U.S. Regulation of Transgenic Plants Called Inadequate

By Cat Lazaroff

WASHINGTON, DC, February 22, 2002 (ENS) - Regulations now in place to protect the public and the environment from potential harmful effects of genetically engineered crops are inadequate, concludes a new review by the National Research Council. The report, released Thursday, says the government must do a better job of screening these crops - both before and after they are planted.


These transgenic plums contain a gene that makes them highly resistant to plum pox virus. (Photo by Scott Bauer. All photos courtesy Agricultural Research Service, except where specified)
The U.S. Department of Agriculture (USDA) should more rigorously review the potential environmental effects of new genetically engineered, or transgenic, plants before approving them for commercial use, argues the report from the National Research Council, which helps advise the federal government on scientific issues.

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.

"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, the William Neal Reynolds professor of entomology at North Carolina State University in Raleigh.

"Our report provides a detailed road map for the federal government to follow as it reinforces its assessment of environmental risks," Gould added.


Geneticist Ann Blechl looks at root growth on genetically engineered wheat plants that may carry new genes for resistance to a bacteria (Two photos by Jack Dykinga)
Adequate analysis of environmental risk, and public acceptance of transgenic plants, depend on a federal regulatory system that communicates the seriousness with which potential environmental risks are being addressed, the report emphasizes.

"The ... report is a good start in terms of highlighting some of the problems that biotech crops pose and holes in regulatory system," said the nonprofit Genetically Engineered Food Alert Coalition in a statement released Thursday.

The group, which has been consistently critical of how the government handles approvals for transgenic crops, added that the report confirms its claims that "regulations in place for genetically engineered crops are weak and inadequate."

The Animal and Plant Health Inspection Service (APHIS) - the arm of the 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 so called notification process, under which applicants simply 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.


This bioengineered barley carries a gene that may help the plants resist attack by barley yellow dwarf virus
But there is no public or independent scientific input in this process, and no limit to the acreage that can be planted, the committee noted.

"The notification process was first used for a limited set of crops, but currently almost all field testing is conducted through the notification process that requires APHIS to complete its decision making in less than 30 days," the committee wrote, noting that typically a single APHIS staff member decides whether to approve further field trials for a particular transgenic plant.

"Some plant products have been commercialized using the notification process, and there is no limit to the acreage that can be planted under the notification system," the committee adds. "Commercialization of certain plant products through notification could result in large plantings and increased risks through scale effects."

The committee discovered one case, for example, where a variety of corn that produces a protein toxic to insects, known as avidin, was grown commercially under the notification process.

The committee did call notification "an important step in effectively streamlining the field testing review process."


Plant physiologist Ken Gross examines tomato fruit used in a genetic engineering research program (Photo by Keith Weller)
"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," the committee recommended. "More detailed investigations should be conducted only when preliminary testing indicates a possible risk."

Most biotech companies now commercialize transgenic plants by petitioning for non-regulated status - in essence, asking 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, perhaps due to the difficulty of obtaining the company documents supporting commercial applications.

"The committee finds that the extent of confidential business information (CBI) in registrant documents sent to APHIS hampers external review and transparency of the decision making process," the NRC wrote. "Indeed, the committee often found it difficult to gather the information needed to write this report due to inaccessible CBI."

The NRC committee called on APHIS to solicit "broad external scientific and public review well beyond the use of the Federal Register" before making precedent setting decisions regarding field testing or deregulation, and said the agency should convene a scientific advisory group before any changes in regulatory policy are made.


APHIS Administrator Bobby Acord (Photo courtesy APHIS)
APHIS Administrator Bobby Acord said Thursday that the USDA has already begun implementing many of the recommendations included in the NRC report.

"USDA has already addressed some specific issues raised in the report, which involve three processes: notification, permitting and petitioning for non-regulated status," said Acord. "APHIS is currently working to incorporate independent scientific input into the 'notification' process. A wider base of scientific knowledge will allow APHIS to ensure that field testing of transgenic plants does not lead to unwanted environmental effects."

APHIS is also "assessing options for monitoring already commercialized transgenic plant products," Acord added. "The agency is considering whether it may be appropriate in some instances for research agencies to gather additional environmental information through non-regulatory means."

One of the issues of most concern to critics of transgenic crops is plants engineered to produce pesticides, which could potentially harm or kill non-target organisms or allow pests to develop immunity to the pesticide. The committee found that APHIS's treatment of these two issues in its environmental assessments is "generally superficial."


Corn engineered to produce the Bt toxin reduces the impact of European corn borers ...
The committee advised that the agency should either increase the rigor of its own analyses 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. Without systematic monitoring, there is no way to ensure that environmental damage has not occurred, the committee noted.

Such monitoring is needed to validate the pre-commercialization environmental testing, and to spot unanticipated or long term environmental impacts, the NRC said.

"Large scale planting might cause environmental effects or impact non-target organisms in ways that could go undetected in the pre-commercialization testing phase," the committee noted, adding that field monitoring will require the development of an independently funded program involving both government agencies and academic scientists.

The Genetically Engineered Food Alert has called on the USDA to announce a moratorium on any new field trials and on commercial deregulation of new transgenic crops until the agency conducts more thorough research and institutes tougher regulations.


... but pollen from Bt corn could harm monarch butterfly larvae (Photo by Kent Loeffler, courtesy Cornell University)
While the NRC committee called on government to improve the regulation of transgenic plants, it also noted that the current level of regulation for such plants is higher than for other agricultural products and practices. Yet 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. The committee said there is no immediate need to regulate conventionally bred crops, but warned that their potential environmental effects should be reevaluated.

"With few exceptions, the environmental risks that will accompany future novel plants cannot be predicted," concluded the NRC. "Therefore, they should be evaluated on a case by case basis."

The study was sponsored by the Department of Agriculture. The report, "Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation," is available at: http://www.nap.edu