Difference between revisions of "Team:Edinburgh OG/Human Practices"

Since the Edinburgh OG iGEM 2016 team has directly worked with non-model organisms we have an obligation to think about the current situation regarding the use of non-model organisms, its regulatory framework and its biosafety and biosecurity status. The goal of our project is to ultimately encourage future iGEM teams to use these microorganisms as well as domesticate additional, novel micro-organisms.

This team has recognised that the intended expansion of strains to be used within the context of synthetic biology through domestication of uncommon microorganisms comes with biosafety and biosecurity issues that need to be addressed properly. For example, filamentous fungi are able to produce a wide array of important secondary metabolites (e.g., naphto-γ-pyrones and ß-lactam antibiotics, such as penicillin) with diverse biological activities relevant for the food, pharmaceutical and cosmetic industries: antimicrobial, antioxidant, anti-cancer, anti-tubercular, anti-HIV and anti-hyperuricuric (Choque et al. 2014). Nonetheless, they may also produce mycotoxins that can cause unwanted health and environmental problems, such as human disease (myxotoxicoses) (Peraica et al. 1999) and food and silage spoilage (Filtenborg et al. 1996). Those issues are magnified by the Open Source Biology (OSB) and Do-It-Yourself Biology (DIYBio) movements – which complement the iGEM competition – since they lead to more permeable boundaries between amateurs and professional scientists.

The commercial applications of SynBio might entail the release of GMOs into the environment, either deliberate or accidental. For instance, the NTU-Taida 2012 iGEM project involved the direct interaction of genetically modified bacteria with humans as they engineered E. coli as a vector to deliver peptide drugs to the human gut (NTU-Taida iGEM 2012). Other examples iGEM projects that are associated with the release of GMOs to the environment the Imperial College London 2011 team, which used genetically modified E. coli to secret the auxin indoleacetic acid (IAA) to prevent erosion (Imperial College London iGEM 2011), and the Lethbridge 2011 team, which developed an toolkit based on genetically modified E. coli to be used for the clean-up of polluted lakes (University of Lethbridge iGEM 2011).

One also has to consider that, once released, GMOs cannot be retrieved and this poses a major risk to the environment. For instance, the differences in the physiology of synthetic and natural microorganisms might alter the manner those interact with their surroundings. Furthermore, the GMOs may survive, evolve and adapt quickly, hence competing successfully with wild-type strains. Another important risk is their gene transfer ability, based on which GMOs could take up genetic material from the environment or exchange it with other microorganisms (Dana et al. 2012).

Moreover, since the events in the US of 9/11 and the anthrax attacks on that same year, security concerns have increased because of the threat of biological or chemical terrorist attacks. These concerns have been compounded by recent in SynBio toolkit hrough which is it now possible, for example, to synthesize entire microorganisms (Hamilton 2015). As a consequence, these incidents have extended the concerns about biosecurity among the entire research community. Therefore, new efforts have been focused to design new ways to hinder malicious uses of the developed technologies (Garfinkel et al. 2007).

A proper and integral way to approach the biosafety and biosecurity aspects is through risk assessment methods that evaluate SynBio activities and techniques in order to determine whether they can be deemed as safe in terms of, or both (Schmidt 2009).

It is worth mentioning that, as the Convention on Biological Diversity (CBD) along with the Cartagena and Nagoya Protocols – its two supplementary agreements – addresses, SynBio activities and their risk assessment methods must comply with local regulatory frameworks and international legislation that oversee biosafety and biosecurity (Marles-Wright 2016). For instance, the European Union has regulations regarding the exposure chain of potential hazards of genetic engineering applications to human health and the environment (Scientific Committees 2015). Specifically, the European Directives 2009/41/EC, 2001/18/EC and (EU) 1829/412 relate to the contained use of GMOs, their deliberate release to the environment and their possible restriction by Member States. Specifically, the Directive 2001/18/EC is important in this case since it states that for an environmental risk assessment the characteristics of a GMO related to potential adverse effects should be compared to the ones from non-modified organisms (European Commission 2016).

Furthermore, in the United Kingdom (UK), the Genetically Modified Organisms (Contained Use) Regulations 2014 document states that the risk assessment of contained use of microorganisms and GMOs must identify the potential hazards of their activities and the level of severity (HSE 2014). Its complement, the Scientific Advisory Committee on Genetic Modification (SACGM) Compendium of Guidance, mentions the regulations of risks presented with the insertion of exogenous DNA sequences in host strains and the need to identify all probable hazards that stem from GMOs (HSE 2004). On the other hand, in the US the NIH Guidelines on the Use of Recombinant or Synthetic Nucleic Acid Molecules specify the practices regarding their construction and handling (NIH 2016a). Moreover, the World Health Organisation (WHO) and the Advisory Committee on Dangerous Pathogens (ACDP) Approved List of Biological Agents have a globally accepted classification of microorganisms according to their risk levels called the Control of Substances Hazardous to Health (COSHH) Regulations, such as the one presented for the iGEM competition to label different microorganisms (HSE 2004).

However, the existing biosafety and biosecurity framework pertaining to molecular biology was created before the fast-paced developments in SynBio, such as DNA synthesis, sequencing and high-throughput assembly, took place. Moreover, risk assessment methods are usually limited to paperwork that is completed and signed off by senior members, while other laboratory members do not contribute in a relevant manner to those assessments (Marles-Wright 2016).

Accordingly, numerous improvements to risk assessment methodologies can be made to ensure that biosafety and biosecurity are guaranteed while the benefits of SynBio developments are not compromised, such as having better communication and cooperation between the SynBio community and society in general (Schmidt 2009) to ensure that the biosafety and biosecurity components are integrated in molecular and synthetic biology research. On this matter, it has been proposed that, by fostering both a social intelligence and public knowledge about science, the contribution of science to benefit society is assured (van Doren & Heyen 2014). Progressively, more initiatives are being presented to make such incorporations. For example, the SYNBIOSAFE project and the SynBio Engineering Research Centre (SynBERC), funded by the European Commission’s Seventh Framework Programme and the US National Science Foundation (NSF) respectively, aim to ensure a successful scientific development while gathering information about the risks and achievable strategies to minimise them (Calvert & Martin 2009).