GENTECH archive


Fwd: substantial equivalence


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It sounds to me like the term "substantial equivalence" refers only to the 
purported genetic structure itself, and not to the larger-scale issues of the 
plant in question. For example, what is the impact on the whole plant of 
having its genetic defense mechanisms invaded? of having a gene in its genome 
that it recognizes as a foreign body? What about the virus vector that is 
used to shoot the foreign gene into the genome? The antibiotic resistance 
markers? What is being used to force the plant to express this foreign genome 
constantly, where in an undamaged plant, the plant itself expresses the genes 
needed when they are needed? If a plant is substantially equivalent to the 
original counterpart, why is it being patented as a novel invention? How 
could a plant that repels the corn borer be "substantially equivalent" to one 
that doesn't? 

It sounds like a quasi-scientific term being used to fool the public into 
thinking that the plant itself is substantially equivalent, rather than just 
a set of genetic sequences.

- Nina

In a message dated 6/22/1999 12:14:44 AM Eastern Daylight Time, 
papadop@PEAK.ORG writes:

>  See e.g.
>  Food Safety Considerations, Safety Assessment
>  This document seems to be describing the report of the 1990 joint FAO/WHO
>  consultation.
>  I've extracted a few phrases ; perhaps someone can tell us how much sense
>  they make.
>  Cheers
>  MichaelP
>  "The presence in foods of new or introduced genes per se was not
>  considered by the Consultation to present a unique food safety risk since
>  all DNA is composed of the same elements."
>  "When a food product is determined to be substantially equivalent to an
>  existing counterpart except for defined differences, it was concluded by
>  the Consultation that further safety assessment should focus only on those
>  defined differences. Typically the defined differences will result from
>  the intended effect of the introduction of genetic material that encodes
>  for one or more proteins that may or may not modify endogenous components
>  or produce new components in the host organism. This category could also
>  include products from genetic modification and that have been shown to
>  produce an unintended substance(s) if that unintended substance(s) is
>  clearly defined. The safety of introduced DNA and messenger RNA (mRNA) per
>  se is not an issue. However, the stability of introduced genetic material
>  and the potential for gene transfer are relevant issues in the assessment.
>  The potential for gene transfer is addressed in Section 6.2. Stability of
>  introduced genetic material should be addressed during both the molecular
>  characterization and the performance evaluation of the genetically
>  modified organism in the development process. These processes minimize the
>  likelihood of unintended effects in subsequent generations.
>  The Consultation considered that the majority of genetically modified
>  products will result from the introduction of genetic material and
>  therefore concentrated on the safety assessment of these types of
>  products. However, the approaches described herein are equally applicable
>  to the assessment of the safety of products which have been genetically
>  modified by other means. The approach to assessing the safety of food
>  products having inserted genetic material should focus on the gene
>  product(s) and their function, including the products produced as a result
>  of their function. The introduced genetic material will typically encode
>  one or more proteins. The safety assessment should concentrate on both the
>  safety of the expressed protein(s) as well as the products produced as a
>  result of the expressed protein(s). These products will most likely
>  include; fats, carbohydrates or modified or new small molecule components
>  (modification of endogenous components or production of new components)."

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