TSRA LICENSING - CLASSIFICATION REQUESTS FOR MEDICAL AND AGRICULTURAL ITEMS

TSRA LICENSING - CLASSIFICATION REQUESTS FOR MEDICAL AND AGRICULTURAL ITEMS

This section provides exporters with additional guidance to identify medical devices, medicines and agricultural commodities that do not require a Commodity Classification from the Department of Commerce, Bureau of Industry and Security (BIS) and that may be eligible for a general license authorization for export and reexport to Iran and Sudan from the Office of Foreign Assets Control (OFAC) at the Department of Treasury. The Trade Sanctions Reform and Export Enhancement Act of 2000, Title IX of Public Law 106 387 (October 28, 2000) (the "TSRA"), provides that the President shall terminate any unilateral agricultural sanction or unilateral medical sanction in effect as of the date of enactment of the TSRA.

On October 12, 2011, OFAC amended the Sudanese Sanctions Regulations, 31 CFR Part 538, and the Iranian Transactions Regulations, 31 CFR part 560, by issuing general licenses that authorize the exportation or reexportation of most food items to individuals and entities in Sudan (other than the Specified Areas of Sudan) and in Iran

On October 22, 2012, OFAC amended the former Iranian Transactions Regulations(now called the Iranian Transactions and Sanctions Regulations ("ITSR")), 31 CFR part 560, to add a general license authorizing the exportation or reexportation of medicine and basic medical supplies to Iran. OFAC has provided a definition for what qualifies as medicine and has provided a list of "basic medical supplies" that are eligible for a general license authorization on its website. These general licenses do not authorize the export or reexport of food, medicine, or basic medical supplies to military or law enforcement purchasers or importers.

NOTE: Medical devices that are not included in the OFAC "List of Basic Medical Supplies" still require a one-year specific license from OFAC but may not require a BIS Commodity Classification as explained below.

Items that do not require a BIS Commodity Classification

  1. OFAC’s List of “Basic Medical Supplies”

  2. Comprehensive List of BIS EAR99 Medical Items   

  3. Medicines

  4. Agriculture Commodities

Items that require a BIS Commodity Classification

  1. Any items not listed above

  2. Other Medicines

  3. Agriculture Commodities

Frequently Asked Questions on Iran/TSRA General Licenses

Today, the Department of the Treasury's Office of Foreign Assets Control (OFAC) issued updated FAQs on Iran/TSRA General Licenses, which pertain to a final rule amending the Iranian Transactions and Sanctions Regulations ("ITSR") by expanding an existing general license that authorizes the exportation or reexportation of food to individuals and entities in Iran to include the broader category of agricultural commodities. The rule also clarifies and adds certain definitions in OFAC regulations. Finally, the rule adds a new general license that authorizes the exportation or reexportation of certain replacement parts for certain medical devices.