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December 16, 2004, Rick Weiss, Washington Post--CropChoice.com:
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."
Source: http://www.washingtonpost.com/wp-dyn/articles/A3132-2004Dec15.html
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