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Date: Feb. 21, 2002
Contacts: Bill Kearney, Media Relations Officer
Andrea Durham, Media Relations Assistant
(202) 334-2138; e-mail <>


Regulation of Transgenic Plants Should Be Reinforced;
Field Monitoring for Environmental Effects Is Needed

WASHINGTON -- The U.S. Department of Agriculture should more rigorously review the potential environmental effects of new transgenic plants before approving them for commercial use, says a new report from the National Academies' National Research Council. The committee that wrote the report also said the public should be more involved in the review process and that ecological testing and monitoring should continue after transgenic plants have entered the marketplace.

Appropriate environmental risk analysis and public acceptance of transgenic plants depend on a federal regulatory system and culture that communicates to society the seriousness with which potential environmental risks are being addressed, the report emphasizes.

"USDA has substantially improved its regulation of transgenic plants, but the process could be improved further by soliciting greater public input, enhancing scientific peer review, and more clearly presenting the data and methods behind regulatory decisions," said committee chair Fred Gould, William Neal Reynolds Professor of Entomology, North Carolina State University, Raleigh. "Our report provides a detailed road map for the federal government to follow as it reinforces its assessment of environmental risks."

While the committee called for an enhanced regulatory process for transgenic plants, it also noted that the current level of regulation for such plants is higher than for other agricultural products and practices. This is the case despite the fact that the committee did not find any strict distinctions between the types of environmental risks posed by plants genetically engineered through modern molecular techniques and those modified by conventional breeding practices. There is typically no formal assessment of potential environmental effects of newly introduced crop varieties produced by conventional breeding. There is no immediate need to regulate conventionally bred crops, but their potential environmental effects should be re-evaluated.

The Animal and Plant Health Inspection Service (APHIS) -- the arm of USDA responsible for regulating transgenic plants -- reviews about 1,000 applications each year from biotechnology companies wishing to field-test new transgenic plants or petitioning to have a plant deregulated altogether. Field-testing of most transgenic plants is approved through the "notification" process, whereby applicants notify APHIS that a plant meets general guidelines for not causing unwanted environmental effects. If the agency agrees, the plant can be grown while the company conducts further field-testing to rule out adverse environmental effects. But there is no public or independent scientific input in this process, and no limit to the acreage that can be planted.

There also is a need to re-examine which transgenic plants should be tested and allowed to grow commercially through notification, the committee said. It discovered one case, for example, where it appears that a variety of corn that produces a protein with insecticidal properties, known as avidin, was grown commercially under the notification process.

At the same time, however, the committee called notification an important step in effectively streamlining the field-testing review process. In fact, given what APHIS has learned about certain plant traits, it should be able to quickly screen many of the current generation of transgenic plants for potential environmental risks. More detailed investigations should be conducted only when preliminary testing indicates a possible risk.

Most biotech companies commercialize transgenic plants by petitioning for non-regulated status -- in essence requesting APHIS to determine that there is no environmental risk associated with a specific transgenic plant. As part of this process, APHIS always conducts a formal environmental assessment that it publishes in the Federal Register, providing the public with a 60-day comment period. But the committee found that almost no one comments. It said that before making precedent-setting decisions regarding field-testing or deregulation, APHIS should solicit broad external scientific and public review well beyond the use of the Federal Register, and that the agency should convene a scientific advisory group before any changes in regulatory policy are made.

Some transgenic plants are engineered to produce a pesticide, which could potentially harm or kill non-target organisms or allow pests to develop immunity to the pesticide. However, the committee found that APHIS's treatment of these two issues in its environmental assessments is generally superficial. The agency should either increase the rigor of its analysis of pest resistance and impacts on non-target species, or completely defer to the U.S. Environmental Protection Agency, which also assesses these risks.

Because APHIS considers deregulation final, it does not conduct post-commercialization monitoring for environmental effects. The committee said that without systematic monitoring, however, there is no way to ensure that environmental damage has not occurred. It recommended that such monitoring take place to validate the pre-commercialization environmental testing and to spot unanticipated or long-term environmental impacts. Large-scale planting might cause environmental effects or impact non-target organisms in ways that could go undetected in the pre-commercialization testing phase. Validation testing can be carried out through existing USDA programs, but field-monitoring will require the development of an interactive program involving government agencies and academic scientists. Additional funding will be needed in both instances.

The study was sponsored by the U.S. Department of Agriculture. The National Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science and technology advice under a congressional charter. A committee roster follows.

The report Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation is available on the Internet at Copies are available for purchase from the National Academy Press; tel. (202) 334-3313 or 1-800-624-6242. The cost of the report is $49.95 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

Division on Earth and Life Studies
Board on Agriculture and Natural Resources
Board on Life Sciences

Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants

Frederic L. Gould (chair)
William Neal Reynolds Professor of Entomology
North Carolina State University

David A. Andow
Professor of Insect Ecology
Department of Entomology
University of Minnesota
St. Paul

Bernd Blossey
Assistant Professor and Director
Biological Control of Non-Indigenous Plant Species Program
Department of Natural Resources
Cornell University
Ithaca, N.Y.

Ignacio Chapela
Assistant Professor
College of Natural Resources
University of California

Norman C. Ellstrand
Professor of Genetics
Department of Botany and Plant Sciences
University of California

Nicholas Jordan
Associate Professor
Department of Agronomy and Plant Genetics
University of Minnesota
St. Paul

Kendall R. Lamkey
Research Geneticist
U.S. Department of Agriculture, and
Department of Agronomy
Iowa State University

Brian A. Larkins*
Porterfeld Professor of Plant Sciences, and
Professor of Molecular and Cellular Biology
Departments of Plant Sciences and Molecular and Cellular Biology
University of Arizona

Deborah K. Letourneau
Professor of Environmental Studies
University of California
Santa Cruz

Alan G. McHughen
Biotechnology Specialist
University of California

Ronald L. Phillips*
Regents' Professor and McKnight Presidential Chair in Genomics
University of Minnesota
St. Paul

Paul B. Thompson
Joyce and Edward E. Brewer Distinguished Professor of Philosophy, and
Director, Center for Food and Animal Productivity and
Purdue University
West Lafayette, Ind.


Kim Waddell
Study Director

* Member, National Academy of Sciences