Oct 3, 2006

Archive

Send

The Ninth International Symposium on the Biosafety of Genetically Modified Organisms in Jeju, South Korea

Research: Expanding the knowledge base for risk assessment

At least 250 representatives from science, industry and approval bodies gathered on Jeju Island, South Korea to share knowledge and exchange information about the status of international safety research on genetically modified plants. The biosafety symposium is held every two years and is organised by the International Society for Biosafety Research (ISBR).

Whilst on previous occasions the main emphasis has been on individual projects and case studies, the organisers of the Ninth Biosafety Symposium in Jeju shifted the focus onto tailoring biological safety research more closely to the requirements of the authorisation process for GM plants.

No GM plants have yet been grown in South Korea. Fourteen GMO products have been approved as food. Agrobiotechnology has been increasingly promoted in Korea in recent years. The NIAB was founded in 2002 and, in addition to its own genome research into various crops, has set up the biogreen21 programme for the development of and risk research into genetically modified plants. Research has been carried out on more than 20 crops, particularly rice and different species of wild cabbage. Outcrossing trials are being conducted with rice. The newly established agricultural research centre has its own genetic engineering exhibition aimed at schools.

All countries basically follow the same procedure: before a genetically modified plant is approved, the relevant authorities carry out a risk assessment. They must then decide whether the release or cultivation of GM plants can be justified based on current knowledge. The authorities expect to be able to base their decision on safety research findings. However, many research groups are concerned with rather more fundamental, long-term issues, like ecosystems or biodiversity. The authorities, on the other hand, need data that is clear, concrete and as accurate as possible on which to base their approval decisions. The aim of the Jeju symposium was to provide new impetus for improved coordination between science and regulatory practice.

“Not everything that counts can be counted, and not everything that can be counted counts.”

In her introductory talk, Sally McCammon from the US regulatory authority and chair of the symposium committee emphasised that after twenty years’ experience it was becoming increasingly clear what risk assessments could achieve with regard to genetically modified plants and where there was a need for further research due to remaining uncertainties. In particular, and here she spoke for many of the regulatory authorities present, there was a need for greater international harmonisation in terms of the risk assessment methods used in practice. In her summary at the end of the conference McCammon expressed her wish for greater collaboration between safety researchers and regulatory authorities in the future.

Industry representatives also encouraged a more concerted international approach to address the remaining uncertainties of risk assessment within regulatory practice. The discussions and talks during the symposium demonstrated that it is widely recognised that not all theoretically possible consequences can be controlled before approving a GM plant and certain “residual uncertainties” have to be accepted.

Sue Meek, a representative of the Australian genetic engineering approval authority, concluded her presentation with the observation that our knowledge base for risk assessments had expanded considerably in recent years, but some uncertainty would always remain. She quoted Albert Einstein: “Not everything that counts can be counted, and not everything that can be counted counts.”

The programme focussed heavily on the individual elements and stages of risk assessments conducted by the regulatory authorities when considering approval applications. For example the potential risks posed by GM maize, oilseed rape and rice, the likelihood of their occurrence and their impact on the environment were analysed. One particular series of lectures presented models for a risk assessment of the potential risks of Bt maize on non-target organisms.

Towards the end of the symposium there was a presentation on the general concepts and concrete findings of almost ten years of monitoring for possible Bt resistance development in the European corn borer. European corn borer populations have been monitored for resistance to the Bt toxin annually in the USA since 1995. So far no decrease in susceptibility has been found.

Setting priorities in safety research

In 2003 the Agricultural Biotechnology Risk Analysis Research task group (AGRA) was established in the USA. The role of this platform, which is affiliated to the NSF (National Science Foundation), is to facilitate communication between the different regulatory authorities and research institutes concerned with risk research. This enables the authorities to obtain direct insights into the status of research. They can translate their requirements more quickly into research and direct public research funding to remaining gaps in knowledge with greater precision.

This platform was rated by many participants at the symposium on Jeju as a successful initiative which once again highlighted the urgent need for increased collaboration between the regulatory bodies and research in the future. The symposium’s organiser, the International Society for Biosafety Research (ISBR), has also launched a similar initiative. Over the coming years the growing worldwide network of representatives from science, regulatory authorities and industry, under the umbrella of ISBR, will highlight topics that are to be a top priority for safety research in the next years.