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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.

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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, focusing especially on standards outside of our region to better educate those within the iGEM Americas region about standards in Europe and Asia.

US/Canada Comparison Chart

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).

Asia

Asia prescribes to the international definitions of the various biosafety levels.

1. Biosafety Level 1 - Not known to consistently cause diseases in immunocompetent adult humans.
2. Biosafety Level 2 - Associated with human disease. Hazard: percutaneous injury, mucous membrane exposure, ingestion.
3. Biosafety Level 3 - Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences.
4. Biosafety Level 4 - Dangerous/exotic agents which pose high risk of life‐threatening disease, aerosol‐transmitted lab infections; or related agents with unknown risk of transmission. (CDC 2002)

However, there have been numerous reports that Asian countries are far more lax in enforcing specific standards for laboratories that deal with these various biosafety levels. “A report recently released by Sandia National Laboratories shows that researchers in 16 Asian countries often use insufficient biosafety practices. Biosafety Level (BSL) 2 practices are often employed for research involving BSL 3 agents. Nearly two-thirds of respondents investigating Japanese encephalitis, avian influenza, and severe acute respiratory syndrome (SARS) - which are all BSL 3 agents - perform their research under BSL 2 specifications” (Business Wire 2006).

Accordingly, the standards required for lab workers and, for example, student workers are much less as lab supervisors are offered much more flexibility in how they manage their lab (CDC 2002).

Asian countries also lack an overarching legal framework governing the entire region. Countries fall within two categories: countries that have fashioned their biosafety regulations independently and countries that have utilized international assistance (Gupta et al, 2008).

Yet, regarding the regulation of the international carriage of dangerous goods, most South-East Asian countries subscribe to European protocols (WHO 2008). Most countries mandate defined risk assessment/management criteria for the import and export of biological materials (Gupta et al, 2008). Like Europe, most countries also subscribe to the Cartagena Protocol on Biosafety on most import and export issues with the notable exception of India (Gupta et al, 2008). If it is established that there is a substantial risk for an adverse effect on the environment, the import/export of that biological material is not allowed (CBD 2012). However, it’s been very difficult to set up appropriate compliance costs for specific laboratories that do not follow appropriate safety guidelines (Gupta et al, 2008).

Most Asian countries seek to heavily involve the public regarding decisions related to GMOs and biosafety (Gupta et al, 2008). Countries like Korea have established community related panels to discuss safety risks and have made most information on GMOs open source (Gupta et al, 2008). However, in line with WTO protocols and specific agreements, some specific information related to organisms remains proprietary especially when it falls under the purview of a copyright or confidentiality agreement.

Europe/Asia Comparison Chart