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
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.
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.