Biotechnology and Biosafety Policy at OECD: Future Trends.

The OECD Council Recommendation on Recombinant DNA Safety Considerations is a legal instrument which has been in force since 1986. It outlines the safety assessment practices that countries should have in place for agricultural and environmental biotechnology. This article suggests possible updates to make it suitable for the modern era.

Transgenerational transfer of gene-modified T cells.

Tumor immunotherapy using gene-modified T cells has already met with considerable success in the treatment of metastatic melanoma and B cell lymphoma. With improving patient prognoses, new questions arise. In particular, the long-term consequences of treatment among individuals of childbearing age could now be considered.

Environmental risk assessment of replication competent viral vectors applied in clinical trials: potential effects of inserted sequences.

Risk assessments of clinical applications involving genetically modified viral vectors are carried out according to general principles that are implemented in many national and regional legislations, e.g., in Directive 2001/18/EC of the European Union.

Cultivated microalgae spills: hard to predict/easier to mitigate risks.

Cultivating algae on a large scale will inevitably lead to spills into natural ecosystems. Most risk analyses have dealt only with transgenic algae, without considering the risks of cultivating the corresponding non-transgenic wild type species. This is despite the long-studied 'paradox of the plankton', which describes the unsuitability of laboratory experimentation or modeling to predict the outcome of introducing non-native algae into a new ecosystem.

General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.

This introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in human gene therapy and/or vaccination. The importance to assess the potential risks for human health and the environment related to the use of genetically modified organisms (GMO) in this case genetically modified viral vectors is highlighted by several examples. This environmental risk assessment is one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO.