Glyphosate, Roundup and the Failures of Regulatory Assessment: Dr Eva Novotny

Glyphosate, Roundup and the Failures of Regulatory Assessment

Dr Eva Novotny

 Dr Eva Novotny has responded to a recent post which concluded that successive governments have injured the health of their people by allowing harmful products to be manufactured and used instead of banning them:

“Contamination of our food must be an important contributor to illness (in addition to the nutrient-poor diets of many people). 

“Agricultural pesticides enter crops and residues can remain.  If the current UK Government proceeds to introduce genetically modified (GM) foods and crops into this country, there will be far more contamination of our diet.

Most GM crops have been designed to tolerate Monsanto’s herbicide Roundup (in fact, the original purpose for creating GM crops was to further the sale of Roundup after its patent expired — so much for the claim that GM crops would reduce pesticide use!).  The declared active ingredient in Roundup is glyphosate, but glyphosate has relatively little effect as a herbicide, while the other ingredients are far more powerful. .

“Gene-edited foods, despite the claims of safety, carry many of the same risks as the older GM crops plus additional dangers: the precision claimed refers to the ability to target a specific gene, which was not possible with the older GM methods.  However, the manipulation of the specific gene causes many additional, uncontrollable changes in the chromosome: insertions, deletions and scrambles of genetic material.  Then, once the specific gene has been edited, a multi-stage process is necessary to produce a whole new organism, just as in the case of the older GMOs.

“Unfortunately, regulators in the EU assess only the “active ingredient”, glyphosate, not Roundup, for harm to health and the environment.  The assessment procedure itself is corrupt.   I have published a paper on these topics.”

Glyphosate, Roundup and the Failures of Regulatory Assessment

Abstract

Roundup is the most widely used herbicide in agriculture. It contains glyphosate as the ‘active ingredient’, together with formulants. There are various versions of Roundup, with somewhat different effects depending on the formulants.

Most genetically-modified crops are designed to tolerate Roundup, thus allowing spraying against weeds during the growing season of the crop without destroying it. Having been so heavily used, this herbicide is now found in the soil, water, air, and even in humans worldwide. Roundup may also remain as a residue on edible crops.

Many studies have found harm to the environment and to health, making it imperative to regulate the use of Roundup and to ensure that its various formulations pose no danger when used in the long-term.

Unfortunately, regulators may only assess the ‘active ingredient’, glyphosate, and ignore the toxicity of the formulants, which can be far more toxic than the active ingredient. This omission is in violation of a ruling by the Court of Justice of the European Union. There are close ties between the regulators and the industry they are supposed to regulate.

Objectionable practices include ‘revolving doors’ between the regulators and the industry, heavy reliance on unpublished papers produced by the industry while dismissing papers published by independent scientists, and strong covert influence on the regulatory process by industry. Although this paper focuses on the European Union (EU), the situation is much the same in the United States.

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MDPI (Multidisciplinary Digital Publishing Institute), a publisher of open access scientific journals, published the full paper on a ‘free to read’ basis.

 

 

 

 

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Pesticide use: the tide appears to be turning

Bayer, the German company which bought the US agrochemical firm Monsanto, acquired its lucrative portfolio of pesticides and genetically modified seeds – and more than 13,000 pending cases relating to glyphosate sold under the brand name Roundup. At its annual meeting in Bonn last month, in an unprecedented revolt, more than 55% of shareholders declared they had no confidence in management. The ongoing fall in its share prices has accelerated. (Reuters 14.5.19).

Prof. Ian Boyd, chief scientific adviser to the UK government points out that regulators around the world have falsely assumed it is safe to use pesticides at industrial scales across landscapes, that other research in 2017 showed farmers could slash their pesticide use without losses and quoted a UNGA report denouncing the “myth” that pesticides are necessary to feed the world.

Recent reports in the BMJ, the International Journal of Epidemiology and the European Food Safety Authority, add weight to Professor Boyd’s stance

• Prenatal and infant exposure to ambient pesticides and autism spectrum disorder in children: population based case-control study, BMJ, 20 March 2019 (open access) notes that common pesticides have been previously shown to cause neurodevelopmental impairment in experimental research and environmental exposures during early brain development are suspected to increase risk of autism spectrum disorders in children. The study’s findings suggest that an offspring’s risk of autism spectrum disorder increases following prenatal exposure to ambient pesticides (including glyphosate, chlorpyrifos, diazinon, and permethrin) within 2000 m of their mother’s residence during pregnancy, compared with offspring of women from the same agricultural region without such exposure. Infant exposure could further increase risks for autism spectrum disorder with comorbid intellectual disability.

• In February, researchers at the University of Washington (UW) published a new scientific analysis of glyphosate (PDF) (right), the active ingredient in Monsanto-owned Bayer’s Roundup, the world’s most popular weedkiller. They concluded that evidence supports a “compelling link” between glyphosate and non-Hodgkin lymphoma (NHL), a type of blood cancer.
• Glyphosate exposure increases cancer risk up to 41% according to a study published in the IInternational Journal of Epidemiology (March). Observations in this analysis of >300 000 farmers and agricultural workers from France, Norway, and the USA, included elevations in risks of non-Hodgkin lymphoid malignancies (NHL) overall in association with the organophosphate insecticide terbufos, of chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) with the pyrethroid insecticide deltamethrin and of diffuse large B-cell lymphoma (DLBCL) with the organophosphorus herbicide glyphosate.

• More transparency sought: an EU court ruled on 7 March that the EU Food Safety Authority (EFSA) should publicise studies about Monsanto’s glyphosate weedkiller. The General Court’s statement said that it annulled decisions by the EU food watch agency “refusing access to the toxicity and carcinogenicity studies on the active substance glyphosate”.

• On March 29th – after safety officials reported human health and environmental concerns – EU states voted for a ban of chlorothalonil, a fungicide, after a review by the European Food Safety Authority was unable to exclude the possibility its breakdown products, cause damage to DNA. EFSA also said “a high risk to amphibians and fish was identified for all representative uses”. Recent research further identified chlorothalonil and other fungicides as the strongest factor linked to steep declines in bumblebees.

Reuters reports that a California jury found on Monday that Monsanto’s Roundup likely caused a couple’s cancer and awarded them a staggering $2.055 billion in damages, in a third consecutive Roundup trial loss for the Bayer-owned unit. In one trial last August, a US court in California awarded damages and costs against Monsanto to 46-year-old park worker Dewayne Johnson, who was diagnosed with cancer after using the chemical.

But there’s still way to go; Monsanto – apparently undaunted – offers another  product, said to have less damage potential

Monsanto is reformulating its dicamba pesticide which tended to drift and earlier damaged millions of acres of crops and wild trees in 2017.

Farmers in 25 states had submitted more than 2,700 claims to state agricultural agencies that year and it was banned in the state of Arkansas last year, where almost 900,000 acres of crop damage (above) were reported. Monsanto unsuccessfully sued the state in an effort to stop the ban.

A lower volatility formulation, M1768, ‘a product with less potential to volatilize and move off the target area’ has been approved by the EPA for use until 2020 – on corn, wheat, cotton, soybeans and other crops – though it has not been evaluated by experts independent of Monsanto. It was obliged by the American government’s Environmental Protection Agency to agree to registration and labelling changes for the 2018 growing season, including making these products restricted-use and requiring record-keeping and additional measures to prevent spray drift.

 

 

 

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Lincoln County Community Rights versus the politically supported pesticides industry

Felicity Arbuthnot draws attention to the achievements of Lincoln County Community Rights whose core members include the owner of a small business that installs solar panels, a semi-retired Spanish translator, an organic farmer who raises llamas, and a self-described caretaker and Navajo-trained weaver.

Although some of the world’s biggest companies poured money into a stealth campaign to stop the ordinance, and the Lincoln activists had no experience running political campaigns, these part-time, volunteer, novice activists managed to stop the spraying of pesticides that had been released from airplanes and helicopters in this rural county for decades.

The Lincoln County aerial spray ban, which passed in May 2017, is just one of 155 local measures that restrict pesticides. Communities around the country have instituted protections that go beyond the basic limits set by federal law. Some are aimed at specific pesticides, such as glyphosate, others list a few; while still others ban the chemicals altogether.

The upturn in local legislation is a testament to public concerns about the chemicals used in gardening, farming, and timber production, and reflect a growing frustration with federal inaction. In recent years, scientific research on pesticides has shown credible links between pesticides and cancer, endocrine disruption, respiratory illnesses and miscarriage, and children’s health problems, including neurobehavioral and motor deficits. As scientists have been documenting these chemicals’ harms, juries have also increasingly been recognizing them.

CropLife America, the industry group, which reported more than $16 million in revenue in 2015, represents and collects dues from the major pesticide manufacturers, including Monsanto, Syngenta, Dow AgroSciences LLC, and DuPont Crop Protection

It ranked state and local issues as the top of its list of “tier 1 concerns” for both 2017 and 2018, according to internal documents obtained by The Intercept that pinpointed Oregon as ground zero for the fight. While it paid for all this, its name never appeared on the materials or was referenced in the local fight, which was instead framed as being led by local farmers.

Like the ordinance in Lincoln County, a similar proposal in neighboring Lane County didn’t just specify that aerial spraying would be outlawed, it asserted people’s “inherent and inalienable right of local community self-government.” Both measures were inspired by the Community Environmental Legal Defense Fund, which views the aerial spraying of pesticides as violations of citizens’ basic rights to clean air, water, and soil.

However, federal regulation has lagged behind both the research and public outrage

The Environmental Protection Agency has allowed glyphosate, the active ingredient in RoundUp, to remain in use despite considerable evidence linking it to cancer. Under Donald Trump, the EPA also reversed a planned ban of chlorpyrifos, a pesticide linked to neurodevelopmental problems in children.

Frustrated by the lack of federal action, many people have turned to their towns and counties, only to find that they have been hamstrung by state laws forbidding local limits on pesticides. In 43 states, laws prevent cities, towns, and counties from passing restrictions on pesticide use on private land that go beyond federal law.

A provision in the Farm Bill now before Congress would extend that restriction to the entire country and could potentially roll back existing local laws. The House version of the bill that passed in June and is now being reconciled with the Senate version included a section that prevents “a political subdivision of a State” from regulating pesticides.And an appeal has been lodged against the Lincoln County aerial spray ban.

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Read more about the tactics used and the money and individuals involved here: https://theintercept.com/2018/09/15/oregon-pesticides-aerial-spray-ban/

 

 

 

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A three-part strategy developed to help to identify whether chemicals can have adverse effects at low doses

Rachel Shaffer, a PhD student of Environmental Toxicology at the University of Washington opens her article: Paracelsus, a Swiss physician known as the father of toxicology, proclaimed that “the dose makes the poison”. She continues: “Increasing evidence suggests that even low levels of endocrine disrupting chemicals can interfere with hormonal signals in the body in potentially harmful ways”.

As standard toxicity tests don’t always detect the effects that chemicals can have at lower levels, the U.S. Environmental Protection Agency (EPA) asked a committee of scientists to study the issue in detail. After several years, the committee’s report was released by the National Academy of Sciences in July. This landmark report provides the EPA with a strategy to identify and analyse data about low-dose health effects, as well as two case study examples. It is an evidence-based call to action for scientists and policymakers.

The committee defined a low dose as “external or internal exposure that falls with the range estimated to occur in humans.” That covers any level of chemical exposure that we would encounter in our daily lives.

It defined adverse health effects as including any biological change that impairs a person’s functional capacity or ability to handle stress, or resist other exposures.

The committee developed a three-part strategy to help the EPA to identify whether chemicals can have adverse effects at low doses which seems to the layperson to be standard scientific procedure:

• First, actively collect a wide range of data with participation from stakeholders and the public.
• Then analyse and integrate the available evidence in a systematic way.
• Finally, act on this evidence to improve risk assessments and toxicity testing.

Using these strategies, the committee conducted a systematic review of two endocrine-disrupting chemicals, assessing the relevant data from human, animal and cell-based lab studies.

The first case study looked at phthalates, chemicals that increase the flexibility of plastic products such as shower curtains and food wrapping. The committee found that diethylhexyl phthalate and other selected phthalates are associated with changes in male reproductive and hormonal health. Overall, the data were strong enough to classify diethylhexyl phthalate as a “presumed reproductive hazard” in humans.

The second case study focused on polybrominated diphenyl ethers, flame retardants used for over 30 years. Though they are now being phased out, these chemicals remain a concern for humans. They are still present in older products and can persist in the environment for many years. Based on data showing the impact of these chemicals on learning and IQ, the panel concluded that developmental exposure is “presumed to pose a hazard to intelligence in humans.”

During its review, the committee encountered a variety of barriers that could impede similar investigations into specific chemicals. Two of several examples were:

• that the committee noted a discrepancy between the concept of doses used in human and animal studies. This made it difficult to compare data from different sources.
• that many toxicology studies focus on only a single chemical. However, as all are exposed to many chemicals, these procedures may be of limited use in the real world.

The committee suggested that toxicologists incorporate real-world mixtures into their studies, to provide more relevant information about the risk to human health.

This report demonstrated the challenges facing the field of toxicology and environmental health: How well can existing and emerging laboratory techniques predict adverse outcomes in humans?

As Rachel says, despite the imperfections of our testing methods, there’s ample evidence about low-dose effects from many chemicals. Many general readers will already have been aware of the dangers of phthalates and flame retardants for some time; the real problem appears to be the lack of political will to act on information already in the public domain.

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Read her article here:https://theconversation.com/can-low-doses-of-chemicals-affect-your-health-a-new-report-weighs-the-evidence-82132

 

 

 

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Should Dow Chemical be allowed to add to the load of toxic chemicals assailing the global public?

NationalJournal.com covers policy in Washington. It is produced by the USA’s National Journal, said to be aimed at ‘Washington insiders’.

In the National Journal, Clare Foran reports that Dow Chemical is seeking federal approval for a herbicide containing a chemical which was one of the main ingredients in Agent Orange.

In March Reuters named the product as Enlist, in full, the Enlist Weed Control System, and said that U.S. regulators indicated they are ready to grant approvals, after more than two years of scrutiny.

The Environmental Protection Agency, which is reviewing Dow’s application, says that the chemical, known as 2,4-D, drifts easily through the air and sometimes kills not just weeds but also crops beyond the fields where it is sprayed. It is banned in Denmark, Sweden, Norway, and some areas of Canada.

Drift ‘improved’ not eliminated

 If sprayed in fields, the EPA says that trace amounts could end up in food and drinking water – but in such small quantities that it would not pose a threat to public health. Enlist combines this component with glyphosate, the chief ingredient in long-used Roundup.

Dow: its product bears little resemblance to the Vietnam War-era weapon

Garry Hamlin, a spokesman for Dow, said. “The idea that this product is anything like Agent Orange just doesn’t hold up. That had a unique contaminant, and it was phased out of use in the U.S. in the 1980s because of those concerns.”

But, critics argue, Dow has made false safety claims in the past

Dow’s Dursban insecticide was a widely used household pesticide for decades until numerous health concerns led the Environmental Protection Agency (EPA) to phase out certain uses in 2000 because of risks found with the active ingredient, chlorpyrifos. In 2010 an Indiana family was awarded more than $23 million for medical problems their children suffered after pesticides, including Dursban, were applied to their apartment.

An Agriculture Department researcher made tests using samples collected in the mid-1990s which found that a chemical in Dow’s product could still contain contaminants similar to those found in Agent Orange.

The study concluded that there was a “need for more investigation into possible human health effects.”

Dow AgroSciences announced approval for Enlist by Canada and Japan, but it was left to Carey Gillam (Reuters) to point out:

“Dow has not yet won China’s approval for import of Enlist crops, and Dow officials said they may go ahead with commercialization in the United States even without Chinese approval. Such an approach could jeopardize some U.S. grain sales to the world’s second-largest economy. A similar scenario involving a biotech corn developed by Syngenta has caused shipments of U.S. corn to be rejected by Chinese importers”.

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We thank Ian Panton of GM free Cymru for bringing this news to our attention.