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
A peer-reviewed article of this Preprint also exists.
Author and article information
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.
Cite this as
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 PeerJ Preprints 6:e27108v1 https://doi.org/10.7287/peerj.preprints.27108v1note This preprint is not peer-reviewed. You may wish to reference the subsequent peer-reviewed version of this article.
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.
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Competing Interests
The author has no competing interests.
Author Contributions
Jack A Heinemann conceived and designed the experiments, performed the experiments, analyzed the data, contributed reagents/materials/analysis tools, prepared figures and/or tables, authored or reviewed drafts of the paper, approved the final draft.
Patent Disclosures
The following patent dependencies were disclosed by the authors:
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Data Deposition
The following information was supplied regarding data availability:
There is no raw data. It is a literature review.
Funding
The author received no funding for this work.
