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). Governments 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 commercialized 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, regulations, 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 registration system is its three separate streams: (1) safety assessment for environmental release from GE crops, (2) safety assessment of GE food, and (3) safety assessment 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 development 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.