www.czu.cz ; www.raupp.info

As detailed in last month?s ISB News Report ("Plant-made pharmaceuticals:
progress and protests"), Sacramento-based Ventria Bioscience sparked a
controversy with its plan to cultivate rice engineered to synthesize
pharmaceutical proteins, November 2004 by Phillip BC Jones .

In July, the Friends of the Earth, Center for Food Safety, Consumers
Union, and Environment California sent copies of a 22-page report,
"Pharmaceutical Rice in California," to California?s Department of Food and
Agriculture, Department of Health Services, and Environmental Protection
Agency. After describing concerns about the genetically modified rice, the
groups urged a moratorium on pharmaceutical-producing crops until state
agencies have investigated potential impacts on human health and the
environment.

A few weeks after the release of the report, representatives of the
International Academy of Life Sciences (IALS) published its views. In a
letter to the same three Californian agencies, Drs. Hilmar Stolte (Hannover
Medical School, Germany) and Robert Rich (University of Illinois,
Urbana-Champaign) countered that the report does not present an objective or
accurate perspective of the risks. Stolte and Rich went further by
concluding that "the authors of this report have intentionally confused
?risk? with ?hazard,? presenting the hazards as if they were risk."

The Center for Food Safety responded to the IALS allegations in a letter
sent to the Californian health, agriculture, and environment agencies. At
the outset, Dr. Doug Gurian-Sherman (Center for Food Safety) and Bill Freese
(Friends of the Earth) targeted the IALS? claim that the "academic
community" supports the idea of producing pharmaceuticals in food crops.
They pointed to recent studies from the National Research Council as
evidence that this strategy for synthesizing drugs does not benefit from a
consensus of the scientific community.

Gurian-Sherman and Freese tackled the IALS contention that their report
confuses risk and hazard. Their report to the Californian agencies, they
stressed, highlights that their concerns represent potential risks, or
hazards that might occur. They explained that the groups called for the
state?s agencies to perform an independent risk assessment to cure a
deficiency in federal regulation. "Federal regulatory agencies," they
asserted, "have not performed risk assessments to determine either how
serious the identified hazards are, the levels of exposure that may cause
harm, or the likelihood that they may occur." In their view, a responsible
risk assessment process must find that a hazard does not exist, or, if the
hazard does exist, that exposure to the hazard either does not occur or is
too low to cause significant harm.

The Center?s response also contends that the IALS exaggerated the
feasibility of producing pharmaceuticals from crops. Gurian-Sherman and
Freese noted that the U.S. Food and Drug Administration has approved over
100 biopharmaceuticals produced in controlled fermentation facilities,
whereas biopharming has not yielded an FDA-approved pharmaceutical despite
14 years of outdoor field trials. Since no plant-made pharmaceutical has
reached the market, they argue, there?s no reason for a commitment to food
crops to produce drugs; alternative plants should be considered.

Copies of the Center for Food Safety/Friends of the Earth response and the
"Pharmaceutical Rice in California" report are available at the Center?s
website [www.centerforfoodsafety.org]

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