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In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii) above. If you are using DNA primers for PCR, you do not need to check the box “recombinant or synthetic DNA/RNA materials, including human gene therapy.”

Biological toxins are defined as toxins produced by microorganisms, animals and plants. Chemicals or products which are considered toxic are not considered biological toxins. For a list of biological toxins and corresponding LD50 values, see the University of Florida’s EH&S webpage (

If your research does not fall into any of the categories listed on this page, you likely do not need to file a biosafety protocol. We are no longer requiring a biosafety protocol for work with chemicals and animals; this work should be covered in your lab’s Chemical Hygiene Plan and Animal Protocol. Call our office (608-263-2037) to verify your work does not require a biosafety protocol.

Still have questions? Call the Office of Biological Safety (OBS) at 608-263-2037. We are happy to help!!

Keywords:recombinant nucleic acids, synthetic nucleic acids, DNA primers, biological toxins   Doc ID:43073
Owner:Donna C.Group:ARROW - Institute for Biosafety Committee
Created:2014-08-21 14:47 CDTUpdated:2016-10-10 13:57 CDT
Sites:ARROW - Institute for Biosafety Committee
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