Select Agent List (PDF)

CDC Select Agent
Program (SAP)

Definition and Instructions

Information for IBC Registration Forms and Determination of Project Exemption

• See the definition of recombinant DNA in the NIH rDNA Guidelines. Go to the table of contents and click Section I-B. An abbreviated version is: “Molecules which are constructed outside living cells by joining DNA segments to DNA molecules that can replicate in a living cell.” (R. Gilpin, PhD, RBP, CBSP, 2002).
   
• SOI: Sequence-Of-Interest. One important characteristic of a SOI is its origin – what species it derives from originally. It may also be important to note the actual origin of the fragment of nucleic acid you are using, for instance, a BAC, a lambda phage or other library. GenBank references are also helpful.
   
• Host: A temporary or endpoint organism used to replicate or express rDNA. For instance, E. coli K-12 used to replicate plasmids, HEK 293 cells used to replicate viral vectors,  transgenic organisms.
   
• Vector: Supplemental DNA used to manipulate (deliver, express, replicate, recombine) the SOI. For instance, some plasmids, and viruses have been engineered to manipulate SOIs.
   
• Host-Vector-SOI Systems (H-V-SOI): A basic “unit” of the NIH rDNA Guidelines. Certain H-V-SOI have been exempted from the requirement for registration with the IBC. Many projects that involve rDNA require several H-V-SOI to manipulate the SOI into the environment where its effects can be studied in vivo. If you can let the IBC know what H-V-SOIs you are using in your project, it can tell you which, if any need to be registered and at what point in the project you need to have IBC approval. Another important part of this process is for the IBC and PI to determine what safety precautions and practices need to take place in the use of the H-V-SOIs in your project.

Exemption Criteria

• Section III-F of the NIH rDNA Guidelines. In Section III-F-6, Appendix C is referred to, which further defines exempt H-V-SOI.
   
• Some transgenic rodents are exempt. See the transgenic rodent IBC registration application.
   
• Corrections to possible misconceptions about exemption to the NIH rDNA Guidelines and safety (safe - means more than basic laboratory precautions and/or microbiological practices are not necessary):
  • Biosafety Level 1 (BSL-1 or BL1) experiments are not automatically exempt.
  • All experiments in E. coli are not necessarily exempt or safe.
  • Commercial (kits) or well-worn host-vector systems are not necessarily exempt or safe.
  • Exempt experiments are not necessarily safe, that is, a higher BSL and/or other precautions and/or practices may be required by the IBC.