http://www.reuters.com/article/2013/02/26/monsanto-brazil-idUSL1N0BQATJ20130226

http://www.chicagotribune.com/features/food/stew/chi-gmos-should-be-safety-tested-before-they-hit-the-market-says-ama-20120619,0,4405082.story

The American Medical Association called for mandatory pre-market safety testing of genetically engineered foods as part of a revised policy voted on at the AMA’s meeting in Chicago Tuesday.

Currently biotech companies are simply encouraged to engage in a voluntary safety consultation with the Food and Drug Administration before releasing a product onto the market.

Some activists concerned about foods made with genetically modified organisms, or GMOs, had hoped the association would have gone so far as to support mandatory labeling of genetically engineered foods. But some still view the policy change as a major breakthrough.

“We applaud the AMA for taking the lead to help ensure a safe and adequate food supply,” said Anne Dietrich of the Truth In Labeling Campaign, which advocates labeling of genetically engineered foods. When Monsanto Co., the world’s largest biotech seed company, testified Sunday at the AMA committee hearing on the policy, its representative did not raise any objections to the mandatory safety assessment provision.

On Tuesday, however, Monsanto spokesman Tom Helscher would not say whether or not the company supports mandatory pre-market testing, only that the current voluntary consultation process “is working,” he wrote to the Tribune. “All of Monsanto’s biotech products, and to our knowledge all those of other companies, go through the FDA consultation process, which provides a stringent safety assessment of biotech crops before they are placed on the market.”

The AMA’s Dr. Patrice Harris said the testing provision was aimed at addressing public interests and ensuring public health.

“Recognizing the public’s interest in the safety of bioengineered foods, the new policy also supports mandatory FDA pre-market systemic safety assessments of these foods as a preventive measure to ensure the health of the public,” Harris said in a statement. “We also urge the FDA to remain alert to new data on the health consequences of bioengineered foods.”

Tuesday afternoon FDA officials would not say whether the department supported mandatory testing. “New foods have an obligation under the Federal Food, Drug & Cosmetic Act to ensure that the foods they offer consumers are safe and in compliance with applicable legal requirements,” the agency said. “In meeting their legal obligation, firms do conduct premarket safety testing.”

The agency was referring to testing manufacturers commission for their own use. Critics, however, argue that independent testing overseen by regulatory authorities often produces different results than testing paid for by the manufacturer.

After the policy was announced Tuesday, Consumers Union senior scientist Michael Hansen released a statement saying: “We wholeheartedly commend AMA for coming out in support of mandatory pre-market safety assessment of (genetically engineered) foods, but are disappointed that AMA did not also support mandatory labeling. … Studies in the scientific literature have suggested that genetic engineering could introduce new food allergens, increase the levels of known allergens, raise or lower nutrient levels and have adverse effects on the animals that eat such foods.”

Just Label It, the national campaign for the labeling of genetically engineered foods (www.justlabelit.org), issued a statement saying “just the fact that the AMA even considered this measure is a significant win for the vast majority (91%) of Americans (see the Mellman Poll findings) who believe they have the right to know about the foods they eat and feed their families — a fundamental right already enjoyed by citizens in more than 50 countries worldwide, including all of Europe, Japan, Russia and China.”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952409/

Abstract

We summarize the major points of international debate on health risk studies for the main commercialized edible GMOs. These GMOs are soy, maize and oilseed rape designed to contain new pesticide residues since they have been modified to be herbicide-tolerant (mostly to Roundup) or to produce mutated Bt toxins. The debated alimentary chronic risks may come from unpredictable insertional mutagenesis effects, metabolic effects, or from the new pesticide residues. The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed. The tests are not compulsory, and are not independently conducted. The test data and the corresponding results are kept in secret by the companies. Our previous analyses of regulatory raw data at these levels, taking the representative examples of three GM maize NK 603, MON 810, and MON 863 led us to conclude that hepatorenal toxicities were possible, and that longer testing was necessary. Our study was criticized by the company developing the GMOs in question and the regulatory bodies, mainly on the divergent biological interpretations of statistically significant biochemical and physiological effects. We present the scientific reasons for the crucially different biological interpretations and also highlight the shortcomings in the experimental protocols designed by the company. The debate implies an enormous responsibility towards public health and is essential due to nonexistent traceability or epidemiological studies in the GMO-producing countries.
Keywords: GMOs, Health risks, Pesticides, Regulatory toxicology, Animal testsDebate on GMOs Health Risks after Statistical Findings in Regulatory Tests
http://www.ncbi.nlm.nih.gov
We summarize the major points of international debate on health risk studies for…See Mor

http://www.reuters.com/journalists/carey-gillam

Weed-Killer Roundup ‘Probably’ Causes Cancer
Posted November 18th, 2015 by Chris Elkins & filed under Current Litigation & Lawsuit News.

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The World Health Organization is declaring the main ingredient in Monsanto’s weed killer Roundup “probably” causes cancer.

After decades of debate, reversed decisions and protests, the WHO’s International Agency for Research and Cancer listed Roundup’s ingredient glyphosate in Group 2A on its list of agents that may cause cancer. A Group 2A listing means the ingredient “is probably carcinogenic to humans.”

The listing means glyphosate has shown limited evidence of cancerous effects in humans and sufficient evidence of cancerous effects in animal studies.

“All three lines of evidence sort of said the same thing, which is we ought to be concerned about this,” the committee chairman, Aaron Blair, told The New York Times.

Blair is a retired epidemiologist from the U.S. National Cancer Institute. He chaired a group of 17 reviewers from around the world which unanimously agreed to classify glyphosate as “probably” cancerous.

Glyphosate is the most-produced and most-used herbicide in the world. The use of the chemical increased drastically after the introduction of genetically-modified plants – known as “Roundup Ready” crops – across the globe. Researchers found glyphosate in the air, water and food in settings where the product was sprayed, according to the WHO.

“We don’t know how IARC could reach a conclusion that is such a dramatic departure from the conclusion reached by all regulatory agencies around the globe,” Philip Miller, Monsanto’s vice-president for global regulatory affairs, said in a press release.

In a press release, the company argued:

IARC’s classification is not a study. There is no new data here.
Relevant, scientific data were excluded from review.
The conclusion is not supported by scientific data.
IARC’s classification does not establish a link between glyphosate and an increase in cancer.
Monsanto introduced glyphosate in 1974 as the top ingredient in its Roundup products. It’s used in more than 160 countries and is used on the majority of the corn and soybean crops in the U.S. The crops were genetically-modified to resist the effects of glyphosate and are referred to as “Roundup Ready.”

Monsanto made billions of dollars annually from the products, including more than $2 billion in 2014 despite the sale of generic glyphosate. The patent for the chemical expired in 2000, according to Reuters.

This isn’t the first time Monsanto, Roundup and glyphosate are under scrutiny. Studies dating back to the 1980s found possible links between glyphosate and cancer.

That’s why farmers, agricultural workers, landscapers and gardeners who developed cancer after spending years working with the herbicide are filing lawsuits against Monsanto. The plaintiffs claim Monsanto failed to warn of the risks of its weed killer and caused them to develop cancer.

If you or a loved one developed cancer after use of Roundup Weed Killer, you may have legal options.GET HELP NOW
Decades of Roundup Cancer Suspicions
In 1985, members of the U.S. Environmental Protection Agency’s Toxicology Branch evaluated the data on glyphosate and determined it was a “Category C oncogene.” That meant it was an indoor or outdoor non-food product that could cause cancer. However, the EPA reversed its ruling after revaluating the same studies in 1991.

The EPA found findings that laboratory mice developed tumors after being exposed to glyphosate were statistically insignificant. It moved glyphosate to Category E, meaning there was no evidence of carcinogenicity in humans, according to the Times.

After the WHO announced glyphosate was “probably carcinogenic” in 2015, the EPA announced it would update its findings. The EPA was working with Canadian regulators to assess the safety and effectiveness of glyphosate.

“The agency plans to re-evaluate risks from glyphosate and certain inert ingredients to humans and the environment during the registration review process,” the EPA told Reuters in March.

World Health Organization Warns Glyphosate ‘Probably Carcinogenic’
In March 2015, the WHO officially announced the addition of glyphosate and other herbicides to Group 2A. The IARC recommended the listing after finding evidence of non-Hodgkin lymphoma in humans in a review of studies published during the last 15 years in the U.S., Canada and Sweden.

Most of the exposure to glyphosate came from the agricultural industry. The organization also found evidence that glyphosate caused cancer in animals.

In a new evaluation of the EPA’s study, the IARC determined glyphosate had carcinogenic effects on laboratory mice. In the study, three out of 50 mice developed a rare type of kidney cancer. The cancer is so rare the WHO was alarmed.

“They literally don’t occur, but they occurred when rodents were dosed with this stuff,” Blair told the Times. The group found similar results when evaluating several other animal studies.

Additionally, the IARC found evidence of DNA and chromosomal damage in human cells when studying residents of a community near locations where glyphosate was sprayed.

The WHO classification caused several ramifications, from state listings of the chemical as cancerous to lawsuits.

California to List Glyphosate as Cancer Causing
The state of California’s Office of Environmental Health Hazard Assessment provided notice in September that it would list glyphosate as cancer-causing under an initiative to inform residents of cancer-causing chemicals called Proposition 65.

The notice received more than 8,000 comments including a 17-page comment from Monsanto. The comments included both supporters and opponents of the listing.

“A listing of glyphosate under Proposition 65 has the potential to deny farmers and public agencies the use of this highly effective herbicide, an herbicide whose use promotes the health, well-being, safety, and environment of Californians,” Monsanto wrote in its comments letter.

However, public health groups including farmer and environmental groups sent letters supporting the listing, according to Reuters.

Other states are taking action too. A councilwoman in Hawaii recently proposed a bill that would outlaw the use of glyphosate in public parks, along county roads, bikeways, sidewalks, trails and waterways by July 1, 2016.

Monsanto’s History of Legal Troubles
Glyphosate isn’t the first herbicide to land Monsanto in legal troubles. The company is still fighting claims in court involving its polychlorinated biphenyls (PCBs). The chemicals are carcinogens, according to the WHO.

Monsanto faces more than 700 lawsuits from people claiming exposure to the herbicides in the 1970s caused them to develop non-Hodgkin lymphoma. The chemical is no longer used in the U.S.

Plaintiffs recently filed the first lawsuits claiming Roundup’s ingredient glyphosate caused cancer.

In one case, Judi Fitzgerald claimed she was exposed to glyphosate while working as a grower’s assistant in New York from 1994 to 1998. She claims Roundup was regularly sprayed indoors and outdoors and she could smell the herbicide in the air while outside.

A doctor diagnosed Fitzgerald with chronic lymphocytic leukemia in 2012. She was forced to quit work and relocate to Virginia. She is seeking reasonable compensation and punitive damages in court.

In another case, Enrique Rubio claimed he was exposed to Roundup while picking vegetables in Oregon from 1986 to 1988, in California from 1988 to 1993 and in Texas from 1993 to 1995. He had to quit work in 1995 after being diagnosed with bone cancer. His lawsuit also seeks compensation and punitive damages.

Both lawsuits claim Monsanto knew of the cancer-causing properties of glyphosate for decades, but the company failed to warn of the risks of its products and falsely advertised them as safe.

Glyphosate is also the ingredient in household Roundup products. Lawsuits and studies have only found cancerous effects on people exposed to glyphosate regularly – like those working in the agricultural or landscaping industries. However, the WHO’s listing suggests exposure to glyphosate from the household products could cause cancer too.

reuters.com/article/us-monsanto-herbicide-weeds-idUSKBN0MR2JT20150331

U.S. regulators will put new restrictions on the world’s most widely used herbicide to help address the rapid expansion of weeds resistant to the chemical, Reuters has learned.

The Environmental Protection Agency confirmed it will require a weed resistance management plan for glyphosate, the key ingredient in Monsanto’s immensely popular Roundup weed-killer.

The agency has scheduled a conference call for next week with a committee of the Weed Science Society of America to discuss what the final plan for glyphosate should entail, said Larry Steckel, a Tennessee scientist who chairs the committee.

An EPA spokeswoman declined to give specifics of the plan, but told Reuters that its requirements will be similar to those placed on a new herbicide product developed by Dow AgroSciences, a unit of Dow Chemical Co..

Requirements for the Dow herbicide include weed monitoring, farmer education and remediation plans. The company is required to provide extensive reporting to the EPA about instances of weed resistance and to let “relevant stakeholders” know about the difficulties of controlling them via a company-established website.

Monsanto spokeswoman Charla Lord would not discuss whether the company was negotiating a plan with regulators, but said Monsanto “will continue to work with the EPA to ensure proper product stewardship as we move through the regulatory process.”

At least 14 weed species and biotypes in the United States have developed glyphosate resistance, affecting more than 60 million acres of U.S. farmland, according to data gathered by the U.S. Department of Agriculture and U.S. weed scientists. The herbicide-resistant weeds hinder crop production and make farming more difficult and expensive.

The EPA’s action comes in the wake of a finding by the World Health Organization’s cancer research unit this month that glyphosate is “probably carcinogenic to humans,” a conclusion the working group said was based on a review of years of scientific research. Testing has found residues of the herbicide in water, food, urine and breast milk.

The EPA’s weed management plan will not address human health concerns, but the agency is also analyzing health data as part of a required reevaluation of the herbicide.

The EPA’s preliminary risk assessment of glyphosate is expected to be released for public comment later this year, and the agency will publish its proposed weed management plan for public comment at the same time.

Regulators in the United States and many other countries have long considered glyphosate among the safest herbicides in use. A review of the chemical by the German government for the European Union last year concluded that no link to cancer has been established.

And Monsanto Co., which held the patent on glyphosate until 2000 and last year sold more than $5 billion of Roundup herbicide, says the weed-killing agent has been proven safe repeatedly. Last week, the company blamed “agenda-driven groups” for fueling false reports about glyphosate.

But the chemical’s critics, including environmentalists, scientists and opponents of genetically modified foods, hope the WHO finding will help convince the EPA that tighter controls on the herbicide are needed, not just to prevent the growth of herbicide-resistant weeds, but also to protect human health.

On March 26, a coalition of public interest groups, including the Natural Resources Defense Council, and the Center for Food Safety sent a letter to EPA administrator Gina McCarthy urging the agency to “weigh heavily” WHO’s finding as it prepares its risk assessment.

HUGE RAMIFICATIONS

How the EPA chooses to handle glyphosate is a closely watched issue for the agricultural industry.

Globally, the herbicide is a key ingredient in more than 700 products and is used to control weeds in gardens, along roadsides and on millions of acres of farmland.

Steckel said that his committee will express some concerns in its call with the EPA next week. Specifically, he said, the group sees shortcomings in the management plant the agency has for Dow AgroSciences and would like a glyphosate plan that allows for state-specific provisions.

“We are here on the ground, and we think we could tailor things to have more impact than just one overarching plan from the federal government…,” said Steckel, a row crop weed specialist at the University of Tennessee. “We have to preserve these herbicides. There really are no new ones.”

At least 283.5 million pounds of glyphosate were used in U.S. agriculture in 2012, the most recent year for which data is available, up from 110 million pounds in 2002, according to the U.S. Geological Survey. (reut.rs/1NcACgm) According to the U.S. Department of Agriculture, more than 90 percent of the soybeans and cotton grown in the United States last year, and 89 percent of the corn, was genetically modified to withstand herbicide applications.

(Reporting by Carey Gillam in Kansas City; Editing by Sue Horton)
http://www.dpreview.com/forums/post/57804801

This guy makes some excellent points. Why was Debbie Wasserman Schultz blaming the Sanders supporters for the debacle in Nevada?

http://www.dpreview.com/forums/post/57753750

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