1. RCR: Export Control and Trade Sanctions In preparation for the Export Control session review the HSPH Export Control website and come prepared to discuss the following:HSPH Export Control website – What items on your research project are subject to export controls? – Do any of these items trigger export control issues? – Which federal regulations are applicable to these items? – What are deemed exports and does this apply to you? – Why is the fundamental research exclusion important to you and your research.

2. EXPORT CONTROLS AND TRADE SANCTIONS Eileen Nielsen Director of Research Administration Education Office of Research Administration Harvard School of Public Health

3. Objectives Learn how export controls laws and regulations relate to you and your research Identify activities that can trigger export control reviews/issues Understand the consequences of non-compliance

4. Cranial Implants You’re on an airplane at about 37,000 feet heading to a conference to present a paper on cranial implants. You’re pounding away on your laptop putting the finishing touches on your presentation. You’re grateful that you have the technology for the implants and related data stored on your laptop for quick reference. You have a few cranial implants with you, along with all of your favorite electronic devices that you never and leave home without. Are any of these items subject to export controls?

5. Exports defined Any oral, written, electronic or visual disclosure, shipment, transfer or transmission of commodities, technology, information, technical data, assistance or software codes to Anyone outside the US (including US citizen) A non-US individual (wherever they are) A foreign embassy or affiliate

6. U.S. Export Control Authorities Treasury DepartmentCommerce DepartmentState Department Office of Foreign Assets Control (OFAC) Bureau of Industry and Security (BIS) Directorate of Defense Trade Controls (DDTC) Foreign Assets Control Regulations Export Administration Regulations (EAR) International Traffic in Arms Regulations (ITAR) Sanction ProgramsCommerce Control List (CCL) United States Munitions List (USML) Transactions with sanctioned countries, entities and persons Exports and re-exports of dual-use commodities, software, equipment and technology Transfers of defense articles and provision of defense services

7. U.S. Export Controls Cover any item in U.S. trade (goods, technology, information) Extend to U.S. origin items wherever located, including U.S. ( Jurisdiction follows the item or technology world wide) Controls have broad coverage and limited exclusions License may be required to export

8. U.S. Export Controls Advance foreign policy goals Restrict export of goods and technology that could contribute to the military potential of adversaries Prevent proliferation of weapons of mass destruction (nuclear, biological, chemical) Fulfill international obligations

9. “Scientific progress on a broad front results from the free play of free intellects, working on subjects of their own choice, in the manner dictated by their curiosity for exploration of the unknown.” “Science the Endless Frontier,” Vannevar Bush, 1945

10. http://www.fas.org/irp/offdocs/nsdd/nsdd-189.htm FUNDAMENTAL RESEARCH – Fundamental Research means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons.” – The Fundamental Research Exclusion applies only to the dissemination of research data and information, not to the transmission of material goods.

11. FUNDAMENTAL RESEARCH EXCLUSION IS DESTROYED IF The university accepts any contract clause that: – Forbids the participation of foreign persons – Gives the sponsor a right to approve publications resulting from the research; or – Otherwise operates to restrict participation in research and/or access to and disclosure of research results. NOTE: “Side deals” between a PI and Sponsor destroy the fundamental research exclusion and may also violate university policies on openness in research

12. Salmonella Typhi You’re an expert on salmonella typhi. Award negotiations for your latest research project are being held up because the sponsor wants to review your publications before you submit your publication to the publisher. To date all your research findings have been published broadly. Based on this you see no harm in accepting this term. Is this a problem?

13. “Deemed” Exports A “deemed” export is an export that occurs when a “foreign person” accesses U.S. technology or source code within the U.S. An export to the country of nationality is “deemed” to have occurred at time of access – even if the technology/source code never goes there (e.g., never leaves the US.)

14. Definition of “release” of technology or software It is available to foreign nationals for visual inspection (such as reading technical specifications, plans, blueprints, etc.) When technology is exchanged orally When technology is made available by practice or application under the guidance of persons with knowledge of the technology

15. The Johnson Lab Students from England, China, France and Iran will be working on the cranial implant technology in the Johnson Lab. Are there any questions that you would like to ask before the students begin their work?

16. OFAC: Office of Foreign Asset Control OFAC administers and enforces economic sanctions programs In general, OFAC programs prohibit the provision of services to countries subject to US sanctions without a license Services may include: – Conducting surveys and interviews in sanctioned countries – Providing marketing & business services to persons in sanctioned countries – Creating new information materials at the behest of persons in a sanctioned country – Financial transactions – Engaging the services of persons in a sanctioned country to develop new information materials NOTE: Restrictions vary by country

17. http://www.ustreas.gov/offices/enforcement/ofac/17 Sanctions - Examples Country OFAC Sanction Programs: Cuba, Iran, North Korea, Syria Sanction OFAC List-Based Sanctions Programs: Anti-Terrorism, non- proliferation, Specially Designated Nationals

18. Global Health Research Project You’re the PI on an international study on the relationship of air pollution and breast cancer. You’ll be travelling to the Mediterranean to collect data via survey’s and air samples. Laptops and air sampling devices will be some of the equipment you’ll be taking with you. What do you need to do before you go?

19. Some Steps For Analyzing Export Control Issues Who? Who wants to travel outside the US? Who is the intended recipient of a piece of equipment, biological or technology? In what country are they located? What? What piece(s) of equipment are intended for export? What technology or biological s are being exported? Where? Where are the individuals traveling? What is the intended destination of the equipment or technology? For a deemed export, what is the nationality of the intended recipient who is a foreign national? When? What is the time frame for export? If it will be returned, when? Has it been sent already? Why? What is the purpose for the export? What is the research project involved? Is there a Statement of Work? Is it the subject of an agreement?

21. Resources HSPH Export Control website Harvard Global Support Services: International Programs Planning Guide Harvard Global Support Services: International Programs Planning Guide Harvard University Information Security Advisory for Travelers Harvard University Information Security Advisory for Travelers

22. CONTACT INFORMATION Eileen Nielsen enielsen@hsph.harvard.edu 617-432-8148