Understanding the Connection between Export Controls and Research

05/03/11 - Life at NYULMC

Many people have heard, even in passing, about export controls and research. You may ask, “What are export controls and what do they have to do with my research?” 

The federal government monitors items, services and knowledge that leave this country (i.e., exports) for the purpose of protecting national security and maintaining economic competitiveness. In the research compliance field, this is referred to as “export controls.” Inattention to export control regulations can result in government scrutiny, fines, and penalties. 

The Medical Center’s research activities, including developing new technologies, subject us to compliance with export controls. 

There are two applicable regulations: Export Administration Regulations (EAR) and the International Traffic in Arms Regulation (ITAR). EAR is administered by the Department of Commerce’s Bureau of Industry and Security and regulates the export of “dual-use” (i.e., commercial and military) articles, software and technology. The Department of State administers ITAR and regulates the export of defense articles and technology. In addition the Office of Foreign Assets Control of the US Department of Treasury also has an interest in controlling the transfer of technologies and assistance to its list of sanctioned countries or individuals. 

EAR and ITAR monitor all exports of “controlled technologies” to foreign destinations or foreign persons. (These are technologies listed on the Commerce Control and the US Munitions Lists.) EAR and ITAR also monitor “deemed exports,” which refers to the access that a foreign national has to any of the technologies. Export controls exclude items in the public domain and artistic or nontechnical publications. 

For biomedical research, there are two things we are typically concerned with: “controlled technologies” and “deemed exports.” Some materials used in biomedical research that could be considered “controlled technologies” regulated by the EAR include select agents, human pathogens and toxins, genetically modified organism pathogens and toxins, vaccines against pathogens and toxins, and medical products containing botulinum or conotoxins. In addition, equipment such as fermenters, centrifugal separators, cross-flow filtration and components, freeze-drying equipment, protective and containment equipment, aerosol challenge chambers and/or spraying or fogging systems are also examples of “controlled technologies.” 

“Deemed exports” are a concern where foreign nationals associated with the Medical Center are involved in the transfer of information, technology, or technical data regulated by EAR or ITAR. The transfer or release of information can occur in a number of ways including by telephone, e-mail, or visual inspection. The government treats this transfer of knowledge as though it was exported to the foreign national’s country of origin just as if physical shipment has occurred. 

Foreign nationals are associated with the Medical Center as faculty, employees, volunteers, visiting faculty, observers, students, and/or research assistants. Unless an exception applies, any release of controlled technologies or deemed exports to a non-permanent resident foreign national may require a license and/or be prohibited. 

Situations that may trigger a review of export controls include:

• shipping or transferring a controlled technology outside of the United States;
• traveling with controlled technology outside of the United States;
• hiring a "non-US person" who will have access to controlled technology;
• allowing visitors and/or students who are non-US persons to access areas with controlled technology; and
• making payments to non-US persons.

A "non-US person" is someone who does not hold one of the following: U.S. citizenship, by birth or naturalization; a green card (i.e. lawful permanent residency); or political asylum in the United States. 

05/03/11 - Life at NYULMC

These activities will not stop biomedical research at the Medical Center because most research here will either not use a controlled technology or will fall under the Fundamental Research Exclusion, which refers to basic and applied research in science and engineering, the results of which are ordinarily published and shared broadly within the scientific community. This is distinguished from research that is proprietary for the purposes of industrial development, design, production and/or product utilization. 

The Fundamental Research Exclusion applies when there are no restrictions on publication (other than short delay and/or sponsor review) and that there are no other agreements for confidentiality like a non-disclosure agreement that include acceptance of export-controlled information. Despite best efforts, the Medical Center may still need to apply for an export control license if a foreign national has access to controlled technology as well as the manuals, blueprints or source code for that technology. Since the application process is a lengthy one and during such time the foreign national must not have access to the technology, it could seriously impede progress on a research project. 

While this is a complicated area of the law, it is important to be aware of export control regulations and the potential for danger. To ensure compliance, do a careful review of the research you are conducting to make sure it meets the requirements of the Fundamental Research Exclusion. Consider:

• What items in your lab might be considered controlled technologies/deemed exports.
• Whether personnel who have access to it are foreign nationals.
• If you are planning travel to sanctioned countries, consider what technologies, if any, you are carrying. 

You can use the Export Control Checklist to do this assessment. If you have any questions or concerns after completing the checklist, please contact the Office of Legal Counsel or the Office of Research Compliance.