November/December 2004
Genetically Manipulated Arthropods Garner Attention
Researchers are designing genetically engineered insects to
benefit public health, enhance agriculture, and provide novel types of economically useful bugs. These efforts include genetically altering mosquitoes to render the insects incapable of transmitting malaria, engineering a bacterium in the kissing bug’s gut to kill the parasite that causes Chagas’ disease, modifying pink bollworms to carry a gene that would prevent offspring from developing, and genetically engineering honeybees to make them resistant to diseases and parasites. According to the Pew Initiative on Food and Biotechnology, genetically modified (GM) insect
projects may advance from confined field trials to full environmental release within three to five years. This same group believes that current regulatory statutes are non-uniform in addressing the risks these organisms pose, and sponsored a two-day workshop during late September 2004, in Washington, D.C.
In the U.S.A., the U.S. Coordinated Framework for Regulation of Biotechnology (CFRB) directs the Food and Drug Administration, the Department of Agriculture, and the Environmental Protection Agency to regulate biotech products according to their intended use, but the CFRB does not address GM insects, and that the federal government has done little to indicate if it will regulate these arthropods. Only the USDA has asserted authority over some GM insects. The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates GM insects that are, or could be, plant pests under the authority of the Plant Protection Act. This statute regulates a GM organism if the donor organism, recipient organism, vector, or vector agent is classified as a plant pest. Potential plant pests are subject to APHIS review and approval before field trials or environmental release. However, no single U.S. statute covers all types of GM insects, and even combined, the statutes leave gaps. While concerns about regulation often focus on the release of GM insects into the environment, development of uniform guidelines to govern the use of GM insects in the laboratory was also an issue. The adequacy of procedures designed to ensure that researchers retain their GM insects in the laboratory is currently assessed on a case-by-case basis, primarily by institutional biosafety committees.
With regard to international statues - several do exist that may address these organisms - although none specify a system for regulating GM insects directly. These include the Cartagena Protocol on Biosafety, the International Plant Protection Convention, and the Codex Alimentarius Commission Ad Hoc Biotechnology Task Force. The Cartagena Protocol on Biosafety applies to the transboundary movement and use of living modified organisms that may have adverse effects on biological diversity and human health. The Protocol may provide a template for the international regulation of biotech insects. Currently, the U.S.A. is not a signatory to the agreement, and the vague Precautionary Principle inspires the Protocol’s decision-making processes. The Precautionary Principle can come into play when policymakers must decide whether to adopt new technology if the technology may harm the environment. A significant problem in implementing the Precautionary Principle as a policy tool arises from the extreme variability in its interpretation with approaches ranging from risk averse to risk-taking. The International Plant Protection Convention aims to prevent the spread and introduction of plant pests and to promote appropriate measures for controlling plant pests. The treaty is governed by the Interim Commission on Phytosanitary Measures, which adopts international standards. These standards may extend to biotech insects considered plant pests, but probably will not cover insects targeted for human and animal diseases (similar to the case of APHIS on a federal level). The Codex Alimentarius Commission aspires to protect consumer health and ensure fair trade practices by establishing standards and principles for use in international food trade. The organization’s first task force on biotechnology completed its work in 2003, and a new biotech task force will begin work next year. The 2005 Task Force may examine the development and regulation of transgenic animals, which could provide a model for regulating biotech insects.
People familiar with the regulatory process believe successful international regulation of GM insects will depend largely on the progress of debates about ethical aspects of the technology, the interpretation of biosafety protocols and other international agreements, and developments in the regulation of biotech bugs in the United States and European Union. International cooperation, as well as public participation, will be needed since GM insects pose novel regulatory issues: engineered insects can scatter throughout their surroundings from their point of release, and many programs will require GM insects to persist in nature. These attributes can produce risks to public health, agriculture, and the environment. Public trust in transgenic insect technology will not be won simply by explaining how potential benefits exceed possible risk. The estimation of a risk - that is, an estimate that a hazard will occur - is a scientific question free of policy implications. On the other hand, the acceptability of risk is a political question, one affected by public concerns. (ISB News Report, http://www.isb.vt.edu & Pew Initiative on Food and Biotechnology, http://pewagbiotech.org, November 2004).
