Category: FDA


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All but one of the hydraulic fracturing companies that received voluntary information requests in September have agreed to submit timely and complete information to help the U.S. Environmental Protection Agency conduct its study on hydraulic fracturing.

Halliburton is the only one that failed to provide EPA the information necessary to move forward with the study so the agency issued a subpoena for the information. One week after EPA announced the subpoena, Halliburton announced a new microsite that, among other things, discloses some information about the identity and common uses of the additives and constituents generally involved in the hydraulic fracturing process.

EPA’s congressionally mandated hydraulic fracturing study will look at the potential adverse impact of the practice on drinking water and public health. The agency is under a tight deadline to provide initial results by the end of 2012 and, according to the agency; the thoroughness of the study depends on timely access to detailed information about the methods used for fracturing.

EPA announced in March that it would conduct this study and solicit input from the public through a series of public meetings in major oil and gas production regions. The agency has completed the public meetings and thousands of Americans from across the country shared their views on the study and expressed full support for this effort.

On Sept. 9, EPA reached out to BJ Services, Complete Production Services, Halliburton, Key Energy Services, Patterson-UTI, RPC, Inc., Schlumberger, Superior Well Services, and Weatherford, seeking information on the chemical composition of fluids used in the hydraulic fracturing process, data on the impacts of the chemicals on human health and the environment, standard operating procedures at their hydraulic fracturing sites and the locations of sites where fracturing has been conducted. Eight of those companies have either fully complied with the request or made unconditional commitments to provide all the information on an expeditious schedule.

The microsite introduces a new fracture fluid system that uses materials sourced from the food industry. The company’s new service will use ultraviolet light instead of additives to control bacteria and another system will treat wastewater at the well site so that it can be reused.

“Halliburton has just made available new web pages to emphasize our forthright disclosure of the additives and constituents that are used for several typical wells in Pennsylvania. We believe this effort represents an important and substantive contribution to the broader long-term imperative of transparency,” said David Adams, vice president of Halliburton’s production enhancement product service line.

While the initial focus of the disclosure pages are limited to activities taking place in Pennsylvania, where development of the Marcellus Shale is already well under way, the company is committed to continuing to provide hydraulic fracturing fluid disclosure information for every U.S. state in which Halliburton’s fracture stimulation services are in use, the press release stated.

Source: Environmental Protection

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Source: By Silvia Ribeiro La Jornada | Pravda

A report by Jeremy Scahill in The Nation (Blackwater’s Black Ops, 9/15/2010) revealed that the largest mercenary army in the world, Blackwater (now called Xe Services) clandestine intelligence services was sold to the multinational Monsanto. Blackwater was renamed in 2009 after becoming famous in the world with numerous reports of abuses in Iraq, including massacres of civilians. It remains the largest private contractor of the U.S. Department of State “security services,” that practices state terrorism by giving the government the opportunity to deny it.

Many military and former CIA officers work for Blackwater or related companies created to divert attention from their bad reputation and make more profit selling their nefarious services-ranging from information and intelligence to infiltration, political lobbying and paramilitary training – for other governments, banks and multinational corporations. According to Scahill, business with multinationals, like Monsanto, Chevron, and financial giants such as Barclays and Deutsche Bank, are channeled through two companies owned by Erik Prince, owner of Blackwater: Total Intelligence Solutions and Terrorism Research Center. These officers and directors share Blackwater.

One of them, Cofer Black, known for his brutality as one of the directors of the CIA, was the one who made contact with Monsanto in 2008 as director of Total Intelligence, entering into the contract with the company to spy on and infiltrate organizations of animal rights activists, anti-GM and other dirty activities of the biotech giant.
Contacted by Scahill, the Monsanto executive Kevin Wilson declined to comment, but later confirmed to The Nation that they had hired Total Intelligence in 2008 and 2009, according to Monsanto only to keep track of “public disclosure” of its opponents. He also said that Total Intelligence was a “totally separate entity from Blackwater”.

However, Scahill has copies of emails from Cofer Black after the meeting with Wilson for Monsanto, where he explains to other former CIA agents, using their Blackwater e-mails, that the discussion with Wilson was that Total Intelligence had become “Monsanto’s intelligence arm,” spying on activists and other actions, including “our people to legally integrate these groups.” Total Intelligence Monsanto paid $ 127,000 in 2008 and $ 105,000 in 2009.

No wonder that a company engaged in the “science of death” as Monsanto, which has been dedicated from the outset to produce toxic poisons spilling from Agent Orange to PCBs (polychlorinated biphenyls), pesticides, hormones and genetically modified seeds, is associated with another company of thugs. Almost simultaneously with the publication of this article in The Nation, the Via Campesina reported the purchase of 500,000 shares of Monsanto, for more than $23 million by the Bill and Melinda Gates Foundation, which with this action completed the outing of the mask of “philanthropy.” Another association that is not surprising.

It is a marriage between the two most brutal monopolies in the history of industrialism: Bill Gates controls more than 90 percent of the market share of proprietary computing and Monsanto about 90 percent of the global transgenic seed market and most global commercial seed. There does not exist in any other industrial sector monopolies so vast, whose very existence is a negation of the vaunted principle of “market competition” of capitalism. Both Gates and Monsanto are very aggressive in defending their ill-gotten monopolies.

Although Bill Gates might try to say that the Foundation is not linked to his business, all it proves is the opposite: most of their donations end up favoring the commercial investments of the tycoon, not really “donating” anything, but instead of paying taxes to the state coffers, he invests his profits in where it is favorable to him economically, including propaganda from their supposed good intentions. On the contrary, their “donations” finance projects as destructive as geoengineering or replacement of natural community medicines for high-tech patented medicines in the poorest areas of the world. What a coincidence, former Secretary of Health Julio Frenk and Ernesto Zedillo are advisers of the Foundation.

Like Monsanto, Gates is also engaged in trying to destroy rural farming worldwide, mainly through the “Alliance for a Green Revolution in Africa” (AGRA). It works as a Trojan horse to deprive poor African farmers of their traditional seeds, replacing them with the seeds of their companies first, finally by genetically modified (GM). To this end, the Foundation hired Robert Horsch in 2006, the director of Monsanto. Now Gates, airing major profits, went straight to the source.
Blackwater, Monsanto and Gates are three sides of the same figure: the war machine on the planet and most people who inhabit it, are peasants, indigenous communities, people who want to share information and knowledge or any other who does not want to be in the aegis of profit and the destructiveness of capitalism.

Source: Washington’s Blog

The FDA is close to approving genetically modified (gm) salmon. See this and this.

We know that at least some genetically modified foods may harm the environment. See this.

And serious questions have been raised about whether some gm foods might increase allergies or cause other health problems in humans and other organisms. See this, this, this, this, this, this, this and this.
Indeed, as Mother Jones pointed out last week, gm salmon may itself increase allergies:

Consumers Union senior scientist Michael Hansen called the company’s food safety tests “woefully incomplete,” and the group pointed out that the FDA approval panel is mostly comprised of GE [i.e. genetic engineering] cheerleaders, with no fish ecologists or allergists. Why’s an allergist important? Because the company’s own tests suggest that the new salmon could be much more allergenic than regular salmon.

In order to understand the allergy tests, a bit of backstory on how AquAdvantage salmon are made is necessary. First, genetic engineers create a “diploid” fish, meaning like people, it has two sets of chromosomes. Then, to make the final market product, they add genetic material from other fish and breed a new salmon with three sets of chromosomes—a “triploid” female that can’t reproduce. AquaBounty researchers compared the allergenicity—or potential to cause an allergic reaction—of a control group of salmon to both the genetically engineered diploids and triploids. They found (PDF, see page 102) that the diploid salmon were 40 percent more allergenic than the control, while the triploid group was 19 percent more allergenic.

AquaBounty says that the triploids’ allergenicity level wasn’t statistically significant, and although the diploids’ level is significant, it doesn’t matter because only triploids will be sold. But Hansen of the Consumers Union finds a few problems with this argument. For starters, the test wasn’t double blind, meaning the researchers knew which fish were part of which test group. Second, the sample size of triploid fish was tiny—only six fish in all. Third, although AquaBounty is going to try to turn all its market-bound fish into triploid sterile females, the process isn’t perfect, and some 5 percent could end up as the more allergenic diploid. Especially scary when you consider that unlike the triploids, the diploids aren’t sterile. So if they escaped, they could breed with wild salmon.

The FDA simply doesn’t have enough information to determine whether AquaBounty’s salmon are likely to cause more allergic reactions than their non-GE counterparts. But there is good reason to be concerned about the potential allergenicity of all GE foods, says Margaret Mellon, director of the scientist Union of Concerned Scientsts’ Food and Environment Program. “You have this technology that allows you to essentially move proteins around from food to food,” she says. “You can move a highly allergenic protein into a new food, and no one will know to avoid the new food.”

Indeed, a 1996 study published in the New England Journal of Medicine found that people who were allergic to Brazil nuts were also allergic to soy beans that had been implanted with a Brazil nut protein. There is also some evidence that even proteins don’t usually cause allergies can become allergenic when they are moved to a new food. A 2005 Australian study found that mice who were fed peas containing a typically non-allergenic protein from kidney beans experienced allergic reactions.

Another worry is that potentially allergenic GE crops might “escape” into foods. In the late ’90s, the pharmaceutical giant Aventis introduced StarLink, a genetically engineered variety of corn. StarLink was approved for sale in the US, but only for non-food uses, since it contained a potentially allergenic protein. But then, traces of it started turning up in food (most famously, Taco Bell taco shells), and 28 people claimed they had suffered allergic reactions to foods containing StarLink. Although the CDC later found no medical evidence that any of those people had an allergy to the corn, an EPA advisory panel acknowledged that the CDC’s tests did “not eliminate StarLink…protein as a potential cause of allergic symptoms.”

The bottom line: It’s not that genetically engineered foods are inherently more allergenic than traditional foods, but transfering genes does make it more likely that allergens might pop up in unexpected places. “There can be a lot of unintended side effects when you do genetic modification, which means you have to test very carefully,” says Wenonah Hauter, executive director of the watchdog group Food and Water Watch. “In the case of salmon, one test on six fish just seems very insufficient for something that will open the floodgates to other GE meat and fish.”
Allergic reactions can – in a small percentage of people – be more severe than just a sniffle or stomach ache. Some people die from allergic reactions.

At least genetically modified salmon will be labeled as such, so people can avoid it if they wish. Right?

Wrong.

As the Washington Post notes:

The FDA says it cannot require a label on the genetically modified food once it determines that the altered fish is not “materially” different from other salmon – something agency scientists have said is true.

Perhaps more surprising, conventional food makers say the FDA has made it difficult for them to boast that their products do not contain genetically modified ingredients.

Unfortunately, stifling the ability of producers of traditional foods to tell consumers they are not using an additive is nothing new. For example, Monsanto has sued milk producers who labeled their product as not containing growth hormone.

Similarly, Scientific American notes that gm seed producers control research, so that independent scientists can’t study the effects of gm:

Scientists must ask corporations for permission before publishing independent research on genetically modified crops.

Liberals and conservatives, progressives and libertarians should all be up in arms about this.

We have a right to know what we’re eating.

Postscript: Farmed salmon contains less of the healthy Omega 3 fatty acids and more pollutants than wild salmon. See this and this. GM salmon will be farmed (unless it escapes into the ocean). So eating wild salmon may potentially be one way to avoid gm salmon, reduce exposure to pollutants, and increase healthy Omega 3s.

The reason that wild salmon has more Omega 3s than farmed salmon is that wild salmon eat Omega 3 rich foods. It is the same reason that grass-fed beef contains more Omega 3s than beef from cows fed corn, meat or other “modern” feeds. See this and this.

Eating Omega 3 rich foods can increase gray matter in adults and boost neurological development in children. Conversely, low dietary levels of Omega 3s in mothers can reduce their kids’ IQ.

This is not entirely surprising, given that (1) our brains are about 60% fat, and (2) leading nutritionists say that humans evolved to consume alot of Omega 3 fatty acids in the wild game and fish which they ate (more), and that a low Omega 3 diet is a very new trend within the last 100 years or so

Source: BBC

The bio-tech company Monsanto can sell genetically modified seeds before safety tests on them are completed, the US Supreme Court has ruled.

A lower court had barred the sale of the modified alfalfa seeds until an environmental impact study could be carried out.

But seven of the nine Supreme Court Justices decided that ruling was unconstitutional.

The seed is modified to be resistant to Monsanto’s brand of weedkiller.

The US is the world’s largest producer of alfalfa, a grass-like plant used as animal feed.

It is the fourth most valuable crop grown in the country.

Environmentalists had argued that there might be a risk of cross-pollination between genetically modified plants and neighbouring crops.

They also argued over-use of the company’s weedkiller Roundup, the chemical treatment the alfalfa is modified to be resistant to, could cause pollution of ground water and lead to resistant “super-weeds”.

But Monsanto says claims its products were dangerous amounted to “bad science fiction with no support on the record”.

Safety Rules Can’t Keep Up With Biotech Industry
Source: By ANDREW POLLACK and DUFF WILSON | New York Times

They are the highly trained, generally well-paid employees in the vanguard of American innovation: people who work in biotechnology labs. But the cutting edge can be a risky place to work.

The casualties include an Agriculture Department scientist who spent a month in a coma after being infected by the E. coli bacteria her colleagues were experimenting with.

Another scientist, working in a New Zealand lab while on leave from an American biotechnology company, lost both legs and an arm after being infected by meningococcal bacteria, the subject of her vaccine research.

Last September, a University of Chicago scientist died after apparently being infected by the focus of his research: the bacterium that causes plague.

Whether handling deadly pathogens for biowarfare research, harnessing viruses to do humankind’s bidding or genetically transforming cells to give them powers not found in nature, the estimated 232,000 employees in the nation’s most sophisticated biotechnology labs work amid imponderable hazards. And some critics say the modern biolab often has fewer federal safety regulations than a typical blue-collar factory.

Even the head of the federal Occupational Safety and Health Administration acknowledges that his agency’s 20th-century rules have not yet caught up with the 21st-century biotech industry.

“Worker safety cannot be sacrificed on the altar of innovation,” said David Michaels, OSHA’s new director. “We have inadequate standards for workers exposed to infectious materials.”

The current OSHA rules governing laboratories, for example, were not written with genetic manipulation of viruses and bacteria in mind. “The OSHA laboratory standard deals with chemicals,” Mr. Michaels said. “It doesn’t deal with infectious agents.”

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Aspartame has been renamed and is now being marketed as a natural sweetener

Source: Ethan Huff | Natural News

In response to growing awareness about the dangers of artificial sweeteners, what does the manufacturer of one of the world’s most notable artificial sweeteners do? Why, rename it and begin marketing it as natural, of course. This is precisely the strategy of Ajinomoto, maker of aspartame, which hopes to pull the wool over the eyes of the public with its rebranded version of aspartame, called “AminoSweet”.

Over 25 years ago, aspartame was first introduced into the European food supply. Today, it is an everyday component of most diet beverages, sugar-free desserts, and chewing gums in countries worldwide. But the tides have been turning as the general public is waking up to the truth about artificial sweeteners like aspartame and the harm they cause to health. The latest aspartame marketing scheme is a desperate effort to indoctrinate the public into accepting the chemical sweetener as natural and safe, despite evidence to the contrary.

Aspartame was an accidental discovery by James Schlatter, a chemist who had been trying to produce an anti-ulcer pharmaceutical drug for G.D. Searle & Company back in 1965. Upon mixing aspartic acid and phenylalanine, two naturally-occurring amino acids, he discovered that the new compound had a sweet taste. The company merely changed its FDA approval application from drug to food additive and, voila, aspartame was born.

G.D. Searle & Company first patented aspartame in 1970. An internal memo released in the same year urged company executives to work on getting the FDA into the “habit of saying yes” and of encouraging a “subconscious spirit of participation” in getting the chemical approved.

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Mom, What does FDA mean?


FDA says it’s unable to regulate BPA

As ‘indirect food additive,’ substance is exempt from scrutiny

Source: by Meg Kissinger | Jounral Sentinel Online

U.S. Food and Drug Administration officials say they are powerless to regulate BPA, although they have declared the chemical to be a safety concern for fetuses, babies and young children.

A quirk in the rules allows BPA makers to skirt federal regulation.

“We may have to go after legislation to change it,” Joshua Sharfstein, the FDA’s principal deputy director, told the Journal Sentinel. The newspaper has been investigating the government’s lack of regulation regarding BPA for three years.

FDA officials announced Friday that they had reversed their position that bisphenol A is safe. The chemical, used to line most food and beverage cans, has been found in the urine of 93% of Americans tested.

The agency now considers BPA to be of some concern for effects on the brain, behavior and prostate glands of fetuses and the very young. Scientific studies have raised concerns about the chemical’s link to breast and prostate cancer, diabetes, obesity, heart disease, reproductive failures and behavioral problems.

The FDA did not ban the chemical, although top scientists, including Linda Birnbaum, director of the National Toxicology Program, say they consider the safety of BPA to be uncertain. An agency source says some from within the FDA wanted to follow Canada’s lead and ban it from baby bottles – or from the lining of infant formula cans – but administration officials have resisted, concerned that babies who rely on bottled formula would be left without healthy alternatives.

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You decide.

The ‘false’ pandemic: Drug firms cashed in on scare over swine flu, claims Euro health chief

Source: Mail Daily UK | By Fiona MacRae

The swine flu outbreak was a ‘false pandemic’ driven by drug companies that stood to make billions of pounds from a worldwide scare, a leading health expert has claimed.

Wolfgang Wodarg, head of health at the Council of Europe, accused the makers of flu drugs and vaccines of influencing the World Health Organisation’s decision to declare a pandemic.

This led to the pharmaceutical firms ensuring ‘enormous gains’, while countries, including the UK, ’squandered’ their meagre health budgets, with millions being vaccinated against a relatively mild disease.

A resolution proposed by Dr Wodarg calling for an investigation into the role of drug firms has been passed by the Council of Europe, the Strasbourg-based ’senate’ responsible for the European Court of Human Rights.

An emergency debate on the issue will be held later this month.

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