Export Control Laws and Governing Agencies

There are three primary sets of regulations restricting the transfer of goods, technology, and information to persons and entities outside of the United States, as well as other activities and services involving such persons and entities:

These regulations serve several purposes:

  • To restrict exports of goods, technology, and information that could contribute to the military potential of U.S. adversaries
  • To prevent proliferation of weapons of mass destruction
  • To advance U.S. foreign policy goals
  • To protect the U.S. economy and promote trade goals

Also applicable are the U.S. anti-boycott laws, which prohibit U.S. persons and their affiliates from participating in the Arab League boycott against Israel.

Export Administration Regulations (EAR)

The Bureau of Industry and Security (BIS), under the U.S. Department of Commerce, administers the EAR, which regulates the export, re-export, or transfer of commercial and “dual-use” items (those items having both a military and commercial application). These items can include equipment, biologics, technologies (including software), and technical data that serve primarily civil uses.

An “export” is an actual shipment or transmission of services or any item, including information, technology, software, and data, out of the United States. How the transfer occurs does not matter in determining export license requirements. An item may be exported even if communicated visually, verbally, or electronically. “Technology” as defined in the EAR is specific information necessary for the “development,” “production,” or “use” of a product. The information takes the form of “technical data” or “technical assistance.”

Although most research activities are not subject to export control regulations (e.g., Fundamental Research), there are certain conditions under which the export of materials, equipment, software, or technology either is prohibited or requires a license (such items are commonly referred to as “controlled” items).

Examples of “controlled” items include materials such as:

  • Certain precursor chemicals
  • Human or animal viruses (e.g., Newcastle Disease Virus (NDV)), and bacteria
  • Toxins, vaccines and plant pathogens
  • Genetic elements, and genetically modified organisms that contain or code for the genes of controlled pathogens and toxins (e.g., vaccine seeds containing at least one intact gene of NDV)
  • Equipment and materials commonly used in laboratories (e.g., batch mixers, centrifugal separators, protective and containment equipment)

Vaccines that have been approved by the U.S. Food and Drug Administration either to be marketed as clinical or medical products or for use as an “Investigational New Drug” are controlled at a low level and only require licenses for sanctioned countries.

Certain “controlled” technology, which includes certain technical and scientific data, requires an export license unless it meets the test that the associated research is intended for publication or otherwise in the public domain under the FRE. For instance, unpublished, proprietary technical data or documents related to a controlled pathogen, such as NDV, are highly controlled and would require authorization for export or release to most foreign destinations or Foreign Persons.

The Commerce Control List (CCL) is a part of the EAR and contains a list of hardware, software, and technologies that are subject to the EAR. Each item on the CCL is assigned an Export Control Classification Number (ECCN), which is either EAR99 (a “basket” category subject to the lowest level of control) or a five-digit alpha/numeric code for items identified on the CCL. The ECCN determines whether or not prior authorization from the U.S. Government is required to export an item to a particular destination.  For example, items classified under ECCNs 4A994, 5A992, 5D992, and EAR99 are subject to a low level of control and generally can be exported to any destination, except to sanctioned countries or Restricted Parties.

Exports and re-exports of items controlled under the EAR may be subject to export license requirements, depending upon the level of controls applicable to the item, the destination country, the identity of the parties, and the purposes for which the item is intended to be used. A number of license exceptions may be available under these regulations, depending upon the facts and circumstances of the particular transaction.

The International Traffic in Arms Regulations (ITAR)

The Directorate of Defense Trade Controls (DDTC), under the U.S. Department of State, implements and administers the ITAR. The ITAR control the export, re-export, temporary import, and brokering of defense articles, defense services, and defense-related technical data by imposing stringent restrictions on their export, re-export, temporary import, or brokering. Virtually all transactions subject to the ITAR require specific authorization from DDTC. Only very limited license exemptions are available under these regulations.

Items covered under ITAR are contained in the United States Munitions List (USML). Defense articles can include hardware or software that has been modified for military use or to military specifications, as well as related technical data. “Technical data” is defined under the ITAR as including:

  • Any information (classified or unclassified) required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance, or modification of defense articles as well as software directly related to defense articles
  • Any classified information relating to defense articles and defense services
  • Software that is directly related to defense articles.

Technical data can include information in the form of blueprints, drawings, photographs, plans, instructions, and documentation. Technical data does not include basic marketing information on function, purpose, or general system descriptions. The ITAR applies not only to U.S.-origin technical data but also to foreign-origin technical data that is brought into the United States.

All exports, re-exports and other transactions involving defense articles, services and technical data must be consistent with the ITAR, and any enhancements or modifications of existing commercial products for military customers or for military applications must be immediately reported to the Export Control Officer.

Economic Sanctions Regulations

The Office of Foreign Assets Control (OFAC), under the U.S. Department of the Treasury, administer economic sanctions and regulations that apply to designated countries, entities, and individuals. The sanctions programs vary in nature (e.g., territorial or “list-based”) and scope (e.g., comprehensive or limited) and may restrict a broad range of exports, imports, and other transactions, including providing educational or research services, collaborating on research, signing contracts, travel to certain countries, and exporting materials, information, or other items to such countries (even for medical or humanitarian reasons). Depending on the sanctions program, restrictions can apply to U.S. entities, U.S. persons wherever located, non-U.S. affiliates of U.S. universities, and transactions involving U.S.-origin items, regardless of the nature of the product.

Icahn School of Medicine at Mount Sinai Parties should not conduct any transactions involving sanctioned countries or travel to such countries for business without consulting the Export Control Officer.

Restricted Parties: Restricted Parties lists are the various lists maintained by the U.S. and other governments of individuals and entities that are subject to economic sanctions or other trade restrictions. Transactions with Restricted Parties are prohibited or substantially restricted. These lists include but are not limited to the following:

  • Entity List (BIS)
  • Debarred List (DDTC)
  • Denied Persons List (BIS)
  • Foreign Sanctions Evaders List (OFAC)
  • Non-Proliferation Sanctions (State Department)
  • Sectoral Sanctions Identifications List (OFAC)
  • Specially Designated Nationals List (OFAC)
  • Unverified List (BIS)

The Restricted Parties lists are also subject to change at any time. It is Icahn Mount Sinai policy to not have any transactions with Restricted Parties without required prior authorization from the U.S. Government. Any activities involving a Restricted Party must be immediately raised with the Export Control Officer.

Economic sanctions regulations and programs are administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) and apply to designated countries, entities, and individuals. The U.S. Government currently maintains comprehensive territorial sanctions and export restrictions against Cuba, Iran, North Korea, Crimea, and Syria as well as more limited sanctions against individuals, entities, or economic sectors in certain countries, including Venezuela, China, Sudan, Ukraine/Russia, Myanmar, and other countries. A current list of OFAC sanctions programs is available. This list may change at any time.

Other Applicable Regulations

There are several other broad areas of regulations that may apply to your activities at Icahn Mount Sinai. It is important to be familiar with these, and contact the Export Control Officer for guidance when appropriate.

Customs Laws and Regulations: U.S. Customs and Border Protection (“CBP” or “Customs”) is the border enforcement agency charged with controlling, regulating, and facilitating the movement of carriers, people, and commodities between the United States and other nations, as well as other functions.

Every article entered into the United States, whether by mail, express courier (such as FedEx, DHL, and UPS), other commercial freight carrier, or as luggage, unless subject to a specific exception, must be declared to CBP at the time of entry into the United States. Individuals must exercise “reasonable care” and “informed compliance” in the movement of any items into the United States (“importation”) and in determining the appropriate tariff classification, customs valuation, country of origin, marking/labeling, tariff rate, quantity and other information provided on import entry documents and must consistently and accurately report such information to CBP. Individuals must maintain entry documents and such other documents to support the tariff classification, customs valuation, country of origin, marking or labeling, quantity, and other information provided on entry documents for a period of not less than five years. Incorrect information provided on Customs entry documents, even if unintentional, can subject Icahn Mount Sinai to significant civil and even criminal penalties.

Additionally, under United States Customs law and regulations, every article of foreign (non-U.S.) origin must be labeled with its country of origin in such manner that the ultimate purchaser will be able to determine the country of origin of the item, unless specifically accepted by law.

Animal Plant Health Inspection Service (APHIS) Regulations: The Department of Agriculture’s APHIS plays a vital role in ensuring the free flow of agricultural trade by keeping U.S. agricultural industries free from pests and diseases and certifying that the millions of U.S. agricultural and food products shipped to markets abroad meet the importing countries' entry requirements. APHIS makes sure that all imported agricultural products shipped to the United States from abroad meet the Agency's entry requirements to exclude pests and diseases of agriculture. Certain plant, animal, and plant organisms, vectors, and agents are subject to APHIS import and/or export permits. Individuals should work with the Export Control Officer to ascertain the requirements for importing or exporting pathogens and other products.

Anti-Boycott Regulations: The anti-boycott laws and regulations administered by the U.S. Department of Commerce and the Internal Revenue Service generally prohibit U.S. entities, and entities controlled by them, from participating in unsanctioned boycotts. The anti-boycott laws were passed primarily to address the Arab League boycott of Israel. A boycott-related request may be oral or written and may or may not require you to take any specific action. In addition, there are reporting requirements under these laws. 

The Export Control Officer is responsible for all such reporting requirements. If you think you have received a boycott request, or have any questions related to anti-boycott issues, please contact the Export Control Officer immediately and do not take any actions with regard to the request until you have received guidance from the Export Control Officer.