BioWorld International Correspondent

BRUSSELS, Belgium - The European Union has finally agreed to new guidelines on risk assessment for biotechnology products.

The guidelines are intended to counter potential adverse effects on human health and the environment. They aim to ensure accurate assessment on a case-by-case basis of any effects stemming directly or indirectly from gene transfer from genetically modified organisms to other organisms. The assessments should allow for risk management strategies to be introduced, the new rules say. The guidelines, which cover all GMOs, microorganisms, animals and plants, specify which elements are to be considered in assessing the environmental risks posed by the release of GMOs.

Risk assessments should be based on the identified characteristics of GMOs and uses liable to have a damaging impact, and must make a comparison with the non-modified organisms from which the GMOs are derived, according to the new rules. The evaluations have to be conducted according to an established scientific method, and on a case-by-case basis, to respond to the broad range of characteristics of GMOs, their proposed uses and their potential host environments. They must also take account of other GMOs already present in the environment. The risk assessment should include an analysis of "cumulative long-term effects."

They define "direct effects" as the primary effects on human health or the environment that can be traced to the GMO itself and which are not due to a sequence of events. The text gives as an example the direct effect of the Bt toxin on target organisms.

"Indirect effects" are defined as the effects due to a sequence of events such as interaction with other organisms, the transfer of genetic material or modifications in use or management. These indirect effects are likely to emerge only over time, such as the impact on other insect populations of a reduction in the number of target insects.

"Immediate effects" are those that can be observed during the period of release of the GMOs, such as the death of insects feeding on transgenic plants.

And "deferred effects" cannot be observed during the period of release of the GMOs but become apparent as direct or indirect effects either at a later stage or after the end of the release period, such as GMOs that take hold or become invasive several generations after their voluntary release.

The rules were pushed through by the European Commission on July 24, after hesitations from several EU member state governments had created something of a legislative void (see BioWorld International, July 17, 2002). The creation of new guidelines was an obligation under the terms of the EU's own 2001 directive on the deliberate release of genetically modified organisms into the environment. The directive set out only the general principles applicable to risk assessment. The member states were supposed to agree to the guidelines, but the directive specified that if they could not or did not (and in the event, both proved to be the case), then the Commission should do so.

The use of guidelines rather than primary legislation is intended to allow frequent updating of the requirements, and the new text emphasizes that its provisions probably will need to be adapted and modified to take account of scientific and technical developments. The Commission also envisages that in the light of further experience, it should be possible to refine the requirements and to differentiate them according to the type of GMO, to provide more appropriate individual guidelines for the specific needs of monocellular organisms, fish or insects, or particular uses of GMOs, such as in the development of vaccines.