2. Summary
An excellent summary graph is given in (Graff et al., 2009) in fig. 1b: innovations active in the R&D pipeline were growing at an increasing rate during the period before 1998, but declined after 1998. Apart from competition of reasonably close non-transgenic substitutes the authors consider one regulatory reason to be the main culprit: The halting of regulatory approvals in 1998 in Europe. Although the authors consider the full extent of reasons still to be conjectural, their data suggest that changes in regulatory environment may have been a cause. In a combination of high costs for lost implementation and high costs for regulatory approvals the present state and operational experience has grown into a major obstacle of modern crop breeding.
Commentary from Table 1: The primary survey combined records from scientific publications, field trial records and regulatory filings to identify 558 transgenic plants with quality improvements and determine how far they had progressed through stages of R&D by 2004, including those that had only been published in the scientific literature; those that had reached initial field trials (defined as having completed 1–3 field trials), mid-stage field trials (4–9 field trials) or advanced field trials (>10); those that had entered regulatory filings; and those that were commercialized. The secondary survey canvassed expectations of firms and analysts about the likelihood and time frame for future commercialization of transgenic product quality innovations. Complete one-to-one correspondence between individual observations of the two surveys was not possible.

More details and literature citations in:
http://www.botanischergarten.ch/AF-10-Over-Regulation/AF-10-Over-Regulation-20091220-web.pdf

1. The Claim
Lovei, G. L., D. A. Andow and S. Arpaia (2009). “Transgenic Insecticidal Crops and Natural Enemies: A Detailed Review of Laboratory Studies.” Environmental Entomology 38: 293-306.
http://www.ingentaconnect.com/content/esa/envent/2009/00000038/00000002/art00001

“This review uses a data-driven, quantitative method to summarize the published, peer-reviewed literature about the impact of genetically modified (GM) plants on arthropod natural enemies in laboratory experiments. The method is similar to meta-analysis, and, in contrast to a simple author-vote counting method used by several earlier reviews, gives an objective, data-driven summary of existing knowledge about these effects. Significantly more non-neutral responses were observed than expected at random in 75% of the comparisons of natural enemy groups and response classes. These observations indicate that Cry toxins and proteinase inhibitors often have non-neutral effects on natural enemies. This synthesis identifies a continued bias toward studies on a few predator species, especially the green lacewing, Chrysoperla carnea Stephens, which may be more sensitive to GM insecticidal plants (16.8% of the quantifed parameter responses were significantly negative) than predators in general (10.9% significantly negative effects without C. carnea). Parasitoids were more susceptible than predators to the effects of both Cry toxins and proteinase inhibitors, with fewer positive effects (18.0%, significant and non-significant positive effects combined) than negative ones (66.1%, significant and non-significant negative effects combined). GM plants can have a positive effect on natural enemies (4.8% of responses were significantly positive), although significant negative (21.2%) effects were more common. Although there are data on 48 natural enemy species, the database is still far from adequate to predict the effect of a Bt toxin or proteinase inhibitor on natural enemies”.

(Lovei et al., 2009).

2. Comments by Shelton et al.
Shelton, A., Naranjo, S., Romeis, J., Hellmich, R., Wolt, J., Federici, B., Albajes, R., Bigler, F., Burgess, E., Dively, G., Gatehouse, A., Malone, L., Roush, R., Sears, M., & Sehnal, F. (2009)
Setting the record straight: a rebuttal to an erroneous analysis on transgenic insecticidal crops and natural enemies. Transgenic Research, 18, 3, pp 317-322
http://dx.doi.org/10.1007/s11248-009-9260-5 open access AND http://www.botanischergarten.ch/Bt/Shelton-Setting-Record-Straight-Lovei-2009.pdf

In a nearly unprecedented speed (Lovei et al., 2009) has been rebutted sharply by (Shelton et al., 2009), a worldwide consortium of specialists on research of non-target insects related to Bt crops: In an unusual straightforward text they criticize heavily the previous publication, and the author of this study agrees fully: it is time to recognize that such studies, even when published in peer reviewed journals, do not help to progress scientific risk assessment of GM crops, on the contrary, they hinder future developments by providing to highly questionable arguments a scientific aura. The pitfalls are not easy to see, due to the complexity of the matter (food webs of parasitoid insects and their prey over development and time). For lay persons, politicians and even regulators it is difficult to develop a critical view and to distinguish junk science from high quality papers.

“As scientists involved in risk assessment of transgenic insecticidal plants, we are greatly concerned about the publication by (Lovei et al., 2009) implying that insect-protected crops based on the Cry proteins of Bacillus thuringiensis may have substantial negative impacts on non-target organisms. We believe that (Lovei et al., 2009) use inappropriate and unsound methods for risk assessment that have led them to reach conclusions that are in conflict with those of several recent comprehensive reviews and metaanalyses (e.g., (Marvier et al., 2007; Naranjo, 2009; O’Callaghan et al., 2005; Romeis et al., 2006; Wolfenbarger et al., 2008). (Lovei et al., 2009) base their findings on an analysis of 55 laboratory studies of Cry proteins and 27 studies of proteinase inhibitors (PIs; including lectins) that were published through mid-2007 and conclude that these proteins ‘‘often have non-neutral effects on natural enemies’’. They further conclude that ‘‘parasitoids were more susceptible than predators to the effects of both (toxins)’’ and that ‘‘conclusions that Bt…gene products have no harm to natural enemies are currently over-generalized and premature’’. We are deeply concerned about the inappropriate methods used in their paper, the lack of ecological context, and the authors’ advocacy of how laboratory studies on non-target arthropods should be conducted and interpreted. Essentially, the authors have conducted a data-mining exercise without prior elaboration of a risk hypothesis framework (Romeis et al., 2008) that can provide context to their findings and interpretations. Therefore, we believe it is very important that readers consider the following points as they read (Lovei et al., 2009).”

for more text click: http://www.botanischergarten.ch/AF-8-Lovei/AF-8-Lovei-Non-Target-20090828-web.pdf

for feedback email to klaus dot ammann at ips dot unibe dot ch

1. Part one
1.1. 35S-Promoter and the stability of transgene inserts
1.2. Antibiotic marker chapter, status 20090725

1.1. The claim for part one on the 35S promoter and Antibiotic marker genes

Summarized in the abstract published:

“As genetically modified (GM) foods are starting to intrude in our diet concerns have been expressed regarding GM food safety. These concerns as well as the limitations of the procedures followed in the evaluation of their safety are presented. Animal toxicity studies with certain GM foods have shown that they may toxically affect several organs and systems. The review of these studies should not be conducted separately for each GM food, but according to the effects exerted on certain organs it may help us create a better picture of the possible health effects on human beings. The results of most studies with GM foods indicate that they may cause some common toxic effects such as hepatic, pancreatic, renal, or reproductive effects and may alter the hematological, biochemical, and immunologic parameters. However, many years of research with animals and clinical trials are required for this assessment. The use of recombinant GH or its expression in animals should be re-examined since it has been shown that it increases IGF-1 which may promote cancer.”

Dona, A. & Arvanitoyannis, I.S. (2009)
Health Risks of Genetically Modified Foods.
Critical Reviews in Food Science and Nutrition, 49, 2, pp 164 - 175 http://www.informaworld.com/10.1080/10408390701855993

Comments on 1.1. by Klaus Ammann and colleagues cited
General comments
This paper, published recently in “Critical Reviews in Food Science and Nutrition” by the internationally well known editorial house Taylor & Francis, needs to be critically commented for a multitude of reasons:
In a first overview, the reader will find a lot of mostly unconfirmed concerns about the safety of foods derived from GM crops, the citations are extremely filtered in a way to depict a negative picture on GM crops, and the review authors seem to lack proper knowledge about the field of food safety as a whole. They also publish numerous paragraphs as their own writings, whereas they are just taken by copy-paste from other publications, and worse: those placatory passages are selected from papers with a negative bias and with notorious contents, which have been rebutted recently and for the majority even some years ago. Most of those rebuttals are written by the best authorities in the field, well publicized and easily obtainable in the internet or in libraries from the best peer reviewed journals. Thus Dona et al.  give the uninformed reader the wrong picture, as if the food safety situation in 2008 would still be precarious. This is simply not the case and in summary this is a blatant example of scientific distortion of the overall picture in this field of scientific research on food safety.
The text below will give some examples, always supported by peer reviewed literature, which is available in abundance. It is hard to understand that Taylor & Francis let pass such a low quality review with numerous errors, and it is even harder to understand that major efforts in food safety research are simply ignored in this review, or mentioned in a misleading way, such as giving only the outlook and summary comment on one of the major efforts ‘ENTRANSFOOD’ in the European research on food safety: Citing only (Kuiper et al., 2004), which concentrates on some future research efforts, gives the erroneous picture, that ENTRANSFOOD came to the conclusion that food safety is not yet secured with the GM crops. But if you make the effort of reading the major official summary of ENTRANSFOOD (Konig et al., 2004), agreed upon by all researchers participating in this project, then you easily fall on their major conclusion:

“In conclusion, the food safety assessment paradigm as described in this paper, under which any differences in the new food are identified and any hazards and risks characterized, relative to the conventional food or product, clearly establishes whether the test food derived from a GM crop is as safe as the conventional counterpart.  It can even be argued that foods from GM crops are better characterized than other non-regulated plant-derived foods, due to the additional rigor in the current regulatory requirements and testing regime compared to that for conventionally-bred crops.”

It should be mentioned, that this summary is based on an impressive number of joint research papers which have been carefully coordinated in their conclusions by a consortium of the most renowned researchers in food safety today. But let us start with some concrete examples in order to illustrate one of the harsh negative but unfounded statements of the review:

for more text, click: http://www.botanischergarten.ch/AF-7-Dona-rebuttal/AF-7-Dona-20091025-web.pdf

for a feedback email to klaus dot ammann at ips dot unibe dot ch

“Failure to Yield is the first report to closely evaluate the overall effect genetic engineering has had on crop yields in relation to other agricultural technologies. It reviewed two dozen academic studies of corn and soybeans, the two primary genetically engineered food and feed crops grown in the United States. Based on those studies, the UCS report concluded that genetically engineering herbicide-tolerant soybeans and herbicide-tolerant corn has not increased yields. Insect-resistant corn, meanwhile, has improved yields only marginally. The increase in yields for both crops over the last 13 years, the report found, was largely due to traditional breeding or improvements in agricultural practices.”

(Gurian-Sherman, 2009)

Gurian-Sherman, D. (2009)
Failure to Yield, Evaluating the Performance of Genetically Engineered Crops, Union ot Concerned Scientists pp (Report)
http://www.ucsusa.org AND http://www.botanischergarten.ch/GM-General/Gurian-Sherman-failure-to-yield-2009.pdf AND
Press conference: http://www.ucsusa.org/food_and_agriculture/science_and_impacts/science/failure-to-yield.html

2. Summary
1. The report deals only with two major crops: Maize and soybean, there is no justification for the sweeping conclusions on all GM crops. Other crops like cotton and oilseed rape show a different, more positive picture, it is misleading to restrict the review to two crops and then conclude for all GM crops.
2. GM crops have – at least in the beginning – not been developed to increase yield per se (the second generation of GM soybean will do this. The first GM crop generation has been conceived to efficiently reduce yield losses to weeds and insects - and thus enhance the economic situation of the farmers, and these promises have been fulfilled properly and with evident success. UCS misleads the reader by not distinguishing those two views of yield.
3. GM crops have also efficiently reduced herbicide use (or made it possible to shift to environmentally more benign ones) and also they have helped to reduce pesticides. It is misleading by UCS not to mention those facts.
4. GM crops have a proven positive influence on the ecological footprint of intensive high production agriculture (no tillage, better life for non-target insects etc.). It is misleading by the UCS report to camouflage those positive effects under “agricultural practices”.

For more text, click: http://www.ask-force.org/web/AF-6-Crop-Failure/AF-6-Crop-Failure-UCS-20100519-web.pdf

for a feedback, email to klaus dot ammann at ips dot unibe dot ch, on special request you can get an open source version of the full text

1. Summary:
The Austrian study which has been prematurely published as a report by the Austrian government does not stand to the review of peer experts. The principal scientist Prof. J. Zentek himself declares the study as a preliminary draft with partially inconclusive results, which needs to be corrected in some points. He is not happy with the present situation and the premature press conference of the Austrian ministry, and particularly he is refuting the conclusions drawn by Greenpeace, requesting the immediate retraction of GM maize in Europe, since there is a real risk that consumers of this maize could become sterile.

Andrew Apel, webmaster and author of http://www.gmobelus.org, a new and excellent website, provides a lot of information, summarizing the case in several features and giving ample background information and lots of links. The study has been refuted by Monsanto in several statements, recently also by EFSA (European Food Safety Authority)

A German text can be found under the newspoints, written by Jan Lucht, on the Internutrition website http://www.internutrition.ch/in-news/point/nov08.html

For more text click: http://www.ask-force.org/web/AF-5-Austrian-Micestudy/AF-5-Austrian-Experiment-20100407-web.pdf

For the background of the story see: http://www.botanischergarten.ch/AF-5-Austrian-Micestudy/AF-5-Austrian-Exp-Background-20090828-web.pdf
for a feedback, email to klaus dot ammann at ips dot unibe dot ch, you can get on special request open source versions of both texts for private use

1. General View
For years, Austria’s governmental and politically motivated claims against the adoption of GM crops have repeatedly been rejected by European Commission officials, by scientists with the European Food Safety Authority (EFSA), and by the judges of two European courts and by numerous scientists.

Government regulators and numerous safety scientists have rejected Austria’s claims about GMOs as well as the country’s attempts to retard EU policy and evade the requirements of European law and decisions.  Austrian ministries (as well as their counterparts in the French and Italian governments) have adopted novel tactics that were invented, suggested and endorsed by anti-GM activists.
As a result, the global media is regularly fed questionable claims based on reports which have not gone through the process of peer review, or – worse – which have passed a flawed peer-review process – examples given in (Miller et al., 2008).  Some journals have accepted papers on the premise that because of the publicity given to studies in the media and on websites, the work should be published so that everyone has a chance to scrutinize the findings (Horton, 1999; Horton et al., 1999).  And, unfortunately, it is also true that lower quality journals accept papers that would be found unacceptable by leading journals – here a few examples to illustrate the whole range of cases given above:

•  Short letters to the editor, written by whistle blowers in good faith – or worse in many of the below cases – with a political agenda - on ‘promiscuity of transgenic plants’ (Bergelson et al., 1998) or the toxicity of Bt maize for non-target insects like the monarch butterflies (Losey, 1999; Saxena et al., 1999), but later devaluated as premature apprehensions.
•  Critical scientists conducting experiments which do not respect the internationally agreed experimental procedures, so actually the results are questionable. But it has to be said that the authors were commenting their own results in a balanced way the possible negative effects by leaving open other causes than transgenesis (effects of transgenic soybeans on mice by (Malatesta et al., 2003; Malatesta et al., 2005; Vecchio et al., 2004)).  Nevertheless, this work is often misinterpreted by opponents who make no mention of the researchers careful qualifications of their findings and certainly no mention of the questionable methodology.
•  Publications by scientists who have a clearly negative view of GM crops that conduct research intended to reveal highly improbable negative effects.  The research protocols and experimental conduct are flawed and the differences they make publicity about are usually not of biological significance or are not even statistically significant. (Seralini et al., 2007), critical comment see (Doull et al., 2007)  (Ewen & Pusztai, 1999), contradiction see in the same Lancet volume: (Kuiper et al., 1999).
•  Publications on topics related to epigenetics neglecting zero comparisons, although the findings per see are correctly commented, but in a balance not giving the whole picture. (Myhre et al., 2006), (Latham et al., 2005). for contradiction see Jens Freitag in GMO Safety.
•  Uncritical reviews by newcomers in the field of food safety (Dona & Arvanitoyannis, 2009),  for contradiction see (Auer, 2008)  and Sorghum (Botha & Viljoen, 2008) who do not understand some of the cited scientific publications seemingly supporting their negative cause of extensive gene flow and worse: ignore important scientific work as reviewers.
•  Papers based on new methodological approaches, not following the internationally agreed protocols, which have to be interpreted with great caution and which need to be independently verified (Finamore et al., 2004; Finamore et al., 2008).
•  Prematurely published reports propagated on numerous websites of the anti-gene-technology-community and in sensational newspaper articles, without having been scrutinized properly by peer-review (Ermakova, 2005a, b, 2007a, b; Marshall, 2007; Marshall et al., 2007). When Ermakova finally revealed her data, it was clear that the research and data did not meet contemporary international standards of experimentation. The high observed mortality of rats in control groups was attributed to mistreatment of the animals.

For a critique on the actual experimentation in the Austrian mice study see http://www.botanischergarten.ch/AF-5-Austrian-Micestudy/AF-5-Austrian-Experiment-20090828-web.pdf

See full details about Pusztai, Ermakova and Dona in the contributions of ASK-FORCE :

About the case of Pusztai:
http://www.botanischergarten.ch/AF-2-Pusztai/Pusztai-Food-Safety-20090828-web.pdf

About the case of Ermakova:
http://www.botanischergarten.ch/AF-4-Ermakova/AF-4-Ermakova-20090828-web.pdf

About the Dona Review:
http://www.botanischergarten.ch/AF-7-Dona-rebuttal/Ammann-et-al.-Rebuttal-Dona-AF-7-20090828-web.pdf

for more text, click http://www.botanischergarten.ch/AF-5-Austrian-Micestudy/AF-5-Austrian-Exp-Background-20090828-web.pdf

for a feedback, write to klaus dot ammann at ips dot unibe dot ch