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Date:

April 25, 2005

Subject:

Saving 5000 Lives Every Day; How Much Land for Ten Billion People?; Rehabilitating Agbiotech: Over-regulated and Under-appreciated

 

Today in AgBioView from www.agbioworld.org: April 25, 2005

* How to Save 5000 Lives Every Day
* How Much Land Can Ten Billion People Spare for Nature?
* Agricultural Biotech: Overregulated and Underappreciated
* ....Experts Respond

How to Save 5000 Lives Every Day

- Greg Bodulovic, Canberra Times, April 25, 2005

If there was a technology which could potentially save the lives of up to 5,000 people a day, would you use it? If you answered yes, you would be in the majority. However, environmental lobby groups would disagree because they reject any solution that involves genetically modified organisms.

Globally, up to 800 million people suffer from vitamin A deficiency, which is a major health problem in South-East Asia and Africa. Every year between 800,000 and two million people die as a result of this deficiency, most of them children and pregnant women. The deficiency is also the leading source of preventable blindness in the world, causing over 500,000 cases of irreversible blindness a year along with millions of cases of xerophtalmia, a condition that causes night blindness and can lead to further eye problems. Vitamin A is a fat-soluble vitamin involved in the formation and maintenance of healthy skin, hair and mucous membranes.

It enables humans to see in dim light and is instrumental in skeletal and tooth development as well as in reproduction. The deficiency can be avoided by eating foods high in pro-vitamin A, a pre-cursor to vitamin A, such as beta-carotene, which is converted to vitamin A in the body. Foods that contain high levels of vitamin A include dark green vegetables, deep yellow fruits and vegetables, meats and dairy products. The deficiency is common among people whose staple crop and often only source of nourishment is rice, because rice does not contain any pro-vitamin A. Our friend and science colleague Professor Ingo Potrykus and his team at the Swiss Federal Institute of Technology have spent the last decade developing golden rice, a strain into which a genetic construct containing two daffodil genes and one bacterial gene have been inserted to produce beta-carotene, which the body can break down into vitamin A. Potrykus and his team have overcome all intellectual-property licensing restrictions associated with the research to enable golden rice seeds to be given free to people in developing nations. However, despite the life- saving potential of this new strain of rice and widespread endorsements from many scientists, health organisations, nIutritionists, media outlets such as Time Magazine and CNN, and even the former US president Bill Clinton, there are still individuals and groups who continue to criticise golden rice.

Greenpeace is just one of the groups which showers golden rice with undeserved criticism. One of its main assertions is that a daily intake of 300 grams of golden rice would not be enough to meet the recommended daily allowance of 750mg of vitamin A a day. Greenpeace contends that a person would need to eat 18kg of cooked golIden rice a day to meet the recommended daily allowance of vitamin A. There are two major inaccuracies with this contention. First, an intake of vitamin A at a level significantly lower than the recommended daily allowance would overcome the effects of vitamin A deficiency. Second, new strains of golden rice containing more beta-carotene have been developed. The newest one was created by Syngenta in Britain and contains a maize gene instead of one of the daffodil genes. It has been dubbed ''golden rice II''I and contains 20 times as much beta-carotene as the original. About 180 grams of this should deliver the recommended daily allowance of vitamin A.

Potrykus and his team have also developed a number of strains of golden rice with higher beta-carotene content than the first variety, using only daffodil genes. These latest developments answer Greenpeace's criticisms about inadequate vitamin A content. However, groups such as Greenpeace are unlikely to welcome the news, given their total opposition to crop biotechnology, even when tangible benefits exist. Consistent with its complete rejection of crop biotechnology, Greenpeace maintains that the provision of vitamin A supplement pills is the best short-term answer to overcome the deficiency. However, with 800million people suffering from it worldwide and many of these living in remote areas, the continual distribution of pills is logistically difficult and costly. Compared with golden rice, distribution of pills seems redundant because golden rice is free, can be planted in the same way as traditional rice varieties and is a continuous and sustainable source of Vitamin A.

All a farmer needs to grow golden rice is one seed which has the potential to generate rice production sufficient to feed 100,000 poor people within two years and effectively reduce the deficiency. There are also problems with the distribution of golden rice because of restrictive regulations imposed on GM crops in some parts of the world. As a publicly funded project, the development of golden rice has not had the budget of privately funded GM crops and is facing major hurdles such as a lack of regulatory expertise, governmental support and opposition from numerous so- called ''humanitarian'' organisations.

Potrykus and his team have mapped the golden rice genome to identify the locations where the introduced genes were inserted into the rice genome. This was done to ensure that the inserted genes functioned properly and did not interrupt the operation of other rice genes. The introduced genes do not move around the genome and were inserted without the use of an antibiotic-resistance marker gene, so there Iis no question of antibiotic resistance occurring in consumers of golden rice. Potrykus has spent the last five years testing the various objections to golden rice. And in field tests at six locations the golden rice consistently produced elevated levels of pro- vitamin A. While such research should be evidence supporting the safety of this rice, many countries where it is most needed are insisting on further tests and trials, often because genetic modification is seen as taboo or is not well understood inI such places.

Meanwhile, privately funded GM crops whose genomes have not been mapped and which benefit only farmers in developed countries continue to be approved around the world. By the time golden rice is finally approved in the countries where it is most needed, it is likely that many more millions of children will have been blinded or died as a result of vitamin A deficiency.

Clearly, as the critics of golden rice state, the best solution to vitamin A deficiency is a balanced and healthy diet, high in green vegetables, yellow fruits and containing meat. However, due to extreme poverty and food shortages in developing nations, many people are unable to achieve balanced diets and as a result suffer from micronutrient deficiencies. These are the people that golden rice was developed to help and will help if it is supported.

So we must ask ourselves, if there was a technology which could potentially save the lives of up to 5000 people a day would we use it?

--
Greg Bodulovic is a PhD student at the ANU's Research School of Biological Sciences where Professor Barry Rolfe is a group leader.
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How Much Land Can Ten Billion People Spare for Nature?

- Paul E. Waggoner, Council for Agricultural Science and Technology, February 1994.

Excerpts below...

Full report at http://www-formal.stanford.edu/jmc/nature/nature.html

Today farmers feed five to six billion people by cultivating about a tenth of the planet's land. The seemingly irresistible doubling of population and the imperative of producing food will take another tenth of the land, much from Nature, if people keep on eating and farmers keep on farming as they do now. So farmers work at the junction where population, the human condition, and sparing land for Nature meet.

The world gives farmers a certain population to feed, and farmers can furnish abundant food or scarcity from either much or little land. By going beyond reporting what has happened or speculating what will happen, agriculturalists can change outcomes. As effective recruits who can make things happen, sparing land rather than merely lamenting loss of Nature, agriculturalists can be drawn into conservation. Agriculture is a participant, not a spectator, sport.

In the eyes of humanity, farmers win the game by growing abundant harvests, dependably and year after year. An abundant harvest is not a sufficient condition for everyone to be well fed, but it is a necessary one. It is the condition humanity depends mainly on farmers to fulfill, while humanity as a whole works to lessen waste and inequity that leave some hungry--even when much is harvested. Although humanity as a whole decides how the pie will be divided, the farmer must first win it. The farmer's success must be tallied in terms of sums and averages. Other things being equal, a larger pie makes larger pieces. And the question is whether winning a pie large enough for ten billion to divide can spare land for Nature.

Arable farming monopolizes my view of sparing land for Nature. Arable is derived from arare, Latin for to plow. Although demands for grazing, lumber, and firewood also press on wilderness, the land spared wholly for Nature, I concentrate on arable farming for three reasons. First, even careful plowing disrupts Nature more than do well managed cattle or chain saws. Second, life's demands for a few thousand calories and a few grams of protein each day from cropland grant no quarter to Nature. Third, envisioning how much cropland and the ten billion will use and so how much land farmers will spare for Nature fills my plate.

To show looking for an answer to the question of the title is not futile, I conclude my introduction with an example of how arable land can be spared in a region. The example should not be surprising when we remember that, despite the simultaneous multiplication of population and expansion of cropland globally, cropland has not expanded as fast as population, and changes in regional land use do not correlate significantly with population. My example of sparing land comes from India. From 1961-1966 Indian farmers grew 0.83 t/ha wheat on 13 million ha. During the next decades, they applied the technology of the Green Revolution to increase production fivefold. Figure 1.1 shows the expanding area they would have used to grow the rising production at the 0.83 t/ha of 1961-1966. The land they actually used, however, expanded by only three-quarters and then leveled off. The difference between the land actually used and the land that would have been used at 0.83 t/ha was spared. Looking back from 1991 to 1961-1966 we see that Indian farmers spared 42 million ha. Looking ahead rather than back, I ask, "How much land can ten billion people spare for Nature?"

In the End

* If people keep on eating and multiplying and farmers keep on tilling and harvesting as today, the imperative of food will take another tenth of the land, much from Nature. So farmers work at the hub of sparing land for Nature.

* Calories and protein from present cropland would give a vegetarian diet to ten billion. A diet requiring food and feed totaling 10,000 calories for ten billion, however, obviously would exceed the capability of present agriculture on present cropland.

* The global totals of sun on land, in the air, fertilizer, and even water could produce far more food than ten billion need.

* By eating different species of crop and more or less vegetarian diets people can change the number who can be fed from a plot. And large numbers of people do change diets.

* Encouraged by incentives, farmers use new technologies to raise more crop per plot and more meat and milk per crop, keeping food prices down despite rising population. Differences in yields among nations and between average and master farmers continue showing that yields can be
raised more.

* Foreseeing the future demands seeing through fluctuations in crop production.

* For each ton of production, growing more food per plot lessens the fallout, for instance, of silt and pesticides, into the surroundings. If several limiting factors are improved together, even adding water and fertilizer can diminish fallout.

* Although the uneven distribution of water among regions and its capricious variation among seasons plague farming, opportunities to raise more crop with the same volume of water kindle hope.

* In Europe and the United States, rising income, improving technology, and leveling populations--which all nations aspire to--elicit forecasts of shrinking cropland.

* So by harvesting more per plot, farmers can help ten billion spare some land that unchanging yields would require to feed them. Glimmers can be seen even of changing diets, never-ending research, encouraging incentives, and smart farmers feeding ten billion at affordable prices while sparing some of today's cropland for Nature.
**********************************************

http://www.issues.org/issues/21.2/miller.html

Agricultural Biotechnology: Overregulated and Underappreciated

- Henry I. Miller & Gregory Conko, Issues In Science & Technology, Winter 2005

'The pursuit of an integrated action plan, including regulatory reform, will help the United States and the world reap enormous benefits that now are thwarted.'

The application of recombinant DNA technology, or gene splicing, to agriculture and food production, once highly touted as having huge public health and commercial potential, has been paradoxically disappointing. Although the gains in scientific knowledge have been stunning, commercial returns from two decades of R&D have been meager. Although the cultivation of recombinant DNA-modified crops, first introduced in 1995, now exceeds 100 million acres, and such crops are grown by 7 million farmers in 18 countries, their total cultivation remains but a small fraction of what is possible. Moreover, fully 99 percent of the crops are grown in only six countries?the United States, Argentina, Canada, Brazil, China, and South Africa and virtually all the worldwide acreage is devoted to only four commodity crops: soybeans, corn, cotton, and canola.

Attempts to expand "agbiotech" to additional crops, genetic traits, and countries have met resistance from the public, activists, and governments. The costs in time and money to negotiate regulatory hurdles make it uneconomical to apply molecular biotechnology to any but the most widely grown crops. Even in the best of circumstances that is, where no bans or moratoriums are in place and products are able to reach the market R&D costs are prohibitive. In the United States, for example, the costs of performing a field trial of a recombinant plant are 10 to 20 times that of the same trial with a virtually identical plant that was crafted with conventional techniques, and regulatory expenditures to commercialize a plant can run tens of millions dollars more than for a conventionally modified crop. In other words, regulation imposes a huge punitive tax on a superior technology.

Singled out for scrutiny

At the heart of the problem is the fact that during the past two decades, regulators in the United States and many other countries have created a series of rules specific for products made with recombinant DNA technology. Regulatory policy has consistently treated this technology as though it were inherently risky and in need of unique, intensive oversight and control. This has happened despite the fact that a broad scientific consensus holds that agbiotech is merely an extension, or refinement, of less precise and less predictable technologies that have long been used for similar purposes, and the products of which are generally exempt from case-by-case review. All of the grains, fruits, and vegetables grown commercially in North America, Europe, and elsewhere (with the exception of wild berries and wild mushrooms) come from plants that have been genetically improved by one technique or another. Many of these "classical" techniques for crop improvement, such as wide-cross hybridization and mutation breeding, entail gross and uncharacterized modifications of the genomes of established crop plants and commonly introduce entirely new genes, proteins, secondary metabolites, and other compounds into the food supply.

Nevertheless, regulations in the United States and abroad, which apply only to the products of gene splicing, have hugely inflated R&D costs and made it difficult to apply the technology to many classes of agricultural products, especially ones with low profit potential, such as noncommodity crops and varieties grown by subsistence farmers. This is unfortunate, because the introduced traits often increase productivity far beyond what is possible with classical methods of genetic modification.

Furthermore, many of the recombinant traits that have been introduced commercially are beneficial to the environment. These traits include the ability to grow with lower amounts of agricultural chemicals, water, and fuel, and under conditions that promote the kind of no-till farming that inhibits soil erosion. Society as a whole would have been far better off if, instead of implementing regulation specific to the new biotechnology, governments had approached the products of gene splicing in the same way in which they regulate similar products?pharmaceuticals, pesticides, and new plant varieties?made with older, less precise, and less predictable techniques.

But activist groups whose members appear to fear technological progress and loathe big agribusiness companies have egged on regulators, who need little encouragement to expand their empires and budgets. The activists understand that overregulation advances their antibiotechnology agenda by making research, development, and commercialization prohibitively expensive and by raising the barriers to innovation.

Curiously, instead of steadfastly demanding scientifically sound, risk-based regulation, some corporations have risked their own long-term best interests, as well as those of consumers, by lobbying for excessive and discriminatory government regulation in order to gain short-term advantages. From the earliest stages of the agbiotech industry, those firms hoped that superfluous regulation would act as a type of government stamp of approval for their products, and they knew that the time and expense engendered by overregulation would also act as a barrier to market entry by smaller competitors. Those companies, which include Monsanto, DuPont-owned Pioneer Hi-Bred, and Ciba-Geigy (now reorganized as Syngenta), still seem not to understand the ripple effect of overly restrictive regulations that are based on, and reinforce, the false premise that there is something uniquely worrisome and risky about the use of recombinant DNA techniques.

The consequences of this unwise, unwarranted regulatory policy are not subtle. Consider, for example, a recent decision by Harvest Plus, an alliance of public-sector and charitable organizations devoted to producing and disseminating staple crops rich in such micronutrients as iron, zinc, and vitamin A. According to its director, the group has decided that although it will continue to investigate the potential for biotechnology to raise the level of nutrients in target crops above what can be accomplished with conventional breeding, "there is no plan for Harvest Plus to disseminate [gene-spliced] crops, because of the high and difficult-to-predict costs of meeting regulatory requirements in countries where laws are already in place, and because many countries as yet do not have regulatory structures."

And in May 2004, Monsanto announced that it was shelving plans to sell a recombinant DNA-modified wheat variety, attributing the decision to changed market conditions. However, that decision was forced on the company by the reluctance of farmers to plant the variety and of food processors to use it as an ingredient: factors that are directly related to the discriminatory over-regulation of the new biotechnology in important export markets. Monsanto also announced in May that it has abandoned plans to introduce its recombinant canola into Australia, after concerns about exportability led several Australian states to ban commercial planting and, in some cases, even field trials.

Other companies have explicitly acknowledged giving up plans to work on certain agbiotech applications because of excessive regulations. After receiving tentative approval in spring 2004 from the British government for commercial cultivation of a recombinant maize variety, Bayer CropScience decided not to sell it because the imposition of additional regulatory hurdles would delay commercialization for several more years. And in June 2004, Bayer followed Monsanto's lead in suspending plans to commercialize its gene-spliced canola in Australia until its state governments "provide clear and consistent guidelines for a path forward."

Another manifestation of the unfavorable and costly regulatory milieu is the sharp decline in efforts to apply recombinant DNA technology to fruits and vegetables, the markets for which are minuscule compared to crops such as corn and soybeans. Consequently, the number of field trials in the United States involving gene-spliced horticulture crops plunged from approximately 120 in 1999 to about 20 in 2003.

Setting matters aright

The public policy miasma that exists today is severe, worsening, and seemingly intractable, but it was by no means inevitable. In fact, it was wholly unnecessary. From the advent of the first recombinant DNA-modified microorganisms and plants a quarter century ago, the path to rational policy was not at all obscure. The use of molecular techniques for genetic modification is no more than the most recent step on a continuum that includes the application of far less precise and predictable techniques for genetic improvement. It is the combination of phenotype and use that determines the risk of agricultural plants, not the process or breeding techniques used to develop them. Conventional risk analysis, supplemented with assessments specific to the new biotechnology in those very rare instances where they were needed, could easily have been adapted to craft regulation that was risk-based and scientifically defensible. Instead, most governments defined the scope of biosafety regulations to capture all recombinant organisms but practically none developed with classical methods.

In January 2004, the U.S. Department of Agriculture (USDA) announced that it would begin a formal reassessment of its regulations for gene-spliced plants. One area for investigation will include the feasibility of exempting "low-risk" organisms from the permitting requirements, leading some observers to hope that much needed reform may be on the horizon. However, regulatory reform must include more than a simple carve-out for narrowly defined classes of low-risk recombinant organisms.

An absolutely essential feature of genuine reform must be the replacement of process-oriented regulatory triggers with risk-based approaches. Just because recombinant DNA techniques are involved does not mean that a field trial or commercial product should be subjected to case-by-case review. In fact, the introduction of a risk-based approach to regulation is hardly a stretch; it would merely represent conformity to the federal government's official policy, articulated in a 1992 announcement from the White House Office of Science and Technology Policy, which calls for "a risk-based, scientifically sound approach to the oversight of planned introductions of biotechnology products into the environment that focuses on the characteristics of the . . . product and the environment into which it is being introduced, not the process by which the product is created."

One such regulatory approach has already been proposed by academics. It is, ironically, based on the well-established model of the USDA's own plant quarantine regulations for non-recombinant organisms. Almost a decade ago, the Stanford University Project on Regulation of Agricultural Introductions crafted a widely applicable regulatory model for the field testing of any organism, whatever the method employed in its construction. It is a refinement of the "yes or no" approach of national quarantine systems, including the USDA's Plant Pest Act regulations; under these older regimens, a plant that a researcher might wish to introduce into the field is either on the proscribed list of plant pests, and therefore requires a permit, or it is exempt.

The Stanford model takes a similar, though more stratified, approach to field trials of plants, and it is based on the ability of experts to assign organisms to one of several risk categories. It closely resembles the approach taken in the federal government's handbook on laboratory safety, which specifies the procedures and equipment that are appropriate for research with microorganisms, including the most dangerous pathogens known. Panels of scientists had stratified these microorganisms into risk categories, and the higher the risk, the more stringent the procedures and isolation requirements. In a pilot program, the Stanford agricultural project did essentially the same thing for plants to be tested in the
field: A group of scientists from five nations evaluated and, based on certain risk-related characteristics, stratified a number of crops into various risk categories. Importantly, assignment to one or another risk category had nothing to do with the use of a particular process for modification or even whether the plant was modified at all. Rather, stratification depended solely on the intrinsic properties of a cultivar, such as potential for weediness, invasiveness, and outcrossing with valuable local varieties.

What are the practical implications of an organism being assigned to a given risk category? The higher the risk, the more intrusive the regulators' involvement. The spectrum of regulatory requirements could encompass complete exemption; a simple "postcard notification" to a regulatory authority (without prior approval required); premarket review of only the first introduction of a particular gene or trait into a given crop species; case-by-case review of all products in the category; or even prohibition (as is the case currently for experiments with foot-and-mouth disease virus in the United States).

Under such a system, some currently unregulated field trials of organisms modified with older techniques would likely become subject to regulatory review, whereas many recombinant organisms that now require case-by-case review would be regulated less stringently. This new approach would offer greater protection and, by decreasing research costs and reducing unpredictability for low-risk organisms, encourage more R&D, especially on noncommodity crops.

The Stanford model also offers regulatory bodies a highly adaptable, scientific approach to the oversight of plants, microorganisms, and other organisms, whether they are naturally occurring or "non-coevolved" organisms or have been genetically improved by either old or new techniques. The outlook for the new biotechnology applied to agriculture, especially as it would benefit the developing world, would be far better if governments and international organizations expended effort on perfecting such a model instead of clinging to unscientific, palpably flawed regulatory regimes. It is this course that the USDA should pursue as it reevaluates its current policies.

At the same time as the U.S. government begins to rationalize public policy at home, it must stand up to the other countries and organizations that are responsible for unscientific, debilitating regulations abroad and internationally. U.S. representatives to international bodies such as the Codex Alimentarius Commission, the United Nations' agency that sets food-safety standards, must be directed to support rational science-based policies and to work to dismantle politically motivated unscientific restrictions. All science and economic attachés in every U.S. embassy and consulate around the world should have biotechnology policy indelibly inscribed on their diplomatic agendas. Moreover, the U.S. government should make United Nations agencies and other international bodies that implement, collude, or cooperate in any way with unscientific policies ineligible to receive funding or other assistance from the United States. Flagrantly unscientific regulation should be made the "third rail" of U.S. domestic and foreign policy.

Uncompromising? Aggressive? Yes, but so is the virtual annihilation of entire areas of R&D; the trampling of individual and corporate freedom; the disuse of a critical, superior technology; and the disruption of free trade.

Strategies for action

Rehabilitating agbiotech will be a long row to hoe. In order to move ahead, several concrete strategies can help to reverse the deteriorating state of public policy toward agricultural biotechnology.

First, individual scientists should participate more in the public dialogue on policy issues. Perhaps surprisingly, few scientists have demanded that policy be rational; instead, most have insisted only on transparency or predictability, even if that delivers only the predictability of research delays and unnecessary expense. Others have been seduced by the myth that just a little excess regulation will assuage public anxiety and neutralize activists' alarmist messages. Although defenders of excessive regulation have made those claims for decades, the public and activists remain unappeased and technology continues to be shackled.

Scientists are especially well qualified to expose unscientific arguments and should do so in every possible way and forum, including writing scientific and popular articles, agreeing to be interviewed by journalists, and serving on advisory panels at government agencies. Scientists with mainstream views have a particular obligation to debunk the claims of their few rogue colleagues, whose declarations that the sky is falling receive far too much attention.

Second, groups of scientists?professional associations, faculties, academies, and journal editorial boards?should do much more to point out the flaws in current and proposed policies. For example, scientific societies could include symposia on public policy in their conferences and offer to advise government bodies and the news media.

Third, reporters and their editors can do a great deal to explain policy issues related to science. But in the interest of "balance," the news media often give equal weight to all of the views on an issue, even if some of them have been discredited. All viewpoints are not created equal, and not every issue has "two sides." Journalists need to distinguish between honest disagreement among experts, on the one hand, and unsubstantiated extremism or propaganda, on the other. They also must be conscious of recombinant DNA technology's place in the context of overall crop genetic improvement. When writing about the possible risks and benefits of gene-spliced herbicide-tolerant plants, for example, it is appropriate to note that herbicide-tolerant plants have been produced for decades with classical breeding techniques.

Fourth, biotechnology companies should eschew short-term advantage and actively oppose unscientific discriminatory regulations that set dangerous precedents. Companies that passively, sometimes eagerly, accept government oversight triggered simply by the use of recombinant DNA techniques, regardless of the risk of the product, ultimately will find themselves the victims of the law of unintended consequences.

Fifth, venture capitalists, consumer groups, patient groups, philanthropists, and others who help to bring scientific discoveries to the marketplace or who benefit from them need to increase their informational activities and advocacy for reform. Their actions could include educational campaigns and support for organizations such as professional associations and think tanks that advocate rational science-based public policy.

Finally, governments should no longer assume primary responsibility for regulation. Nongovernmental agencies already accredit hospitals, allocate organs for transplantation, and certify the quality of consumer products ranging from seeds to medical devices. Moreover, in order to avoid civil legal liability for damages real or alleged, the practitioners of agricultural biotechnology already face strong incentives to adhere to sound practices. Direct government oversight may be appropriate for products with high-risk characteristics, but government need not insinuate itself into every aspect of R&D with recombinant DNA-modified organisms.

The stunted growth of agricultural biotechnology worldwide stands as one of the great societal tragedies of the past quarter century. The nation and the world must find more rational and efficient ways to guarantee the public's safety while encouraging new discoveries. Science shows the path, and society's leaders must take us there.

--
Henry I. Miller ( miller@hoover.stanford.edu) is a research fellow at Stanford University's Hoover Institution. Gregory Conko is the director of food safety policy at the Competitive Enterprise Institute. This article is derived from their book The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution (Praeger Publishers, 2004), selected by Barron's as one of the 25 Best Books of 2004.
*******

Genetically Modified Crops

- Forum, Issues In Science & Technology, April 1 2005

In their excellent "Agricultural Biotechnology: Overregulated and Underappreciated" (Issues, Winter 2005), Henry I. Miller and Gregory Conko lay out a compelling argument in support of ag biotech. I agree with their principal conclusions. However, I must set the record straight on one item in their piece that seems to have become an enduring myth about the early days of the science. They state that "some corporations . . . lobbied for excessive and discriminatory government regulation . . . they knew that the time and expense engendered by overregulation would also act as a barrier to market entry by smaller companies." Monsanto, DuPont, and Ciba-Geigy (now Syngenta) were listed in the article as the short-sighted companies that brought long-lasting restrictive regulations. In reality, only Monsanto argued for regulation; the other companies were not then significant players in the field.

I was CEO of Monsanto in 1983 when our scientists for the first time put a foreign gene into a plant, which started the commercial path to the science. My job for the dozen years before first commercialization was to ensure funding for this far-future science. Wall Street hated something that might pay out in the mid-1990s-if ever. Even within Monsanto, there were quarrels about R&D resources being siphoned away from more traditional research, especially toward research that might never succeed. Besides, even if it did, it would face the avalanche of opposition sure to come from "tinkering with Mother Nature." Consider: We were only a few years away from the Asilomar conference, which had debated that perhaps this "bioengineering" should be left stillborn. Rachel Carson had warned of science gone amok. Superfund had been enacted to clean up hazardous waste from science-based companies. A little later, an ambitious researcher in California had grown genetically modified strawberries on a lab rooftop, causing a furor by violating the rules at that time, which forbade outdoor testing. Pressure was mounting, as one opponent put it, "to test the science until it proved risk-free, since the scientists obviously couldn't self-police." "How long should we test?" I asked the opponent. "Oh, for about 20 years" was the response.

I had been invited to participate in a debate in support of ag biotech against Senator Al Gore at the National Academy of Sciences. I don't think we won against his TV camera. As we proceeded in the research, the new Biotechnology Industry Organization (comprised primarily of the small companies doing research) was lobbying for no regulation. Their champion was Vice President Dan Quayle, who headed the Competitiveness Council in the first Bush administration. I visited Quayle on several occasions and finally persuaded him that the public would not accept this new science without regulation and that we needed the confidence that the public had in the regulatory bodies. I argued that each agency should practice its traditional oversight in its field: the Food and Drug Administration, Environmental Protection Agency, and U.S. Department of Agriculture-without establishing a new agency just for biotech, a move that was gaining traction in the opposing communities. I argued that the real test should be the end product and its risk/benefit, not the method of getting there. Quayle is one of the unsung heroes of the ag biotech saga. He carried the day on the "no new regulatory body" argument. Be assured that at no time did I or my associates working on these policies give a moment's thought to shutting out smaller companies with a thicket of regulation. We wanted only "the right to operate with the public's acceptance."

The U.S. public now accepts the products of agricultural biotechnology in large part because they have confidence in the institutions that approved them. Regrettably, in Europe in the late 1990s another course was taken by those making decisions at the time: confrontation, not collaboration. The price is still being paid. The new leadership of Monsanto, with some 90 percent worldwide market share in these biotech crops, is making Herculean efforts to work within the culture, laws, and regulations of the European Union, much as we did in the United States in the 1980s and early 1990s. They will eventually succeed, because public confidence is a necessary ingredient of new technologies-something, to their credit, that this current management recognizes.

RICHARD J. MAHONEY

Chairman/CEO Monsanto Company (retired), Executive in Residence, The Weidenbaum Center on the Economy, Government, and Public Policy Washington University at St. Louis, St. Louis, Missouri

--------

Henry I. Miller and Gregory Conko are valiant champions of reason against the forces of unreason. As someone who has seen the growing influence of the anti-science lobby in Britain and Europe, I find it disturbing to discover similar attitudes reflected in regulatory policy in the United States. It seems that for the world to benefit from new transgenic staple crops that could reduce hunger and poverty, we will have to look mainly to China, and in due course India, rather than Europe or America. By the end of 2003, more than 141 varieties of transgenic crops, mainly rice, had been developed in China, 65 of which were already undergoing field trials. However, overregulation in Europe casts a shadow even in China, because rules on labeling and traceability present a formidable hurdle to the export of transgenic crops or even of any crops that contain the slightest so-called "contamination" by genetically modified products.

Why has this technology not been treated according to its merits? The influence of green activists goes further than opposition to transgenic crops. It can be traced to a form of environmentalism that is more like religion than science. It is part of a back-to-nature cult with manifestations that include the fashion for organic farming and alternative medicine. The misnamed "organic" movement (all farming is of course organic) is based on the elementary fallacy that natural chemicals are good and synthetic ones bad, when any number of natural chemicals are poisonous (arsenic, ricin, and aflatoxin for starters) and any number of synthetic ones are beneficial (such as antibacterial drugs like sulphonamides or isoniazid, which kill the tuberculosis bacillus). The movement is essentially based on myth and mysticism.

Similarly, homeopathy is growing in popularity and official recognition, although it is based on the nonsense that "like cures like" and that a substance diluted to a strength of 1 to the power of 30 or more (1 followed by more than 30 zeros) can still have any effect except as a placebo. Many of those who believe in alternative medicine also argue that remedies that have been used for centuries must be good, as if medical practice is some kind of antique furniture whose value increases with age. It is belief in magic rather than science.

However, antiscience views are most passionately aroused in the debate about genetic modification. Campaigners even tear up crops in field trials that are specifically designed to discover if those crops cause harm to biodiversity. Like the burning of witches, such crops are eliminated before anyone can find out if they actually cause harm. In many parts of Europe, the green movement has become a crusade. That makes it dangerous. Whether the rejection of the evidence-based approach takes the form of religious fundamentalism (Islamic, Jewish, or Christian) or eco-fundamentalism, the threat is not just to scientific progress but to a civilized and tolerant society.

LORD DICK TAVERNE, London, England, Office@taverne.me.uk
Lord Dick Taverne is a former member of Parliament and the founder of Sense About Science.
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The overregulation of agricultural biotechnology, so well described by Henry I. Miller and Gregory Conko, carries a particularly heavy price for farmers in developing countries. In South Africa, the only nation in Africa to have permitted the planting of any genetically modified (GM) crops so far, small cotton farmers have seen their incomes increase by $50 per hectare per season as a result, and one group of academics has projected that if cotton farmers in the rest of Africa were also permitted to plant GM cotton, their combined incomes might increase by roughly $600 million per year. If India had not delayed the approval of GM cotton by two years, farmers in that country might have gained an additional $40 million. India has not yet approved any GM food or feed crops. One biotech company recently gave up trying to get regulatory approval for a GM mustard variety in India, after spending nearly 10 years and between $3 million and $4 million, in regulatory limbo. Robert Evenson at Yale University has recently estimated the total loss of potential farm income due to delayed regulatory approval of GM crops throughout the developing world, up through 2003, at roughly $6 billion.

The case made by Miller and Conko for a less stifling regulatory environment may soon grow even stronger, particularly for the poorest developing countries. Several biotech companies have recently been able to transfer genes conferring significant drought tolerance into a number of agricultural crop plants, including soybeans, rice, and maize, with exciting results in early greenhouse and field trials. Something of exceptional value to the poor will be provided if these drought-tolerant genes can also be engineered into crops grown by farmers in semiarid Asia and Africa. The drought of 2001-2002 in southern Africa put 15 million people at risk of starvation. If overregulation keeps new innovations such as drought-tolerant crops out of the hands of poor African farmers in the years ahead, the costs might have to be measured in lives as well as dollars.

Miller and Conko might have added to their argument a list of the international agencies that have recently acknowledged an apparent absence of new risks to human health or the environment, at least from the various GM crop varieties that have been commercialized to date. Even in Europe, the epicenter of skepticism about genetic modification, the Research Directorate General of the European Union (EU) in 2001 released a summary of 81 separate scientific studies conducted over a 15-year period (all financed by the EU rather than private industry) finding no scientific evidence of added harm to humans or to the environment from any approved GM crops or foods. In December 2002, the French Academies of Sciences and Medicine drew a similar conclusion, as did the French Food Safety Agency. In May 2003, the Royal Society in London and the British Medical Association joined this consensus, followed by the Union of German Academies of Science and Humanities. Then in May 2004, the Food and Agriculture Organization (FFAO) of the United Nations issued a 106-page report summarizing the evidence-drawn largely from a 2003 report of the International Council for Science (ICSU)-that the environmental effects of the GM crops approved so far have been similar to those of conventional agricultural crops. As for food safety, the FAO concluded in 2004 that, "to date, no verifiable untoward toxic or nutritionally deleterious effects resulting from the consumption of foods derived from genetically modified foods have been discovered anywhere in the world."

ROBERT PAARLBERG
Professor of Political Science, Wellesley College, Wellesley, Massachusetts, rpaarlberg@wellesley.edu
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Henry I. Miller and Gregory Conko make a convincing case that a different paradigm for regulating agricultural biotechnology is desperately needed. Recombinant DNA technology allows plant breeders and biologists to identify and transfer single genes that encode specific traits, rather than relying on trial-and-error methods of conventional biotechnology. Thus, it is much more precise, better understood, and more predictable than conventional genetic modification.

Agricultural biotechnology should have been a boon for the green revolution, but gene-spliced crops still represent a small fraction of total world supply. Why has recombinant DNA technology not borne fruit? Unscientific fears, fanned by activists and short-sighted government policies, have led to a regulatory framework that singles out genetically modified crops for greater scrutiny and even prohibition. Guided by the "precautionary principle," whose purpose is "to impose early preventive measures to ward off even those risks for which we have little or no basis on which to predict the future probability of harm," European governments, in particular, have chosen to err on the side of caution when it comes to agricultural biotechnology.

The trouble with the precautionary principle is that it ignores the risks that would be reduced by a new technology and focuses only on the potential risks it might pose, creating an almost insurmountable bias against trying anything new. In the case of agricultural biotechnology, the implications can be heartbreaking. The authors describe how Harvest Plus, a charitable organization dedicated to providing nutrient-rich crops to hungry people, feels it must eschew gene spliced crops because of regulatory barriers and uncertainties.

To begin to realize the potential that agricultural biotechnology holds, we must change the incentives that guide policymakers in Washington, the European Union, and elsewhere. Regulatory gate-keepers face well-documented incentives to err in the direction of disapproving or delaying approval of new products. If a gatekeeper approves a product that later turns out to have adverse effects, she faces the risk of being dragged before Congress and pilloried by the press. On the other hand, since the potential benefits of a new product or technology are not widely known, the risks of disapproval (or delays in approval) are largely invisible, so the consequences of delay are less severe.

Policymakers regulating agricultural biotechnology face pressure from well-organized activists to constrain the new technology. Large biotech companies do not speak out aggressively against unscientific policies, either because they don't dare offend the regulators on whom their livelihood depends, or because regulations give them a competitive advantage. There is no constituency for sound science, and the general public, particularly in developing nations, who would gain so much from innovations in agricuFltural biotechnology, are unaware of their potential.

Miller and Conko encourage scientists, academics, the media, companies, and policymakers to help correct these biases by raising awareness of the potential benefits that molecular biotechnology promises, speaking out against irrational fears and unscientific arguments and championing sound scientific approaches to overseeing agricultural applications. We should heed Miller and Conko's prescription for rehabilitating agricultural biotechnology if it is to fulfill its promise.

SUSAN E. DUDLEY
Director, Regulatory Studies Program, Mercatus Center at George Mason University Fairfax, Virginia;
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Henry I. Miller and Gregory Conko's assertion that high regulatory approval costs have limited the number and variety of transgenic crops on the market to four commodity crops and essentially two traits is supported by data presented at a November 2004 workshop sponsored by the U.S. Department of Agriculture's (USDA's) ARS/CSREES/APHIS, the National Center for Food and Agricultural Policy (NCFAP), and Langston University. (Workshop proceedings will be available on the USDA-CSREES Web site in June 2005.)

For readers unfamiliar with the long-established system for developing new crop varieties, the public sector assumes responsibility for funding research on small-market (i.e., not profitable) crops. Plant breeders at land-grant universities and government research institutes use the funds to genetically improve crops, and then they donate the germplasm or license it to private firms for commercialization. At the November workshop, public-sector scientists and small private firms described scores of small-acreage transgenic crops that they had developed but could not release to farmers because of the $5 million to $10 million price tag for regulatory approval, not to mention additional millions to meet regulatory requirements for post-commercialization monitoring of transgenic crops. (Based on recommendations from the November workshop, the USDA agencies are now developing methodologies to help public-sector researchers move transgenic crops through the regulatory approval
process.)

Miller and Conko also attribute ag biotech's disappointing performance to "resistance from the public and activists," perhaps because the authors accept the media's extrapolation from activist resistance to public resistance. During the 15 years that I have made presentations on ag biotech to diverse audiences that truly represent the general public, I have encountered little resistance (even in Europe!). Instead, I continually find open-minded people, eager for factual information, full of common sense, and perfectly capable of assimilating facts and making informed decisions. In addition, objective measures of public Fsentiment such as product sales, surveys, and ballot initiatives consistently reveal a public that is not resistant to transgenic crops.

The activist community's contribution to the paltry number and variety of transgenic crops on the market is indisputable, however. Their remarkable success stems not only from effectively lobbying for a regulatory process that is so costly only large companies developing commodity crops can afford it, but also from causing the premature demise of transgenic crops that had made it through the approval process. Because food companies are fearful of activist demonstrations that are so imaginative and visuallyF compelling that the media cannot resist making them front-page news, some companies have told their suppliers that they will not buy approved transgenic crops, such as herbicide-tolerant sugar beets and pest-resistant potatoes. According to NCFAP, if U.S. farmers had grown these two transgenic crops, they would have increased total yields while decreasing pesticide and herbicide applications by 2.4 million pounds per year.

I find this paradox fascinating: Through their words and deeds, activists have created their own worst nightmare. In the words that a biologist would use, they have established an environment that selects for large corporations with deep pockets and large-scale farmers who grow huge acreages of a few commodity crops, and selects against small companies, small farms that promote sustainability through small acreages of diverse crops, and crops that maintain yields with fewer chemical inputs.

ADRIANNE MASSEY, A. Massey and Associates, Chapel Hill, North Carolina; a.massey@earthlink.net

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