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. Risk analyses of transgenic strains of native algae can be based on whether they are more fit or less fit than their wild type, but these are not possible with non-native species. Risks from spills can be minimized by mutagenically or transgenically deleting genes that are unnecessary in culture but obligatory in nature.

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. Recent developments in vector design have a large impact on the concepts that underpin the risk assessments of viral vectors that are used in clinical trials. The use of (conditionally) replication competent viral vectors (RCVVs) may increase the likelihood of the exposure of the environment around the patient, compared to replication defective viral vectors. Based on this assumption we have developed a methodology for the environmental risk assessment of replication competent viral vectors, which is presented in this review. Furthermore, the increased likelihood of exposure leads to a reevaluation of what would constitute a hazardous gene product in viral vector therapies, and a keen interest in new developments in the inserts used. One of the trends is the use of inserts produced by synthetic biology. In this review the implications of these developments for the environmental risk assessment of RCVVs are highlighted, with examples from current clinical trials. The conclusion is drawn that RCVVs, notwithstanding their replication competency, can be applied in an environmentally safe way, in particular if adequate built-in safeties are incorporated, like conditional replication competency, as mitigating factors to reduce adverse environmental effects that could occur.