The formal comments were filed by Monsanto with the state’s Office of Environmental Health Hazard Assessment (OEHHA), part of California’s environmental regulatory office, on the final day the state accepted public comments about its intention to list glyphosate as a cause of cancer.

Glyphosate is the main ingredient in Monsanto’s Roundup herbicide as well as many other herbicides.

The OEHHA gave notice in September that it intended to list glyphosate under Proposition 65, a state initiative enacted in 1986 to inform residents about cancer-causing chemicals. State officials said the action is required after the World Health Organization’s (WHO) cancer research committee in March classified glyphosate as a probable human carcinogen.

The WHO’s research unit said it reviewed many scientific studies, including two out of Sweden, one out of Canada and at least three in the U.S. before making its classification.

Roughly 8,000 comments were filed regarding the state action, according to officials, including those from Monsanto.

Listing glyphosate as a cancer cause “has the potential to deny farmers and public agencies the use of this highly effective herbicide,” Monsanto said in its public filing. “Global regulatory authorities… agree that glyphosate is not carcinogenic.”

Others applauded California’s effort to list glyphosate as a cause of cancer. On Monday, several farming, public health and environmental groups sent a letter to OEHHA supporting the listing, and said that rising use of glyphosate presents a danger to people and animals.

Glyphosate was introduced in 1974 and is the key ingredient in Monsanto’s branded Roundup line of herbicides, as well as hundreds of other products. It is registered in more than 160 countries, and has been embraced by farmers, homeowners and others because of its efficacy in killing tough weeds.

But many scientific studies have raised questions about the health impacts of glyphosate and consumer and medical groups have expressed worries about glyphosate residues on food.

Since the WHO classification, the New York-based mass-tort firm of Weitz and Luxenberg and other firms representing U.S. farm workers have filed lawsuits against Monsanto, accusing the company of knowing of the dangers of glyphosate for decades.

Monsanto has said the claims are without merit.

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

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The latest lawsuit was filed Wednesday in Delaware Superior Court by three law firms representing three plaintiffs.

The lawsuit is similar to others filed last month in New York and California accusing Monsanto of long knowing that the main ingredient in Roundup, glyphosate, was hazardous to human health. Monsanto “led a prolonged campaign of misinformation to convince government agencies, farmers and the general population that Roundup was safe,” the lawsuit states.

The litigation follows a declaration in March from the World Health Organization’s cancer agency that there was sufficient evidence to classify glyphosate as “probably carcinogenic to humans.”

“We can prove that Monsanto knew about the dangers of glyphosate,” said Michael McDivitt, whose Colorado-based law firm is putting together cases for 50 individuals. “There are a lot of studies showing glyphosate causes these cancers.”

The firm held town hall gatherings in August in Kansas, Missouri, Iowa and Nebraska seeking clients.

Monsanto said the WHO classification is wrong and that glyphosate is among the safest pesticides on the planet.

“Glyphosate is not a carcinogen,” company spokeswoman Charla Lord said in an emailed statement. “The most extensive worldwide human health databases ever compiled on an agricultural product contradict the claims in the suits.”

Roundup is used by farmers, homeowners and others around the globe and brought Monsanto US$4.8 billion in revenue in its fiscal 2015. But questions about Roundup’s safety have dogged the company for years.

Attorneys who have filed or are eying litigation cited strong evidence that links glyphosate to non-Hodgkin lymphoma (NHL). They said claims will likely be pursued collaboratively as mass tort actions.

To find plaintiffs, the Baltimore firm of Saiontz and Kirk advertises a “free Roundup lawsuit evaluation” on its website. The Washington, D.C. firm Schmidt and Clark is doing the same, as are other firms in Texas, Colorado and California.

One plaintiff in the Delaware lawsuit, Joselin Barrera, 24, a child of migrant farm workers, claims her NHL is related to glyphosate exposure. Elias de la Garza, a former migrant farm worker and landscaper diagnosed with NHL, has a similar claim. Both live in Texas.

The third plaintiff is Judi Fitzgerald, a horticultural worker diagnosed with leukemia in 2012. The Virginia resident joined the Delaware case after asking for dismissal of a similar lawsuit initially filed in federal court in New York.

Monsanto is also fending off claims over its past manufacturing of polychlorinated biphenyls (PCBs), which the WHO classifies as known carcinogens.

At least 700 lawsuits against Monsanto or Monsanto-related entities are pending, brought by law firms on behalf of people who claim their non-Hodgkin lymphoma was caused by exposure to PCBs that the company had manufactured until the late 1970s.

— Carey Gillam is a Reuters correspondent in Kansas City.

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The company, which said it expected low prices for agricultural products to squeeze results well into 2016, also reported a much wider quarterly loss and gave an outlook below many analysts’ expectations.

The layoffs would affect 11.6 per cent of Monsanto’s regular workforce, according to the company.

The global restructuring will also include an exit from the sugarcane business and “streamlining and reprioritizing” some commercial and research and development work.

To try to shore up investor confidence, the company announced a $3 billion accelerated share repurchase program that chairman Hugh Grant said would be completed in the next six months (all figures US$).

Monsanto said it expected to incur restructuring costs of $850 million to $900 million. When completed, the moves should help save as much as $400 million a year.

The restructuring, which caps a year when Monsanto’s sales fell more than five per cent, comes during an agricultural slump and a currency collapse in the important Brazilian market.

Swiss rival Syngenta, which Monsanto had tried to acquire over the summer, has said it is trying to bolster its bottom line by selling a vegetable seed business and undertaking a $2 billion share repurchase. And DuPont, which operates agricultural seed seller DuPont Pioneer, has lowered its profit outlook.

Monsanto forecast earnings per share of $5.10 to $5.60 for its new fiscal year, which began on Sept. 1. That’s well below many analysts’ expectations for more than $6.

The company said its losses widened to $1.06 a share in the fourth quarter ended on Aug. 31 from 31 cents a year earlier.

Sales of corn seeds and traits, Monsanto’s key products, fell five per cent to $598 million in the quarter. And sales at the company’s agricultural productivity unit, which includes Roundup herbicide, dropped 12 per cent to $1.1 billion.

Despite the bleak results, Grant said the company’s fundamentals were strong.

Monsanto will remain focused on achieving growth targets for its core seeds and traits business and be “disciplined” with its herbicide business, he said.

The company said it would still meet its target of more than doubling fiscal 2014 earnings per share, excluding special items, by 2019.

Strong demand for corn and soybeans remains a key fundamental for Monsanto, Grant said.

The company has particularly high hopes for new soybeans, corn and cotton that can be sprayed with a new combination of Monsanto’s glyphosate-based Roundup and dicamba herbicides. The combination is aimed at combating widespread weed resistance to glyphosate.

Monsanto still needs final regulatory approvals but advance orders for Roundup Ready Xtend soybeans were on track to sell out by early December, company officials said. It expects pricing at a $5- to $10-an-acre premium.

Monsanto also wants to expand sales of agricultural digital data products designed to help farmers boost crop yields. It will soon start field trials in Brazil, officials said.

While farmers have shown interest in the new software and hardware data products offered by Monsanto and several competitors, they have been reluctant to pay for them.

Monsanto also said Wednesday it plans to close its sugarcane operations in Brazil, where it had operated under the CanaVialis brand, and focus on seed and crop protection in that country.

At Tuesday’s close, Monsanto stock had dropped roughly 30 per cent from a high set last February. The company’s growth strategy has under intense investor scrutiny after the failed Syngenta takeover attempt.

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

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The lawsuits come six months after the World Health Organization’s cancer research unit said it was classifying glyphosate, the active weed-killing ingredient in Roundup and other herbicides, as “probably carcinogenic to humans.”

One suit, filed in U.S. District Court in Los Angeles on Sept. 22, names as plaintiff 58-year-old Enrique Rubio, a former farm worker in California, Texas and Oregon who over several years laboured in fields of cucumbers, onions and other vegetable crops.

His duties included spraying fields with Roundup and other pesticides before Rubio was diagnosed with bone cancer in 1995, the lawsuit states.

A separate lawsuit making similar claims was filed the same day in federal court in New York by Judi Fitzgerald, 64, who claims she was exposed in the 1990s to Roundup when she worked at a horticultural products company. Fitzgerald was diagnosed with leukemia in 2012.

Attorney Robin Greenwald, one of the attorneys who brought Rubio’s case, said on Tuesday that she expects more lawsuits to follow because Roundup is the most widely used herbicide in the world and the WHO cancer classification gives credence to long-held concerns about the chemical.

“I believe there will be hundreds of lawsuits brought over time,” said Greenwald.

Monsanto spokeswoman Charla Lord said the claims are without merit and that glyphosate is safe for humans when used as labeled.

“Decades of experience within agriculture and regulatory reviews using the most extensive worldwide human health databases ever compiled on an agricultural product contradict the claims in the suit which will be vigorously defended.”

The lawsuits claim that Roundup was a “defective” product and “unreasonably dangerous” to consumers, and that Monsanto knew or should have known that glyphosate could cause cancer and other illnesses and injuries, failing to properly warn users of the risks.

The lawsuits claim the Environmental Protection Agency changed an initial classification for glyphosate from “possibly carcinogenic to humans” to “evidence of non-carcinogenicity in humans” after pressure from Monsanto.

WHO scientists cited several studies showing cancer links to glyphosate, though Monsanto has said the findings are wrong.

Since the WHO unit’s statement, some product liability lawyers have been seeking out plaintiffs for potential class-action lawsuits over glyphosate, postings on legal websites show.

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

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The ruling by the U.S. Court of Appeals for the Ninth Circuit, in San Francisco, is significant for commercial beekeepers and others who say a dramatic decline in bee colonies needed to pollinate key food crops is tied to widespread use of a class of insecticides known as neonicotinoids. Critics say the Environmental Protection Agency is failing to evaluate the risks thoroughly.

The lawsuit was filed in 2013 against the EPA by organizations representing the honey and honey beekeeping industry. The groups specifically challenged EPA approval of insecticides containing sulfoxaflor, saying studies have shown they are highly toxic to honey bees.

Dow AgroSciences first sought EPA approval for sulfoxaflor in 2010 for use in three products. Brand names include Transform and Closer.

“It’s a complete victory for the beekeepers we represent,” said Greg Loarie, an attorney who represents the American Honey Producers Association, the American Beekeeping Federation and other plaintiffs in the case. “The EPA has not been very vigilant.”

Dow said in a statement that it “respectfully disagrees” with ruling and will “work with EPA to implement the order and to promptly complete additional regulatory work to support the registration of the products.”

The EPA said it was reviewing the court’s decision and would have no further comment.

California’s Department of Pesticide Regulation issued a statement Thursday noting that it has long had concerns about sulfoxaflor’s impact on bees and has never allowed unconditional registration in that key farming state.

Honeybees pollinate plants that produce roughly a quarter of the food consumed by Americans. The demise of the bees has become a hotly debated topic between agrichemical companies, which say the insecticides they sell are not to blame, and those who say research shows a direct connection between neonicotinoids and large bee die-offs.

The White House has formed a task force to study the issue and the EPA has said it is trying to address concerns.

In its ruling, the court found that the EPA relied on “flawed and limited data” to approve the unconditional registration of sulfoxaflor, and that approval was not supported by “substantial evidence.”

Dow had asked the EPA to approve sulfoxaflor for use on a variety of crops, including citrus, cotton, canola, strawberries, soybeans and wheat.

The EPA analyzed studies and data provided by Dow about the effects of sulfoxaflor on various species, including bees, and initially proposed several conditions on approval due to insufficient data provided by Dow, the court found.

However, in May 2013 the EPA decided to go ahead with unconditional registration even though the record revealed Dow never completed additional requested studies, the ruling stated.

In vacating the EPA approval, the court said that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.”

The EPA must obtain further data regarding the effects of sulfoxaflor on bees as required by EPA regulations before it grants approval, the court said.

The U.S. Department of Agriculture said earlier this year that losses of managed honeybee colonies hit 42.1 per cent from April 2014 through April 2015, up from 34.2 per cent for 2013-14, and the second-highest annual loss to date.

In Canada, Dow picked up full federal registration in June this year for sulfoxaflor as an active ingredient in Closer, Transform, Twinguard and Isoclast insecticides.

According to Health Canada, sulfoxaflor is a nicotinic acetylcholine receptor agonist, like neonicotinoids, but has a different mode of action, which puts it in the sulfoximine class.

In its registration decision, Health Canada’s Pest Management Regulatory Agency said that while sulfoxaflor is “unlikely to pose a risk to bee colonies, it may pose a potential risk to adult foraging bees exposed directly to spray droplets or to fresh residues on plants.”

Those effects, PMRA said, “are relatively short-lived, lasting approximately three days or less. When the risk reduction measures included on the label are followed, risks to bees are considered to be acceptable.”

— Carey Gillam is a Reuters correspondent covering agribusiness from Kansas City. Includes files from AGCanada.com Network staff.

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Syngenta shares fell more than 18 per cent on the news, while Monsanto shares jumped more than seven per cent.

The Swiss agrichemicals group said its board unanimously rejected the offer, which it said “significantly undervalued the company.” Monsanto, the world’s largest seed company, said it still believes in the value of a combination. It will focus on building its core business and meeting long-term growth objectives and also said it was resuming a share buyback program.

Some farmers had feared that a combined company would have too much power to raise prices for seeds and herbicides. Both companies had acknowledged that a deal would face antitrust scrutiny in several countries.

Syngenta chairman Michel Demare said the company had engaged with Monsanto in good faith and would prosper without the deal.

“Our board is confident that Syngenta’s long-term prospects remain very attractive with a leading portfolio and a promising pipeline of new products and technologies. We are committed to accelerate shareholder value creation,” he said in a statement.

Still, some Syngenta shareholders expressed disappointment over the scuttled deal and questioned Syngenta’s ability to improve its financial fortunes.

“They have to justify to their shareholders that they can create the value that they have just turned down,” said Pauline McPherson, co-fund manager of Kames Capital’s global equity fund, which holds Syngenta stock.

Billionaire hedge fund manager John Paulson, whose Paulson + Co. had taken a stake in Syngenta, had no comment.

Monsanto confirmed that it made a revised offer to Syngenta on Aug. 18, raising a previous offer to 470 Swiss francs (C$664) per share, valuing the company at roughly US$47 billion. It also confirmed it raised a reverse break-up fee to US$3 billion.

Syngenta said the verbal proposal set a price of 245 Swiss francs in cash and a fixed ratio of 2.229 Monsanto shares per Syngenta share. At market close on Aug. 25 this equated to a price of 433 Swiss francs per Syngenta share.

Monsanto has said that it wanted to acquire Syngenta primarily to boost its agrichemicals portfolio, which now relies mainly on glyphosate-based herbicides branded as Roundup.

Monsanto is known for its development of genetically altered crops, while Syngenta is the world’s largest agrichemical company and has a broad portfolio of insecticides, herbicides, fungicides and seed treatments used by farmers around the world.

The takeover effort became a public spectacle of sorts over recent months as leaders at both companies argued the merits the proposed deal through the media, videos and other online forums.

Monsanto’s management also tried to force Syngenta’s management team to come to the bargaining table by wooing support from Syngenta shareholders, and met with several farm groups to solicit support for the deal.

But Syngenta’s management team refused repeatedly to open their books and begin negotiations. Syngenta officials insisted that Monsanto was undervaluing the company and that an attempted combination would raise serious antitrust issues in many countries, possibly provoking lengthy and costly delays.

Many U.S. farmers had feared a deal would limit their choices and spell higher prices for seeds and chemicals. The National Farmers Union (NFU) said it was relieved that Monsanto dropped its bid.

“This is clearly not only good news for family farmers, but for economically competitive markets as well,” said NFU president Roger Johnson.

Syngenta also said Monsanto had been unclear on key issues including estimated revenue syngergies.

Monsanto said it could handle antitrust hurdles, and said it would sell off Syngenta’s seeds and genetic traits businesses. The deal would have brought “substantial synergies” translating to higher profits for a combined company, Monsanto said.

Monsanto officials “are pretty fed up. There is a complete frustration about the whole pursuit and that is why this is the end of the Syngenta talks,” said Piper Jaffray analyst Brett Wong.

Wong said Monsanto would probably stake out another acquisition target soon to boost its crop chemicals holdings.

Monsanto officials also said they still plan to deliver on a five-year plan to more than double fiscal-year 2014 ongoing earnings per share by 2019.

— Carey Gillam is a Reuters correspondent covering agribusiness from Kansas City. Additional reporting for Reuters by Oliver Hirt in Zurich, Svea Herbst in Boston, Sinead Cruise in London and Mike Stone in New York.

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The lawsuit, brought by the Center for Food Safety (CFS) against USDA’s Animal and Plant Health Inspection Service (APHIS), claims the regulator has routinely failed to respond as required to requests for records that relate to many concerns with crops deemed genetically modified organisms (GMOs).

The lawsuit accuses the agency of violating the Freedom of Information Act dozens of times, unlawfully withholding information for more than 13 years. APHIS had no immediate response.

In particular, the lawsuit alleges that the agency failed to respond as required to requests for records related to new GMO regulations that APHIS proposed in 2008 but withdrew earlier this year.

The lawsuit also accuses the agency of failing to respond as required to inquiries about the handling of experimental genetically engineered wheat that was found growing uncontrolled in an Oregon field in 2013. That incident led to lost U.S. wheat export sales as foreign markets feared contaminated supplies.

The lawsuit says APHIS has also failed to respond to requests or withheld records it sought about the handling of other experimental crops that the group believes have escaped review and regulation.

The requests have covered GMO wheat, rice, alfalfa, sugar beets, bent grass, corn and other GMOs. Delays in providing information have run years for some requests, and violated federal law covering the release of public information, according to the lawsuit.

For years, advocacy groups, lawmakers and others critics have harshly criticized U.S. regulation of GMOs as too lax. APHIS has been cited in government auditing for oversight lapses. Some GMO contamination events have led to food recalls and disrupted trade.

In July, the White House directed APHIS and the two other U.S. agencies that oversee biotech crop products, the Environmental Protection Agency and the Food and Drug Administration, to improve and modernize their regulatory framework to boost public confidence.

The CFS lawsuit, filed in federal court in Washington, asks the court to declare APHIS’s actions unlawful and order the agency to produce the records by date to be set by the court. CFS also asks that the court supervise the regulator for compliance.

The Freedom of Information Act provides for the release of federal agency records when requested, with certain exemptions and provisions, and imposes strict deadlines on government agencies to respond.

— Carey Gillam is a Reuters correspondent covering the agribusiness sector from Kansas City.

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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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Coalitions of opponents are being formed and market analyses being done, moves that underscore the hurdles U.S.-based Monsanto will face in any deal to take over Swiss-based Syngenta.

“We will aggressively oppose it,” said Roger Johnson, president of the U.S. National Farmers Union. “This would reduce competition in the marketplace that is already highly concentrated.”

Monsanto, the world’s largest seed company, has yet to persuade Syngenta, the world’s top provider of agricultural chemicals, to even start negotiations.

But Monsanto says it is making progress persuading Syngenta shareholders that its US$45 billion acquisition offer should not be ignored. It says the deal would win regulatory approval despite market concerns.

Monsanto spokeswoman Sara Miller said farmers would benefit through greater product innovation. “Farmers remain our No. 1 priority,” she said. “That will not change.”

The NFU is one of several groups in a loose coalition that is on working the objections it will present to the Justice Department if a deal comes together. The Food + Water Watch consumer advocacy group is doing a market analysis on which to base its objections.

The American Antitrust Institute nonprofit group also will lobby against any deal. Diana Moss, its president, said Monsanto’s stated intention of selling off Syngenta’s seeds and traits businesses is a “red herring” and that the combined company would be a dominant player in the key agricultural platforms of seeds, genetic traits and crop chemicals.

“Farmers are already paying through the nose,” Moss said. “This would take it to a whole new level.”

Some individual farmers are also making their opposition clear.

“I hope they don’t get it done,” said Ohio farmer John Davis, past president of the Ohio Corn and Wheat Growers. “They could get to the point where they could charge whatever they want.”

Large soybean and corn grower groups are not taking an official position yet as they wait to see the details of any deal. But they say they have concerns.

The National Corn Growers Association met with Monsanto leaders to discuss the proposed merger in mid-July.

The group appreciates Monsanto’s “transparency,” but will seek an independent analysis of the merger’s market impact, chief executive Chris Novak said.

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

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Company executives have been criss-crossing the U.S. heartland, meeting with soybean and corn growers and a range of powerful farm lobby organizations to seek their support, company and farm officials say. And the company has launched a website promoting the benefits of the proposed US$45 billion acquisition of Syngenta, which the Swiss company has thus far rebuffed.

Monsanto leaders have also been making appearances on national and regional broadcasts to make their case that combining two of the world’s largest agricultural companies will help, not hurt, their customers.

The efforts follow weeks of Monsanto executive meetings with Syngenta shareholders.

It’s an all-out approach that analysts and marketing experts say is unusual in a corporate acquisition effort, and one that requires Monsanto to walk a fine line.

“If they soothe the worries of the marketplace that helps a lot,” said William Carner, a Westminster College business professor and marketing expert.

“They’ve got to show Syngenta how profitable this will be. At the same time they have to tell the markets they aren’t going to gouge them. It’s a nice little tightrope they’ve got themselves on,” Carner said.

Among those Monsanto has been lobbying is the American Farm Bureau Federation, which calls itself the “voice of agriculture.”

The group has no formal position on the proposal. But Dale Moore, who oversees its public policy arm, said there are questions about how prices and product innovation could be impacted.

Monsanto is the world’s largest seed company, while Syngenta is a global leader in farm chemicals.

“One question would be if this is going to cause a contraction in new R&D or leverage it. We love competition because competition usually means there is… choice,” Moore said.

Edward Jones analyst Matt Arnold said Monsanto’s push could help lower regulatory antitrust hurdles.

“If the customer gets on board… that would put less pressure on regulators to scrutinize the deal or block it,” Arnold said.

Monsanto CEO Hugh Grant said Friday he is frustrated with Syngenta’s refusal to come to the bargaining table.

“They need to get real and see if we can get this over the line,” Grant said in a televised appearance on CNBC.

— Carey Gillam is a Reuters correspondent covering U.S. agribusiness from Kansas City.

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