Reaching Others University at Buffalo - The State University of New York
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Select Agents

The U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) have published the regulations that govern the possession, use, and transfer of Select Agents and Toxins (42 CFR part 73, 7 FR part 331, and 9 CFR part 121).

Any researcher desiring to obtain, possess or work with Select Agents must be approved by the Department of Health and Human Services or the United States Department of Agriculture(USDA) . Please contact the University at Buffalo’s Responsible Official (829-3301) to begin the application process.

The list of agents and toxins maybe found at: http://www.selectagents.gov/resources/List_of_Select_Agents_and_Toxins_2012-12-4.pdf

Researchers desiring to work with regulated Select Toxins of biological origin should be aware that possession of small quantities not exceeding a maximum threshold may be allowed under the Select Agent regulations. The list of toxins and exempt quantities may be found at http://www.selectagents.gov/Permissible%20Toxin%20Amounts.html. Note the use of select agent toxins of biological origin in any quantity may require approval of the University's Institutional Biosafety Committee.

Coding for these toxins may be restricted, even if the amount of toxin generated or possessed remains under the maximum threshold. See Restricted Experiments below. 

An individual or entity may not conduct, or possess products (i.e., select agents that are not known to acquire a drug resistance trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture, or recombinant and/or synthetic nucleic acids containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] < 100 ng/kg body weight) resulting from, the following experiments unless approved by and conducted in accordance with the conditions prescribed by the Administrator:

Restricted experiments:

  1. Experiments that involve the deliberate transfer of, or selection for, a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture.
  2. Experiments involving the deliberate formation of synthetic or recombinant nucleic acids containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50]<100 ng/kg body weight.

NOTE: These types of experiments are NOT prohibited, but permission must be obtained from the lead agency, which in our case is the CDC.

Example:

The gene for Tetrodotoxin is transduced from the natural symbiotic host bacterium Pseudoalteromonas tetraodonis, found in the Puffer fish to E. coli K-12. It is then amplified, but the amount of tetradotoxin produced is in the nanogram range, well under the 100 milligrams. permissible amount.

This is a restricted experiment under the rules. The E. coli K-12 genomic construct would have be identified on the permit and handled under the regulations.

Note, this is true even though:

  1. The natural host bacteria (or others such as Vibrio sp.) are not regulated
  2. E. Coli K-12 is not a select agent.
  3. The amount of Tetrodotoxin produced will never exceed threshold amounts.

If you have any questions please contact the Responsible Offical at EH&S 829-3301.