Biotechnology and the Environment: Navigating the Regulatory Maze - ABA YLD 101 Practice Series

By Guy R. Knudsen

Genetically engineered (GE) plants and microbes have potential to transform agriculture and environmental protection. Since the first commercial introduction of transgenic corn plants in 1995, a number of crops engineered for insect or disease resistance, herbicide tolerance, or other properties are either in production or proposed for release. Various bacteria and fungi also have been genetically engineered for biological pest control, remediation of pollutants, and other purposes.

However, concerns persist in the public mind as well as the scientific and legal communities, about potential environmental risks of released GE organisms, and the subject remains controversial and often litigious. An evolving and sometimes conflicting body of regulation confronts the attorney representing either a company wishing to release a biotechnology product, or a client with concerns about environmental risk. The rules change quickly in this arena, and sometimes it is difficult to know where to turn for information. This article discusses the respective areas of responsibility of the major regulatory bodies, and the potential impact of some recent case history.

In 1986, the Coordinated Framework for the Regulation of Biotechnology was established for federal oversight of GE products (51 FR 23302). Regulatory policies are intended to be based on scientific understanding of the nature of biotechnology products, and optimal practices for their safe use. Following an update to the framework in 2001, oversight for GE organisms is assigned as follows. Three federal agencies share regulatory responsibility: USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to review by one or more of these agencies. Each agency maintains a website that should be consulted for the most current status of regulations, permit applications, etc. Also, the prudent attorney should plan to personally contact regional office representatives of these agencies, in light of the evolving nature of the regulations.

  • USDA-APHIS
    Within USDA-APHIS, the Biotechnology Regulatory Services (BRS) wing implements rules for GE organisms that may pose risks to plant health. APHIS exercises its authority through a system of permits and notifications. APHIS oversees the field testing of biotechnology-derived plants as "regulated articles," and a petition for nonregulated status must be granted before commercial growth and sale of any GE crop.
  • EPA
    EPA has regulatory authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA) for GE crops that produce their own protection against pests. EPA evaluates crops with pesticidal properties to assure that their use will not pose unreasonable risks of harm to human health and the environment. EPA also regulates GE microorganisms under the Toxic Substances Control Act. This oversight includes biotechnology microorganisms used commercially for industrial enzymes, in agriculture, and for environmental remediation.
  • FDA
    Biotechnology food products essentially face the same regulatory requirements that FDA uses to safeguard all foods in the marketplace. GE foods are judged on safety and nutrition characteristics, rather than on the methods used to produce them, and legal responsibility to ensure their safety rests with the food company. In 2001, FDA proposed a rule change requiring companies to submit data and information on GE foods before commercial distribution, replacing the current system of voluntary premarket consultation.
  • Other federal and state regulatory agencies
    In some cases, other federal agencies may exert the authority of the Endangered Species Act, the National Invasive Species Act, or other federal legislation, where GE organisms have potential to interact adversely with the environment. Such agencies include the U.S. Fish and Wildlife Service, the Bureau of Land Management, and the National Marine Fisheries Service. In addition, state regulatory authorities commonly have oversight authority for wildlife and fisheries resources within state boundaries. In particular, several states have issued regulations prohibiting the release of aquatic or marine GE organisms.
  • Two recent significant c ases
    The venerable NEPA, enacted well before the advent of GE organisms, showed its teeth in a recent appellate court decision (Geertson Seed Farms v. Monsanto, 9th Cir. 2008, No. 07-16458). The court affirmed an injunction on all planting of GE 'Roundup Ready' alfalfa seed, on essentially procedural grounds. The court ruled that APHIS violated NEPA by failing to require a full environmental impact statement (EIS) from the seed company. The decision was viewed widely as a strategic victory for the several environmental groups opposing release of the GE seeds. However, in a decision that may prove more favorable to producers of GE products, the Supreme Court (Winter v. NRDC, S.Ct. No. 07-1239 (2008)) reiterated a standard requiring that injunctive relief in environmental protection cases be based on demonstration that irreparable environmental injury is "likely", rather than merely "possible." At the least, these cases demonstrate the need for environmental attorneys to remain apprised of relevant environmental case law, in addition to the pertinent agency regulations.

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About the Author

Guy R. Knudsen is a private practice attorney in the area of environmental law, and is also Professor of Microbial Ecology and Plant Pathology at the University of Idaho, Moscow, Idaho. He can be contacted at gknudsen@uidaho.edu or (208) 885-7933.

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