10 October 2018
Bayer AG is trying to undo a $289 million verdict over Monsanto’s Roundup weedkiller that it blames on misinformation fed to a jury, while also seeking to avoid having its next test cases go to trial on an accelerated schedule.
Honey bees exposed to levels of glyphosate commonly found in the environment had decreased amounts of microbiota in their gut—which leaves them prone to early death, according to a study released today.
Honey bees' health is directly tied to the helpful organisms in their gut. These "microbiota" help the bees' metabolism, weight gain and immune system. The new findings go against previous claims that glyphosate — the active ingredient in Bayer's Monsanto Roundup weedkiller — does not harm wildlife, and offers another possible clue as to why honey bee colonies are dying at an increased rate.
"Gut microbiota is involved in nutrition for bees, helping break down components of cell walls in pollen grains and protecting against different pathogens," Nancy Moran, senior author of the study and evolutionary biologist at the University of Texas, told EHN.
She and colleagues published the study today in the Proceedings of the National Academy of Sciences (PNAS).
The researchers collected hundreds of honey bees from a single hive and exposed some of them to levels of glyphosate commonly found in the environment, and then returned them to the hive. After three days, the total gut bacteria already decreased in the treated bees. When treated bees were exposed to a harmful pathogen, they were more likely to die if they had the reduced microbiota in their gut.
They repeated the experiment with other hives and bees and saw the same impacts.
The colored markings were used to track individual bees during the study. (Credit: Vivian Abagiu, The University of Texas at Austin)
It was previously thought that glyphosate was harmless to bees since it targets an enzyme usually found only in plants and microorganisms—however, bee gut bacteria contain that same enzyme, Moran said. "It's true the bee itself has no molecular targets from glyphosate but its gut bacteria do have targets," she said. "It's similar to humans taking antibiotics where there can be trouble if you upset the normal microbiota."
She said honey bees are relatives to bumble bees and share similar gut microbiota. So, glyphosate is bad for bumble bees as well.
The experiment is concerning as the value of insect pollination to U.S. farming is about $16 billion a year, and honey bee colonies — and pollinators in general — are in trouble.
A third of our food relies on pollinators, and while honey bees are one of many species that pollinate, the U.S. Department of Agriculture estimates about a 30 percent overwinter colony loss annually for honey bees over the past decade.
Over the past year, the Bee Informed Partnership, a nonprofit working with beekeepers, research labs and universities to better understand honey bee declines in the U.S., estimated beekeepers lost 40 percent of their managed colonies.
The culprits for the colony collapses are unclear: Researchers have previously pointed to diseases, parasites, habitat loss, pesticides, and a combination of all of these stressors.
Glyphosate is the world's most heavily used herbicide. More than 3.5 billion pounds have been applied in the U.S. alone over the past four decades—two-thirds of which were applied over the past decade, according to a 2016 study.
Moran said the new study isn't enough evidence to say if glyphosate is having population level impacts on the honey bees, "but there really is a lot of [glyphosate] in both agricultural and urban areas," she said.
"At the moment, there are no guidelines that you should avoid spraying glyphosate on or near bees, since it's considered completely innocuous," she added.
The study is the latest blow to Monsanto's popular weedkiller. The company was ordered to pay a $289 million award last month to a former groundskeeper with terminal cancer who said Roundup exposure gave him the illness. The company is now fighting that ruling.
However, the agribusiness is facing an estimated 8,000 similar lawsuits.
Consumers and journalists around the world were stunned earlier this month when Monsanto, after being forced in a court of law for the first time to defend the safety of its popular weed killer Roundup, was found liable for the terminal cancer of California groundskeeper Dewayne Johnson.
The unanimous 12-member jury found that Mr. Johnson's exposure to Monsanto's weedkiller was a "substantial" contributing factor to his disease and that there was "clear and convincing" evidence that Monsanto acted with "malice or oppression" because the risks were evident and Monsanto failed to warn of those known risks.
Aside from dueling expert testimony on both sides, the jury was provided with internal company emails and work plans indicating that Monsanto had been corrupting the scientific record by ghostwriting literature asserting safety.
As the jury's decision sets in, and thousands of additional plaintiffs who have filed similar suits wait for their day in court, it is worth taking time to understand exactly what "ghostwriting" by Monsanto means, how it has influenced, and still is influencing, material found in peer-reviewed scientific journals.
We offer this example:
When the scientific journal Critical Reviews in Toxicology (CRT) published a series of papers reviewing the carcinogenic potential of weed-killing agent glyphosate, the main ingredient in Monsanto's Roundup, in September 2016, the findings were so significant that they were widely reported by media outlets around the world.
The papers, published in a special issue of CRT entitled "An Independent Review of the Carcinogenic Potential of Glyphosate," directly contradicted the findings of the World Health Organization's International Agency for Research on Cancer (IARC), which in 2015 found glyphosate to be a probable human carcinogen. The authors of the 2016 review found that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people.
The findings were critical to Monsanto – the company was facing doubts by European regulators about allowing glyphosate to remain on the market. As well, Monsanto was facing a growing mass of lawsuits claiming its weed killer caused people to develop non-Hodgkin lymphoma.
Sixteen scientists from "four independent panels" signed their names to the published work, declaring to readers that their conclusions were free of Monsanto's intervention. Underscoring the supposed independence of the work, the declaration of interest section stated: "Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel's manuscripts prior to submission to the journal."
It has since become evident that these papers were anything but independent. Internal Monsanto documents forced into the public spotlight through litigation show that the papers were conceptualized from the outset as a deceptive strategy for Monsanto. One of Monsanto's top scientists not only reviewed the manuscripts but had a hand in drafting and editing them. The finished papers were aimed directly at discrediting IARC's classification.
In one internal email, Monsanto's chief of regulatory science, William Heydens, told the organizer of the panel: "I have gone through the entire document and indicated what I think should stay, what can go, and in a couple spots I did a little editing."
The internal documents show that Heydens even argued over statements that he wanted included but that author John Acquavella deemed "inflammatory" and "not necessary" criticisms of IARC. Draft documents show Heydens' edits contradicted Acquavella's edits even though Heydens was not supposed to have even reviewed the papers. Heydens went so far as to state: "I would ignore John's comment" and "I don't see a reason for deleting the text that John did below."
Other edits show Heydens attempting to control the tone of the manuscript, stating: "The deleted statement below has nothing to do with IARC criticism and should be put back in, John over-stepped the bounds here" and "I can live with deleting the text below, assuming that exposure text above … is added back in." He also argued for putting a deleted phrase back in because it gave "clarity about IARC's approach." "This is not inflammatory, it is descriptive," he wrote.
The importance of the papers to Monsanto as a tool to counter IARC's classification of glyphosate as a probable carcinogen was laid out in a confidential document dated May 11, 2015, naming several of the scientists who could be used as authors to give the papers credibility. The internal documents speak of "ghost-writing" strategies aimed at using non-company scientists as authors to lend credibility to the findings.
When placed under oath in a deposition, Heydens acknowledged that the manuscripts were sent to him and he read "parts of some of them," prior to their submission to the journal. He said he did not "recall" whether or not he made the 28 edits that plaintiffs' attorneys counted in the internal records.
All of this was among the evidence presented to jurors in San Francisco Superior Court as they considered Johnson's claims. But the evidence of ghostwriting and misconduct have far broader implications than one lawsuit.
How many ghostwritten papers declaring pesticide safety are littering the scientific literature? And given the evidence of misconduct in this instance, why are these papers still in publication? Why has there been no retraction, no clarification, no correction to the obviously deceptive disclosure?
Last August, after the documents gained media attention CRT editor Roger McClellan said the "serious accusations" deserved "careful investigation," and he and CRT publisher Taylor & Francis would take "appropriate action."
Shortly thereafter the Center for Biological Diversity and three other national environmental-health organizations sent a letter to CRT and Taylor & Francis detailing the ethical misconduct and formally asking for a retraction. It's been more than a year since this investigation was begun and, despite multiple follow-up requests by the organizations, no action has been taken.
With Taylor & Francis's own policy being to issue a retraction for misconduct "when there has been an infringement of publishing ethics," the case for retraction couldn't be more clear.
Monsanto's fingerprints are all over this "independent" review, as laid out in Monsanto's own internal documents.
Taylor & Francis must determine the standards to which it is willing to hold scientists who publish in its journals – if not for the reputation of the journals themselves, then for the sake of scientific integrity itself and the public's right to the truth.
Nathan Donley, Ph.D, is a former cancer researcher who now works as senior scientist in the Center for Biological Diversity's environmental health program.
Editor's note: Charles Benbrook served as an expert witness in support of Lee Johnson, a groundskeeper suffering from terminal non-Hodgkin lymphoma following heavy use of, and exposures to Monsanto's Roundup herbicide.
Johnson sued Monsanto and was awarded $289 million in damages last week, after the jury delivered a stunning, unanimous verdict against Monsanto.
Hardly a day goes by without a new scientific paper or news coverage addressing problems down on the farm.
Just this month, for example, two studies highlighted the growing problem of weeds resistant to the herbicide glyphosate—the main ingredient in Monsanto's Roundup—and how this continues to push herbicide use, expenditures, and collateral damage upward. The more herbicide farmers spray, the faster herbicide efficacy slips.
The studies found:
Unfortunately, there is no Plan B for committed, large-scale genetically engineered (GE) crop farmers, many of whom find themselves locked onto a costly herbicide-use treadmill.
For corn, soybean, and cotton farmers in the U.S., many of today's problems are rooted in bad decisions made in the early 1990s as first-generation, GE crops were reviewed and approved by government agencies, and then marketed by the industry.
In a new paper I focus on how the industry, regulators, and the scientific community dealt with the significant increase in selection pressure on insect populations and weed communities.
Past mistakes in the testing and regulation of first-generation GE-crops are widely recognized.
While there is general agreement of why the GE-crop train jumped the tracks, there has been little serious discussion of solutions and today, constructive engagement by regulators or Congress is nearly unimaginable.
In the hope of triggering reforms, here are five fixes to shortcomings in current law and ag biotech regulation.
Each new GE crop technology goes through a voluntary review of food safety risks triggered by a letter from technology developers to the U.S. Food and Drug Administration (FDA). Through these "voluntary consultations," the companies provide basic information to the FDA on the genes moved into the new GE crop.
The primary focus of the FDA's voluntary consultation is whether the composition and nutrients in the GE crop is "substantially equivalent" to that of the not-engineered crop. The FDA reviews the data, raises any questions it has, and, in most cases, accepts the conclusions of the technology developer.
The FDA does not conduct an independent safety determination, nor does it do any testing of a newly proposed GE crop, but rather accepts the company's assertion of its safety. It is a shallow and flawed process, that has been "under review" for two decades, but persists because of the lack of consensus on a better way forward.
The U.S. Department of Agriculture's (USDA) focus in the regulatory review process is driven by an old federal statute, the Plant Pest Act. The USDA must determine whether the technology might trigger a new, or worsen an existing "plant pest" (i.e., a weed, insect, or fungal pathogen that attacks or competes with plants). If there is no evidence of such "plant pest" risk, the USDA deregulates the new GE-crop trait, and companies are then free to move the new trait into various crop cultivars.
In the case of GE crops that entail expression of compounds that act as pesticides, the EPA also has to approve the new crops under national pesticide law. For GE crops engineered to tolerate applications of herbicides after the crop has emerged and is actively growing, the EPA typically has to approve: (a) new and/or higher tolerance levels covering residues in food, and (b) herbicide product labels that contain different directions for use.
Each agency's role and authority is seriously limited because Congress has been unable to pass new legislation to give the agencies the tools and mandates needed to conduct thorough reviews of the risks, benefits, costs, and uncertainties associated with novel GE-crop technologies. As a result, pre-approval risk assessments are typically a mile wide but just inches deep. Some of the most worrisome risks are largely ignored.
Credit: Mike Mozart/flickr
Every pesticide sold to farmers contains one or more "active ingredients" that kill or control pests, and several "inert ingredients" that help assure the pesticide accomplishes its desired impact.
Inert ingredients help keep the active ingredient in suspension, and assure the pesticide sticks to plant or weed tissues long enough to be absorbed or come into contact with an insect pest. Some promote compatibility when mixed with other pesticides or liquid fertilizers, prior to spraying on a field.
For decades, a dangerous myth has persisted -- "inert ingredients" in formulated, ready-for-sale pesticides are not harmful to human health and the environment. For this reason, the impact of inert ingredients are not taken into account when the industry and government conducts a risk assessment of an active ingredient. Federal law classifies inert ingredients as "Confidential Business Information" (CBI), and blocks disclosure to poison control centers and physicians routinely treating pesticide poisoning victims.
The heightened toxicity of Roundup and other glyphosate-based herbicides, in contrast to pure glyphosate, played a dual role in Lee Johnson's trial in San Francisco, CA.
EPA's near-sole focus on the toxicity of pure glyphosate undermined the relevance of the agency's reassuring risk assessment, since no one ever sprays, or is exposed to pure glyphosate.
Monsanto's systematic effort over decades to suppress chronic animal studies on formulated Roundup, despite knowing from its own studies that the inert ingredients in its many Roundup brands increased risks substantially, no doubt influenced the jury, especially as it pondered the award of punitive damages.
Old myths die hard, despite the now well-known fact that inert ingredients in the world's leading, formulated herbicide, Roundup, and the world's leading family of insecticides (called neonicotinyls) dramatically increase toxicity to organisms up and down the tree of life, including people.
The policy fixes for problem #2 are obvious and simple—Congress needs to amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to: (a) require all active and inert ingredients to be disclosed on pesticide product labels, and (b) direct the EPA to require chronic feeding studies in mice and rats on at least some major formulations when there is evidence from short-term testing of heightened toxicity following exposures to formulated pesticides, as opposed to pure active ingredients.
Despite shortcomings in risk assessments, regulators generally are aware of the major areas of concern and uncertainty. In the first few years post-approval of a new GE technology, research and mandatory monitoring should be conducted to gain deeper understanding of human exposures and risks, unforeseen environmental impacts, or whether efficacy is slipping or uneven, raising the risk of resistance.
By targeting such monitoring in areas where new GE technology, and/or associated pesticides, have been most rapidly adopted, post-approval monitoring can serve as an early-warning system. Data gathered can alert the industry, farmers, and regulators of the need for more in-depth study and possible changes in the way a pesticide or GE-crop technology is used.
Credit: Jo Zimny/flickr
Regulators focus on the impact of one pesticide at a time, in isolation. Yet, adverse impacts arise as a result of all the pesticides, toxics, and technology deployed by farmers in a given area.
Tactical changes within prevention-based pest management systems are the surest way to achieve real progress toward safer pest management. Tweaking labels can reduce risks at the margins, but do nothing to stabilize failing pest management systems.
Both farmers and regulators need help, and new tools to recognize when a pest management system is failing because of the spread of resistant organisms, emergence of secondary pests, or unacceptable collateral damage on the environment, human health, or international trade flows.
In such cases, systemic pesticide regulatory interventions need to be considered that help farmers move away from heavy reliance on pesticides, and toward multi-tactic, prevention-based management systems.
Pest management specialists generally agree on the factors eroding the efficacy of a pest management system, or nudging risks and costs incrementally higher year to year. But they lack the tools and support needed to convince farmers to adopt system changes to alter underlying crop and pest-population dynamics.
Finding ways to reduce reliance on pesticides has proven elusive over the last half-century, despite general consensus that such system changes are necessary, especially in the case of pest management systems in active decline (e.g., soybean and cotton weed management; whiteflies and thrips in some vegetable and citrus crops).
Tackling this 5th problem will be difficult and take time. Fortunately, progress in addressing the other four problems will reduce risks in the interim, while also encouraging farmers to invest more management attention in preventing spikes in pest populations.
Ironically, reducing reliance on pesticides is the surest way to assure effective ones will be accessible when really needed.
Charles Benbrook is a Visiting Scholar in the Bloomberg School of Public Health, Johns Hopkins University, and a Visiting Professor at the University of Newcastle in the U.K.
Benbrook has served as an expert witness in several major pesticide and food-labeling related cases in which government regulatory policy has played a central role. He worked as a testifying expert in the Lee Johnson case, and is involved in other, similar litigation.
Visit his website or contact him at email@example.com.
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