The Department of Treasury’s Office of Foreign Assets Control (OFAC) has announced new rules, which will take effect December 23, 2016, amending the Iranian Transactions and Sanctions Regulations, 31 C.F.R. part 560 (ITSR). The revised rules expand the scope of medical devices and agricultural commodities that may be exported or re-exported to Iran without specific authorization, pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA).

OFAC is amending the existing general license relating to authorized exports or re-exports of certain medical devices specified on the List of Medical Supplies. As amended, the general license has been expanded to authorize the exportation or re-exportation to Iran of all items meeting the definition of the term “medical device” as set forth in § 560.530(e)(3), except for certain medical devices that are explicitly excluded from the authorization as specified in a new List of Medical Devices Requiring Specific Authorization, which is maintained on OFAC’s website on the Iran Sanctions page. In addition, authorization is being extended to cover training, replacement parts, software and services for the operation, maintenance, and repair of medical devices, and items that are broken or connected to product recalls or other safety concerns.

OFAC is also narrowing the list of excluded agricultural commodities. The general license now authorizes the exportation or re-exportation to Iran of live shrimp and shrimp eggs. In addition, OFAC is adding a new provision to generally authorize the provision of training necessary and ordinarily incident to the safe and effective use of agricultural commodities exported or re-exported pursuant to the general license.

The revised rules also update the definition of the terms “goods of Iranian origin” and “Iranian-origin goods” as goods that do not include the following categories, provided that such goods were not grown, produced, manufactured, extracted, or processed in Iran:

  1. goods exported or re-exported to Iran under an authorization issued pursuant to the ITSR (e.g., a medical device or a personal communications device exported or re-exported to Iran pursuant to a general or specific license issued pursuant to the ITSR) and that subsequently have been re-exported from and are located outside of Iran, or
  2. goods transported on a vessel or aircraft that passed though Iranian territorial waters or stopped at a port or place in Iran en route to a destination outside of Iran and that have not otherwise come into contact with Iran.