IBC> Select Agent Government Regulations> List of Select Agents
List of Select Agents
Select agents are regulated by either the U.S. Department of Health and Human Services (HHS) or the U.S. Department of Agriculture (USDA). Some of the select agents are considered "overlap" select agents as both departments consider them to be a biological threat. Below is the link to the CDC website where a List of Select Agents (HHS, USDA, and overlap) that require registration can be found. If you
have in your possession, or plan to work, receive or transfer any of these Select
Agents, you must notify the Responsible Official or the Alternate Responsible Official. Failure
to register your lab could result in a fine or imprisonment for up to 5 years,
or both, for the individual investigator and a fine for the Institution.
In addition to the listing above, Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms fall under the category of select agents if any of the following conditions are met.
- Nucleic acids that can produce infectious forms of any of the select agent viruses listed
- Recombinant nucleic acids that encode for the functional form(s) of any of the toxins listed if the nucleic acids 1) can be expressed in vivo or in vitro, or 2) are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
- Any select agent or toxin listed that has been genetically modified
There are quantity exclusions to some of the agents on the HHS and overlap list, i.e. if you work with these agents in small enough quantities, the institution does not have to register their use. HOWEVER, the Responsible Official or Alternate Responsible Official still MUST be notified of your intentions to work with these agents.
Exclusions to the HHS Select Agent List (If the amount under the control of any one investigator is less than the amounts listed below, the material is excluded from the regulations.)
- 100mg of Abrin
- 100mg of Conotoxins
- 1,000mg of Diacetoxyscirpenol
- 100mg of Ricin
- 100mg of Saxitoxin
- 100mg of Shiga-like ribosome inactivating proteins
- 100mg of Tetrodotoxin
Exclusions to the Overlap Select Agent List (If the amount under the control of any one investigator is less than the amounts listed below, the material is excluded from the regulations.)
- 0.5mg of Botulinum Toxin
- 100mg of Clostridium perfringes epsilon toxin
- 100mg of Shigatoxin
- 5mg of Staphylococcal entertoxins
- 1,000mg of T-2 toxin
Exclusions to the USDA Select Agent List (If the amount under the control of any one investigator is less than the amounts listed below, the material is excluded from the regulations.)
To view the Select Agent Final Rule go to http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf