Unless exempt (under 42 CFR 73 and 7 CFR 331 & 9 CFR 121), an individual or entity shall not possess, use or transfer any CDC/USDA select agent or toxin without a certificate of registration issued by the HHS Secretary or the USDA Secretary.
Principal Investigators (PI) interested in working with select agents or toxins must contact the Office of Biosafety, the PI in coordination with the RO will complete the application packet and the RO will submit the completed application to the appropriate federal agency.
Select agents or toxins that fall under the category of excluded or exempt must still register these agents with the Office of Biosafety.
All protocols that involve the use of select agents and/or toxins must be reviewed and approved by the Institutional Biosafety Committee (IBC).
Pathogen specific protocols must also be submitted to CDC/USDA when applying for agent specific registration.
If PI proposes the use of animals in the select agent and toxin protocol, then approval from Institutional Animal Care and Use Committee (IACUC) is required.
Investigators interested in working with select agents and/or toxins must contact the Office of Biosafety and allow ample time for both federal and university approval processes.
Office of Biosafety, Tulane University, New Orleans, LA 70112 504-988-0300 email@example.com