BRUSSELS, Belgium - Under the terms of the EU's 1990 rules on the contained use of genetically modified microorganisms (GMM), new criteria establishing their risks to human health and the environment must be defined before Dec. 5.

The nature of the authorization and degree of containment required for research on GMMs will be governed by the degree of risk each GMM carries, according to these criteria. The European Commission has just launched a debate on how these new criteria should be phrased.

The Commission proposed a series of general criteria, including source verification/authentication and a compulsory documentary dossier guaranteeing safety and genetic stability. And it suggested a series of specific criteria: whether a GMM is non-pathogenic, non-toxic and non-allergenic; the absence of pathogenic agents; the extent of transfer of genetic material; and environmental safety in case of deliberate release.

Each proposed contained use would be assessed for possible harmful effects such as giving rise to disease, making prophylaxis or treatment ineffective, damaging organisms or natural populations present in the environment, or creating harm by gene transfer to other organisms. In the light of the nature and scale of operations, and risks of harm, containment requirements will be determined.

The Commission stressed that genetic modification of a microorganism may increase or decrease its ability to cause harm to human health and the environment, so the recipient organism should be assessed against the GMM's pathogenicity and virulence, infectivity, allergenicity, toxicity and vectors of disease transmission, the nature of indigenous vectors and adventitious agents, where they could mobilize the inserted genetic material, and the frequency of mobilization.