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TITLE:  U.S. EPA launches comprehensive review of Bt crops
SOURCE: Environmental News Service, by Cat Lazaroff
        http://ens.lycos.com/ens/aug2000/2000L-08-10-07.html
DATE:   August 10, 2000

-------------------- archive: http://www.gene.ch/ --------------------


U.S. EPA launches comprehensive review of Bt crops

WASHINGTON, DC, - The U.S. Environmental Protection Agency plans to 
undertake a comprehensive scientific and public review of its current 
approval for corn and cotton seeds genetically engineered to make 
their own pesticides. Biotech opponents criticized the EPA for 
granting the crops a temporary extension. The EPAÕs reassessment is 
intended to assure that the decisions on the renewal of the 
registrations for these crops "are based on the most current health 
and ecological data," the EPA said August 9 in a Federal Register 
notice.

The announcement is part of President Bill Clinton's initiative, 
announced May 3, to strengthen U.S. regulatory oversight of 
genetically engineered foods and to focus on current and future 
safety issues. The announcement also expands the level of public 
comment in the regulatory process. The decision affects corn or maize 
and cotton seeds genetically engineered to produce Bacillus 
thuringiensis (Bt), a naturally occurring soil bacterium. The 
bacterium produces a toxin that acts as a pesticide when a Bt gene is 
inserted into selected corn and cotton genes.


Bt corn reduces the impact of European corn borers on corn crops

Bt corn, which became commercially available in 1997, is resistant to 
the European corn borer, according to the U.S. Department of 
Agriculture (USDA). In May 1999, Cornell University published a study 
indicating that the corn could pose risks to non-target species like 
the monarch butterfly, leading to a wave of criticism of the 
engineered crop. Bt cotton has been genetically altered to control 
the tobacco budworm, bollworm and pink bollworm. Neither genetically 
modified (GM) seed has been shown to present any human or animal 
hazards, the USDA says. Some scientists warn that bollworms in 
regions using large amounts of Bt cotton, such as the American South, 
may already be showing the first signs of resistance to the Bt toxin.

EPA is one of three U.S. agencies charged by federal law with 
regulating agricultural biotechnology products. Regulation is also 
provided by the USDA's Animal and Plant Health Inspection Service and 
the Food and Drug Administration. Under the current regulatory 
process, EPA must approve the registration of a new pesticide before 
it can be sold or distributed in the U.S. An EPA registration is a 
pre-market licensing of pesticides based on scientific evidence that 
they are safe and will have no adverse effects on human health.

EPA said it will publish its risk assessment of the two GM seeds for 
public comment and conduct a scientific peer review of its assessment 
by the EPA's Scientific Advisory Panel (SAP). Because the process 
announced August 9 will take additional time, EPA says it will extend 
the existing license approval of Bt cotton and Bt corn until 
September 30, 2001. "EPA has strengthened resistance management 
requirements for both corn and cotton in the past year and believes 
these strengthened requirements, along with the original registration 
conditions, are more than adequate to be protective during the 
extension period," the EPA notice said.


The evaluation process requires five phases:

Completion of comprehensive risk assessments, which are currently 
under way Seeking scientific and public comment on the risk 
assessments by fall 2000 Incorporating comments from SAP, the 
National Academy of Sciences, public and the administration view by 
fall 2000 and winter 2000/2001 Revising risk assessments and propose 
registration decisions by winter 2000/2001 to early spring 2001 
Issuing final re-registration decisions by summer 2001

U.S. pesticide law gives EPA the authority to amend or revoke 
existing registrations in the event "unreasonable adverse effects" 
have been observed. In addition, EPA can impose new measures as new 
information becomes available. For example, for purposes of insect 
resistance management, beginning in the 2000 crop year, growers must 
plant an area of non-Bt corn equal to 20 percent of their acreage, 
along with their Bt corn seeds. For Bt corn grown in cotton areas, 
farmers must plant at least 50 percent non-Bt corn. This provides 
what is called a "refuge" and is used to manage the genetics of pest 
insect populations to prevent the development of resistance to Bt in 
insects feeding on the corn.

The EPA plans to review all potential human and environmental risks 
from Bt corn and cotton, including the potential that insects will 
develop resistance, human health effects, possible gene transfers 
between engineered crops and their wild cousins, and effects on non-
target species.

The conservation group Environmental Defense said the comprehensive 
review was "welcome news," but questioned the wisdom of allowing 
continued plantings of Bt crops while the review is underway.

International environmental group Greenpeace said the EPA has not 
gone far enough to address the dangers posed by biotech crops. 
Greenpeace has called on EPA to cancel the registration of Bt crops, 
and is working with the Center for Food Safety on a series of legal 
challenges. "We will continue to challenge EPAÕs unwarranted and 
unscientific defense of Bt crops as long as the agency refuses to 
take precautionary action to prevent harm to the environment,"said 
Charles Margulis, Greenpeace genetic engineering specialist. 
"Consumers and growers need to know that organic food and the 
environment wonÕt be sold out for biotech industry profits."

The EPA's Federal Register notice is on the Internet at:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=
2000_register&docid=00-20174




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