Europe's new rules governing releases of GMOs into the environment require molecular data on genetic stability as well as comprehensive environmental risk assessment, which, if strictly implemented, could sink all GMOs (ISIS News 11/12). Unfortunately, the process of watering down has already begun in the United Kingdom, Europes most corporate-friendly nation. Dr. Mae-Wan Ho reports.
Europes New Rules on Releases of GMOs (Directive 2001/18) entered into force on 17 April 2001, but member states have until 17 October 2002 to take measures at national level. UKs Advisory Committee for Releases to the Environment (ACRE) has issued a draft document "Guidance on best practice for the presentation of molecular data" to provide advice for companies applying for approval of release of GM crops. ACRE is the main scientific body that sets standards for the molecular data.
A careful reading of the document reveals that it effectively requires no molecular evidence of genetic stability.
The document begins by reminding the applicant of the new Directive,
"An essential component of applications to release is molecular characterisation of the genetically modified plant. Applicants must provide information on what transgenes have been inserted during the genetic modification process, their copy number and stability, the expression of the transgene and the mode of action of any transgene products."
This message is repeated in different forms elsewhere throughout the document. But beneath the strict-sounding rhetoric, the company is given plenty of leeway. The first major loophole is under differentiated procedures.
Even though the molecular data must be supplied for both part B (research & development) and part C (commercial) approval, companies often apply for the "First Simplified Procedure" to enter varieties into the National Seed testing programmes. "This procedure allows for an a priori programme of work and takes account of the fact that at the time of application it might not be known what will be the location of the other releases in the programme of work." In other words, companies are given permission to carry out an unspecified number of future tests whenever and wherever they like.
Genetically modified plants qualify for the First Simplified Procedure if:
These are extremely weak criteria compared to those required by the present Directive. Notably, no molecular characterisation is demanded, nor is molecular evidence of stability required, except for a derisory "inheritance patterns in one generation", or the transfer of transgene "through one cycle of tissue culture".
For part C approval, companies have to provide molecular data to ensure traceability and labelling.
The molecular data here should enable regulators to identify specific GM lines and distinguish among them. Each GM line results from random gene insertion events that took place in a single cell, out of which an entire plant was produced, and after several generations of propagation, a GM line is obtained. The molecular identification is unique to each GM line, and depends on the genetic stability of the GM line obtained.
Here too, we are treated to long admonitions of the detailed molecular information that must be supplied, only to discover at the end that ACRE does not ask for molecular data of genetic stability as such!
Genuine molecular data on genetic stability should consist of at least five successive generations of relevant molecular analyses, to show that the insert has remained stable in both its structure and its location in the plant genome.
Genetic stability is the single most important criterion in biosafety risk assessment in terms of concreteness and simplicity. Unfortunately, evidence is accumulating that GM lines are inherently unstable. Genetic instability not only compromises agronomic performance, it is a safety issue, as unstable transgenes could spread out of control by horizontal gene transfer and recombination (see "Mexican corn contaminated by horizontal gene transfer?", this issue).
Decades and billions of dollars of investments have already been wasted on GM, on account of the failure to take genetic stability seriously. This should now be put right under Europes new Directive.
Be sure to send comment before 28 February 2002 to The Secretary, ACRE, Floor 3/H11, Ashdown House, London SW1E 6DE. The document you need is:
Guidance on best practice for the presentation of molecular data in submissions to the advisory committee on releases to the environment. Advice for applicants seeking permission to deliberately release genetically modified organisms into the environment (under Directive 2001/18/EC)
Article first published February 2002