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Story at-a-glance -

  • The sole purported legal basis for the marketing of GE foods in the United States is the FDA’s fraudulent claim that they are Generally Recognized as Safe (GRAS)
  • According to the law, no GE food can qualify as GRAS unless there is overwhelming consensus about its safety within the scientific community, and that consensus cannot be based on hypotheses or speculation; it has to be based on solid evidence
  • In the case of GE foods, there is no such evidence. FDA’s own files contain the admission that they didn’t have any technical evidence upon which to base their presumption that GE foods are GRAS
  • On January 24, 2015 a statement signed by 300 scientists was published in a peer-reviewed journal, asserting that there is no scientific consensus about the safety of GE foods – which confirms that they are on the US market illegally

Altered Genes, Twisted Truth—How GMOs Took Over the Food Supply, Part 2 Druker

March 15, 2015 | 253,647 views

By Dr. Mercola

Genetically engineered (GE) foods are a serious threat to our environment and our health.

In this article, Steven Druker, author of Altered Genes, Twisted Truth, continues the fascinating story of how GMOs came into being and have been allowed to permeate our food supply through illegal means and without legally required safety testing.

If you missed the first installment of this interview, you may want to read through Part 1 first.

The subtitle of his book, How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public, is quite descriptive, and Steven has done a wonderful job of exposing this extraordinary fraud.

Not only has he exposed it, but he’s also taken an activist role and actually sued the Food and Drug Administration (FDA) in 1998 and challenged their 1992 policy statement that presumed genetically engineered foods are Generally Recognized as Safe (GRAS).

That ’92 policy serves as the fraudulent foundation by which the biotechnology industry has been able to get away with marketing GE foods without having to first demonstrate that they’re safe. There’s so much information here, I strongly encourage you to get a copy of his book if you have any interest in this topic.

It will give you a clear understanding of what the problems are and how we got to the point where we are now.

Key Facts Overlooked by Federal Judge

In part one of this interview, we reviewed his lawsuit against the FDA, and how the federal judge appointed to the case failed to rule in accordance with the law.

"She actually ignored some very important evidence that was in the FDA files and that the other attorneys and I presented," Steven says.

"I cannot speculate as to the judge's motivations other than when I read the opinion, I find it difficult to understand how such an opinion came out because there are some serious facts that were overlooked."

One the main pieces of evidence that came straight from the FDA’s own files was a letter written by the FDA’s biotechnology coordinator, sent to a Canadian health official only seven months before the FDA announced its policy on GE foods in May 1992.

In that policy, the FDA purported there was an overwhelming consensus within the scientific community that these foods are safe—so safe in fact that they do not need to be tested.

But in the preceding letter, the FDA’s biotechnology coordinator had admitted that there was not a consensus about safety of these foods in the scientific community at large...

In fact, FDA scientists had overwhelmingly concluded that GE foods present a different array of risks than their conventionally produced counterparts; that none of them can be presumed safe; and that they need to be demonstrated safe through rigorous testing, which also happens to be the law.

“Both what the law was requiring and what the FDA’s own scientists, from their own analysis, were recommending was the same thing: these foods cannot be presumed safe and they need to be tested,” Steven says.

"Unfortunately, the decision makers of the FDA...who were far more under the influence of political and economic considerations than scientific ones, covered that up, and lied about it.

They said they weren’t aware of any information showing that these foods differ in any meaningful or uniform way from other foods. The problem is that the judge should’ve factored that information in.

She never mentioned that letter and that admission from the FDA’s biotechnology coordinator, although we had called it to her attention several times. There’s something strange when that happens.”

By Law, the Requisite Scientific Consensus Cannot Be Based on Hypothesis or Speculation

Another key aspect to the GRAS requirement as per US law is that not only must there be overwhelming consensus present within the scientific community, that consensus cannot be based on hypotheses or speculation; it has to be based on solid evidence. But in the case of GE foods, there is no such evidence.

“The FDA’s own files contain the admission that they didn’t have any such evidence... Both of those criteria that are necessary failed abjectly.

The FDA’s own files basically provide all the information the judge would have needed to have ruled that that was the case. Not only did she improperly not take account of the FDA’s scientist’s concerns and of that admission by the FDA biotechnology coordinator, she completely evaded the issue of whether the technical evidence was there—even though at the beginning of her opinion she acknowledged that that was one of the two prongs that had to be proven.

And then she never came back to the issue even though we certainly drilled it home several times in the various submissions we made to the court. That’s why it’s very difficult to understand how this could’ve happened.”

The Food Additives Amendment of 1958 was created to protect the public from potentially harmful substances added to foods, and this law specifically places the burden of proof on the manufacturers of new additives. This law presumes that all new additives are unsafe until proven safe.

Astoundingly, in the case of GE foods, the federal government has, over the years, slowly, surreptitiously, and illegally shifted that burden of proof—taking it off of the shoulders of the manufacturers, and placing it on consumers and critics. We now have to prove that GMOs are unsafe, which is absurd!

Why the Appeal Was Dropped

The FDA's presumption that GMOs are GRAS is supposed to be rebuttable. (The judge even emphasized that the FDA had emphasized that fact.) In this case, the only way you can rebut a presumption made about GMOs in 1992 is with evidence that came out after 1992. Otherwise, you cannot rebut the presumptions. Here too, the judge did something absurd.

"In 1998, we brought out solid evidence that rebutted [the presumption made in 1992], and... essentially, [the judge] said that 'you have rebutted it, but this evidence is irrelevant.' She made a rebuttable presumption irrebuttable and irrefutable by ignoring any evidence that we introduced after May of 1992. That was just another absurdity I want to make sure has been brought to the fore," Steven says.

An appeal was filed, but after the filing, the FDA announced that it was coming out with a new regulation on GE foods. The May 1992 policy statement was not a regulation. In fact, it didn’t regulate the biotech industry one iota. It was completely nonbinding. The FDA stated it would create a new regulation requiring manufacturers to give prior notice before marketing a GE food in the US. No labeling or safety testing would be required, but it was still significant because it was a new regulation that would supersede the policy statement.

“If we brought a lawsuit against that new regulation, all of the evidence we had brought in 1998 that the judge excluded would have to be relevant, because the FDA knew of it in early 2001 when they issued that preliminary regulation. So, they issued notice of a proposed regulation and they called for comments. It looked like they were actually seriously going to enact the regulation.

On the last possible day to drop an appeal, we dropped the appeal because it appeared it would be a waste of time. The intelligent thing to do would be to wait for the new regulation and sue on it, [so that] all of the evidence the judge excluded would be relevant, and the FDA would clearly lose. There was no way they could've won... But then, in the spring of 2003, more than two years later, the FDA announced that they were putting that [regulation] on the back burner...

That regulation never moved beyond the proposed state. They basically backtracked to the safety of the May 1992 policy statement that had already been upheld in court, and they stayed with that. That's where we still are today."

Claim of Scientific Consensus on GMO Safety Is Patently FALSE

The 1992 FDA policy statement, which was invalid when it was made, has been repeatedly rebutted and refuted, and yet that policy statement is still the sole purported legal basis for the presence of GE foods in the US. The FDA knew the legal criteria of their policy had not been fulfilled, and today there's even more evidence of conflict and disagreement within the scientific community. In fact, on January 24, a statement signed by 300 scientists, researchers, physicians and scholars was published in the peer-reviewed journal Environmental Sciences Europe,1 asserting that there is no scientific consensus on the safety of GMOs.

Moreover, the paper, titled "No Scientific Consensus on GMO Safety," states that the claim of scientific consensus on GMO safety is in actuality "an artificial construct that has been falsely perpetuated." The paper also notes that such a claim "is misleading and misrepresents or outright ignores the currently available scientific evidence and the broad diversity of scientific opinions among scientists on this issue."

In addition, the FDA still does not possess any evidence demonstrating safety because they do not even do scientific reviews. And even if they did, a large number of scientists say there's still no evidence demonstrating that GE foods are safe, while a number of independent studies have raised serious health concerns. Quite clearly, there is NOT a "general recognition of safety among scientists," and these foods are on the market illegally. They were illegal when they were first introduced in 1992, and they continue to be illegal now in 2015.

"One of the nation's most important and most venerable consumer safety statutes, consumer protection laws, has been blatantly and intentionally violated by the agency that's supposed to uphold it, and they've been getting away with it all these years," Steven says. "It's time to really pull the rug out from under the whole thing, because the evidence is overwhelming. All people have to do is just read it."

What Geneticists Could Learn from Computer Scientists

Besides analyzing genetic engineering from the standpoint of biological science, there’s another important field of science that is relevant to the discussion of GMO safety, and that is information technology and computer science, especially software engineering. The reason for this is because genetic engineers are taking huge and very complex information systems (the genomes of plants), and they are making radical revisions to them based on a very deficient knowledge base.

“There is so much about the genome of the plants that they are reconfiguring, of which they are unaware,” Steven says. “It’s well-known that the genomes of plants and animals are by far the biggest, most complex, and most intricately interrelated information systems on our planet. They dwarf any manmade system...And yet, when we look at the experience of computer science and the lessons that have been learned the hard way over many years... there’s no way to safely revise them. Or I should say, no way to revise them in a way that can be presumed to be safe.” 

Computer scientists have learned that they cannot assume that a revision only changes what they wanted it to change. Even if it was very precisely done and very minor, they have to presume that it might have unintended effects. This is especially true when that program is a life-critical program—one of the programs that if it were to fail would involve more than just an annoying crash of your word processing program; it could be a crash of a jetliner, or it could be the malfunction of an X-ray machine. In fact, Steven notes there have been fatal accidents with radiation machines in which a minor problem in the revision of the computer code led to the death of patients who received the wrong radiation dose.

“Certainly, it doesn’t take much imagination to know what could go wrong if there’s a bug in the airplane guidance system. The plane can go down. That’s why any revision made to such life-critical software systems has to go through rigorous testing after each revision. And put not only through the tests that were done beforehand, but a new battery of tests that weren’t even done when that system was first approved.

But there’s nowhere near the same parallel kind of testing in the case of genetically engineered food. Nowhere near it. Even the most rigorous tests that have been done on genetically engineered food fall far short of the rigor with which life-critical software programs are tested after every revision...

The genetic engineers cannot control where the packet of new genetic information (the DNA) is going. It's randomly inserted. It's a radical revision in several other ways too. They have very little understanding about those informational systems, because after all, they didn't design them. We know that they're far more complex and far more intricately interrelated than any human-made software...

And yet, they’re making the assumption that they can presume that what they’re doing will have only introduced the one change they want and will have not disrupted anything else in a deleterious manner. That is—from the standpoint of computer science—insanity. It’s certainly reckless... I think anybody listening who knows something about software engineering should definitely dig into that chapter and start sharing it with your colleagues, because I think that can catch the imagination of the entire information technology community.

That community obviously is not anti-technology. They embrace cutting-edge technology, but they've also learned that when you're doing cutting-edge technology, you also have to be aware of the risks and you have to do testing to help minimize unintended consequences. They've learned the lesson about unintended consequences."

The Media Has Promulgated Lies and Failed to Do Due Diligence

The reason Steven wrote the book was to get all the evidence out there, and I am currently in discussions with filmmakers to see if we can turn Steven's book into a documentary or wide-media series. If you're listening to this interview and have connections, let me know, and we'll see if we can make something happen. There's undoubtedly an important need for this, as the conventional media is clearly corrupted by multinational corporate interests and the persuasive molecular biologist community as discussed in part one.

When endeavoring to get the suppressed information from the FDA’s files publicized, Steven would travel to all sorts of media events, interviews would be done, but the key facts would not get published. Instead, the reports were spun to hide the crucial facts and make GE foods and the FDA’s policy look good. The media also failed to properly report on the matter back in 1998, when the lawsuit against the FDA was filed.

“There is an entire chapter devoted to the malfunction of the American media, and the subtitle is “Pliant Accomplices in Cover-up and Deception.” Because unfortunately, the mainstream American media have behaved very badly when it comes to genetically engineered food. Certainly, the way they’ve treated the lawsuit and the FDA files that it brought to light is a case study in irresponsibility.

There have been several instances in which I have given information, key memos from the FDA files, to investigative journalists... who work for mainstream journals and mainstream newspapers. They wanted to do something with it, and it got shut down by the editors.”

The US Has Strong Food Safety Laws, But Those Laws Are Being Violated

Many Americans believe the reason the US has so many GMOs permeating our marketplace while other nations, including the European Union (EU), do not is because those countries have stronger, more rigorous regulations ensuring safety. While this should be a correct assumption in theory, it’s not based in actual reality. Because, as Steven’s book points out, the US actually has stronger food safety laws in regard to GE foods than the EU, but those laws are being violated.

And they’ve been violated since 1992. In fact, GMOs are on the market because our food safety laws have been illegally circumvented. Moreover, the EU is not fully upholding its laws either. The precautionary principle is supposed to be the guiding principle in European Food Safety law. The European Commission has emphasized that several times. But in the case of GE foods, they are not following a precautionary approach—instead they’re being quite lax; and part of the problem is the general belief that the US has done the necessary legwork.

The US media has also played a significant role in allowing this fraud to be perpetuated without backlash. In more recent years, the European media has become more like the media in the US, but in the ‘90s and the early 2000s, the European media was very open to reporting problems about genetically engineered foods. Most importantly, they would quote scientists who were voicing concerns, and that had a huge effect on the consumers.

"It was the consumers that made it clear to the major grocery chains that they would not buy genetically engineered food. Several major grocery chains made it clear to the manufacturers that they would not buy them either because the consumers didn't want them.

That essentially stopped genetically engineered foods from getting directly into the human food chain in the European Union. It was consumer understanding, not consumer ignorance, but consumers being informed by the media who reported about courageous scientists who have spoken up [that created the] public backlash. That never happened in the US... That's important to understand."

Misrepresentations by Molecular Biologists Led to the Creation of One of the Biggest Frauds in History

Ultimately, the blame for this fraud has to be put at the feet of the molecular biology establishment—the main scientific establishment in the life sciences—which Steven discussed in Part 1 of this interview. His book goes into this part of history in great detail, demonstrating how the aggregate misleading statements about the science behind GMOs and their purported safety were born back in the early 1970s when genetic engineering was first established. Within the context of the history of science, the fraud related to GE foods is one of the biggest and most pernicious ever committed by scientists, and it began with molecular biologists who wanted to protect the budding science of genetic engineering by whitewashing potential concerns.

In the 12th chapter of Steven’s book, “Unfounded Foundational Presumptions,” he shows that even when the evidence goes against the genetic engineers of today, they always fall back on some of those initial presumptions made by the molecular biology establishment—presumptions that support the notion genetic engineering is a safe enterprise—and they never really acknowledge that those presumptions have been solidly refuted.

"One of the key ones of those, which I think is important to bring out, is that somehow, no matter how unruly and unpredictable somebody can demonstrate genetic engineering to be, they will always say, 'Well, conventional breeding is worse. Nature is far more random, unruly, and risky.' That is a very important point to bring out, because there are so many Americans who probably, just as a matter of course, believe what they're being told about this.

They don't understand that that is actually a foundational assumption—that you can't actually trust food that's been here for a long, long time; that nature is somehow being slandered and disparaged as being far more unruly, unpredictable, and dangerous. Every act of pollination is somehow supposed to be at least as risky, if not riskier, and more unpredictable than these radical insertions of foreign genetic material into soybeans, corn, and zucchinis. That I found to be gross slander against nature. I think more and more people need to understand that."

More Information

To get the full story, to truly understand how GE foods became the status quo by illegal means and why we need to abandon genetic engineering in agriculture, please pick up a copy of Steven’s book, Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public.

He also plans to publish a free executive summary of the book online, so look for it on his website: AlteredGenesTwistedTruth.com. The site also provides all of the key FDA documents discussed in this interview. Truly, Steven has given the world a phenomenal gift through this work, and his book is really an indispensable resource on the topic of GMOs.

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