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