U.S. Differences With Europe on Plant Biotechnology

I am from Iowa. I have seen first-hand in my home state biotechnology's positive economic and environmental effects. These benefits are being seen around the world, with more and more countries, especially developing countries, appreciating the great potential of this vital and safe technology. EU policies, derived from political decisions made with insufficient concern for science-based risk analysis and management, are imposing serious costs and must be changed. They have directly impeded the broader adoption of this new technology and put the integrity of the rules-based system for international trade in agricultural and food products at risk. Even more distressing, in the past few months we have seen extremely unfortunate indirect and unforeseen consequences of EU policies. I am speaking about a number of southern African countries with millions of citizens at risk of starvation, who have mistakenly questioned the safety of food aid shipments and delayed its distribution.

I have discussed the practical use of biotechnology with farmers from Iowa to South Africa. This technology is farmer-friendly. It helps raise productivity and income, reduces sickness caused by over-exposure to chemicals, makes crops easier to tend and provides enhanced nutritional benefits. For poor farmers especially, the ability to concentrate the technological benefits in seeds holds great promise in reducing dependence on expensive inputs such as fertilizer, herbicides and pesticides.

Review of the Evidence

As you know, biotech crops are plants in which DNA has been engineered using modern molecular biology. The most common commercially available biotech crops are Bt-cotton (insect-resistant), Bt-corn (insect-resistant), and herbicide tolerant soybeans, corn, and canola (tolerant to a particular herbicide).

Corn and soybeans are two of the most prevalent crops in the U.S. food supply and are found in a large percentage of processed food items. Americans have been consuming these products since 1996 and there have been no reported negative effects.

Commercially produced bio-engineered plant varieties in the United States that may be used for U.S. domestic consumption or for food export, including food aid, have completed the necessary rigorous reviews under the U.S. regulatory process.

Americans have been safely consuming biotech foods for many years now. Several countries have approved the biotech varieties I mentioned previously. Food crops derived from biotechnology have been approved for human consumption by governments all over the world, including Argentina, Australia, Canada, Japan, South Africa, South Korea, and China. Even the EU permits the import of five types of biotech corn for human consumption.

In the fall of 2001, the European Commission released a study reviewing 80 studies of biotech products. With respect to food products, the Commission found that "classical", i.e. conventional food safety risks, are of "comparable, if not larger, magnitude to those of modern biotechnology". In January this year, the Commission released an important report called "Life Sciences and Biotechnology - A Strategy for Europe". In the agro-food area, for instance, the report notes biotechnology's potential to deliver better quality and environmental benefits. The Commission notes that the "longer Europe hesitates" to develop biotechnology, the greater the likelihood it will have to accept a "passive role".

For a good review of the science, I would also recommend Ronald Bailey's article, which I believe sparked the idea for this conference.

Several renowned non-American authorities have spoken on the benefits of biotechnology. I am thinking in particular of Professor Huang of the Chinese Academy of Sciences, who made a compelling presentation on the benefits of biotech for Chinese cotton farmers at the World Food Summit. The head of the British Food Standards Agency, Sir John Krebs, who chaired the 2001 OECD Edinburgh conference, has also made a great contribution to educating the public on biotech's positives.

The recent World Food Summit in Rome calls for the FAO, in conjunction with the Consultative Group on International Agricultural Research (CGIAR), and other international research institutes, to advance research into new technologies, including biotechnology. The EU signed on to this commitment. I would hope it takes this undertaking seriously and that the EU bases its decisions on serious scientific research.

Biotechnology's positive environmental effects are by now quite well known. Biotech crops allow farmers to grow more food on less land and help preserve natural environments such as wetlands and rain forests. The need for chemical fertilizer, herbicides and pesticides is dramatically reduced, bringing improvements in the quality of soil and water and reducing potentially dangerous chemical exposure for farmers and their families.

Biotechnology's most important and positive impact could be in the developing world. We must increase agricultural productivity around the world if we are to feed the world’s people.

The United States Government has an agricultural productivity initiative that seeks to contribute to the goal of reducing by half the number of people living in absolute poverty by 2015, and reducing by half the number of severely undernourished people by 2015.

The agricultural productivity initiative has many components. Biotechnology is clearly going to be one key component, especially if the goal of achieving 4-6% growth rates in agricultural production, especially in sub-Saharan Africa, over the next 12 years, is to be achieved. The U.S. has already spent $55 million over the last two fiscal years in biotech initiatives in the developing world. Over the next seven years, USAID will be managing a $105 million Collaborative Agriculture Biotechnology (CABio) program.

CABio and other initiatives have the potential of improving human lives dramatically. Especially in sub-Saharan Africa, research into developing, for instance, a drought-resistant sweet potato, will be critical to sustaining an ever-increasing population. Similarly, a high-protein variety of maize, currently under development, holds the potential for improving the health of people who depend on maize as a staple, in much of sub-Saharan Africa.

New products will offer many advantages, but developing country farmers are also taking advantage of existing biotechnology products. Let me offer just a few other examples of how developing countries are using this new technology.

India recently announced its decision to approve the application of Monsanto and its Indian partner Mahyco for commercialization of biotechnology cotton. This decision came after an exhaustive scientific evaluation and mounting pressure from cotton farmers for access to this technology.

China is developing the largest plant biotechnology capacity outside North America, with poor farmers there cultivating more area of biotech plants than small farmers in any other developing country. Diminished pesticide use in China is having positive health benefits. The Chinese experience is actually quite dramatic with Chinese officials saying that reduced pesticide use is saving thousands of farmers' lives - we are talking about very farmer-friendly new technology benefiting some of the most vulnerable people on the planet.

President Obsanjo of Nigeria recently announced a three-year $19.4 million program for the development of biotechnology. The country's National Biotechnology Development Agency (NABDA) is charged with the objective of making Nigeria a biotechnology leader. There are important ag biotech breakthroughs being made in the Philippines and countries such as Argentina, Brazil, South Africa, and Kenya are making important strides in this area.

Most of the world outside Europe has essentially made a choice in favor of plant biotechnology, recognizing its benefits and adopting for the most part appropriate science-based analysis and management policies.

Nevertheless, the EU’s anti-biotech policies, perhaps aided and abetted by misinformation from a few NGOs, have sown doubt among the governments of some of the most vulnerable people in the world. EU officials have expressed concern about the safety of products that people in this room consume every day. The EU issued two press statements clarifying the situation, and I welcome this. But the fact is that the history of EU biotech policy has contributed unfairly to stigmatizing biotech products to the extent that perfectly safe food aid shipments have been rejected. It is time for the EU to fix its policies.

The United States has profound problems with EU biotechnology policy. The policy is responsible for not only creating a completely unnecessary U.S.-EU trade issue, but far more significantly, the European position threatens the integrity of the world trading system and undermines development and food security of the poorest countries.

I welcome the comments of EU Commissioner for Health and Consumer Safety Byrne, who has emphasized that biotech products are as safe as their conventional counterparts and that Europe's approach to plant biotech must change, specifically that the moratorium on reviews and approvals must end.

The problem stems from the EU decision four years ago to stop considering applications for approval of biotechnology products. Three years ago, the EU formalized this policy through a de facto moratorium on EU approvals for biotech engineered plant products. This moratorium even applies to biotech varieties that have received a positive risk assessment from EU member state scientific committees.

The EU has a right, of course, to protect its citizens and environment. The Union has the right to apply appropriate science-based standards. The Food and Drug Administration's successful record in protecting food safety, and the Environmental Protection Agency's equally successful record in protecting the environment, demonstrate that regulators can fulfill their health and environmental mandates, while at the same time living within trade rules and permitting of the development of new technologies offering much to humanity.

The key here is that regulatory decisions affecting trade must have a science or health-based justification. In other words, the EU has to allow for rigorous scientific risk assessment and risk management. This approach is necessary both to maintain credibility and the confidence of the public, as well as to meet the requirements of the trading system.

The Uruguay Round agreements provide some basic rules which all World Trade Organization members are obligated to follow. This, after all, is what brings predictability to the international trading system.

In this context, the key Uruguay Round agreement to refer to is the Sanitary and Phytosanitary (SPS) Agreement. This agreement mandates science-based decision-making for food safety.

The SPS agreement's Article 5.7 allows Members to adopt provisionally measures such as bans even when scientific evidence is "insufficient". However, if a Member resorts to such a measure, it is then obliged to obtain additional information required for a more objective assessment of risk and then review the measure within a reasonable period of time. In the four years since the moratorium, international research and the EU’s own studies have all demonstrated that there is no scientific rationale for the EU’s ban.

European Commission officials recognize that that there is no foundation in EU law for refusing to even consider biotechnology product applications. The moratorium is plainly not consistent with either EU or international trade law.

But this is more than just a U.S.-EU trade dispute. The EU's position on biotech is a threat to the global rules-based trading system.

Last year, the EU Commission submitted proposals on tracing & labeling for food and animal feed. The U.S. Government provided critical comments on those proposals and cautioned Europe on the potential negative consequences for world trade and the development of this promising technology.

In July this year, the European Parliament passed amendments to the Commission proposals. These amendments were even worse than the original proposals. Most recently, Commissioner Byrne said on September 10 in Denmark: "This is not a public health issue, this is a consumer choice issue". Unfortunately, taken together, Commission and Parliamentary proposals are onerous, discriminatory, and do not enhance consumer choice. Let me explain why.

With respect to regulations, the Parliament has removed from the Traceability and Labeling regulations the option of using a label which would state that a product "may contain genetically engineered product". If this stands, global commodity trade, including $4 billion in U.S. soybean and meal exports, could be threatened because a whole new infrastructure would have to be created to list unique identifiers without any scientific basis for such an action.

Parliament lowered the Commission's proposed maximum Adventitious Presence (AP) threshold for biotech labeling from 1% to 0.5% of approved biotech material. The Commission's proposal would already add substantial costs and set an extremely difficult compliance standard, without any scientific or public health justification. Moreover, the practical effect would be to make market access to Europe more difficult, i.e. it would discriminate against non-European suppliers, including many poor nations.

Both the Commission and Parliament propose labeling for highly processed products such as oils, even when there is no biotech protein or DNA in the final product. This proposal is intellectually indefensible, an invitation to fraud, and disruptive to trade. Moreover, it would add nothing to consumer choice because the practical challenges of regulating this requirement would be virtually insurmountable.

More generally on the issue of consumer choice, I recognize that some consumers may decide to avoid biotech products, despite their demonstrated safety. Certainly, if there is significant demand for non-biotech products, industry will want to serve it. In fact, the most straightforward way to provide consumer choice would be to establish a government supervised program for labeling products as biotech-free, just as we in the U.S. have developed a system for the marketing of organically-grown products. We should encourage industry to develop truthful and non-misleading voluntary labels. I believe regulators should facilitate the creation of labeling regimes that do not intentionally or inadvertently stigmatize biotech products. The fact that the EU continues to reject this approach makes clear that consumer choice is not really the motivation for EU policy.

European opposition to agricultural biotechnology is rooted in problems of their own food safety system and lack of consumer confidence in the ability of government regulators to deal with real food and health safety issues like "mad cow" disease (BSE). They have nothing to do with biotechnology or any health or environmental risks associated with biotechnology.

Europe is willing to consume biotech-engineered medicines and to consume wine and cheese produced with biotech enzymes. However, when it comes to food products imported from the United States or other countries, obstacles are raised. This is neither rational nor principled.

European policymakers should not see themselves as prisoners of public opinion. European officials, elected and non-elected, have influenced public opinion negatively through words and deeds and through their silence. To maintain public trust and confidence, European officials must speak and act responsibly, basing decisions on scientific risk analysis and management.

There is a fairly simple way out. Permit the market to function. Allow science to determine food safety regulatory decisions. Consider voluntary biotech-free labeling systems. Make it possible for those consumers who so desire to purchase non-biotech, but let them pay the higher price for these products.

The EU moratorium on biotech approvals is a threat to the global trading system and the stability of the international food supply system. It is a problem that Europe has created. Now is the time for European leaders to face up to their responsibility to resolve this problem. This is a question of leadership. It is heartening that the EU is now addressing directly the safety of our food aid shipments to southern Africa. But it is well past time for governments and consumers in Europe to address the same issues domestically. The EU should end its moratorium on agricultural biotechnology. It should not institute problematic new regulations. And lastly, it should work with the United States and other nations to help developing countries adopt these new technologies.