Industry and Security Bureau June 12, 2006 – Federal Register Recent Federal Regulation Documents

The Bureau of Industry and Security (BIS) is publishing this final rule to amend the Export Administration Regulations (EAR) to expand export and reexport controls on certain biological agents and toxins (referred to, herein, as ``select agents and toxins'') that have been determined by the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, 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). Prior to the publication of this rule, twenty-two of these agents were not listed on the Commerce Control List (CCL) and one of these agents was incompletely specified therein. By amending the EAR to add a new 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 AHPIS have imposed on the possession, use, and transfer of these select agents and toxins within the United States. 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. This rule also amends the EAR to clarify controls on certain medical products containing 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 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. In addition, this 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. Finally, 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.