Chemical Biological Safety Section

Select Agent Program and Dual Use Research of Concern (DURC)


Select Agent Program

Dual Use Research of Concern (DURC)

The Office of Environmental Health and Safety via its Chemical / Biological Safety Section (CBSS) provides oversight and administration of the VCU Select Agent Program. The VCU Biosafety Officer is the University's designated Responsible Official (RO) for the Select Agent Program. If you have questions about select agents and toxins, email the VCU Biosafety Officer or call 804-400-4984.

The list of agents and toxins classified by the Federal government (USDA and CDC/HHS) as Select Agents are those agents or toxins deemed a severe threat to public, animal or plant health, or to animal or plant products. Any possession, use, transfer or shipment of these materials is strictly controlled by regulation. For the most up to date listing, please check the Select Agents and Toxins List.

Principal Investigators considering work with any of these materials must first contact the VCU Biosafety Officer to initiate the approval process which consists of security and containment assessments, permits, personnel security clearances and other necessary paperwork. All registration activities for these agents must be coordinated through the Biosafety Office; researchers cannot register directly with the USDA or CDC. Be aware that VCU/Federal approval can take 6 months or more to complete in advance of any project. A detailed listing of steps to complete registration is available from the VCU Biosafety Office. General information on select agents and toxins can be found on the Federal Select Agent Program website.

Note that the following are also considered select agents and require full registration:

  1. Nucleic acids that can produce infectious forms of any of the select agent viruses listed (e.g. nucleic acids from positive strand RNA viruses: Tick-borne encephalitis complex (flavi) viruses, and the togaviruses (Venezuelan Equine Encephalitis virus and Eastern Equine Encephalitis virus).
  2. Recombinant nucleic acids that encode for the functional forms of any toxin listed if the nucleic acids
    • can be expressed in vivo or in vitro OR
    • are in a vector or recombinant host genome and can be expressed in vivo or in vitro
  3. Select agents and toxins listed that have been genetically modified.

Certain attenuated strains are excluded from the select agent regulations provided there is no reintroduction of factor(s) associated with virulence or other manipulations that modify the attenuation to restore or enhance virulence. A current list of excluded strains can be found via the Select Agents and Toxins Exclusions website. Note that the use of these strains at VCU still requires university registration for the purposes of monitoring inventories and intra-university transfers.

Some types of diagnostic work with select agents are exempt from full federal registration, but restrictions apply. Please contact the VCU Biosafety Officer to discuss diagnostic work or work with non-confirmed specimens.
Select agent toxins do not require full federal registration if the amount under the control of a principal investigator, veterinarian or treating physician does not exceed, at any time, the amounts listed in the Permissible Toxin Amounts on the Select Agent website. The use of these toxins also requires university registration for the purposes of monitoring inventories and intra-university transfers.

Failure to comply with Select Agents and Toxins federal regulations is punishable by both fines and imprisonment.

FORMS

University Registration: Use this form to register the select agent or toxin if not previously registered or if adding a "new" select agent or toxin to the laboratory. Return the completed and signed registration form by email to the VCU Biosafety Officer or by faxing to 804-828-1157 or by Campus Mail to PO Box 98011. Annually, the VCU Biosafety Officer conducts a review to verify / confirm types, locations, quantities, and security controls of all select agents and toxins.

Select Toxin Transfer Due Diligence: Use this form to document the due diligence performed for any transfer of select toxins in any amount (internally or externally) to any entity or individual. According to 42 CFR 73.3(d), a registered entity transferring an amount of select toxin otherwise excluded must:

  • Transfer the amounts only after the transferor uses due diligence and documents that the recipient has legitimate need (i.e., reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins.
  • Report to CDC if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to a toxin.

Dual use research of concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misused to pose a significant threat with broad consequences to public health and safety, agricultural crops and other plants, animals, the environment, or national security. The National Institutes of Health, Office of Science Policy website, describes the policies, practices, and procedures required to ensure that DURC is identified and risk mitigation measures are implemented.

DURC Policy

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, effective September 24, 2015, describes the policies, practices, and procedures required to ensure DURC is identified and risk mitigation measures are implemented. EH&S and the Institutional Biosafety Committee (IBC), with assistance from the Office of Research and Innovation, are responsible for developing and implementing the University's DURC policy.
Research involving any of the agents or toxins subject to policy requirements must be reviewed for DURC. If research with these agents is anticipated to create any experimental categories of concern listed below, it can also be DURC.

Agents and toxins subject to DURC policy:

  1. Avian influenza virus (highly pathogenic)
  2. Bacillus anthracis
  3. Botulinum neurotoxin
  4. Burkholderia pseudomallei
  5. Burkholderia mallei
  6. Ebola virus
  7. Foot-and-mouth disease virus
  8. Francisella tularensis
  9. Marburg virus
  10. Reconstructed 1918 influenza virus
  11. Rinderpest virus
  12. Toxin-producing strains of Clostridium botulinum
  13. Variola major virus
  14. Variola minor virus
  15. Yersinia pestis

Experimental categories of concern:

  1. Enhances the harmful consequences of the agent or toxin
  2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification
  3. Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
  4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
  5. Alters the host range or tropism of the agent or toxin
  6. Enhances susceptibility of a host population to the agent or toxin
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above

DURC Procedures

DURC Application: Principal Investigators are required to complete and submit a DURC application is research involves any agents subject to DURC policy. This is required initially and then every three years or more frequently if there is a change in agents or experimental effects. The three year renewal will be made concurrent with the Memorandum of Understanding and Agreement (MUA) renewal date when applicable.

DURC Institutional Review Entity (IRE): The DURC IRE (a sub-committee of the VCU IBC) is required to assess all research agents subject to the DURC policy. Refer to the DURC IRE charter for details concerning responsibilities, membership, and meetings.

Risk Mitigation Plan: If research with the listed agents is anticipated to involve any experimental effects of concern is an considered DURC, the IRW will work with the Principal Investigator and the funding sponsor to develop a risk mitigation plant that will be updated annually or more frequently as needed.

VCU DURC Review Process: For a visual representation, visit the Process Map located at: LINK TBD

Training: DURC Training is required for Principal Investigators and their research personnel if their research involves the agents covered in the DURC policy. Training slides from the US Department of Health and Human Services are available at: http://www.phe.gov/s3/dualuse/Documents/durc-us-policy-trng.pdf. PI's are required to document review of these training materials and maintain that training record for 3 years.

Questions? Email the VCU Institutional Contact for Dual Use Research (who is also the VCU Biosafety Officer) or call 804-400-4984 for more information.


  about Select Agents, contact Mike Elliott.
 

  400-4984


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This page last updated 10/05/15.