Table 1.
Regulatory frameworks for biotechnology analyzed in this study—Legal foundations, characteristics and regulatory requirements for unconfined release e.g., for commercial cultivation or the marketing of regulated biotechnology products.
| Country | Main biosafety legislation | Framework or specific law (for env. release) | Regulatory trigger* | Regulatory requirements for unconfined environmental release | Authorisation period (for marketing) |
|---|---|---|---|---|---|
| European Union | Biosafety Directives and Regulations (food/feed, env. release) (1990, updated 2001/2003) | Dir 2001/18/EC, supplemented by implementing regulations and GM food and feed regulation (2003) | Process-oriented** | Risk assessment, risk management, coexistence, monitoring, labeling, detection methods | 10 years, renewable |
| Argentina | Regulation Framework for Agricultural Biotechnology (1991) | Supplementary Resolution for release of GMOs | Process-oriented | Risk assessment, socio economic considerations | Not limited (possibility of revocation) |
| Australia | Gene Technology Act (2000), Food Standards Australia New Zealand Act (1991) | Supplementary Regulations e.g., Gene Technology Regulation (2001) | Process-oriented | Risk assessment, risk management and monitoring | Not limited (possibility of revocation) |
| Brazil | Biosafety law (1995; updated 2005) | Biosafety Law supplemented by implementing Resolutions | Process-oriented | Risk assessment, coexistence, monitoring, labeling, optional socio economic considerations | Not limited (possibility of revocation) |
| Canada | Regulatory Framework for Biotechnology (1993) | Framework includes regulations for plants with novel traits and novel foods and feeds | Product-oriented (novelty- and risk-based) | Risk assessment, stewardship (risk management) | Not limited (possibility of revocation) |
| Norway | Gene Technology Act (1993) | Regulations for risk assessment | Process-oriented | Risk assessment, risk management, monitoring, labeling, detection methods, socio-economic/sustainability assessment | 10 years, renewable |
| New Zealand | Hazardous Substances and New Organisms Act (1996), Food Standards Australia New Zealand Act (1991) | Supplementary Regulations (1998, 2003) and Methodology Order (1998) | Process-oriented | Risk assessment, risk management, monitoring (for conditional releases) | Not limited (possibility of revocation) |
| South Africa | GMO Act (1997) | GMO Regulations (amended in 2010) | Process-oriented | Risk assessment, monitoring, labeling, detection methods, optional socio economic considerations | Not limited (possibility of revocation) |
| Switzerland | Gene Technology Act (2003) | Release Ordinance (2008) | Process-oriented | Risk assessment, monitoring, labeling, detection methods | 10 years, renewable |
| USA | Coordinated framework for the regulation of biotechnology (1986) | Framework refers to relevant sectoral legislation (e.g., Plant Protection Act, Federal Insecticide, Fungicide, and Rodenticide Act, Toxic Substances Control Act) | Product-oriented (risk-based) | Risk assessment | Not limited (possibility of revocation) |
*
Classification of the regulatory triggers is not based on legal determination, but according to an assessment by the authors, based on information in the literature and information gathered from interviews with regulatory experts.