Public Access to Biotechnology Applications

In a democratic society, the public has a broad right to participate in government activities that assure the safety of commercial products. Public involvement means participation in government agency reviews of particular products and assurance that products meet certain standards of health and safety. Public scrutiny of agency activities improves decision making by providing the views of those without a financial interest in approval or disapproval of products as well as oversight of the integrity of agency operations. The public's ability to participate in government reviews of specific products is entirely dependent on access to information, specifically the experimental data underlying assessments of risk. Obtaining such experimental data is the subject of this article, which analyzes the experience of the National Wildlife Federation (NWF) as it has routinely sought health and safety data on the early products of the new biotechnology industry. The biotechnology industry, having achieved its first commercial success with pharmaceuticals, is now creating a broad variety of genetically engineered products for use in the environment. Many of these products are in the first and second year of field tests, prior to fullscale commercial production. Even before fullscale commercial production, many people are concerned that organisms with novel combinations of genes and traits will have unanticipated effects in the environment. Modern genetic engineering techniques, such as recombinant DNA or gene-splicing methods, can circumvent natural reproductive mechanisms to combine genes from organisms in different species, families, and even kingdoms. Scientists, for example, have placed human genes in fish and bacteria, and insect and mouse genes in tobacco plants. Novel organisms like these pose risks ranging from displacing existing organisms to creating new plant and animal pests. Two agencies, the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA), review releases of engineered organisms under several federal statutes. USDA examines engineered organisms under the Virus-Serum-Toxin Act (VSTA), 21 U.S.C. §§ 151-59, and the Federal Plant Pest Act (FPPA), 7 U.S.C. §§ 15Oaa-jj. EPA analyzes novel organisms under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136-36y, and the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601-29In addition, the USDA oversees experimental releases derived from research that it sponsors under its research funding authority. 7 U.S.C. § 3121(12). Agency reviews are based on industry applications that contain data necessary to assess human health and ecological risks. Thus far, over eighty applications to release organisms in twenty states have been submitted to USDA and EPA.