Environmental Safety of Genetically Engineered Crops

Systems to Regulate Genetically Engineered Plants: Similarities and Differences among Countries

147 Systems to Regulate Genetically Engineered Plants Similarities and Differences among Countries Karen Hokanson and Alejandra Ferenczi In 1986, the United States was the first country to establish its regulatory authority for genetically engineered organisms when it published its “Coordinated Framework for the Regulation of Biotechnology.” The global community has since then gained experience in the regulation of genetically engineered plants during the 20 years since genetically engineered organisms were first regulated, and a growing list of plants have been safely approved for experimental and commercial use. Yet, considering that human beings have been domesticating plants for at least 10,000 years, and systematically breeding plants for about 300 years, and successfully genetically engineering plants for less than 30 years, the regulation of this technology is still relatively new and continues to evolve with the science. A number of other countries also have developed systems to regulate biotechnology. With the adoption of the Cartagena Protocol on Biosafety in 2000, which is a legally binding global protocol for transboundary movement of products of biotechnology, many more countries, including developing countries, now see the need to establish their own regulatory systems. Where they exist, national laws, policies, and regulations of countries that are party to the Protocol are being posted in the Biosafety Clearing-­ House (BCH) database established by the Convention on Biological Diversity through the Cartagena Protocol (SCBD 2000). The regulatory systems that have been developed in different countries to date are similar in some ways and different in others, and countries that are adopting new regulatory systems can learn from these similarities and differences (Frederick 1998; Flint et al. 2000; Solleiro and Galvez 2002; McLean et al. 2003; Nap et al. 2003; Jaffe 2004; Ramessar et al. 2009). This chapter describes and compares different frameworks for the regulation of genetically engineered crop plants, selected to serve as examples of different approaches. Included are the regulatory frameworks of the United States, Canada, South Africa, the European Community , and countries from the Regional Trade Agreement in South America: Argentina, Brazil, Paraguay, and Uruguay. 148| Karen Hokanson and Alejandra Ferenczi The United States and Canada Being among the first countries to develop regulatory systems for genetically engineered crop plants, and neighbors to each other, the United States and Canada have developed systems that are similar in many ways, but with some notable differences. The original coordinated framework in the United States mainly involves three agencies that derive their authority from laws that existed when the framework was first developed. The U.S. Food and Drug Administration (FDA) considers whether genetically engineered organisms are safe for human health under the Federal Drug and Cosmetics Act. The U.S. Environmental Protection Agency (EPA) is responsible for the safe use in the environment of plant-­ incorporated protectants (PIPs, or plants engineered with genes to protect them from insects and disease) within its jurisdiction under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetics Act. The Animal and Plant Health Inspection Service (APHIS), an agency within the U.S. Department of Agriculture, determines safety of genetically engineered plants for agriculture and the environment under the Plant Protection Act (although this act was only finalized in 2000, replacing the previous Federal Pest Act and Plant Quarantine Act under which the coordinated framework for biotechnology was developed). Under these existing laws, different U.S. agencies are involved at different stages in the development of the engineered plant. During the early development phase, when plants are being developed and tested in the laboratory or greenhouse, research is conducted according to guidelines set forth by the U.S. National Institute of Health (NIH), and compliance with these guidelines is voluntary. Institutional biosafety committees may also have guidelines and requirements for compliance during this phase. When the plants reach the confined field trial stage, which involves a small-­ scale controlled “release” into the environment, a permit must be obtained from APHIS, and there are stringent requirements to ensure confinement of the plant material during the trial. If the field trial involves a PIP and is over 10 acres, an experimental use permit is also required by the EPA. Before the plants are approved for commercial-­ scale production, APHIS, EPA if the plant is a PIP, and FDA if the plant is intended for food or feed, will all be involved in the safety assessment. The various agencies employ scientists, trained in various disciplines, to conduct technical assessments, and external scientific experts may also be consulted during the...