Topics: The Regulatory Process

The science review centres on particular scientific topics being debated widely by the science community and others. The Forum closed for contributions on 15 October.

This section of the science review considers the scientific issues arising from the risk assessment process that is central to the regulation of the deliberate release of genetically modified organisms to the environment. The issues are wide-ranging. A few examples are listed which have been debated by scientists over recent years engaged in GM regulation, and these are mentioned to help prime the review. We hope that scientists working in areas outside GM will make contributions that might offer insights. It also provides background information on the regulatory regime that exists to protect human health and the environment from the release of genetically modified organisms.

How is environmental safety currently assessed?

Within the European Community the release and marketing of GMOs into the environment is regulated by Directive 2001/18 (see for example the EU Joint Research Centre web site Within England and Wales, legislation is at The aim of the legislation is to protect human health and the environment from the release of GMOs, and to achieve this objective each GMO is subjected to a detailed science-based risk assessment. Risk assessment involves first identifying the potential hazards associated with the release, and then estimating the likelihood of those hazards occurring and the consequences. This relies on scientific knowledge (for example, on issues like gene flow and the factors that determine whether species are invasive), together with specific information about the GMO under consideration that is usually supplied by the applicant.

In the UK, all of this information is evaluated and weighed by the Advisory Committee on Releases to the Environment (ACRE), an independent, expert scientific committee. On this basis, the committee advises whether there are any significant risks associated with the GMO release. Further details of the regulatory system can be found on the following website:

Key issues

  • Is the risk assessment process sufficiently robust to achieve the goal of protecting human health and the environment? Some would argue that a basic weakness in the process is that there may be gaps in scientific understanding, or the scientific community may not have reached a consensus on a particular issue. How big a problem is this and can it be dealt with during the risk assessment?
  • Of particular concern to some are the difficulties of assigning hazards during the risk assessment process - is it possible to be certain that all potential hazards have been identified?
  • It is also argued that the risk assessment process cannot take into account long-term effects of GMOs unless it is supported by long-term studies. What approaches can be used to address this?