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WASHINGTON -- The Commerce Department's Bureau of Export Administration (BXA) today imposed an $824,000 civil penalty on Allergan, Inc. (Allergan) of Irvine, California for allegedly violating export controls on biological agents by shipping botulinum pharmaceutical toxin product without the required export licenses, F. Amanda DeBusk, assistant secretary for Export Enforcement, announced.
"Today's action sends a message that this Administration is deeply concerned about the worldwide proliferation of biological weapons and will vigorously enforce multilateral export controls on biological agents like a botulinum toxin," DeBusk said.
The Department alleged in today's settlement that, on 412 separate occasions between July 1992 and October 1993, Allergan exported U.S.-origin botulinum toxin product from the United States to various countries without the required export licenses. An investigation began in 1992 when Congressman Tom Lantos (CA-12) requested that the Commerce Department make inquiries about various shipments to Iran. BXA's Office of Export Enforcement Los Angeles field office conducted the investigation.
The export controls on biological agents are part of U. S. obligations to the 30-nation Australia Group, whose members are committed to curbing the proliferation of chemical and biological weapons. All member countries require licenses to export biological agents with both legitimate civilian uses and possible uses in biological weapons. Biotoxins are considered among the most dangerous items controlled by Australia Group members because some nonmember countries have produced or acquired them for biological weapons purposes.
DeBusk believes the settlement with Allergan will be instructive for other companies. "This was an unusual case because the botulinum toxin product exported, BOTOX, has medical applications. We hope that other companies developing or selling biological products will take note of this case and be very careful to comply with the export control laws," she said.
The Bureau of Export Administration controls and licenses exports and reexports of dual-use commodities, technology and software for reasons of national security, foreign policy, nonproliferation and short supply.