Hope Not Hype - Third World Network

140 Hope Not Hype
purposely manipulated in vitro and then re-introduced into an organism) should require
an application to ERMA are apparently being made by advisors based on an informal
process that may not result in even the exchange of recorded scientific evidence. 9
Since regulators show an unexpected diversity of thought on the definition of genes
and modern biotechnology, the authors of the Synthesis Report felt that it was necessary
to clarify these definitions. When considering both the value and costs of modern
biotechnology for meeting the Assessment goals, all its forms must be recognized,
understood and properly regulated.
9
I refer here to the hypothetical case where ERMA said it might not require DNA used in a transient
transformation procedure to require ERMA approval when ERMA was satisfied that the DNA could not
either replicate or recombine with an existing DNA molecule in the recipient. I conflate that case with the
actual case where an applicant was not required to submit an application for the use of dsRNA molecules
that cause a change in the pattern of gene expression in recipients through several different amplifiable,
and in some organisms heritable, pathways. The information upon which informal advice was given was
based on standards of evidence that could not be immediately or uniformly articulated even by those
present in the meeting and which, I argue, should be available for oversight and review in the way that
evidence in an application is.