Environmental, Health and Safety Services

Select Agents and Toxins Research

Select Agents and Toxins (SAT)

  • These are biological agents and toxins (often referred to as simply 'select agents') which possess the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products.
  • A list of these agents and toxins is maintained by the Federal Select Agent Program, and is regularly updated.
  • Many select agents must be handled using the strict containment and PPE requirements of Biosafety Level 3 or 4, although some can be manipulated at BSL-2. However, ALL select agent research must take place under high security conditions that are regulated by federal code and overseen by HHS-CDC and/or USDA.

The Centers for Disease Control and Prevention (CDC) is the oversight body that approves and monitors research involving select agents and toxins at Virginia Tech. The Institutional Biosafety Committee (IBC) reviews and approves research involving select agents to ensure that it complies with federal regulations.

  • Principal investigators who are interested in conducting work with select agents must:
    • Contact the Responsible Official.
    • Submit a protocol to the IBC for review and approval, and for periodic renewal.
  • Students who have an interest in participating in research that involves select agents should contact the Responsible Official to learn more.

The Federal Select Agent Program

  • The program is a joint effort of the Centers for Disease Control and the U.S. Department of Agriculture. Regulatory authority is federally granted by 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.
  • This program oversees the possession, use and transfer of biological select agents and toxins by:
    • Developing, implementing and enforcing the Select Agent Regulations.
    • Inspecting entities that possess, use or transfer select agents.
    • Ensuring that all individuals who work with these agents undergo a security risk assessment performed by the FBI/ Criminal Justice Information Service.
    • Providing guidance to regulated entities for achieving compliance with the regulations.
    • Investigating of any incidents in which non-compliance may have occurred.
  • All entities performing work on select agents in the U.S. must be officially registered with the program and subscribe to its oversight.

The VT Select Agent Program:

  • Ensures compliance with CDC and APHIS regulations which apply to:
    • research activities conducted at Virginia Tech involving select agents, including possession and use, tranfers within the U.S., and importations.
    • VT facilities where select agents are used and stored, including animal research facilities.
    • individuals (VT faculty, staff, students and visitors) requiring access to select agents, or access to an area where select agents are present.
  • Aids VT principal investigators, researchers and supervisors working with select agents to achieve and maintain compliance.
  • Is administered by VT Environmental Health and Safety through the Responsible Official (RO) and Alternate Responsible Officials (ARO), who maintain VT's registration with the Federal Select Agent Program.
  • The Responsible Official (or ARO in the RO's absence):
    • Acts as a liaison for VT with regulatory agencies, state health agencies, and emergency response providers.
    • Investigates all incidents of loss, theft or release of select agents, and is the reporting authority for these incidents to regulatory agencies and to academic departments.
    • Conducts regular inspections of select agent facilities, including animal research facilities.
    • Reviews and approves risk assessments, and safety, security and incident response procedures for select agent research.
    • Coordinates with the EHS Occupational Health group as needed regarding appropriate medical surveillance and care for personnel in the VT Select Agent Program.
    • Conducts personnel suitability evaluations and investigations when required.
    • Provides administrative processing and select agent training for new personnel.
    • Provides annual training for all personnel in the VT Select Agent Program, and for those professionals who would respond to an incident or emergency at VT select agent facilities.
  • Lab Worker Requirements
    • To be granted access to VT select agent facilities (other than an approved, escorted visitor) and to conduct work with select agents therein, an individual must:
    • Undergo a federal Security Risk Assessment approval and maintain security approval.
    • Undergo a personnel suitability assessment and maintain suitability approval.
    • Initially complete and keep up-to-date with all required select agent training and IBC-required training.
    • Initially complete and keep up-to-date all VT Occupational Health requirements.
    • Comply with all approved select agent program written plans and procedures (incident response plan, security, biosafety, lab-specific SOPs, etc.)

Biotoxins as Select Agents and the Due Diligence Provision

  • Some biotoxins are classified by the federal government as Select Agents due to their potential to pose a severe threat to public health and safety. Possession, use and transfer of these toxins is highly regulated.
  • In small quantities, some of these agents are exempt from Select Agent registration but must still be registered with, and approved for use by the VT IBC.
    ToxinExempted Amount (≤)
    Abrin100 mg
    Botulinum neurotoxins0.5 mg
    Short, paralytic alpha conotoxins (containing the amino acid sequence X1CCX2PACGX3X4X5X6CX7)100mg
    Diacetoxyscirpenol (DAS)1000mg
    Ricin100mg
    Saxitoxin 100mg
    Staphylococcal enterotoxins (Subtypes A, B, C, D, E)5 mg
    T-2 toxin1000mg
    Tetrodotoxin100mg
  • Because it would be possible to stockpile toxins in multiples of these amounts which are small enough to be excluded from regulation, the 'Due Diligence' policy places the following responsibilities on Principal Investigators, veterinarians or medical doctors:

    IF YOU POSSESS ANY OF THESE TOXINS, YOU MUST:

    1. Declare your possession and provide inventory documentation to Virginia Tech's Responsible Official (RO) and Alternate Responsible Official (ARO).
    2. Contact the RO and/or ARO to schedule a SHORT informational session regarding requirements related to possession of these toxins.
    3. If no additional toxin is received after the declaration date, but at least annually, you must verify and declare your possession to Virginia Tech's RO and ARO.
    4. Immediately notify Virginia Tech's RO and ARO if your toxin inventory amounts, per toxin, ever exceed specified permissible limits.

    IF YOU TRANSFER ANY OF THESE TOXINS TO ANOTHER ENTITY, YOU MUST:

    1. Apply due diligence in assessing/ensuring that the recipient of these toxins has a legitimate need to handle/use such toxins.
    2. Complete documentation prior to the transfer which records your information and the recipient's intended use of the toxin. The Notification of Toxin Transfer form (template can be found in the Appendices of this manual) must be submitted to Virginia Tech's RO and ARO.
    3. Immediately report to Virginia Tech's RO and ARO, if a violation of federal law is detected, or if suspicious activity related to the toxin is discerned.

    IF YOU RECEIVE ANY OF THESE TOXINS FROM ANOTHER ENTITY, YOU MUST:

    1. Immediately notify Virginia Tech's RO and ARO of the receipt of the toxin, update your inventory, and submit inventory documentation to the RO and ARO.

CONTACTS:

TitleNamePhoneEmailMail Code
ROCharlotte Waggoner540-231-5864ren@vt.edu0423
AROAnna Kroner540-231-1122akroner@vt.edu0423
AROShilpa Soni540-231-0976shilpa@vt.edu0423

Guidance and Further Information:

IBC
Federal Select Agent Program
EHS Biosafety Office