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Appendix One: What is a GMO 129 Appendix One What is a GMO JUST saying what a genetically modified organism (GMO) is, is complicated. Text approved in the Biotechnology theme of the Synthesis Report drew attention to this issue in connection with the definition of modern biotechnology and its products, particularly transgenic organisms: Currently the most contentious issue is the use of recombinant DNA [rDNA] techniques to produce transgenes that are inserted into genomes. Even newer techniques of modern biotechnology manipulate heritable material without changing DNA. To illustrate the importance of this issue, I will use the case of double-stranded RNA (dsRNA, Box A1.1) and how it is viewed under New Zealand’s regulations. As this case involves concepts that are highly technical, the following is an overview of the generic issue at stake. Box A1.1: Double-stranded RNA is genetic material Double-stranded RNA is an alternate means of creating genetic modifications that can affect the properties of organisms without necessarily changing their DNA. RNA is genetic material for two reasons. First, it is unambiguously the nucleic acid genome of some viruses. Second, RNA molecules that are reproduced using ubiquitous enzymatic activities can in some organisms or circumstances demonstrate the ability to transfer traits or characteristics infectiously or across generations. These are the same criteria used to originally identify DNA as genetic material (Heinemann and Roughan, 2000). The use of dsRNA in genetic modification is growing and it is currently the basis for pre-commercial research to develop products such as caffeine-free coffee and insecticide plants (Gordon and Waterhouse, 2007; Ogita et al., 2003). Yet because its heritability has not been understood until relatively recently, it will not always be covered by appropriate legal and regulatory standards set for risk assessment even though it is a nucleic acid and therefore covered by the Cartagena Protocol on Biosafety. Definitions will often determine whether a new understanding in science is covered or not, and it is in such instances that these definitions carry considerable importance.
130 Hope Not Hype In New Zealand, the Environmental Risk Management Authority (ERMA) regulates activities involving genetic modification under the Hazardous Substances and New Organisms (HSNO) Act. In 2005, ERMA adopted a policy that identified certain forms of RNA that cause gene silencing, e.g., RNAi, antisense, dsRNA-mediated methylation and so on, as lying outside the scope of its governing legislation (ERMA, 2006). Gene silencing by so-called “regulatory RNAs”, because they modulate gene expression, is a recently discovered phenomenon that is operative in organisms of all biological kingdoms. The RNA molecules involved are called, variously, dsRNA, short/ small interfering RNAs (siRNAs), repeat-associated short interfering RNAs (rasiRNAs), microRNAs (miRNAs) and short-hairpin (sh)RNA (Denli and Hannon, 2003; Meister and Tuschl, 2004; Paddison et al., 2002). These cause the related phenomena known by many different names such as RNAi, RNA silencing, inhibitory RNA, quelling, MSUD, co-suppression and post-transcriptional gene silencing (PTGS) and even paramutation (Ashe and Whitelaw, 2007; Chandler and Vaucheret, 2001). The precursors of dsRNAmediated-silencing replication are provided by the reaction transcription and include dsRNA as a co-factor. Gene silencing is rapidly being adopted as a GM technology, making more widely available the tools necessary to construct the recombinant DNA, or transgenes, that produce dsRNA when inserted into a recipient organism. In vitro synthesized dsRNA also can be introduced directly without creating recombinant DNA because dsRNA is far more horizontally mobile (i.e., infectious) than DNA (as discussed below). Regulatory RNA molecules that are derived from in vitro manipulated DNA, such that the DNA was made a stable part of an organism’s genome, were deemed to be covered by the HSNO Act (ERMA, 2006). On the other hand, regulatory RNA molecules derived through in vitro synthesis or extracted from one organism and then introduced into another, were considered not to be subject to the HSNO Act. The rationale for the exclusion of the latter set of approaches resulting in gene silencing is stated as follows: Treatment of organisms with these molecules affects protein expression in the cell but not by modifying the organism’s genome. The use of RNAi technology is not therefore considered to be the development of a genetically modified organism under the HSNO Act as the genes of the host organism are not modified, although it is acknowledged that the pattern of gene expression in the host is modified (ERMA, 2006, p. 58). This interpretation of “genome”, a term not defined by the Act, is unclear, but it has the effect of excluding the evaluation of the risks arising from certain types of in vitro modified RNA, or RNA derived from modified DNA and synthesized in a cell-free system; these same molecules are unambiguously captured under the Biosafety Protocol. It would also be inconsistent with a common definition of the term “genome” as all material that could transfer traits to other organisms and to descendants. 1 ERMA’s flawed description 1 “Genome” is a derivative of “genetics”, which is defined by the US Congress Office of Technology Assessment as “The study of the patterns of inheritance of specific traits” (US Congress Office of Technology Assessment. http://www.bis.med.jhmi.edu/Dan/DOE/prim6.html. Date of access: 4 January 1999). This definition is inclusive and does not assume the physical basis of traits as DNA.
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