BIS Final Rule Amends the EAR to Expand Export and Reexport Controls on Certain Biological Agents and Toxins
The Bureau of Industry and Security (BIS) has issued a final rule, effective June 12, 2006, which amends the Export Administration Regulations (EAR) by expanding export and reexport controls on certain biological agents and toxins (referred to as select agents and toxins) that have been determined by the Centers for Disease Control and Prevention (CDC), and the Animal and Plant Health Inspection Service (APHIS) to have the potential to pose a severe threat to human, animal, and plant life, as well as certain sectors of the U.S. economy (e.g. agriculture).
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Additional Agents Added to the CCL, but are Expected to Have a Minimal Impact on U.S. Industry
BIS states that this final rule amends the EAR to add a new Commerce Control List (CCL) entry that controls CDC and/or APHIS select agents and toxins (including associated genetic elements, recombinant nucleic acids, and recombinant organisms) not previously specified on the CCL. This rule complements the controls that CDC and APHIS have imposed on the possession, use, and transfer of these select agents and toxins within the U.S. The addition of these items to the CCL is expected to have a minimal impact on U.S. industry, since the volume of exports and reexports is extremely limited.
(According to BIS, prior to the publication of this rule, twenty-two of these agents were not listed on the CCL and one of these agents was incompletely specified therein.)
Controls on Certain Medical Products Containing AG-Controlled Toxins Clarified
According to BIS, this rule also amends the EAR to clarify controls on certain medical products containing Australian Group (AG)-controlled toxins, other than ricin or saxitoxin, by revising the definition of such products to clearly indicate that they include pharmaceutical formulations, prepackaged for distribution as clinical or medical products, that have been approved by the Food and Drug Administration (FDA) for use as an Investigational New Drug'' (IND).
Specifically, this rule clarifies that FDA-approved IND products containing AG-controlled toxins (except ricin or saxitoxin) are considered to be "medical products" as described in the CCL entry that controls vaccines, immunotoxins, medical products, and diagnostic and food testing kits.
BIS states that it is making this clarification because the previous revision to the definition of medical products inadvertently failed to specify that such products include IND items. Furthermore, this clarification is consistent with the language in the AG exemption for clinical and medical products containing botulinum toxins and conotoxins, since the AG exemption applies when such products are designed for "testing," as well as human administration, in the treatment of medical conditions.
License Requirements for Certain Exports and Reexports to St. Kitts and Nevis Modified
According to BIS, the final rule removes the license requirements for exports and reexports to St. Kitts and Nevis of items that require a license for export or reexport only to countries of concern for chemical and biological weapons proliferation (CB) reasons. This change is being made because St. Kitts and Nevis is not listed in Country Group D:3. As a result of this change, there is now a one-to-one correspondence between the countries included in Country Group D:3 and the countries for which a license requirement is indicated under CB Column 3 of the Commerce Country Chart.
Updated List of Countries That Currently are States Parties to the CWC
Additionally, this rule updates the list of countries that currently are States Parties to the Chemical Weapons Convention (CWC) by adding Antigua and Barbuda, Bhutan, Cambodia, the Democratic Republic of the Congo, Djibouti, Grenada, Haiti, Honduras, Liberia, and Vanuatu, which recently became States Parties. As a result of this change, the CW (Chemical Weapons) license requirements and policies in the EAR that apply to these countries now conform with those applicable to other CWC States Parties.
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 final rule 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 July 12, 2006, 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 July 27, 2006. Any such items not actually exported or reexported before midnight, on July 27, 2006, 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 July 27, 2006. Beginning at midnight on July 27, 2006, 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.
BIS Contact - Douglas Brown (202) 482-5808
BIS Final Rule (D/N 060228055-6055-01, FR Pub Date 06/12/06) available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-8995.pdf