Health IssuesMartha RosenbergOrganic Consumers AssociationMay 27, 2016
day of the dead skulls, 420 x 280
If you’re worried about thinning bones, or bone fractures, you probably have Big Food and Big Pharma to thank for keeping you up at night.
For decades, these two industries have used scare tactics to convince the general population that they’re bones are at risk—and that they, and they alone, have the answers to your thinning bone problems.
But the healthy bone “solutions” peddled by Big Food and Big Pharma have in most cases proven healthier for corporate profits, than for consumers’ bones. And some of those “solutions” have actually contributed to thinning bones.
‘Milking’ consumer fear
Almost 20 years ago, the dairy industry announced a fictitious “calcium crisis” caused by too many young people drinking beverages other than milk. In addition to rolling out new bottles that made milk drinking seem “fun,” the dairy industry launched its “Milk: It Does a Body Good” campaign that told teens and tweens they should drink milk now to prevent osteoporosis in later life.
There were two obvious problems with the “Milk: It Does a Body Good” campaign. First, 12-year-olds don’t worry about the condition their bones will be when they are 58 years old. And second, milk is neither the best or only source of calcium.
But the marketing geniuses behind the campaign didn’t let a few inconvenient facts get in the way. They forged ahead, undaunted.
Meanwhile, even though milk sales were falling, cows were being “culled” to keep prices up, and the government was buying up the milk surplus no one wanted, Monsanto in the 1990s was busy at work developing recombinant bovine growth hormone (rBGH) which let dairy operations get seven to 14 additional pounds of milk daily out of a single cow.
It wasn’t long before questions arose about the fate of an rBGH by-product called Insulin-like growth factor 1 or IGF-1 in the human body. As reported in the New York Times, male rats developed cysts on their thyroid glands and abnormalities on their prostates. But that didn’t stop Donna Shalala, then-secretary of the Health and Human Services Department, from refusing a request by Senators to investigate whether or not the U.S. Food & Drug Administration (FDA) had overlooked rBGH safety evidence.
Shalala even went so far as to help kick off the National Dairy Council and the National Osteoporosis Foundation's national "milk mobile" which toured 100 cities, offering free bone density screenings and a chance to be in a milk mustache ad. Shalala herself posed in a milk mustache ad.
Bone drugs a ‘bone-anza’ for Big Pharma
Big Pharma has done an even better job of instilling, in women especially, a fear of bone loss in order to sell pharmaceutical products.
When hormone replacement therapy (HRT) proved to be a 40-year scam (causing the very same symptoms it was supposed to prevent), Big Pharma rolled out a “thinning bones” campaign to retain the same women customers. Watch out, the drug companies told women—your bones are probably thinning and soon you will have fractures, a stooped posture and worst of all, you’ll “look old.”
Soon, just as model Lauren Hutton had sold HRT, Meredith Vieira from the Today show, former Charlie’s Angel Cheryl Ladd and actress Sally Field were selling bone drugs.
But it was the bisphosphonate class of drugs—Fosamax, Boniva, Actonel and Reclast—that proved to be the real “bone-anza” for Big Pharma. By stopping the body’s natural process of bone remodeling—in which mature bone tissue is removed from the skeleton through resorption and new bone tissue is formed—these drugs appeared to prevent osteoporosis or thinning bones. The operative word being “appeared.”
Soon after their approval, bisphosphonates were linked to serious side effects, including heart problems, intractable pain, jawbone death, esophageal cancer and the very fractures they were supposed to prevent. Many wondered why the drugs were approved. For example, if patients did not sit upright after taking a bisphosphonate, they could end up in the ER with esophageal damage. And the disfiguring side effect of jawbone death sometimes required a tracheostomy (an incision in the windpipe), bone grafts and even jaw removal.
So much for staying young and pretty.
Drug companies knew, but didn’t tell
Court documents show that Merck, who made the popular bisphosphonate Fosamax, knew about jawbone death since the 1970s but marketed the drug anyway. In fact, it was dentists, not the FDA or Big Pharma who first reported the problem. In 2013, Merck agreed to pay $27.7 million for multiple Fosamax lawsuits.
In 2013, I interviewed Dr. William Banks Hinshaw, a gynecologist and chemist in North Carolina about the emerging side effects of the popular bone drugs. He told me:
“One hundred and fifty years ago, people who worked around white phosphorus in factories where matches were made in the U.S. and Europe sometimes developed "phossy jaw" (osteonecrosis) and thigh bone fragility similar to bisphosphonate effects we see today. The chemical culprit is likely to have been a substance in the white phosphorus smoke that inhibits an enzyme involved in the process of bone remodeling and bisphosphonates happen to have been innocently developed as synthetic versions of that substance. I have researched this extensively, including U.S. Army reports about white phosphorus smoke which was shown to include large amounts of the same substance.”
In addition to knowing about the side effect of jawbone death for years, Big Pharma must have known about the likelihood of fractures in people taking the bone drugs too because they were well reported in medical journals. “We report atypical skeletal fragility in three subjects after long-term, combined anti-remodeling therapy,” said the authors of a 2008 Journal of Clinical Endocrinology & Metabolism study. “An Emerging Pattern Of Subtrochanteric Stress Fractures: A Long-Term Complication Of Alendronate [Fosamax] Therapy?” read the headline of an article that appeared in Injury the same year. And this from the Journal of Orthopedic Trauma: “Low-Energy Femoral Shaft Fractures Associated With Alendronate Use.”
How could such drugs with clear and expected dangers become bestsellers I asked Dr. Hinshaw. “The enthusiastic industrial support of the clinical trials has created a cadre of dedicated bisphosphonate supporters, convinced that the presumed benefits outweigh any possible risk,” he told me.
The "industrial supporters" were no doubt also helped by a sneaky scheme concocted by Fosamax-maker Merck. It hired the consulting firm of former drug researcher Jeremy Allen to whip up fears of osteopenia—the risk of getting osteoporosis—by placing bone density–measuring machines, machines that had barely existed until then, in medical offices across the country.
According to National Public Radio, Allen also created the faux “Bone Measurement Institute” to establish “osteopenia” as a health epidemic. He even pushed through the Bone Mass Measurement Act which transferred the cost of bone scans to onto Medicare.
Yes, taxpayers ended up paying for scans for a largely made-up condition. All for the enrichment of Big Pharma.
Along comes an ‘unBisphosphonate’ just as bad as its predecessor
As many Pharma watchers know, genetically engineered biologic drugs that are liquids not pills (think Humira, Remicide and Xolair) are the new pharmaceutical profit center. So when an injectable drug to treat thinning bones, the biologic Prolia, was approved in 2010, Wall Street and Pharma had high hopes.
Not only do biologics bring in as much as $20,000 per patient per year, it was hoped that Prolia would lack the serious side effects of bisphosphonates.
But two years after its approval, Prolia’s maker Amgen issued a warning that included bisphosphonates' risks and more. Prolia could cause "hypocalcemia, serious infections, suppression of bone turnover, including osteonecrosis of the jaw” as well as “atypical femoral fracture” and “dermatologic adverse events," warned Amgen.
Clearly Prolia was the same old wine in a different "syringe."
As with bisphosphates, Prolia’s action could easily have been predicted. According to transcripts from FDA hearings, monkeys developed tooth and jaw abscesses on the drug, and human subjects developed cervical, ovarian, pancreatic, gastric and thyroid cancers. During trials, 10 people were hospitalized with the skin infection cellulitis, and one died.
Breast cancer, according to the transcripts, was the "most common adverse event that led to discontinuation" in trials. Breast cancer a mere “adverse event?” Tell that to the women who endured chemotherapy—and the families of those who died.
Like most of Pharma’s new biologics, Prolia compromised the immune system and invited opportunistic infections. But though FDA clinical reviewer Adrienne Rothstein, M.D. stated during hearings that Prolia "has the potential to affect multiple layers of the immune system" and that "three subjects required hospitalization for pneumonia after a single dose,” the FDA approved Prolia two months earlier than expected.
Amgen deployed 1,000 reps to sell the drug which is still being marketed.
Ask your doctor . . .
As anyone who follows pharmaceutical marketing knows, direct-to-consumer advertising has created blockbuster drugs through selling and redefining diseases so that more patients take more drugs for a longer time.
For example, depression was once a self-limiting condition not a ailment that requires life-long drugs and add-on drugs as it is portrayed now. And Gastroesophageal Reflux Disease or GERD, while it does exist, has been whipped up by Big Pharma as a common ailment in order to sell expensive drugs called Proton Pump Inhibitors (PPIs) like Prilosec, Prevacid, Nexium and Protonix. Usually what passes for “GERD” is just heartburn that can be treated with TUMS or Maalox, or something as simple as eating less.
Convincing people they have depression or GERD is not just a question of marketing expensive drugs they may not need. Both of the drugs prescribed for these conditions are highly linked to bone thinning!
“Patients with gastroesophageal reflux disease (GERD) receive long-term therapy with proton pump inhibitor (PPI) agents. Several studies have recently been published suggesting that treatment with PPI may cause bone fractures,” according to a 2013 article in Rheumatology International. The FDA agreed. A review of several epidemiological studies found an “increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use,” the agency saidin 2011.
The aggressively marketed antidepressants called SSRIs, including Celexa, Paxil, Prozac and Zoloft, are also linked to fractures say journal articles. SSRIs “may increase the risk of bone fractures, according to new research, reported Medical News Today, citing an article in BMJ Injury Prevention. WebMD agreed. "SSRIs appear to increase fracture risk among middle aged women," it wrote, citing research in the journal Injury Prevention that appeared last year.
Keeping bones strong
While osteoporosis and related bone conditions certainly exist and do sometimes require treatment, fear of “thinning bones” and “osteopenia” is largely an industry concoction to sell products.
Evidence strongly suggests that bisphosphonates and Prolia can make bones weaker (as can GERD and depression meds)—but so can the high-saturated fat, low-fiber Western diet that Big Food pushes. In fact, people in poorer countries where milk is not consumed often have lower fracture rates than the U.S. notes T. Colin Campbell, PhD, in The China Study, debunking the idea of "milk deficiencies."
According to an article in the American Journal of Clinical Nutrition, “Elderly women with a high dietary ratio of animal to vegetable protein intake have more rapid femoral neck bone loss and a greater risk of hip fracture than do those with a low ratio.”
The best way to avoid thinning bones, says Consumer Reports, is to follow the advice doctors and nutritionists gave long before “milk deficiencies” were identified and bisphosphonates existed. Get busy with weight-bearing aerobic activities like walking, dancing and yoga. And eat a nutritious diet. In some cases, it may make sense to take calcium supplements, but beware—not all calcium supplements are created equal and careful attention should be paid to taking calcium and vitamin supplements in the right combination, as noted in this article on Mercola.com. More here on how calicium taken with Vitamins D and K2 provide the best balance of bone health-supporting nutrients.
Martha Rosenberg is a contributing writer to the Organic Consumers Association.
Belong to campaign: Cook Organic Not the PlanetCategory: Food Safety, Health IssuesArea: USA
You probably don’t eat at Kentucky Fried Chicken. But KFC’s “finger-lickin’ good” chicken poses a threat to your health, whether you eat it or not.
The Washington Post just reported that “for the first time, researchers have found a person in the United States carrying bacteria resistant to antibiotics of last resort, an alarming development that the top U.S. public health official says could mean ‘the end of the road for antibiotics.”
It’s a widely reported fact that one of the primary reasons antibiotics that once helped save lives are now ineffective is the over-use of antibiotics by factory farms. And KFC, one of the world’s largest fast-food chicken restaurants, is partly to blame.
TAKE ACTION: Tell KFC: ‘Just Say No’ to Antibiotics in Chicken!Read more
Belong to campaign: Cook Organic Not the PlanetCategory: Environment & Climate, Farm IssuesArea: USA
If you’re one of the two million people who suffered from an antibiotic-resistant infection in the past 12 months, Joe Sanderson, CEO of one of the four largest chicken factory farms in the U.S.—Sanderson Farms—has this to say about that:
“There’s no reliable science that says by using these [government] approved antibiotics, that there is going to be any resistance. We have a duty to take care of the animals.”
No reliable science. Except, for starters, a 2013 report from the U.S. Centers for Disease Control revealing that 23,000 people in the U.S. alone die every year from antibiotic-resistant infections. And a 2015 report commissioned by the UK government estimating that by 2050, the annual global death toll from antibiotic resistant disease will reach 10 million, and the global cost for treatment will be around $100 trillion.
TAKE ACTION: Tell Sanderson Farms to end the reckless use of antibiotics in its poultry factory farms!Read more
Genetic EngineeringRTMay 20, 2016https://www.rt.com/news/343929-monsanto-bayer-march-gmo/http://on.rt.com/7ddl
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March Against Monsanto at Union Square Park, NY
photo credit: Time's Up! @nyctimesup
More than 400 simultaneous demonstrations around the world are voicing fury at US biotech leviathan Monsanto, which is facing a hostile takeover from German pharmaceuticals company Bayer.
People take part in a march to protest against US biotechnology group Monsanto in Toulouse, on May 21, 2016 © Pascal Pavani / AFP
Genetic Engineering, Health IssuesMartha Rosenberg and Ronnie CumminsOrganic Consumers Association May 24, 2016
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The two multinationals that teamed up during the Vietnam War to poison millions of people with their Agent Orange herbicide—St. Louis, Mo.-based Monsanto and Germany’s Bayer AG—are looking to become one.
Bayer has announced a bid to buy Monsanto in a deal that would expand Bayer's GMO and pesticide holdings and add drugs to Monsanto’s global portfolio. Monsanto has rejected the latest bid, but the two are still in talks.
If Monsanto, perhaps the most hated GMO company in the world, joins hands with Bayer, one of the most hated Big Pharma corporations on Earth (whose evil deeds date back to World War I and the Nazi era), the newly formed seed-pesticide-drug behemoth would have combined annual sales of $67 billion.
That’s a staggering figure. But here’s another, even more alarming: Combined, the new mega-chemical/seed company would control 29 percent of the world’s seed market and 24 percent of the pesticide market.
The Bayer-Monsanto merger is the third recent proposed consolidation in the agriculture markets in just months, following on the heels of proposed mergers between chemical and agritoxics titans Dow and DuPont, and ChemChina and Syngenta.
"All of a sudden we have three major transactions at the same time," Matt Arnold, an Edward Jones analyst, told the News Journal. "One would think that would prompt regulators to really dial up the scrutiny and think long and hard about whether that much consolidation is in the best interest of farmers and consumers."
Indeed, reports the Journal, all three proposed mergers face antitrust reviews by agencies in the U.S., Europe and China, reports the Journal, including by the Federal Trade Commission, U.S. Department of Justice, the European Commission and stockholders of the publicly traded companies.
Already shareholders have spoken out, terming the move "arrogant empire-building," reported Reuters. Shareholders also worry that the takeover would dilute Bayer’s core drug business currently flush with sales of its blood-thinner Xarelto and Eylea, a drug to treat blindness.
As noted, this is not the first time Bayer and Monsanto will have teamed up, if the deal goes through. “During the Vietnam war, Bayer was involved in the development of Agent Orange production....carried out at the firm Mobay, founded jointly by Bayer and Monsanto,” says Coalition Against Bayer Dangers. The defoliant herbicide Agent Orange was sprayed over millions of acres in Vietnam for over a decade in “Operation Ranch Hand,” despite numerous scientific studies and thousands, later millions of medical cases linking the toxic chemical to birth defects and stillbirths in animals and humans.
Bayer, a history of unsafe drugs
Bayer and Monsanto both sell controversial toxic agricultural chemicals and GMO seeds. But if Bayer’s bid to take over Monsanto goes through, it would mark Monsanto’s first entry into Big Pharma.
Last year, Bayer was named the ninth largest drug company in the world on the basis of its yearly revenue of $25.47 billion. The drug giant, though, has been beset with drug safety scandals, including deaths, for at least three decades. Here are just a few of the scandals that made the news,
• Blood clotting drug spread AIDS
In the 1980s, Bayer sold Factor VIII concentrate, a blood-clotting medicine acquired from Cutter Laboratories in 1978. Though Factor VIII carried a high risk of transmitting AIDS and Bayer knew, Bayer continued to sell the drug in Asia and Latin America while selling a new, safer product in the West.
In Hong Kong and Taiwan alone, more than 100 hemophiliacs got H.I.V. and "many have since died," reported the New York Times. Cutter's "financial investment in the product was considered too high to destroy the inventory," said William Heisel of the Center for Health Reporting. "Cutter continued to sell the contaminated AHF to markets willing to accept it, including overseas markets in Asia and Latin America, without the recommended precaution of heat treating the product to eliminate the risk."
• Statin Baycol recalled
In 2001, Bayer withdrew its lucrative new statin drug Baycol because more than 50 people had died and more than six million patients were at risk from the deadly side effects of rapidly dissolving of muscle tissue. Bayer removed the drug from pharmacy shelves in the U.S., Europe and Japan, and U.S. and German lawyers announced that they are planning an amended class-action lawsuit in the U.S. that would allow European victims to seek damages.
As deaths grew, Bayer stuck to its story "that there is currently no proof that the drug is the cause of the deaths" and assured shareholders that "Our sales this year will increase even though Baycol will now be absent." Recently, Bayer was sentenced to pay damages to Baycol victims in in Argentina and Italy. "Internal documents show that Bayer’s management was aware of the serious health risk for patients and even ignored warnings from within the company," .
• Yaz birth control pill causes deaths
Bayer's Yaz birth control pills promised to clear up acne and treat severe PMS in addition to preventing pregnancy. But soon after the Yaz launch in 2006, there were reports of associated blood clots, gall bladder disease, heart attacks and even strokes. The Bayer birth control pills contained drospirenone, a drug that was never before marketed in the U.S. and likely caused the heart problems through elevated potassium, and a change in acid balance of the blood.
TV ads for Yaz in 2008 were so misleading, the U.S. Food & Drug Administration (FDA), in a rare move, ordered Bayer to run correction ads. Thousands of injuries and approximately 100 deaths were linked to Yaz in law filings that followed.
• Xarelto, shady approval of a dangerous drug
In 2012, the New York Times reported on a class of new anti-clotting drugs which have no antidote and can cause alarming bleeding deaths. Xarelto is one of them. Even as 379 deaths have been linked to Xarelto, there are reports of hidden and falsified data and faulty technology that helped win the controversial drug FDA approval. Trials were conducted by Duke's Robert Califf, who later became the new FDA Commissioner. No conflict of interest there.
• Baytril, animal antibiotic blocked by FDA
A 2015 Bayer brochure, coinciding with public awareness of antibiotic abuse in livestock, says Bayer Animal Health "objects" to "routine prophylactic use in healthy animals" of fluoroquinolones, a type of antibiotic.
Yet it was just such "prophylactic use" that got Bayer's fluoroquinolone Baytril blocked by the FDA a decade ago. The FDA said the routine use of Baytril in chickens "has made it difficult for doctors to treat human patients who have food poisoning." Union of Concerned Scientists called the decision a "big victory for public health." The FDA Commissioner at the time, Lester Crawford, remarked that Baytril "has not been shown to be safe for use in poultry." The FDA continues to struggle against the powerful lobbying of drug companies selling livestock antibiotics, often by the ton.
The devil’s chemist
Many people have heard rumors about Bayer’s roles in WWI and WWII. Sadly, they are true and sometimes worse than have been reported. “Carl Duisberg, the Bayer General Director for decades, was personally involved in the development of poison gas such as ‘Mustard Gas’ in World War I and pushed for its use on the front–contrary to international law,” reports Coalition against Bayer Dangers. Duisberg demanded the deportation of tens of thousands of Belgian forced laborers, according to the Coalition, and “strongly supported the merging of the German chemical industry to create the Ig Farben” implicated in Nazi atrocities.
“The Ig Farben cartel was crucial to the Nazi war effort by supplying synthetic fuel, rubber, and other chemicals,” reports Natural News. The cartel also manufactured Zyklon-B, the nerve gas used to kill millions at the concentration camps of Auschwitz, Birkenau and elsewhere. Later known as the Devil's Chemists, Ig Farben used unwilling inmates of the concentration camps as slave laborers and guinea pigs to test chemicals, pharmaceuticals, and vaccines. Tens of thousands died, and those who became too ill to be of any use were murdered in the gas chambers, according to a Natural News report.
It is hard to believe a company linked to the Holocaust, including grisly human experiments conducted on concentration camp victims, would be thriving in the pharmaceutical, agrochemical and GMO sectors. But it’s true, as evidenced by this correspondence between an Auschwitz camp commander and Bayer Leverkusen, which cites the “sale” of 150 female prisoners for experiments:
With a view to the planned experiments with a new sleep-inducing drug we would appreciate it if you could place a number of prisoners at our disposal (...)" - "We confirm your response, but consider the price of 200 RM per woman to be too high. We propose to pay no more than 170 RM per woman. If this is acceptable to you, the women will be placed in our possession. We need some 150 women (...)" - "We confirm your approval of the agreement. Please prepare for us 150 women in the best health possible (...)" - "Received the order for 150 women. Despite their macerated condition they were considered satisfactory. We will keep you informed of the developments regarding the experiments (...)" - "The experiments were performed. All test persons died. We will contact you shortly about a new shipment (...)"
From chemical warfare to “crop science”
Bayer is in agrochemicals and GMOs as deeply as Monsanto, the company it seeks to buy. In 2008, the German Coalition against Bayer brought a charge against the Bayer Board of Management with the Public Prosecutor in Freiburg (south-western Germany) accusing Bayer of contributing to the mass death of bees all over the world through its aggressive pesticide marketing. Since then, the bee debacle has only grown worse, with thousands of hives collapsing after poisoning by the pesticide clothianidin, producing a worldwide crisis.
Since 1991, Bayer has been producing the insecticide Imidacloprid, one of the world’s best-selling insecticides. Imidacloprid is used to pre-treat genetically engineered corn, sunflower and rapeseed (canola) seeds, despite evidence seeds with insecticides is ineffective. Imidacloprid was one of Bayer´s top pesticides, exported to more than 120 countries. When its patent expired, Bayer brought a similarly functioning successor product, Clothianidin, onto the market in 2003. Both substances are systemic chemicals that work their way from the seed through the plant. The substances also get into the pollen and the nectar and can damage beneficial insects such as bees.
In 2006, the Washington Post reported that Bayer’s GMO rice, LLRICE 601 rice, endowed with bacterial DNA that makes rice plants resistant to a weed killer made by the agricultural giant Aventis, was spreading out of control. U.S. commercial supplies of long-grain rice had become inadvertently contaminated with the rice not approved for human consumption, said Agriculture Secretary Mike Johanns.
The following year, Bayer admitted it was unable to control the spread of its genetically-engineered organisms despite “the best practices [to stop contamination],” demonstrating once again that all outdoors field trials or commercial growing of GMO crops must be stopped.
Europe has been way ahead of the U.S. in acknowledging the dangers and banning GMOs and dangerous pesticides.
Is merger a sign of decline?
While a Bayer-Monsanto deal (like a DuPont-Dow deal or ChemChina-Syngenta deal) certainly threatens the world food supply with domination by GMOs and destructive agrochemicals, there may be an underreported bright side: Industries that are doing well generally spin off; industries that are performing poorly generally merge and consolidate.
Recent reports suggest the stock of large agricultural, biotech and seed companies, including Monsanto, is foundering, --a likely reflection of the growing, world-wide rejection of their products. Moreover, even though the long-awaited, industry-friendly National Academies of Sciences, Engineering and Medicine report did not find human “dangers” in eating GMOs, it also definitively did not find they produced greater crop yields. Wait—wasn’t that the justification given for creating GMO crops?
Thanks in large part to the global anti-GMO and Millions Against Monsanto movement, the Biotech Tech Bully from St. Louis is on the ropes. By changing its name, Monsanto hopes we’ll forget its evil deeds.
Not a chance, On October 14-16, merged or not with Bayer, the OCA and the global grassroots will expose Monsanto’s crimes against humanity and the environment at the Monsanto Tribunal, a citizens’ tribunal which will take place in The Hague, Netherlands.
Perhaps it’s time to put Bayer and Big Pharma on trial as well and build an even larger global united front: Billions Against Bayer-Monsanto.
Martha Rosenberg is a contributing writer to Organic Consumers Association.
Ronnie Cummins is international director of the Organic Consumers Association.
May 24, 2016Organic Consumers AssociationKatherine PaulGenetic Engineering, Health Issues
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If you participated in the glyphosate test project launched last year by The Detox Project (formerly Feed The World) and Organic Consumers Association, you probably failed.
A staggering 93 percent of Americans tested positive for glyphosate, according to the test results, announced yesterday (May 25, 2016).
What makes that figure even more alarming is that many of you who sent in urine samples for testing probably eat more organic than non-organic food. Which suggests that either your organic food has been contaminated and/or you’re being exposed to glyphosate via unknown sources.
Worse yet? Children had the highest levels.
The testing, carried out by a laboratory at the University of California San Francisco (UCSF), was the first-ever comprehensive and validated LC/MS/MS testing project to be carried out across America. According to the results, people who live in the west and mid-west tested higher than those living in other regions of the country.
It's way past time for the world to wake up and smell the poison.
Even before glyphosate, the most-used herbicide in the world, was labeled a ‘probable human carcinogen’ by the World Health Organization’s cancer agency IARC in 2015, the chemical, prevalent in Monsanto’s Roundup herbicide, was under fire from scientists who say the chemical makes us sick. Internal documents reveal that Monsanto has known this all along.
Despite the warnings, in 2012, the U.S. Environmental Protection Agency EPA), under pressure from Monsanto, raised the allowed limits for glyphosate residue on fruits and vegetables. The U.S. Department of Agriculture (USDA), claiming pesticide residues are “safe,” doesn’t test for glyphosate residue on food.
Only recently has the U.S. Food & Drug Administration (FDA) said it will begin testing human food for glyphosate. The FDA is a bit late to the testing party. Independent testing has already found glyphosate in many foods. It’s also been found in breast milk.
The endocrine-disrupting (and more) chemical is even in your beer.
Fortunately, there are glimmers of hope that at least some parts of the world are waking up to the obvious dangers associated with poisoning our food, our ecosystem and ourselves. The European Commission has so far rejected Monsanto’s bid to renew its licensing of glyphosate in the EU.
Glyphosate is also up for renewal in the U.S. The EPA, amid controversy and under pressure, is stalling.
What progress has been made so far, in exposing the dangers of Roundup and glyphosate and taking steps to ban it, have resulted from people power. In October, we’ll take that people power to the next level, when we expose Monsanto’s crimes at the Monsanto Tribunal, a citizen’s tribunal that will be held October 15-16 in The Hague, Netherlands.
Read the Detox Project glyphosate testing press release
TAKE ACTION: Tell the EPA: Don’t Re-Up Roundup!
Support the Monsanto Tribunal
Katherine Paul is associate director of the Organic Consumers Association.
Food Safety, Health IssuesUCSFThe Detox ProjectMay 25, 2016
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Glyphosate, the most used herbicide in the World, has been found in the urine of 93% of the American public during a unique testing project that started in 2015.
Glyphosate, labeled a ‘probable human carcinogen’ by the World Health Organization’s cancer agency IARC in 2015, has now been revealed to be ubiquitous in the first ever comprehensive and validated LC/MS/MS testing project to be carried out across America.
The European Union is currently in the process of putting restrictions on the use of glyphosate due to health concerns, with Member States so far unable to agree on the re-approval of the chemical beyond June 2016.
Glyphosate-containing herbicides are sold under trademarks such as Monsanto’s ‘Roundup’.
Summary of Testing
• Urine and Water Testing Results
93% of the urine tested by the University of California San Francisco lab tested positive for glyphosate residues. No glyphosate was found in the tap water samples. These results are only from a small percentage of the total samples collected – more data will be released later in 2016.
The results of this bio-survey come from the first in-lab validated LC/MS/MS testing method used for glyphosate testing of the general public in America.
• Is Glyphosate Safe at Real-Life Exposure Levels?:
Glyphosate has never been studied by regulators or the chemical industry at levels that the human population in the U.S. is being exposed to (under 3 mg/kg body weight/day). This is a huge hole in the global risk assessment of glyphosate, as there is evidence suggesting that low levels of the chemical may hack hormones even more than at mid and high levels, according to independent science – a higher dose does not necessarily make a more toxic, hormone disruptive effect.
• Unique Testing Project
The Detox Project is a unique platform for the testing of toxic chemicals in our bodies and in our food. The aim of the project is to cut out all conflicts of interest in chemical bio-surveys by allowing the public to pay directly for chemical testing that they are interested in.
Urine and Water Testing Results
In a unique public testing project carried out by a laboratory at the University of California San Francisco (UCSF), glyphosate was discovered in 93% of urine samples during the early phase of the testing in 2015.
The urine and water testing was organized by The Detox Project and commissioned by the Organic Consumers Association.
The unique project, which has already provided more urine samples for testing than any other glyphosate bio-monitoring urine study ever in America, was supported by members of the public, who themselves paid for their urine and water samples to be analyzed for glyphosate residues by the UCSF lab.
The data released in a presentation by the UCSF lab only covers the first 131 people tested. Further data from this public bio-monitoring study, which is now completed, will be released later in 2016.
The Detox Project will be working alongside a new larger lab later this year to enable the public to once again test their urine for glyphosate residues.
The UCSF full presentation of these initial results can be found here.
Glyphosate was found in 93% of the 131 urine samples tested at an average level of 3.096 parts per billion (PPB). Children had the highest levels with an average of 3.586 PPB.
The regions with the highest levels were the West and the Midwest with an average of 3.053 PPB and 3.050 PPB respectively.
Glyphosate residues were not observed in any tap water samples during the early phase of the project, most likely due to phosphorus removal during water treatment.
The results from the UCSF urine testing in America showed a much higher frequency and average glyphosate level than those observed in urine samples in the European Union in 2013. The average level in Europe was around 1 PPB with a frequency of detection of 43.9%.
Glyphosate (N-(phosphonomethyl)glycine ) is directly analyzed using liquid chromatography- tandem mass spectrometry (LC-MS/MS). Water and urine samples are prepared for analysis by solid phase extraction using an ion exchange column. Extracted samples are injected to the LC-MS/MS and the analyte is separated using an Obelisc N column (SIELC Technologies, Prospect Heights, IL) through isocratic elution. Ionization of glyphosate is achieved using an electrospray ionization source operated in negative polarity. The analyte is detected by multiple reaction monitoring using a 13C-labelled glyphosate as internal standard. Quantification of the analyte is done by isotope dilution method using an eight-point calibration curve.
The assay has a limit of quantification of 0.5 ng/mL. The intra- and inter-day precision observed are 6-15% in concentrations that range 0.5-80 ng/mL. Recoveries for glyphosate range 70-80% at concentrations within the assay’s linear dynamic range.
Contact at UCSF lab: Dr. Roy Gerona - Roy.Gerona@ucsf.edu
Is Glyphosate Safe at Real-Life Exposure Levels?
Glyphosate has never been studied by regulators or the chemical industry at levels that the human population in the U.S. is being exposed to (under 3 mg/kg body weight/day). This is a huge hole in the risk assessment process for glyphosate, as evidence suggests that low levels of the chemical may hack hormones even more than high levels – a higher dose does not necessarily mean a more toxic, hormone disruptive effect.
Industry funded science from the dark ages suggested that the higher the dose of a chemical the more dangerous it was. However, modern independent science has discovered that many toxic chemicals have as much or even more of an influence on our health at low doses– these chemicals are known as hormone hackers (endocrine disruptors).
A study from March 2015 stated that the health costs to the European Union of just some hormone hacking chemicals, in connection with a subset of illnesses known to be linked to hormone interference, is over EUR 150 Billion per year! The study stated that lower IQ, adult obesity and 5% or more of autism cases are all linked to exposure to endocrine disruptors.
Glyphosate is likely to be one of these hormone hacking chemicals at real-life exposure levels down to 0.1 ppb or below, according to independent science. Regulators and the chemical industry have simply not studied the toxic effects of glyphosate at real-life exposure levels. Find more information on this here.
More information: How safe are “safe” levels of glyphosate?
Regarding Real-Life Exposure Levels of Glyphosate:
Dr. Pete Myers, Founder, CEO and Chief Scientist of Environmental Health Sciences - JPMyers@ehsic.org
Dr. Michael Antoniou, molecular geneticist, London, UK - firstname.lastname@example.org
“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. Thus the information gathered by the glyphosate public testing service being offered by the Detox Project is most timely and will provide invaluable information for the consumer and scientists like myself evaluating the toxicity of real world levels of exposure to this most widely used pesticide.”
For more comments on the Testing Results contact:
Henry Rowlands, Director, The Detox Project - email@example.com
“These results show that both the U.S. regulators have let down consumers in America. Independent science shows that glyphosate may be a hormone hacker at these real-life exposure levels found in the food products. The safe level of glyphosate ingestion is simply unknown despite what the EPA and Monsanto would have everyone believe.”
“The Detox Project which organized this testing is a research platform that brings awareness to the public by testing for toxic chemicals in our bodies and in our food at a very personal level. We believe everyone has the right to know what man-made toxic chemicals are in our bodies and in our food.”
Ronnie Cummins, International Director, Organic Consumers Association - firstname.lastname@example.org
"If consumers had any doubt about the extent to which they are being poisoned by Monsanto's Roundup, these tests results should put those doubts to rest."
"These test results highlight the massive failure of U.S. regulatory agencies, including the EPA, USDA and FDA, to protect us even as they continue to perpetuate the myth that low-level exposure to glyphosate is harmless. We must bring down this poison-for-profit model and build in its place a food and farming system that regenerates and heals, before it's too late."
Belong to campaign: Millions Against MonsantoCategory: Genetic Engineering, Politics & GlobalizationArea: USA
The OCA, along with IFOAM International Organics, Navdanya, Regeneration International (RI), Millions Against Monsanto and dozens of global food, farming, environmental justice groups have announced they will put Monsanto on trial for crimes against nature and humanity, and ecocide!
The trial will take place in The Hague, Netherlands, next year on World Food Day, October 16, 2016.OCA, Millions Against Monsanto and other groups are organizing a global protest against Monsanto on the same day.
We need your help! Sign up to organize a Monsanto protest in your city on October 16, 2016! More details to come, including materials and tips on how to organize your event.
Genetic Engineering, Health IssuesKatherine Paul and Ronnie CumminsOrganic Consumers AssociationMay 19, 2016
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A new report from the National Academies of Sciences, Engineering, and Medicine (NAS) on GE crops and technology was met with cheers from the biotech industry, but little meaningful scrutiny by the mainstream media.
Initial media reports boiled the message down to “GMOs Are Safe” and even “healthy.” Some even claimed the study “proves” the safety of genetically modified crops.
Aside from the obvious—that the headlines over-simplify the NAS findings in a way that spins favorable for the biotech industry—the media also overlooked the influence, as reported by Food & Water Watch, of the biotech industry on The National Research Council (NRC), the research arm of the NAS.
According to F&WW, the NRC takes millions of dollars in funding from biotechnology companies; invites sponsors like Monsanto to sit on high-level boards overseeing the NRC’s work; invites industry-aligned, pro-GMO scientists to author NRC reports; draws scientific conclusions based on industry science; and operates at times as a private contractor for corporate research.
An NAS spokesman defended the report, telling the Washington Post that the NAS didn’t appoint anyone from the biotech industry to the committee, didn’t use any money from the industry to fund the study, and that all committee members were required to disclose any potential conflicts of interest.
Biased or not, and despite the positive spin by most media outlets, the report’s “conclusions” left plenty of room for doubt on a range of issues, from safety, to improved yields, to damage to the environment. On many issues the committee, made up of 20 scientists and policy experts, couldn’t—or wouldn’t—commit.
Instead the experts produced a 400-page report full of equivocations, and of recommendations the committee knows will be ignored, but little in the way of clarity.
Here are three take-aways from the NAS report.
GMOs are safe, but . . . Media spin aside, here’s how the Washington Post summed up the NAS findings on whether or not GMOs are safe:
No "substantiated" evidence exists that genetically engineered crops have caused health problems in humans or damaged the environment, but it’s too soon to be making broad statements, positive or negative, about laboratory-based manipulations of crop genomes, an elite panel of scientists concluded in a report Tuesday.
Saying there’s no evidence that GMOs harm human health or the environment isn’t the same thing as saying GMOs are safe, a fact the committee chair admitted at a press briefing, according to a UPI report:
"Absence of evidence is not absence of effect," Dr. Fred Gould, a professor at North Carolina State University and chair of the Committee on Genetically Engineered Crops, told UPI. "We're very clear to point out that with very subtle long-term health effects, it's really difficult to point out such a thing."
What the report actually says is that it’s too soon to make that determination. Maybe that wouldn’t be the case, if GMOs had been required to undergo pre-market safety testing 20 years ago. Instead, they were unleashed, untested, into the environment, and into the food stream, on the basis of proprietary industry-funded testing that U.S. regulatory agencies accepted at face value.
The NAS also overlooks the fact that there is massive published evidence in the public domain that GMOs and the toxic chemicals that always accompany them are dangerous—to human health, to animals, the environment and climate stability.
The report also warns against making “sweeping generalizations.” Again this summary from the Washington Post, which sounds more equivocal than the media headlines would lead you to believe:
Every newly introduced plant should undergo safety testing regardless of how it was created, the report states. But, it also says, the fact that previous GE crops have not caused health or environmental problems does not mean that all prospective GE plants should be presumed to be benign.
We don’t need labels, but . . . The committee said mandatory labeling isn’t “justified” on the basis of the need to protect the public health. But on the other hand . . . labeling GMO products serves other purposes, beyond those of food safety:
There clearly are strong non-safety arguments and considerable public support for mandatory labeling of products containing GE material. . . . U.S. policy-makers and the private sector have the ability to address the broader social and economic issues to balance the competing interests involved.”
Charles Benbrook, who directed the NAS Board on Agriculture from 1984-1990, takes exception to the committee’s argument that labeling is a purely political, not scientific issue. Benbrook cited the example of labels on GE sweet corn, which would give both mothers and pediatricians a reason to add Bt proteins to the list of possible cause when treating kids for new food allergies.
Labeling GE food is no panacea, but it will increase the odds that problems will be detected sooner rather than later. The decision to not label GE foods has the effect of keeping the entire medical community on the sidelines, neither aware of possible GE food-allergen problems, nor capable of doing anything about them.
The labeling movement has long argued that without labels, it’s almost impossible to link GMOs directly to food allergies. The NAS addresses the allergy issue this way, as reported by U.S. Right to Know’s Carey Gillam in Huffington Post:
Regarding specific concerns about GMOs and concerns about ties to allergies, the committee said that “testing for allergenicity before commercialization could miss allergens to which the population had not previously been exposed,” and “post-commercialization allergen testing would be useful in ensuring that consumers are not exposed to allergens,” though the committee said it realized such testing would be difficult to conduct.
GMOs don’t harm the environment, but . . . Here, the experts went from “GMOs are safe for the environment” to “the complex nature of assessing long-term environmental changes often made it difficult to reach definitive conclusions.”
Despite finding no “conclusive cause-and-effect evidence of environmental problems from GE crops,” Gilliam wrote, the committee concluded that “evolved resistance to current GE characteristics in crops is a major agricultural problem.”
In other words, a problem for farmers, but no problem for the environment.
As for the chemicals—herbicides and pesticides—used to grow GE crops, according to Benbrook, committee chair Fred Gould told the press:
“More pounds [of herbicide] per acre doesn’t automatically translate to more harm to human health or the environment.”
Does that mean that small amounts of herbicide cause harm, but larger amounts don’t cause any additional harm? Or does it mean herbicides are harmless? If so, there’s a mountain of studies that say otherwise, including this recent one, from the Pesticide Action Network which outlines the dangers faced by kids who live near heavily sprayed farm fields.
As for glyphosate, the most heavily used herbicide in the world—and the most controversial—the NAS committee “dropped the ball,” said Benbrook. Despite the fact that the World Health Organization last year classified glyphosate as a “probable human carcinogen,” the committee sounded no alarms about the chemical, the key active ingredient in Monsanto’s Roundup.
Did the committee make any definitive, declarative statements? Perhaps this one: Contrary to the biotech industry propaganda, GMO crops are doing nothing to improve farmers’ yields or feed the world.
The committee examined data on overall rates of increase in yields of soybean, cotton, and maize in the U.S. for the decades preceding introduction of GE crops and after their introduction, and there was no evidence that GE crops had changed the rate of increase in yields.
But we already knew that.
We urge U.S. consumers and farmers to follow the example of most people in the world, and their own common sense—boycott GMOs and the toxic chemicals that are the cornerstone of industrial agriculture and factory farms. Avoid foods and food production systems that are unhealthy, inhumane, chemical-intensive, and climate destabilizing. Eat fresh organic and grass-fed foods, especially those produced locally and regionally, today and every day.
Katherine Paul is associate director of the Organic Consumers Association.
Ronnie Cummins is international director of the Organic Consumers Association.
Belong to campaign: Safeguard Organic StandardsCategory: All About OrganicsArea: USA
When it comes to eggs, USDA organic is the right choice. But unfortunately, not all organic eggs are created equal. That’s because not all organic egg producers play by the rules, especially when it comes to how they treat, and house, their hens.
The people who make the rules—the folks who run the National Organic Program (NOP), which operates under the U.S. Department of Agriculture (USDA)—want to improve the lives of egg-laying hens and other animals. But some members of Congress, including members of the Senate Appropriations Committee, are trying to block them.
TAKE ACTION: Tell Congress to let the National Organic Program finish its work to improve the lives of egg-laying hens and other animals.Read more
Genetic Engineering, Health IssuesOrganic Consumers AssociationMay 15, 2016
march against monsanto banner, 1000 x 667
Saturday, May 21, is global March Against Monsanto Day.
Saturday is also a great opportunity to let the world know that we, the people, will hold Monsanto accountable for its crimes against humanity and nature, at the October 15-16 International Monsanto Tribunal.
Please join a march near you, or organize a march in your community. Use this year’s march to let your community know about the upcoming International Monsanto Tribunal, and that we will need everyone’s help to organize even bigger rallies against Monsanto on October 16, World Food Day, the day the tribunal wraps up its formal testimony.
Find a march near you.
Download leaflets and posters for your May 21 march.
Learn more about the International Monsanto Tribunal.
Download a media advisory template that you can personalize and send to your local newspapers to let them know about your upcoming march.
Thanks to your help, Monsanto’s diabolical plan to win the hearts and minds of consumers is failing.
Monsanto’s profits are down. And for the first time in 20 years, the number of acres planted in GMO crops has decreased.
Nearly 40 countries have banned GMO crops.
The European Commission is under increasing pressure to reject Monsanto’s request to renew its license for Roundup/glyphosate, and in the U.S., more than half a million people have petitioned the EPA to do the same.
Last year, the 17 scientists on the World Health Organization’s prestigious International Agency for Research on Cancer (IARC) panel unanimously agreed that Monsanto’s Roundup is a probable human carcinogen.
This year, the grassroots food movement has blocked efforts by Monsanto and the Grocery Manufacturers Association to pass a federal law preempting Vermont’s mandatory GMO labeling law. The law will take effect July 1, unless a last-ditch effort by Monsanto and Big Food stops it.
Many food companies are already labeling, or have announced plans to label their GMO ingredients. Some of those companies say they now support mandatory labeling.
It has taken nearly 20 years, but we—and that means you—have come a long way in our efforts to bring down one of the largest, most destructive, multinational corporations in the world.
But we cannot yet claim total victory. That’s why we need you to get out Saturday and join a Monsanto protest near you.
We also need you to help publicize the upcoming Monsanto Tribunal, and begin organizing the world’s largest protest against Monsanto, on October 16, World Food Day.
See you out there!
Food Safety, Health IssuesElaine Catherine R. Ferrer and Ronnie CumminsOrganic Consumers AssociationMay 9, 2016
It’s safe to say that most American consumers probably can’t recall the last time they ate a meal prepared entirely from wholesome, farm-to-table ingredients, without any canned or prepackaged products. That’s because most Americans today consume mostly processed foods—foods produced with pesticides, GMOs and synthetic chemicals, routinely laced with too much sugar, salt and unhealthy fats.
In fact, processed foods make up as much as 70 percent of people’s diets– meaning only 30 percent of what they consume consists of wholesome, natural, or organic foods!
But here’s the truth about processed foods: Long-term consumption of these “food products” spell bad news for your health.
Processed vs. ultra-processed: What’s the difference?
The U.S. Food and Drug Administration (FDA) defines “processed food” as any raw agricultural commodity that has been subjected to processing methods, including canning, cooking, dehydration, freezing or milling. This means that the only time a food can be classified as “fresh” is when you’ve taken it straight from the source (washing it is okay, and would not be classified as a form of processing) and eaten it. By this definition, most foods would be considered processed.
However, in layman’s terms, processed foods can refer to sodas, potato chips, candy, baked pastries with extended shelf life–basically, “convenient,” easy-to-eat products that have been altered through the addition of artificial or ingredients, synthetic flavorings, fillers and chemical or genetically engineered additives. But this type of description actually refers to “ultra-processed food.” Researchers from the University of São Paulo and Tufts University define “ultra-processed” as:
Formulations of several ingredients which, besides salt, sugar, oils, and fats, include food substances not used in culinary preparations, in particular, flavors, colors, sweeteners, emulsifiers and other additives used to imitate sensorial qualities of unprocessed or minimally processed foods and their culinary preparations or to disguise undesirable qualities of the final product.
But most people use the term “processed food” and “ultra-processed food” interchangeably when talking about these consumer products. Conventional processed foods today come in a variety of forms. These include:
• Canned and frozen fruits and vegetables
• Canned meats (luncheon meat and sausage, corned beef, and meatloaf)
• Breakfast foods, including cereals, oatmeal, energy bars
• Canned, bottled, or tetra-packed fruit juices, energy drinks, and soda
• Jarred baby foods and infant cereals
• Foods “fortified” with nutrients
• Ready to eat meals, microwave dinners
• Ramen noodles
• Pastries, including cookies, breads, frozen pizza, and pies
• Condiments, seasonings and marinades, salad dressing, and jams
• Yogurt and other commercially made fermented foods
The simplest way to determine if a food is processed is by looking at the ingredient list at the back of its packaging. The longer the ingredient list, the more processed a food is likely to be.
After more than 20 years of struggle by consumer activists and public interest groups such as the Organic Consumers Association, major food manufacturers are finally being forced to label GMO ingredients in processed foods sold in grocery stores. Because of this, many of them are starting to remove GMOs from their products, along with other artificial chemicals and additives.
The history of ‘processing’
Humans have been “processing” food through traditional methods for thousands of years. Egyptians have used salt for 4,000 years to extend the shelf life of food. In ancient sites in Italy, Russia and the Czech Republic, there was evidence that early humans pounded cattails and ferns into flour and mixed it with water to bake bread.
Other methods of food preservation, including fermentation, pickling and curing, have also been used for thousands of years, in different cultures. The food was used to help survive long winters and voyages, and also as rations when soldiers went to war. This led to the production of foods like beer, wine, cheeses, yogurt and butter.
The 19th century saw the rise of modern food processing methods. Canning and bottling began mainly to serve military needs, although the initial cans used were hazardous, as they were contaminated with lead.
Pasteurization, a method that prolongs the shelf life of dairy and wine to allow increased production and distribution, was discovered and patented by Louis Pasteur in the mid-1800s.
In the 20th century, the rising consumer society in the U.S. contributed to the growth of food processing. Advances such as freeze drying, spray drying and juice concentrates were developed. At the same time, coloring agents, preservatives and artificial sweeteners were introduced. Self-cooking meals, “TV dinners,” reconstituted fruits and juices and other “instant” foods like coffee and noodles became popular. These were mostly marketed to working wives and mothers who were tired of preparing foods from scratch.
To convince people that processed foods were as good, or even better, than wholesome foods, they were marketed as a means for people to save time and money–hence the term “convenience foods.”
But do the time and money you save by choosing these processed goods make up for the havoc that they wreak with your health?
Not what the human body needs, or wants
The human body is not designed to thrive on processed foods. And foods are not meant to be altered. The more altered they are, the worse they are for your health.
Processed foods are actually lacking in nutritional content compared to natural foods. For example, processed bread and other snacks use refined grains that have the bran and germ removed and, along with it, important nutrients like fiber, iron and B-vitamins.
Dehydrated foods not only have reduced amounts of vitamin C and fiber, but they also become more energy dense, which causes them to contribute to weight gain. When dehydrated foods are constituted and cooked with water, even more nutrients leach out.
Processed foods are also loaded with sugar, unhealthy fats and sodium, all of which your body is not designed to handle in high amounts, and all of which can endanger health. Particularly damaging are refined sugars, like high-fructose corn syrup (HFCS), which convert into fat in your body. This wreaks havoc on your insulin and leptin levels, and leads to chronic diseases like obesity, diabetes and cancer. Meanwhile, synthetic trans fats, in the form of partially hydrogenated vegetable oils, have been linked to heart disease.
And of course processed foods are routinely laced with hazardous genetically engineered and pesticide-drenched ingredients derived from GMO corn, soybeans, canola, sugar beets and cotton (cottonseed oil is common in low-grade vegetable oils). According to the Grocery Manufacturers of America, 80 percent of all (non-organic) supermarket processed foods contain GMOs. Only now are those ingredients being labeled, as food manufacturers are being forced to comply with Vermont’s GMO labeling law.
Loaded with health-harming synthetic additives
Close to 5,000 additives are now allowed to be used in food products. And this number keeps growing. If you factor in the additives found in the packaging (which can also leach into your food), that number of additives can rise to 10,000!
What’s worse, most of these food additives have not undergone any safety testing, and very few have been tested according to the way that they are ingested–meaning in combination with other additives. Some of these additives are downright dangerous. For example:
• Diacetyl and 2,3-pentanedione (PD), both of which are added to microwave popcorn to give it a buttery aroma, are linked to brain health, Alzheimer’s disease and respiratory toxicity.
• Monosodium glutamate (MSG), which is found in chips, processed meats and a wide array of other foods, is an excitotoxin that can lead to cell damage, triggering brain dysfunction and leading to learning disabilities, Lou Gehrig's disease, Parkinson's disease, Alzheimer's disease and more.
• Artificial food dyes like Red #40, Yellow 5, and Blue #2 are linked to brain tumors, hyperactivity, hypersensitivity and other behavioral effects in children.
• Preservatives like butylated hydroxyanisole (BHA) and butylated hydroxyl toluene (BHT) can mess with your brain’s neurological system, causing behavioral problems and even cancer. Another preservative, tertiary butylhydroquinone (TBHQ), is also deadly. In fact, just five grams can kill you, according to the FDA.
Giving up processed foods—easier said than done
If you think you can simply shake off your processed food cravings, you’re wrong. These foods are intentionally addictive. They stimulate dopamine, a “feel-good” neurotransmitter that affects your brain similarly to how drugs affect you. Manufacturers are fully aware of this, and actually engineer their products to produce this “delicious” yet dangerous effect. (Michael Moss details this in his book, “Salt, Sugar, Fat: How the Food Giants Hooked Us.”)
Sadly, many people still consume GMO and pesticide-tainted, highly processed foods because of their affordability, convenience and “delicious” flavor. But what you save in terms of money and convenience will ultimately put a double whammy on your health.
Instead, go for a diet composed mostly of wholesome foods, like organic fruits and vegetables, grass-fed and pasture-raised meat and raw (unpasteurized and unhomogenized) dairy, and healthy saturated fats like coconuts, coconut oil, avocados and raw nuts. For your beverage, choose pure water and fresh green juice instead of processed fruit juices, soda and energy drinks.
In addition, make sure to cook these wholesome foods in your home, so you can be sure that nothing harmful goes into your meals. Cooking at home will also help you avoid dining at fast foods and restaurants (which also use processed ingredients). Encouraging your whole family to sit down and have a hearty meal together not only cultivates good health, it cultivates good relationships.
Elaine Catherine R. Ferrer is a contributing writer to the Organic Consumers Association and Mercola.com.
Ronnie Cummins is international director of the Organic Consumers Association.
May 4, 2016Organic Consumers AssociationKatherine PaulGenetic Engineering, Health Issueshttps://action.organicconsumers.org/o/50865/p/dia/action3/common/public/?action_KEY=16052
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· Eddie Becker
Every 15 years, pesticides come up for review by the U.S. Environmental Protection Agency (EPA). Last year, 2015, was the year the EPA was supposed to review and either renew, or reject, glyphosate.
We’re still waiting. Meanwhile, glyphosate, the key ingredient in Monsanto’s Roundup, was as ubiquitous in the media this week as it is in our environment—and on our food.
As OCA, Friends of the Earth, Moms Across America and other groups planned our May 4 petition delivery (over half a million signatures) to EPA officials in Washington D.C., asking the agency to reject the renewal of glyphosate, the EPA was busy posting—then un-posting—documents the agency will use to justify its final, and presumably Monsanto-friendly, decision. From Politico:
The EPA on Monday [May 2] posted online and then removed an October 2015 final report from its Cancer Assessment Review Committee, which is made up of staff, that concluded glyphosate is "not likely to be carcinogenic to humans."
The move prompted House Committee on Science Space and Technology Chairman Lamar Smith (R-Texas) to fire off a letter to EPA Administrator Gina McCarthy. In the letter, according to Politico, Smith said that the decision to yank the report "raises questions about the agency's motivation in providing a fair assessment of glyphosate."
Smith wasn’t the only one with questions. The Center for Biological Diversity issued a press release accusing the EPA of using industry-funded studies to refute the World Health Organization’s findings that glyphosate is a probable carcinogen:
“EPA’s determination that glyphosate is non-carcinogenic is disappointing, but not terribly surprising — industry has been manipulating this process for years,” said Nathan Donley, a scientist with the Center for Biological Diversity. “The analysis done by the World Health Organization is more open and transparent and remains the gold standard.”
US Right to Know (USRTK)’s Carey Gillam outlined the significance of the yanked document as it relates to protecting Monsanto from any legal liability from cancer patients:
Monsanto touted and tweeted the release of the document, which follows the release by EPA of a different memorandum supporting the safety of glyphosate last June. The newest memo gives the company added evidence to defend itself against a mounting stack of lawsuits filed by agricultural workers and others alleging Monsanto’s glyphosate-based Roundup herbicide gave them cancer.
In other glyphosate news this week? Quaker Oats faces a class action lawsuit for being “deceptive and misleading” after glyphosate is detected in its oatmeal. Members of the European Parliament call for the European Commission to rethink plans to renew glyphosate in the EU.
And then there was this gem from Mercola.com: “Many Surprising Foods Found to Contain Monsanto's Deadly Poison.” Not to mention our Video of the Week, from ABC News, about glyphosate in your California wine.
The EPA now says it will be the end of 2016 before they issue their final ruling. That's how long we have to stop the madness.
What Is Going on with Glyphosate? EPA’s Odd Handling of Controversial Chemical
TAKE ACTION: Tell the EPA: Don't Re-Up Roundup!
Belong to campaign: Millions Against MonsantoCategory: Environment & Climate, Genetic EngineeringArea: USA
Genetically engineered mosquitoes, or Frankenbugs, are one step closer to being released in Florida.
And U.S. Food & Drug Administration (FDA) officials are about to greenlight the plan, unless we can convince the not to.
TAKE ACTION: Tell the FDA: Don’t release GMO mosquitoes in Florida!Read more
Belong to campaign: Millions Against MonsantoCategory: Genetic Engineering, Health IssuesArea: USA
Glyphosate, the main ingredient in Monsanto’s Roundup herbicide, is probably causing cancer in humans. That’s according to the World Health Organization’s (WHO) panel of cancer experts, which published its latest review of the cancer risks of glyphosate in March 2015.
The U.S. Environmental Protection Agency (EPA) should defer to WHO, but instead it is bowing to pressure from Monsanto. On Friday, the EPA published its own finding, based largely on unpublished, industry-funded studies, that glyphosate is “Not Likely to be Carcinogenic to Humans.”
This means that the EPA, which is conducting its once-every-15-year review of the herbicide, will likely choose to re-up Roundup.
Sometimes, dangerous pesticides get banned in the U.S., only to continue to be used in other countries with weaker safety standards. With Roundup, the U.S. could end up being the world’s toxic dump, if we don’t make our voices heard at the EPA.
TAKE ACTION! Tell the EPA: Don’t re-up Roundup!Read more
Health IssuesMartha RosenbergOrganic Consumers AssociationMay 2, 2016
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The autopsy results from Prince’s unexpected death are not in yet, but it has been reported that the musical star had the prescription opioid painkiller Percocet in his possession when he died. Unconfirmed reports suggest Prince not only used prescription opioids for pain but may have had an addiction.
If so, Prince is like millions of other Americans who have become opioid addicts through a Pharma-backed prescribing spree that is still going on. The government has made efforts to better “educate” doctors about opioid dangers, and added better warnings on some drugs. Regulatory agencies have cracked down on pill mills, traffickers and even the shipping giants Federal Express and United Parcel Service (who knowingly delivered “controlled substances and prescription drugs from online pharmacies to individuals who subsequently died or accidentally caused the death of others” said a federal lawsuit).
But here are two things the government has not done. It hasn’t acknowledged that the opioid addiction epidemic was created by Big Pharma. And it hasn’t stopped waving through its continuing stream of new dangerous drugs.
In fact, on the same day the U.S. Food & Drug Administration (FDA) announced plans to tighten restrictions on hydrocodone combination products like Vicodin, the agency also approved the long-acting drug Zohydro with five to 10 times the abuse potential of OxyContin. The opioids Actiq (fentanyl) and the long-acting hydrocodone (Zydone) are also readily available.
Don’t blame users, blame Pharma
Pharma fostered the opioid addiction epidemic in four ways. It introduced long-acting opioids like OxyContin that could be crushed and snorted, or shot for heroin-like highs. Industry also changed pain condition guidelines so that opioids were the first choice in conditions like lower back pain—conditions that never used to justify prescribing opioids.
Pharma also pushed and promoted the long-term use of opioids though no studies show such use effective or safe according to respected medical groups, including the Cochrane Collection. And finally, the industry misinformed doctors, patients and the public, claiming that only “some” people become addicted to narcotics—when in fact narcotics are addictive, period. In fact, until Pharma’s opioid revival, narcotics were administered only after surgery, accidents and for palliative care in the chronic and terminally ill.
The result is what anyone familiar with the history of narcotics could have predicted. Over 47,000 people in the U.S. die each year from drug overdoses, mostly opioids, says the CDC. Opioids are now prescribed for almost all “causes of human suffering,” wrote Businessweek in 2012. “Back pain, fibromyalgia, toothaches, cancer, depression, divorce, boredom, mental illness, unemployment, hip replacement or withdrawal symptoms.”
So many Americans are taking opioids, an ad for opioid-related constipation ran during the 2016 Super Bowl.
The opioid use epidemic has created confusion between real pain patients, false “patients” reselling drugs and “real” patients who became addicted through being kept on opioids for longer than a short time—in other words, inappropriate medical care. Pain clinics and pill operations “cut off” such patients despite often being largely responsible for their addiction. It’s a classic case of blaming the victim. Patients who legitimately fear withdrawal symptoms and a return of their pain when cut off from opioids often turn to heroin. That’s why we now have a parallel heroin addiction epidemic.
How Pharma ‘sold’ opioids
It is no secret that the drug industry pays doctors and medical associations to promote drugs. So many doctors receive payments from Pharma, that in 2012, when the FDA considered loosening its conflicts-of-interest standards so doctors could participate on advisory committees, the agency couldn’t find enough doctors not taking Pharma money! A few years ago, a marketing partnership between drug maker Merck and the American Academy of Pediatrics showed that even children’s medicine marketing is riddled with conflicts of interest.
So it is no surprise that opiate makers have paid doctors, associations and even universities to help sell opiates. According to investigative reporter John Fauber, half the American Geriatrics Society panel’s experts who revised opioid guidelines in 2009 “had financial ties to opioid companies, as paid speakers, consultants or advisers.” What changes did the experts make to the guidelines? “That over-the-counter pain relievers, such as ibuprofen and naproxen, be used rarely and that doctors instead consider prescribing opioids for all patients with moderate to severe pain,” declared the American Geriatrics Society. The University of Wisconsin’s Pain & Policy Studies Group received $2.5 million from opioid makers, too—as the group pushed for looser opioid use guidelines reports Fauber.
To facilitate approval of new opioids, a Pharma lobbying group called IMMPACT pushed through what it calls “enriched enrollment” which allows Pharma companies to weed out, before a clinical trial begins, subjects who won’t respond well or tolerate a drug. This makes approvals quicker and cheaper for Pharma. But of course this practice ensures that we won’t know what happens when the general public uses the drugs.
To assure doctors and patients that addictive drugs won’t addict, a pain guide called “Finding Relief: Pain Management for Older Adults,” funded by opioid maker Janssen with the American Geriatrics Society and American Academy of Pain Medicine listed as “partners” actually says:
Myth: Opioid medications are always addictive.
Fact: Many studies show that opioids are rarely addictive when used properly for management of chronic pain.
Overdoses aren’t the only problem
Despite Pharma’s promotion of long-term use of opioids for chronic pain, the pills actually make patients worse, say experts. Opioids increase patients’ “disability conviction,” keeping them dependent on the healthcare system and doctors, and discouraging them from pursuing more effective multidisciplinary treatment for their pain, including treatments offered by physical therapists, psychologists and other professionals says, Sridhar Vasudevan, M.D. an internationally known pain specialist. Opioids also decrease testosterone and immune responses, and cause personality changes like irritability, depression, amotivational syndromes and actual antisocial or law-breaking behavior, according to Dr. Vasudevan.
In Responsible Opioid Prescribing, Scott Fishman M.D. says opioids pose many risks including "heightened fracture risk related to effects and bone metabolism and from falls," and increased risks for the elderly and "those with impaired renal or hepatic function; individuals with cardiopulmonary disorders, such as chronic obstructive pulmonary disease (COPD); congestive heart failure (CHF), sleep apnea, or mental illness; and in patients who combine opioids with other respiratory depressants such as alcohol, sedative-hypnotics, benzodiazepines, or barbiturates."
There is another danger associated with opioids such as Percocet, which Prince was reportedly using. Such short-acting opioids contain acetaminophen (Tylenol), which in large doses or after extensive use can cause liver damage and even liver failure. The risks are greater than once thought, prompting government agencies to issue increasingly strong warnings.
Ironically, long-acting opioids like OxyContin were meant to spare patients such liver risks. “Because short-acting drugs, which are taken as needed, require 20–30 minutes to work and last only 2–4 hours, the patient’s peak of pain is often missed. This can lead patients to exceed their doses and risk abuse and toxicity,” writes Dr. Vasudevan. “Secondly, most short-acting opioids are combined with acetaminophen (Tylenol) which causes liver damage at high doses. Long-acting opioids lacked Tylenol, so if patients had to take ‘rescue doses’ of short-acting opioids for ‘breakthrough’ pain, there were less risks.”
A final irony
There is a final irony in Pharma’s promotion of addictive drugs for long-term use in pain conditions. The pills only produce 20 - 30 percent pain relief. “If you give an antibiotic for a UTI [urinary tract infection] and it doesn’t treat the infection, you stop it,” wrote Richard W. Rosenquist, M.D. in a pain newsletter from the Cleveland Clinic. “The same principle applies [to opioids]. Many patients are on opioids for a long time without ever achieving a good outcome, yet their providers fail to question it and try something different.”
And there is a bigger irony with long-term use. Opioids are often perpetuating patients’ pain through an underreported phenomenon known as “opioid-induced hyperalgesia” or OIH, not much discussed by Pharma. “If you took a hundred patients who are on chronic pain medication and take them off the medicine and move them through three physical therapy pool exercises a day, a lot of them are going to feel better. The reason is the opioids are usually causing the pain through opioid-induced hyperalgesia,” says Harry Haroutunian M.D., physician director of the Licensed Health Professionals Program at the Betty Ford Center.
Clearly the millions of patients on opioids today do a lot more for Pharma’s “health” than Pharma does for theirs.
Martha Rosenberg is a contributing writer to the Organic Consumers Association.
April 27, 2016Organic Consumers AssociationKatherine Paul and Ronnie CumminsGenetic Engineering, Politics & Globalization
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Oh, to be a fly on the wall inside the offices of the top lobbyists for the Grocery Manufacturers Association.
So close to the July 1 deadline for complying with Vermont’s GMO labeling law, and still no court ruling to overturn Vermont’s law. Still no federal legislation to preempt Vermont’s law.
Hundreds of millions of dollars spent to keep labels off GMO ingredients. Lawsuits, dirty tricks, shady schemes—all, so far, for naught. Meanwhile, food corporations are labeling, or announcing plans to label, and preparing to implement those plans. Others, including Dannon, will remove GMO ingredients from their products.
Is victory really within our grasp this time?
The closer we get to July 1, the closer we are to winning the battle of all labeling battles. Which is all the more reason to keep up the pressure, on all fronts.
Can U.S. Senate put together a deal before July 1?
So far, efforts by Sen. Pat Roberts (R-Kan.) to pass a federal law which would preempt Vermont’s mandatory labeling law have failed.
But we haven’t heard the end of the DARK—Deny Americans the Right to Know—Act. At least not yet.
Politico reports that Sen. Debbie Stabenow (D-Mich.) on April 26, told a gathering of the North American Agricultural Journalists, “There could be a deal” before July 1. According to Politico, Stabenow said: “We've offered some very specific language and there is a lot of support for it."
Stabenow didn’t divulge what that “very specific language” was, or who among those who have so far voted against the DARK Act might go for this new language. But our sources tell us Stabenow is pushing for the same old QR code and/or 1-800 telephone numbers that USDA Secretary Tom Vilsack has proposed—but with one difference. Stabenow wants those QR codes to be mandatory, not voluntary.
Will Roberts, who so far has adamantly opposed any option that actually requires labels, cave? If Stabenow’s version also includes a plan that would delay implementation of Vermont’s law?
Stabenow is in a tight spot. Nine out of 10 of her constituents want labels on GMOs, and they’ve been relentlessly vocal about that. But she’s under tremendous pressure from industry—including Michigan’s GMO sugar beet growers who fear food companies will switch to sugar cane rather than label—to stop Vermont’s law in its tracks.
The clock is ticking. But it hasn’t run out. The worst thing we can do now is be silent. It’s more critical than ever that we keep the pressure on.
What happens in Vermont doesn’t stay in Vermont
Meanwhile, back in Vermont, things heated up last week as the food industry looked for ways to stall and weaken Vermont’s Act 120.
In a nutshell, here’s what happened, as explained by Nancy Remsen in this April 25 report. The Vermont Retail & Grocers Association wanted to tweak the Vermont law, to the advantage of food companies (not consumers, of course). Specifically, the industry group wanted: 1) to prevent consumers from suing if they find non-labeled products on store shelves during the 18 months immediately after the law takes effect on July 1; and 2) to exempt food prepared in stores (think potato salad, sandwiches and baked goods).
How did industry plan to make changes to a law passed two years ago, and set to take effect in two months? By attaching them to the state’s budget bill—a bill lawmakers want wrapped up and passed by May 6, when the legislative session is due to end.
OCA and other groups called on our networks to let Vermont lawmakers know we expect them to stand strong against any attempts to weaken or delay Vermont’s law. We generated more than 500 calls to the Vermont State House because the future of the GMO labeling movement now comes down to upholding Vermont’s Act 120—a bill the national movement fought for and helped pass.
In the end, the Vermont Senate’s appropriations bill included a provision to delay the possibility of consumer lawsuits, by one year (January 1, 2018) instead of the 18 months industry requested. (The states’ attorney general retains the power to enforce the law beginning January 1, 2017, as specified in Act 120, and has said he will do so). Because the House version of the budget didn’t include the provision delaying consumer lawsuits, the final decision will have to be made when the House and Senate meet to negotiate a final bill.
Monsanto still fiercely protecting its right to deceive
While Big Food has been tinkering with the Vermont law, the state’s attorney general has been trying to pry incriminating evidence out of the hands of Monsanto and other biotech and food corporations. And that move may just work to the benefit of consumers who want labels.
According to Food Dive, Attorney General William Sorrell wants “major seed and food companies” to hand over internal research on GMO crops. The request comes as part of the GMA’s lawsuit, filed nearly two years ago.
Food Dive reports:
Requested research includes those related to "potential health or environmental impacts" of GMO crops and the pesticides used on them (from Monsanto, DuPont, and Syngenta). It also includes "consumer survey research" from the past decade about GMO foods and the use of the term "natural" on their product labels (from ConAgra, Kellogg, and Frito-Lay North America).
We think it's a safe bet that the GMA and Monsanto probably realize that they are better off labeling their products in compliance with Vermont's law, than risking the public release of their own potentially incriminating research on the health impacts of GMO crops and the pesticides used to grow them.
It’s one thing for the World Health Organization to come out with the determination that glyphosate and Monsanto’s Roundup are probably carcinogenic. It’s quite another if word gets out that Monsanto has known this all along—but kept the information to itself. The latter is clear grounds for legal action.
Katherine Paul is associate director of the Organic Consumers Association.
Ronnie Cummins is international director of the Organic Consumers Association.
Belong to campaign: Millions Against MonsantoCategory: Genetic EngineeringArea: USA
Remember the Monsanto Protection Act? Well, Monsanto’s minions in Congress have a new one for you: The Monsanto Promotion Act.
Now that the IRS has filled the government’s coffers, Congress gets to decide how to spend your hard-earned money.
The U.S. House Agriculture Appropriations Subcommittee has decided that:
$3,000,000 shall be used by the Commissioner of Food and Drugs, in coordination with the Secretary of Agriculture, for consumer outreach to promote understanding and acceptance of agricultural biotechnology and biotechnology-derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian benefits of such biotechnology, food products, and feed.
Wow, with legislation as crazy as this, it’s hard to know where to start.
TAKE ACTION! Ask your Member of Congress and Senators to remove the Monsanto Promotion Act. Tell them you don’t want your taxes to be spent on corporate welfare or industry propaganda, especially not to promote Monsanto’s GMOs!Read more
All About Organics, Health IssuesOrganic Consumers AssociationApril 23, 2016
Baby being fed with bottle 420x280
The Honest Co. and Earth’s Best (made by Hain Celestial) Infant Formula Brands Contain Long List of Ingredients Prohibited by Federal Law under USDA Organic Standards
FOR IMMEDIATE RELEASE: April 26, 2016
CONTACT: Katherine Paul, email@example.com, 207.653.3090
FINLAND, Minn. – The Organic Consumers Association (OCA) announced today that the nonprofit consumer advocacy group has filed suit against two infant formula makers—The Hain Celestial Group (NASDAQ: HAIN), owner of the Earth’s Best infant and toddler formula brands, and The Honest Co.—for falsely labeling “organic” products that contain ingredients prohibited under the Organic Food Production Act of 1990 (OPPA).
“It is fitting that we draw attention to these two companies for violating U.S. Department of Agriculture (USDA) organic standards this week, when leaders of the organic industry are convening to discuss and uphold organic standards at the Spring National Organic Standards Board (NOSB) meeting in Washington, D.C.,” said Ronnie Cummins, OCA’s international director.
“No one is more concerned about food labels and ingredients than new mothers responsible for feeding infants whose immune systems and brain development are so underdeveloped and vulnerable,” Cummins said. “As consumers, these mothers must rely on truthful labeling in order to make the best choices for feeding their infants and toddlers. Our job as a consumer advocacy group is to call out and hold accountable companies like The Honest Co. and Hain Celestial when they knowingly and intentionally mislead consumers. OCA has long been a defender of organic standards, which means also defending the organic label. Our goal with this lawsuit is to force these companies to either comply with USDA organic standards or stop calling their products ‘organic.’”
The lawsuit against The Honest Co. alleges that the company is falsely representing its Premium Infant Formula as “organic,” when the product in fact contains 11 substances prohibited by federal law from organics. Some of the ingredients are federally regulated as hazardous compounds. At least one is irradiated. And some have not even been assessed as safe for human foods, much less for infant formulas.
The lawsuit against Hain Celestial alleges that the company’s Earth’s Best brands including Organic Infant Formula, Organic Soy Infant Formula, Organic Sensitivity Infant Formula and Organic Toddler Formula are all falsely labeled organic because they contain a spectacular array of ingredients that are non-agricultural and non-organic, all of which are prohibited under OPPA. For example, of the 48 ingredients in Earth’s Best Organic Infant Formula alone, more than half violate USDA Organic Standards.
The lawsuits were filed by OCA on behalf of the general public, with the help of Yve Golan of The Golan Firm; Kim Richman of The Richman Law Group, Todd Garber of Finkelstein, Blankinship, Frei-Pearson & Garber, LLP, and Beth Terrell of Terrell Marshall Law Group PLLC.
Full complaint against The Honest Co.
Full complaint against The Hain Celestial Group
The Organic Consumers Association (OCA) is an online and grassroots non-profit 501(c)3 public interest organization campaigning for health, justice, and sustainability. The Organic Consumers Fund is a 501(c)4 allied organization of the Organic Consumers Association, focused on grassroots lobbying and legislative action.
Genetic EngineeringSteven HoffmanOrganic Consumers AssociationApril 24, 2016
Repeat after me: Clustered Regularly Interspaced Short Palindromic Repeats.
That’s CRISPR, a new GE technology that uses an enzyme, Cas9, to cut, edit or remove genes from a targeted region of a plant’s DNA. And because it doesn’t involve transgenics, i.e., inserting genes from foreign species into an animal or plant, foods produced in this manner just received a free pass from the U.S. Department of Agriculture (USDA) to be sold into the marketplace.
In an April 2016 letter to Penn State researcher Yinong Yang, USDA informed the associate professor of plant pathology that his new patent-pending, non-browning mushroom, created via CRISPR technology, would not require USDA approval.
“The notification apparently clears the way for the potential commercial development of the mushroom, which is the first CRISPR-Cas9 gene-edited crop deemed to require no regulatory review by USDA,” reported Chuck Gill in Penn State News.
Why does this anti-browning mushroom not require USDA regulation? ”Our genome-edited mushroom has small deletions in a specific gene but contains no foreign DNA integration in its genome," said Yang. "Therefore, we believed that there was no scientifically valid basis to conclude that the CRISPR-edited mushroom is a regulated article based on the definition described in the regulations."
The USDA ruling could open the door for many genetically engineered crops developed using CRISPR-Cas9 technology, said Penn State. In fact, just days after USDA's notification regarding Yang's anti-browning mushroom, the agency announced that a CRISPR-Cas9-edited corn variety developed by DuPont Pioneer also will not be subject to the same USDA regulations as traditional GMOs.
In response to Pioneer's "Regulated Article Letter of Inquiry," about the new GE corn product, the USDA said that it does not consider the CRISPR corn "as regulated by USDA Biotechnology Regulatory Services," reported Business Insider.
Not so fast, cautions Michael Hansen, Ph.D. Just because USDA says CRISPR needs no regulation, the U.S. Food and Drug Administration (FDA) – which uses the international CODEX definition of “modern biotechnology” – would “clearly include” the new Penn State CRISPR mushroom, says the Senior Scientist for Consumers Union.
“The biotechnology industry will be trying to argue to USDA that these newer techniques are more "precise and accurate" than older GE techniques and should require even less, or no scrutiny,” he says. “Thus, the issue of what definition to use for GE is a crucial one,” Hansen points out.
“The government does realize that there is a disconnect between USDA and EPA and FDA about what the definition of genetic engineering is, and that is part of the reason why it is in the process of reviewing the Coordinated Framework for the Regulation of Biotechnology,” Hansen says. “Thus, the last sentence in USDA’s letter to Dr. Yang at Penn State would say, ‘Please be advised that your white button mushroom variety described in your letter may still be subject to other regulatory authorities such as FDA or EPA.’”
Yang does plan to submit data about the CRISPR mushroom to the U.S. Food and Drug Administration (FDA) as a precaution before introducing the crop to the market, he says. While FDA clearance is not technically required, Yang told Science News, “We’re not just going to start marketing these mushrooms without FDA approval.”
Gary Ruskin, co-director of the advocacy group U.S. Right to Know, told Fusion on April 25 that the organization’s concerns about genetically engineered food crops extend to Penn State’s new CRISPR mushroom. “What are the unknowns about CRISPR generally, and in particular, in its application in this mushroom?” he asked. “Regulators should determine whether there are off-target effects. Consumers have the right to know what’s in our food.”
In Europe, however, where anti-GMO advocates have strongly opposed CRISPR, Urs Niggli, director of the Swiss Research Institute of Organic Agriculture (FiBL) was recently quoted in the German newspaper Taz that CRISPR may be different from traditional GMO technologies and could alleviate some concerns groups like FiBL have with older gene-editing techniques. His comments have since been subject to much interpretation and criticism among both pro- and anti-GMO circles.
While biotech proponents claim that CRISPR has much to offer, Nature reported in June 2015 that scientists are worried that the field's fast pace leaves little time for addressing ethical and safety concerns. The issue was thrust into the spotlight in April 2015, when news media reported that scientists had used CRISPR technology to engineer human embryos. The embryos they used were unable to result in a live birth. Nature reported that the news generated heated debate over whether and how CRISPR should be used to make heritable changes to the human genome. Some scientists want to see more studies that probe whether the technique generates stray and potentially risky genome edits; others worry that edited organisms could disrupt entire ecosystems, Nature reported.
Steve Hoffman is a communications consultant for Regeneration International, a project of the Organic Consumers Association.