• Nucleic acids that can produce infectious forms of any of the select agent viruses.

• Recombinant nucleic acids that encode for the functional form(s) of select agent toxins if the nucleic acids:

  • Can be expressed in vivo or in vitro or,

  • Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.

• Select agents and toxins that have been genetically modified.

The purpose of this regulatory language is to address advancements in molecular biology that may influence the production of infectious forms of select agent viruses, or the active forms of select agent toxins. It has been demonstrated, for example, that the single stranded (positive strand) RNA viruses and certain double stranded DNA viruses that utilize host polymerases contain nucleic acids that can produce infectious forms. Examples of select agent viruses that meet this criterion, and would therefore be regulated, include:

• Tickborne encephalitis complex (flavi) viruses:

  • Central European Tick borne encephalitis

  • Far Eastern Tickborne encephalitis

  • Russian Spring and Summer encephalitis

  • Kyasanur Forest Disease

  • Omsk Hemorrhagic Fever

• Eastern Equine Encephalitis virus

• Venezuelan Equine Encephalitis virus

• Classical Swine Fever Virus

• Foot-And-Mouth Disease Virus

• Japanese Encephalitis Virus

• Swine Vesicular Disease Virus

• Cercopithecine Herpesvirus 1 (Herpes B virus)

• Malignant Catarrhal fever Virus (Alcelaphine Herpesviurs Type 1)

Under the current select agent regulations the following are examples of materials that would not be regulated as a select agent:

• Non-infectious components of select agent viruses including:

  • Material from regulated genomes that has been rendered non-infectious

  • cDNA made from regulated select agent genomes

  • Genomic fragments from select agents (unless they encode for a functional form of a select agent toxin)

  • Complete genomes of single-stranded negative-strand RNA viruses, double-stranded RNA viruses, and double-stranded DNA