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

A new generation of genetically engineered crops that produce drugs and
chemicals is fast approaching the market - bringing with it a new wave of
concerns about the safety of the global food and feed supply, April 2007
by Denise Caruso.

The plants produce medicinal substances like insulin, anticoagulants and
blood substitutes. They produce vaccine proteins for diseases like cholera,
as well as antibodies against tooth decay and non-Hodgkin?s lymphoma.
Enzymes and other chemicals from the plants can be used for a range of
industrial processes.

As in past debates over genetically modified crops, biotech developers say
that the benefits outweigh the risks, and that the risks are manageable.
Critics question the benefits, and say the risk of a contaminated and
potentially toxic food supply is untenable.

In the middle, balancing economic benefit and public safety, are our
appointed arbiters of risk, the government regulators.

Controversies over biotech risk are caused by a crisis in ?official
scientific expertise,? according to Jerome Ravetz, an associate fellow at
the James Martin Institute for Science and Civilization at the University of
Oxford.

The crisis, he said, stems from the conflicting roles of government. On one
side, businesses provide regulators with scientific evidence about the risk
and safety of their product innovations. On the other, suspicious citizens
demand that regulators challenge that evidence.

The side whose expertise is accepted as ?official? calls the shots.

So far, the business sector has tipped the scales in its favor. Despite
science-based concerns voiced by farmers, environmentalists and even its own
researchers, the United States Department of Agriculture has approved more
than 100 applications to grow so-called biopharma crops of corn, soybeans,
barley, rice, safflower and tobacco in the United States.

Developers say these crops are the best way to achieve the economies of
scale and cost savings that will let them meet rising demand for drugs like
human insulin.

They acknowledge that growing pharmaceutical crops is riskier than making
drugs in factories. They know that the plants contain potentially toxic
drugs and chemicals, and because they look like ordinary crops, they can be
mistaken for food, both before and after harvest.

The most important thing, then, is to keep biopharma plants, pollen and
seeds confined to the fields where they are planted. Otherwise, they may
contaminate other crops, wild relatives and the environment.

Developers say they have worked with the Agriculture Department to develop
containment procedures for biopharma crops.

?Under our system, the degree of oversight is commensurate with the risk of
the crops,? said John Turner, director of the policy coordination program
for the agency?s Biotechnology Regulatory Services. ?We take extraordinary
measures to make sure these pharma and industrial crops are kept separate
and confined.?

To this end, some developers use plants like rice and safflower that
self-pollinate, reducing the risk of contaminating nonpharma plants by wind
and insect pollination.

They also provide regulators with data on the potential health and
environmental effects of the special chemicals in their crops.

For example, SemBioSys, a Canadian company, has applied to the U.S.D.A. for
permits to grow safflower-based human insulin. It is already field-testing
safflower crops in the United States and Chile that produce carp growth
hormone for aquaculture feed, to bolster the weak immune systems of farmed
shrimp.

The company?s chief executive, Andrew Baum, says ?categorically? that the
insulin derived from its plants has no biological effects while in plant
form, and is activated only after processing. And the evidence his company
has gathered indicates that its carp growth hormone affects only shrimp.

The new methods, Mr. Baum said, can cut capital costs by 70 percent, and
?reach levels of scale easier than any other system.?

But there is some scientific evidence not acknowledged in biopharma risk
assessments that casts a dark cloud over this silver lining.

For starters, the ?system? under discussion is nature, and despite our best
efforts it always manages to elude our puny attempts at controlling it. The
containment practices used by developers assume an ability to control living
and propagating organisms, which scientific evidence does not support.

One scientist familiar with some of the issues raised by pharma crops is
Norman C. Ellstrand, a professor in the department of genetics at the
University of California, Riverside, and director of its Biotechnology
Impacts Center. Professor Ellstrand is known as a fair and credible critic
of various aspects of agricultural biotechnology.

He is deeply skeptical that efforts to confine biopharma genes in open
fields will work.

?I don?t think that engineering plants for pharma is a bad idea, with two
caveats,? Professor Ellstrand said. One, he says he thinks that planting
should be done in greenhouses rather than in open fields. ?The other issue
is food,? he said. ?Why do we have to do this in food crops? It doesn?t
matter what you?re squeezing the compound out of. It could be a carnation, a
corn plant or a castor bean.?

Professor Ellstrand also said that self-pollination does not eliminate gene
flow between plants, and that cross-pollination is not the only way that
pharma crops can escape confinement. Once harvested, seeds can move easily,
accidentally or deliberately, across and beyond borders. As a result,
valuable biopharma crops may well end up growing in fields far from the
controlled environment on which developers depend for safety. And what
happens from there is anyone?s guess.

Once the rogue seeds are replanted, could the plants thrive in their new
home and possibly overtake native varieties or wild relatives? Could the
pharma trait increase in frequency and concentration, until it reaches a
?dose? that causes health effects in those who consume it unwittingly? The
probability for any one of these situations may be low, Professor Ellstrand
said, but the scientific answer to each question is yes.

What is most worrisome is that the Agriculture Department seems to reject
such reasonable, science-based public safety concerns. Agency policy allows
developers to withhold data on pharma crops from the public as confidential
business information, and the public is not allowed to comment on biopharma
planting applications until after an official risk evaluation is completed.

Such behavior has raised the hackles of many farmers and food producers who
are concerned about biopharma crops. Rice farmers, in particular, know what
happens when a food crop is contaminated with unapproved genes. The U.S.D.A
has presided over two such scares in less than a year, and the rice industry
has suffered greatly as it tries to purge contaminants from crops.

AT the end of March, the Agriculture Department approved a permit allowing a
California biotech company, Ventria Bioscience, to plant its pharmaceutical
rice in open fields in Kansas.

Ventria?s pharma rice is engineered to produce two of the human proteins
found in breast milk and other body fluids. Once harvested, the proteins
will be used in treatments for diarrhea and infections, as well as in
nutritional supplements.

In a public comment demanding that the Agriculture Department withdraw the
Ventria approval, the U.S.A. Rice Federation wrote: ?If Ventria?s
pharmaceutical rice were to escape into the commercial rice supply, the
financial devastation to the U.S. rice industry would likely be absolute.
There is no tolerance, either regulatory or in public perception, for a
human gene-based pharmaceutical to end up in the world?s food supply.?

So whose market is more important: the farmers? or the drug makers?? Whose
health matters more: people who need drugs or people who eat food?

Scientists often dismiss the idea that people without technical knowledge
can help them make risk assessments. As a result, biotech scientists and
regulators have long made safety determinations from within an opaque system
of their own design, using only the evidence they accept as valid.

But scientific evidence is not a constant, like the speed of light or pi.
Especially in biology, where we still know so little, ?evidence? is often
just a small circle of light surrounded by the darkness of the unknown.
Decisions about risk cannot safely be made in a private club that accepts
only its members? notions of scientific evidence.

The best research on risk declares the opposite to be true: that risk
evidence is particularly subject to distortion by conflicting interests, and
that the best foil for such distortions is to ensure that the people whose
fate is at stake participate in the analysis.

We need a new policy framework for scientific evidence that is built on this
foundation. If developers want to sell their products, they must subject
their inventions to the helpful scrutiny of people outside the club ? before
radical technologies like biopharma are brought to market.

[www.nytimes.com]