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SELECT AGENT REGISTRATION

A Principal Investigator (PI) may not possess or use, receive from outside the United States, or transfer from within the United States, any biological agent or toxin listed as a Select Agent by DHHA or the USDA until they have been approved to use the biological agent or toxin by Penn EHRS and have been granted a certificate of registration by the DHHA Secretary of the USDA Secretary.

Prior to possession, use or transfer of any Select Agent, a principal investigator (PI) must registerd with the appropriate federal agency (CDC and/or APHIS). Application packets are available at the following websites:

DHHS CDC packet

USDA APHIS packet

  1. The PI must complete PENN's Select Agent Registration Form, in its entirety.


  2. The PI must complete the appropriate agency registration packet in coordination with EHRS.


  3. The PI must submit an IBC registration document to the PENN Institutional Biosafety Committee (IBC) for approval to use the following genetic elements, recombinant nucleic acids, or recombinant organisms:
    1. Select Agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the select agent viruses.


    2. Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the listed toxins if the nucleic acids: a) are in a vector or host chromosome; b) can be expressed in vivo or in vitro; or c) are in a vector or host chromosome and can be expressed in vivo or in vitro.


    3. Listed viruses, bacteria, fungi, and toxins that have been genetically modified.


  4. After all local documents are completed and approved, the director of EHRS (RO) will sign the agency registration packet and submit it to the appropriate agency


  5. If the PI proposes the use of a Select Agent in animals, approval from the Institutional Animal Care and Use Committee (IACUC) and EHRS is required. A copy of PENN's IACUC Protocol Review Form and the EHRS Review process can be found at the EHRS website.


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