BIS Issues Final Rule on EAR Changes to Chemicals and Biological Agents

The Bureau of Industry and Security published a final rule amending the Export Administration Regulations based off edits from the multilateral Australia Group, which maintains export controls on a list of chemicals, biological agents and related equipment and technology. The rule becomes effective June 5. It changes various Export Control Classification Numbers to reflect Australia Group (AG) plenary changes to the list of Biological Agents for Export Control. The ECCNs edited in the rule are:

• ECCN 1C351, which covers human zoonotic pathogens and toxins. The rule adds botulinum neurotoxin producing strains of the following bacteria: Clostridium argentinense (formerly known as Clostridium botulinum Type G); Clostridium baratii; and Clostridium butyricum. The rule also clarifies certain controls, and adds SARS-associated coronavirus and tick-borne encephalitis virus (Siberian subtype).
• ECCN 1C354, plant pathogens; adding five new fungi and clarifying the controls on other plant pathogens listed under 1C354.
• ECCN 2B352, equipment capable of use in handling biological materials; adds new controls for certain spray-drying equipment.
• The rule removes ECCN 1C360, which covered select agents. The items that were controlled by ECCN 1C360 -- and continue to be identified on the lists of the Centers for Disease Control and Prevention and the Animal and Plant Health and Inspection Service -- are now controlled by ECCNs 1C351 and 1C354. To reflect the removal of 1C360, the rule also makes conforming changes to sections 740.20 and 742.2 of the EAR and to ECCNs 1C353, 1C991, 1E001 and 1E351.

The rule also eliminates redundant controls on two bacteria of the Mycoplasma mycoides cluster: Mycoplasma capricolum subspecies capripneumoniae and Mycoplasma mycoides subspecies mycoides small colony. The bacteria are now controlled under ECCN 1C352.b.1.

Finally, the rule edits the license requirements section of each ECCN to indicate that ECCNs 1C351, 1C352, 1C353, and 1C354 control all biological agents or toxins -- no mater the quality or attenuation -- identified in the List of Items Controlled for each ECCN. This includes quantities or attenuated strains of select biological agents or toxins that are excluded from the lists of select biological agents or toxins by APHIS or the CDC. This change does not affect the scope of the ECCNs.