Genetically engineered foods are inherently unstable.  Each insertion of a novel gene, and the accompanying “cassette” of promoters, antibiotic marker systems and vectors, is random.  GE food producers simply do not know where their genetic “cassette” is being inserted in the food, nor do they know enough about the genetic/chemical makeup of foods to establish a “safe” place for such insertions.  As a result, each gene insertion into a food amounts to playing food safety “roulette,” with the companies hoping that the new genetic material does not destabilize a safe food and make it hazardous.  Each genetic insertion creates the added possibility that formerly nontoxic elements in the food could become toxic.

FDA was well aware of the “genetic instability” problem prior to establishing their no-testing policy.  FDA scientists warned that this problem could create dangerous toxins in food and was a significant health risk.  The scientists specifically warned that the genetic engineering of foods could result in “increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, [and] increased capability of concentrating toxic substances from the environment (e.g., pesticides or heavy metals).”  These same FDA scientists recommended that long term toxicological tests be required prior to the marketing of GE foods.  FDA officials also were aware that safety testing on the first genetically engineered food, the Calgene Flavr Savr tomato, had shown that consumption of this product resulted in stomach lesions in laboratory rats.

FDA’s response to the potential toxicity problem with genetically engineered foods was to ignore it.  They disregarded their own scientists, the clear scientific evidence and the deaths and illnesses already attributed to this problem.  The agency refused to require pre-market toxicological testing for GE foods or any toxicity monitoring.  FDA made these decisions with no scientific basis and without public notice and comment or independent scientific review.  The agency’s actions can only be seen as a shameful acquiescence to industry pressure and a complete abandonment of its responsibility to assure food safety.