Biosafety by definition: 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
- Biodiversity, Biotechnology, Molecular Biology, Legal Issues
- Keywords
- RNA interference, biosafety regulation, dsRNA, gene silencing, risk assessment, genetically modified organisms
- Copyright
- © 2018 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
- 2018. Biosafety by definition: 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 6:e27108v1 https://doi.org/10.7287/peerj.preprints.27108v1
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. dsRNA molecules can be potent gene regulators in eukaryotes, causing what is known as RNA interference. RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation but also raises the threat of unintended consequences. The Decision rests on their conclusion that dsRNA treatments do not modify genes or other genetic material and are therefore not heritable. The EPA conclusion is not consistent with the totality of peer-reviewed research on dsRNA or industry claims. The Decision applies to nearly all eukaryotes, however, the EPA relied upon knowledge of relatively few eukaryotes and its analysis neglected known exceptions. The Decision also has not taken into account the unique eukaryotic biodiversity of the country, much of which is still to be described. The regulator has potentially created precedent-setting definitions of previously undefined or alternatively defined key terms that trigger obligations under binding international agreements, in addition to domestic legislation. Finally, by placing no restriction on the source or means of modifying the dsRNA, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes. This article examines the scientific evidence, conclusions and recommendations of the EPA and also presents some additional options.
Author Comment
Genetically modified organisms (GMOs) are subject to compulsory risk assessment prior to release into New Zealand's environment. The risk assessment is required by law and conducted by the Environmental Protection Authority (EPA). EPA has statutory power to determine if an organism is a GMO as defined by legislation. Recently, the EPA decided that eukaryotes treated with and external source of double-stranded (ds)RNA are not GMOs. External treatments include ingestion, inhalation and absorption. The decision allows most eukaryotes to be treated with dsRNA from any source and to alter any traits, in the environment without a risk assessment. The EPA decision was based on a literature analysis of dsRNA effects on "genes and other genetic material", wherein the EPA concluded that no modification to chromosomal DNA occurred, and therefore treatment of eukaryotic organisms could not result in heritable changes.
I have completed a parallel review of the scientific literature specific to the facts relied upon by EPA and found exceptions to each among different species of eukaryotic organisms. Moreover, the EPA decision is extrapolated from a small minority of eukaryotes that have been studied for their responses to external dsRNA treatments to the effects on possibly tens of thousands of eukaryotes native to, possibly unique to, New Zealand. The evidence of heritable changes following treatment with dsRNA is so strong that products based on dsRNA to treat eukaryotes in the environment have been patented for their heritable effects.
Upon receiving new information, the EPA could choose to review its decision. This review was conducted to assist the EPA in New Zealand, and equivalent regulators in other countries, in evaluating when or if organisms treated with dsRNA should be subject to a pre-release risk assessment.