The U.S. Government exercises export controls over certain microorganisms, toxins, biological equipment, and related technology to further U.S. foreign policy interests in opposing the proliferation and use of biological weapons. The U.S. Government implements these export controls multilaterally in coordination with the Australia Group (AG), a forum of 33 nations cooperating to halt the proliferation of chemical and biological weapons. The U.S. Government also supports international efforts to effect a total ban on biological weapons in compliance with the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (BWC).15
Licensing Requirements and Licensing Policy
The licensing requirements for biological agents, related equipment, and technology, as specified on the Commerce Control List (CCL), are as follows:
A. The U.S. Government requires a license for the export to all destinations of certain human pathogens, zoonoses, toxins, animal pathogens, genetically modified microorganisms and plant pathogens, as well as the technology for their production and/or disposal.
The U.S. Government requires a license for the export to specified countries of certain dual-use equipment and materials that can be used in the production of biological agents, and related production technology. The countries for which this licensing requirement applies are those indicated in Column CB:3 of the Commerce Country Chart, Supplement No. 1 to Part 738 of the EAR, as well as the embargoed destinations identified in EAR Part 746.
On December 1, 2003, the Department of Commerce issued a revision to the rule issued on June 10, 2003 (68 FR 34526), amending the Export Administration Regulations (EAR) to implement the understandings reached at the June 2002 plenary meeting of the Australia Group (AG). The June 10, 2003, final rule contained errors in the List of Items Controlled for Export Control Classification Numbers (ECCNs) 2E001 and 2E002 on the Commerce Control List (CCL), as well as an error in the licensing policy provisions of the EAR that apply to items identified on the AG lists. The December 1 revision corrected those errors.
The U.S. Government also controls items subject to the EAR because of biological end-use or end-user concerns. These controls are part of the Enhanced Proliferation Control Initiative (EPCI), announced by the President on December 13, 1990.
B. The Department of Commerce will review applications for licenses on a
case-by-case basis to determine whether the export would make a material
contribution to the design, development, production, stockpiling, or use
of biological weapons. When the Department of Commerce determines that an
export will make such a contribution, the application will be denied.
The controls described above are intended to prevent a U.S. contribution to the proliferation and illegal use of biological weapons, and to support multilaterally coordinated control efforts. The controls also provide the regulatory authority to stop the export of any item from the United States when there is a significant risk that it will be used for biological weapons purposes. The controls implement certain measures directed in Executive Order 12735 of November 16, 1990, its successor, Executive Order 12938 of November 14, 1994, and the Enhanced Proliferation Control Initiative announced on December 13, 1990.
The U.S. Government implements these controls in coordination with the AG. The AG works to accomplish this objective through the harmonization of export controls, the exchange of information, and other diplomatic means. In addition, these EAR controls demonstrate the commitment of the United States to its obligation under the BWC not to develop, produce, stockpile, acquire or retain biological agents, weapons, equipment or the means of delivery for warfare purposes or to assist others in such activities. The controls also advance the goals of the 1925 Geneva Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or other Gases and of Bacteriological Methods of Warfare (Geneva Protocol), prohibiting the use in war of chemical or biological weapons.
1. Probability of Achieving the Intended Foreign Policy Purpose. The Secretary has determined that these controls are likely to achieve the intended foreign policy purpose, in light of other factors, including the U.S. Government’s negotiations with its partners in the AG and in the BWC. The Secretary has made this determination despite the existence of certain factors, including availability of these items from other sources, that challenge that achievement. These controls affirm U.S. opposition to the development, proliferation, and use of biological weapons and serve to distance the United States from such activities.
2. Compatibility with Foreign Policy Objectives. The Secretary has determined that these controls are compatible with U.S. foreign policy objectives and will not have any significant adverse foreign policy consequences with the extension of these controls. The U.S. Government has a strong interest in remaining at the forefront of international efforts to stem the proliferation of biological weapons. Also, these controls are compatible with the multilateral export controls for biological materials agreed to by the AG.
3. Reaction of Other Countries. The Secretary has determined that any adverse reaction to these controls is not likely to render the controls ineffective nor will any adverse reaction by other countries be counterproductive to U.S. foreign policy interests. The U.S. Government continues to discuss biological export controls with countries outside of the AG to advance the goals of nonproliferation.
4. Economic Impact on U.S. Industry. The Secretary has determined that any adverse effect of these controls on the economy of the United States, including on the competitive position of the United States in the international economy, does not exceed the benefit to United States foreign policy objectives. In FY 2003, the Department of Commerce approved 695 license applications, valued at $41 million, for the export or reexport of biological agents and equipment. The vast majority of the approvals were for toxins in Export Control Classification Number (ECCN) 1C351. This includes a $32 million approved export of toxins to be used as raw materials for the production of medical products. The Department of Commerce denied four license applications for biological agents/equipment valued at $339,870, and returned without action 34 license applications valued at $168,144.
5. Effective Enforcement of Control. The Secretary has determined the United States has the ability to effectively enforce these controls. Enforcing controls on biological weapons materials poses problems similar to the enforcement of chemical controls, but with additional difficulties. Biological materials are microscopic organisms that require technical expertise and specialized facilities to identify and to handle them. Because of their size, biological agents can often be concealed and transported with ease.
To meet the challenge of effective enforcement of these proliferation controls, the Department of Commerce has redirected resources toward preventive enforcement. Enforcement personnel conduct an extensive, ongoing outreach program to educate industry about export controls. The program also is designed to increase industry’s awareness of suspect orders for products or equipment that could be used for biological weapons proliferation. In cases where unlicensed shipments of biological materials have already taken place, the Department of Commerce has found that, as in other export control enforcement cases, commercial shipping documentation can form the basis for successful investigations and prosecutions.
Exporters of biological products include commercial firms as well as academic and government entities. The Department of Commerce maintains ongoing interaction with individual exporters, Technical Advisory Committees (TACs), and trade associations to discuss proposed export transactions and marketing plans to facilitate the thorough, yet prompt, review of export license applications. Through the TACs, the Department of Commerce keeps industry representatives abreast of licensing proposals for items on the control list and gives them the opportunity to provide technical input. During the reporting period, the Department of Commerce representatives participated in briefings on chemical/biological export control issues for trade associations such as the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization.
In an October 21, 2003, Federal Register notice, the Department of Commerce solicited comments from industry on the effectiveness of U.S. foreign policy-based export controls. Comments were solicited from all six of the Department’s TACs, which advise the Bureau of Industry and Security (BIS), as well as from the President’s Export Council Subcommittee on Export Administration. Comments also were solicited from the public via the BIS webpage. The comment period closed on November 21, 2003, and eight comments were received.
Sandia National Laboratories’ Cooperative Monitoring Center provided
a summary of new rules implemented by the U.S. Government since the attack
of September 11, 2001, relating to the domestic lab-to-lab transfer of certain
microbiological agents and toxins. Sandia notes that there are no comparable
controls for the international transfer of these agents and recommends that
these agents, currently controlled by Health and Human Services (HHS) and
the U.S. Department of Agriculture (USDA), should be added to the CCL. Sandia
provided a list of these HHS- and USDA-regulated pathogens. A detailed review
of all comments received can be found in Appendix I.
Recognizing that multilateral coordination of export controls and enforcement actions is the most effective means of restricting proliferation activities, the U.S. Government coordinates its controls on biological items with other countries in the AG. On June 10, 2003, the EAR provisions pertaining to biological controls were revised to add eight new toxins to the list of AG-controlled human and zoonotic pathogens and toxins described in Export Control Classification Number (ECCN) 1C351. The EAR was also revised to include medical products (ECCN 1C991) containing any of the eight toxins now subject to control. These revisions to the EAR, proposed by the United States, were made based on actions taken at the AG Plenary meeting held in June 2002. Additional actions taken at the AG Plenary that led to revisions in the EAR entries on chemicals and chemical equipment are referenced in Chapter 6 of this report.
The U.S. Government continues to address the problem of biological weapons proliferation through a variety of international fora and urges other AG members to pursue export control cooperation with non-members on a bilateral or regional basis.
The U.S. Government continues to address the problem of biological weapons proliferation on a number of fronts. Direct negotiations with countries intent on acquiring biological weapons are not likely to prevent the use of U.S.-origin materials for such activities; neither are such negotiations likely to affect the behavior of these countries.
Alternative means to curtail the acquisition and development of biological warfare capabilities, such as diplomatic negotiations, do not obviate the need for controls. The following examples demonstrate additional means that have been, and will continue to be, used in an attempt to curb the use and spread of biological weapons:
The negotiations and alternative means undertaken by the U.S. Government demonstrate that reasonable efforts have been made to achieve the purposes of the controls but these actions have not had the results that are as effective as the maintenance and renewal of the controls.
Most of the AG-controlled biological agents, and related equipment to produce them, are available from many sources. (Biological agents are, in fact, endemic.) Notwithstanding the difficulties related to the effective control of these items, the United States and its AG partners consider it necessary to maintain controls in order to stem shipments to potential proliferators. Foreign availability is a factor considered by the AG member countries in their coordination of controls.
15 The Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (BWC) was signed in 1972 and ratified by the United States in 1975.
16 As of December 2003, the countries in Country Group D:3 included Afghanistan, Armenia, Azerbaijan, Bahrain, Belarus, Bulgaria, Burma, China (PRC), Cuba, Egypt, Georgia, India, Iran, Iraq, Israel, Jordan, Kazakhstan, North Korea, Kuwait, Kyrgyzstan, Lebanon, Libya, Macau, Moldova, Mongolia, Oman, Pakistan, Qatar, Russia, Saudi Arabia, Syria, Taiwan, Tajikistan, Turkmenistan, Ukraine, the United Arab Emirates, Uzbekistan, Vietnam, and Yemen.