Table 2.
Regulatory aspects related to nGM applications.
| Country | Current regulatory approach | Policy development regarding nGMs | Focus of policy amendments | Current experiences with nGM applications |
|---|---|---|---|---|
| European Union | Determination if specific types of nGMs are subject to GMO legislation | No amendment of Directive 2001/18/EC proposed by Europ. Commission, but Europ. Court of Justice ruled that directed mutagenesis is subject to GMO legislation (ECJ 2018) | – | No experience on European level with applications for unconfined release and placing on the market; however field trials with some nGM applications are conducted (SAM, 2017) |
| Argentina | Determination if nGM product is subject to GMO legislation | Supplementary resolution adopted 2015 providing criteria for case-by-case decisions (Resolution No. 173/2015) | – | Until June 2018 12 requests were evaluated according to Resolution No. 173/2015, incl. 10 applications of genome editing, mostly in plants, mostly not regulated (OECD, 2018) |
| Australia | Determination if nGM process is subject to GMO legislation | OGTR proposed technical amendments to legislation, consultation in progress | Genome editing (SDN-1) | No applications for unconfined release; field trials with some nGM applications are conducted |
| Brazil | Determination if nGM product is subject to GMO legislation | Supplementary resolution adopted in January 2018 (Normative Resolution No 16) comparable to supplementary regulation in Argentina) | – | Use of nGMs in contained use facilities; two yeast lines modified by genome editing were evaluated according to Resolution No 16 (not regulated) |
| Canada | Determination if individual nGM product is novel | Review of risk assessment requirements initiated | – | Several applications authorized (e.g., cisgenic potato, genome edited oilseed rape) |
| New Zealand | GMO legislation is currently applied for all nGMs | Government adopted policy to direct technical ruling by NZ-EPA, no immediate policy changes foreseen | GMO legislation only exempts chemical or radiation induced mutagenesis | Use of nGMs for research and development activities; some genome editing determined to be regulated |
| Norway | Determination if specific types of nGMs are subject to GMO legislation | Technical discussions to inform further steps (following EU approach) | – | No applications for unconfined release submitted; use of nGMs in contained use facilities |
| South Africa | GMO legislation is currently applied for all nGMs | Discussion on policy amendment ongoing | – | No applications for unconfined release submitted; use of nGMs in contained use facilities |
| Switzerland | Determination if specific types of nGMs are subject to GMO legislation | Stakeholder discussions to inform future policy | – | No applications for unconfined release; field trials with some nGM applications are conducted |
| USA | Determination if individual nGM product is regulated | Consultations on policy to deregulate certain techniques (e.g., cisgenesis) | – | Several decisions to exempt nGM applications from regulation; a number of nGM applications in regulatory review |