Frequently Asked Questions

• The carriage or shipment of certain sensitive hardware, software, microorganisms, and other items out of the U.S.;
• The disclosure of certain non-public data or source code to non-U.S. persons in the U.S. (a “deemed export”); and
• Travel to-and activities in-countries subject to U.S. trade sanctions.

Research institutions typically have students, staff, and researchers who are visiting the U.S. on some sort of visa.  How do institutions deal with the risk of “deemed exports” of data or code, given the presence of so many non-U.S. persons?

A combination of two principal approaches to the “deemed export” problem is typically employed:

• The Fundamental Research Exclusion (FRE) is a regulatory concept that excludes the results of fundamental research typically undertaken at universities and other institutions from the scope of data subject the EAR and ITAR. In other words, the results of fundamental research may generally be disclosed to non-U.S. students, staff, and researchers without federal authorization because the results are not regulated by export controls, as a threshold matter.  (Grant or contract terms that restrict publication or impose citizenship/nationality requirements can invalidate the FRE; research results from projects subject to those terms may be subject to the EAR or ITAR.  In addition, the FRE does not apply to proprietary information that outside parties may furnish.) It is important to note that even in the conduct of fundamental research and instruction, an export control license may be required if the project involves a Non-Disclosure Agreement (NDA) covering the exchange of export-controlled information, access to export-controlled technology, a non-research function (e.g., a service agreement) where there is access to export-controlled technology, or access to ITAR-controlled equipment.
• When data or code does not qualify for the FRE, institutions can protect that information from unauthorized release by the implementation of a Technology Control Plan (TCP). TCPs vary significantly in their details, but generally include instructions on the identification, segregation, and security of controlled information.  If a researcher identifies a need to disclose controlled information to a non-U.S. student, visitor or employee, it may be possible to obtain U.S. government authorization (or make use of a regulatory exception or exemption) for the “deemed export,” depending on the technology, nationality, and other circumstances involved.

How entities apply these approaches can fall along a spectrum.  Some institutions prefer to engage in only fundamental research as a matter of default policy, thus reducing the need for TCPs and licenses for “deemed exports.”  The benefits of this approach include lower regulatory risks and compliance costs.  The chief downside is that many grants and contracts (especially for the Department of Defense and its contractors) have mandatory terms that are inconsistent with the FRE, and cannot be accepted.

At the other end of the spectrum, some institutions readily accept grants and contracts for proprietary or restricted research that falls outside of the FRE.  These institutions must implement TCPs and related measures to ensure that they comply with the relevant export control and security requirements.  This approach grants researchers the flexibility to pursue non-fundamental research opportunities, but requires a greater investment in the institution’s compliance infrastructure.

These phrases refer to technical information beyond general and basic marketing materials about a controlled commodity. They do not refer to the controlled equipment/commodity itself, or to the type of information contained in publicly available user manuals. Rather, broadly speaking, the terms “technology” and “technical data” mean specific information necessary for the development, production, or use of a commodity, and usually takes the form of blueprints, drawings, photographs, plans, diagrams, models, formulae, tables, engineering specifications, and documentation. The U.S. government regulates the transfer of technology or technical data to foreign nationals in the U.S. (i.e., a deemed export). You may need a license prior to sharing export-controlled technology or technical data.

Generally, technology or technical data that is publicly available does not require a license to export. Such technology may become publicly available through three ways:

• Information that arises through fundamental research where the information is ordinarily published is considered to be publicly available. 22 C.F.R. ¬ß 120.11(8); 15 C.F.R. ¬ß 734.8.
• Information contained in a patent or published patent application. 22 C.F.R. ¬ß 120.11(5); 15 C.F.R. ¬ß 734.10.
• Information that is published and generally accessible or available to the public 22 C.F.R. ¬ß 120.11; 15 C.F.R. ¬ß 734.7.

Information is “published” when it becomes generally accessible to the interested public in any form, including: (1) publication in periodicals, books, print, electronic, or other media available for general distribution (including websites that provide free uncontrolled access) or to a community of persons interested in the subject matter, such as those in a scientific or engineering discipline, either free or at a price that does not exceed the cost of reproduction and distribution; (2) information readily available at libraries open to the public or at university libraries; (3) patents and published patent applications available at any patent office; or (4) information released at an open conference, meeting, seminar, trade show, or other open gathering held in the U.S. (ITAR) or anywhere (EAR).

• Note 1: Prepublication review by a sponsor of research solely to ensure that the publication does not compromise patent rights or inadvertently divulge proprietary information that the sponsor has furnished to the researchers does not change the status of the research as fundamental research, so long as the review causes no more than a temporary delay in publication of the research results. However, if the sponsor will consider as part of its prepublication review whether it wants to withhold publication of the research results, then the research would no longer qualify as “fundamental”. As used in the export regulations, it is the actual and intended openness of research results that primarily determines whether the research counts as “fundamental” and not subject to the export regulations. Research is not considered “fundamental research” if the institution or its researchers accept (at the request, for example, of an industrial sponsor) restrictions on publication of scientific and technical information resulting from the project.
• Note 2: A conference or gathering is “open” if all technically qualified members of the public are eligible to attend and attendees are permitted to take notes or otherwise make a personal record of the proceedings and presentations. A conference is considered open notwithstanding a registration fee reasonably related to cost, and there may be a limit on actual attendance as long as the selection is either ‘first come’ or involves selection based on relevant scientific or technical competence.
• Note 3: Some information, even if publicly available, may still be restricted depending on with whom you are sharing the information or for what purpose. For example, providing export-controlled information to a foreign military may be a defense service, which would require an export control license. In addition, certain end uses, such as research on biological weapons, or end users, such as those named on restricted lists, may also require an export control license.

No, generally this is not a concern, as long as your research is not subject to restricted publication or access. However, please contact your Research Administrator if the information you intend to release is encryption software.

For researchers  working with biological items, there is a number of items that will require export licenses prior to being shipped outside the U.S. Examples are attenuated forms of bacteria, toxins, viruses, and fungi that are on the Select Agents and Toxins list or on the  ITAR Category XIV (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment)  list.  There are many items that  require export licenses even for minuscule quantities or for snippets of genomic elements. Lists of items controlled by EAR can be found here:  https://www.bis.doc.gov/index.php/regulations/export-administration-regulations-ear. Searchable ITAR list: https://www.learnexportcompliance.com/tools/updated-itar/. Contact the NMC Biosafety Officer if you have any planned shipment of these items so that the required export licenses can be requested. Note that these may take 6 weeks or longer to obtain.

It depends. Fundamental research is basic and applied research where the results are ordinarily published and shared broadly within the research community. To qualify for the Fundamental Research Exclusion, you must intend to publish the results. If you are aware that a journal may restrict an article that contains information on certain biological agents while engaging in your research, then your research may not qualify for fundamental research, and would be subject to the export control regulations; a license or management plan would be necessary for a foreign national to access the biological agents and/or participate in the research.

You should consult with the Biosafety officer and COO. The shipping, receipt, and handling of such items may require import permits and licenses.