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… Unlike the NIH Guidelines, the City sees nothing as exempt. Here is some of the non-hazardous work that needs to be registered. Its unfortunate that our registration form uses biohazardous when work like this is really biological in nature.

NIH Guidelines: Definition of rNA Molecules constructed by joining nucleic acids & can replicate in a living cell NIH does define what a recombinant molecule is. In the diagram we see how insulin is made. Note that there is a push to cover more synthetic biology work and some proposed changes to the Guidelines have been circulated.

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