An example of fatal "substantial equivalence"

The Japanese company Showa Denko engineered the genes of a microorganism to produce tryptophan at high levels. There are strong reasons to believe tha this genetic manipulations also led to the production of trace quantities of an unexpected substance.

This substance was highly toxic, killing 37 people and causing severe suffering with chronic pain and disability to 1500 more.

The organism was "substantially equivalent" with the parental organism, and the product was "substantially equivalent", yes it appeared identical to other tryptophan products according to the kind of superficial testing that is considered sufficient in this safety assessment procedure. Although the organism was "sustantially equivalent" to an unusual extent compared to most cases of GE food organisms, it produced an unexpected toxic substance.

This was not discovered because the approval procedure based on the principle of substantial equivalence does not require the search for unexpected toxins when the organism is "substantially equivalent" so even a deadly toxin can pass undetected.

Comment by PSRAST

This drastically illustrates the complete uselessness of the principle of substantial equivalence. A very toxic substance was unexpectedly produced although the genetically engineered organism producing it was "substantially equivalent" with the natural non-engineered organism. Only with safety evaluation methods far more rigorous than substantial equivalence would this toxin have been detected.

It is a well-known fact that genetic engineering can give rise to unexpected substances, some of which may be harmful. Therefore it is a matter of time only before a harmful GE food passes the approval procedure as long as it is based on "substantial equivalence". (This procedure was not developed by scientists but was designed by lawyers to create an excuse for not submitting GE foods to the very expensive safety assessment that science demanded. Policy-makers, who cared more about the interest of the biotech industry than public health, did the rest to make this an established procedure.)

It cannot be excluded that some of the GE foods on the market may be harmful because all have been approved on the basis of this useless assessment procedure (some harmful effects, like carcinogenicity or mutagenicity are not immediately obvious). This is why we demand that all GE-foods should be withdrawn from the market.

Related articles

• New! (Aug 2007) The Showa Denko Tryptophan disaster. Recent discoveries make it highly likely that genetic engineering was the cause of the appearance of the deadly poison.
• Inadequate safety assessment of GE foods. [EL] Explains the standard "substantial equivalence" procedure for assessing the safety of GE foods.