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June 25, 2007


Monsanto Responds to Rat Study; Rice Yields Cholera Vaccine; Modified Mushrooms


* GEAC approves Bt cotton trials
* RR alfalfa no threat
* Modified Mushrooms
* Monsanto Response to Rat Feeding Study
* Food Safety Western Australia Style
* Rice-based vaccine for cholera
* Is it a rosato? A lemato?


GEAC approves MLRT strip trials of several Bt cotton

- Fibre2Fashion (India), June 23, 2007


The 78th meeting of the Genetic Engineering Approval Committee (GEAC) approved Multi Location Research Trials (MLRT) of several Bt cotton. The food crops rice, okra, corn, brinjal and potato could not get approval.

Permission to conduct MLRT of Bt cotton expressing approved gene/events have been approved. This includes BG I cotton hybrids, BG II cotton hybrid, cry1Ac gene, 3 intra - hirsutum hybrids, 2 inter-specific hybrids, 3 inter-specific hybrids, 5 Bt cotton hybrids, Bollgard cotton hybrids has been given.

The MLRT will be taken in central and south zones at various locations. The Committee also approved the proposal for strip trials of Bt cotton expressing approved gene/events.

This will cover 35 Bt cotton hybrids, 115 transgenic Bt cotton hybrids, 29 intra-specific Bt cotton hybrids and others will be included. Experimental seed production of Bt cotton expressing approved gene/events has also been given approval.

MLRT of GM food crops were not given approval. Companies require to submit validated protocol for detection of 0.01 per cent level contamination. Subject to this submission they will get approval later on.

This include six transgenic Bt rice hybrids, 3 transgenic Bt Okra hybrids, YieldGuard corn parental lines, Roundup Ready Corn hybrid, Bt brinjal, 8 cotton hybrids, flex cotton hybrids etc.

The Large Scale Field Trials (LSFT) of Bt cotton expressing new gene/events did not get approval because they did not complete full bio-safety studies. This include cotton hybrids expressing Cry1C gene and seed production of cotton hybrids.

The Committee has approved the import of Soybean oil obtained from round-up ready Soybean by M/s. Solvent Extractors' Association of India.


RR alfalfa no threat to organic, export markets

- Mike Waters, The Prairie Star, June 22, 2007


Organic activists and environmental extremist groups would have the public believe that Roundup Ready (glyphosate tolerant) alfalfa is a "threat to organic alfalfa and alfalfa export markets." Reality says otherwise.

Of the 22 million acres of alfalfa grown in the U.S. last year, USDA estimates that only about 200,000 acres were Roundup Ready - about 0.01 percent of the total. And the risk of cross pollination in forage production is extremely remote.

According to the University of California - Davis (http://alfalfa.ucdavis.edu - click on 'Biotech Alfalfa') for gene flow to occur from one hay field to another, the following must occur: 1) Fields must flower simultaneously, 2) pollinators must move between fields; 3) pollen must fertilize plant; 4) embryos must turn into seeds: 5) seed must fall to ground and germinate; 6) germinating plants must compete with existing alfalfa.

Agronomic experts point out that there are severe environmental limits to each of these steps happening, and further, most hay is harvested pre-bloom; the few surviving seeds that may germinate do not contribute significantly to hay biomass (estimates at <0.001 percent).

RR alfalfa a threat to export hay markets? Hardly. About 90 percent of alfalfa produced in the U.S. is consumed domestically, much of it consumed on the farm where it is produced. Japan - the largest recipient of U.S. hay, representing over 75 percent of all U.S. alfalfa hay and hay product exports - approved RR alfalfa for import last year.

Over 98 percent of U.S. alfalfa hay/hay products exported is concentrated in five countries: Japan, South Korea, Taiwan, Canada and Mexico. All five countries have a process for approving import of biotech crops and currently import products derived from U.S. produced biotech soybean, corn, canola and/or cotton.

The U.S. court has already accepted the fact that Roundup Ready alfalfa poses no harm to humans and livestock, and other regulatory agencies around the world, including Canada and Japan, have confirmed the environmental safety of RR alfalfa. Further, farmer stewardship agreements provide an expected level of responsibility, following proper production practices just as conventional and organic producers adhere to required production practices.

Montana is a leading alfalfa producing state in the nation, and while RR alfalfa isn't a fit for all producers, it offers distinct advantages for some, including a better chance of stand establishment in the spring, and for selling into segments of the hay and forage market that demands a high quality, weed-free product, such as horses and purebred livestock breeders.

What really happened here is that a bunch of environmental groups bent on an all organic, no biotech crop agenda went shopping for a judge friendly to their cause. It's important to note, however, that the San Francisco judge's ruling halting the production of RR alfalfa isn't permanent. It's only until USDA completes an Environmental Impact Statement.

Longtime ag writer Harry Cline, editor of the Western Farm Press, was sharply critical about the ruling. "All this to appease a bunch of radicals bent on destroying the American economy," he wrote. "(The ag community) must appeal this ridiculous decision to protect American agriculture from a threat far more insidious than any transgenic gene or weed." (Mike Waters, Froid, Mont., serves on the board of Growers for Biotechnology, a group of crop producers who volunteer their time to promote and facilitate the research, development and acceptance of biotechnology in agriculture.)


Modified Mushrooms May Yield Human Drugs

- Science Daily, June 22, 2007


Mushrooms might serve as biofactories for the production of various beneficial human drugs, according to plant pathologists who have inserted new genes into mushrooms.

"There has always been a recognized potential of the mushroom as being a choice platform for the mass production of commercially valuable proteins," said Charles Peter Romaine, who holds the John B. Swayne Chair in spawn science and professor of plant pathology at Penn State. "Mushrooms could make the ideal vehicle for the manufacture of biopharmaceuticals to treat a broad array of human illnesses. But nobody has been able to come up with a feasible way of doing that."

Dr. Romaine and his colleague, Xi Chen, then a post-doctoral scholar at Penn State and now a Syngenta Biotechnology Inc. research scientist, have developed a technique to genetically modify Agaricus bisporus -- the button variety of mushroom, which is the predominant edible species worldwide. One application of their technology is the use of transgenic mushrooms as factories for producing therapeutic proteins, such as vaccines, monoclonal antibodies, and hormones like insulin, or commercial enzymes, such as cellulase for biofuels.

"Right now medical treatment exists for about 500 diseases and genetic disorders, but thanks to the human genome project, before long, new drugs will be available for thousands of other diseases," Dr. Romaine said. "We need a new way of mass-producing protein-based drugs, which is economical, safe, and fast. We believe mushrooms are going to be the platform of the future."

To create transgenic mushrooms, researchers attached a gene that confers resistance to hygromycin, an antibiotic, to circular pieces of bacterial DNA called plasmids, which have the ability to multiply within a bacterium known as Agrobacterium.

The hygromycin resistance gene is a marker gene to help sort out the transgenic mushroom cells from the non-transgenic cells, Dr. Romaine explained. "What we are doing is taking a gene, as for example a drug gene, that is not part of the mushroom, and camouflaging it with regulatory elements from a mushroom gene. We then patch these genetic elements in the plasmid and insert it back into the bacterium," he added.

The researchers then snipped small pieces off the mushroom's gill tissue and added it to a flask containing the altered bacterium.

Over the course of several days, as the bacterium goes through its lifecycle, it transfers a portion of its plasmid out of its cell right into the mushroom cell, and integrates the introduced gene into the chromosome of the mushroom.

Next, the researchers exposed the mushroom cells to hygromycin. The antibiotic kills all the normal cells, separating out those that have been genetically altered for resistance.

The test demonstrates that if a second gene, insulin for example, were to be patched in the plasmid, that gene would be expressed as well.

"There is a high probability that if the mushroom cell has the hygromycin resistance gene, it will also have the partner gene," Dr. Romaine added.

The degree of gene expression ultimately depends on where exactly the imported gene lands in the mushroom chromosome, among a complexity of other factors, but researchers point out that the process of producing biopharmaceuticals is potentially faster and cheaper with mushrooms than conventional technologies. Unlike plants that have long growth cycles, "with mushrooms, we can use commercial technology to convert the vegetative tissue from mushroom strains stored in the freezer into vegetative seed. A crop from which drugs may be extracted could be ready in weeks," Dr. Romaine said. A mushroom-based biofactory also would not require expensive infrastructure set up by major drug companies, he added.

The technology is patented by Penn State and Agariger, Inc. has an exclusive license to develop the technology. Dr. Romaine is a co-founder of the company.


Monsanto Company Response to a Crii-Gen Report Relating to the NK 603 Maize Rat Feeding Study

- Eric Sachs, Bruce Hammond, Margaret Nemeth, and Kerstin Kramer, June 24, 2007

Subject: Controversial effects on health reported after subchronic toxicity test: 90-day study feeding rats (June 2007) by Seralini, Gilles-Eric, Cellier, Dominique, and Joel Spiroux de Vendomois

- A Crii-Gen [Internet] Report on NK603 GM maize produced by Monsanto Company

- Announced by Greenpeace in a press statement

- Restricted access to the critique, accessible only from Greenpeace or Gilles-Eric Seralini


Greenpeace issued on 14 June 2007 a press release (http://www.greenpeace.org/eu-unit/press-centre/press-releases2/seralini-NK603) highlighting 67 statistically significant differences between test and control treatments in the NK 603 maize 90-day rat feeding study submitted to European Union (EU) regulatory authorities prior to approval in the EU for import, feed and processing under Directive 2001/18/EC on 19 July 2004 and under the Novel Food and Novel Food Ingredient Regulation on 3 March 2005. The analysis by Crii-Gen (Committee for Independent Research and Genetic Engineering) focused on statistically significant differences between rats that received NK603 in their diet and those fed conventional maize. Greenpeace demanded the withdrawal of NK 603 maize and all other GMOs and a review of the European Union risk assessment system.

Importantly, the Crii-Gen report does not include any new data or statistical analysis of the original study data and has not been published in a peer-reviewed scientific journal. It is a critique of the analyses carried out by Monsanto scientists and the conclusions reached by regulatory authorities in the EU in support of the safety of NK 603 maize for use in feed and processed foods. The authors of the Internet report and Greenpeace are calling for further investigation and funding for Crii-Gen to conduct new experiments of longer duration on two generations of rats.

The principal claims of Crii-Gen and Greenpeace include:

- Differences in kidney, brain, heart and liver measurements, as well as weight differences, could be warning signs of toxicity, but were not further investigated by Monsanto or other independent researchers.

- Long term consumption of GMOs could lead to "alarming health anomalies."

- EU risk assessment procedures are not adequate and respective authorities are "just rubberstamping company dossiers."

- The study conducted by Monsanto scientists "is likely to seriously impair the independence of the expertise involved"

The criticisms of the NK 603 maize rat feeding study by the Crii-Gen team led by Seralini are contradicted by the assessments by EU member state authorities, the European Food Safety Authority, and expert reviewers of the study published in a leading toxicology journal (Hammond et al. 2004, Food Chem. Toxicol.). All statistically significant differences were investigated and no biologically or toxicologically significant differences were observed. This study was published in a peer-reviewed scientific journal, Food and Chemical Toxicology, in 2004.

Hammond, B., R. Dudek, J. Lemen, and M. Nemeth. 2004. Results of a 13-week safety assurance study with rats fed grain from glyphosate tolerant corn. Food and Chemical Toxicology 42 (2004) 1003-1014.

Regulatory Process

The 90 day rat study with NK 603 maize was conducted in accordance with EU regulations and followed strict OECD guidelines for laboratory animal testing. The key steps to date in the EU regulatory process for NK603 include:

- The Spanish Comision Nacional de Bioseguridad reviewed the rat feeding study as Rapporteur as part of Monsanto's notification C/ES/00/01 under Directive 2001/18/EC. Its assessment report concludes that "there is no scientific evidence which indicate any risk for human and animal health or the environment of NK603 maize".

- The Committee on the Safety Assessment of Novel Foods of the Health Council of the Netherlands reviewed the rat feeding study as Rapporteur as part of Monsanto's notification under Regulation (EC) No 258/97. Its assessment report concludes that "the consumption of NK603 maize and foods and food ingredients derived from this is just as safe for humans as the consumption of non-genetically modified maize and maize products".

- The rat feeding study was circulated to all EU Member States as part of the above notifications, after the respective rapporteur reviews.

- The European Food Safety Authority later issued a scientific opinion on above applications for NK603: "The EFSA GMO Panel considered the information made available by the applicant as sufficient to evaluate the safety of NK603 maize and derived products, food and feed ingredients and to address all the specific questions raised by the Member States related to the risk assessment", and further concludes: "NK603 maize is as safe as conventional maize and therefore the placing on the market of NK603 maize for food or feed use of the grain or processing is unlikely to have an adverse effect on human or animal health or, in that context, on the environment."

- NK603 was approved in the European Union for import, feed and processing under Directive 2001/18/EC on 19 July 2004 and under the Novel Food and Novel Food Ingredient Regulation on 3 March 2005.

Comments on the critique by Crii-Gen

Gilles-Eric Seralini and the co-authors of the Crii-Gen report are critical of the risk assessment process used by regulatory authorities to assess the safety of food and feed derived from GM crops. They do not understand, or are unwilling to accept, the science that underpins the safety assessment of biotechnology-derived crops. This safety assessment process has been articulated by experts (EC, 2003; OECD, 1993; 2002a; EFSA, 2006; FAO/WHO 1996, 2000, 2003; Kuiper et al., 2001, 2002) in Europe and published in numerous monographs. The authors of the report are not toxicologists, oppose the commercial use of GM crops, and frequently challenge the safety of GM crops without legitimate scientific basis. These views are not shared by an overwhelming majority of scientific and regulatory experts around the world and these views were published on the internet, not in a peer-reviewed scientific journal.

The authors remark that "All the scientific committees consulted agree with Monsanto that statistically significant differences were reported during the 90-day study..." Their concerns are based on the finding of 67 statistically significant differences among some 1050 comparisons of overall health, body weight, food consumption, clinical pathology parameters, organ weights, and gross and microscopic appearance of tissues between test and control rats during the duration of the feeding study. There were a large number of comparisons made in the study and a number of statistically significant differences were expected to occur at random. All statistically significant differences were investigated and no biological or toxicological differences were observed (Hammond et al., 2004). A statistically significant finding does not automatically constitute definitive evidence of an adverse or toxicologically important effect. The magnitude of departure from the normal range, the consistency of the out-of-range responses, and the relationships of the abnormal responses to the physiological, physical, biochemical, and metabolic well-being of an animal all have to be considered. These must be evaluated on a case-by-case basis, taking into consideration such factors as the direction of change (i.e., increase or decrease), evidence of a dose response, the presence of a similar effect in animals of the other sex, and the presence of other indicators of clinico-pathology including, specific organ toxicity (Chan et al., 1982; Gad, 2001; Lewis et al., 2002; SOT, 1982; Weil and gad, 1980; Wilson et al., 2001).

Importantly, scientific experts participating in OECD provided guidance on the interpretation of statistical findings in toxicology studies:

"Because of normal biological variation in inter-animal values, and the alterations in values in response to a variety of inputs, evaluators have to contend with much "noise" in this area; they are frequently presented with statistically significant but scattered effects, in the absence of any evidence of clinically significant relationships with specific toxicity endpoints....To deal with the noise it is necessary to examine whether an effect is within the normal range of variation, using concurrent and historical controls...Frequently these data show apparently random changes in individual groups, or, less commonly, trends in changes across groups that are unrelated to dose. If, as an aid to evaluation, historical control data are used for comparison, it must be kept in mind that "normal" values in haematological and clinical chemistry measurements depend on the specific methods used to generate the data. Thus, only values obtained using identical methods at the same laboratory are valid in such comparisons." (OECD, 2002b)

The authors acknowledge the need to evaluate the biological relevance of statistical findings. They state "The statistical analysis must be completed with data being interpreted by biologists, toxicologists and physicians (pathologists) in order to correlate the statistically significant differences and the possible development of signs of toxicity, clinical symptoms or pathologies (Remark 6)." They also acknowledge that the majority of scientific experts on government scientific committees evaluated all of the data according to the principles stated in the previous paragraph and concluded they were "not biologically meaningful." In spite of this important understanding, the Crii-Gen authors conclude that a statistically significant finding is evidence of an adverse effect and recommend "additional statistical analysis in a serious and independent way."

The procedures used by Monsanto statisticians followed internationally accepted guidelines recognized by regulatory agencies and other government authorities. Not surprisingly, the authors still recommend that the data be subjected to more statistical analysis using additional methods. There are many tests that can be used to evaluate biological data, and some are more appropriate than others, depending upon the design of the toxicology study. In consideration of the many kinds of statistical tests that are available, and to bring some order to way that toxicology data is evaluated statistically for regulatory submissions, regulatory agencies and government authorities have provided guidance on how data should be evaluated (FDA, 2000; OECD, 2002b; WHO, 1987).

Importantly, it does not matter how many ways the data is analyzed statistically, the data still remain the same. Expert toxicologists have concluded that the measured responses of rats fed NK 603 grain fall within normal limits. There is no basis for conducting more statistical tests since more testing will not change the conclusion that no meaningful differences were observed in rats fed NK 603 grain when compared to rats fed control corn grain.

Monsanto Responses to Specific Remarks in the Crii-Gen Report

Remark 1- Claim that the study conducted by Monsanto scientists "is likely to seriously impair the independence of the expertise involved"

The study design was adapted from OECD Guideline No. 408 (1981) and the study was conducted in general compliance with OECD Good Laboratory Practice guidelines at the Metabolism and Safety Evaluation-Newstead, toxicology laboratory. Toxicology studies conducted at Monsanto laboratories are subject to inspections by Federal Regulatory Agencies in the U.S. (Hammond et al., 2004).

Remark 2- Claim that there may have been toxic effects of glyphosate residues not assessed in the study design

Glyphosate has an excellent human health and environmental profile and a long history of safe use in more than 130 countries. This has been a key factor in the acceptance of glyphosate products as among the most widely used herbicides in the world. When used according to label directions, these products do not represent a hazard to human health and the environment. This is confirmed by extensive studies as well by the firsthand experience of millions of farmers and home gardeners who have used this product.

Glyphosate, the active ingredient in Roundup branded agricultural products, inhibits an enzyme that is essential to plant growth; this enzyme is not found in humans or other animals, contributing to the low risk to human health from the use of glyphosate according to label directions (Franz et al., 1997). Comprehensive toxicological studies in animals have demonstrated that glyphosate does not cause cancer, birth defects, mutagenic effects, nervous system effects or reproductive problems (U.S. EPA, 1993; Williams et al., 2000; European Commission, 2002; WHO/FAO, 2004). In fact, after a thorough review of all toxicology data available, the U.S. EPA concluded that glyphosate should be classified in Category E ("Evidence of Non-carcinogenicity in Humans"), the most favorable category possible (U.S. EPA, 1993). Glyphosate has favorable environmental characteristics, including tight binding to most soils, making it unlikely to move to groundwater or reach nontarget plants, and degradation over time in soil and natural waters (Giesy et al., 2000). Finally, glyphosate has been shown to have favorable environmental characteristics compared to other herbicides (Nelson and Bullock, 2003).

Remark 3- Recommendation for further investigations using two-way ANOVA with specific focus on interactions

The ANOVA used in the original analysis by Monsanto did take interaction into account when it compared the test to the control for each of the diets (11% and 33%). If another ANOVA were to be performed for only groups 1 to 4 and the interaction turned out to be significant then one would compare the test to the control at each of the diets which is exactly what was originally done. This second analysis for groups 1 to 4 would have less power than the original analysis since inclusion of the reference groups increased the degrees of freedom (information) for experimental error for comparing the test to the control.

Remark 4- Claim that the study analysis must include a comparative growth curve analysis

The Monsanto original analysis compared the test and control weight for each diet at each time point. While a growth curve analysis can be done, the most relevant and important end result is whether the body weights fall within normal biological limits. The body weight and weight gain were comparable for the male and female groups fed NK 603 maize, control, and reference control groups (Hammond et al., 2004).

Remark 5- Claim that Monsanto scientists should have used multivariate methods like principal components analysis, data mining, and MANOVA

For a similar rat feeding study, Monsanto scientists evaluated additional statistical tests, which included repeated measures analysis of body weight taking into account correlations across time and increasing variability over time and multivariate analyses (MANOVA, principal components, and canonical correlation) for clinical chemistry and organ weight measurements. None of these additional analyses changed any of the conclusions from the original analysis. There are many different types of statistical analyses which can be done. Statistical analyses provide scientific validity to the study conclusions but statistical significance does not equal biological significance. Use of statistically significant differences alone as the basis for claiming biological significance is scientifically inappropriate. Scientists must look at the whole picture, including the biological context, not just a few isolated statistical differences which can occur by chance alone; or because small experimental variability identifies small numerical differences as statistically significant.

Remark 6- Claim that statistical analysis must be interpreted by biologists, toxicologists, and physicians in order to correlate the statistically significant differences with biological findings

Monsanto scientists, regulatory agencies, and government authorities agree that it is necessary to evaluate the biological relevance of statistical findings. Statistically significant differences must not be considered a biologically relevant finding of an effect in isolation of other relevant biological data. Remarkably, in spite of the author's apparent understanding of this basic principle of analysis of experimental data, they conclude that a statistically significant finding is evidence of an adverse effect and recommend "additional statistical analysis in a serious and independent way."

The authors also criticize the use of historical control data, yet scientific experts recognize this information may be used when needed to assist in the interpretation of "noise," which occurs in these studies (OECD 2002; Deschl et al., 2002).

Monsanto Summary and Recommendations

The European Union and other authoritative guidelines for the safety and risk assessment of biotechnology-derived crops include sufficiently robust experimental and statistical methods to ensure the safety of food and feed derived from GM crops.

The NK 603 maize study was conducted in accordance with European Union regulations and following strict OECD guidelines for laboratory animal testing.

The European Food Safety Authority concluded, "NK603 maize is as safe as conventional maize and therefore the placing on the market of NK603 maize for food or feed use of the grain or processing is unlikely to have an adverse effect on human or animal health or, in that context, on the environment."

Monsanto published the results of the NK 603 maize 90-day rat study in a peer-reviewed, highly regarded toxicology journal and provides additional information on our website supporting the safety of NK 603 maize (see: http://www.monsanto.com/monsanto/content/products/technicalAndSafety/roundup_corn/pss_NK603.pdf .

There is no scientific basis for conducting additional, independent studies. The conclusion by Seralini and the co-authors of the Crii-Gen report that the absence of additional studies "may present a serious risk to human and animal health" is not supported by the overwhelming majority of scientific and regulatory experts around the world.

Regulatory agencies, media, and the general public should be wary of allegations released in press releases by activist groups and based on reports by anti-GM scientists placed on the Internet. These groups do not recognize the well-established safety assessment process for food and feed derived from GM crops that is supported by regulatory agencies and government authorities around the world.

Regulatory authorities should not consider unpublished claims by activist groups first communicated by press release and via the Internet as worthy of consideration; unless and until such time that their claims have been peer-reviewed by qualified, reputable experts in the appropriate field and published in a mainstream scientific journal.


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Food Safety Western Australia Style

- Ian B. Edwards, PhD; D.Sc; FCSSA, Chairman - AgBio Advisory Group - AusBiotech

GMOPundit a.k.a. David Tribe, June 23, 2007


Australia has one of the most rigorous and transparent gene technology regulation Acts in the world, and is achieving its objective in protecting the health and safety of people and the environment. This was one of the key findings of the Independent Panel Review of the Gene Technology Act 2000, published in 2006. To those involved in the life sciences industry the act is considered almost draconian in its level of rigor, but most accept the fact that if we are to build public confidence in agricultural biotechnology it is both necessary and should be respected. However, this is clearly not the viewpoint of certain NGO's ideologically opposed to biotech crops, and certainly not the viewpoint of Kim Chance, Western Australia's Minister for Agriculture.

Under Australia's Act the areas of human health and safety are a Federal mandate, while the states do have certain marketing rights. However Minister Chance, not content with imposing a state moratorium in April 2004 on the growing of all biotech or GM crops in Western Australia, took it upon himself to openly criticize Food Standards Australia - New Zealand (FSANZ) for not adequately safeguarding human health. In late 2005 he made public his intent to commission an independent feeding trial on GM crops so that supposedly unbiased data would be obtained. He openly expressed a concern shared by Greenpeace that, because the companies submit data to the Gene Technology Regulator it is somehow automatically subject to bias. Lost in all this was the fact that Australia subscribes to the Codex Alimentarius Commission (CODEX), which mandates world's best practice in food standards, and FSANZ not only uses the information supplied by companies and independent laboratories commissioned to do the specialized animal feeding trials, but also takes account of peer reviewed university studies and the findings of other regulatory systems such as the US, Canada, and the European Union.

The group he selected to conduct the feeding studies was the Institute for Health and Environmental Health in Adelaide, comprising three individuals (led by Dr Judy Carman), none of whom have scientific records in conducting or analyzing long term feeding studies. Dr Carman toured around with UK activist Dr Mae Wan Ho to speak against GM crops and food safety. Ho has a relentlessly anti-science agenda against GM crops (and modern Darwinian theory), while Carman has constantly attacked FSANZ for alleged food regulatory inadequacies, and had two articles ("Health Concerns" and "Threats to our Health") published in Greenpeace's True Food Guide 2003. To most rational individuals this would have raised a flag about Dr Carman's competency to conduct independent trials, but not to Minister Chance.

In December 2005 Professors Stephen Powles (University of Western Australia) Graeme Robertson (Muresk Institute - Curtin University) and Mike Jones (Director - State Agricultural Biotechnology Centre - Murdoch University) pointed out to Chance that the IHER is in fact only a website and post office box, without employees, laboratories and infrastructure that one would reasonably expect to be associated with an organization purporting to undertake research/analytical work on health and environmental matters. They called into question the degree to which Judy Carman's research could be construed as being independent. They also drew attention to the national framework for gene technology regulation. This advice was ignored.

This was followed up by thirteen international scientists writing to then Premier Geoff Gallop expressing concern over the approach of Minister Chance in who he selected to do the research, and also the manner in which the research was funded. The study was not submitted to the normal tender process and Chance has since claimed that this was not necessary because it was approved by Cabinet. In response to a question in the WA State Parliament (May 2006: Hansard 179) by Anthony Fels to the Minister regarding his attack on the regulatory system and the letter from distinguished scientists, Chance responded by saying (under Parliamentary privilege) that he had looked into these people an found that they were all in the pay of multinational companies. Perhaps two paragraphs from the response to this allegation that was provided by one of the signatories, Professor Bruce Chassy of the University of Illinois might be appropriate:


"I do not consult for ag biotech companies, I have never had a grant or contract from ag biotech companies, I have never worked for them, with them, or collaborated with them. I do not own and have never owned stock in a biotech company".


"............It might be wise to point out that it isn't just a handful of scientists which Chance asserts are in the pockets of the biotech companies. It is the overwhelming preponderance of the scientific community, including some of its leading members. It is also the UN, OECD, FAO, WHO, The US Academy of Sciences (along with the academies of many other nations), The Royal Society London, a great many medical societies, and a host of the leading scientific societies around the world who have unanimously concluded that GMO's are as safe or safer than conventionally bred crops and pose no threat to consumers or the environment".


Minister Chance went ahead with the study by the IHER, with funding of $92,000. When questioned by the press on GM matters Chance has often stated that he has an expert "Ministerial GMO Reference Group" whose function it is to advise the government. As a member of this group I can state that the animal feeding study by Judy Carman was never referred to the reference group, but the Agriculture Department has since been directed to fund the project in Adelaide, South Australia. In a letter to an industry representative in February 2007 it was stated that the draft protocol was sent to 15 scientific experts in eight countries for comment before it was given to the Steering Committee to consider. The 10 person Steering Committee is reputedly made up of experts in a range of disciplines. However, the Minister has refused to disclose the protocol, the 15 international reviewers or the names of the Steering Committee to his own Ministerial Reference Group. He invited Judy Carman to address the group on May 25th, 2007 and, apart from her usual litany of complaints against FSANZ, she also refused to answer these questions. The Minister supported her position, totally ignoring the fact that public funds are involved. The study will apparently be published in peer-reviewed journals and "the protocol will be revealed at this time".

So what answers on food safety does the Chance expect from a $92,000 study? During our June 20th Ministerial Reference Group Meeting he conceded that the funding was very small and is unlikely provide the answers being sought, but may raise questions for future studies. He also stated that "maybe Judy Carman may have other sources of funding to contribute to the study". This is the new way of examining Food Safety Western Australia style! Health concerns are a Federal Mandate, we have an inter-governmental agreement that is possibly being violated, and by both his statements and his actions the Minister is undermining public confidence in the national regulatory system. He has sided with a very narrow constituency, he has chosen to ignore the preponderance of scientific opinion and regulatory determinations worldwide that have guided GM crops through 11 years of commercial practice, and he has funded a secret study by a known anti-GM activist under the preposterous claim that it is "independent".

As a footnote, a Freedom of Information claim was filed under Section 30 of the Freedom of Information Act, 1992 by John Cudmore of Perth-based Crabtree Consulting Company. In his decision of June 20th, 2007 the Minister claimed that the Information Commissioner believes that the information should not be disclosed, and that "the information does not appear to be from a bona fide public interest inquiry, but rather it is being sought to pursue a narrow private interest. There remains a right of appeal to this ruling.

Who are the real losers in all this? It is the farmers of Western Australia who are being denied a choice of technology to use on their farms while the Minister seeks excuses to continue the moratorium on GM crops. The leading farm organizations in Western Australia have all asked that the moratorium be dropped, and Victoria is reviewing their state moratorium at this time. Again, the question must be asked: "Who is Minister Chance serving?"


Giant strides in crop biotechnology

A new rice-based vaccine promises effective treatment for the dreaded cholera

- Gurumurti Natarajan, The Financial Express (India), June 24, 2007


DR Tomonori Nochi and his colleagues at the University of Tokyo's Institute of Medical Science has made an astounding breakthrough in tackling the scourge of cholera that afflicts a vast majority of Africa, Latin America and parts of Asia. A new rice-based vaccine has been developed to deliver effective and inexpensive treatment against this killer disease.

Cholera is a severe intestinal disease endemic to the tropics, manifesting as diarrhoea. The causal organism, a bacterium, Vibrio cholerae, spreads among humans through ingestion of contaminated food or water. The pathogen produces an enterotoxin that acts on the mucosal epithelium lining the small intestine and is responsible for the characteristic massive diarrhoea caused by the disease. In its most severe forms, cholera is one of the most rapidly fatal illnesses known and can cause death in a healthy adult within 24 hours of onset of the disease! Although antibiotics such as tetracycline, ciprofloxacin and azithromycin can reduce the duration and severity of cholera, drug-resistance is being reported regularly.

Traditional protection from cholera, as indeed with many other diseases caused by microbial infections, has been bolstered through immunity either through exposure to the disease-causing organism or through vaccines containing live, modified or dead micro-organisms. Vaccines and their administration though are not without their share of impediments. Right from preparation until it is administered, with intervening steps of packaging, storage and transportation, vaccines typically require an unbroken cold chain which is rather hard to come by in developing third-world nations that are struggling to have road lights and clean drinking water in their taps. The assistance of trained para-medics is mandatory as most vaccines are administered through a syringe and a needle. Recycling needles often resorted to in indigent societies to save on costs open a Pandora's box of spread of other diseases on an unsuspecting population already beset with maladies of diseases, malnutrition and poverty. Besides, vaccines come with a fixed shelf-life and have been known to be ineffective even under the best of cold-chain practices.

In their research paper to be published shortly in the prestigious Proceedings of the National Academy of Sciences, (USA), Dr Nochi's team details their work on genetically-modifying Kitaake rice plant's genome to include a gene from the disease-causing bacteria. The gene expresses a subunit of the disease-causing cholera toxin B, about 30 micrograms of which accumulated in each rice seed. Experimental mice fed on the transgenic rice in the form of powder, absorbed the cholera toxin B antigen, which in turn caused their immune system to release very specific antibodies that were capable of neutralising the cholera toxin. Interestingly, the rice-based vaccine was also resistant to digestion by gastric juices in the stomach and remained active even after long-term storage at room temperature. The authors conclude that "rice-based mucosal vaccines offer a highly practical and cost-effective strategy for orally vaccinating large populations against mucosal infections, including those that may result from an act of bioterrorism".

This innovation augers well for the suffering masses plagued by cholera and other endemics. Since the rice-based vaccine comes from an edible part of the plant, it is safe, inexpensive to produce in large quantities and can be orally administered. It is, further, a massive improvement over most other traditional plant-based oral vaccines since rice can easily be stored at room temperature for 18 or more months, and, once administered, its protein body protects the vaccine from digestive enzymes that would otherwise render it ineffective. Rice also has greater protein content than some of the other starch-based edible vaccines currently under experimentation for a variety of infectious diseases.

Besides, being a major food staple in most of the developing countries that are predominantly afflicted by similar diseases, the tradition of cultivating paddy in these societies helps. In addition to the huge savings from obviating the cold chain which could run into several hundred millions of dollars annually, additional issues of purifying the antigen from the rice prior to administering it to humans is also rendered unnecessary. Other diseases targeted for rice-based vaccines include the pesky influenza and the much dreaded HIV.

Less than two weeks ago in an article extolling the potential benefits of modern agricultural biotechnology in this column, I had highlighted the numerous opportunities that this emerging facet of science was unravelling. Genetic engineering is not a silver bullet to ameliorate all ills of modern society but is for sure establishing itself to be one of the viable options by scaling new vistas of science with each passing day. It therefore merits its space under the sun without the cacophony of Luddites that seek to set us back to a bygone era, opposing the gains of modern science for no known reason.

- The author is a specialist in agri-businesses; comments: Dr.GuruNat+at+gmail.com


Is it a rosato? A lemato? GM tom has floral, fruity smell

- PhysOrg.com, June 24, 2007


Tomatoes. Israeli researchers say they have genetically engineered tomatoes to give hints of lemon and rose aromas that have done well in testing on volunteers. Tomatoes. Israeli researchers say they have genetically engineered tomatoes to give hints of lemon and rose aromas that have done well in testing on volunteers.

Israeli researchers say they have genetically engineered tomatoes to give hints of lemon and rose aromas that have done well in testing on volunteers.

The transgenic tomato includes a gene from a variety of lemon basil, Ocimum basilicum, that produces an aroma-making enzyme called geraniol synthase, Efraim Lewinsohn of Newe Yaar Research Centre and colleagues report.

A panel of 82 people have tested the experimental fruit against unmodified counterparts.

Nearly all of them were able to detect novel aromas, which the testers variously described as "perfume," "rose," "geranium" and "lemongrass."

When put to the taste, the GM tomatoes were preferred by 49 members of the panel, while 29 preferred unmodified tomatoes and four expressed no preference.

The GM tomatoes have only a light red colour, though, because they have only half as much lycopene as conventional tomatoes. In addition to conferring a bright blush to tomatoes, lycopene is an antioxidant, a compound credited with health-giving qualities.

Offsetting the low levels of lycopene are higher levels of compounds called volatile terpenoids, which possess antimicroial, pesticidal and antifungal qualities, so the GM tomato may have longer shelf life and need less pesticide to grow, Lewinsohn contends.

The team believes that other crops and flowers that, like tomatoes, produce carotenoids, could also be engineered to change their smell annd taste.

The first genetically-modified tomato, the so-called FlavrSavr, hit the US market in 1994. It had a modified gene that was involved in fruit softening, meaning that the tomato could be left to ripen on the vine and have a longer shelf life.

FlavrSavr was eventually withdrawn because of disappointing sales.

Today, no genetically modified tomatoes are being commercially grown in the United States, according to (www.gmo-compass.org), a European Commission-backed website for information about GM crops.

Fresh GM tomatoes have never gone in sale in Europe and other markets where there are worries about the environmental and health impact from transgenic food.

The Israeli paper is published online on Sunday by Nature Biotechnology, part of the Nature group of science journals.

*by Andrew Apel, guest editor, andrewapel+at+wildblue.net