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Appendix F.4

Assessment of Developments in Agrobiotechnology in the United States and Russia

[Summarized Version]
Dr. Peter Raven and Dr. Konstantin Skryabin1 September 2011

INTRODUCTION

Genetically engineered (GE) crops were first commercialized in 1994 in the United States. In 2010, 148 million hectares in 29 countries, or 10 percent of the world’s agricultural land, were planted with GE crops (1). They have not yet been commercialized on more than a pilot scale in Russia.

Current GE technology has the capability to protect crop yields, improve water and soil quality, and improve feed grain safety (2). Future innovations in this field may increase efficiency in the use of water, sunlight, and fertilizer; increase tolerance to drought, frost, and salinity; improve photosynthesis; and make the crop’s use of nitrogen more efficient. GE traits can directly improve the nutritional qualities of the foods produced as well: high vitamin or protein levels, fruits with delayed ripening, and oilseeds with lower saturated fat. GE crops can also be designed to produce pharmaceutical compounds for human and animal health.

 

1 This assessment was prepared in accordance with a joint decision of the Russian Academy of Sciences and the National Academy of Sciences in June 2009 to have experts prepare an analysis of the safety aspects of the introduction of genetically engineered organisms into agricultural systems. The authors express their appreciation to the staff of the National Academy of Sciences and to the members and staff of the Russian Academy of Sciences who supported this activity.



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Appendix F.4 Assessment of Developments in Agrobiotechnology in the United States and Russia [Summarized Version] Dr. Peter Raven and Dr. Konstantin Skryabin1 September 2011 INTRODUCTION Genetically engineered (GE) crops were first commercialized in 1994 in the United States. In 2010, 148 million hectares in 29 countries, or 10 percent of the world’s agricultural land, were planted with GE crops (1). They have not yet been commercialized on more than a pilot scale in Russia. Current GE technology has the capability to protect crop yields, improve water and soil quality, and improve feed grain safety (2). Future innovations in this field may increase efficiency in the use of water, sunlight, and fertilizer; increase tolerance to drought, frost, and salinity; improve photosynthesis; and make the crop’s use of nitrogen more efficient. GE traits can directly improve the nutritional qualities of the foods produced as well: high vitamin or protein levels, fruits with delayed ripening, and oilseeds with lower saturated fat. GE crops can also be designed to produce pharmaceutical compounds for human and animal health. 1  This assessment was prepared in accordance with a joint decision of the Russian Academy of Sciences and the National Academy of Sciences in June 2009 to have experts prepare an analysis of the safety aspects of the introduction of genetically engineered organisms into agricultural systems. The authors express their appreciation to the staff of the National Academy of Sciences and to the members and staff of the Russian Academy of Sciences who supported this activity. 233

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234 APPENDIX F.4 INTERNATIONAL PRINCIPLES GUIDING THE REGULATION OF GE ORGANISMS In 2003, the Codex Alimentarius Commission, a joint body of the Food and Agriculture Organization and World Health Organization, issued Principles for the Risk Analysis of Food Derived from Modern Biotechnology (3). Building on the concept of substantial equivalence, the Principles instruct regulators to assess GE food products for toxicity, allergenicity, stability of the inserted gene, and nutritional or other unintended effects resulting from gene insertion. The regulatory system in the United States follows these principles. However, parties to the Organization for Economic Cooperation and Development have expressed different degrees of comfort with the concept of substantial equivalence (4). Gov- ernments agree to the need for appropriate risk assessment, but nations disagree as to the level of risk that should be accepted in applications of this technology. In the world’s experience of 15 years of commercial use of GE crops, analysis of the results of specialized studies, national data (5), and international scientific assessments, there has not been a single proven case of toxic or adverse effects of GE crops that have been registered as food or feed. In addition, there are no scientifically credible reports indicating adverse ecological effects of com- mercialized biotech crops. AGRICULTURAL BIOTECHNOLOGY IN RUSSIA The development of a national regulatory system for GE in Russia began in 1995–1996. The law FZ-86 (amended in 2000 and 2010) has been the main legal tool for the protection of the environment and human health and for governing relations arising within the conduct of GE activity. More than 60 laws, regula- tions, and other regulatory documents supplement the legislation for safe use and environmental release of GE crops (6). Unfortunately, they are sometimes not coordinated with one another. A distinctive feature of the Russian registra- tion system is its three separate streams: (1) safety assessment for environmental release from GE crops, (2) safety assessment of GE food, and (3) safety assess- ment of GE feed. During 1999–2011, 20 GE lines developed by Russian scientists passed the full cycle of medical and biological studies. Currently, 17 GE lines are approved for use in food (four soybean lines, nine maize lines, two potato varieties, one rice line, and one sugar beet line). The technical capability is certainly present in Russia to allow the develop- ment of agriculturally important products. For example, in 2010, the Russian Academy of Sciences developed fast-growing transgenic aspen and Lombardy poplar as potential sources of biofuels. Russia could play an important role in bioenergy, a commercially attractive industry, by producing fast-growing plants, including GE willow, poplar, and miscanthus.

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APPENDIX F.4 235 However, a serious concern is a “de facto moratorium” on seed production and large-scale cultivation of GE crops in the open systems in Russia, which has existed since 2004. In 2002, the Ministry of Industry and Science gave pre- liminary approval to the registration of two GE potato varieties resistant to the Colorado potato beetle (Superior NewLeaf and Russet Burbank NewLeaf of the Monsanto company), but the registration process was discontinued. As a result, not one square meter of land in Russia is used for growing GE crops, a condi- tion that continues lower productivity, lower value of the crops, more use of chemical pesticides and fertilizers (which sometimes pose problems to the health of humans and animals), and more energy used on crops, with a concomitant increase in the production of greenhouse gases. AGRICULTURAL BIOTECHNOLOGY IN THE UNITED STATES In order for a GE crop to be approved for commercial use in the United States, it must pass through the regulatory review process to ensure it does not have unforeseen adverse effects on food safety or the environment. Soybean, corn, and cotton have been the most successful GE crops commercially, and about one-half of U.S. agricultural fields were planted with a GE variety of one of these crops in 2010. GE varieties of canola, sugar beet, papaya, squash, sweet corn, potato, and alfalfa have also been commercialized; however, GE potato and tomato are no longer sold. Intellectual property law in the United States grants seed innovators exclu- sive rights to multiply and market new varieties, including those developed with GE technology. These proprietary rights give companies control over the seeds even after they have been purchased by farmers. Research, development, and commercialization is an expensive and time-consuming endeavor, so it is not surprising that the private sector has focused its efforts on soybean, corn, and cotton, which are likely to generate returns on investment because of their domi- nance in U.S. agriculture. Conversely, public research has addressed issues in much smaller markets. For example, commercialization of GE papaya, which in the United States is only grown in Hawaii, was undertaken by the public sector to prevent a virus from devastating papaya production. GE technology has not been introduced into a wider array of crops, because few other crops are planted on so many acres. Introducing GE traits into less widely grown crops increases the regulatory costs as a percentage of the costs invested in research and development. Also, the environmental risk associated with gene flow from GE plants to non-GE plants is lower for corn, soybean, and cotton than for most other crops. Resistance by consumers and growers has been a barrier to further com- mercialization of the technology. Consumers appear to be more willing to accept GE products that are further removed from direct human consumption. Corn and soybean are used primarily for animal feed and are often highly processed when

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236 APPENDIX F.4 in food products. It is estimated that 70 percent of all processed U.S. food con- tains products from plants that have GE characteristics. However, products from crops that are consumed directly by humans, such as wheat, rice, and potatoes, seem to cause more concern. Some U.S. wheat growers have been wary of the commercialization of GE wheat for fear that Japan could issue an import ban on all wheat if the United States grew any GE varieties, although there are signs that this reluctance is weakening as the need to enhance wheat production worldwide becomes more evident. There have been instances when unapproved GE crops have entered the U.S. food system. When this has occurred, the U.S. government has addressed the issue quickly and determined that the inadvertent releases did not present a health or environmental risk. The U.S. regulatory system has proved effective in ensuring the safety of GE food for consumers and managing GE crops in the environment. RECOMMENDATIONS FOR NEXT STEPS If GE crops were to have a level of absolute safety far beyond that required for competitive crop varieties before being used, they would never be used. But as has been demonstrated in many countries, a reasonable level of safety can be ensured through sound regulatory practices. The U.S. and Russian academies of science could work together to improve understanding of the need for safety evaluations and realistic expectations from these evaluations. The authors of this paper suggest that the following steps be undertaken by the academies in the two countries: • Letters to appropriate officials of the two governments calling for reex- amination of the characterization of risks related to GE crops, taking into account recent advances in GE approaches and the available evidence as to the risks associated with GE crops that are currently being produced. • Holding of an international forum on scientific opportunities and regula- tory barriers concerning the future contribution of GE crops to the global food supply, perhaps organized by the InterAcademy Council. • Development of a communications strategy for improving understanding of both governments and the public on issues related to GE crops, including food safety, coexistence with organic and conventional crops, ecological benefits, and other aspects of GE crops. • Encouragement of educational programs in genetic engineering, bioeth- ics, and modeling of scenarios for implementation of innovations in GE technol- ogy, with participation of students and young researchers. Finally, we recommend that approaches to ensuring appropriate food and environmental safety of GE plants and animals should be on the agenda of the

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APPENDIX F.4 237 InterAcademy Council, for consideration by experts from countries throughout the world with their recommendations sent to the appropriate bodies of the United Nations, to relevant international scientific organizations, and to interested regional organizations. REFERENCES 1. James, C., Global Status of Commercialized Biotech/GM Crops, ISAAA Brief 42-2010: Executive Summary, The International Service for the Acquisition of Agri-biotech Applications, 2011. 2. National Research Council, The Impact of Genetically Engineered Crops on Farm Sustain- ability in the United States, Washington, D.C., National Academies Press, 2010. 3. CAC (Codex Alimentarius Commission), Principles for the Risk Analysis of Food Derived from Modern Biotechnology, CAC/GL 44-2003, Food and Agriculture Organization/World Health Organization, Rome, 2003. 4. OECD (Organization for Economic Cooperation and Development), Science, Safety and Society, Conference on new biotechnology food and crops, Bangkok, July 10–12, 2001. 5. “A Decade of EU-funded GMO Research (2001–2010),” http://ec.europa.eu/research/ quality-of-life/gmo/index.html, Skryabin, Konstantin, editor, Agrobiotechnology in Russia and in the World, Bioengineering, Russian Academy of Sciences, 2008. 6. Russian Federal Laws, “On State Regulation of Genetic Engineering Activity” (FZ-86, 1996, amended in 2000 and 2010); “On Sanitary and Epidemiological Well-being of the Population” (FZ-52, March 30, 1999); “On the Quality and Safety of Food Products” (FZ-29, January 2, 2000); “On Amendments to the Federal Law ‘On Protection of Consumer Rights’” (FZ-234, October 25, 2007); “On Environmental Protection” (FZ-7, 2002).

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