www.checkbiotech.org ; www.raupp.info ; www.czu.cz

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", November 2006 by Shreema Mehta.

In response to a bill proposed last year that would have put a moratorium
on biopharming crops 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 banned
biopharming in the state. While the bill was not passed, 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.

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.

[newstandardnews.net]

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