Organic Consumers Association

Lawsuit Filed Against Biopharm Crops

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Lawsuit Challenges Open-Air Testing of Genetically Engineered 'Biopharm'

USDA Not Adequately Protecting Food Supply

NOVEMBER 12, 2003

HONOLULU - November 12 - Attorneys with Earthjustice and the Center for Food
Safety filed suit in federal district court in Honolulu today asking the
court to order the U.S. Department of Agriculture (USDA) to assess the
environmental and public health risks of, and better regulate, the open-air
testing of biopharmaceutical test crops in Hawaii and throughout the United
States. The attorneys represent a coalition that includes Friends of the
Earth, KAHEA, Pesticide Action Network North America, and Center for Food

USDA has authorized corporations such as Monsanto, DuPont, ProdiGene, and
Dow to conduct hundreds of field tests of biopharm crops genetically
engineered to produce pharmaceuticals, industrial chemicals, and other
medical and industrial products, including a blood clotting agent, a blood
thinner, various blood proteins, experimental animal vaccines, industrial
enzymes, antibodies, and a potent abortion-inducing compound once considered
for use as an AIDS drug. Well over 4,000 field tests of genetically
engineered crops have been conducted in Hawaii, more than anywhere else in
the world, including more than two dozen tests of biopharm crops.

None of these biopharm crops has been approved for human or animal
consumption, or even for general release into the environment. Despite 12
years of open-air field testing, not a single plant-produced biopharm drug
has been approved by the FDA. Yet USDA allows these tests to be conducted in
open fields, conceals the trials' locations from the public, and in most
cases refuses to disclose the substances being grown. Moreover, the tests
typically use food crops like corn and soybeans, dramatically increasing the
risk of contaminating the food or livestock feed supply with powerful,
biologically active chemicals.

Farmers are kept in the dark about biopharm experiments taking place in
their vicinity, and other members of the public are unaware that
experimental drugs and chemicals could contaminate their food. Yet neither
USDA nor any other government agency has prepared an Environmental Impact
Statement or assessed the risk to endangered species. USDA's regulation of

field-testing is inadequate to assure that biopharm crops do not contaminate
soil or food supplies, harm humans or wildlife, or cross-breed with wild or
other farmed plants. This lack of oversight violates the National
Environmental Policy Act and the Endangered Species Act.

"The shroud of secrecy surrounding biopharming is unacceptable," said Paul
Achitoff of Earthjustice. "Members of the public have the right to know
about these potentially harmful substances being grown in their backyards."

Biopharm testing in Hawaii carries risks above and beyond those of testing
elsewhere. Hawaii has over 300 endangered species - more than a third of all
U.S. endangered species and more per square mile than anywhere else on earth
- and about 97 percent of all native species in Hawaii are found nowhere
else. Open-air biopharm field trials risk catastrophic impacts to these

Hawaii also hosts a large seed corn industry, valued at $35 million annually
and using about 3,000 acres, that ships seed all over the world. Corn is the
most popular biopharm crop, and corn also disperses pollen over a wide area,
where it may pass its genetic material to seed corn. Last year the U.S.
Environmental Protection Agency fined Dow AgroSciences and Pioneer Hi-Bred
International for increasing the risk of cross-breeding by failing to comply
with permits to test non-biopharm genetically engineered corn on Kaua`i and

"Open-air testing of genetically engineered plants in vulnerable ecosystems
presents unacceptable risks to Hawaii's fragile biodiversity," said Cha
Smith, executive director of KAHEA. "Pollen from plants that are engineered
to produce powerful chemicals will assuredly be carried by trade winds and
eaten by insects and birds. There is no way to prevent the spread of genetic
material to native plants and animals."

A 2002 study by the National Academy of Sciences found the environmental
impacts of biopharm agriculture cannot be predicted, and that the novel
compounds being produced by these plants may contaminate human and animal
food supplies.

"Despite the Starlink corn fiasco, regulation of biotech crops remains way
behind the science," said Skip Spitzer, program coordinator at Pesticide
Action Network North America. StarLink is a transgenic corn variety that was
approved only for animal feed but found its way into the human food supply,
prompting hundreds of product recalls.

Other scientific reviews indicate that, despite USDA's existing regulatory
program, growing such crops could:

(a) Spread new and unwanted compounds into the air, water, soil, foods and
beverages that could threaten public health;

(b) Pose occupational safety hazards, since chemicals from biopharm crops
may cause harm to humans through inhalation, unintended ingestion and skin
contact; and

(c) Persist in the environment and bioaccumulate in wildlife, plants, and
soil microorganisms leading to both acute and chronic toxicity and major
ecological disruption.

USDA regulates biopharm agriculture under the Plant Protection Act, which
authorizes the agency to publish regulations "to prevent the introduction of
plant pests into the United States or the dissemination of plant pests
within the United States." Under those regulations, genetically engineered
pharmaceutical- producing plant varieties are regulated as potential plant
pests. Permits for biopharm field tests are issued by USDA's Animal and
Plant Health Inspection Service (APHIS).

"Until the USDA develops a system to contain these biopharm 'plant pests,'
the utmost caution should be taken," said Joseph Mendelson, legal director
for Center for Food Safety. "The existing regulatory system merely assumes
that growing these crops is harmless, even in places where they can
contaminate the environment and get into the food supply."

The lawsuit filed today asks the court to require USDA to develop an
Environmental Impact Statement, to consult with the Fish and Wildlife
Service as required by the Endangered Species Act, to fully consider the
effects of growing biopharm crops on listed species, and to develop
regulations that adequately protect public health and the environment.

Mistakes on Record

There have already been potentially dangerous slip-ups. Last fall, for
example, USDA had to quarantine and destroy 500,000 bushels of soybeans in
Nebraska meant for human consumption that had been contaminated with corn
genetically engineered to produce a pig vaccine. At about the same time,
USDA ordered that 155 acres of corn in Iowa be pulled and burned because of
potential contamination from biopharm crops. The grower in both instances,
ProdiGene, is conducting open-air field tests in Hawaii.

"Given the USDA's failure to adequately assess health and environmental
impacts and its careless handling of genetically engineered pollution last
year, there's no way the government can claim biopharming is safe," said
Larry Bohlen of Friends of the Earth. "Researchers should focus instead on
developing fermentation production systems that are containable,
controllable and, unlike plant biopharming, are a proven means to produce

Secretive Testing

In July 2003, Earthjustice, on behalf of Center for Food Safety, filed a
suit in First Circuit Court, State of Hawaii, against the Hawaii Department
of Agriculture seeking public access to state records regarding biopharm
field tests in Hawaii that may contain important information about the kind
of substances being produced, how and where these substances are being
released, and what the responsible authorities are doing to control them.
The agency has refused to release any information, in violation of the state
open records law. See Center for Food Safety v. Department of Agriculture,
Civ. No. 03-1-1509 (2003).

Read complaint filed today:

Backgrounder: Genetically Engineered Biopharmaceutical Crops



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