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Risk assessment process tainted / Farmers worry about GM rice approval (22/5/2007)

1.Risk assessment of harmful GMOs, chemicals in environment tainted
2.Farmers Worry About Genetically Modified Rice Approval

EXTRACTS: Failures by regulatory agencies to adequately assess the safety of a product may result from an ideological rather than truly scientific approach to risk assessment. This ideology results in part from the undue influence of industry on government and its regulatory agencies. Another factor is the belief that technical innovation is, fundamentally, a good thing because it drives economic growth and progress. This belief interferes with an unbiased assessment process.

"The more regulatory agencies limit free access to the data upon which their decisions are based, the more compromised becomes the claim that the regulatory process is 'science based.' Lack of transparency in the current approval process leads to an inability to evaluate the scientific rigour of the assessment process, and thus compromises the confidence that society can place in the regulatory framework." (item 1)

The decision "poses a potential risk to the American food supply," said the National Farmers Union, NFU, which represents 250,000 farm and ranch families in all U.S. states.

"America's farmers have suffered the economic consequences of two major instances when unapproved genetically modified rice entered the food supply in the past year," said NFU President Tom Buis. (item 2)

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1.Risk assessment of harmful GMOs, chemicals in environment tainted
Paul Hanley
The StarPhoenix (Canada), May 22 2007
http://www.canada.com/saskatoonstarphoenix/news/lifestyle/story.html?id=f6b6d178-3aad-4d97-96cf-b968a7eddea3

The social license to release products like chemicals, pesticides and genetically-modified organisms (GMOs) into the environment is based on public confidence that these products have been adequately tested to ensure safety. In fact, we have no reason to be assured that the risk assessment process is adequate.

Take the recent decision by a California court, in which the judge concluded that the U.S. government had failed to follow its own rules for assessing GMOs, in particular Monsanto's Roundup Ready genetically-modified (GM) alfalfa.

The court stated that the U.S. Department of Agriculture failed to discharge its responsibilities by ignoring the fact that there were doubts surrounding the likelihood of contamination of non-modified alfalfa by the modified type. It then made a previously temporary ban on this product in the U.S. permanent.

Failures by regulatory agencies to adequately assess the safety of a product may result from an ideological rather than truly scientific approach to risk assessment. This ideology results in part from the undue influence of industry on government and its regulatory agencies. Another factor is the belief that technical innovation is, fundamentally, a good thing because it drives economic growth and progress. This belief interferes with an unbiased assessment process.

GM alfalfa by Monsanto has been approved for use in Canada since Sept. 7, 2004, using similar criteria to those used in the U.S., which are now suspect.

In 2001, the Royal Society of Canada's Expert Panel on Food Biotechnology warned of fundamental flaws in the adequacy of Canada's risk assessment process. The panel urged that the system be changed to strengthen "the scientific basis of the regulatory process by increasing the transparency and validation of the risk assessments upon which regulatory decisions are based. Peer review and independent verification of research findings are principles of the scientific method. The more regulatory agencies limit free access to the data upon which their decisions are based, the more compromised becomes the claim that the regulatory process is 'science based.' Lack of transparency in the current approval process leads to an inability to evaluate the scientific rigour of the assessment process, and thus compromises the confidence that society can place in the regulatory framework."

The panel also stressed the need for regulators to remain independent, neutral and unbiased.

Canada is now in the process of merging its regulatory system for products like GMOs and pesticides with that of the U.S. This is a good idea in principle -- in fact, there should be a uniform, global regulatory system -- but the U.S. system is currently under attack for being under the influence of the companies it is supposed to regulate.

It is not just Greenpeace and the like questioning the quality of risk assessment in the U.S. In 2005, the Governmental Accountability Office raised the alarm about corporate sway over the U.S. Environmental Protection Agency.

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2.Farmers Worry About Genetically Modified Rice Approval
WASHINGTON DC, May 21 2007 (ENS)
http://www.ens-newswire.com/ens/may2007/2007-05-21-09.asp#anchor2

The National Farmers Union expressed "great concern" over today's approval by the U.S. Department of Agriculture's Animal Plant and Health Inspection Service, APHIS, to allow Ventria Bioscience to plant rice that is genetically modified to produce pharmaceuticals in Kansas.

The decision "poses a potential risk to the American food supply," said the National Farmers Union, NFU, which represents 250,000 farm and ranch families in all U.S. states.

"America's farmers have suffered the economic consequences of two major instances when unapproved genetically modified rice entered the food supply in the past year," said NFU President Tom Buis.

Ventria Bioscience, a biotech company based in Sacramento, California, is developing a product made from genetically engineered rice that helped reduce the duration of diarrhea in children by 30 percent, as part of an oral rehydration solution. Childhood diarrhea is the second leading killer of children, according to the World Health Organization.

Last September, Kansas and Ventria officials agreed to establish a bioprocessing facility for plant-made pharmaceuticals in Junction City.

Kansas Governor Kathleen Sebelius said, "I welcome Ventria Bioscience to Kansas and look forward to their contributions to the health of children worldwide."

The facility will process Ventria's biotech rice. Proteins extracted from the rice will be incorporated into oral rehydration solutions to address childhood diarrhea. Ventria is also developing other products using these proteins. The rice itself is discarded.

Farmers are expected to be among the project's major beneficiaries, as those who grow the rice that supplies the facility can earn a premium compared to their next most lucrative crop, said Kansas Agriculture Secretary Adrian Polansky.

"This is as an important development for Kansas farmers, who stand to benefit from the additional income," Polansky said. "They also have the satisfaction of knowing they are helping provide affordable healthcare products to children who desperately need it."

Buis said National Farmers Union is concerned that the Ventria Bioscience's proposal does not specifically address the necessary safety precautions for transit of the rice.

He said that a significant risk may exist to all crops and soils neighboring the transportantion route.

Buis said that despite Kansas' recent devastating tornadoes and disastrous flooding, part of APHIS' response to official comments was that "extreme weather events are unlikely to occur in the area of the field trial."

"Until USDA and FDA improve oversight and regulation of pharma crops, NFU will remain extremely concerned about pharma commodity production based on economic, environmental, food safety and liability risks to both producers and consumers," Buis said.

The U.S. Food and Drug Administration has not approved the rice-grown drugs due to potentially hazardous side effects. "This lack of approval means Ventria Bioscience does not have a sufficient market," said Buis, "thus the production of this crop appears to provide no benefit to Kansas farmers or the economy."

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