Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monsanto colluded with EPA

SUBHEAD: They were unable to prove Roundup does not cause cancer, unsealed court docs reveal.

By Tyler Durden on 14 Marxh 2017 for Zero Hedge -
(http://www.zerohedge.com/news/2017-03-14/court-docs-prove-monsanto-collusion-epa-kill-cancer-study-admits-cant-say-roundup-do)

http://www.islandbreath.org/2017Year/03/170314doc1big.jpg
Image above: Illustration of Monsanto government collusion in hiding danger of GMO food and Round-Up by David Dees. From (https://uspiked.com/health/2017/03/02/glyphosate-monsanto-and-epa-under-the-scope/).

If we had a dime for every kooky, left-wing theory we've heard alleging some vast corporate conspiracy to exploit the treasures of the Earth, destroy the environment and poison people with unknown carcinogens all while buying off politicians to cover their tracks, we would be rich. The problem, of course, is that sometimes the kooky conspiracy theories prove to be completely accurate.

Lets take the case of the $60 billion ag-chemicals powerhouse, Monsanto, and their controversial herbicide, Roundup as an example.

For those who aren't familiar, Roundup Ready is Monsanto’s blockbuster weedkiller, credited with transforming U.S. agriculture, with a majority of farm production now using genetically modified seeds resistant to the chemical.

For years the company has assured farmers that their weed killing product was absolutely safe to use. As proof, Monsanto touted the approval of the chemical by the Environmental Protection Agency (EPA).

That said, newly unsealed court documents released earlier today seemingly reveal a startling effort on the part of both Monsanto and the EPA to work in concert to kill and/or discredit independent, albeit inconvenient, cancer research conducted by the World Health Organization's International Agency for Research on Cancer (IARC)....more on this later.

But, before we get into the competing studies, here is a brief look at the 'extensive' work that Monsanto and the EPA did prior to originally declaring Roundup safe for use (hint: not much).

As the excerpt below reveals, the EPA effectively declared Roundup safe for use without even conducting tests on the actual formulation, but instead relying on industry research on just one of the product's active ingredients.

"EPA's minimal standards do not require human health data submissions related to the formulated product - here, Roundup. Instead, EPA regulations require only studies and data that relate to the active ingredient, which in the case of Roundup is glyphosate.

As a result, the body of scientific literature EPA has reviewed is not only primarily provided by the industry, but it also only considers one part of the chemical ingredients that make up Roundup."

Meanwhile, if that's not enough for you, Donna Farmer, Monsanto's lead toxicologist, even admitted in her deposition that she "cannot say that Roundup does not cause cancer" because "[w]e [Monsanto] have not done the carcinogenicity studies with Roundup."

http://www.islandbreath.org/2017Year/03/170314doc1big.jpg
Image above: Document #2 from original article. Click to enlarge.

And just in case you're the super skeptical type, here is Farmer's actual email, from back in 2009, which seems pretty clear:

"you cannot say that Roundup does not cause cancer..we have not done carcinogenicity studies with "Roundup".

http://www.islandbreath.org/2017Year/03/170314doc2big.jpg
Image above: Document #2 from original article. Click to enlarge.

And while the revelations above are quite damning by themselves, this is where things get really interesting.

In early 2015, once it became clear that the World Health Organization's IARC was working on their own independent study of Roundup, Monsanto immediately launched their own efforts to preemptively discredit any results that might be deemed 'inconvenient'.

That said, Monsanto, the $60 billion behemoth, couldn't possibly afford the $250,000 bill that would come with conducting a legitimate scientific study led by accredited scientists.  Instead, they decided to "ghost-write" key sections of their report themselves and plotted to then have the independent scientists just "sign their names so to speak."
"A less expensive/more palatable approach might be to involve experts only for the areas of contention, epidemiology and possibly MOA (depending on what comes out of the IARC meeting), and we ghost-write the Exposure Tox & Genetox sections...but we would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak."


http://www.islandbreath.org/2017Year/03/170314doc3big.jpg
Image above: Document #3 from original article. Click to enlarge.

Finally, when all else fails, you call in those "special favors" in Washington D.C. that you've paid handsomely for over the years.

And that's where Jess Rowland, the EPA's Deputy Division Director for the Office of Chemical Safety and Pollution Prevention and chair of the Agency's Cancer Assessment Review Committee, comes in to assure you that he's fully exploiting his role as the "chair of the CARC" to kill any potentially damaging research..."if I can kill this I should get a medal."

http://www.islandbreath.org/2017Year/03/170314doc4big.jpg
Image above: Document #4 from original article. Click to enlarge.

All of which begs the question of whether the D.C. swamp is just too large to be drained.

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Is being anti GMO anti science?

SUBHEAD: And more importantly, are the arguments for the safety of GMO "science" really scientific? 

By Curt Kobb on 24 July 2016 for Resource Insights -
(http://resourceinsights.blogspot.com/2016/07/are-you-anti-science-if-you-dont-like.html)


Image above: Discerning safety of an apple. Go for the 94750 barcode. From (http://healingulcerativecolitis.com/recommended-diet-for-colitis/dangers-of-gmos/).

It's all the rage to call people who oppose the cultivation of genetically engineered crops anti-science. But if science is an open enterprise, then it should welcome discussion and challenges to any prevailing idea.

We should, however, remember that in this case genetic engineering of crops is not merely a scientific enterprise; it's big business. A lot of people have a lot to lose if the public rejects genetically engineered foods, often referred to as genetically modified organisms (GMOs). We are not by any measure in the preliminary phases of this technology. We are not considering it or calmly debating it before its release. We have long since been launched into an uncontrolled mass experiment, the results of which are unknown.

Knowledge is admittedly a double-edged sword. One might argue that any scientific advance brings risks. I would agree. Understanding nuclear fission and then nuclear fusion led to the atomic bomb and then the hydrogen bomb.

More than 30 years ago millions of people across the world flocked to the nuclear freeze movement out of fear that newly elected American president Ronald Reagan would seek a nuclear buildup and a confrontation with the Soviet Union. Were these millions anti-scientific or the voice of reason?

Nuclear discoveries also led to the widespread application of nuclear fission as a source of heat for electricity generating plants, the dangers of which have most recently been on display at the Fukushima Daiichi power plant in Japan. The results of our grand nuclear experiment are ongoing.

Opposition to practical applications of scientific discoveries cannot willy nilly be labeled anti-science. We now know how to clone humans, but so far, human society has chosen to prohibit this use of cloning.

One does not have to be anti-science to mount a reasoned case for such a prohibition. The American Association for the Advancement of Science opposes reproductive cloning, while supporting stem cell research and research on therapeutic cloning (the production of replacement tissues for humans).

The vast majority of those who want GMO foods labeled or their cultivation banned do not advocate an end to genetic research. They are not anti-scientific. They have legitimate concerns about the safety of crops derived from a specific application of this research, both for humans and for the broader environment.

Let's see if the arguments used to label those who oppose GMOs as anti-science make sense.

1. Lots of scientists endorse the safety and promise of GMOs.
This argument was most recently trotted out as a petition directed at Greenpeace, asking the organization to cease its opposition to GMOs and more specifically to what is called Golden Rice, a rice that produces its own Vitamin A. (Vitamin A deficiency remains a problem in parts of Asia).

It is understandable that those involved in a political debate over the regulation and even prohibition of GMOs will seek visible shows of support from others who are like-minded. This is part of the persuasion process.

But does this prove that those who oppose GMOs are anti-science? More to the point, are scientists who question the safety of GMOs anti-science even as they continue their scientific research?

We must be careful to distinguish research designed merely to understand the workings of the physical world from an endorsement of specific applications of our knowledge to products and practices. There is a big difference between science and applied science.

This is where the problem of what a friend of mine calls the Midgley Effect arises. Thomas Midgley Jr. was a renown American chemist in the first half of the 20th century. He was asked to find compounds that could be added to gasoline to reduce "knocking" in engines (which can cause damage). Midgley's solution was tetraethyllead which became the basis for leaded gasoline.

Midgley assured the public that leaded gasoline was safe. In fact, Midgley was given the prestigious William H. Nichols Medal by the American Chemical Society in 1923 for his breakthrough. Despite concerns about the release of lead into the environment and deaths at a pilot plant, the U.S. Surgeon General and the U.S. Public Health Service both concluded that there was no evidence that leaded gasoline would cause human health problems. Thus, yet another uncontrolled mass experiment began with humans as the subjects.

Only unrelated research on the age of the Earth revealed abnormally high levels of lead in the environment which interfered with such age calculations and led to concerns about leaded gasoline--which, of course, was eventually banned.

But Midgley's work on chlorofluorocarbons (CFCs) as refrigerants was probably even more significant. At the time existing refrigerants--fluids that circulate in refrigerators and draw heat away from their interiors--were corrosive or flammable. The industry wanted something that wasn't either.

Midgley's solution was a set of inert compounds that would easily vaporize and recondense called chlorofluorocarbons and that eventually went by the trade name Freon.

Nonflammable, noncorrosive, nontoxic to humans and able to circulate in refrigerators for years, even decades without breaking down, his discovery found wide application in refrigeration and eventually air conditioning. So safe were CFCs deemed that they were used in aerosol spray cans and even asthma inhalers.

For his work on CFCs Midgley received another award, the Perkin Medal from the Society of Chemical Industry in 1937.

If chemist F. Sherwood Rowland had not asked in the early 1970s where CFCs go once they are released, we might now be living without the better part of the Earth's ozone layer.

 His work alerted the world that CFCs were indeed quite long-lived as advertised, were making their way continuously to the Earth's ozone layer and were systematically destroying it. Without the ozone layer much greater ultraviolet radiation would hit the Earth and endanger all living things. CFCs were ultimately banned by the Montreal Protocol.

Shall we consider the scientist who discovered the deleterious effect of CFCs on the ozone layer anti-science? Shall we consider the geochemist who discovered the widespread dissemination of lead in the environment that was linked to leaded gasoline anti-science?

Of course not. Pointing out potential and actual dangers of a specific application of scientific research in not anti-science at all.

In these cases we must remember that lots of people who called themselves scientists assured us that leaded gasoline and CFCs were safe. But, they were wrong, grievously wrong. And, we must remember that it took decades to uncover the widespread damage being done by both.

The U.S. Food and Drug Administration (FDA) long ago ruled that GMO foods are "substantially equivalent" to their non-GMO counterparts and therefore do NOT require any testing. Those supporting the widespread dissemination of GMOs could be very wrong as well. There isn't enough information to know what the ultimate results will be for human and animal health.

What is more interesting is that the authors of the petition mentioned above have essentially admitted that we are doing an uncontrolled experiment on humans (because governments required no controlled studies). They write:
But the science telling us GM [genetically modified] crops and foods are safe has been confirmed by vast experience. Humans have eaten hundreds of billions of GM based meals in the past 20 years without a single case of any problems resulting from GM.
The petition writers, of course, do not adduce any evidence that there has not been a single case of a problem with genetically engineered foods. They merely assert it. I would hazard a guess that they did not do an exhaustive survey to find any cases.

This leads us to the second claim that is supposed to prove that somebody is anti-science if he or she opposes GMOs.

2. There is no evidence that GMOs are harmful.
Anecdotal evidence and even some scientific studies suggest that GMOs may be harmful in one or more these three categories. Even if that evidence is valid, it begs the question, How harmful? Do the supposed benefits of GMOs outweigh any alleged or actual harm?

The problem with engaging assertion number 2 above is that it is an inversion of responsibility. The GMO industry and its supporters assume that it is the responsibility of the public to discover any harm and to document it sufficiently to prove that harm.

But the real responsibility ought to lie with the industry. Typically, the way this is done is that the government requires studies under controlled conditions to establish the safety of a product. Individual consumers and independent researchers don't have the financial and technical resources to do this.

If the industry wants to warrant that GMOs are safe for human consumption, it should have to follow protocols designed for novel products which it wants to introduce into the human body. These protocols are generally reserved for new drugs. But some scientists in the FDA suggested that just such protocols would be necessary to assure that GMOs are safe before their release to the public. (They were overruled.)

The industry assures us that GMOs are not novel. After all, the FDA ruled that GMOs are "substantially equivalent." On that basis all patents for GMOs crops would be invalid since they are not novel. But it is precisely based on the novelty of specific genetic alterations of plants that the GMO companies have successfully obtained patents on their products.

If GMO plants are indeed novel as the companies insist when they go to the patent office, then they ought to be obliged to prove they are safe under established protocols for novel products designed for human consumption.

Don't let the industry get away with this inversion of responsibility. Can the industry really make the claim that those who oppose GMOs because the foods derived form them are not properly tested are anti-science? Isn't the industry really anti-science for opposing the testing of novel foods in the same way the drug companies are obliged to test novel compounds? Isn't the industry being anti-science by claiming that GMOs are not novel? (Maybe that's just straight out lying.)

There is a third claim that is supposed to demonstrate that those who oppose GMOs are both anti-science and ignorant.

3. GMO crops are no more risky than crops by crossbreeding.
This is a clever argument indeed. For it tries to get the listener to accept the equivalence of the two types of genetic alteration. But they are not equivalent. And, the key reason is not the one cited most often by GMO critics, namely transgene splicing, the splicing of genes from completely different categories (from a fish to a tomato to cite a real example).

While it's theoretically possible for such gene transfers to take place in nature, they are highly unlikely. (How often is a fish in the wild going to come into contact with a tomato?)

What is more important is that humans have ample experience with crossbreeding. The fact that humans are still here in the numbers that they are testifies to the safety of crossbreeding which has been practiced for a very long time.

This does not testify to safety in every instance, but to safety in general. Historically, crossbred plants are tested in small areas to see whether thrive and to see how they interact with other plants. These small experiments keep any mistakes contained.

GMO crops on the other hand are poorly tested[1] and then introduced practically worldwide within a few years. If there is a hidden adverse interaction with the environment, we will be subject to worldwide effects before we are aware. Those effects might take years to become apparent. And, it might take us years to trace those effects to GMO crops. The adverse environmental effects of GMOs will not be contained. There will be no small mistakes.

Since our experience with GMOs is limited, there has been very little time to discover unintended consequences. The fact that GMO crops to date have not produced catastrophic systemic failures in farm fields or in the surrounding environment does not prove that the next new GMO crop won't produce such a failure or that existing GMO crops under some as yet unencountered situation won't produce such failures.

Now, here's the key point: Because we cannot from experience judge the risks of GMOs to the broader environment (as we can with crossbreeding), and we cannot anticipate all the interactions between GMOs and the environment, THERE IS A NONZERO RISK OF SYSTEMIC CATASTROPHE, namely, worldwide crop failure or systemic ruination of adjacent ecosystems.

The proponents will say that the risk of such systemic effects is small. But it does not matter how small that risk is if we intend to keep subjecting the environment to novel crop genes. If the risk is nonzero and we metaphorically pull the gene gun trigger enough times, we will eventually create systemic ruin.

We are playing a game of Russian roulette with the many genetic engineering techniques we are now employing. Techniques which have a nonzero risk of creating systemic ruin should be banned. Ruin is too great a price to pay no matter how big the perceived benefits are (and the supposed benefits of GMOs are hotly disputed).

The foregoing discussion is really a reiteration of something I've covered before based on the work of risk expert Nassim Nicholas Taleb. Taleb explains why the precautionary principle should apply to GMOs.

Perhaps risk is not the purview of the pure scientist. But it certainly must be the purview of the applied scientist. To misunderstand risk in the worldwide dissemination of genetically novel crops is to set oneself up to be the next Thomas Midgley and to risk the lives and livelihoods of millions, even billions of people based on a mere feeling that what one is doing is low risk.



[1] The U.S. Department of Agriculture (USDA) requires field testing of GMO plants to determine whether they have the potential to harm other plants. The genetic contamination of non-GMO plants (through the exchange of pollen) which is prevalent worldwide seems of little concern to the USDA which seems not to regard this as a harm to other plants. This is particularly a problem for organic growers who are forbidden to use GMO crops and those conventional growers seeking non-GMO verification of their crops.

The FDA regulates as a pesticide any GMO plant which produces its own pesticide (as many of them do) and determines whether ingesting that pesticide in the amounts in the plant poses a hazard to human health--not particularly appetizing. A summary of these regulations can be found on p. 4 of this document.

Kurt Cobb is an author, speaker, and columnist focusing on energy and the environment. He is a regular contributor to the Energy Voices section of The Christian Science Monitor and author of the peak-oil-themed novel Prelude. In addition, he has written columns for the Paris-based science news site Scitizen, and his work has been featured on Energy Bulletin (now Resilience.org), The Oil Drum, OilPrice.com, Econ Matters, Peak Oil Review, 321energy, Common Dreams, Le Monde Diplomatique and many other sites. He maintains a blog called Resource Insights and can be contacted at kurtcobb2001@yahoo.com.

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GE salmon - What could go wrong?

SUBHEAD: Genetically modified salmon will eventually escape and establish populations in the wild.

By Kurt Cobb on 22 November 2015 for Resource Insights -
(http://resourceinsights.blogspot.com/2015/11/genetically-engineered-salmon-what.html)


Image above: Salmon is native to the northern Atlantic Ocean, in rivers that flow into the north Atlantic and, due to human introduction, in the north Pacific Ocean. From (http://www.wikiwand.com/en/Atlantic_salmon).

[IB Publisher's note: Our best guess is that these GE salmon, like most fish farm operations, feed on GMO corn products - just like most dogs and cats are fed.]

As U.S. regulators cleared genetically engineered salmon for sale in the United States last week, they opened the door to what many scientists already feel is inevitable: The escape and reproduction of GE salmon in the wild and the possible destruction of competing wild species.

Under the U.S. Food and Drug Administration-approved application, the company behind the so-called AquAdvantage Salmon, Aqua Bounty, can only raise such salmon in land-based tanks with "multiple and redundant levels of physical barriers to prevent eggs and fish from escaping." These barriers are described in detail and suggest that it will be very difficult for any eggs or fish to escape into waterways.
The FDA said it considered four interrelated questions about confinement of the fish:
  1. What is the likelihood that AquAdvantage Salmon will escape the conditions of confinement?
  2. What is the likelihood that AquAdvantage Salmon will survive and disperse if they escape the conditions of confinement?
  3. What is the likelihood that AquAdvantage Salmon will reproduce and establish if they escape the conditions of confinement?
  4. What are the likely consequences to, or effects on, the environment of the United States should AquAdvantage Salmon escape the conditions of confinement?
Right away we can see that the FDA is asking these questions in the wrong way because it misunderstands the risks involved. It should be asking if there is ANY LIKELIHOOD WHATSOEVER that the salmon will escape, survive, disperse, reproduce and establish populations in the wild.

Why is it important to ask the question in this way? Because although the salmon are sterilized, the "sterilization technique is not foolproof," according to The New York Times.

So, here is the relevant principle: Any invention with a nonzero risk of systemic ruin and which is produced and deployed long enough will with almost 100 percent certainty create that ruin. Put more informally, if you keep repeating something that each time you repeat it has a small chance of creating catastrophe, eventually you will produce catastrophic conditions, that is, systemic ruin.

Systemic ruin in this case would be the ruination of the wild salmon fisheries overrun by the GE type.
And, the damage might include other harmful effects to waterways and their associated wildlife that we cannot now anticipate. Remember, this is a fish that we've never seen operate in any existing ecosystem. We have no empirical data about its possible effects; and, releasing such fish into the wild to obtain that data risks the very ruin we wish to avoid.

Now, there is one final question which the FDA asks: "What are the likely consequences to, or effects on, the environment of the United States should AquAdvantage Salmon escape the conditions of confinement?"

Again, this is the wrong way to ask the question. The effects would not be confined to the United States since the escape of one unsuccessfully sterilized salmon into the wild could lead to a worldwide infestation. (In any case, the facilities approved for farming the salmon are in Prince Edward Island, Canada and in Panama. But apparently, only the possible environmental effects in the United States were considered.)

Anything that is novel cannot by definition have a history to draw on. A novel invention might not alter the environment very much or it might alter it radically. We cannot know. To say that we should subject the world's salmon fisheries to the possibility of ruin in order to find out reveals a failure to understand that self-propagating, worldwide dangers do not lend themselves to cost-benefit analysis.

When the cost is the complete ruination of a system, we must judge costs to be incalculable. The complete destruction of the global wild salmon population is not 10 times worse than the destruction of 10 percent of that population. It is infinitely worse. It is infinitely worse because you cannot repopulate the world with an extinct species (except perhaps in science fiction movies). There is no remedy.

And, we must keep in mind that we do not now know how many other facilities like those built by Aqua Bounty will be constructed. The danger of release grows with each added facility. And, of course, we must assume that Aqua Bounty wants to expand as a company which implies many more facilities should the company become successful.

Also, keep in mind that such facilities, although on land, must have extensive plumbing and drains which must ultimately connect with the external world. Is it rational to believe that GE salmon or salmon eggs will never, ever make it into a waterway and survive, an event which must happen only once for a possible cascade of destruction of wild species to take place?

So, we should say that the risk is real and the scope and severity, if realized, would be catastrophic.
Understanding this allows us to see why the precautionary principle applies in this situation and in the cases of all genetically engineered plants and animals. Anything that is novel, self-propagating and worldwide in reach has the possibility of creating systemic ruin. Which leads us to another key principle: It does not matter how many times something succeeds if failure is too great to bear.*

In other words, it does not matter if millions upon millions of GE salmon are produced without any release into the environment when the inevitable release of one (by mistake, carelessness, accident or poor design) could create ruinous global consequences. (And, if the GE salmon industry grows, it is difficult to believe that there will be only one inadvertent release over time. Accidents happen--even when we think we have designed foolproof systems.)

Whether such a fish is safe for human consumption is not the key question--though the FDA answers that it is safe. That's what makes the announcement of the approval so misleading. What difference does it make if this GE salmon is safe to eat if, in the event of escape and propagation, it ultimately destroys the entire wild salmon fishery and has other unforeseen and catastrophic effects on marine life.
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*This formulation comes from author and risk expert Nassim Nicholas Taleb, author of The Black Swan and many other works on risk.

See also:
Ea O Ka Aina: Unlabled GMO Frankenfish 11/20/15

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Unlabled GMO Frankenfish

SUBHEAD: FDA approves genetically modified salmon that will grow twice as fast and be unlabled in stores.

By AP Staff on 20 November 2015 in the New York Post -
(http://nypost.com/2015/11/20/frankenfish-salmon-coming-soon-to-a-supermarket-near-you/)


Image above: Salmon on display in supermarket. Photo by Robert Miller.  From original article.

What’s for dinner? Before long, it may well be genetically modified salmon, the first such altered animal cleared for human consumption in the United States.

Critics call it “Frankenfish,” but the Food and Drug Administration granted its approval on Thursday, saying the faster-growing salmon is safe to eat. It could be available in a couple of years.

“There are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon,” the agency said.

The Obama administration had stalled in approving the salmon for more than five years amid consumer concerns about genetically modified foods. The fish grows twice as fast as normal salmon, so it reaches market size more quickly.

AquAdvantage Salmon is engineered by the Massachusetts-based company AquaBounty. Ron Stotish, the company’s CEO, said in a statement that the fish is a “game changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats.”

AquaBounty said the fish could be on grocery store shelves in about two years, which is how long it takes the salmon to grow.

Once the salmon reach stores, consumers may not know they are eating them. Because there are no material differences between an engineered and a normal salmon, the FDA says the law does not require the fish to be labeled as engineered. AquaBounty says that genetically modified salmon have the same flavor, texture, color and odor as the conventional fish.

The FDA released separate wording that would set guidelines for retailers who do want to label the fish, along with additional guidance for voluntary labeling of genetically modified plant foods.

Some retailers have said they won’t sell the fish at all — retailers Whole Foods, Trader Joe’s, Target and Kroger have all said they are not planning to sell AquAdvantage Salmon.

Critics have pressured retailers to reject the salmon, which they have labeled “Frankenfish.” They worry it could cause human allergies and the eventual decimation of the natural salmon population if it escapes into the wild.

“There’s no place on our dinner plates for genetically engineered fish,” said Lisa Archer of the environmental advocacy group Friends of the Earth. “We will continue to work to ensure the market, from grocery retailers to restaurants, continues to listen to the majority of consumers that don’t want to eat this poorly studied, unlabeled genetically engineered fish.”

Just hours after the announcement, another advocacy group, The Center for Food Safety, said it would sue the FDA to block the approval.

Alaska Sen. Lisa Murkowski, a Republican, has said the engineered salmon could harm her state’s wild salmon industry. She took to the Senate floor to criticize the FDA shortly after the announcement, saying she was “spitting mad.” She and other Alaska and Pacific Northwest lawmakers said they will swiftly push legislation to mandate labeling of the modified fish.

The FDA said the salmon will be allowed to be raised only in land-based, contained hatchery tanks at two facilities in Canada and Panama, and that other facilities in the US or elsewhere cannot breed or raise the salmon for human consumption. Those restrictions limit the amount of food the company can produce.

The agency said there are “multiple and redundant levels of physical barriers” in the facilities to prevent the escape of fish. The fish would be bred to be female and sterile, so if any did escape, they should not be able to breed.

The salmon has an added growth hormone from the Pacific Chinook salmon that allows that fish to produce growth hormone all year long. Engineers have been able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an “on” switch. Typical Atlantic salmon produce the growth hormone for only part of the year.

Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine, said the agency “has thoroughly analyzed and evaluated the data and information” submitted by AquaBounty. To approve an engineered animal for human consumption, the agency reviews a company’s data and must determine that the food is safe to eat, that the engineering is safe for the fish and that the company’s claim — in this case, faster growth — is accurate.

AquaBounty’s Stotish said he is hopeful the fish will gain consumer acceptance as people learn more about it.

“We think time and education and information may allow many of these folks to change their mind,” he said of critics.

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