GENTECH archive


Re: substantial equivalence

Roberto Verzola wrote:
> - is SE species-specific, or does it have to be established
>   for every species consuming the food/feed?
The uses considered are the same as the uses of the equivilent product.
> - if I add 1 ppm (or even 1 ppb) of toxin to a food that is known
>   to be safe, is there SE between the food with the toxin and the food
>   without the toxin?
Only if the toxin has a common history in most other variants of the
ie.)  You could get away with causing a freak beta-carotene free carrot
to express Beta-Carotene.  (of course, there would probably be other
problems with such a freakish carrot)
If the compound has never been seen before in the product, it is not
> - does the WHO officially endorse SE for food safety assessment?
>   (a reference to a WHO document would be appreciated)
I've no references handy, but SE is the priciple developed by the Joint
FAO/WHO Food Standards Programme - SE may have been around earlier as an
idea, but they essentially invented it as a global standard.

Remember, SE is a term that is outlined in principle by academic
precident, and international bodies like the Codex Alimentarius
Commission;  it is defined in practice by the local agencies that
regulate products.
> I hope those who believe in the SE concept can clarify these issues
> for me. Thanks a lot.

Food safety is more critical now than it was 100 years ago because we
have 6 billion people, and millions of them travel.  The Western
standard of living has left us with huge scales of food production as
well as huge demand for non-traditional foods (Like kiwis).  The Green
Revolution, the rate of population growth, and environmental pressures
have left our academic community with an implicit mandate for increased
agricultural efficiency in production levels and quality for all
markets, not just the West.  The two World Wars and ongoing military
conflict make our generation consider our increased capability of
self-destruction; the reaction of increased mercantilism/interdependence
is encouraged by the apparent failure of isolation economies (the Soviet
Union).  These factors combine to encourage large scale food production
as well as continual new product research.  Agricultural disasters now
effect the globe.  Islands of agricultural evolution are now only a
result of protected ecosystems, not isolation.  We NEED a system of
restricting the randomness of new product experimentation and
development.  We can no longer rely on mother nature or our isolation to
save us from our mistakes.  SE ensures exactly that - that within our
abilities, we restrict ourselves to products which present risks no
greater than what we've historically accepted.  If we can not get ALL
governments to accept this principle, then the caution of all of
humanity can be thrown to the wind by a single careless administration. 
I find it reprehensible that governments all over the world still permit
unregulated, or minimally regulated R&D in food production.  It may SEEM
like harmless experimentation, but transportation rates and production
levels coud magnify a small problem into a huge disaster.  We need
unified, global, minimum standards like the SE principles.

Trevor Lien.