GENTECH archive


Re: Fw: On the Subject of Organic Foods and Seed Segragation

> Mr. Deelstra:
> GE plants have been declared substantially equivalent by the FDA, an
> notoriously driven by industry, not consumer or scientific, concerns, and
> is largely populated by a staff with roots in the "life science" industry.

I'm affraid this is incorrect. GE plants have NOT been declared
substantially equivalent, but are only declared so when they meet certain
criteria. Furthermore substantial equivalence is not a declaration of safety
but just a regulatory construction. This construction eases the choice of
tests to do on GM foods.

Probably a wise decision of the FDA; substantial equivalence is necessary to
avoid 'pharmaceutical' testing of foods.

> Are these the people we want to trust to make a decision so basic to the
> integrity of our ecosystems?  When the FDA decided that GE plants were
> substantially equivalent, what types of laboratory tests had been done?
> When a new drug is introduced by a pharmaceutical company, a lot of rats
> are killed to determined its potential toxicity.

> Why hasn't the industry been forced to prove the safety of GE plants?  Why
> are laboratory-produced plants that never occur in nature fundementally
> different from laboratory-produced drugs that never exist in nature?

To prove the safety of GE plants is impossible. To prove the safety of a GE
plant is still impossible. Analysis has to be done on a case-by-case basis.
(This has been done for Bt plants).
If the FDA required a pharmaceutical type of testing for GE plants, food
would become ultimately too expensive, because new varieties would only be
allowed on the market after expensive tests.

> Furthermore, GE plants exists only because they are patentable, ie, are
> clearly and distinctly different from other plants.  No drug company would
> bother to make a GE plant if it wasn't patentable and they could recover
> their expenses.

I. Even if GE plants were not patentable the Golden Rice would have been
II. Not only companies make GE plants.
III. EU patent laws (on ge/organs/animals) are a mess. EPO is inconsistent
regarding the position of GM plants; do they belong to the patent system or
do they fall under the protection of the Union for the Protection of New
Varieties of Plants? See also Nature 2 March 2000 p 13. 'Patent confusion in
law on new plant varieties'.

Be aware that substantial equivalence is just a regulatory framework, on
which regulatory bodies can base their evaluations (and requests for tests).


Heine J. Deelstra

"There is no evidence that genetically modified crops are inherently (!)
dangerous than their conventionally bred counterparts"