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Export Control Regulations on Biological/Chemical Goods Updated

Wednesday, March 26, 2014
Sandler, Travis & Rosenberg Trade Report

The Bureau of Industry and Security has issued a final rule that, effective March 26, amends the Export Administration Regulations concerning biological and chemical goods. This rule reflects the understandings reached at the June 2013 plenary meeting of the Australia Group and the December 2012 AG intersessional decisions. The AG is a forum of 41 countries that maintain export controls on a list of chemicals, biological agents, and related equipment and technology that could be used in a chemical or biological weapons program.

- The “sample shipments” provisions in license requirement note 1 of ECCN 1C350 is revised to change the reporting requirement from quarterly to annual, consistent with the frequency of the reports required for imports and exports of Chemical Weapons Convention Schedule 2 and 3 chemicals.

- ECCN 1C352.a.8, which controls certain animal pathogens, is amended to clarify that it controls the rabies virus and all other members of the Lyssavirus genus.

- ECCN 1C351, which controls human and zoonotic pathogens and toxins, is revised to clarify that the export controls on Clostridium perfringens apply only to the following exotoxins: Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins.

- A license exception STA paragraph is added to ECCN 1C351 to clarify the scope of eligible items.

- ECCN 1C353 is revised to clarify that “genetic elements” include not only chromosomes, genomes, plasmids, transposons and vectors, whether genetically modified or unmodified, but also those chromosomes, genomes, plasmids, transposons and vectors that have been chemically

synthesized in whole or in part.

- ECCN 2B350, which controls chemical manufacturing facilities and equipment, is amended to clarify the controls that apply to certain agitators for use in reaction vessels or reactors and to impellers, blades or shafts designed for such agitators.

- ECCN 2B352, which controls equipment capable of use in handling biological materials, is amended to reflect a clarification of controls on fermenters and certain components thereof in the AG Control List of Dual-Use Biological Equipment and Related Technology and Software.

- The EAR are amended to reflect the (a) Aug. 12, 2013, addition of Mexico as a participating country in the AG, thus removing the license requirements indicated under CB column 2 in the Commerce Country Chart, and (b) additions of Somalia (June 28, 2013) and Syria (Oct. 14, 2013) as states party to the CWC, thus removing some restrictions on exports to those countries.

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