Science in Society Archive

Circulated to all delegates at the Biosafety Protocol Conference, April 22-26, 2002, The Hague

Insist on Event-Specific Molecular Data!

The 'Unique Identifier' Required for Biosafety Purposes is Event-Specific Molecular Characterisation

Unique identifiers are necessary and essential for all LMOs, regardless of how they have been classified. This is because all LMOs carry the same risks and hazards, and have to be properly identified. Dr. Mae-Wan Ho

The OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants (ENV/JM/MONO(2002)7) is irrelevant for biosafety purposes. The OECD identifier is a "key to accessing information in the OECD product database and interoperable systems for the products of modern biotechnology which have been approved for commercial use". It simply provides a code that allows the user/regulator to access a limited amount of information on the LMO on an electronic database.

For the Biosafety Protocol, the unique identifier should enable one to trace the LMO and products thereof, whether it is of plant, animal, bacterial or viral origin, whether intended for release into the environment, for food, feed or for processing, for contained use, or in transit.

It could be argued that unique identifiers are even more important for GM bacteria, viruses and other GM constructs intended for contained use, in view of the dangers of biological weapons and related research that might result in the deliberate or unintentional release of pathogens into the environment.

In the case of transgenic plants and animals and products thereof, the unique identifiers are necessary for taking prompt remedial actions in case of harm, and in tracking down the liable parties in the event of transgenic contamination or other damaging consequences resulting from the spread of transgenes.

The current controversy over the transgenic pollution of Mexican maize landraces highlights the importance of molecular data that would uniquely identify each transgenic line. The disagreement among scientists is not whether transgenic contamination has occurred. Rather, it is the finding that the transgenic constructs appear to have fragmented into pieces that is being disputed. Did that happen before or after the transgenes have entered the landraces, or both?

Unfortunately, there are no data that would allow precise identification of the transgenic line or lines that have contaminated the landraces, simply because such data have never been required by the regulatory authorities. If they exist, they are being concealed under "commercial confidentiality".

This should change in Europe with the new EC Directive on deliberate release agreed last year, unless it is watered down when implemented at national level.

The molecular data required must give the structure of each transgenic insert and its position in the plant genome. This consists of the base sequence of the insert plus sequences of the host genome flanking the insert.

On account of the random insertion of transgenic constructs into the host genome, each insertion event is unique, and hence, should automatically give rise to an unique 'event-specific' identifier, provided that the transgenic insert is genetically stable over successive generations.

There is no need to add another piece of DNA to serve as unique identifier. Any superfluous sequence will require additional risk assessment effort.

More importantly, transgenic lines that are unstable will also be revealed by such data, and eliminated from approval, according to the new EC Directive, as transgenic inserts that are unstable have the potential to spread out of control by horizontal gene transfer and recombination.

Key I-SIS papers for further details available at this conference:

Article first published 23/4/02

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