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?
- 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:
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
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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.
Last Updated: December 2017