Restricted Biological Agents Guide

Both the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR) have provisions for the control of biological agents. The control level is different depending on which regulations control the material.

If you work with any of the following or similar agents and/or you intend to send samples or data abroad or plan to collaborate with foreign colleagues either within the United States or in foreign countries, please contact Vanderbilt Export Compliance. We will help you determine what restrictions apply to the agents in your lab and how to incorporate the export control requirements into your research program.

WHAT BIOLOGICAL AGENTS ARE RESTRICTED?

Which research materials are affected?

US export controls impose a requirement to obtain export authorization for shipment to any international destination (including Canada) of certain controlled human, animal, and plant bacteria, viruses, fungi, and toxins. In addition, they restrict the export of genetically modified organisms (GMOs) or genetic elements that contain or code for the genes of controlled pathogens or subunits of controlled toxins, including in some cases where the GMOs or genetic elements are not themselves pathogenic. Importantly, the controls apply not only to the complete, wild-type organisms listed in the above-referenced ECCNs, but also to any GMO that contains, or any genetic element that codes for, genes of the listed organisms or subunits of the listed toxins. “Genetic elements” is broadly defined to include (without limitation) chromosomes, genomes, plasmids, transposons, vectors, and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesized in whole or in part.

Notably, while a GMO that contains, or genetic element that codes for, genes of controlled bacteria and fungi is subject to control if it “[i]n itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health” or “[c]ould endow or enhance pathogenicity,”  GMOs that contain, or genetic elements that code for, genes of controlled viruses, or subunits of controlled toxins, are controlled for export even if they are not themselves harmful.

Below is a list of agents restricted for export by the U.S. Department of Commerce. Be aware that this list is not exhaustive but is limited to biological agents likely to be used at Vanderbilt and have export control restrictions.

These listed items are controlled for export regardless of quantity or attenuation, genetic elements or genetically modified organisms for such agents or “toxins”, including small quantities or attenuated strains of select biological agents or “toxins” that are excluded from the lists of select biological agents or “toxins” by APHIS, CDC, or DHHS.

NOTE: Genetic elements from any of the below are also controlled. Specifically, any nucleic acid sequences which code for biological toxins, any nucleic acid sequences that are a hazard to human health when transcribed or translated, or any nucleic acid sequence that would make any restricted microorganism above more pathogenic. This also covers microorganisms that have been genetically altered to express the above genetic elements.

1. 1.  Any agent on the Select Agent List found here: http://www.selectagents.gov/SelectAgentsandToxinsList.html
   2.  Additionally, any item listed by the Department of Commerce (see Commerce Control List, Category 1: “Materials, Chemicals, Microorganisms and Toxins“):
   • • Bacteria
     • Fungi
     • Toxins
     • Viruses

  BACTERIA

 FUNGI

  TOXINS

  VIRUSES