§ 73.4 Overlap select agents and toxins.
(a) Except for exclusions under paragraphs (d) and (e) of this section, the HHS Secretary has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. The select agents and toxins marked with an asterisk (*) are designated as Tier 1 select agents and toxins and are subject to additional requirements as listed in this part.
(b) Overlap select agents and toxins:
Bacillus anthracis *
Bacillus anthracis Pasteur strain
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei *
Burkholderia pseudomallei *
Hendra virus
Nipah virus
Rift Valley fever virus
Venezuelan equine encephalitis virus
(c) Genetic Elements, Recombinant and/or Synthetic Nucleic Acids, and Recombinant and/or Synthetic Organisms:
(1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph (b) of this section.
(2) Recombinant and/or synthetic nucleic acids that encode for the toxic form(s) of any overlap toxins listed in paragraph (b) of this section if the nucleic acids:
(i) Can be expressed in vivo or in vitro, or
(ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
(3) Overlap select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) Overlap select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: