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Date:

July 16, 2007

Subject:

Descendants of Dolly; Through the magnifying glass; Fatal flaws in regulation

 

* Descendants of Dolly
* Through the magnifying glass
* Fatal flaws in regulatory policies
* Sixty-two years of fighting hunger
* The status of GM rice R&D in China
* Sweden Ag Biotech Report 2007
* The Market Effect of a Food Scare
* A debate hijacked by rumours

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Descendants of Dolly

Scientists will have to work hard to persuade a cynical public to tuck in to the idea of cloned meat

- James Randerson, The Guardian, July 16, 2007

http://www.guardian.co.uk/commentisfree/story/0,,2127257,00.html

How would you feel about tucking into a burger from a cloned cow or serving rashers of cloned bacon to your kids? Since Dolly the sheep was revealed in 1997, cloning has been a distant science for most people. But that will soon change. Scientists predicted last week that cloned meat could be on American dinner plates within two years. And Europe may not be far behind.

Scientists point out that anyone who eats meat is bound to have eaten cuts from identical twin animals, so having clones in the food chain is not new. But if the public rejection of GM crops in the UK is anything to go by, scientists will have their work cut out to convince us that cloned meat is worth having.

What, though, do scientists and farmers actually want to use cloning for? The technology is already well established in research circles: several thousand cloned animals have been created, among them sheep, cattle, goats, horses, dogs, cats, rats, mice and ferrets.

Mainly because of the high cost of cloning, however, farmers will not use it to create herds of genetically identical pigs or cattle. Its main advantage, they say, will be in disseminating genetic advances created by selective breeding, for instance genetic traits for improved milk and meat production or resistance to diseases. At present, semen from the best bulls is routinely transported widely for artificial insemination. That avoids having to transport the bull. Cloning will provide another way of doing this. A herd could be started with a few cells for cloning and a surrogate cow. This, say the scientists, translates into cheaper food for the consumer, more sustainable farming and welfare benefits because of less animal disease.

Cloning also offers other advantages, such as the ability to bank cells from highly valuable animals. If a prize bull is injured or killed, a "spare" can be created from his cells in a freezer. The same principle could be used to keep rare breeds on ice that are out of fashion. They might, for instance, contain vital genes to fight a new strain of foot and mouth disease. Cloning would allow scientists to literally bring them back from the dead.

Cloning will not be a mass-use technology but a way of disseminating useful traits and of creating a genetic insurance. What ends up on the supermarket shelves will probably not be from cloned animals themselves but from the children and grandchildren of clones.

So will the UK public buy it? Most important are the questions over animal welfare and human health. Even under the most favourable conditions, around one-fifth of cloned pigs die in the womb - twice as many as naturally conceived litters. Scientists say success rates are improving, but this will put off some consumers already sceptical of industrial farming methods.

Everyone will want to know whether cloned meat is safe. And on this point, the current science is clear. The US Food and Drug Administration's preliminary report on cloned meat released earlier this year was unequivocal. "Edible products derived from the progeny of clones pose no additional food consumption risks relative to corresponding products from other animals."

But the GM experience should tell scientists that this will not be enough. Researchers make similar statements about the safety of eating GM crops, and there is no evidence that GM food is dangerous to human health - yet the European public remains opposed. That scepticism stemmed from a feeling that genetic tinkering is "unnatural", coupled with a barrage of negative media coverage and fears about the effect of GM crops on the environment. If cloned meat is not to go the same way, scientists will have to explain to consumers what they have to gain from it.

******************

Through the magnifying glass

- Joel I Cohen, Nature Biotechnology, vol. 25, page 728, July 2007

Book Reviewed - Seeds for the Future: The Impact of Genetically Modified Crops

by Jennifer A Thomson (Cornell University Press: 2007 208 pp. $24.95, ISBN 978080147368-5)

Jennifer Thomson's Seeds for the Future takes a macroscopic view of issues regarding surrounding the research and development of genetically modified crops. A wide-lens view is evident, as the book captures many examples, references and data, including classical plant breeding, traits expressed in genetically modified (GM) crops, socioeconomic impact and specific policy areas. It concludes with a future look at biotech developments currently in the pipeline. All of these data, information, case examples and complex policy matters come out in a highly readable, concise format, making the book useful for educators, researchers, policy makers and politicians.

The book looks at real opportunities for GM crops while balancing a sense of optimism with hardy doses of reality. This realism comes from Thomson's own work in biotech, her many years in Africa and a well-planned analysis of foreseeable outcomes from the use of biosafety-approved GM crops. Topics include insect and virus resistance, herbicide tolerance, effects on biodiversity and chances for cross-pollination. She gives concrete examples of how GM traits are advancing, and alerts the reader to any significant environmental effects. Although many GM crops are in use, a precautionary approach regarding field trials and commercial approval for use continues. The reasons for the disparity between scientific advances, science-based regulatory data and encouraging results from many economic impact studies on the one hand, and precautionary approaches towards regulation and use on the other, are debated globally. Thomson provides a concise, well-referenced explanation of these findings and complexities.

Regarding biosafety, the author emphasizes why the focus point for regulation should be on the product, not the process. Although useful in many ways, this position has its difficulties. First, many governments and the public want to know the process used (not just the product). Second, the Cartagena Biosafety Protocol calls for a process-oriented approach. Third, concerns exist that conventionally bred crops could be required to pass regulatory standards in addition to those already in use.

When scientists discuss GM crops with broad or lay audiences, many participants express concern about safety and risk. However, separating development from safety assessment creates a misperception. The fact is that advancing GM crops automatically includes biosafety assessments. This point is often missed by the public, believing that research focuses on development alone and that safety is minimized while trying to rush products to the field. It is not clearly understood that safety is an integral part of GM crop development, as numerous biosafety reports demonstrate. In chapter 8, a section titled "A strong regulatory system" describes key topics that warrant continued international examination, helping to build regulatory leadership that provides greater confidence in undertaking regulatory reviews.

The book's final chapter presents an exciting look at new GM crop developments in the making; however, most important is the section titled "Genetically modified crops and hunger relief in developing countries." Thomson's discussion of world food production, redistribution, organic farming, effects of GM seeds on the informal seed sector and the reality of soil and environmental constraints is very useful. As for nutritionally enhanced crops, she states, "Unfortunately, the introduction of Golden Rice into target countries has been seriously delayed by the lengthy processes necessary to obtain permits to deploy seed for field testing." The book increases its credibility by describing the many factors needed, and those lacking, for successful crop productivity, including soil degradation, use of fertilizer and organic farming methods. These broader reflections make it clear that GM crops are only one possible approach to overcoming the stresses, diseases and productivity decline in developing countries.

The one drawback of Seeds of the Future is the lack of a final synthesis, bringing the total picture together. For example, the current state of use or non-use of GM crops in developing countries is described very clearly in chapter 9. What's missing are the implications of this situation. For example, could the author identify areas where research is urgently needed to increase informed decision-making regarding specific GM crops and traits in developing countries? Given Thomson's own experiences here as a microbiologist very familiar with African regulatory systems, a well-crafted summary should be possible.

This does not detract from the overall success of Thomson's effort. For, as the author states in a concluding sentence, "This is one scientist's effort to facilitate the understanding of the effects of GM crops on the environment." In fact, the book succeeds beyond this goal, covering socioeconomic analysis, costs of GM seed and licenses, profitability, production inputs and policy matters dealing with regulation and intellectual property rights.

Thomson's view through the magnifying glass is rewarding. Readers will find many aspects of GM crops identified and discussed in an open, balanced manner. Social, economic and safety concerns are addressed directly and clearly. It is rewarding to see a competent author put forward clear messages in a concise manner, and to see financial support for such rather than dialogues to ensure 'broad stakeholder participation' while leading to no explicit action plan or follow up. The author puts the emphasis on the right topics at the right time and openly addresses the reasons for concern regarding GM crops in the developing world. To get all of this into a brief book is clearly a great accomplishment.

------

See also, http://www.amazon.com/Seeds-Future-Genetically-Modified-Environment/dp/0801473683

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Fatal flaws in agbiotech regulatory policies

The major national regulatory regimes for agbiotech products fail to satisfy scientific legitimacy on several counts

- GMO Pundit a.k.a. David Tribe, July 11, 2007

http://gmopundit.blogspot.com/2007/07/fatal-flaws-in-agbiotech-regulatory.html

Nature Biotechnology Vol 25 Number 7 July 2007, p. 725

Alan McHughen

The seven flaws:

Flaw 1: process versus product. Many regulatory regimes assume wrongly that the process of transgenesis (recombinant DNA technology) inherently poses risk, so categorically all products developed using recombinant DNA must be scrutinized. At the same time 'conventional' processes of breeding - including such genetically disruptive methods as irradiation mutagenesis - are assumed to be risk free and therefore warrant little or no regulatory scrutiny.

Flaw 2: unnaturalness. Another misconception is that combining genes from different species is unnatural and risky. This instills unnecessary anxiety in consumers and motivates the demand to regulate GMOs exclusively.

Flaw 3: skewing the playing field. Products posing similar degrees of risk should face similar degrees of scrutiny.

Flaw 4: lack of context. Because risk is relative, it must be assessed in context and compared with alternatives, yet many recombinant DNA risk-assessment protocols assess GMOs in isolation, lacking real world context...First, science cannot prove a negative (that a product will never cause harm); and second, because everything carries some risk, nothing is 'absolutely' safe.

Flaw 5: lack of scientific merit. ... An assay conducted with technical skill is insufficient to make the overall work scientifically sound; the reason for conducting the assay in the first place must also be scientifically valid.

Flaw 6: overkill. In risk assessment, most GMO data requirements are excessive, well beyond those required to reach a determination on relative safety.

Flaw 7: politics, ethics and economics. Political and ethical factors are included in many risk assessments, diluting the scientific focus.

******************

Sixty-two years of fighting hunger: personal recollections.

- Borlaug, N. E., Euphytica online first: DOI 10.1007/s10681-007-9480-9

Full document at

http://www.botanischergarten.ch/TraditionalKnowledge/Borlaugh-Sixty-two-Years-2007.pdf

International wheat breeding began 60 years ago in the Mexican-Rockefeller Foundation Office of Special Studies. A novel technique of shuttle breeding was adopted in Mexico, enabling photoperiod sensitivity to be overcome, a pivotal step in creating internationally adapted spring wheat germplasm that eventually spread throughout the world. The high-yielding technologies developed in Mexico helped revolutionize cereal production during the 1960s and 1970s, and came to be known as the Revolution.In the process, a highly effective system of international agricultural research centers evolved under the umbrella of the Consultative Group for International Agriculture (CGIAR).

This international system has weakened in recent decades, despite the enormous challenges facing humankind to expand food production in environmentally sustainable ways. Biotechnology holds great promise to develop improved crop varieties to deal with new pests and diseases, drought, and to enhance nutritional content. Those on the food front still have a big job ahead of us to feed the world. There is no room for complacency.

******************

The status of GM rice R&D in China

- Yanqing Wang & Sam Johnston, Nature Biotechnology 25, 717 - 718 ( July 2007); Reprinted in Agbioview with the permission of the editor.

To the editor: Rice products originating from China have recently encountered trade restrictions in Europe because of concerns over the presence of unapproved genetically modified (GM) rice expressing Bacillus thuringiensis (Bt) toxin1, 2. As Beijing is currently considering the first market authorizations for several GM rice varieties, and detailed information on GM rice development in China remains difficult to access, we have undertaken a comprehensive and detailed analysis of the current status of GM rice R&D in the country (for a full report, see ref. 3), the main findings of which are summarized below.

China is the largest rice producer and consumer in the world. Since the mid-1980s, it has invested heavily in biotech and GM varieties of rice in particular. Experimental lines of GM rice have been developed with such traits as increased yield, quality improvement, disease and insect resistance, herbicide resistance, salt and drought tolerance; some even produce biopharmaceutical products (Table 1).

In 2000, Beijing suspended commercialization of new GM varieties in response to global concerns concerning potential environmental and human food safety issues with GM food staples. As of 2005, >100 GM rice varieties have been in field testing. Most of them are insect-resistant lines. Four GM rice varieties - two Bt rice, one rice transgenic for the Xa21 gene and one herbicide-resistant rice - are now close to approval for commercialization.

Commercialization is overseen by both the Ministry of Agriculture and the relevant agricultural administrative departments of the State Council through the Regulation on Safety of Agricultural Genetically Modified Organisms (2001) and the Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms (2002). The 2001 regulations provide the Ministry of Agriculture with overall national authority to oversee the use of GM rice, whereas the 31 provincial biosafety management offices are responsible for the supervision and administration of biosafety in their respective areas. Under these regulations, GM rice is subject to a safety assessment procedure divided into five stages: laboratory research, restricted field testing (small scale under contained/controlled conditions), enlarged field testing (medium-scale evaluation in the field), productive field testing (large-scale testing in the field carried out before commercial production) and application for a safety certificate. The 2001 regulations meet the generally accepted risk assessment procedures outlined in the relevant international instruments and also stipulate a comparative risk assessment approach, in which a GM crop is compared with the corresponding nontransgenic crop for environmental/ecological safety and food safety.

These regulations have been carefully applied to the development of GM rice. Extensive laboratory and field trials have been conducted to examine the effects of GM rice on nontarget pest, predators, soil microbes, gene flow, emergence of resistance and food safety3, 4. Risk assessment procedures and results are improving and evolving in China as more experience is gained in the technology and the procedures.

Nevertheless, some areas merit further attention. A first problem is that the majority (>70%) of studies on GM rice have been conducted under laboratory conditions. These studies have limited predictive ability regarding large-scale, long-term effects in the field. For this reason, the impact of human activities and agricultural practices on GM rice performance has not been adequately incorporated into the Chinese risk assessment process. For example, although there is a considerable amount of research on natural pollen dispersal in China, under certain conditions human-mediated seed dispersal may have a stronger influence on the risks associated with gene flow5. To address such issues, China should consider undertaking something similar to the 'farm-scale evaluations' undertaken in the United Kingdom, the results of which were published in 2003 (ref. 6).

Furthermore, relatively few data have been gathered on the development of resistance by insects and pathogens to Bt rice or Xa21 rice in China. Assessment of these issues should be undertaken before commercialization of GM rice in the country.

Third, socioeconomic considerations need to be considered concerning the actual and potential consequences of adoption of GM rice, such as the potential impact on farmers' incomes and welfare, cultural practices, community well-being, traditional crops and varieties, rural employment, trade and competition, ethics and religion, consumer benefits and ideas about agriculture, technology and society. Taking such considerations into account during the risk assessment process is not legally required in China. But experience has shown they are important factors in China; for example, several empirical economic studies on cotton have revealed income gains for small farmers who plant Bt cotton seeds7. More attention needs to be paid to this issue if GM rice is to be commercialized in a sustainable manner.

Fourth, China's sheer size poses a headache for compliance and risk management. Any coordinated management effort must oversee millions of farms. One report assessing the productivity and health effects of two insect-resistant transgenic rice varieties8 highlighted the fact that farmers were cultivating GM rice without the assistance of knowledgeable technicians. This assessment method was contrary to that set down in the 2001 regulations and raises questions about implementation of regulations and whether the safeguards to prevent GM contamination are effective9, 10.

Questions have also been raised about the extent that farmers are using GM rice illegally, and the significant international consequences of possible 'contamination' of the Chinese rice supply. The Ministry of Agriculture has conducted a series of investigations and clarifications11, 12, issuing The Guidelines of Biosafety Investigation on Field-Testing of GM Crops in May 2006 to clarify legal requirements for field testing of GM crops. Even so, as the experience with illegal use in India, Argentina and Brazil and admixture in the United States have demonstrated, illegal use and mixing GM and non-GM staples in the food supply are likely to be ongoing problems. Clearly, greater awareness about the requirements of the regulations among farmers using GM crops would be helpful. Greater vigilance by the Ministry of Agriculture is also needed. If compliance problems persist, then stronger sanctions will need to be considered. But as a first step, a more independent investigation of compliance and illegal use is warranted in China.

We conclude that Chinese scientists are using procedures to assess the risks associated with GM rice that meet international standards. Even so, more attention needs to be paid to some critical areas, such as field testing, scientific uncertainty and socioeconomic considerations. Comparative and collaborative studies with other countries would be helpful in developing better procedures. Perhaps the most pressing issue though is addressing compliance issues and the illegal use of GM crops. The need for a more independent evaluation of these issues is clear.

References

1. Marris, E. Escaped Chinese GM rice reaches Europe. news@nature.com 5 Sept, (2006). <http://www.nature.com/news/2006/060904/full/060904-5.html>

2. European Commission (2007). Summary Record of the Standing Committee on the Food Chain and Animal Health Held in Brussels on January 16, 2007 (EC, Brussels, 2007). <http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/summary12_en.pdf>

3. Wang, Y. & Johnston, S. UNU-IAS Working Paper No. 152 (United Nations University-Institute of Advanced Studies, Yokohama, Japan, 2007). &<http://www.ias.unu.edu/resource_centre/152%20Yanqing%20Wang.pdf&>

4. Chen, M. et al. Insect Sci. 13, 409-420 (2006).

5. Snow, A.A. et al. Ecol. Appl. 15, 377-404 (2005).

6. Andow, D. Nat. Biotechnol. 21, 1453-1454 (2003).

7. Huang, J. & Wang, Q. AgBioForum. 5, 122-135 (2002).

8. Huang, J., Hu, R., Rozelle, S. & Pray, C. Science 308, 688-690 (2005).

9. http://english.people.com.cn/200506/14/print20050614_190130.html>

10. http://english.people.com.cn/200603/15/eng20060315_250850.html>

11. http://news.xinhuanet.com/newscenter/2005-08/10/content_3335353.htm>; <http://www.china.org.cn/english/2005/Apr/125745.htm>

12. http://www.stee.agri.gov.cn/biosafety/zhbd/t20060331_583313.htm>

-------

See also, "Review on GM Rice Risk Assessment in China," Yanqing Wang and Sam Johnston, UNU-IAS Working Paper No. 152, doi:10.1038/nbt0707-717, April 2007

http://www.ias.unu.edu/resource_centre/152%20Yanqing%20Wang_1.pdf

******************

Sweden Agricultural Biotechnology Report 2007

- Asa Lexmon, USDA Foreign Agricultural Service, GAIN Report SW7010, July 10, 2007

http://www.fas.usda.gov/gainfiles/200707/146291641.pdf

[excerpted]

As a member of the European Union (EU), Sweden fully applies EU regulations regarding approvals, traceability and labeling of genetically engineered (GE) products.

In 1998, the breakdown of the EU's approval process for GE products blocked U.S. exports of several agricultural products to Sweden. Since then, the U.S. has lost its share of the Swedish market for soybean oilcake/meal. On January 1, 2006, Sweden's meat industry ended its decade-long ban on GM feed. This policy shift was attributed to the increasing cost of sourcing GM-free Brazilian soybean meal. As a result, small quantities of GM soy products have been imported into Sweden. In 2006, Sweden's imports of soybean meal were valued at about 52 million Euros (about USD 65 million), of which meal valued at 41,000 Euros originated in the US. Over the past five years, total imports were valued at a total of 314 million Euros (about USD 395 million). At present, the dairy, egg and poultry sectors continue to hold firm to their GM-free policy.

Sweden continues to import conventional sweet corn from the United States for human consumption. However, U.S. feed corn has been locked out of the market. The value of the opportunity lost in supplying to Sweden a wide range of U.S. processed products containing GE ingredients is impossible to quantify.

The food processing and retail sectors remain concerned over the possibility of negative consumer reaction and the ever-present threat of disruptions from anti-biotech demonstrators.

This report provides an overview of the situation for genetically engineered products with regard to regulation, policy, and the marketing environment in Sweden.

******************

Estimating the Market Effect of a Food Scare: The Case of Genetically Modified StarLink Corn

- Colin A. Carter and Davis Aaron Smith, The Review of Economics and Statistics, August 2007, Vol. 89, No. 3, Pages 522-533 Posted Online July 12, 2007. (doi:10.1162/rest.89.3.522)

http://www.mitpressjournals.org/doi/abs/10.1162/rest.89.3.522

In 2000, a genetically modified corn variety called StarLink that was not approved for human consumption was discovered in the food-corn supply. To estimate the price impact of this event on the U.S. corn market, we develop the relative price of a substitute method. This method applies not only to the StarLink event but also to rare events in other markets. We find that the contamination led to a 6.8% discount in corn prices and that the suppression of prices lasted for at least a year.

******************

GMO: a debate hijacked by rumours.

The case of MON863 corn

How a cell of French anti-GMO activists, financially supported by a transnational retailer chain and backed by influential media, impose their views and undermine science-based GMO risk assessment

- Marcel Kuntz*, Translated from an article originally published by the Association Francaise pour l'Information Scientifique

http://pseudo-sciences.org/spip.php?article734

Was a corn destructive insect intentionally introduced into Europe to help sell GMOs?

Diabrotica virgifera virgifera, better known as western corn rootworm, is a small Coleopteran originating from Central America, which in the Sixties became the major corn pest in North America. It first appeared in Europe in 1992 (in Serbia), then spread to other European countries, arriving in France in 2002. In France, the Service for the Protection of Plants attempted to eradicate the infections by compulsory insecticidal treatment of corn fields covering a radius of 10 km around the points of capture of the rootworm and by 1- or 2-year crop rotation in order to break the insect's life cycle [1]. In the United States, monoculture and the appearance of mutants able to circumvent the obstacle of rotation largely limited the effectiveness of these measures. Will the development of Bt-type corn MON863 containing the insecticide protein cry3Bb1 [2] allow effective and durable protection? Is it a useful element in the combat against this threat?

For the French newspaper Le Monde, this is missing the point. Let's examine what was stated in an article entitled 'An American insect seriously threatens European corn'(26th September 2002) - "For Criigen, an association opposing GMOs chaired by Corinne Lepage (a lawyer and former French Environment Minister, [author's note]), the speed of reaction of the large international firms is considered to be suspicious. The president of Criigen's scientific committee, Dr. Gilles-Eric Séralini, had already questioned in his book 'GMO, the real debate' (Flammarion, 2000) the coincidence of the arrival of diabrotica in the kit of an army on campaign (the American army [author's note]) with the proposal of GMO solutions to counteract the pest... He evokes, but without proof, those elements likely to support his accusations". It should be pointed out that the aforementioned elements have not been produced to date. In addition, it should be noted that the actual date of arrival in Europe (probably before 1992) is long before the development of corn MON863. This did not prevent the French TV channel Canal+ from diffusing, on Monday 7th April 2003, a report entitled 'A devastating insect debarks in France' where the charge is repeated. The advertisement for the programme (Canal+, the subscribers' magazine, April 2003) reads: "according to specialists, it [diabrotica] should have never have appeared so quickly", "who benefits? ", "many professionals think...". The viewer discovers that the list of "specialists" are limited to anti-GMO militants quoted above. As for " professionals": questioned by a field, one farmer admits... having heard somebody say, at a meeting that...

The charges of deliberate introduction are repeated in 2005

The case continues. Citing lengthily an article by Miller et al.[3], Sebastien Genest, President of an environmentalist organisation, France Nature et Environnement, revives the charge in an open letter addressed to the Prime Minister dated 1st December 2005. He "asks for the opening of an investigation..." and, in case the Prime Minister does not understand clearly, he drives the point home: "... without dismissing the assumption of a deliberate introduction in the home territory".

What did Miller et al. demonstrate? That there were at least three independent arrivals of the rootworm, probably by air cargo (the insect was always found located initially in the vicinity of airports). Here is the article's conclusion: "our finding... suggest incursions from North America are chronic. Prevention of future invasion will require action against multiple invasion route... Our study also raises questions concerning the changing circumstances (such as adaptation by the insect or exchanges in control measures or transportation practices) that have permitted a sudden and recent burst of transatlantic introductions".

In other words, there is no trace in this article of any information supporting premeditated introduction. It should be pointed out that destructive insects do not require deliberate assistance to travel from one continent to another: vine Phylloxera arrived in Europe from America, the European corn borer travelled in the opposite direction and the New World screw-worm fly travelled from America to North Africa. As for the horse chestnut leaf miner, it has spread all over Europe, sometimes with the help of contaminated wood cargoes.

Expertises hiding the truth?

The MON863 corn saga does not stop there. During examination of the medical risks evaluation dossier, one of the French commissions, the Commisssion du Génie Biomoléculaire (CGB) requested a complementary expertise [4]. The dossier's reporter, Dr. Gerard Pascal (INRA)stated: "my analysis report... reveals a certain number of significant differences between the rat group fed with the non-transgenic parental corn line and the group fed with MON863 corn, in particular regarding renal hypotrophy and a greater number of histological anomalies at the level of the kidney in the MON863 fed group. Without concluding the slightest risk, the CGB requested some explanation". It is at this time that Corinne Lepage seizes the Commission d'Accès aux Documents Administratifs (CADA). Le Monde reiterated the claims in a series of articles [5] stating: "For the first time, one discovers that experts admit that the ingestion of GMOs has significant effects on animals". "No one would have heard anything about it... if the lawyer, Corinne Lepage,... hadn't forced the CGB's door". The minutes of the CGB's meetings... could be made public for the first time". However, the CBG's perfectly clear opinion was already on a website! Yes, but the trick was to request the meeting's minutes. Henceforth, the CGB also publishes the meetings' minutes...

What has become of those famous kidney "anomalies"? Quoting G. Pascal's, regarding the conclusions of the more advanced expertise "carried out by reputed anatomo-pathologists, one of whom is the world specialist in laboratory rat kidney pathology. This expertise emphasised that the anomalies observed in the kidneys of the MON863 corn fed rats were the same as those observed in the control group of rats, even if they were slightly more numerous, but not statistically significant, and that they were identical to those observed normally in laboratory rats. This expertise was re-appraised by a French expert: same conclusions. " In the CGB's opinion of 16th September 2004 [6], one learns that this is a progressive chronic nephropathy which develops spontaneously in the rat... As for the "renal hypotrophy", a new study did not reveal any significant difference in the kidney weight of control rats and those rats fed with various transgenic MON863 corn lines. On 23rd November 2004 [7], the CGB thus finally concluded, like all the other agencies [8], the lack of biological and toxicological significance of the variations which had previously held its attention.

"Secret" or "prohibited" documents?

On 22nd May 22 2005, a British newspaper, The Independent, echoed the existence of a "secret report", held by Monsanto, which shows the harmfulness of corn MON863 [9]. Details even include the length of the document: 1139 pages! The news propagated on the anti-GMO websites. The European Food and Safety Authority (EFSA) intervened [10] to specify that these 1139 pages are, in fact, those of the medical safety evaluation dossier for this corn (that studied by the CGB and other agencies). The trick was, here again, to play on words: the dossier is actually confidential (but was communicated in its entirety to the official agencies involved in the evaluation, who accepted to respect the confidentiality of the industrial formulas contained within) but not secret (all the agencies published their argued conclusions).

Despite all that, Canal+ diffused its report 'The accusing study' and repeat all the already contradicted elements. The socialist Member of Parliament Jean-Yves Déaut, Vice-president of the Office Parlementaire d'Evaluation des Choix Scientifiques et Technologiques (OPECST), wrote a strong letter of protest to Canal+ in which he stated that he is "staggered by the total lack of critical assessment and objectivity... by the journalist who made the film". He recalls that the subject "had been widely tackled during the contradictory round table" of a parliamentary information commission on 2nd February 2005 [11].

The next anti-MON863 campaign, from November 2006, led hundreds of thousands of web-surfers to watch a video "banned from broadcast" by Canal+, and which, moreover, will be soon withdrawn from the web! The truth finally got out: this is about the report 'The accusing study', mentioned above and diffused by the station on 15th November 2005 [12]...

Let's focus one moment on another aspect of report, the interview with Dr. Marc Fellous (Institute Cochin and President of the CGB). Dr. Fellous circulated the following detail: "This document lacks objectivity, and accumulates errors and inaccuracies; with carefully chosen cuts, I am said to hold opinions which, taken out of their context, give rise to erroneous interpretations... It is surprising that Dr. Gerard Pascal, member of the CGB, toxicologist, the dossier's reporter and who was at the origin of the questions raised by the CGB regarding the dossier, was not questioned by Canal+".

"Independent" studies calling into question risk assessment?

The following campaign was launched on 13th March 2007. However, already in 2005 a Le Monde article (dated 20th October 2005) entitled 'Greenpeace wants to re-examine a GMO corn', gives word (exclusively) to the same anti-GMO militants along with a newcomer, a lecturer in mathematics and also a Criigen member. Why a mathematician? To develop a new argumentation: 'The either dishonest or deficient choice of statistical tools' of the studies on rats fed on MON863 corn. The article also mentions that Greenpeace obtained the communication of the study on the rats from the German judiciary. This too had been the object of a publication by three Monsanto researchers in February 2006 [13]. On 13th March 2007, Corinne Lepage announced "new revelations" thanks to an analysis [14], using other statistical methods, of the toxicological data from the same source (the famous 1139 pages). These "appropriate" statistical methods describe the "renal hypotrophy" but neglect to give the values for all the rat groups, which allows to conclude opportunely "a statistically significant difference", where the CGB concluded that this "fell within the range of natural variation". Other just as " significant" differences were found for other parameters. Revelations? The French food safety agency AFSSA report dated of 2nd December 2003 [8] states: "some statistically significant variations were observed. However, under the study's experimental conditions, the variations regarding haematology, biochemical and tissue parameters, limited to one or the other sex and independent of the duration of the treatment, are without biological significance, especially if one takes into account the historical data concerning these parameters for the rat model used". In other words, whereas the rat represents a useful model in toxicology, it is not perfect. Then why not associate another model? The AFSSA report reveals that this was done! On growing chickens. The report concludes "the absence of significant differences between treated chickens and control chickens".

On 14th March 2007, Le Monde published an article entitled: 'Strong suspicions of toxicity of a GMO corn'. Regarding the funding of the Criigen study by Greenpeace and the retailer chain Carrefour, the newspaper justifies it because "there is, unfortunately, no public funding for this kind of work". Which is inaccurate since European and French projects on risk assessment were and are currently funded. On 29th March 2007 the German agency BfR, on 26th April 2007 AFSSA and on 15th June 2007 the CGB all rejected the conclusions of the Criigen publication [15]. At the request of the European Commission, the EFSA set up a "task force" which auditioned the publication's authors and examined closely the statistical aspects. The conclusion returned on 28th June 2007 is irrevocable [16]: the paper does not raise new issues with respect to the safety of MON863, the results are considered not to be biologically relevant and are even misleading. Le Monde did not even bother to mention this...

References

-1) http://www.inra.fr/la_science_et_vous/dossiers_scientifiques/maladies_emergentes/la_chrysomele_des_racines_du_mais

-2) http://www.agbios.com/dbase.php. MON863 is authorized since 2001 in the United States for human food and animal fedd (marketed since 2003).

-3) Miller et coll., Science, vol. 310, 11 nov. 05, p. 992.

-4) Oct 31, 03, the Commission du Génie Biomoléculaire (CGB) requests 'thorough interpretations' in particular 'of anomalies of the kidneys' in MON863 fed rats.

-5) April 23, 04, Le Monde publishes 4 articles of which: The confidential expertise on a worrying transgenic corn

http://www.fairelejour.org/article.php3?id_article=566

and

Three questions to ... Corinne Lepage

http://www.lemonde.fr/cgi-bin/ACHATS/acheter.cgi?offre=ARCHIVES&type_item=ART_ARCH_30J&objet_id=850870

-6) Sept. 16 04, the CGB, after consultation of external experts, concludes that the 'anomalies' are due to 'progressive chronic nephropathy' and 'nephrocalcinosis', common affections of laboratory rats, without link to corn

http://www.ogm.gouv.fr/mise_marche/avis_scientifiques/pdf/AVDE029compl2FINAL.pdf

-7) Nov. 23 04, favourable opinion of the CGB after complementary study and expertise on the other variations: http://www.ogm.gouv.fr/mise_marche/avis_scientifiques/pdf/AVDE029compl3_231104.pdf

-8) April 8, 03, favourable German scientific opinion http://gmoinfo.jrc.it/csnifs/C-DE-02-09_RiskAssessment.pdf ;

Dec 2 .03, favourable opinion of the French Agence française de sécurité sanitaire des aliments (AFSSA) : http://www.afssa.fr/Ftp/Afssa/22026-22027.pdf ;

April 2, 04: favourable opinion of the European Food Safety Authority(EFSA): www.efsa.eu.int/science/gmo/gmo_opinions/381_en.html

-9) May 22, 05, The Independent U.K. publishes 2 articles on Monsanto's Secret Study: Health Fears Over Secret Study into GM Food & When Fed to Rats it Affected their Kidneys and Blood Counts. So What? Might it do to Humans ? We Think You Should be Told

http://www.organicconsumers.org/monsanto/secret062305.cfm

-10) May 24, 04, the EFSA dismisses the rumour about Monsanto's Secret Study

http://www.efsa.eu.int/press_room/press_statements/929_en.html

-11) Contradictory round table on GMO safety issues. ? Les enjeux sanitaires des OGM :

http://www.assemblee-nationale.fr/12/rap-info/i2254-t2-05.asp#P8053_1517739 ;

Testimony of Dr. Gerard PASCAL

http://www.assemblee-nationale.fr/12/rap-info/i2254-t2-03.asp#P5775_1087455

-12) Nov 15, 05, broadcasting on TV channel Canal+ of the documentary 'the accusing study'.

http://www.lemonde.fr/cgi-bin/ACHATS/acheter.cgi?offre=ARCHIVES&type_item=ART_ARCH_30J&objet_id=924158

-13) Hammond et coll., Food and Chemical Toxicology, Feb. 2006, vol. 44 (2), p. 147-160.

-14) Seralini et coll., Archives of Environmental Contamination and Toxicology, May 07, vol. 52(4), pp 596-602 (Press statement: March 13, 07).

-15) Opinion of the German Bundesinstitut für Risikobewertung (BfR) dated March 29, 07: 90-Tage-studie an Ratten mit MON863-mais: Keine Gesundheitliches Risiko.

http://www.bfr.bund.de/cm/208/90_tage_studie_an_ratten_mit_mon863_mais.pdf ;

Opinion of AFSSA relating to the recent study published on modified genetically corn MON863 (April 26, 07):

http://www.afssa.fr/Object.asp?IdObj=40727&Pge=0&CCH=070623:26:4&cwSID=5F58F578470146749B7BAB56BCB6F4BA&AID=0 ;

Opinion of CBG dated June 15, 07 :

http://www.ogm.gouv.fr/experimentations/evaluation_scientifique/cgb/autres_avis/Avis_CGB_MON863_15juin2007.pdf

-16) http://www.efsa.europa.eu/fr/press_room/press_release/pr_efsa_maize_Mon863.html

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* Marcel Kuntz is Director of Research at the Centre National de la Recherche Scientifique (France) and author of the book 'OGM, l'environnement et la santé' (Publisher: Ellipses).

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