Biosafety Manual
Safety guidance, policies, and procedures for work with biological materials
Select Agents
Summary
How to manage and work with biological select agents and toxins.
Who is this for?
All students, faculty, and staff who possess or use select agents or toxins.
Managing select agents and toxins
The Federal Select Agent Program (FSAP) regulates possessing, using, and transferring biological select agents and toxins that could severely threaten animal, plant, or public health. FSAP also addresses security concerns about potentially misusing these agents.
You can only possess or use these agents and toxins at Harvard:
- Excluded or exempt select agents.
- Permissible amounts of select toxins.
You must register and receive approval from the Committee on Microbiological Safety (COMS) following COMS policy before using any select agents or toxins.
Contact biosafety@harvard.edu if you discover a select agent or toxin, notice suspicious activity, or suspect a federal violation, loss, or theft. EHS will notify FSAP.
Non-regulated quantities of select toxins
Certain select toxins are exempt from full FSAP regulations when they are either:
- Non-viable.
- Present in non-regulated quantities specified in Department of Health and Human Services regulation 42 CFR 73.3(d)(7) and remain under the control of a Principal Investigator (PI), treating physician, or veterinarian.
- Present in their naturally occurring environment.
Review Select Agent Program Permissible Toxin Amounts for a list of allowed exempt select agent quantities.
PIs must register all work with select agents and toxins, including exempt quantities, with COMS.
All lab staff who use toxins must complete lab-specific safety training that includes:
- Toxin inventory recordkeeping.
- Toxin characteristics and hazards.
- Equipment and personal protective equipment (PPE) for working with toxins.
Never exceed the maximum allowable amount of toxins.
Only trained and approved staff can access toxins.
Follow a toxin-specific standard operating procedure (SOP) when handling each toxin.
Each SOP must include:
- Required PPE.
- Safe handling, storage, and use.
- Decontamination, inactivation, and disposal.
Keep an inventory of all toxins used in your lab and their available quantities.
Store toxins in secondary containment with restricted access, such as a locked freezer or lock box.
You must receive approval from EHS and COMS before transferring toxins. Contact biosafety@harvard.edu to request a transfer.
Document each time you destroy and dispose of toxins using a select agent toxin exempt quantities destruction form.
Related resources
Find documents and online tools to manage select agents and toxins.
Select Agent Toxin Exempt Quantities Destruction Form
Form to document destroying exempt quantities of select agent toxins
Select Agent Toxin Exempt Quantities Inventory Form
Form to record an inventory of exempt quantities of select agent toxins
Learn more
Contact biosafety@harvard.edu or your Biosafety Officer (BSO) for more information about select agents and toxins at Harvard.
Review these FSAP resources about select agents and toxins:
- Select Agents and Toxins List.
- Permissible Toxin Amounts.
- Select Agent and Toxin Exclusions.