Old Title vs New Title  NIH Guidelines for Research Involving Recombinant DNA Molecules   NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules  Implement by 3/3/13

Is chemical synthesis covered? synthesizer Not until in a …

III-F Registrations  Nothing exempt in Boston BPHC adopts updated Guidelines unless… Using nonhazardous plasmids (pBR) to clone gene of interest into host (nonpathogenic E.coli) Often the first step in creating a transgenic animal New exemptions for synthetic NA  No origin of replication, no integration…

NIH Guidelines: Definition of rNA  Molecules constructed by joining nucleic acids  & can replicate in a living cell

NIH Guidelines: synthetic  Nucleic acids that can base pr w naturally occurring nucleic acids

NIH Definitions Continued  Molecules resulting from replication of rNA or synthetic nucleic acids in past two slides

Other Changes  Fewer AAV serotypes need review  Transfer of drug resistance traits  Human Gene Transfer w nucleic acids

Risk Assessment & Synthetics  % of genome from each parent  Fn/purpose of each sequence Assume same fn as original host? Synergism between sequences & transgenes

What Next? - XNA  ~6 sugars can form NA bbone  Store & retrieve genetic info  Medical benefit? Slower breakdown in stomach & bloodstream

Real World Examples  iGEM 2006  Jay Keasling