FDA Suspends Testing for Glyphosate Residues in Food

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By Carey Gillam

Government testing for residues of an herbicide that has been linked to cancer has been put on hold, slowing the Food and Drug Administration’s first-ever endeavor to get a handle on just how much of the controversial chemical is making its way into U.S. foods.

The FDA, the nation’s chief food safety regulator, launched what it calls a “special assignment” earlier this year to analyze certain foods for residues of the weed killer called glyphosate after the agency was criticized  by the U.S. Government Accountability Office for failing to include glyphosate in annual testing programs that look for many less-used pesticides. Glyphosate is the most widely used herbicide in the world, and is the key ingredient in Monsanto Co.’s branded Roundup herbicide line.

Glyphosate is under particular scrutiny now after the World Health Organization’s cancer experts last year declared the chemical a probable human carcinogen. Several private groups and nonprofits have been doing their own testing, and have been finding glyphosate residues in varying levels in a range of foods, raising consumer concerns about the pesticide’s presence in the American diet.

The FDA’s residue testing for glyphosate was combined with a broader herbicides analysis program the FDA set in motion in February of this year. But the glyphosate testing has been particularly challenging for the FDA. The agency was finally forced to put the glyphosate residue testing part of the work plan on hold amid confusion, disagreement and difficulties with establishing a standard methodology to use across the agency’s multiple U.S. laboratories, according to FDA sources. Equipment issues have also been a problem, with some labs citing a need for more sensitive instruments, sources within FDA said.

FDA spokeswoman Megan McSeveney confirmed the testing suspension and said the agency is not sure when it will resume.

“As testing for glyphosate will expand to several locations, we are currently working to ensure that the methods are validated for use in these labs. As soon as the validation is completed, testing for glyphosate will resume,” she said. “We cannot speculate on timing at this point.”

Alongside the testing for glyphosate, the FDA laboratories have also been analyzing foods for 2,4-D and other “acid herbicides,” documents obtained from the FDA show. The category of acid herbicides includes five of the top 10 active ingredients used in homes and gardens. Usage of 2,4-D is expected to triple in the coming year, according to the FDA.

The FDA work detail calls for the examination of roughly 1,340 food samples, 82 percent of which are to be domestic and 18 percent imported. The foods are to be collected from warehouse and retail stores only, and are to include a variety of cereal grains, vegetables and non-flavored, whole milk and eggs. Documents obtained from the agency through Freedom of Information requests show the agency has been testing corn and soybeanswheat, barley, sugar beets, rice, and even samples of yellow popcorn and “organic white popcorn.” 

McSeveney said glyphosate residues were only being analyzed in soy, corn, milk and eggs and the popcorn samples, while the other foods are being tested for residues of other herbicides.

Earlier this year, one of the agency’s senior chemists also analyzed glyphosate residues in honey and oatmeal and reported his results to the agency. Some honey samples contained residue levels well over the limit allowed in the European Union. The United States has no legal tolerance for glyphosate in honey, though the Environmental Protection Agency (EPA) said recently it may set one because of the FDA findings. The results for honey and oatmeal are not considered to be part of the official assignment, however, according to McSeveney.

With the testing on hold, it is not clear when the agency might have final results on the glyphosate residue analysis. McSeveney said preliminary results showed no violations of legal tolerance levels allowed for glyphosate in the foods tested. She did not provide details on what, if any, levels of residue were found. Tolerance levels are set by the EPA for a variety of pesticides expected to be found in foods. When residue levels are detected above the tolerance levels, enforcement action can be taken against the food producer.

Monsanto said earlier this year that no data has ever indicated residue levels of more than a fraction of allowable levels, and it is confident FDA testing will reaffirm the safety of its herbicide.

Though FDA annually tests domestic and imported foods for residues of other pesticides, it never tested for glyphosate before. It has not routinely tested for 2,4-D either, a fact also criticized by the GAO. The FDA testing for 2,4-D residues comes as the use of 2,4-D with food crops is expected to start rising due to the commercialization of new formulated herbicide products that combine glyphosate and 2,4-D. Safety questions have been raised about the combination. But the EPA gave a green light on Nov. 1 to a Dow AgroSciences’ herbicide combination of glyphosate and 2,4-D. The new products are intended to counter widespread weed resistance to glyphosate, and be used with new types of genetically engineered herbicide-tolerant crops.

The agrichemical industry asserts that residues of glyphosate, 2,4-D and the array of other chemicals used in modern-day agriculture do not pose a danger to human health, but the lack of testing to determine actual residue levels of some of the most-used chemicals, like glyphosate and 2,4-D, has been troubling to many consumer groups.

Getting solid data on glyphosate’s presence in the American food supply is more important than ever now as the EPA finalizes a risk assessment for glyphosate and tries to determine if any limits should be put on future use of the herbicide. The FDA work covers only a few foods, but is a long-needed, good first step. Consumers can only hope the testing resumes soon.

The article was first published in the Huffington Post

More Bad News for Honey as U.S. Seeks to Get Handle on Glyphosate Residues in Foods

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Testing for residues of an herbicide developed by Monsanto Co. that has been linked to cancer has turned up high levels in honey from the key farm state of Iowa, adding to concerns about herbicide contamination that have triggered at least two lawsuits against honey industry players and prompted scrutiny by regulators.

The Food and Drug Administration began glyphosate residue testing in a small number of foods earlier this year after the International Agency for Research on Cancer classified glyphosate as a probable human carcinogen in March 2015. The “special assignment,” as the FDA refers to the testing project, is the first time the FDA has ever looked for glyphosate residues in food, though it annually tests foods for numerous other pesticides.

Research by FDA chemist Narong Chamkasem and John Vargo, a chemist at the University of Iowa, shows that residues of glyphosate – the chief ingredient in Monsanto’s branded Roundup herbicide – have been detected at 653 parts per billion, more than 10 times the limit of 50 ppb allowed in the European Union. Other samples tested detected glyphosate residues in honey samples at levels from the low 20s ppb to over 123 parts per billion ppb. Some samples had none or only trace amounts below levels of quantification. Previous reports had disclosed glyphosate residues in honey detected as high as 107 ppb. The collaborative work was part of an effort within FDA to establish and validate testing methodology for glyphosate residues.

“According to recent reports, there has been a dramatic increase in the usage of these herbicides, which are of risk to both human health and the environment,” Chamkasem and Vargo stated in their laboratory bulletin.

Because there is no legal tolerance level for glyphosate in honey in the United States, any amount could technically be considered a violation, according to statements made in FDA internal emails, obtained through Freedom of Information Act (FOIA) requests.

The Environmental Protection Agency may soon move to set a tolerance, however. The agency has set tolerance levels for glyphosate residues in many foods the EPA expects might contain residues of the weed killer. When residue levels are detected above the tolerance levels, enforcement action can be taken against the food producer.

“EPA is evaluating the necessity of establishing tolerances for inadvertent residues of pesticides in honey,” the agency said in a statement. The EPA also said there was no reason for consumers to be concerned about the residue in honey.  “EPA has examined the glyphosate residue levels found in honey and has determined that glyphosate residues at those levels do not raise a concern for consumers,” the agency said.

Despite the reassurances, at least two lawsuits have been filed over the issue. The Organic Consumers Association and the Beyond Pesticides nonprofit group filed suit Nov. 1 against the Sioux Honey Association Cooperative, a large Iowa-based group of bee keepers who produce the nationally known brand Sue Bee Honey. Sue Bee bills itself as “America’s Honey,” but the lawsuit alleges that the labeling and advertising of Sue Bee Products as “Pure,” “100% Pure,” “Natural,” and “All-natural” is “false, misleading, and deceptive.” Some of the glyphosate residues detected in the FDA tests were found in the Sue Bee brand, according to the FDA documents obtained through FOIA requests

The claims are similar to another lawsuit, which seeks class action status, that was filed against Sioux Honey Association in late September in U.S. District Court for the Eastern District of New York.

Quaker Oats was sued earlier this year on a similar claim regarding glyphosate residues. The FDA has also found glyphosate residues in oatmeal, including several types of infant oat cereal.

Considering corn is the key crop grown in Iowa, and most of the U.S. corn crop is genetically modified to tolerate being sprayed directly with glyphosate, it is not necessarily surprising that glyphosate residues are showing up in honey in Iowa and other farm states. Honey bees naturally migrate from field to field and plant to plant, so can become contaminated by the pesticide easily and then transfer pesticide residues to their honey, according to bee industry leaders.

“It’s a chemical intrusion, a chemical trespass into our product,” said Darren Cox, president of the American Honey Producers Association. “We have really no way of controlling it. I don’t see an area for us to put our bees. We can’t put them in the middle of the desert. They need to be able to forage in ag areas. There are no ag areas free of this product.”

Sioux Honey Association President David Allibone said no one from the FDA has communicated with his group about the chemical residues found in honey, and he said he could not discuss the issue further because of the litigation.

The lawsuit filed Tuesday acknowledges the difficulties beekeepers face. They “are often the victims of, and have little recourse against, contamination of their hives caused by pesticide applications in the fields where bees forage,” the lawsuit states.

The glyphosate residues showing up in food are surprising and worrisome, according to dietitian Mitzi Dulan, a nationally known nutrition and wellness expert.

“I think more testing should be done so that we are armed with the knowledge and then we can decide what we want to put into our bodies,” Dulan said. “I do believe in minimizing pesticide exposures whenever possible.”

Jay Feldman, executive director of Beyond Pesticides, a plaintiff in the lawsuit filed Tuesday, said regulators need to do more to address the issue.

“Until U.S. regulatory agencies prohibit Monsanto and other manufacturers of glyphosate from selling pesticides that end up in the food supply, we need to protect consumers by demanding truth and transparency in labeling,” Feldman said.

(Article first appeared in The Huffington Post)

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.

Upcoming EPA Meetings on Safety of Monsanto Weed Killer Drawing Scrutiny

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By Carey Gillam

Bayer better be paying attention to this.

The German company’s intended $66 billion acquisition of Monsanto Co. comes amid growing concern over the future of the company’s top-selling weed killer, a chemical called glyphosate that Monsanto introduced to the world 40 years ago as the active ingredient in its Roundup herbicide. Monsanto reaps billions of dollars annually, roughly a third of its sales, from those products.

So it’s no small matter that in mid-October the Environmental Protection Agency (EPA) plans to spend four days holding public meetings with a scientific advisory panel on the topic of whether or not glyphosate can cause cancer. The idea of shining a public spotlight on this mounting concern about the world’s most widely used herbicide has not set well with Monsanto and the rest of the industry that profits from glyphosate products like Roundup. Agrichemical interests have gone so far as to tell the EPA that the meetings should not be held at all, and have said that if they are, many of the world’s top scientists should be excluded from participating.

The industry clearly does not welcome the public scrutiny the meetings bring, but it should be satisfied that the EPA has made it clear it has no intention of contradicting Monsanto’s claims of glyphosate’s safety. After all, in a Sept. 12 report issued to the public, the EPA offered a 227-page evaluation of glyphosate’s cancer-causing potential that ended with a “proposed” conclusion that glyphosate was ‘“not likely to be carcinogenic to humans’ at doses relevant to human health risk assessment.” All of this before the meetings are held.

To its credit, the EPA did issue several caveats in that report, acknowledging that some research does link glyphosate to cancer, but offering various explanations as to why the agency doesn’t believe those study results are significant, and/or are outweighed by other studies. The agency also added a host of qualifiers, stating that with respect to epidemiological studies, the data is limited and outdated. Because there has been such an “increased use of glyphosate following the introduction of glyphosate-tolerant crops in 1996, there is a need for more recent studies since a large number of studies were conducted prior to 1996,” the EPA stated. The agency also said that research needs to be done on glyphosate formulations, not just glyphosate alone.

And the agency included a specific caveat with respect to research tying glyphosate to non-Hodgkin lymphoma (NHL), saying: “There are conflicting views on how to interpret the overall results for NHL. Some believe that the data are indicative of a potential association between glyphosate exposure and risk of NHL.” The agency added: “Due to study limitations and contradictory results across studies… a conclusion regarding the association between glyphosate exposure and risk of NHL cannot be determined based on the available data.”

There is obviously a lot at stake – Monsanto is currently being sued by dozens of people who say the company’s Roundup herbicide gave them or their family members NHL, and the company is fighting a court battle with the state of California over regulatory efforts to add glyphosate to a list of known or probable carcinogens. And there remains the matter of the EPA’s long overdue environmental and health risk assessment for glyphosate, in which the EPA could add restrictions to the use of glyphosate if the agency deems those are necessary. That risk assessment was due out in 2015. Then the agency said it would be released in 2016. Now the agency says it may be completed by spring of 2017.

With the Bayer acquisition, the lawsuits and the risk assessment looming, Monsanto has been pulling out all the stops to defend glyphosate. The pressure on the EPA to defend glyphosate began immediately after the World Health Organization’s International Agency for Research on Cancer (IARC) declared in March 2015 that research showed glyphosate was “probably” carcinogenic to humans. The IARC decision was announced on Friday, March 20, 2015 and by the following Monday morning, Monsanto’s Dan Jenkins, the company’s regulatory affairs leader, was already calling and emailing EPA officials demanding they “correct” the record on glyphosate. Emails obtained through Freedom of Information request show Jenkins submitted “talking points” to the EPA to try to contradict IARC. And since then Monsanto has only intensified its efforts to invalidate the findings of the IARC group, attacking the veteran scientists as an “unelected, undemocratic, unaccountable and foreign body.”

Monsanto has also subpoenaed emails and other records from the chairman of that IARC committee, Aaron Blair, a scientist emeritus at the National Cancer Institute, who served as chairman of the IARC team. Blair has a long career of accolades and appointments that acknowledge his expertise, and he has served on numerous national and international scientific review groups, including for the EPA. But Monsanto has deemed Blair’s work suspect.

And Monsanto’s apparently has done some arm-twisting in Congress. On Monday, the chairman of the House Committee on Oversight and Government Reform wrote to the National Institutes of Health, reciting many of the complaints Monsanto and its allies have made about IARC and challenging grants the NIH has made to IARC.

The EPA’s appearance of aligning with Monsanto angers many in the scientific community who say the EPA is straying from established scientific principles and ignoring key evidence so it can keep the corporate interests who profit from glyphosate herbicides happy.

“This chemical is a probable human carcinogen by any reasonable definition. It is nonsense to say otherwise,” said Christopher Portier, former director of the National Center for Environmental Health and Agency for Toxic Substances and Disease Registry at the U.S. Centers for Disease Control and Prevention (CDC). Prior to that role, Portier spent 32 years with the National Institute of Environmental Health Sciences (NIEHS), where he served as the NIEHS associate director, director of the Environmental Toxicology Program, and associate director of the National Toxicology Program. In retirement, Portier, who was an “invited specialist” to the IARC review on glyphosate, has done some part-time work for the Environmental Defense Fund.

Portier and more than 90 other international scientists have issued a detailed report laying out the specific research that ties glyphosate to cancer both in animal studies and in human observations. The scientists said the only way for regulators to discount the evidence is to bend well-established rules for scientific evaluations. They say available human evidence does show an association between glyphosate and non-Hodgkin lymphoma, while significant carcinogenic effects are seen in laboratory animals for rare kidney and other types of tumors. There is also “strong evidence of genotoxicity and oxidative stress,” including findings of DNA damage in the peripheral blood of people exposed to glyphosate, the scientists said.

“The most appropriate and scientifically based evaluation of the cancers reported in humans and laboratory animals as well as supportive mechanistic data is that glyphosate is a probable human carcinogen,” the report states. “On the basis of this conclusion and in the absence of evidence to the contrary, it is reasonable to conclude that glyphosate formulations should also be considered likely human carcinogens.”

“The EPA is in a bad spot with this. The pushback really has come out of the industry based on things that are not scientifically sound,” said Maarten Bosland, one of the authors of the report on glyphosate research. Bosland is director of the Center for Global Health Outreach Department of Pathology at The University of Illinois at Chicago, and holds a Ph.D. in experimental pathology. “The amount of money that is involved in this compound is gigantic. It’s a worldwide conglomerate of financial interests that are affected by this.”

It seems more than coincidental that the EPA’s rationale for dismissing scientific studies that IARC said showed cancer links closely dovetails with the findings of a 16-member Monsanto-funded panel. That group of 16 scientists, all but four of whom had previously worked either as employees or consultants for Monsanto, issued a report in December that supported Monsanto’s contention that there is no real evidence that glyphosate can cause cancer. Leading the work was Gary M. Williams, director of environmental pathology and toxicology at New York Medical College, and a consultant to Monsanto. Williams has a history of publishing positive findings about glyphosate; he was an author of one of Monsanto’s most-touted studies, a 2000 research report that concluded glyphosate is not only not a carcinogen, but “is considered to be practically nontoxic.”

That panel is preparing to release five articles supporting glyphosate safety in the journal Critical Reviews of Toxicology soon, according to Intertek Scientific & Regulatory Consultancy, which was paid by Monsanto to arrange the panel.

In the EPA report, the one bright spot for critics of glyphosate is that the EPA does call for more testing. Specifically, the agency acknowledges the need to explore the fears that glyphosate formulations may be more toxic than glyphosate alone. The EPA is developing a “research plan” with the National Institute of Environmental Health Sciences to “evaluate the role of glyphosate in product formulations and the differences in formulation toxicity,” the EPA said.

Fresh answers can’t come soon enough for consumers who worry about persistent levels of glyphosate in the food they eat. The FDA this year found high levels of glyphosate in U.S. honey, some levels more than double what is considered safe in the European Union.

The meetings in Washington run Oct. 18-21, and are expected to draw a variety of attendees – lawyers, activists, farmers, environmentalists and corporate allies are all making their travel plans.

It should be interesting.

(Article first appeared in The Huffington Post)

FDA Finds Monsanto’s Weed Killer In U.S. Honey

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By Carey Gillam

The Food and Drug Administration, under public pressure to start testing samples of U.S. food for the presence of a pesticide that has been linked to cancer, has some early findings that are not so sweet.

In examining honey samples from various locations in the United States, the FDA has found fresh evidence that residues of the weed killer called glyphosate can be pervasive – found even in a food that is not produced with the use of glyphosate. All of the samples the FDA tested in a recent examination contained glyphosate residues, and some of the honey showed residue levels double the limit allowed in the European Union, according to documents obtained through a Freedom of Information Act request. There is no legal tolerance level for glyphosate in honey in the United States.

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 its cancer experts determined glyphosate is a probable human carcinogen. Other international scientists have raised concerns about how heavy use of glyphosate is impacting human health and the environment.

Records obtained from the FDA, as well as the Environmental Protection Agency and the U.S. Department of Agriculture, detail a range of revelations about the federal government’s efforts to get a handle on these rising concerns. In addition to honey, the records show government residue experts discussing glyphosate found in soybean and wheat samples, “glyphosate controversies,” and the belief that there could be “a lot of violation for glyphosate” residues in U.S. crops.

Even though the FDA annually examines foods for residues of many 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 residues 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. The government and Monsanto have maintained that any glyphosate residues in food would be minimal enough to be safe. But critics say without robust testing, glyphosate levels in food are not known. And they say that even trace amounts may be harmful because they are likely consumed so regularly in many foods.

The residue issues are coming into the spotlight at the same time that the EPA is completing a risk assessment to determine if use of this top-selling herbicide should be limited. The agency has scheduled public meetings on the matter Oct. 18-21 in Washington. The EPA’s risk assessment report was initially due out in 2015, but still has not been finalized. The agency now says it will be completed in “spring 2017.”

In the records released by the FDA, one internal email describes trouble locating honey that doesn’t contain glyphosate: “It is difficult to find blank honey that does not contain residue. I collect about 10 samples of honey in the market and they all contain glyphosate,” states an FDA researcher. Even “organic mountain honey” contained low concentrations of glyphosate, the FDA documents show.

According to the FDA records, samples tested by FDA chemist Narong Chamkasem showed residue levels at 107 ppb in samples the FDA associated with Louisiana-based Carmichael’s Honey; 22 ppb in honey the FDA linked to Leighton’s Orange Blossom Honey in Florida and residues at 41 ppb in samples the FDA associated with Iowa-based Sue Bee Honey, which is marketed by a cooperative of American beekeepers as “pure, all-natural” and “America’s Honey.” Customers “can be assured that Sue Bee Honey is 100% pure, 100% all-natural and 100% American,” the Sioux Honey Association states.

In a Jan. 8, 2016 email Chamkasem pointed out to fellow FDA scientists that the EU tolerance level is 50 ppb and there is no amount of glyphosate allowed at all in honey in the United States. But Chris Sack, an FDA chemist who oversees the agency’s pesticide residue testing, responded by reassuring Chamkasem and the others that the glyphosate residues discovered are only “technically a violation.”

“The bee farmers are not breaking any laws; rather glyphosate is being introduced by the bees,” Sack wrote in response. “While the presence of glyphosate in honey is technically a violation, it is not a safety issue.”

Sack said the EPA had been “made aware of the problem” and was expected to set tolerance levels for honey. Once tolerance levels are set by EPA – if they are set high enough – the residues would no longer be a violation. When contacted this week, the EPA said there are currently no pending requests to set tolerance levels for glyphosate in honey. But, the agency also said: “there is no dietary risk concern from exposure to glyphosate residues in honey at this time.”

Sioux Honey Vice President Bill Huser said glyphosate is commonly used on farm fields frequented by bees, and the pesticide travels back with the bees to the hives where the honey is produced.

“The industry doesn’t have any control over environmental impacts like this,” Huser said. Most of Sue Bee’s honey comes from bees located near clover and alfalfa in the upper Midwest, he said. Beekeepers located in the South would have honeybees close to cotton and soybean fields. Alfalfa, soybeans and cotton are all genetically engineered to be sprayed directly with glyphosate.

The FDA results are not the first to find glyphosate in honey. Sampling done in early 2015 by the scientific research company Abraxis found glyphosate residues in 41 of 69 honey samples with glyphosate levels between 17 and 163 ppb, with the mean average being 64 ppb.

Bee keepers say they are innocent victims who see their honey products contaminated simply because they might be located within a few miles of farms where glyphosate is used.

“I don’t understand how I’m supposed to control the level of glyphosate in my honey when I’m not the one using Roundup,” one honey company operator said. “It’s all around me. It’s unfair.”

The FDA did not respond to a question about the extent of its communications with Monsanto regarding residue testing, but the records released show that Monsanto has had at least some interaction with the FDA on this issue. In April of this year, Monsanto’s international regulatory affairs manager Amelia Jackson-Gheissari emailed FDA asking to set up a time to talk about “enforcement of residue levels in the USA, particularly glyphosate.”

The FDA routinely looks for residues of a number of commonly used pesticides but not glyphosate. The look for glyphosate this year is considered a “special assignment” and came after the agency was criticized by the U.S. Government Accountability Office in 2014 for failing to test for glyphosate.

The FDA has not released formal results of its testing plans or the findings, but Sack made a presentation in June to the California Specialty Crops Council that said the agency was analyzing 300 samples of corn; 300 samples of soy; and 120 samples each of milk and eggs. He described some partial results achieved through April that showed glyphosate levels found in 52 samples of corn and 44 samples of soybeans but not above legally allowed levels. The presentation did not mention honey. The presentation also stated that glyphosate testing at the FDA will be expanded to “routine screening.”

The USDA also will start testing for glyphosate, but not until next year, according to information the agency gave to the nonprofit group Beyond Pesticides in a meeting in Washington in January. Documents obtained through FOIA show a plan to test in syrups and oils in 2017.

Soybeans and Wheat

Like the FDA, the USDA has dragged its feet on testing. Only one time, in 2011, has the USDA tested for glyphosate residues despite the fact that the agency does widespread testing for residues of other less-used pesticides. In what the USDA called a “special project” the agency tested 300 soybean samples for glyphosate and found more than 90 percent – 271 of the samples – carried the weed killer residues. The agency said then that further testing for glyphosate was “not a high priority” because glyphosate is considered so safe. It also said that while residues levels in some samples came close to the very high levels of glyphosate “tolerance” established by EPA, they did not exceed those levels.

Both the USDA and the FDA have long said it is too expensive and is unnecessary to test for glyphosate residues. Yet the division within the USDA known as the Grain Inspection, Packers & Stockyards Administration (GIPSA) has been testing wheat for glyphosate residues for years because many foreign buyers have strong concerns about glyphosate residues. GIPSA’s testing is part of an “export cargo sampling program,” documents obtained from GIPSA show. Those tests showed glyphosate residues detected in more than 40 percent of hundreds of wheat samples examined in fiscal 2009, 2010, 2011 and 2012. The levels vary, the data shows. GIPSA has also been helping FDA access soybeans to test. In a May 2015 email, GIPSA chemist Gary Hinshaw told an FDA food safety official that “it isn’t difficult to find soybeans containing glyphosate.” In a December 7, 2015 email from FDA chemist Terry Councell to Lauren Robin, also a chemist and an FDA consumer safety officer, Councell said that glyphosate was present even in processed commodities, though “way below tolerance.”

The fact that the government is aware of glyphosate residues in food, but has dragged its feet on testing for so long, frustrates many who are concerned about the pesticide.

“There is no sense of urgency around these exposures that we live with day in and day out,” said Jay Feldman, executive director of Beyond Pesticides.

(First appeared in The Huffington Post)

Glyphosate ‘Revolution’ Growing — Consumers Want Answers

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By Carey Gillam 

They’re calling it a glyphosate “revolution.” Consumers around the world are waking up to the fact that they’re living in a world awash in the weed-killing pesticide known as glyphosate. And they don’t like it one bit.

Over the last several years, some scientists have been warning that the long-touted environmental and health safety promises associated with glyphosate, the chief ingredient in Monsanto’s branded Roundup, may not be as iron-clad as asserted. Last year’s finding by the World Health Organization’s cancer research experts that glyphosate “probably” is a human carcinogen sparked a firestorm that only grows more heated by the day. Consumers in the United States, Europe and elsewhere are now demanding that regulators step up and restrict or ban glyphosate herbicides – the most widely used in the world – to protect both human health and the environment.

Glyphosate’s current license for use in the EU expires in June, and the European Union recently delayed making a decision on extending the registration due to the controversy.

The U.S. Environmental Protection Agency is similarly stymied. Last month a petition signed by thousands of Americans was presented to EPA demanding glyphosate be revoked in the United States. A group of U.S. scientists and activists has a meeting scheduled with the EPA on June 14 to try to convince the regulatory agency it needs to restrict or ban glyphosate. The agency is trying to finish a long-overdue new risk assessment for the chemical.

More fuel was added to the fire this week when a coalition of scientists and activists working through what they call “The Detox Project” announced that testing at a University of California San Francisco laboratory revealed glyphosate in the urine of 93 percent of a sample group of 131 people. The group said it used a method known as liquid chromatography-mass spectrometry or LC/MS/MS, to analyze urine and water samples. (The group said it found no glyphosate residues in tap water.) Further data from this public bio-monitoring study will be released later in 2016, according to the group overseeing the testing.

In the urine tests, glyphosate was detected at an average level of 3.096 parts per billion (PPB) with children having the highest levels with an average of 3.586 PPB, according to Henry Rowlands, director of the Detox Project.

Private groups have already been testing foods for glyphosate residues in the absence of testing by the Food and Drug Administration (FDA), and they have found residues in a variety of products on grocery store shelves. Glyphosate is used widely in production of numerous food crops, most notably with biotech crops genetically engineered to tolerate being sprayed directly with glyphosate. The FDA said in February it would start some limited testing for food residues, but has provided few details.

Michael Antoniou, a molecular geneticist from London who has been studying glyphosate concerns for years and is supporting the Detox Project, said more testing is needed. “With increasing evidence from laboratory studies showing that glyphosate-based herbicides can result in a wide range of chronic illnesses through multiple mechanisms, it has become imperative to ascertain the levels of glyphosate in food and in as large a section of the human population as possible,” he said in a statement.

The Detox Project is billing itself as a platform for consumers to submit their personal bodily fluids for testing. The urine testing was commissioned by the Organic Consumers Association, and one of the objectives is to gather research to determine if eating an organic diet has any effect on the level of synthetic chemicals in people’s bodies.

Earlier in May test results for urine samples from members of the European Parliament also showed glyphosate in their systems.

Monsanto and leading agrichemical scientists say glyphosate is among the safest of pesticides on the market, and essential to robust food production. They point to decades of safety studies and regulatory approvals around the world. They say even if glyphosate residues are in food, water and bodily fluids, they aren’t harmful.

Support for that argument came last week from a United Nations panel of scientists who proclaimed that a thorough review of the scientific literature made it clear that glyphosate was probably not carcinogenic to humans. But the finding was quickly pilloried as tainted because the chairman of the panel, Alan Boobis, also helps run the International Life Science Institute (ILSI), which has received more than $500,000 from Monsanto and other large donations from additional agrichemical interests.

The uproar over glyphosate shows no sign of easing. Next month, the consumer group Moms Across America is launching a “National Toxin Free Town Tour” to crisscross the country to advocate for a pull back on glyphosate and other chemicals seen as harmful.

To be sure, glyphosate, which is used in hundreds of herbicide products globally, is only one of many chemicals pervasive in today’s environment. It seems that everywhere we turn, worrisome chemicals are found in our food supply, our water, our air, our land. Heightened consumer awareness about glyphosate comes as consumers are increasingly demanding more information and tighter controls on many aspects of how their food is produced.

Those behind the Detox Project have an agenda, just as do many of the group’s pushing for regulatory restrictions, and those supporting continued use of glyphosate. But the concern about glyphosate’s impact on human health and the environment cannot be swept aside.

On one of its webpages, Monsanto uses the motto “We May Not Have All the Answers But We Keep on Searching.”

The consumer groups pushing for more testing and more regulatory controls on glyphosate are saying the same thing.

This article originally appeared in Huffington Post. Want more food for thought? Sign up for the USRTK Newsletter.

Carey Gillam is a veteran former Reuters journalist and now research director for U.S. Right to Know, a food industry research group.  Follow Carey Gillam on Twitter: www.twitter.com/careygillam

Organic Trade Meets in D.C. as Battle Brews Over Standards

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This article originally appeared in Huffington Post

It’s “Organic Week” again in Washington, D.C., and attendees of the “signature policymaking event” for the Organic Trade Association (OTA) have much to celebrate. Last week, the OTA, the leading voice for the organic industry, announced that the sector posted its largest-ever annual dollar gain in 2015, with total organic retail sales growing by $4.2 billion, or 11 percent, to a record of $43.3 billion.

“Fueled by consumer choice, organic is the future of farming,” the OTA said in a statement touting the conference, which runs May 23-May 27.

Still, the industry acknowledges that future is clouded by persistent supply shortages in the face of what OTA calls the “seemingly unquenchable consumer demand for organic.”

Agriculture Secretary Tom Vilsack is slated to address the OTA Wednesday, to tell organic leaders that the U.S. Department of Agriculture wants to make it easier for new farmers to become certified organic and to help the organic sector with its demand problem.

But across the country, in a federal courtroom in California, a group of consumer and environmental lawyers and nonprofit groups are raising a red flag in the face of the USDA push to grow the organic sector. Corners are being cut, they allege. Standards are being shirked, and consumers are being short-changed by USDA National Organic Program standard changes.

A hearing is scheduled Thursday in one key case involving synthetic chemicals in compost in organic production. The Center for Environmental Health, the Center for Food Safety and Beyond Pesticides sued Vilsack and other USDA officials last year for issuing a guidance document in 2010 that “radically changed organic requirements.” Under the new provision, organic producers can use compost materials that have been treated with synthetic pesticides that otherwise are banned from organic use.

Under the changes introduced by USDA, organic producers can use materials such as lawn trimmings that have been contaminated with synthetic pesticides as compost feedstocks for their crops. Compost contaminated with an insecticide known as bifenthrin and other pesticides are now allowed, the lawsuit alleges.

This flouts a key appeal of organics – the idea that synthetic pesticides have little to no place in production, the groups argue. And the agency violated the law by failing to give public notice or allow for public comment as they created this “loophole,” the groups allege.

“Organic consumers are being misled, and can no longer rely on the organic label to ensure the food they purchase is produced without synthetic pesticides in agricultural inputs,” the lawsuit states.

The Center for Food Safety and other plaintiffs describe themselves in court pleadings as working to protect the environment and public health and to act as a watchdog on the integrity of organic production. They expected the OTA to back up their bid for organic integrity, or at least not to try to get in their way. But on May 2, OTA asked to participate in the case not on the side of the consumer advocates but against them.

In its filing, OTA, along with California Certified Organic Farmers (CCOF) have joined with Western Growers Association (WG), which represents farmers responsible for roughly a third of fresh U.S. organic produce, to oppose the consumer protection groups over the compost issue. The OTA and other industry groups are arguing that if the USDA provision allowing for synthetic pesticides in compost is thrown out by the court, organic practices would be “severely unsettled.”

The groups say in court filings that it would be analytically and economically impossible to demonstrate all compost is free of each synthetic chemical substance prohibited in organic crop production. They say a sudden elimination of the compost provision could lead to costly civil litigation and many growers’ organic certifications would be directly at risk. Unwinding the USDA’s “professional and responsible approach to a complex subject” would be “extremely disruptive,” the organic groups say.

The plaintiffs counter that such claims of disruptive consequences are a “red herring.” An erosion of organic standards may help expand production and meet consumer demands, but such a path could make for a slippery slope and an ultimate demise of the draw organics hold. “These environmental values, and specifically not supporting pesticide-dependent agriculture, are a major driver to why consumers pay the premium to buy organic foods,” their filing states.

Thursday’s hearing in San Francisco will take up pending cross motions for summary judgment in the case. Meanwhile back in Washington, the OTA will be marking “advocacy day,” fanning out through Capitol Hill to meet with lawmakers and push for policies that support continued organic industry growth.

Consumers would do well to keep an eye on both.

Carey Gillam is a veteran former Reuters journalist and now research director for U.S. Right to Know, a food industry research group.  Follow Carey Gillam on Twitter: www.twitter.com/careygillam 

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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