Opinion: Airtightness for Decontamination by Fumigation of High-Containment Laboratories.

Introduction: While the European legislation states that laboratories of high-containment must be sealable for fumigation, they do not prescribe a minimal value for airtightness. Starting from a previous study in which we measured the airtightness in 4 BSL-3 laboratories with blower-door tests, we discuss the connection between airtightness and a successful decontamination by fumigation. Methods: Biological indicators (BIs) consisting of spores of Geobacillus stearothermophilus on metal disks were laid out in laboratories of different levels of airtightness before performing a fumigation with aerosolized hydrogen peroxide using an automated device, according to the manufacturer's instructions. Results: Incubation of all BI disks placed in the facility with the highest level of airtightness showed complete inactivation of spores. However, in the facility with a lower level of airtightness, not all spores were inactivated. Discussion: Air leaks might be a factor in the outcome of the decontamination of a room by fumigation, as seen in the laboratory with a lower level of airtightness, but other factors associated with the fumigation process might also be critical for a successful decontamination. Conclusion: We argue that a validation of the decontamination procedure, before first use or after important renovations of a laboratory of high-containment, is a more effective endpoint than reaching a predefined level of airtightness.

Engineering nucleases for gene targeting: safety and regulatory considerations.

Nuclease-based gene targeting (NBGT) represents a significant breakthrough in targeted genome editing since it is applicable from single-celled protozoa to human, including several species of economic importance. Along with the fast progress in NBGT and the increasing availability of customized nucleases, more data are available about off-target effects associated with the use of this approach. We discuss how NBGT may offer a new perspective for genetic modification, we address some aspects crucial for a safety improvement of the corresponding techniques and we also briefly relate the use of NBGT applications and products to the regulatory oversight.

Environmental risk assessment of clinical trials involving modified vaccinia virus Ankara (MVA)-based vectors.

The modified vaccinia virus Ankara (MVA) strain, which has been developed as a vaccine against smallpox, is since the nineties widely tested in clinical trials as recombinant vector for vaccination or gene therapy applications. Although MVA is renowned for its safety, several biosafety aspects need to be considered when performing the risk assessment of a recombinant MVA (rMVA). This paper presents the biosafety issues and the main lessons learned from the evaluation of the clinical trials with rMVA performed in Belgium. Factors such as the specific characteristics of the rMVA, the inserted foreign sequences/transgene, its ability for reconversion, recombination and dissemination in the population and the environment are the main points of attention. Measures to prevent or manage identified risks are also discussed.

Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination.

The modified vaccinia virus Ankara (MVA) strain is a highly attenuated strain of vaccinia virus that has been demonstrated to be safe for humans. MVA is widely considered as the vaccinia virus strain of choice for clinical investigation because of its high safety profile. It also represents an excellent candidate for use as vector system in recombinant vaccine development for gene delivery or vaccination against infectious diseases or tumours, even in immunocompromised individuals. The use of MVA and recombinant MVA vectors must comply with various regulatory requirements, particularly relating to the assessment of potential risks for human health and the environment. The purpose of the present paper is to highlight some biological characteristics of MVA and MVA-based recombinant vectors and to discuss these from a biosafety point of view in the context of the European regulatory framework for genetically modified organisms with emphasis on the assessment of potential risks associated with environmental release.

Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?

In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.

Bringing scientists to the people--the Co-Extra website.

Disseminating and facilitating access to science-based information is a necessity to enable the public to make informed decisions about appropriate uses of biotechnology products. It is also one of the major objectives of Co-Extra, a European-funded project addressing co-existence of genetically modified organisms and non-genetically modified organisms in Europe and their traceability. To this end, a dynamic and interactive website has been developed as the core element of the Co-Extra external communication strategy. This website has been designed to make it attractive and accessible to a large audience in a very simple and practical manner, building on practical experiences gained in the development of other websites related to biotechnology and genetically modified organisms. The website delivers popularized information for the general public as well as scientific data meant primarily for the more expert readers. It also provides for various permanent tools allowing multidirectional interaction with its visitors. Content is displayed using a web-based platform, based on a sophisticated Content Management System. First results indicate a high level of interest from the general public and from experts, showing that the content of this website can contribute by communicating science-based information to improve awareness and understanding of biotechnology.