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July 2006 Updates

Can Bacillus thuringiensis (Bt) corn residues and Bt-corn plants affect life-history traits in the earthworm Aporrectodea caliginosa?

Applied Soil Ecology (Volume 32, Issue 2)

Maria Laura Vercesi, Paul Henning Krogh and Martin Holmstrup National Environmental Research Institute, Department of Terrestrial Ecology, P.O. Box 314, Vejlsøvej 25, DK-8600 Silkeborg, Denmark


Bt-corn is genetically engineered to express proteins from the common soil bacterium Bacillus thuringiensis which presents specific toxicity to targeted insect pests. One type of Bt-corn expresses the Cry1Ab protein that provides protection against certain lepidopteran pests, mainly the European corn borer (Ostrinia nubilalis) and the Mediterranean stalk borer (Sesamia nonagroides). Vast areas of agricultural soils worldwide are grown with transgenic Bt-corn. With such widespread use of Bt-corn, it is important to evaluate the potential risks of Bt-protein to non-target organisms in agro-ecosystems such as earthworms. In this study, we investigated the effects of Bt-corn on important life-history traits (survival, reproduction and growth) of the earthworm Aporrectodea caliginosa under various experimental conditions. Finely ground Bt-corn leaves added to soil had no deleterious effects on survival, growth, development or reproduction in A. caliginosa, even in high concentrations that could be considered as a worst-case scenario. Also, growth of juvenile A. caliginosa was unaffected when worms were kept in pots with a growing Bt-corn plant. Only when considering cocoon hatchability did we see a slight, but statistically significant, negative effect of Bt-corn residues. The implications of these results for risk assessment of Bt-corn are discussed.



Babies As Guinea Pigs

By Silvia Ribeiro
La Jornada, Mexico
July 1 2006

Biotech company turns two Peruvian hospitals into laboratories

The biotech company Ventria Biosciences sponsored tests on babies and children hospitalized at two pediatric institutes in Peru, of two new experimental drugs derived from transgenic rice that was genetically engineered with synthetic human genes to produce artificial human milk proteins.

The experiments - results of which were revealed this May in the US - were carried out at the Institute for Child Health and at the Nutrition Research Institute, both in Lima, Peru. The Peruvian public found out about the experiments when they were denounced by the Peruvian Human Rights Association and the Network for a GMO-Free Latin America.

Ventria is a biotech company that specializes in so-called "Pharming," which refers to planting genetically-modified crops that are cultivated to produce pharmaceutical agents or chemicals. Such plant varieties are even more controversial than the GM (genetically-modified) crops designed for agricultural use. This is because the "Pharm" crops could contaminate food crops, via the movement of pollen or accidental mixing of crop residue, with significant health risks, particularly if they enter the human food chain.

So far, no drug produced by transgenic crops has been approved for human use in the US or anywhere else in the world. Ventria began planting GM pharma crops in California, but was forced to move them to Missouri and then to North Carolina in response to resistance by farm groups and by consumer and environmental organizations.

Because of the long and uncertain approval process for new drugs, especially those of this type, the company apparently decided to carry out their experiments on children in the Third World, where regulations are more lax and where it seems easier to find institutions that lack adequate funding (or ethics).

In a recent public relations move to makeover its image, Ventria now calls these products "medical foods," most likely in order to evade the stricter regulations for drug approvals. The company is carrying out experimental production of two recombinant human proteins, Lactoferrin and Lysozyme, which are present in their natural forms in mothers' milk, saliva, semen and other human bodily fluids. The recombinant versions are produced in genetically engineered rice, which contains the synthesized human gene sequences responsable for their production. Two of these, extracted from the modified rice, were tested on Peruvian children.

Ventria experimented with 140 children from the age of 5 months to 3 years who were suffering from diarrhea and were hospitalized at the above mentioned pediatric institutes. The tests lasted 48 hours in the hospital, with two follow-up visits during the following two weeks. The children were divided into three groups. One so called "control group" received an oral glucose-based re-hydration solution, a second group received a (non transgenic) rice-based solution, and a third group got the same rice solution with the addition of the recombinant Lactoferrin and Lysozyme.

According to the brief summary of the results that was published by the company, the children who received the recombinant treatment took an average of 3.67 days to recover, while the control group took an average of 5.21 days. Ventria announced the results while ignoring the fact of having used Peruvian children as guinea pigs, when they wouldn't have been allowed to administer the same tests in their own country. The purpose of the tests is to hasten approval and attempt to gain moral legitimacy for the commercial use of their controversial product, which they now say is mostly for the Third World.

Nevertheless, their preferred market is not that of children in poor countries suffering from diarrhea, but rather the more lucrative market for so-called "nutriceuticals", including sports drinks and dietary supplements, among others. The Third World children simply offer more public relations value for the company.

According to US pediatrician Jim Diamond, a surprising aspect of the results published by Ventria is that they used a group of children given a glucose solution as a control group, when there is an abundant medical literature showing that rice-based (non-transgenic) solutions work faster and more effectively in treating acute diarrhea.

This means that the company, with the complicity of the Peruvian institutes, may have intentionally used a less effective control for comparison purposes, in order to make the positive effects of their product appear more dramatic. On the one hand, they exposed one group of children to unapproved transgenic drugs, while on the other, another group may have had their recovery delayed, because of an inferior treatment, for the purpose of obtaining better looking results.

There are many scientific articles -- readily available on the Internet -- that reveal cases of adverse reactions like allergies, formation of anti-bodies, etc. caused by exposure to transgenic human proteins, such as anti-coagulants, growth hormones and insulin. In some cases this has led to the removal of products from the market.

During the process of public consultation motivated by Ventria's experimental use applications to grow experimental field trials of pharma crops in the US, a number of organizations, including Consumers Union, the Center for Food Safety and Friends of the Earth-USA, provided authorities with comprehensive reports, referencing the scientific literature, in which they described in detail the possible adverse health effects of Ventria's recombinant Lactoferrin and Lysozyme. (1) They pointed out that the recombinant proteins are not identical to their natural counterparts, which means they could provoke immune system disorders or allergic reactions. The increased levels of Lactoferrin and Lysozyme could also favor the growth of pathogens, like the Helicobacter pyloris bacteria, which can cause gastritis and stomach cancer, the bacteria that cause meningitis, and others that cause illnesses that are difficult to treat because of antibiotic resistance.

Obviously Ventria knew about these reports when they decided to go ahead and place Third World children and infants at risk in experimental drug trials. If the Peruvian institutes also knew about these reports, then their complicity is criminal. If they didn't carry out due diligence concerning risks, then their negligence is of the same order.

Translated by Peter Rosset (original in Spanish at - the original Spanish version didn't include footnotes)

(1) Consumers Union's Comments on USDA Animal Plant Health Inspection Service (APHIS) Environmental Assessment for Field Test of Permit of Ventria Bioscience rice genetically engineered to express human lactoferrin, USDA/APHIS Docket No. 05-006-1,

Freese, Bill; Hansen, Michael and Gurian-Sherman, Doug. "Pharmaceutical Rice in California", July 2004,

Bill Freese at the Center for Food Safety has written an excellent summary on this issue. The briefing paper "An Assessment of Genetically Engineered Pharmaceutical Rice and Its Potential Use in Oral Rehydration Solutions to Treat Severe Diarrhea" will soon be available at


Genetically Modified Ice Cream Could Be Coming to Britain

By Geoffrey Lean and Jonathan Owen
July 9, 2006

A fish from the Atlantic depths has lent its survival secret to a food giant searching for improved product 'texture'.

New designer ice cream, made possible by genetic modification, threatens to set off a "time bomb" in the health of British children, scientists are warning. The scientists, from Britain and Canada, have alerted an official committee which this month will rule on the safety of the ice cream, being sold increasingly worldwide by the food giant Unilever. It contains an artificial protein copied, through a GM process, from a fish living in the frigid waters of the bottom of the North-west Atlantic.

An "anti-freeze" protein allows the fish - the ocean pout - to survive extreme cold. Unilever, the world's biggest ice cream maker, says using its artificial equivalent allows it "to produce products with more intense flavour delivery, a wider range of novel textures and more intricate shapes".

Unilever also says it can improve the "healthiness" of the ice cream by cutting its fat and sugar content - a claim that particularly angers its critics.

The scientists - Professor Malcolm Hooper, Emeritus Professor of Medical Chemistry at Sunderland University, Professor Joe Cummins, Emeritus Professor of Genetics at the University of Western Ontario, and geneticist Dr Mae-Wan Ho, director of the Institute of Science in Society - retort that it risks "letting off an immunological time bomb".

The company, which has been making ice cream for more than 70 years under such brands as Wall's, Magnum and Carte d'Or, and now owns Ben and Jerry's, has sold it with the protein in the United States for three years, and has approval to do so in Chile, Indonesia, Mexico and the Philippines.

It has also had the go-ahead in Australia and New Zealand despite objections by the health departments of the states of Victoria, Queensland and New South Wales and the New Zealand Food Safety Authority.

Now it has applied to the Food Standards Agency to be allowed to use it in "edible ices" sold in Britain, including sorbets, water ice, fruit ice, frozen desserts, iced smoothies - and ice cream. The agency's Advisory Committee on Novel Foods and Processes is due to consider the plea at its next meeting, on 20 July.

If the committee gives it the green light, as is likely, it will then have to go to the European Union for approval, a lengthy process but one also expected to give it the go-ahead. The new products could go on sale in Britain in two years' time.

The key step in making the ice cream is getting hold of the ocean pout's secret, called an ice-structuring protein because rather than preventing freezing altogether, it lowers the temperature at which ice crystals grow, and changes their shape and structure so that they do less damage to living tissues.

In theory, Unilever could go out and catch loads of the fish - an eel-like species that lives on the ocean floor - extract the protein and add it to the ice cream like any other ingredient. But this would be expensive and, as the company, which has a good record in combating overfishing, points out, would cut the population of the fish, whose stocks are already declining.

So it has resorted to a GM process already widely used to produce vitamins and enzymes for food, including vegetarian cheese. A synthetic gene for the protein is added by genetic modification to bakers' yeast, which is fermented to manufacture more. The protein is then extracted so that the final product does not contain any modified yeast cells. This has led to a semantic battle over whether the final product is "GM ice cream". Unilever says that it is not; the scientists maintain it is. "This is about as genetically modified a product as you can get," says Professor Cummins.

The more important debate is whether the end result is safe, particularly for children. Unilever accepts that the main danger is that people may prove allergic to the protein. But it points out that people have eaten its natural form in ocean pout for decades, and says that the artificial version is identical. It adds that extensive tests on the artificial protein for allergic effects gave it the all clear.

Unexpectedly perhaps, many of the most prominent anti-GM pressure groups, including Friends of the Earth, GM Freeze, and Genewatch, say, in effect, that they are not too bothered, and that it is well down their priority list. But the scientists, who have a record of GM scepticism, are deeply disturbed, as is The Soil Association.

The scientists insist that the protein is changed in the processing, and may pose a danger. Professor Hooper told The Independent on Sunday yesterday: "This is a novel protein manufactured by genetically modified organisms and its characteristics have never been fully evaluated. It needs to be checked out before it is widely introduced into the human diet."

He and his colleagues also dispute the adequacy of Unilever's safety checks, not least because it checked the protein against the blood of people allergic to cod, not the pout fish,

The Soil Association calls the ice cream "a frivolous application of a dangerous and unwanted technology". It adds: "Just because there won't be any traces of the GM material in the ice cream does not mean that the product is safe. It certainly should not be marketed as a 'healthier alternative' simply on the grounds that it is low fat."

The Soil Association says research shows that "genetic engineering produces a range of unpredictable biological side-effects". This includes, it is believed, "new toxins and allergens even if the original GM material is absent".

It points to a GM food supplement, L-tryptophan, which "killed over 37 people and disabled over 1,500 others" in the US in 1989 even though it also "did not contain any GM material in the final product".

Unilever responded yesterday: "This is an exciting new technology that has potential benefits for ice cream, including the possibility of increased fruit content and lower fat content. The process itself is widely used within the food industry, but the Food Standards Agency process is designed to solicit opinion from others and we would not want to influence that process whilst it is still running its course."

The row comes as the biotech industry is attempting a comeback with the help of the European Commission. Modified products were swept from the shelves in the face of public refusal to buy them, and the EU instituted a six-year moratorium on approving new ones.

But this came to an end two years ago and biotech firms have jumped in. Adrian Bebb of Friends of the Earth says: "Their latest tactic is to swamp committees with dozens of applications for new GM foods. It is hard to imagine that the scientists working for these committees will be able to pay as much attention to their safety as they merit."

EU governments are deadlocked on the applications but, under the rules, the pro-GM European Commission then nods them through. Seven different types of GM maize have been approved for food in the past two years: applications for GM rice, sugar beet and potato are in the pipeline. But there is no sign of them appearing on British supermarket shelves - because most still refuse to buy GM food.

Additional research by Julia Belgutay

GM Protein in Ice Cream

By Prof. Joe Cummins, Dr. Mae-Wan Ho and Prof. Malcolm Hooper

Genetically modified fish antifreeze protein is potentially able to cause inflammation and should not be approved without comprehensive tests

This report has been submitted to the Food Standards Agency to oppose approval of Unilever’s application on behalf of the Independent Science Panel

Unilever is seeking approval of a genetically modified (GM) (FAQ on genetic engineering) ice-structuring protein derived from a polar fish, ocean pout, for use in making ice cream smoother and creamier. The GM protein is produced in transgenic bakers’ yeast. Ice-structuring, or antifreeze protein protects the ocean pout in freezing waters by preventing large ice crystals forming; in ice cream and other frozen food it would have the same effect.

Unilever applied to the Food Standards Agency (FSA) UK for approval, and its proposal is now open for public comment [1]. Unilever has sent similar petitions to the United States Food and Drug Administration (FDA) to obtain the Generally Recognized As Safe (GRAS) status for the food additive [2] and to Food Standards Australia New Zealand [3]. Both applications have been approved, which is unfortunate.

The transgenic protein produced in yeast was designated ISP Type III HPLC 12 glyco–ISP. The preparation tested by Unilever contained peptides from yeast and sugars along with the recombinant protein. Unilever conducted a subchronic feeding test of the preparation on rats by oral gavage (force feeding) for 3 weeks, as well as a battery of genotoxicity tests that proved to be negative. A series of tests that included those suggested by the World Health Organisation for allergy were carried out, along with tests for reactivity with serum obtained from a few people allergic to fish.

The report stressed that the recombinant protein was identical to protein found in edible fish [1], although that kind of statement is generally untrue as will be discussed below. There is voluminous literature on antifreeze glycoproteins, particularly those from polar fish. There are four main types of glycoproteins each differing significantly from the others. Type III proteins are around 6500 daltons in size, they form a beta-sandwich structure and are found only in ocean pout [4]. Although the antifreeze protein itself is not immunogenic for the ocean pout, there is nevertheless a strong immune response to the micro ice crystals complex with antifreeze protein circulating in the fish’s blood, indicating that the complex functions as conventional antigens for the ocean pout [5].

The GM protein from transgenic yeast is the product of a synthetic approximation of the pout antifreeze protein gene. The code sequence was altered to facilitate production in yeast without altering the amino acid sequence. Multiple copies of the synthetic gene were inserted into the yeast chromosomes to boost the synthesis of the protein [1].

Production of proteins in yeast destined for human consumption or therapy is fraught with the problem of secondary modification of the proteins by glycosylation or other modifications that result in the human (or animal) immune system recognizing the yeast modified proteins as antigens. There has been progress in "humanizing" the glycosylation patterns of proteins produced in yeast [6, 7]. However, there has been no effort to "humanize" the glycosylation pattern of the antifreeze protein produced in the yeast strain used to produce the protein.1

Are the cursory studies on allergenicity carried out by Unilever on the GM protein to be used in ice cream adequate to rule out allergy and other immune reactions in the tens of millions of people that will consume the ice cream?

It is worth pointing out that the transgenic protein is already used in ice cream in the USA, Australia and New Zealand, and that ice cream has not been labeled, so any problems resulting from its use may go unrecognized.

We should recall that the transgenic expression of a bean gene in peas turned it into a strong immunogen, resulting in debilitating even fatal lung inflammation in mice. That response was related to the glycosylation pattern of the transgenic protein [8, 9] ("Transgenic pea that made mice ill", SiS 29).

Unilever does not appear to have carried out the inflammation tests even though there is every indication from the scientific literature that pouter antifreeze protein is immunologically active. There is also the question of latency. Some chronic inflammatory diseases emerge gradually, building up from an initial response that is small and clinically variable or insignificant (asymptomatic) [10]. But there is a potential cascade effect that when triggered, will lead to autoimmune effects that could affect any organ. Without long term testing, we could be letting off an immunological time bomb. Tests for inflammatory effects must be done in both young and older animals with full analysis of inflammatory cytokines, antibodies and related molecules. Tests in young animals are particularly important as ice cream is consumed from the earliest age when there are crucial development processes occurring.

In conclusion, contrary to the claims of Unilever, there is no evidence that the transgenic ice- structuring protein is identical to the protein produced in pouter fish. The transgenic protein appears to have the glycosylation pattern of yeast, making that protein a unique antigen. Even though allergenicity was studied in a cursory way, there is clear precedent for studying inflammation comprehensively in the long term in both young and older animals before exposing the European public to the transgenic ice cream.

References available on request.


How the Flood of GM Goods Was Driven Off The Shelves

Geoffrey Lean
July 9, 2006

Seven short years ago, when The Independent on Sunday began its campaign on GM foods and crops, 60 per cent of the products on our supermarket shelves contained modified ingredients.

Now only two GM products are left on sale: Schwartz's Bacon Flavour Bits Salad Topping, and Betty Crocker Bac-Os - neither exactly household names.

Then, too, widespread cultivation of GM crops throughout Britain was thought to be only a year away. No less than 53 of them were confidently awaiting approval. Now not a single GM plant is growing anywhere in any British field, and no one expects any to be sown any time in the foreseeable future.

At the time ours appeared a hopeless cause. The giant biotech companies seemed unstoppable: Monsanto, which led their charge, was poised to make a merger that would have turned it into the world's largest corporation. It had the full backing of the Government, fired by the messianistic determination of Tony Blair to make the country "the European hub" of biotechnology. Both the US administration and the British scientific establishment were urging him on.

The Prime Minister privately dismissed public opposition as "a flash in the pan", and so it appeared. Ranged against the Goliaths of the boardrooms and the cabinet rooms were a motley band of Davids, ranging from Prince Charles to pressure groups such as Greenpeace, Friends of the Earth and the Soil Association.

But we reckoned without the most powerful force of all, the superwomen (and supermen) of the shopping aisles who, informed of the presence of GM products in their foods and the arguments for and against, simply refused to buy them. Thus the public achieved what parliament has repeatedly failed to do - stopping one of Tony Blair's dodgier crusades in its tracks.

We started our campaign in February 1999 by calling for a pause in the rush to a GM future, demanding a three-year moratorium in cultivating modified crops while more research was carried out. By the end of the year we had our wish: Michael Meacher, the then Environment minister, skilfully persuaded the biotech industry to agree to a three-year halt, pending official field trials.

The trials, in true Whitehall fashion, were designed to clear the crops. Everyone knew that the main danger that the crops posed was that they would cross-pollinate with nearby plants, creating superweeds, So the tests avoided this issue altogether, focusing on the relatively minor issue of the effects of weedkiller on them.

Everyone expected this jiggery-pokery to succeed - including the environmental campaigners who repeatedly pulled up the GM crops, in an attempt to scupper the trails (after one protest Lord Melchett, the then head of Greenpeace, was arrested with 20 supporters - only to be acquitted by a jury). But when the results were published modified crops were still generally found to be more damaging to wildlife than conventional ones, even on these limited grounds.

Even worse for Monsanto and Mr Blair, public opinion had by then decisively turned against GM. Both ministers and the industry had fondly believed that the pause would allow the controversy to die down, but they were sorely disappointed.

By the time the tests ended, 84 per cent of Britain's had decided they would not touch the stuff. The supermarket chains fell over themselves to clear it from their shelves - and the big food manufacturers rushed to abjure its use.

Monsanto closed its seed cereal business in Britain and Europe, and the industry withdrew the last of the 53 applications it had once assumed would be granted. Anyone for Betty Crocker Bac-Os?

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