Bruce F. Mackler

National Environmental Policy Act

In 1969, the United States Congress enacted a landmark environmental statute: the National Environmental Policy Act (NEPA). Responding to reports of increasing harm to the environment of the United States, Congress substantially elevated the importance of environmental factors in government decision-making. For the first time, all federal agencies were compelled to consider the environmental implications of their major actions. In addition, a new entity, the Council on Environmental Quality (CEQ), was established to help coordinate federal environmental policy. CEQ was also directed to submit an annual report to Congress on the status of the environment.

Coordinating Federal Biotechnology Policy

Until recently, there was relatively little need for United States agencies to develop a coordinated approach for regulating biotechnology-derived products. As long as recombinant DNA was primarily a laboratory research tool, the National Institutes of Health recombinant DNA Guidelines were sufficient. Other agencies exercised only minimal authority with respect to these activities. Although there were some preliminary discussions among agencies regarding cooperation, formal inter-agency coordination was basically unnecessary.1

Regulation of the Biotechnology Industry Under the Pollution Control Laws

Only a small number of biotechnology companies produce biochemical or microbial pesticides, and are thereby subject to The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Most biotechnology companies are interested in the manufacture of foods, drugs, biologics and medical devices, all of which are outside the reach of TSCA. Nonetheless, virtually every biotechnology company generates pollutants, and thus is subject to pollution control regulation by the EPA.

EPA and Pesticides

In the United States, the authority to regulate is divided primarily along product lines. Biotechnology is utilized in a wide array of industries -- agricultural, pharmaceutical, chemical, and waste degradation, to name a few. No one agency has authority over all these product areas. As a consequence of this division, the power to address biotechnology-related environmental questions rests with several independent government entities.1

Product Liability and Private Environmental Litigation

Government regulation presents the most specific and direct control upon environmental aspects of biotechnology in the United States. As the preceding chapters have shown, there is already an extensive body of explicit rules bearing upon biotechnology. Although the rules and requirements regarding biotechnology-derived products are still evolving, there are now identifiable agencies that have the responsibility for regulating particular products. For example, a company that wishes to field test a new genetically engineered pesticide must obtain EPA approval; genetically engineered animal vaccines require USDA clearance before they can be marketed.

The Regulation of Agricultural Applications of Biotechnology

Few sectors of the world economy will be affected as strongly by biotechnology as agriculture. Biotechnology, particularly recombinant DNA techniques, is expected to result in new plant varieties which are more nutritionally balanced and less susceptible to disease and climatic conditions. For example, approvals have already been sought to field test nutritionally improved corn plants and disease resistant tobacco plants. Also, genetically engineered bacteria to enhance frost resistance in potatoes and strawberries have been developed, and approvals obtained to field test them in the environment.2

Environmental and Manufacturing Applications: The Toxic Substances Control Act

During the 1960s and early 1970s, the health and environmental risks presented by chemicals received increasing attention. Incidents involving mercury, polychlorinated biphenyls, vinyl chloride, and other chemicals heightened public and congressional apprehension over chemical substances. Eventually, a consensus developed that a new law was necessary to address the safety of the tens of thousands of chemicals already being sold in the United States, and the thousands more that would be developed.

Environmental Aspects of Biotechnology Regulation

Biotechnology is unusual in several respects. Few other technologies have been applied to so many diverse types of products in such a short time. These products range from pesticides to plastics, from pharmaceuticals to therapeutic agents for farm animals. Biotechnology is also distinctive in its rapid adoption throughout the world. Virtually all industrialized nations already have, to a greater or lesser degree, incorporated biotechnology into their own industries.

The Canadian Regulatory Framework for Biotechnology

Biotechnology has been recognized in Canada, as in most other developed nations, as a priority for research and development, leading to new opportunities for future industrial growth. In 1980, the Ministry of State for Science and Technology (MOSST) established a Task Force on Biotechnology2 to advise the Minister on the development of an effective Canadian strategy for promotion of biotechnology. The task force recommended a long-term federal funding commitment, industrial stimulation through tax incentives and technology transfer from government and university laboratories, and increased financial support to the Medical and National Research Councils (MRC and NRC) for interdisciplinary research, development and training. Priority research areas were identified in nitrogen fixation and plant strain development, human and animal health care, cellulose utilization and waste treatment, mineral leaching, and metals recovery. This National Biotechnology Strategy was adopted in 1983 by the federal government.

The Regulation of the Environmental Aspects of Biotechnology in the United Kingdom

Biotechnological processes have been used in the United Kingdom (UK), as in other countries, for many years. Consequently, the products of “traditional” biotechnology have long been subject to regulation, generally on the basis of the product involved rather than the process. Pharmaceutical products have been regulated under the Medicines Act (1968), food and food additives under the regulations promulgated under the Food Act (1984)2 and biological pesticides under the Pesticides Safety and Precautions Scheme (PSPS)3 operated by the Ministry of Agriculture, Fisheries and Food (MAFF). The safety of industrial processes using microorganisms and other biological processes is itself regulated by the Health and Safety Executive (HSE) under the Health and Safety at Work, etc. Act (1974).