Safety

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3) Playing by the rules:

There is already a number of international and national guidelines, laws and professional associations that you have to consider. Here is an overview of some of them:

International

• World Health Organisation (WHO)
  • Laboratory Biosafety Manual
• Convention on Biological Diversity
  • The Cartagena Protocol on Biosafety
  • Biosafety Clearing House

USA

• National Institute of Health (NIH)
  • Institutional Biosafety Committees
  • Guidelines For Research Involving Recombinant DNA Molecules (NIH Guidelines)
• American Biological Safety Association
• Centre for Disease Control (CDC)
  • Office of Health and Safety
  • Biosafety in Microbiological and Biomedical Laboratories
  • CDC Presentation on Biosafety

Europe

• European Commission
  • Directive 2009/41/EC on the contained use of genetically modified micro-organisms
  • Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
  • Directive 2001/18/EC concerning the traceability and labelling of genetically modified organisms and the update Regulation 1830/2003
  • Regulation 1829/2003 on genetically modified food and feed
  • Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms
• European Biosafety Association EBSA
• Switzerland
  • Verordnung über den Umgang mit Organismen in der Umwelt: Freisetzungsverordnung
  • Verordnung über den Umgang mit Organismen in geschlossenen Systemen: Einschliessungsverordnung
• Germany
  • Bundesamt für Verbraucherschutz und Lebensmittelsicherheit:
    • Liste risikobewerteter Spender- und Empfängerorganismen für gentechnische Arbeiten (list of risk assessed donor and host organisms for genetic engineering)
    • Zentrale Kommission für die Biologische Sicherheit
• United Kingdom
  • Health and Safety Executive:
    • Guidance from the Scientific Advisory Committee on Genetic Modification
    • Notification of Accidents Involving Genetically Modified Organisms
    • Risk assessment of genetically modified microorganisms
• Belgium
  Belgian Biosafety Server
• Netherlands
  • Commissie Genetische Modificatie COGEM

Asia

• PR China
  • National Biosafety Office, Ministry of Environmental Protection
  • Biosafety of GMOs
  • Biosafety regulation on pathogenic microbes
• Japan
  • Japan Biosafety Clearing House
• Asia-Pacific Biosafety Association: A-PBA
• Singapure:
  • Institutional Biosafety Committee

Africa

• Republic of South Africa
  • Biosafety South Africa

Latin America

• Brasil
  • Associação Nacional de Biossegurança: ANBio

 

If you have additonal relevant info, send them to safety AT igem.org

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4) Other ideas

4.1. Biosafety engineering

Synthetic biology holds the potential to make biology not only easier to engineer but also safer to engineer. In many established engineering disciplines (e.g. mechanical engineering, aviation, space flight, electronics, software) safety engineering is already an established subset of systems engineering. (System) safety engineering is an engineering discipline that employs specialized professional knowledge and skills in applying scientific and engineering principles, criteria, and techniques to identify and eliminate hazards, in order to reduce the associated risks. Safety engineering assures that a system doesn't pose a risk even when parts of it fail. This is more than needed in synthetic biology due to the evolutionary forces of biological systems. If synthetic biology is going to become the new systems engineering of biology, then it needs to establish an equivalent subset in safety engineering: biosafety engineering (Schmidt 2009).

Biosafety engineering could be practiced by designing robust genetic circuits that account for possible failure of single parts or subsystems, but still keep working or at least don't cause any harm to human health or the environment. Safety engineering has many techniques to design safer circuits (systems), for example

• Event Tree Analysis and
• Fault Tree Analysis

Both methods are normally used in assessing the safety of engineering systems (e.g. aircraft, space travel, mechanical engineering, nuclear energy) based on standardized parts and true engineering designs.

In a device or system, for example, a mutation in one of the bioparts could cause the part to become dysfunctional. The Event Tree Analysis (ETA) would look at the way the whole system is going to be affected by the failed part. It will answer the questions: Will the device or system still be able to fulfill its tasks? Will it behave in a different way, and if yes in which way? Or will it shut down completely? Based on this analysis additional safety systems could be installed, such as redundant sub-circuits.

The Fault Tree Analysis (FTA), on the other hand, looks at defined unwanted failures of the systems and then traces backward to the necessary and sufficient causes. For example, a genetic circuit should not fail in a way that leads to the overproduction of a particular protein that is regulated by the network. The FTA can show which basic events could cause such an overproduction, and thus help to improve the circuit to avoid these unwanted failure, for example in designing the circuit in a way that all basic events would cause the expression of the protein to diminish but never to increase.  

The full range of possibilities to include safety considerations in designing biological circuits has not yet been explored in great detail but will be extremely helpful. How could you contribute to make it happen?

4.2. Designing and using a safer host organims/chassis

4.3. Public perception of risks and safety issues

As we work with a technology that is in the public eye, we need to understand that besides scientific risk ''assessment'', as described before, there is also a public risk ''perception'' of what we do. It is useful to understand the "soft facts" of risk perception that, especially in case of lay people, outdo the "hard facts" such as technical or medical expertise. Experts typically define risk strictly in terms of the probability of a certain damage (e.g. mortalities, life years lost, financial loss). Lay people, however, almost always include other factors in their definition of risk, such as catastrophic potential, equity, effects on future generations, controllability, involuntariness and trust in the people responsible. These differing conceptions often result in lay people assigning relatively little weight to risk assessments conducted by technical experts or government officials, instead they use these other factors to form an opinion. See table for some of the most relevant factors affecting risk perception:

attenuate risk perception		amplify risk perception
familiar	↔	exotic
individual control	↔	controlled by others
natural	↔	manmade
statistical	↔	catastrophic
clear benefits	↔	little or no benefit
fairly distributed	↔	unfairly distributed
voluntary	↔	imposed
information by trusted sources	↔	information by untrusted sources
trust in responsible persons/organisation	↔	lack of trust
not in the media	↔	in the media

How do you think synthetic biology, and especially the iGEM competition, is perceived by the public? What could you do to influence that?

There is already heaps of articles on risk perception, for an introduction see:

Schmidt M. 2004. Investigating risk perception: a short introduction. Chapter 3 PhD Thesis, Vienna, Austria

Sjöberg L. 2000. Factors in Risk Perception. Risk Analysis, Vol. 20, No. 1, pp.1-11

Slovic P. 1987. Perception of Risk. Science Vol. 236, pp. 280-285