OGTR | General advice from the Regulator on coverage of new technologies

The object of the Gene Technology Act 2000 (the Act) is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).

Section 10 of the Act contains a broad definition of ‘gene technology’ and thus also a broad definition of GMO. The Gene Technology Regulations 2001 (the Regulations) provide some exclusions to the definitions, which were amended in April 2019 to clarify the status of several new technologies. The majority of these changes came into effect on 8 October 2019 and one further change came into effect on 8 October 2020.

Gene technology is a rapidly developing field of science, and future developments may pose challenges in applying the current definitions. If you have queries about regulatory coverage please discuss these with OGTR. You may also seek your own legal advice. The Regulator can only provide advice on a case-by-case basis and on an understanding of the technology as presented and the legislation in its form at the time. When considering new technologies the Regulator must take a conservative approach, consistent with promoting the object of the Act, and the broad scope of the definition of GMO contained in Section 10.