Gene Ecology taking off/Scientists slam Bush again/US regs inadequate (1/4/2004)

"Bayer's decision not to commercialize its GM corn in UK will be music to the ears of the anti-biotech lobby in Europe.  This is precisely what they have been dreaming of for long." - see item 4

1.Gene-ecology agreement circles the globe
2.Concern is more than just 'ruffled feathers'
3.GM Regulation in US Falls Short, Report Says
4.Syngenta man on Bayer pull out

1.Gene-ecology agreement circles the globe
Nature 428, 6 (04 March 2004); doi:10.1038/428006b

Thirty hours of flight time separate Tromsø in Norway and Christchurch in New Zealand. But researchers in the two cities have unearthed a common interest — gene flow — that springs from their respective positions as gateways to pristine polar regions.

And last week, at the first meeting of parties to the biosafety protocol (see Nature 428, 6; 2004), they agreed to team up to help other nations assess the risks of genetically modified organisms.

The Norwegian Institute of Gene Ecology (GenØk), based at the University of Tromsø, and the New Zealand Institute of Gene Ecology at the University of Canterbury in Christchurch, signed an agreement with the United Nations Environment Programme to help poor countries build the infrastructure needed to test genetically modified organisms against environmental safety standards.

The two institutes have pioneered the new and contentious field of gene ecology, a discipline that includes the study of how consumption of transgenic foods affects the genes and long-term health of animals. "We start out by looking for differences where other groups assume everything will be the same," says Terje Traavik, scientific director of GenØk. The subdiscipline combines genetics, biochemistry, ecology and social analysis of related issues, he says.

The collaborators have received 5 million kroner (US$700,000) for the project's first year from the Norwegian government, and hope this will be renewed annually.

2.Concern is more than just 'ruffled feathers'
Nature 428, 255 (18 March 2004); doi:10.1038/428255a

Sir – Your News story "Scientists slam Bush record" (Nature 427, 663; 2004) reports on the statement by 63 prominent scientists accusing the Bush administration of "misrepresenting and suppressing scientific knowledge". John Marburger, the administration's head of science and technology policy, quickly responded to the initiative from the Union of Concerned Scientists (UCS) by dismissing the move as political and simply the result of a few individuals having their "feathers ruffled", according to the New York Times.

A similar response greeted Congressman Henry Waxman's like-minded report last August.

The administration's response to the UCS initiative shows that nothing short of a broad-based condemnation will deter this administration's misuse of science.

We are PhD students and postdocs at Stanford and the University of California, Berkeley, who are attempting to publicize the widespread alarm of scientists at the Bush administration's use of science (http://www.scienceinpolicy.org). We have examined a broad range of environmental issues and uncovered a pervasive pattern of misuse, suppression and contradiction of science, including that performed by the administration's own researchers.

This is not about a few "ruffled feathers". At the time of writing, more than 1,000 scientists, from all 50 US states and from around the world, have signed our statement decrying the Bush administration's misuse of science.

Many of us are publicly funded researchers who feel that, if the current US administration is abusing science to justify its policies, we have a moral responsibility to speak out.

We invite you to join in these efforts to restore scientific integrity to US policy-making.

Kai M. A. Chan & Stephen Porder
Department of Biological Sciences, Stanford University, Stanford, California 94305-5020, USA

Paul A. T. Higgins
151 Hilgard Hall, University of California, Berkeley, California 94720-3110, USA

Sasha B. Kramer
Department of Biological Sciences, Stanford University, Stanford, California 94305-5020, USA

3.Biotech Regulation Falls Short, Report Says
Pew Study Calls for Better Oversight
By Justin Gillis
Washington Post Staff Writer
Thursday, April 1, 2004; Page E03

Federal regulation of the increasingly exotic products of the biotechnology industry may soon be inadequate to assure the public the products are safe, according to a new report.

Opinion in Washington is sharply divided on whether the 18-year-old biotech regulatory system can be fixed with administrative tweaking or whether Congress needs to pass new laws, said the report by the Pew Initiative on Food and Biotechnology, a think tank. But either way, the report cites numerous examples to make the case that action by the federal government is needed to ensure credible oversight of an industry that is tinkering with the very foundations of life.

"The regulatory system isn't broken, but it is showing signs of wear and tear," said Michael Rodemeyer, executive director of the Pew Initiative, which has taken a centrist position in weighing the risks and benefits of agricultural biotechnology.

The need for fixes is likely to grow pressing as the industry develops gene-altered fish and insects, farm animals that produce human drugs in their milk, and plants that make drugs or industrial compounds in their leaves and seeds, he added. A handful of these products are already in the late stages of development, but for many of them, federal agencies have produced no final guidance on how -- or even whether -- they will be regulated.

The Pew report, to be formally released today, is the most detailed analysis in years of a plan devised during the Reagan administration to oversee the new crops scientists were designing in their laboratories. The heart of that plan was to reinterpret existing laws, some of them passed decades earlier, to apply to the new technology. The result was a patchwork regulatory system that split jurisdiction among three agencies, all using different laws and standards.

The crops commercialized under that system have included corn, soybeans, cotton and other plants into which new genes have been inserted to confer better resistance to weeds and insects. Americans have been eating such foods for nearly a decade, but polls show most don't know it. Europeans have been more aware -- and more skeptical -- of the crops, with European politicians repeatedly citing the perception that the U.S. regulatory system is weak to oppose the technology in their own countries.

While maintaining that the current crops are safe to eat, biotechnology and food companies have feared a repeat of the controversy as new biotech animals near commercialization. That is one reason the industry is among those pressing for clearer regulations.

One proposal for tighter regulation of biotech crops was endorsed several years ago by virtually every group with a stake in the issue: the biotech industry, the food industry, environmentalists and consumer groups. The proposal was nearing approval as the Clinton administration left office, but the Bush administration has not acted on it.

Thomas Hoban, a sociologist and food scientist at North Carolina State University who has followed public opinion on biotech issues for years, said he visited the Food and Drug Administration last week to brief lower-level staff members. He described polls showing rising public unease with agricultural biotechnology. The staffers, mostly scientists, "were livid" that the Clinton-era proposal had languished, he said. "The scientists are saying, 'We need it,' " Hoban said.

Forthcoming products, ranging from a salmon designed to grow twice as quickly as normal to plants designed to act as medicines, are likely to pose tricky new issues of safety and public confidence, but the FDA has been slow to clarify how it will regulate some of these products, he said. "I want a much, much stronger FDA on this, as do most consumers," Hoban said.

Several people in Washington trade groups, speaking on condition that they not be identified because they need to maintain good relations with the FDA, said the process of creating new rules had been bogged down by disagreement between some of the scientists in the agency and the FDA's general counsel, Daniel E. Troy. Troy is said to be more cautious about expanding the FDA's authority to regulate various products.

Before joining the Bush administration, Troy was a lawyer who sometimes represented tobacco and pharmaceutical companies in disputes with the FDA. He declined requests for an interview through an agency spokesman. The spokesman, Brad Stone, issued a statement saying "the agency and the administration are carefully weighing the public health, scientific and legal ramifications of this technology." The statement said this review would necessarily take time, but it added that "the agency is prepared to take any appropriate measures necessary to protect the public health."

Indeed, it is clear that the Bush administration is well aware of many of the looming issues, and the White House science office is leading discussions aimed at clarifying government regulations.

Perhaps the biggest dispute now is how to regulate genetically engineered animals, such as fish meant for human consumption and farm animals genetically altered to produce human drugs in their milk.

Two plans have been widely discussed in Washington. One would create a system of voluntary consultations between the FDA and the biotech industry. That plan, similar to the approach the FDA takes now for biotech crops, enjoys little support among industry, consumer or environmental groups, but it is something the FDA clearly has legal authority to do. A stricter plan, favored by virtually all groups, would regulate the animals under a statute originally designed for new animal drugs, and would involve detailed, mandatory reviews of food safety. But it would also require a creative interpretation of the laws governing the FDA.

The Pew report said it's not clear that even the stricter approach would provide for an adequate review of environmental questions involving gene-altered animals, one reason some groups want Congress to pass a new biotech law.

4.Syngenta man on Bayer pull out

The following e-mail was posted on CS Prakash's AgBioView list. It comes from Dr. Sivramiah "Shanthu" Shantharam who is both the President of Biologistics International and the Regulatory Compliance Manager at Plant Sciences Division, Syngenta Basel, Switzerland.

Until recently, he was the Head of Stakeholder Relations and Technology Communications in the same company. He has also been responsible for developing "public affairs and communications strategies" for Golden Rice. You get the picture.

Prior to joining Syngenta, Shanthu Shantharam was employed with the US Department Agriculture’s Biotechnology Regulatory Program in Washington for 14 years.

Note how he relates the concerns over GMOs purely to Europe as if there were no conerns in his native India, in Africa or elsewhere in the South.

Subject: RE: Bayer decides against GM crop cultivation in the UK
Date: Wed, 31 Mar 2004 17:45:16 -0800
From: "Sivramiah Shantharam" <[email protected]>

Déjà vu!  All Over again!

Bayer's decision not to commercialize its GM corn in UK will be music to the ears of the anti-biotech lobby in Europe.  This is precisely what they have been dreaming of for long.

If Governments support GM technology based on sound scientific advise and add caveats (to please detractors and opponents) that makes it prohibitively expensive to comply with it is as good as banning it for reason other than safety is a sure way to kill the development of technology.  Similar thing has just happened in Germany where restaurants are asked to label any food that contains GMO.

Now, what kind of approval is this?  Do the authorities stop to think how impossible is it to comply with these unscientific regulations?  The cost of regulations is going through the roof at this rate, and it is given that if developing countries adopt such rules on labeling, and segregations after KL biosafety protocol meetings, then there is no hope for large scale commercialization of GMO there either as the basic infrastructure to handle commodities are so inadequate to comply with the requirements.

Europeans are doing one thing after another to really kill development.

- Shanthu Shantharam, Biologistics International LLC, Ellicott City, MD

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