No scientific consensus on GMO safety

A broad community of independent scientific researchers and scholars challenges recent claims of a consensus over the safety of genetically modified organisms (GMOs). In the following joint statement, the claimed consensus is shown to be an artificial construct that has been falsely perpetuated through diverse fora. Irrespective of contradictory evidence in the refereed literature, as documented below, the claim that there is now a consensus on the safety of GMOs continues to be widely and often uncritically aired. For decades, the safety of GMOs has been a hotly controversial topic that has been much debated around the world. Published results are contradictory, in part due to the range of different research methods employed, an inadequacy of available procedures, and differences in the analysis and interpretation of data. Such a lack of consensus on safety is also evidenced by the agreement of policymakers from over 160 countries - in the UN’s Cartagena Biosafety Protocol and the Guidelines of the Codex Alimentarius - to authorize careful case-by-case assessment of each GMO by national authorities to determine whether the particular construct satisfies the national criteria for ‘safe’. Rigorous assessment of GMO safety has been hampered by the lack of funding independent of proprietary interests. Research for the public good has been further constrained by property rights issues, and by denial of access to research material for researchers unwilling to sign contractual agreements with the developers, which confer unacceptable control over publication to the proprietary interests. The joint statement developed and signed by over 300 independent researchers, and reproduced and published below, does not assert that GMOs are unsafe or safe. Rather, the statement concludes that the scarcity and contradictory nature of the scientific evidence published to date prevents conclusive claims of safety, or of lack of safety, of GMOs. Claims of consensus on the safety of GMOs are not supported by an objective analysis of the refereed literature

Scientists’ warning : we must change paradigm for a revolution in toxicology and world food supply

We propose a new paradigm, as toxicology currently lacks the proper perspective. From the 1950s to the 1970s, at least one-third of all toxicological testing in the United States, including for chemicals and drugs, was misleading scientists, and this worldwide issue persists today. Moreover, petroleum-based waste and heavy metals have been discovered in pesticide and plasticizer formulations. These contaminations have now reached all forms of life. Widespread exposure to chemical mixtures promotes health and environmental risks. We discovered that pesticides have never undergone long-term testing on mammals in their full commercial formulations by regulatory authorities or the pesticide industry; instead, only their declared active ingredients have been assessed, contrary to environmental law recommendations. The ingredients of these formulations are not fully disclosed, yet the formulations are in general at least 1000 times more toxic at low environmentally relevant doses than the active ingredients alone under conditions of long-term exposure. A similar lack of comprehensive toxicological evaluation applies to plasticizers. Their regulatory authorisations might have been obtained by incomplete, misleading and potentially false input data. This has profound implications not only for scientific knowledge, but also for public and environmental health. We propose pragmatically a paradigm shift in regulation: 1/to lower the ADI of polluting substances by at least a factor of 100 for already authorized products; 2/for new compounds, the obligation to test the full pesticide formulations in vivo chronically at environmentally relevant levels. This is necessary because pesticides are synthesized from petroleum, which can contain heavy metals. Moreover, formulated pesticides can contain plasticizers. The declared active substance, as an isolated compound of this mixture chosen by the company, will not have to be tested by itself alone. Compensation could be organized for pesticide use reduction, this will save health and environmental degradation; 3/the complete toxicological raw data for individual animals should be published on the Internet, including the precise protocols by which they were obtained, and they must be accessible for the scientific community, including students. There is no reason to keep these data secret. Implementing these changes would also support the advancement of agroecological alternatives

Co-Formulants in Glyphosate-Based Herbicides Disrupt Aromatase Activity in Human Cells below Toxic Levels

Pesticide formulations contain declared active ingredients and co-formulants presented as inert and confidential compounds. We tested the endocrine disruption of co-formulants in six glyphosate-based herbicides (GBH), the most used pesticides worldwide. All co-formulants and formulations were comparably cytotoxic well below the agricultural dilution of 1% (18–2000 times for co-formulants, 8–141 times for formulations), and not the declared active ingredient glyphosate (G) alone. The endocrine-disrupting effects of all these compounds were measured on aromatase activity, a key enzyme in the balance of sex hormones, below the toxicity threshold. Aromatase activity was decreased both by the co-formulants alone (polyethoxylated tallow amine—POEA and alkyl polyglucoside—APG) and by the formulations, from concentrations 800 times lower than the agricultural dilutions; while G exerted an effect only at 1/3 of the agricultural dilution. It was demonstrated for the first time that endocrine disruption by GBH could not only be due to the declared active ingredient but also to co-formulants. These results could explain numerous in vivo results with GBHs not seen with G alone; moreover, they challenge the relevance of the acceptable daily intake (ADI) value for GBHs exposures, currently calculated from toxicity tests of the declared active ingredient alone

A Roundup herbicide causes high mortality and impairs development of Chrysoperla carnea (Stephens) (Neuroptera: Chrysopidae)

Glyphosate has and is being used extensively in herbicide formulations worldwide. Thus, glyphosate-based herbicides (GBH) substantially add to the environmental load of pesticides and warrant a strict risk assessment. Ecotoxicological testing of herbicides focuses on non-target plants and higher animals while direct effects on arthropods are only cursory tested on the premise of contact exposure. However, oral exposure, as we show in our case, can be highly relevant for systemic pesticides, such as GBH. Specifically, in crop systems including genetically modified crops that are tolerant to GBH, these herbicides and their breakdown products are present both internally and externally of the crop plants and, therefore, are ingested by the crop-associated arthropod fauna. We tested the effects of oral uptake of the Roundup formulation WeatherMax on larvae of the lacewing Chrysoperla carnea, a model organism in ecotoxicity testing programs. Long-term oral exposure of C. carnea larvae throughout its juvenile life stages was tested with concentrations ranging from 0.001 to 1 % dilution, thus, lower than the 1.67 % recommended for field applications. Inhibition of metamorphosis was observable at 0.1 % but at a concentration of 0.5 %, GBH significantly impaired cocoon formation and led to massive lethal malformations. At GBH concentration of 1 % half of the individuals remained permanent larvae and no adult hatched alive. The effects observed followed a clear dose-response relationship. The hazard caused by direct insecticidal action of GHB after oral uptake is highly relevant for the environmental safety and reveals a gap in regulatory risk assessments that should urgently be addressed, specifically in light of the on-going insect decline.ISSN:0048-9697ISSN:1879-102

Dig1 protects against locomotor and biochemical dysfunctions provoked by Roundup

International audienceBACKGROUND: Plant medicinal extracts may be claimed to prevent or cure chemical intoxications. Few of these are tested for their mechanisms of actions in vivo and for their cellular impacts. In 2011, we demonstrated that hepatic cell mortality induced by environmentally realistic levels of the widely used herbicide Roundup (R) in vitro can be almost entirely prevented by plant extracts called Dig1 (D, Digeodren).METHODS: We tested the in vivo effects of D alone (1.2 ml/kg bw/d), but also prior to and during 8 days of R intoxication (at 135 mg/kg bw/d) in a total of 4 groups of 40 adult Sprague-Dawley male rats each. After treatments, horizontal and vertical locomotor activities of the animals were measured by use of actimeters. Brain, liver, kidneys, heart and testes were collected and weighted. Body weights as well as feed and water consumption were recorded. Proteins, creatinine, urea, phosphate, potassium, sodium, calcium, chloride ions, testosterone, estradiol, AST and ALT were measured in serum. In liver S9 fractions, GST, GGT, and CYP450 (1A2, 2C9, 2C19, 2D6, 3A4) were assessed.RESULTS: D did not have any physiological or biochemical observable impact alone at 2 %. Out of a total of 29 measured parameters, 8 were significantly affected by R absorption within only 8 days. On these 8 parameters, only 2 were not restored by D (GGT activity and plasmatic phosphate), 5 were totally restored (horizontal and vertical locomotor activities, CYP2D6 activity, plasmatic Na + and estradiol), and the 6th was almost restored (plasmatic K+). The specificities of the toxic effects of R and of the therapeutic effects of D treatment were thus demonstrated, both at the behavioural and biochemical levels.CONCLUSIONS: D, without any side effect observable in these conditions, presented strong preventive and therapeutic properties in vivo after a short-term intoxication by the widely used pesticide Roundup

Conflicts of interests, confidentiality and censorship in health risk assessment: the example of an herbicide and a GMO

We have studied the long-term toxicity of a Roundup-tolerant GM maize (NK603) and a whole Roundup pesticide formulation at environmentally relevant levels from 0.1 ppb. Our study was first published in Food and Chemical Toxicology (FCT) on 19 September, 2012. The first wave of criticisms arrived within a week, mostly from plant biologists without experience in toxicology. We answered all these criticisms. The debate then encompassed scientific arguments and a wave of ad hominem and potentially libellous comments appeared in different journals by authors having serious yet undisclosed conflicts of interests. At the same time, FCT acquired as its new assistant editor for biotechnology a former employee of Monsanto after he sent a letter to FCT to complain about our study. This is in particular why FCT asked for a post-hoc analysis of our raw data. On 19 November, 2013, the editor-in-chief requested the retraction of our study while recognizing that the data were not incorrect and that there was no misconduct and no fraud or intentional misinterpretation in our complete raw data - an unusual or even unprecedented action in scientific publishing. The editor argued that no conclusions could be drawn because we studied 10 rats per group over 2 years, because they were Sprague Dawley rats, and because the data were inconclusive on cancer. Yet this was known at the time of submission of our study. Our study was however never attended to be a carcinogenicity study. We never used the word ‘cancer’ in our paper. The present opinion is a summary of the debate resulting in this retraction, as it is a historic example of conflicts of interest in the scientific assessments of products commercialized worldwide. We also show that the decision to retract cannot be rationalized on any discernible scientific or ethical grounds. Censorship of research into health risks undermines the value and the credibility of science; thus, we republish our paper

Laboratory Rodent Diets Contain Toxic Levels of Environmental Contaminants: Implications for Regulatory Tests

The quality of diets in rodent feeding trials is crucial. We describe the contamination with environmental pollutants of 13 laboratory rodent diets from 5 continents. Measurements were performed using accredited methodologies. All diets were contaminated with pesticides (1-6 out of 262 measured), heavy metals (2-3 out of 4, mostly lead and cadmium), PCDD/Fs (1-13 out of 17) and PCBs (5-15 out of 18). Out of 22 GMOs tested for, Roundup-tolerant GMOs were the most frequently detected, constituting up to 48% of the diet. The main pesticide detected was Roundup, with residues of glyphosate and AMPA in 9 of the 13 diets, up to 370 ppb. The levels correlated with the amount of Roundup-tolerant GMOs. Toxic effects of these pollutants on liver, neurodevelopment, and reproduction are documented. The sum of the hazard quotients of the pollutants in the diets (an estimator of risk with a threshold of 1) varied from 15.8 to 40.5. Thus the chronic consumption of these diets can be considered at risk. Efforts toward safer diets will improve the reliability of toxicity tests in biomedical research and regulatory toxicology.</p

Co-formulants in glyphosate-based herbicides disrupt aromatase activity in human cells below toxic levels

Pesticide formulations contain declared active ingredients and co-formulants presented as inert and confidential compounds. We tested the endocrine disruption of co-formulants in six glyphosate-based herbicides (GBH), the most used pesticides worldwide. All co-formulants and formulations were comparably cytotoxic well below the agricultural dilution of 1% (18-2000 times for co-formulants, 8-141 times for formulations), and not the declared active ingredient glyphosate (G) alone. The endocrine-disrupting effects of all these compounds were measured on aromatase activity, a key enzyme in the balance of sex hormones, below the toxicity threshold. Aromatase activity was decreased both by the co-formulants alone (polyethoxylated tallow amine—POEA and alkyl polyglucoside—APG) and by the formulations, from concentrations 800 times lower than the agricultural dilutions; while G exerted an effect only at 1/3 of the agricultural dilution. It was demonstrated for the first time that endocrine disruption by GBH could not only be due to the declared active ingredient but also to co-formulants. These results could explain numerous in vivo results with GBHs not seen with G alone; moreover, they challenge the relevance of the acceptable daily intake (ADI) value for GBHs exposures, currently calculated from toxicity tests of the declared active ingredient alone.Fil: Defarge, Nicolas. Universite de Caen Basse Normandie; Francia. CRIIGEN; FranciaFil: Takács, Eszter. National Agricultural Research and Innovation Centre; HungríaFil: Lozano, Verónica Laura. Universite de Caen Basse Normandie; Francia. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Mesnage, Robin. Universite de Caen Basse Normandie; Francia. CRIIGEN; FranciaFil: de Vendômois, Joël Spiroux. CRIIGEN; FranciaFil: Séralini, Gilles Eric. Universite de Caen Basse Normandie; Francia. CRIIGEN; FranciaFil: Székács, András. National Agricultural Research and Innovation Centre; Hungrí