1. 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

2. Is chemical synthesis covered?
synthesizer
Not until in a …

3. 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.

4. 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.

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

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

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

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

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

10. Real World Examples
iGEM 2006
Jay Keasling