BIS Final Rule Implements Decision of AG Intersessional on Pathogens, Toxins
The Bureau of Industry and Security has issued a final rule, effective September 12, 2011, which amends the Export Administration Regulations (15 CFR Parts 740, 742, and 774) to implement a decision adopted under the Australia Group (AG) intersessional silent approval procedures in November 2010.
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ECCN 1C351. This rule amends Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL) (Supplement No. 1 to 15 CFR Part 774) by revising the list of viruses contained in 1C351.a to reflect the changes to the AG List of Biological Agents.
Consistent with the changes to ECCN 1C351 described above, this rule alphabetizes and renumbers the list of viruses in ECCN 1C351.a to conform with the format in the AG List of Biological Agents.
In addition, for the convenience of exporters attempting to determine the control status of certain pathogens and toxins, this rule alphabetizes and renumbers the lists of bacteria and toxins contained in ECCN 1C351.c and .d, respectively.
Consistent with this reordering, this rule revises references to certain agents identified in the ‘‘CW Controls’’ paragraph of this ECCN, in the ‘‘License Requirements Notes’’ under the License Requirements section of this ECCN, and/or in the ‘‘Related Controls’’ paragraph under the List of Items Controlled section of this ECCN.
ECCN 1C360. Although this rule removes ‘‘Flexal virus’’ from ECCN 1C351, consistent with the AG intersessional changes to the AG List of Biological Agents as described above, this virus continues to be listed on the CCL. Specifically, this rule adds ‘‘Flexal virus’’ to ECCN 1C360 (Select agents not controlled under ECCN 1C351, 1C352, or 1C354), because the virus is included in the list of select agents and toxins maintained by the Centers for Disease Control and Prevention (CDC) in 42 CFR 73.3(b).
ECCNs 1C351 and 1C352. This rule also amends ECCNs 1C351 and 1C352 by revising the ‘‘Related Controls’’ paragraph under the List of Items Controlled for each ECCN to correct the references to the regulations maintained by CDC and the Animal and Plant Health Inspection Service (APHIS), that apply to certain select agents and toxins.
License Exception STA, CWC, ECCN 1C991. Finally, this rule amends 15 CFR 740.20 (License Exception STA), Section 742.18 (license requirements and policies related to the Chemical Weapons Convention), and the List of Items Controlled section in ECCN 1C991 (Vaccines, immunotoxins, medical products, and diagnostic and food testing kits) to update the references to certain items controlled under ECCN 1C351 that were alphabetized and renumbered, as described above.
15 CFR 740.20 also is amended to include in paragraph (b)(2)(vi) certain toxins controlled by ECCN 1C351.d that were inadvertently omitted by the License Exception STA rule that BIS published on June 16, 2011. The toxins identified in 15 CFR 740.20(b)(2)(vi) may be exported under License Exception STA to countries listed in 15 CFR 740.20(c)(1), provided that such exports conform with the limits specified in 15 CFR 740.20(b)(2)(vi)(A) and (b)(2)(vi)(B).
Changes Do Not Increase Scope of Controls in ECCNs 1C351 and 1C991
None of the changes made by this rule increase the scope of the controls in ECCNs 1C351 and 1C991 (i.e., the items that are controlled under these ECCNs remain the same, although certain items are now specifically identified under separate listings in ECCN 1C351.a. “Flexal virus,” which was previously controlled under ECCN 1C351.a, is now controlled as a “select agent” under ECCN 1C360.a; however, the license requirements for this virus remain unchanged.
Saving Clause
Shipments of items removed from eligibility for export or reexport under a license exception or without a license (i.e., under the designator “NLR”) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting carrier, or en route aboard a carrier to a port of export, on October 12, 2011, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previously applicable license exception or without a license (NLR) so long as they are exported or reexported before October 27, 2011. Any such items not actually exported or reexported before midnight, on October 27, 2011, require a license in accordance with this regulation.
“Deemed” exports of “technology” and “source code” removed from eligibility for export under a license exception or without a license (under the designator “NLR”) as a result of this regulatory action may continue to be made under the previously available license exception or without a license (NLR) before October 27, 2011. Beginning at midnight on October 27, 2011, such “technology” and “source code” may no longer be released, without a license, to a foreign national subject to the “deemed” export controls in the EAR when a license would be required to the home country of the foreign national in accordance with this regulation.
1The AG 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. The AG periodically reviews items on its control list to enhance the effectiveness of participating governments’ national controls and to achieve greater harmonization among these
controls.
BIS contact - Elizabeth Sangine (202) 482-3343.
BIS final rule (D/N 110222155-1110-01, FR Pub 09/12/11) available here