In his ruling, U.S. District Judge William Shubb called California’s cancer warning misleading and said the state’s label is not backed up by regulatory findings.

Regulators worldwide have determined glyphosate to be safe with the exception of the World Health Organization’s cancer research arm, which determined the herbicide to be a “probable carcinogen” in 2015.

Shubb on Monday said that finding alone did not support California’s requirement to label glyphosate products with the term “known to the state of California to cause cancer.”

Bayer in a statement welcomed the decision, calling the ruling very important for California agriculture and for science.

The ruling, which permanently bars California from requiring a cancer warning on glyphosate-based products, is separate from the wider litigation over whether Roundup causes a type of blood cancer.

Bayer, which acquired Roundup with its US$63 billion purchase of Monsanto in 2018, faces lawsuits by more than 52,500 U.S. Roundup users, and juries in three trials have ordered the company to pay billions after finding the product caused cancer. Plaintiffs allege that Bayer manipulated studies and deceived the scientific community.

Bayer, which is appealing the verdicts, denies the claims and insists glyphosate does not cause cancer and is safe for people to use.

The company is pursuing an out-of-court settlement of the litigation, which analysts estimate could result in a US$10 billion agreement.

The office for California Attorney General Xavier Becerra did not immediately respond to a request for comment.

More than a dozen agricultural groups together with Bayer sued California in 2017, saying the warning label threatens significant disruptions to the U.S. food production supply chain if farmers are no longer able to use glyphosate.

— Reporting for Reuters by Tina Bellon in Warwick, Rhode Island; additional reporting by Jonathan Stempel in New York.

The post U.S. court blocks California cancer label on Roundup appeared first on Farmtario.

Bayer is due to host its annual general meeting on April 28 but the company still faces potentially huge litigation risks stemming from its US$63 billion purchase of Monsanto in 2018.

One leading shareholder advisory firm, ISS, on Tuesday backed a motion to support the actions of the management and supervisory board.

“Qualified support for both discharge proposals is warranted as there does not appear to be any evidence that the boards have not fulfilled their fiduciary duties for the 2019 fiscal year,” it said.

Another large advisory group, Glass Lewis, said on April 6 that investors should abstain because of ongoing proceedings regarding pesticide Roundup, acquired via the takeover of Monsanto.

Shares in Bayer have shed more than a quarter of their value since mid-2018 when the company lost a U.S. lawsuit claiming that glyphosate-based Roundup causes cancer.

Bayer denies that glyphosate or Roundup cause cancer and is appealing. The company has received tentative backing from some legal and regulatory experts.

The U.S. Environmental Protection Agency (EPA) also reaffirmed this year that glyphosate was safe.

In December, the U.S. Justice Department said in a so-called amicus brief that a federal appeals court should reverse the lower court verdict finding Bayer liable in a Californian Roundup case.

Major regulators, including those overseeing European and U.S pesticide markets, have deemed it safe but the World Health Organization’s International Agency for Research on Cancer (IARC) concluded in 2015 that glyphosate probably causes cancer.

Glass Lewis said the ongoing proceedings could have a bearing on how the boards’ performance is viewed, so recommended that shareholders abstain from voting on a ratification proposal.

“We continue to believe that shareholders are not currently in a position to meaningfully assess whether the ratification of the acts of management board members for the past fiscal year is currently in their best interests,” it said.

— Reporting for Reuters by Edward Taylor.

The post Proxy advisers split over endorsing Bayer management appeared first on Farmtario.

The federal health department said Friday it has reviewed eight notices of objection received after it released its final re-evaluation decision on glyphosate in April 2017.

The objections were filed with Health Canada in June and July that year by individuals and on behalf of groups including Safe Food Matters, Right On Canada, Environmental Defense Canada and the David Suzuki Foundation, among others.

Health Canada, in a statement Friday, said its scientists “assessed the validity of any studies” raised in the objections, “to determine whether any of the issues raised would influence the results of the assessment and the associated regulatory decision.”

The department also noted “concerns raised publicly about the validity of some of the science around glyphosate in what is being referred to as the Monsanto Papers.”

However, Health Canada said, “we have concluded that the concerns raised by the objectors could not be scientifically supported when considering the entire body of relevant data.”

Furthermore, the department said, “the objections raised did not create doubt or concern regarding the scientific basis for the 2017 re-evaluation decision for glyphosate.”

That re-evaluation, launched back in late 2009 as per routine federal practice for registered pesticides in Canada, ruled in 2017 that products containing glyphosate are “not a concern to human health and the environment” when used following updated label directions.

Crop chemical companies in 2017 were given until late April this year to revise their glyphosate product labels as per Health Canada’s ruling.

Health Canada’s “overall finding” from its re-examination of glyphosate found the product is “not genotoxic and is unlikely to pose a human cancer risk.”

Dietary exposure, via food or drinking water, associated with the use of glyphosate is “not expected to pose a risk of concern to human health,” the department said at the time.

Occupational and residential risks linked with use of glyphosate are also “not of concern, provided that updated label instructions are followed.”

Each notice of objection is to receive a separate response from the department, which will be posted publicly Monday in the public registry of Health Canada’s Pest Management Regulatory Agency (PMRA).

Health Canada said Friday its scientists “left no stone unturned in conducting this review,” having access to “all relevant data and information from federal and provincial governments, international regulatory agencies, published scientific reports and multiple pesticide manufacturers. This includes the reviews referred to in the Monsanto Papers.”

It also had access to “numerous individual studies and raw scientific data during its assessment of glyphosate, including additional cancer and genotoxicity studies.”

To help ensure an “unbiased assessment” of the information, Health Canada said, it chose a group of 20 of its own scientists, none of whom were involved in the 2017 re-evaluation, to evaluate the eight notices of objection.

‘Actual risk’

Glyphosate, which Monsanto (now part of Bayer) first brought to market under the Roundup brand in 1974, has run up against new scrutiny from a human health angle in the past few years.

The International Agency for Research on Cancer (IARC), an arm of the World Health Organization, announced in a 2015 report that it would move glyphosate into its Group 2A — “probably carcinogenic to humans.”

More recently, a California jury last summer found in favour of a school groundskeeper’s claim that glyphosate-based herbicides had caused his cancer and Monsanto failed to warn consumers about the risks. The jury awarded him US$289 million, later reduced to US$78 million.

Health Canada’s re-evaluation, while not related to the IARC report, had described the IARC reclassification of glyphosate as “a hazard classification,” not a health risk assessment.

“This means that the level of human exposure, which determines the actual risk, was not taken into account by IARC.”

‘Industry-manipulated’

The Western Canadian Wheat Growers, in a separate release, said it was “pleased and proud” with Health Canada’s announcement Friday.

“The defense of many modern agriculture practices, like the use of crop protection products, has been exhausting these past few years and its refreshing to see science win this battle,” WCWG director Cherilyn Nagel said in the release.

“The strong language used in the Health Canada statement is clear and it has certainly renewed my faith in our regulatory system.”

Several of the groups who filed objections said jointly Friday they were “disappointed” by Health Canada’s decision, which they said was reached “despite concerning evidence that industry-manipulated science features in the assessment.”

“We maintain that the scientific process at Health Canada appears to have been compromised by manipulated data and flawed analyses,” Annie Berube, director of government relations for Equiterre, said Friday in the groups’ release.

“Today’s decision continues to entrench glyphosate-based agriculture in Canada at the expense of our health and the environment. Meanwhile, other countries like France are implementing plans to phase out glyphosate and encouraging healthier, more sustainable food production.”

Right On Canada, in a separate release last month, noted several groups have called on federal Health Minister Ginette Petitpas Taylor to hold a “new, independent review” of glyphosate. The groups alleged Health Canada’s 2017 review was “scientifically defective and ethically tainted.” — Glacier FarmMedia Network

The post Health Canada dismisses glyphosate objections appeared first on Farmtario.

U.S. District Judge William Shubb said the warnings would be misleading because glyphosate is not known to cause cancer, according to court documents filed on Monday in California. He still allowed the state to keep glyphosate on a list of cancer-causing products.

“Given the heavy weight of evidence in the record that glyphosate is not in fact known to cause cancer, the required warning is factually inaccurate and controversial,” Shubb wrote.

The judge’s decision is important for Monsanto because warnings could discourage use of glyphosate, which is widely used by farmers on genetically engineered crops and by consumers on lawns. The company’s agricultural productivity segment, which includes glyphosate, had net sales of US$3.7 billion in fiscal-year 2017.

Monsanto, which is being acquired by Bayer, and U.S. farm groups sued California in November to stop the warnings.

The state added glyphosate, the main ingredient in Monsanto’s herbicide Roundup, to its list of cancer-causing chemicals in July 2017 and had planned to require that products containing the chemical carry warnings by July 2018.

California’s Office of Environmental Health Hazard Assessment (OEHHA) said on Tuesday its actions were lawful and that it was pleased the judge denied Monsanto’s request for an injunction against including glyphosate on the list.

The state acted after the World Health Organization’s International Agency for Research on Cancer (IARC) concluded in 2015 that glyphosate was “probably carcinogenic.”

Other studies have found the opposite, including one released by the U.S. Environmental Protection Agency in December.

A large, long-term study on glyphosate use by U.S. agricultural workers, published in November as part of a project known as the Agricultural Health Study, or AHS, also found no firm link between exposure to glyphosate and cancer.

Reuters reported in June that an influential scientist was aware of new AHS research data while he was chairing a panel of experts reviewing evidence on glyphosate for IARC in 2015. He did not tell the panel about it.

“Glyphosate is a vital tool that growers have trusted to provide safe, affordable food,” said Chandler Goule, CEO for the National Association of Wheat Growers.

— Tom Polansek reports on agriculture and agribusiness for Reuters from Chicago.

The post U.S. judge halts California plan for warnings on glyphosate appeared first on Farmtario.

After months of indecisive votes among the 28 member states in Brussels, Germany, whose Chancellor Angela Merkel has yet to form a new coalition after a September election, came off the fence after abstaining in previous meetings. It said it backed a European Commission proposal against the wishes of France.

The Commission, the European Union’s executive, said in a statement that 18 countries had backed its proposal to renew the chemical’s licence. Nine countries were against and one abstained, giving a “positive opinion” by the narrowest possible margin under rules requiring more than a simple majority.

The extension was opposed by Germany’s centre-left Social Democrats (SPD), with which Merkel is expected to launch exploratory talks this week on renewing their “grand coalition” after plans for an alliance with two other parties failed.

French President Emmanuel Macron, who was elected in May on a platform of pursuing deeper EU integration alongside Germany, had wanted a shorter extension and a rapid phasing out of glyphosate, which is a mainstay of farming across the continent.

After the vote, he said he would take all necessary measures to ban the product, originally developed by Monsanto, as soon as an alternative is available and at the latest within three years. Monsanto declined to comment.

Despite the EU’s five-year extension, its rules allow France to unilaterally ban the substance. France has already decided to do so for private individuals in 2019.

‘Collective responsibility’

Europe has been wrestling for the past two years over what to do with the chemical, the active ingredient in Monsanto’s top-selling Roundup, whose licence was set to expire on Dec. 15.

The chemical has been used by farmers for more than 40 years, but its safety was cast into doubt when a World Health Organization agency, the International Agency for Research on Cancer (IARC), concluded in 2015 it probably causes cancer.

The European Union agreed to roll over the licence for 18 months pending the results of a study by the European Chemicals Agency, which said in March this year that there was no evidence linking glyphosate to cancer in humans.

Protest groups, however, seized on the IARC report, questioned the science in other studies and complained about the influence of big business.

“The people who are supposed to protect us from dangerous pesticides have failed to do their jobs and betrayed the trust Europeans place in them,” Greenpeace said after Monday’s vote.

In theory, the Commission could have pushed through a licence extension, but it said it wanted governments to make the call on an issue that has become so politically charged. After a series of indecisive votes, they finally produced a clear majority in favour of the Commission’s proposal.

“Today’s vote shows that when we all want to, we are able to share and accept our collective responsibility in decision-making,” said health and food safety commissioner Vytenis Andriukaitis.

Farmers’ association Copa-Cogeca said it was glad a decision had been taken, but regretted the licence renewal had not been for 15 years given strong scientific evidence from EU agencies.

The key swing vote came from Germany, whose government is operating in an acting capacity following the indecisive election. Berlin abstained earlier, but threw its weight behind a decision opposed by France.

Poland, Bulgaria and Romania all did likewise, leaving only Portugal still on the fence on Monday. Had any of the others continued to abstain, deadlock would have gone on. An extension required 16 states representing 65 per cent of the EU population to vote in favour. The 18 supporters account for 65.7 per cent.

The German vote exposed internal divisions in Berlin ahead of this week’s coalition talks. Environment Minister Barbara Hendricks, an SPD lawmaker, accused the chancellor’s centre-right group of reneging on a deal to continue abstaining.

French Agriculture Minister Stephane Travert told reporters that Paris would push to change farming practices that embraced alternatives to glyphosate, so that its use could be ended.

— Reporting for Reuters by Philip Blenkinsop in Brussels; additional reporting by Peter Maushagen in Brussels, Sybille de La Hamaide in Paris and Thorsten Severin and Andreas Rinke in Berlin.

The post Germany swings EU vote in favour of glyphosate appeared first on Farmtario.

The International Agency for Research on Cancer (IARC), a semi-autonomous unit of the WHO, is currently under scrutiny by influential members of the United States Congress, who in the past year have launched investigations into the way it conducts its assessments.

Led by Wild since 2009, IARC wields great influence with its classifications of carcinogens. It describes its mission as “to coordinate and conduct research on the causes of human cancer, the mechanisms of carcinogenesis, and to develop scientific strategies for cancer control”.

A job advert posted on IARC’s website invited candidates to send applications to the WHO’s director-general, Tedros Adhanom Ghebreyesus, by a deadline of mid-February 2018.

It said the new IARC director would be appointed in May 2018 for a five-year term starting Jan. 1, 2019. The candidate may be eligible for one further five-year term, it added.

A spokesman for the WHO’s headquarters in Geneva declined to give details on the timing of or reason for the job posting, but said it “should be a regular turnover”. He referred further questions to IARC, but IARC did not respond to Reuters emails.

Known as Monographs, IARC’s assessments are designed to review scientific evidence and classify whether a substance can cause cancer in people.

They have prompted some controversy, with critics accusing IARC of lacking transparency and being too quick to conclude that substances might cause cancer, sparking unnecessary health scares.

IARC is also at odds with the European Food Safety Authority (EFSA) and U.N. and U.S. regulators over glyphosate, a widely used weedkiller developed by Monsanto.

Wild has defended IARC’s work, saying the Monographs are “widely respected for their scientific rigour, standardised and transparent process and … freedom from conflicts of interest”.

The post WHO seeks new director for cancer agency facing U.S. scrutiny appeared first on Farmtario.

Documents seen by Reuters show how a draft of a key section of the International Agency for Research on Cancer’s (IARC) assessment of glyphosate — a report that has prompted international disputes and multi-million-dollar lawsuits — underwent significant changes and deletions before the report was finalized and made public.

IARC, based in Lyon, France, wields huge influence as a semi-autonomous unit of the WHO, the United Nations health agency. It issued a report on its assessment of glyphosate — a key ingredient in Monsanto’s top-selling herbicide Roundup — in March 2015. It ranked glyphosate a Group 2a carcinogen, a substance that probably causes cancer in people.

That conclusion was based on its experts’ view that there was “sufficient evidence” glyphosate causes cancer in animals and “limited evidence” it can do so in humans. The Group 2a classification has prompted mass litigation in the U.S. against Monsanto and could lead to a ban on glyphosate sales across the European Union from the start of next year.

The edits identified by Reuters occurred in the chapter of IARC’s review focusing on animal studies. This chapter was important in IARC’s assessment of glyphosate, since it was in animal studies that IARC decided there was “sufficient” evidence of carcinogenicity.

One effect of the changes to the draft, reviewed by Reuters in a comparison with the published report, was the removal of multiple scientists’ conclusions that their studies had found no link between glyphosate and cancer in laboratory animals.

In one instance, a fresh statistical analysis was inserted — effectively reversing the original finding of a study being reviewed by IARC.

In another, a sentence in the draft referenced a pathology report ordered by experts at the U.S. Environmental Protection Agency. It noted the report “firmly” and “unanimously” agreed that the “compound” — glyphosate — had not caused abnormal growths in the mice being studied. In the final published IARC monograph, this sentence had been deleted.

Reuters found 10 significant changes that were made between the draft chapter on animal studies and the published version of IARC’s glyphosate assessment. In each case, a negative conclusion about glyphosate leading to tumors was either deleted or replaced with a neutral or positive one. Reuters was unable to determine who made the changes.

IARC did not respond to questions about the alterations. It said the draft was “confidential” and “deliberative in nature.” After Reuters asked about the changes, the agency posted a statement on its website advising the scientists who participate in its working groups “not to feel pressured to discuss their deliberations” outside the confines of IARC.

Reuters contacted 16 scientists who served in the IARC expert working group that conducted the weedkiller review to ask them about the edits and deletions. Most did not respond; five said they could not answer questions about the draft; none was willing or able to say who made the changes, or why or when they were made.

The chairman of the IARC sub-group tasked with reviewing evidence of glyphosate’s effect on laboratory animals was Charles Jameson, an American toxicologist. In testimony as part of personal-injury lawsuits against Monsanto in the U.S., Jameson told lawyers for Monsanto he did not know when, why or by whom the edits had been made.

Monsanto is facing multiple legal claims in the U.S. from plaintiffs who allege glyphosate gave them or their loved ones cancer. Jameson is an expert witness for the plaintiffs. He did not respond to questions for this article.

Scott Partridge, Monsanto’s vice-president of global strategy, told Reuters the changes to the draft showed how “IARC members manipulated and distorted scientific data” in their glyphosate assessment.

IARC declined to comment.

Numerous national and international agencies have reviewed glyphosate. IARC is the only one to have declared the substance a probable carcinogen. Compared with other agencies, IARC has divulged little about its review process. Until now, it has been nearly impossible to see details, such as draft documents, of how IARC arrived at its decision.

The European Food Safety Authority (EFSA) said that in its assessment of the weedkiller, the scientific decision-making process “can be traced from start to finish.” Jose Tarazona, head of EFSA’s pesticides unit, told Reuters: “Anyone can go to EFSA’s website and review how the assessment evolved over time. So you can see clearly how experts… appraised each and every study and also how comments from the public consultation were incorporated into the scientific thinking.”

In the U.S., the Environmental Protection Agency published a full 1,261-page transcript of a three-day scientific advisory panel meeting on its ongoing evaluation of the carcinogenic potential of glyphosate in December 2016.

No such record of the deliberations behind IARC’s monographs is published.

In a previous response to questions about the transparency of the IARC process, the agency’s director, Chris Wild, referred Reuters to a letter in which he said his agency’s assessments are “widely respected for their scientific rigor, standardized and transparent process.” Wild also said IARC’s methods are intended to allow scientists to engage in free scientific debate at its monograph meetings.

Deletions and additions

IARC says its working group scientists are selected for “their expertise and the absence of real or apparent conflicts of interest.” For the panel that evaluated glyphosate and four other pesticides in what is known as IARC’s Monograph 112, scientists from 11 countries met at the agency’s headquarters in Lyon for a week-long meeting starting on March 3, 2015. The meeting “followed nearly a year of review and preparation” by IARC staff and working group members, “including a comprehensive review of the latest available scientific evidence,” IARC said in a statement at the time.

In June, Reuters reported how the chairman of the IARC working group was aware of new data showing no link between glyphosate and cancer in humans, but the agency did not take it into account because it had not been published.

No drafts of IARC’s glyphosate assessment have surfaced before. However, a draft was obtained by Monsanto as part of the legal proceedings in the United States. Reuters reviewed chapter 3, the section on animal studies, which is the only section no longer covered by a confidentiality order of the court.

The glyphosate review in IARC’s Monograph 112 runs to 92 pages; the chapter on animal studies consists of just over 10 pages. Reuters has not seen any other sections of the draft and cannot say whether they also underwent significant edits.

In comparing draft and final versions of chapter 3, Reuters found that in several instances comments in the draft were removed; the comments noted that studies had concluded glyphosate was not carcinogenic. They were replaced in the final version with the sentence: “The Working Group was not able to evaluate this study because of the limited experimental data provided in the review article and supplemental information.”

This sentence was inserted six times into the final version. Each time it replaced a contrary conclusion, noted in the draft, by the original investigators on the study being considered, such as: “The authors concluded that glyphosate was not carcinogenic in Sprague Dawley rats”; “The authors concluded that glyphosate technical acid was not carcinogenic in Wistar rats”; and “The authors concluded that glyphosate was not carcinogenic in CD-1 mice in this study.”

Reuters also found changes to the conclusions and statistical significance of two mouse studies. These studies were cited in IARC’s ultimate finding of “sufficient” evidence that glyphosate causes cancer in animals.

One edit concerned a 1983 study in mice. IARC’s published monograph contains a fresh statistical analysis calculation as part of its review of that study. The original investigators found no statistically significant link between glyphosate and cancer in the mice. IARC’s new calculation reached the opposite conclusion, attributing statistical significance to it.

This new calculation was inserted into the final published assessment, but was not in the draft version seen by Reuters. The change gave the working group more evidence on which to base its conclusion that glyphosate was probably carcinogenic.

In further discussion of the same 1983 study, IARC’s final published report refers to expert pathologists on a panel commissioned to reanalyze the work of the original investigators. The IARC draft notes that these pathologists “unanimously” agreed with the original investigators that glyphosate was not related to potentially precancerous tissue growths in the mice. IARC’s final report deletes that sentence.

Reviewing a second mouse study, the IARC draft included a comment saying the incidence of a type of animal cancer known as haemangiosarcoma was “not significant” in both males and females. IARC’s published monograph, by contrast, inserts a fresh statistical analysis calculation on the data in male mice, and concludes that the findings were statistically significant.

Influential monograph

IARC’s assessment that glyphosate is a probable human carcinogen is an outlier. In the 40 or so years since the weedkiller first came to the market, glyphosate has been repeatedly scrutinized and judged safe to use.

A year after IARC issued its evaluation, a joint United Nations and World Health Organization panel reviewed the potential for glyphosate in food to cause cancer in people. It concluded the weedkiller was “unlikely to pose a carcinogenic risk to humans.”

The U.S. Environmental Protection Agency, which first assessed glyphosate in the 1980s and has reviewed it several times since, says it has “low toxicity for humans.” The European Food Safety Authority and the European Chemicals Agency, which advise the 28 members of the EU, have also assessed glyphosate within the past two years and ruled it safe.

But IARC’s Monograph 112 has had great influence.

It is weighing heavily on a pending European Union decision — due by the end of the year and possibly to be made next week — on whether glyphosate should be relicensed for sale across the 28 member states. France, one of the bloc’s agricultural powerhouses, has said it wants the weedkiller phased out and then banned, provoking protests by its vocal farmers, who argue glyphosate is vital to their business.

A failure to renew glyphosate’s license by the end of the year would see an EU ban kick in on Jan. 1, 2018.

In the U.S., Monsanto — the firm that first developed and marketed glyphosate — is facing litigation in California involving at least 184 individual plaintiffs who cite the IARC assessment and claim exposure to RoundUp gave them a form of cancer known as non-Hodgkin lymphoma. They allege Monsanto failed to warn consumers of the risks. Monsanto denies the allegations. The case is ongoing.

Members of the U.S. Congress, concerned about what they described as IARC’s “inconsistent” standards and determinations for classifying substances as carcinogenic, last year launched investigations into American taxpayer funding of IARC. The investigations are ongoing.

In Europe, IARC has become embroiled in a public spat with experts at the European Food Safety Authority, which conducted its own review of glyphosate in November 2015 and found it “unlikely to pose a carcinogenic hazard to humans.”

With IARC monograph meetings, some outside observers are selected and allowed to witness proceedings, but they are banned from talking about what goes on. Journalists are generally not allowed in.

Last year, Reuters reported on an email sent by IARC to the experts on its glyphosate working group in which the agency advised them not to discuss their work or disclose documents. The email said IARC “does not encourage participants to retain working drafts or documents after the monograph has been published.”

Reuters sent questions about the draft version of the glyphosate assessment to members of the IARC working group that assessed the herbicide as well as to the head of IARC’s monograph program, Kurt Straif, and to Kathryn (Kate) Guyton, the staffer responsible for the glyphosate review. IARC responded by posting the following message on its website:

“Members of the IARC Monograph Working Group which evaluated glyphosate in March 2015 have expressed concern after being approached by various parties asking them to justify scientific positions in draft documents produced during the Monographs process. IARC would like to reiterate that draft versions of the Monographs are deliberative in nature and confidential. Scientists should not feel pressured to discuss their deliberations outside this particular forum.”

IARC answered none of Reuters’ specific questions about changes to the draft.

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

The post In glyphosate review, WHO cancer agency edited out ‘non-carcinogenic’ findings appeared first on Farmtario.

A transatlantic row over possible risks to human health has prompted investigations by congressional committees in the U.S., and in Europe has forced a delay to a re-licensing decision for Monsanto’s big-selling Roundup herbicide.

A new study issued in March by the European Chemical Agency (ECHA) paved the way for the Commission’s decision to restart negotiations with EU nations over renewing the licence for glyphosate, despite opposition from environmental groups.

The EU body, which regulates chemicals and biocides, said glyphosate, the key ingredient in Roundup, should not be classified as a substance causing cancer.

A spokeswoman for the Commission said it had “taken into account the latest state of scientific research and would “work with the member states to find a solution that enjoys the largest possible support.”

No date has yet been set for when discussions with representatives of EU member states will start.

Pending the results of the ECHA study, the EU granted an 18-month extension last July of its approval for the weed killer after a proposal for full licence renewal met opposition from member states and campaign groups.

While the World Health Organization’s cancer agency, the International Agency for Research on Cancer (IARC), classifies glyphosate as “probably carcinogenic,” many other government regulators, including in the U.S., see the herbicide as unlikely to pose a cancer risk to humans.

The European Food Safety Authority (EFSA), which has found that glyphosate is “unlikely to pose a carcinogenic hazard to humans,” welcomed ECHA’s opinion on Wednesday, as did lobby groups for farmers, who make wide use of products containing glyphosate.

But environmental groups said doubts remain over its safety.

“It makes no sense to accept the wide range of risks associated with glyphosate,” said Bart Staes, a Green group member of the European Parliament.

The decision to seek a 10-year rather than a longer approval was also criticized by supporters of the herbicide. The European Crop Protection group called it “short-sighted,” saying it pandered to activists.

According to data published by IARC, glyphosate was registered in over 130 countries as of 2010 and is one of the world’s most heavily used weed killers.

Analysts have estimated that Monsanto could lose out on up to US$100 million of sales if glyphosate was banned in Europe.

— Reporting for Reuters by Alissa de Carbonnel in Brussels.

The post EU to propose 10-year licence renewal for glyphosate appeared first on Farmtario.

The re-evaluation, launched in late 2009 in a standard federal practice for registered pesticides in Canada, has ruled that products containing glyphosate — when used following the new label directions — are “not a concern to human health and the environment.”

The federal health department’s final re-evaluation decision, released Friday, sticks close to the decision it first proposed and released for public comment in April 2015.

The proposed new label updates — which marketers of commercial products containing glyphosate must include on labels “no later than 24 months” from Friday — are meant to “help provide additional protection to humans and the environment.”

The new labels must include a statement that people’s re-entry into glyphosate-sprayed farm fields should be restricted to 12 hours after application.

A statement must also be added to labels that the product is to be applied “only when the potential to spread to areas of human activity, such as houses, cottages, schools and recreational areas, is minimal.”

The new labels must also include “instructions for spray buffer zones to protect non-targeted areas and aquatic habitats from unintended exposure,” plus “precautionary statements to reduce the potential for runoff of glyphosate into aquatic areas.”

Health Canada’s “overall finding” from its re-examination of glyphosate found the product is “not genotoxic and is unlikely to pose a human cancer risk.”

Dietary exposure, via food or drinking water, associated with the use of glyphosate is “not expected to pose a risk of concern to human health,” the department added.

Occupational and residential risks linked with use of glyphosate are also “not of concern, provided that updated label instructions are followed.”

Spray buffer zones, however, “are necessary to mitigate potential risks to non-target species” such as vegetation near treated areas, aquatic invertebrates and fish, due to spray drift.

Used according to revised label directions, glyphosate products “are not expected to pose risks of concern to the environment,” the department added.

All currently registered glyphosate uses, Health Canada said, “have value for weed control in agriculture and non-agricultural land management.”

Glyphosate, which crop chemical and seed firm Monsanto first brought to market under the Roundup brand in 1974, has run up against new scrutiny from a human health angle in the past couple of years.

The International Agency for Research on Cancer (IARC), an arm of the World Health Organization, announced in a 2015 report that it would move glyphosate into its Group 2A — “probably carcinogenic to humans.”

Health Canada’s re-evaluation, while not related to the IARC report, described the agency’s reclassification of glyphosate as “a hazard classification and not a health risk assessment.

“This means that the level of human exposure, which determines the actual risk, was not taken into account by IARC.” — AGCanada.com Network

The post Glyphosate clears Health Canada re-evaluation appeared first on Farmtario.

A row over possible effects of glyphosate — an ingredient in Monsanto’s herbicide Roundup — has prompted investigations by congressional committees in the U.S. and forced a delay in Europe to a decision on whether it should be banned or re-licensed for sale.

Giving details and preliminary findings of the latest study to Reuters, Italian scientist Fiorella Belpoggi said experimental rats exposed to the herbicide at levels equivalent to those allowed in humans showed no initial adverse reaction.

“Exposed animals had no evident differences from non-exposed animals,” Belpoggi, who is director of the Cesare Maltoni Cancer Research Centre at the Ramazzini Institute in Italy, said in a telephone interview.

“But this tells us very little at the moment, because the examinations of key parameters that could be affected by exposure are still being done (and) we are waiting for those results,” Belpoggi added.

Those parameters include any genetic changes, as well as potential toxic effects on measures related to fertility, such as sperm, embryo development and offspring growth, she said.

Argument over glyphosate centres on whether it is carcinogenic. Scientists at the International Agency for Research on Cancer (IARC) say it probably does cause cancer, putting them at odds with scientists at the European Food Safety Authority, the U.S. Environmental Protection Agency and multiple other safety and regulatory agencies around the world, who say it likely doesn’t.

Congressional committees in the U.S. have raised questions about the work and funding of IARC, which is based in Lyon, France, and the Ramazzini Institute, based in Bologna.

IARC and Ramazzini defend the independence of their work and say their research is conducted to the highest scientific standards.

Decades of research

A spokesman for Monsanto said: “There are nearly a thousand scientific studies from decades of research that are already available to every regulatory agency in the world, which have all concluded that glyphosate is safe to use.”

According to data published by IARC, glyphosate was registered in more than 130 countries as of 2010 and is one of the most heavily used weedkillers in the world. Analysts have estimated Monsanto could lose out on up to US$100 million of sales if glyphosate were banned in Europe.

Belpoggi said her team decided to conduct their trial to produce fresh, independent results in an effort to settle differences over glyphosate’s health effect.

But she stressed that due to time constraints, the study is not able to analyse the weed killer’s potential carcinogenicity, which would take several years to research properly, given the time any tumours might take to develop and grow.

“We are focused on reproductive and developmental issues, in other words, whether glyphosate… affects the development of embryos, foetuses and pups,” she said.

Chemicals that can affect hormones and reproduction are known as endocrine disruptors and, like carcinogens, are subject to strict regulations in the European Union.

This study involves scientists working at five laboratories, Belpoggi’s and one other in Italy, and three outside the country. “This was to ensure we would have the best experts analyze each end point,” Belpoggi said. The study is funded by the Ramazzini Institute, a research co-operative of around 28,000 members who are its co-owners and raise funds for its work.

Using laboratory rodents known as Sprague Dawley rats, the researchers exposed them to low levels of glyphosate and its formulation Roundup in their diet, equivalent to U.S. acceptable daily intake (ADI) levels permitted in humans.

The U.S. ADI for glyphosate is 1.75 milligrams per kilogram of body weight per day while the European Union ADI for consumers is 0.5 milligrams per kilogram of body weight.

Full results should be available by June, Belpoggi said, and will be submitted in a paper for peer review and publication in a scientific journal. A draft copy of the results will be sent at the same time to the European Commission.

The Commission has said it expects to restart talks with EU member states by August on re-approving the use of glyphosate in herbicides. A decision is due before the end of 2017.

“We would like to have the results in time to help regulators have a good judgment about this chemical,” Belpoggi said. “If it is negative (no effect), then I will be happy because I am also exposed. But if there is some damage, then we would like everyone to know.”

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

The post New study on glyphosate to feed into crucial EU vote appeared first on Farmtario.