Scientists Call for Sharp Curbs on Biopharming

Press Release from the Union of Concerned Scientists

December 15, 2004

Food Supply Vulnerable to Contamination by Drugs and Plastics from
Gene-Altered Crops
UCS Calls for Ban on Food Crops Genetically Engineered to Produce
Pharmaceuticals, Industrial Chemicals

WASHINGTON, D.C. - For more than a decade, corn, soybeans, and other food
crops genetically engineered to produce drugs, vaccines, and industrial
chemicals have been grown on American farms. But a new report by six
agricultural experts now warns that the food supply is vulnerable to
contamination by these "pharmaceutical crops" unless substantial changes are
made in the ways and places such crops are grown and managed.

Based on the experts' findings, the Union of Concerned Scientists (UCS)
today called on the U.S. Department of Agriculture (USDA) to immediately ban
the field production of corn, soybeans, and other food crops engineered to
produce pharmaceutical and industrial chemicals. UCS recommends that the
USDA spearhead a major campaign to encourage and fund safer alternatives
like non-food crops or growing pharmaceutical food crops indoors.

"Nobody wants drugs in their cornflakes," said Dr. Margaret Mellon, Director
of the Food and Environment Program at UCS. "Consumers who discover that
they have unwittingly ingested drugs in their cereal and taco shells are
likely to direct their ire-and their lawsuits -against the companies that
sold them the food."

UCS convened the panel of experts to determine whether it is possible to
produce pharmaceuticals in familiar food crops like corn or soybean (the two
plants most often used for pharmaceutical production) without contaminating
human food or animal feed. The panel-acting independently of UCS-analyzed
the current system for growing food- and feed-grade corn and soybeans and
identified many points where drugs and plastics could pass to the food
supply if pharmaceutical crops were grown under the same system. After
evaluating various approaches to blocking contamination at those points, the
panel concluded that the current corn and soybean production system cannot
be used for pharmaceutical corn and soybean in the United States while
ensuring virtually no contamination of the food and feed system.

"It is sobering that drugs and industrial chemicals could have so many
routes to the food supply," said Dr. David Andow, editor of the technical
report and a professor in the Department of Entomology at the University of
Minnesota. "Pollen can be carried to fields with food crops by the wind or
insects, seeds lodged in the crevices of harvesting equipment could come
loose while harvesting food, and plants can come up as volunteers in the
middle of a food crop. To protect the food supply, each potential route has
to be blocked."

The expert panel said it is theoretically possible for the government to
create a new system that would allow corn or soybean to be safely used as
pharmaceutical crops. Establishing that system, however, especially if it
permits pharmaceutical crop production to continue within traditional
food-crop regions, would require new management systems, new oversight, and
new uses of some equipment and technologies-all built from the ground up.
The expert panel strongly encouraged development of this new system.

UCS doubts the USDA could establish, monitor, and ensure the successful
operation of a new system of this magnitude. Over the past few years, the
federal government has put together a piecemeal system, which, while moving
in the right direction, is not enough to protect the food supply. The better
way to reap the benefits of pharmaceutical crops is to stop the use of food
crops now and begin to explore other production methods, like non-food crops
or plant cell cultures.

"Consumers and food companies alike will not accept a system that allows
drugs to seep into the food supply-even at very low levels," said Dr. Jane
Rissler, Deputy Director of UCS's Food and Environment Program. "But
alternatives will not emerge overnight. That's why the USDA must embark
immediately on a major campaign to encourage and fund alternatives to the
outdoor use of food and feed crops in pharmaceutical and industrial crop
production."

The technical report was written by scientists at Iowa Sate University,
University of Central Florida, University of California at Davis, University
of Illinois, and University of Minnesota, and an agricultural management
expert based in Hudson, Iowa. An introduction to the technical report and
UCS conclusions and recommendations were written by Drs. Mellon and Rissler.
The technical report and UCS conclusions and recommendations are being
released today as one document, A Growing Concern: Protecting the Food
Supply in an Era of Pharmaceutical and Industrial Crops.

A Growing Concern can be found on the web at www.ucsusa.org. Formed in 1969
at the Massachusetts Institute of Technology, UCS is a nonprofit partnership
of scientists and citizens combining rigorous scientific analysis,
innovative policy development and effective citizen advocacy to achieve
practical environmental solutions.

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Scientist group calls for tighter rules on biopharming
By Rachel Melcer
St. Louis Post-Dispatch
Wednesday, Dec. 15 2004

Companies and researchers engaged in biopharming - genetically modifying
crops to produce drugs and industrial chemicals - need to take a step back
if the process is to safely move forward, according to a report released
Wednesday.

The technology could lead to cheap and abundant production of much-needed
vaccines and medical treatments, as well as valuable plastics and polymers,
said a panel of six academic experts commissioned by the Union of Concerned
Scientists, a Washington-based environmental advocacy group.

But unless regulations are tightened and new agricultural oversight systems
put in place, the scientists fear that plant-made chemicals could turn up in
consumers' corn flakes. The Union is calling for an immediate ban on
biopharming research and production in food crops in open fields, to avoid
contamination of the food supply.

"Consumers have a right to safe food," said Margaret Mellon, director of the
Union's food and environment program. "As the system exists today, corn and
soybeans cannot be used" for pharma production without undue risk.

Biopharming, which is still in an early and largely experimental phase, uses
plants such as corn and soybeans to produce non-food chemicals and proteins
that could be harmful if eaten. These valuable ingredients are extracted,
purified and processed into drugs, vaccines or industrial enzymes; the
plants themselves are destroyed.

Monsanto Co. of Creve Coeur, the world's leading producer of genetically
modified crops, has decided not to pursue biopharming. But some of its
corporate competitors, as well as small startup firms, are developing it as
the potential underpinning of a lucrative new industry.

Chlorogen Inc., based at the Nidus Center for Scientific Enterprise in Creve
Coeur, has genetically engineered and grown tobacco plants that contain
human blood plasma. Sigma-Aldrich Corp., headquartered downtown, is
developing expertise in extracting and purifying active ingredients from
biopharm crops. Their efforts are welcomed by civic leaders working to
expand the local biotech economy.

The Union of Concerned Scientists doesn't want to halt this type of
progress, Mellon said. But it does not believe the U.S. Agriculture
Department is properly regulating it. The Union worries that biopharm crops
will cross-pollinate with those meant for food production; or that biopharm
seeds will inadvertently mix into the general-use supply.

"The USDA ... has failed to allay concerns. The (oversight) system, despite
being headed in the right direction, is still a work in progress. The
piecemeal manner in which its provisions were issued make it unclear whether
they are voluntary or mandatory," the UCS report said.

Jim Rogers, a spokesman for the USDA's Animal and Plant Health Inspection
Service, which regulates biotech crops, said the agency's requirements "are
pretty stringent now" - and they are in the process of being revised to keep
up with advances in technology.

Roger Beachy, president of the Donald Danforth Plant Science Center in Creve
Coeur, said scientists must be free to experiment in open fields if they are
to understand and develop biopharming techniques. These experiments are
adequately controlled, and new genetic technology is increasing the number
of ways in which crops can be produced without risk of cross-pollination, he
said.

"A ban would significantly halt the technology of producing drugs more
cheaply in plants" than through current methods, Beachy said. And if work on
biopharming to grow industrial chemicals were halted, "then you have stopped
another kind of advance that we're looking for to give an economic advantage
to our farmers."

The Union's call for a ban goes further than the recommendations of the
scientists it empaneled. The academics - including Henry Daniell, who
developed the technology on which Chlorogen is based - simply say that much
care must be taken. They present three possible paths, each with its own
challenge:

Geographically isolate particular biopharm crops, corn or soybeans for
example, from those grown for food use - but there might not be enough
suitable land available.

Implement a biopharm production system entirely separate from commodity
agriculture, from seed development and sales through harvest, distribution
and processing - though this would be very expensive.

Limit biopharming to non-food crops, such as tobacco, guayule (which is used
in rubber production), or jojoba (which produces oil for industrial
purposes) -but much research would have to be done to understand and
genetically modify these plants.

"All three of these will require some additional work and regulatory
oversight in order to make sure that ... there is virtually zero
contamination of the food supply," said David Andow, a University of
Minnesota entomologist and editor of the report.

Questions raised by the panel should be examined, Beachy said. "We need
criticism and caution to be presented - but then we should allow the
technology to respond appropriately and to meet the challenges (so) this
whole area can move forward."

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Oversight on Bioengineered Crops Is Poor, Report Says

By Rick Weiss
Washington Post Staff Writer
Thursday, December 16, 2004

Federal oversight of crops genetically engineered to produce medications in
their seeds and leaves is inadequate to prevent unwanted contamination of
food crops, according to an analysis released yesterday by a scientific
advocacy group. As a result, the report concludes, consumers are at risk of
inadvertently dosing themselves with prescription drugs while eating a
morning bowl of cereal.

The report, which biotech executives and regulators denounced as
overwrought, is the latest to look at the small but rapidly growing "pharma"
sector of agriculture, in which corn, soybeans and other plants are being
designed to produce high-tech drugs or industrial compounds in their
tissues.

The approach has many advantages over traditional systems for manufacturing
those products, including potential cost savings, the report concludes. But
it also raises the specter of accidental contamination of the food supply
with blood thinners, hormones or any of the scores of biologically active
compounds being made experimentally in plants.

"No one -- not consumers, not food companies, not biotech companies -- wants
to discover drugs in our cornflakes," said Margaret Mellon of the Union of
Concerned Scientists (UCS), a group long critical of the federal regulatory
scheme for agricultural biotechnology.

The group commissioned six independent experts in the fields of agronomy,
entomology and ecology to conduct an analysis of the fledgling industry,
which makes a few chemicals for industrial uses and an array of drugs, none
of which is yet approved for marketing. The analysis concluded that
significant changes are needed in the way the Agriculture Department
oversees the cultivation of such plants if the risk of contamination is to
be brought close to zero.

"Genes can move in pollen by wind or insects. Seeds can get stuck in
machinery or mixed in storage and transportation systems. There are very
many routes of vulnerability," panel chairman David Andow of the University
of Minnesota said yesterday in a telephone news conference timed to coincide
with release of the report, "A Growing Concern: Protecting the Food Supply
in an Era of Pharmaceutical and Industrial Crops."

The expert panel -- which Andow said operated independently of the UCS --
recommended that any one of three approaches be taken: Grow pharma crops in
geographically isolated parts of the country; set up a harvest, storage and
processing system completely separate from the existing network of farm
equipment, silos and other facilities used to grow and store food crops; or
ban all outdoor cultivation of food crops engineered to make medications or
chemicals -- a move that would require companies to switch to less familiar
plant species for their pharma experiments.

The UCS called for such a ban yesterday, saying it is unrealistic to think
that any other system could prevent cross-contamination.

History shows that genetic isolation of crops is a challenge. In 2002, for
example, ProdiGene Inc. botched efforts to contain a pig vaccine it was
developing in corn. With contamination of field corn and soybeans suspected,
large quantities of those crops had to be burned, and the USDA began to
develop new rules.

In March 2003, those rules went into effect. They require larger buffer
zones around pharma fields to decrease the odds that gene-altered pollen
will drift onto conventional crops; dedicated farm equipment to make sure
altered seeds and other plant parts do not get mixed with food crops; a
sevenfold increase in federal inspections of experimental fields; and other
restrictions.

Those safeguards are "absolutely" adequate, said Cindy J. Smith, deputy
administrator of biotechnology regulation for the USDA's Animal and Plant
Health Inspection Service, which oversees pharma crops. Smith noted there
were only 44 acres devoted to U.S. field trials of such crops this year.

The guidelines are "very stringent" said Lisa Dry, a spokeswoman for the
Biotechnology Industry Organization. "This is not some cavalier, 'Let's grow
some duckweed and make some drugs!' "

Andrew Baum, president and chief executive of SemBioSys Genetics Inc., a
Calgary-based pharma crop company growing drugs in safflower, said food
crops are ideal for the new science because their biology is so well
understood. He said he opposes a ban but welcomes governmental oversight, if
nothing else, to allay the emerging business sector's liability concerns.

"We realize that if we screw this up, we're out of business," Baum said. "We
want regulation, and we want it visible. I mean, bring it on."

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