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Biosafety Alert
Dr. Mae-Wan Ho
The US and European Union are trying to ‘harmonize’ approval
process for genetic engineered products through the TransAtlantic Economic
Partnership (TEP) – a kind of free-trade agreement, according to its
critics. The first and possibly most important aspect considered is the
molecular genetic characterization provided by the industry for gaining
approval. A meeting to be held on Jan. 12 in Washington will consider a
technical annex circulated by the USDA and Canada, which gives an idea of
the kind of data required in these countries.
The data are grossly inadequate. It does not protect US and Canadian
consumers as it is and it will be disastrous for the Biosafety Protocol if
the EU were to go along. Our US and Canadian scientists should be on hand
to fight it. Essentially, the data required do not enable anyone to
identify each transgenic line separately, and give no guarantee that what
is submitted for approval is genetically (as well as phenotypically)
stable. First, on account of the uncontrollable, random nature of the
genetic engineering process, each transgenic line will be distinct, even
though the same materials, gene-constructs and vector systems are used.
Second, because of the inherent instability of the transgenic lines,
further changes may occur during cultivation, so that, in effect, the
properties will become quite different from the orginally approved line.
I have asked the Consumer Choice Council to submit my comments below to
the Conference, as I cannot attend myself. I urge as many scientists as
possible to submit comments of their own. For further details of the
meeting please contact Consumer Choice Council
Biotechnology Pilot Project of the Trans-Atlantic Economic Partnership
Action Plan – A Prelude to Harmonization of GMO Regulation and Trade
A Pilot Project was set up by the Biotechnology Group in the
Trans-Atlantic Economic Partnership Action Plan (TEP) to compare the
molecular genetic characterization that industry has to submit on both
sides of the Atlantic to gain regulatory approval for release to the
environment. The processing of a simultaneous application to both sides of
the Atlantic from industry will then be monitored. The TEP is generally
regarded as a transatlantic free-trade agreement, and this Pilot Project
is the first step towards harmonization of GMO regulation and trade.
A joint EU-US workshop was held in Luxembourg (19-21 October, 1999). The
key outcome of the Workshop will be a technical annex (Annex 3) of the
molecular genetic characterization required on both sides.
A draft Annex 3 circulated for comments after the workshop was actually
drawn up as the result of an earlier meeting of regulatory officials from
the United States and Canada aimed at comparing and harmonizing the
molecular genetic characterization of the two countries. My comments are
addressed at this draft Annex 3
The molecular genetic characterization in the draft Annex 3 does not
take account of the random nature of the genetic transformation process.
Each random insertion of transgenic DNA will differ in location and in
structure from all other inserts, and will be accompanied by a different
pattern of unintended positional and pleiotropic effects, due
respectively, to the location of the insert and functional interactions
with host genes.
Thus, each transgenic line (or GMO) resulting from the same process,
despite using the same vector system and plant materials under the same
conditions, will be distinct, and must be treated as such.
In practice, each transgenic line must be characterized with regard to
- identity – number of inserts, location and structure of each
insert
- stability – in terms of functional expression and inheritance of
the intended trait in successive generations, as well as in terms of
structural constancy (location in the genome and structural arrangement)
of the insert(s))
- unintended positional and pleiotropic effects
Failure to require informative data on these characterizations will mean
in practice that unstable lines may be approved, which will change its
characteristics in successive generations of growth; or multiple
transgenic lines, all with different characteristics, may be released
after a single line has been approved. More importantly, it will be
impossible to monitor for the post-release spread of transgenic DNA,
either by cross-pollination or by horizontal gene transfer. In the event
that the released GMO causes damage to health or biodiversity, it will
also be impossible to trace the liable party or to take proper remedial
action.
Suggested changes to text of Annex 3
(These suggested changes are offered as illustrations of how the issues
of identity and stability arising from the random unpredictability of the
transformation process may be addressed. The competent authorities of the
EU member states, I am sure, will come up with better ways to address
those issues.)
Minor changes
Suggested additions to existing text are in square brackets
Stability [a. functional stability] – the ability of the
transgenic trait to be expressed in the transformed plant line, and plant
lines derived thereform in a consistent, reliable, and predictable manner
[in successive generations.]
[b. structural stability – the ability of the structure of each
transgenic insert and its location in the host genome to remain unchanged
in successive generations].
1.2.1.3 The function [of each genetic component] in the
plant.
1.2.1.4 The source (scientific and common, or trade name of the
donor organism[(s)]).
1.2.1.7 If there is a history of safe use of the source
organism[(s)]or components thereof.
2.1 For plants which are either male or female fertile or both,
provide data that demonstrate the pattern and stability of inheritance and
expression of the new transgenic traits [in successive generations, as
well as the structural stability of each transgenic insert].
2.2 For plants which are either infertile or for which it is
difficult to produce seed (such as vegetatively propagated male-sterile
potatoes), provide data to demonstrate that the transgene trait [and
transgenic insert(s)]are stably maintained and expressed.
Major changes
An additional Section to go before the existing Section 2, and could
replace some items in Section 3
2 Molecular Identity of the transformed line
2.1 The transformed line must be identified in terms of its
transgenic DNA as follows:
- total number of inserts of transgenic DNA
- location of each insert, whether organelle or chromosomal
- Precise position of each insert (ie where on which chromosome)
- structure of each insert (whether duplicated, deleted, rearranged,
etc.)
- complete genetic map of each insert, identifying coding regions,
marker genes, noncoding regions, promoters, introns, leader sequences,
terminators, enhancers, oriV, oriT, T-DNA borders, plamid sequences,
linkers, etc. , including any truncated, incomplete sequences.
- the complete base sequence of each insert
- the base sequence of at least 10kbp of flanking host genome DNA on
either side, including changes in methylation patterns.
- appropriate molecular probes for each insert with flanking host
genome (organelle) sequences which can be used to monitor for structural
stability of the insert.
2.2 Each transformed line must be identified in terms of total
protein profiles, to monitor for unintended changes in the pattern of gene
expression.
2.3 Each transformed line must be identified in terms of
metabolic profiles to monitor for unintended changes in metabolism.
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