Sane how, the critical distinction between this method of 
mutation induction and the creation of truly novel recombinant organisms 
by gene splicing has never been made and therefore the regulatory 
superstructure that has grcwn up around recombinant DNA has 
automatically included both. 
It is this scientifically invalid and retrogressive situation 
that has spawned the opportunistic litigation of Rifkin et al and it 
needs to be corrected on legal as well as on philosophical grounds. 
It is proposed that paragraph I-B of the guidelines be amended 
to read: " (i) molecules which are constructed outside living 
cells by joining synthetic DNA segments or DNA segments from one or more 
-foreixm species to DNA molecules that can replicate " The new 
language is underlined and, as you will perceive, it totally excludes 
all self-cloning from the Guidelines. While this exclusion is broader 
than that of just deletions, we feel that it represents an absolutely 
logical division, based on the above argument; although the objection 
will be raised that it excludes such experiments as cloning a toxin gene 
on a high copy plasnid, etc., we would argue (a) that one can easily 
generate hyper-producing strains without gene splicing and (b) since 
many toxin genes are transposable, their attachment to a high copy 
plasmid, specifically, could also occur by natural means. 
Recombinant DNA Research, Volume 1 1 
[ 243 ] 
