THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear friends and colleagues,
New Zealand’s regulation of gene editing and synthetic biology and the need for strengthened regulatory regimes
Earlier this year, the Secretariat of the Convention on Biological Diversity (CBD) made a call for submission of information on synthetic biology.
The submission by the Sustainability Council of New Zealand highlights important elements in the New Zealand Hazardous Substances and New Organisms Act 1996 (HSNO) for good governance of GMOs, gene editing and synthetic biology, and stresses the critical importance of strengthening national and international biosafety regimes for these technologies, particularly for gene drives.
Under New Zealand’s HSNO, all types of modern biotechnology are covered. In addition, any organism not present in the country on 29 July 1998 is deemed to be a new organism and is also covered by the Act. This means that all gene editing and other new techniques of synthetic biology are covered by the Act, and their products are regulated as GMOs. This has been confirmed by the High Court in New Zealand in 2014 and subsequently affirmed following a government review of the regulations in 2016.
Like GMOs, field trials and any releases of gene edited organisms and products of synthetic biology from laboratory containment require risk assessment and prior regulatory approval. Field trials must be contained such that heritable genetic material does not leave the site during the trial and is removed after the trial. All applications must be publicly notified, subject to public consultation, open to submissions by any stakeholder, and involve a public hearing.
In making its assessment, the regulator must consider economic impacts (costs and benefits) of the proposed use, in addition to scientific, ethical and social matters. In order to incentivise consideration of alternatives prior to application, the relevant comparator used to assess an application is the best practicable alternative. The scope and these features of the New Zealand Act are important elements for good governance of GMOs, gene editing and synthetic biology.
However, due to their very purpose, gene drives and other GM approaches that are designed to spread through ecological systems and eliminate species pose greater challenges to risk assessment and risk management than currently established genetic engineering applications. Two fundamental issues are the identification of standards and procedures to allow appropriate ecological risk assessment, and the development of an international governance regime that can meet these challenges.
The Cartagena Protocol on Biosafety’s procedures were designed essentially to regulate intended movements of GMOs from one country to another, and had not been designed with gene drives in mind. The lack of adequate international governance arrangements for gene drives is a critical issue that needs to be addressed before any release is considered. In order to meet those challenges, all national and international biosafety regimes must be strengthened.
The submission is available on the Biosafety Clearing-House: https://bch.cbd.int/database/record.shtml?documentid=112070
With best wishes,
Third World Network
131 Jalan Macalister
Websites: http://www.twn.my/and http://www.biosafety-info.net/
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