Monsanto and Syngenta, with similar patented technology, have vowed not to commercialize it. Public research policy and the role of universities and government labs in creating, owning, and commercializing IP is a hotly debated area, and not only in agbiotech. In the corporate world, IP functions more clearly as a competitive tool.
When it comes to doing business, "generating IP and blocking other companies' positions is nothing new, and anyone that can do it, does it," says Gary H. Richardson, president, chairman, and CEO of Akkadix, a small San Diego-based agbiotech firm.
He does not see IP access as a problem at the research stage. "IP certainly is important and makes you think about how you go forward," he explains. However, it is only one among many factors to be considered when choosing what business to pursue, he says, especially when others have already made sizable investments and carved out market positions.
"When you get right down to it, it's still the market segment and how you can participate in it," Richardson says. He suggests that, in agbiotech, getting a product into the now highly concentrated seed distribution channels actually presents a bigger challenge than the IP area.
"I can get people as smart as the large companies have to generate IP to invent around or block them, if that were my goal," he explains. "But the reality is that I can't get the market access they've got with the infrastructure they've developed."
As the agbiotech industry began building its technology and marketing infrastructure, companies also started battling each other in lawsuits alleging antitrust violations and patent infringement. Many are still not resolved, whereas others have resulted in both sides losing rights.
"Patents are a double-edged sword--they cost a lot to get in place and they cost a lot to defend," Richardson says. "I believe many people have found out that it's easier to collaborate than to fight and destroy each other's work after all the years it took to get there."
"One of the things that's nice about intellectual property is that you can segment its uses between research and commercial applications." WITH THIS CHANGE in attitude, he's optimistic that, if the need arises to discuss licensing, "the doors would open and we could go in and talk." Small companies still have much room to create technologies or products that will interest larger firms and lend leverage to negotiations. "There are so many things still to be patented--no large company has cornered all the creativity," he adds.
"Both Monsanto and the industry as a whole engage in quite a bit of cross-licensing," Horsch says, "but you don't hear about it because it's not contested." The patent system also has a tendency to self adjust, he adds, especially when it comes to very broad patents that are the easiest to challenge and offer the most incentive to be challenged.
"When a company has a very broad patent, they are more reasonable about licensing it," Horsch says. "The rationale is that there is much more profit to be made by going for a large market share as possible by nonexclusive licenses." He points to Roundup Ready, or herbicide-tolerant, soybeans, where more than 200 soybean seed companies have licenses from Monsanto. On the other hand, he adds, "we do not let other companies use Roundup Ready technology for their own purposes."
Monsanto and other agbiotech majors have established policies about donating data and technologies, licensing intellectual property royalty-free, and working with researchers in the public sector and in developing nations. Monsanto's commitment to share knowledge and technology with public institutions to benefit health and the environment is part of its recent corporate pledge. It has at least a dozen such programs around the world, many begun a decade ago.
Although the shared technology may help developing countries meet their agricultural needs, oftentimes the donations are in crops or in countries and markets of little commercial interest anyway. Critics, therefore, see these actions as trying to curry public favor in light of questions raised about the safety, risks, and benefits of agbiotech products. "The agbiotech industry has found itself under such a cloud that it really had to do some things to be perceived as more socially responsible," NABC's Hardy says.
Horsch admits that Monsanto's programs might have external benefits, such as good public relations, but he says no single factor motivates the company. Instead, he says the motivation is a mix of factors that includes philanthropic interests; humanitarian needs; employee concerns; and the ability to leverage expertise, advance technology, and increase the company's impact through collaborations.
There are also aspects that are "in the long-term business interests of the company," Horsch says. "There are ways we can share our knowledge and technology that do not hurt the financial interests of our shareowners and don't detract from the commercial opportunities.
"What we share can translate into real benefits for farmers in developing countries. They will get richer and when they get rich enough, they'll start to look like customers," he continues. "So there is a long-term market development impact that will come from the sharing."
Monsanto and Syngenta both have donated technology and patent rights to help in the development of beta-carotene-containing, or "golden," rice. Syngenta has made its IP available and signed a collaborative development agreement with Greenovation, a German biotech firm that had received rights to golden rice from the university inventors. As part of the deal, Syngenta retained commercial rights for developed countries.
ALTHOUGH SUCH gestures might seem magnanimous, less developed countries actually don't lack access to technologies, according to the International Food Policy Research Institute. "Intellectual property rights assigned to the key-enabling technologies used to transform crops are mainly held in, and are therefore primarily relevant to, rich-country jurisdictions," it says. "Thus, for most of the crops that matter for food security in poor countries, researchers' freedom to operate is not impeded," if the crops are not exported to countries in which patents would apply.
In the case of golden rice, about 70 or more patents held by some 30 public and private entities are related to the rice. However, the International Service for the Acquisition of Agri-biotech Applications (ISAAA) has found that, depending on the country, zero to 44 patents actually apply. The largest numbers are in developed countries--40 or so in the U.S. and Europe, and about 20 in Japan--while 10 or very often fewer might be an obstacle in many developing countries.
However, whereas developing countries may not face patent obstacles today, the complex and contentious area of global intellectual property law is shifting. The implementation of new international agreements--now being finalized under the auspices of the World Trade Organization and United Nations--is likely to alter how intellectual property is protected and enforced. The new rules will bring about even more changes in agricultural practices; use of genetic resources; and agbiotech research, investment, and commercialization.
MARKETS: Agbiotech Adoption Continues To Grow
Amid controversy surrounding genetically engineered crops and food, agricultural biotechnology markets are continuing to expand in the U.S. However, the growth rate has slowed from a few years ago.
Companies that offer both agrochemicals and seeds--such as Monsanto, DuPont, and Syngenta--have very mixed results. They and the rest of the agricultural supply chain--seed producers, distributors, retailers, and farmers--are selling into a depressed market. Sales figures thus reflect shifts in pricing, volumes, and product use.
Sales at Monsanto's seeds and genomics division fell 10% to about $935 million in the first half of this year. However, the company reports that lower sales of conventional seeds were offset somewhat by increased revenues from biotech sales.
DuPont's Pioneer seed unit reported sales up just about 1% in the first quarter of this year to $929 million. Falling prices contributed a negative 2%, while volumes were up 3%. In the second quarter, Pioneer's sales fell 4%, to $771 million.
Syngenta's sales of seeds for field crops fell 7% in the first half, to $407 million. Volumes were down 4%, prices up 1%, and currency exchange had a negative 4% effect. However, about 16% of the total sales was genetically engineered crops, compared with 15% in the same period last year. In North America, herbicide-tolerant soybeans are about 80% of its regional seed sales. The U.S. plants nearly 70% of the world's acreage of biotech crops. The Department of Agriculture reported in June that U.S. farmers increased their combined planting of genetically engineered corn, cotton, and soybeans in 2001 by 18% to about 82 million acres, compared with no overall increase in 2000. Monsanto accounts for most biotech sales; the company reports an 11% increase in U.S. acres planted with its products in 2001.
Biotech corn, affected by the controversy over Aventis' StarLink variety (C&EN, Jan. 22, page 23), accounted for 26% of all U.S. corn acres, just 1% more than in 2000, USDA reports. Insect-resistant and herbicide-tolerant cotton was planted on 69% of cotton acreage, up from 61% last year. Farmers planted herbicide-tolerant soybeans on 68% of U.S. soybean acreage, compared with 54% in 2000.
While most farm and agriculture groups, such as the National Corn Growers Association, use the USDA figures, the American Corn Growers Association conducted its own June survey of 509 farmers in 14 states. It found 21% of corn acreage planted with biotech corn in 2001, or 6% fewer acres than the previous year.
Environmental activist groups, such as the Organic Consumers Association, also dispute USDA figures. The group warns that "current government or industry figures on biotech crops are all estimates, thereby subject to manipulation." It alleges that agency predictions in spring 2000 that biotech corn acres would decrease were "recently recalculated" to show no change, "apparently after hearing from Monsanto, Aventis, and Syngenta that projections like these were bad for their bottom line."
Beyond this year, the future for agbiotech markets, particularly international ones, remains uncertain. Argentina, which is second among nations planting agbiotech crops, recently granted new approvals. Elsewhere in the world, some products have moved ahead--even in Europe--while others haven't; the net effect could be more growth.
However, in the U.S., the Environmental Protection Agency is now reviewing renewal or extension of the time-limited registrations for insect-resistant corn and cotton. In response to requests, EPA just recently extended the time for public comment on the apparent risk and benefits of agbiotech crops.
DEVELOPMENTS: Agbiotech Wheat Faces Obstacles
A major genetically engineered crop in development is Monsanto's herbicide-tolerant wheat. In the past, the company has said it anticipates a U.S. launch between 2003 and 2005, but only after receiving approvals in both the U.S. and Japan. However, even the idea of a biotech wheat is causing a stir, especially in light of what corn producers experienced when their harvests were contaminated with StarLink corn.
Japan, one of the largest buyers of U.S. wheat, is not receptive, and has said it would buy elsewhere if the U.S. could not guarantee biotech-free wheat. With restrictions on unapproved crops and new food labeling rules for genetically engineered content, Japan and other countries are concerned about the ability of the grain handling system to identify and segregate the wheat. Europe, another major wheat market, has its own rules and opposes biotech crops in general.
Wheat industry representatives have traveled to Japan to hold discussions and found "no market or consumer acceptance for wheat derived from biotechnology," reports the trade group U.S. Wheat Associates (USWA). The industry also is keeping an eye on Canada, a major wheat exporter and U.S. competitor, because it's unclear what position it will take. U.S. legislative bans on biotech wheat were proposed, but were later defeated in North Dakota and Montana.
USWA, as well as the National Association of Wheat Growers, Canadian Wheat Board, and many trade groups on the state level are taking a cautious approach. They urge technology providers to obtain international regulatory approvals and customer and consumer acceptance before commercializing biotech wheat. Many also want guarantees that identity preservation and segregation systems are in place.
In response, Monsanto has formed a wheat industry advisory committee to provide advice and counsel on how best to bring forward biotech wheat products. The committee includes participants from the seed trade, farming, grain handling, export, flour milling, and baking arenas. The company says it hopes to gain an understanding of the feasibility, strategy, and standards for acceptance; develop and review plans for grain handling; and learn how to steward and commercialize its wheat.