USDA orders environmental evaluation of transgenic plants, animals

WASHINGTON, DC, January 23, 2004 (ENS): Transgenic fish, shellfish, trees, grasses, insects, and microbes are being evaluated for release in the United States, in addition to the transgenic corn, soy beans, cotton, fruits and vegetables now being planted across the country. To prepare for this new wave of genetically engineered organisms, agriculture officials have been directed to re-evaluate the environmental impact of the department's biotechnology regulations, Agriculture Secretary Ann Veneman said Thursday. Rules covering the import, interstate movement and environmental release of genetically engineered organisms will be reconsidered.

The evaluation is the first step in developing a multi-tiered, risk based permitting system to replace the current U.S. Department of Agriculture (USDA) permit and notification system, along with changes to the deregulation process to provide for long term monitoring of transgenic organisms, Veneman said.

The environmental rethinking exercise follows a new report issued Tuesday by a committee of the National Research Council that warns developers of genetically engineered organisms to consider how to prevent transgenic animals and plants from escaping into natural ecosystems and breeding or competing with their wild relatives.

No single bioconfinement method is likely to be 100 percent effective, the committee said, and developers of genetically engineered organisms need to use more than one method to lower the chance of failure.

"Deciding whether and how to confine a genetically engineered organism cannot be an afterthought," said committee chair T. Kent Kirk, professor emeritus, department of bacteriology, University of Wisconsin, Madison, and a former microbiologist with the U.S. Department of Agriculture. "Confinement won't be warranted in most cases, but when it is, worst-case scenarios and their probabilities should be considered."

He suggested biological techniques such as induced sterility to control the impact of transgenic plants and animals on natural organisms, and recommended more research aimed at developing new biological confinement methods to minimize risks and boost the public's confidence in biotechnology.

The report was requested by the U.S. Department of Agriculture. Ensuring confinement for some of these new organisms may become one of the new requirements for regulatory approval.

“The science of biotechnology is continually evolving, so we must ensure that our regulatory framework remains robust by anticipating and keeping pace with those changes,” Veneman said. “A comprehensive environmental impact statement is the critical first step in the process. Our regulatory system must be both rigorous and flexible and based on sound science principles and mitigation of risks.”

The agency's Animal and Plant Health Inspection Service (APHIS), which has regulated agriculture biotechnology since 1987, will prepare the environmental impact statement.

Veneman says that to date APHIS has ensured the safe field testing of more than 10,000 genetically engineered organisms and overseen the deregulation of more than 60 transgenic products.

Dr. Val Giddings, vice president of agriculture of the Biotechnology Industry Organization, emphasized the past safety of genetic engineering, and said members of his organization already have techniques to confine the products of genetic engineering.

"As policy-makers study this report to set a future course of regulation," Giddings said, " the goal should be to reinforce the three fundamental principles of existing regulation - that all regulations are science based; that they focus on properties of the transferred gene, not its origin in recognition that DNA is DNA; and that the level of regulation is based on the level of risk to public health, not a precautionary doomsday approach."

Dr. Kirk's committee paid particular attention to transgenic fish, shellfish, trees, grasses, and microbes, because many of these organisms have been engineered successfully and are now undergoing regulatory evaluation.

Genetically engineered aquatic species can be confined by physical barriers, by disrupting sexual reproduction, or by methods that prevent their survival in the wild, the committee explained. For example, one technique can sterilize some fish and shellfish by adding an extra set of chromosomes to the animal's cellular makeup, although the report said this technique "cannot guarantee 100 percent sterility."

Fish also can be engineered to rely on a manufactured substance for survival, so that they would die if they escaped into the wild.

For plants, bioconfinement methods include inserting genes that induce sterility, or engineering plants not to produce pollen, which can help close this avenue of gene flow, the committee said.
There are two major bioconfinement methods for microbes, the report says. One method involves engineering bacteria or fungi to use so much energy or nutrients that they do not compete well with native bacteria and fungi. Because of the rapid adaptability of microbes, the effectiveness of this bioconfinement method remains unclear, the committee cautioned.

The second method is to use a chemical to trigger what the committee called "suicide genes" in bacteria or fungi if they escape confinement and pose a risk, though this method has never been field tested.

Little research has been done on bioconfinement of genetically engineered insects, the committee noted, and that gap poses problems that must be solved 1before transgenic insects are released, warns the Pew Initiative on Food and Biotechnology in a new report issued Thursday.

The Pew report, "Bugs in the System? Issues in the Science and Regulation of Genetically Modified Insects," says the federal government lacks a clear regulatory framework for reviewing environmental safety and other issues associated with transgenic insects.

In the works are insects with traits that could help curb disease and create industrial materials. There are genetically modified mosquitoes incapable of transmitting malaria, which is contracted by up to 500 million people annually and kills between up to three million people worldwide each year.

Honeybees are being genetically engineered so they are resistant to diseases and parasites, which have devastated the honeybee population in the last decade.

Silkworms are being made to produce pharmaceutical and industrial proteins, like those used to create a particularly strong spider silk that could be used to make bulletproof vests, parachutes, and artificial ligaments.

And parasites unable to transmit Chagas’ disease are being engineered. This disease currently infects up to 18 million people annually and kills nearly 50,000 people each year in Northern South America, Central America and Mexico.

But there is uncertainty about the lasting effects these insects could have on ecosystems, public health and food safety once released, the Pew report warns. In some cases, success depends on fertile transgenic insects that replace wild insect populations and become established in the environment.

Release of fertile genetically engineered insects increases the potential that transgenic traits could spread throughout the insect population, potentially making pre-existing pest problems worse or creating new challenges.

The Pew report cautions that the release of transgenic insects to control the spread of disease could have the unintended consequence of enabling an insect to more effectively spread disease or even carry a human disease it was never before able to transmit.

There is the possibility that modifying the genetic composition of honeybees could alter the composition of the honey they produce, potentially creating a food safety concern, the Pew report says.

“Although it may be several years before scientists are ready to conduct a wide scale release of transgenic insects, the research threatens to outpace regulatory preparedness,” said Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology.

“The benefits of GM insects could be significant, but the federal government needs to move quickly to clarify how it will provide an adequate review of these insects and the many questions they raise regarding the environment, public health, agriculture and food safety,” he said.

The USDA says it has tasked APHIS with the environmental impact review to address these issues.

Rodemeyer commended APHIS for "taking the first steps needed to ensure that the regulatory review process keeps pace with the application of genetic engineering technology to agriculture."

"By proposing to conduct this review in a transparent manner in which all interested parties can participate," he said, "APHIS is taking an important step toward safeguarding public trust in the regulatory system and helping build confidence in the environmental safety of the products it approves.”

APHIS welcomes comments and input from stakeholders and the public by March 23 to help determine the scope of the environmental impact statement and any proposed regulations. This notice is published in today's Federal Register and is online at:

APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at

Send an original and three copies of postal mail or commercial delivery comments to Docket No. 03-031-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road, Unit 118, Riverdale, Maryland 20737-1238.

Email comments to: Comments must be contained in the body the message; do not send attached files. Please include your name and address in the body of the message and use “Docket No. 03-031-2" on the subject line.

Copyright Environment News Service (ENS) 2004. All Rights Reserved.

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