GENTECH archive


Re: Fwd: substantial equivalence

An excellent example of a major organizations perspective on identifying
elements which are not equivilent; worth reading:

Trevor Lien. wrote:
>                                                   ------------------------------------------------------------------------
> Subject: Re: substantial equivalence
> Date: Tue, 22 Jun 1999 06:34:26 EDT
> From:
> To: papadop@PEAK.ORG
> 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)."
> >
> >