Hope Not Hype - Third World Network

Appendix One: What is a GMO
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Therefore, heritability is sufficient but not necessary as evidence to establish the
need for a risk assessment, and exposure to modified nucleic acids is sufficient to conclude
that an organism is genetically modified. It would not appear to be appropriate to counsel
potential applicants that the use of rDNA that “did not replicate or recombine” is exempt
from the legal requirement of an ERMA risk assessment.
RNA is genetic material but not always “heritable”
DNA may modify the genes or other material of an organism without being heritable,
as described above. There is no reason a priori to believe that this would be a characteristic
unique to DNA. Many of the above examples could be recreated by re-introducing the
mRNA molecule in place of the DNA molecule. Thus, ERMA’s determination as to the
intent of lawmakers would also make clear that all organisms modified by exposure to
RNA should be considered GMOs and require an ERMA risk assessment (ERMA, 2006,
p. 44). However, the use of in vitro synthesized dsRNA, or dsRNA isolated from an
organism and then re-introduced into a recipient organism would presumably not be subject
to regulatory oversight as long as ERMA retained its policy (ERMA, 2006). In so doing,
the policy makes this application of RNA distinct from equivalent treatments using DNA.
The only way that can be done is to assume that: (1) RNA is not genetic material, (2) gene
silencing is not a heritable trait or character, and/or (3) the instigating dsRNA, amplified
or persistent, or chromatin modifications/DNA/histone methylation that maintain the effect,
are not the product of replication.
The use of dsRNA in genetic engineering is growing (Ivashuta et al., 2008). Though
unintended, it appears in retrospect to be behind the trait in the now defunct FlavrSavr
tomato first produced by Calgene (Ivashuta et al., 2008; Sanders and Hiatt, 2005). dsRNA
is the basis of pre-commercial research to develop caffeine-free coffee through gene
silencing (Ogita et al., 2003) and the basis for viral resistance in papaya (Tennant et al.,
2001). dsRNA has been intentionally tested as an insecticide (Baum et al., 2007; Mao et
al., 2007). The researchers demonstrated that dsRNA produced by transgenes in plants
can be infectiously transferred through food to gut cells in insects, and subsequently spread
within the animals separately from the rDNA (Gordon and Waterhouse, 2007). In contrast
perhaps with the New Zealand regulator, the Monsanto Company declared that
“[e]stablishing a well-documented history of safe consumption for RNA molecules
including those that mediate RNAi (e.g. miRNAs and siRNAs) will be an important
component of this weight of evidence approach for evaluating the safety of crop products
developed utilizing RNAi-mediated gene suppression” (Monsanto study published under
Ivashuta et al., 2008).
Conclusions
From the above discussion it is clear that RNA is unambiguously among the materials
that through in vitro modification would create a GMO as defined by the HSNO Act.
Meanwhile, decisions on whether particular applications of RNA or DNA (where they are