TSRA LICENSING - CLASSIFICATION REQUESTS FOR MEDICAL AND AGRICULTURAL ITEMS

This section provides exporters with additional guidance on how to apply a Commodity Classification from the Department of Commerce, Bureau of Industry and Security (BIS) to support for a 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.

On April 7, 2014, 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.

On December 23, 2016, The Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations(https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-30968.pdf)  31 C.F.R. part 560 (ITSR) to expand the scope of medical devices and agricultural commodities generally authorized for export or reexport to Iran pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000, as amended.  This amendment also includes new or expanded authorizations related to 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.  Additionally, this amendment revises the definition of the terms “goods of Iranian origin” and “Iranian-origin goods."

NOTE:  OFAC amended the existing general license in §560.530(a)(3) relating to authorized exports or reexports  of certain medical  devices specified on the List of Medical Supplies.  As amended, the general license has been expanded to authorize the exportation or reexportation 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, as set forth in revised §560.530(a)(3)(ii).    The exportation and reexportation of the specified excluded medical devices requires specific authorization from OFAC, as reflected in amended §560.530(a)(1)(ii)(C). Medical devices other than those specified on the new List of Medical Devices Requiring Specific Authorization may be exported or reexported to Iran without separate authorization from OFAC.  https://www.treasury.gov/resource-center/sanctions/Programs/Documents/iran_gl_med_supplies.pdf

To determine if your item requires a Commodity Classification (CCAT), please consult OFAC’s webpage:

Frequently Asked Questions on Iran/TSRA General Licenses

How to apply for a Commodity Classification:

https://www.bis.doc.gov/index.php/forms-documents/regulations-docs/143-bis-eccn-pdf/file

Medical CCAT specific tips:

For other than simple items please provide a product brochure.

Please state if the CCAT is for an OFAC license.

If your product has an FDA # please provide it.

NOTE:
FDA regulates drugs of abuse test kits as medical devices, specifically in vitro diagnostics (IVDs). For Drugs of Abuse Tests visit http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/DrugsofAbuseTests/default.htm  for the various product classifications for  IVDs. To receive an EAR99 medical classification exporters must provide documentation that the FDA has classified the drugs of abuse test kits as a medical device marketable in the United States. Please consult the FDA website for more information.

Diagnostic tests for food or water borne pathogens are regulated by the  Center for Food Safety and Applied Nutrition (CFSAN)  and are not medical devices

 

   
© BIS 2016