pesticides

Collusion or Coincidence? Records Show EPA Efforts to Slow Herbicide Review Came in Coordination with Monsanto

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Posted on by Carey Gillam

Newly released government email communications show a persistent effort by multiple officials within the Environmental Protection Agency (EPA) to slow a separate federal agency’s safety review of Monsanto’s top-selling herbicide. Notably, the records demonstrate that the EPA efforts came at the behest of Monsanto, and that EPA officials were helpful enough to keep the chemical giant updated on their progress.

The communications, most of which were obtained through Freedom of Information Act (FOIA) requests, show that it was early 2015 when the EPA and Monsanto began working in concert to stall a toxicology review that a unit tied to the Centers for Disease Control and Prevention (CDC) was conducting on glyphosate, the key ingredient in Monsanto’s branded Roundup herbicide products. The details revealed in the documents come as Monsanto is defending itself against lawsuits alleging that it has tried to cover up evidence of harm with its herbicides.

The Agency for Toxic Substances and Disease Registry (ATSDR), a federal public health agency that along with the CDC is part of the U.S. Department of Health and Human Services (HHS), is charged with evaluating the potential adverse human health effects from exposures to hazardous substances in the environment. So it made sense for the ATSDR to take a look at glyphosate, which is widely used on U.S. farms, residential lawns and gardens, school playgrounds and golf courses. Glyphosate is widely used in food production and glyphosate residues have been found in testing of human urine.

The ATSDR announced in February 2015 that it planned to publish a toxicological profile of glyphosate by October of that year. But by October, that review was on hold, and to this date no such review has yet been published.

The documents reveal this was no accident, no bureaucratic delay, but rather was the result of a collaborative effort between Monsanto and a group of high-ranking EPA officials.

For Monsanto, the timing of the ATSDR review was worrisome. In March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) had declared glyphosate to be a probable human carcinogen, and Monsanto feared ATSDR might have similar concerns about the chemical. Previous reports have described how one EPA official, Jess Rowland, communicated to Monsanto in April 2015 his willingness to try to kill the ATSDR review. Rowland, who retired in 2016, was the deputy division director within the health effects division of the EPA’s Office of Pesticide Programs (OPP). Allegations of collusion between Rowland and Monsanto have prompted a probe by the EPA’s Office of Inspector General.

But the trove of documents newly obtained from within EPA and HHS demonstrate that the assistance to Monsanto came not only from Rowland but also from even higher-level EPA officials. Rather than encourage and assist the toxicology review of glyphosate, Monsanto and EPA officials repeatedly complained to ATSDR and HHS that such a review was unnecessarily “duplicative” and should take a back seat to an EPA review also underway.

The following timeline shows how the events unfolded:

May 19, 2015 – Michael Dykes, who at that time was Monsanto’s long-time vice president of government affairs, wrote directly to the EPA’s Jim Jones, the Assistant Administrator for the Office of Chemical Safety & Pollution Prevention. Jones had oversight of the EPA’s Office of Pesticide Programs (OPP) and was a presidential appointee who carried significant clout. The afternoon was waning when the email came in at 3:28 p.m. Dykes reminded Jones that they had recently discussed the HHS’ ATSDR glyphosate review at a meeting. “You were not aware of their review. Did you learn anything more about their efforts?” Dykes asked.

Jones did not waste time. Roughly an hour later he forwarded the message to OPP Director Jack Housenger, writing “Monsanto thinks atsdr is doing a glyphosate Assessment. Could you guys run that down?” Housenger responds quickly: “Yes. Jess checked with them…. It has been difficult to get information.”

Within an hour Jones instructed a member of his staff to get him contact information for the head person responsible for ATSDR. She replied the next morning that Dr. Patrick Breysse was the point person. Breysse joined the CDC in 2014 as director of its National Center for Environmental Health, overseeing the NCEH’s ATSDR.

May 20, 2015 It was only a little after 8:30 a.m. but Jones told the staff member to instruct Housenger to get in touch with Breysse, and within two hours Housenger had penned an email to Breysse explaining that an EPA’s own re-evaluation/risk assessment of glyphosate was nearing completion, and asking Breysse if “you would still feel the need to do your assessment.” Housenger told Breysse that he already had reached the individual assigned to the ATSDR assessment and she had indicated she would “coordinate” with EPA, but that was not sufficient. Housenger did not mention Monsanto’s outreach to EPA on the issue, but instead questioned “whether this is a good use of government resources” for ATSDR to continue with its review. Breysse responded that he would “look into this” and Housenger thanked him for his quick response. Breysse then reached out to an ATSDR division director named James Stephens to arrange a discussion about the EPA request.

May 21, 2015 James Stephens wrote back to Patrick Breysse that the ATSDR team thought the EPA work “overlaps but isn’t totally duplicative…” and stated that the ASTDR team has not been able to see draft copies of the EPA’s work. “I think we would all welcome further discussion with EPA but would hope to use it to help us find out more about what they are doing, ” he told Breysse. After hearing from Stephens, Breysse wrote back to Housenger saying ATSDR staff would be in touch to discuss. Housenger replied with his reiteration that the ATSDR review would be a “duplicative government effort” and that the EPA draft would be out in July of 2015. (As of this writing, that EPA preliminary risk assessment still has not been released, though in 2016 the EPA did release a cancer assessment report that declared glyphosate was not likely to cause cancer.)

June 4, 2015 Pressing the issue, EPA’s Housenger wrote again to Breysee to say he had not heard from anyone yet. The ATSDR’s Stephens wrote back promising to make sure “someone gives you a ring.” Internal Monsanto emails show that at the same time, Monsanto was also pushing the “duplicative” narrative with HHS, meeting on June 4 with HHS Deputy Assistant Secretary for Global Health Mitchel Wolfe to ask him to help repudiate the IARC classification and to recognize that a review of glyphosate was “not the primary role” for his agency. “Dr. Wolfe said he would follow up on what was going on with ATSDR and he was encouraged to have discussions with EPA staff, as well,” a Monsanto memo detailing the meeting states.

June 9, 2015 Henry Abadin, an ATSDR supervisory scientist, reported to Stephens that he had talked with Housenger and explained that the agency did not believe it was “duplicating efforts.” Nevertheless, he said he told EPA, “we did not have a problem with putting the glyphosate profile on hold, pending the OPP final report.”

June 19, 2015 To further ensure the ATSDR review didn’t move forward, Monsanto’s Dykes talked again with HHS’s Wolfe, asking for an update on ATSDR. “I explained… our question was about the purpose and scope of such a duplicative review by ATSDR. I also told him that we were concerned that ATSDR may come out any day with a report. I again stressed that we were concerned that they were even reviewing glyphosate as were the people we talked with at EPA,” Dykes wrote to colleagues.

June 21, 2015 It was a Sunday, but Monsanto’s Dykes was still concerned enough about the ATSDR review to copy multiple colleagues on a late night email to report that he had continued to press the “duplicative” point with ATSDR but was concerned about a “glyphosate review coming any day.” In a text message sent that same day, Monsanto scientist Eric Sachs reached out to a former EPA toxicologist named Mary Manibusan asking for contacts at ATSDR. “We’re trying to do everything we can to keep from having a domestic IARC occur w this group. may need your help,” Sachs wrote. The text messages were among certain internal Monsanto records obtained by cancer victims who are suing Monsanto alleging Roundup caused their diseases.

June 23, 2015 By Tuesday, Monsanto’s Jenkins had good news: He had heard from Housenger that the EPA official had been successful in garnering a promise from ATSDR to put its report “on hold.” The review was not dead, however, he wrote: ATSDR argues “that their process is distinguishable and not duplicative. They look at different endpoints and told EPA they don’t “make a call on cancer”, but I think we should continue to be cautious.”

On June 24, 2015 Monsanto’s chief scientist William Heydens responded:“’Distinguishable and not duplicative’? Seriously? And I will believe the not ‘making a call on cancer’ part when I see it. Anyway, at least they know they are being watched, and hopefully that keeps them from doing anything too stupid…” Jenkins wrote back, acknowledging that Monsanto had much more to fear from ATSDR than EPA as the two agencies had arrived at “different conclusions” on other issues. He reported he had been told ATSDR was “VERY conservative and IARC like…”

By October 23, 2015 EPA and Monsanto had the ATSDR review fully on hold. EPA’s Housenger wrote to update Monsanto’s Jenkins: “They are waiting for our glyphosate RA. And they agreed to share what they do.”

That same month, the EPA’s Cancer Assessment Review Committee (CARC), which was chaired by Rowland, issued an internal report stating that contrary to IARC, the EPA’s review of glyphosate found it “not likely to be carcinogenic to humans.”

The EPA still has yet to issue the overall new risk assessment it said would be out in 2015. The agency has offered ever-changing timelines for the assessment, but now says its intends to release a draft risk assessment sometime this year. That will be followed by a 60-day public comment period. After the public comment period the EPA will determine whether any risk management is needed. In the meantime, Monsanto has cited the EPA’s backing of glyphosate safety as repudiation of the IARC finding both in court and with regulators in Europe who are also looking at glyphosate safety issues.

The EPA did not respond to a request for comment about its efforts to delay the ATSDR report or communications with Monsanto regarding that effort.

But Brent Wisner, a lawyer representing many of the cancer victims who are suing Monsanto, said the documents offer damning evidence of improperly close ties between the EPA and the chemical company.

“I think it’s very clear… that EPA officials and Monsanto employees worked together to accomplish a goal of stopping that analysis at ATSDR. That is collusion. I don’t know what else you’d call that,” said Wisner.

For its part, the ATSDR said this week that the review it started in 2015 “is not complete” but that it anticipates a draft glyphosate toxicological profile to be issued for public comment by the end of this year. A spokesperson for the agency declined to discuss the circumstances surrounding the delay in the review.

And Jones, whose EPA job ended when the Trump administration took over, defended his responsiveness to Monsanto’s concern about the ATSDR review, saying it had only to do with the “efficient use of government resources.”

“Had any party contacted me and informed me that another agency within the Administration was simultaneously assessing a chemical as my organization, I would have intervened,” Jones said. “There is no value to the same government investing limited resources to work on the same issue. As you know resources at the federal level were and are scarce which made duplication even more problematic.” Jones said additionally that “when two organizations assess the same chemical, it is very likely there will be differences in their assessments. Even when these differences don’t matter from a public health perspective, an enormous amount of energy is spent attempting to resolve these differences” and that is not ultimately in the “public interest.”

Monsanto Spin Doctors Target Cancer Scientist In Flawed Reuters Story

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Posted on by Carey Gillam

In a well-orchestrated and highly coordinated media coup, Monsanto Co. and friends this week dropped a bombshell on opponents who are seeking to prove that the company’s beloved Roundup herbicide causes cancer.

A widely circulated story published June 14 in the global news outlet Reuters (for which I formerly worked) laid out what appeared to be a scandalous story of hidden information and a secretive scientist, “exclusive” revelations that the story said could have altered a critical 2015 classification that associated Monsanto’s Roundup to cancer and triggered waves of lawsuits against Monsanto.

It was a blockbuster of a story, and was repeated by news organizations around the globe, pushed by press releases from Monsanto-backed organizations and trumpeted by industry allies like the American Chemistry Council.

It was also flawed and misleading in a number of critical respects.

Authored by Reuters’ reporter Kate Kelland, who has a history of cozy relations with a group partly funded by agrichemical company interests, the piece accused a top epidemiologist from the U.S. National Cancer Institute of failing to share “important” scientific data with other scientists as they all worked together assessing the herbicide glyphosate for the International Agency for Research on Cancer (IARC). That group reviewed a wide body of research on glyphosate and determined in March of 2015 that the pesticide should be classified as a probable human carcinogen. Had the group known of this missing data, it’s conclusion could have been different, according to Reuters.

The story was particularly timely given glyphosate and Roundup are at the center of mass litigation in the United States and under scrutiny by U.S. and European regulators. After the IARC classification, Monsanto was sued by more than 1,000 people in the United States who claim they or their loved ones got non-Hodgkin lymphoma (NHL) from exposure to Monsanto’s glyphosate-based Roundup and the company and the cases could start going to trial next year. Roundup is the most widely used herbicide in the world and brings in billions of dollars a year for Monsanto. The company insists the IARC classification is meritless and the chemical is proven safe by decades of research.

So yes, it was a big story that scored big points for Monsanto in the debate over glyphosate safety. But drilling deeply into the sourcing and selective nature of the Reuters piece makes it clear the story is not only seriously flawed, but that it is part of an ongoing and carefully crafted effort by Monsanto and the pesticide industry to discredit IARC’s work.

The story contains at least two apparent factual errors that go to the credibility of its theme. First the story cites “court documents” as primary sources when in fact the documents referred to have not been filed in court and thus are not publicly available for reporters or members of the public to access. Kelland does not share links to the documents she references but makes it clear her information is largely based on a deposition from Aaron Blair, the National Cancer Institute epidemiologist who chaired the IARC working group on glyphosate, as well as related emails and other records. All were obtained by Monsanto as part of the discovery process for the Roundup litigation that is pending in federal court in San Francisco. By citing court documents, Kelland avoided addressing whether or not Monsanto or its allies spoon-fed the records to her. And because the article did not provide a link to the Blair deposition, readers are unable to see the full discussion of the unpublished study or the multiple comments by Blair of many other studies that do show evidence of links between glyphosate and cancer. I’m providing the deposition here, and disclosing that I requested and obtained it from attorneys involved in the Roundup litigation after Kelland’s story was published.

Second, the story relies in part on an anti-IARC view of a scientist named Bob Tarone and refers to him as an “independent” expert, someone “independent of Monsanto.” Kelland quotes Tarone as saying that IARC’s evaluation of glyphosate is “flawed and incomplete.” Except, according to information provided by IARC, Tarone is far from independent of Monsanto; Tarone in fact has acknowledged that he is a paid consultant to Monsanto, and a piece cited by Reuters and authored by Tarone last year in a European scientific journal is being recorrected to reflect Tarone’s conflict of interest, according to IARC, which said it has been in communication with that journal.

But much more noteworthy than the errors is how selective the story is in pulling from the Blair deposition. The story ignored Blair’s many affirmations of research showing glyphosate connections to cancer, and focused instead on Blair’s knowledge of one unpublished research study that was still in progress. The story hones in on speculation that the data perhaps could have been finished and published in time to be reviewed by IARC and further speculation by Blair, prodded by a Monsanto attorney, that had it been finished and had it been published it could have helped counter the other studies IARC viewed that showed positive cancer connections.

That research, part of a massive ongoing project by U.S. government researchers called the Agricultural Health Study, includes hundreds of studies and years of data analyzing pesticide impacts on farmers. Blair, who retired from the National Cancer Institute in 2007, was not leading that research but was part of a team of scientists who in 2013 were analyzing data about pesticide use and the risk of non-Hodgkin lymphoma. The data specific to glyphosate did not show a connection to NHL but in working to publish a paper about all the data the group had gathered, they decided to narrow the focus to insecticides and in 2014 did publish a paper on that work. The data on glyphosate and NHL has yet to be published, and some scientists who are familiar with the work say it has not tracked people long enough yet to be definitive given NHL generally takes 20 or more years to develop. A prior compilation of data by AHS researchers that also showed no connection between glyphosate and NHL was published in 2005 and was considered by IARC. But because the newer data was not published it was not considered by IARC.

Blair said the decision to limit the published work to insecticides was to make the data more manageable and was made well before IARC announced it would be looking at glyphosate in 2015.

“The rule is you only look at things that are published,” Blair told me this week after the Reuters story was published. “What would it be like if everyone on the working group whispered things they knew but weren’t published and made decisions on that?” IARC confirmed it does not consider unpublished research. In his deposition, Blair states that nothing has changed his opinion about glyphosate and NHL.

Epidemiologist and University of Toronto scientist John McLaughlin, who sat on the glyphosate working group for IARC with Blair, said to me in a note this week that the information about the unpublished work written about by Reuters did not alter his view of the validity of IARC conclusion on glyphosate either.

Also left out of the Reuters story – the deposition and a draft copy of the study in question shows that there were concerns about the AHS results due to “relatively small” subgroups of exposed cases. And notably, the Reuters report leaves out Blair’s discussion of the North American Pooled Project, in which he participated, which also contains data related to glyphosate and NHL but is not favorable to Monsanto. A synopsis of that project presented to the International Society for Environmental Epidemiology in 2015 showed that people who used glyphosate for more than five years had significantly increased odds of having NHL, and the risk was also significantly higher for people who handled glyphosate for more than two days per year. That information, like the new AHS data, was not given to IARC because it wasn’t yet published.

“When Dr. Blair’s deposition transcript is read in total, it shows that nothing was wrongfully withheld from IARC,” said Plaintiffs’ attorney Aimee Wagstaff. She said Monsanto was using pieces of the deposition to “further its agenda in the media.”

To epidemiologist Peter Infante, who spent more than 20 years leading a cancer identification unit at the Occupational Safety and Health Administration and analyzed a body of epidemiology research on glyphosate in testimony to an Environmental Protection Agency (EPA) Scientific Advisory Committee in December, the attention drawn to unpublished data that supports Monsanto’s position is much ado about nothing.

“You still have other studies that show dose response,” he told me. “This Agricultural Health Study is not the gold standard. For glyphosate and NHL they haven’t been following people long enough. Even if the data had been published and had been considered by IARC it would be in the context of all the other study results.”

And finally, in an odd exclusion, the story fails to disclose that Kelland herself has at least tangential ties to Monsanto and friends. Kelland has helped promote an organization called the Science Media Centre, a group whose aim is to connect certain scientists such as Tarone with journalists like Kelland, and which gets its largest block of funding from corporations that include the agrichemical industry. Current and past funders include Monsanto, Monsanto’s proposed merger partner Bayer AG, DuPont and agrichemical industry lobbyist CropLife International. Kelland appears in a promotional video for SMC touting the group and authored an essay applauding the SMC that appeared in a SMC promotional report.

As a Reuters reporter for 17 years (1998-2015) I know the value of an “exclusive.” The more such scoops a reporter garners, the more bonus points and high praise from editors. It’s a system seen in many news agencies and it works great when it encourages dogged, investigative journalism. But powerful corporations like Monsanto also know how eager reporters are to land exclusives and know that handing favored journalists cherry-picked information with the promise of exclusivity can serve their public relations needs quite well. Follow up the hand-fed story with a press release from an industry-funded outlet and calls for an investigation from the industry group American Chemistry Council and you have propaganda gold.

What you don’t have is the truth.

Of Mice, Monsanto and a Mysterious Tumor

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Posted on by Carey Gillam

Call it the case of the mysterious mouse tumor.

It’s been 34 years since Monsanto Co. presented U.S. regulators with a seemingly routine study analyzing the effects the company’s best-selling herbicide might have on rodents. Now, that study is once again under the microscope, emerging as a potentially pivotal piece of evidence in litigation brought by hundreds of people who claim Monsanto’s weed killer gave them cancer.

This week tissue slides from long-dead mice in that long-ago research study are being scrutinized by fresh eyes as an expert pathologist employed by lawyers for cancer victims looks for evidence the lawyers hope will help prove a cover-up of the dangers of the weed killer called glyphosate.

Glyphosate, which is the active ingredient in Monsanto’s branded Roundup products, is the most widely used herbicide in the world, and is applied broadly in the production of more than 100 food crops, including wheat, corn and soy, as well as on residential lawns, golf courses and school yards.

Residues have been detected in food and human urine, and many scientists around the world have warned that exposure through diet as well as through application can potentially lead to health problems. The World Health Organization’s International Agency for Research on Cancer (IARC) declared glyphosate a probable human carcinogen in 2015 based on a review of scientific literature, triggering the wave of lawsuits against Monsanto, and pushing California regulators to announce they would add glyphosate to a list of known carcinogens.

What the expert finds, or doesn’t find, is expected to be key evidence in hearings slated for the week of Dec. 11 in dozens of consolidated cases being overseen by a federal judge in San Francisco.

Rewind to 1983

Monsanto, as well as many other scientists and regulatory bodies, have defended glyphosate’s safety. They say research showing a cancer connection is flawed and hundreds of studies support its safety.

And yet—rewind to July 1983 and a study titled “A Chronic Feeding Study of Glyphosate (Roundup Technical) in Mice.” Following the document trail that surrounds the study offers an illuminating look into how science is not always clear-cut, and the lengths Monsanto has had to go to in order to convince regulators to accept scientific interpretations that support the company’s products.

The two-year study ran from 1980-1982 and involved 400 mice divided into groups of 50 males and 50 females that were administered three different doses of the weed killer or received no glyphosate at all for observation as a control group. The study was conducted for Monsanto to submit to regulators. But unfortunately for Monsanto, some mice exposed to glyphosate developed tumors at statistically significant rates, with no tumors at all in non-dosed mice.

A February 1984 memo from Environmental Protection Agency toxicologist William Dykstra stated the findings definitively: “Review of the mouse oncogenicity study indicates that glyphosate is oncogenic, producing renal tubule adenomas, a rare tumor, in a dose-related manner.” Researchers found these increased incidences of the kidney tumors in mice exposed to glyphosate worrisome because while adenomas are generally benign, they have the potential to become malignant, and even in noncancerous stages they have the potential to be harmful to other organs. Monsanto discounted the findings, arguing that the tumors were “unrelated to treatment” and showing false positives, and the company provided additional data to try to convince the EPA to discount the tumors.

But EPA toxicology experts were unconvinced. EPA statistician and toxicology branch member Herbert Lacayo authored a February 1985 memo outlining disagreement with Monsanto’s position. A “prudent person would reject the Monsanto assumption that Glyphosate dosing has no effect on kidney tumor production,” Lacayo wrote. ”Glyphosate is suspect. Monsanto’s argument is unacceptable.”

Eight members of the EPA’s toxicology branch, including Lacayo and Dykstra, were worried enough by the kidney tumors in mice that they signed a consensus review of glyphosate in March 1985 stating they were classifying glyphosate as a Category C oncogen, a substance “possibly carcinogenic to humans.”

Research rebuttal

That finding did not sit well with Monsanto, and the company worked to reverse the kidney tumor concerns. On April 3, 1985, George Levinskas, Monsanto’s manager for environmental assessment and toxicology, noted in an internal memorandum to another company scientist that the company had arranged for Dr. Marvin Kuschner, a noted pathologist and founding dean of the medical school at the State University of New York at Stony Brook, to review the kidney tissue slides.

Kushner had not yet even accessed the slides but Levinskas implied in his memo that a favorable outcome was assured: “Kuschner will review kidney sections and present his evaluation of them to EPA in an effort to persuade the agency that the observed tumors are not related to glyphosate,” Levinskas wrote. Notably, Levinskas, who died in 2005, was also involved in efforts in the 1970s to downplay damaging findings from a study that found rats exposed to Monsanto’s PCBs developed tumors, documents filed in PCB litigation revealed.

Kuschner’s subsequent re-examination did —as Monsanto stated it would—determine the tumors were not due to glyphosate. Looking over slides of the mouse tissue from the 1983 study, Kuschner identified a small kidney tumor in the control group of the mice – those that had not received glyphosate. No one had noted such a tumor in the original report. The finding was highly significant because it provided a scientific basis for a conclusion that the tumors seen in the mice exposed to glyphosate were not noteworthy after all.

Additionally, Monsanto provided the EPA with an October 1985 report from a “pathology working group” that also rebutted the finding of the connection between glyphosate and the kidney tumors seen in the 1983 study. The pathology working group said “spontaneous chronic renal disease” was “commonly seen in aged mice.” Monsanto provided the report to the EPA stamped as a “trade secret” to be kept from the prying eyes of the public.

The EPA’s own scientists still did not agree, however. An EPA pathologist wrote in a December 1985 memo that additional examination of the tissue slides did not “definitively” reveal a tumor in the control group. Still, the reports by the outside pathologists brought into the debate by Monsanto helped push the EPA to launch a reexamination of the research.

And by February 1986 an EPA scientific advisory panel had dubbed the tumor findings equivocal; saying that given the tumor identified in the control group by some pathologists, the overall incidences of tumors in the animals given glyphosate were not statistically significant enough to warrant the cancer linkage.

The panel did say there may be reason for concern and noted that the tumor incidences seen in the mice given glyphosate were “unusual.”

The advisory panel told the EPA the studies should be repeated in hopes of more definitive findings, and that glyphosate be classified into what the agency at that time called Group D—“not classifiable as to human carcinogenicity.” The EPA asked Monsanto for a repeat of the mouse oncogenicity study but Monsanto refused to do so.

The company argued “there is no relevant scientific or regulatory justification for repeating the glyphosate mouse oncogenicity study.” Instead, the company provided EPA officials with historical control data that it argued supported its attempt to  downplay the tumor incidences seen in the worrisome 1983 study.

The company said the tumors in mice appear “with some regularity” and were probably attributable to “genetic or environmental” factors. “It is the judgement of Monsanto scientists that the weight-of-evidence strongly supports a conclusion that glyphosate is not oncogenic in the mouse.” Monsanto said repeating the mouse study would “require the expenditure of significant resources… and tie-up valuable laboratory space.”

Feds fold

The discussions between Monsanto and the EPA dragged on until the two sides met in November 1988 to discuss the agency’s request for a second mouse study and Monsanto’s reluctance to do so. Members of the EPA’s toxicology branch continued to express doubts about the validity of Monsanto’s data, but by June of 1989, EPA officials conceded, stating that they would drop the requirement for a repeated mouse study.

By the time an EPA review committee met on June 26, 1991, to again discuss and evaluate glyphosate research, the mouse study was so discounted that the group decided that there was a “lack of convincing carcinogenicity evidence” in relevant animal studies. The group concluded that the herbicide should be classified far more lightly than the initial 1985 classification or even the 1986 classification proposed by the advisory panel. This time, the EPA scientists dubbed the herbicide a Group E chemical, a classification that meant “evidence of non-carcinogenicity for humans.” At least two members of the EPA committee refused to sign the report, stating that they did not concur with the findings. In a memo explaining the decision, agency officials offered a caveat. They wrote that the classification “should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances.”

Despite the EPA’s ultimate conclusion, the mouse study was among those cited by IARC for classifying glyphosate as a probable human carcinogen. Indeed, many other animal studies have similarly had questionable results, including a 1981 rat study that showed an increase in incidences of tumors in the testes of male rats and possible thyroid carcinomas in female rats exposed to glyphosate and a 1990 study that showed pancreatic tumors in exposed rats. But none have swayed the EPA from its backing of glyphosate safety.

Christopher Portier, who was an invited specialist to the IARC review of glyphosate and is 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, believes the evaluations applied to glyphosate data by regulators are “scientifically flawed” and putting public health at risk.

“The data in these studies strongly supports the ability of glyphosate to cause cancer in humans and animals; there is no reason to believe that all of these positive studies arose simply by chance,” Portier said.

Monsanto fought the plaintiffs’ request to view the mouse tissue slides, calling it a “fishing expedition,” but was overruled by U.S. District Judge Vince Chhabria who is overseeing the roughly 60 combined lawsuits under his purvey. Monsanto has confirmed that roughly 900 additional plaintiffs have cases pending in other jurisdictions. All make similar claims – that Monsanto manipulated the science, regulators and the public in ways that hid or minimized the danger posed by its herbicide.

“The importance of the original kidney slides and the re-cut kidney slides is immense to the question of general causation and played a critical role in the EPA’s decision to re-categorize glyphosate…” the plaintiffs’ attorneys stated in a court filing.

Plaintiffs’ attorney Aimee Wagstaff reiterated that in a recent court hearing, telling Judge Chhabria that the events surrounding the 1983 mouse study “sort of dominoed,” and potentially are “extremely relevant” to the cancer litigation.

(First published in Environmental Health News)

(Coming in October 2017 – Whitewash- The Story of a Weed Killer, Cancer, and the Corruption of Science, Island Press)

FDA Resumes Testing Foods For Weed Killer, Safety Questions Grow

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Posted on by Carey Gillam

The Food and Drug Administration (FDA) has resumed its first-ever endeavor to evaluate how much of a controversial chemical is making its way into the U.S. food supply. And the tests can’t come soon enough as safety concerns about the herbicide known as glyphosate grow.

The FDA, the nation’s chief food safety regulator, launched what it calls a “special assignment” last year to analyze certain foods for glyphosate residues 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 in foods. But the agency scuttled the testing after only a few months amid disagreement and difficulties with establishing a standard methodology to use across the agency’s multiple U.S. laboratories, according to FDA sources.

Many observers suspected the suspension might be politically motivated because it came after one FDA chemist found glyphosate in several samples of U.S. honey and oatmeal products, including baby food. As well, private organizations have detected glyphosate residues in an array of food products. In April the Canadian Food Inspection Agency reported that it found glyphosate residues – mostly in small amounts – in roughly 30 percent of foods it tested. The U.S. Department of Agriculture had intended to start testing some food samples for glyphosate in April of this year, agency documents obtained through Freedom of Information Act requests show. But the agency decided to abandon that plan.

Sources inside the FDA said agency glyphosate testing resumed in early June and FDA spokeswoman Megan McSeveney confirmed the news this week. Alongside the testing for glyphosate, the FDA laboratories have also said they were analyzing foods for 2,4-D and other “acid herbicides.” Chemical company players have started combining 2,4-D and the herbicide dicamba with glyphosate in new weed-killing products and use is expected to rise, so tracking residues in food is important. But the FDA has provided few details about any of the testing, and what is known has mostly been learned through internal documents obtained through Freedom of Information requests.

Glyphosate is the most widely used herbicide in the world, and is the key ingredient in Monsanto Co.’s branded Roundup herbicides. It has been classified as a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer (IARC), which said that years of research on the chemical shows evidence of genotoxicity and oxidative stress from glyphosate, including findings of DNA damage in the peripheral blood of exposed humans. But U.S. and other many other regulatory bodies have said there is not sufficient evidence to support that view.

There was also news on Wednesday that the Environmental Protection Agency’s (EPA), Office of Inspector General is initiating a probe into possible collusion between Monsanto and a former top EPA official who provided favorable assessments of the safety of glyphosate while at the EPA. That official, Jesudoss Rowland, was deputy division director within the health effects division of the Office of Pesticide Programs. Rowland managed the work of scientists who assessed human health effects of exposures to pesticides and he chaired the EPA’s Cancer Assessment Review Committee (CARC) that contradicted the IARC finding and 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.

Rowland had a long history of taking a favorable position on Monsanto’s glyphosate. In 1998, Rowland and the hazard identification assessment review committee ― where he served as executive secretary at the time ― recommended that the EPA drop the extra safety margin designed to protect children in the agency’s re-evaluation of what constituted a safe dose of glyphosate. Rowland and another EPA scientist authored the report making the recommendation. The decision to drop the extra safety margin called for in the Food Quality Protection Act was important in helping Monsanto gain approval for expanded tolerance levels for glyphosate residues in food. Pesticide residues are legal in food if they fall under the so-called “maximum residue levels” or MRLs set by the EPA.

As the FDA tests for glyphosate residues in food the agency specifically will be looking to see if residues they do find fall within those MRLs. Over the years, the legal limits for glyphosate in food have risen multiple times as glyphosate use has risen.

Glyphosate exposures in food and in the environment need much more scrutiny, according to a group of 20 doctors and scientists who put their concerns in writing last month: “Should the public be assured of the safety of glyphosate? We think not…” the group wrote. “We urge the public not to be duped by chemical company apologists who attempt to obscure independent scientific findings that threaten a highly profitable product.”

(First published in Huffington Post)

Canadians Report Weed Killer Detected in 30 Percent of Food Tested

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Posted on by Carey Gillam

The Canadian Food Inspection Agency has gone where the U.S. government dares not tread – testing thousands of foods commonly consumed by its citizens for residues of a controversial herbicide linked to cancer. And the findings are less than appetizing.

The agency said it found the pesticide known as glyphosate, the key ingredient in Monsanto Co.’s Roundup branded herbicides and other products, in 29.7 percent of 3,188 foods tested in 2015 and 2016. Glyphosate was found in 47.4 percent of beans, peas and lentil products; 36.6 percent of grain products; and 31 percent of baby cereals, the agency report states.

Only 1.3 percent of the total samples were found with glyphosate residue levels above what Canadian regulators allow, though 3.9 percent of grain products contained more of the weed killer than is permissible. These legally allowable levels are referred to as Maximum Residue Limits (MRLs), and they vary from food to food and pesticide to pesticide, as well as from country to country. Regulators and agrichemical industry interests say as long as residue levels are lower than the established MRLs, consuming the pesticide residues is not harmful to humans. But a growing number of scientists and medical professionals say such claims are false, particularly with pesticides like glyphosate, which is the most widely used agrichemical on the planet, commonly used in the production of dozens of food crops. Glyphosate is sprayed directly onto crops like corn, soybeans, sugar beets and canola, all of which are genetically engineered to tolerate the pesticide. Monsanto has also encouraged farmers to spray the chemical directly on oats, wheat, peas and lentils shortly before harvest to help dry them out.

“It’s all guesswork, and not based on a lot,” Dr. Bruce Blumberg, Professor of Developmental and Cell Biology in the University of California, Irvine’s School of Biological Sciences said of the MRLs. “Nobody is actually measuring levels of this pesticide in humans. They don’t do that but they should.”

The World Health Organization’s International Agency for Research on Cancer classified glyphosate as a probable human carcinogen in 2015 and said years of research on the chemical shows strong evidence of genotoxicity and oxidative stress from glyphosate, including findings of DNA damage in the peripheral blood of exposed humans. Many regulatory bodies, including the U.S. Environmental Protection Agency, have determined glyphosate is not carcinogenic, but the issue is the subject of much controversy. Internal Monsanto documents revealed through litigation in California indicate that the company may have ghost-written studies attesting to the safety of the chemical that were relied on by regulators. They also show the company discussing an EPA official that may help “kill” a cancer study of glyphosate.

Oddly, the USDA did intend to start testing some food samples for glyphosate this year, with a start date of April 1, agency documents obtained through Freedom of Information Act requests show. But the agency decided to abandon that plan earlier this year. As well, the FDA started its first-ever glyphosate testing program last year but suspended that “special assignment” in September. Even the CFIA has handled the glyphosate testing in a curious manner: The agency said it would not release detailed data on glyphosate residues found in food because it is considered “confidential business information.”

A source within the FDA said there has been political pressure not to delve too deeply into the issue of glyphosate residues. But both the USDA and FDA have said their reasons for not testing have nothing to do with outside influence and are purely based on the fact that glyphosate is more difficult and expensive to test for than other pesticides, and the fact that it is considered safe. The FDA has said it is working on resuming its limited testing of corn, soy, eggs and milk for glyphosate residues.

“I’m not sure what is going on, but it doesn’t smell good,” said Blumberg, who has been active in lobbying Irvine school districts and city leaders to reduce their use of glyphosate and other pesticides in public areas.

USDA Drops Plan to Test for Monsanto Weed Killer in Food

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Posted on by Carey Gillam

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.)

New Data on Pesticides in Food Raises Safety Questions

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Posted on by Carey Gillam

As Americans gather their families to share a Thanksgiving meal this week, new government data offers a potentially unappetizing assessment of the U.S. food supply: Residues of many types of insecticides, fungicides and weed killing chemicals have been found in roughly 85 percent of thousands of foods tested.

Data released last week by the U.S. Department of Agriculture shows varying levels of pesticide residues in everything from mushrooms to potatoes and grapes to green beans. One sample of strawberries contained residues of 20 pesticides, according to the “Pesticide Data Program” (PDP) report issued this month by the USDA’s Agricultural Marketing Service. The report is the 25th annual such compilation of residue data for the agency, and covered sampling the USDA did in 2015

Notably, the agency said 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. Prior years also showed roughly 40-50 percent of samples as free of detectable residues, according to USDA data. The USDA said it is not “statistically valid” to compare one year to others, however, because the mix of food sampled changes each year. Still the data shows that 2015 was similar to the years prior in that fresh and processed fruits and vegetables made up the bulk of the foods tested.

Though it might sound distasteful, the pesticide residues are nothing for people to worry about, according to the USDA. The agency said “residues found in agricultural products sampled are at levels that do not pose risk to consumers’ health and are safe…”

But some scientists say there is little to no data to back up that claim. Regulators do not have sufficient comprehensive research regarding how regular, repeated consumption of residues of multiple types of pesticides impact human health over the long term, and government assurances of safety are simply false, say some scientists.

“We don’t know if you eat an apple that has multiple residues every day what will be the consequences 20 years down the road,” said Chensheng Lu, associate professor of environmental exposure biology at the Harvard School of Public Health. “They want to assure everybody that this is safe but the science is quite inadequate. This is a big issue.”

The USDA said in its latest report that 441 of the samples it found were considered worrisome as “presumptive tolerance violations,” because the residues found either exceeded what is set as safe by the Environmental Protection Agency (EPA) or they were found in foods that are not expected to contain the pesticide residues at all and for which there is no legal tolerance level. Those samples contained residues of 496 different pesticides, the USDA said.

Spinach, strawberries, grapes, green beans, tomatoes, cucumbers and watermelon were among the foods found with illegal pesticide residue levels. Even residues of chemicals long banned in the United States were found, including residues of DDT or its metabolites found in spinach and potatoes. DDT was banned in 1972 because of health and environmental concerns about the insecticide.

Absent from the USDA data was any information on glyphosate residues, even though glyphosate has long been the most widely used herbicide in the world and is commonly sprayed directly on many crops, including corn, soy, wheat, and oats. It is the key ingredient in Monsanto Co.’s branded Roundup herbicide, and was declared a probable human carcinogen last year by a team of international cancer scientists working with the World Health Organization. But Monsanto has said glyphosate residues on food are safe. The company asked the EPA to raise tolerance levels for glyphosate on several foods in 2013 and the EPA did so.

The Food and Drug Administration also annually samples foods for residues of pesticides. New documents obtained from the FDA show illegal levels of two types of insecticides – propargite, used to kill mites, and flonicamid, usually aimed at killing aphids and whiteflies – were recently found in honey. Government documents also show that DEET, a common insect repellant, was recently detected by regulators in honey, and the herbicide acetochlor was found on mushrooms.

FDA scientists also reported illegally high levels of the neonicotinoid thiamethoxam found in rice, according to information from the agency. Syngenta has asked the Environmental Protection Agency to allow for higher residues of thiamethoxam permitted in numerous crops because the company wants it to have expanded use as a leaf spray. That request with EPA is still pending, according to an agency spokeswoman.

The most recent public residue report issued by the FDA shows that violation rates for pesticide residues have been climbing in recent years. Residue violations in domestic food samples totaled 2.8 percent for the year 2013; double the rate seen in 2009. Violations totaled 12.6 percent for imported foods in 2013, up from 4 percent in 2009.

Like the USDA, the FDA has skipped glyphosate in decades of testing for pesticide residues. But the agency did launch a “special assignment” this year to determine what levels of glyphosate might be showing up in a small group of foods. An FDA chemist reported finding glyphosate residues in honey and several oatmeal products, including baby food.

Private testing data released this month also reported the presence of glyphosate residues in Cheerios cereal, Oreo cookies and a variety of other popular packaged foods.

QUESTIONS ON CUMULATIVE IMPACTS
Whether or not consumers should worry about food containing pesticide residues is a matter of ongoing dispute. The trio of federal agencies involved in pesticide residue issues all point to what they refer to as “maximum residue limits” (MRLs), or “tolerances,” as benchmarks for safety. The EPA uses data supplied by the agrichemical industry to help determine where MRLs should be set for each pesticide and each crop the pesticides are expected to be used with.

As long as most of foods sampled show pesticide residues in food below the MRLs, there is no reason to worry, the USDA maintains. “The reporting of residues present at levels below the established tolerance serves to ensure and verify the safety of the Nation’s food supply,” the 2015 residue report states. The agrichemical industry offers even broader assurances, saying there is nothing to fear from consuming residues of the chemicals it sells farmers for use in food production, even if they exceed legal tolerances.

But many scientists say the tolerances are designed to protect the pesticide users more than consumers. Tolerances vary widely depending upon the pesticide and the crop. The tolerance for the insecticide chlorpyrifos on an apple, for instance, is very different than the amount of chlorpyrifos allowed on citrus fruits, or on a banana or in milk, according to government tolerance data.

In the case of chlorpyrifos, the EPA has actually said it wants to revoke all food tolerances because studies have linked the chemical to brain damage in children. Though the agency has long considered residues of chlorpyrifos safe, now the agency says, they may not be.

The “EPA cannot, at this time, determine that aggregate exposure to residues of chlorpyrifos, including all anticipated dietary exposures and all other non-occupational exposures for which there is reliable information, are safe,” the EPA said last year. Dow AgroSciences, which developed chlorpyrifos in the 1960s, is protesting the EPA efforts, arguing chlorpyrifos is a “critical tool” for farmers. In the latest USDA residue report, chlorpyrifos was found in peaches, apples, spinach, strawberries, nectarines and other foods, though not at levels considered to violate tolerances.

The EPA defends its work with tolerances, and says it has been complying with the Food Quality Protection Act that requires the EPA to consider the cumulative effects of residues of substances “that have a common mechanism of toxicity.” The agency says to set a tolerance for a pesticide, it looks at studies submitted by pesticide companies to identify possible harmful effects the chemical could have on humans, the amount of the chemical likely to remain in or on food and other possible exposures to the same chemical.

But critics say that is not good enough – assessments must consider more realistic scenarios that take into account the broader cumulative impacts of many different types of pesticide residues to determine how safe it is to consume the mixtures seen in a daily diet, they say. Given that several pesticides commonly used in food production have been linked to disease, declines in cognitive performance, developmental disorders, and attention-deficit/hyperactivity disorder in children, there is an urgent need for more in-depth analysis of these cumulative impacts, according to many scientists. They point to the National Research Council’s declaration years ago that “dietary intake represents the major source of pesticide exposure for infants and children, and the dietary exposure may account for the increased pesticide-related health risks in children compared with adults.”

“With the ubiquitous exposure to chemical mixtures, assurances of safety based on lists of individual toxicity thresholds can be quite misleading,” said Lorrin Pang, an endocrinologist with the Hawaii Department of Health and a former advisor to the World Health Organization.

Tracey Woodruff, a former EPA senior scientist and policy advisor who specializes in environmental pollutants and child health, said there is a clear need for more research. Woodruff directs the Program on Reproductive Health and the Environment at the University of California San Francisco School of Medicine.

“This is not a trivial matter,” she said. “The whole idea of looking at cumulative exposures is a hot topic with scientists. Evaluating individual tolerances as if they occur in solo is not an accurate reflection of what we know – people are exposed to multiple chemicals at the same time and the current approaches do not scientifically account for that.”

Critics say scrutiny of pesticide safety is likely to only soften given President-elect Donald Trump’s decision to name Myron Ebell to oversee transition efforts at the EPA. Ebell, director of the Center for Energy and Environment at the Competitive Enterprise Institute, is a staunch advocate of pesticides and their safety.

“Pesticide levels rarely, if ever, approach unsafe levels. Even when activists cry wolf because residues exceed federal limits that does not mean the products are not safe,” states the SAFEChemicalPolicy.org website Ebell’s group runs. “In fact, residues can be hundreds of times above regulatory limits and still be safe.”

The mixed messages make it hard for consumers to know what to believe about the safety of pesticide residues in food, said Therese Bonanni, a clinical dietitian at Jersey Shore University Medical Center.

“Although the cumulative effect of consuming these toxins over a lifetime is not yet known, short-term data suggests there is certainly a reason to be cautious,” she said. “The message to consumers becomes very confusing.”

(Article first appeared in The Huffington Post)

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

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Posted on by Carey Gillam

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)

Glyphosate ‘Revolution’ Growing — Consumers Want Answers

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Posted on by Carey Gillam

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

Conflict of Interest Concerns Cloud Glyphosate Review

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Posted on by Carey Gillam

By Carey Gillam

It’s been a little more than a year since the World Health Organization’s (WHO) cancer research experts upended the agrichemical industry’s favorite child. The group, the International Agency for Research on Cancer (IARC) declared the globe’s most widely used herbicide – glyphosate – to be a probable human carcinogen.

Since then, Monsanto Co., which draws roughly a third of its $15 billion in annual revenues from its Roundup branded glyphosate-based herbicide products, (and much of the rest from glyphosate-tolerant crop technology) has been on a mission to invalidate the IARC finding. Through an army of foot soldiers that include industry executives, public relation professionals and public university scientists, the company has called for a rebuke of IARC’s work on glyphosate.

How successful those efforts will or will not be is still an open question. But some answers are expected following a meeting being held this week in Geneva, Switzerland. An “international expert scientific group” known as JMPR is reviewing IARC’s work on glyphosate, and the results are expected to offer regulators around the world a guide for how to view glyphosate.

The group, officially known as the Joint FAO-WHO Meeting on Pesticide Residues (JMPR), is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and WHO. JMPR meets regularly to review residues and analytical aspects of pesticides, to estimate maximum residue levels, and to review toxicological data and estimate acceptable daily intakes (ADIs) for humans.

After this week’s meeting, set to run from May 9-13, JMPR is expected to issue a series of recommendations that will then go to the FAO/WHO Codex Alimentarius Commission. The Codex Alimentarius was established by FAO and the World Health Organization develops harmonized international food standards as a means to protect consumer health and promote fair practices in food trade.

The meeting comes as both European and U.S. regulators are wrestling with their own assessments and how to react to the IARC classification. It also comes as Monsanto looks for backing for its claims of glyphosate safety.

Glyphosate is not just a lynchpin for sales of the company’s herbicides but also for its genetically modified seeds designed to tolerate being sprayed with glyphosate. The company also is currently defending itself against several lawsuits in which farmworkers and others allege they contracted cancer linked to glyphosate and that Monsanto knew of, but hid, the risks. And, a rebuke of IARC’s glyphosate classification could help the company in its lawsuit against the state of California, which aims to stop the state from following the IARC classification with a similar designation.

Depending on the result of the JMPR, the Codex will decide on any actions necessary regarding glyphosate, said WHO spokesperson Tarik Jasarevic.

“It is the JMPR’s function to conduct risk assessment for agricultural use and assessing the health risks to consumers from residues found in food,” said Jasarevic

The outcome of the JMPR meeting is being watched closely by a number of environmental and consumer groups that want to see new safety standards for glyphosate. And not without some worry. The coalition, which includes the Natural Resources Defense Council and Friends of the Earth, has expressed concern about apparent conflicts of interest on the expert advisory panel. Some individuals appear to have financial and professional ties to Monsanto and the chemical industry, according to the coalition.

The coalition specifically cited concerns with member ties to the nonprofit International Life Sciences Institute (ILSI), which is funded by Monsanto and other chemical, food and drug companies. The Institute’s board of trustees includes executives from Monsanto, Syngenta, DuPont, Nestle and others, while its list of member and supporting companies includes those and many more global food and chemical concerns.

Internal ILSI documents, obtained by a state public records request, suggest that ILSI has been generously funded by the agrichemical industry. One document that appears to be ILSI’s 2012 major donor list shows total contributions of $2.4 million, with more than $500,000 each from CropLife International and from Monsanto.

“We have significant concerns that the committee will be unduly influenced by the overall pesticide industry and particularly Monsanto- the largest producer of glyphosate in the world,” the coalition told WHO in a letter last year.

One such JMPR expert is Alan Boobis, professor of biochemical pharmacology and director of the toxicology unit in the faculty of medicine at Imperial College London. He is a member and a past chairman of the board of trustees of ILSI, vice-president of ILSI Europe and chair of ILSI.

Another member is Angelo Moretto, Director of the International Centre for Pesticides and Health Risks Prevention at “Luigi Sacco” Hospital of the ASST Fatebenefratelli Sacco, in Milan, Italy. The coalition said that Moretto has been involved in various projects with ILSI and has served as a member of the steering team for an ILSI project on risks of chemical exposures financed by agrichemical companies that included Monsanto.

Another is Aldert Piersma, a senior scientist at the National Institute for Public Health and the Environment in the Netherlands and an advisor to projects of ILSI’s Health and Environmental Sciences Institute.

In all the JMPR list of experts totals 18. Jasarevic said that the roster of experts are chosen from a group of individuals who expressed interest in being involved, and all are “independent and are selected based on their scientific excellence, as well as on their experience in the field of pesticide risk assessment.”

Aaron Blair, a scientist emeritus at the National Cancer Institute and the chairman of the IARC group that made the glyphosate classification, has defended IARC’s work as based on a thorough scientific review. He said he had no concerns to discuss regarding the  JMPR review of IARC’s work.

“I am sure the evaluation by the joint FAO/WHO group will make the reasons for their evaluation clear, which is what is critical for the press and public,” he said.

The world is waiting.