Questions about EPA-Monsanto collusion raised in cancer lawsuits

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Now  it’s getting interesting.

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

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

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

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

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

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

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

MONSANTO WANTS DOCUMENTS KEPT SECRET

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

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

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

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

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

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

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