Select agents and toxins are highly regulated by the Centers for Disease Control and Prevention and the United States Department of Agriculture. These materials are regulated because of their ability to cause severe disease resulting in a significant threat to human, animal and plant health, and can also affect plant and animal products. The list of select agents can be found at http://www.selectagents.gov, and can change periodically as the regulations and listing of agents is reviewed approximately every 3-5 years. Select agent research is only permitted in certain rooms and buildings, and must be approved by the CDC/ USDA prior to commencing work. All persons must also receive prior approval from REHS and the CDC/USDA as appropriate.

If you wish to work with select agents, or applying for a grant where select agent research is proposed, you must contact the University Biosafety Officer immediately at 973-972-8424. If you find any select agent material improperly stored in your laboratory you must also contact the University Biosafety Officer immediately.

Bacteria, viruses, and parasites are regulated at any level, but some toxins are regulated stringently only at certain amounts. PIs can possess some toxin in their regular laboratory with minimal requirements at exempt levels. Exempt levels of toxin research MUST be registered with the Institutional Biosafety Committee prior to obtaining and working with the toxin, and the toxin MUST be secured within the laboratory against unauthorized access.

Maximum permissible toxin amounts include (this is PER investigator):

HHS Toxins [§73.3(d)(3)]

Amount

Abrin

1000 mg

Botulinum neurotoxins

1 mg

Short, paralytic alpha conotoxins

100 mg

Diacetoxyscirpenol (DAS)

10,000 mg

Ricin

1000 mg

Saxitoxin

500 mg

Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)

100 mg

T-2 toxin

10,000 mg

Tetrodotoxin

500 mg