GMOs, Substantial Equivalence, and Lies That Affect Public Safety

You may have read about GMOs recently in the news. These are Genetically Modified Organisms, in particular, new foods that are created by combining the DNA from different sources, often different species. Somehow, these GM foods have found their way into the majority of our packaged foods (estimates are at 70%) without labeling, adequate testing, or public disclosure.

How is this possible?

Our government has established agencies like the FDA to regulate 'food' and 'drugs' to ensure the public safety. How did something so novel become such a dominant part of our food supply without testing or even a requirement to be labeled?

The answer lies in 'Substantial Equivalence'.

Substantial Equivalence is a concept that "maintains that a novel food (genetically modified foods) should be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food."

I guess the problem here is that they are claiming the same 'composition'. What does that mean? How can recombinant DNA (rDNA) be considered the same composition as the original?

Looking further, they determine substantial equivalence by comparing food biochemical profiles such as protein, carbohydrate, fatty acid levels, nutrients and antinutrients and other plant metabolites between the novel food and it's traditional counterpart.

Even with this limited range, there are no clear guidelines regarding how it is tested, or how similar the profiles should be. For example: Roundup Ready Soybeans contain a previously unknown enzyme, which the manufacturer dismissed as irrelevant because the enzyme would be deactivated in cooking, but this active enzyme could be consumed with meat if the soybeans are fed to cattle. This was approved by the FDA without testing.

Equivalence seems to be open to whatever the manufacturer decides is equivalent. New compounds that show up, and differences in their profiles can be dismissed as irrelevant, without testing.

It makes one wonder what our Food and Drug Administration is doing to regulate our foods.

Isn't the purpose of this agency to confirm that these foods are safe? Rather than looking out for the public safety, the FDA seems to be letting the supplier define what is safe, what is important, what is irrelevant, what is 'equivalent'.

There seems to be a vast difference in how the FDA regulates food and how it regulates drugs.

Both food and drugs are critical to the health of the citizens.

Both food and drugs are products that go INTO our bodies - this is not the same as regulating the safety of a toaster. These are products that will interact with all the chemical processes in our bodies. The reason why drug companies list side effects is because often the body reacts in ways outside of the proposed use of the drug.

One difference is that foods are approved by the FDA without testing, as long as the manufacture claims that it's equivalent to its original natural form.

This is absurd.

A drug company can not even market a drug for a new use - for example, a cancer drug that is approved for breast cancer, may not be approved for prostate cancer. It's the same product, and approval is impossible without extensive clinical trials.

By contrast, a GM tomato with flounder genes developed to extend the growing season, or a corn that is designed to produce its own pesticide (which now can't be washed off) is approved by the FDA because it's substantially equivalent. No testing necessary.

Even a car manufacturer who makes an improvement on a new part MUST test it for safety. They can not just claim that its substantially equivalent to the previous model.

So, why? Why, with food allergies cropping up everywhere, with chronic illnesses like cancer, diabetes, and cardiovascular disease going through the roof, in families with NO genetic history of the disease - Why is the FDA not testing our food for safety?

Additionally, recent research shows that micro-DNA is surviving the digestive process. Traces of DNA from our food is found in our liver, for example. Changes to the DNA in the foods we eat, will interact with our body, in ways we don't yet understand.

What we DO know is that animals fed GM foods have had significant health complications.

It doesn't take a brain surgeon or rocket scientist to see where substantial equivalence fails.

• Every attempt to clone an animal, which is not only substantially equivalent, it is genetically equivalent, has failed. The offspring either died, or couldn't reproduce, or had health issues...
  
  
• Animal testing shows adverse affects when fed GM foods that did not occur with the original food, proving that these foods are not equivalent in how the body processes it, or reacts to it.
  
  
• New enzymes and other components are created in the new GMO, which is clearly different. You can't call this equivalent, not even substantially equivalent. I wouldn't even call it somewhat equivalent. I prefer 'completely different'.
  
  

One has to wonder why a government agency, the FDA, so quickly adopts the concept of substantial equivalence, when anyone who reads the newspaper knows that these genetic experiments do NOT produce anything remotely equivalent to original. Even when a scientist actively try to keep all parts of the original DNA equivalent it is not the same - how can a few biochemical profiles be considered equivalent?

How is it that the FDA doesn't question this?

It seems clear that Substantial Equivalence is not useful as a means to regulate food.

In fact, the Royal Society of Canada states: "Substantial equivalence does not function as a scientific basis for the application of a safety standard, but rather as a decision procedure for facilitating the passage of new products, GE and non-GE, through the regulatory process."

So, why would a regulatory agency like the FDA adopt the use of 'substantial equivalence' for a product they are required to regulate?

The answer seems to point to Michael R. Taylor, who was the FDA's Deputy Commissioner for Policy when GM seeds were declared to be 'substantially equivalent' to non-GM seed, which meant proof of the harmlessness of GMs was unnecessary. Michael R. Taylor had previously worked as a lawyer for Monsanto (the largest producer of GM seeds), and after his tenure at the FDA, Taylor became a vice-president of Monsanto. On July 7, 2009, Taylor returned to government as the 'senior advisor' to the Commissioner of the FDA for the Obama administration.

Seems to be a conflict of interest, our government regulatory agency seems to be in the hands of the corporations it is supposed to be regulating.

A child can't just go to their teacher and tell them how they should be graded. A criminal can't just go to the judge and say "Hey, let me just rewrite that law for you. Oh look, I'm innocent."

The next time you read an article about the debate over GMOs, watch out for claims of substantial equivalence. You will likely see a lot of that as Monsanto, and the FDA try to promote the safety of GM foods.

Since the government is not regulating this, it's up to us to regulate our own food supply, and buy from local farms, and eat organic when we can.

In the meantime, there are many trying to push for labeling of GM foods, but I would love to see this taken a step farther: ban GM foods until they have been thoroughly tested and proven safe for humans (or as feed to farm animals). Many other countries have adopted these bans, there is no reason the United States can't provide equal protection of its citizens.