GE Salmon? Are You Out of Your Minds?!

No Frankenfish! Act Now

To help stop GE salmon, please sign petitions to the food industry and Congress.

Has the FDA gone completely mad? Why are they trying to open the flood gates to genetically engineered (GE) salmon—a move that will go down in history as one of the most asinine and dangerous ever made by our government? What’s it going to take for them to actually start protecting public health?

Frankenfish can promote disease

The FDA is reviewing data submitted by AquaBounty, the company that spliced a growth hormone gene into Atlantic salmon, forcing it to grow up to five times faster, and reach market size in about 18 months instead of 3 years. But according to the evidence, their buff salmon might have higher levels of a cancer promoting hormone IGF-1, more antibiotics, and more of a potentially life-threatening allergen(s).

The FDA failed to learn their lesson with their idiotic approval of genetically engineered bovine growth hormone. It also has higher levels of IGF-1 and more antibiotics. Now it’s condemned by the American Public Health Association and the American Nurses Association, banned in most other countries, and has been banished by most US dairies. Even Wal-Mart won’t allow the stuff into their milk.

The GE soy and corn on the market, which the FDA continues to pretend is just the same as the natural stuff, also has higher levels of allergens, and has been linked to numerous disorders. Now the American Academy of Environmental Medicine condemned genetically modified organisms (GMOs) and urged all physicians to prescribe non-GMO diets. “GMO-Free” is one of the fastest growing health claims among US brands for the past two years, and a tipping point of consumer rejection of all GE ingredients appears to be just over the horizon.

Then there is the threat of Frankenfish escaping into the wild. Here too, the FDA ignores the lessons from GE crops which, in spite of early assurances to the contrary, have been contaminating non-GE crops and wild relatives all over the world for more than a decade. Their self-propagating genetic pollution is irreversible; it can outlast the effects of global warming and nuclear waste. But somehow escaped GE salmon carry an even greater hazard.

Frankenfish can wipe out natural salmon

According to a Purdue University computer model that tracked the effects of releasing just 60 Frankenfish (not salmon) into a population of 60,000, there was a shocking complete extinction in just 40 fish generations. Apparently their bigger size, which attracted mates more easily, combined with a slight reduction in survival rates, was a killer combination.

Canadian scientists engineered their own set of fast growing salmon and tested their behavior in tanks with other fish. When there was sufficient food, all was fine. When food stocks decreased, the Frankenfish freaked. They became cannibals, attacking and killing other fish—whether GE or natural. Their unexpected behavior resulted in population crashes or complete extinctions in the fish tanks. The study also suggested that if released, these ravenous aggressive salmon would pursue and consume other types of fish.

I’m not sure which scenario is worse: The complete extinction of salmon, or gangs of voracious mutant freaks scouring the ocean, attacking anything that can feed their rapidly-expanding, always-hungry bodies. (Heck, let’s just give the fish automatic weapons.)

Never mind that the GE AquAdvantage salmon are supposed to be grown in inland tanks and are supposed to be sterile. In reality, they won’t all be sterile; and there are numerous ways that these salmon, whose eggs will regularly be shipped from Prince Edward Island, Canada to growing tanks in Panama, can escape into the ocean. It only takes one!

Corporate interests and politics run the FDA show

US consumers have been clear for years that we don’t want Frankenfish, Frankenpigs, Frankenmosquitoes, Frankenanything that walks, flies, slithers, or swims. And most Americans are now uneasy about the Frankencrops already growing in our fields. So who is clamoring for GE salmon? Who’s getting the FDA to push open the doors to GE animals against public opinion?

Thank you Union of Concerned Scientists for the answer. Your September 12th survey of 1710 FDA employees explains who is really driving the bus at the agency. One staff member said, “Food safety has succumbed to the higher priority of global corporate profits.” In fact, 38 percent of respondents agreed or strongly agreed that “public health has been harmed by agency practices that defer to business interests.”

Another employee points to political interference: “I have been here for 26 years and it still amazes me . . . how politics filter down to the lowest levels of government.”

So its corporate profits and politics. Anyone surprised? About 1 in 4 surveyed admit that they had personally experienced, either frequently or occasionally, “situations where corporate interests [or members of Congress, or special interests] have forced the withdrawal or significant modification of [an agency] policy or action designed to protect consumers or public health.”

If there is one face that best captures the FDA’s conflict-of-humanity’s-interest, it would be Michael Taylor. Taylor is the US Food Safety Czar. You’d think that if there were significant safety concerns about the GE salmon, our Czar would step in to preserve and protect. Don’t count on it.

Back when the first Bush White House had instructed the FDA to promote biotechnology, the agency created a special position for Taylor to be in charge. He had been the outside attorney for biotech giant Monsanto, where he had dreamed up a regulatory facade that would allow GMOs to be brought to market with maximum speed and minimum oversight. Then he took a position with the FDA where he could apparently implement it himself. His GMO policy falsely claimed that the agency was unaware of information showing GM foods to be different. On that basis, no testing or labeling was required. Years later, 44,000 documents made public from a lawsuit revealed that the consensus among FDA’s own scientists was that GM foods were unsafe, and should be carefully tested for allergies, toxins, new diseases, and nutritional problems.

Soon after leaving the FDA, Michael Taylor went to work as Monsanto’s vice president.

So the person who lied about GMO safety to push them on the market now sits above the folks that are looking at GE Salmon. Not a comforting thought.

Stacking the deck for approving salmon

How else does corporate influence play out in the current FDA debacle?

Consider Alison L. Van Eenennaam. She too used to work for Monsanto, and now has been added as a temporary voting member on the committee that advises the FDA about the salmon. She also advises the USDA and promotes GE animals on Youtube.

Kevin G. Wells was also added as a temporary voting member for salmon. He works at Revivicor, a company that genetically engineers pigs. Do you suppose there is any conflict of interest for him establishing an easy ride for GE animal approvals? Perhaps.

Gregory Jaffe was also imported into the committee as their supposed consumer advocate. In reality, he is with the pro-GMO Center for Science in the Public Interest (CSPI), an organization that consistently ignores the mounting evidence of adverse health impacts from GE crops. Jaffe even filed a complaint to the FDA in 2001 complaining of companies that label their products as non-GMO. What further qualified Jaffe for his committee position was his published article Questions About Genetically Engineered Animals, where he touts the environmental benefits of AquAdvantage salmon.

The engineered bias of the FDA advisory committee is made even more clear by who is absent. There are no experts on allergies or hormones who can address the possible health damaging effects of the fish, and no fish ecologists who can figure out whether our grandchildren will live in a world without wild salmon.

Institutionalized stupidity

But even before the committee was picked, the deck was stacked in favor of approvals. In 2008, the Bush administration rolled out a policy in which GE animals would be approved as if they were animal drugs. This latest square peg is part of a continuing effort to regulate GMOs without asking Congress to pass any new laws. So, since 1992, the government has been jerry-rigging inadequate pre-existing laws to handle the unique and complex safety and environmental considerations of genetically engineered organisms.

Even if GE animals weren’t infinitely more complex than some drug compound, using the FDA drug approval process shouldn’t give us great confidence. Between 1976 and 1985, for example, more than half of their drug approvals turned out to have lethal or serious side effects, forcing withdrawal or added label warnings. Try conducting a recall of GE salmon from the ocean.

Failing grades all around

Even with stacked committee membership, an antiquated approval policy, and an agency that is officially mandated to promote biotechnology, the Frankenfish did not swim past the advisory committee on September 19th and 20th. That’s because the committee agreed with safety experts like Dr. Michael Hansen of the Consumers Union (they publish Consumer Reports) that the evidence presented by AquaBounty was abysmal and insufficient. Using a sample size of only 6 fish, employing insensitive detection methods that could easily miss cancer-promoting hormones or allergens, and testing fish that were raised in a completely different climate than what is planned, were among the sloppy science that the FDA had accepted. (See addendum below for examples.)

In fact the only person on the committee who had any experience with fish, Gary Thorgaard, completely disagreed with the FDA’s conclusion that the Frankenfish didn’t threaten the environment. He called for a full Environmental Impact Statement.

Hansen says, “The data and analysis of food safety risks from the AquAdvantage Salmon are so sloppy and inadequate that, if this were an undergraduate paper, it would get a failing grade.  No self-respecting scientist could conclude that these data demonstrate that AquAdvantage salmon are safe to eat.”

Thus, in spite of the fact that the company had been submitting data to the FDA for more than ten years, the advisory committee concluded that the evidence was insufficient to conclude that GE salmon was safe for the environment and for human health. They told AquaBounty to go back and to do more testing.

I propose a different recommendation. This little exercise made it perfectly clear that AquaBounty is either completely incompetent to evaluate the safety of their own creation, or they’re intentionally hiding evidence. In either case, let’s not send the same folks back to do more research, hoping they’ll get it right. Instead, tell these jokers that they have proved to the world that they are never ever ever to be trusted with the future of salmon or the safety of the human food supply.

And what about the FDA—the brain cell behind the Don’t-ask-don’t-tell food safety assessments? They have again demonstrated that they too are not competent to protect the public from the unique unpredictable dangers of genetically engineered foods.

If you want to GE salmon stopped for good, now is the time to raise your voice. Since the FDA has been ignoring US citizens in favor of business interests and politics, please join me in inviting the food industry and Congress to stop in and stop this madness. Go to our action alert pages to sign the petitions today.

. . .

Addendum: How Not to Do a Food Safety Assessment

The FDA’s evaluation of GE salmon is the first of its kind. Because it will set a precedent for all future GE animal approvals, the bar should be set very high. According to Dr. Michael Hansen, who testified at the FDA advisory committee meeting on behalf of Consumers Union, the FDA set the bar a foot off the ground.

When AquaBounty looked for potentially dangerous growth hormones in the salmon, for example, they used a detection method so insensitive, it couldn’t find any hormones in any fish. The FDA therefore concluded that there was no relevant difference in hormone levels in GE salmon. Dr. Hansen told the committee, “This would be like the police using a radar gun that cannot detect speeds below 120 mph and concluding that there is no ‘relevant difference’ in the speed of cars versus bicycles.”

Because the company also used an insensitive test to measure cancer-promoting insulin-like growth hormone factor one (IGF-1), levels were detected in only a few fish. Of these, the GE salmon was 40% higher. Again, insufficient data combined with faulty reasoning allowed the FDA to conclude that IGF-1 from GE salmon is not a problem.

Even then, these test results were not from the type of GE salmon that the company plans to market. Instead, the tests were conducted on the GE salmon variety that will produce the fish eggs in Canada. The DNA of these “egg-layers” have the normal two sets of chromosomes (diploid). The GE salmon to be grown from their eggs in Panama, however, end up with three sets of chromosomes (triploid)—so that most will be sterile. It’s the Panama-grown triploid variety that will go onto our dinner table if the FDA has their way. So what was the response by the FDA and AquaBounty when asked for the IGF-1 levels of the actual fish (raised in the actual conditions) that people would actually eat? “Well…er….uhm…we’ll get back to you.”

The situation with allergies is worse. According to Hansen, the tests conducted by AquaBounty confirmed that “the act of genetic engineering did lead to an increase in allergenic potency.” In fact, when the flesh from egg-laying (diploid) fish was exposed to the blood (sera) of people who are allergic to salmon, there was a whopping 52% increase in reaction levels. Furthermore, the specific allergen that had increased in the Frankenfish was not supposed to be affected. It did not come from the inserted gene. Rather, the increase in this potentially life-threatening allergen was just one of the unpredictable side-effects that can result from the process of genetic engineering itself.

The FDA decided this time to ignore this troublesome finding, since it was from the egg-laying diploids. The company did test the allergic reaction to the triploids (the ones we’ll eat), but used fish that were raised in Canada, not Panama. This should have disqualified the fish study, according to Hansen, since the composition of GE salmon can obviously be affected by water temperature, and growing conditions. Still, the Canadian raised Frankenfish still elicited an allergic response level that was 20% higher than normal salmon. But the FDA dismissed this figure since it was not statistically significant and concluded that the GE salmon was safe to eat. But of course it wasn’t statistically significant. They used just six fish in the sample size! The easiest way to prevent statistical significance is by using a pathetically small number of subjects in your experiment. Hansen said:

“To base a conclusion of no additional risk on exactly six engineered fish, when those data themselves suggest a possible problem, is not responsible science or responsible risk assessment. FDA owes it to the thousands of Americans who are allergic to finfish to demand more data on the allergenicity of these engineered salmon from AquaBounty.”

Thank you Dr. Hansen for helping to protect us from the bungling Frankenfish promoters. Let’s hope they will listen.

Don’t forget to sign the petitions to the food industry and Congress.

International bestselling author and filmmaker Jeffrey M. Smith is the executive director of the Institute for Responsible Technology. His first book, Seeds of Deception: Exposing Industry and Government Lies About the Safety of the Genetically Engineered Foods You’re Eating, is the world’s bestselling and #1 rated book on GMOs. His second, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, documents 65 health risks of the GM foods Americans eat every day. Both are distributed by Chelsea Green Publishing. To help you choose healthier, non-GMO brands, use the Non-GMO Shopping Guide.

Monsanto: The World’s Poster Child for Corporate Manipulation and Deceit – Part 3

2010-02-05-cornscary.jpgWhen Forbes magazine declared Monsanto as the Company of the Year for 2009, millions of surprised people were forced to reevaluate their opinions about a major corporation. Now they no longer trust Forbes.

Monsanto is one of the most despised corporations on earth. This is the third in a series of articles that expose their not-so-hidden dark side and how, if unrestrained, Monsanto could unleash a cataclysm. Indeed, it has already started…

Part 3 of 10

Covering up health dangers

The policy Taylor oversaw in 1992 needed to create the impression that unintended effects from GM crops were not an issue. Otherwise their GRAS status would be undermined. But internal memos made public from a lawsuit showed that the overwhelming consensus among the agency scientists was that GM crops can have unpredictable, hard-to-detect side effects. Various departments and experts spelled these out in detail, listing allergies, toxins, nutritional effects, and new diseases as potential problems. They had urged superiors to require long-term safety studies. In spite of the warnings, according to public interest attorney Steven Druker who studied the FDA’s internal files, “References to the unintended negative effects of bioengineering were progressively deleted from drafts of the policy statement (over the protests of agency scientists).”

FDA microbiologist Louis Pribyl wrote about the policy, “What has happened to the scientific elements of this document? Without a sound scientific base to rest on, this becomes a broad, general, ‘What do I have to do to avoid trouble’-type document. . . . It will look like and probably be just a political document. . . . It reads very pro-industry, especially in the area of unintended effects.”

The FDA scientists’ concerns were not only ignored, their very existence was denied. Consider the private memo summarizing opinions at the FDA, which stated, “The processes of genetic engineering and traditional breeding are different and according to the technical experts in the agency, they lead to different risks.” Contrast that with the official policy statement issued by Taylor, Monsanto’s former attorney: “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way.” On the basis of this false statement, the FDA does not require GM food safety testing.

Fake Safety Assessments

Monsanto participates in a voluntary consultation process with the FDA that is derided by critics as a meaningless exercise. Monsanto submits whatever information it chooses, and the FDA does not conduct or commission any studies of its own. Former EPA scientist Doug Gurian-Sherman, who analyzed FDA review records obtained through the Freedom of Information Act, says the FDA consultation process “misses obvious errors in company-submitted data summaries, provides insufficient testing guidance, and does not require sufficiently detailed data to enable the FDA to assure that GE crops are safe to eat.”

But that is not the point of the exercise. The FDA doesn’t actually approve the crops or declare them safe. That is Monsanto’s job! At the end of the consultation, the FDA issues a letter stating:

“Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. . . . As you are aware, it is Monsanto’s responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements.

The National Academy of Sciences and even the pro-GM Royal Society of London describe the US system as inadequate and flawed. The editor of the prestigious journal Lancet said, “It is astounding that the US Food and Drug Administration has not changed their stance on genetically modified food adopted in 1992. . . . Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health.”

One obvious reason for the inflexibility of the FDA is that they are officially charged with both regulating biotech products and promoting them–a clear conflict. That is also why the FDA does not require mandatory labeling of GM foods. They ignore the desires of 90% of American citizens in order to support the economic interests of Monsanto and the four other GM food companies.

Monsanto: The World’s Poster Child for Corporate Manipulation and Deceit – Part 2

2010-02-05-cornscary.jpgWhen Forbes magazine declared Monsanto as the Company of the Year for 2009, millions of surprised people were forced to reevaluate their opinions about a major corporation. Now they no longer trust Forbes.

Monsanto is one of the most despised corporations on earth. This is the second in a series of articles that expose their not-so-hidden dark side and how, if unrestrained, Monsanto could unleash a cataclysm. Indeed, it has already started…

Part 2 of 10

Infiltrating the Minds and Offices of the Government

To get their genetically modified products approved, Monsanto has coerced, infiltrated, and paid off government officials around the globe. In Indonesia, Monsanto gave bribes and questionable payments to at least 140 officials, attempting to get their genetically modified (GM) cotton accepted. In 1998, six Canadian government scientists testified before the Senate that they were being pressured by superiors to approve rbGH, that documents were stolen from a locked file cabinet in a government office, and that Monsanto offered them a bribe of $1-2 million to pass the drug without further tests. In India, one official tampered with the report on Bt cotton to increase the yield figures to favor Monsanto. And Monsanto seems to have planted their own people in key government positions in India, Brazil, Europe, and worldwide.

Monsanto’s GM seeds were also illegally smuggled into countries like Brazil and Paraguay, before GMOs were approved. Roberto Franco, Paraguay’s Deputy Agriculture Ministry, tactfully admits, “It is possible that [Monsanto], let’s say, promoted its varieties and its seeds” before they were approved. “We had to authorize GMO seeds because they had already entered our country in an, let’s say, unorthodox way.”

In the US, Monsanto’s people regularly infiltrate upper echelons of government, and the company offers prominent positions to officials when they leave public service. This revolving door has included key people in the White House, regulatory agencies, even the Supreme Court. Monsanto also had George Bush Senior on their side, as evidenced by footage of Vice President Bush at Monsanto’s facility offering help to get their products through government bureaucracy. He says, “Call me. We’re in the ‘de-reg’ business. Maybe we can help.”

Monsanto’s influence continued into the Clinton administration. Dan Glickman, then Secretary of Agriculture, says, “there was a general feeling in agro-business and inside our government in the US that if you weren’t marching lock-step forward in favor of rapid approvals of biotech products, rapid approvals of GMO crops, then somehow, you were anti-science and anti-progress.” Glickman summarized the mindset in the government as follows:

“What I saw generically on the pro-biotech side was the attitude that the technology was good, and that it was almost immoral to say that it wasn’t good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . And there was a lot of money that had been invested in this, and if you’re against it, you’re Luddites, you’re stupid. That, frankly, was the side our government was on. Without thinking, we had basically taken this issue as a trade issue and they, whoever ‘they’ were, wanted to keep our product out of their market. And they were foolish, or stupid, and didn’t have an effective regulatory system. There was rhetoric like that even here in this department. You felt like you were almost an alien, disloyal, by trying to present an open-minded view on some of the issues being raised. So I pretty much spouted the rhetoric that everybody else around here spouted; it was written into my speeches.”

He admits, “when I opened my mouth in the Clinton Administration [about the lax regulations on GMOs], I got slapped around a little bit.”

Hijacking the FDA to Promote GMOs

In the US, new food additives must undergo extensive testing, including long-term animal feeding studies. There is an exception, however, for substances that are deemed “generally recognized as safe” (GRAS). GRAS status allows a product to be commercialized without any additional testing. According to US law, to be considered GRAS the substance must be the subject of a substantial amount of peer-reviewed published studies (or equivalent) and there must be overwhelming consensus among the scientific community that the product is safe. GM foods had neither. Nonetheless, in a precedent-setting move that some experts contend was illegal, in 1992 the FDA declared that GM crops are GRAS as long as their producers say they are. Thus, the FDA does not require any safety evaluations or labels whatsoever. A company can even introduce a GM food to the market without telling the agency.

Such a lenient approach to GM crops was largely the result of Monsanto’s legendary influence over the US government. According to the New York Times, “What Monsanto wished for from Washington, Monsanto and, by extension, the biotechnology industry got. . . . When the company abruptly decided that it needed to throw off the regulations and speed its foods to market, the White House quickly ushered through an unusually generous policy of self-policing.” According to Dr. Henry Miller, who had a leading role in biotechnology issues at the FDA from 1979 to 1994, “In this area, the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do.”

The person who oversaw the development of the FDA’s GMO policy was their Deputy Commissioner for Policy, Michael Taylor, whose position had been created especially for him in 1991. Prior to that, Taylor was an outside attorney for both Monsanto and the Food Biotechnology Council. After working at the FDA, he became Monsanto’s vice president. He’s now back at the FDA, as the US food safety czar.

Monsanto: The World’s Poster Child for Corporate Manipulation and Deceit – Part 1

2010-02-05-cornscary.jpgMonsanto’s public relations story about genetically modified organisms (GMOs) is largely based on five concepts:

1. GMOs are needed to feed the world.

2. GMOs have been thoroughly tested and proven safe.

3. GMOs increase yield.

4. GMOs reduce the use of agricultural chemicals.

5. GMOs can be contained, and therefore coexist with non-GM crops.

All five are pure myths—blatant falsehoods about the nature and benefit of this infant technology. The experience of former Monsanto employee Kirk Azevedo helps expose the first two lies, and provides some insight into the nature of the people working at the company.

In 1996, Monsanto recruited young Kirk Azevedo to sell their genetically engineered cotton. Azevedo accepted their offer not because of the pay increase, but due to the writings of Monsanto CEO Robert Shapiro. Shapiro had painted a picture of feeding the world and cleaning up the environment with his company’s new technology. When he visited Monsanto’s St. Louis headquarters for new employee training, Azevedo shared his enthusiasm for Shapiro’s vision during a meeting. When the session ended, a company vice president pulled him aside and set him straight. “Wait a second,” he told Azevedo. “What Robert Shapiro says is one thing. But what we do is something else. We are here to make money. He is the front man who tells a story. We don’t even understand what he is saying.” Azevedo realized he was working for “just another profit-oriented company,” and all the glowing words about helping the planet were just a front.

A few months later he got another shock. A company scientist told him that Roundup Ready cotton plants contained new, unintended proteins that had resulted from the gene insertion process. No safety studies had been conducted on the proteins, none were planned, and the cotton plants, which were part of field trials near his home, were being fed to cattle. Azevedo “was afraid at that time that some of these proteins may be toxic.”

He asked the PhD in charge of the test plot to destroy the cotton rather than feed it to cattle, arguing that until the protein had been evaluated, the cows’ milk or meat could be harmful. The scientist refused. Azevedo approached everyone on his team at Monsanto to raise concerns about the unknown protein, but no one was interested. “I was somewhat ostracized,” he said. “Once I started questioning things, people wanted to keep their distance from me. . . . Anything that interfered with advancing the commercialization of this technology was going to be pushed aside.” Azevedo decided to leave Monsanto. He said, “I’m not going to be part of this disaster.”

Monsanto’s Toxic Past

Azevedo got a small taste of Monsanto’s character. A verdict in a lawsuit a few years later made it more explicit. On February 22, 2002, Monsanto was found guilty for poisoning the town of Anniston, Alabama with their PCB factory and covering it up for decades. They were convicted of negligence, wantonness, suppression of the truth, nuisance, trespass, and outrage. According to Alabama law, to be guilty of outrage typically requires conduct “so outrageous in character and extreme in degree as to go beyond all possible bounds of decency so as to be regarded as atrocious and utterly intolerable in civilized society.”

The $700 million fine imposed on Monsanto was on behalf of the Anniston residents, whose blood levels of Monsanto’s toxic PCBs were hundreds or thousands of times the average. This disease-producing chemical, used as coolants and lubricants for over 50 years, are now virtually omnipresent in the blood and tissues of humans and wildlife around the globe. Ken Cook of the Environmental Working Group says that based on Monsanto documents made public during a trial, the company “knew the truth from the very beginning. They lied about it. They hid the truth from their neighbors.” One Monsanto memo explains their justification: “We can’t afford to lose one dollar of business.” Welcome to the world of Monsanto.

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