sustainablepulse--2020-03-30--Monsanto To Pay $39 M in Roundup False Ad Class Settlement

Monsanto has settled claims in a proposed class action alleging that it falsely advertised that the active ingredient in Roundup Weed & Grass Killer only affects plants with a $ 39.5 million deal that includes changing the labels on its products , Law360 reported Saturday .
The proposed class , led by named plaintiff Lisa Jones , asked a Missouri federal court on Monday to approve the deal , saying the fund , none of which will revert to Monsanto if money is left over , represents a fair settlement that will benefit not only the plaintiffs in this case @ @ @ @ @ @ @ changing the products ’ labels .
In the February 2019 suit , Jones says Monsanto falsely claimed through its labeling that glyphosate , the active ingredient in Roundup , targets an enzyme that is only found in plants and would therefore not affect people or pets .
According to the suit , that enzyme is in fact found in people and pets and is critical to maintaining the immune system , digestion and brain function .
According to Monday ’ s motion , the litigation in other cases against Monsanto over Roundup — @ @ @ @ @ @ @ court — contributed to the settlement , as discovery conducted in Blitz was applied to this case .
The plaintiffs in Blitz made similar claims against Monsanto in June 2017 .
After their class certification was denied in January 2019 , named plaintiff Thomas Blitz opted to continue his action individually .
He filed a stipulation of voluntary dismissal in his case on Monday , according to court documents .
The proposed class in Jones ’ case seeks to represent all people in the U.S. who bought Roundup that included the claim that @ @ @ @ @ @ @ statutes of limitations for false advertising or breach of warranty in their states .
Of the $ 39.5 million settlement fund , up to $ 1.3 million will go to administrating the settlement , and Monsanto has agreed not to contest attorney fees of up to 25 % of the amount available to the class .
Read More Details Here on Law360

Monsanto has settled claims in a proposed class action alleging that it falsely advertised that the active ingredient in Roundup Weed & Grass Killer only affects plants with a $39.5 million deal that includes changing the labels on its products, Law360 reported Saturday.
The proposed class, led by named plaintiff Lisa Jones, asked a Missouri federal court on Monday to approve the deal, saying the fund, none of which will revert to Monsanto if money is left over, represents a fair settlement that will benefit not only the plaintiffs in this case, but also the general public by changing the products’ labels.
In the February 2019 suit, Jones says Monsanto falsely claimed through its labeling that glyphosate, the active ingredient in Roundup, targets an enzyme that is only found in plants and would therefore not affect people or pets. According to the suit, that enzyme is in fact found in people and pets and is critical to maintaining the immune system, digestion and brain function.
Glyphosate Box Glyphosate Residue Free Certification for Food Brands – Click Here Test Your Food and Water at Home for Glyphosate – Click Here Test Your Hair for Glyphosate and other Pesticides – Click Here to Find Out Your Long-Term Exposure
According to Monday’s motion, the litigation in other cases against Monsanto over Roundup — including Blitz v. Monsanto in Wisconsin federal court — contributed to the settlement, as discovery conducted in Blitz was applied to this case.
The plaintiffs in Blitz made similar claims against Monsanto in June 2017. After their class certification was denied in January 2019, named plaintiff Thomas Blitz opted to continue his action individually. He filed a stipulation of voluntary dismissal in his case on Monday, according to court documents.
The proposed class in Jones’ case seeks to represent all people in the U.S. who bought Roundup that included the claim that glyphosate targets only plants within the applicable statutes of limitations for false advertising or breach of warranty in their states.
Of the $39.5 million settlement fund, up to $1.3 million will go to administrating the settlement, and Monsanto has agreed not to contest attorney fees of up to 25% of the amount available to the class.
Read More Details Here on Law360


sustainablepulse--2020-03-28--Fiji Moves Towards Ban on Glyphosate Herbicides

According to local sources Fiji is now moving towards a full ban on glyphosate-based herbicides , after the sugarcane industry announced that glyphosate will be banned for use on sugarcane farms in the country from December 31st 2020 .
Fiji ’ s Sugar Industry Tribunal Commissioner , Timothy Brown , told the Fiji Times on Saturday that the ban was in line with the local sugar industry ’ s efforts to ensure Fairtrade Certification for all sugar produced in and exported from the country .
Brown stated that “ Glyphosate is a toxic and dangerous chemical .
As such , @ @ @ @ @ @ @ ensure such chemicals are not used on Fairtrade certified crops sold on their markets.
” This is not the first harmful chemical that has faced a ban in Fiji recently .
The Ministry of Agriculture banned the importation , sale , and use of the herbicide Paraquat and the insecticide Imidacloprid at the end of 2019 .
The ban on glyphosate use on sugarcane farms is particularly important as for more than a century , the sugar industry has been perceived as the backbone of the Fijian economy , given its contributions to @ @ @ @ @ @ @ employment generation .
Sugarcane is thought to be indigenous to the islands of the South Pacific .
It was found growing in Fiji by the early European settlers .
Fijians grew sugar cane for chewing and they are known to have used the juice for sweetening food .

According to local sources Fiji is now moving towards a full ban on glyphosate-based herbicides, after the sugarcane industry announced that glyphosate will be banned for use on sugarcane farms in the country from December 31st 2020.
Fiji’s Sugar Industry Tribunal Commissioner, Timothy Brown, told the Fiji Times on Saturday that the ban was in line with the local sugar industry’s efforts to ensure Fairtrade Certification for all sugar produced in and exported from the country.
Brown stated that “Glyphosate is a toxic and dangerous chemical. As such, our sugar buyers and consumers wish to ensure such chemicals are not used on Fairtrade certified crops sold on their markets.”
This is not the first harmful chemical that has faced a ban in Fiji recently. The Ministry of Agriculture banned the importation, sale, and use of the herbicide Paraquat and the insecticide Imidacloprid at the end of 2019.
Glyphosate Box Glyphosate Residue Free Certification for Food Brands – Click Here Test Your Food and Water at Home for Glyphosate – Click Here Test Your Hair for Glyphosate and other Pesticides – Click Here to Find Out Your Long-Term Exposure
The ban on glyphosate use on sugarcane farms is particularly important as for more than a century, the sugar industry has been perceived as the backbone of the Fijian economy, given its contributions to gross domestic product (GDP) and employment generation.
Sugarcane is thought to be indigenous to the islands of the South Pacific. It was found growing in Fiji by the early European settlers. Fijians grew sugar cane for chewing and they are known to have used the juice for sweetening food.


sustainablepulse--2020-03-20--Seralini Calls for Retraction of ‘Biased’ EU Study on GM Maize

Prof Gilles-Eric Séralini of the University of Caen has published a peer-reviewed paper criticising the EU-funded 2-year feeding study on GM maize that claimed to show no adverse effects from the GM diet .
The EU-funded study was published in 2019 by Pablo Steinberg and colleagues and reported the results of the 2-year rat feeding study , called G-TwYST , on a GM Roundup-tolerant maize , NK603 .
The published paper claimed that there were “ no adverse effects ” related to the feeding of the GM maize cultivated with or without Roundup spraying and that no further long-term studies @ @ @ @ @ @ @ in spite of the fact that the male rats in this study that were fed NK603 maize sprayed with Roundup had a significantly increased mortality rate compared with controls .
The main cause of death was pituitary tumours , followed by kidney disease .
The Steinberg study was carried out to follow up the study led by Prof Séralini , which was initially published in 2012 .
The Séralini study had found serious adverse effects in rats fed NK603 maize and very low doses of Roundup fed both separately and together with the @ @ @ @ @ @ @ strongly paralleled the findings of Steinberg ’ s team , including severe kidney disease and increased mortality .
The pituitary gland was the second most tumour-affected organ in females after the mammary gland .
Now Prof Séralini has responded to the Steinberg study in a new peer-reviewed publication .
Séralini draws attention to the differences between his own team ’ s and Steinberg and colleagues ’ study , as follows .
Steinberg and colleagues used a rat strain that was not sensitive to tumour-causing substances : Steinberg and colleagues used a rat strain @ @ @ @ @ @ @ sensitive to substances causing tumours than the Sprague-Dawley rat used by Séralini ( and Monsanto in its shorter study ) .
In GMWatch ’ s view this is only understandable on the basis that they were actively trying not to find tumorigenic and carcinogenic effects from the GM maize tested .
The Sprague-Dawley rat is one of the most commonly used models for human breast cancer risk .
In other words , the Sprague-Dawley rat is about as sensitive to substances causing mammary tumours as humans and thus a suitable model for a @ @ @ @ @ @ @ .
Steinberg and colleagues didn ’ t study Roundup or glyphosate alone : Long-term effects of Roundup alone at environmentally relevant levels ( 0.1 ppb ) on a diet without pesticides were not tested by Steinberg and colleagues , unlike Séralini ’ s team .
Séralini ’ s team found severe health effects from this low dose of Roundup , including non-alcoholic fatty liver disease , which was confirmed by separate research carried out by a different group of researchers at a later date .
Heavy contamination of diets in Steinberg and colleagues @ @ @ @ @ @ @ could be masked : Glyphosate-based residues were present at high levels in the diets in Steinberg and colleagues ’ study , including the control diets , even though the aim was to study a glyphosate-tolerant GMO .
The levels of glyphosate found corresponded to 300–1400 times more glyphosate than was present in the dose of Roundup found to be toxic in the Séralini study .
Steinberg and colleagues also found many other contaminants in the analysis of their feeds .
The authors considered a priori that all the feed contaminations would have no @ @ @ @ @ @ @ This is only their subjective opinion , and many indications that we have cited can prove the contrary.
” The bottom line is that the effects of such mixtures have not been properly tested for , so it is not valid to claim that they have no effect .
This heavy contamination of the feeds , Séralini suggests in the new paper , increased the background level of serious diseases in the controls , preventing many observable effects of the GMO treatment on animals .
He writes that such contamination would have prompted @ @ @ @ @ @ @ began : “ Given such neglect of the contamination issue , we would have stopped there instead of drawing scientifically inadequate conclusions.
” The probable reason for the differences in contamination levels was that in the Séralini study , the crops were grown specially using organic methods .
Thus pesticide residues were so low as to be undetectable – at least , by the detection methods available at the time , which were less sensitive than those available now .
Therefore the researchers were able to highlight any effects from the GMO and/or @ @ @ @ @ @ @ and GMO contamination of the base and control diets in the Séralini team ’ s experiment , it is perhaps not surprising that they found 5–8 times fewer tumours and diseases in their control rats than did Steinberg and colleagues .
Separate research led by Séralini showed that laboratory rat feeds are routinely contaminated by many pollutants , including GMOs , heavy metals , dioxins , and pesticides .
High mortality rates in males fed GM NK603 corn dismissed by Steinberg and colleagues : Séralini writes , “ In spite of the many @ @ @ @ @ @ @ et al .
still found significant differences , most notably in male mortality , which was higher in the animals fed the GM corn sprayed with Roundup for 2 years .
In addition , increased incidence of pituitary neoplasia , and disorders of the sex hormones estradiol and thyroid in females were also noticed.
” GMWatch has also drawn attention to these dramatic findings .
But bafflingly , not a single mainstream media outlet has reported on them , even though they will be clearly evident to anyone who reads the full paper @ @ @ @ @ @ @ press statements put out by the G-TwYST researchers .
As Séralini points out in the new paper , these findings in Steinberg and colleagues ’ experiment were the same as those observed in the earlier Séralini study .
But Steinberg and colleagues dismissed these effects as “ not… adverse ” , due to the lack of histopathological alterations in the estrogen-sensitive tissues and organs .
However , Séralini counters , “ Lesions can be missed in the histopathological sectioning , and/or some functional alterations that have biological effects on the organism may not @ @ @ @ @ @ @ not the place of Steinberg et al .
to dismiss such changes based on assumptions , like EFSA or industry conclude , particularly in a research study conducted with the aim of revealing any health risk to humans.
” This brings us to an important omission in Steinberg and colleagues ’ paper .
As Séralini writes , the histopathological sections are not shown even in supplementary data , and thus can not be analysed by others to confirm or refute the interpretation of Steinberg and colleagues that there were no adverse effects from @ @ @ @ @ @ @ closer examination of the Steinberg and colleagues ’ publication , GMWatch has noticed that they did not conduct their histology ( microscopic analysis of tissues ) and histopathology ( microscopic analysis of tissues with the aim of studying development of disease ) blinded .
They justify this highly unusual move on the grounds of saving time and money .
However , the issue with this is that absence of blinding allows bias to creep in .
They also state that they didn ’ t look at tissues from all the animals – but @ @ @ @ @ @ @ animals .
The problem with that is that they could easily have missed important effects in the lower dose groups .
Steinberg and colleagues dismiss differences in GM-fed animals for invalid reasons : Steinberg and colleagues dismissed some statistically significant differences in treatment groups as not biologically relevant since they are “ small ” or “ not dose-related ” , the latter meaning there should be an effect proportional to the dose of the GMO .
But as Séralini writes , “ Such assertions are not scientifically justifiable .
A dose-related observation begins @ @ @ @ @ @ @ to OECD [ Organisation for Economic Cooperation and Development , which sets protocols for industry experiments conducted for regulatory purposes ] .
Moreover , an effect that is statistically significant should not be dismissed as ‘ small ’ and the effects of hormone disruptors are often not proportional to the dose.
” In order to dismiss the differences in GM-fed animals , Steinberg and colleagues compare the effects observed in this experiment with the “ historical control data ” obtained from previous feeding trials .
Séralini points out that this use of unrelated @ @ @ @ @ @ @ of the Organisation for Economic Cooperation and Development ( OECD ) on the conduct and design of chronic toxicity and carcinogenicity studies [ 30 ] — guidelines that Steinberg and colleagues cite in their paper .
The OECD states , “ the concurrent control group is always the most important consideration ” when considering the effects of the test substance .
Séralini writes that he finds it surprising that the authors conclude from their findings that “ we should no longer bother to conduct long-term studies on agricultural GMOs in general ” .
@ @ @ @ @ @ @ contrary to the spirit of scientific inquiry and ( more importantly ) is not supported by the concerning results that were found in spite of the methodological weakness of the study ” .
Séralini continues by pointing out the many conflicts of interest of Pablo Steinberg , which were not declared in the G-TwYST study publication .
For example , elsewhere Steinberg noted that he was an expert for the International Life Science Institute ( ILSI ) , an industry lobby group funded by the likes of Monsanto and Syngenta , which has @ @ @ @ @ @ @ including of GMOs and pesticides , and supports their use .
Séralini concludes that the results of Steinberg and colleagues ’ paper are “ unreliable ” and that the paper “ should be retracted , and the results deleted from regulatory appraisals and risk assessments ” .
— Update on long-term toxicity of agricultural GMOs tolerant to Roundup Gilles-Eric Seralini Environmental Sciences Europe volume 32 , Article number : 18 ( 2020 ) enveurope.springeropen.com/articles/10.1186/s12302-020-0296-8 Agricultural genetically modified organisms ( GMOs ) are plants obtained by gene transfer or more recently by gene-editing .
@ @ @ @ @ @ @ 99 % have been modified is that these are designed to be grown with pesticides , which may bioaccumulate in the plants and/or the consumer , and/or express insecticides in their cells .
Examples of both types are Roundup-tolerant soy and corn and Bt insecticidal plants .
Recently , Steinberg et al .
concluded that there were no adverse effects in rats from consumption of a GM corn tolerant to Roundup , called NK603 , and that no other long-term studies are justified .
This contradicts several of our in vivo studies on @ @ @ @ @ @ @ either the same GMO , other GMOs , or the pesticide Roundup itself .
Our results were attributed in particular to the long-term in vivo effects of Roundup residues , which also present toxic and endocrine-disrupting effects in vitro .
These effects were clearly linked to the formulants of the pesticide , such as petroleum residues and heavy metals , and not to glyphosate alone .
In fact , the treated rats in Steinberg et al.
’ s experiment showed many adverse effects , some of which , including increased mortality in males @ @ @ @ @ @ @ statistically significant .
Other adverse effects affected both treated and control groups .
The latter trend may be due to contamination of the feed of the control animals by many carcinogenic pollutants , including pesticides , but also by Roundup residues and Roundup-tolerant GMOs .
For instance , glyphosate contained in Roundup was found to be 300–1400 times more elevated in their control feed than in our treated group .
In conclusion , Steinberg et al.
’ s study is invalidated by the contaminated feed , biased interpretations , and major undeclared conflicts @ @ @

Prof Gilles-Eric Séralini of the University of Caen has published a peer-reviewed paper criticising the EU-funded 2-year feeding study on GM maize that claimed to show no adverse effects from the GM diet.
The EU-funded study was published in 2019 by Pablo Steinberg and colleagues and reported the results of the 2-year rat feeding study, called G-TwYST, on a GM Roundup-tolerant maize, NK603. The published paper claimed that there were “no adverse effects” related to the feeding of the GM maize cultivated with or without Roundup spraying and that no further long-term studies with GMOs were justified.
This was in spite of the fact that the male rats in this study that were fed NK603 maize sprayed with Roundup had a significantly increased mortality rate compared with controls. The main cause of death was pituitary tumours, followed by kidney disease.
The Steinberg study was carried out to follow up the study led by Prof Séralini, which was initially published in 2012. The Séralini study had found serious adverse effects in rats fed NK603 maize and very low doses of Roundup fed both separately and together with the maize. Effects in most treatment groups strongly paralleled the findings of Steinberg’s team, including severe kidney disease and increased mortality. The pituitary gland was the second most tumour-affected organ in females after the mammary gland.
Now Prof Séralini has responded to the Steinberg study in a new peer-reviewed publication. Séralini draws attention to the differences between his own team’s and Steinberg and colleagues’ study, as follows.
Steinberg and colleagues used a rat strain that was not sensitive to tumour-causing substances:
Steinberg and colleagues used a rat strain, the Wistar, that was less sensitive to substances causing tumours than the Sprague-Dawley rat used by Séralini (and Monsanto in its shorter study). In GMWatch’s view this is only understandable on the basis that they were actively trying not to find tumorigenic and carcinogenic effects from the GM maize tested. The Sprague-Dawley rat is one of the most commonly used models for human breast cancer risk. In other words, the Sprague-Dawley rat is about as sensitive to substances causing mammary tumours as humans and thus a suitable model for a study intended to look at carcinogenic effects.
Steinberg and colleagues didn’t study Roundup or glyphosate alone:
Long-term effects of Roundup alone at environmentally relevant levels (0.1 ppb) on a diet without pesticides were not tested by Steinberg and colleagues, unlike Séralini’s team. Séralini’s team found severe health effects from this low dose of Roundup, including non-alcoholic fatty liver disease, which was confirmed by separate research carried out by a different group of researchers at a later date.
Heavy contamination of diets in Steinberg and colleagues’ study meant effects of the GMO could be masked:
Glyphosate-based residues were present at high levels in the diets in Steinberg and colleagues’ study, including the control diets, even though the aim was to study a glyphosate-tolerant GMO. The levels of glyphosate found corresponded to 300–1400 times more glyphosate than was present in the dose of Roundup found to be toxic in the Séralini study.
Steinberg and colleagues also found many other contaminants in the analysis of their feeds. The authors considered a priori that all the feed contaminations would have no effect. But Séralini comments, “This is only their subjective opinion, and many indications that we have cited can prove the contrary.” The bottom line is that the effects of such mixtures have not been properly tested for, so it is not valid to claim that they have no effect.
This heavy contamination of the feeds, Séralini suggests in the new paper, increased the background level of serious diseases in the controls, preventing many observable effects of the GMO treatment on animals. He writes that such contamination would have prompted him to abandon the experiment before it began: “Given such neglect of the contamination issue, we would have stopped there instead of drawing scientifically inadequate conclusions.”
The probable reason for the differences in contamination levels was that in the Séralini study, the crops were grown specially using organic methods. Thus pesticide residues were so low as to be undetectable – at least, by the detection methods available at the time, which were less sensitive than those available now. Therefore the researchers were able to highlight any effects from the GMO and/or the Roundup.
Given the low-to-non-existent pesticide and GMO contamination of the base and control diets in the Séralini team’s experiment, it is perhaps not surprising that they found 5–8 times fewer tumours and diseases in their control rats than did Steinberg and colleagues. Separate research led by Séralini showed that laboratory rat feeds are routinely contaminated by many pollutants, including GMOs, heavy metals, dioxins, and pesticides.
High mortality rates in males fed GM NK603 corn dismissed by Steinberg and colleagues:
Séralini writes, “In spite of the many weaknesses of the study design, Steinberg et al. still found significant differences, most notably in male mortality, which was higher in the animals fed the GM corn sprayed with Roundup for 2 years. In addition, increased incidence of pituitary neoplasia, and disorders of the sex hormones estradiol and thyroid in females were also noticed.”
GMWatch has also drawn attention to these dramatic findings. But bafflingly, not a single mainstream media outlet has reported on them, even though they will be clearly evident to anyone who reads the full paper rather than just the abstract and the press statements put out by the G-TwYST researchers.
As Séralini points out in the new paper, these findings in Steinberg and colleagues’ experiment were the same as those observed in the earlier Séralini study. But Steinberg and colleagues dismissed these effects as “not… adverse”, due to the lack of histopathological alterations in the estrogen-sensitive tissues and organs. However, Séralini counters, “Lesions can be missed in the histopathological sectioning, and/or some functional alterations that have biological effects on the organism may not result in histopathological changes. It is not the place of Steinberg et al. to dismiss such changes based on assumptions, like EFSA or industry conclude, particularly in a research study conducted with the aim of revealing any health risk to humans.”
Steinberg and colleagues haven’t published their histopathology slides:
This brings us to an important omission in Steinberg and colleagues’ paper. As Séralini writes, the histopathological sections are not shown even in supplementary data, and thus cannot be analysed by others to confirm or refute the interpretation of Steinberg and colleagues that there were no adverse effects from the GM maize.
Moreover, on closer examination of the Steinberg and colleagues’ publication, GMWatch has noticed that they did not conduct their histology (microscopic analysis of tissues) and histopathology (microscopic analysis of tissues with the aim of studying development of disease) blinded. They justify this highly unusual move on the grounds of saving time and money. However, the issue with this is that absence of blinding allows bias to creep in. They also state that they didn’t look at tissues from all the animals – but only the control and high dose group animals. The problem with that is that they could easily have missed important effects in the lower dose groups.
Steinberg and colleagues dismiss differences in GM-fed animals for invalid reasons:
Steinberg and colleagues dismissed some statistically significant differences in treatment groups as not biologically relevant since they are “small” or “not dose-related”, the latter meaning there should be an effect proportional to the dose of the GMO. But as Séralini writes, “Such assertions are not scientifically justifiable. A dose-related observation begins with three doses and not two according to OECD [Organisation for Economic Cooperation and Development, which sets protocols for industry experiments conducted for regulatory purposes]. Moreover, an effect that is statistically significant should not be dismissed as ‘small’ and the effects of hormone disruptors are often not proportional to the dose.”
Steinberg and colleagues misuse historical control data to dismiss differences:
In order to dismiss the differences in GM-fed animals, Steinberg and colleagues compare the effects observed in this experiment with the “historical control data” obtained from previous feeding trials. Séralini points out that this use of unrelated historical control data violates the Test Guidelines of the Organisation for Economic Cooperation and Development (OECD) on the conduct and design of chronic toxicity and carcinogenicity studies [30] — guidelines that Steinberg and colleagues cite in their paper. The OECD states, “the concurrent control group is always the most important consideration” when considering the effects of the test substance.
Séralini writes that he finds it surprising that the authors conclude from their findings that “we should no longer bother to conduct long-term studies on agricultural GMOs in general”. This, he states, “is contrary to the spirit of scientific inquiry and (more importantly) is not supported by the concerning results that were found in spite of the methodological weakness of the study”.
Séralini continues by pointing out the many conflicts of interest of Pablo Steinberg, which were not declared in the G-TwYST study publication. For example, elsewhere Steinberg noted that he was an expert for the International Life Science Institute (ILSI), an industry lobby group funded by the likes of Monsanto and Syngenta, which has worked to weaken regulation and testing, including of GMOs and pesticides, and supports their use.
Séralini concludes that the results of Steinberg and colleagues’ paper are “unreliable” and that the paper “should be retracted, and the results deleted from regulatory appraisals and risk assessments”.
Report By: Claire Robinson
—
Update on long-term toxicity of agricultural GMOs tolerant to Roundup
Gilles-Eric Seralini
Environmental Sciences Europe volume 32, Article number: 18 (2020)
enveurope.springeropen.com/articles/10.1186/s12302-020-0296-8
Abstract
Agricultural genetically modified organisms (GMOs) are plants obtained by gene transfer or more recently by gene-editing. Their major common phenotypic trait for which 99% have been modified is that these are designed to be grown with pesticides, which may bioaccumulate in the plants and/or the consumer, and/or express insecticides in their cells. Examples of both types are Roundup-tolerant soy and corn and Bt insecticidal plants. Recently, Steinberg et al. concluded that there were no adverse effects in rats from consumption of a GM corn tolerant to Roundup, called NK603, and that no other long-term studies are justified. This contradicts several of our in vivo studies on the short- and long-term toxicological effects of either the same GMO, other GMOs, or the pesticide Roundup itself. Our results were attributed in particular to the long-term in vivo effects of Roundup residues, which also present toxic and endocrine-disrupting effects in vitro. These effects were clearly linked to the formulants of the pesticide, such as petroleum residues and heavy metals, and not to glyphosate alone. In fact, the treated rats in Steinberg et al.’s experiment showed many adverse effects, some of which, including increased mortality in males fed GM corn + Roundup, were statistically significant. Other adverse effects affected both treated and control groups. The latter trend may be due to contamination of the feed of the control animals by many carcinogenic pollutants, including pesticides, but also by Roundup residues and Roundup-tolerant GMOs. For instance, glyphosate contained in Roundup was found to be 300–1400 times more elevated in their control feed than in our treated group. In conclusion, Steinberg et al.’s study is invalidated by the contaminated feed, biased interpretations, and major undeclared conflicts of interest.


sustainablepulse--2020-03-20--US Government Proposes Allowing GMO Crops on Thousands of Acres of National Wildlife Refuges

The US government has proposed to approve genetically modified crops on national wildlife refuges throughout the southeastern United States , a step likely to increase use of glyphosate and other pesticides known to harm wildlife .
The previous US government administration acted in 2014 to phase out GM crops on all national wildlife refuges following a successful decade-long campaign by the Center for Food Safety and others .
The current administration reversed that decision in 2018 , prompting a lawsuit from the Center for Biological Diversity and Center for Food Safety challenging the action in September 2019 .
The proposal @ @ @ @ @ @ @ escalating uses of GM crops and harmful pesticides across the Southeastern Region of the refuge system , which includes 131 refuges in 10 states , Puerto Rico and the U.S. Virgin Islands .
“ Only the Trump administration would aggressively promote the use of crops genetically engineered for pesticide tolerance on wildlife refuges , ” said Hannah Connor , an attorney at the Center for Biological Diversity .
“ It ’ s a no-brainer that this kind of pesticide-intensive agriculture shouldn ’ t be allowed on public lands that are critical to wildlife @ @ @ @ @ @ @ of the southeastern U.S. ” National wildlife refuges are federal public lands specifically designated to protect fish and wildlife .
The Southeastern Region is comprised of almost 4 million acres of refuge lands and waters that provide vital habitat for dozens of endangered species known to be imperiled by pesticide use — including bats , birds , freshwater mussels , and fish like the pallid sturgeon and Alabama cavefish .
“ National wildlife refuges are vital sanctuaries for our natural heritage for present and future generations , ” said Sylvia Wu , an @ @ @ @ @ @ @ .
“ Permitting GE crops and neonicotinoid pesticides on the refuges threatens one of the few places that pollinators and protected species should be able to find shelter from the onslaught of toxic pesticides threatening their existence.
” Approximately 44,000 acres of refuges lands in the Southeastern Region are currently devoted to farming practices , with corn , soybeans and rice the most commonly farmed crops .
Genetically engineered corn and soy are typically designed to survive what would normally be fatal spraying with herbicides like glyphosate , dicamba and 2-4 , D @ @ @ @ @ @ @ pesticides prophylactically , especially in the summer months after the crops have emerged .
Increased pesticide-use periods often correspond with key wildlife feeding and breeding times , when pesticides can be especially harmful to species .
Glyphosate use on GM crops may have significantly contributed to monarch butterflies ’ 80 % decline over the past two decades .
This is because the pesticide is a uniquely potent killer of milkweed , the monarch caterpillar ’ s only food .
Recent estimates indicate that monarch populations have further plunged by over half in the @ @ @ @ @ @ @ in the midst of a biodiversity crisis , ” said Ben Prater , Southeast program director at Defenders of Wildlife .
“ Industrial agriculture with pesticide-intensive genetically engineered crops has no place on national wildlife refuges dedicated to conservation of our most vulnerable species , including pollinators like hummingbirds , bumble bees and monarch butterflies.
” The southeastern United States is home to unparalleled biodiversity , though the region ’ s species are suffering from pollution , habitat destruction and pesticide-intensive industrial agriculture .
Twenty-eight percent of the region ’ s fish species @ @ @ @ @ @ @ % of southeastern mussels are facing extinction .
The area covered by today ’ s proposal also includes the southern portions of the Atlantic and Mississippi flyways , which are vital migratory paths for endangered birds such as wood storks , piping plovers and sandhill cranes .
Refuges also support a diversity of native pollinators .
The proposal and draft environmental assessment will be open for public comment for 30 days .

The US government has proposed to approve genetically modified crops on national wildlife refuges throughout the southeastern United States, a step likely to increase use of glyphosate and other pesticides known to harm wildlife.
The previous US government administration acted in 2014 to phase out GM crops on all national wildlife refuges following a successful decade-long campaign by the Center for Food Safety and others. The current administration reversed that decision in 2018, prompting a lawsuit from the Center for Biological Diversity and Center for Food Safety challenging the action in September 2019.
The proposal released this week opens the door to escalating uses of GM crops and harmful pesticides across the Southeastern Region of the refuge system, which includes 131 refuges in 10 states, Puerto Rico and the U.S. Virgin Islands.
“Only the Trump administration would aggressively promote the use of crops genetically engineered for pesticide tolerance on wildlife refuges,” said Hannah Connor, an attorney at the Center for Biological Diversity. “It’s a no-brainer that this kind of pesticide-intensive agriculture shouldn’t be allowed on public lands that are critical to wildlife conservation and preservation of the unique ecosystems of the southeastern U.S.”
National wildlife refuges are federal public lands specifically designated to protect fish and wildlife. The Southeastern Region is comprised of almost 4 million acres of refuge lands and waters that provide vital habitat for dozens of endangered species known to be imperiled by pesticide use — including bats, birds, freshwater mussels, and fish like the pallid sturgeon and Alabama cavefish.
“National wildlife refuges are vital sanctuaries for our natural heritage for present and future generations,” said Sylvia Wu, an attorney at the Center for Food Safety. “Permitting GE crops and neonicotinoid pesticides on the refuges threatens one of the few places that pollinators and protected species should be able to find shelter from the onslaught of toxic pesticides threatening their existence.”
Approximately 44,000 acres of refuges lands in the Southeastern Region are currently devoted to farming practices, with corn, soybeans and rice the most commonly farmed crops.
Genetically engineered corn and soy are typically designed to survive what would normally be fatal spraying with herbicides like glyphosate, dicamba and 2-4,D. This allows farmers to use these pesticides prophylactically, especially in the summer months after the crops have emerged. Increased pesticide-use periods often correspond with key wildlife feeding and breeding times, when pesticides can be especially harmful to species.
Glyphosate use on GM crops may have significantly contributed to monarch butterflies’ 80% decline over the past two decades. This is because the pesticide is a uniquely potent killer of milkweed, the monarch caterpillar’s only food. Recent estimates indicate that monarch populations have further plunged by over half in the past year alone.
“We are in the midst of a biodiversity crisis,” said Ben Prater, Southeast program director at Defenders of Wildlife. “Industrial agriculture with pesticide-intensive genetically engineered crops has no place on national wildlife refuges dedicated to conservation of our most vulnerable species, including pollinators like hummingbirds, bumble bees and monarch butterflies.”
The southeastern United States is home to unparalleled biodiversity, though the region’s species are suffering from pollution, habitat destruction and pesticide-intensive industrial agriculture. Twenty-eight percent of the region’s fish species, 48% of crayfish and 70% of southeastern mussels are facing extinction.
The area covered by today’s proposal also includes the southern portions of the Atlantic and Mississippi flyways, which are vital migratory paths for endangered birds such as wood storks, piping plovers and sandhill cranes. Refuges also support a diversity of native pollinators.
The proposal and draft environmental assessment will be open for public comment for 30 days.


sustainablepulse--2020-03-20--Farmer and Eco Groups Sue EPA over Re-Approval of Glyphosate Herbicides

On Friday , Center for Food Safety ( CFS ) on behalf of a broad coalition of farmworkers , farmers , and conservationists , filed a federal lawsuit against the Environmental Protection Agency ( EPA ) over its January 2020 re-approval of the herbicide glyphosate , best known as the active ingredient in Monsanto ’ s Roundup herbicide .
The suing organizations are CFS , Beyond Pesticides , the Rural Coalition , Organización en California de Lideres Campesinas , and the Farmworker Association of Florida .
While EPA defends glyphosate , juries in several cases have found it to cause @ @ @ @ @ @ @ impacted by exposure .
Glyphosate formulations like Roundup are also well-established as having numerous damaging environmental impacts .
After a registration review process spanning over a decade , EPA allowed the continued marketing of the pesticide despite the agency ’ s failure to fully assess glyphosate ’ s hormone-disrupting potential or its effects on threatened and endangered species .
The review began in 2009 , has already taken 11 years , without a full assessment of the widespread harmful impacts on people and the environment in that time period .
“ EPA ’ @ @ @ @ @ @ @ approval sacrifices the health of farmworkers and endangered species at the altar of Monsanto profits , ” said George Kimbrell , legal director for CFS and counsel for the coalition .
“ The reckoning for Roundup is coming.
” While EPA has declared that glyphosate does not cause cancer , the world ’ s foremost cancer authorities with the World Health Organization declared glyphosate to be ‘ probably carcinogenic to humans ’ in 2015 .
Over 40,000 lawsuits have been filed against the Monsanto ( recently acquired by Bayer ) by cancer victims @ @ @ @ @ @ @ or their loved ones to develop non-Hodgkin lymphoma , including many farmworkers .
Plaintiffs have prevailed in the three cases decided thus far , with victims awarded roughly $ 80 million in each case .
“ Contrary to the Trump EPA ’ s claims , both regulatory and independent scientific studies demonstrate that glyphosate herbicides are carcinogenic and have adverse effects on internal organs , ” said Bill Freese , science policy analyst at CFS .
“ Far from consulting the ‘ best available science , ’ as EPA claims , the agency @ @ @ @ @ @ @ , cherry-picking the data that suits its purpose and dismissing the rest , ” added Freese .
“ EPA ’ s glyphosate decision shows the same hostility to science that we ’ ve come to expect from this administration , whether the issue is climate change or environmental health.
” EPA judged glyphosate far more critically in the 1980s , when the agency designated it a possible carcinogen and identified harmful effects on the liver , kidney , and reproductive systems .
Thanks to pressure from Monsanto/Bayer , EPA has since dismissed these @ @ @ @ @ @ @ – the daily amount of glyphosate regarded as safe over a lifetime – by 20 times .
“ The farmworkers and farmers we serve are the backbone of our food system .
Their families are the first – but are not the last – to bear the huge costs of EPA ’ s irresponsible decision , while corporate shareholders of Monsanto-Bayer benefit , ” said Lorette Picciano , executive director of the Rural Coalition .
EPA has also failed to collect basic data on how much glyphosate is taken into human bodies via @ @ @ @ @ @ @ .
These exposure routes are particularly significant for farmworkers and others who work around and/or use Roundup , the very people who are at greatest risk of cancer and other health harms .
“ How many more farmworkers have to suffer health impacts to themselves and their families before EPA “ sees ” them – the “ invisible people ” – and takes action ?
” said Jeannie Economos of the Farmworker Association of Florida .
“ EPA must protect human health before one more person suffers acute or chronic illness from exposure.
@ @ @ @ @ @ @ lines of the pesticide exposure crisis providing vital food for American families , ” said Suguet Lopez of the Organización en California de Lideres Campesinas .
“ They deserve a duty of care from the government which it has failed to provide.
” Glyphosate herbicides also threaten numerous species , including fish , amphibians , and aquatic as well as terrestrial plants .
EPA discounts these risks by low-balling exposure estimates and ignoring critical studies showing glyphosate ’ s potency , and by relying on ineffective and toothless changes to the language on @ @ @ @ @ @ @ ” risks .
Even worse , despite again registering the pesticide , EPA failed to complete any assessment of its impacts on thousands of potentially harmed endangered species , delaying it until a future decision .
“ EPA failed to consider if Roundup disrupts the balance of nature and ecosystem health , critical to the survival of a vast number of organisms on which life depends – from beneficial insects , such as parasitoid wasps , lacewings , ladybugs , and endangered bumblebees , monarch butterflies , to fish , small mammals , @ @ @ @ @ @ @ , executive director of Beyond Pesticides .
To give just one example , the massive use of glyphosate has nearly eradicated milkweed , the monarch butterfly ’ s host plant , from Midwest farmers ’ fields , a major factor in the catastrophic decline in monarchs over the past two decades .
Even though monarchs are under consideration for protection under the Endangered Species Act , EPA ’ s registration decision contains no effective measures to protect milkweed and monarchs from still more glyphosate damage .

On Friday, Center for Food Safety (CFS) on behalf of a broad coalition of farmworkers, farmers, and conservationists, filed a federal lawsuit against the Environmental Protection Agency (EPA) over its January 2020 re-approval of the herbicide glyphosate, best known as the active ingredient in Monsanto’s Roundup herbicide. The suing organizations are CFS, Beyond Pesticides, the Rural Coalition, Organización en California de Lideres Campesinas, and the Farmworker Association of Florida.
While EPA defends glyphosate, juries in several cases have found it to cause cancer, ruling in favor of those impacted by exposure. Glyphosate formulations like Roundup are also well-established as having numerous damaging environmental impacts. After a registration review process spanning over a decade, EPA allowed the continued marketing of the pesticide despite the agency’s failure to fully assess glyphosate’s hormone-disrupting potential or its effects on threatened and endangered species. The review began in 2009, has already taken 11 years, without a full assessment of the widespread harmful impacts on people and the environment in that time period.
“EPA’s half-completed, biased, and unlawful approval sacrifices the health of farmworkers and endangered species at the altar of Monsanto profits,” said George Kimbrell, legal director for CFS and counsel for the coalition. “The reckoning for Roundup is coming.”
While EPA has declared that glyphosate does not cause cancer, the world’s foremost cancer authorities with the World Health Organization declared glyphosate to be ‘probably carcinogenic to humans’ in 2015. Over 40,000 lawsuits have been filed against the Monsanto (recently acquired by Bayer) by cancer victims asserting that exposure to Roundup caused them or their loved ones to develop non-Hodgkin lymphoma, including many farmworkers. Plaintiffs have prevailed in the three cases decided thus far, with victims awarded roughly $80 million in each case.
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“Contrary to the Trump EPA’s claims, both regulatory and independent scientific studies demonstrate that glyphosate herbicides are carcinogenic and have adverse effects on internal organs,” said Bill Freese, science policy analyst at CFS. “Far from consulting the ‘best available science,’ as EPA claims, the agency has relied almost entirely on Monsanto studies, cherry-picking the data that suits its purpose and dismissing the rest,” added Freese. “EPA’s glyphosate decision shows the same hostility to science that we’ve come to expect from this administration, whether the issue is climate change or environmental health.”
EPA judged glyphosate far more critically in the 1980s, when the agency designated it a possible carcinogen and identified harmful effects on the liver, kidney, and reproductive systems. Thanks to pressure from Monsanto/Bayer, EPA has since dismissed these harms and illegitimately raised the safety threshold – the daily amount of glyphosate regarded as safe over a lifetime – by 20 times.
“The farmworkers and farmers we serve are the backbone of our food system. Their families are the first – but are not the last – to bear the huge costs of EPA’s irresponsible decision, while corporate shareholders of Monsanto-Bayer benefit,” said Lorette Picciano, executive director of the Rural Coalition.
EPA has also failed to collect basic data on how much glyphosate is taken into human bodies via skin contact or inhalation of spray droplets. These exposure routes are particularly significant for farmworkers and others who work around and/or use Roundup, the very people who are at greatest risk of cancer and other health harms.
“How many more farmworkers have to suffer health impacts to themselves and their families before EPA “sees” them – the “invisible people” – and takes action?” said Jeannie Economos of the Farmworker Association of Florida. “EPA must protect human health before one more person suffers acute or chronic illness from exposure.”
“Farmworkers are on the front lines of the pesticide exposure crisis providing vital food for American families,” said Suguet Lopez of the Organización en California de Lideres Campesinas. “They deserve a duty of care from the government which it has failed to provide.”
Glyphosate herbicides also threaten numerous species, including fish, amphibians, and aquatic as well as terrestrial plants. EPA discounts these risks by low-balling exposure estimates and ignoring critical studies showing glyphosate’s potency, and by relying on ineffective and toothless changes to the language on glyphosate herbicide product labels to “mitigate” risks. Even worse, despite again registering the pesticide, EPA failed to complete any assessment of its impacts on thousands of potentially harmed endangered species, delaying it until a future decision.
“EPA failed to consider if Roundup disrupts the balance of nature and ecosystem health, critical to the survival of a vast number of organisms on which life depends – from beneficial insects, such as parasitoid wasps, lacewings, ladybugs, and endangered bumblebees, monarch butterflies, to fish, small mammals, and amphibians,” said Jay Feldman, executive director of Beyond Pesticides.
To give just one example, the massive use of glyphosate has nearly eradicated milkweed, the monarch butterfly’s host plant, from Midwest farmers’ fields, a major factor in the catastrophic decline in monarchs over the past two decades. Even though monarchs are under consideration for protection under the Endangered Species Act, EPA’s registration decision contains no effective measures to protect milkweed and monarchs from still more glyphosate damage.


sustainablepulse--2020-03-13--Long-Term Analysis Shows GMO Cotton No Match for Insects in India

Genetically modified ( GM ) Bt cotton produces its own insecticide .
The seeds were introduced in India in 2002 and today account for 90 % of all cotton planting in the country .
Bt cotton is now the most widely planted GM crop on small farms in the developing world .
In India , Bt cotton is the most widely planted cotton crop by acreage , and it is hugely controversial .
Supporters long touted increased yields and reduced pesticides to justify its pickup .
But that argument does not hold up under the first long-term study of Bt @ @ @ @ @ @ @ is co-authored by a Washington University in St. Louis anthropologist in the journal Nature Plants .
Bt cotton is explicitly credited with tripling cotton production during 2002-2014 .
But the largest production gains came prior to widespread seed adoption and must be viewed in line with changes in fertilization practices and other pest population dynamics , according to Glenn Davis Stone , professor of sociocultural anthropology and environmental studies , both in Arts & Sciences .
“ Since Bt cotton first appeared in India there has been a stream of contradictory reports that @ @ @ @ @ @ @ triumph , ” Stone said , noting the characteristic deep divide in conversation about GM crops .
“ But the dynamic environment in Indian cotton fields turns out to be completely incompatible with these sorts of simplistic claims.
” Many economists and other observers based their assessments on much shorter time frames than Stone ’ s new study , which spans 20 years .
“ There are two particularly devastating caterpillar pests for cotton in India , and , from the beginning , Bt cotton did control one of them : the ( @ @ @ @ @ @ @ continued .
“ It initially controlled the other one , too—the pink bollworm—but that pest quickly developed resistance and now it is a worse problem than ever .
“ Bt plants were highly vulnerable to other insect pests that proliferated as more and more farmers adopted the crop .
Farmers are now spending much more on insecticides than before they had ever heard of Bt cotton .
And the situation is worsening.
” Stone , an internationally recognized expert on the human side of global agricultural trends , has published extensively on GM @ @ @ @ @ @ @ previous work has been funded by the Templeton Foundation and the National Science Foundation .
To prepare this new analysis , Stone partnered with entomologist K.R .
Kranthi , the former director of India ’ s Central Institute for Cotton Research .
Kranthi is now the head of a technical division at the Washington-based International Cotton Advisory Committee .
“ Yields in all crops jumped in 2003 , but the increase was especially large in cotton , ” Stone said .
“ But Bt cotton had virtually no effect on the rise in @ @ @ @ @ @ @ than 5 % of India ’ s cotton crop at the time.
” Instead , huge increases in insecticides and fertilizers may have been the most significant changes .
“ Now farmers in India are spending more on seeds , more on fertilizer and more on insecticides , ” Stone said .
“ Our conclusion is that Bt cotton ’ s primary impact on agriculture will be its role in making farming more capital-intensive—rather than any enduring agronomic benefits.
” Most scholarship on the closely-watched case of genetically modified Bacillus thuringiensis ( Bt @ @ @ @ @ @ @ short-term impacts and has also ignored other major changes in India ’ s cotton agriculture .
This Perspective combines several data sources over a 20-year span to provide long-term comparisons of Bt adoption with yields and other inputs at both countrywide and state-specific scales .
Bt cotton adoption is shown to be a poor indicator of yield trends but a strong indicator of initial reductions in pesticide use .
Yield increases correspond to changes in fertilizer and other inputs .
Bt cotton has continued to control one major cotton pest , but with @ @ @ @ @ @ @ populations of non-target pests , farmers now spend more on pesticides today than before the introduction of Bt .
Indications are that the situation will continue to deteriorate .

Genetically modified (GM) Bt cotton produces its own insecticide. The seeds were introduced in India in 2002 and today account for 90% of all cotton planting in the country. Bt cotton is now the most widely planted GM crop on small farms in the developing world.
In India, Bt cotton is the most widely planted cotton crop by acreage, and it is hugely controversial. Supporters long touted increased yields and reduced pesticides to justify its pickup. But that argument does not hold up under the first long-term study of Bt cotton impacts in India. The analysis is co-authored by a Washington University in St. Louis anthropologist in the journal Nature Plants.
Bt cotton is explicitly credited with tripling cotton production during 2002-2014. But the largest production gains came prior to widespread seed adoption and must be viewed in line with changes in fertilization practices and other pest population dynamics, according to Glenn Davis Stone, professor of sociocultural anthropology and environmental studies, both in Arts & Sciences.
“Since Bt cotton first appeared in India there has been a stream of contradictory reports that it has been an unmitigated disaster—or a triumph,” Stone said, noting the characteristic deep divide in conversation about GM crops. “But the dynamic environment in Indian cotton fields turns out to be completely incompatible with these sorts of simplistic claims.”
Many economists and other observers based their assessments on much shorter time frames than Stone’s new study, which spans 20 years.
“There are two particularly devastating caterpillar pests for cotton in India, and, from the beginning, Bt cotton did control one of them: the (misnamed) American bollworm,” Stone continued. “It initially controlled the other one, too—the pink bollworm—but that pest quickly developed resistance and now it is a worse problem than ever.
“Bt plants were highly vulnerable to other insect pests that proliferated as more and more farmers adopted the crop. Farmers are now spending much more on insecticides than before they had ever heard of Bt cotton. And the situation is worsening.”
Stone, an internationally recognized expert on the human side of global agricultural trends, has published extensively on GM crops in the developing world. His previous work has been funded by the Templeton Foundation and the National Science Foundation.
To prepare this new analysis, Stone partnered with entomologist K.R. Kranthi, the former director of India’s Central Institute for Cotton Research. Kranthi is now the head of a technical division at the Washington-based International Cotton Advisory Committee.
“Yields in all crops jumped in 2003, but the increase was especially large in cotton,” Stone said. “But Bt cotton had virtually no effect on the rise in cotton yields because it accounted for less than 5% of India’s cotton crop at the time.”
Instead, huge increases in insecticides and fertilizers may have been the most significant changes.
“Now farmers in India are spending more on seeds, more on fertilizer and more on insecticides,” Stone said. “Our conclusion is that Bt cotton’s primary impact on agriculture will be its role in making farming more capital-intensive—rather than any enduring agronomic benefits.”
—
Long-term impacts of Bt cotton in India
K.R. Kranthi & Glenn Davis Stone
Nature Plants volume 6, pages 188–196(2020)
www.nature.com/articles/s41477-020-0615-5
Abstract
Most scholarship on the closely-watched case of genetically modified Bacillus thuringiensis (Bt) cotton in India has focused on short-term impacts and has also ignored other major changes in India’s cotton agriculture. This Perspective combines several data sources over a 20-year span to provide long-term comparisons of Bt adoption with yields and other inputs at both countrywide and state-specific scales. Bt cotton adoption is shown to be a poor indicator of yield trends but a strong indicator of initial reductions in pesticide use. Yield increases correspond to changes in fertilizer and other inputs. Bt cotton has continued to control one major cotton pest, but with Bt resistance in another pest and surging populations of non-target pests, farmers now spend more on pesticides today than before the introduction of Bt. Indications are that the situation will continue to deteriorate.


sustainablepulse--2020-03-06--California Shareholder Sues Bayer over Monsanto Acquisition ‘Disaster’

A California shareholder of Bayer AG on Friday filed a lawsuit against the companies ’ top executives claiming they breached their duty of “ prudence ” and “ loyalty ” to the company and investors by buying Monsanto Co. in 2018 , an acquisition the suit claims has “ inflicted billions of dollars of damages ” on the company , USRTK reported Friday .
Plaintiff Rebecca R. Haussmann , trustee of the Konstantin S. Haussmann Trust , is the sole named plaintiff in the suit , which was filed in New York County Supreme Court .
The named defendants include @ @ @ @ @ @ @ the $ 63 billion Monsanto purchase , and Bayer Chairman Werner Wenning , who announced last month he was stepping down from the company earlier than planned .
The suit claims that Wenning ’ s decision came after Bayer improperly obtained a copy of the then-draft shareholder lawsuit “ through corporate espionage.
” The lawsuit also claims that Bayer ’ s recent announcement of an audit of its acquisition actions is “ bogus ” and “ part of the ongoing cover-up and intended to create a legal barrier to this case to protect @ @ @ @ @ @ @ is a shareholder derivative complaint , meaning it is brought on behalf of the company against company insiders .
It seeks compensatory damages for shareholders and disgorgement of “ all compensation paid to the Bayer Managers and Supervisors who participated in bringing about this Acquisition… ” The suit also seeks return of funds paid to banks and law firms involved in the acquisition .
The defendants include not only Baumann and Wenning , but also some present and former Bayer directors and top managers , as well as BOFA Securities , Inc. , @ @ @ @ @ @ @ AG and the law firms of Sullivan & Cromwell LLP and Linklaters LLP .
A Bayer spokesman did not respond to a request for comment .
The lawsuit comes a little more than a month before Bayer ’ s April 28 annual shareholders ’ meeting in Bonn , Germany .
At last year ’ s annual meeting , 55 percent of shareholders registered their unhappiness with Baumann and other managers over the Monsanto deal and the subsequent loss of roughly $ 40 billion in market value .
Bayer ’ s purchase of Monsanto @ @ @ @ @ @ @ of lawsuits alleging Monsanto ’ s glyphosate-based herbicides cause non-Hodgkin lymphoma and that the company deceived customers about the risks .
Bayer proceeded with the acquisition even after the International Agency for Research on Cancer in 2015 classified glyphosate as a probable human carcinogen with a positive association to non-Hodgkin lymphoma , and despite knowledge of the spreading legal claims .
Bayer then completed the Monsanto purchase just two months before the first Roundup cancer trial ended with a $ 289 million verdict against the company .
Since that time two more trials @ @ @ @ @ @ @ company with verdicts totaling more than $ 2 billion , though the trial judges in each case have lowered the verdicts .
All are now on appeal .
Bayer has said there are more than 45,000 plaintiffs currently making similar claims .
The company has been working to settle the lawsuits for a figure widely reported to be around $ 10 billion but has thus far not been successful in putting an end to the litigation .
The lawsuit claims that during 2017 and 2018 , as the filing of new Roundup cancer @ @ @ @ @ @ @ Bayer management to conduct due diligence into Monsanto and the litigation risks was “ severely restricted.
” As a result , “ Bayer could not conduct the kind of intrusive and thorough due diligence into Monsanto ’ s business and legal affairs called for under the circumstances.
” The suit claims that Monsanto did not disclose a material risk from Roundup and failed to quantify any potential financial impact .
Monsanto ’ s executives “ had every incentive to minimize the Roundup risk in order to get Bayer to close the deal , @ @ @ @ @ @ @ lawsuit claims that “ these types of mass-tort cases… can destroy a company.
” The lawsuit points to the fact that Monsanto ’ s glyphosate herbicides are now being restricted and/or banned in many parts of the world , including in Germany .
“ The Monsanto Acquisition is a disaster .
Roundup is doomed as a commercial product , ” the lawsuit states .

A California shareholder of Bayer AG on Friday filed a lawsuit against the companies’ top executives claiming they breached their duty of “prudence” and “loyalty” to the company and investors by buying Monsanto Co. in 2018, an acquisition the suit claims has “inflicted billions of dollars of damages” on the company, USRTK reported Friday.
Source: By Carey Gillam usrtk.org
Plaintiff Rebecca R. Haussmann, trustee of the Konstantin S. Haussmann Trust, is the sole named plaintiff in the suit, which was filed in New York County Supreme Court. The named defendants include Bayer CEO Werner Baumann, who orchestrated the $63 billion Monsanto purchase, and Bayer Chairman Werner Wenning, who announced last month he was stepping down from the company earlier than planned. The suit claims that Wenning’s decision came after Bayer improperly obtained a copy of the then-draft shareholder lawsuit “through corporate espionage.”
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The lawsuit also claims that Bayer’s recent announcement of an audit of its acquisition actions is “bogus” and “part of the ongoing cover-up and intended to create a legal barrier to this case to protect Defendants from their accountability…”
The action is a shareholder derivative complaint, meaning it is brought on behalf of the company against company insiders. It seeks compensatory damages for shareholders and disgorgement of “all compensation paid to the Bayer Managers and Supervisors who participated in bringing about this Acquisition…” The suit also seeks return of funds paid to banks and law firms involved in the acquisition.
The defendants include not only Baumann and Wenning, but also some present and former Bayer directors and top managers, as well as BOFA Securities, Inc., Bank of America, Credit Suisse Group AG and the law firms of Sullivan & Cromwell LLP and Linklaters LLP.
A Bayer spokesman did not respond to a request for comment.
The lawsuit comes a little more than a month before Bayer’s April 28 annual shareholders’ meeting in Bonn, Germany. At last year’s annual meeting, 55 percent of shareholders registered their unhappiness with Baumann and other managers over the Monsanto deal and the subsequent loss of roughly $40 billion in market value.
Bayer’s purchase of Monsanto has been clouded by tens of thousands of lawsuits alleging Monsanto’s glyphosate-based herbicides cause non-Hodgkin lymphoma and that the company deceived customers about the risks. Bayer proceeded with the acquisition even after the International Agency for Research on Cancer in 2015 classified glyphosate as a probable human carcinogen with a positive association to non-Hodgkin lymphoma, and despite knowledge of the spreading legal claims.
Bayer then completed the Monsanto purchase just two months before the first Roundup cancer trial ended with a $289 million verdict against the company. Since that time two more trials have ended in similar findings against the company with verdicts totaling more than $2 billion, though the trial judges in each case have lowered the verdicts. All are now on appeal.
Bayer has said there are more than 45,000 plaintiffs currently making similar claims. The company has been working to settle the lawsuits for a figure widely reported to be around $10 billion but has thus far not been successful in putting an end to the litigation.
The lawsuit claims that during 2017 and 2018, as the filing of new Roundup cancer lawsuits was escalating, the ability of Bayer management to conduct due diligence into Monsanto and the litigation risks was “severely restricted.” As a result, “Bayer could not conduct the kind of intrusive and thorough due diligence into Monsanto’s business and legal affairs called for under the circumstances.”
The suit claims that Monsanto did not disclose a material risk from Roundup and failed to quantify any potential financial impact. Monsanto’s executives “had every incentive to minimize the Roundup risk in order to get Bayer to close the deal,” the lawsuit states.
The shareholder lawsuit claims that “these types of mass-tort cases… can destroy a company.”
The lawsuit points to the fact that Monsanto’s glyphosate herbicides are now being restricted and/or banned in many parts of the world, including in Germany.
“The Monsanto Acquisition is a disaster. Roundup is doomed as a commercial product,” the lawsuit states.


sustainablepulse--2020-03-05--Next Generation Effects from GMO Crops Are a Serious Risk for Ecosystems – New Study

A new peer reviewed paper published in the international Environmental Sciences Europe journal has focused for the first time on the risk assessment of so-called next generation effects from GM Crops .
The review addresses unintended effects that were observed in spontaneous hybrid offspring but absent in the original plants .
Some of the risks included a higher invasive potential of the GMO plants and/or disruption of associated ecosystems .
“ If gene flow to natural populations can not be prevented , this can put biodiversity and the livelihoods of future generations at risk .
These risks concern the cultivation @ @ @ @ @ @ @ in the US , Canada and Australia ; Camelina in the US ; rice in Asian countries and cowpeas in Africa , ” stated Christoph Then of Testbiotech , who is one of the authors .
“ There is also a risk caused by import of GE plants for the EU , if for example spillage occurs during transport from viable kernels of GE oilseed rape .
Plants growing from these kernels can survive in the environment and spread uncontrollably , ” Then continued .
In many cases the observed effects in the @ @ @ @ @ @ @ first generations of the genetically engineered plants .
They include a higher amount of seeds or pollen , enhanced stress resistance and changes in other biological characteristics of the GE plants .
The reasons are diverse , including environmental stress factors as well as genomic interactions in the hybrid offspring .
In view of these findings , the authors suggest the introduction of new ‘ cut-off criteria ’ in risk assessment that explicitly address the spatio-temporal control of GE organisms .
If the criteria are not fulfilled , the authors suggest that their @ @ @ @ @ @ @ “ This additional step in risk assessment is becoming increasingly important as research is ongoing to develop for example gene drives in GE insects that can persist and propagate in the environment .
These projects could pose a major threat to nature conservation in the future , ” says Then .
The new paper was published in the follow up to the international RAGES research project ( Risk Assessment of Genetically engineered organisms in the EU and Switzerland ) which was carried out between 2016 and 2019 .
RAGES was carried out independently @ @ @ @ @ @ @ Mercator Switzerland .
The project provides strong evidence that , contrary to what is claimed by the Biotech industry , the risks of genetically engineered plants are not sufficiently investigated .
Against the backdrop of this new research , Testbiotech is particularly concerned about a possible EU-US trade deal which aims to speed up the approval process for GE organisms in the EU and threatens the precautionary principle as a foundation of EU policy making .

A new peer reviewed paper published in the international Environmental Sciences Europe journal has focused for the first time on the risk assessment of so-called next generation effects from GM Crops. The review addresses unintended effects that were observed in spontaneous hybrid offspring but absent in the original plants. Some of the risks included a higher invasive potential of the GMO plants and/or disruption of associated ecosystems.
“If gene flow to natural populations cannot be prevented, this can put biodiversity and the livelihoods of future generations at risk. These risks concern the cultivation of GE plants such as oilseed rape in the US, Canada and Australia; Camelina in the US; rice in Asian countries and cowpeas in Africa,” stated Christoph Then of Testbiotech, who is one of the authors.
“There is also a risk caused by import of GE plants for the EU, if for example spillage occurs during transport from viable kernels of GE oilseed rape. Plants growing from these kernels can survive in the environment and spread uncontrollably,” Then continued.
In many cases the observed effects in the hybrid generations were not predictable from the first generations of the genetically engineered plants. They include a higher amount of seeds or pollen, enhanced stress resistance and changes in other biological characteristics of the GE plants. The reasons are diverse, including environmental stress factors as well as genomic interactions in the hybrid offspring.
In view of these findings, the authors suggest the introduction of new ‘cut-off criteria’ in risk assessment that explicitly address the spatio-temporal control of GE organisms. If the criteria are not fulfilled, the authors suggest that their environmental release should not be permitted.
“This additional step in risk assessment is becoming increasingly important as research is ongoing to develop for example gene drives in GE insects that can persist and propagate in the environment. These projects could pose a major threat to nature conservation in the future,” says Then.
The new paper was published in the follow up to the international RAGES research project (Risk Assessment of Genetically engineered organisms in the EU and Switzerland) which was carried out between 2016 and 2019.
RAGES was carried out independently of the biotech industry and funded by Mercator Switzerland. The project provides strong evidence that, contrary to what is claimed by the Biotech industry, the risks of genetically engineered plants are not sufficiently investigated. Against the backdrop of this new research, Testbiotech is particularly concerned about a possible EU-US trade deal which aims to speed up the approval process for GE organisms in the EU and threatens the precautionary principle as a foundation of EU policy making.


sustainablepulse--2020-03-02--Glyphosate-Based Herbicides Trigger Loss of Biodiversity – New Study

One of the world ’ s most widely used glyphosate-based herbicides , Roundup , can trigger loss of biodiversity , making ecosystems more vulnerable to pollution and climate change , say researchers from McGill University in Canada .
The widespread use of Roundup on farms has sparked coancerns over potential health and environmental effects globally .
Since the 1990s use of the herbicide boomed , as the farming industry adopted “ Roundup Ready ” genetically modified crop seeds that are resistant to the herbicide .
“ Farmers spray their corn and soy fields to eliminate weeds and boost production , @ @ @ @ @ @ @ into the surrounding environment .
In Quebec , for example , traces of glyphosate have been found in Montérégie rivers , ” says Andrew Gonzalez , a McGill biology professor and Liber Ero Chair in Conservation Biology .
To test how freshwater ecosystems respond to environmental contamination by glyphosate , researchers used experimental ponds to expose phytoplankton communities ( algae ) to the herbicide .
“ These tiny species at the bottom of the food chain play an important role in the balance of a lake ’ s ecosystem and are a key @ @ @ @ @ @ @ Our experiments allow us to observe , in real time , how algae can acquire resistance to glyphosate in freshwater ecosystems , ” says post-doctoral researcher Vincent Fugère .
Ecosystems adapt but at the cost of biodiversity The researchers found that freshwater ecosystems that experience moderate contamination from the herbicide became more resistant when later exposed to a very high level of it – working as a form of “ evolutionary vaccination.
” According to the researchers , the results are consistent with what scientists call “ evolutionary rescue , ” which until @ @ @ @ @ @ @ laboratory .
Previous experiments by the Gonzalez group had shown that evolutionary rescue can prevent the extinction of an entire population when exposed to severe environmental contamination by a pesticide thanks to the rapid evolution .
However , the researchers note that the resistance to the herbicide came at a cost of plankton diversity .
“ We observed significant loss of biodiversity in communities contaminated with glyphosate .
This could have a profound impact on the proper functioning of ecosystems and lower the chance that they can adapt to new pollutants or stressors @ @ @ @ @ @ @ ecosystems are grappling with the increasing threat of pollution and climate change , ” says Gonzalez .
The researchers point out that it is still unclear how rapid evolution contributes to herbicide resistance in these aquatic ecosystems .
Scientist already know that some plants have acquired genetic resistance to glyphosate in crop fields that are sprayed heavily with the herbicide .
Finding out more will require genetic analyses that are currently under way by the team .
“ Community rescue in experimental phytoplankton communities facing severe herbicide pollution ” by Fugère V. , @ @ @ @ @ @ @ C.C.Y.
, Barrett R.D.H.
, Beisner B.E.
, Bell G. , Fussmann G.F. , Shapiro B.J.
, Yargeau V. , and Gonzalez A. is published in Nature Ecology & Evolution .
DOI : doi.org/10.1038/s41559-020-1134-5 .
The authors acknowledge support and operating funds from the Natural Sciences and Engineering Research Council of Canada ( NSERC ) , the Fonds de Recherche du Québec – Nature et Technologies ( FRQNT ) , the Canada Research Chair Program ( R.D.H.B.
, A.G. , B.J.S . )
, the Quebec Centre for Biodiversity Science ( QCBS ) @ @ @ @ @ @ @ en Limnologie et environnements aquatiques ( GRIL ) .
The Canadian Foundation for Innovation and the Liber Ero Chair in Biodiversity Conservation provided funding to A.G. to construct the LEAP mesocosm facility .

One of the world’s most widely used glyphosate-based herbicides, Roundup, can trigger loss of biodiversity, making ecosystems more vulnerable to pollution and climate change, say researchers from McGill University in Canada.
The widespread use of Roundup on farms has sparked coancerns over potential health and environmental effects globally. Since the 1990s use of the herbicide boomed, as the farming industry adopted “Roundup Ready” genetically modified crop seeds that are resistant to the herbicide. “Farmers spray their corn and soy fields to eliminate weeds and boost production, but this has led to glyphosate leaching into the surrounding environment. In Quebec, for example, traces of glyphosate have been found in Montérégie rivers,” says Andrew Gonzalez, a McGill biology professor and Liber Ero Chair in Conservation Biology.
To test how freshwater ecosystems respond to environmental contamination by glyphosate, researchers used experimental ponds to expose phytoplankton communities (algae) to the herbicide. “These tiny species at the bottom of the food chain play an important role in the balance of a lake’s ecosystem and are a key source of food for microscopic animals. Our experiments allow us to observe, in real time, how algae can acquire resistance to glyphosate in freshwater ecosystems,” says post-doctoral researcher Vincent Fugère.
Ecosystems adapt but at the cost of biodiversity
The researchers found that freshwater ecosystems that experience moderate contamination from the herbicide became more resistant when later exposed to a very high level of it – working as a form of “evolutionary vaccination.” According to the researchers, the results are consistent with what scientists call “evolutionary rescue,” which until recently had only been tested in the laboratory. Previous experiments by the Gonzalez group had shown that evolutionary rescue can prevent the extinction of an entire population when exposed to severe environmental contamination by a pesticide thanks to the rapid evolution.
However, the researchers note that the resistance to the herbicide came at a cost of plankton diversity. “We observed significant loss of biodiversity in communities contaminated with glyphosate. This could have a profound impact on the proper functioning of ecosystems and lower the chance that they can adapt to new pollutants or stressors. This is particularly concerning as many ecosystems are grappling with the increasing threat of pollution and climate change,” says Gonzalez.
The researchers point out that it is still unclear how rapid evolution contributes to herbicide resistance in these aquatic ecosystems. Scientist already know that some plants have acquired genetic resistance to glyphosate in crop fields that are sprayed heavily with the herbicide. Finding out more will require genetic analyses that are currently under way by the team.
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About the study
“Community rescue in experimental phytoplankton communities facing severe herbicide pollution” by Fugère V., Hébert M.-P, Costa N.B., Xu C.C.Y., Barrett R.D.H., Beisner B.E., Bell G., Fussmann G.F., Shapiro B.J., Yargeau V., and Gonzalez A. is published in Nature Ecology & Evolution. DOI: doi.org/10.1038/s41559-020-1134-5.
The authors acknowledge support and operating funds from the Natural Sciences and Engineering Research Council of Canada (NSERC), the Fonds de Recherche du Québec – Nature et Technologies (FRQNT), the Canada Research Chair Program (R.D.H.B., A.G., B.J.S.), the Quebec Centre for Biodiversity Science (QCBS), and the Groupe de Recherche Interuniversitaire en Limnologie et environnements aquatiques (GRIL). The Canadian Foundation for Innovation and the Liber Ero Chair in Biodiversity Conservation provided funding to A.G. to construct the LEAP mesocosm facility.


sustainablepulse--2020-02-26--Bayer Chairman Quits as Roundup Settlement Talks Progress

Chairman Werner Wenning , one of the architects of a $ 63 billion takeover deal that has left the German crop protection company fighting costly lawsuits , will step down in April , it said on Wednesday , Reuters reported .
Bayer shares have plunged about a quarter in value since August 2018 , when the company lost the first U.S. lawsuit claiming weedkiller Roundup – acquired via the takeover of Monsanto – causes cancer .
“ We have made and continue to make progress in handling the legal issues in the U.S. That ’ s why now is a @ @ @ @ @ @ @ successor , ” the 73-year-old Wenning said in a statement .
Norbert Winkeljohann , who was head of auditing firm PricewaterhouseCoopers Europe SE until June 2018 and has been a member of Bayer ’ s supervisory board since 2018 , will succeed Wenning after the annual shareholders ’ meeting on April 28 , the company added .
Wenning , whose term as chairman of Bayer ’ s non-executive supervisory board would have expired in 2022 , said he had originally intended to step down last year after reaching the board ’ s recommended @ @ @ @ @ @ @ asked to stay on .
Bayer last year started negotiations with plaintiffs ’ lawyers to settle more U.S. lawsuits involving Roundup .
In October 2019 , the number of plaintiffs more than doubled to 42,700 within just three months , and analysts have predicted it may cost they company up to $ 12 billion to lay the claims to rest .

Chairman Werner Wenning, one of the architects of a $63 billion takeover deal that has left the German crop protection company fighting costly lawsuits, will step down in April, it said on Wednesday, Reuters reported.
Bayer shares have plunged about a quarter in value since August 2018, when the company lost the first U.S. lawsuit claiming weedkiller Roundup – acquired via the takeover of Monsanto – causes cancer.
“We have made and continue to make progress in handling the legal issues in the U.S. That’s why now is a good time to hand over to my successor,” the 73-year-old Wenning said in a statement.
Glyphosate Box Glyphosate Residue Free Certification for Food Brands – Click Here Test Your Food and Water at Home for Glyphosate – Click Here Test Your Hair for Glyphosate and other Pesticides – Click Here to Find Out Your Long-Term Exposure
Norbert Winkeljohann, who was head of auditing firm PricewaterhouseCoopers Europe SE until June 2018 and has been a member of Bayer’s supervisory board since 2018, will succeed Wenning after the annual shareholders’ meeting on April 28, the company added.
Wenning, whose term as chairman of Bayer’s non-executive supervisory board would have expired in 2022, said he had originally intended to step down last year after reaching the board’s recommended age limit of 72, but was asked to stay on.
Bayer last year started negotiations with plaintiffs’ lawyers to settle more U.S. lawsuits involving Roundup.
In October 2019, the number of plaintiffs more than doubled to 42,700 within just three months, and analysts have predicted it may cost they company up to $12 billion to lay the claims to rest.


sustainablepulse--2020-02-20--Biotech Industry’s New Hope ‘Gene Editing’ Dealt a Serious Double Blow

The U.S. Food and Drug Administration ( FDA ) and a French court have dealt separate blows to the Biotech industry and their attempt to slide new gene editing techniques through the back door and in to the foods we eat .
The Conseil d ’ Etat , France ’ s top administrative court , recently ruled that organisms obtained via new plant breeding techniques ( NPBTs ) , namely gene editing and in-vitro mutagenesis , should be subject to GMO regulation , EURACTIV reported .
The court ordered the government to update regulation to include such crops within six @ @ @ @ @ @ @ plant varieties which have been obtained by these techniques and subjecting them to the assessments applicable to GMOs .
The court also said that authorities should carry out an assessment to evaluate potential risks related to herbicide-resistant crops and define growing conditions intended to limit the use of herbicides .
In a statement on the Conseil d ’ Etat ’ s website , they say that , in accordance with the precautionary principle , the prime minister “ can not refuse to take preventive measures for the use of plant varieties that have @ @ @ @ @ @ @ French government will now study how to implement the court ’ s ruling in line with EU legislation , the French Agriculture and Environment Ministries said in a joint statement .
Meanwhile in the U.S. , the FDA released an expert statement , in which they outline the need to be careful regarding the use of gene-editing in animals .
Steven M. Solomon , Director of the FDA ’ s Center for Veterinary Medicine , made this strongly worded statement outlining the possible “ unintended consequences ” of gene-editing ; “ Today , @ @ @ @ @ @ @ analysis ‘ Template plasmid integration in germline genome-edited cattle , ’ which describes how a bioinformatics method developed by FDA scientists was able to detect previously unreported , unintended alterations in genome-edited bulls .
The analysis emphasizes the FDA ’ s expertise and critical role in risk-based evaluation of intentional genomic alterations .
“ Our analysis demonstrated that genome editing in animals can have unintended consequences , and in this case , it caused foreign DNA to be integrated into the animals ’ genomes .
While the existence of an unintended alteration does @ @ @ @ @ @ @ is unsafe to animals or consumers , it does show that both scientists and regulators need to be alert to the potential for such unintended alterations to take place .
“ A companion piece , ‘ Genome editing in animals : Why FDA regulation matters , ’ also published today explains the value of the agency ’ s oversight of intentional genomic alterations in animals to protect animal and human health , even when the intended modification seeks to replicate a naturally occurring mutation .
The commentary further describes the FDA ’ s @ @ @ @ @ @ @ while balancing the agency ’ s role to protect public health through a risk-based approach .
”

The U.S. Food and Drug Administration (FDA) and a French court have dealt separate blows to the Biotech industry and their attempt to slide new gene editing techniques through the back door and in to the foods we eat.
The Conseil d’Etat, France’s top administrative court, recently ruled that organisms obtained via new plant breeding techniques (NPBTs), namely gene editing and in-vitro mutagenesis, should be subject to GMO regulation, EURACTIV reported.
The court ordered the government to update regulation to include such crops within six months, which includes identifying the agricultural plant varieties which have been obtained by these techniques and subjecting them to the assessments applicable to GMOs.
The court also said that authorities should carry out an assessment to evaluate potential risks related to herbicide-resistant crops and define growing conditions intended to limit the use of herbicides.
In a statement on the Conseil d’Etat’s website, they say that, in accordance with the precautionary principle, the prime minister “cannot refuse to take preventive measures for the use of plant varieties that have been made tolerant to herbicides.”
The French government will now study how to implement the court’s ruling in line with EU legislation, the French Agriculture and Environment Ministries said in a joint statement.
Meanwhile in the U.S., the FDA released an expert statement, in which they outline the need to be careful regarding the use of gene-editing in animals.
Steven M. Solomon, Director of the FDA’s Center for Veterinary Medicine, made this strongly worded statement outlining the possible “unintended consequences” of gene-editing;
“Today, the journal Nature Biotechnology published the FDA-authored analysis ‘Template plasmid integration in germline genome-edited cattle,’ which describes how a bioinformatics method developed by FDA scientists was able to detect previously unreported, unintended alterations in genome-edited bulls. The analysis emphasizes the FDA’s expertise and critical role in risk-based evaluation of intentional genomic alterations.
“Our analysis demonstrated that genome editing in animals can have unintended consequences, and in this case, it caused foreign DNA to be integrated into the animals’ genomes. While the existence of an unintended alteration does not necessarily mean that the genome edit is unsafe to animals or consumers, it does show that both scientists and regulators need to be alert to the potential for such unintended alterations to take place.
“A companion piece, ‘Genome editing in animals: Why FDA regulation matters,’ also published today explains the value of the agency’s oversight of intentional genomic alterations in animals to protect animal and human health, even when the intended modification seeks to replicate a naturally occurring mutation. The commentary further describes the FDA’s intent to support innovative scientific approaches, while balancing the agency’s role to protect public health through a risk-based approach.”