Regulatory “science” under the spotlight

Fallout continues from the World Health Organisation’s classification of glyphosate herbicide as a probable carcinogen.

Following is a collection of comments on the story. In item 3, Senator Ed Markey calls for the US EPA to quickly complete its planned review of glyphosate, taking into account the new information from the WHO.

However, unless the EPA reforms its evaluation processes, it will not take the WHO report into serious consideration.

This is because the EPA, in common with regulatory authorities worldwide, routinely ignores or dismisses the independent studies that the WHO examined in order to reach its conclusion. Instead regulators base their evaluations on data from outdated tests conducted by industry, the details of which are kept secret from the public and independent scientists.

This has led to diverging scientific streams of thought, in which independent studies frequently find harm from a substance that regulators insist is safe.

A few NGOs, including GMWatch, Earth Open Source, Pesticide Action Network Europe, and the independent chemicals consultant Tony Tweedale have been drawing attention to this issue for years. The WHO’s classification of glyphosate and its divergence from regulatory opinions will throw it into the spotlight as nothing else has done before.

1. The glyphosate saga and “independent scientific advice” according to Germany, the UK, & France – Corporate Europe Observatory
2. Herbicide horror –
3. Dem senator urges EPA to test "probably carcinogenic" pesticides –
4. Why is Roundup, a probable carcinogen, being sprayed over Ocotillo’s only water supply? – East County magazine

1. The glyphosate saga and “independent scientific advice” according to Germany, the UK, & France

Corporate Europe Observatory, April 2, 2015

[Summary] The World Health Organisation (WHO) recently classified glyphosate, the active substance of Monsanto's RoundUp herbicide, as “probably causing cancer in human beings”. Germany is charged by the EU with the safety review of glyphosate: yet three scientists sitting on its scientific panel on pesticides are employees of BASF and Bayer, two major pesticides producers. Meanwhile, the UK has simply privatised its governmental Food and Environment Research Agency (FERA) outright, and France's experts in charge of assessing the safety of medicines have been shown to have been selling undeclared advisory services to pharmaceutical companies on how to best to file their market authorisation applications.

Glyphosate, the active ingredient present in Monsanto's weed killer Roundup, again hit the headlines when the WHO recently classified it as probably causing cancer in human beings. The International Agency for Research on Cancer (IARC) – WHO’s cancer research agency – published their study in The Lancet Oncology on 20 March 2015. Monsanto is up in arms – and has already asked for its retraction, saying the study was “junk science”, "biased and contradicts regulatory findings that the ingredient, glyphosate, is safe when used as labelled".

The battle is fierce, since glyphosate is a cornerstone of Monsanto's business (the company sold more than 5 billion dollars of RoundUp last year). Monsanto has always claimed the herbicide to be much less toxic for animals and humans than other weed killers. But is is not only about Monsanto: pretty much all chemical companies market glyphosate-based herbicides since the patent expired in 2000.

Roundup is sprayed widely in North and South America, where millions of hectares of glyphosate-tolerant GM crops are grown. But also in Europe: where it is widely used by farmers, gardeners and public authorities to kill weeds in public spaces, or on train tracks. It is (together with its degradation product AMPA) the most detected pesticide in French rivers. In 2013, tests commissioned by Friends of the Earth Europe  showed that people in 18 countries across Europe had traces of glyphosate in their urine. The Netherlands has banned the use of Roundup (and other glyphosate-based herbicides) in public spaces like parks and side walks as from November 2015. In general, detailed formulations of Roundup are not publicly known as they are considered a trade secret by Monsanto.

Yet in the EU, the issues around glyphosate seem caught in a never-ending saga of delays and conflicts of interest. Glyphosate has been around since the '70s, and was last given re-approval in the EU in 2002. A next re-approval was scheduled for 2012.

Germany is the EU rapporteur member state (RMS) for glyphosate – i.e. has been designated responsibility for assessing its safety on behalf of the EU.

The European Commission caused surprise when it decided to delay glyphosate's review (due in 2012) to 2015. The German Government body dealing with the glyphosate review, the Federal Office for Consumer Protection and Food Safety (BVL), explained  that the reason was that the European Commission and the European Food Safety Authority (EFSA) were overworked. The review of 39 other pesticides was also delayed.

The current authorisation of glyphosate relies on old, outdated testing protocols, and almost exclusively on industry studies. According to a 2011 report by the NGO Earth Open Source, EU regulators knew decades ago that glyphosate causes malformations, something that could even be deducted from industry's own studies, but kept this away from the public.

Germany submitted its glyphosate renewal assessment report (RAR) in January 2014, which was a vast document written up by its Federal Institute for risk assessment (Bfr). It also published a separate answer to critics, arguing among other things that several studies indicating harm could not be fully taken into account given that they did not follow certain very expensive international standards such as GLP (Good Laboratory Practice).

In its report, Germany concluded that “the available data do not show carcinogenic or mutagenic properties of glyphosate nor that glyphosate is toxic to fertility, reproduction or embryonal/foetal development in laboratory animals”. Germany recommended not only the re-approval of glyphosate for use in Europe, but even an increase in the acceptable daily intake (ADI) from 0.3 to 0.5 mg per kg body weight per day.

Both EFSA and the German regulatory agencies however refuse to disclose the two key chronic toxicity studies that this decision was based on, because these would contain commercially confidential information.

Testbiotech, a German research NGO, strongly criticised Germany's report saying that it failed to evaluate several peer reviewed studies which were omitted for unknown reasons. And to reassure everyone, Bfr's pesticide committee has employees from pesticide giants that profit from glyphosate, two from BASF and one from Bayer, among its members. The current committee (from 2014) includes Monika Bross and Ivana Fegert of BASF, and Frank Pierre Laport of Bayer CropScience. The previous such committee (2011-2013) included two from BASF and two from Bayer CropScience. And the one before that (2008-2010) again two from BASF and one from Bayer CropScience. Bfr's boss, Andreas Hensel, told the newspaper TAZ, “We consciously selected also professionals from the industry for our committees. Many facts around for instance cosmetics or plastics can only be judged by those that work with them”. (A comparable situation prevails at the Bfr GMO committee, as shown by this 2012 report by Testbiotech.)

It should be noted that even at EFSA, where we found that 59% of scientific panels members had direct or indirect links with the agri-food industry, such a situation could not happen as industry employees are banned from sitting on these panels. You cannot work for a corporation and for a government agency charged with regulating that corporation at the same time!

Were such industry employees involved in the glyphosate review? Bfr claimed that the pesticide committee had no formal role in writing the Renewal Assessment Report. So who did write it? We don't know. The authors are not mentioned anywhere in the RAR.

What is clear  from the RAR though is that Bfr did not draft its report from scratch but rather used the work of the Glyphosate Task Force (GTF), a “consortium of companies joining resources and efforts in order to renew the European glyphosate registration with a joint submission”. This is how Bfr describes its work:

“Due to the large number of submitted toxicological studies, the RMS was not able to report the original studies in detail and an alternative approach was taken instead. The study descriptions and assessments as provided by GTF were amended by deletion of redundant parts (such as the so-called ”executive summaries”) and new enumeration of tables. Obvious errors were corrected. Each new study was commented by the RMS. These remarks are clearly distinguished from the original submission by a caption, are always written in italics and may be found on the bottom of the individual study summaries.”

In other words, the Bfr was overwhelmed by the volume of industry's submission and only commented on the summaries provided by the Glyphosate Task Force.

As if so many gaps in our knowledge of the safety of glyphosate weren't enough, there is a crucial additional dimension to the problem. So far we've only been talking about glyphosate itself, Roundup's declared active ingredient, because this is the only element within RoundUp to be actually assessed by public authorities. However, by the time its sprayed on the field, its mixed with many other chemicals. Glyphosate-based herbicides' formulations are not public (producers say they're a trade secret), but we know they combine glyphosate with, for instance, surfactants that facilitate the herbicide being taken up by the plant. These chemicals are very toxic, some more than glyphosate  itself. As journalists Pete Farrer and Marianne Falck reported  in The Ecologist, Germany has secretly forbidden the use of the most dangerous surfactant (POEA, polyethoxylated tallow amine) - but is not warning the rest of the EU. Green MEP Martin Haüsling commented: "Even though I have been criticising the European Food and Safety Authority for many years because of its conflict of interest with the agricultural industry, it would be wrong to blame them alone. The national authorities play a big role in this process."

The UK has just taken a far more drastic step than appointing industry employees on its public risk assessment panels when it comes to undermining independent scientific advice. The government privatised its public research agency altogether. The country's Food and Environment Research Agency (FERA), employing over 400 researchers, has just been sold off to consultancy group Capita, a faceless outsourcing giant reported by The Guardian  to be swallowing up to 3.3 billion GBP in government spending for doing work outsourced by numerous government departments. Capita was dubbed "Crapita" by the British satirical magazine Private Eye for its many blunders, such as the catastrophic way they managed housing benefits.

For some years, the Department for Environment, Food, and Rural Affairs (DEFRA), then led by agribusiness champion Owen “Badgers” Paterson, said it was looking into possibilities for "partnerships" with the private sector, but in the end outright privatisation must have seemed the simpler option. This privatisation of a public service is part of what is ironically called the "Civil Service Reform Plan".

What could possibly be the benefit of selling this service off for at least the next 10 years for a mere 20 million GBP? Capita promises to invest more in the next five years and double FERA's “sales” by expanding its commercial services.

This means zero independence left, since the Agency will have the same corporations as clients that they also need to help regulate by delivering scientific assessments. For Defra this does not seem problematic. They commented in the media that the joint venture "will enable Fera to play an even greater role in helping to drive growth in our £100 billion agri-food industry". So much for food safety!

Professor Tim Lang told The Independent  that “once the agency is privatised, it will be under pressure to ignore low-paying projects vital to public safety and the environment in favour of more lucrative research.” He added, “No one will pay for evidence about food and biodiversity, or food and pesticide residues”.

It is ironic that it was precisely in the UK that many staunchly defended the former post of Chief Scientific Adviser to the EU Commission President in the name of independent science. When a broad group of NGOs (including CEO) wrote last summer in an open letter to Commission President Juncker that the CSA role should be scrapped as it concentrated too much influence in one person and undermined scientific research and assessments already being done by the rest of the EU' scientific evidence appraisal system, these NGOs were lambasted as “anti-science” in a well-orchestrated campaign by UK-based organisations. But now that it is not a top-level adviser but an entire public food safety research institution which is being scrapped, these enthusiastic defenders of independent science remain silent.

Last but not least, in our sobering tour of national scientific authorities' performance at making independence from big business a bad joke: a big scandal broke last week in France after journalists from Mediapart revealed that, for more than a decade, key members of the country's national expert commissions in charge of assessing the safety of medicines prior to their market authorisation were at the same time selling undeclared consultancy services to these pharmaceutical companies on how best to present their applications, with payments made in cash and not declared as revenue. One of them, J.P. Reynier, even sat on the Board of the European Medicines Agency between 1996 and 2003.

There are heated discussions these days about the problematic consequences of public suspicion of science and technology. But how can one expect popular trust when public regulators are siding with the corporations whose products they are supposed to regulate, rather than with the public interest?

2. Herbicide horror

by Michelle Adelman, April 1, 2015

* Once thought safe enough to drink, the most popular weed killer on earth is increasingly difficult to avoid - and critics charge it's contributing to chronic illnesses

Farmer Tom Slumskie once ended up in hospital on an IV after adding insecticides to the seeds in his planter. That was 35 years ago, and it was a wake-up call.

It made him cautious about using pesticides like glyphosate - the active ingredient in Monsanto's Roundup - on the 283 hectares he farms in Bruce County.

The bestselling herbicide in Canada and the world, glyphosate was once promoted as safe enough to drink. But some critics are raising renewed alarm. One of them is Thierry Vrain, a plant pathologist and former head of biotechnology with Agriculture Canada, who says there is no safe intake level for this toxic chemical, which appears to be linked to a rising tide of chronic illnesses. Indeed, the World Health Organization's International Agency for Research on Cancer has just declared glyphosate a "probable carcinogen". (More on IARC's study here).

Farmers have used glyphosate to weed Ontario fields since 1978. But the introduction of genetically modified (GM) crops in 1997 - most of them designed to be glyphosate-tolerant - was a game changer. Farmers could now raze weeds with a single blanket spray of glyphosate without killing their crops.

Though industry promised GM crops would drive down pesticide application, glyphosate use has risen dramatically, by some 76 per cent between 2003 and 2008 in Ontario.

That helped reverse a decades-long decline in pesticide use that was already well under way before a single GM plant appeared in farm fields. By 2012, glyphosate had captured almost 53 per cent of the western Canadian herbicide market - more than the dozen next-most-popular herbicides put together.

But GM crops aren't powering glyphosate's growth single-handedly.

Farmers are increasingly using the herbicide as a desiccant (dryer) on both GM and conventional plants, making harvesting easier or moving up a harvest threatened by bad weather.

There are no official Ontario data on how widely desiccation is practised, though Slumskie estimates it's used on up to 15 per cent of GM soy.

It's increasingly difficult to avoid the most popular herbicide on earth. A recent study of U.S. honey found 59 per cent of samples contained glyphosate. Though a safe glyphosate level in honey hasn't been determined, recent research suggests the current level of glyphosate exposure in general may constitute a health threat to the population.

You might think organic crops would be free of this chemical, but glyphosate has recently been discovered in samples of air and water, so all food may now be tainted.

Pesticide makers say their products have never been safer, and pesticide residues represent such a minute health risk that people need not worry.

Well, critics disagree. They point to the chemistry behind the herbicide's action.

Glyphosate was first thought to pose little threat because neither human nor animal cells have shikimate pathways, a metabolic route used by plants and bacteria. Glyphosate does its deadly work by binding to the metal atoms of enzymes in the plant's pathways, preventing them from producing critical amino acids. Without those, the plant dies.

New discoveries about the human microbiome - including the 100 trillion bacteria in the human gut - are starting to reveal the critical role microorganisms play in promoting human health.

Don Huber, professor emeritus of plant pathology at Purdue University, says that just as it attacks plants, glyphosate can demobilize the bacteria on which humans and animals depend.

But Joe Schwarcz, director of the Office for Science & Society at McGill University, says the theories need to be proven under proper laboratory conditions before they should be believed.

On the issue of nutrition, Schwarcz agrees that glyphosate binds to minerals, which humans and animals need for health. He insists, though, that the chemical is applied in just the right strength to kill weeds but not enough to disable the minerals plants pull up from the earth.

But some studies suggest the opposite is true.

The U.S. Department of Agriculture found herbicide-tolerant soy contained lower nutrient levels than conventional soybeans.

Further evidence might be the manganese and B12 deficiencies often found in the livers of slaughtered animals. Commercial packing houses are said to throw out 80 per cent of their livers because they are so damaged, says Huber.

But another possible health threat is glyphosate's antibiotic action.

Monsanto patented the chemical as an antibiotic in 2010, a tacit acknowledgement of its effectiveness in killing microbes, though the pesticide industry maintains it's applied to fields in concentrations too low to produce any serious antimicrobial effects in the animals, including us, consuming those crops. Schwarcz insists the antibiotic effect is "absolutely trivial".

But Huber argues that increasing miscarriages, birth defects, and chronic botulism in cattle, sheep and pigs are signs of glyphosate's strong antibiotic activity against beneficial organisms.

Backing up Huber, Vrain points to research from 2013 showing that, at a concentration of just one part per million, glyphosate killed all the beneficial bacteria in the guts of poultry. Only salmonella and clostridium survived - pathogens blamed for farm animal illness.

In the meantime, a recently published study by Nancy Swanson virtually twinned increasing rates of glyphosate use with rising incidence of a host of chronic diseases. They include liver, kidney, and bladder cancers; Crohn's and celiac disease; stroke, diabetes, and autism, among others.

Some shrug these correlational studies off as coincidence. But to dismiss them because they don't prove cause "is a completely unscientific position," says Vrain. The Swanson study's close correlations are a hugely strong argument for more research, he says.

Huber goes so far as to call for a return to the precautionary principle until that research is done, but there are no signs of any curbs being contemplated for glyphosate use.

New GM seeds resistant to glyphosate, as well as 2,4-D, are expected to start rolling out across Canada this year. The new seeds will help farmers battle glyphosate-resistant weeds.

While Vrain admits that biotechnology has been transformative for the just over 2 per cent of Canadians who farm, "One hundred per cent of people eat," he says.

Slumskie remembers when the herbicide atrazine was first introduced years ago. Farmers started applying it at 2 pounds per acre, which soon ballooned to 8. Nearby rivers became badly contaminated.

"Now here we are with glyphosate, 40 or 45 years later, and the same thing is going on," he says. "History will repeat itself when the lesson is never learned."

Michelle Adelman writes on environment and health issues. She's a graduate of the Munk Fellowship in Global Journalism at the University of Toronto.

3. Dem senator urges EPA to test 'probably carcinogenic' pesticides

by Lydia Wheeler, 1 April 2015

Sen. Ed Markey (D-Mass.) is asking the Environmental Protection Agency to evaluate the herbicide glyphosate, amidst growing concerns that the chemical in one of the world’s most widely used weed killers “probably” causes cancer.

The United Nations World Health Organization’s International Agency for Research on Cancer (IARC) released a scientific assessment of five organophosphate pesticides last week that found that the insecticides malathion and diazinon, and herbicide glyphosate are “probably carcinogenic to humans”. Glyphosate is one of the key ingredient’s of Monsanto’s weed killer Roundup.

IARC also found that parathion and tetrachlorvinphos, found in pet flea treatments, are “possibly carcinogenic to humans”.

In a letter to the EPA Administrator Gina McCarthy this week, Markey requested the agency “quickly complete its pesticide registration review of these substances and consider the new information when determining whether additional labeling or restrictions may be needed to protect public health from these cancer-causing chemicals”.

According to IRAC, Markey said glyphosate is in more than 750 different products and has been detected in the air during spraying, in water and food.

“Additionally, research has noted glyphosate absorption in the body, as it has been found in the blood and urine of agriculture workers who handle glyphosate-containing products,” he said.

Markey asked McCarthy to respond to his letter with a specific timeline for EPA’s review of these substances that addresses whether EPA will incorporate IARC's findings into its analysis by April 24.

His letter comes about a week after public interest organizations including Just Label It, the Center for Food Safety, the Environmental Working Group (EWG) and the Natural Resources Defense Council sent a similar letter to the EPA.

In a news release, Scott Faber, executive director of Just Label It and EWG senior vice president of government affairs, said the new evidence that the main pesticide used on genetically modified crops is a “probable human carcinogen” is even more reason consumers should have the right to know what’s in their food.

In an email Wednesday, EPA spokeswoman Cathy Milbourn said the agency plans to publish a proposed weed resistance management document for a 60-day public comment period at the time the preliminary risk assessment on glyphosate is released later this year.

4. Why is Roundup, a probable carcinogen, being sprayed over Ocotillo’s only water supply?

By Miriam Raftery
East County Magazine, 1 April 2015

Residents of Ocotillo [in San Diego, California] after discovering in late March that a powerful herbicide was been sprayed on desert soil over a federally protected aquifer – the town’s sole-source water supply.

ECM photographer Jim Pelley, an Ocotillo resident, photographed workers spraying the substance on Bureau of Land Management public property.  “A BLM representative was there and they told me they were spraying Round-UP Pro,” Pelley says.

On March 22nd, Reuters reported that the World Health Organization’s cancer arm, the International Agency for Research on Cancer, concluded that glyphosate, the active ingredient in the Monsanto Company’s herbicide, RoundUp, is “classified as probably carcinogenic to humans".

East County Magazine has contacted Senator Barbara Boxer, ranking minority member on the Senate Environment and Public Works Committee, to request comment on this issue and we will report back once a response is received.