Overview

The Office of the Vice Provost for Research is grateful to the Harvard School of Public Health (HSPH) for the export controls content in this and the following sections.  The HSPH export controls website can be reached by clicking here. 

Harvard University engages in research both in the United States and overseas.  Research activities can include the use of technology, the development of items (e.g., products, goods, hardware, software, and materials), or the communication of information, that are subject to U.S. export-control laws and regulations including bio-security oversight. 

Some activities that may trigger export control restrictions are:

• Traveling outside the United States, including to attend conferences
• Shipping items or technology to another country
• Transporting items or technology while traveling abroad (Export Control regulations do not distinguish between shipping an item and carrying an item.  For a more complete discussion, please click here.) 
• Disclosing technology or information about a technology to a foreign national, including foreign nationals working in Harvard research facilities
• Providing financial assistance to certain countries, persons, or entities
• Providing professional services to certain countries, persons, or entities

(In addition, technology, know how, and non-encryption source code that is released to a foreign national within the U.S. may be “deemed” to be an export to the country where the person is a resident or citizen and could be subject to licensing requirements.  This is what is commonly known as the “deemed export” rule.)

Bio-Security

Life-scientists should be aware that their work may be subject to export-control restrictions if it involves:

• "Select Agents;" or
• "Dual-Use Research" (i.e. research leading to technologies that, while intended to be potentially beneficial or therapeutic, could be reasonably anticipated to be misused to pose a threat to public health and safety)

Additionally, use of recombinant DNA or other potentially biohazardous materials may trigger oversight under lab or biosafety rules.

Civil penalties for export and trade sanctions violations can range up to $65,000 and $250,000 for civil violations depending on the authorizing legislation.  Criminal penalties for individuals can be up to $1,000,000 and 20 years of imprisonment.  The government generally has the authority to charge more than one violation per transaction.  Penalties can also include restrictions on the ability of Harvard to be eligible for continued exports.

The Vice Provost for Research (VPR) oversees Harvard's compliance with U.S. export-control laws and regulations.  Any questions regarding compliance or Harvard's policy and procedures should be directed to viceprovost_research@harvard.edu.

External Oversight

Three federal agencies govern the export of items and technology to another country or to a foreign national (i.e., non-U.S. citizen).  An overview of these agencies follows, with a more in-depth discussion provided here.

U.S. Department of Commerce, Bureau of Industry and Security (BIS).  BIS regulates items and technologies that are commercial or dual-use in nature (i.e., have both civil and military applications).

Common examples of items controlled under the EAR are:

• Chemicals, Microorganisms, and Toxins
• Computers and GPS equipment
• Electronics
• Information Security
• Radiological Equipment
• Sensors and Lasers
• Toxicological Agents and Equipment

U.S. Department of State, Directorate of Defense Trade Controls (DDTC): DDTC regulates items that are “inherently military” in nature or designed for intelligence and space-related purposes.  The DDTC administers the International Traffic in Arms Regulations (ITAR) created under the Arms Export Control Act of 1976.  Items regulated by the DDTC are described in the U.S. Munitions List of the ITAR.   

Common examples of items controlled under the ITAR are:

• Chemical and Biological Agents and Associated Equipment
• Electronic Equipment
• Protective Personnel Equipment
• Specialized Lasers
• Spacecraft Systems and Associated Equipment
• AND technical data related to the above

U.S. Department of the Treasury, Office of Foreign Assets Control (OFAC): OFAC regulates all financial transactions abroad with prohibited parties, such as individuals and countries subject to U.S. embargoes.  Under U.S. export control laws and regulations, the release or disclosure of technology to a foreign national is deemed to be an export to that foreign national’s country of origin.  See the OFAC website for a listing of sanctioned countries and specially designated nationals.  It is important to note that important exceptions to these regulations exist for “Fundamental Research”; these exceptions are discussed at the end of this section.

For detailed information about the three federal agencies and their oversight of export controls, please click here.

Fundamental Research

The term 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." 

Fundamental Research Exclusion (FRE)
Fundamental research as defined above is not subject to export control laws and regulations.  This exclusion permits Harvard University to allow our international community (e.g., students, faculty, and visitors) to participate in research projects involving export-controlled information on campus in the U.S. without the need for a license. However it does not permit the transfer of export controlled information, materials, or items abroad, even to research collaborators, unless another exemption or exclusion is available.  Moreover, Harvard may lose eligibility for the exclusion if there are publication restrictions on the research.  Thus, in accepting an award, Harvard must be careful to avoid any publication delays beyond the standard review periods for sponsors and patents.

Select Agents and Dual-Use Research

The Centers for Disease Control administer the Select Agent Program, which regulates the laboratories that may possess, use, or transfer select agents within the United States. 

The U.S. Government established the National Science Advisory Board for Biosecurity (NSABB) in 2003 to advise how to oversee the generation and communication of new life-science technologies with the potential for malevolent use.  The NSABB issued a 2007 report detailing a Proposed Framework for the Oversight of Dual Use Life Science Research.  The report proposes a criterion for identifying dual-use research of concern ("research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or material") and recommends strategies for the responsible generation and communication of such research.  The development and implementation of the Framework is ongoing. 

Investigators should be aware of the potential for malevolent misuse of their research findings and should contact the individuals listed on the right for guidance when unsure of oversight requirements.

Harvard Policies, Procedures & Guidance

Harvard is committed to complying with applicable U.S. laws and regulations pertaining to exports of items, services and technology by or on behalf of the University. The Harvard policy statement applies both to exports outside the U.S., as well as to exports to foreign nationals within the U.S. The Vice Provost for Research (VPR) oversees Harvard’s compliance with U.S. export-control laws and regulations.  The VPR and the University’s Chief Research Compliance Officer co-chair the Harvard University Export Control Council that reviews and advises the VPR on export control issues.  See Harvard's Export Control Policies and Procedures for a full overview of applicable guidelines.

All communications with U.S. licensing authorities shall be made through the VPR or a person designated by the VPR as an “empowered” official. Researchers seeking to ship or transport an item to another country or disclose technology to a foreign national are responsible for determining whether such item or technology is subject to export-control regulations.  Investigators should be aware also that as of February 20, 2011, the U.S. Citizenship and Immigration Services (USCIS) Form I-129 will include a "Deemed Export Attestation" that requires the petitioner (i.e. the University) to certify whether visa petitions for certain classes of foreign person work visas will require a license or other government authorization for the release of export-controlled technology or technical data to the foreign person in the United States during their employment. To meet this requirement, the University’s visa application now includes a “Deemed Export Certification.”   This certification must be signed by the  Principal Investigator or Department Chair and the School’s Compliance Officer, attesting whether or not a deemed export license is required prior to  the release of technology or technical data to the foreign person.  For further guidance, please click here or contact one of the individuals listed on the right.

Because awareness and oversight of Export Controls are best accomplished at the local level, the members of the Council are expected to oversee the implementation of compliance procedures within their respective schools, centers, laboratories and departments.  Some Harvard departments and centers, such as the Department of Earth and Planetary Sciences and the Harvard-Smithsonian Center for Astrophysics, have well-established organizational export control procedures that are additive to those of the University.

Any questions regarding compliance or Harvard’s policies and procedures should be directed to viceprovost_research@harvard.edu.