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Introduction
Transgenic
acreage grows amid changing regulation
The United States requires permits
for field-testing new genetically engineered varieties; before
they are marketed they must be "deregulated" by three
federal agencies. Above, soybeans resistant to the herbicide
glyphosate (Roundup). Photos: Monsanto |
Acreage in genetically engineered (GE) crops has increased steadily
since their introduction in 1996, to 167 million acres worldwide
in 2003. However, these crops remain controversial: advocates say
they will help people and the environment but opponents fear they
will hurt both. Regulations for producing, trading and labeling
GE organisms are still evolving at the international, national and
even local levels. Most recently, on March 2 California's Mendocino
County became the first in the nation to ban production of GE plants
and animals.
 “New
technology needs to be reviewed case-by-case until we're comfortable
with it,” says Norman Ellstrand, a UC Riverside geneticist
and director of the UC Biotechnology Impacts Center.
Virtually
all commercial GE crops are either herbicide-tolerant or pest-resistant.
The United States is the largest producer of the 18 countries that
grow GE crops, followed by Argentina, Canada and China. In 2003,
significant portions of the worldwide harvest in four commodities
were genetically engineered: 55% of soybeans, 21% of cotton, 16%
of canola and 11% of corn, according to a 2003 report by ISAAA (International
Service for the Acquisition of Agri-biotech Applications).
Three-part regulatory process
New technologies bring new regulations. The United States currently
requires permits for field-testing GE varieties during their development;
then, companies wishing to commercialize GE crops must pass a three-part
regulatory-approval process that involves the U.S. Environmental
Protection Agency, U.S. Department of Agriculture (USDA) and U.S.
Food and Drug Administration (page 106).
"People
need to know that there is oversight," says Christine Bruhn,
director of the Center for Consumer Research at UC Davis. "The
risks need to be acknowledged and controlled. Public education on
the benefits is also key."
However,
regulations can also hamper the development of GE crops. "Regulations
can make it too expensive for the smaller market crops," says
Kent Bradford, director of the Seed Biotechnology Center at UC Davis.
Many of these (primarily horticultural) crops require dozens of
varieties to match growing seasons and market preferences. U.S.
regulations stipulate that a GE version of each variety must be
registered separately. Alternatively, a single GE version may be
registered and then the trait can be crossed into each of the varieties,
but this is also time-consuming and expensive, Bradford says.
"By
contrast, Canadian regulations focus on the safety and impact of
the trait itself rather than on where it came from," Bradford
notes. "No distinction is made between genetic engineering
and conventional breeding in evaluating whether a novel trait may
be introduced into the marketplace."
USDA
to revise rules. On Jan. 22, the USDA announced plans to update
and strengthen U.S. biotechnology regulations, which cover the importation,
interstate movement and environmental release of GE organisms. "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," U.S. Agriculture Secretary
Ann Veneman said.
Since 1987,
more than 10,000 GE organisms have been field-tested and more than
60 have been "deregulated." Currently, GE crops are no
longer regulated once they have been approved for commercial production.
The move
to update U.S. regulations coincided with the release of a National
Research Council report on "bioconfinement" (see box,
page 73). USDA sponsored the report because a number of GE organisms
(such as transgenic fish) now exist that had not yet been developed
when the current biotechnology regulations were established in 1986.
The proposed
regulatory changes would include a requirement for ongoing monitoring
of GE organisms after deregulation, and the development of a multitiered
permitting system that both streamlines the approval of crops for
commercial production and provides more oversight for the riskiest
GE organisms.
In March 2004, Mendocino County passed
Measure H, which bans the growing of genetically engineered
plants and animals. Proponents were concerned about cross-contamination
of organic crops by biotech seeds and crops. photo courtesy
of Barbara Alonso |
Mendocino
County ban. On March 2, Mendocino County passed Measure H with
56% of the vote, making it the first county nationwide to ban growing
GE plants and animals. The measure's supporters included the owners
of an
organic brewpub in Ukiah, who wanted to protect the county's organic
produce industry from genetic contamination. Organic producers are
prohibited from using GE organisms or ingredients.
The new
ban has little immediate practical significance because no GE crops
are currently grown in Mendocino County. "The measure and the
vote were largely symbolic," Bradford says. However, he added,
the ban does set a precedent. "If similar measures pass in
counties where GE crops such as herbicide-tolerant or insect-resistant
(Bt) cotton are grown, that could increase the costs of pesticide
use and labor and make California farmers less competitive."
Groups in
other California counties, including Humboldt and possibly Sonoma,
Santa Cruz and El Dorado, are expected to start trying to qualify
similar initiatives for the November 2004 ballot. In addition, Measure
H opponents are considering challenging the Mendocino initiative
in court.
U.S.
labeling movement. The U.S. currently does not require labeling
for foods that contain GE ingredients. In July 2003, U.S. Representative
Dennis Kucinich (D-Ohio) introduced a House bill that would require
food companies to label all foods containing GE material. In addition,
Barbara Boxer (D-Calif.) is expected to introduce this bill to the
Senate by the end of the year.
International trade
After biotech
crops are developed, approved and planted in the United States,
they cannot be shipped to other nations without approval from each
importing country. These rules can vary significantly from country
to country. Some major trade partners of the United States have
taken a precautionary approach toward allowing new biotech crops:
Europe has had a moratorium for 5 years, while Japan approves them
on a case-by-case basis.
Cartagena
Protocol on Biosafety. This global treaty helps member countries
regulate the movement of GE organisms across national borders. The
protocol established a biosafety clearinghouse that allows member
nations to ban GE products that lack safety information, and requires
labeling for international shipments. Effective in September 2003,
the protocol is a supplement to the 1992 U.N. Convention
on Biological Diversity.
As of March,
87 parties, including the European Community, India and the United
Kingdom, had ratified the Cartagena Protocol. Countries that have
not ratified it include the United States, China and the Russian
Federation. Countries that are not members must still adhere to
the protocol's provisions when shipping GE products to participating
nations. In February, protocol members adopted two new documentation
requirements for bulk agricultural shipments.
European
Union and Britain. In January, the European Commission ended
its 5-year moratorium on new GE foods by approving the sale of canned,
frozen and fresh GE sweet corn. (These corn products are
already approved in the United States, Canada, Australia and Switzerland.)
E.U. members have 3 months to endorse or reject the commission's
approval. Britain is currently considering allowing the cultivation
of GE corn; Germany and Spain are the only E.U. countries that grow
GE crops.
— Robin Meadows
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NRC
recommends “bioconfinement” measures
On Jan. 20, a committee of the National Research Council
(NRC) released "Biological Confinement of Genetically
Engineered Organisms," a USDA-sponsored report calling
for measures to prevent genetically engineered (GE) organisms
from escaping into ecosystems or from passing engineered traits
to other species.
The NRC committee's concerns included that GE crops could
pass pesticide or disease resistance to weedy relatives, making
them invasive; GE organisms could breed with or out-compete
their wild relatives; and species engineered to produce pharmaceuticals
could harm people or animals that eat them by mistake.
"Some things, such as future pharmaceutical crops, will
need to be grown under regulation," says UC Riverside
geneticist Norman Ellstrand, director of the UC Biotechnology
Impacts Center and a member of the NRC committee.
Bioconfinement methods for plants include inserting genes
that make them sterile or that keep them from producing pollen.
"Confinement won't be warranted in most cases, but
when it is, worst-case scenarios and their probabilities should
be considered," said NRC committee chair Kent Kirk, professor
emeritus of the University of Wisconsin, Madison.
The NRC committee's recommendations included:
- More research should be conducted about
how bioconfinement methods work.
- More than one bioconfinement method should be
used,
because no single method is likely to be completely effective.
- Combinations of bioconfinement methods should be tested
on representative organisms in a variety of environments.
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