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
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,
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
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
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
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: http://www.aphis.usda.gov/.
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 http://www.aphis.usda.gov/ppd/rad/webrepor.html.
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
Email comments to: email@example.com.
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.
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