lunes, diciembre 23, 2013

End double standards in evaluating GMO safety studies – say scientists

TO READ THE FULL DOCUMENT:
http://www.ensser.org/media/0813/

Europe’s food safety agency only criticises studies that find risk, new analysis shows

ENSSER Press release

17.12.2013


The controversy about the Séralini et al. study, which reported negative health effects of Monsanto's NK603 GM maize and Roundup herbicide fed to rats over the long term,[1] is still going on. According to a new review published in Environmental Sciences Europe, the European Food Safety Authority (EFSA) used unscientific double standards to dismiss the Séralini study on genetically modified (GM) maize.[2]


The publication of this latest review comes just days after the retraction of the Séralini paper by Elsevier, the publisher of Food and Chemical Toxicology (FCT), on the unprecedented grounds of the “inconclusive” nature of some of the findings. ENSSER condemned the retraction[3] .


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Hartmut Meyer, one of the authors of the new review, said, “Use of such double standards is a common response from scientists calling for GMO deregulation and, somewhat surprisingly, also from some government authorities, to studies that show negative environmental and health effects of GMOs. Only those studies that find problems are subjected to excessive scrutiny and rejected as defective. This approach appears to be a tactic to avoid dealing with ‘inconvenient’ results, whilst selecting for ‘convenient’ results."

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miércoles, diciembre 18, 2013

No hay consenso científico sobre la seguridad de los OMGs

ENLACE 


Ciencia y conocimiento
Como científicos, médicos, académicos y expertos en disciplinas relevantes para la evaluación de los aspectos científicos, legales, sociales y de seguridad de los organismos genéticamente modificados (OGMs), rechazamos enérgicamente las afirmaciones hechas por aquellos que desarrollan las semillas GM y algunos científicos, comentaristas y periodistas quienes concluyen la existencia de un “consenso científico” sobre la seguridad de los OGMs y que el debate entorno a esta cuestión está “cerrado”.
Consideramos que es apremiante desmentir dichas afirmaciones porque el pretendido consenso sobre la seguridad de los OGMs no existe. Afirmar lo contrario es engañoso y no representa de forma adecuada ni la evidencia científica actual ni la amplia diversidad de opiniones entre los científicos sobre esta materia. Además, estas declaraciones fomentan un clima de complacencia que puede llevar a una falta de rigor y de la cautela necesaria en el ámbito regulatorio y científico, potencialmente poniendo en peligro la salud de las personas, animales y el medio ambiente.
Para acceder al documento completo (formato PDF) haga clic en el enlace a continuación y descargue el archivo:
Fuente: ENSSER

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lunes, diciembre 16, 2013

ENSSER Comments on the Retraction of the Séralini et al. 2012 Study

http://www.ensser.org/democratising-science-decision-making/ensser-comments-on-the-retraction-
of-the-seralini-et-al-2012-study/

Journal's retraction of rat feeding paper is a travesty of science and looks like a bow to industry


Elsevier's journal Food and Chemical Toxicology has retracted the paper by Prof. Gilles-Eric Séralini's group which found severe toxic effects (including liver congestions and necrosis and kidney nephropathies), increased tumor rates and higher mortality in rats fed Monsanto's genetically modified NK603 maize and/or the associated herbicide Roundup[1]. The arguments of the journal's editor for the retraction, however, violate not only the criteria for retraction to which the journal itself subscribes, but any standards of good science. Worse, the names of the reviewers who came to the conclusion that the paper should be retracted, have not been published. Since the retraction is a wish of many people with links to the GM industry, the suspicion arises that it is a bow of science to industry. ENSSER points out, therefore, that this retraction is a severe blow to the credibility and independence of science, indeed a travesty of science.


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jueves, noviembre 14, 2013

Number of scientists who say GMOs not proven safe climbs to 230

http://www.ensser.org/media/0613/

Developer of first commercialised GM food says debate isn’t over


Press release, 30 October 2013


http://www.ensser.org/media/


Contact: Dr Angelika Hilbeck: ahilbeck@ensser.org / Tel.: +49 30 20 654 857




The number of scientists, physicians and legal experts who have signed the group statement, “No scientific consensus on GMO safety”[1] has climbed to 230 in just over a week – and it’s still growing.


The number of initial signatories stood at almost 100 on the day the statement was released, 21 October. It has more than doubled since.


A recent signatory is Dr Belinda Martineau, former member of the Michelmore Lab at the UC Davis Genome Center, University of California, who helped commercialise the world’s first GM whole food, the Flavr Savr tomato. Dr Martineau said:


“I wholeheartedly support this thorough, thoughtful and professional statement describing the lack of scientific consensus on the safety of genetically engineered (GM/GE) crops and other GM/GE organisms (also referred to as GMOs). Society's debate over how best to utilize the powerful technology of genetic engineering is clearly not over. For its supporters to assume it is, is little more than wishful thinking.” 


Another signatory, Dr Judy Carman, director of the Institute of Health and Environmental Research, Adelaide, and adjunct associate professor, health and the environment, Flinders University, South Australia, said:


“Of the hundreds of different GM crops that have been approved for human and animal consumption somewhere in the world, few have been thoroughly safety tested. So it is not possible to have a consensus that they are all safe to eat – at least, not a consensus based on hard scientific evidence derived from experimental data.”


A third signatory, Prof Elena Alvarez-Buyllla, coordinator of the Laboratory of Molecular Genetics of Plant Development and Evolution, Institute of Ecology, UNAM, Mexico, said:


“Given the scientific evidence at hand, sweeping claims that GM crops are substantially equivalent to, and as safe as, non-GM crops are not justifiable.


We must be especially cautious in the case of proposed release of a GM crop in the centre of genetic origin for that crop. An example is the planting of GM maize in Mexico. Mexico is the centre of genetic origin for maize. GM genes can irreversibly contaminate the numerous native varieties which form the genetic reservoir for all future breeding of maize varieties. In addition, maize is a staple food crop for the Mexican people. So GMO releases can threaten the genetic diversity on which food security depends, both within Mexico and globally.


Such decisions with broad implications for society should not be made by a narrow group of self-selected experts, many of whom have commercial interests in GM technology, but must also involve the millions of people who will be most affected. As things stand, in Mexico we have an ongoing uncontrolled experiment with no independent scientific or popular mandate, in which GM genes are allowed to crossbreed with native maize varieties. The inevitable result will be genetic alterations with unpredictable effects.”


A fourth signatory, Dr Joachim H. Spangenberg, faculty member at the UFZ Helmholtz Centre for Environmental Research, Leipzig, Germany, said:


“Researchers in ecology and relevant environmental sciences have predicted negative environmental impacts from GM crops for around 25 years. Over the years, many of these impacts have been empirically documented. One example is the development of pest resistance to GM Bt insecticidal crops and weed resistance to the required herbicides for GM herbicide-tolerant crops. These resistance problems are now an increasing problem for farmers – to the benefit of the GM seed and agrochemical corporations – and are forcing farmers back to older, even more toxic chemical pesticides.


Twenty years ago, the international academic associations of ecologists and molecular biologists met at the International Council for Science. The two groups agreed that their fields of expertise were complementary and that they needed to cooperate in order to assess the ecological impacts of GM crops in a systematic way. However, many molecular biologists involved in GM crop development today persistently ignore their own blind spots and the science emerging from the complementary environmental segments of the science community, turning the application of GM technology into a social risk.”


ENDS




Note to editors: Contrary to some media reports, most signatories to the statement are not members of ENSSER. ENSSER’s role has been to coordinate and publish the statement and to administer the collection of signatures

References

[1]http://www.ensser.org/increasing-public-information/no-scientific-consensus-on-gmo-safety/

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miércoles, noviembre 13, 2013

Sources and Mechanisms of Health Risks from Genetically Modified Crops and Food

http://www.biosafety-info.net/article.php?aid=1022

November 13, 2013

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 
Dear Friends and Colleagues 

We are pleased to highlight the attached TWN Biosafety Briefing which identifies the sources of health risks that can potentially arise from GM foods as well as presents the increasing body of evidence that shows the disruptive effect of the GM transformation process and clear signs of toxicity in well-controlled animal feeding studies even of a short-term nature. 
This paper was presented at the Scientific Conference 2012 jointly organized by the European Network of Scientists for Social and Environmental Responsibility (ENSSER), Third World Network and Tara Foundation, 'Advancing the Understanding of Biosafety: GMO Risk Assessment, Independent Biosafety Research and Holistic Analysis', held on 28-29 September 2012 in Hyderabad, India, and was first published in the Conference Proceedings. 

With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang 
Malaysia
To subscribe to other TWN information services: www.twnnews.net 

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viernes, noviembre 23, 2012

Questionable Biosafety of GMOs, Double Standards and, Once Again, a "Shooting-the-Messenger" Style Debate


European Network of Scientists for Social and Environmental Responsibility (ENSSER)

Summary and Main Issues
The European Network of Scientists for Social and Environmental Responsibility (ENSSER) welcomes the study "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" of a group of research scientists of the French Committee for Research and Independent Information on Genetic Engineering (CRIIGEN), an institutional member of ENSSER. Séralini et al. (2012) report on a two-year, full life-cycle study with rats testing Monsanto's NK603 glyphosate-tolerant GM maize (single trait glyphosate tolerance) and its Roundup co-technology in the journal Food and Chemical Toxicology.

The group of researchers led by Prof. Séralini has published previous toxicology studies on Roundup and its active ingredient glyphosate (Gasnier et al. 2009; Benachour et al. 2007; Benachour & Séralini 2009). The scientists also evaluated industry data submitted in support of the company’s dossiers seeking approval for food/feed import. When re-analysing the developer’s raw data, they found signs for toxicological effects on rat liver and kidneys after 90 days of feeding with GM maize, including the GM maize NK603 tested in this new study (de Vendômois et al. 2009; Séralini et al. 2007; Séralini et al. 2011).

Repeated calls that regulators should require more rigorous, long-term follow-up studies by the developers have consistently been ignored or rejected. Until 2011, the European Food Safety Authority (EFSA) rejected mandatory 90-day feeding studies as a requirement for applications for GM food and feed (European Food Safety Authority 2011). The few studies that were carried out by developers were voluntary and applied protocols of their choosing.

Main issues
  1. CRIIGEN's research[2] was crucial in finally eliciting a policy response by the European competent authority, the European Commission’s Directorate-General SANCO (Health and Consumer Safety) in 2012. In its draft Implementing Regulation on applications for authorisation of genetically modified food and feed (European Commission 2012), the European Commission stated: "toxicological studies with the whole genetically modified food and feed shall be carried out." If adopted, applicants "shall include a 90-day feeding study with whole food and feed in rodents for the assessment of food and feed containing, consisting of or produced from genetically modified plants [...].."
  1. After a comparative analysis of both published industry data and the data of CRIIGEN, ENSSER concludes that many arguments which attempt to invalidate the Séralini et al. study cannot hold up to closer scrutiny. Raised criticisms are to a large extent either wrong or apply double standards. The weak point of the pilot study by Séralini et al. is the number of animals used, which does not allow a statistical analysis of the raw data regarding one parameter measured out of over 30 - mortality. This has been acknowledged by the authors and needs to be considered/remediated in follow-up studies.
  1. The controversy and vitriolic attacks evoked by the study reveal one underlying aspect: The lack of appropriate and agreed methodologies for long-term studies to scientifically assess the effects of life-time consumption of GM foods.
  1. The development of such methodology and tests, which have been demanded by concerned scientists ever since GM food was announced to be introduced into international markets, has systematically been blocked by lobby groups of industry and associated scientists. International bodies such as the Codex Alimentarius and national governments - including most EU governments and their authorities - accepted instead the concept of substantial equivalence and the concept of familiarity to evade any scientific mandatory testing of GM food for human health safety. These concepts enable authorities to easily and declare significant differences found between GMOs and their unmodified parents as ‘biologically irrelevant’ in an assumption-based approach without agreed methodology and thresholds.
  1. The acceptance of these industry-led, constructed models providing the conceptual justification for evading testing of food-related risks associated with the introduction of this new technology and neglecting the clearly formulated demands of European citizens led to the crisis of trust in science and regulations that now come to light with full force.
  1. Due to the proven close links between industry and EU risk assessors and the documented disproportional influence on regulations by developers and owners of the technology, it is predictable and expected that these authorities, including EFSA, will not be able to substantially revise their original assessment of GM maize NK603 (and any other application) as their credibility is at stake. These on-going conflicts of interests within EFSA have led to the European Parliament (2012) refusing the discharge of the EFSA 2010 budget as long as there is no fundamental change in policy, leadership and guidance.

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martes, octubre 02, 2012

Scientific debate, not ad hominem attacks




ENSSER calls for scientific debate of potential health risks of GM wheat instead of ad hominem attacks on researchers
19 Sep 2012 - On 11 September 2012, the Science Media Centre (SMC) published response comments (by Prof. Rick Roush, Assoc. Prof. Peter Dearden, Prof. Peter Langridge and Dr. Ian Edwards) in reply to expert scientific opinions about the safety of GM wheat varieties that have been developed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) of Australia. The expert opinions were written by three risk assessment researchers, molecular biologist Prof. Jack Heinemann of Canterbury University (New Zealand), biochemist and epidemiologist Assoc. Prof. Judy Carman of Flinders University (Australia), and molecular geneticist Dr. Michael Antoniou of Kings College London (UK). The expert opinions were written in the form of reports and were prepared at the request of the Safe Food Institute of Australia, and communicated by the associated Safe Food Foundation.
After reviewing the response comments, ENSSER is disappointed by the Science Media Centre's decision to post personal attacks by the commentators on the authors of the original reports, rather than engage in a scientific debate that might have been useful to journalists, its stated audience.
ENSSER encourages the three commentators posting to the SMC website to take future opportunities to address the science rather than use these platforms to engage in ad hominem argumentation. The CSIRO, the Australian regulator (the OGTR), and each of these commentators could, and still can, put forth their own risk assessments to the public at any time. This is what we would have expected if the SMC were intending to provide clarity to the media.
In their post to the SMC, the commentators challenge the reports produced by Carman and Heinemann based on normative judgements, unsubstantiated assumptions, an apparently poor understanding risk assessment processes, and undignified name-calling.
Roush and Langridge begin their comments with an attempt to discredit the scientists by calling them "anti-GM campaigners" and "ideologically opposed to GM crops". Roush accuses the scientists of "deliberately bypass[ing] independent scientific assessment" and of practising "anti-GM so-called 'science'", while Edwards accuses them of "grossly premature alarmism". Langridge claims that the authors of the expert opinions "studiously ignore[d] the majority of the scientific literature and data". He further accuses them of deliberately avoiding "the normal process of peer review" and seeking "the appearance of credibility" for "scientifically flawed articles" by putting out a statement by someone with "no real knowledge" of the relevant science and pretending it is "proper science". In other words, Langridge is accusing the authors of perpetrating a kind of scientific fraud. None of these claims can be substantiated, and the commentators do nothing to substantiate them.
Roush and Dearden call Heinemann's report 'speculative'. All risk assessments are speculative because they are performed before the release of the product, whether for a field trial, for animal or human testing, or for a full release. The process requires considering exposure pathways that would exist, adverse effects that could arise, and hypotheses about how to detect any adverse effect if it were to occur and finally to determine if the effect was caused by the genetic modification and how this would be detected. Only after such experimentation is completed would the assessment not be speculative, but then there would be no point to risk assessment!
And we note that when CSIRO in its response says, "High amylose wheat has increased levels of resistant starch, which could have positive benefits for bowel health and people with diabetes" [emphasis added], this is also 'speculative'.
Roush claims erroneously that the authors "bypassed independent scientific assessment." when they did not. Like many government and other reports, they had their findings critically reviewed by fellow scientists (in addition to Dr. Antoniou). They did not send their report to a journal in this instance or seek blind review. However, neither has Roush for his claims (made to ABC radio that the "likelihood that this would happen in humans is very very small"). This conclusion is the outcome of a risk assessment and therefore, by Roush's standard, should have been subjected to "independent scientific assessment". At this time, we are not aware of any blind peer-reviewed journal articles that demonstrate the absence of the potential adverse effects outlined by Drs. Heinemann and Carman, who have publicly requested the evidence. Nor have we seen any blind peer-review of the Australian regulator's risk assessment.
Langridge accuses the report authors of ignoring "the majority of the scientific literature and data" on the safety of GM crops. Is Langridge aware that proper risk assessment is performed on a case-by-case basis? The safety of this particular form of GM wheat cannot be extrapolated from risk assessments of other kinds of plants, other kinds of modifications and modifications for other intended purposes, nor could the OGTR accept such an extrapolation.
Meanwhile, industry representative Edwards quizzically imposes an expiration date on risk assessments. If a risk was not raised at one time, he seems to believe that it cannot be raised later, even if it is a valid risk. We are not aware of any competent authority that would exclude new information at any time. Contrary to Edwards' highly personal views, CSIRO says 'the claims [by Heinemann, Carman and Antoniou] will be considered by CSIRO and the regulatory bodies in the context of all other relevant research in this area.' This is what the report authors were seeking and ENSSER welcomes that response by CSIRO.
ENSSER believes that the public, and science, are done a disservice when debate is reduced to ad hominem attack. Further, we believe that both science and the public can be harmed if research is impeded by the 'chilling effect' of such attacks. The public is entitled to a full and informed debate; scientific disagreement should result in further research, not dismissal through personal attack. Drs. Antoniou, Carman and Heinemann have engaged in proper scientific debate. Their expert opinions are based on evidence; their methodology, assumptions, reasoning and data have been provided for all to evaluate. SMC and other such outlets as well as fellow scientists should ensure that responses to their work do the same.
Contact:
Dr. Angelika Hilbeck, ETH Zürich, (E) angelika.hilbeck@env.ethz.ch
Dr. Hartmut Meyer, ENSSER, (E) hmeyer@ensser.org
The European Network of Scientists for Social and Environmental Responsibility (ENSSER) brings together independent scientific expertise to develop public-good knowledge for the critical assessment of existing and emerging technologies. The objective of ENSSER is the advancement of public-good science and research for the protection of the environment, biological diversity and human health against adverse impacts of new technologies and their products. ENSSER advocates benign and peaceful use of scientific discoveries and technological developments, while expanding diverse approaches to assess their utility and safety in society. More information available at: http://www.ensser.org

ANNEX: Setting the record straight
The Safe Food Institute had requested from Drs. Carman and Heinemann reports evaluating the risk assessment of GM wheat being developed in Australia by the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The wheat is genetically modified using new dsRNA-mediated silencing; the OGTR has given CSIRO approval for field testing and a human feeding study. The Safe Food Institute then asked Dr. Antoniou, among others, to serve as an expert external reviewer of the reports. Dr. Antoniou provided his own conclusions and summary.
Carman and Heinemann are experts in their respective scientific fields and in biotechnology risk assessment. Assoc. Prof. Carman has expertise in animal and human biochemistry, nutrition and infectious diseases. Her work in epidemiology and risk assessment requires her understand how food consumption can affect the health of animals and humans. Prof. Heinemann has expertise in genetics and molecular biology, with an emphasis in infectious genetic elements and horizontal gene transfer. Both scientists have been actively involved in GMO risk assessment for over a decade. In their reports they give their recommendations for a robust sequence of experiments to address plausible potential hazards of the novel food. Proper risk assessment involves identifying potential hazards followed by constructing, where possible, specific and testable hypotheses for how these hazards might arise and how they would be detected.
Prof. Heinemann first constructed an exposure analysis. He asked: How could humans or animals come into contact with the dsRNAs uniquely produced in the GM wheat? The obvious way is through ingestion or inhalation of flour. Then he provided an extensive analysis of peer-reviewed scientific research that demonstrates unequivocally that dsRNA is sufficiently stable to be able to pass through food to humans and animals; it resists digestion, low pH and cooking temperatures.
Having established a scientifically plausible exposure pathway, he then hypothesised how the dsRNA produced by the wheat could cause an adverse effect. The most obvious means would be by doing in the human or animal what it is intended to do in the wheat, and cause gene silencing. He then provided an extensive analysis of peer-reviewed literature that demonstrates unequivocally that ingested dsRNAs either directly, or through amplification of secondary dsRNAs, silence genes in ingesting animals and human tissue culture cells.
A prediction of Prof. Heinemann's hypothesis is that the dsRNA would have to have sequence similarity to human genes in order to cause gene silencing. RNA is composed of nucleotides of mainly four types: A, G, U, C (and sometimes I). These nucleotides can form base-pairs when align and bond with their complementary nucleotides, in the same way as double-stranded DNA. When RNA does this, it is called double-stranded (ds) RNA. He sourced a sequence of the gene targeted for silencing in the wheat, called the SEI gene from Aegilops tauschii (a donor of one of the genomes in the multi genome wheat), as the sequence was deposited by the CSIRO on a public database. He found matches between short stretches of the wheat SEI gene and a similar human gene called GBE, and short matches to many other human genes.
For silencing, overall similarity between genes is not important. What is important is the concentration of similarity over a very short stretch of bases pairs in a sequence. The most potent dsRNA for causing silencing is about 21 nucleotides long and is a perfect match to a target, but as few as 7 contiguous base matches can be enough to cause silencing. Prof. Heinemann found too many potential targets to list them individually. So he published the list as Appendix 2 to his report.
Prof. Heinemann thus drew the conclusions that:
1. Exposure to the genetically engineered dsRNA molecules was likely;
2. Uptake was probable; and
3. Unintended silencing of human and animal genes was possible.
In light of his findings, Prof. Heinemann produced a list of 5 essential studies for risk assessment. At no time did he say that the CSIRO product would cause diseases or adverse effects. He did, however, ask for assurance from the Australian regulator and the CSIRO that this risk scenario had been excluded through proper scientific experimentation.
Dr. Carman considered that the most likely gene to be silenced in animals and people would be a similar gene to the one designed to be silenced in the GM wheat varieties. She therefore concentrated her risk assessment on the effects of silencing that gene. She determined that the GM wheat varieties were designed to silence a branching enzyme in the wheat plant that changed the type of carbohydrate that was stored in the plant. She used widely-available sources to determine that a silencing of the equivalent gene in animals and people could cause serious ill-health by changing the way carbohydrate is stored in the body, from a highly branched, soluble form of glycogen to an insoluble form of glycogen with far fewer branches. She further found that some people already suffer from this condition and provided information that severely affected children usually die from the condition.
She then reviewed the animal and human testing suggested by the CSIRO. She found evidence that testing was being conducted to determine if the wheat varieties produced the hoped-for beneficial effects on health but did not find any evidence that any potential adverse effects were being assessed. In fact, she found that the regulator (the OGTR) had determined that "the potential for increased weediness, allergenicity or toxicity ... is not an identified risk and will not be assessed further".
At no time did she say that the CSIRO product would cause a disease or adverse effects. She did, however, provide a list of additional safety assessments on animals and humans that she recommended be done in order to properly investigate possible adverse effects, and she recommended that these be done before the GM wheat varieties entered the animal feed and human food supplies.
Despite their protestations, neither Roush, Langridge, Edwards nor Dearden have offered evidence that these wheat varieties are safe to eat. However, Roush, Langridge and Edwards liberally resort to ad hominem attack and speculation on the report authors' motives; speculation for which they have only themselves as sources. None of them provides references to peer-reviewed literature that proves the GM wheat was safety tested on animals before its intended use in a human feeding trial. Such an evidence-based safety assessment is central to a scientific assessment of potential risks.
None of the commentary presented by SMC addresses these issues. None of these commentators provided evidence to prove, or even suggest, that the dsRNA molecules do not transmit to humans or other animals, or that the dsRNA molecules in this GM wheat won't, given the findings that similar plant derived molecules do just that. None of them provided references to peer-reviewed literature that proves the GM wheat was safety tested on animals before its intended use in a human feeding trial. Instead, Roush, Langridge and Edwards liberally resort to ad hominem attack and speculation on the report authors' motives; speculation for which they have only themselves as sources.

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