POSTED: 8 JUNE 2004 - 8:00am HST

Biopharming Lawsuit

Not exactly a mortar and pestle.This is a fully automated TFF (Tangential Flow Filtration)
System from
the biopharmaceutical division of CEM Engineering Inc, Mission Viejo CA.

Biopharming Lawsuit
by Joan Conrow in April 2004 in the Honolulu Weekly

Forget the sterile labs, petri dishes and test tubes that produced so many drugs in the past. Tomorrow’s "miracle cures" are more likely lurking in plants, and not the kind traditionally used by healers, or anyone else, for that matter. Instead, researchers are tinkering with the genetic structure of staples like soybeans and rice so they produce proteins or chemicals needed to make drugs and other industrial substances. This new approach to manufacturing is one of the more controversial applications of genetic engineering, driven by drug and chemical companies eager to cut costs and accelerate product development. They view commodity crops as a relatively cheap and easy way to obtain large quantities of the raw materials needed for their trade, and they’ve slowly begun moving their research outdoors, perhaps to a corn field near you.

That’s the part that worries Earthjustice attorney Paul Achitoff. The U.S. Department of Agriculture has permitted hundreds of open-air trials for biopharmaceutical plants, which produce growth hormones, vaccines, blood thinning and clotting agents, enzymes and numerous other compounds, but refuses to disclose the exact locations of test sites. It’s likely, however, that some are in Hawaii, given the state’s dubious distinction as the world leader in open-field testing of other genetically modified crops, with some 4,000 conducted to date.

Achitoff and his clients -- representing a coalition of local and national organizations -- believe that people have a right to know where biopharmaceuticals are being grown, especially since none have been approved for use by human or animals. They’re trying to force disclosure through a lawsuit against the Hawaii Department of Agriculture that challenges the agency’s right to restrict access to public records -- namely the applications for testing permits filed by industry representatives.

“The shroud of secrecy surrounding biopharming is unacceptable,” Achitoff said. “Clearly, risks do exist, and they’re not always the obvious ones.”

He and his clients are pursuing another lawsuit, filed last November, aimed at requiring the USDA to take a closer look at those risks. “Industry is basically regulating itself, and their attitude has consistently been there aren’t any environmental risks,” Achitoff said. “But of course there have been any number of instances that have shown the controls are not adequate to contain these crops in open fields.”

In recent years, the USDA has destroyed large quantities of soybeans and corn inadvertently contaminated by biopharm crops due to drifting pollen and a storage mix-up. The incidents prompted critics to renew their call for a ban on the use of food crops in biopharming, contending the practice endangers the nation’s food supply. America’s giant food processing industry, worried about expensive recalls in the event of future contaminations, also supports such a move. Even the Biotech Industry Organization endorsed a moratorium on open-field testing of corn, the most popular biotech crop, in the Midwest farm belt.

Locally, activists are concerned that biopharming could derail the state’s $35 billion seed corn industry. But they’re even more worried about environment damage, saying biopharming poses unacceptable risks to Hawaii and its many endangered plants and animals. “Pollen from plants that are engineered to produce powerful chemicals will assuredly be carried by trade winds and eaten by insects and birds,” said Cha Smith, executive director of KAHEA, which joined the Earthjustice lawsuits. “There is no way to prevent the spread of genetic material to native plants and animals.”

The lawsuit would require the USDA to conduct an EIS (Environmental Impact Statement) on its regulatory program for genetically engineered crops in general and biopharmaceuticals in particular, as well as for each field trial.

Achitoff said the EIS process is important because it would force industry to reveal its rationale for present practices and explore alternatives, while giving the public more say. The agency also would have to consult with the U.S. Fish and Wildlife Service to determine if any endangered species could be affected by a proposed field trial.

Government attorneys have filed motions to dismiss the suit on the grounds that all biotech field trials in Hawaii are complete, so the action is moot, and besides, the plaintiffs can’t prove they’ve been harmed by the field trials because they don’t even know where the tests took place.

The USDA, meanwhile, announced earlier this year that agency regulations -- tightened after the biopharm contamination incidents to include a one-mile buffer zone around genetically engineered crops and at least five agency inspections during each growing season -- will be reviewed and perhaps revised. The agency will begin by preparing an EIS to evaluate its biotechnology rules, although a USDA spokeswoman insisted the action was not prompted by the Earthjustice lawsuit.

“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,”said Agriculture Secretary Ann M. Veneman in a prepared statement. Still, she maintained that existing rules had been adequate
“to ensure the safe field testing of more than 10,000 GE (genetically engineered) organisms and deregulation of more than 60 GE products.”

Veneman also noted that the Bush Administration had developed a compliance and enforcement unit to ensure agency rules are followed.

Achitoff, who expects to see the USDA lawsuit resolved this year, remains unimpressed by the agency’s claims. “No matter what they’re doing, it can’t possibly be adequate,” he said.


Protesters arrrested at biotech conference
By Paul Elias on 8 June 2004 in the Associated Press

Police arrested 29 protesters Tuesday after some allegedly chained themselves together and blocked an intersection near where a biotechnology conference was being held.

About 200 other demonstrators critical of the $40 billion industry protested on the sidewalks, but failed to shut down the annual Biotechnology Industry Organization gathering, as they had vowed. They did cause minor disruptions, however, harassing and heckling conference attendees as they attempted to enter the Moscone Convention Center.

‘‘Arrest them!" protesters shouted when police helped attendees cross the otherwise barricaded street in front of the center.

Most of the protesters, such as Kamala Stuart, 53, of Oakland, were demonstrating against genetically modified food. ‘‘They should label the food, if they think it's so good," she said, waving a sign that stated, ‘‘label GM Foods." ‘‘We want people to know, to question this stuff."

But conference organizers said most attendees were affiliated with the pharmaceutical industry, not the food industry. ‘‘This is a protest rooted in ignorance," said Jeffrey Feldman, a merchant banker from Philadelphia attending the conference.

An estimated 18,000 biotechnology scientists, executives and government officials are in town for the convention.

About 12 protesters were arrested when they carried out what they called ‘‘guerrilla gardening" in the intersection in front of the center. Surrounding some potted plants, they linked themselves together by grasping chains covered with plastic pipe. It was unclear what the others were arrested for.

A group calling itself Reclaim the Commons had said it would try to prevent attendees from entering the convention center Tuesday. Protesters say genetically engineered crops haven't been adequately proven safe for human consumption and the environment.

BIO officials have said they support the right of protesters to peacefully demonstrate, but wondered how anyone could be against fighting disease, which they say is the main focus of most of the industry.


!-- End of StatCounter Code -->