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BIS Amends 4 ECCNs to Implement 2011 Australia Group Plenary Changes

The Bureau of Industry and Security issued a final rule to amend the Export Administration Regulations (EAR), effective July 2, to implement the understandings reached at the June 2011 plenary meeting of the Australia Group. The final rule amends the following 4 ECCNs: 1C351 (Human and zoonotic pathogens and “toxins”); ECCN 1C353 (Genetic elements and genetically modified organisms); ECCN 2B350 (Chemical manufacturing facilities and equipment); and ECCN 2B352 (Equipment capable of use in handling biological materials).

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(The Australia Group is a multilateral forum consisting of 40 participating 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.)

Specifically, the final rule implements the following changes in order to implement the 2011 Australia Group changes:

ECCN 1C351: Removes and reserves paragraph .b (Rickettsiae), since, according to BIS, these organisms are more appropriately identified as bacteria. Coxiella burnetii and Rickettsia prowasecki (a.k.a. Rickettsia prowazekii), which were previously controlled under ECCN 1C351.b.2 and .b.3, respectively, are now controlled as bacteria under ECCN 1C351.c.10 and .c.13, respectively. Bartonella Quintana (Rochalimea Quintana, Rickettsia Quintana) and Rickettsia rickettsii, which were previously controlled under ECCN 1C351.b.1 and .b.4, respectively, are removed from ECCN 1C351, since they are no longer included on the Australia Group “List of Biological Agents.”

ECCN 1C353: Revises Technical Note 1 and adds a new Technical Note 4 to clarify that this ECCN controls certain de novo chemically synthesized genetic material and artificially-produced organisms.

ECCN 2B350: Adds a new Technical Note 3, at the end of the entry, to clarify that materials used for gaskets, packing, seals, screws or washers, or other materials performing a sealing function, do not determine the control status of the items listed in ECCN 2B350, provided that such components are designed to be interchangeable.

ECCN 2B352: Revises the introductory text of paragraph .d.1 to remove the phrase “without propagation of aerosols.”

ECCNs 2B350 and 2B352: Clarifies certain control parameters for pumps (i.e., multiple-seal and seal-less pumps and vacuum pumps) and steam sterilizable freezedrying (lyophilization) equipment, respectively.