The GE salmon comes from AquaBounty Technologies. They’ve been seeking approval for their engineered fish for over a decade. And now the FDA is seriously considering their proposal. Until recently there hasn’t been much information about how this salmon measures up. That’s because the FDA is regulating the GE salmon…not as an animal – but as an animal drug. And the FDA’s animal drug process allows companies to keep their proprietary information secret.

Obviously, that’s pretty unusual. Animal drugs are usually used for health purposes. But there’s no therapeutic benefit linked to this GE fish. However AquaBounty made the classification request…and the FDA has processed it as such.

The FDA held a recent public meeting about the fish. And attending experts weren’t happy about what they learned. This is what the meeting revealed.

AquaBounty took an Atlantic salmon and added a growth hormone gene from Chinook salmon. Then they spliced in a genetic “on-switch” from an eel-like ocean fish called pout.

The reasons for this are purely about commercial yield. Salmon don’t naturally produce growth hormones in cold weather. But the “on-switch” allows GE salmon to keep producing growth hormones all year round. And that makes GE salmon very valuable to the food industry.

It doesn’t grow any bigger than natural salmon. But it does grow twice as fast. Instead of taking two to three years to mature, it takes just 15 to 18 months. And it grows year round, which increases production. So the commercial benefits are obvious. But does it deliver the same health benefits as regular salmon? And does it pose health risks that all-natural salmon don’t?

Certainly AquaBounty has done its best to make it appear so.

It conducted its own studies and submitted them to the FDA for review. And the FDA is making its decision based solely on this data.

But even that data shows big problems. And independent experts who testified at the FDA public meeting say it’s seriously flawed.

One such testifying expert was Dr. Michael Hansen. He’s the senior staff scientist for Consumer Reports. He’s also served on the USDA Advisory Committee on Agricultural Biotechnology. And on a joint WHO/ FAO board for GE Animals.

He says the FDA review is critical to the future of the GE industry. That’s because the standards they set now will define how rigorous the safety tests are for all other products that come in the future.

This is the defining FDA review. And Dr. Hansen says the standards need to be set high. But that’s not what’s happened.

“The FDA set the bar low,” he says. And that means the safety bar is set low for all future GE applications.

He also testified that the studies conducted by AquaBounty were flawed.

“There is sloppy science, small sample sizes, questionable practices, and woefully inadequate analysis,” he says.

You can read his full comments about the FDA review in this online paper.

“The company submitted data on the levels of the growth hormone in the flesh of these fish,” he said. “They tested 73 fish and the method they used was so insensitive that they could not detect it in a single fish. So that means zero data on the growth hormone levels. That’s just not good science.”

In other words… one of the AquaBounty studies didn’t show any risky growth hormones in the fish. But they used a detection method that couldn’t detect any growth hormones in any fish. That includes both GE and natural.

Now think about that. They chose a detection method which couldn’t find any growth hormones at all. But we know that all fish have growth hormones. And the GE salmon have been developed to produce growth hormone all year round… unlike natural salmon. That’s the whole commercial benefit of them. So that growth hormone has to be present. Why is this so important? Because a certain growth hormone – IGF-1 – has been linked to cancer in humans. (More about IGF-1 a little later…)

Bottom line: there’s no way to know whether the hormones that these GE fish must contain are dangerous or not.

Dr. Hansen points to two other reasons why the data is flawed:

AquaBounty wasn’t required to show data that meets the conditions that the GE salmon will actually be produced under. And that’s more important than it may sound. The fish they tested didn’t come from the water where the commercial GE salmon will spawn. That’s important because environment changes the development of fish. A difference in water temperature may alter the biology of the GE fish. So there’s no way to know how the GE salmon will change once it’s actually being commercially produced.

AquaBounty tested less than 100 fish. And they were allowed to handpick the fish they wanted to test. That’s also suspicious. Why is it suspicious? Because it makes it easier to reduce the differences between regular and GE salmon.

However, there were experts at the meeting who think the GE fish should finally be approved.

Dr. William Muir says the FDA should give the approval. He’s a professor of animal sciences at Purdue University.

“Any new technology can have risks,” says Dr. Muir. “Those risks need to be assessed in a convincing manner. Once the assessment has been completed…the next step is to allow sale of the product.”

The problem is plenty of people don’t think those risks have been convincingly assessed.

Those people include doctors, consumer rights advocates and even politicians.

For example, a group of eight senators have joined together to tell the FDA to table the approval. They say GE fish could harm consumers. And they don’t see any cause to develop the fish in the first place.

“I just don’t see a reason why we have to start manufacturing ‘Frankenfish’ when we have incredible fisheries that employ thousands of people,” says Alaskan Senator Mark Begich.

So is the AquaBounty application thorough and convincing? Do their studies prove that GE salmon are safe and healthy? And how do GE salmon measure up to natural salmon?

Here are the facts about the application.

Frightening Facts About “Frankenfish”

The angle of the application doesn’t explore the possible dangers of GE salmon.

It simply compares the hormone levels, nutritional values and potential allergic reactions between regular and GE salmon. And the AquaBounty studies weren’t very positive even under that limited criteria.

This is what they found.

• Remember that the primary AquaBounty study didn’t find any growth hormones in the flesh of salmon? A second, smaller AquaBounty study did. It looked at six fish, much smaller than what consumers would normally buy. And it revealed that these GE salmon did contain 40 percent more IGF-1 than natural salmon. That’s a hormone that’s been linked to breast, colon, lung, and prostate cancer in humans. However, based on the size of the fish…the small number involved… and some impressive number-crunching and data-spinning analysis by the FDA review…they concluded this wasn’t significant.

• The tests also showed that the GE salmon lacks the nutritional punch of wild-caught salmon. As longtime readers will know, salmon is a critical part of a healthy diet because it has a high omega-3 / low omega-6 ratio. That’s vital to good health for dozens of reasons. As a quick refresher, check out our article here on the subject. But the GE salmon had the lowest omega-3 / omega-6 ratio in all of the nutritional comparison studies that the FDA reviewed.

• Those comparison studies also showed that GE salmon has a 20-52-percent higher chance of causing allergic reactions. Again, experts like Dr. Hansen believe this finding requires further testing into the allergic potential posed by GE salmon.

Keeping “Frankenfish” Secret

But there’s something else that is concerning experts.

AquaBounty doesn’t want labels on the packaging identifying the fish as GE. The makers are concerned it will hurt sales. And the FDA is also considering this request.

After all, AquaBounty argues, GE crops aren’t always necessarily labeled. And they’re right about that. You can read more about it in a recent report in the New York Times.

But does that make it right? Should consumers have the right to know if what they’re eating is natural or GE?

Professor Marion Nestle says they obviously should. She heads up diet and nutrition research for New York University. And she says it’s irresponsible that GE animal products may soon be turning up in your grocery store…with no acknowledging label.

“The public wants to know and has a right to know,” she says. “I think the agency (is) under enormous political pressure to approve (the salmon) without labeling.”

So why doesn’t AquaBounty want to label its food as what it is? Because they say labels aren’t necessary.

“Our fish is identical to traditional Atlantic salmon,” says Ronald Stotish. He’s a chief executive at AquaBounty. “If there’s no material difference, then it would be misleading to require labeling.”

But Dr. Hansen disagrees.

“This notion that there has to be (a) physical difference is just false,” he says.

He points to Hydrolyzed protein to prove his point. This protein exists in canned foods. And in 1991 the FDA required that companies show whether it came from an animal. The decision was made so vegetarians, Jews and Muslims wouldn’t have to violate their dietary restrictions.

“The food source of a protein hydrolysate is information of material importance for a person who desires to avoid certain foods for religious or cultural reasons,” the FDA wrote in 1991.

So Dr. Hansen argues that the same courtesy should be extended to other consumers. Those who prefer not to eat GE foods for example.

Conflicts of Interest?

We’ve heard why the AquaBounty application is weak. And that the data is flawed. So why is the FDA setting the bar so low? Why isn’t the FDA demanding more rigorous testing? Or further analysis?

One reason may be due to a legal loophole developed in 1992. That’s when the FDA published its policy stating that there is no need to test GE plants or animals for safety purposes. Why? Because the FDA argues that DNA is safe, so GE DNA is safe too. You can review the official FDA policy here.

But that doesn’t sit comfortably with what we now know. The UK’s Food Standards Agency did a human study on how we digest GE food. They found that when we eat GE soy, the bacteria in our gut absorbs the soy’s engineered DNA. The scientists call it “horizontal gene transfer.”

In the case of new GE foods like salmon…it’s possible our digestive tracks will absorb the new engineered salmon genes. But because of their policy on DNA…the FDA isn’t reviewing this aspect at all or what the consequences might be.

And there could be other reasons too.

There may be conflicts of interest in the FDA review. At least according to Jeffrey Smith, executive director of the Institute for Responsible Technology (IRT). He’s “the leading world expert in the understanding of health issues surrounding GE foods,” according to the US National Institutes of Health.

Smith believes the FDA’s conflict of interest comes from the top. And points to Michael Taylor.

“Taylor is the US Food Safety Czar,” says Smith. “You’d think that if there were safety concerns about the GE salmon, our Czar would step in to preserve and protect. Don’t count on it.”

Smith links Taylor to the GE food industry.

The FDA’s website tells us that Taylor was named the deputy commissioner for foods at the FDA just last year.

According to his FDA webpage, he’s responsible for:

• strategies for food safety
• planning for new food safety legislation
• ensuring that food labels contain clear information on nutrition

“We look forward to working in new ways…with the food industry to tackle important challenges – and unprecedented opportunities (that) we currently face,” says Taylor.

What his FDA page doesn’t say is that 30 years ago he represented Monsanto. That’s the biotech company that dominates the GE food industry. Or that he developed their “food and drug law” practice. And later…he became Monsanto’s vice president of public policy.

And the FDA / GE food industry links don’t end with him.

Alison L. Van Eenennaam is a temporary voting member on the FDA committee. She gets to vote on the AquaBounty application. But she’s also a former Monsanto employee.

And she’s joined by Kevin Wells. He’s also a temporary voting member on the committee. And he currently works at Revivicor. They genetically engineer pigs.

So what’s the conclusion? Consumer advocates like Smith are convinced that the FDA is “stacking the deck to approve (GE) salmon.”

What We Know About Existing GE Products

That’s what we know about GE salmon and the FDA review.

But we only have to look at the research that’s been published about GE vegetables products to see what risks GE foods pose.

Today about 95 percent of soy and 93 percent of corn have been genetically engineered by scientists. Genes are engineered to protect the plants from pests and disease, and to yield a better crop. So there’s plenty of thorough research on how GE vegetable products affect biology.

Russian biologist Dr. Alexey Surov led a recent study for the Russian National Academy of Sciences.

He and his team were investigating the effects of GE soy. That’s the kind that is grown on 91 percent of US soybean fields.

The study ran for two years. It involved 200 hamsters…and spanned three generations. The results made headline news. And that’s because the researchers observed the effect of GE foods on the evolution of hamsters…and not just on one generation.

The researchers began their study with 20 hamsters, split between four different diet groups.

Each group consisted of five hamsters. And each group was fed a healthy diet that is normal for hamsters. The only difference in the diet groups was how much GE soy they were fed.

• Group one was fed no soy at all.
• Group two was fed non-GE soy.
• Group three was fed GE soy.
• Group four was fed higher amounts of GE soy.

“Originally everything went smoothly,” says Dr. Surov. And the first generation showed no significant changes between the groups.

But that began to change by the second generation. While non-GE groups enjoyed normal development…the results were very different for the GE groups.

“We noticed quite a serious effect when we selected new pairs from their cubs and continued to feed them as before,” says Dr. Surov. “Growth rate was slower and reached sexual maturity slowly.”

Those growth and sexual defects became more significant by the third generation.

Most third-generation GE soy-fed hamsters were entirely sterile. They had major growth problems. And there was a high mortality rate among the young.

Here are the statistics broken down:

• 78 pups were born in the non-soy group.
• 52 pups were born in the non-GE soy group.
• 40 pups were born in the GE soy group. (And 25 percent of these died.)
• 16 pups were born in the high GE soy group. (And only one single female was able to conceive. Plus 20 percent of her pups died.)

“The low numbers in the (third generation) showed that many animals were sterile,” says Dr. Surov.

And that’s not all. There was one other major difference seen only in the GE soy groups. The third generation developed spiky hair inside recessed pouches in their mouths.

“Some of these pouches contained single hairs,” says Dr. Surov. “Others (had) thick bundles of colorless hair reaching as high as their teeth. Sometimes the tooth row was surrounded with a regular brush of hair bundles on both sides. The hairs grew vertically and had sharp ends, often covered with lumps of mucous.”

And Dr. Surov’s study isn’t the only one to show the dangers of GE foods. It’s just the most recent. There are dozens of international studies linking GE foods to fertility and growth problems.

Here are just three:

• The Russian National Academy of Sciences ran an earlier study which found similar results. They reported that mother rats that were fed GE soy lost 50 percent of their babies within three weeks. That was five times higher than a second group that was fed a non-GM soy diet. The babies that did survive were smaller and sterile. The study also showed a physical change in male rats that were fed GM soy. Researchers recorded that their testicles changed from pink to blue.

• Italian researchers found that GE food caused changes in mice testes. Blood tests showed this resulted in damaged young sperm cells.

• An Austrian government study linked GE corn products to sterility. Researchers found mice raised on high GE corn diets had fewer babies. And the babies they had were smaller.

That’s just a small sample of what we know about GE vegetable foods. But no one knows what the effect will be once we start eating GE animal products.

This is why so many scientists and consumer advocacy groups are demanding we need more testing before opening the floodgates to this new kind of food.

“We have no right to use GE (foods) until we understand the possible adverse effects,” says Dr. Surov. “Not only to ourselves but to future generations. We definitely need fully detailed studies to clarify this.”

What Now?

The food that we eat may be about to take another evolutionary change. And if GE animal products are approved, you’ll have to be more aware than ever when shopping at the grocery store.

But don’t be discouraged. We’ll be following this issue as it develops and keeping you informed so you can protect yourself and the ones you love.

Even if GE animal products are approved, there are simple steps you can take to stay healthy and natural.

First, stick with wild-caught fish like Wild Alaska Sockeye Salmon. It comes with lots of natural vitamins, minerals and nutrients. It’s a good source of protein. And unlike GE salmon, it’s rich in Omega-3 fatty acids. It’s also loaded with antioxidants and contains no detectable mercury.

Next, purchase only organically grown fruits and vegetables. And only buy grass-fed beef. You can find more information on choosing the best natural foods for your biology here.

For a more comprehensive guide on the most natural way to eat for prime health check out our Directive Report here.

To your best health,

Michael Jelinek,

Managing Editor, NHD “Health Watch”