Overlap select agents and toxins.

CFR · 2024-01-01 · US · Title 9

(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator 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: * (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 forms of any overlap toxin listed in paragraph (b) of this section if the nucleic acids: (i) Can be expressed (ii) Are in a vector or recombinant host genome and can be expressed (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: (1) Any overlap select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (2) Nonviable overlap select agents or nontoxic

official document · source cfr-2024 · id 9:§ 121.4