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Appendix One: What is a GMO
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of RNAi (ERMA, 2006, pp. 57-58) could have contributed to this policy conclusion.
While ERMA considered gene silencing that arises from direct and ongoing activity at the
level of mRNA (the intermediate molecules used in protein synthesis), it fails to mention
important heritable pathways of RNAi caused by other pathways, such as chromatin
modification (Chong and Whitelaw, 2004; Lippman and Martienssen, 2004; Meister and
Tuschl, 2004).
In discussions with ERMA on this issue 2 , staff stated that they considered that there
were cases where even the use of rDNA does not constitute the creation of a GMO. In
such cases, they said that ERMA therefore may not require a developer to seek regulatory
approval when using the same techniques and molecules that are unambiguously covered
by the Act (section 2 and 1998 Regulations) and the Biosafety Protocol for other
developments.
What is a gene
DNA is an obvious chemical form of genes because it has the properties necessary
to make accurate copies via a reaction called DNA replication, and thus be passed on
either infectiously or from parent to offspring. Each strand of the double helix is used as a
co-factor in DNA replication so that two identical double helices are produced through
replication.
In considering the term replicate the Authority has adopted a broad definition that encompasses
“can be copied” as well as “copies itself” (ERMA, 2006, p. 44).
In the strictest sense, nothing biological and smaller than a cell has the ability to
autonomously copy itself, since even DNA is the product of a series of biochemical reactions
in which it is a co-factor and a product (Figure A1.1). ERMA presumably relates “copies
itself” to the common understanding of DNA replication where the existing molecule
serves as a co-factor, or template, for the synthesis of descendant molecules. The concept
of “can be copied” presumably relates to other biochemical pathways where the element
that is inherited is a product and the product influences the existence of the pathway that
creates it. They apply this to inheritable protein structure states evident in prions, the
agents of diseases such as Mad Cow Disease. However, it would also apply to some
instances of regulatory RNA.
2
Meeting with ERMA staff, 20 August 2007.