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Rethinking the Regulation of Bioengineered Crops
Rethinking the Regulation of Bioengineered Crops
Why European and American Biotechnology Rules are Bad for Less Developed Countries
May 23, 2003
Full Document Available in PDF
U.S. State Department conference,
Agricultural Biotechnology and Developing Countries, May 21, 2003
Advances in plant molecular biology and recombinant DNA techniques hold real promise for advancing the food security interests of poor farmers and consumers in less developed nations. To date, however, a variety of factors have limited the ability of those farmers to take part in the biotechnology revolution. In part, these limitations stem from the unaffordability of patented gene sequences and technologically sophisticated laboratory equipment. A far bigger problem, though, is overly restrictive public policies in both industrialized and less developed countries, which needlessly raise the cost of research and development and make it difficult or impossible to introduce bioengineered varieties.
By now, many readers will be familiar with the story of Zambian president Levy Mwanawasa who, last autumn, rejected some 23,000 tons of U.S. food aid in the midst of a two-year-long drought that threatened the lives of over two million Zambians. Mwanawasa’s public explanation was that the bioengineered corn from the United States was “poison.” But other Zambian government officials conceded that the bigger concern was for future food exports to the European market. If even a little of the corn were diverted to seed stock, it could potentially threaten the exportability of the entire Zambian corn crop and much corn-fed livestock for many years to come (Neuffer 2002).
What readers may not know, however, is that Zambia is not unique. European biotechnology restrictions have had other, similar, consequences throughout the developing world. Thai government officials have been warned by European food importers not to authorize any bioengineered rice varieties in that country, and the Indian government recently halted its research program on bioengineered basmati rice before the first field trials could be conducted (Economic Times 2003). Uganda stopped funding research on bioengineered bananas and postponed their introduction indefinitely (Thurow, Mitchener, and Kilman 2002). Even China, which has spent the equivalent of hundreds of millions of dollars funding advanced biotechnology research, has refused to authorize any new bioengineered food crops since the moratorium began (Paarlberg 2001).
Clearly, European public attitudes and government policies have played an integral role in keeping new bioengineered crop plants out of the hands of farmers in less developed nations. This was a key talking point for US policy makers in the wake of the United States governments’ recent decision to file a complaint with the World Trade Organization against the de facto EU moratorium on new bioengineered crop varieties (USTR 2003). But problematic restrictions extend far beyond the EU moratorium. They include overly precautionary regulation and labeling requirements in Europe and other industrialized countries, the intentional export of EU-style regulatory policies to other countries, and a public opinion war that has extended to some of the poorest nations on Earth.
International Barriers to Biotechnology Adoption
The European Union’s moratorium on new variety approvals is the most overt barrier against adoption of bioengineered crops in countries across the globe—both industrialized and less developed. The EU, for example, has approved just two bioengineered crop varieties for human consumption (one each of corn and soybean) and has not approved any others since 1998, even though many have successfully completed internal scientific reviews. In practice, this means that countries such as the United States, Argentina, and South Africa have been willing to commercialize only the same variety of soybean, so that soybean growers in those countries can continue exporting to the European market. But, because the United States has approved more than a dozen different corn transformation events for commercialization, practically no U.S. corn at all may be shipped to western Europe. The moratorium has made those and other countries understandably nervous about approving new bioengineered crop varieties that have not already been approved by the EU.
Consequently, bioengineered varieties of some of the most important export crops—including rice, wheat, coffee, fresh fruits and vegetables—cannot be introduced without automatically forfeiting European markets, a price many Asian and African countries cannot afford to pay. For example, even though several insect-resistant, pathogen-resistant, and herbicide-tolerant rice varieties have been developed by Asian, North American, and European scientists using rDNA methods, not a single one of them has yet been commercialized.
Complicating matters further is the fact that most bioengineered food products that do make it to market have to be labeled in the European Union and certain other industrialized countries, including Japan and South Korea. This makes bioengineered foods, and companies who sell them, easy targets for anti-biotechnology campaigners. Curiously, the biggest problem with labeling has neither been one of added cost (which is not insignificant) nor one of consumer rejection per se. Despite a seemingly widespread concern about so-called “genetically modified” foods throughout western Europe, some affirmatively-labeled bioengineered products can still be found on supermarket shelves. And where both bioengineered and non-bioengineered products are sold, there does not appear to be any price premium for non-bioengineered foods. Indeed, most consumers must actually have the “GM” label pointed out to them before they reject those products (Noussair, Robin, and Ruffieux 2002). Thus, while the deep resentment of, or ambivalence toward, bioengineered food that shows up in consumer surveys may in fact be real, it appears to be an attitude not so deeply held that it actually impacts purchasing decisions.
A much bigger problem in the European market, then, is not that consumers have rejected labeled bioengineered foods, but that major producers and retailers have. With Greenpeace and Friends of the Earth campaigners so eager to protest against supermarket chains and food processing companies who use bioengineered ingredients, it is understandable that few firms are willing to put their hard-earned brand reputations at risk. And the bigger the companies, the less willing they seem to use biotechnology in a way that subjects their products to the labelling mandate (Kalaizandonakes and Bijman 2003).
For example, labelled cans of processed paste from the Zeneca company’s bioengineered tomato variety sold well in British grocery stores until retailers were hounded by anti-technology activists to disavow biotech foods (Gaskell et al. 2000). The product, which was sold under various retail “store-brand” labels, contained about one-eighth more tomato paste than competing brands at the same price and reputedly held a 60 percent market share up until the day it was taken off store shelves. Even in the United States, the few food companies that have voluntarily removed bioengineered ingredients from their products under Non-Governmental Organization (NGO) pressure are market segment leaders—including Gerber baby foods with a 70 percent market share and Frito Lay with a 60 percent market share (Kalaizandonakes and Bijman 2003). Thus, convincing major food companies to adopt bioengineered ingredients, and convincing government regulators to permit them, will likely prove to be the two most important keys to opening the European market.
Then, of course, we must deal with the problem of NGO scare campaigns. Not satisfied to scare wealthy and well-fed Europeans and North Americans away from eating bioengineered foods, NGOs such as Greenpeace, Friends of the Earth, and the European-dominated and funded Third World Network have set out to scare consumers and farmers in less developed countries as well. In Zambia, for example, anonymous NGO officials have accused the United States of using Africans as guinea pigs to prove that bioengineered foods are safe to eat. Rumors were circulated among the locals that women would become sterile and people would get AIDS, if they ate the corn donated as food aid (Thurow, Mitchener, and Kilman 2002).
Of course, it is easy to vilify food that comes from major multinational corporations headquartered in the United States and Europe—“Mon-Satan” makes an attractive whipping boy. But even many public sector developments are similarly ridiculed by NGOs that try to scare poor farmers about their provenance. Thus, even Golden Rice, developed by public sector scientists in Europe, with primary funding from the New York-based Rockefeller Foundation, has been ridiculed as a “Great Yellow Hype”—another ploy by multinational biotechnology corporations to get the world hooked on bioengineering (Pollan 2001).
It’s instructive to note that Golden Rice has been condemned both for having too much beta-carotene and for having too little. And those attacks by American and European NGOs have influenced public policy in less developed countries. Golden Rice is now trapped in a politically motivated regulatory maze. Co-inventor Peter Beyer laments how governments are requiring battery upon battery of tests for nutritional equivalence, bioavailability, digestibility, and toxicity—as if beta carotene were something entirely new to the food chain (Beyer 2002). More recently, the International Rice Research Institute in the Philippines, which has been assigned the task of field-testing Golden Rice, has indefinitely postponed its plans for environmental release in the Philippines, fearing backlash from NGO protestors (Paarlberg 2003).
Accusations that industrialized country consumers are not actually eating bioengineered crops grown there, but rather exporting them to less developed countries for experimentation are pervasive. The result is widespread unease manifested among consumers and “opinion elites” alike. And, in the absence of any organized pro-technology response, the natural reaction by governments is to erect stifling over-regulation at home (Alvarez-Morales 2003). These regulations make it prohibitively expensive for public sector and charitable institution scientists to test new bioengineered crops outside laboratory or greenhouse environments, and make it all but impossible to commercialize them.
Domestic Barriers to Entry
As is done routinely in agricultural research and development, possible risks to the environment should be considered when any new plant variety is introduced into a farming system—whether or not it was developed with recombinant DNA techniques. But, without any scientific justification, bioengineered plants have been subjected to extraordinary scrutiny, which in the vast majority of cases is unwarranted—especially in view of the virtual absence of government oversight of varieties developed with less precise and less predictable technology. A general consensus of the scientific community holds that the techniques of bioengineering do not themselves introduce any novel risk. Instead, the risk of any modified organism depends upon the characteristics of the host organism, the genes that are transferred, and the use to which it is put—and this is the case for both bioengineered and conventionally modified organisms (NRC 1989).
To put the risks into perspective, it is important to note that entirely new genes and gene products that have never before been part of the food supply are routinely introduced into food crops from distantly related wild relatives with conventional breeding techniques. And rDNA techniques are at times used to transfer genes between very closely related species, or from one variety to another of the same species. The former example of conventional breeding can confidently be said to be effused with greater uncertainty and to pose greater risk than the latter example of bioengineering. Yet there are no countries where the former is subject to greater regulation, because plant breeders have done a generally good job (though not perfect) over the years keeping potentially harmful new varieties off the market.
Bioengineered plants, on the other hand, are subject to repeated and technically challenging safety assessments over lengthy time periods, which no conventionally bred variety could pass.
In most industrialized nations, well-established biosafety policies governing the movement or release of new plants into the environment were in place long before the advent of recombinant DNA technology. In many less developed nations, however, the formal screening of new crop plants for biosafety had not been well established prior to the appearance of bioengineered crops. Screening had traditionally been viewed as a costly and technically demanding task that was far less important than boosting farm yields or addressing public health problems (Paarlberg 2001). Nevertheless, a combination of stimuli from industrialized country governments and NGOs is now spurring less developed countries to establish complex biosafety systems based on the American and European models, but only for bioengineered varieties. One very real cost of such a precautionary step is the forgone improvements of plants with higher yields, greater nutritive elements, and other benefits.
In an atmosphere when public financing of agricultural research has remained stagnant or is falling in real terms, it is tragic then that international support is more often available to train local scientists how to regulate or to build regulatory structures than to fund ongoing research into improving crops with advanced methods. For example, the United Nations Environment Program (UNEP) established a $38 million initiative last year to help less developed countries set up infrastructure for the testing and commercialization of products made with recombinant DNA technology (UNEP 2002). The three-year project will center on “building capacity for assessing risks, establishing adequate information systems and developing expert human resources in the field of biosafety.” Other, similar programs are aimed at achieving the same goal.
European government grants to the Consultative Group on International Agricultural Research, a network of World Bank-sponsored research institutes established in the 1970s to help poor farmers in the tropics breed better crops, often stipulate that the money cannot be used to fund research using rDNA techniques. And even most U.S. biotechnology grants, administered by the U.S. Agency for International Development or the U.S. Department of Agriculture, go toward so-called regulatory “capacity building,” rather than applied research. This is “like offering swimming lessons to people in the Sahara,” according to Calestous Juma, a former executive secretary of the U.N.’s Convention on Biological Diversity, now director of the Science, Technology and Innovation Program at Harvard University (Adam 2002).
Although corporate-funded researchers in industrialized countries often have little difficulty affording the expense of complying with overly precautionary regulations, few public sector researchers—especially those in poor countries—have the financial resources to devote to sometimes duplicative and often unnecessary laboratory or field assessments. Furthermore, subjecting even very safe bioengineered varieties to the vagaries of political bureaucracies means necessarily subjecting them to political decisions.
One good example is a rice variety developed by breeders at the International Rice Research Institute in the Philippines who transferred a gene known as Xa21 that confers resistance to a common bacterial blight. The Xa21 gene is found in wild rice populations, but repeated attempts to breed the gene into elite cultivars without eroding other important traits proved unsuccessful. Until recently, it was only possible to move Xa21 into elite cultivars with bioengineering techniques (Tu et al. 1998). Yet, even though this breakthrough product would have received no government oversight and no special attention from anti-biotechnology campaigners if it had been produced with conventional methods, NGO protesters held up field trial approvals for many years, arguing that it posed a biosafety threat to Filipino rice growers because there were blight strains against which Xa21 was not effective (Bengwayan 2000).
This serves to illustrate one important problem with industrialized country biosafety systems: They apply an equally heavy regulatory burden on all bioengineered plants, regardless of the relative safety or danger of individual varieties. This needlessly focuses regulatory attention away from more pressing health and environmental risks, and often acts to keep potentially beneficial products out of the hands of those who need them. Wealthy countries may be able to afford the significant opportunity costs that necessarily result from targeting even the most unlikely risks. But such rules add extraordinarily little, or nothing at all, to environmental and human health protection in industrialized countries, and they do far more harm than good in less developed ones. They are a luxury few least developed countries (LDCs) can afford, and which none should adopt.
In addition, forcing such policies on LDCs sets unrealistic and inappropriate standards for testing and data evaluation that poor countries often do not have the capacity to meet, even when the product applications are otherwise complete and unassailable. Complicating matters further, biosafety regulators in those countries have every incentive to move slowly because they know that observers believe they lack the technical capacity to implement their regulations, and they know NGOs and the media will challenge them at every turn if they release any bioengineered crops for commercial use. Repeating the regulator’s all too common claim, Achyut Gokhale, former chairman of India’s Genetic Engineering Advisory Committee, told a Newsweek International reporter: “We took a lot of flak over GM cotton…It was my job to ensure we weren’t accused of over-hastiness” (Guterl 2003). Thus, we have regulators making decisions not on the merits of products, but on the basis of political calculations that include their own perceptions of public attitudes about the likelihood of regulators making mistakes.
This is a surprisingly high degree of risk-aversion, given that most LDCs have never been greatly concerned about the biosafety risks of farming—with good reason: In such countries, insecticide spraying, the mismanagement of irrigation, encroachment into forests, and the destruction of wildlife habitat are all common features of agriculture. The greatest biosafety and environmental hazards in rural areas of the developing world have in the past come not from crop plants at all, but from intentional destruction of wildlife habitat for agricultural expansion or other development, and from non-domesticated “exotic” plant and animal species from distant regions introduced intentionally or accidentally into new ecosystems.
Crop plants (bioengineered or otherwise) are seldom invasive, because crops bred for human use are generally poorly competitive outside of their protected and high-maintenance farming environments (National Research Council 1989). By contrast, non-coevolved, or exotic, species can do devastating damage if introduced into new environments in circumstances in which the natural competitors or predators that usually control them are absent. According to some estimates, the introduction of such exotic species (which have nothing at all to do with biotechnology) in the developing world currently generate losses to agriculture of tens of billions of dollars annually (Bright 1999).
Conclusion: Moving Forward
What can be done to turn the tide of stifling regulation, so that LDCs can begin to introduce safe and beneficial bioengineered crops? First must be a concerted effort by non-corporate scientists to counter the NGO scare campaigns. NGOs have had such successes because their primary opponents, multinational corporations, are easy to vilify. Only if academic and public sector scientists become willing to meet with community leaders, newspaper reporters and editors, and other “opinion elites,” and discuss the technology with them openly and honestly can we ever expect the public’s concerns to be assuaged. Opinion elites should be targeted because they act as a filter through which news and other information distil to the general public. It is they who establish the boundaries within which members of the public feel comfortable expressing their own views. Elites are therefore the gateway to public opinion. Ultimately, though, the most important thing is for the audience to have its concerns addressed in a dialogue, not a one-way lecture.
Next, both industrialized countries and less developed countries must rethink their regulatory systems—or at least rethink the kind of regulatory systems they help impose on researchers and farmers in poor regions. Although wealthy industrialized countries can afford the foolishness of treating all bioengineered crops as though they pose an inherent risk, poor countries cannot and should not. The United States and other grantor nations should immediately encourage LDC governments to create an expedited regulatory process for crops that are bioengineered using nucleic acid sequences from donor plants related closely enough for normal sexual reproduction. Oregon State University professor Steven Strauss (2003) suggests a model for streamlining exploratory field trial regulation for such plants, with somewhat greater scrutiny during pre-commercialization field trials. Ideally, such streamlining should occur throughout the regulatory process, however, and these very low-risk crops should be exempt from all but the most cursory regulatory reviews.
Governments should then reconsider how they regulate all introductions of new bioengineered, conventionally modified, and unmodified crop plants. In most cases, it will be possible to characterize the likely risk that individual organisms will pose based on prior knowledge of the host crop and transferred genetic material. These should then be stratified according to the level of risk they pose, with lower regulatory hurdles for lower-tier plants. A suggested model has been proposed by the Stanford University Project on Regulation of Agricultural Introductions (Barton, Crandon, Kennedy, and Miller 1997). This may mean shifting greater regulatory attention and enforcement resources to unmodified exotics, but it should also mean somewhat lower regulatory hurdles for most low-risk bioengineered plants. As the world’s largest producer and grower of bioengineered crops, the United States should make a point of adopting such a system and championing it in international venues including the Codex Alimentarius Commission. It must reject the current one-size-fits all regulatory structure.
Finally, efforts to require labeling of all bioengineered food items regardless of risk should be avoided wherever possible. These serve no legitimate function, but only act to alert NGOs to easy targets for their anti-science, anti-choice campaigns.
Naturally, such suggestions are easier said than done. Even in the United States, there is much resistance to rationalizing the regulatory process for new plant variety introductions. And, because the coalition-building required of multi-party parliamentary governments in western Europe tends to give Green parties, radical activists, and single-issue voters tremendous influence over regulatory policies, making progress there will be extremely difficult. Nevertheless, probably the best way to end the general antipathy to bioengineered organisms is to have them on the market and to have consumers exposed to good experiences with them. Accomplishing that will be key, so fighting in favor of progress, development, and principle will be worth the effort.
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