USDA Drops Plan to Test for Monsanto Weed Killer in Food

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By Carey Gillam

The U.S. Department of Agriculture has quietly dropped a plan to start testing food for residues of glyphosate, the world’s most widely used weed killer and the key ingredient in Monsanto Co.’s branded Roundup herbicides.

The agency spent the last year coordinating with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) in preparation to start testing samples of corn syrup for glyphosate residues on April 1, according to internal agency documents obtained through Freedom of Information Act requests. Documents show that at least since January 2016 into January of this year, the glyphosate testing plan was moving forward. But when asked about the plan this week, a USDA spokesman said no glyphosate residue testing would be done at all by USDA this year.

The USDA’s plan called for the collection and testing of 315 samples of corn syrup from around the United States from April through August, according to the documents. Researchers were also supposed to test for the AMPA metabolite, the documents state. AMPA (aminomethylphosphonic acid) is created as glyphosate breaks down. Measuring residues that include those from AMPA is important because AMPA is not a benign byproduct but carries its own set of safety concerns, scientists believe.

On Jan. 11, USDA’s Diana Haynes wrote to colleagues within USDA: “Based on recent conversations with EPA, we will begin testing corn syrup for glyphosate and its AMPA metabolite April 1, 2017 with collection ending August 31, 2017. This program change will need to be announced at the February PDP Conference Call.” Haynes is director of a USDA Agricultural Marketing Service division that annually conducts the Pesticide Data Program (PDP), which tests thousands of foods for hundreds of different pesticide residues.

The USDA spokesman, who did not want to be named, acknowledged there had been a glyphosate test plan but said that had recently changed: “The final decision for this year’s program plan, as a more efficient use of resources, is to sample and test honey which covers over 100 different pesticides.” Glyphosate residue testing requires a different methodology and will not be part of that screening in honey, he said.

The USDA does not routinely test for glyphosate as it does for other pesticides used in food production. But that stance has made the USDA the subject of criticism as controversy over glyphosate safety has mounted in recent years. The discussions of testing this year come as U.S. and European regulators are wrestling with cancer concerns about the chemical, and as Monsanto, which has made billions of dollars from its glyphosate-based herbicides, is being sued by hundreds of people who claim exposures to Roundup caused them or their loved ones to suffer from non-Hodgkin lymphoma. Internal Monsanto documents obtained by plaintiffs’ attorneys in those cases indicate that Monsanto may have manipulated research regulators relied on to garner favorable safety assessments, and last week, Congressman Ted Lieu called for a probe by the Department of Justice into Monsanto’s actions.

Along with the USDA, the Food and Drug Administration also annually tests thousands of food samples for pesticide residues. Both agencies have done so for decades as a means to ensure that traces of weed killers, insecticides, fungicides and other chemicals used in farming do not persist at unsafe levels in food products commonly eaten by American families. If they find residues above the “maximum residue level” (MRL) allowed for that pesticide and that food, the agencies are supposed to inform the EPA, and actions can be taken against the supplier. The EPA is the regulator charged with establishing MRLs, also called “tolerances,” for different types of pesticides in foods, and the agency coordinates with USDA and FDA on the pesticide testing programs.

But despite the fact that glyphosate use has surged in the last 20 years alongside the marketing of glyphosate-tolerant crops, both USDA and FDA have declined to test for glyphosate residues aside from one time in 2011 when the USDA tested 300 soybean samples for glyphosate and AMPA residues. At that time the agency found 271 samples contained glyphosate, but said the levels were under the MRL – low enough not to be worrisome. The Government Accountability Office took both agencies to task in 2014 for the failure to test regularly for glyphosate.

Europe and Canada are well ahead of the United States when it comes to glyphosate testing in food. In fact, the Canadian Food Inspection Agency (CFIA) is preparing to release its own findings from recent glyphosate testing. The CFIA also routinely skipped glyphosate in annual pesticide residue screening for years. But it began collecting data in 2015, moving to address concerns about the chemical that were highlighted when the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as a probable human carcinogen in March 2015.

Canadian food activist and researcher Tony Mitra obtained more than 7,000 records from CFIA about its glyphosate testing last year, and claims that results are alarming, showing glyphosate pervasive in many foods. CFIA would not respond to requests for comment about its glyphosate testing.

One of the USDA’s explanation’s for not testing for glyphosate over the years has been cost – the agency has said that it is too expensive and inefficient to look for glyphosate residues in food headed for American dinner tables. And because glyphosate is considered so safe, testing would be a waste of time, the USDA has stated. That argument mimics Monsanto’s own – the company, which patented glyphosate in 1974 and has been a dominant provider of glyphosate ever since, says if the USDA did seek to test for glyphosate residues in food it would be a “misuse of valuable resources.”

FDA TESTS REMAIN IN LIMBO

The FDA began its own limited testing program for glyphosate residues – what it called a “special assignment” – last year. But the effort was fraught with controversy and internal difficulties and the program was suspended last fall. Before the suspension, one agency chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. That revelation caused angst in the beekeeping industry and at least one large honey company was sued by consumer organizations over the glyphosate contamination. The same chemist also found glyphosate levels in many samples of oatmeal, including infant oat cereal. The FDA did not publicize those findings, but they were revealed in internal records obtained through a FOIA request.

Officially, the FDA was only looking for glyphosate residues in corn, soy, eggs and milk in last year’s testing assignment, though internal records discussed tests on sugar beets, popcorn, wheat and other foods or grains. Newly obtained FDA documents show the agency is engaged now in a “glyphosate collaboration” designed to validate the testing methodology to be used by multiple FDA laboratories.

“Once the first phase of this collaboration is completed and approved by quality control reviewers, the special assignment can be restarted,” said FDA spokeswoman Megan McSeveney.

CropLife America, an industry organization that represents the interests of Monsanto and other agrichemical companies, keeps a close eye on the government’s pesticide residue testing. Last year the organization sought to diffuse potential legal problems related to glyphosate and other pesticides in honey by asking EPA to set a blanket tolerance that would cover inadvertent contamination of honey by pesticides. Records show regulators have found 26 different pesticides in honey samples in past tests.

CropLife also has complained to USDA that data from its testing program is used by proponents of organic agriculture to promote organics over conventional foods. The group last year sent USDA a series of questions about its testing, and asked USDA: “What can we do to assist you in fighting these scaremongering tactics?”

The USDA’s most recent published report on pesticide residues in food found that for 2015 testing, only 15 percent of the 10,187 samples tested were free from any detectable pesticide residues. That’s a marked difference from 2014, when the USDA found that over 41 percent of samples were “clean” or showed no detectable pesticide residues. But the agency said the important point was that most of the samples, over 99 percent, had residues below the EPA’s established tolerances and are at levels that “do not pose risk to consumers’ health and are safe.”

Many scientists take issue with using MRLs as a standard associated with safety, arguing they are based on pesticide industry data and rely on flawed analyses. Much more research is needed to understand the impact on human health of chronic dietary exposures to pesticides, many say.

(First appeared in The Huffington Post.)

Questions about EPA-Monsanto collusion raised in cancer lawsuits

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Now  it’s getting interesting.

A new court filing made on behalf of dozens of people claiming Monsanto Co.’s Roundup herbicide gave them cancer includes information about alleged efforts within the Environmental Protection Agency to protect Monsanto’s interests and unfairly aid the agrichemical industry.

The filing, made late Friday by plaintiff’s attorneys, includes what the attorneys represent to be correspondence from a 30-year career EPA scientist accusing top-ranking EPA official Jess Rowland of playing “your political conniving games with the science” to favor pesticide manufacturers such as Monsanto. Rowland oversaw the EPA’s cancer assessment for glyphosate, the key ingredient in Monsanto’s weed-killing products, and was a key author of a report finding glyphosate was not likely to be carcinogenic. But in the correspondence, longtime EPA toxicologist Marion Copley cites evidence from animal studies and writes: “It is essentially certain that glyphosate causes cancer.”

Attorneys for the plaintiffs declined to say how they obtained the correspondence, which is dated March 4, 2013. The date of the letter comes after Copley left the EPA in 2012 and shortly before she died from breast cancer at the age of 66 in January 2014. She accuses Rowland of having “intimidated staff” to change reports to favor industry, and writes that research on glyphosate, the key ingredient in Monsanto’s Roundup, shows the pesticide should be categorized as a “probable human carcinogen.” The International Agency for Research on Cancer, an arm of the World Health Organization, declared as much – that glyphosate was a probable human carcinogen – in March 2015 after reviewing multiple scientific studies. Monsanto has rejected that classification and has mounted a campaign to discredit IARC scientists.

The communication, if authentic, could be an explosive development in the snowballing multi-district litigation that now comprises more than 60 plaintiffs from around the United States accusing Monsanto of covering up evidence that Roundup herbicide could cause cancer. The plaintiffs, all of whom are suffering from non-Hodgkin lymphoma (NHL) or lost a loved one to NHL, have asserted in recent court filings that Monsanto wielded significant influence within the EPA’s Office of Pesticide Programs (OPP), and had close ties specifically to Rowland, who until last year was deputy division director within the health effects division of the OPP. Rowland managed the work of scientists who assessed human health effects of exposures to pesticides like glyphosate and he chaired the EPA’s Cancer Assessment Review Committee (CARC) that determined glyphosate was “not likely to be carcinogenic to humans.” Rowland left the EPA in 2016 shortly after a copy of the CARC report was leaked and cited by Monsanto as evidence that the IARC classification was flawed.

Lawyers for the plaintiffs want the federal judge in the case to lift a seal on documents that detail Monsanto’s interactions with Rowland regarding the EPA’s safety assessment of glyphosate. Monsanto turned the documents over in discovery but marked them “confidential,” a designation plaintiffs’ attorneys say is improper. They also want to depose Rowland. But Monsanto and the EPA object to the requests, court documents show. Rowland could not be reached for comment, and the EPA declined to comment about the court matters.

“The Plaintiffs have a pressing need for Mr. Rowland’s testimony to confirm his relationship with Monsanto and EPA’s substantial role in protecting the Defendant’s business…” plaintiff’s attorneys wrote in the Feb. 10 filing in the multi-district litigation, which has been consolidated in the U.S. District Court for the Northern District of California. “Mr. Rowland operated under Monsanto’s influence to cause EPA’s position and publications to support Monsanto’s business.”

The EPA has spent the last few years assessing the health and environmental safety profile of glyphosate as global controversy over the chemical has mounted. The agency had planned to finish its risk assessment on glyphosate in 2015; then said it would be completed in 2016; then said it would be finished by the first quarter of 2017. Now the agency says it hopes to have it completed by the end of the third quarter of 2017.

MONSANTO WANTS DOCUMENTS KEPT SECRET

In a bid to stop the release of further damning documents, attorneys for Monsanto on Monday asked the federal judge in the Roundup litigation to block plaintiffs’ attorneys from including copies of documents they’ve obtained through discovery as exhibits in the court filings because members of the public and the media can see them. They argued that plaintiffs’ attorneys were unfairly attempting to “try this case in the court of public opinion.” Monsanto specifically complained that the organization I work for, U.S. Right to Know, was monitoring the court docket looking for confidential materials to report to the public. The company said reporting on “cherry-picked documents” could be “potentially prejudicial” to its business and to the fairness of the litigation, potentially tainting a jury pool. “Litigation in the press is not in the public interest,” Monsanto’s filing states.

The company asked Judge Vince Chhabria to order that discovery materials not be filed as exhibits or other types of filings that could be visible to the public.

Monsanto also made a new filing in the litigation on Friday, laying out its assertion that there is no evidence Roundup and glyphosate products are “defective or unreasonably dangerous” and said the products complied with “all applicable government safety standards.” There is no evidence of carcinogenicity in glyphosate or Roundup, Monsanto said in its filing.

In a separate filing made on Feb. 8, Monsanto submitted a court brief arguing that the IARC classification of glyphosate as a probable human carcinogen is not relevant to the question of whether or not Roundup caused the plaintiffs’ cancers. IARC’s approach is “less rigorous” than EPA’s in evaluating scientific evidence, and IARC’s conclusions are “scientifically unreliable,” according to the brief. Monsanto told the court that neither the views of IARC or EPA are necessarily relevant to the general causation issue of the litigation because plaintiffs will need to present admissible expert testimony showing the company’s products in fact caused their cancers.

As the litigation drags on, legislation that could potentially benefit Monsanto and numerous other companies facing consumer class action lawsuits was proposed on Feb. 9. The “Fairness in Class Action Litigation Act of 2017” (H.R. 985) was introduced in the U.S. House of Representatives by House Judiciary Chairman Bob Goodlatte (R-VA.) Business interests backing the law say it would reduce frivolous suits and ensure that plaintiffs receive the bulk of any damage awards rather than enriching the attorneys who bring such lawsuits. But opponents say it would make it nearly impossible for individuals with limited financial resources to challenge powerful corporations in court. The bill would apply both to pending and future class action and multi-district litigation.

“The bill is designed to ensure that no class action could ever be brought or litigated for anyone,” said Joanne Doroshow, executive director of the Center for Justice & Democracy. “It would obliterate civil rights, antitrust, consumer, essentially every class action in America.”

IARC Scientists Defend Glyphosate Cancer Link; Surprised by Industry Assault

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Don’t mess with Monsanto Co. That is the message being delivered right now by the agrichemical industry as it makes a full-fledged assault on the team of international cancer scientists who dared to declare cancerous connections to the widely used herbicide called glyphosate, the chief ingredient in Monsanto’s Roundup brand.

Industry swagger is on full display in Washington where Monsanto and its friends at CropLife America are driving efforts to cut off U.S. funding for the World Health Organization’s International Agency for Research on Cancer (IARC) after IARC scientists declared glyphosate a probable human carcinogen in March 2015.  The industry is also demanding that the Environmental Protection Agency fully repudiate the IARC classification and green-light continued use of glyphosate herbicides, which spell billions of dollars in sales annually to Monsanto and the agrichemical brethren.

The EPA has been evaluating glyphosate as part of a re-registration review process for more than five years, and was initially expected to complete that review last year. The EPA then said it would complete the review by the end of 2016, and now says it will be 2017 before it offers a final report. The work has been drawn out as the EPA wrestles with the IARC classification, which has both legal and economic implications for the agrichemical industry. The EPA had planned to hold four days of public meetings – over industry objections- to examine scientific research on glyphosate. But the industry, which deemed the meetings “unnecessary” and “inappropriate,”  successfully derailed   those Oct. 18-21 public meetings by challenging certain scientists appointed by EPA to an advisory panel. The EPA has “postponed” the meetings and has yet to reschedule.

Now, industry ally U.S. Rep. Lamar Smith is taking EPA officials to task for engaging with IARC on glyphosate concerns, demanding that EPA instead rely on the “sound science” that the industry promotes.  Smith, Chairman of the House Committee on Science, Space and Technology, accuses IARC of playing an “activist role” and EPA officials, of aiding that effort. In an Oct. 25 letter to EPA Administrator Gina McCarthy, Smith complained of “constant delays” by EPA in completing the re-registration of glyphosate, and demanded that EPA officials appear before his committee to explain themselves. Monsanto, which is fending off lawsuits by people who claim Roundup gave them cancer, has also been demanding IARC members turn over documents related to their work. The company has labeled the IARC findings as “junk science,” and claims the IARC members are part of an “unelected, undemocratic, foreign body.” 

It’s all a bit overwhelming for the members of the IARC working group, who are not accustomed to assaults on their character.  After all, these scientists that assembled for the glyphosate review were among the elite, routinely seen as independent experts, pulled from top institutions around the world. Frank Le Curieux, senior scientific officer at the European Chemicals Agency in Helsinki, Finland, and an expert in toxicology, was part of the team. So was French scientist Isabelle Baldi, who holds a Ph.D in epidemiology with a research specialty in environmental toxicology, and works as assistant professor in occupational epidemiology and public health at Bordeaux University. Experts also came from Australia, New Zealand, Canada, The Netherlands, and Nicaragua. Several came from the United States, including Matthew Martin, a biologist with the EPA’s National Center for Computational Toxicology who received awards for his work with toxicity data.  Aaron Blair, a scientist emeritus at the National Cancer Institute, served as chairman of the IARC team. Blair has specialty knowledge in research that focused on evaluating cancer and other disease risks associated with agricultural exposures, as well as chemicals in the workplace and the general environment. He has received numerous awards over his career and has served on many national and international scientific review groups, including for the EPA.  He has also authored more than 450 publications on occupational and environmental causes of cancer.

The fact that Monsanto and the agrichemical industry is coming after them has left them stunned. IARC issued a statement last week saying some also felt “intimidated” by the industry actions

“We were not expecting this strong reaction and what happened,” said Francesco Forastiere, head of occupational epidemiology at the Lazio Regional Health Service in Italy who participated in glyphosate working group for IARC. “We were doing our job. We understood there were other issues… economic consequences. But none of us had a political agenda. We simply acted as scientists, evaluating the body of evidence, according to the IARC criteria.”

Another working group member, Australian epidemiologist Lin Fritschi, who has been part of other IARC classifications, said the team’s work was solid and the industry attacks on the team’s credibility are unwarranted.

“I definitely wasn’t expecting anything at all,” said Fritschi, who specializes in the occupational causes of cancer and holds the “distinguished professor” title at Curtin University in Australia. “We were independent and just looked at the science.  We had strict rules on what was admissible and came to a conclusion based on that evidence. We made the right decision based on the evidence.”

The team was not charged with doing new research, but rather with reviewing research already conducted, trying to determine how the various findings added up. The members analyzed older research as well as more recent studies, weighed the methods used, the consistency of results and the levels of adherence to research standards.  There were numerous animal studies to pore over, but fewer looking at glyphosate connections to health problems in humans. The evidence with respect to cancer in humans came from studies of exposures, mostly in agricultural settings. The group determined that the best research showed a distinct association between non-Hodgkin lymphoma (NHL) and glyphosate. The team also noted that there were ties linking glyphosate to multiple myeloma, but the evidence for that disease was not as strong as the evidence tying glyphosate to NHL, the group determined.

The team also evaluated several studies that showed animals developed rare kidney tumors and other health problems after exposure. Those studies combined to provide “sufficient evidence” of glyphosate’s carcinogenicity in laboratory animals, the IARC team found.  On top of that, the IARC team concluded that there was strong evidence of genotoxicity and oxidative stress from glyphosate, including findings of DNA damage in the peripheral blood of exposed humans. The team also said it was noteworthy that in one study, people showed chromosomal damage after glyphosate formulations were sprayed nearby.

Overall, IARC concluded that there was “limited evidence” that glyphosate can cause non-Hodgkin lymphoma and “convincing evidence” that glyphosate can cause cancer in laboratory animals. The conclusion would have been for “sufficient” evidence of cancer problems for humans, but for one large U.S. study run by the federal government that did not show connections between cancer and glyphosate, Forastiere said.

The team ultimately decided the weight of the evidence was not strong enough to say glyphosate was definitively carcinogenic, but there was more than enough evidence for the caveat “probably” carcinogenic.

Blair, Forastiere and the others said after the fact that they felt quite comfortable with the work of the IARC team and proud of the thoroughness of what was a complicated undertaking.

“We should all minimize our use as much as possible,” said Fritschi, “The people most at risk are people who use glyphosate a lot, such as farmers and gardeners, and they are the ones who should try and reduce their use,” she said.

Monsanto and other industry players can’t afford for that kind of talk to take root; which is exactly why we’re seeing these extraordinary efforts to undermine the scientists and push EPA to ignore cancer concerns.  One letter in particular submitted by CropLife America to EPA this month shows the depths of the industry’s efforts to rein in EPA’s probe of glyphosate. CropLife told the EPA it was out of line for proclaiming a need for independent research on formulated glyphosate products – such as Roundup. The agency said in September it has been collaborating with the National Toxicology Program of the National Institute of Environmental Health Sciences to develop a research plan to evaluate the role of glyphosate in product formulations and the differences in formulation toxicity. But apparently, it neglected to get industry permission.

“We also question why EPA would collaborate and develop a research program with the National Toxicology Program without input from the registrant,” CropLife wrote. “Should data be required to address specific questions relevant to the registration or reregistration of a product, the registrant would be the appropriate source of those data.”

The industry message to EPA is loud and clear: Independent research and international scientific findings should not take precedence over protection of a multi-billion-dollar agent like glyphosate. The public can only watch, wait, and hope that the EPA doesn’t listen.

(Article first appeared in The Huffington Post)

EPA Bows to Chemical Industry in Delay of Glyphosate Cancer Review

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By Carey Gillam

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This might have been a tough week for Monsanto Co. The Environmental Protection Agency was slated to hold four days of public meetings focused on essentially one question: Is glyphosate, the world’s most widely used herbicide and the lynchpin to Monsanto’s fortunes, as safe as Monsanto has spent 40 years telling us it is?

But oddly, the EPA Scientific Advisory Panel (SAP) meetings, called to look at potential glyphosate ties to cancer, were “postponed“ just four days before they were to begin Oct. 18, after intense lobbying by the agrichemical industry. The industry first fought to keep the meetings from being held at all, and argued that if they were held, several leading international experts should be excluded from participating, including “any person who has publicly expressed an opinion regarding the carcinogenicity of glyphosate.”

As the meetings drew near, CropLife America, which represents the interests of Monsanto and other agribusinesses, specifically took issue with at least two scientists chosen for the panel, alleging the experts might be unfavorably biased against industry interests. On Oct. 12, the group sent a letter to the EPA calling for Dr. Kenneth Portier of the American Cancer Society to be more deeply scrutinized for any “pre-formed conclusions” about glyphosate.

More notably, CropLife called for leading epidemiologist Dr. Peter Infante to be completely disqualified from panel participation: “EPA should replace Dr. Infante with an epidemiologist without such patent bias,” CropLife told EPA. The chemical industry group said Infante was unlikely to give industry-sponsored research studies the credibility the industry believes they deserve. CropLife said Infante has testified in the past for plaintiffs in chemical exposure cases against Monsanto. Croplife also argued that because Infante was the “only epidemiologist on the glyphosate SAP” he would have enhanced influence in the evaluation of epidemiological data about glyphosate and cancer.

The CropLife letter was dated last Wednesday, and by Friday the EPA announced it was looking for additional epidemiology expertise to ensure “robust representation from that discipline.” EPA also said one panelist had voluntarily departed, though the agency refused to say who that panelist was.

Challenging Infante’s role is a gutsy move. After all, Infante spent 24 years working for the Occupational Safety and Health Administration helping determine cancer risks to workers during the development of standards toxic substances, including asbestos, arsenic, and formaldehyde. His resume includes a stint at the National Institute for Occupational Safety and Health where he conducted epidemiological studies related to carcinogens, and he has served as an expert consultant in epidemiology for several world bodies, including the EPA and the World Trade Organization.

According to sources close to the situation, Infante remains a panelist as of this week, but there is no certainty when the meetings might be rescheduled, and what the panel membership might look like when they are rescheduled. The EPA has refused to discuss who remains on the panel and who does not at this point, and some onlookers said the EPA was clearly bowing to agrichemical industry interests.

“This is outrageous. The industry wants to say that our own government scientists, the top ones in their fields, aren’t good enough for these panels.”

“This is outrageous. The industry wants to say that our own government scientists, the top ones in their fields, aren’t good enough for these panels,” said Michael Hansen, senior staff scientist at the Consumers Union. “If the EPA wants to add extra epidemiologists that is great but why didn’t they do it before? They are doing this because of pressure from industry.”

The industry clearly has much at stake, as does the public. Glyphosate is the key ingredient in Monsanto’s branded Roundup herbicides as well as herbicides marketed by numerous agrichemical companies around the world. It is also the key to what has been 20 years of sales of genetically engineered glyphosate-tolerant crops developed by Monsanto. The future sales of both the chemical and the crops are being jeopardized by the mounting concerns that glyphosate can cause cancer and other illnesses or disease. Scientists around the world have been raising red flags for years over worrisome research findings, and last year the International Agency for Research on Cancer (IARC), said glyphosate was a probable human carcinogen. More than three dozen lawsuits have been filed against Monsanto by people claiming Roundup gave them non-Hodgkin lymphoma, and both European and U.S. regulators are evaluating the chemical for continued use.

Since the IARC classification, Monsanto has asked the EPA to back industry assurances that glyphosate is safe, and so far, the EPA has done exactly that, issuing a series of reports and memos that dovetail with Monsanto’s position. Monsanto also has sought to bolster arguments for glyphosate’s safety by pointing to supportive research papers published in late September in Critical Reviews in Toxicology. Monsanto hired the group that arranged for the panel, and most of the 16 scientists involved are former Monsanto employees or Monsanto consultants. At least one, Gary Williams, has also consulted for Monsanto on litigation matters involving glyphosate. Despite all those affiliations, the research is touted as “independent.”

It seems more than a little hypocritical that those scientists are presented as credible by the industry, but scientists like Infante and Portier are said to be unfit to advise EPA because of suspected bias. Like Infante, Portier has a long track record as an independent scientist. He is vice president of the Statistics & Evaluation Center at the American Cancer Society. He has participated in over 60 other SAP meetings and has served on expert and advisory panels for the National Institutes of Health, National Institute of Environmental Health Sciences, the National Toxicology Program, and the World Health Organization Food and Agriculture Organization.

Portier also would not comment about the industry concerns about him, the postponement or changes to the makeup of the SAP, other than to say that as of today, he remains on the panel.

EPA said it is “working to reschedule as soon as possible.” But the delay and the maneuvering by industry to influence panel participation does little bolster consumer confidence in an objective outcome.

This article was originally published in Huffington Post.

FDA Tests Confirm Oatmeal, Baby Foods Contain Residues of Monsanto Weed Killer

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The U.S. Food and Drug Administration, which is quietly starting to test certain foods for residues of a weed killing chemical linked to cancer, has found the residues in a variety of oat products, including plain and flavored oat cereals for babies.

Data compiled by an FDA chemist and presented to other chemists at a meeting in Florida showed residues of the pesticide known as glyphosate in several types of infant oat cereal, including banana strawberry- and banana-flavored varieties. Glyphosate was also detected in “cinnamon spice” instant oatmeal; “maple brown sugar” instant oatmeal and “peach and cream” instant oatmeal products, as well as others. In the sample results shared, the levels ranged from nothing detected in several different organic oat products to 1.67 parts per million, according to the presentation.

Glyphosate, which is the key ingredient in Monsanto Co.’s Roundup herbicide, is the most widely used weed killer in the world, and concerns about glyphosate residues in food spiked after the World Health Organization in 2015 said a team of international cancer experts determined glyphosate is a probable human carcinogen. Other scientists have raised concerns about how heavy use of glyphosate is impacting human health and the environment.

The EPA maintains that the chemical is “not likely” to cause cancer, and has established tolerance levels for glyphosate residues in oats and many other foods. The levels found by the FDA in oats fall within those allowed tolerances, which for oats is set by the EPA at 30 ppm. The United States typically allows far more glyphosate residue in food than other countries allow. In the European Union, the tolerance for glyphosate in oats is 20 ppm.

Monsanto, which derives close to a third of its $15 billion in annual revenues from glyphosate-based products, has helped guide the EPA in setting tolerance levels for glyphosate in food, and in 2013 requested and received higher tolerances for many foods. The company has developed genetically engineered crops designed to be sprayed directly with glyphosate. Corn, soybeans, canola and sugar beets are all genetically engineered to withstand being sprayed with glyphosate.

Oats are not genetically engineered. But Monsanto has encouraged farmers to spray oats and other non-genetically modified crops with its glyphosate-based Roundup herbicides shortly before harvest. The practice can help dry down and even out the maturity of the crop. “A preharvest weed control application is an excellent management strategy to not only control perennial weeds, but to facilitate harvest management and get a head start on next year’s crop,” according to a Monsanto “pre-harvest staging guide.”

In Canada, which is among the world’s largest oat producers and is a major supplier of oats to the United States, the Monsanto marketing materials tout the benefits of glyphosate on oat fields: “Pre-harvest application of Roundup WeatherMAX and Roundup Transorb HC are registered for application on all oat varieties – including milling oats destined for human consumption.” Glyphosate is also used by U.S. oat farmers. The EPA estimates that about 100,000 pounds of glyphosate are used annually in production of U.S. oats.

Glyphosate is also used on wheat shortly before harvest in this way, as well as on other crops. A division of the U.S. Department of Agriculture known as the Grain Inspection, Packers & Stockyards Administration (GIPSA) has been testing wheat for glyphosate residues for years for export purposes and have detected the residues in more than 40 percent of hundreds of wheat samples examined in fiscal 2009, 2010, 2011 and 2012.

Even though the FDA annually examines foods for residues of many other types of pesticides, it has skipped testing for glyphosate residues for decades. It was only in February of this year that the agency said it would start some glyphosate residue analysis. That came after many independent researchers started conducting their own testing and found glyphosate in an array of food products, including flour, cereal, and oatmeal.

Monsanto and U.S. regulators have said glyphosate levels in food are too low to translate to any health problems in humans. But critics say such assurances are meaningless unless the government actually routinely measures those levels as it does with other pesticides.

And some do not believe any level of glyphosate is safe in food. Earlier this year, Taiwan recalled more than 130,000 pounds of oat supplies after detecting glyphosate residues. And San Francisco resident Danielle Cooper filed a lawsuit in May 2016 seeking class action status against the Quaker Oats Co. after glyphosate residues were found in that company’s oat products, which are used by millions of consumers as cereal and for baking cookies and other treats. Cooper said she expected the oat products, which have been labeled as “100% Natural,” to be pesticide free.

“Glyphosate is a dangerous substance, the presence and dangers of which should be disclosed, the lawsuit states.

Quaker Oats has said any trace amounts of glyphosate found in its products are safe, and it stands by the quality of its products.

HERBICIDE IN HONEY

In addition to oats, the FDA also earlier this year tested samples of U.S. honey for glyphosate residues and found all of the samples contained glyphosate residues, including some with residue levels double the limit allowed in the European Union, according to documents obtained through a Freedom of Information Act request. The EPA has not set a tolerance level for glyphosate in honey, so any amount is problematic legally.

Despite internal discussions about a need to pursue action after the honey findings in January, the FDA did not notify the honey companies involved that their products were found to be contaminated with glyphosate residues, nor did it notify the public.

The FDA has also tested corn, soy, eggs and milk in recent months, and has not found any levels that exceed legal tolerance, though analysis is ongoing.

“These preliminary results showed no pesticide residue violations for glyphosate in all four commodities tested. However, the special assignment is ongoing and all results must go through the FDA’s quality control process to be verified,” said FDA spokeswoman Megan McSeveney. The tests on honey were not considered part of the official special assignment, said McSeveney.

“Dr. Narong Chamkasem, an FDA research chemist based in Atlanta, tested 19 samples of honey as part of a research project that he individually conducted,” she said.

The glyphosate residue testing by FDA may be headed for a slow-down. Sources say there it talk of closing the FDA’s Atlanta laboratory that has done glyphosate residue tests. The work would then reportedly be shifted to other facilities around the country.

The revelations about glyphosate residues in certain foods come as both European and U.S. regulators are evaluating glyphosate impacts for risks to humans and the environment. The EPA is holding four days of meetings in mid-October with an advisory panel to discuss cancer research pertaining to glyphosate, and debate is ongoing over whether or not the team of international scientists who last year declared it a probable human carcinogen were right nor not.

Aaron Blair, the chairman of the International Agency for Research on Cancer (IARC) working group that classified glyphosate as probably carcinogenic to humans, said that the science on glyphosate is still evolving. He said that it is common for it to take years, sometimes decades, for industry and regulators to accept certain research findings and for scientists to reach consensus. He likened glyphosate to formaldehyde, which many years ago was also classified by IARC as “probably carcinogenic” to humans before it later was accepted to be carcinogenic.

“There is not a single example of IARC being wrong, showing something is a probable carcinogen and then later it is proven not to be,” Blair said.

(This story first appeared in The Huffington Post)

What Is Going On With Glyphosate? EPA’s Odd Handling of Controversial Chemical

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By Carey Gillam

The Environmental Protection Agency’s ongoing risk assessment of the world’s most widely used herbicide is starting to generate more questions than answers. On Monday, it also generated a giant “oops” from the EPA.

On Friday, April 29, the EPA posted on its website a series of documents related to its long-awaited risk assessment for glyphosate, the active ingredient in Monsanto’s Roundup herbicide and other weed-killing products sold around the world. The risk assessment started in 2009 and was supposed to conclude in 2015. But questions about whether or not glyphosate may cause cancer are dogging the agency’s review, and have slowed the process.

On Monday, after the contents of the documents started to generate questions from media, EPA yanked those documents from its website:

An agency spokeswoman said this:

“Glyphosate documents were inadvertently posted to the Agency’s docket. These documents have now been taken down because our assessment is not final. EPA has not completed our cancer review. We will look at the work of other governments as well as work by HHS’s Agricultural Health Study as we move to make a decision on glyphosate. Our assessment will be peer reviewed and completed by end of 2016.”

The EPA said it was “working through some important science issues on glyphosate, including residues of the chemical in human breast milk;” an “in-depth human incidents and epidemiology evaluation;” and a preliminary analysis of glyphosate toxicity to milkweed, a critical resource for the monarch butterfly.

Inadvertent or not, one of those documents posted and then withdrawn was a doozy, a heavy hammer that seeks to knock down worries about glyphosate ties to cancer. The agency released an Oct. 1, 2015 internal EPA memorandum from its cancer assessment review committee (CARC) that contradicts the March 2015 finding by the World Health Organization’s International Agency for Research on Cancer (IARC) classifying glyphosate as a probable human carcinogen. EPA found instead that glyphosate is “Not Likely to be Carcinogenic to Humans.”

The memorandum stated that the classification was based on “weight-of-evidence considerations.”

CARC said this:

“The epidemiological evidence at this time does not support a causal relationship between glyphosate exposure and solid tumors. There is also no evidence to support a causal relationship between glyphosate exposure and the following non-solid tumors: leukemia, multiple myeloma, or Hodgkin lymphoma. The epidemiological evidence at this time is inconclusive for a causal or clear associative relationship between glyphosate and NHL. Multiple case-control studies and one prospective cohort study found no association; whereas, results from a small number of case-control studies (mostly in Sweden) did suggest an association.”

Monsanto touted and tweeted the release of the document, which follows the release by EPA of a different memorandum supporting the safety of glyphosate last June. The newest memo gives the company added evidence to defend itself against a mounting stack of lawsuits filed by agricultural workers and others alleging Monsanto’s glyphosate-based Roundup herbicide gave them cancer.

“This is the EPA’s highest ranking for product safety—they also do nice job of explaining all of IARC’s mistakes,” Monsanto Chief Technology Officer Robb Fraley said in a twitter posting.

Monsanto has been calling on EPA to defend glyphosate against the cancer claims since the IARC classification came out in March 2015. A March 23, 2015 EPA email string released as part of a Freedom of Information request details Monsanto’s efforts to get EPA to “correct” the record on glyphosate “as it relates to carcinogenicity.”

Another document newly released by EPA – which was also then withdrawn – illustrates just why EPA’s risk assessment about the safety of glyphosate matters so much. In a memorandum dated Oct. 22, 2015, EPA detailed how extensively glyphosate is being used on food items.

That memo updates estimates of glyphosate use on crops in top agricultural states, and provides annual average use estimates for the decade 2004-2013. Seventy crops are on the EPA list, ranging alphabetically from alfalfa and almonds to watermelons and wheat. Glyphosate used on soybean fields, on an annual basis, is pegged at 101.2 million pounds; with corn-related use at 63.5 million pounds. Both those crops are genetically engineered so they can be sprayed directly with glyphosate as farmers treat fields for weeds. Cotton and canola, also genetically engineered to be glyphosate tolerant, also have high use numbers. But notable glyphosate use is also seen with oranges (3.2 million lbs); sorghum (3 million lbs); almonds (2.1 million lbs); grapes, (1.5 million lbs); grapefruit and apples (400,000 lbs each); and a variety of fruits, vegetables and nuts.

Despite – or perhaps because of – the delays in issuing a final regulatory risk assessment on glyphosate, questions about the impact of the chemical on human health and the environment have been mounting. In addition to the lawsuits alleging glyphosate caused cancer in farm workers and others, private groups are scrambling to test a variety of food products for glyphosate residues.

On Friday a lawsuit with a new twist on glyphosate concerns was filed in U.S. District Court in San Francisco. That suit, which seeks class action status, alleges that glyphosate residues found in Quaker Oats invalidates claims by the Quaker Oats Co. that its product is wholly natural. “Glyphosate is a synthetic biocide and probable human carcinogen, with additional health dangers rapidly becoming known,” the lawsuit states. “When a product purports to be ‘100% Natural,’ consumers not only are willing to pay more for the product, they expect it to be pesticide-free,” the lawsuit states.

Questions about glyphosate have become so prevalent that U.S. Rep. Ted Lieu wrote a letter to EPA officials in December requesting EPA scientists meet with a group of independent scientists to go over “troubling information” related to glyphosate. Lieu cited concerns that EPA is relying on Monsanto-backed data rather than independent, peer-reviewed research in assessing glyphosate. Sources close to the situation say that meeting has been scheduled for June 14, though both EPA and Lieu’s office declined to comment.

The EPA’s diligence on digging into glyphosate questions and concerns is encouraging to those who want to see a thorough risk assessment done. But the delay and the questionable actions with releasing documents and then withdrawing them from the public eye does not inspire confidence.

Indeed, in another curious move, the EPA on May 2 also issued a newly updated “registration review schedule.“ But while three dozen other chemical draft risk assessments are listed on the EPA website for release by the end of 2016, glyphosate was not included.

Oops?

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group. Follow her on Twitter @CareyGillam

What Killed Jack McCall? A Farmer Dies; A Case Against Monsanto Takes Root

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By Carey Gillam

CAMBRIA, Calif.- Standing on the ridge overlooking her central California farm, new widow Teri McCall sees her husband Jack nearly everywhere. There, atop the highest hill, is where the couple married in 1975- two self-described “hippies’ who knew more about how to surf than farm. And over there, surrounded by the lemon, avocado and orange trees Jjack mccall copyack planted, sits the 800-square-foot house the young Vietnam veteran built for his bride and a family that grew to include two sons and a daughter. Solar panels Jack set up in a sun-drenched stretch of grass power the farm’s irrigation system.

And down there, clasped in the cusp of the velvet green valley sits the century-old farmhouse Jack and Teri eventually made their permanent home. Jack installed a stained glass window featuring a heart and flowers over the front door.

“Literally hundreds of times a day, something reminds me of him,” McCall says, as she and a visitor strolled through the orchards on a recent sunny spring morning. “That’s part of why it’s so hard to believe… I can never see him again.”

Anthony ‘Jack’ McCall, 69, died Dec. 26 after a painful and perplexing battle with non-Hodgkin lymphoma. The loss is certain, fixed forever into his family’s heartbreak. But questions about why and how he was stricken – a man who never smoked, stayed fit and had no history of cancer in his family – are part of what some legal experts see as a potential landmark legal claim against one of the world’s largest agrichemical companies, Monsanto Co.

McCall shunned pesticide use on his farm, except for the herbicide called Roundup – marketed by Monsanto as having extremely low toxicity. He used Roundup regularly, spraying it himself around the farm to drive back worrisome weeds. He even recommended Roundup to friends, telling them it was supposed to be much safer than alternatives on the market, and touting its effectiveness.

But now in his death, McCall is one of several plaintiffs in more than a dozen lawsuits that claim the active ingredient in Roundup – a chemical called glyphosate – gave them cancer, and that Monsanto has long known glyphosate poses “significant risks to human health, including a risk of causing cancer.”

The lawsuits, brought by plaintiffs in California, Florida, MissouriDelaware, Hawaii,and elsewhere over the last several months, claim Monsanto has hidden evidence, and manipulated regulators and the public into believing in the safety of glyphosate, which annually brings in about $5 billion, or a third of total sales, for the agribusiness giant. Like McCall, many farmed, or worked in agricultural jobs in which they regularly were using or exposed to glyphosate.

The claims come at a critical time for Monsanto and its signature product as regulators in the United States and other countries evaluate whether or not to continue to allow glyphosate herbicides. Last year the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen. That team, the International Agency for Research on Cancer (IARC), said glyphosate shows a “positive association” for non-Hodgkin lymphoma. 

The outcomes of the legal battle and the regulatory reviews could have broad implications. Glyphosate is the most widely used herbicide on the planet, sprayed on fields for row crops like corn, soybeans and wheat, as well as a variety of fruits, nuts and vegetable crops such as almonds, apples, cherries and oranges.

That ubiquitous role played by glyphosate means the litigation, plaintiffs’ lawyers say, marks the beginning of a potential wave of legal actions against Monsanto. Teams of attorneys have been criss-crossing the country lining up potential plaintiffs who they say will likely number in the hundreds and possibly thousands. It’s a time-tested practice by plaintiffs’ attorneys who have brought similar mass actions in the past against tobacco, pharmaceutical and chemical industries.

“Monsanto has deliberately concealed or suppressed information about the dangers of its product,” said environmental and chemical pollution attorney Robert F. Kennedy Jr., who is assisting in litigating glyphosate cases. “This is big. It’s on every farm in the world.”

Kennedy predicts glyphosate liability litigation will become as widespread as has been decades of litigation over asbestos, which is seen in legal circles as the longest-running mass tort action in U.S. history. Asbestos was used for years as a safe and effective flame retardant in the construction industry but has been tied to lung diseases and cancers, and spawned hundreds of millions of dollars in legal claims.

The glyphosate litigation partly mirrors courtroom battles Monsanto has been fighting for years involving the polychlorinated biphenyls, or PCBs it once manufactured. Plaintiffs in those cases also claim PCBs caused them to fall ill while Monsanto hid the risks. Monsanto claims plaintiffs cannot definitively link illnesses to PCB exposure.

AMONG THE SAFEST OPTIONS
Patented by Monsanto and commercialized in 1974, glyphosate herbicide has long been considered among the safest pesticide options on the market. The weed-killer came off patent in 2000 and is now used in more than 700 products around the world, beloved by farmers, homeowners, and groundskeepers. The chemical is the world’s most widely used herbicide with an estimated 1.8 billion pounds applied in 2014, up 12-fold from 1994, according to recently published research.

But as use has grown, concerns about safety have also mounted. Residues have been documented by public and private researchers in waterways, air, food and in human bodily fluids. Several scientific studies tied the chemical to cancers and other health problems before the March 2015 classification by IARC.

Lawyers for plaintiffs in the glyphosate cases say that among the evidence that glyphosate’s toxicity has long been known is an EPA memo detailing how glyphosate was classified by agency scientists as a possible human carcinogen in 1985 before classified in 1991 as a having “evidence of non-carcinogenicity” for humans. The classification was changed despite the fact that some peer review members did not concur. The lawsuits also cite evidence of fraud at laboratories used by Monsanto to perform toxicology studies of glyphosate, and point to fraud convictions of executives at those labs.

St. Louis-based Monsanto, a global agrichemical and seed powerhouse, cites its own evidence to counter both the validity of the allegations in the lawsuits, as well as the IARC findings. Last year, the company hired a team of experts to review the safety of glyphosate, and said that team found no cancer links. 

“Comprehensive long-term toxicological studies repeated over the last 30 years have time and again demonstrated that glyphosate is unlikely to pose a cancer risk in humans,” Monsanto states on its website. ‘Regulatory authorities and independent experts around the world have reviewed numerous long-term/carcinogenicity and genotoxicity studies and agree that there is no evidence that glyphosate… causes cancer, even at very high doses.”

Monsanto attorneys have been seeking to dismiss and/or delay several cases thus far filed, asserting that federal law and approvals by the Environmental Protection Agency for labels on Roundup herbicide products protect Monsanto from the claims in the lawsuits. In recent arguments in U.S. District Court in Northern California, for example, lawyers for Monsanto argued that “EPA repeatedly has concluded that glyphosate is not a carcinogen.” But in April a federal judge in California ruled that Monsanto was not protected from liability by the EPA registration and approved labels.

In a Missouri case that Monsanto also was unable to get dismissed, discovery is starting, and plaintiffs’ lawyers are eagerly awaiting what they hope will be a treasure trove of evidence for their clients.

The legal claims come at the same time that European and U.S. regulators are conducting their own assessments of the safety of glyphosate and considering restrictions, processes that have become fraught with infighting and accusations of bias from both fans and foes of glyphosate. The European Food Safety Authority (EFSA) said in November that evidence shows glyphosate is unlikely to be carcinogenic. But the European Parliament has said the herbicide use should be reined in with a ban on non-professional use and around parks and playgrounds because of the health worries.

The EPA was due to release a fresh risk assessment on glyphosate nearly a year ago, but has stalled the process amid the uproar. And in an odd twist to the saga, on April 29, the agency posted an internal document to its website, showing that the EPA’s cancer assessment experts have determined that glyphosate is “Not Likely to be Carcinogenic to Humans.”

On May 2, EPA withdrew the memo from its website and said it was not supposed to have been released because the cancer assessment is ongoing. But Monsanto heralded the release of the document as proof of what it has been saying about glyphosate’s safety.

Wall Street is keeping a wary eye on the litigation. But generally market watchers care less about Monsanto’s risk from potential liability payouts and more about any potential long-term revenue hit if regulators were to restrict or ban glyphosate, said Piper Jaffray analyst Brett Wong, who tracks Monsanto’s business strategies and financial health. The courtroom battles could influence regulators, he said.

“There are obviously a lot of lawsuits,” Wong said. “They aren’t intrinsic to impacting their business but there is always some sentiment pressure on investors. If it were to impact the regulatory structure and glyphosate was banned… that could obviously have an impact.”

Legal experts with experience defending the chemical industry are watching the cases with interest, and many say given a lack of regulatory support for the cancer linkage, plaintiffs’ attorneys have an uphill climb to make such claims stick.

“The evidence to support the claims isn’t there, said one prominent lawyer, declining to be quoted by name. “It’s not mothers’ milk by any means. I wouldn’t mix it in my drink, but it’s one of the safest chemicals out there,” he said.

Attorney Brent Wisner, who is representing the McCall family, said he is confident in the strength of the evidence against Monsanto. “It’s going to be a fairly large litigation when it’s all said and done. We’re confident we’ll be able to show that Monsanto controlled research and suppressed science,” he said.

Back in Cambria, Jack McCall’s son Paul McCall is running the farm in his father’s place. His eyes tear quickly when asked about his father’s diagnosis in September 2015 and death only three months later, the day after Christmas. He doesn’t want to talk about the lawsuit, other than to say he has no use for glyphosate now, and wants to warn others away from it.

“This is a battle that has to be fought,” he said.

How big and how bloody the litigation becomes is still an open question. The shouting from both sides of the issues is getting louder with each passing day. But the deep questions about the safety of this herbicide deserve serious and scientific review as the answers hold implications for our food production, our environment and the health of our families well into the future.

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group