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New Scientist (UK)
July 6, 2002
Drug genes could enter food chain
BY Philip Cohen; San Francisco

Loopholes in US regulations raise fears that food crops will be contaminated
with pharmaceuticals

THE rules the US government is proposing for field tests of crops that have
been genetically modified to produce pharmaceutical products are not strict
enough to prevent the contamination of food crops, experts have told New
Scientist.

They say the proposed rules are based on flawed science, that there are
loopholes allowing them to be bypassed, and that companies do not even have
to disclose what genes have been added. And they warn of severe
environmental consequences if a drug-laced plant were to breed with other
crops or wild relatives.

Biotech companies plan to produce a vast range of products, from drugs to
vaccines, in plants. "These plants have the potential for more benefit than
any other agribiotech product," says Jane Rissler of the Union of Concerned
Scientists in Washington DC. "But to realise those benefits we have to be
very careful about the risks." The US Department of Agriculture's (USDA)
plans don't come close, she says. What scares Rissler and others is that
there could be a rerun of the Starlink debacle, in which GM corn strictly
not intended for human consumption ended up on grocery shelves. If any
contamination involved a crop producing a potent drug, the consequences
could be far more serious, she says.

The proposed rules require the "pharmed" plants to be separated from other
crops in time as well as space. For example, pharmed maize must be grown at
least 400 metres away from other maize. It must also be planted two weeks
before or after nearby crops, so that it isn't fertile at the same time.
Similar regulations have been outlined for other plants that have been
engineered to make drugs, including barley, corn, rice and sugar cane. But
when it comes to keeping harvested products separate, the rules are vague,
talking only of "adequate identification, packaging and segregation".

Companies that violate these procedures can be fined $250,000, and
individuals could face jail sentences of up to five years. James White, the
USDA's branch chief for biotech evaluations, is confident the rules will do
their job: "The chance of gene flow is essentially zero."

"These rules are more stringent than prior recommendations, and I applaud
that," says Norman Ellstrand of the University of California, Riverside, who
sat on a National Academy of Sciences committee that reviewed the
regulations for GM crops. "But there are big holes in the system."

The NAS report points out that some of the USDA's rules have no clear
scientific rationale. For instance, the isolation distance for corn is
simply double the 200 metres it recommends for the production of GM seeds.
The assumption is that this spacing will reduce contamination to 0.1 per
cent, but there is no evidence that the contamination risk drops off with
this increase in distance. Only last week, Australian researchers reported
that pollen from oilseed rape had contaminated fields up to 3 kilometres
away, and that there was no obvious drop-off with distance (Science, vol
296, p 2386).

Another serious concern is that the USDA focuses on the intended use of a
crop product and ignores its other possible impacts. For instance, the
Texas-based company Prodigene applied to grow maize that produces a
chicken-egg protein called avidin, which is known to kill or harm 26 species
of insects. But because avidin is not classed as a drug, the crop doesn't
come under the pharming regulations. Nor did the USDA look at the maize's
environmental impact because the crop wasn't being grown in order to kill
insects. "If they had used the same protein as an insecticide, they would
have called in the Environmental Protection Agency to regulate it," says
Ellstrand.

While avidin's properties are well known, that is not the case with every
drug that might end up being grown in crops. Ellstrand and his colleagues
were disturbed to discover that the publicly available descriptions of genes
spliced into some plants are incredibly vague.

White says the USDA will start posting fact sheets on genes in transgenic
plants later this month. When a company wants to keep the identity of a gene
secret, it will give it a code name and a general description, such as "Gene
S is a hormone in humans. It is harmless to invertebrates," and so on.

He also says the only drugs so far being grown in crops are proteins that
would simply be digested if accidentally eaten by humans or animals. "The
risks are minimal," White says. "No one is making Viagra in a field." But
there's nothing to stop companies producing a Viagra crop if they want to.
"It's a disaster waiting to happen," says Doreen Stabinsky, a science
adviser for Greenpeace. "Grow this stuff in a greenhouse or a cave, not in
an open field where animals can grab the seeds."

Ellstrand agrees that stricter containment is needed. Pharmed plants could
be genetically engineered to prevent gene flow using methods such as the
infamous Terminator technique, which makes seeds sterile, or a newly
proposed one dubbed the Exorcist (see "Begone! evil genes"). And to be
absolutely certain the food supply is safe, he argues that only plants that
aren't grown for food should be used to make drugs.

White points out that when the long-awaited regulations are finally
published, the public will have 120 days to respond. "I wouldn't be
surprised if we got thousands of letters telling us: not in food."


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