European Food Safety Authority: A Playing Field for the Biotech Industry

Testbiotech
December 01, 2010

Summary

Testbiotech investigations have revealed that conflicts of interest have a severe impact on the work of the GMO Panel at the Food Safety Authority (EFSA). The EFSA GMO Panel is responsible for the risk assessment of genetically engineered plants. Harry Kuiper, a leading scientist there since 2003, chairs the EFSA GMO Panel. Just before he joined the EFSA, he worked for a so-called Task Force established by the International Life Sciences Institute (ILSI). A Monsanto member of staff heads this Task Force and all other members are representatives from large biotech-corporations. Even after starting work at EFSA, Kuiper is still currently active within ILSI. There is also at least one other EFSA GMO Panel member who has worked for the Task Force.

The collaboration between ISLI and the GMO Panel experts has had a marked effect on EFSA. According to ILSI, the work of the Task Force has had an impact on the EFSA guidelines for the risk assessment of genetically engineered plants. Comparative Assessment was implemented as a starting point for risk assessment. So-called Comparative Assessment is based on the assumption that conventional breeding and genetic engineering can generally be seen as being equivalent. As a result, the risks of genetically engineered plants are less rigorously investigated than they would be if EFSA assumed that genetic engineering and conventional breeding are basically different \u2013which is much more plausible from a scientific point of view.

Further problems arise from the fact that ILSI set up the databank used to compare the compounds of genetically manipulated plants with those of plants derived from conventional breeding. This constellation does not appear to provide adequate protection from targeted manipulation by industry.

Further evidence that the ILSI influences the EFSA GMO Panel has been found in the context of feeding trials. EFSA does not normally require feeding studies using genetically engineered to test for potential health impacts. The document published by EFSA to explain why feeding trials are not necessary, was partially plagiarized from an ILSI paper.

The Testbiotech investigation cannot give a fully comprehensive picture of the situation. More likely this is only the tip of the iceberg. The risk assessment of genetically engineered plants has been influenced by the relationship between the EFSA GMO Panel experts and biotech industry on several levels, and this is cause for concern.

Testbiotech recommends a far-reaching re-organisation of EFSA with significant participation of environmental and consumer organisations. As a first step, all members of staff, experts and members of the EFSA management board active in ILSI should step down from their positions at EFSA.

Genetically Modified Apple Doesn't Brown

By Tracy Staedter
Discovery News
December 02, 2010

The Canadian specialty fruit company, Okanagan, has a way to modify the genetics of apples and other fruits to prevent them from browning. The company licensed the technology from Australian researchers, who pioneered it in potatoes, and is asking the USDA for approval to sell the apple in the States.

So why does fruit brown in the first place? Apples and other fruits, including pears, bananas and peaches, contain a chemical compound that consists partly of iron. These fruits also contain certain proteins, called enzymes, that accelerate chemical reactions. So when you slice an apple, the enzyme speeds up the reaction between oxygen in the air and the iron-containing compound. The chemical reaction that occurs is similar to what happens when metal rusts, and alas, the apple turns brown.

Okanagan's genetic modification silences the browning reaction.

You may be asking yourself, why would anyone go to such lengths to stop apples and other fruits from browning? I did. But Okanagan specializes in providing fresh-cut, packaged fruit for sale in supermarket delis and fast food restaurants, to name a few. Obviously, brown fruit doesn't sell as well as fresh-looking fruit. And other methods to reduce browning, such as adding antioxidants, add cost to a company's bottom line.

But as as Todd Fryhover, president of the apple commission in Washington state, told the Huffington Post, "Genetically modified - that's a bad word in our industry."

Would you eat one?

Clearance for Field Trial of Genetically Modified Rubber?

By K. A. Martin
The Hindu
December 02, 2010

In the face of opposition from the Kerala government to all genetically modified (GM) crops, the Genetic Engineering Approval Committee (GEAC) is learnt to have approved a proposal from the Rubber Board for conducting field trials of GM rubber. The GEAC has been constituted by the Union Ministry of Environment and Forests to oversee the manufacture, export or import and storage of microorganisms and genetically engineered organisms. Kerala has the highest cropped area under rubber among Indian States, and it accounts for 90 per cent of the aggregate production of natural rubber in the country.

Informed sources in the Rubber Research Institute of India based in Kottayam told The Hindu on Wednesday that after laboratory trials proved successful, an application was submitted to the Union government for field trials. The Institute was awaiting a formal letter of clearance from the GEAC.

The sources indicated that about an acre of land had been identified in one of Kerala's leading rubber-growing districts for the field trial.

However, when his attention was drawn to this matter, State Minister for Agriculture, Mullakkara Ratnakaran, told The Hindu that he had not received any official communication. He had come across some unofficial information, he said. He would convey the State's protest to the Union government if the clearance was indeed being granted.

GM-free State

The reported approval from the GEAC comes in the background of the government making it clear that it would not allow GM crops in the State. Kerala has been declared a GM-free State and organisations opposed to GM crops have expressed concern over the possible approval by the GEAC.

They recall that the Union Ministry of Environment and Forests had recognised the concerns of the public in disallowing field trials of Bt. brinjal and other GM vegetables in the country.

They point out that the Task Force on Application of Biotechnology in Agriculture chaired by Professor M.S. Swaminathan had recommended keeping agro-biodiversity hotspots GM-free. The Western Ghats region is one such hotspot and a global natural heritage.

The State government has not, however, so far made a clear distinction between food crops and non-food crops (such as GM cotton) in its stance on GM varieties.

The proposed GM rubber field trial comes at a time when natural rubber production has virtually stagnated while demand is on the rise worldwide. Production of natural rubber in India in October 2010 fell by 7.6 per cent to 82,000 tonnes compared to 88,775 tonnes during October last year. Consumption of natural rubber during the month was 81,500, compared to 77,950 tonnes in previous October.

The cumulative production during April-October 2010 stands at 4,57,250 tonnes compared to 4,337,400 tonnes during the same period in 2009. This is a growth of 4.5 per cent. Aggregate consumption for the first six months of the current financial year stands at 5,50,550 tonnes against 5,34,315 tonnes. This is a growth of three per cent.

The Rubber Board has pointed to a protracted period of heavy rain to production loss during October. Natural rubber production in countries such as Thailand and Indonesia too has come down due to heavy rain.

Over the recent months, rubber prices have appreciated about 100 per cent, raising input costs for automotive tyre manufacturers and other consuming industry components. Yet, farmers in Kerala have not quite reaped the benefits of higher prices because of disruption in tapping.

US Calls for an End to the EU Block on GM and Nanotechnology

By Tom Levitt and Vi Nguyen
The Ecologist
December 07, 2010

European agriculture is being left behind because of its opposition to GM crops and nanotechnology, US officials have warned.

Speaking to the House of Lords Committee on Agriculture, Fisheries and Farming, officials from the US Department of Agriculture (USDA) said both technologies needed to be accepted by EU consumers to allow for 'more sustainable agriculture' in the future.

"I'm a little surprised and disappointed that agriculture, which began so strong in Europe hasn't taken a greater leap forward to being a part of the economy that might be if these new technologies and approaches were carried forward," said USDA chief scientist Dr Roger Beachy.

He said scientists had to find ways to make new technologies like GM sound 'non-threatening' to consumers.

Many European countries have opposed the introduction of GM crops with a recent Greenpeace and Avaaz petition calling for a ban gaining more than one million signatures of support. MEPs voted in July to ban meat and dairy products from cloned animals and a introduce a moratorium on foods using nanotechnology until potential health risks can be ruled out.

However, committee member Baroness Howarth of Breckland spoke out in support of the US line and said the EU had "failed to look at the research objectively" on GM and had been "driven by particular lobbying groups".

"I think that is likely to happen with other new technologies unless scientists find ways of presenting the information differently and engaging consumers on a different level," she said.

Court Delays Order To Uproot Genetically Modified Sugar Beets

By Bill Tomson
Dow Jones Newswires
December 07, 2010

WASHINGTON - An appeals court has postponed a judge's ruling to uproot hundreds of acres of genetically modified sugar beet seed-producing plants.

U.S. District Court Judge Jeffrey White ordered the plants uprooted beginning Dec. 6, but the U.S. Court of Appeals for the Ninth Circuit issued an emergency stay on Monday, pushing that date to Dec. 23.

The stay gives the appeals court more time to decide whether or not the plants should remain in the ground - possibly for months - while the U.S. Department of Agriculture seeks to overturn White's ruling.

On Aug. 13 Judge White invalidated the government's approval of genetically modified sugar beets, but the USDA defied that ruling in September and issued permits to four companies - Syngenta (SYT), American Crystal Sugar Company, SES Vanderhave USA and Betaseed Inc. - to plant sugar beet seed-producing plants.

The Center for Food Safety, the Sierra Club, the Organic Seed Alliance and High Mowing Organic Seeds challenged the permits and Judge White agreed the sugar beet plants should be pulled out of the earth.

Those seed-producing "steckling" plants would help supply the genetically modified seeds farmers hope to plant in 2012. Whether or not farmers will be allowed to plant genetically modified seeds in 2011 is a separate issue that the USDA has promised to address. White's August ruling prohibits any new planting of biotech seeds, but the USDA has already said it is considering a proposal that ignores the prohibition.

About 95% of the sugar beets harvested this year were genetically modified and about 60% of the sugar produced in the U.S. comes from sugar beets. The rest comes from sugar cane.

Lessons From Bayh-Dole

By Bhaven N. Sampat
Nature
December 09, 2010

Developing countries wanting to boost commercialization of their academic research should learn from the mistakes of US patenting legislation, says Bhaven N. Sampat.

Thirty years ago this month, the US Congress passed the Bayh-Dole Act. The policy replaced a mishmash of rules that had governed the ownership of patents resulting from publicly funded research. Under the act, grantees and contractors, instead of government funding agencies, hold title to inventions.

Bayh-Dole has been widely celebrated for its effect on US universities. Since its passage, the number of patents that universities have been granted has climbed from fewer than 300 a year to more than 3,000. And, having earned very little from licensing before the act, US universities now earn almost US$2 billion annually1.

Policy-makers in other countries have taken these trends as evidence that promoting patents and exclusive licensing on the outputs of taxpayer-funded research enhances technology transfer, commercialization and innovation. This has led numerous developing countries - including South Africa, the Philippines and Brazil - to enact Bayh-Dole-style legislation. Others, including India, are considering similar approaches.

Increased patenting and licensing could lead to pharmaceutical breakthroughs in developing countries such as India, but slow progress in other areas.

Yet countries looking to boost commercialization should be wary of the myth that the act transformed US universities into entrepreneurial institutions capable of generating successful spin-off firms, high-tech jobs and self-sustaining research funds - and all at no cost to the taxpayer. Instead, they should note the problems that have arisen with the act, such as the overly restrictive patenting and licensing mentality it has generated among many technology-transfer offices, and craft their own legislation to avoid these pitfalls.

The Bayh-Dole legislation was passed in response to a particular set of US problems at a particular time. An important motivation was to give universities the right to patent drug compounds, and to exclusively license them to companies. Before the act, to do either was difficult because of bureaucracy, particularly at the Department of Health, Education and Welfare. Policy-makers were also concerned that aggressive patent policies established in the 1960s by the National Institutes of Health's medicinal-chemistry programme had reduced collaboration between universities and industry.

Another major concern in the 1970s was the allegedly low rate of commercialization of federally funded research, including that conducted outside universities. Less than 5% of the 28,000 patents owned in 1976 by the government were licensed to industry2.

The economic argument for allowing companies exclusive access to drug compounds is a strong one. Universities generated nearly one-fifth of the drugs with the greatest clinical impact approved by the US Food and Drug Administration during the past three decades3. It is hard to imagine that the profit-oriented companies who developed these drug candidates and put them through clinical trials would have invested the hundreds of millions of dollars needed if competitors could copy and market the drug themselves.

Antiquated arguments

Thirty years on, the 1976 licensing figure and the rise of university licensing since 1980 (see 'Technology transfer') form the central arguments used to claim that the Bayh-Dole Act was needed to boost technology transfer for all government-funded research, not just for pharmaceuticals. But these figures are misleading because they downplay the other ways in which universities contribute to economic growth and innovation. Researchers also disseminate their findings and ideas through consulting, publishing and teaching4. Indeed, the development of numerous US industries - including chemical engineering, aeronautics, computing and agriculture - relied heavily on academic research, but with little or no university patenting5.

Although universities would probably not have made as much money, many of the non-drug technologies licensed after Bayh-Dole, including some of the most lucrative biotechnology techniques, would have been picked up anyway from academic publications and other traditional channels of dissemination. The Cohen-Boyer patent, for example, which covers recombinant DNA cloning techniques and is held jointly by Stanford University in California and the University of California, has generated more than $250 million, but even Niels Reimers, who managed Stanford University's licensing programme at the time, noted in a 1997 interview that - whether we licensed it or not, commercialization of recombinant DNA was going forward-6.

In short, Bayh-Dole replaced one set of frictions with another - it eliminatated restrictions on patenting and technology-transfer licensing in favour of promoting excessive patenting and overly restrictive licensing. The growing aggressiveness of some technology-transfer offices in asserting their patents is now souring relationships between universities and industry, especially in information technology. Wayne Johnson, vice-president for university relations at computer giant Hewlett Packard in Palo Alto, California, testified before Congress in 2007 that Bayh-Dole has "fuelled mistrust, escalated frustration, and created a misplaced goal of revenue generation, which has moved universities and industry farther apart than they've ever been" 7.

Developing countries should not follow the United States in enacting policies that undermine traditional ways of commercializing research output. Patents and exclusive licences can boost technology transfer when significant follow-on investment is needed to promote commercialization - for instance, in the development of pharmaceutical compounds or prototypes for medical devices. But outputs that can be used off-the-shelf, such as computer software and biotechnology techniques, can be more effectively transferred by academic publishing, collaborations and teaching.

In India, a version of Bayh-Dole-type legislation, drawn up in 2008, came close to mandating the patenting of all academic research output; institutions that did not comply would risk having their funding withdrawn. An outcry from academics and others has led policy-makers to soften their approach8. But the policy now under consideration still encourages patenting and licensing across the board - for example, for many of the software inventions emerging from Indian laboratories. In the Philippines, the recently passed Bayh-Dole analogue similarly fails to distinguish between inventions that should and shouldn't be patented, although regulations to control how the legislation is implemented are still being developed.

Indeed, policies promoting broad and aggressive patenting may be more of a problem in developing countries now than they were 30 years ago in the United States. More things are legally considered patentable, and under-resourced patent offices may struggle to weed out applications that aren't truly innovative. Legislators in developing countries need to distinguish between, and provide guidance on, the types of research that should be patented and exclusively licensed, and those that should be widely disseminated.

Countries considering Bayh-Dole type legislation should also be prepared to subsidize their technology-transfer offices. Few US universities are making large returns9 and many make negligible income or even a net loss. One approach to this problem is for funders to allocate grant money for the management of intellectual-property rights for the types of research likely to need it.

A complicated issue for developing countries is whether they should treat academic patents and licences as a way to ensure that domestic firms and consumers, rather than large multinational companies, enjoy most of the benefits of taxpayer-funded research. This is particularly salient in countries without strong indigenous commercial capability, and where companies from developed nations might be better able to exploit innovations. Here again, drugs are a special case. For drug candidates with substantial markets in developed countries - those for 'global' diseases such as HIV or cancer - university licensing policies could be designed to simultaneously promote local access and preserve strong incentives for drug development3.

There is no one-size-fits-all solution. Given the growing importance of developing-country universities in the global scientific enterprise, and the importance of public sector research for development, it is crucial that nations base their patent-reform laws on a clear-eyed assessment of their own problems and priorities. The choices made today will have profound effects on research, innovation and society for decades to come.

References available on request

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