Monsanto, Pilot Grove Settle Patent Dispute

By Theresa Krebs
Boonville Daily News
September 4, 2008

Boonville, Mo. - A legal dispute that has involved more than 100 local farmers and a global biotechnology firm was settled in federal court Tuesday in St. Louis.

David Brumback, who farms about 2,800 acres south of Pilot Grove, was served a subpoena by Monsanto in December 2007 with claims that he infringed the company's patent agreement. Brumback, who maintains he has never planted a brown bag seed, said investigators representing Monsanto harrassed him and his family regularly for months. He said a Monsanto district sales manager told him about a month ago that the company would be issuing him an apology, a communication he is still awaiting.

Bees Can Mediate the Escape of Genetically Engineered Material over Several Kilometres

PhysOrg.com
September 22, 2008

The research, which was partly funded by USAID and the Rockefeller Foundation, was triggered by the planned release of insect-resistant genetically engineered cowpea in Africa, where cowpea's wild relative, Vigna unguiculata var. spontanea, is widely distributed. For the first time with insect pollinators, the scientists used radio tracking to determine the movements of the carpenter bee Xylocopa flavorufa and their implications for long-distance pollen flow.

"Bees can visit flowers as far as six kilometres away from their nest. From complete flight records in which bees visited wild and domesticated plant populations, we concluded that bees can mediate gene flow, and potentially allow transgenes to escape over several kilometres," explains icipe scientist Remy S. Pasquet.

He adds that for genetically engineered cowpea in Africa, these results indicate that although pollen movement beyond a few hundred meters has a low probability, strict isolation by distance may not be feasible. This research therefore confirms the widely held hypothesis that deploying genetically engineered cowpea in sub-Saharan Africa may mean that an escape of the transgene to the wild cowpea relative is inevitable.

China Plans $3.5 Billion GM Crops Initiative

By Richard Stone
Science Magazine, USA [Vol 321 (5894): 1279]
September 05, 2008

BEIJING--Confronted with land degradation, chronic water shortages, and a growing population that already numbers 1.3 billion, China is looking to a transgenic green revolution to secure its food supply. Later this month, the government is expected to roll out a $3.5 billion research and development (R&D) initiative on genetically modified (GM) plants. "The new initiative will spur commercialization of GM varieties," says Xue Dayuan, chief scientist on biodiversity at the Nanjing Institute of Environmental Science of the Ministry of Environmental Protection.

A central aim is to help China catch up with the West in the race to identify and patent plant genes "of great value," says Huang Dafang, former director of the Biotechnology Research Institute of the Chinese Academy of Agricultural Sciences in Beijing. Once intellectual property rights are in place, says Huang, transgenic technology could transform Chinese farming "from high-input and extensive cultivation to high-tech and intensive cultivation."

In the decade since China first allowed commercial planting of four GM crops, the government has moved cautiously, granting only two further approvals for small-market species: poplar trees and papaya (see table). Currently, just one GM crop--insect-resistant cotton--is now planted widely, says Xue. China has balked at commercializing GM versions of staples such as rice, corn, and soybeans.

That may change, as China's leadership has thrown its weight fully behind GM. "To solve the food problem, we have to rely on big science and technology measures, rely on biotechnology, rely on GM," Premier Wen Jiabao told academicians last June at the annual gathering of the Chinese Academy of Sciences (CAS) and the Chinese Academy of Engineering. China's State Council, which Wen leads, approved the GM initiative in July.

Details of the new initiative, including which crops will gain initial support, are being hammered out, scientists say. Some funds will go to R&D on transgenic livestock, an area that has lagged behind GM crops. By 2006, the Chinese government had granted permits for 211 field trials of 20 GM crops, including the six approved for commercial production. As in other countries, the varieties that China has commercialized so far are equipped with genes to resist pests, tolerate herbicides, or stay fresh longer--not genes that directly boost yields.

Proponents note that China's cautious embrace of transgenic technology has yielded a major success story: GM cotton. Introduced into commerce in 1997, 64 varieties of pest-resistant cotton are now grown on 3.7 million hectares, or about 70% of the area devoted to commercial cotton, averting the use of 650,000 tons of pesticides, says Huang.

The big prize is GM rice. Three years ago, Huang Jikun, director of CAS's Center for Chinese Agricultural Policy in Beijing, and colleagues reported that field trials of GM rice in China were going well--boosting yields and reducing pesticide use on plots--and predicted that the varieties were on the threshold of commercialization (Science, 29 April 2005, p. 688). But the Chinese government is reluctant to tinker with the country's most important crop and has put off commercialization. The new initiative might break the logjam, says Huang Jikun. "I hope the commercialization of GM rice will come within a couple of years," he says.

Although the central government has not released a budget figure for the new initiative, a spokesperson for the Ministry of Agriculture told Science that it would cost $3.5 billion over 13 years. Half is expected to come from local governments on whose land GM crops will be grown and from agricultural biotechnology companies. "It's a new way to support a big science project in China," says Huang Dafang. Another departure from other R&D initiatives, he says, is that each funded program is expected to produce an economic payoff.

One component of the initiative will be to educate the public about GM crops, says Huang Jikun. Although China is unlikely to see the sort of protests that have derailed field trials and commercialization in Europe, there are currents of disquiet in the general population. "For consumers, the safety of GM crops is the biggest worry. Just like some people are afraid of ghosts, some people are afraid of GM crops," says Zeng Yawen of the Biotechnology and Genetic Resources Institute of the Yunnan Academy of Agricultural Sciences in Kunming. Although Zeng believes that GM food safety will be demonstrated adequately, he worries that the new initiative will push China to "move too fast to commercialize GM varieties."

But with questions mounting about China's ability to feed itself, others contend that not pushing ahead with GM varieties could be more detrimental than any theoretical hazard. "Any kind of new technology may have risk," says Huang Dafang. But legitimate concerns, he says, should not be overshadowed by scare tactics designed to "mislead the public in the name of environmental protection." With the country's leaders firmly behind GM crops, it's unlikely that any protests would get very far.

With reporting by Chen Xi and Jia Hepeng.

Is the FDA Doing Its Job?

By Carmelo Ruiz-Marrero
Blade - The GMO Debate
September 15, 2008

The main argument of defenders of products derived from genetically modified organisms (GMOs) is that the US Food and Drug Administration (FDA) determined in 1992 that they are safe and therefore need no further safety testing.

The FDA refused to allow the public to view the internal documents related to these tests, which caused in 1998 a lawsuit by a coalition of civil society and public interest groups headed by the Alliance for Biointegrity demanding that these be made public. The judge ruled in the plaintiffs' favor, resulting in the release of over 44,000 pages of documents. These show that contrary to the agency's top officials' assurances, staff scientists had major misgivings about the safety of GM foods.

The declassified documents are revealing and extremely interesting. In one of them, dated March 6 1992, microbiologist Louis Pribyl says that "The unintended effects cannot be written off so easily by just implying that they too occur in traditional breeding. There is a profound difference between the types of unintended effects of traditional breeding and genetic engineering.

Compliance officer Linda Kahl warned in a memo dated January 8 1992 that by "trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices the FDA was "trying to fit a square peg into a round hole... The processes of genetic engineering and traditional breeding are different and according to the technical experts in the agency, they lead to different risks.

The man put in charge of overseeing the GMO evaluations at the FDA, Michael Taylor, was not a scientist but a lawyer. He had previously represented US biotechnology giant Monsanto. After leaving the FDA he went back to his private practice, eventually becoming Monsanto's vice president. This is a classic case of the revolving door syndrome, the conflict of interest caused by the constant movement of professionals back and forth between the private and public sectors.

Taylor's case is in no way unique. US Supreme Court judge Clarence Thomas was a Monsanto lawyer. Former US defense secretary Donald Rumsfeld was for eight years the CEO of the Searle pharmaceutical company, which Monsanto bought in 1985. And Anne Veneman, first agriculture secretary of the Bush-Cheney administration, was a member of the board of directors of the Calgene corporation, bought by Monsanto in 1997.

Activist and researcher Beth Burrows, president of the Edmonds Institute, investigated for years the biotechnology revolving door in the United States but eventually gave it up, reasoning that it would be more useful to document cases of public servants that were NOT moving into the biotechnology industry.

Michael Taylor's direct supervisor at the FDA was James Maryanski. French film maker Marie Monique Robin confronted him in her recent documentary Le Monde Selon Monsanto regarding the internal memoranda that indicated that staff scientists had doubts about the safety of GM foods. Marynski acknowledged the dissent but stated that in the end everyone agreed GM was perfectly safe.

The FDA is required to approve a food or medication only if there is a broad consensus among its staff about its safety and if there is a substantial body of peer reviewed studies supporting its safety. GM foods did not meet either requirement.

References

Ruiz Marrero is founder and director of the Puerto Rico Project on Biosafety. http://bioseguridad.blogspot.com/

Farmers Oppose GM Potatoes

By Melanie Gosling
Cape Times, Business Report
September 17, 2008

The proposed commercial release of a genetically modified (GM) spud in South Africa has become something of a hot potato as farmers and some major food giants say they will not use them.

Potato SA, which represents potato farmers, has written to the department of agriculture saying the potential costs, particularly of consumer backlash and possible loss of exports, outweigh the potential benefits.

This is the first time organised agriculture has opposed the introduction of a GM crop in South Africa.

The submission is in response to a permit application by the Agricultural Research Council (ARC), which has been working with Michigan State University to develop tuber moth-resistant potatoes with funding from USAid.

Ben Pieterse, research manager at Potato SA, said tuber moth was not a major problem in South Africa.

"The benefit is far less than the potential damage to the industry. We won't save that much on pesticide as we will still have to spray for other pests.

"There is no mandatory labelling for GM products, and no testing or tracing procedure, so how do you keep the GM potatoes separate?"

Pieterse said this was important for export markets and farmers who supplied major food companies that would not take GM crops.

Diale Mokgojwa, who manages Potato SA's emerging and small farmers' programme, says this sector also opposes the commercial release of GM potatoes.

The GM potato is the Spunta variety, which is not suitable for processing, so the big food chains would not use it anyway.

The plan is to transfer the GM technology to other varieties of potato in time.

Owen Porteus, managing director of McCain Foods, the biggest producer of frozen potato products globally, said all the company's products were GM-free.

"We're very much driven by consumer needs and they don't want GM."

Kobie de Ronde, the ARC scientist who heads the GM potato project, said much of the resistance to GM was because of lack of understanding. All GM crops underwent a full safety assessment before being approved for production.

ARC's application for commercial release contained a "full set of environmental, food and feed safety data" that indicated GM potatoes were as safe to grow and eat as conventional spuds.

"This is not an application for a full commercial permit so that potatoes will be on the market tomorrow. We'd still have to plant them in specific areas so we can evaluate certain questions," De Ronde said.

She agreed GM labelling needed to be addressed. ARC was discussing this with the department of health.

Consumer Rights Recognised: GM Foods Will Be Labelled in South Africa

Press Release
SAFeAGE
September 17, 2008

Cape Town - History was made yesterday when the Department of Trade and Industry handed down a ruling for mandatory labelling of genetically modified foods.

The decision came after a clause to this effect, which had been removed from the draft Consumer Protection Bill last year, was reinstated.National Co-ordinator of SAFeAGE, a consumer GMO watchdog that has been lobbying for two years to have this clause reinstated said, "The GMO Act does not protect consumers, it is rather a permitting system that welcomes untested, unlabelled and irresponsible genetic modification to run rife in our country. Consumers will finally have the right to choose once this Bill is implemented".

Parliament"s Trade and Industry committee also withdrew a clause from the original Bill that rendered GMOs exempt from liability for damage caused by them. "Why should food that has been spliced with virus, anti-biotic resistant and herbicide genes be exempt from liability," questioned Treherne."These foods should be subject to more stringent labelling, not exemption."

The Department of Trade and Industry"s labelling laws have not gone unopposed. Both the Department of Agriculture and Department of Health have opposed mandatory labelling saying it would send out a confusing signal to consumers. However, spokesperson for the Safe Food Coalition, Andrew Taynton said that "the Department of Trade and Industry should be congratulated for this bold move. Current GM labelling laws in South Africa are so flawed that they do not label any of the GM foods currently on the market."

Mariam Mayet of the African Centre for Biosafety (ACB) commented that "government has embarked upon the first step towards regulating agribusiness involved with GMOs. Not only have consumers been given a choice to reject GM foods, now, GM food can also be tracked from farm to fork in order to hold Monsanto and others liable when we discover that something has gone wrong."

Treherne was however concerned that the Department of Agriculture would still be responsible for determining the thresholds and technical requirements of these new regulations, saying, "We hope this does not undermine the excellent work done by Parliament and the Department of Trade and Industry on the Consumer Protection Bill.

FDA Issues Rules for Genetically Modified Animals

By Christopher Doering
Reuters
September 18, 2008

WASHINGTON - Genetically engineered animals moved closer to the dinner table on Thursday as the U.S. Food and Drug Administration made the process it will use to review new proposals public.

The FDA published proposed detailed guidelines that producers of genetically engineered animals would have to follow to determine whether there are any risks to humans, the environment and the animals themselves.

The guidelines bring the decades-old technology of genetic engineering for animals one step closer to the market.

Genetically modified cattle, pigs, fish and goats are being produced for a variety of uses. Some produce pharmaceuticals in their milk or blood. Others are resistant to diseases such as mad cow or produce healthier meat or milk.

"Many kinds of genetically engineered animals are in development, although none has yet been approved by the agency for marketing," FDA Deputy Commissioner Randall Lutter said.

It was important to formalize procedures the FDA uses to regulate genetically engineered animals, Lutter said, "because the technology has evolved to a point where commercialization of these animals is no longer over the horizon."

The agency is inviting public comment on its proposals until November 18 and could modify them before they become final.

Several Questions

Consumer groups called the FDA's action a good first step, but said the guidelines fail to answer several important questions.

One concern is the approval process, which would be secretive to protect companies' proprietary interests.

"It's unclear whether FDA has the authority and expertise to address the full range of risks," said Gregory Jaffe of the Center for Science in the Public Interest.

Foods produced from some bioengineered animals will not have to be labeled, the FDA said, also drawing some ire.

"It is incomprehensible to us that FDA does not view these animals as different from their conventional counterparts," said Jean Halloran, director of food policy initiatives at Consumers Union.

"Consumers have a right to know if the ham, bacon or pork chops they are buying come from pigs that have been engineered with mouse genes."

But the FDA said labeling would be required if there is a significant change in the food. For example, pork from pigs engineered to produce meat with higher levels of omega-3 fatty acids would need a label.

Producers will be required to describe what DNA they have inserted into the animal, and how it behaves in the animal, the impact on the animal's health, and show the product is not different from traditional food.

Companies also would have to tell the FDA how they would track the animals and dispose of them when they die. If there is a high risk, the FDA might require the animals to be sterilized.

The FDA said it has the authority to regulate genetically engineered animals through the Federal Food, Drug and Cosmetic Act. The measure identifies a drug as anything that changes the "structure or function" of the person or animal.

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