Health Sciences Partners

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Health Sciences Personnel (including the Stempel College of Public Health, the Wertheim College of Medicine, and the Wertheim College of Nursing) are key partners in compliance. They are instrumental in facilitating a variety of activities, including supporting research, facilitating shipping and travel, hosting foreign visitors, and procuring laboratory equipment.

To help our Health Sciences partners, we have pulled together links to specific information, forms, and guidance documents targeted to Health Sciences interests. Please do not hesitate to contact Export Control for assistance and help with questions.

For Biosafety Level 2 and Level 3 Laboratories:

Many biological materials which require containment in Biosafety Level 2 facilities and all biological materials requiring BSL-3 containment (including recombinant and genetically modified materials derived from these biologics) are highly controlled under Category 1C351 and 1C353 of the EAR’s Commerce Control List (CCL). The reason for this level of control is based on their potential to be used for military bio-terrorism applications. Export controls on these materials include restrictions on international shipment to most countries and, in certain cases, transfer of development and production technology for these materials to foreign nationals (including transfers that occur in the U.S.).

Deemed exports and controlled biologics

With respect to potential foreign national restrictions associated with accessing or using export controlled biologics, the CCL covers certain technology pertaining to the development and production of controlled materials (listed viruses, toxins, bacteria, fungi, etc.) as well as materials that incorporate or express these controlled materials including (but not limited to) genetically modified materials, viral vector systems, and expression of recombinant DNA in BSL-2 and 3-assigned organisms. In general, the mere use or operation of such controlled materials by foreign national researchers does not in itself constitute a deemed export.

However, when such use involves proprietary, non-fundamental research, “gain of function” (GoF) development technology; or, in the case of certain BSL-3 biologicals, meets the specific criteria set forth by the CDC as Dual Use Research of Concern (DURC), transfer of the information to foreign national researchers may constitute a deemed export. Within sponsored research (federally or industry generated), this level of technology will typically be incorporated into the Agreement Scope of Work and include specific publication and/or citizenship restrictions. However, institutionally- funded research (self-funded) can result in the same export-controlled applications. When the research activity triggers a potential deemed export, FIU must first determine whether an export license from the Department of Commerce is necessary for participation by and/or transfer to a foreign national researcher. If a license is required, access to and use of the controlled technology must be restricted from the foreign national until such time as license approval is obtained.

Shipment of Controlled Biologics

In addition to deemed export requirements, proposed international shipments of BSL-2 and BSL-3 materials also require export license review. In the event that you intend to transfer any biological material internationally, please complete FIU’s International Shipping Request Form and follow the instructions for routing to our export control function for review. We will quickly determine whether an export license is required based on the biological content of your proposed shipment, destination, and end use, and proceed accordingly. Where possible, please notify the Export Office within 30 days of the proposed shipment, so that there is sufficient time to submit the license application where required.

International Agreements:

Agreements with international parties (including international institutions, companies, and researchers) should be carefully reviewed for potential export control concerns, including but not limited to:

  1. Engagement with a Sanctioned or Restricted party
  2. Export or import of controlled items, materials, and/or biologics
  3. Export of controlled technical data
  4. Travel to a sanctioned destination

If you have questions about a proposed international agreement, please contact the Export Office for assistance.

Information on Specific Activities

Export Information by Topic

Useful Forms