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From 2013.igem.org

A Policy Analysis on the Implications of iGEM and DIY biology on Biosecurity and Law

Despite decades of pushing for public acceptance of genetically modified organisms, the public is still largely against the use of genetic engineering to modify life. The ASU iGEM team recognizes this issue as one that requires more effective education for the masses and an understanding of the inherent risks involved in genetic engineering and synthetic biology when translated into real world applications. We wanted to move beyond the lab bench to analyze the impact that students of iGEM can have on the public with their research and explain why good science alone is not the answer to public acceptance of synthetic biology principles.

Members of the 2013 ASU iGEM Team recently had the privilege to enroll in a second-year law course at ASU’s Sandra Day O’ Connor School of Law through the Barrett Honors college Project Excellence program. Three undergraduate students attending Arizona State University were permitted to enroll in Dr. Gary Marchant’s "LAW691: Biotechnology: Law, Science, and Policy" course, in which the legal, ethical, and societal implications of biotechnology were discussed in great deal with a strong focus on policy. Based on education from the course, members of ASU iGEM evaluated various safety and security points in both synthetic biology and the biotechnology movement as a whole.

VIEW OUR PAPER HERE

Global Safety Standards Analysis

Given the global nature of iGEM, the team also believed it was important to understand the global implications of distribution potentially hazardous parts to different areas of the world and the different standards that regions hold for biological distribution. Because our project also involved the use of potentially hazardous genetic information, we understood that it was essential to realize potential differences in laws and regulations governing distribution of these parts, especially in an open source organization. We researched and compared biosafety and distribution standards around the world and curated them here to

Europe

According to the Official Journal of the European Communities, the Council Directive of November 1990 provides general requirements on the protection of workers from risks related to exposure to biological agents at work. Article 2 states:

1. group 1 biological agent means one that is unlikely to cause human disease;
2. group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available;
3. group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available;
4. group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available. (OJEC 1990)

European standards mandate that labs involved in work with biosafety level 2, 3 and 4 must establish appropriate containment measures and consistently update their classifications in light of technical progress and revisions in international standards (EASHW 2000).

Workers must meet stringent requirements per the group under study and usually student workers are unlikely to work past group 2 (EASHW 2000)

The European Union and most European countries are parties to the Cartagena Protocol on Biosafety (CBD 2012). This protocol operates on the precautionary principle in that the transfer of organisms that could potentially have adverse effects on the sustainability of biological diversity is prohibited (CBD 2012).

Two classifications from transport of infectious substances to/from Europe: 1.) Infectious substance, affecting humans (UN2814) and 2.) Infectious substance, affecting animals only (UN2900).

Regarding open source access to information, the Cartagena Protocol on Biosafety states that open public access is available to the point where it does not infringe upon certain copyright protect information or information protected by confidentiality agreements. In certain circumstances, information that could be damaging to the public good regarding genetic organisms must be kept secret (IUCN 2003).