. "Appendix E: Applicability of the Select Agent Regulations to Issues of Synthetic Genomics." Sequence-Based Classification of Select Agents: A Brighter Line. Washington, DC: The National Academies Press, 2010.
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Sequence-Based Classiﬁcation of Select Agents: A Brighter Line
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