* EU gets extra time to end bans
* France, Germany Seek to Break Deadlock
* EFB open letter to Dimas Stavros
* Sprouting EU Food Wars
* Australian states lift bans
* Jeffrey Smith exposed in The Weekly Times
* How Plants Respond to Light
* Mushrooms may provide vaccines
* Is technology unnatural?
* Fine levied over biotech bentgrass
EU given extra time to end GMO bans
- Laura Crowley, Food Navigator, Nov. 23, 2007
The European Union yesterday won a two month extension for ending its ban on imports of genetically modified (GMO) foods.
The extension means the EU has more time to reach conclusions over those member states implementing their own GMO bans and will avoid disciplinary action for the moment.
Last November, the World Trade Organisation (WTO) ordered Europe's ban be lifted following a case brought by leading GMO producers Argentina, Canada and the US under claims that their farmers were losing millions of euros annually because of the EU.
The WTO had previously faulted the EU for undue delay in approving GMO products for a four-year period ending in 2003 and accused a number of member states of maintaining unjustified bans on those products already found safe by the EU.
Peter Power, EU spokesman for trade, confirmed to FoodNavigator.com that a negotiation has been made extending the ban, with a new deadline set as 11 January 2008. However, he was unable to comment on the reasons for requesting the extension, and what developments will be made before meeting new deadline.
However, EU member states have operated their own GMO bans, making it difficult for the Commission to comply with the WTO ruling.
Last month, EU environment ministers failed to agree on whether to force Austria to lift its national ban on two types of GM maize, produced by US biotech company Monsanto and German drugs group Bayer. The decision has now been left in the hands of the Commission.
It was the third time since 2005 that ministers had failed to reach a majority verdict, and meant the EU could not meet the WTO's original deadline of 21 November 2007.
When the EU was given this time limit, it decided not to appeal, much to the anger of green organisations who are concerned about the effect of genetic modification on the environment.
Friends of the Earth trade campaigner Sonja Meister said: "The WTO is the wrong body for settling trade disputes. It has a long history of putting corporate interests firmly ahead of environmental protection, public safety and democracy."
France, Germany Seek to Break Deadlock on GMO Foods
- Jeremy Smith, Reuters via Planetark, Nov. 27, 2007
BRUSSELS - Agricultural powerhouses France and Germany sought on Monday to break the deadlock that has kept genetically modified crops out of most of Europe, saying rules must be changed to ease their approval.
"This authorisation process of GMOs is highly unsatisfactory and worrying, it cannot stay like this," German Agriculture Minister Horst Seehofer told reporters on arriving for a meeting of EU farm ministers.
"One commissioner says it's okay and another says it's not. (It's not acceptable) that we politicians decide according to a majority and current mood. This is not how we can deal with it."
The EU has not approved any new GMOs for growing since 1998, in large part because of huge public resistance to what are sometimes called "Frankenstein foods".
At present, EU biotech policy involves some five or six departments of the executive European Commission, who can often be at odds.
But with international grain prices soaring and supply shortages being faced by the EU's livestock and animal feed sectors, pressure has been rising for the Commission to do something about the speed at which the EU approves new GMOs.
French Agriculture Minister Michel Barnier echoed Seehofer's comments, saying time might be needed to review the process.
"There is a very high public sensitivity (over GMOs), a lot of fears," he said. "And we don't want to limit imports."
"We have to take time to put procedures into place that can't be challenged," he told reporters. "I back my German colleague that we have to take time at European level."
An internal study published by Commission agriculture experts in June said the EU took a minimum of 2.5 years, and often much longer, to complete new GMO authorisations compared with an average of 15 months in the United States.
The other main issue is that since EU law does not give a tolerance threshold for the accidental presence of unauthorised GMOs that have been approved in exporter countries, trade flows can be disrupted if an EU-bound cargo is found to contain them.
In the past, that has resulted in temporary import bans that are a result of what are known as "asynchronous authorisations".
For the Commission's agriculture unit, this is a big problem. However, its food safety department, responsible for the temporary bans, is keen to keep unauthorised GMOs out of the EU food chain with a "no compromise" policy -- but has also suggested reaching agreements with exporter countries aiming at better coordination between approval processes and rules.
"It is obvious that the problems of asynchronous approvals will be increasing and we will face huge problems in the agricultural sector," EU Agriculture Commissioner Mariann Fischer Boel told a news conference.
"To postpone any new approvals will have dramatic consequences. The production of meat will move out of Europe and then we will have to import meat (from animals that are) fed with GMO products. So we will be eating it anyway," she said. (Additional reporting by Yves Clarisse, Ilona Wissenbach, editing by Michael Roddy)
Open letter EFB to Commissioner for the Environment Dimas Stavros
- European Federation of Biotechnology (open letter), Nov. 28, 2007
Mr Stavros Dimas
Commissioner for the Environment
Rue de la Loi 200
Brussels, 28 November 2007
Dear Commissioner Dimas,
The European Federation of Biotechnology, EFB, is very concerned to read about your draft decisions to reject two Bt maize product submissions based on discredited scientific arguments that have not been reviewed by your own independent scientific body, the European Food Safety Authority.
We consider that the draft decisions do not have a scientific basis and seem to be made without considering the consequences for Europe or the fact that similar varieties have been growing in Europe for the past 9 years with high adoption rates with no adverse environmental effects and in coexistence with conventional and organic farming.
Concerning the scientific studies contained in your draft decisions, that claim to demonstrate environmental risks presented by Bt maize, nine out of the eleven publications actually confirm the environmental safety of Bt maize cultivation and in fact do not identify any environmental risk with respect to the cultivation of Bt maize in the EU.
Only two of these publications (Hilbeck et al., 2006, & Rosi-Marshall et al., 2007) allege potential environmental risks; the former being a philosophical approach, rather than scientific data, and the latter is a questionable extrapolation from laboratory tests. Indeed the Rosi-Marshall et al. paper is based solely on laboratory experiments, whereas the field data of the same authors demonstrates no Bt effect on aquatic organisms (as shown on their own website). As far as the field test is concerned, it lacks decisive data on which transgenic maize plants were used and the entire experimental documentation appears sloppy and not meriting peer reviewed publication1. In contrast to the theoretical risk projections of Hilbeck, other authors have published a meta-analysis, of all available studies carried out with Bt crops based on real, scientifically acquired data that confirm there is no indication of ecological risk arising from the cultivation of Bt maize (Marvier et al., 2007; Romeis et al., 2007). There is no new scientific evidence to contradict the conclusions reached by the GMO Panel of the EFSA on the safety of Bt maize cultivation in the EU. Furthermore, in July 2007, the OECD published a consensus document 2 on safety information of transgenic plants expressing Bt.
This document thoroughly reviews and confirms the safety and high degree of specificity of the Bt proteins expressed in Bt maize, including the protein expressed in line 1507.
Another inconsistency of your draft decisions is that they fail to draw on a substantial body of scientific data accumulated over several years and published in the last 12 months that highlight the economic, environmental and consumer benefits of Bt maize. A total of 63 peer-reviewed publications attest to the fact that Bt toxin does not accumulate in the soil and does not affect aerial and soil-based non-target organisms, on the contrary, there is ample evidence that non-target insects are severely threatened and reduced in their populations by spraying pesticides.
In considering the environmental safety of Bt maize, it is pertinent to note that Bacillus thuringiensis has been widely used as an insecticide spray for the control of European corn borer in Europe since 1938, when the first commercial Bt preparation (Sporeine) came onto the market in France. Given that Bt is a commonly used insecticide in organic agriculture and given the current trend in the expansion of organic farming in Europe, and the year-on-year northward spread of European corn borer, it is inevitable that Bt spraying will be on the increase. The scientific data accumulated over recent years as part of biosafety assessment dossiers compiled on the various Bt crop varieties for commercial release will provide useful evidence for assessing the environmental impact of organic farming. As for the present time these environmental assessments of Bt sprays with their much higher concentrations have not been properly carried through, and also not published in peer reviewed journals - this in contrast to the many peer reviewed papers testifying no negative effects in soil and agricultural environment of GM Bt crops.
Agriculture is vital to the European economy, and Europe stands to gain much by the cultivation of new high performance crop varieties. Bt maize ensures productivity in years of heavy infestations and reduces the need for pesticides. In 2006, GM maize varieties including these two products were planted on 25.2 million hectares around the globe, and on 62,187 hectares in Europe. Spain has grown Bt maize for 9 years, and the benefits of Bt maize to Spanish farmers are well documented: average yield benefits have often been 10% and sometimes higher, which adds 15 million Euros income to Spanish growers. Recent field trials in Italy showed that Bt maize performed better than conventional varieties with yield increases of between 28 and 43 percent. These trials demonstrated that Bt maize can not only be more profitable for farmers, but is healthier because of lower contamination with hazardous fungal mycotoxins which represent a significant health threat to humans and animals when present in the food chain (Regulation (EC) No 1881/2006).
Farming systems are very diverse, from conventional to organic or genetically modified (GM). This ensures that agriculture provides an abundant and affordable supply of healthy food and feed, and offers consumers more choice. The EU's explicit policy is that 'No form of Agriculture should be excluded from the Union', and the European Commission asks Member States to develop rules for the coexistence of different production systems, like Bt maize and non-GM maize, all long term scientific coexistence studies on maize demonstrate the feasibility of coexistence. It is important that the consequences of any obstacles to the cultivation of GM maize varieties such as these are carefully evaluated, since a number of alarming indicators point to a future collapse of the EU livestock production due to the unavailability of imported feedstuffs.
The Portuguese Council Presidency has recently called for an open debate on the impact of the EU GM policy on food and feed security, in the light of an extra cost of 2 Bio Euros for EU-livestock producers resulting from de-facto import bans on feed maize and corn gluten feed from GM corn producing countries.
The draft Commission Decisions are totally unacceptable, not only for European farmers and consumers, but also set a terrible example for other parts of the world that presently draft guidelines for the cultivation of GM crops, since they look to Europe as an example. This is especially true in the developing world where there is an urgent need of new technologies to raise agricultural productivity. Other GM strains of maize are under development that will have enhanced nutritional quality or tolerance to drought, and must be given the chance to reach those who need them the most. It is a proven fact that in developing countries Bt maize is healthier due to its much lower content of mycotoxins, which have dramatic detrimental effect on human health (cancer, spina bifidis).
In conclusion, Commissioner, your proposals to not approve the two Bt maize lines for cultivation based on discredited scientific arguments would not only undermine the EU's own scientific advice and risk assessment procedure but would also represent a significant threat to the competitiveness of European farmers.
To impose such bans is economically wrong, and pesticide use for controlling European corn borer would continue, It is also wrong on grounds of human health considerations. European farmers would be denied a valuable economic choice and Europe would import more grain to meet demand, but from where. It would do nothing to support the choice of feed producers or consumers. Such a move would violate EU procedures and without scientific evidence to support them would ultimately be rejected.
As European scientists we urge you to reconsider and return to a reasoning based on science and experience. The consequences of approving these draft Decisions and the precedents they would set would be the marginalisation of science in Europe, the discrediting of the European Food Safety Authority and the collapse of the EU-livestock industry.
Emeritus Professor Marc Van Montagu
President of the European Federation of Biotechnology
1 More detailed comments on the study can be visualized at http://pubresreg.org/index.php?option=com_smf&Itemid=27&topic=9.0
Sprouting EU Food Wars
- Toni Johnson, Council on Foreign Relations, Nov. 20, 2007
This fall the European Union allowed imports of four new genetically modified crops (Reuters) - three types of corn and one sugar beet. The approval came through a default legal process that kicks in when EU environmental ministers cannot agree. Since 2004, a number of modified foods have been allowed into the EU market this way. But individual countries, including Austria, Hungary, and Italy have established national bans in defiance of EU rulings, and at least thus far EU ministers have not stopped them. Now a bigger battle is looming, including possible WTO sanctions if EU countries continue to block imports.
Just days after the EU's latest crop approval, its environment officials failed - for the third time - to agree to end Austria's import ban (EUObserver) on genetically modified corn. The ban dates to the 1990s, and was deemed a trade violation in 2006 by the World Trade Organization. The European Commission, which already twice found the corn to be safe, must now act by November 21 to bring Austria in line, or risks facing WTO sanctions. A Wall Street Journal editorial noted that both the WTO and the EU allow countries to ban unsafe foods, but added that in Austria's case "the facts don't line up with their fears."
Genetically modified organisms, or GMOs, are designed to improve crop yields, withstand herbicide treatment, resist insects, and even in some cases deliver vaccines (Scientific American) or extra vitamins (BBC). But some environmental and consumer activists believe genetically modified crops - sometimes dubbed "frankenfoods" by critics - could harm biodiversity and potentially be toxic (Deutsche-Welle). The European Commission's eight-year "de facto moratorium" (Euractiv.com) on GM foods ended with the establishment of a tough labeling law, but did not resolve a trade fight with the United States. Nor did it placate European fears over genetically modified foods.
Earlier this year, EU regulators failed to reach agreement on Hungary's two-year-old ban on GM corn. Meanwhile, Italy's state-run science agency finds itself besieged by accusations that it suppressed findings (Foodnavigator.com) from a field trial on corn produced by Monsanto, the world's leading producer of GM seeds. Three million Italians have signed a petition for an "unlimited moratorium" (AFP) on modified produce. Germany is moving on a plan to approve GM crops, but only if they are accompanied by strict environmental monitoring. And French President Nicolas Sarkozy recently suspended cultivation of modified crops until their safety is evaluated, saying he didn't want to contradict EU law but made the choice in line with "precautionary principle" (Reuters). One environmental advocate called the pro-business president's shift "seismic."
This resistance to GM crops could be a setback for an industry struggling to get off the ground in Europe. European GM growers reported 77 percent growth (CORDIS) last year, in terms of total area planted. Yet even with these gains, only about one percent of the world's genetically modified corn is grown in Europe, and sixty varieties of crops remain backlogged for approval. EuropaBio, a European biotech lobby group, called for automatic approval of GM foods that pass their risk assessments. The United States, Argentina, Canada, and Brazil pick up the slack, accounting for 94 percent (PDF) of global GMO plantings, according to a 2006 paper published by Harvard's Belfer Center. The paper notes that the environmental effects from GM crops planted in these countries have been "strongly positive to date."
NSW, Vic lift GM bans in landmark moves
- ABC News (Australia), Nov. 27, 2007
The Victorian and New South Wales governments have become the first in Australia to allow farmers to grow genetically-modified (GM) food crops.
NSW Primary Industries Minister Ian Macdonald has announced the state is ending its four-year moratorium on GM canola crops, despite a last-minute plea from Western Australia and Tasmania to maintain the ban.
Mr Macdonald says the move will put NSW farmers on a level playing field with overseas farmers because GM canola now accounts for 70 per cent of the global canola market.
Victorian Premier John Brumby agrees there are great economic benefits.
"You need to be able to compete and you need to be able to maximise your yields," he told farmers.
Mr Macdonald says NSW farmers will need to get approval from authorities before they plant the crops.
"It is a cautious approach to this issue to balance the various stakeholder interests and concerns," he said.
He says GM canola crops will be segregated to protect non-GM crops, but Biological Farmers Australia director Scott Kinnear has questioned the effectiveness of that strategy, saying the wind tends to carry GM seeds into non-GM areas.
The Minister says strict labelling laws will be in place so people will know what they are eating.
He says growing GM canola will have a positive impact on the environment because it reduces the need for pesticides, but NSW Greens MP Ian Cohen is strongly opposed to the move.
"We really are moving into a new set of circumstances in agricultural production and consumption," he said. "It's going to be very difficult, if not impossible, to turn it back."
The Victorian Government decided to lift its ban after a review it commissioned concluded there would be no great health or environmental risks.
Mr Macdonald says his Government's decision was made after an inquiry chaired by former Nationals leader Ian Armstrong.
"This panel received 1,375 submissions and conducted more than 30 interviews on issues associated with the marketing and trade aspects of GM crops," he said in a statement.
"The review found that it was time for change and that farmers and markets wanted the choice.
"There is a confidence out there in the industry that it is time to move into the future on this important issue."
The Minister says South Australia is also due to make a decision on GM canola soon.
He says a limited supply of GM canola will be available in NSW for next year's planting season.
Misleading and inacurate claims by Jeffrey Smith about GM crops exposed in The Weekly Times
- David Tribe a.k.a. GMO Pundit, Nov. 28, 2007
REPORTED IN FULL IN THE PUBLIC INTEREST with links to be added to document the commentary in detail.
Scare tactics fail in anti-GM battle
The Weekly Times, Melbourne November 28th 2007
A high profile book warning against GM crops is short on scientific credibility, says Peter Hunt
Anti-GM campaigners rolled out "acclaimed" author Jeffrey Smith this month to fire some last-gasp shots at the Victorian and other state governments as they prepared to lift their bans on GM food crops.
Mr Smith's book Genetic Roulette makes claims based on what appear to be hard science that would alarm any reader. The book warns GM crops are not only toxic, they could lead to the creation of new super diseases, endanger children and the unborn and cause infertility in rats, pigs and cows.
But what every politician, farmer and journalist should be doing is conducting a simple test to determine the credibility of Mr Smith's work.
Open the book, to any page you like and test Mr Smith's claims against the scientific references listed in the back of his book.
Mr Smith claims: "Glufosinate-tolerant crops may produce herbicide inside our intestines." He states Liberty Link crops convert the Liberty (glufosinate ammonium) herbicide into a harmless derivative called NAG (N-acetyl-L-glufosinate).
He argues:"The problem is that NAG, which is not naturally present in plants, remains there and accumulates with every subsequent spray. Thus when we eat these GM crops, we consume NAG.
"Once the NAG is inside our digestive system, some of it may ( be re-transformed back into the toxic herbicide.
"In rats fed NAG, for example, 10 per cent of it was converted back into glufosinate by the time it was excreted in the faeces." (Reference 6) What Mr Smith doesn't tell you is that the international Food and Agriculture Organisation report he is quoting states: "The Meeting concluded that the intake of residues of glufosinate ammonium resulting from its uses, that have been considered by the JMPR (Joint FAO/WHO Meeting on Pesticide Residues), is unlikely to present a public health concern."
The other important point to make is that NAG quickly breaks down in the plant and does not accumulate in the way Mr Smith claims.
(See GMO Pundit Post Good News About Glufosinate (Liberty) Herbicide: Most is washed off in Rain, Stays Put in Leaves, Or Flushed Down The Toilet.)
Mr Smith states that research by "leading scientist" Irina Ermakova at the Russian Institute of Higher Nervous Activity suggests feeding GM soy to pregnant rats leads to the stunting and premature death of their young.
Mr Smith even leads off this chapter of the book with the claim that "most offspring of rats fed Roundup Ready soy died within three weeks".
It all sounds very worrying.
Why is it then, that every other study by scientists across the globe has failed to fmd any impact on rats and other mammals from eating GM Roundup Ready soy?
It turns out that our "leading scientist", Dr Ermakova, admitted in an interview in the prestigious Nature Biotech journal last September that:
* She bought the RR soybeans and protein isolate used in her rat feeding trials from ADM in the Netherlands. ADM does not sell (and has never sold) pure 100 per cent RR soybean preparations.
* She ignored the standard scientific practice of submitting her research for peer review before publicising her results. Dr Ermakova has still not submitted her work to peer review for publication.
* Dr Ermakova fed her control group of rats a product called Arcon SJ, which is a soy protein concentrate that contains 70 per cent protein as opposed to the other rats in her trial, which were fed soy beans containing 40-45 per cent protein.
* Dr Ermakova did not record the exact dietary composition of each feed or the amount each rat ate. There were only five rats in each experimental group in her study. The international standard for such a feeding trial is 20-25 rats per group, to ensure statistical rigour.
(See GMO Pundit Post Toxicity tests are tricky for tyro toxicologists to try.)
Mr Smith headlines this chapter with: "Sheep died after grazing in Bt cotton fields".
After the cotton harvest, sheep grazed continuously on Bt cotton. Reports from four villages revealed that about 25 per cent of sheep died within a week." One Indian shepherd who ate the flesh of one of these dead sheep even reported suffering from diarrhoea.
Well that does sound awful.
But anyone with even just a smattering of rural knowledge would soon realise that these sheep are more likely to have suffered from nitrate poisoning or the impact of consuming cotton, which contains high levels of tannin. Mr Smith writes the sheep were grazed continuously on the Bt cotton, eating the tender leaves and pods of the plants.
What's remarkable about Mr Smith's claims about GM crops containing Bt is that this is the same compound found in the bacterial sprays used by many of the organic farmers who funded his book.
So, why is it that our scientific community struggles to counter the claims of anti-GM activists like Mr Smith? The answer lies in the fact , that Mr Smith can fire off 60-odd claims that create fear and panic. In contrast, scientists' responses to these claims are often complex, take time to understand and cannot be delivered in snappy little phrases.
(GMO Pundit comment: Similar qualifications can be made about other scare stories which mention how stock suffer after transfer to new diet. Common agricultural explanations like grain-bloat after shifting steers from pasture to grain, or mould-toxins in rain affected cereal feeds have to be discussed as likely alternatives. Unless of course you really want to carry out a witch hunt.)
Illuminating Study Reveals How Plants Respond to Light
- National Science Foundation (Press Release 07-176), Nov. 23, 2007
Plants prepare to respond to light while still in the dark An illustration of the intracellular process of a plant's response to light
[illustration] How a light signal reaches the nucleus of a plant cell http://www.nsf.gov/news/news_images.jsp?cntn_id=110725&org=NSF
Most of us take it for granted that plants respond to light by growing, flowering and straining towards the light, and we never wonder just how plants manage to do so. But the ordinary, everyday responses of plants to light are deceptively complex, and much about them has long stumped scientists.
Now, a new study "has significantly advanced our understanding of how plant responses to light are regulated, and perhaps even how such responses evolved," says Michael Mishkind, a program director at the National Science Foundation (NSF). This study, which was funded by NSF, will be published in the November 23, 2007 issue of Science.
By conducting experiments with Arabidopsis--a small flowering plant widely used as a model organism--the researchers discovered that the plant prepares to respond to light while it is still in the dark, even before it is exposed to light. This preparation involves producing a pair of closely related proteins (known as FHY3 and FAR1) that increase production of another pair of closely related proteins (known as FHY1 and FHL) that had been identified in previous studies as critical participants in the plant's light response.
Haiyang Wang, a member of the research team from Boyce Thompson Institute for Plant Research, says that the plant probably stockpiles these proteins needed for light responses in the dark for the same reason that a traveler fills his car's gas tank the night before a morning journey: in order to be able to get going, without delay, at first light.
With a plant so primed in the dark, it detects and responds to light via the following steps:
* Light-sensing pigment proteins known as phytochrome A located in the cytoplasm of plants cells detect the light in the far-red end of the spectrum.
* The phytochrome A is activated through a change in shape that allows it to bind to FHY1 and FHL.
* The binding of FHY1 and FHL to phytochrome A results in the accumulation of phytochrome A in the cell nucleus, possibly by helping to import phytochrome A into the nucleus.
* The activated phytochrome A changes the activity of genes located in the cell nucleus that govern plant growth and development.
* Resulting changes in gene expression produce the plant's developmental responses to light, such as growth, flowering and straining towards the light.
Although these steps had been identified in previous studies, the discovery of how FHY3 and FAR1 regulate plant responses to light adds an important new dimension to our understanding of them.
Moreover, the researchers also discovered the existence of a negative feedback loop between accumulations of phytochrome A in the cell nucleus and the FHY3 and FAR1 proteins that prime the plant's light response system: the more phytochrome A accumulates in the nucleus, the less FHY3 and FAR1 proteins are produced, and so less phytochrome A is imported into the nucleus. "This feedback loop serves as a built-in brake that limits the flow of light responses," says Wang.
"I can't explain why nature created such a complex process to trigger a plant's light responses," says Wang with a sigh. Among the process's complexities is a resemblance between FHY3 and FAR1 proteins and certain enzymes produced by some mobile DNA elements or so-called "jumping genes." (Jumping genes are so named because they can move between various positions in a cell's genetic code.) "This resemblance initially puzzled the research team when we were trying to identify the molecular function of the proteins," says Wang.
Nevertheless, the resemblance between the FHY3 and FAR1 proteins and jumping gene enzymes may represent a biological blessing in disguise. Why? Because the researchers now believe that they have built a convincing case that FHY3 and FAR1 may have evolved from the jumping gene material. If indeed the proteins did so, this important chapter in evolution may have helped make possible the establishment of flowering plants on earth, says Wang.
Mushrooms may aid rapid vaccine response
- The Penn State Department of Plant Pathology (press release), Nov. 19, 2007
University Park, Pa. - A rapid production of therapeutic human drugs using modified mushrooms may help mount a quicker response to various public health problems, according to plant pathologists who have received a federal grant to perfect their technique.
C. Peter Romaine, professor of plant pathology at Penn State and holder of the John B. Swayne Chair in Spawn Science, said. "We are looking to address several public health issues through our research."
Romaine and his colleague, Xi Chen, previously a post-doctoral scholar at Penn State, hold the patent to genetically modify Agaricus bisporus - the button variety of mushroom, which is the predominant edible species worldwide.
The Defense Advanced Research Projects Agency (DARPA) recently awarded Penn State and Agarigen Inc., Romaine's spin-off company based in Research Triangle Park in Raleigh, N.C., $2.2 million in initial funding under the Accelerated Manufacture of Pharmaceuticals (AMP) program for the rapid production of vaccines and other therapeutic proteins in altered mushrooms. The total value of the effort, if both phases of the development program are completed, could be up to $5.9 million.
"Our immediate research goals are to maximize the level of expression of various biopharmaceuticals and to devise efficient and economical methods for their extraction and purification from mushroom tissue," Romaine said.
At the end of the second year of the contract, Romaine and his colleagues, who include Agarigen cofounder and former Penn State graduate Dr. Donald S. Walters, Penn State post-doctoral research associate Dr. Carl Schlagnhaufer and a team of nine Agarigen scientists, are expected to demonstrate an ability to produce vaccines or other biological drugs within 12 weeks.
"It will be a blind test," said Romaine. "We will be handed genes for vaccines, monoclonal antibodies or other therapeutic proteins, and asked to produce them in the mushroom."
The drugs will then be extracted from the mushroom into forms that could be administered to people. In a pending third year of the project, the researchers are expected to show they can execute a full-scale manufacturing effort and produce three million doses of a drug in 12 weeks.
Researchers at Penn State and Agarigen are currently focusing on assembling gene components for expression in the mushroom, and fine-tuning their techniques to ensure a consistently high level and quality of the drug.
"We are evaluating different gene sequences from a broad array of organisms to determine which provide us the highest level of drug expression in the mushroom," explained Romaine. "It is an empirical process, but we are leaving no stone unturned to achieve our end goal."
Is technology unnatural?
- Philip Ball, Nature (book review), Nature 450, 614 (29 November 2007) | doi:10.1038/450614a, Nov. 29, 2007 (reproduced with permission)
Book reviewed: The Artificial and the Natural: An Evolving Polarity
Edited by Bernadette Bensaude-Vincent and William R. Newman MIT Press: 2007. 331 pp. $40
The topic of this book - how boundaries are drawn between the natural and the synthetic - has received too little serious attention, both in science and in society. Chemists are justifiably touchy about descriptions of commercial products as 'chemical-free', but the usual response, which is to lament media or public ignorance, fails to recognize the complex history and sociology that lies behind preconceptions about chemical artefacts. The issue is much broader, however, touching on areas ranging from stem-cell therapy and assisted conception to biomimetic engineering, synthetic biology, machine intelligence and ecosystem management.
And it is not an issue for the sciences alone. Arguably, the distinction between nature and artifice is equally fraught in what we now call the fine arts - where again it tends to be side-stepped. Some modern artists address the matter head on with their interventions in nature - for example, the artificial rainbows of Andy Goldsworthy - but much popular art criticism now imposes a contemporary view, even on the old masters. Through this lens, Renaissance writer Giorgio Vasari's astonishment that Leonardo's painted dewdrops "looked more convincing than the real thing" seems a little childish, as though he has missed the point of art. No one today believes that the artist's job is to mimic nature as accurately as possible. Perhaps with good reason, but it is left to art historians to point out that there is nothing absolute about this view. Is technology unnatural?
At the heart of the matter is the fact that 'art' has not always meant what it does today. Until the late Enlightenment, it simply referred to anything human-made, whether a sculpture or an engine. The panoply of mutated creatures described in Francis Bacon's The New Atlantis (1627) were the products of 'art', and so were the metals generated in the alchemist's laboratory. The equivalent word in ancient Greece was technÄ", the root of 'technology' of course, but in itself a term that embraced subtle shades of meaning, examined here in ancient medicine by Heinrich von Staden and in mechanics by Francis Wolff.
The critical issue was how this 'art' was related to 'nature', roughly identified with what Aristotle called physis. Can art produce things identical to those in nature, or only superficial imitations of them? (The latter belief left Plato rather dismissive of the visual arts.) Does art operate using the same principles as nature, or does it violate them? Alchemy was commonly deemed to work simply by speeding up natural processes: metals ripened into gold sooner in the crucible than they did in the ground, and (al)chemical medicines accelerated natural healing. And although some considered 'artificial' things to be inferior to their 'natural' equivalents, it was also widely held that art could exceed nature, bringing objects to a greater state of perfection, as Roger Bacon believed of alchemical gold.
The emphasis in The Artificial and the Natural is historical, ranging from Hippocrates to nylon. These motley essays are full of wonders and insights, but are ultimately frustrating in their microcosmic way. There is no real synthesis on offer, no vision of how attitudes have evolved and fragmented. There are too many conspicuous absences (Leonardo da Vinci for one) for the book to represent an overview.
It would have been nice to see some analysis of changing ideas about experimentation, the adoption of which was surely hindered by Aristotle's doubts that 'art' (and thus laboratory manipulation) was capable of illuminating nature. Prejudices about experiments often went further: even in the Renaissance, one was free to disregard their results if they conflicted with a priori 'truths' gleaned from nature, rather as Pythagoras advocated studying music by "setting aside the judgement of the ears". And it would have been fascinating to see how these issues were discussed in other cultures, particularly in technologically precocious China.
But most important, the discussion sorely lacks a contemporary perspective, except for Bernadette Bensaude-Vincent's chapter on plastics and biomimetics. This debate is no historical curiosity, but urgently needs airing today. Legislation on trans-species embryology, reproductive technology, genome engineering and environmental protection is being drawn up, based on what sometimes seems to be little more than a handful of received wisdoms (some of them scriptural) moderated by conventional risk analysis. There is, with the possible exception of discussions on biodiversity, almost no conceptual framework to act as a support and guide.
All too often, what is considered 'natural' assumes an absurdly idealized view of nature that owes more to the delusions of Rousseau's romanticism than to any historically informed perspective. By revealing how sophisticated, and yet how transitory, the distinctions have been in the past, this book is an appealingly erudite invitation to begin the conversation.
Scotts to pay $500,000 fine over biotech bentgrass
- Christopher Doering, Reuters, Nov. 26, 2007
Washington - Scotts Miracle-Gro Co will pay a $500,000 fine over allegations it failed to comply with U.S. rules while testing a genetically engineered grass variety that could one day be used on lawns and athletic fields, the Agriculture Department said on Monday.
The settlement involves field tests in Oregon and 20 other states of creeping bentgrass modified to resist weed killers such as Monsanto Co's Roundup. A golf course, for example, could be sprayed to kill weeds without hurting the grass. Genetically engineered grasses have not been approved by USDA.
The civil penalty is the largest allowed by the Plant Protection Act of 2000, according to the USDA's Animal and Plant Health Inspection Service (APHIS).
An APHIS spokeswoman said the allegations included failure by Scotts to follow proper equipment-cleaning procedures and to have all required buffer zones around the genetically engineered crop to prevent mixing with traditional crops.
Jim King, a Scotts spokesman, said the company takes responsibility for the mistakes and has implemented steps to prevent them from happening again.
"This is an issue that we view as largely behind us," said King. "The outcome that (USDA) announced today was not inconsistent with what we would have expected to see from them. We will pay the fine and move on."
APHIS also alleged Scotts failed to prevent bentgrass or its offspring from persisting in the environment following a field trial in Oregon in 2003.
The government instructed Scotts in 2004 to locate and remove any accidentally released bentgrass to address past allegations that the company failed to notify APHIS of the problem. Since then, there have been more findings of the genetically engineered crop in the environment.
As part of the agreement, Scotts will conduct three public workshops for other potential developers of genetically engineered plants and other interested parties within one year that focus on the best ways to grow biotech crops and how to quickly resolve biotechnology compliance incidents.
"USDA takes compliance with its biotechnology regulations very seriously," said Bruce Knight, under secretary for marketing and regulatory programs. "Compliance is, and will always be, our highest priority and we will continue our rigorous oversight of regulated genetically engineered plants."
A U.S. district judge ruled in February that the Agriculture Department must conduct a more thorough review of applications for field trials of genetically engineered crops to determine if they pose a threat to the environment.
The ruling by U.S. District Judge Henry Kennedy said APHIS failed to adequately consider whether field tests for genetically engineered bentgrass from Scotts could harm the environment.
The lawsuit, filed by the Center for Food Safety and other groups in 2003, alleged APHIS violated environmental regulations when it approved field tests without determining whether genetically modified bentgrass was a plant pest and could breed with native plants.
*by Andrew Apel, guest editor, andrewapel+at+wildblue.net