Biosafety considerations of open air genetic engineering. An analysis of the New Zealand Environmental Protection Authority’s reasons for not classifying organisms treated with double-stranded RNA as genetically modified or new organisms
- Published
- Accepted
- Subject Areas
- Biotechnology, Molecular Biology, Legal Issues
- Keywords
- biosafety regulation, RNA interference, eGE, dsRNA, genetically modified organisms, gene silencing
- Copyright
- © 2019 Heinemann
- Licence
- This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. For attribution, the original author(s), title, publication source (PeerJ Preprints) and either DOI or URL of the article must be cited.
- Cite this article
- 2019. Biosafety considerations of open air genetic engineering. An analysis of the New Zealand Environmental Protection Authority’s reasons for not classifying organisms treated with double-stranded RNA as genetically modified or new organisms. PeerJ Preprints 7:e27545v1 https://doi.org/10.7287/peerj.preprints.27545v1
Abstract
The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. The Decision rests on the EPA’s conclusion that dsRNA is not heritable and therefore treatments using dsRNA do not modify genes or other genetic material. I found from an independent review of the literature on the topic that each of the major scientific justifications relied upon by the EPA to conclude that exposures to exogenous sources of dsRNA were out of legislative scope was based on either an inaccurate interpretation or failure to consult the research literature on all types of eukaryotes. The Decision also has not taken into account the unique eukaryotic biodiversity of the country. The safe use of RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation. However, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes by failing to restrict the source or means of modifying the dsRNA.
Author Comment
This is a significantly revised version of the pre-print that has improved readability through reorganisation, corrects some grammatical errors and includes some more recent papers that have been published in the interim.
It is complete review article on the biology of exogenously applied dsRNA molecules for purposes of regulation in New Zealand.