# Implementation of Unilateral Chemical/Biological (CB) Controls on Certain Biological Agents and Toxins; Clarification of Controls on Medical Products Containing Certain Toxins on the Australia Group (AG) Common Control Lists; Additions to the List of States Parties to the Chemical Weapons Convention (CWC)
> **Bureau of Industry and Security** · Final rule. · Published 2006-06-12 · Effective 2006-06-12 · 71 FR 33614
## Document
- **Document number:** E6-8995
- **Category:** bis-export-control
- **Sub-agency:** Bureau of Industry and Security
- **Federal Register citation:** 71 FR 33614
- **CFR reference:** 15 CFR 738
- **Publication date:** 2006-06-12
- **Effective date:** 2006-06-12
- **Commerce docket:** Docket No. 060228055-6055-01
## Abstract

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

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2006/06/12/E6-8995/implementation-of-unilateral-chemicalbiological-cb-controls-on-certain-biological-agents-and-toxins)
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