Biological research and the shipment of biologicals are subject to the oversight of various agencies and their regulations, including export control laws and, potentially, DOT/ IATA and CDC and APHIS regulations. The costs and consequences of non-compliance can be significant, as was the case with a U.S. university recently fined $54,000 by the Department of Commerce for export control violations related to the shipment of animal pathogens (in this case VSV-G packaging plasmids) overseas. Although the material was not a fully virulent select agent, the items being shipped still contained genetic material from the select agent and were subject to export control restrictions. For this reason, contact the Export Control Office before shipping biologicals to ensure that your shipment is in compliance with relevant laws.
Two sets of export controls govern biological research and the physical shipments of biologicals: the Export Administration Regulations (EAR), which control dual-use items and technologies and software with commercial and military applications; and the International Traffic in Arms Regulations (ITAR), which control materials, technologies and software specially designed for military applications. Note that the EAR imposes controls over a broader group of items than those controlled by other U.S agencies, including APHIS and the CDC.
The EAR controls “certain viruses, bacteria, fungus and toxins, as well as genetic elements or genetically modified organisms that contain or code for the genes of controlled pathogens, even if that genetic material is not, itself, pathogenic.” It is important to note, too, that export controls apply regardless of quantity or attenuation, including to small quantities or attenuated strains of select agents of toxins that are excluded from lists administered by APHIS or the CDC. Finally, the controls apply to shipments to all countries and for all purposes and “even when the materials at issue are widely available and in use internationally.”
The transport of materials across or outside of the U.S. border may require special handling, export or import licenses, and/or Customs clearance. Contact the Export Control Office at email@example.com if you plan to ship any of the following controlled materials, technologies, or software:
- Materials listed on the Commerce Control List (CCL) under Export Control Numbers (ECCNs) 1C351 and 1C 354, including: Chikungunya virus; Cholera toxin; Ebola virus; Salmonella typhi; and Saxitoxin. As noted above, the CCL is broader than the Select Agents List. (See pages 65-73 at for a current version of the full list of controlled materials.)
- Genetic elements and genetically modified organisms that contain or code for genes of the pathogens and toxins above; therefore, the controls apply not only to “the complete, wild-type organisms” on the CCL, 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 defined broadly, and includes, 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 ,” as described under ECCN 1C353. (See pages 70-71 at for a complete description.)
- Vaccines against the items referred to above, or immunotoxins containing items referred to above.
Other controls apply to material that can be used offensively or that might be used by a recipient in the design, development, production, stockpiling, or use of chemical or biological weapon. Additionally, export controls will limit shipments to countries (Cuba, Iran, North Korea, and Sudan) or individual entities that are sanctioned by the US government.
If you have questions:
Contact Export Control Office at firstname.lastname@example.org with questions about shipments of biological materials. Our office can help secure appropriate permissions and serve as a clearing house to connect you with other IU offices that can assist with logistics, packaging, and the other complex requirements that may apply.