Use of Select Agents and Potentially Hazardous Biological Materials Policy

Policy Summary

Any activity involving Select Agents or Potentially Hazardous Biological Materials or conducting life sciences Dual Use Research of Concern requires prior review and approval by the Institutional Biosafety Committee (IBC). Activity involving Select Agents (other than exempt quantities of listed Toxins) also requires express written permission from the Associate Vice Provost for Research Integrity and Compliance. All IBC-approved activities involving Select Agents or Pathogens must be conducted in accordance with this policy. Failure to comply with this policy may result in disciplinary action up to and including termination.

Related Regulations

Who is Governed by this Policy 

  • Students
  • Staff
  • Faculty
  • Non-university entities using university property, equipment, or facilities

Policy

Prior Approval 

Anyone proposing to engage in an activity involving a Potentially Hazardous Biological Material must first check the Select Agent/ Toxin List and the Centers for Disease Control (CDC) / National Institutes of Health (NIH) publication Biosafety in Microbiological and Biomedical Laboratories to determine if the Agent or Toxin is a Select Agent or Pathogen.

Prior to obtaining Pathogens or Select Agents, storage and use must be reviewed and approved by the Institutional Biosafety Committee (IBC) and Office of the Vice Provost for Research (OVPR). To obtain a review, complete and submit to the Biosafety Officer within the Office of Research Safety (ORS) the IBC application containing a summary of the proposed research and a written protocol detailing the specific steps for material handling in the laboratory or animal facility. The protocol must address all hazards posed by the Select Agents or Potentially Hazardous Biological Materials to be used. 

If the proposed work will include Select Agents, there are additional requirements that will need to be met before approval will be granted. Requirements for approval include registration, background checks, and written protocols that address biosafety and containment, security, and incident response. Because of the many governmental requirements involved, the review process must be instituted well in advance of the proposed activity. Contact the Biosafety Officer within ORS to initiate the review process. Proposed use of materials deemed to be exempt under the regulations due to low quantities still must be reviewed and approved by the IBC prior to engaging in the activity to confirm safety measures are in place and that the use is truly exempt. Note also that any Select Agent discovered in any patient or other specimen must be reported to ORS immediately.

As Select Agents pose a risk under Occupational Health and Safety Administration (OSHA) regulations, Risk Management must be made aware of the use and storage of Select Agents on campus. Once the IBC and the Associate Vice Provost for Research Integrity and Compliance have approved the protocol involving the use of Select Agents, ORS will notify Environmental Health & Safety of the intended use. 

An individual who willfully or negligently violates this policy, federal, or state rules and regulations governing the use of Select Agents or Potentially Hazardous Biological Materials may have their approval use suspended or revoked by the Biosafety Officer pending review by the Associate Vice Provost for Research Integrity and Compliance. 

Usage 

Those working with Select Agents or Potentially Hazardous Biological Materials first must complete biosafety training and must read and comply with the university’s Biosafety Manual. Workers also must comply with all written protocols required by the IBC, all government regulations, and must cooperate in periodic reviews by the IBC. The IBC can at any time make changes to the requirements for the material. 

If the activity also involves recombinant DNA, review and approval is required in accordance with the Policy Regarding Use of Recombinant DNA (rDNA).

Storage, Disposal, and Transfer

Storage and disposal of Select Agents or Potentially Hazardous Biological Materials must comply with the Biosafety Manual and the conditions of the IBC approval. All storage, disposal, or transfer of select agents must comply with federal law and the conditions of its registration. In the event of transferring Potentially Hazardous Biological Materials off campus, contact the Biosafety Officer for requirements on transfer and shipping. If the transfer will be to another country or to a foreign national, review the university’s Export Control Policy and contact OVPR before the transfer. 

Definitions

Agents: Substance, whether biological or chemical, capable of producing an effect or reaction in living matter. An agent that is “infectious” is one that has the potential to produce disease. 

Potentially Hazardous Biological Materials: Infectious agents, human and non-human primate materials (including established cell lines), toxins of biological origin, regulated carcignogens, chemotherapy drugs, select agents, recombinant and synthetic nucleic acid molecules.

Pathogens: Those infectious agents identified by the CDC or NIH as having a biosafety level (BSL) of 2 or higher due to their ability to cause disease in healthy human adults. 

Select Agents: Pathogens (including genetically altered forms) or Toxins deemed by the CDC or U.S. Department of Agriculture to pose a high risk to human, animal, or plant health and could be utilized for terrorist activity. Also included are nucleic acids from these agents that could produce an infectious form or code for a toxin. The lists are incorporated in 42 CFR §73, 7 CFR §331 and 9 CFR §121 but a complete list can be found here. 

Toxins: Poisonous compounds produced by certain microorganisms, plants, or animals that produce disease. 

Procedures

Further information and guidelines regarding Select Agents and Pathogens, and regarding IBC guidance and forms, is available on the ORS website and the university’s Biosafety Manual.

Related Information

Contacts

Contact Phone Number Email Address
Office of Research Safety 202-994-2407 [email protected]

 

Responsible University Official: Vice Provost for Research
Responsible Office: Office of the Vice Provost for Research

Noncompliance with this policy can be reported through this website.