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 Hawai'i, 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 Hawai'i carries risks above and beyond those of testing elsewhere. Hawai'i 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 Hawai'i are found nowhere else. Open-air biopharm field trials risk catastrophic impacts to these species.
Hawai'i 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 Moloka`i.
"Open-air testing of genetically engineered plants in vulnerable ecosystems presents unacceptable risks to Hawai'i’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 Hawai'i.
"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 pharmaceuticals."
In July 2003, Earthjustice, on behalf of Center for Food Safety, filed a suit in First Circuit Court, State of Hawai'i, against the Hawai'i Department of Agriculture seeking public access to state records regarding biopharm field tests in Hawai'i 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).