How to use this tool

Select Agents and Toxins are subject to stringent regulatory requirements under 42 CFR 73 for their potential to pose a severe threat to public, animal or plant health or to animal or plant products. These toxins are indicated in the list below.

Experiments involving any of the following are also regulated:

GENETIC ELEMENTS, RECOMBINANT NUCLEIC ACIDS, AND RECOMBINANT ORGANISMS

1. ​Nucleic acids that can produce infectious forms of any of the select agent viruses.
2. Recombinant nucleic acids that encode for the functional form(s) of any of the select agent toxins if the nucleic acids: a) can be expressed in vivo or in vitro; or b) are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
3. Select agents that have been genetically modified.

OTHER RESTRICTED WORK

1. ​Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to the listed agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
2. Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of listed toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight.

Exemptions

The following select agents or toxins are exempt:

• Any select agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracred from its natural source.
• Non-viable select agent organisms or nonfunctional toxins.
• Toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor, if the aggregate amount does not, at any time, exceed the amount listed in parenthesis next to the toxin.
• Medical use of toxins for patient treatment.
• Additional exemptions are listed on the CDC website.

* A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral pathogenicity index in day-old chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

** Short, paralytic alpha conotoxins containing the following amino acid sequence: X₁CCX₂PACGX₃X₄X₅X₆CX₇

*** Tier 1 agents

^α APHIS Plant Pathogen

^ψ HHS Select Infectious Agent

^β USDA High Consequence Livestock Pathogen or Toxin

^χ USDA-HHS Overlap Agent