Biotechnology Pilot Project of the Trans-Atlantic Economic Partnership Action Plan A Prelude to Harmonization of GMO Regulation and Trade
Dept. Open University, UK
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
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
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.)
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].
3. The function [of each genetic component] in the plant.
4. The source (scientific and common, or trade name of the donor organism[(s)]).
7. If there is a history of safe use of the source organism[(s)]or components thereof.
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. 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.
B. Major changes
An additional Section to go before the existing Section 2, and could replace some items in Section 3
1. MOLECULAR IDENTIFY OF THE TRANSFORMED LINE
1. The transformed line must be identified in terms of its transgenic DNA as follows:
a. total number of inserts of transgenic DNA
b. location of each insert, whether organelle or chromosomal
c. Precise position of each insert (ie where on which chromosome)
d. structure of each insert (whether duplicated, deleted, rearranged, etc.)
e. 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.
f. the complete base sequence of each insert
g. the base sequence of at least 10kbp of flanking host genome DNA on either side, including changes in methylation patterns.
h. 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.
1. Each transformed line must be identified in terms of metabolic profiles to monitor for unintended changes in metabolism.