The EPA’s announcement reaffirms its earlier findings about the safety of glyphosate, the key ingredient in Bayer’s Roundup. The company faces thousands of lawsuits from Roundup users who allege it caused their cancer.

“EPA continues to find that there are no risks to public health when glyphosate is used in accordance with its current label and that glyphosate is not a carcinogen,” the agency said in a statement.

Farmers spray glyphosate, the most widely used herbicide in U.S. agriculture, on fields of soybeans and other crops. Roundup is also used on lawns, golf courses and elsewhere.

The EPA did previously find ecological risks from the chemical and has proposed new measures to protect the environment from glyphosate use by farmers and to reduce the problem of weeds becoming resistant to it.

Bayer said it was pleased the EPA and other regulators who have assessed the science on glyphosate for more than 40 years continue to conclude it is not carcinogenic.”Bayer firmly believes that the science supports the safety of glyphosate-based herbicides,” it said in a statement. The company has repeatedly denied allegations that glyphosate and Roundup cause cancer.

But critics of the chemical disputed the EPA’s assurances.

“Unfortunately American consumers cannot trust the EPA assessment of glyphosate’s safety,” said Nathan Donley, a senior scientist at the environmental group Center for Biological Diversity.

Monsanto developed Roundup as the first glyphosate-based weed killer, but it is no longer patent-protected and many other versions are available. Bayer bought Monsanto last year for $63 billion (all figures US$).

The debate over glyphosate’s safety has put a spotlight on regulatory agencies around the world in recent years and, more recently, on U.S. courtrooms.

In 2015, the World Health Organization’s cancer arm classified glyphosate as “probably carcinogenic to humans.” But the EPA in 2017 said a decades-long assessment of glyphosate risks found the chemical was not likely carcinogenic to humans.

In February, analysts at Brazilian health agency Anvisa also determined the weed killer does not cause cancer while recommending limits on exposure.

In the first U.S. Roundup trial, a California man was awarded $289 million in August 2018 after a state court jury found the weed killer caused his cancer. That award was later reduced to $78 million and is being appealed by Bayer.

A U.S. jury in March awarded $80 million to another California man who claimed his use of Roundup caused his cancer.

— Reporting for Reuters by Tom Polansek; additional reporting by Kate Kelland in London.

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In a letter and an email seen by Reuters, officials from the International Agency for Research on Cancer (IARC) cautioned scientists who worked on a review in 2015 of the weedkiller glyphosate against releasing requested material.

The review, published in March 2015, concluded glyphosate is “probably carcinogenic,” putting IARC at odds with regulators around the world. Critics say they want the documents to find out more about how IARC reached its conclusion.

“IARC is the sole owner of such materials,” IARC told the experts. “IARC requests you and your institute not to release any (such) documents.”

Asked about its actions, the agency told Reuters on Tuesday it was seeking to protect its work from external interference and defending its panels’ freedom to debate evidence openly and critically.

In recent years IARC, a semi-autonomous unit of the WHO based in Lyon, France, has caused controversy over whether such things as coffee, mobile phones, red and processed meat and chemicals such as glyphosate cause cancer.

Its critics, including in industry, say the way IARC evaluates whether substances might be carcinogenic can cause unnecessary health scares. IARC assesses the risk of a substance being carcinogenic without taking account of typical human exposure to it.

Glyphosate is a key ingredient of the herbicide Roundup, sold by Monsanto. According to data published by IARC, glyphosate was registered in over 130 countries as of 2010 and is one of the most heavily used weedkillers in the world.

Pressure has been growing on the experts who worked on IARC’s glyphosate review in part because other regulators, including in the U.S., Europe, Canada, Japan and New Zealand, say the herbicide is unlikely to pose a cancer risk to humans.

The conflicting scientific assessments have delayed a decision on whether glyphosate should be relicensed for sale in Europe, and prompted senior U.S. lawmakers to question whether IARC should receive funding from U.S. taxpayers.

IARC defends its methods as scientifically sound and says its monographs — the name it gives to its classifications of carcinogens — are “widely respected for their scientific rigor, standardized and transparent process and… freedom from conflicts of interest.”

IARC’s advice to experts not to release documents came in April after IARC said it learned that members of the scientific panel that reviewed glyphosate in 2015 had been issued with legal requests for information relating to their work.

Multiple subsequent freedom of information requests by the U.S. conservative advocacy group the Energy and Environment Legal Institute (E and E Legal) have since been turned down by agencies and universities citing IARC’s reasoning that it owns the documents.

David Schnare, general counsel of E and E Legal, told Reuters his group is now pursuing a legal challenge over whether the documents belong to IARC, or are the property of the U.S. federal and state institutions where the panel experts work.

He said E and E wants access to the documents and emails because it wants to know more about the way IARC reviews the scientific evidence, and about its relationship with the U.S. Environmental Protection Agency (EPA).

“Private emails”

An email dated April 1 was addressed to six members of the working group for monograph 112, which considered glyphosate, including experts at universities in Texas and Mississippi as well as scientists attached to the EPA.

Signed and sent by Kathryn (Kate) Guyton, the IARC staffer responsible for the glyphosate review, the email said IARC “does not encourage participants to retain working drafts or documents after the monograph has been published.”

Monsanto’s vice-president of strategy, Scott Partridge, told Reuters he considered IARC’s actions “ridiculous.”

“The public deserves a process that is guided by sound science, not IARC’s secret agendas,” he said.

Responding to Reuters’ questions about the letter and email, IARC said it had been previously informed by experts on the panel who “had been approached by interested parties, including lawyers representing Monsanto… and asked to release private emails as well as draft scientific documents.”

It said that as international agencies, both IARC and the WHO “have policies to protect their work, and the contributions of their expert Working Groups, from external interference.”

In a statement to Reuters, IARC said the letter and email were sanctioned by the agency’s director, Chris Wild. It added: “IARC staff did not instruct anyone not to comply with records requests made under national or local law.”

It said it is vital that scientists in its working groups “are able to openly and critically debate the scientific evidence.”

“IARC considers any measures that would discourage scientists from participating in Monographs or would detract from open scientific debate to be contrary to the best interests of international public health,” it added.

Ivan Rusyn, one of the recipients of the IARC’s April letter and email and a professor at Texas A and M University who worked on the glyphosate review, said he was glad to have IARC’s advice regarding whether documents should be released.

“I don’t see anything inappropriate here,” he told Reuters. “It’s very appropriate for IARC to advise its working group members as to what the procedures are.”

— Kate Kelland is a Reuters health and science correspondent based in London, England.

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The 86-page report, seen by Reuters and published Friday on the regulations.gov website that the EPA manages, was from the EPA’s cancer assessment review committee (CARC). It found that glyphosate, the active ingredient in the world’s mostly widely used weedkiller, was “not likely to be carcinogenic to humans.”

The EPA took down the report and other documents on Monday afternoon, saying it did so “because our assessment is not final,” in an emailed statement to Reuters. The agency said the documents were “preliminary” and that they were published “inadvertently.”

But a covering memo that was part of the documents seen by Reuters described the report as the committee’s “final Cancer Assessment Document.” “FINAL” was printed on each page of the report, which was dated Oct. 1, 2015.

The EPA declined to comment on whether the report, or the 13 other documents that were also published and subsequently taken down Monday, indicate whether the agency ultimately will conclude that glyphosate is not carcinogenic.

Glyphosate has been the subject of controversy over whether it is cancer-causing. Last year, the World Health Organization’s cancer arm, the International Agency for Research on Cancer, classified glyphosate as “probably carcinogenic to humans.”

Other government authorities have issued a variety of opinions on glyphosate. The European Food Safety Authority last November said glyphosate was “unlikely to pose a carcinogenic hazard to humans.”

Report “clearly labeled”

Monsanto, whose Roundup herbicide line uses glyphosate as a key active ingredient, responded to the EPA’s document, saying in a statement on Monday that the agency had issued an “official classification” that glyphosate was not likely to be carcinogenic.

Monsanto said the document was “clearly labeled and signed as the final report of EPA’s Cancer Assessment Review Committee,” in an email to Reuters on Monday after the documents had been removed.

The EPA said its documents are part of its broader registration review, which began in 2009, of glyphosate and its potential human health and environmental risks.

“EPA has not completed our cancer review,” the EPA told Reuters in a statement. “We will look at the work of other governments as well as work by (the U.S. Department of Health and Human Services’) Agricultural Health Study as we move to make a decision on glyphosate.”

The EPA said its assessment will be peer reviewed and completed by the end of 2016.

A reporter with Bloomberg BNA, a subsidiary of Bloomberg, had posted a link to the documents on Twitter on Monday morning. The EPA documents, while available, sparked strong reactions from critics of the world’s most widely used herbicide.

“All they’re doing is reviewing studies that are funded by the industry,” said Jennifer Sass, a senior scientist at Natural Resources Defense Council, an environmental and public health advocacy group.

In addition to the cancer assessment report, the documents that the EPA removed included summaries of three 2015 meetings between EPA officials and Monsanto; preliminary ecological risk assessments of glyphosate on milkweed, which is key to the health of monarch butterflies; a report discussing possible label amendments to two of Monsanto’s Roundup products when used on oilseeds, fruit and other crops; and a six-slide Monsanto presentation to the EPA officials.

— P.J. Huffstutter reports on agriculture and agribusiness for Reuters from Chicago.

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The 16-member panel, assembled by Intertek Scientific and Regulatory Consultancy, was to present its findings to the annual meeting of the Society for Risk Analysis on Monday (Dec. 7), aiming to publish the study at a later date after peer review. Monsanto paid Intertek for the panel’s work.

The group said the WHO’s International Agency for Research on Cancer (IARC) misinterpreted or incorrectly weighted some of the data it reviewed and ignored other data before classifying glyphosate as a probable human carcinogen, according to an abstract of its findings.

“Thus, none of the results from a very large database, using different methodologies, provides evidence of, or a potential mechanism for, human carcinogenesis,” the abstract said.

The panel’s assessment is similar to that of the European Food Safety Authority (EFSA), which last month said glyphosate was not likely carcinogenic.

IARC was not immediately available for comment.

The U.S. government says the herbicide is considered safe. In 2013, Monsanto requested and received approval from the U.S. Environmental Protection Agency for increased tolerance levels for glyphosate, which is mainly used to kill weeds in fields planted with corn and soybeans that are genetically modified to survive it.

But concerns about glyphosate on food have been a hot topic of debate in the U.S. recently and contributed to the passage in Vermont last year of the country’s first mandatory labeling law for foods that are genetically modified.

Critics say that industry-linked scientists are downplaying the risk to human health and trying to discredit the IARC report by casting doubt on some of the scientific studies that it reviewed.

Ten of the 16 scientists on the Intertek panel have been consultants for Monsanto in the past and two others are former Monsanto employees, according to a roster published on Monsanto’s website.

“IARC’s goal was just to score the cancer hazard, that’s it. They’ve looked at all the data and they have really convincing evidence,” said Jennifer Sass, senior scientist with the National Resources Defense Council.

“What this panel is trying to do is death by a thousand cuts. They’re taking a good stack of evidence and starting to hack through it to try to kill it,” she said.

— Karl Plume reports on agriculture and ag commodity markets for Reuters from Chicago.

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In reaching the 2A classification, the Working Group’s review of 800 existing epidemiological studies from around the world “concluded that there is limited evidence in human beings for the carcinogenicity of the consumption of red meat,” and that “… no clear association was seen in several of the high-quality studies and residual confounding from other diet and lifestyle risk is difficult to exclude.”

The IARC monograph reported that colorectal cancer was its principle focus relative to red meat and that “a meta-analysis of colorectal cancer in 10 cohort studies reported a statistically significant dose-response relationship, with a 17 per cent increased risk (95 per cent CI 1·05–1·31) per 100 grams per day of red meat.” The American Society of Clinical Oncology has estimated that “a person with an average risk of colorectal cancer has about a five per cent chance of developing colorectal cancer overall.”

By this estimate, consuming 100 grams per day of red meat would increase the risk of colorectal cancer by just under one per cent in absolute terms. The meat industry has previously estimated that, on average, Canadians consume approximately 50 grams of fresh red meat or half this amount. Accordingly, if there is an increase in the potential risk of colorectal cancer from red meat consumption, by these estimates it is small and must be considered relative to the very significant nutritional benefits that red meat provides.

While meat’s very significant nutritional benefits are not considered directly in the IARC evaluation, it did note that “red meat contains high biological value proteins and important micronutrients such as B vitamins, iron (both free iron and haem iron), and zinc.”

The World Health Organization has previously stated that two billion people — over 30 per cent of the world’s population — have anemia, many due to iron deficiency. Beef is among the best food sources of well-absorbed iron. Meat has long provided an important source of nutrients for Canadians and the industry takes pride in providing high-quality beef products to consumers.

There are many theories why red and processed meat may be linked to cancer, however, it’s important to note that no scientific consensus has been reached.

Canadians hear a great deal about what foods we should eat and the perspective from the scientific community can change over time. Certainly cancer is a complex disease with many contributing factors including age, genetics, and lifestyle.

As with so many aspects of daily life achieving the right balance for your individual circumstance is key and we continue to recommend to Canadians that they follow the Government of Canada’s Food Guide.

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The International Agency for Research on Cancer (IARC), a research arm of the World Health Organization, on Monday published a report placing processed meats in its Group 1 category, which includes substances such as tobacco and asbestos with “sufficient evidence” of links to cancer.

The IARC on Monday also put red meat, such as beef, pork and lamb, in its Group 2A — where glyphosate, the active ingredient in Roundup herbicide, was recently also classified as a “probable” carcinogen. (The IARC’s Group 2B, of “possible” carcinogens, recently saw 2,4-D herbicide added to the list.)

In its response Monday to the report, the Canadian Meat Council emphasized that the IARC defines an agent that “may cause cancer at some level, under some circumstance,” as a “cancer hazard.”

However, the CMC said, actual “cancer risk” gauges the likelihood of experiencing cancer after being exposed to a “cancer hazard,” and the IARC identifies such hazards even when the risks are “very low.”

Such findings aren’t unusual for the IARC, the Canadian Cattlemen’s Association said in a separate release, saying the agency “has found hazards in about half of the agents it has reviewed.”

For its 2A classification for red meat, the CCA said, the IARC’s review of existing epidemiological studies “concluded that there is limited evidence in human beings for the carcinogenicity of the consumption of red meat,” and “no clear association was seen in several of the high quality studies and residual confounding from other diet and lifestyle risk is difficult to exclude.”

Colorectal cancer was the IARC report’s “principal focus” relative to red meat, the CCA said. The report had cited 10 cohort studies with a “statistically significant dose–response relationship,” with a 17 per cent increased risk per 100 grams per day of red meat.

Given that the American Society of Clinical Oncology has estimated a person with an “average” risk of colorectal cancer has about a five per cent chance of developing colorectal cancer overall, consuming 100 g per day of red meat would increase the risk of colorectal cancer by just under one per cent in absolute terms, the CCA said.

The meat industry has previously estimated Canadians, on average, eat only about 50 g of fresh red meat per day. Thus, the CCA said, “if there is an increase in the potential risk of colorectal cancer from red meat consumption, by these estimates it is small and must be considered relative to the very significant nutritional benefits that red meat provides.”

“It is regrettable that, in arriving at its split decision, the IARC panel reportedly chose to disregard certain studies which present high quality evidence to the contrary,” CMC president Joe Reda said.

“Furthermore, the agency did not balance its verdict by taking into account either the proven benefits of meat or the substantive implications of removing meat from the diet… Risks and benefits should both be considered before recommending what people eat and drink.” — AGCanada.com Network

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There are two key factors that necessitate regulatory action to protect human health, according to the column: a sharp increase in herbicide applied to widely planted genetically modified (GMO) crops used in food, and a recent World Health Organization (WHO) determination that the most commonly used herbicide, known as glyphosate, is probably a human carcinogen.

The opinion piece was written by Dr. Philip Landrigan, a Harvard-educated pediatrician and epidemiologist who is Dean for Global Health at the Mount Sinai Medical Center in New York, and Chuck Benbrook, an adjunct professor at Washington State University’s crops and soil science department.

“There is growing evidence that glyphosate is geno-toxic and has adverse effects on cells in a number of different ways,” Benbrook said. “It’s time to pull back… on uses of glyphosate that we know are leading to significant human exposures while the science gets sorted out.”

The column argues that GMO foods and herbicides applied to them “may pose hazards to human health” not previously assessed.

“We believe that the time has therefore come to thoroughly reconsider all aspects of the safety of plant biotechnology,” the column states.

The authors also argue that the U.S. Environmental Protection Agency has erred in recently approving a new herbicide that uses glyphosate because it relied on outdated studies commissioned by the manufacturers and gave little consideration to potential health effects in children.

Glyphosate is best known as the key ingredient in Roundup developed by Monsanto, one of the world’s most widely used herbicides, but it is used in more than 700 products.

It is sprayed directly over crops such as corn genetically engineered to tolerate it and is sometimes used on non-GMO crops, like wheat before harvest. Residues of glyphosate have been detected in food and water.

The WHO’s cancer research unit after reviewing years of scientific research from different countries on March 20 classified glyphosate as “probably carcinogenic to humans.”

But regulators and agrichemical companies in the United States and other countries still consider glyphosate among the safest herbicides in use.

In July, Monsanto said it had arranged for an outside scientific review of the WHO finding

— Carey Gillam is a Reuters correspondent covering agriculture and agribusiness from Kansas City.

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