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Oregon Committee Invites Contested ‘Biopharmingâ€TM of GE Plants*

by Shreema Mehta

As companies experiment with growing drugs in common food crops, watchdogs say even the most deliberative attempts by government to scrutinize the practice fall short of protecting the public.

*A correction was appended to this news article after initial publication.

Nov. 8, 2006 – The latest spat over genetic engineering centers on Oregon, where activists and regulators are battling over the safety of so-called "pharmacrops" – controversial plants genetically modified to produce medicine through "biopharming."

In response to a bill proposed last year that would have put a moratorium on some biopharming in Oregon, a state committee has recommended inviting biopharming in the state, with a few caveats. The committee wants the state to have a say in permit approval for the technology, as well as increased public access to the application process.

But critics say the proposed safeguards will do little to reduce threats biopharmaceutical crops poses to the environment and food supply. There are currently no such crops growing in Oregon.

Pharmacrops are grown by splicing human or animal genes onto plants such as corn or tobacco. The genetic engineering causes the plants to produce proteins that can be used to make pharmaceuticals. Proponents say the technology can mass producing medicines easier and cheaper.

But some scientists and environmentalists oppose the practice. They worry pollen from the genetically engineered (GE) plants, or the plants themselves, will contaminate surrounding soil and other crops, including food grown for humans. Critics are especially concerned about the use of plants like corn or rice for biopharming, because the practice could facilitate pollution of the food-crop supply with potentially dangerous drug ingredients.

Critics worry genetically engineered will contaminate human food supplies.

Some critics also doubt that reduced drug-production costs will mean savings for consumers.

Although some major biotechnology players such as Monsanto have backed down from biopharming, at least 20 companies have invested in the science, estimates Michael Phillips, vice president of the Biotechnology Industry Organization.

The Food and Drug Administration is reviewing some biopharmed drugs, though it has not yet approved a drug developed from a genetically modified plant.

Last year, Oregon lawmakers considered legislation that would have placed a moratorium on biopharming any types of crops commonly used as food for humans or animals. It also would have banned all outdoor pharmacrops. While the bill was not passed, the state Senate and governor ordered the departments of Agriculture and Human Services to form a committee to make recommendations on how biopharmaceuticals should be produced in the state.

Instead of recommending a moratorium on biopharming, the Oregon committee urged a memorandum of understanding with the federal government that would allow state "input" on the federal review of biopharming applications. The committee also "encouraged" avoiding the use of food crops, instead using plants such as tobacco.

In the event that crops like corn are used in biopharming, the committee suggested having a comprehensive safety plan in place to prevent the contamination of food crops through cross-pollination or other avenues.

Some critics also doubt that reduced drug-production costs will mean savings for consumers.

Dan Hilburn, an administrator with the Oregon Department of Agriculture, said the committee’s recommendations require extra safety precautions missing in USDA enforcement while allowing a practice that can potentially produce necessary drugs on a large scale.

"If you consider the USDA review that happens now, that review is pretty much the same for Oregon or Idaho," Hilburn told The NewStandard. With different crops and geography, he added, states need their own review process.

Some scientists and environmental activists say the USDA has been weak in enforcing biopharming regulations and applaud the Oregon recommendations as a step forward in regulating biotechnology companies. But they add that the recommendations do not go far enough to contain the threat of genetically modified plants dispersing into the soil and human food supply.

Some critics say biopharming should be restricted to types of plants not also eaten by people; others call for a total ban on the practice.

"Think about producing a drug in a pharmaceutical factory," said Bill Freese, an analyst with the advocacy group Center for Food Safety. "You can imagine the stringent controls in place. Now think about growing a plant that’s been engineered [when] you can’t control the soil."

With wind, insects and other factors driving dispersal, containing engineered crops grown outside expensive greenhouses is nearly impossible. In numerous cases, genetically modified crops planted outdoors have cross-pollinated with nearby food supplies or otherwise been mixed with non-GE plants.

As previously reported by TNS, in August the USDA announced that Bayer Science had quietly reported that a genetically engineered rice strain had contaminated commercial rice supplies. In 2004, Syngenta admitted it had sold unapproved GE maize in the US. In 2001, the USDA ordered now-defunct ProdiGene to destroy 155 acres of corn after finding genetically-engineered corn plants growing in nearby soybean and corn fields that were supposed to be GE-free.

The USDA does nothing to ensure that growers will restrict public access to pharmacrops – even plants that look and taste like their conventional food counterparts.

But Hilburn, of the Oregon Agriculture Department, said the state review process would minimize dispersal by placing the engineered crops in a greenhouse or establishing a wide distance between genetically engineered crops and food crops.

Freese challenged that solution as inadequate, saying his group thinks biopharming should not be done in types of crops also used for food, "especially when you’re dealing with an irresponsible industry."

Biopharming can also harm the environment, said Jane Rissler, a senior scientist with the Union of Concerned Scientists. "Plant material breaks down in the soil," she told TNS. "They would release the compound [produced by the spliced gene], some of which could be harmful to microorganisms, insects, birds." The group Physicians for Social Responsibility has echoed this concern.

Biotechnology companies are not the only targets of criticism. An internal audit by the USDA’s inspector general found that the agency has failed to minimize the chance that GE crops such as corn or rice will cross-pollinate with crops grown for food. After approving applications to grow GE crops, the USDA does nothing to ensure that the permit holder will restrict public access to them – even plants that look and taste like their conventional food counterparts.

Auditors concluded that the USDA did not adequately enforce its own regulations. Crop inspectors sometimes failed to record permit violations and did not keep track of companies’ required progress reports. The result was firms often self-reported violations late or not at all, without any federal oversight. Inspectors also sometimes failed to inspect all required sites.

The Oregon committee report calls for public comment periods to be part of the biopharming permit process. But Freese said the recommendation to increase public access to biopharming permit applications will do little to hold companies accountable. "I think you have to look at that, and you have to decide to what extent are [state officials] really serious, and to what extent is it fluff to satisfy their critics," he remarked.

Freese predicted the call to establish a "memorandum of understanding" between the federal and state governments will lead to the state bowing to federal regulators.

Phillips, the industry advocate, argued that biopharming can allow companies to produce cheaper drugs on a larger scale, and that companies with a rising demand for a certain drug would find it easier to use plants for production. "You don’t have to have the brick and mortar of labs that have to meet stringent standards," he said.

Advocates for stricter biopharming regulations say they are skeptical of any suggestion that the process will yield cheaper drugs, since patent-holding drug companies often have a virtual monopoly on a particular drug and charge what the market will bear.


Minor Change:

The original version of this article stated that a 2005 bill considered by the Oregon legislature would have put a moratorium on biopharming. In fact, the bill would have put a moratorium only on raising biopharmaceuticals in crops usually used food, or growing any pharmacrops in an outdoor environment.

The original version also stated that the state Senate ordered the departments of Agriculture and Human Services to form a committee to make recommendations on how biopharmaceuticals should be produced in the state. In fact, both the Senate and the governor made this charge.

 | Change Posted November 9, 2006 at 16:34 PM EST

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The NewStandard ceased publishing on April 27, 2007.

Shreema Mehta is a staff journalist.

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