TSRA LICENSING - CLASSIFICATION REQUESTS FOR MEDICAL AND AGRICULTURAL ITEMS

This section provides exporters with additional guidance on how to apply for 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.

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:

BIS ECCN Brochure

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:

The 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

BUREAU OF INDUSTRY AND SECURITY

CHEMICAL AND BIOLOGICAL CONTROLS DIVISION

Have you ever wondered what does nonproliferation and WMD mean ?

Are you interested in Government policy and regulations ?

Do you want experience on your resume that almost every company in the U.S. would be interested in ?

The Bureau of Industry and Security administers nonproliferation policy and implements these policies via the Export Administration Regulations and export controls. The Chemical and Biological Controls Division is responsible for export controls on biological agents, chemicals, equipment and technology. You will work on export licensing, industrial impact analyses, and international policy of the U.S. in Australia Group preparations.

We are accepting resumes for UNPAID INTERNs from all students – undergraduate and graduate.

Persons interested should submit a resume and transcripts and a letter explaining what experience you would like gain. Email your application package request to:Frank Trevino Jr, Engineer, CBC Division: This email address is being protected from spambots. You need JavaScript enabled to view it. or call 202-482-2711.

GENERAL INFORMATION

The Chemical and Biological Controls Division (CBC) is the focal point within the United States Government (USG) for implementing dual-use export controls for chemical and biological (CB) equipment, materials and technology (e.g., toxins, chemicals, fermenters, pumps, valves). These export controls are in place for chemical and biological weapons concerns and to prevent the diversion of such items to destinations and end-users of concern. These items are generally found in Category 1 (Materials, Chemicals, Microorganisms and Toxins) and Category 2 (Materials Processing) of the CCL.

CBC carries out this responsibility by:

• Participating in multilateral export control activities with the Australia Group
• Responsible for export licensing of CB items
• Responsible for commodity classifications, advisory opinions, licensing determinations, and commodity jurisdiction requests for chemical, biological, and medical items.
• Ensuring U.S. industry interests are taken into consideration in the development of export control laws and regulations.
• Participating in interagency discussions on biological and chemical safety and security initiatives
• Managing the Materials Technical Advisory Committee

CBC plays a strong role in implementing policies that promote U.S. nonproliferation and security goals while minimizing the burden to industry and protecting company business information.

CBC LICENSING

• In order to help exporters evaluate export requirements, the documents below provide detailed guidance on determining if a license is required and how to fill out an export license application.

• Does your item require a license?
  • CBC ECCNs
  • What is controlled:
    • Chemicals
    • Biological
    • Equipment
    • General Overview
  • CB related advisory opinions
  • Note to ECCN 2B350
  • Deemed Export and Fundamental Research for CB related items
  • RPL License Exception

• How to complete an application for CB items

CBC is here to answer any questions you have regarding chemical and biological items, please contact us:

• Staff Directory

For all questions pertaining to general licensing procedures or how to apply for an export license, please contact our Exporter Services Hotline at 202-482-4811.

Recent Licensing Activity

In fiscal year 2017, CBC approved 1,410 license applications valued at $96.5 million for the export or re-export of biological processing equipment, chemical process control software, vaccines, medical kits, production, design and disposal technology. In addition, CBC approved 2,588 license applications valued at $1,158 million for the export or re-export of chemical precursors, equipment, and related technology.

Recent Regulations affecting CB Items

•On December 16, 2016, Federal Register notice81 FR 90983, was issued for the Implementation of the February 2016 Australia Group (AG) Intersessional Decisions and the June 2016 AG Plenary Understandings. The final rule amends the Export Administration Regulations (EAR) to implement the recommendations presented at Australia Group (AG) Intersessional Implementation Meeting held in Brussels, Belgium, on February 2, 2016, and adopted pursuant to the AG silent approval procedure in April 2016, and the understandings reached at the Implementation Meeting of the 2016 AG Plenary held in Paris, France, from June 6-10, 2016.  Specifically, this rule amends ECCN 1C351 by removing dengue fever virus, consolidating the controls for Shiga toxin and Verotoxin (and other Shiga-like ribosome inactivating proteins) under a single listing, and updating the nomenclature for certain bacteria and toxins to reflect the 2016 AG updates to the “List of Human and Animal Pathogens and Toxins for Export Control.”  In addition, this rule amends ECCN 2B352 to reflect the 2016 AG updates to the controls on biological containment facilities and related equipment, fermenters, and cross (tangential) flow filtration equipment, described on the “Control List of Dual-Use Biological Equipment and Related Technology and Software”.

•On July 28, 2016, Federal Register notice 81 FR 49517 was issued for the Addition of Items Determined to No Longer Warrant Control under United States Munitions List Category XIV (Toxicological Agents) or Category XVIII (Directed Energy Weapons).This final rule indicates how articles the President has determined no longer warrant control under Category XIV (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment) or Category XVIII (Directed Energy Weapons) of the United States Munitions List (USML) will be controlled under the Commerce Control List (CCL) and became effective on December 31, 2016. The affected Category XIV articles consist primarily of dissemination, detection and protection “equipment” and related articles and will be controlled under new Export Control Classification Numbers (ECCNs) 1A607, 1B607, 1C607, 1D607, and 1E607, as described in this final rule. The affected Category XVIII articles consist primarily of tooling, production “equipment,” test and evaluation “equipment,” test models and related articles and will be controlled under new ECCNs 6B619, 6D619 and 6E619, as described in this final rule. This final rule was published in conjunction with a final rule from the Department of State, Directorate of Defense Trade Controls, which amends the list of articles controlled by USML Categories XIV and XVIII and which also became effective on December 31, 2016.

 AUSTRALIA GROUP – RECENT EVENTS

• The Australia Group (AG)  is an informal forum of countries which, through the harmonization of export controls, seeks to ensure that exports do not contribute to the development of chemical or biological weapons. Coordination of national export control measures assists Australia Group participants to fulfill their obligations under the Chemical Weapons Convention and the Biological and Toxin Weapons Convention to the fullest extent possible.

Statement by the Chair of the 2017 Australia Group Plenary

No new members were admitted in 2017.  The AG Plenary will be held in Paris, France from June 4-8, 2018.

MATERIALS TECHNICAL ADVISORY COMMITTEE (MTAC) – CBC UPDATES

The Materials Technical Advisory Committee is the place for you to help mould and draft government decisions and regulations. This committee exclusively provides information to the Department of Commerce on the efficacy and impact of export regulations/controls on life science research and materials research. Membership allows you to be informed of pre-decisional activities, stay in the loop on deemed export requirements and export controls on items covered by the committee, and be aware of technology controls on such items.

What is a Technical Advisory Committee? Technical Advisory Committees (TACs) meet quarterly to advise the Department of Commerce (DOC) on the technical parameters for export controls applicable to dual use commodities and technology and on the administration of those controls. The TACs are composed of expert representatives from industry, academia with ex-officio government employees representing diverse points of view on the concerns of the exporting community. TAC members are appointed by the Secretary of Commerce, and serve terms of not more than four consecutive years. The membership reflects the Department's commitment to attaining balance and diversity. TAC members must obtain secret-level clearances prior to appointment. TAC meetings have an open session where all interested members of the public are invited. Members of the TACs are not compensated for their services.

What is the MTAC? The Materials Technical Advisory Committee (MTAC) is the place for you to help mould and draft government decisions and regulations. The Materials TAC covers a wide variety of items including articles, materials, and supplies for radar absorption, jet engine turbines blades, super conductivity, fluids, lubricants, and composites. Chemical precursors, biological agents, biological and chemical processing equipment are also under the MTAC purview. Many of the commodities in Category 1 and Category 2 are covered by the MTAC. The committee consists of technical experts, lawyers and export compliance people who create proposals for CCL reform, and for various export control regimes including Wassenaar Arrangement, Australia Group,the Nuclear Suppliers Group, and Missile Technology Control Regime.

MTAC Membership Information

Last Updated: December 2017