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Naturalnews.com claims that in explaining why Monsanto doesn't run human clinical trials on GM crops on its own website, the company uses 'absurd logic' to justify its stance and makes 'pseudoscientific' claims that "everything can be considered non-toxic and safe because it is all made of atoms, just like our bodies!"

Monsanto claims that

There is no need for, or value in testing the safety of GM foods in humans. So long as the introduced protein is determined safe, food from GM crops determined to be substantially equivalent is not expected to pose any health risks.

Given that the page would probably be aimed at the non-scientific reader trying to understand more about genetic modification, are the claims correct and if so, are such claims justified?

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    I've reworded your question significantly and added an excerpt from the Monsanto site to make clear what Monsanto actually claims. – Mad Scientist Jan 24 '12 at 11:03
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    As a side note: Long before modern biotechnology, farmers were modifying crops (e.g. ancient egyptians). So basically, we have been eating genetically modified food for thousands of years. – Oliver_C Jan 24 '12 at 12:12
  • @Oliver_C - the cognitive dissonance between people who oppose GMO while making fun of real political conservatives is ... amusing. – user5341 Jan 24 '12 at 16:04
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    @Oliver_C: there is a difference in the possible severity of bad outcomes between traditional breeding (which may include irradiating seeds) and transferring DNA from entirely different organisms. Molecular genetic modifications allow for a much wider (though, arguably, more controlled) array of changes. – Jonas Jan 24 '12 at 22:27
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    In general Natural News is not terribly reliable with regards to their reporting integrity. Mike Adams especially. – Darwy Jan 25 '12 at 10:40
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Summary

The FDA requires toxicology and allergy tests for GM foods for human consumption before the product can be sold in the US (similar mechanisms are in place in the EU as well).

If some of these tests have already been made in a different context, the FDA does not require repeating the animal trials, since that would be pointless killing of lab rats.

Clinical trials are for medication, not for food, though new food additives (as well as other substances, such as pesticides) may be tested on humans for potential allergic reactions.

Details on the original claim

Clinical trials are performed for new medication in order to test whether they provide a significant benefit compared to placebo and/or to existing medication. GM food is not medication. Therefore, Monsanto is not required to run clinical trials on GM food. However, they cannot claim GM food cures cancer, either.

Toxicity tests are performed for food and medication, and are performed on animals, usually rats. A toxicity test aims to determine LD50, the dose (relative to the specimen's weight) at which 50% of the animals die (which is why you don't perform this on humans). The safe dose for humans is then determined as "much less than LD50". Once an LD50 is known, it is possible to test the substance at realistic dosage in humans to see whether they may have an allergic reaction.

Toxicology studies on BT have been done, and the protein has even been tested in humans, when the product was being tested as a pesticide for organic farming. BT turns out to be harmless in humans. Since the BT protein is indeed the same between what is produced by bacteria as organic pesticide, or by GM crops, Monsanto may indeed not have had to do any toxicology testing on GM food.

"everything can be considered non-toxic and safe because it is all made of atoms, just like our bodies!"

This is a misrepresentation of the issue. What naturalnews.com asks is more similar to requiring that if Kellogg comes out with a new formulation of cereal, they need to test whether wheat flour is fit for human consumption.

What needs to be tested by the FDA?

The FDA tests new food additives

FDA field investigators inspect food companies, examine food shipments from abroad, and collect samples. Laboratory scientists analyze samples. Compliance officers recommend legal action and follow through on enforcement issues. What undergoes premarket approval? New food additives and color additives must be approved before they can be used in foods. These additives are considered food under the law.

New food additives, including substances added intentionally to food and substances that may migrate to food because they contact food (e.g., food packaging) must be shown to be safe to FDA's satisfaction before companies can market them.

Companies that want to add new additives to food bear the responsibility of providing FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the additive is safe for its intended use.

An approved food additive must be used in compliance with its approved uses, specifications, and restrictions. Certain food ingredients, such as those with a long history of safe use in food, do not require premarket approval.

As part of the approval process, food additives have to be tested for toxic effects.

HIGHLIGHTS OF TOXICOLOGY RECOMMENDATIONS IN THE 2002 GUIDANCE Safety Summary and Comprehensive Toxicological Profile (CTP). The safety information for a food contact notification (FCN) should contain both a safety summary and a comprehensive toxicological profile (CTP) of the food contact substance (FCS) that is the subject of the notification. The safety summary is Part III of FDA Form 3480 and should provide the basis for the notifier's determination that the intended use of the FCS is safe. The CTP should provide summaries of all the available toxicological information pertinent to the safety evaluation of the FCS. In some cases, a notification may need to include a CTP for a toxicologically relevant constituent of the FCS. If a constituent of an FCS is carcinogenic, the CTP in the notification should include a quantitative risk assessment.

Safety Testing Recommendations for Food Contact Substances (FCSs) and Their Constituents. This document recommends safety testing of FCSs and their constituents, primarily based on a series of genetic toxicity tests and, when justified by the exposure level, subchronic toxicity studies. The recommendations describe the minimum level of safety testing generally considered appropriate at various exposures. For an initial or incremental exposure of an FCS at or less than 0.5 parts per billion (ppb), no safety tests are recommended. For a cumulative exposure between 0.5 ppb and 1 part per million (ppm), genetic toxicity tests and/or subchronic tests are recommended. At a cumulative exposure at or greater than 1 ppm, FDA normally requires, under the authority of Section 409 (h)(3)(B) of the Federal Food, Drug and Cosmetic Act, that a food additive petition be submitted for the use of an FCS.

Evaluation of Structural Similarities to Known Toxicants. To the extent feasible, knowledge in predicting potential toxicity based on structure/activity relationships may be incorporated into the safety assessment of an FCS. Such information may be used as part of an overall strategy for assessing the safety of an FCS or to help interpret safety test results.

Specifically in the case of GM foods, the FDA states

In formulating FDA policy, we reviewed new foods under development through biotechnology, and found they shared certain common characteristics: (1) Recombinant DNA techniques are being used to introduce copies of one or a limited number of well-characterized genes into a desired food crop. The introduced gene or genes then become integrated in the plant and are passed to successive generations of plants by the natural laws of genetics; (2) In most cases, these genes produce proteins, or proteins that modify fatty acids or carbohydrates in the plant, in other words, common food substances; and (3) The proteins, fatty acids, and carbohydrates introduced into food crops are well- characterized and not known to be toxic and they would be digested to normal metabolites in the same manner that the body handles the thousands of different proteins, fat and carbohydrates that make up our diet today.

Since newly introduced substances in foods derived using recombinant DNA techniques would be proteins, fats or carbohydrates, we then examined the safety questions that should be addressed before products reach the market. We identified four broad safety issues that should be evaluated: (consumption; (2) the need to ensure that the changes in the food, such as the level of natural toxins in the food, if any, stay within normal safe levels; (3) the need to ensure that significant nutrients stay within normal range; and (4) the need to analyze the potential for introduced proteins to cause allergic reactions. We incorporated these and other issues into a comprehensive guidance to industry that is central to our policy.

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    not to mention cyanide is highly toxic and it only contains carbon and nitrogen both not considered toxic on there own (or in other consumables) – ratchet freak Jan 24 '12 at 16:02
  • Excellent answer. Is there a way to quote FDA regulations on what does and doesn't need to be tested (or at least "For Dummies" version)? – user5341 Jan 24 '12 at 16:06
  • @DVK: I have added a better tl;dr, and a few more quotes from the FDA for "patient dummies". Feel free to add emphasis on the parts you're most interested in. – Jonas Jan 24 '12 at 16:36
  • Great edits! Too bad can't give another +1 – user5341 Jan 24 '12 at 17:58
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I am just going to describe what the Monsanto quotation means in terms of molecular genetics.

Basically every "segment" of DNA (DNA segments can have varying lengths until the stop codon) codes for a protein. GMO is all about inserting new base pairs into the DNA, so that the protein coded for is somehow altered.

The quotation says "So long as the introduced protein is determined safe, food from GM crops determined to be substantially equivalent is not expected to pose any health risks."

Since the proteins that result can be studied, if they know the proteins that result from the DNA, then they claim they know enough about the makeup of the food to determine that the food is safe.

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