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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 39 nations and the European Commission cooperating to halt the proliferation of chemical and biological weapons. The U.S. Government also supports international efforts to secure 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). 13
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, and 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 CB2 of the Commerce Country Chart, Supp. No. 1 to Part 738 of the Export Administration Regulations (EAR), as well as the embargoed destinations identified in EAR Part 746.
On June 12, 2006, the Department of Commerce published a rule in the Federal Register (71 FR 33614) to establish export and reexport controls on certain biological agents and toxins (referred to, herein, as “select agents and toxins”) that have been determined by the Centers for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services, and/or the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture, to have the potential to pose a severe threat to human, animal and plant life, as well as certain sectors of the U.S. economy (e.g., agriculture). Prior to the publication of the rule, 21 of these agents were not listed on the Commerce Control List (CCL) and one of these agents was incompletely specified therein. By amending the CCL to control CDC and/or APHIS select agents and toxins (including associated genetic elements, recombinant nucleic acids, and recombinant organisms) not previously specified on the CCL, this rule compliments the controls that CDC and APHIS have imposed on the transfer and possession of these select agents and toxins within the United States .
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 President George H. W. Bush on December 13, 1990 .
The U.S. Government requires a license for the export of any commodity, technology, or software when the exporter knows that it will be used in the design, development, production, stockpiling, or use of biological weapons in, or by, any country anywhere in the world, including AG member countries.
No U.S. person may knowingly support such an export, reexport, or transfer without a license. “Support” is defined as any action, including financing, transportation, or freight forwarding that facilitates the export, reexport, or transfer of these items.
In addition, no U.S. person may, without a license, perform any contract, service, or employment knowing that it will directly assist in the design, development, production, stockpiling, or use of biological weapons in, or by, any destination or country anywhere in the world.
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, it will deny the application.
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 (EPCI) 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 availability of relevant items from other countries, and that the foreign policy purpose cannot fully be achieved through 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, which challenge the full achievement of foreign policy goals. 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 that the extension of these controls will not have any significant adverse foreign policy consequences. 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 Fiscal Year 2006, the Department of Commerce approved 1,363 license applications, valued at $29 million, for the export or reexport of biological agents and equipment. The vast majority of the licenses approved were for toxins in ECCN 1C351. The Department of Commerce denied two license applications for biological agents/equipment valued at $1,232, and returned without action 81 license applications valued at $508,228. The primary reason cited for returning applications was for insufficient information about the transaction.
5. Effective Enforcement of Controls. The Secretary has determined the United States has the ability to enforce these controls effectively. Enforcing controls on biological weapons-related 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. 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 focused 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, analysis of commercial shipping documentation can lead to successful investigations and prosecutions.
On September 1, 2006, Thomas Campbell Butler, M.D., of Lubbock, Texas was ordered to pay a civil penalty of $37,400 and denied export privileges for ten years, as part of a settlement to resolve charges that Butler had violated the Export Administration Regulations (the "Regulations") in connection with the unlicensed export of 30 vials of the human pathogen yersinia pestis (Plague) to Tanzania. The Bureau of Industry and Security (BIS) charged that Butler violated the Regulations when he knowingly exported the Plague to Tanzania in September, 2002 without the license required by the Regulations. BIS also charged that Butler evaded the Regulations by providing false information on his shipping documents and by neglecting to file the proper paperwork with his export to conceal the fact that his export required a license.
On December 28, 2005, Becton, Dickinson, & Co., of Franklin Lakes, New Jersey, was ordered to pay a $123,000 fine, and was subjected to an audit requirement. Becton, Dickinson, & Co., and their Singapore subsidiary committed a total of 36 violations of the EAR by exporting various life sciences research products to listed entities from the Indian Department of Atomic Energy and Indian Ministry of Defense.
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 keeps industry representatives abreast of licensing proposals for items on the control list and gives them the opportunity to provide technical input.
In an October 23, 2006 , Federal Register notice (71 FR 62065), the Department of Commerce solicited comments from industry on the effectiveness of U.S. foreign policy-based export controls. In addition, comments were solicited from the public via the BIS website. Comments from the Department’s six Technical Advisory Committees and the President’s Export Council Subcommittee on Export Administration are solicited on an ongoing basis and are not specific to this report. The comment period closed on November 22, 2006 , and three comments were received. A detailed review of all public 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.
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:
Regulations issued by the Public Health Service (42 CFR Part 72) pursuant to “The Antiterrorism and Effective Death Penalty Act of 1996” (Sec. 511 of Pub. L.104-132, April 24, 1996, 110 Stat. 1214) place additional shipping and handling requirements on laboratory facilities that transfer or receive select infectious agents capable of causing substantial harm to human health.
The Chemical and Biological Weapons Control and Warfare Elimination Act of 1991 (Pub. L.102-182, Title III, December 4, 1991, 105 Stat. 1245) provides for the imposition of sanctions on foreign persons or countries for certain kinds of chemical and biological weapons-related activity. To date, no sanctions have been imposed for biological weapons-related activities.
The negotiations and alternative means undertaken by the U.S. Government demonstrate that it has made reasonable efforts to achieve the purposes of the controls; however, these actions have not had 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 weapons developers. Foreign availability is a factor considered by the AG member countries in their coordination of controls.
12 Chapter 6 of this report addresses U.S. chemical controls.
13 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.